Vol. 143, No. 20 — May 16, 2009

Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issue and objectives

Chemical substances can have detrimental effects on the environment and/or human health when released in a certain quantity or concentration in the environment. A scientific assessment of the impact of human and environmental exposure to bisphenol A has determined that it is toxic to human health and 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 pursuant to subsection 90(1) of CEPA 1999, is to add Phenol, 4,4' -(1-methylethylidene)bis- (bisphenol A); Chemical Abstracts Service Registry Number (CAS RN) 80-05-7 to the List of Toxic Substances in Schedule 1 of CEPA 1999. This addition would enable the development of measures (which could include regulatory and non-regulatory instruments) under CEPA 1999 to manage human health and environmental risks posed by this substance.

Description and rationale

Background

As is the case in many other countries, Canada’s laws require that companies submit information on new chemical substances for scientific assessment before they can be manufactured or imported in the country. However, many substances have been in use well before these laws were in place. “Categorization” was required by CEPA 1999 and was a first step to finding out which of these “existing” chemical substances may present the greatest potential for exposure or that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms and that therefore require further attention in the form of assessment, research and/or measures to control their use or release. In September 2006, the Minister of the Environment and the Minister of Health (the Ministers) completed the categorization of the approximately 23 000 existing chemical substances listed on Canada’s Domestic Substances List (DSL). Categorization identified approximately 4 300 chemical substances needing further attention by the Government, approximately 200 of which were identified as high priorities for action.

As a result of categorization, on December 8, 2006, the Government of Canada launched the Chemicals Management Plan (the Plan) with the objective of improving the degree of protection from hazardous chemicals. The Plan includes a number of new proactive measures to manage chemical substances.

A key element of the Plan is the collection of information on the properties and uses of the approximately 200 priority substances mentioned above. 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; they are referred to as “ecological priority substances”; and/or
• that were found either to meet the categorization criteria for greatest potential for exposure 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; they are referred to as “human health priority substances.”

This information is being used to make decisions regarding the best approaches 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 12 to 20 substances, and every three months a batch is released, and stakeholders are required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Stakeholders are required to submit this information to better inform decision-making with regards to determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999, that is to say if the substance is entering or may enter the environment in a quantity or concentration or under conditions that

• has 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 developed in order to assess whether substances meet the criteria of section 64. These screening assessments are required under section 74 of the Act. They are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government pertaining to the application of precaution and/or weight of evidence in screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www. chemicalsubstances.gc.ca along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

Pursuant to section 91 of the Act, the Minister of the Environment is required to publish in the Canada Gazette a proposed regulation or other instrument establishing preventive or control actions within two years of publishing a statement that Ministers recommend adding the substance to Schedule 1. Section 92 then requires that the regulation or other instrument be finalized within a further 18 months.

Listing these substances on Schedule 1 of the Act allows the Ministers to develop risk management tools under CEPA 1999 to meet these obligations. The Act provides the Government of Canada with strong risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health that 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. “Risk management approach” documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 2 substances and are available online.

On April 19, 2008, the draft screening assessment of bisphenol A, a substance that is included in the second batch of the Challenge, was published on the Chemical Substances Web site, and the statement recommending addition to Schedule 1 was published in the Canada Gazette. It was announced ahead of the other Batch 2 substances because public and media interest in it is high and has focussed on human health concerns. It was concluded to meet the criteria of section 64 as both a human health and ecological priority substance.

The assessment summary and conclusion and an overview of the public comments received during the public comment period for this substance is presented below.

Substance description and use

Bisphenol A is an industrial chemical used to make a hard, clear plastic such as polycarbonate, which is used in many consumer products, including reusable water bottles and baby bottles. Bisphenol A is also found in epoxy resins, which act as a protective lining on the inside of metal-based food and beverage cans.

Polycarbonates have wide application in consumer products (e.g. repeat-use polycarbonate containers), in medical devices, glazing applications, film and the electronics industry, while epoxy resins are used in protective coatings, structural composites, electrical laminates and as adhesives and sealants.

Bisphenol A is a high-volume chemical, with global production estimated at 4 billion kg/year in 2006. Based on a survey conducted under section 71 of CEPA 1999, bisphenol A was used in Canada in the range of 100 000 to 1 000 000 kg and approximately half a million kilograms were imported into Canada either alone, in a product, in a mixture or in a manufactured item. Based on the survey, no bisphenol A was manufactured in Canada at quantities equal to or greater than the reporting threshold of 100 kg, in 2006.

Assessment summary and conclusion

The available data indicate that bisphenol A does not persist significantly under aerobic conditions. However, the substance has been found not to degrade or to degrade only slowly under conditions of low or no oxygen. This stability, combined with significant production and use, could lead to increased levels of bisphenol A in the environment.

Most data point to low bioaccumulation potential and a capacity for metabolism in various species. Studies confirm that bisphenol A can be assimilated by organisms and can accumulate in tissues to some degree.

Bisphenol A is acutely toxic to aquatic organisms and is considered highly hazardous to the aquatic environment. It can also impact the normal development of individual organisms and influence the development of their offspring. There is evidence that exposure to bisphenol A, particularly at sensitive life cycle stages, may lead to permanent alterations in hormonal, developmental or reproductive capacity.

On the basis of expected continued or increasing exposure of biota, and information indicating the potential for long-term adverse effects to organisms within the range of concentrations currently measured in the environment, it is considered appropriate to apply a precautionary approach when characterizing risk. As such, it was concluded that bisphenol A 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.

Human exposure to bisphenol A in Canada can result from dietary intake, environmental media, use of consumer products and other sources. Dietary intake is the primary source of exposure. Concern for neurobehavioural effects in newborns and infants was identified. Given that available data indicate potential sensitivity to the pregnant woman/fetus and infant, and that animal studies suggest a trend towards heightened susceptibility during stages of development in rodents, it was considered appropriate to apply a precautionary approach when characterizing risk. As such, it was concluded that bisphenol A be considered as a substance that 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.

The final screening assessment report, the proposed risk management approach document and the complete responses to comments received on the draft screening assessment report were published on October 18, 2008, and may be obtained from the Chemical Substances Web site at www.chemicalsubstances.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-4936 (fax), Existing.Substances.Existantes@ec.gc.ca.

Alternatives

The following measures can be applied 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, the implementation of virtual elimination.

It has been concluded in the final screening assessment report that bisphenol A 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 defined under section 64 of CEPA 1999. It has also been concluded that bisphenol A 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. Bisphenol A poses a risk to human health and the environment and meets one or more of the criteria under section 64 of CEPA 1999. Adding this substance to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.

Benefits and costs

Listing bisphenol A on Schedule 1 enables the Ministers to develop risk management proposals for it under CEPA 1999, which may be both regulatory and 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 Government 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.

Consultation

In accordance with the Act, on April 19, 2008, the Ministers published a summary of the scientific assessment for bisphenol A 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 bisphenol A. Prior to this publication, Environment Canada and Health Canada informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessment report, the risk management scope document, and the public comment period mentioned above. No comments were received from CEPA NAC. Additionally, the Challenge Advisory Panel provided advice that the weight of evidence and the application of precaution support the conclusion reached by both departments related to this substance. Advice from the Panel was taken into consideration during the development of the final screening assessment report.

During the 60-day public comment period, a total of 21 submissions, from 4 Canadian citizens, 3 industry stakeholders, 5 industry associations, 6 non-governmental organizations and 3 public health organizations were received on the scientific assessment, the notice (proposing that this substance meets the criteria of section 64 of the Act) and risk management scope document. One non-governmental organization submitted comments on behalf of 16 organizations and 3 individuals. Two petitions were also received. One petition requested a complete ban on bisphenol A (951 signatures) and the other promoted breastfeeding as a way of limiting the exposure of infants to bisphenol A (28 signatures). All comments were considered in developing the final screening assessment.

Comments received on the proposed scope of risk management regarding bisphenol A were considered during the development of the proposed risk management approach, which is also subject to a 60-day public comment period.

Below is a summary of comments received and responses relevant to the overall process and approach to the assessment, as well as those specific to bisphenol A. In cases where comments were made concerning whether or not bisphenol A meets the criteria of section 64 of the Act due to lack of information or uncertainty, the Government errs on the side of precaution to protect the health of Canadians and their environment. Complete responses to the comments received are available on the Chemical Substances Web site at www.chemicalsubstances.gc.ca.

Summary of general comments

An industry association commented that screening assessments are an oversimplification and do not make use of all the available information on the substance.

It is standard procedure for screening assessments under the Challenge program to focus on information which is critical to determining whether the substance meets the criteria for finding that a chemical is toxic under section 64 of CEPA 1999. While not all the data used are presented, the broader database of Canadian and international data and scientific assessments was considered in the preparation of the screening assessment. The most salient data supporting the lines of evidence are presented.

Summary of comments received on issues related to the environment

Industry stakeholders and associations

• A chemical industry association commented that the validity of the studies used in the assessment of aquatic and terrestrial toxicity has not been determined, as the studies were not subjected to a critical review for study quality following internationally accepted practices.

While it is recognized that some toxicity values reported in the screening assessment were derived from studies which examined non-traditional endpoints, all studies cited in the assessment were critically reviewed and evaluated for data quality. Only studies that were deemed to be of satisfactory reliability and acceptable quality were used in the assessment and both traditional and non-traditional endpoints from acceptable studies were used in the weight of evidence.

• A chemical industry association and a chemical manufacturer noted that Environment Canada has overstated the releases of bisphenol A to the environment, and that the assessment does not correctly represent industrial processes and makes non-validated assumptions.

The screening assessment declared concentrations measured in Canadian industrial wastewaters and in waste products from sewage treatment plants which may receive industrial inputs. Bisphenol A is present in industrial wastewaters originating from chemical and chemical products facilities and a variety of miscellaneous industries, confirming that there are many potential sources of releases of bisphenol A into the Canadian environment. In addition, the substance has been detected in sewage treatment plant sludge and in sewage treatment plants’ final effluents being discharged into receiving waters.

• One chemical industry association expressed the view that the weight-of-evidence evaluation concerning the persistence of bisphenol A is incomplete, and the interpretations are not supported by the weight of the scientific evidence.

While studies conducted using well-established and reliable testing methods have determined that bisphenol A does not always meet biodegradation criteria, the weight of scientific evidence suggests that bisphenol A can be expected to biodegrade under aerobic conditions in water and soils. Significant biodegradation may still occur in some environmental media.

A review of the data on the potential for biodegradation under anaerobic conditions has determined that the studies cited in the screening assessment are of acceptable quality and provide information that is both appropriate and relevant to the consideration of potential biodegradation under environmental conditions of low oxygen. Applying a weight-of-evidence approach and precaution, the screening assessment determined that the evidence is sufficient to conclude that bisphenol A has the potential to remain stable or to degrade slowly under conditions of low or no oxygen.

• A chemical industry association commented that bisphenol A does not meet the definition of a bioaccumulative chemical. Statements which specify that bisphenol A is bioavailable and can accumulate in tissues are overstated and are not supported by the weight of evidence.

Various studies identified in the screening assessment support evidence that bisphenol A can be assimilated by organisms and can accumulate in tissues of biota to some degree.

Non-governmental organizations

• It was noted that more research is needed on the use of plastic (polycarbonate) water pipes and how they might increase human and environmental exposure through bisphenol A dissolving in water. The opinion was also expressed that more research is needed to accurately characterize human and environmental exposure to substances in the Challenge.

The available Canadian data respecting bisphenol A concentrations in effluent and the environment are considered current. They are also considered sufficient to characterize exposures representing Canadian conditions, albeit high-end exposure conditions which are considered protective of the environment. International data on environmental concentrations were also considered for comparative purposes in the screening assessment. These data, used in conjunction with other lines of evidence reported in the screening assessment, are considered sufficient to support a conclusion of toxic under section 64 of CEPA 1999. Nevertheless, the screening assessment also acknowledges the uncertainties surrounding the available data on environmental concentrations.

Summary of comments received on issues related to human health

Industry associations

• Chemical industry associations expressed concern that the draft screening assessment relies on low-dose studies which do not support a finding of potential effects on the developing brain that constitute or may constitute a danger in Canada to human life or health.

The draft screening assessment considered data available in the scientific literature. Scientists focused on effects which were considered most relevant for human health. Studies identified for the assessment of effects on the developing nervous system were considered to be well conducted and of high quality by an expert panel of U.S. scientists and adequate for inclusion in hazard identification and risk characterization. Collectively, considering the broad spectrum of endpoints assessed, loss of male- and female-specific behaviour emerges as a consistent bisphenol A-related effect. Scientists within and external to the Government of Canada with the required expertise were consulted for peer review and had significant input on the validity of the scientific evidence included in the draft screening assessment.

• A chemical industry association and a manufacturer commented that the draft screening assessment mischaracterizes the weight of scientific evidence.

The weight-of-evidence approach accounts for and weighs multiple sources of information to identify critical values used in the assessment and to evaluate multiple lines of evidence in order to determine whether a substance may pose a risk. An in-depth assessment was conducted for bisphenol A entailing a detailed review of all relevant health-related data (including data available in the scientific literature, evaluations by other jurisdictions, expert panel conclusions and information submitted to the Government during the information-gathering phase of the assessment) and full weight-of-evidence analysis for hazard characterization associated with effects on the developing nervous system. This included evaluating the quality and quantity of available scientific evidence, determining the adequacy and/or limitations of studies, identifying critical toxicological endpoints, and determining the nature of the dose-response curve.

• The chemical industry associations and a manufacturer were of the view that the application of the precautionary principle is without appropriate scientific basis.

CEPA 1999 states that lack of full scientific certainty shall not restrict the Canadian government from taking preventative measures when reasonable evidence indicates that a situation could cause some significant adverse health effect.

The evidence from the rodent developmental neurotoxicity dataset is suggestive of potential adverse effects of bisphenol A at doses marginally higher than estimated human exposures, particularly for the most highly exposed subpopulation consisting of newborns and infants. A number of uncertainties exist in the data for bisphenol A; thus, the margins of exposure which may be calculated based on the neurotoxicity dataset may not be adequate to account for uncertainty in the low-dose health effects database. The Government of Canada considered it appropriate to apply precaution in order to minimize exposures to bisphenol A and to achieve the highest level of protection to newborns and infants.

• A chemical industry association commented that there is not enough scientific evidence pertaining to metabolic capacity to suggest that a fetus or neonate may be more sensitive to bisphenol A.

Studies have shown that the activity of the major enzymes involved in the metabolism of chemicals, including bisphenol A, is low in pregnant and developing animals. In the developing human fetus and neonate, the activity of these enzymes does not mature to the adult level until several months after birth. In addition, it is not clear at this time how bisphenol A is handled in developing animals. In the absence of fully understood actions of bisphenol A in developing animals and reduced activity of metabolic enzymes in the feto-maternal unit and their age-dependent maturation, the pregnant animal and neonate may be considered more sensitive to bisphenol A.

• A chemical industry association commented that exposure estimates assuming regular use of boiling water in baby bottles are very conservative.

Exposure estimates were provided for two formula preparation scenarios: (i) as per directions typically specified, and (ii) a plausible high-temperature use. Furthermore, average concentrations of bisphenol A, not maximum concentrations, from studies representative of the above scenarios, were used.

Non-governmental organizations

• Various comments supported the draft screening assessment conclusions that newborns and infants represent vulnerable populations. It was suggested that women of child-bearing age, pregnant women and fetuses should be added to the list of “susceptible populations” as the exposure to these subpopulations could well be underestimated.

 The Government of Canada has identified newborns and infants under 18 months of age as potentially vulnerable populations based on exposure estimates that identified this subpopulation as the most highly exposed group. The Government of Canada is conducting several research studies on chemicals and human health, which involve biomonitoring of bisphenol A in the general population, including pregnant women, newborns and infants. These studies will provide additional information for more refined estimates of exposure for potentially vulnerable subpopulations. Currently, there are no data to suggest that women of child-bearing age would have any increased exposure to bisphenol A.

Implementation, enforcement and service standards

The proposed Order would add bisphenol A to Schedule 1 of CEPA 1999. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. The Government will undertake an appropriate assessment of implementation, compliance and enforcement during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for bisphenol A.

Contacts

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Québec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

Arthur Sheffield
Acting Director
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: Arthur_Sheffield@hc-sc.gc.ca

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 to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 1-800-410-4314 or 819-953-4936; email: Existing.Substances. Existantes@ec.gc.ca).

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, May 7, 2009

MARY PICHETTE
Assistant Clerk of the Privy Council

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:

Phenol, 4,4' -(1-methylethylidene)bis-, which has the molecular formula C₁₅H₁₆O₂

COMING INTO FORCE

2. This Order comes into force on the day on which it is registered.

[20-1-o]

Footnote a
 S.C. 2004, c. 15, s. 31

Footnote b
 S.C. 1999, c. 33

Footnote 1
 S.C. 1999, c. 33

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