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Revisions and Response to Comments Resulting from the Canada Gazette, Part I, Publication of the Proposed 2-Butoxyethanol Regulations
The Ministers of the Environment and Health published the proposed 2-Butoxyethanol Regulations under the title Regulations Respecting 2-Butoxyethanol, in Part I of the Canada Gazette on July 9, 2005.
Stakeholders had 60 days to provide comments on the proposed Regulations. Written comments, questions and concerns on the proposed Regulations were received from a variety of stakeholders including private industry, industry associations, as well as other levels of government. All comments received during 60-day comment period have been considered in the preparation of the final Regulations, which were published in Canada Gazette, Part II on December 27, 2006.
Part I of this document identifies and explains revisions made to the proposed Regulations which are now found in the final Regulations. Part II of this document presents the comments and issues raised by stakeholders on the proposed Regulations with Environment Canada's response.
Part I: Revisions
The revisions from Canada Gazette, Part I to Canada Gazette, Part II are administrative in nature and serve to clarify the 2-Butoxyethanol Regulations. The revisions as well as the rationale for each are provided below.
Revision #1: The exemption in Paragraph 1(a) for products "designed for outdoor use" has been revised in the Application Section.
The exemption in Paragraph 1(a) has been removed and the expression "for indoor use" has been added to Section 1 in the final Regulations. This modification was to be consistent with the intent of the risk assessment of 2-BE.
Revision #2: An exemption for products for use "in a commercial activity as paints or coatings, including automobile refinish coatings" has been added.
Several stakeholders commented on the application of the Regulations. In particular, they indicated that products intended for professional and commercial use are distributed through defined commercial outlets and are not available to the general public. For this reason, stakeholders suggested that professional and commercial-use products should be exempted from the Regulations.
This proposal has been accepted and an Environmental Performance Agreement (EPA) addressing this specific issue has been developed. The purpose of the EPA is to provide assurance that all paint and coatings companies will take specific actions to ensure that any commercial paint and coatings for indoor use, containing 2-BE with a concentration exceeding the limits set out in Schedule 1 of the Regulations, will continue to be sold exclusively to industrial and commercial applicators and not to the general public. The EPA outlines roles and responsibilities for all signatory parties and includes a verification program. The Canadian Paint and Coatings Association (CPCA) and paint and coating companies have already signed the EPA as an alternative control measure to control only indoor commercial paints and coatings.
Finally, an exemption to automotive refinish coatings used in a commercial activity has been added. Automotive refinish coatings used in commercial operations are sprayed in professionally designed spray booths and all users are trained in the safe use and handling of these coatings. These coatings are not intended to be sold to the general public. The health risk associated with these coatings is minimal and the exemption is expected to be a minimal impact on the risk management objective.
Revision #3: Clarification that the concentration limits for 2-BE set out in column 2 of Schedule 1 are intended to apply to the final products (ready to use) has been added.
The concentration limits for 2-BE set out in column 2 of the Schedule 1 of the proposed Regulations were intended to apply to the final products (ready to use). Therefore, information regarding the concentration limits for 2-BE set out in column 2 of Schedule 1 apply to the final products (ready to use) in accordance with the manufacturer's instructions. This information has been added in Sections 2 and 3 of the Regulations. This change is also reflected in the Record Keeping Section of the Regulations.
Revision #4: A year to sell and offer for sale has been added to products that were manufactured or imported under a permit issued.
Since the Regulations were modified to allow the sell and offer for sale of pre-Regulation inventories for a year after the coming into force of the manufacture and import provision (see Coming into Force Section), a year to sell and offer for sale has been also added to products that were manufactured or imported under a permit issued to provide consistency.
Revision #5: Flexibility in the permit application format has been added.
The Permit Section has been modified to allow the flexibility to apply for permits in electronic media. This change is also reflected in the Record Keeping Section of the Regulations.
Revision #6: The Report Section and report information have been removed from the Regulations.
The reporting obligations were seen as an onerous administrative burden to industry, without a counter-balancing benefit to the federal government or to human health. Environment Canada and Health Canada concluded that reporting is not necessary for the purposes of compliance and enforcement activities, and have removed the reporting requirements from the text of the Regulations.
Revision #7: The title "Testing requirements" has been renamed "Analysis by Accredited Laboratory".
Revision #8: The term "or by a laboratory that meets an equivalent standard" has been removed.
This revision was made to provide for greater clarity and certainty
Revision #9: Certification Section has been moved.
The Certification Section has been incorporated into the Permit Section and the Record Keeping Section of the Regulations.
Revision #14: The location where results of analysis are kept has been added.
Record Keeping Section has been revised to include the requirement of providing the location of where results of analysis are kept. This requirement has been added for inspection purposes. This is also consistent with the other sections.
Coming into Force
Revision #10: The coming into force in one year after the day on which the Regulations are registered for the sale and offering for sale provisions has been changed to coming into force in two years after the day on which the Regulations are registered.
The Regulations have been modified to allow for the sale and offering for sale of pre-Regulation inventories for two years after the Regulations are registered. The coming into force of the manufacture and import provisions remains at one year. Stakeholders have been provided advance notice through extensive consultations, since early 2004 in order to meet these requirements.
Schedule 1 - Concentration Limits
Revision #11: Clarification on the measuring unit of the concentration limits has been added.
The unit of measure of the concentration limits has been clarified as weight/weight (w/w) percentage concentration of 2-BE in the product.
Revision #12: A new category Laundry Stain Remover has been added.
Consumer exposure resulting from the use of 2-BE containing laundry stain removers was found to be different than that resulting from other cleaners. Hence, a separate category for laundry stain removers has been included in Schedule 1. The following product concentration limit has been added:
This new category was added after Environment Canada and Health Canada learned of at least one such product for consumer use containing 2-BE. A model of consumer exposure (ConsExpo model), was subsequently undertaken to determine its 2-BE limit.
The study on this product containing 2-BE is available upon request by contacting Judith Tessier by phone at 819-934-7061 or by e-mail at email@example.com.
Schedule 2 - Information to be Contained in an Application for a Permit
Revision #13: The requirement concerning to whom the manufacturer or importer intends to sell has been removed.
This modification addressed retailers' concerns, as it would have been extremely difficult for them to fulfill the requirement. Therefore, this requirement has been removed.
Revision #14: The requirement "an indication as to whether a permit has been issued under Section 5 of these Regulations for each proposed use for product" has been added.
Since the initial permit may be extended once for the same use of 2-BE, this requirement has been added.
Revision #15: Information that must be submitted with a request for confidentiality has been added.
This change was made to clarify what information needs to accompany a request for confidentiality.
Part II: Summary of Response to Comments on the Proposed 2-Butoxyethanol Regulations
Part II of this document summarizes and responds to the comments submitted by stakeholders on proposed Regulations during the 60-day comment period. All comments have been noted and considered, however they may not be reported verbatim as similar comments have been combined and paraphrased to ensure brevity.
Comment #1: It was suggested that the maximum four year time limit on permits was too short, based on the absence of adequate substitutes for certain applications.
Environment Canada and Health Canada consider that stakeholders have been provided advance notice through extensive consultations, beginning early in 2004. In addition, the Regulations will come into force one year after the day on which they are registered for the import and manufacture of products, and two years after the day on which the Regulations are registered for the sale or offer for sale of products. Therefore, the four-year time limit in permits is considered reasonable.
Comment #2: It was recommended that the permitting process mechanism be developed in advance of the Regulations entering into force.
The permitting process mechanism will be developed in advance of the Regulations entering into force. Information will be distributed to stakeholders as part of the compliance promotion material.
Comment #3: Concern was expressed regarding the method and the cost of testing requirements.
The testing requirements are only for the purpose of enforcement activities. Although the regulatee will need to have testing done to ensure they are in compliance, there are no mandatory testing requirements in the Regulations for regulatees,
Comment #4: It was suggested that keeping records at a Canadian civic address was not necessary.
The requirement of keeping records at a Canadian civic address was not removed. This requirement is necessary to facilitate enforcement activities and is consistent with other regulations under CEPA, 1999.
Comment #5: The record keeping provisions in these regulations should be harmonized with those in Consumer Chemicals and Containers Regulations (CCCR). Under the CCCR, the records have to be maintained for a period of 3 years and the records must be produced within 15 days upon request.
Environment Canada considers the requirement to keep records for a period of 5 years reasonable and these are required for inspection purposes. Further, these requirements are consistent with other Environment Canada regulations such as the Prohibition of Certain Toxic Substances Regulations, 2005.
Comment #6: It was suggested that a period of two years or more would be necessary for industry to fully reformulate and sell pre-Regulation inventories. It was also suggested that products manufactured prior to the coming into force of the Regulations should be exempted.
The Regulations were modified to allow for the sale and offering for sale of pre-Regulation inventories for two years after the Regulations are registered. The coming into force of the manufacture and import provisions will remain at one year. Stakeholders have been provided advance notice through extensive consultations, since early 2004.
Comment #7: The concentration limit of 0.1 % for 2-BE content in spray paint was identified as unreasonable, because 2-BE is very likely to be present in trace amounts in certain mixtures.
The concentration limit of 0.1 % for spray paints was not changed. The exemptions and the permits system provide enough flexibility to industry to comply with the concentration limits.
Comment #8: It was suggested that the Wall Paints Exposure Model should be used to determine the concentration limits of 2-BE for paints, instead of the ConsExpo consumer exposure model.
Health Canada and Environment Canada have reviewed the Wall Paints Exposure Model and have concluded that the ConsExpo model is more appropriate in establishing 2-BE concentration limits for paints and coatings for the purposes of developing these regulations.
Comment #9: There is lack of harmony with the United States and European legislation, as well as the fact that the U.S. recently removed 2-BE from their Hazardous Air Pollutant list.
Environment Canada and Health Canada realize that the U.S. Environmental Protection Agency removed 2-BE from their Hazardous Air Pollutant list, because concentrations of 2-BE in ambient air are below levels of concern. This result is consistent with our assessment. However, 2-BE has not been evaluated in the context of indoor-air applications in the U.S. or in Europe. These Regulations control indoor-air concentrations of consumer and commercial products containing 2- BE. The Government of Canada is taking a proactive and leading role in regulating 2-BE, in order to protect the health of Canadians.
Comment #10 It was indicated that the Regulatory Impact Analysis Statement (RIAS) was not clear that industrial paints and coatings were included in the scope of application of the Regulations.
This was clarified in the present RIAS; industrial applications are not part of the scope of the Regulations.
Comment #11: Concern was expressed about the potential for duplicating reformulation costs to comply with these Regulations and with future initiatives controlling Volatile Organic Compounds (VOCs) in the same products. It was also indicated that incremental costs associated with future controls on VOCs should be factored into the cost analysis of these Regulations.
Costs associated with other initiatives will be included as part of the impact analysis of those initiatives. Public consultations on initiatives under development for controlling the VOC content in a range of product categories have provided industry with information about the objectives and intent of the Government of Canada. Therefore, industry may be able to reformulate once, to take into consideration the concentration limits set out by the Regulations and the VOC initiatives. In cases where this is not possible, industry may need to reformulate twice.
Comment #12: It was indicated that if the health benefits are real, then they should be quantifiable.
The health risk posed by 2-BE is real and was established through the risk assessment. However, this health risk was deemed not quantifiable because of the lack of epidemiological data. As a result, the health benefits stemming from the Regulations cannot be quantified or monetarily measured. The analysis of benefits was qualitative and relies on indicators of the number of people predicted to use products that could result in harmful exposure to 2-BE.
Comment #13: The "Net benefits" section of the RIAS was understood by some stakeholders to indicate that the net benefits of the Regulations are negative.
This resulted from a straight comparison of quantitative costs and qualitative benefits. Such comparison can only be qualitative in nature. The net benefits cannot be quantified with the available information and knowledge. The name of the section was changed to "Conclusion", to better reflect its content and purpose.
Comment #14: It was raised that the possibility of Canada's ability to compete for new global investment may be limited, as a consequence of the restrictions imposed by these Regulations.
The Regulations provide for a level playing field. Firms operating within Canada and firms operating abroad are subject to the same requirements for commercializing their products in the Canadian market. The Regulations will not trigger incremental costs for firms operating in Canada when compared with firms operating abroad, and are therefore not expected to have any material implications on firms' global investment decisions.
Comment #15: Concern was expressed regarding the costs of regulating automotive refinish paints and coatings may outweigh the benefits of such measure.
Automotive refinish coatings used in commercial operations are sprayed in professionally designed spray booths and all users are trained in the safe use and handling of these coatings. In addition, these coatings are not intended to be sold to the general public. Hence, an exemption to automotive refinish coatings used in a commercial activity was provided in the Regulations. This exemption limits the burden on industry and targets an activity that does not present a health risk to the general public.
Comment #16: The RIAS does not deal with the viability of candidate replacement substances.
Substitutes and candidate replacement substances were studied in detail in the report "2-Butoxyethanol and 2-Methoxyethanol: current use patterns in Canada, toxicology profiles of alternatives, and feasibility of performing an exposure assessment study", May 2003, prepared by ToxEcology Environmental Consulting Ltd.
Comment #17: The proposed Regulations are substance specific. There may be hundreds of regulations after the assessment of the chemicals on the Domestic Substance List. A "one window" approach should be considered to regulate many substances to minimize the confusion and burden of tracking the various issues.
After extensive analysis, it was determined that a stand alone regulation was the most appropriate instrument to control 2-BE. Please note that each proposed control measure is evaluated on a case by case basis. For example, 2-methoxyethanol has been added to the Regulations of Certain Toxic Substances Regulations, 2005, this was determined to be the most appropriate approach to manage the risk.
Comment #18: Concern was expressed with the decision to add 2-BE to the List of Toxic Substances in Schedule 1 of CEPA 1999.
An open consultative process had been followed leading to the announcement by the Governor in Council in the Canada Gazette, Part II that 2-BE had been added to the List of Toxic Substances in Schedule 1 of CEPA 1999 on March 9, 2005. A response to a similar comment as this one had been provided for that process. The responses to all the comments may be found on the Environment Canada Web site at the following address:
Comment #19: It was suggested that danger to human health posed by 2-BE in consumer products might be more appropriately managed under the provisions of the Hazardous Products Act, rather than using the provisions of CEPA 1999.
The Minister of Health is responsible for administering the Hazardous Products Act and shares responsibility with the Minister of the Environment for administering CEPA 1999. The Minister of Health made a choice between these two statutes and decided, with the Minister of the Environment, to address the danger to human health posed by 2-BE by recommending that the Governor in Council add 2-BE to the List of Toxic Substances in Schedule 1 of CEPA 1999, which was done on February 22, 2005. Since then, the Ministers of Environment and Health followed with the proposed Regulations on 2-BE under CEPA 1999 in Part I of the Canada Gazette on July 9, 2005, and with the final Regulations in Part II of the Canada Gazette on December 27, 2006.
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