Summary of Comments and Environment Canada's Response to Comments Following Consultations on the Proposed Risk Management Instrument to Control the Release of Phenol, 4,4'-(1-methylethylidene) bis (Bisphenol A)

The final Screening Assessment Report ² published in October 2008, concluded that bisphenol A (BPA) may be harmful to human health and the environment at current levels of exposure. A Risk Management Approach³, published at the same time, recommended as one of the risk management actions to protect the environment, to develop a regulation to reduce releases of BPA from industrial facilities into the environment.

A consultation session, which took place in Toronto (Ontario) on November 27^th 2009, followed by a 30 day comment period that ended on December 27^th 2009, gave interested and affected stakeholders an opportunity to provide input into the development of the BPA regulatory proposal. This consultation session focused on environmental and economic issues associated with the proposed regulations and did not address human health concerns associated with the use of BPA.

Environment Canada received over 200 comments from 22 individual submissions. Comments received during this consultation period were considered during the development of the proposed risk management instrument.

The Government of Canada had originally considered developing a regulation to control industrial releases of BPA which, based on data from 2006, appeared to be the major source of ecological concern. However, since that time the importation and use of BPA has decreased dramatically therefore eliminating significant sources of BPA through industrial effluent.

A Pollution Prevention Planning Notice was therefore determined to be the most appropriate regulatory instrument at this time for industrial effluent releases of Bisphenol A. A Pollution Prevention Planning Notice is a legal instrument under CEPA 1999 that requires industrial facilities using BPA above a given threshold to develop and implement a plan to keep any effluent below a set standard. It is a significant measure in addressing and monitoring industrial releases to the environment because it focuses on prevention at the source.

A summary of the comments received, and Environment Canada's responses can be found below, organized by the following topics:

• Risk Assessment
• Risk Management Approach
• Application and Exemptions
• Environmental Concerns
• Economic Considerations
• Technology/Alternatives
• Environmental Management System
• Release Limit (Increase/Decrease)
• Sampling and Analysis
• Reporting
• Monitoring
• Stakeholders Coordination
• Enforcement
• Industrial Usage

Surface water sampling data gathered under the Environment Canada's monitoring program, demonstrates that most surface water samples have no or very low BPA content.

These low concentrations are further corroborated by Kleca et. al (2009) in a report called Exposure Analysis of Bisphenol A in Surface Water Systems in North America and Europe. This report shows that the median BPA concentrations for fresh surface waters for North America and Europe were 0.081 µg/L and 0.01 µg/L, while 95th percentiles were 0.47 µg/L and 0.35 µg/L, respectively.

Based on the weight of the evidence BPA does not pose a threat of serious or irreversible damage to human health or the environment at the concentrations measured in the environment. As such, does not meet the definition of "toxic" under CEPA 1999.

The final Screening Assessment Report for BPA was published on October 18, 2008. This risk assessment examined critical scientific information and used a weight-of-evidence and precautionary principal, as required under section 76.1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), to conclude that BPA meets the criteria of toxicity to the environment and human health under sections 64 (a) and (c) of CEPA 1999.

Preliminary data gathered in 2008-2010 from Chemical Management Plan (CMP) Monitoring and Surveillance program indicates that BPA is present at concentrations that may cause adverse effects to aquatic organisms in surface water sampling sites from across Canada. Indicating that there is a risk of harm to aquatic organisms from exposure to BPA at these sites.

It is unclear why a regulation was chosen by the Government. Other instruments such as P2 Planning Notice or a Code of Practice offer more flexibility and have been historically effective.

At the time of the consultations, a regulation was considered and discussed as a means of managing industrial releases of BPA. However, through further information gathering and the completion of a socio-economic study on the substance, it was determined that industrial releases of BPAin Canada have sharply declined. BPA is not manufactured in Canada, but is imported for company use of the substance. Since 2006 imports of BPA have decreased by 75% and major industrial facilities, such as those producing resins, have stopped importing and using BPA in Canada, therefore eliminating significant sources of BPA releases through industrial effluent.

It is for these reasons that regulations are no longer considered the most appropriate or cost-effective risk management instrument to manage industrial releases of BPA. As such, the Government has proposed a Pollution Prevention Planning Notice (P2 Planning Notice) to control the release of BPA from industrial facilities.

BPA is imported for use in a number of sectors such as: Investment casting, Epoxy Resin Polyvinyl Chloride Compounding, Wire cable coating and Can Coatings. It is these industrial sectors that the P2 plan notice targets.

At this time, the P2 Plan is expected to only apply to a few facilities which still have effluent containing BPA.

It is recommended that the Government expand its risk management plan to address the broader use of BPA in order to minimize environmental and health-related risks associated with the substance.

Health Canada and Environment Canada work closely to manage substances such as BPA. Environment Canada has proposed a P2 Planning Notice to address releases of BPA from industrial facilities. The P2 Planning Notice is part of government actions to manage risks associated to BPA. An Actions Milestones Table can be found on the Chemical Management Plan web site.

The Government of Canada is engaged in a comprehensive monitoring program to gather scientific information on BPA release into the environment and is conducting research to investigate human exposure to BPA from canned foods and beverages. The Government is committed to reporting back on the findings in a timely fashion and taking further action if and where it is warranted.

The Government should promote pollution prevention at the source. As such, the risk management approach should include the elimination of BPA in food and beverage containers given that human exposure is possible through these products.

The proposed P2 Planning Notice will place an emphasis on the reduction of BPA at the source rather than preventing the release of BPA contained in industrial effluents at the end of the pipe.

Health Canada is currently supporting industry in developing a Code of Practice to reduce levels of BPA in canned infant formula, is committed to setting migration targets for BPA in infant formula cans, is exploring setting migration targets for BPA in canned foods for the general population and is facilitating the assessment of proposed industry alternatives to BPA.

In addition, Health Canada is also engaged in research and monitoring to investigate human exposure to BPA from canned foods and beverages through both targeted surveys and the Canadian Total Diet Study.

We are concerned that the current proposal applies broadly to all facilities that manufacture, process or use BPA and may unintentionally capture facilities and activities that do not appear to be the focus of the risk management activities.

The proposed regulations should consider exempting specific industries where insufficient free or available BPA is present. In addition, the focus should be on regulating processes that have the potential to generate significant amounts of BPA in wastewater that is discharged to surface water, as opposed to facilities that process materials that contain trace amounts of BPA. As such, we recommend that the following sectors (i.e. paper recycling, plastic and vehicle manufacturing) be exempted from the proposed regulations.

The proposed P2Planning Notice applies to facilities that manufacture or use BPA, or a mixture containing BPA, where the total quantities of BPA are equal to or greater than 100kg over a calendar year, and, a result of manufacturing or use, whose effluent at the final discharge point contains BPA. These requirements limit the applicability of the P2 Planning Notice to those facilities that both release BPA from their effluents and use a significant amount of the substance or a mixture containing the substance in their processes.

Sectors or activities are considered for exemption under the proposed instrument in cases where existing or under development risk management tools may be assisting in minimizing releases of BPA to the environment. With respect to paper recycling activities, consideration of available international and Canadian research suggests that the Pulp and Paper Effluent Regulations (PPER) under the Fisheries Act may contribute to minimizing the release of BPA below 1.75 µg/L. However, the Government will continue to monitor and evaluate these activities to validate these findings and ensure that releases do not cause adverse effects on the environment or human health.

In addition, support will be provided to industry through compliance promotion activities to ensure that facility owners and operators are aware of and understand their obligations under the P2 Planning Notice.

Data referenced in the risk assessment identified that the highest median concentrations in industrial effluent from pulp and paper industries and from commercial laundries. It is recommended that Environment Canada justify through analysis that this approach will capture the highest contributions of BPA to the environment.

Pulp and paper mills in Canada are regulated under the Pulp and Paper Effluent Regulations (PPER) under the Fisheries Act. These regulations establish environmental effluent release limits for biochemical oxygen demand matter and total suspended solids, and require those effluents to be non-acutely lethal. In order to meet the effluent quality requirements of the PPER, all mills in Canada that recycle waste paper and discharge effluent to the environment currently have secondary treatment systems in place. Some mills that recycle waste paper discharge to off-site treatment facilities, which may also be subject to the PPER and/or have secondary treatment systems in place. Although BPA is not specifically targeted under the PPER, available international and Canadian research data suggest that the regulations may be assisting in minimizing releases of BPA to the environment. The research indicates that the mills of interest are those that recycle waste paper, and that secondary wastewater treatment may be sufficient to reduce effluent BPA concentrations to less than 1.75 µg/L. These findings are being validated.

Environment Canada will continue to monitor levels of BPA in various environmental media. The results will be used to assess the efficacy of proposed risk management instruments. The proposed P2 Planning Notice does not rule out future actions on other potential sources of releases to the environment. As appropriate, further risk management measures may be developed to address BPAreleases into the environment.

There is no justification to exempt facilities that manufacture, release or otherwise use less than 100 kg of BPA per year, nor is there a rationale for exempting facilities that use BPA in finished products.

We recommend that there are no thresholds and that all users be subject to the regulations regardless of whether BPA is used during manufacturing or product use.

The objective of the proposed instrument is to limit releases of BPA into the environment. A threshold of 100 kg has been proposed in order to target the most significant industrial users of BPA. Environment Canada believes that this strategy will be an efficient and effective strategy to attain the risk management objective for BPA. Environment Canada will continue to monitor levels of BPA in various environmental media and will take additional measures that could include reassessing the 100 kg threshold if warranted.

We are concerned that BPAnot destroyed during the removal process may defer the current problem pertaining to industrial effluent to sludge.

We request that any further discussion of the regulations contain information about the final disposition of BPA removed from the effluent stream by control and capture technology, and that these regulations address this matter.

We also recommend against the use of municipal sludge containing BPA for agricultural purposes. This activity spreads BPA more widely, and can impact ecosystems and create another source of human exposure through food.

The proposed P2 Planning Notice is the latest in a series of government actions to manage risks associated with BPA. Levels of BPA in sewage sludge are currently being monitored through the Chemical Management Plan (CMP) Monitoring and Surveillance Program. The results of this program will provide additional information which will assist in determining the need to further action. The Government is committed to reporting back on the results of the CMP Monitoring and Surveillance Program in a timely fashion.

Use of biosolids in agriculture spreading is currently managed by provincial and territorial legislation. The Government of Canada is working closely with its provincial, territorial and municipal counterparts to prevent and minimize the quantities of BPA released into the Canadian environment from the disposal of sludge.

In addition, the Canadian Council of Ministers of the Environment (CCME) is currently developing a Canada-wide approach for the management of wastewater biosolids which includes developing an inventory of emerging contaminants in biosolids as well as performing a review of the current Canadian legislative frameworks surrounding biosolids.

The economic burden (e.g. the costs associated to implementing an Environmental Management System (EMS), the cost of substituting materials and the feasibility of removing BPA using technologies) could be potentially detrimental to industry, especially to small and medium size companies that correctly manage BPA or where there is little to no release to the environment.

Based on the report The Economic Benefits of BPA to the United States and Canadian Economies (September 2008), the cost of substitute materials to replace polycarbonate plastics products would be substantial, while the environmental reward would be small.

We recommend the use of other methods such as cost per kg and/or removal rates to reduce releases of BPA.

The proposed P2 Planning Notice is designed to allow facilities the latitude necessary to develop a Pollution Prevention Plan that is suitable and most cost effective for their facility, provided it meets the requirements of the notice.

The Notice applies to facilities that manufacture or use BPA, or a mixture containing BPA, where the total quantities of BPA are equal to or greater than 100 kg over a calendar year, and, a result of manufacturing or use, whose effluent at the final discharge point contains BPA. These requirements limit the applicability of the P2 Planning Notice to those facilities that both release BPA from their effluents and use a significant amount of the substance or a mixture containing the substance in their processes.

A recent socio-economic study has identified many potential alternatives for BPA in sectors impacted by the proposed P2 Planning Notice. It is acknowledged that some facilities will be required to change formulation or processes to reduce or eliminate the concentration of BPA in their effluent. However, the study concluded that facility compliance costs will have a low impact on the overall Canadian economy.

The Government approach should focus on protecting the environment and human health rather than emphasize the need to identify what is technically and economically feasible.

The proposed approach focuses on the protection of the environment by establishing a limit of BPA release from industrial facilities to prevent surface water concentration above a concentration that may cause adverse effects to aquatic organisms. This limit is based on the Predicted No Effects Concentration (PNEC) as identified in the final Screening Assessment Report. In addition, the proposed P2 Plan requires that facilities take into consideration the lowest level that is technically and economically feasible, to prevent or further reduce releases of BPA into the environment.

There are no alternatives for BPA in products. The alternatives that do exist do not perform up to the same standards or are extremely expensive. As well, the technologies proposed to limit effluent releases are untested, experimental and extremely costly.

The Government should identify safe potential non-toxic substitutes and implement a Life Cycle analysis to manage BPA releases.

Environment Canada has recently conducted a costs & benefits assessment of various alternatives and control technologies that can be used to reduce the concentration of BPA in industrial effluent. Findings indicate that there are efficient and effective alternative substances or processes that can be used to meet the risk management objective of the proposed P2 Planning Notice.

The proposed Notice will allow facilities the flexibility to adopt pollution prevention actions individualized to each facility. As such, facilities may choose to use alternative substances, change their manufacturing processes or implement capture technologies

Requiring facilities to implement an Environmental Management System (EMS) in a regulation will create unnecessary confusion, international precedent and would be deviating from the voluntary nature of the standard. An EMS has too narrow of focus, will increase burden on industry with no environmental benefit in return. At present, Canada lacks the human and financial resources and infrastructure to manage third party certification of an EMS.

We recommend that Environment Canada explore ways to encourage voluntary adoptions of an EMS in Canadian industry, without making such adoptions mandatory by law.

Environment Canada's intention was not to require mandatory implementation of EMS at industrial facilities. The intention was to promote best management practices - by requiring facilities to develop and implement pollution prevention measures as a means of addressing the release of BPA and other substances of concern to the environment. Environment Canada also promotes such practices in handling and disposing substances to prevent accidental releases, spills, etc.

The approach to promoting best management practices has been modified in the proposed P2 Planning Notice to provide more clarity on this aspect of the control instrument.

The proposed release limit is an intensity-based, end-of-pipe measure rather than an absolute limit and does not restrict the actual amount of BPA that a facility can discharge into wastewater. This could result in a disproportionate and potentially harmful amount of BPA entering the environment, and would be conflicting with the risk management objective of achieving the lowest level of release technologically possible.

We recommend that the release limit of 1.75 µg/L be lowered over time (eventually zero) and an absolute limit be set for the total quantity released each year. In setting the release limit, use of trends and geographical location of industries should be considered to ensure that the limit is adequate to protect the environment.

Environment Canada is taking measures to protect the environment by establishing a risk management objective of 1.75 µg/L BPA concentration in effluent from industrial facilities. This proposed limit is based on the Predicted No Effects Concentration identified in the final Screening Risk Assessment report. The proposed limit, even when considering geographical locations and historical trends, will contribute to reducing levels of BPA in the Canadian environment, in particular those originating from industrial applications.

In addition, the proposed P2 Planning Notice promotes reduction at the source and encourages continual improvement to prevent or minimize the release of BPA beyond the release limit stated in the P2 Planning Notice and, where possible, substitute BPA for alternative substances that will reduce or minimize environmental risks.

BPA is highly biodegradable and is 99% removed from wastewater treatment plants. As such, there should be a limit for direct discharge to surface water and a higher release limit for discharge to municipal treatment plants.

The degree to which BPAis removed is dependent on the type of wastewater treatment employed. As such, Environment Canada has chosen to place the emphasis on the reduction of release of BPA at the source and proposed a risk management objective for industrial facilities, to achieve and maintain an effluent concentration that does not take into consideration whether the effluent is directly discharged to surface water or to a wastewater treatment system. Ongoing monitoring programs are also examining the presence of BPA in biosolids from wastewater treatment systems. As additional information becomes available, this approach may be reviewed.

The Government of Canada intends to develop regulations that would limit the release of BPA in industrial effluent to a maximum concentration of 1.75 μg/L. The maximum effluent concentration was calculated based on the Predicted No Effect Concentration (PNEC), as identified in the final Screening Assessment Report.

Two issues undermine the validity of the proposed effluent limit. First is that the Lahnsteiner study, which forms the basis of the PNEC is flawed. Second the Screening Assessment does not employ a species sensitivity distribution (SSD) approach.

When calculated using the most recent, validated science and using a SSD approach, the PNEC for BPA is 22 µg/L. Applying a factor of ten to account for treatment and/or dilution, this translates to an effluent limit of 220 µg/L.

As with all data cited in the screening risk assessment, the Lahnsteiner et al. study, which served as the starting point for derivation of the PNEC, was critically reviewed and determined to be reliable and acceptable for use in the risk assessment.

For this assessment, Environment Canada did not employ the Species Sensitivity Distribution approach for the derivation of PNECvalues in risk assessment. However, the PNEC was derived following established methods as described in Environment Canada's guidance for conducting screening assessments. This document is available to the public upon request.

Based on the available information, the Government considers the proposed concentration limit for BPA will contribute to reducing levels of this substance in the environment, in particular those originating from industrial releases.

Additionally, the Government will continue to monitor levels of BPA in various environmental media. The results will be used to inform the Government on ambient levels of BPA in the environment and will help assess the efficacy of proposed risk management instruments.

The proposed regulations do not provide enough guidance on sampling protocols. As such, do not achieve comparability from facility to facility or site to site.

It is recommended that the proposed RM approach provide guidance to sampling (methodology, frequency, limit and confidence). However, sampling flexibility should be provided to small facilities that have little or no BPA effluent releases.

To ensure the reliability and comparability, the proposed Notice provides the following guidance on sampling activities:

• The sampling should be representative of regular or typical operating conditions related to the manufacturing or use of BPA.
• Samples should be undiluted, unfiltered and representative of the industrial facility's effluent.
• Samples should be collected and analysed at a minimum of four times per year using a composite sampling method.
• Analysis of the samples should be performed in accordance with generally accepted standards of good scientific practice at the time of the analysis by a laboratory that is accredited by a Canadian accrediting body under the International Organization for Standardization standard ISO/IEC 17025.

The intention is to have sampling and analysis requirements that are easily adopted by each facility. Facilities will have the flexibility to decide when and at what frequency effluent testing will be done.

It is not clear that there are commercial laboratories that use validated and reliable analytical methods or technologies to detect, sample and analyze BPA in industrial effluent at the concentrations that would be required by the proposed regulations.

Detecting BPA in drinking water, distilled water, and even surface water samples is different than detecting BPA in industrial effluent due to the potential interferences in effluents.

There are several Canadian laboratories, certified under ISO 17025, that have the capacity to analyse BPA in industrial effluent at the level required under the proposed Notice. The level of detection, depending on the type of effluent, ranges between 0.5ng/L to 4ng/L.

In addition, Environment Canada will be developing guidance documents to help facilities sample and analyse industrial effluents.

We recommend that the Government employ mandatory tools under CEPA 1999 to collect information from industry on BPA uses and releases and that this information be made publicly available.

We also recommend that facilities report the location and recipient of off-site disposal and that the National Pollution Release Inventory (NPRI) threshold be lowered.

As part of the P2 Planning Notice, facilities subject to the Notice will be required to report the quantities and concentrations of BPA used, released and/or sent off-site for disposal; all effluent test results obtained; and the actions taken to achieve the risk management objectives. EC intends to make this information available to the public through the Pollution Prevention Planning section of Environment Canada's website.

The P2 Planning Notice is expected to be the primary source of information gathering pertaining to release of BPA through industrial effluent. The National Pollution Release Inventory (NPRI) will continue to be used as an additional information gathering source and will be reviewed periodically to determine if modifications to reporting requirements are warranted

The monitoring must have more transparency regarding the selection process and the results following monitoring. Most monitoring sites are located in southern urban areas. As such, they do not give a good representation of Canadian environment.

We recommend that a monitoring program, with sites carefully chosen to allow a comparison between baseline concentrations, be developed to monitor concentrations of BPA in the environment. We recommend that more monitoring sites be added to this program, especially in northern communities, to ensure adequate Canadian environment representation.

As part of the Government's monitoring program under CMP, BPA is currently being monitored on a national scale in the following media: wastewater systems influent, effluent and sludge; landfill leachate; wildlife; fish; and surface water. Where possible, sampling sites have been chosen for several environmental media to coincide and permit potential further investigations on fate and exposure. Sampling sites for wildlife, fish and water are located across Canada, including urban, rural, and northern regions, and were selected in order to achieve a national perspective. In addition, sector-based sampling sites were selected to be representative of a range of variables in Canadian facilities.

The information gathered through this program will be used to inform the Government on ambient levels of BPA in the environment and will help assess the efficacy of proposed risk management instruments.

We recommend better coordination between regulatory bodies including provinces, territories and municipalities, as well as international agencies, such as the US Environmental Protection Agency (EPA) and the World Health Organization.

In addition, we believe that the Arctic and the Inuit peoples have not been adequately represented in the proposal.

The Government works closely with provinces, territories, municipalities and other jurisdictions on many aspects of risk management of chemicals. Reporting requirements in the P2 Planning Notice will also allow the Government to continue gathering information on BPA in order to be ready to align Canadian policies with any new information that may come forward from other jurisdictions.

In regards to the Arctic and Inuit people, the proposed Notice will be a national instrument that will address releases from all industrial facilities in Canada, including those found in northern communities. The Government will continue monitoring ambient environmental exposure on a national level, including northern regions, to inform on effectiveness of risk management in Canada and to inform on exposure and risk to the environment from BPA

Information is required on the various compliance and enforcement measures as well as proposed penalties being considered as part of the regulations (e.g. EMS, sampling, testing, reporting, exceeding the limits, etc).

Failure to comply with any provisions of CEPA 1999 may result in warnings, environmental protection compliance orders or prosecutions. Enforcement activities and provision can be found under part 10 of the Act.

The use of epoxy resins in pipes and pipelines may contain BPA. Since this is a large concern for Inuit and other populations in remote communities, it is recommended that EC examines this use more thoroughly and ensure it does not affect various water bodies and groundwater.

The Government of Canada is taking a holistic approach to risk management of BPA. This proposed P2 Planning Notice is the latest in a series of government actions to manage the risks of BPA and does not preclude future action on other potential sources of BPA releases.

Environment Canada will continue monitoring ambient environmental levels of BPA on a national level, including northern regions, to determine the effectiveness of risk management actions in Canada and to provide information on environmental exposure to BPA.

¹ The Chemical Abstracts Service (CAS) Information is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

² Screening Assessment for the Challenge Phenol, 4,4′ -(1-methylethylidene)bis-(Bisphenol A)

³ Proposed Risk Management Approach for Phenol, 4,4'-(1-methylethylidene) bis (Bisphenol A)