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Environment Canada and Health Canada’s Response to

Comments Following Consultations on the

Proposed Regulations Respecting Products Containing Certain Substances Listed

in Schedule 1 to the Canadian Environmental Protection Act,

1999

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Overview:

Proposed regulations on mercury-containing products entitled Regulations Respecting Products Containing Certain Substances Listed in Schedule 1 to the Canadian Environmental Protection Act, 1999 were published on February 26, 2011 in the Canada Gazette, Part I, for a 75-day comment period that ended May 12, 2011.

The Regulations will broadly prohibit mercury-containing products, regardless of the industry or sector they are from. This approach supports the risk management objective of reducing releases of mercury from products to the lowest level possible. Certain exemptions are included for products deemed to be essential and without viable alternatives.

Identified stakeholders in Canada and the United States were advised of the consultation via regular mail and email. A press release and supporting information were published on Environment Canada’s Mercury and the Environment Website to widely disseminate information. Furthermore, Environment Canada notified the World Trade Organization’s Technical Barriers to Trade Committee since the Regulations could affect international trade. Follow-up discussions were also conducted with some stakeholders to obtain further information or clarification.

Environment Canada and Health Canada committed to summarizing the feedback received and publishing a response. These responses outline how Environment Canada and Health Canada intend to take the comments received into consideration in the development of the final regulations. In order to facilitate the process, similar comments have been merged. Therefore this document does not provide individual responses to each comment received. Should further information be required, please contact Megan Lewis at 819-997-5876 or [email protected].

Over seventy submissions were received on the proposed Regulations from companies, environmental and health organizations, government departments, individuals, and industry associations: Agilent Technologies; Association of International Automobile Manufacturers of Canada; Baseline Water Resources; Best Buy Canada Ltd; Boeing Canada; Canadian Association of Chemical Distributors; Canadian Chamber of Commerce; Canadian Environmental Network; Canadian Consumer Specialty Products Association; Canadian Council of Oral Medicine and Toxicology; Canadian Cosmetic, Toiletry and Fragrance Association; Canadian Manufacturers and Exporters; Canadian Paints and Coatings Association; Canadian Vehicle Manufacturers’ Association; Canon; CentraBalance Canada Inc.; Chemistry Industry Association of Canada; Communications and Information Network Association of Japan; Consumer Electronics Association; Crop Life Canada; Design Chain Associates LLC;

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Department of National Defence; Dow Chemical Company; Electro-Federation Canada; Electronics Product Stewardship Canada-Information Technology Association of Canada; Environmental Health Association of Nova Scotia; Fisher Scientific; Food & Consumer Products of Canada; Friends of Cathedral Grove; GE Healthcare; GE Power and Water; Globe Electric Company; Hewlett-Packard Company; International Academy of Oral Medicine and Toxicology; International Imaging Industry Association; Japan Business Machine and Information System Industries Association); Japan Electrical Manufacturers’ Association; Japan Electronics & Information Technology Industries Association; Japan Machinery Center for Trade and Investment; Learning Disabilities Association of Canada; MEDEC (Canada’s Medical Device Technology Companies); Mercotac Inc.; Mod-Tronic Instruments Ltd.; Motorcycle & Moped Industry Council-Canadian Off-Highway Distributors Council; Nalco Canada Company; Natural Resources Canada; Ontario Dental Association; Panasonic Canada Inc.; Philips Lighting; Pollution Probe; Select Design Corporation (a division of Tiercel Technology); Silicones Environmental, Health and Safety Council of North America; Sigma-Aldrich Canada Ltd.; Spectrum Brands Inc.; Summerhill Impact; Suncor Energie; Toronto Public Health; UV Pure Technologies Inc.; Water Quality Association; World Alliance for Mercury-Free Dentistry; and 14 individuals. A summary of the comments received, and Environment Canada and Health Canada’s responses can be found below, organized by the following topics:

General o Objective o The Regulations as a Policy Framework for Toxic Substances in

Products o Harmonization with Requirements in Other Jurisdictions

Application

o Legislative Overlap o Mercury Compounds o Definition of Product

Non-Application

o Incidental Presence o Drugs o Waste o Other Products o Requests for Non-Application

Prohibitions

Permits

o General o Permit Application

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o Permit Criteria and Conditions of Issuance o Permit Timeframes

Labelling

o General o Flexibility and Harmonization o Label Information – Section 8(1) o Label Description – Section 8(2) o Label Location – Section 8(3) o Hg Symbol – Section 9 o Labelling of Replacement Parts

Reports, Record Keeping and Format for Submission

o General o Reports – Section 10 o Format for Submission – Section 14 o Record Keeping – Section 15 and 16

Testing Requirements

o General o Accredited Laboratories – Section 11 o Quantity of Mercury or Mercury Compound – Section 12 o Certification of Lamps – Section 13

Coming into Force

Exemptions

o General o Dental Amalgam o Lamps o Replacement Parts o Other Exemptions o Requests for Exemptions o Medical Devices

End-of-Life Management of Mercury-containing Products

Education

International

Regulatory Review

Compliance Promotion and Enforcement

Consultation

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Regulatory Impact Analysis Statement (RIAS)

o General o Cost Benefit Analysis

General

Objective Comment Summary Response The objective should be to prohibit and phase out all products containing mercury because the adverse impacts of mercury in products outweigh any benefits.

As stated in the Regulatory Impact Analysis Statement (RIAS), the objective is to reduce releases of mercury from products used in Canada to the lowest level possible. However, due to its unique properties, mercury continues to be required in certain products such as lamps and dental amalgam. The Government has determined that the benefits of continuing to use these products outweigh the costs. For example, mercury is required in lighting, which is an essential technology for Canadians. The Government will continue to assess available technologies and alternatives to mercury-containing products; and eventually, the Regulations could be amended to remove exempted products or lower content limits.

The Regulations as a Policy Framework for Toxic Substances in Products Comment Summary Response There is a need to control mercury in products, but extending the Regulations beyond mercury would be inappropriate. The Regulations should be re-written to make them “mercury-only” and remove any wording regarding a generic application for products containing other substances listed on Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

If the government were to proceed with a generic product regulation, it should include a full suite of risk management tools and there should be full consultation with all potentially affected industries to determine the best course of action for regulating current and future Schedule 1 substances in products.

Environment Canada and Health Canada have determined that the final Regulations will not maintain their proposed generic framework. The final Regulations will focus exclusively on mercury-containing products and will also be re-named in order to reflect this decision.

Harmonization with Requirements in Other Jurisdictions Comment Summary Response Existing laws and regulations in the European Union (EU) and the United States (US) should be taken into account to avoid

Canada’s approach to mercury-containing products has been developed through a process of extensive consultations over a number of years1. The Regulations will involve a broad prohibition of mercury-containing products,

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making Canada’s regulations out of alignment and creating potential barriers to trade.

In particular, harmonization with requirements in US states should be pursued. This would be in-keeping with commitments made under the Canada-US Regulatory Cooperation Council.

with some exemptions for essential products with no viable alternatives.

Environment Canada has examined measures taken in other jurisdictions and has sought alignment where possible. Adjustments will be made to the final Regulations in order to further harmonize with measures in the US and EU where practical. Responses to comments about specific harmonization issues (e.g. labelling, exemptions) will be addressed in their respective sections of this document.

The Regulations are not deemed to create barriers to trade. It should be noted that negotiations are being held under the United Nations Environment Program towards a global legally binding instrument on mercury, including provisions on mercury-containing products.

Application

Legislative Overlap Comment Summary Response Clear policy co-ordination is required between different pieces of federal legislation and regulations governing products (e.g. Canada Consumer Product Safety Act2, Food & Drugs Act3, Pest Control Products Act4, and Significant New Activity provisions (SNAc’s)5 under CEPA 1999) in order to avoid duplication and confusion.

The Government of Canada is using its authority under CEPA 1999 to regulate toxic substances in products. However, some of these products may already be regulated under other legislation; government departments have therefore been co-ordinating activities in order to avoid duplication. For example, in the final Regulations food, consumer paints and other surface coatings (including those applied to toys), and cosmetics will be specifically excluded since they are covered under other existing legislation. The Government of Canada is committed to using the best-placed and most effective program and legislation to manage the risk posed by substances.

Mercury Compounds Comment Summary Response Given that mercury compounds are not yet listed on Schedule 1 of CEPA 1999, and that no exemptions were included in the Schedule of the proposed Regulations for products containing mercury compounds, mercury compounds should be removed from the Regulations.

Once mercury compounds are added to Schedule 1 of CEPA 1999, further consultations should be held regarding their inclusion in these Regulations, as well as any exempted products and maximum quantities.

A process is underway to add mercury compounds to Schedule 1 of CEPA 1999. On October 1st 2011, a proposed order was published in the Canada Gazette, Part I for a 60-day public comment period6. As mentioned in the RIAS for the proposed Regulations, once mercury compounds are added to Schedule 1 of CEPA 1999, the Regulations would apply to products which contain mercury compounds.

However, Environment Canada acknowledges that further consultation is required with stakeholders regarding mercury compounds (including appropriate prohibitions, exemptions, maximum quantities and timelines for coming into force) prior to the publication of the final Regulations. Environment Canada will consult regarding products containing mercury compounds, such as batteries and also invites stakeholders to provide additional information.

Definition of Product Comment Summary Response Does the term “product” refer to the mercury component, products that contain a mercury component, or both? A definition, or at a minimum guidance, should be provided

Exempted products and their content limits are listed in the Schedule of the Regulations. Testing requirements will apply specifically to the product listed in the Schedule of the Regulations. In the final Regulations, Environment Canada intends to remove the requirement to obtain third party certification of the mercury content of lamps. Reporting obligations are defined in Section

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regarding what constitutes a product.

Without this clarity, there could be confusion about which obligations apply in which manner (e.g. who needs to obtain certification, who needs to report, how should products be labelled).

10 and are the responsibility of the manufacturer or importer of the product into Canada.

Labelling obligations are shared between the manufacturer, importer and retailer. Labelling will be of the specific mercury-containing component or the product containing the component, depending on what is most logical. For example, when labelling a product with a mercury-containing component (e.g. electronic equipment), label placement should take into consideration the need to inform both consumers and recyclers/dismantlers about the presence of the mercury-containing component.

Non-Application

Incidental Presence Comment Summary Response The Regulations should not apply to products that are “mercury-free”. Mercury-free should have the following definition: a product with no addition of mercury and with a maximum concentration value of 0.1% by weight. This is the value used in the EU RoHS Directive.7

Test procedures cannot demonstrate the total absence of mercury, but this definition of “mercury-free” would indicate that a product contained no intentional addition of mercury.

Environment Canada and Health Canada may consider setting a maximum value for mercury in products. This would mean that no part of the Regulations would apply to products containing mercury in a quantity less than the maximum value.

In conjunction, further clarity will be provided surrounding the term “incidentally present” (see below).

The term “incidentally present” should be clarified.

Environment Canada is working to add clarity to the concept of “incidentally present” in the final Regulations. For example, Environment Canada will investigate the use of wording such as “naturally occurring” and “unintentional trace amounts”. In addition, the final Regulations may include a maximum concentration value and additional non-applications.

Canadian coal, and the burning of coal, should be targeted by these Regulations.

The intent of these Regulations is to target products to which mercury is deliberately added such as lamps, thermometers and other measuring devices. Environment Canada does not intend to regulate coal with these Regulations as mercury is a naturally occurring substance found in trace amounts in coal (i.e. incidentally present). When coal is combusted, this mercury can be released to the environment. Environment Canada is addressing this in two ways:

In 2006, the Canadian Council of Ministers of the Environment (CCME) established the Canada-wide Standards for Mercury Emissions from Coal-Fired Electric Power Generation Plants8; and

The Government of Canada is also developing regulations to reduce greenhouse gas (GHG) emissions from the coal-fired electricity generation in Canada, to take effect July 1st, 20159.

Drugs Comment Summary Response The rationale for excluding drugs from the Regulations was requested, as well as

The Government of Canada is using its authority under CEPA 1999 to control mercury releases to the environment from mercury-containing

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information on the use of mercury in drugs.

The Regulations should apply to mercury-containing vaccines because they are dangerous to infants and pregnant women.

Canada needs stricter measures for testing and regulation of products such as antiseptic and antibacterial cream, skin lightening creams, antibiotics for the eye, some nasal preparations, and ear preparations.

products; however, it was recognized that certain products are already regulated under other legislation or are essential products which have no viable alternatives. Mercury-containing drugs, including vaccines, were proposed to be excluded from the regulations because they are an essential product with no viable alternative and are already regulated under the Food and Drugs Act.

The Food and Drugs Regulations prohibit the use of mercury or any of its salts or derivatives unless the drug is an ophthalmic drug or other drug used in the area of the eye, is a drug for nasal administration, is a drug for optic administration, or is a drug for parenteral administration that is packaged in a multi-dose container in which the mercury or the salt or the derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.10

Thimerosal is a preservative that contains mercury and it has been used in some vaccines and other products since the 1940's to prevent spoilage and contamination. Making vaccines safer and more effective is a constant goal for the federal government and vaccine manufacturers. But decisions must be based on weighing the risks and benefits of each vaccine. In some cases, mercury-free alternatives may not be available or may not be as suitable as the thimerosal formulations. Since thimerosal vaccines contain only minute levels of mercury, the benefits of vaccination with them far outweigh the minimal risks associated with thimerosal. Most vaccines licensed in Canada do not contain thimerosal. Since 1994, all routine childhood vaccines, with the exception of the flu vaccine, administered in Canada have not contained thimerosal. Thimerosal is not added to single dose vaccines.11

Mercury is listed as a prohibited item on the Cosmetic Ingredient Hotlist, which is an administrative tool, to assist in the interpretation of the cosmetic safety provisions of section 16 of the Food and Drugs Act. Compliance with the provisions of section 16 are monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations of the Food and Drugs Act, which requires that all manufacturers and importers provide a list of the cosmetic’s ingredients to Health Canada.12 Cosmetics will be specifically excluded from the final Regulations since Health Canada is managing the risk from mercury in cosmetics under the Food and Drugs Act.

Waste Comment Summary Response “Waste” should be defined since ambiguity could create compliance and enforcement issues.

The reference to waste is meant to apply to the notion as defined in its ordinary sense in dictionaries. The intention of making the regulations explicitly not applicable to waste is to be clear that the Regulations will apply to new products, not products at their end-of-life that are intended to be disposed.

Other products Comment Summary Response How is mercury in surface coating materials used in paints, pigments, flooring and toys regulated?

Mercury in consumer paints or coatings is managed under the Surface Coating Materials Regulations under the authority of the Canada Consumer Product Safety Act. These regulations limit the quantity of total mercury in consumer paints and other surface coating materials imported, advertised or sold in Canada to 10 mg/kg. In addition, the Toys Regulations prohibit any

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compound of mercury in the surface coating material that is applied to a product that is used by a child for learning or play. Surface coating materials, including those applied to toys will be specifically excluded from the final Regulations since Health Canada is managing the risk from mercury in under the Canada Consumer Product Safety Act.

Requests for Non-Application Comment Summary Response Since the Food and Drugs Act sets the allowable level of mercury in commercial fish, the Regulations should not apply to food.

The wording in the final Regulations will be adjusted to reflect that foods such as fish and seafood, where mercury is only incidentally present, are meant to be excluded from the scope. Any potential risk of mercury in fish is already being managed by Health Canada and the Canadian Food Inspection Agency, under the authority of the Food and Drugs Act.

The Regulations should not apply to industrial, scientific, medical or broadcasting/professional equipment. This type of equipment is produced in low volumes, for specific applications, and does not enter the consumer market.

These Regulations will apply broadly to all mercury-containing products. The Regulations will not apply to products where the risk from mercury is covered under another act or regulation. Exemptions will be included for essential products with no viable alternatives such as certain scientific, medical and industrial products (e.g. reference electrodes). Exempted products will be subject to the regulatory requirements such as labelling, reporting and record-keeping. It will also be possible for manufacturers and importers to apply for permits for new, unforeseen products that contain mercury if they offer human health or environmental benefits.

The Regulations should not apply to military and defence products. These products are typically built to government-specified designs or acquired through government-to-government procurement processes and may be subject to export control laws or national security classifications. The products are carefully managed through their life-cycle including after decommissioning.

These Regulations will apply broadly to all mercury-containing products. The proposed Regulations do not apply to ammunition and explosives under the direction or control of the Minister of National Defence. Environment Canada is not considering excluding all military and defence products from the scope of the Regulations. However, Environment Canada is currently considering requests for several exemptions for specific mercury-containing military and defence products. Stakeholders should notify Environment Canada immediately of any existing specific military or defence products they believe will need to continue to be imported, manufactured or sold in Canada following the coming into force of the Regulations. A detailed rationale should be provided as to why the product should receive an exemption. It will also be possible for manufacturers and importers to apply for permits for new, unforeseen military and defence products that contain mercury.

The Regulations should not apply to explosives covered by the Explosives Act.

Adjustments will be made to the final Regulations to reflect that Natural Resources Canada controls the risks from mercury in explosives under the Explosives Act13. According to Natural Resources Canada, approximately 2.5 kg of mercury is imported in explosives per year (in the form of old ammunition or arms cartridges) and this figure is expected to decline. Note that mercury is not found in fireworks.

The Regulations should not apply to photographic films and papers due to the very small total quantity of mercury used in these products annually (grams). This would be in-line with measures taken in US states including New York, Maine, and Vermont.

Environment Canada acknowledges that professional photographic films and papers contain very small quantities of mercury, don’t have comparable alternatives, and that some US state regulations do not apply to these types of products. However, these Regulations will apply broadly to all mercury-containing products, with certain exemptions. Since no other legislation addresses the risk from mercury in these types of products, Environment Canada intends for the Regulations to apply to photographic films and papers (with exemptions).

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The EU Directive on the Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)14 exempts implantable medical devices from any restrictions.

The EU RoHS Directive does not apply to “active implantable medical devices”. However, before Environment Canada would consider excluding them from the scope of the Regulations, it requires further information about the type of mercury-containing product in implants. Environment Canada is working with Industry Canada, Health Canada and relevant stakeholders to investigate this comment in further detail.

The EU RoHS Directive does not apply to batteries.

These Regulations broadly prohibit all mercury-containing products other than those listed in the Schedule or to which the Regulations do not apply.

The EU has a separate directive, the EU Battery Directive, which controls the quantity of mercury in batteries.15

Environment Canada had not intended to grant any exemptions for batteries containing mercury or mercury compounds. However, as noted above, Environment Canada acknowledges that further consultation is required with stakeholders regarding mercury compounds (including appropriate prohibitions, exemptions, maximum quantities and timelines for coming into force) prior to the publication of the final Regulations. Environment Canada will consult regarding products containing mercury compounds, such as batteries and also invites stakeholders to provide additional information.

The Regulations should not apply to products covered under the Pest Control Products Act.

The Regulations do not apply to products covered under the Pest Control Products Act, and the Government is considering whether to adjust the final Regulations to provide this clarification.16

Prohibitions

Comment Summary Response To avoid stockpiling, the sale of products manufactured or imported before the Regulations come into force should be limited to one year. There could be a rush to import products prior to the coming into force of the Regulations.

Environment Canada does not intend to limit the sale of mercury-containing products that were manufactured in Canada or imported in Canada prior to the coming into force of the Regulations. The intent of this provision is to allow the sale of existing mercury-containing products already in Canada to be allowed indefinitely, in order to account for the sale of products such as antiques, old appliances, thermostats already installed in buildings, etc.

As written, Section 3(2)(c) (which allows the sale of products manufactured or imported before the coming into force of the Regulations) could allow the continued import or manufacture of products if it was read as meaning a product that is series-built in an unchanged style.

The Regulations will prohibit the import and manufacture of mercury-containing products after the coming into force of the Regulations.

A list of all mercury-containing products being prohibited by the Regulations was requested.

Environment Canada will not list all the products being prohibited by the Regulations, since the Regulations broadly prohibit all mercury-containing products other than those listed in the Schedule or to which the Regulations do not apply.

Since lamps and dental amalgam make up almost three quarters of all uses of mercury in products, the Regulations should focus on these products.

The Government has determined that there are no viable alternatives to these products and that their use remains essential to Canadians. The Government will continue to assess available technologies and alternatives to mercury-containing products.

Dental amalgam waste is managed through the Pollution Prevention Notice for Dental Amalgam Waste17, and end-of-life mercury-containing lamps will be managed by the proposed Extended Producer Responsibility Regulations

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that are currently being developed by Environment Canada.

Thermometers and barometers should not be prohibited because people only buy one or two of them in their lifetime.

Thermometers and barometers will be prohibited because viable mercury-free alternatives exist for these products.

The prohibition of all mercury-containing batteries, including zinc air, silver oxide, and alkaline manganese dioxide is consistent with commitments made by the National Electrical Manufacturers Association (NEMA) members to phase out production of mercury-containing varieties of button cell batteries by 2011 in the US market.18

Environment Canada had not intended to grant any exemptions for batteries containing mercury or mercury compounds. However, as noted above, Environment Canada acknowledges that further consultation is required with stakeholders regarding mercury compounds (including appropriate prohibitions, exemptions, maximum quantities and timelines for coming into force) prior to the publication of the final Regulations. Environment Canada will consult regarding products containing mercury compounds, such as batteries and also invites stakeholders to provide additional information.

Permits

General Comment Summary Response Permitting should not be part of the Regulations as it contradicts their objective.

Permits could be required for new and unforeseen products. The Government expects to issue very few permits. Permits are intended to be used only in exceptional circumstances and according to specific criteria set out in the Regulations.

Can permits be used as a transitional measure to continue importing or selling an existing product until mercury-free alternatives are developed or phased in?

If not, how will orderly phase-outs be achieved?

Permits are intended to be used for new, unforeseen products with environmental or health benefits. Permits are not intended to be used as a transitional measure for existing products.

Environment Canada has consulted extensively to determine the list of exempted products, including pre-Canada Gazette, Part 1 consultations and the Canada Gazette, Part 1 consultations. Environment Canada has also examined legislation and regulations in other jurisdictions. Stakeholders should notify Environment Canada immediately of any remaining existing products they believe will need to continue to be imported, manufactured or sold in Canada following the coming into force of the Regulations. A detailed rationale should be provided as to why the product should receive an exemption.

Permit Application Comment Summary Response Who can apply for a permi t?

Can the applicant be a company/corporation?

Will users be able to submit permit applications on behalf of manufacturers or importers who may not be of Canadian origin?

Will globally based parent manufacturers be able to apply for a permit on behalf of Canadian importers and distributors?

The person who will import or manufacture the product should apply for the permit (i.e. must conduct activities in Canada). Globally based parent manufacturers may assist importers in preparing the permit application. However the permit application itself must come from the importer or manufacturer conducting activities in Canada. Further guidance material will be developed following the publication of the final Regulations.

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Can a foreign parts supplier apply?

In subsection 4(2)(e) and 5(1)(c), “harmful effect” should be changed to reflect risk since the harmful effect of a substance cannot be altered.

This comment will be considered in the development of the final Regulations.

Add “if known at the time of application” to items 4(2) (b) (iv), (c), (d), (e) and (f) as the information requested is end user specific and therefore not available to an importer.

This comment will be considered in the development of the final Regulations with regards to Section 4(2)(b)(iv) only.

There is no public transparency about the granting of permits. Permits applications should be made publically accessible, and stakeholders should be involved in their review.

Environment Canada will not publish permit applications.

Permit Criteria and Conditions of Issuance Comment Summary Response The permit criteria are too restrictive and could stifle innovation. In particular, requiring applicants to demonstrate that a product “plays an important role in the protection of the environment or human health” does not recognize that some products may provide other unique or irreplaceable benefits.

Other criteria that should be considered include: “critical to Canada”, “serves some other important function”, “national security”, “Best Available Technology Economically Achievable”, and the “socio-economic impact of substitution”

How could a product demonstrate that it plays an important role in the protection of the environment or human health? An essential product may not be listed on the Schedule, and the restrictive permitting scheme may not give the government enough leeway to allow it.

The use of mercury, a toxic substance, in new products is not encouraged and is expected to diminish. However, Environment Canada’s intention is for applicants who demonstrate that new mercury-containing products that would play an important role in the protection of the environment or human health, to be able to obtain a permit. Options to further clarify the permit criteria will be explored in the development of the final Regulations.

Environment Canada is also participating in international negotiations towards a global legally binding instrument on mercury under the United Nations Environment Program, which are expected to conclude in 2013.19 At that time, Environment Canada will assess whether the permit criteria need to be adjusted to reflect the obligations in the globally negotiated instrument.

The permit process should include a means by which an applicant can challenge a permit denial.


During the renewal application process, the permit should be in place until a decision has been made to extend or withdraw the permit. If it is withdrawn, there should be a wind-down period so companies can adjust their operations.

Environment Canada has determined that permits will last 3 years. Provided the permit holder submits their renewal application at least 90 days before the permit expires, they will receive a response from Environment Canada within that time. If the permit is not renewed, it is because Environment Canada has determined that the permit conditions are no longer met.

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Permit Timeframes Comment Summary Response There should be timelines or service standards for the review of permit applications.

Service standards will not be included in the Regulations themselves. However, Environment Canada does commit to timely review of permit applications within a period of approximately 90 days, which the same timeline as for the renewal application process.

Having permits that last for only 3 years will stifle innovation. Permits should last a minimum of 4 years.

Three years is excessively long for a permit to last. One year would be better.

Environment Canada will maintain the permit length of 3 years as this length of time provides a balance between giving business certainty for companies and needing to re-assess the original conditions of issuance, in particular the availability of mercury-free alternatives.

Add a temporary import scheme that could expedite approval for one-time, specific circumstances.

Should a specific request be time-sensitive, this should be indicated and explained in the permit application.

It is not possible to implement the plan described in section 4(2)(e) (e.g. end-of-life management) in 30 days. Instead, it could be on a case-by-case basis, or with a requirement to notify the government that the plan is implemented prior to proceeding with the action.

Options to increase the flexibility with regards to the implementation of the plan will be explored in the development of the final Regulations.

Labelling

General Comment Summary Response Consumers might be overwhelmed and confused if too much complex information is included on labels. It would be challenging to get suppliers to label some imported products, and therefore the implementation will be left to the distributors. There would be little benefit in labelling large, complex products with a mercury-containing component.

Environment Canada’s overall intentions with the labelling requirements are to inform consumers they are purchasing a mercury-containing product and to ensure they are aware the product requires appropriate end-of-life management. Labelling of the product is also important to inform recyclers and workers who are handling end-of-life products such as lamps.

Labelling will be a shared responsibility between the manufacturers, importers and sellers of mercury-containing products.

Labelling should not be required for products and components built for export. (i.e. only products for sale in Canada).

This comment will be considered in the development of the final Regulations. The intention of the Regulations is to require labelling for products to be sold in the Canadian marketplace, not products manufactured for export.

Flexibility and Harmonization Comment Summary Response The wording requirements should be flexible so that the labels can be harmonized with other global requirements and industry norms.

Environment Canada will consider options to increase the flexibility of the wording where appropriate. Specific suggestions or examples should be sent to Environment Canada for consideration. It is noted that some consistency must be maintained in order for consumers to learn to recognize and

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The proposed labelling requirements are more onerous than those in either the US or the EU.

understand the information presented.

Environment Canada will further review the labelling requirements in the EU and the US in order to promote harmonization where possible and practical.

Industrial products, scientific instrumentation, research thermometers and laboratory analytical standards should not require additional labelling.

All new mercury-containing products entering the Canadian marketplace will require labelling, except for products to which the Regulations do not apply.

The requirements should avoid duplication and allow for coordination (including wording, timing and scope) with other regulations affecting packaging such as the Consumer Packaging and Labelling Regulations and the Energy Efficiency Act.

This comment will be considered in the development of the final Regulations. However, Environment Canada does not believe there is any duplication with existing packaging regulations. The Consumer Packaging and Labelling Regulations require labelling regarding, for example, product identity and net quantity20 as well as language (English and French). The Energy Efficiency Act requires labelling of lamps regarding, for example, their light output, energy use, and lifespan.21 Environment Canada invites stakeholders to raise any inconsistencies or duplication.

Label Information – Section 8(1) Comment Summary Response Regarding lamps, the current practice of marking the lamp with the Hg symbol and the package with a statement “Lamp contains mercury. Manage in accordance with disposal laws. See www or call 1-800 for more information” should be sufficient. The wording “Caution / Mise en garde” should not be required.

Labelling should align with requirements in the US in order to have one North American marketplace (e.g. US Federal Trade Commission labelling rule). Differing labelling requirements could affect the availability and cost of lamps offered in Canada.

Environment Canada intends to remove the words “Caution” and “Mise en garde” from the required labelling information in Section 8(1)(a) of the final Regulations to align with the US. For the same reason, Environment Canada also intends to adjust Section 8(1)(f) to allow for continued use of the phrase “Manage in accordance with disposal laws”

It is noted that the US Federal Trade Commission will require the wording “for more on clean up and safe disposal visit…” on mercury-containing light bulbs.22 Environment Canada believes that inclusion of a similar statement on mercury-containing products such as lamps would meet the proposed requirements in Sections 8(1)(d) and (e). Certain US states have labelling requirements for mercury-containing products including Connecticut, Louisiana, Maine, Massachusetts, Minnesota, New York, Rhode Island, Vermont, and Washington.

One element that cannot be aligned with the US is the requirement for labelling to be in both official languages in accordance with the Consumer Packaging and Labelling Act23 and Regulations24.

Subsections 8 (1)(b) and (c), which would require labelling of the quantity of mercury in the product, should be deleted. Providing this information:

would not provide any additional information other than that the fact that product conforms to the Regulations;

would not provide any environmental benefit;

would have no value to the consumer or the end user.

The quantity of mercury in the product should be reported to Environment Canada, but should not be required on the label.

Environment Canada intends to remove the requirements in subsections 8(1)(b) and (c) from the final Regulations. The quantity of mercury in the product will still need to be reported to Environment Canada.

Different views were expressed on 8(1) (d) Environment Canada intends to maintain the proposed regulatory text with

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and (e) regarding alternative methods of communicating the information to consumers:

The wording “for a person who can provide that information” should be removed. It is more appropriate to refer users to a website as people’s names and emails change regularly.

A website may not be available in an emergency and providing a phone number is important for these situations.

regards to the provision of a website or contact information. Note that “person” could refer to a 1-800 number where a consumer could speak to someone who could provide the information (i.e. does not need to refer to one specific person).

Regarding subsection 8(1)(e), providing the disposal requirements of all jurisdictions where the product may be used is impractical. Environment Canada and Natural Resources Canada should provide recycling information on their websites linking consumers to recycling programs.

In keeping with the concept of producer responsibility, Environment Canada believes that manufacturers, importers and sellers of mercury-containing products should be able to tell their customers how to safely dispose or recycle their products. For example, in the US, producers provide information about the disposal and recycling of lamps through the lamprecycle.org website.

The most important information for consumers is the fact that the product contains mercury and instructions for appropriate end-of-life management. These are the points covered by the EU Waste Electronic and Electrical Equipment Directive (WEEE) Directive25 and US state laws and regulations.

Environment Canada intends to maintain the requirements in Sections 8(1)(d), (e) and (f) which require information on the risks associated with the use of the product, disposal and recycling options, and the need to properly dispose of the product.

The label should include the symbol for poison.

The poison symbol means that “licking, eating, drinking, or sometimes smelling, this product will cause illness or death.26” Putting a hazard poison symbol was deemed inappropriate because the risks from the types of products containing mercury that will be allowed are not of that magnitude.

Label Description – Section 8(2) Comment Summary Response Languages other than the two official languages may be needed in some regions.

In Canada, labelling information is provided in both official languages.

The font size should be flexible depending on the product. For example, a range could be provided.

Environment Canada intends to maintain the labelling character size at a minimum of 3 mm, which is equivalent to an 8 point font. In the US, the Federal Trade Commission is requiring larger (10 point) font for the labelling of lamps.27

Label Location – Section 8(3) Comment Summary Response There should be the option to place the information on the product, on the packaging, or in the product documentation (i.e. notice or user manual). Labelling should be flexible to allow the

The Hg symbol will always have to be on the mercury-containing product. The Regulations already include the possibility to place other labelling information on the package, in a notice, or a manual.

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manufacturer to determine the most suitable location such that it would direct the warning to the person interacting with the mercury-added component (e.g. recycler, consumer).

Web-based product information sheets or user manuals could provide additional information. For example, the EU WEEE passport concept should be considered.

Environment Canada will pursue the inclusion of web-based information sources in the development of the final Regulations.

The wording “or its configuration cannot reasonably” should be added to Section 8(3) (product not large enough) to account for the infeasibility of labelling certain products.

Environment Canada does not intend to add this wording to the final Regulations because it is too vague.

Hg Symbol – Section 9 Comment Summary Response Labelling requirements for the “circled Hg” mark should be harmonized with state laws in the United States.

Environment Canada will investigate this comment in further detail. Alignment with state laws in the United States will be sought where possible and practical.

What is the purpose of the Hg symbol? It should be deleted.

Comments were received about the location of the Hg symbol:

The Hg symbol should go on the lamp or component containing mercury. In cases where the mercury-containing lamp or component cannot be marked or the mark would not be readily identifiable, the external surface of the product could be marked. E.g. “Hg Lamp/lampe”.

Labelling should not be required for final products with a mercury-containing component. When there is no possibility for users to touch or replace the mercury-containing component, the label should be placed in the product documentation only.

Since mercury-containing components in vehicles are not visible once the vehicle is assembled; labelling should be on a vehicle (e.g. door jamb) rather than a component. A single simplified label identifying the presence of mercury and referencing where further information can be found would suffice.

The purpose of the Hg symbol is to inform dismantlers and recyclers that the product contains mercury. It will also serve to as a reminder to consumers or workers that the product requires appropriate handing and end-of-life management.

The Hg symbol must go on the mercury-containing product listed in the Schedule of the Regulations. The other labelling requirements in Section 8 will provide more detailed information, either on the product, packaging, or other product documentation.

The Green Dot and the EU WEEE “wheelie bin” symbols should be considered to indicate the presence of recycling options and to serve as warning for proper end-of-life recycling because consumers already

The Green Dot symbol has a specific meaning in certain EU countries with regards to the producer’s participation in a recovery and recycling program.28 Similarly, the EU “wheelie bin” symbol has specific meanings under the EU RoHS Directive.

Environment Canada is working on developing Extended Producer

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recognize them. Responsibility regulations for mercury-containing lamps, which will require manufacturers and importers to implement a program for their environmentally sound recycling, including a public education component.

Labelling of Replacement Parts Comment Summary Response Labelling should not be required for replacement parts that are:

stored in inventory;

manufactured before the entry into force of the Regulations; or

shipped or stocked prior to the coming into force of the Regulations.

Environment Canada intends to remove the labelling requirements for all replacement parts manufactured before and after the entry into force of the regulations (item 31 in the Schedule of the proposed Regulations) because replacement parts would only be for a few very specific products.

Reports, Record Keeping and Format for Submission

General Comment Summary Response The reporting and record-keeping requirements should be deleted or substantially simplified because: they do not help identify non-

compliance, they only add to the burden for those already complying;

they do not provide an environmental benefit;

they are onerous and excessive; they are more aggressive than the EU

RoHS Directive which does not require reporting.

If reporting is required, it should be limited to situation involving permits issued.

Environment Canada is sensitive to regulatory burden on industry and will consider this comment in the development of the final Regulations.

The purpose of the reporting requirements is for the Government to know the quantity of mercury entering the country in products in order to assess the effectiveness of the Regulations. The purpose of the record-keeping requirements is for those subject to the Regulations to demonstrate their compliance. Records must be available to be shown to enforcement officers on request.

Can a foreign parts supplier submit the report? How will duplication of reporting be avoided? Are permit holders subject to record-keeping requirements?

Environment Canada does not intend for there to be duplication in reporting. The manufacturer or importer of the mercury-containing product listed in the Schedule of the Regulations would be responsible for reporting.

Any person who manufactures, imports or sells a mercury-containing product listed in the Schedule of the Regulations would be subject to the record-keeping requirements. Permit holders would also be subject to record-keeping requirements.

Reporting and record-keeping obligations overlap with those required by the Canadian Border Services Agency (CBSA). The information should instead be obtained from CBSA.

CBSA collects data according to Harmonized System (HS) codes. These codes are not specific to mercury-containing products. Specific information is necessary for enforcement purposes and performance measurement of the regulations.

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Reports – Section 10 Comment Summary Response Reporting should be required less frequently. Instead of annual reports, a five-year cycle would reduce the burden on industry while still aiding in performance measurement. A 3-year cycle should be used for reporting on the mercury content as it does not change frequently from year to year. The US Interstate Mercury Education & Reduction Clearinghouse (IMERC) also collects data every 3 years. Environment Canada should consider partnering and/or harmonizing with the IMERC reporting requirements and database in the US.

Environment Canada is sensitive to issues of harmonization and regulatory burden on industry. However, Environment Canada will require data to assess the performance of the Regulations. Therefore, depending on the timing of the publication of the final Regulations and of the reporting cycle in the US, a first report may be required earlier in order for Environment Canada to obtain data in a timely manner. Following that initial report, harmonization with the 3-year year reporting cycle in the US will be considered.29

Environment Canada will investigate the suggestion of further harmonization with IMERC however it is anticipated that a separate reporting format will be created for reporting under these Canadian regulations.

How will Environment Canada use the reporting data? How will data be stored and how will confidential business information be handled?

There should be confidentiality provisions in the Regulations to keep sales and product specific information from being released publicly, or non-disclosure agreements between the Government and companies submitting information.

Environment Canada will use reported information to assess the success of the Regulations in achieving their objective of reducing mercury in products entering Canada to the lowest level possible.

CEPA 1999 already provides for the protection of confidential information.

Reporting should only be required for products to be sold in Canada.

The Regulations will place reporting obligations on manufacturers exercising activities in Canada or importers of products into Canada. The quantity of the products sold in Canada is information to be provided in the report, but is not a qualifier as to whom the obligations apply.


Quantifying and reporting on each unit manufactured, imported or sold, along with the mercury content therein would be burdensome. Does the annual report require new tests for each model for each year?

It is Environment Canada’s expectation that reports will contain summarized information by product (i.e. according to the list of exempted products in the Schedule of the Regulations or permitted products). The average mercury content in the product obtained through testing would be reported to Environment Canada. It is the manufacturer or importer’s responsibility to use a sampling plan that achieves statistically significant results. This may not necessarily require annual testing if changes are not made to the product design or manufacturing process.

Instead of reporting the number of lamps imported and sold each year (which are generally the same), only the annual sales in units by category should be reported.

Environment Canada will consider this comment in the development of the final Regulations.

Reports should be allowed to be submitted by individual companies or through a trade association.

Reporting must be submitted by those who are subject to the Regulations. Since the Regulations will target individual manufacturers, importers and sellers of mercury-containing products, reporting will be required on an individual company basis. Individual reporting is also necessary for compliance promotion and enforcement purposes.

Reporting requirements should not be required for replacement parts.

Reporting will apply to replacement parts in order to allow Environment Canada to obtain data on mercury-containing products manufactured or

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imported into Canada.

Format for Submission – Section 14 Comment Summary Response The electronic format for reporting should be made public prior to the publication of the final Regulations so that companies can be ready to report when the Regulations enter into force.

Environment Canada intends to publish the reporting format in a timely manner so that those subject to the Regulations can be ready to report when the Regulations come into force.

Record Keeping – Section 15 and 16 Comment Summary Response Manufacturers should only be required to keep data for a maximum of 3 years.

Environment Canada intends to maintain the record-keeping requirements at 5 years.

Testing Requirements

General Comment Summary Response How often must the testing and certification requirements be provided to customers and authorities?

Certification is an ongoing process which is conducted by the Certification Body. In the final Regulations, Environment Canada intends to remove the requirement to obtain third party certification of the mercury content of lamps.

Are the testing requirements also imposed on products with a mercury-containing lamp?

Do end products have to be tested or just components?

The requirements to use accredited laboratories and a specified test method will apply to the mercury-containing products listed in the Schedule of the Regulations and to products that are granted permits under these Regulations.

If a product in the Schedule does not have a maximum quantity of mercury, is testing required to confirm its mercury content?

Yes, laboratory testing is required to determine the mercury content of the product in order to fulfill the reporting requirements of the Regulations.

Will Articles 11 and 12 only be used by Canadian authorities in order to check the conformity of products?

Articles 11 and 12 will be used as required by regulatees in order to fulfill reporting requirements. Canadian authorities enforcing the Regulations would also follow the requirements set out in Articles 11 and 12 to perform their analysis.

Accredited Laboratories – Section 11 Comment Summary Response Will accredited laboratories be available and will they be able to perform the required tests? Sections 11 and 12 should only apply once one or more accredited laboratories are available in Canada.

The global market offers countless laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories for heavy metals testing, which is a routine type of testing. If not already present in an accredited laboratory’s testing scope of accreditation, signatories have a process for extending a laboratory’s scope upon request, to add the test method for mercury testing. New or un-accredited laboratories may apply for

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accreditation to ISO 17025 with an ILAC signatory at any time.30

The requirements for accreditation of laboratories should be deleted. Requiring testing by an accredited laboratory is burdensome because it effectively rules out in-house analysis by companies. Instead, testing should be done in accordance with the methods published by international standard organizations (e.g. ISO or IEC) or comparable methods adopted within the EU, US or Canada.

Laboratory accreditation allows for independent and unbiased testing of the product to the IEC test method. Accreditation and laboratory testing are conducted to ISO standards, which are globally accepted.

If a given method or standard is performed by an unaccredited laboratory, the competency of that laboratory could not be demonstrated and its results would therefore be in question.

The inclusion of an equivalent standard for laboratory accreditation should be retained.

Environment Canada intends to remove the allowance for use of an equivalent standard for laboratory accreditation. There is no international standard equivalent to ISO 17025.

Quantity of Mercury or Mercury Compound – Section 12 Comment Summary Response Method IEC 62321 does not provide enough information for labs to properly and consistently analyze the mercury content of lamps. A new standard (IEC 62554) is being developed regarding pre-treatment processes for lamps and will be completed in the next 12 months. Section 12 should only apply once this standard is established.

IEC 62321 is a published standard, available for use now and applicable to mercury testing as set out in the regulations. IEC 62321 will be updated to reference IEC 62554 once it is finalized. It is expected that this will be completed prior to the Regulations coming into force.

Mercury content limits should be applied to the average level of mercury by type/model of lamp rather than each individual lamp, as is done in the NEMA LL8-2010 standard.31

The mercury content limits will apply to the average level of mercury by type/model of lamp and not to each individual lamp. The average level for each type/model shall be determined by use of a sampling plan that achieves statistically significant results.

Environment Canada should determine whether the IEC standard is appropriate to refer to exclusively in the regulations. How will non-electronic products be addressed?

It has been determined that the IEC standard is the appropriate standard for reference since most products listed in the Schedule are electrotechnical products. IEC standards are internationally accepted normative standards that are bilingual and developed on an international consensus basis. Canada is an IEC member. However, Environment Canada will consider whether other methods should be allowed for products that are not electrotechnical during the development of the final Regulations.

Certification of Lamps – Section 13 Note: Environment Canada has decided to remove the requirement to obtain third party certification of the mercury content of lamps. However, questions on certification are responded to below in order to provide further details about the concept. Comment Summary Response Certification by a third party should not be required and Section 13 should be deleted. Instead, manufacturers should use declarations of conformity for the mercury content of products. These “self-certification

Vendor attestations or Supplier Declarations of Conformity (SDoC) are claims about a product, issued by a body that manufactures, owns or supplies the product. There is no unbiased demonstration that the product meets the requirements of the product standard. Vendor attestations or the Supplier Declaration of Conformity is a tool that is used in the European

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approvals” are already used in North America and the EU for various products.

End product manufacturer should report using these vendor attestations.

Union.

Canada’s legislative and regulatory structure is very different than the structure in Europe and therefore does not currently support the use of these first party claims across the spectrum of products that are regulated for the health and safety of the Canadian public. Instead, Canada generally uses the conformity assessment model whereby a product is verified to meet a standard through independent testing and evaluation by an unbiased, independent third party that has no connection or vested interest in the product.

The proposed regulatory requirement for certification of the mercury content for the products identified in the Schedule align with the conformity assessment model that is traditionally used in Canada, including for the energy efficiency of lamps.

This being said, in the final Regulations, Environment Canada will remove the requirement to obtain third party certification of the mercury content of lamps. Options are being explored regarding the self-certification approach proposed by industry.

Does Section 13 require inspection of every single product that enters the marketplace?

Because of the supply chain in the electronics industry, it would be difficult, burdensome and impractical to guarantee the conformance of every component, especially if they need to be assessed through chemical analysis. This might raise issues from a technical barrier to trade perspective.

The requirements do not specify 100% inspection. Certification involves initial verification that the product meets the requirements of a standard, followed by ongoing surveillance of the product over time to confirm that it continues to meet the standard. Surveillance may involve periodic factory inspections, product sampling and/or retesting of products. Each and every unit would not necessarily need not be inspected.

Conformity assessment, including the surveillance activities previously described, is conducted in accordance with international standards. The product certifications, product testing and the accreditation of product certifiers and testing laboratories are conducted to international standards by bodies that operate internationally in WTO countries. Furthermore, the Standards Council of Canada and ILAC members are signatories to international and regional mutual recognition arrangements. The described structure is set up to increase access for all, to international markets, and to open doors for recognition of products and services, and therefore, to overcome technical barriers to trade.

Third party certification could let non-conforming products to be on the market because after certification is obtained, non-conforming products can later be distributed.

After obtaining their certification, manufacturers or importers cannot change their process or products without notifying the Certification Body. Certification Bodies conduct ongoing surveillance of the product to ensure the product continually meets the standard over time. Certification Bodies have processes and the latitude for imposing corrective action to be taken by the manufacturer and to quarantine a product at the factory to stop its release. This greatly reduces the risk of non-conforming products being released into the marketplace. Environment Canada will be enforcing the Regulations to verify the conformity of products with the Regulations.

How would certification work if the product was manufactured or imported from outside of Canada?

The Standards Council of Canada32 operates its accreditation programs internationally in WTO countries. Likewise, Certification Bodies accredited by the Standards Council of Canada are not restricted to operating their certification programs in Canada alone. In fact, the majority offer certification outside of Canada. In doing so, many have established satellite offices worldwide near manufacturing bases in places such as China, Europe, South America and USA. Therefore, their services are easily accessible by manufacturers globally, often with local or regional representation.

The requirement for testing laboratories to be accredited by an Accreditation Body that is a signatory to the ILAC Mutual Recognition Arrangement also supports access to testing services worldwide. ILAC is an international

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cooperation of laboratory accreditors, including 71 signatories, which are based in countries around the globe. The arrangement allows for mutual recognition of each other’s competent accreditation of laboratories to the international standard ISO 17025.

This means that products can be tested, evaluated and certified to Canadian requirements in the country or region where they are manufactured before being exported to Canada.

Other options to obtain reliable data on the quantity of mercury include:

engaging certification bodies in an audit process of production processes and facilities where the mercury dose being delivered to the lamps can be precisely measured

relying on product formulation data

Verification of production processes and factory visits (inspections) are typical mechanisms incorporated into the surveillance activities of Certification Bodies.

In addition to having product samples tested, Certification Bodies acquire various types of information from manufacturers about the product to establish its makeup and design as part of the evaluation process. The Certification Body uses this information on an on-going basis during inspections of the manufacturer’s factory operations to determine whether the product continually being produced is the same as those samples that were evaluated and tested initially for certification. Product formulation data is typically used by Certification Bodies to establish the chemical composition of a product.

Why do only lamps require certification? Lamps should not require higher scrutiny than other products.

Environment Canada included the third party certification of mercury-containing lamps in the proposed Regulations for several reasons:

To control lamps manufactured in Canada as well as those imported into Canada

To ensure that the content limits for lamps would be respected (other products in the Schedule do not have content limits)

To manage the risk associated with one of the major sources of mercury entering Canada in products (other products represent a smaller portion of the mercury entering Canada in products).

As described above, Environment Canada intends to remove the requirement to obtain third party certification of the mercury content of lamps.

Coming into Force

Comment Summary Response In order to bring products into compliance (including testing, labelling and certification requirements, as well as engineering and validating new designs), there should be a delayed entry into force. There should be a more gradual and phased in approach that considers the actions and requirements in other jurisdictions. Requests ranged from 6 months to 5 years after the publication of the final Regulations, with most requests being for one year.

Environment Canada intends for the Regulations to come into force one year after they are registered. It is anticipated that the Regulations will be published in the Canada Gazette, Part II in summer 2012.

The entry into force date should not retroactively trigger the requirement for data from before the regulations come into force. Reporting requirements should start after

Since Environment Canada intends to delay the coming into force of the Regulations by one year following the day they are registered, reporting requirements will not be retroactively triggered.

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the “first full calendar year of effective regulation”.

Exemptions

General Comment Summary Response Exempted products should have time restrictions to encourage the phase out of all mercury-containing products. Otherwise, by granting exemptions, there is no incentive to seek alternatives.

Environment Canada included one phase-out period for mercury vapour lamps for general lighting purposes (≥40 watts et ≤1000 watts) (sub-item 6 in the Schedule to the proposed Regulations). Environment Canada does not intend to include other time restrictions on the list of exempted products, as it is not aware of the imminent development of viable mercury-free alternatives for these products. However, Environment Canada does commit to staying abreast of advances in technology and amending the Schedule of the Regulations to remove exempted products or lower content limits, as appropriate.

How were the exemptions and content limits established? There should be a process for adding products to the Schedule, either because they were missed during consultation, or because the short-term permitting is not suitable. For example, the EU exemptions process, where persons can apply for exemptions that would apply to more than one person, should be considered.

Environment Canada has consulted extensively to determine the list of exempted products, including consultations on the Risk Management Strategy for Mercury-containing Products and the Proposed Risk Management Instruments for Mercury-containing Products, as well as pre-Canada Gazette, Part 1 and the Canada Gazette, Part 1 consultations. Environment Canada has also examined legislation and regulations in other jurisdictions. Stakeholders should notify Environment Canada immediately of any remaining existing products they believe will need to continue to be imported, manufactured or sold in Canada following the coming into force of the Regulations. A detailed rationale should be provided as to why the product should receive an exemption.

After the Regulations have entered into force, a permit would be required to manufacture or import a mercury-containing product not listed in the Schedule of the Regulations. If a demonstrated need arose, Environment Canada could amend the Regulations to make additional exemptions available to more than one person.

Dental Amalgam Comment Summary Response Dental amalgam should not be exempted from the Regulations. Banning amalgam would result in a cleaner environment by stopping mercury emissions and protecting human health.

The Government of Canada is using its authority under CEPA 1999 to regulate mercury releases to the environment from mercury-containing products. Dental amalgam was exempted because it is considered an essential product which has no viable alternative. Dental amalgam releases to the environment are controlled through the Pollution Prevention Planning Notice for Dental Amalgam Waste33.

The safety of dental amalgam has been evaluated by Health Canada.34 Dental amalgam has viable alternatives. Resin and ART (atraumatic restorative treatment) are appropriate for most cavities.

The Government should have a time-limited exemption on dental amalgam in order to reassess the availability of alternatives later.

The Government will continue to monitor available alternatives and actions taken in other jurisdictions, including the global legally binding instrument on mercury pollution that is currently being negotiated under the United Nations.

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Dental workers are exposed to mercury. These Regulations under CEPA 1999 do not address occupational health and safety.

Voluntary measures for dental amalgam have failed, and the Pollution Prevention Notice for Dental Amalgam Waste35 is not enforceable. Dental amalgam accounts for half of the mercury currently entering the Canadian marketplace in products, and should be subject to regulatory measures.

Releases of mercury to the environment from dental amalgam waste are being managed using a pollution prevention notice, which is an enforceable instrument under CEPA 1999.

The Regulations should align with the US, which recently announced that they support a phase down of dental amalgam.

A phase down of dental amalgam use is expected in Canada due to the development of improved oral health promotion and disease prevention programs, research into alternative dental restorative materials and improved access to dental care.

There should be labelling of dental amalgam.

Dental amalgam products will require labelling under the Regulations. Dental amalgam products are already voluntarily labelled.

Lamps Comment Summary Response How was the average mercury content in lamps noted in footnote 32 of the RIAS developed?

As noted in the RIAS, the average mercury content was provided by Electro-Federation Canada, the industry association representing lamp manufacturers and importers in Canada. It was calculated by dividing the total mercury content of all fluorescent and discharge lamps sold in Canada by Electro-Federation members by the total number of lamps sold in Canada for a specified year.

Exemptions for electrical and electronic products (i.e. lamps) should be aligned with those in the EU RoHS Directive, unless there is a specific reason not to do so.

Environment Canada will consider modifications to the lamp exemptions in order to align with those in the EU RoHS Directive where practical. However, it is important to note that North America uses different lighting systems than Europe; for example, North America typically uses 120 volt systems whereas Europe uses 220/240 volt systems. Related to this, the markets have evolved differently, including longer life lamps in North America than in Europe (e.g. North America has 4-foot lamps rated at 24,000, 30,000, 36,000, and 42,000 hours compared to Europe where 4-foot lamps are rated at 12,000, 15,000, 18,000, 25,000 and 34,000). Therefore the Canadian regulations may require different exemptions or content limits.

Compact fluorescent lamps for general lighting purposes should have limits of 4 mg for 24 watts and under and 5 mg for the higher wattages.

Environment Canada recognizes that these are the content limits that industry has voluntarily committed to under the National Electrical Manufacturers Association (NEMA) in the US.36 However, the limits in the EU RoHS Directive will also be considered. The June 2011 recast of the EU RoHS Directive contains limits for CFLs ranging from 2.5 mg to 15 mg depending on the wattage and the timing of the exemption.

The exemption for high pressure sodium vapour lamps should be 40 mg per Arc Tube.

Environment Canada is considering making this modification in the development of the final Regulations.

Definitions were proposed for CFLs, linear fluorescent lamps and general lighting purposes.

Environment Canada does not intend to include definitions of terms or products in the Regulations.

The exemption for linear fluorescent lamps for general lighting purposes should be

Environment Canada is considering making these modifications to the final Regulations. However, Environment Canada will also consider the limits set

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changed to:

triphosphate lamps with normal lifetime: 5 mg

triphosphate lamps with long lifetime: 8 mg

halophosphate lamps: 10 mg

in the recast EU RoHS Directive.

The exemption for metal halide lamps >300 and ≤ 700 watts should be changed to:

>300 and ≤ 500 watts: 65 mg

<500 and ≤ 700 watts: 85 mg

The exemption for metal halide lamps >700 and ≤ 1000 watts should be 160 mg.

Environment Canada intends to make these modifications in the development of the final Regulations.

The mercury content limit for automobile headlamps and cold cathode fluorescent lamps less than 1.5 m should be raised from 5 mg to 10 mg in order to establish consistency with the US and EU.

Environment Canada intends to make this modification in the development of the final Regulations.

Is exemption 17 a catch-all? (i.e. if the lamp is not covered by exemptions (2) to (16), then (17) applies).

For example, are UV lamps (e.g. germicidal, water sample analysis) exempted under item 17, or should they have a separate exemption?

Since there are such a wide variety of lamp types, it is likely that not all mercury-containing lamps would be covered by any given list of exemptions. Also, Environment Canada is aware of several specialized lamp types (e.g. disinfection, medical, tanning, video projection) with small market shares that would be subject to these Regulations. These are the types of lamps that would be covered by exemption (17). Environment Canada will gather information on the import, manufacture, sale, and mercury content of these types of lamps through the reporting provisions of the Regulations and could amend the Schedule of the Regulations to add additional items in the future if necessary.

Lamp limits need to be ramped down. Environment Canada will continue to monitor advances in technology and limits set in other jurisdictions, including the global legally binding instrument on mercury pollution that is currently being negotiated. In the future, Environment Canada may amend the Schedule, including the list of exempted lamps and their content limits, as appropriate.

It is strange for the Government to ban some products containing mercury and promote others (e.g. CFLs). Consumers should not be encouraged to use CFLs since they contain mercury. Testing and certification is not enough and CFLs should be taken off the market. There should be a timed review to reassess the exemption for CFLs.

All fluorescent lamps such as tubes used in commercial applications and CFLs, require a small amount of mercury in order to operate efficiently. CFLs produce the same light output as regular incandescent bulbs but use about one-quarter of the energy. The exemption for CFLs is in-line with amendments to Natural Resources Canada’s Energy Efficiency Regulations, which will phase out inefficient incandescent lamps and are proposed to come into place in 2014.

As for all exempted products, Environment Canada will continue to stay abreast of advances in technology and alternative mercury-free products and, in the future, could amend the Regulations to remove exempted lamps or lower content limits. Environment Canada’s initiative to introduce Extended Producer Responsibility regulations for mercury-containing lamps will ensure mercury doesn't end up in landfills and that Canadians can benefit from the high energy efficiency of this product.

The use of CFLs could increase as incandescent lamps are phased out. With the increased use of CFLs, even if the quantity of mercury in each bulb is low,

Environment Canada recognizes that CFLs contain mercury and must be managed appropriately at their end of life. To that end, Environment Canada is currently developing Extended Producer Responsibility (EPR) regulations that would require manufacturers and importers to implement programs to

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mercury releases to the environment could increase. Efforts must be placed on phasing out CFLs and replacing them with mercury-free alternatives.

collect and recycle mercury-containing lamps such as CFLs at their end of life.

According to consultations with industry, LEDs and other non-mercury alternatives are available to Canadian consumers and more should be introduced in the coming years at a reasonable price.

Replacement Parts Comment Summary Response What are replacement parts? Definitions will be addressed in guidance material prepared following

publication of the final Regulations. In general, a product would be covered by the exemption for replacement parts if no direct mercury-free replacement is available and a redesign or new system would be required to replace the product (e.g. lamp) with one that is mercury-free.

The exemption for replacement parts should be removed as it would impede the development of mercury-free replacement parts.

Environment Canada intends to maintain the exemption for replacement parts in order to ease the transition to mercury-free alternatives. The manufacture, import and sale of new mercury-containing products would be prohibited, so it is expected that the transition to mercury-free products will occur in a timely manner. Environment Canada also acknowledges that in some cases, it would not be possible or feasible to develop mercury-free replacement parts.

Replacement parts will be necessary not only for products put on the market prior to the coming into force of the Regulations, but for any products that legally contained the part (e.g. as a result of permit or exemption) at the time of manufacture or import.


Other Exemptions Comment Summary Response In exemption (18) for “high tech micro switch and high tech micro relay for monitoring and control equipment, what is meant by “high tech”?

The phrase “high tech” refers to high technology, or the most advanced technology currently available. It is often used in reference to micro-electronics. Environment Canada is considering using the wording in the EU RoHS Directive, which is more specific: “very high accuracy capacitance and loss measurement bridges and in high frequency RF switches and relays in monitoring and control instruments”. This exemption would apply, for example, to digital telecommunication applications.

Does exemption (20) for “scientific instrumentation for the calibration of medical devices or for the calibration of scientific research instruments” mean calibration apparatus used to calibrate other scientific instrumentation connected to it?

This exemption refers to any products (i.e. instrumentation) that are necessary for the completion of calibration protocols.

What is intended by exemption (22) “scientific instrumentation used as reference for clinical validation studies”? This exemption should be limited to studies already underway.

Environment Canada is aware of the recommendation that for clinical validation studies, mercury sphygmomanometers should remain available as reference for alternative mercury-free blood pressure measurement devices.37 Environment Canada does not intend to limit the exemption to studies already underway.

Could exemption (23) for “scientific instrumentation for measuring the quantity

This exemption refers specifically to the measurement of mercury in the environment.

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of mercury in the environment” also apply to the measurement of other chemical substances? Alternatives are available for the products listed in exemptions (19) - (21) and (23) - (30) (e.g. various health, safety and research applications) so they should not be exempt. The Government of Canada is encouraged to review examples in other jurisdictions regarding the elimination of mercury within the health care sector, and to commit to a process to engage stakeholders to develop a strategy to eliminate mercury use in health, safety and research sectors.

The Regulations will prohibit many products which have the potential to be used in health, safety and research sectors; however, exemptions were included for specific products where alternatives are not available. The rationale for exempted products is that they are essential to Canadians and no viable alternative exists. Environment Canada has consulted extensively to determine the list of exempted products, including pre-Canada Gazette, Part 1 consultations and the Canada Gazette, Part 1 consultations. Environment Canada has also examined legislation and regulations in other jurisdictions. Environment Canada commits to staying abreast of advances in technology and amending the Schedule of the Regulations as appropriate. Environment Canada encourages all sectors to eliminate their use of mercury-containing products.

Requests for Exemptions Comment Summary Response The mercury content limits in the EU Battery Directive should be adopted. While some mercury-free button cell batteries are available, issues remain related to power capacity, leakage, and mass production.

Environment Canada had not intended to grant any exemptions for batteries containing mercury or mercury compounds. However, as noted above, Environment Canada acknowledges that further consultation is required with stakeholders regarding mercury compounds (including appropriate prohibitions, exemptions, maximum quantities and timelines for coming into force) prior to the publication of the final Regulations. Accordingly, stakeholders should provide Environment Canada with further information regarding products containing mercury compounds, such as batteries.

Environment Canada is aware of other jurisdictions that have controlled the quantity of mercury in batteries including the European Union38, the US39, and the US states of Maine, Connecticut and Rhode Island.

There should be exemptions for various aerospace applications such as coatings and lighting.

Environment Canada requires more information in order to determine whether to include these exemptions, including: product purpose, availability of alternatives, quantity of mercury in the product (per product and total imported or manufactured in Canada per year), and end-of-life management practices. As well, any request for exemption should specifically name the mercury-containing product. Various specialized lamp types should be covered by Schedule item (17). Environment Canada will investigate this request in further detail.

There should be an exemption for mercury in slip rings (rotating electrical connectors) in industrial applications and wind turbines.

Mercury-containing slip rings will not receive an exemption since mercury-free alternatives are available.

There should be an exemption for mercury-containing tire balancers.

Mercury-containing tire balancers will not receive an exemption since mercury-free alternatives are available. Traditional tire balancers were made of lead but a transition is being made towards zinc which is less hazardous. Some US states such as Illinois are banning both mercury and lead tire balancers.40

There should be an exemption for “pressure sensors used in polyethylene manufacturing and processing”.

Environment Canada requires more information in order to determine whether to include this exemption, including: product purpose, availability of alternatives, quantity of mercury in the product (per product and total imported or manufactured in Canada per year), and end-of-life management practices. Environment Canada is investigating this request in further detail.

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There should be an exemption for manometers.

Manometers will not receive an exemption since mercury-free alternatives are available. Alternatives to manometers include devices that use a non-mercury liquid, needle bourdon gauges, aneroid manometers, and digital manometers. Digital manometers can be more accurate than mercury manometers if properly calibrated. It will also be possible to obtain replacement parts for products which contained the part prior to the coming into force of the Regulations.

There should be a general exemption for “scientific equipment or instrument” and could be linked to small volume.

There should also be the following specific exemptions:

“mercury intended for use in laboratory research applications” (no limit)

“mercury compounds intended for use in laboratory research applications” (no limit)

“a laboratory analytical standard” (no limit) – mercury compounds

Environment Canada does not intend to include a general exemption for scientific equipment or instruments. Stakeholders should notify Environment Canada immediately of any specific exemptions that are needed for scientific instruments beyond those already provided for in Schedule items (19) – (23) and include a detailed rationale.

These Regulations will apply to mercury-containing products, and not to the substances and compounds themselves. Therefore it is not necessary to include exemptions for elemental mercury.

As mentioned above, Environment Canada will be consulting further with stakeholders regarding mercury compounds (including appropriate prohibitions, exemptions, maximum quantities and timelines for coming into force) prior to the publication of the final Regulations. Environment Canada will consider the exemption for laboratory analytical standards containing mercury compounds during the development of the final Regulations.

Thermometers and scientific instruments used in quality control laboratories for petrol refining should be added to exemptions 19 and 20. Mercury-containing thermometers and hydrometers are required by ASTM methods.

Environment Canada intends to make this modification during the development of the final Regulations.

Medical Devices Comment Summary Response The EU RoHS Directive will apply to medical devices only in 2014 or 2016. The EU provided a phase-in because the products contain a limited amount of mercury and the design, validation and verification requirements that apply to changes in medical devices are mandated by law, time-consuming to complete, and costly to implement.

A transition period of 5 years should be granted for medical devices, or they should be exempt from the Regulations.

Medical devices are licensed under Health Canada’s Medical Devices Regulations to ensure their safety, efficacy and quality.41

Environment Canada is working with Industry Canada, Health Canada and relevant stakeholders to investigate this comment in further detail.

There should be an exemption for medical device product refurbishment and resale.

Environment Canada will consider this comment during the development of the final Regulations. These regulations are intended to target products manufactured or imported after the coming into force of the Regulations, not existing products.

Exemption (18) for “high tech micro switches and micro relays for monitoring and control equipment” should also include medical devices.

Environment Canada is working with Industry Canada, Health Canada and relevant stakeholders to investigate this comment in further detail.

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Medical devices should have exemptions rather than having to use the restrictive permitting system.

Environment Canada is open to including exemptions for specific mercury-containing medical devices that are essential and have no viable alternatives. However, the Department requires more information on the specific mercury-containing products, including: product purpose, availability of alternatives, quantity of mercury in the product (per product and total imported or manufactured in Canada per year), and end-of-life management practices. Permits are intended to be used for new, unforeseen products that did not exist before the coming into force of the Regulations.

End-of-Life Management of Mercury-containing Products

Comment Summary Response The government should implement Extended Producer Responsibility for mercury-containing lamps, including CFLs. The proposed instrument should be complementary to existing provincial programs.

Environment Canada is currently in the process of developing proposed Extended Producer Responsibility regulations which would require manufacturers and importers to implement programs for the collection and environmentally sound recycling of mercury-containing lamps such as CFLs. Environment Canada is working to ensure that the proposed Regulations are complementary to and do not duplicate existing provincial programs in British Columbia, Quebec and Manitoba.

The government should ensure the proper management of all mercury-containing products, including safe use, inventory reporting and appropriate disposal/recycling. Producers should be responsible for the collection and end-of-life management of their products.

What should companies do with excess mercury and products?

How mercury is collected and stored in Canada?

How do dentists dispose of dental amalgam waste?

How are old thermometers disposed of?

Environment Canada recognizes it is important that mercury-containing products are handled appropriately to prevent releases to the environment. Mercury-containing waste must be managed in accordance with all relevant governmental requirements and policies. To plan for the proper recycling of mercury-containing products, mercury recycling companies, hazardous waste management firms and/or certified carriers should be contacted and products should be properly packaged prior to transport to help prevent breaks or leaks.

Furthermore, the control of hazardous waste and hazardous recyclable material within Canada is a shared responsibility between the federal, provincial/territorial and municipal governments. Since the provinces/territories are responsible for establishing controls for licensing hazardous waste generators, carriers and treatment facilities within their jurisdiction, provincial/territorial government’s may also be contacted for guidance. Mercury-containing products may also be collected as part of municipal household hazardous waste collection programs and many companies will take back mercury-containing products.

At the federal level Environment Canada has taken action to ensure the proper management of various mercury-containing products at their end-of-life. For example, under the Pollution Prevention Planning Notice for Dental Amalgam Waste, dentists should contact an authorized carrier to dispose of their dental amalgam waste. Environment Canada is also in the process of developing an Extended Producer Responsibility regulation for the collection and recycling of mercury-containing lamps. By prohibiting most mercury-containing products, these Regulations will mean there will be far fewer mercury-containing products to manage at their end-of-life.

Education

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Comment Summary Response Environment Canada, Health Canada, Natural Resources Canada and impacted regulatees should implement a national education and outreach campaign that will educate Canadians about the risks associated with mercury-containing products, which products contain mercury, the availability and reliability of alternative products, labelling information and symbols and disposal options for mercury-containing products. In particular, information should be provided on the recycling of fluorescent lamps.

The Government will retain this suggestion and will consider conducting an education campaign when the Regulations come into force.

Environment Canada, Health Canada, and Natural Resources Canada already provide information on their websites regarding the risks of mercury, mercury-containing products and their alternatives, disposal and clean-up.

Environment Canada - Mercury and the Environment:

http://www.ec.gc.ca/mercure-mercury

Health Canada - Mercury and Human Health:

http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/environ/merc-eng.php

Natural Resources Canada – Compact Fluorescent Lamps:

http://oee.nrcan.gc.ca/residential/business/manufacturers/mercury.cfm?attr=4

The Extended Producer Responsibility Regulations that are being developed by Environment Canada will include communication and education activities to increase awareness of the collection and recycling program.

Health Canada should implement an education and outreach campaign within the dental industry to educate Canadians about the health impacts of mercury-containing dental amalgam and to raise awareness of the non-mercury options available.

Health Canada has reviewed the safety of dental amalgam and provided advice.

International

Comment Summary Response Support was voiced for Canada’s efforts to reduce global mercury pollution through the United Nations international negotiations towards a global legally binding instrument on mercury pollution. The regulations were seen as a signal to the international community of Canada’s commitment to reduce mercury pollution.

How is the Government addressing the arrival of foreign mercury emissions? The mercury removed from products in Canada would be small compared to global use.

Canada is working diligently with other countries to reduce mercury emissions around the world, for the benefit of the environment and health of Canadians. Canada strongly supports the decision taken by the United Nations Environment Programme (UNEP) Intergovernmental Negotiation Committee (INC) to develop a global, legally binding treaty on mercury, with negotiations expected to conclude in 2013. The Canadian government supports the development of this treaty and has been actively participating in the INC. These Regulations on mercury-containing products represent Canada’s commitment to target one of the largest remaining domestic sources of mercury emissions.

The proposed Regulations are anticipated to reduce Canadian releases of mercury to the environment by 54 000 kg over 20 years, including a reduction of releases to air of about 10 000 kg. Action by Canada on products will substantially reduce Canada’s remaining emissions and will strengthen its position internationally when seeking to obtain commitments from foreign jurisdictions to reduce their mercury emissions.

Regulatory Review

Comment Summary Response The Regulations should be subject to periodic review in order to assess their

Environment Canada will use data acquired through the reporting requirements of the Regulations to monitor their performance and

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http://www.ec.gc.ca/mercure-mercury

http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/environ/merc-eng.php



performance and effectiveness. The review should include: participation from civil society, exemptions and content limits, permitted products, quantity of mercury entering Canada in products.

effectiveness. Progress, performance, and overall effectiveness would be reported on through a variety of means including the CEPA 1999 annual report and departmental performance reports. Comments and input from civil society would be welcomed at any time.

Compliance Promotion and Enforcement

Comment Summary Response Resources will need to be assigned to compliance promotion and enforcement to ensure a level playing field for those who comply with the Regulations.

The RIAS outlines the resources that will be assigned to the compliance promotion and enforcement of these Regulations, including training, inspection, investigations and prosecutions. In total, the present value of the compliance promotion and enforcement costs over the 20-year period will be $4.2 million. Compliance promotion will be focused on the first 3 years, and enforcement will be ongoing.

Consultations

Comment Summary Response ENGO participation in the development of regulations for all aspects of mercury pollution has been insufficient. There need to be more face-to-face meetings.

Consultation is an integral part of the success of CEPA 1999. Industry, and individuals, and all interested parties (such as ENGOs) are continually invited to participate in a wide variety of public consultations through notices published in Canada's official parliamentary journal, the Canada Gazette, as well as other more informal means on a sector-by-sector basis.

The regulatory process has been very long and has contributed further costs to health and environment.

Canada’s approach to mercury-containing products has been developed through a process of extensive consultations over a number of years42. Consultation is required at all stages of the process in order to ensure that meaningful and effective measures are developed, and to give industry time to adjust. These Regulations will contribute to further reductions in mercury emissions from products.

Regulatory Impact Analysis Statement (RIAS)

General Comments Comment Summary Response The RIAS incorrectly states that products containing mercury would be subject to similar provisions in US states and/or the European Union. The proposed Regulations are not harmonized with requirements in either region.

In the United States, mercury-containing products are controlled through a variety of federal and state measures, which include product bans, content limits and labelling requirements, among others. Similarly in the European Union a variety of Directives exist on mercury-containing products such as electronics and electrical products, batteries, and measuring and control devices. In contrast, Canada’s Regulations will bring together requirements for all mercury-containing products under one instrument and will therefore be collectively similar in scope.

Environment Canada will further harmonize the final Regulations with provisions in the US and EU where possible and practical, in particular with

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regards to mercury content limits.

Various information and analysis was requested, including:

The quantity mercury in products over a number of years

The cumulative quantity of mercury used in dental amalgam and lamps in Canada over time

A list of all mercury-containing products imported into Canada

An example of the mass balance framework, including the assumptions used to determine the baseline scenarios and releases to each media (air, land and water)

These points will be considered in the development of the final RIAS.

Regarding the list of mercury-containing products imported into Canada, Environment Canada gathered data from the Canadian Border Services Agency, industry associations, and other sources. However, since importers of mercury-containing products do not currently have to report to any government department or agency, it is possible that some minor sources could have been missed. It is for that reason that Environment Canada has consulted broadly and repeatedly regarding these Regulations

The mass balance framework and assumptions regarding the various product streams are available in the 2009 report prepared by ToxEcology for Environment Canada entitled “Socio-Economic and Mass Balance Study for Mercury-Containing Products”. Part of the report is available on-line through the United Nations website at: http://www.unep.org/hazardoussubstances/Portals/9/Mercury/Documents/INC2/Canada%20information.pdf

Note that certain parts are blacked out in order to protect Confidential Business Information.

Cost Benefit Analysis Comment Summary Response What impact will these Regulations have on jobs in Canada and how will we cope with the added unemployed workforce?

As described in the RIAS, the manufacture of mercury-containing products in Canada is limited to mercury-containing lamps and neon signs, which will be exempted (and subject to content limits) under the Regulations. Importers and retailers may pass on some minor temporary cost increases for mercury-free alternatives to their consumers, but this is not expected to result in job losses.

Efforts at identifying mercury exposure costs on the healthcare system have not been done.

Within the Canadian context, monetizing with confidence the health benefits of reduced mercury emissions is challenging as reliable data on the cost of exposures is difficult to access. The expected benefits would likely be small compared to the benefits that could be realized by greater global action.

There may be an underestimation of the quantity of mercury in products as the development of new products containing mercury has not been accounted for and since it has been assumed that the quantity of mercury in lamps will not change. The projections for the growth in the market for mercury-containing lamps may also be underestimated.

The introduction of new products containing mercury under the baseline scenario (business as usual) is very difficult to anticipate and quantify in a cost benefit analysis. Under the regulatory scenario, very few new mercury-containing products are anticipated to enter the Canadian marketplace through the permitting scheme. The quantity of mercury from major North American and E.U manufactured products have been declining for years. There is no information at this time to support a growing trend in the mercury content levels of lamps.

Mercury-containing lamps should meet the content limits set by the Regulations.

The sales projections for mercury lamps include significant market growth in the short (25%) and medium term (10%) to account for the phase out of inefficient lamps under Natural Resources Canada’s Energy Efficiency Regulations, which will come into force in 2014. After this time it is expected that sales of mercury containing lamps will slow, due to their longer lifetime in comparison with the incandescent lamps, as well as new, high-efficiency mercury-free lamps becoming more commercially available.

These projections were based on several factors including sales data, the regulatory landscape, and the lifespan of the products. Projections for the growth in the lamp market will be re-examined in the development of the final

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http://www.unep.org/hazardoussubstances/Portals/9/Mercury/Documents/INC2/Canada%20information.pdf

http://www.unep.org/hazardoussubstances/Portals/9/Mercury/Documents/INC2/Canada%20information.pdf

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RIAS in the context of the proposed delay in the implementation of the energy efficiency standards for general service lamps by Natural Resources Canada.

The international negotiations towards a global legally binding instrument on mercury under the United Nations will provide further signals to industry that a world-wide shift towards mercury-free products is underway. Environment Canada will monitor the quantity of mercury entering Canada in products through the information reported under these Regulations.

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17 Environment Canada. 2010. Notice Regarding Pollution Prevention Planning in Respect of Mercury Releases from Dental Amalgam Waste. Available online at: http://www.ec.gc.ca/planp2-p2plan/default.asp?lang=En&n=EB42EEDF-1 18 National Electrical Manufacturers Association. 2006. NEMA Announces Battery Industry Commitment to Eliminating Mercury in Button Cells. Available online at: http://www.nema.org/media/pr/20060302a.cfm. 19 United Nations Environment Programme. 2011. The Negotiating Process. Available online at: www.unep.org/hazardoussubstances/MercuryNot/MercuryNegotiations/tabid/3320/language/en-US/Default.aspx 20 Department of Justice. 2011. Consumer Packaging and Labelling Regulations. Available online at: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._417/index.html. 21 Natural Resources Canada: Office of Energy Efficiency. 2009. Canada's Energy Efficiency Regulations. Lighting Products - Package Labelling. Final Bulletin – December 2008. Available online at: http://oee.nrcan.gc.ca/regulations/bulletin/lighting-products-dec08.cfm?attr=0. 22 US Federal Trade Commission. 2010. 16 C.F.R. Part 305: Appliance Labeling Rule: Final Rule Amending the Lamp Labeling Requirements In the Appliance Labeling Rule, and Requesting Further Comment On Several Issues For Consideration In Any Subsequent Rulemaking. Available online at: www.ftc.gov/os/2010/06/index.shtm#18. 23 Department of Justice. 2011. Consumer Packaging and Labelling Act. Available online at: http://laws-lois.justice.gc.ca/eng/acts/C-38/ 24 Department of Justice. 2011. Consumer Packaging and Labelling Regulations. Available online at: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._417/index.html. 25 Official Journal of the European Union. 2011. Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002L0096:EN:HTML 26 Health Canada. 2003. Stay Safe: An Education Guide to Hazard Symbols. Available online at: www.hc-sc.gc.ca/cps-spc/pubs/indust/stay_safe-soyer_en_securite/index-eng.php 27 US Federal Trade Commission. 2010. 16 C.F.R. Part 305: Appliance Labeling Rule: Final Rule Amending the Lamp Labeling Requirements In the Appliance Labeling Rule, and Requesting Further Comment On Several Issues For Consideration In Any Subsequent Rulemaking. Available online at: www.ftc.gov/os/2010/06/index.shtm#18. 28 Repak Ltd. 2011. Green Dot. Available online at: www.greendot.ie/. 29 Northeast Waste Management Officials' Association. 2011. Mercury-added Product Database. Available online at: www.newmoa.org/prevention/mercury/imerc/Notification/about.cfm 30 International Laboratory Accreditation Cooperation. 2011. Available online at: www.ilac.org/ 31 National Electrical Manufacturers Association. 2010. Limits on Mercury Content in Self-Ballasted Compact Fluorescent Lamps. Available online at: http://www.nema.org/stds/ll8.cfm. 32 Standards Council of Canada. 2011. Available online at: www.scc.ca. 33 Environment Canada. 2010. Notice Regarding Pollution Prevention Planning in Respect of Mercury Releases from Dental Amalgam Waste. Available online at: http://www.ec.gc.ca/planp2-p2plan/default.asp?lang=En&n=EB42EEDF-1 34 Health Canada. 1996. The Safety of Dental Amalgam. Available online at: www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/pubs/dent_amalgam-eng.php. 35 Environment Canada. 2010. Notice Regarding Pollution Prevention Planning in Respect of Mercury Releases from Dental Amalgam Waste. Available online at: http://www.ec.gc.ca/planp2-p2plan/default.asp?lang=En&n=EB42EEDF-1 36 National Electrical Manufacturers Association. 2011. 2010 NEMA Voluntary Commitment on Mercury in Compact Fluorescent Lamps. Available online at: http://www.nema.org/gov/env_conscious_design/lamps/cfl-mercury.cfm 37 European Commission: Scientific Committee on Emerging and Newly Identified Health Risks. 2009. Mercury Sphygmomanometers in Healthcare and the Feasibility of Alternatives. Available online at: http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_025.pdf 38 Official Journal of the European Union. 2006. Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and

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accumulators and repealing Directive 91/157/EEC. Available online at: http://ec.europa.eu/environment/waste/batteries/index.htm 39 US Library of Congress. 1996. Mercury-Containing Battery Management Act. Available online at: http://thomas.loc.gov/cgi-bin/query/z?c104:H.R.2024.ENR:# 40 Illinois Law Banning Lead and Mercury Wheel Weights Goes into Effect January 2012. 2011. Available online at: www.epa.state.il.us/mercury/mercury-wheel-weights.pdf 41 Health Canada. 2010. Medical Devices. Available online at: www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php 42 Environment Canada. 2011. Proposed Regulation of Mercury-containing Products in Canada: Development of the Proposed Regulation. Available online at: www.ec.gc.ca./mercure-mercury/default.asp?lang=En&n=7EB39FAC-1.