Bisphenol A in industrial effluents: response to comments on proposed notice
Risk management instrument selection
Comment #1: Environment and Climate Change Canada should explain the rationale for the change in instrument from a regulation to a P2 planning notice. They should also articulate how this proposal fits into the overall approach for managing releases of bisphenol A (BPA). Considering that BPA is acutely toxic and an endocrine disruptor, a stronger regulatory measure, such as eventually phase-out of BPA, should be considered.
Response #1: 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, between 2006 and 2009, the importation of BPA was reduced by 75%, dramatically decreasing uses in Canada and eliminating significant sources of BPA releases through industrial effluent. Given this recent reduction in importation and use and the limited number of facilities now releasing BPA, a P2 planning notice was selected as the most appropriate and efficient instrument to control the release of BPA from industrial facilities.
A P2 planning notice is a legal instrument issued under the authority of the Canadian Environmental Protection Act, 1999 (CEPA 1999). It addresses industrial releases by requiring facilities to develop and implement pollution prevention practices (such as minimizing or avoiding the creation of pollutants and wastes). Interim reporting on progress in the implementation of plans is also required. In addition, a P2 planning notice allows the government to gather additional information and to monitor releases in order to make any adjustment that may be required in the future.
The Government of Canada has taken a holistic approach to manage the ecological and human health risk associated with BPA. This P2 planning notice targets industrial effluent releases and is only one risk management action which pertains to BPA. Other instruments, such as Health Canada's prohibition of the importation, sale and advertising of polycarbonate baby bottles that contain BPA are expected to mitigate human health risks.
Media of concern
Comment #2: An ecosystem approach should be used to manage substances identified as a concern to the environment. As such, the P2 planning notice should be expanded to account for all environmental media including releases to water, air and land.
Response #2: The final screening assessment report (FSAR) for BPA was published in 2008. The FSAR reviewed and assessed BPA in all environmental media including air, water and soil. However, due to its persistence in sediment, it was determined that exposure to BPA in the aquatic environment was the main source of concern for this substance. For these reasons, this P2 planning notice focuses on the release of BPA to water, and more specifically on releases from industrial effluent.
Furthermore, the government will continue to monitor BPA on a national scale in the following media: wastewater systems influent, effluent and sludge; landfill leachate; and surface water.
The information gathered through this program will be used to inform the government on levels of BPA in the ambient environment and will help to assess the effectiveness of the P2 planning notice.
Consumer and personal care products
Comment #3: The presence of BPA in a wide range of consumer and personal care products should be taken into consideration in the development of the risk management instrument. These products, which are disposed to landfills or wastewater systems, may result in significant releases of BPA into to the environment. As a result, the proposed instrument should include the risk management of landfill sites.
Response #3: The government is continuing to undertake research, evaluate findings from new studies, and investigate other potential sources of BPA releases into the environment (such as consumer products and landfills). The government will implement further risk management activities if warranted.
Comment #4: The definition of final discharge point as "identifiable" is problematic. Not all facilities will have a grasp or knowledge of where that point is actually located. More so, what if the final discharge point is underground in the middle of the road (hence not identifiable)?
Response #4: The release limit applies at the last point where the operator has a control over the quality of his effluent, whether this location is at the end-of-pipe or earlier in the process (such as production, packaging or cleaning). The intention of the notice is not to require facilities to re-engineer or to build infrastructures in order to access a final discharge point.
However, in the event that the final discharge point is inaccessible, facilities can take effluent samples earlier or later in the process, provided that the concentration of the effluent at the sampling location is as close as possible to the expected concentration of BPA resulting from normal operating conditions or could lead, by using an estimation method, to the concentration of BPA at the final discharge point. Facilities should record sampling site information such as identifying at which location in relation to the process that sampling was conducted, the rational for the site location and the predicted concentration of BPA at the final discharge point as a result of any removal or treatment of BPA by the industrial facility.
Scope of application
Comment #5: Several stakeholders feel that all facilities that manufacture, use, import, sell, release or dispose of BPA should be required to complete the notice. There should not be any exemptions or thresholds. More importantly, stakeholders feel that the pulp and paper sector should be fully investigated before being considered for exemption. A concern was raised that BPA is present in effluent as a result of thermal paper deinking and the existing Pulp and Paper Effluent Regulations may not be sufficient to control BPA releases into the environment.
Nevertheless, other stakeholders feel that the exemptions for this or other sectors should be granted when/where appropriate. More specifically, the government should consider exempting manufacturers and processors who solely use products which contain minimal (unintentional) amounts of BPA (such as polycarbonates, plastic parts, adhesives, sealers and vehicle fluids, consumer and industrial products, and food manufacturers).
Response #5: The notice applies to all facilities which use or manufacture BPA or mixture containing BPA in a quantity equal or greater than 100 kg and, and a result of this use or manufacturing, the effluent release contains BPA. The objective of the notice is to limit releases of BPA from industrial facilities as it was determined that exposure to BPA in the aquatic environment was the main source of concern for this substance. The threshold of 100 kg has been proposed in order to target the most significant industrial users of BPA. In addition, Environment and Climate Change Canada reviewed the use and potential discharge of BPA from pulp and paper industry and, given that pulp and paper recycling mills are subject to the under the Fisheries Act, and based on results from a voluntary BPA sampling study, it was determined that a sector-specific approach would be the most appropriate to manage the risk in this sector. Environment and Climate Change Canada is working with the paper recycling sector to develop this sector-specific risk management approach which will meet the intent of the notice. The government will continue to examine this sector and other sectors to ensure releases do not cause adverse effects on the environment or human health.
Comment #6: The government should re-evaluate the 100 kg threshold and assess the cumulative impact of facilities releasing BPA in close proximity.
Response #6: The objective of the P2 planning notice is to limit releases of BPA into the environment. Based on a socio-economic study, it was determined that less than 5 facilities had the potential to release BPA into the environment, and that over 90% of facilities using more than 100 kg of BPA did not release BPA into the environment. The study also demonstrated that facilities releasing BPA were located in separate areas across Ontario and Quebec. Therefore, Environment and Climate Change Canada does not anticipate any cumulative effects in one given area. Environment and Climate Change Canada will continue to monitor levels of BPA in various environmental media, and will take additional measures that could include re-evaluating the 100 kg threshold if warranted.
Comment #7: P2 plan requirements should not be evergreen, and if facilities can demonstrate that they meet the risk management objective (RMO) they should be removed from the notice.
Response #7: The intention of the notice is to reduce BPA releases into the environment through the implementation of pollution prevention practices (such as minimizing or avoiding the creation of pollutants and wastes by the facility). Facilities meeting the criteria set in the P2 planning notice are required to prepare and implement a pollution prevention plan that will prevent or control the releases of BPA into the environment.
Facilities subject to the notice that have achieved the RMO ahead of the schedule could complete schedule 5, following one year of monitoring, declaring that they have fully implemented their plan.
Factors to consider
Comment #8: The notice suggests achieving the RMO through methods other than dilution. However, conditions can exist where process waste water is diluted by waste water from other stream (such as waste stream joins sanitary effluent). As such, facilities should not be required to re-engineer/build their infrastructures in order to comply with the notice. In addition, this notice should not apply to facilities that only release sanitary effluent, as these facilities do not have control over the quantity of BPA released from this source.
Response #8: The notice applies to facilities that manufacture or use the substance in a quantity greater than 100 kg, and as a result release an effluent which contains BPA. Facilities are not expected to re-engineer or re-build their plants to have process wastewater separate from any other wastewater stream. However, it is expected that samples be taken prior to the junction of the different waste streams. Persons subject to the notice should not use deliberate dilution as a means of achieving the RMO. The intention of the notice is to reduce BPA releases into the environment through the implementation of pollution prevention practices (such as minimizing or avoiding the creation of pollutants and wastes by the facility).
Comment #9: Pollution prevention and use of alternatives should be mandatory requirements in the notice. More specifically, industry should demonstrate how alternatives contribute to ensure the safety of the environment and human health. In addition, alternatives should also be assessed by the government and made publically available upon request.
Response #9: As part of a socio-economic study, Environment and Climate Change Canada has conducted a costs and benefits assessment of various alternatives and control technologies for certain sectors. Findings indicate that there are efficient and effective processes and alternative substances that can be used to meet the RMO of the notice. The notice states in the section dealing with factors to consider in preparing a plan that first consideration should be given to pollution prevention activities prior to considering pollution control activities. However, Environment and Climate Change Canada recognizes that in some instances, facilities may not be able to implement pollution prevention practices or use alternatives. As such, other tools such as pollution control may be needed to meet the RMO.
As a result, flexibility has been built into the P2 planning notice to allow facilities to choose the mechanism that is most suitable for their facility (such as substitution, pollution control, best management practices, etc.). As part of the requirements under the notice, facilities should demonstrate and report how these mechanisms contribute to the reduction in release of BPA into the environment.
Finally, through the Chemicals Management Plan and the New Substances Notification Program, the government will continue to assess risks to the environment and human health from all chemical substances in Canada, including any potential existing or new alternatives to BPA.
Comment #10: The RMO for this notice is identical for facilities that discharge directly to the environment and for facilities that discharge to a wastewater system. Information presented during the consultation demonstrates that wastewater system removal is quite variable. As such, certain stakeholders feel that the government should not rely on municipal wastewater systems to address BPA releases.
Other stakeholders are of the opinion that if municipal plants can effectively treat BPA, then the government should avoid duplicative efforts by increasing the RMO concentration limit for facilities that send their effluent to a wastewater system.
Response #10: Environment and Climate Change Canada has taken into consideration, information which suggests that wastewater system removal of BPA is quite variable. Therefore, Environment and Climate Change Canada has chosen to place the emphasis on the reduction of BPA at the source by requiring industrial facilities that manufacture or use BPA to adopt pollution prevention practices. As such, the intention of the notice is to achieve and maintain an effluent concentration below the RMO regardless of whether the effluent is discharged directly to surface water or to a wastewater system.
Technical and economical considerations
Comment #11: The RMO of achieving an effluent concentration below 1.75µg/L is in direct conflict with the RMO of achieving the lowest level of release that is technically and economically feasible. There may be situations where the lowest level of release, technically and economically feasible, is higher than 1.75µg/L. In these events, technical and economical considerations should take precedence.
Response #11: Environment and Climate Change Canada has taken this comment into consideration and there is now only one RMO which states "The risk management objective for this notice is to continually improve towards achieving the lowest level of bisphenol A in the environment. This is to be accomplished by achieving and maintaining the lowest total bisphenol A concentration that is economically and technically feasible and is less than 1.75 µg/L in effluent released at the final discharge point of the facility through methods other than dilution".
Sampling and analysis
Comment #12: The sampling process should be further enhanced by creating a guidance document for sampling and analysis that includes the following recommendations:
- facilities should individually determine representative sampling for their facility
- sampling frequency should increase from 4 to 12 times per year to account for seasonal fluctuations
- samplings should increase when the production levels of a facility is greater than normal practices or when concentration level exceed 1.75μg/L
- additional sampling should be required following public complaints
A guidance document will be developed to help ensure monitoring consistency. This guidance document will provide additional information with respect to sampling and analysis including sampling methods/frequencies, sampling locations, laboratory information, etc. This will be available on Environment and Climate Change Canada's website shortly after publication of the P2 planning notice.
The P2 planning notice provides flexibility so that facilities can determine their sampling schedules. The requirements for four effluent samples per year, are a minimum requirement. Facilities are expected to sample as often as necessary to ensure the sampling results are representative of regular or typical operating conditions related to the manufacturing or use of BPA and have included seasonal fluctuation due to batch processes.
In regards to public complaints, enforcement officers will examine every suspected violation of which they have knowledge, and will take action consistent with the Compliance and Enforcement Policy for CEPA 1999.
Comment #13: The government should ensure there is a valid analytical methodology commercially available for BPA. Commercial laboratories may not be able to reliably measure BPA in industrial effluent due to interferences from other contaminants.
Also given the potential number of facilities involved, there must be a sufficient number of Canadian laboratories available to deliver results in an economical manner. In addition to this:
- analysis should not require third party verification
- analysis should not be limited to ISO/IEC17025:2005 accredited laboratories
Finally, facilities should not be required to submit their laboratory's accreditation number
Response #13: The government has completed several sampling studies, and can confirm that there are several laboratories in Canada that can analyse BPA in industrial effluent at levels required in the notice and that these laboratories are all accredited under ISO/IEC 17025:2005 for analysis of BPA.
Facilities should submit their laboratory's accreditation number to ensure reliability of analysis. Laboratories are required to perform their analysis in accordance with generally accepted standards of good scientific practice under the ISO/IEC 17025 standard. ISO/IEC 17025 is an international standard recognized for its general requirements for testing and/or calibrations.
Finally, third party verification is not required.
Comment #14: A minimum threshold, (such as 1 μg/L) applicable at the final discharge point, should be added to the notice. This type of threshold would ensure that the level of detection for sampling is consistent from facility to facility and would ensure that the notice only applies to facilities where releases are sufficiently large enough to contribute to environmental impacts.
Response #14: The objective of the notice is to achieve the lowest concentration of BPA technically and economically possible below 1.75 μg/L. As a result, an effluent concentration limit (such as 1 μg/L) would be in conflict with the RMO to reduce releases of BPA to the lowest level technically and economically possible.
To ensure that laboratory analyses are consistent from facility to facility, analyses should be completed by a laboratory accredited under ISO/IEC 17025:2005.
Comment #15: The government should articulate how its monitoring program relates to the notice. This monitoring program should consider:
- a life cycle approach
- specific timelines and frequencies
- additional locations in the Great Lakes, arctic and indigenous communities
In addition, the monitoring program should validate assumptions made in the socio-economic study (such as which sector releases BPA and at what concentration) and verify the monitoring data supplied by facilities.
Response #15: The information gathered through the Chemical Management Plan Monitoring and Surveillance program will be used to inform the government on ambient levels of BPA in the environment and will help assess the effectiveness of the BPA P2 planning notice.
As part of the government's monitoring program under the Chemical Management Plan, BPA is currently being monitored using a life cycle approach on a national scale in the following media: twice annually in wastewater systems (warm season and cold season); once annually at landfills; and monthly in surface water. Where possible, sampling sites have been chosen for different environmental media to provide information on BPA at several points in the lifecycle, such as releases from product use (through wastewater monitoring) and from disposal of products (through landfill monitoring). Sampling sites for surface water are located across Canada, and represent a range of influences including urban, rural, and background, and were selected in order to achieve a national perspective.
In addition, work has been completed to characterize BPA content in effluents from industrial facilities likely to be implicated in the notice.
Comment #16: The pulp and paper mills participating in the government's monitoring study are not representative of this sector in Canada. In addition, the numbers of samples taken to date (3 to 6 samples) are insufficient to determine trends or to give an accurate picture of the concentration of BPA in the effluent.
Furthermore, the results should be publically available.
Response #16: There are approximately 30 operational paper recycling mills in Canada. Of those, 23 mills have on-site wastewater treatment, discharge effluent to the environment, and are subject to the effluent quality requirements in the Pulp and Paper Effluent Regulations (PPER). The other 7 mills discharge effluent to off-site municipal wastewater treatment facilities and are not subject to the effluent controls in the PPER.
In 2000, an Environment and Climate Change Canada study of BPA in various wastewaters and wastewater treatment processes indicated that close to all paper recycling mills with secondary wastewater treatment had effluent BPA concentrations less than 1.75 µg/L. An ongoing voluntary study by Environment and Climate Change Canada to validate this research for operating paper recycling mills has commenced. This included sampling at 10 paper recycling mills, representing ~30% of all paper recycling mills. Mills were selected to be representative of the sector: mills that produce a high percentage of recycled pulp with different type of papers recycled and processed, 8 are mills with on-site wastewater treatment and discharge to the environment and 2 mills with on-site primary wastewater treatment prior to discharging to a municipal wastewater treatment facility. Three sampling events have been conducted at each mill for a total of 30 effluent samples. Ongoing work and analysis is being carried out to further delineate the environmental releases from the paper recycling sector. A summary of the results will be made available upon request.
Evaluation of notice
Comment #17: How and when will the government evaluate the effectiveness of the notice? Specifically, while the government "encourages continual improvements beyond the RMO of 1.75 µg/L", the establishment of a review of this level should be undertaken within 2 years to reflect the monitoring data gathered through the notice.
In addition, the government should articulate the number of facilities that will be subject to the notice and how the notice will contribute to the reduction of BPA in the environment.
Response #17: It is currently estimated, based on a socio-economic study and recent monitoring data, that fewer than 5 facilities will be impacted by this notice on the date of publication. However, the notice captures all facilities that meet the thresholds.
The overall effectiveness of the P2 planning notice in meeting the RMO is monitored and assessed by Environment and Climate Change Canada before, during and following implementation of the notice. The RMO and other performance indicators will be evaluated through the submission of interim progress reports. The P2 planning notice will be evaluated using several different performance indicators including but not limited to: the number of facilities that have met the RMOs and the quantity of BPA that has been prevented from being released to the environment.
The overall impact of a reduction in releases of BPA in industrial effluents will be evaluated through analysis of monitoring data and other studies completed to characterize levels of BPA in environment. If levels continue to be measured at concentrations of concern, other measures may be introduced to further reduce releases of BPA to the environment.
Comment #18: The notice should only focus on the activities related to effluent releases and should not require facilities to report information related to the manufacture or use of the substance. This type of information is not pertinent and creates an undue burden on industry.
Response #18: In addition to being an instrument that prevents BPA releases into the environment, the P2 planning notice requires that pollution prevention actions be taken through the entire lifecycle of the substance.
In order for Environment and Climate Change Canada to review the effectiveness of the notice, information such as the quantity of BPA manufactured, used and released must be assessed. This type of information allows the government to effectively evaluate different options in order to determine the effectiveness of the notice.
Comment #19: The government should allow organizations to file one report (such as declaration of implementation, interim progress report, etc.) on behalf of each facility instead of requiring them to file a separate report. This change would save time and resources, and would allow organizations to better align their approaches.
Response #19: The Minister asks for reporting by facilities as individual facilities under the same company or organization often have different operational needs and objectives. As such, Environment and Climate Change Canada requires reports to be filed on behalf of each individual facility. However, organizations may share common pollution prevention plans between facilities, as they meet the requirements of the notice.
Comment #20: Currently interim progress reports are not required for facilities that became subject to the notice after the date of publication. This is problematic as there may be several years of data gaps between submissions, particularly if time extensions have been granted. Therefore, interim progress reports should be required each year until the facility has implemented their P2 plan.
Response #20: Interim progress reports will now be required from facilities when time extensions to implement P2 plans have been granted for more than 1 year.
Comment #21: The timeframe for the implementation of P2 plans is set for December 31, 2016. This timeframe is too flexible and generous to industry and should be reduced.
Response #21: Although a socio-economic study and recent discussions with industry have identified potential alternatives and options for facilities, it appears they will not be available to some facilities at the time of publication. As such, given the complexity and effort required by these facilities to comply with this notice, Environment and Climate Change Canada feels that current timelines are reasonable, achievable and sufficient to protect the environment. However, facilities may implement their P2 plans and submit the declarations of implementation (schedule 5) ahead of schedule.
Comment #22: The deadlines in the notice are reasonable, therefore, time extensions should not be granted. However, if necessary because of high cost and complexity a time extensions may be permitted, but should not exceed 1 year to avoid undue delays.
Response #22: Time extensions may be granted because facilities often have varying operational needs and objectives (such as reformulation cost, equipment availability, approval process, etc). Therefore, facilities may need, due to varying complexities, a short time extension to achieve the desired results. Request for time extensions are reviewed on a case-by-case basis and normally do not exceed one year. To ensure public transparency, CEPA 1999 requires the name(s) of facilities that have been granted a time extension, including the newly extended deadlines to prepare or implement the plan, to be published in the Canada Gazette. This information is also made public on Environment and Climate Change Canada's P2 planning website
Comment #23: We are concerned with the general lack of requirements for transparency. The information provided to the government on BPA should be published and available to every Canadian. As such, the government should not allow the facility the ability to request confidentiality.
Response #23: Information submitted in declarations of preparation, interim progress reports and declarations of implementation is made available to the public through Environment and Climate Change Canada's P2 planning website. However, CEPA 1999 acknowledges that confidentiality may be important in some contexts, such as trade-secrets. As such, a person who provides information to the Minister under CEPA 1999, may submit a written request under Section 313(1), for the information be treated as confidential, subject to certain exceptions.
Waiver of a factor to consider
Comment #24: Facilities should not be allowed to waive a "Factor to consider in preparing a plan" under part 4 of the notice. These are central to the concept of pollution prevention and must be fully considered by the facility before implementation.
Response #24: Waiver of a "Factor to consider in preparing a plan" is granted on a case-by-case basis. Even though Environment and Climate Change Canada recognizes that these factors are crucial to achieve the RMO, in some situations it could be neither reasonable, nor practicable, to consider a factor when preparing and implementing pollution prevention plan.
Penalties and enforcement
Comment #25: There is a general lack of penalties for facilities that do not meet the RMO, use pollution prevention, or fail to monitor effluents according to the requirements in the notice. This may result in an increase of BPA in the environment.
Response #25: Facilities must consider all elements of the notice in the development of their pollution prevention plan, including: risk management objective, pollution prevention, use of alternatives, monitoring (such as sampling), etc. Compliance with CEPA 1999 is mandatory and subject to enforcement activities under the CEPA 1999 Compliance and Enforcement Policy.
Comment #26: The government should ensure sampling and reporting requirements are harmonised with other jurisdictions ensure that future facilities will not contribute to increasing BPA releases into the environment. In addition, the government should ensure that facilities know whether or not they are subject to the notice?
Response #26: The government works closely with provinces, territories, municipalities and other jurisdictions on many aspects of the risk management of chemicals. Facilities subject to the notice may use existing, prepared or implemented plans, including those developed under other jurisdictions, provided that the plans meet all the necessary requirements identified in the P2 planning notice for BPA.
New facilities (in other words, facility not in existence at the time the notice was published) are captured in the notice provided that they meet all the necessary requirements identified in the scope of application. These facilities are required to fulfil all the requirements of the notice, but are given less time than facilities that were subject on the day of publication.
A comprehensive compliance promotion strategy, which will include reminder letters and follow-up, has been prepared to ensure stakeholders are aware of the notice and its requirements.
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