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Vol. 143, No. 29 — July 18, 2009

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice is hereby given that, pursuant to section 127 of the Canadian Environmental Protection Act, 1999, Disposal at Sea Permit No. 4543-2-06588 authorizing the loading for disposal and the disposal of waste or other matter at sea is approved.

 1. Permittee: Torngat Fish Producers Co-operative Society Limited, Happy Valley-Goose Bay, Newfoundland and Labrador.

 2. Waste or other matter to be disposed of: Fish waste and other organic matter resulting from industrial fish-processing operations.

2.1. Nature of waste or other matter: Fish waste and other organic matter consisting of fish and shellfish waste.

 3. Duration of permit: Permit is valid from October 10, 2009, to October 9, 2010.

 4. Loading site(s): Makkovik, Newfoundland and Labrador, at approximately 55°05.30′ N, 59°14.60′ W (NAD83).

 5. Disposal site(s): Makkovik, within a 250 m radius of 55°05.60′ N, 59°10.20′ W (NAD83), at an approximate depth of 37 m.

 6. Method of loading: The Permittee shall ensure that the material is loaded onto floating equipment complying with all applicable rules regarding safety and navigation and capable of containing all waste cargo during loading and transit to the approved disposal site.

6.1. The Permittee shall ensure that the waste to be disposed of is covered by netting or other material to prevent access by gulls and other marine birds, except during direct loading or disposal of the waste.

6.2. Material loaded for the purpose of disposal at sea may not be held aboard any ship for more than 96 hours from the commencement of loading without the written consent of an enforcement officer designated pursuant to subsection 217(1) of the Canadian Environmental Protection Act, 1999.

6.3. The loading and transit shall be completed in a manner that ensures that no material contaminates the marine environment, notably the harbour and adjacent beaches. The Permittee shall also ensure that the loading sites are cleaned up and, if necessary, that spilled wastes are recovered.

 7. Route to disposal site(s) and method of transport: Most direct navigational route from the loading site to the disposal site.

 8. Method of disposal: The Permittee shall ensure that the waste to be disposed of shall be discharged from the equipment or ship while steaming within the disposal site boundaries and in a manner which will promote dispersion.

 9. Total quantity to be disposed of: Not to exceed 500 tonnes.

10. Inspection: By accepting this permit, the Permittee and their contractors accept that they are subject to inspection pursuant to Part 10 of the Canadian Environmental Protection Act, 1999.

11. Contractors: The loading or disposal at sea referred to under this permit shall not be carried out by any person without written authorization from the Permittee.

11.1. The Permittee shall ensure that all contractors involved in the loading or disposal activity for which the permit is issued adhere to the conditions identified in the permit and are aware of possible consequences of any violation of these conditions.

12. Reporting and notification: The Permittee shall provide the following information at least 48 hours before loading and disposal activities commence: the expected period of loading and disposal activities. The above-noted information shall be submitted to Mr. Rick Wadman, Environmental Protection Operations Directorate, Environment Canada, 6 Bruce Street, Mount Pearl, Newfoundland and Labrador A1N 4T3, 709-772-5097 (fax), rick. wadman@ec.gc.ca (email).

12.1. The Permittee shall submit a written report to the Minister, as represented by the Regional Director of the Environmental Protection Operations Directorate, c/o Mr. Rick Wadman, as identified in paragraph 12, within 30 days of either the completion of the work or the expiry of the permit, whichever comes first. This report shall contain the following information: the quantity of matter disposed of at the disposal site(s) and the dates on which disposal activities occurred.

12.2. This permit shall be displayed in an area of the plant accessible to the public.

I. R. GEOFFREY MERCER
Environmental Protection Operations Directorate
Atlantic Region
On behalf of the Minister of the Environment

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice is hereby given that, pursuant to section 127 of the Canadian Environmental Protection Act, 1999, Disposal at Sea Permit No. 4543-2-06589 authorizing the loading for disposal and the disposal of waste or other matter at sea is approved.

 1. Permittee: Torngat Fish Producers Co-operative Society Limited, Happy Valley-Goose Bay, Newfoundland and Labrador.

 2. Waste or other matter to be disposed of: Fish waste and other organic matter resulting from industrial fish-processing operations.

2.1. Nature of waste or other matter: Fish waste and other organic matter consisting of fish and shellfish waste.

 3. Duration of permit: Permit is valid from October 10, 2009, to October 9, 2010.

 4. Loading site(s): Nain, Newfoundland and Labrador, at approximately 56°32.61′ N, 61°41.30′ W (NAD83).

 5. Disposal site(s): Nain, within a 250 m radius of 56°32.61′ N, 61°41.00′ W (NAD83), at an approximate depth of 17 m.

 6. Method of loading: The Permittee shall ensure that the material is loaded onto floating equipment complying with all applicable rules regarding safety and navigation and capable of containing all waste cargo during loading and transit to the approved disposal site.

6.1. The Permittee shall ensure that the waste to be disposed of is covered by netting or other material to prevent access by gulls and other marine birds, except during direct loading or disposal of the waste.

6.2. Material loaded for the purpose of disposal at sea may not be held aboard any ship for more than 96 hours from the commencement of loading without the written consent of an enforcement officer designated pursuant to subsection 217(1) of the Canadian Environmental Protection Act, 1999.

6.3. The loading and transit shall be completed in a manner that ensures that no material contaminates the marine environment, notably the harbour and adjacent beaches. The Permittee shall also ensure that the loading sites are cleaned up and, if necessary, that spilled wastes are recovered.

 7. Route to disposal site(s) and method of transport: Most direct navigational route from the loading site to the disposal site.

 8. Method of disposal: The Permittee shall ensure that the waste to be disposed of shall be discharged from the equipment or ship while steaming within the disposal site boundaries and in a manner which will promote dispersion.

 9. Total quantity to be disposed of: Not to exceed 500 tonnes.

10. Inspection: By accepting this permit, the Permittee and their contractors accept that they are subject to inspection pursuant to Part 10 of the Canadian Environmental Protection Act, 1999.

11. Contractors: The loading or disposal at sea referred to under this permit shall not be carried out by any person without written authorization from the Permittee.

11.1. The Permittee shall ensure that all contractors involved in the loading or disposal activity for which the permit is issued adhere to the conditions identified in the permit and are aware of possible consequences of any violation of these conditions.

12. Reporting and notification: The Permittee shall provide the following information at least 48 hours before loading and disposal activities commence: the expected period of loading and disposal activities. The above-noted information shall be submitted to Mr. Rick Wadman, Environmental Protection Operations Directorate, Environment Canada, 6 Bruce Street, Mount Pearl, Newfoundland and Labrador A1N 4T3, 709-772-5097 (fax), rick.wadman@ec.gc.ca (email).

12.1. The Permittee shall submit a written report to the Minister, as represented by the Regional Director of the Environmental Protection Operations Directorate, c/o Mr. Rick Wadman, as identified in paragraph 12, within 30 days of either the completion of the work or the expiry of the permit, whichever comes first. This report shall contain the following information: the quantity of matter disposed of at the disposal site(s) and the dates on which disposal activities occurred.

12.2. This permit shall be displayed in an area of the plant accessible to the public.

I. R. GEOFFREY MERCER
Environmental Protection Operations Directorate
Atlantic Region
On behalf of the Minister of the Environment

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 15543

Whereas the Minister of the Environment and the Minister of Health have assessed information pertaining to the substance Poly[oxy(methyl-1,2-ethanediyl)], a-sulfo-w-hydroxy-, branched alkyl ethers, sodium salts;

And whereas the Ministers suspect that the substance is toxic,

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

JIM PRENTICE
Minister of the Environment

ANNEX

Conditions

(Section 84 of the Canadian Environmental Protection Act, 1999)

The person who complies with subsection 81(1) of the Canadian Environmental Protection Act, 1999 (the Notifier hereafter) may manufacture or import the substance if that person also complies with the following conditions:

Restriction

1. The Notifier may import the substance in order to use it only in oil production operations.

2. The Notifier may manufacture the substance, if, at least 60 days prior to the beginning of the manufacturing, they inform the Minister of the Environment, in writing, and provide the Minister with the following information:

(a) the information specified in item 5 of Schedule 10 to the New Substances Notification Regulations (Chemicals and Polymers);

(b) the information specified in paragraph 11(c) of Schedule 11 to those Regulations; and

(c) the following information related to the manufacturing and processing of the substance in Canada:

(i) a brief description of the manufacturing process that details precursors of the substance, reaction conditions (e.g. temperature, pressure, catalysts and reaction stoichiometry), and the nature (batch or continuous) and scale of the process,

(ii) a flow diagram of the manufacturing process that includes features such as process tanks, holding tanks and distillation towers, and

(iii) a brief description of the major steps in process operations, the chemical conversions, the points of entry of all feedstock, the points of release of substances, and the processes to eliminate environmental releases.

Disposal Restriction of the Substance

3. (1) The Notifier must destroy or dispose of the substance or any waste containing it, by

(a) on-shore deep-well injection in accordance with the laws of the jurisdiction where the well is located;

(b) incineration in accordance with the laws of the jurisdiction where the disposal facility is located; or

(c) depositing it in a secure landfill, in accordance with the laws of the jurisdiction where the landfill is located, if it cannot be destroyed or disposed of in accordance with paragraph (a) or (b).

(2) For the purpose of subitem (1), “waste” includes wastes resulting from rinsing transport vessels, storage vessels or blending vessels that contained the substance, process effluents, and any residual amounts of the substance.

Environmental Release

4. Where any release of the substance to the environment occurs in contravention of the present ministerial conditions, the Notifier shall immediately take all measures necessary to prevent any further release, and to limit the dispersion of any release. Furthermore, the Notifier shall inform the Minister of the Environment immediately by contacting an enforcement officer, designated under the Canadian Environmental Protection Act, 1999, of the Environment Canada Regional Office that is closest to where the release occurred.

Record-keeping Requirements

5. (1) The Notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

(a) the quantity of the substance that the Notifier manufactures, imports, purchases, sells and uses;

(b) the name and address of each person obtaining the substance from the Notifier; and

(c) the name and address of the person in Canada who has disposed of the substance or of the waste containing the substance for the Notifier, the method used to do so, and the quantities of the substance or waste shipped to that person.

(2) The Notifier shall maintain electronic or paper records mentioned in subitem (1) at the Notifier’s principal place of business in Canada.

Other Requirements

6. The Notifier shall inform all persons who obtain the substance from them, in writing, of the terms of the present ministerial conditions. The Notifier shall obtain, prior to any transfer of the substance, written confirmation from these persons that they will use the substance only in oil production operations, and comply with the terms of the present ministerial conditions as if they had been imposed on them. These records shall be maintained at the Notifier’s principal place of business in Canada.

Coming into Force

7. The present ministerial conditions come into force on July 2, 2009.

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2009-66-05-01 Amending the Non-domestic Substances List

The Minister of the Environment, pursuant to subsection 66(2) of the Canadian Environmental Protection Act, 1999 (see footnote a), hereby makes the annexed Order 2009-66-05-01 Amending the Non-domestic Substances List.

Ottawa, June 30, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-66-05-01 AMENDING THE NON-DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part I of the Non-domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

1121-22-8

740817-93-0

923586-78-1

1834-30-6

740817-96-3

928663-45-0

3086-72-4

740817-99-6

929253-05-4

5256-79-1

740818-00-2

934201-27-1

13552-21-1

742087-48-5

934390-23-5

17865-85-9

742087-49-6

939799-14-1

18923-59-6

815580-59-7

943002-55-9

23432-65-7

823178-41-2

943609-24-3

67423-04-5

847871-06-1

949488-60-2

71604-74-5

852227-26-0

950918-18-0

83418-60-4

853030-17-8

956147-76-5

91844-53-0

854737-08-9

960154-34-1

120128-90-7

862286-80-4

1001354-72-8

134818-68-1

863393-25-3

1002097-01-9

136954-25-1

870778-34-0

1003582-37-3

156324-82-2

878545-84-7

1003863-30-6

202330-92-5

883454-06-6

1004294-95-4

252254-51-6

888480-69-1

1004312-45-1

308362-88-1

894082-03-2

1012042-03-3

352206-47-4

908018-24-6

1028343-04-5

572882-37-2

915152-15-7

1028343-07-8

685090-03-3

918814-85-4

 

685517-66-2

920979-81-3

 

2. Part II of the List is amended by adding the following in numerical order:

14949-0

Heteromonocycle, polymer with 2,4-disubstituted benzene,
C10-rich, C9-11 branched and linear alcohols and heteromonocycle-substituted propane blocked

 

Hétéromonocycle polymérisé avec le 2,4-disubstituébenzène, des
alcools en C9-11, riches en C10, ramifiés et linéaires, bloqué avec un
hétéromonocycle substitué propane

18025-7

Molybdate (Mo8O264-), hydrogen, compound with N,N-dialkyl-1-dodecanamine (1:4:4)

 

Molybdate d’hydrogène, composé avec la N,N-dialkyldodécan-1-amine (1:4:4)

18026-8

Heteroaromaticsulfonic acid, (tetrahalogen-1,3-dihydro-1,3-
dioxo-2H-isoindol-2-yl)-(tetrahalogen-3-hydroxy-1-oxo-1H-inden-2-yl)-, metal salt

 

Acide hétéroaromatiquesulfonique, (tétrahalogène-
1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-(tétrahalogène-3-hydroxy-
1-oxo-1H-indèn-2-yl)-, sel métallique

COMING INTO FORCE

3. This Order comes into force on the day on which it is published in the Canada Gazette.

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of Naphthalene, chloro derivatives, CAS No. 70776-03-3 — substances specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas naphthalene, chloro derivatives are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas “naphthalene, chloro derivatives” describes variable chemical mixtures that contain chlorinated naphthalenes;

Whereas a summary of the draft Screening Assessment Report conducted on chlorinated naphthalenes pursuant to section 74 of the Act is annexed hereby;

Whereas polychlorinated naphthalenes, chlorinated naphthalenes that contain two to eight chlorine atoms, meet one or more of the criteria set out in section 64 of the Act; and

Whereas the Minister of the Environment and the Minister of Health are satisfied that polychlorinated naphthalenes meet the criteria set out in subsection 77(4) of the Act since they are persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, their presence in the environment results primarily from human activity and they are not naturally occurring radionuclides or naturally occurring inorganic substances,

Therefore, notice is hereby given that the Minister of the Environment and the Minister of Health intend to recommend to Her Excellency the Governor in Council that polychlorinated naphthalenes be added to Schedule 1 to the Act.

Notice is further given that the Minister of the Environment proposes the implementation of virtual elimination of polychlorinated naphthalenes under subsection 65(3) of the Act.

Notice is furthermore given that the Minister of the Environment and the Minister of Health have released a risk management scope document for this substance to initiate discussions with stakeholders on the development of a risk management approach.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the Ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the CEPA Registry Web site (www.ec.gc.ca/CEPARegistry/subs_list/assessments.cfm). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

MARGARET KENNY
Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment

KAREN LLOYD
Director General
Chemicals, Air and Water Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Draft Ecological Screening Assessment Report of Chlorinated Naphthalenes

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on chlorinated naphthalenes. “Naphthalene, chloro derivatives,” Chemical Abstracts Service Registry No. 70776-03-3, was identified as meeting the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms. “Naphthalene, chloro derivatives” is a variable chemical mixture that covers the chemical class of chlorinated naphthalenes.

Chlorinated naphthalenes were not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Chlorinated naphthalenes (CNs) have the molecular formula C10H8-nCln, where n = 1–8. There are 75 possible chlorinated naphthalenes, which are divided into 8 homologue groups based on the number of chlorine atoms in the molecule. These homologue groups are referred to with the prefixes mono- to octa- (e.g. mono-CNs, di-CNs). The number, and to a lesser extent the positions, of the chlorine atoms within the CN molecule are the key determinants of the physical and chemical properties of the CN congeners.

Key physical and chemical properties of CNs are useful in predicting their environmental fate. Water solubility, vapour pressure, and Henry’s Law constant values tend to decrease when progressing from mono- to octa-CNs, whereas log Kow, melting point, and boiling point tend to increase when progressing from mono- to octa-CNs.

Sources of CNs to the environment are mainly anthropogenic. Beginning around 1910, mono- to octa-CNs were produced commercially for a variety of uses. Chlorinated naphthalenes were likely never manufactured in Canada, but they were imported from manufacturers in the United States. Although CNs have not been in commercial use in Canada for more than two decades, they could be produced unintentionally as a by-product of industrial processes involving chlorine, especially in the presence of heat, such as waste incineration, cement and magnesium production, refining of metals such as aluminum, drinking water chlorination, and pulp and paper production (chlor-alkali process). Releases from some of these sources have not been well characterized. Other sources of CNs to the environment include disposal of products containing CNs in landfill sites and old industrial sites where CNs were used. There are reports that CNs have been released to the atmosphere from the domestic combustion of wood. A possible non-anthropogenic (i.e. natural) source of CNs is formation through the combustion of wood during forest fires.

Fugacity modeling is used to predict which environmental compartments CNs will partition to. Chlorinated naphthalenes tend to partition mainly to air and/or soil if released only to air. Chlorinated naphthalenes tend to partition mainly to water and sediment if released only to water.

Chlorinated naphthalenes have been detected in the following environmental samples from Canada: Arctic and urban air, Lake Ontario water, fish and birds from the Great Lakes and environs, Pacific killer whales, seals and whales from the Canadian Arctic, and Vancouver Island marmots. The database of environmental concentrations of CNs in Canada is limited. Much more environmental data on CNs, including data from sediments and soils, have been collected in the United States and in Europe.

Di- through octa-CNs are persistent in air. The potential for long-range transport was estimated to be moderate for di-CNs and high for tri- through octa-CNs, indicating that some CNs may be subject to atmospheric transport to remote regions such as the Arctic. In addition, di- through octa-CNs are predicted to be persistent in water, and tri- through hepta-CNs are persistent in both sediment and soil. Based on weight of evidence, including, in particular, measured log Kow values for di- to octa-CNs, the measured bioconcentration values for di- to penta-CNs in fish, measured biomagnification factors for tetra- to hepta-CNs, the high dietary uptake efficiencies of hexa- to octa-CNs in northern pike, and the very slow elimination of hexa-CNs from the bodies of rats and humans, it is concluded that di- to octa-CNs are also bioaccumulative.

The available empirical and modeled aquatic toxicity data for CNs indicate that di-, tri-, tetra- and penta-CNs may be harmful to aquatic organisms at relatively low concentrations — below 1 mg/L for acute tests, and 0.1 mg/L for chronic tests. Hexa-, hepta- and octa-CNs were found to cause harmful effects to mammals (particularly cattle) at doses of 0.69 mg/kg b.w./day and above.

Evidence that a substance is highly persistent and bioaccumulative, as defined in the Persistence and Bioaccumulation Regulations of CEPA 1999, when taken together with potential for environmental release or formation and potential for toxicity to organisms, provides a significant indication that the substance may be entering the environment under conditions that may have harmful long-term ecological effects. Substances that are persistent remain in the environment for a long time after being released, increasing the potential magnitude and duration of exposure. Substances that have long half-lives in mobile media (air and water) and partition into these media in significant proportions have the potential to cause widespread contamination. Releases of small amounts of bioaccumulative substances may lead to high internal concentrations in exposed organisms. Highly bioaccumulative and persistent substances are of special concern, since they may biomagnify in food webs, resulting in very high internal exposures, especially for top predators.

Based on the lines of evidence presented above, particularly the evidence for persistence, bioaccumulation and potential to cause harm at low exposure values, and taking into account the limitations of existing quantitative risk estimation methods when applied to such substances, especially data-poor ones like CNs, and recognizing that, although CNs are no longer in commercial use in Canada, they continue to enter the Canadian environment from unintentional production as well as transboundary movement of air, it is concluded that di- through octa-CNs have the potential to cause environmental harm in Canada.

Therefore, it is proposed that di- through octa-CNs, or polychlorinated naphthalenes, are entering the environment in quantities or concentrations or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity.

Proposed conclusion

Based on the information available, it is proposed that polychlorinated naphthalenes meet one or more of the criteria set out in section 64 of CEPA 1999. They are persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, their presence in the environment results primarily from human activity, and they are not a naturally occurring radionuclide or a naturally occurring inorganic substance; therefore, they meet the criteria set out in subsection 77(4) of CEPA 1999 and are proposed for the implementation of virtual elimination under subsection 65(3) of CEPA 1999.

The draft Screening Assessment Report for chlorinated naphthalenes as well as the proposed risk management scope document are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF FOREIGN AFFAIRS AND INTERNATIONAL TRADE

NOTICE OF INTENT TO CONDUCT A STRATEGIC ENVIRONMENTAL ASSESSMENT OF THE CANADA-EUROPEAN UNION COMPREHENSIVE ECONOMIC AND TRADE AGREEMENT

The Government of Canada has recently launched negotiations for a Comprehensive Economic and Trade Agreement (CETA) with the European Union (EU). It is now conducting a Strategic Environmental Assessment (EA) to inform these negotiations. Comments are invited on any likely and significant environmental impacts which this prospective CETA may have on Canada.

The Government of Canada is committed to sustainable development. Mutually supportive trade, investment and environmental policies can contribute to this objective. To this end, the Minister of International Trade has directed trade officials to improve their understanding of, and information based on, the relationship between trade and environmental issues at the earliest stages of decision making, and to do this through an open and inclusive process. Environmental assessments of trade negotiations are critical to this work.

This process is guided by the 2001 Framework for Conducting Environmental Assessments of Trade Negotiations and with direction from the 2004 Cabinet Directive on the Environmental Assessment of Policy, Plan, and Program Proposals.

For more information, please visit the following Web site:

All interested parties are invited to submit their views on any likely and significant environmental impacts on Canada resulting from the prospective Canada-EU CETA by Friday, September 18, 2009.

Contributions can be sent by email, fax or mail to consultations@international.gc.ca (email), 613-944-0757 (fax), Consultations and Liaison Division, Environmental Assessment Consultations — Canada-EU CETA, Foreign Affairs and International Trade Canada, Lester B. Pearson Building, 125 Sussex Drive, Ottawa, Ontario K1A 0G2.

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DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Food and Drug Regulations — Amendments

Interim Marketing Authorization

A provision currently exists in the Food and Drug Regulations (the Regulations) for the use of lecithin as a release agent on surfaces that come in contact with food at a maximum level of use consistent with good manufacturing practice. Provisions also exist in the Regulations for the use of lecithin as an emulsifying agent in cheese at a maximum level of use of 0.2%, in bread at a maximum level of use consistent with good manufacturing practice, in infant formula at a maximum level of use of 0.3% as consumed and in unstandardized foods at a maximum level of use consistent with good manufacturing practice. Paragraph B.25.062(2)(c) of the Regulations allows only the use of soybean lecithin in rice cereal that is labelled or advertised for consumption by infants.

Health Canada has received a submission to permit the use of lecithin as a release agent in infant cereals at a maximum level of use of 1.75% as consumed. Evaluation of available data supports the safety and effectiveness of lecithin as a release agent in the production of infant cereals.

The use of lecithin as a release agent in infant cereals will benefit consumers and industry by reducing the adhesion of the cereal to the processing equipment, which will improve the colour and flavour of the finished cereal products.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of lecithin as a release agent in the production of infant cereals at a maximum level of use of 1.75% as consumed.

As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of lecithin, as indicated above, while the regulatory process is undertaken to amend the Regulations. The unstandardized foods listed above are exempted from the application of paragraphs B.01.043(a) and B.25.062(2)(c), and section B.16.007, of the Food and Drug Regulations.

The proposed regulatory amendments would be enabling measures to allow the sale of additional foods containing lecithin as a release agent. The amendments are supported by the safety assessment and would have a low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.

Interested persons may make representations, with respect to Health Canada’s intention to amend the Regulations, within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the contact person identified below.

Contact

Marie-Claude Tardif, Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 251 Sir Frederick Banting Driveway, Address Locator 2203B, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-6625 (fax), sche-ann@hc-sc.gc.ca (email).

July 3, 2009

MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch

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Footnote a
S.C. 1999, c. 33

Footnote 1
Supplement, Canada Gazette, Part I, January 31, 1998