The government of Canada this week took strong action towards increased controls on Bisphenol A. In a release issued Wednesday, October 14, Jim Prentice, Minister of the Environment, and Leona Aglukkaq, Minister of Health stated that adding Bisphenol A to Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), enables increased development of regulatory risk management measures.

"The Government of Canada has a strong record of taking action on Bisphenol A to protect the environment and health of Canadians," said Minister Prentice. "We are continuing our leadership on this issue and Canadians can rest assured that we are working hard to monitor and manage Bisphenol A."

"The Government of Canada is a world leader in chemicals management," said Minister Aglukkaq. " Our science indicated that Bisphenol A may be harmful to both human health and the environment and we were the first country to take bold action in the interest of Canadians. Today's action strengthens our efforts to protect Canadians."

The Final Order adding Bisphenol A to Schedule 1, published in the Canada Gazette, is included below:




CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999

P.C. 2010-1109 September 23, 2010

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 May 16, 2009, a copy of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the form set out in the annexed Order, 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, Her 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:

96. 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.

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 have detrimental effects on the environment and/or human health when released in a certain quantity or concentration or under conditions in the environment. A scientific assessment of the impact of human and environmental exposure to bisphenol A has determined that this substance constitutes or may constitute a danger to human health and the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999, also referred to as “the Act”).

The objective of the Order Adding a Toxic Substance 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, is to add Phenol, 4,4′ -(1-methyl-ethylidene)bis- [Chemical Abstracts Service Registry Number (CAS RN) 80-05-7], hereafter referred to as bisphenol A, to the List of Toxic Substances in Schedule 1 of CEPA 1999. This addition enables the Minister to develop a proposed regulation or instrument to manage human health and environmental risk posed by this substance under CEPA 1999. The Ministers may also choose to develop non-regulatory instruments to manage these risks.

Description and rationale

Background

Approximately 23 000 substances (often referred to as “existing” substances) were in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), but many of them have never been assessed as to whether they meet any of the criteria set out in section 64 of CEPA 1999. Section 73 of the Act required that substances on the DSL be categorized to determine which of them pose the greatest potential for exposure to the general population. Categorization also determines which of these substances are persistent or bioaccumulative in accordance with the regulations and inherently toxic to human beings or to non-human organisms. Pursuant to section 74 of the Act, substances that were flagged during the categorization process must undergo an assessment to determine whether they meet any of the criteria set out in section 64.

The Minister of the Environment and the Minister of Health (the Ministers) completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention, and 200 of these were identified as high priorities for action.

As a result of categorization, the Chemicals Management Plan (the Plan) was launched on December 8, 2006, with the objective of enhancing protection against hazardous chemicals.

A key element of the Plan is the collection of information on the properties and uses of the approximately 200 substances identified as high priorities for action. This includes substances

    * that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; these substances are considered to be high priorities for assessment of ecological risk; and/or
    * that were found either to meet the categorization criteria for greatest potential for exposure of Canadians or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; these substances are considered to be high priorities for assessment of risk to human health.

This information is being used to make decisions regarding the best approaches to be taken in order to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”

To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 “batches” of approximately 15 substances each. A batch is released every three months, 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. Affected parties are required to submit this information to better inform decision making, including determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999 — that is to say, whether the substance is entering or may enter the environment in a quantity or concentration or under conditions that

    * have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
    * constitute or may constitute a danger to the environment on which life depends; or
    * constitute or may constitute a danger in Canada to human life or health.

Based on the information received and other available information, screening assessments are conducted in order to assess whether substances meet one or more of the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, made up of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to the Government on the application of precaution and weight of evidence to screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca along with notices that are published in the Canada Gazette, Part I, that signal the Ministers’ intent with regard to further risk management.

The final screening assessment of bisphenol A, a substance that is included in the second batch of the Challenge comprising 17 substances, was published on the Chemical Substances Web site (www.chemicalsubstanceschimiques.gc.ca), and the statement recommending the addition to Schedule 1 was published in the Canada Gazette, on May 16, 2009. It was announced ahead of the other Batch 2 substances because of the intense public and media interest regarding concerns for human health of exposure to the substance. The final screening assessment concluded that bisphenol A met the criteria as both a human health and ecological priority substance under section 64 of CEPA 1999.

The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed regulation or instrument establishing preventive or control actions within two years of publishing a statement under paragraph 77(6)(b) of CEPA 1999 indicating that the measure the Ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999. Section 92 then requires that the regulation or instrument be finalized and published in the Canada Gazette within a further 18 months.

The addition of this substance to Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet these obligations. The Act enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health. 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 bisphenol A and is available on the Chemical Substances Web site listed above.

A summary of the assessments and conclusions and an overview of the public comments received during the public comment period on the draft assessment report and on the risk management scope document for the substance are available from the Chemical Substances Web site, at www.chemicalsubstanceschimiques. gc.ca.

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 used in the manufacture of 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 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. Information received from industry subsequent to the survey indicates a significant decrease has occurred in the quantity of bisphenol A believed to be in commerce in Canada since 2006.

Assessment summary and conclusion

The available data indicate that bisphenol A does not persist 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 points to low bioaccumulation potential and a capacity for metabolism in various species. Studies confirm that bisphenol A can be absorbed 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 certain animals in the environment 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 for aquatic organisms.

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 ecological risk. Therefore, 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.

The European Chemicals Bureau (2003) has classified bisphenol A as a Category 3 reproductive toxicant, that is, a substance which causes concern for human fertility based on sufficient evidence of reproductive toxicity in experimental animals.

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 neurobehavioral effects in newborns and infants was suggested from the neurodevelopmental and behavioral dataset in rodents. 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 to human health. Therefore, it was concluded that bisphenol A should 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 for bisphenol A were published on October 18, 2008, and may be obtained from the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/index-eng.php or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), [email protected].

Alternatives

The following measures can be applied after a screening 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 a substance meets the criteria in section 64 or not);
    * taking no further action in respect of the substance; or
    * recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable, recommending the implementation of virtual elimination.

It has been concluded in the 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.

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

Adding bisphenol A to Schedule 1 enables the Ministers to develop a proposed regulation or instrument to manage human health and environmental risks posed by this substance. The Ministers may also choose to develop non-regulatory instruments to manage these risks. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

On April 19, 2008, the Ministers published, for a 60-day public comment period in the Canada Gazette, Part I, a summary of the scientific assessment for bisphenol A. A risk management scope document was also released on the same date outlining the preliminary options being examined for managing the risks associated with 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 weight of evidence and precaution were appropriately applied in the assessment and they supported 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 was subject to a 60-day public comment period.

Below is a summary of comments specific to the assessment conclusion and the departments’ responses to them. In cases 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 set of Government responses to comments received are available via the Government of Canada’s Chemical Substances Web site or by request via the address, fax number or email mentioned above.

Summary of comments received on issues related to the environment

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

Response: While studies conducted using well-established and reliable testing methods have determined that bisphenol A does not always biodegrade readily, the weight of scientific evidence suggests that bisphenol A can be expected to biodegrade under aerobic conditions in water and soils. However, a review of the data on the potential for biodegradation under anaerobic conditions has determined that the evidence is sufficient, based on studies of acceptable quality, to conclude that bisphenol A has the potential to remain stable or to degrade only slowly under conditions of low or no oxygen.

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

Response: Various studies (see bisphenol A screening assessment report on the Web site mentioned above) 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.

Summary of comments received on issues related to human health

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

Response: The weight-of-evidence approach accounts for and weighs lines of evidence in order to determine whether a substance may pose a risk. An in-depth assessment was conducted for bisphenol A, including consideration of available relevant health-related data (including data available in scientific literature, evaluations by other jurisdictions, expert panel conclusions and information submitted to the Ministers during the information-gathering phase of the assessment) and weight-of-evidence analysis for hazard characterization associated with potential neurodevelopmental and behavioral effects in animal tests. This included evaluating the quality and quantity of available scientific evidence, determining the adequacy and limitations of studies and identifying critical endpoints.

Comments received following publication of the proposed Order in the Canada Gazette , Part I

In accordance with the Act, on May 16, 2009, the Ministers published a proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 in the Canada Gazette, Part I, for a 60-day public comment period. During this public comment period, one letter of support to the addition of the substance to Schedule 1 was received from a non-governmental organization. Also, an industry association filed a notice of objection and requested the establishment of a board of review under section 333 of CEPA 1999 on the assessment. Additional comments were received from a foreign government, which are already covered in the notice. None of the comments received were on the environmental aspect of the assessment. Below is a summary of the notice of objection and the Ministers’ responses relevant to the proposed addition to the List of Toxic Substances in Schedule 1 of CEPA 1999 of this substance.

The chemical industry association and the foreign government stated that risk assessments conducted in other jurisdictions have all determined that the potential exposures to humans do not constitute a danger to human health. The industry association states that there is a marked divergence in findings between Canada and the other national regulators, which suggests that there is not credible scientific basis for CEPA toxic declaration. Risk assessments conducted by the European Union via the European Food Safety Authority (EFSA) and national regulators including those of Australia, Belgium, Denmark, France, Germany, Japan, New Zealand, Norway, Sweden, Switzerland, the United Kingdom and the United States as well as an independent review by NSF International have all determined that the potential exposures to humans do not constitute a danger to human health.

Response: Health Canada conducted an in-depth assessment of bisphenol A (available at www.chemicalsubstanceschimiques. gc.ca/challenge-defi/batch-lot-2/index-eng.php) including an evaluation of the quantity and quality of available scientific evidence, a determination of the adequacy and limitation of studies, an identification of toxicological endpoints, and consideration of risk assessments and conclusions from other jurisdictions. Health Canada considers that the in-depth assessment of bisphenol A resulted in robust and relevant scientific evidence. In the approach taken by Health Canada, critical effects for bisphenol A were identified and used to characterize risk to human health from exposure to bisphenol A. This approach led to the conclusion that bisphenol A constitutes or may constitute a danger to human life or health.

Health Canada also noted that the risk assessments from some other jurisdictions were primarily based on the results of studies conducted according to guidelines for good laboratory practices. Health Canada considered these studies as well as studies not conducted according to these guidelines as they were considered relevant to risk characterization. Heath Canada considers that the screening assessment reflects current scientific information and presents a defensible science-based risk characterization of potential health effects (see www. chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/ index-eng.php).

Consistent with Health Canada’s assessment, the US National Toxicology Program (NTP) and the Center for the Evaluation of Risks to Human Reproduction (CERHR) have evaluated the extensive scientific dataset and have concluded that there is some concern for neural and behavioral effects of bisphenol A in potentially susceptible populations at current human exposures. Subsequent to the publication of the final screening assessment report, the U.S. Environmental Protection Agency (U.S. EPA) announced an action plan to address the issues related to bisphenol A (www.epa.gov/oppt/existingchemicals/pubs/ actionplans/bpa.html). In addition, on the basis of a new assessment by the National Food Institute at the Technical University of Denmark (DTU Food), Denmark has introduced a temporary national ban in materials in contact with food for children aged 0 to 3 years wecf.eu/english/articles/2010/03/ denmark-bisphenola.php). Other jurisdictions, including the European Union via the European Food Safety Authority (EFSA), the U.S. Food and Drug Administration (U.S. FDA) and the WHO/FAO are re-examining their current conclusions while more widely reviewing the recent scientific literature. In the interim, based on some concern about the potential effects of bisphenol A on fetuses, infants and young children, the U.S. FDA is taking steps to reduce human exposure to BPA in the food supply (www.fda.gov/NewsEvents/ PublicHealthFocus/ucm197739.htm#current).

Thus, Health Canada affirms that the potential harmful effects of bisphenol A during development cannot be dismissed and that the application of precaution is warranted. Accordingly, the Ministers support action to add bisphenol A to Schedule 1 of CEPA. In addition, they established a prohibition under the Hazardous Products Act of polycarbonate baby bottles containing bisphenol A on March 31, 2010 (www.gazette.gc.ca/rp-pr/p2/2010/2010-03-31/html/sor-dors53-eng.html).

The chemical industry association and the foreign government mentioned that the assessment is not supported by the weight of evidence. The precautionary principle should be applied when the weight-of-evidence suggests that a potential threat to human health or the environment exists and when that threat is of serious and irreversible danger (see section 76.1 of CEPA 1999 at www. ec.gc.ca/CEPARegistry/the_act/).

Response: Health Canada’s assessment of all relevant data, including the additional information submitted during the public comment period, indicates that there is reasonable and increasing evidence from animal studies to suggest cause for concern and justification for the application of precaution (see screening assessment report on the website mentioned earlier). Effects on central nervous system development and behaviour are considered serious and potentially irreversible. Based on the current state of the science, including knowledge gaps and uncertainties as identified in the final screening assessment, Health Canada affirms that the potential for harmful effects of bisphenol A during development cannot be dismissed and that application of precaution is warranted.

The notice of objection states that the final assessment devotes only one paragraph to epidemiological studies, primarily to highlight the limitation of the few small-scale studies available. The conclusions are based on laboratory animals, in particular studies that are acknowledged to have significant limitations and uncertainties. Scientific new research published after the publication of the final assessment or soon to be published address the specific areas identified as the basis for the precautionary approach.

Response: Health Canada reviewed the epidemiology studies that were available up to the publication of the final assessment and clearly stated that these studies had limitations in design that prevented elimination of uncertainty in the identification of potential health risk of bisphenol A. Health Canada is confident that animal models and animal test results can be relied upon as a basis for human health risk assessment.

Health Canada welcomes the receipt of new data regarding the substances that the department is assessing or managing. In the context of the full body of research on the potential health effects of bisphenol A, the information is taken into account as appropriate to its content and to the stage of the assessment process. Since the publication of the assessment, new epidemiological evidence of the possible human health effects of bisphenol A became available. Although additional studies are required to confirm causality, and relevance to the general population is uncertain, results from the studies that have been published recently and considered by Health Canada are consistent with conclusions in the final screening assessment (see screening assessment report on the Web site mentioned earlier) which are based on animal data. Health Canada is monitoring developments from studies that investigate the effects of bisphenol A exposure on human health, including neurodevelopment and behavior.

Limited data in the final assessment suggests that infants and children may not be able to metabolize and eliminate bisphenol A as efficiently as adults. A recent peer-reviewed study concludes that the presence of bisphenol A in urine from premature infants must be interpreted with caution. The study indicates that even premature infants have the capability and capacity to metabolize bisphenol A at levels expected from dietary sources as well as at the elevated levels from other sources observed in the study. These results show that one of the bases for application of the precautionary principle, highlighted susceptibility of infants to bisphenol A, is not supported by the scientific data.

Response: Health Canada has critically reviewed the studies submitted. The results are subject to several limitations, including small study size, incomplete number of replicates and no access to medical records. Although Health Canada recognizes that data gaps exist and has identified research needs as listed in the assessment, the department maintains that sufficient evidence is available to support developing appropriate measures to protect the most highly exposed subpopulation, newborns and infants.

With exposure of infants to bisphenol A from polycarbonate baby bottles essentially eliminated, exposure from baby food and powdered infant formula shown to be extremely low, and the ongoing voluntary initiative to reduce bisphenol A in canned liquid infant formula to the lowest level achievable, the basis for the Order has been substantially weakened. These new data on potential human exposure to bisphenol A do not support the addition to Schedule 1 of CEPA and, as a minimum, indicate there is no urgency to proceed with the Order.

Response: These new data increase the department’s knowledge of sources and their contribution to overall exposure to susceptible subpopulations. This allows Health Canada to focus its risk management actions appropriately. However, proceeding with the Order does allow for regulatory actions to be taken under CEPA 1999.

The notice of objection argues that new evidence has emerged which demonstrates that the Government of Canada was under pressure to ban the use of bisphenol A.

Response: A science-based assessment process of bisphenol A was carried out, including an external peer review and consultation for which comments on the technical portions relevant to human health were received from scientific experts in the group Toxicology Excellence for Risk Assessment (TERA), the University of Lethbridge, Alberta, and Carleton University, Ottawa (see www.chemicalsubstanceschimiques.gc.ca/ challenge-defi/batch-lot-2/index-eng.php). The department also followed a multi-staged, consultative process in collecting and analyzing information and compiling evidence that was incorporated into the assessment. Health Canada considers that sufficient evidence relating to human health has been presented to justify the conclusion that bisphenol A is harmful to human life and should be added to Schedule 1 of CEPA.

As required under CEPA, Health Canada and Environment Canada risk assessment conclusions apply precaution to ensure that decisions will be protective of human health and the environment. When there is a notice of objection under CEPA subsection 332(2), the Minister of Environment must decide whether or not to exercise the authority under CEPA to establish a board to review, whose mandate would be to inquire into the nature and extent of the danger posed by the substance subject to the Order. The Ministers carefully analyzed the information from other national and international organizations and concluded that the information from available studies is sufficient to support the addition of bisphenol A to Schedule 1.

Implementation, enforcement and service standards

The Order adds the substance mentioned above to Schedule 1 of CEPA 1999, thereby allowing the Ministers to publish proposed regulations or instruments no later than October 16, 2010, and finalize them no later than April 16, 2012. 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 this substance.

Contacts

Mark Burgham
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-7155
Email: [email protected]

Arthur Sheffield
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: [email protected]

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