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Notice

Vol. 136, No. 17 — April 27, 2002

Regulations Amending the Food and Drug Regulations (1311 — Pyridaben)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Pyridaben is registered under the Pest Control Products Act as a miticide/insecticide for the control of mites on apples, cucumbers, grapes, peaches/nectarines, pears, peppers and strawberries. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of pyridaben at 2 parts per million (p.p.m.) in strawberries, 1.5 p.p.m. in peaches/nectarines, 1 p.p.m. in peppers, 0.75 p.p.m. in pears, 0.5 p.p.m. in apples, 0.3 p.p.m. in grapes and 0.1 p.p.m. in cucumbers, and at 0.05 p.p.m. in imported almonds. MRLs have also been established at 0.05 p.p.m. in the meat of cattle, goats, horses, and sheep, and 0.01 p.p.m. in milk to cover residues in food derived from animals fed with crops treated with pyridaben. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other foods is 0.1 p.p.m.

The Pest Management Regulatory Agency (PMRA) of Health Canada has recently approved an application to amend the registration of pyridaben in order to allow its use for the control of mites on tomatoes. This proposed regulatory amendment would establish an MRL for residues of pyridaben resulting from this use in tomatoes, in order to permit the sale of food containing these residues.

Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable.

The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a level that has no observable adverse effect or, in appropriate cases, by applying a risk factor that is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future.

After the review of all available data, the PMRA has determined that an MRL for pyridaben of 0.15 p.p.m. in tomatoes would not pose an unacceptable health risk to the public.

Alternatives

Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of pyridaben, establishment of an MRL for tomatoes is necessary to support the additional use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues.

Benefits and Costs

The use of pyridaben on tomatoes will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues.

Some costs may be incurred related to the implementation of analytical methods for analysis of pyridaben in the food mentioned above. Resources required are not expected to result in significant costs to the Government.

Consultation

Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organization for Economic Cooperation and Development. Individual safety evaluations conducted by the PMRA include a review of the assessments conducted at the international level as part of the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme in support of the Codex Alimentarius Commission, as well as MRLs adopted by other national health/ regulatory agencies.

Compliance and Enforcement

Compliance will be monitored through ongoing domestic and/or import inspection programs conducted by the Canadian Food Inspection Agency when the proposed MRL for pyridaben is adopted.

Contact

Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1311 — Pyridaben).

Interested persons may make representations with respect to the proposed 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 Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.: (613) 736-3692; Fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, April 18, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1311 — PYRIDABEN)

AMENDMENT

1. The portion of item P.8.01 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1)  in columns III (see footnote 2)  and IV (see footnote 3)  is replaced by the following:

  III IV
Item No. Maximum Residue Limit p.p.m Foods
P.8.01










2
1.5
1
0.75
0.5
0.3
0.15
0.1
0.05

0.01
Strawberries
Peaches/nectarines
Peppers
Pears
Apples
Grapes
Tomatoes
Cucumbers
Almonds, meat of cattle, goats, horses and sheep
Milk

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[17-1-o]

Regulations Amending the Food and Drug Regulations (1312 — Rimsulfuron)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Rimsulfuron is registered under the Pest Control Products Act as an herbicide for the control of a wide variety of weeds and grasses in corn, potatoes and field tomatoes for processing only as a post-emergence treatment. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the Maximum Residue Limit (MRL) for residues of rimsulfuron in any food is 0.1 parts per million (p.p.m.).

The Pest Management Regulatory Agency (PMRA) of Health Canada has approved an application to amend the registration of rimsulfuron in order to allow its use for the control of hairy nightshade in field tomatoes for fresh market as a post-emergence treatment. This proposed regulatory amendment would establish an MRL for residues of rimsulfuron resulting from this use in tomatoes, in order to permit the sale of food containing these residues.

Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable.

The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a no observable adverse effect level or, in appropriate cases, by applying a risk factor that is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future.

After the review of all available data, the PMRA has determined that an MRL for rimsulfuron of 0.05 p.p.m. in tomatoes would not pose an unacceptable health risk to the public. This new MRL harmonizes with the one established by the United States Environmental Protection Agency.

Alternatives

Under the Food and Drugs Act, the sale of food containing residues of pest control products at a level less than or equal to 0.1 p.p.m. is permitted unless a lower MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of rimsulfuron, establishment of an MRL for tomatoes is necessary to support the additional use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues.

Benefits and Costs

The use of rimsulfuron on tomatoes will provide joint benefits to consumers and the agricultural industry as a result of the improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues.

Some costs may be incurred related to the implementation of analytical methods for analysis of rimsulfuron in the food mentioned above. Resources required are not expected to result in significant costs to the Government.

Consultation

Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organization for Economic Cooperation and Development. Individual safety evaluations conducted by the PMRA include a review of the assessments conducted at the international level as part of the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme in support of the Codex Alimentarius Commission, as well as MRLs adopted by other national health/ regulatory agencies.

Compliance and Enforcement

Compliance will be monitored through ongoing domestic and/ or import inspection programs conducted by the Canadian Food Inspection Agency when the proposed MRL for rimsulfuron is adopted.

Contact

Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote b)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1312 — Rimsulfuron).

Interested persons may make representations with respect to the proposed 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 Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.: (613) 736-3692; Fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, April 18, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1312 — RIMSULFURON)

AMENDMENT

1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 4)  is amended by adding the following after item Q.1:

  I II III IV


Item
No.

Common
Chemical
Name


Chemical Name of
Substance
Maximum
Residue Limit
p.p.m.



Foods
R.1 rimsulfuron



N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide 0.05



Tomatoes



COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[17-1-o]

Regulations Amending the Food and Drug Regulations (1314 — Ethylenebisdithiocarbamate fungicides)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Ethylenebisdithiocarbamate fungicides including mancozeb, maneb, metiram and zineb are registered under the Pest Control Products Act for the control of fungal diseases on various crops. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of ethylenebisdithiocarbamate fungicides resulting from this use in Canada and in other countries at 7 parts per million (p.p.m.) in apples, broccoli, Brussels sprouts, cabbage, cauliflower, eggplants, endives, grapes, lettuce, mushrooms, onions (green), pears and peppers, 5 p.p.m. in celery, 4 p.p.m. in cucumbers and tomatoes, and 0.5 p.p.m. in onions (dry). By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other foods is 0.1 p.p.m.

The Pest Management Regulatory Agency (PMRA) of Health Canada has recently approved an application to amend the registration of the ethylenebisdithiocarbamate fungicide, mancozeb, in order to allow its use for the control of anthracnose and ascochyta blight on lentils. This proposed regulatory amendment would establish an MRL for residues of ethylenebisdithiocarbamate fungicides resulting from this use in lentils, in order to permit the sale of food containing these residues.

Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable.

The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a level that has no observable adverse effect or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future.

After the review of all available data, the PMRA has determined that an MRL for ethylenebisdithiocarbamate fungicides of 6 p.p.m. in lentils would not pose an unacceptable health risk to the public.

Alternatives

Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of ethylenebisdithiocarbamate fungicides, establishment of an MRL for lentils is necessary to support the additional use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues.

Benefits and Costs

The use of ethylenebisdithiocarbamate fungicides on lentils will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues.

Some costs may be incurred related to the implementation of analytical methods for analysis of ethylenebisdithiocarbamate fungicides in the food mentioned above. Resources required are not expected to result in significant costs to the Government.

Consultation

Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organization for Economic Cooperation and Development. Individual safety evaluations conducted by the PMRA include a review of the assessments conducted at the international level as part of the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme in support of the Codex Alimentarius Commission, as well as MRLs adopted by other national health/regulatory agencies.

Compliance and Enforcement

Compliance will be monitored through ongoing domestic and/or import inspection programs conducted by the Canadian Food Inspection Agency when the proposed MRL for ethylenebisdithiocarbamate fungicides is adopted.

Contact

Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote c)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1314 — Ethylenebisdithiocarbamate fungicides).

Interested persons may make representations with respect to the proposed 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 Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.: (613) 736-3692; Fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, April 18, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1314 — ETHYLENEBISDITHIOCARBAMATE FUNGICIDES)

AMENDMENT

1. The portion of item E.5 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 5)  in columns III (see footnote 6)  and IV (see footnote 7)  is replaced by the following:

  III IV

Item No.
Maximum Residue Limit p.p.m.
Foods
E.5










7



6

5

4

0.5
Apples, broccoli, Brussels sprouts, cabbage, cauliflower, eggplants, endives, grapes, lettuce, mushrooms, onions (green), pears, peppers
Lentils

Celery

Cucumbers, tomatoes

Onions (dry)
     

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[17-1-o]

Regulations Amending the Food and Drug Regulations (1317 — Zoxamide)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Under authority of the Pest Control Products Act, the Pest Management Regulatory Agency (PMRA), of Health Canada, has approved an application for the registration of the pest control product (pesticide) zoxamide as a fungicide for the control of early and late blight in potatoes and for the control of black rot, downey mildew and powdery mildew in grapes. This proposed regulatory amendment would establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for residues of zoxamide resulting from this use in grapes and raisins, and for residues of zoxamide and its metabolites resulting from this use in potato processed fractions (chips, flakes and granules) and potatoes, in order to permit the sale of food containing these residues.

Before making a registration decision regarding a new pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. Pest control products will be registered if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable.

The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a level that has no observable adverse effect or, in appropriate cases, by applying a risk factor that is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future.

After the review of all available data, the PMRA has determined that MRLs for zoxamide of 15 parts per million (p.p.m.) in raisins and 3 p.p.m. in grapes, and MRLs for zoxamide and its metabolites of 0.3 p.p.m. in potato processed fractions (chips, flakes and granules) and 0.06 p.p.m. in potatoes would not pose an unacceptable health risk to the public. These new MRLs harmonize with those established by the United States Environmental Protection Agency.

Alternatives

Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. Also under the Food and Drugs Act, the sale of food containing residues of pest control products at a level less than or equal to 0.1 p.p.m. is permitted unless a lower MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of zoxamide establishment of MRLs for grapes, potato processed fractions (flakes, chips and granules), potatoes and raisins is necessary to support the use of a pest control product which has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues.

Benefits and Costs

The use of zoxamide on grapes and potatoes will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues.

The review of the application for registration of zoxamide was conducted jointly by the PMRA and the United States Environmental Protection Agency. The joint review was completed in 2001 and MRLs in grapes, potato processed fraction (chips, flakes and granules), potatoes and raisins have since been established in the United States. Registration of this pest control product and establishment of MRLs in Canada will benefit the Canadian agricultural industry and will prevent interruption of trade in food commodities between the two countries.

Some costs may be incurred related to the implementation of analytical methods for analysis of zoxamide and its metabolites in the foods mentioned above. Resources required are not expected to result in significant costs to the Government.

Consultation

Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organization for Economic Cooperation and Development. Individual safety evaluations conducted by the PMRA include a review of the assessments conducted at the international level as part of the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme in support of the Codex Alimentarius Commission, as well as MRLs adopted by other national health/ regulatory agencies.

Compliance and Enforcement

Compliance will be monitored through ongoing domestic and/or import inspection programs conducted by the Canadian Food Inspection Agency when the proposed MRLs for zoxamide are adopted.

Contact

Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote d)  of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1317 — Zoxamide).

Interested persons may make representations with respect to the proposed 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 Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.:(613) 736-3692; Fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, April 18, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1317 — ZOXAMIDE)

AMENDMENT

1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 8)  is amended by adding the following after item Z.2:

  I II III IV


Item
No.

Common
Chemical
Name


Chemical Name of Substance
Maximum Residue Limit
p.p.m.



Foods
Z.3












zoxamide












3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide
3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide, including the metabolites 3,5-dichloro-1,4-benzene-dicarboxylic acid and 3,5-dichloro-4-hydroxymethyl benzoic acid
15

3

0.3






0.06
Raisins

Grapes

Potato processed fractions (chips, flakes and granules)


Potatoes

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[17-1-o]

Regulations Amending the Territorial Lands Regulations

Statutory Authority

Territorial Lands Act

Sponsoring Department

Department of Indian Affairs and Northern Development

REGULATORY IMPACT ANALYSIS STATEMENT

Description

An amendment is required in order to modernize a provision of the Territorial Lands Regulations which, apart from the fee schedule, have not been revised in over 41 years.

The federal government, through the Department of Indian Affairs and Northern Development (DIAND), is responsible for the administration and disposal of territorial lands in the Yukon Territory, the Northwest Territories and Nunavut pursuant to the Territorial Lands Act (TLA) and the Territorial Lands Regulations (the Regulations), which provide the Minister of Indian Affairs and Northern Development (the Minister) with the authority to sell lands up to a value of $5,000.

In the past five years, DIAND has processed 55 order-in-council submissions for the sale of lands valued at between $5,800 and $46,000:

  1997 11 submissions $6,000 to $24,500  
  1998 9 submissions $5,800 to $22,000  
  1999 18 submissions $6,000 to $13,500  
  2000 5 submissions $6,000 to $46,000  
  2001 12 submissions $6,000 to $27,335  

Pursuant to subsection 8(1) of the Regulations, the Minister is authorized to sell lands up to a value of $5,000. The sale of lands valued at over $5,000 has to be approved by the Governor in Council. The number of sales per year over $5,000 is likely to increase as the North continues to develop.

This signing authority delegation to the Minister is considered insufficient to allow for the orderly administration of territorial lands and gives rise to a substantial number of costly order-in-council submissions. The $5,000 value limit does not reflect today's reality and this amount has not been indexed since the Regulations came into force in 1960. In the 1960s, there were no requests for approval for sale of lands over $5,000. The Minister's signing authority was relative to the then value of lands. Gradually, the value of lands in the North has increased, yet the Minister's signing authority has remained the same. Based on the Bank of Canada Consumer Price Index, the actualization of a $5,000 value in 1960 to a 2001 value is about $32,000.

In order to streamline and make the sale of lands process more cost-efficient, the Minister proposes to have his signing authority for the sale of lands increased to $32,000. This increase will provide him with a more current and realistic level of authority to sell lands in the Yukon Territory, the Northwest Territories and Nunavut while staying proportionate with today's land prices.

Alternatives

The only alternative is to leave the Regulations intact. This would likely mean an increase in the requests for order-in-council submissions that have to be processed by DIAND, an increase in the time it takes for these submissions to be approved by the Governor in Council, and a decrease in client satisfaction for the services provided by DIAND.

Benefits and Costs

By enacting this amendment to the Regulations pursuant to the TLA, the Department will establish a more efficient, modern and cost-efficient lands administration regime while maintaining the underlying precepts of the TLA and the supporting Regulations.

The amendment to the Regulations will not interfere with the government's long-term plan to devolve the administration of land and resources to the territorial governments. This amendment is considered housekeeping in nature and will still leave the territorial governments with flexibility to develop their own land administration programs.

These Regulations are applicable equally to both genders and will advantage both men and women who plan to purchase Crown lands in the Yukon Territory, the Northwest Territories and Nunavut.

Consultation

Territorial governments and northern Aboriginal organizations have been informed by letter of the Department's plan to amend the Regulations. Specific consultation was not considered appropriate since the proposed amendment would in no way change or affect the number of land sales in the North but merely improve the efficiency of land administration.

In addition, notice of intent to revise the Regulations was provided on the Department's Internet site for the past two years.

Compliance and Enforcement

This amendment does not result in any change to the existing compliance mechanisms.

Contact

Chris Cuddy, Chief, Land and Water Management Division, Department of Indian Affairs and Northern Development, Les Terrasses de la Chaudière, 10 Wellington Street, Ottawa, Ontario K1A 0H4, (819) 994-7483 (Telephone), (819) 997-9623 (Facsimile), cuddyc@inac.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 8 of the Territorial Lands Act, proposes to make the annexed Regulations Amending the Territorial Lands Regulations.

Interested persons may make representations with respect to the proposed Regulations within 30 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 Mr. Chris Cuddy, Chief, Land and Water Management Division, Department of Indian Affairs and Northern Development, Room 648, Les Terrasses de la Chaudière, Hull, Quebec K1A 0H4, Telephone: (819) 994-7483, Fax: (819) 997-9623, E-mail: cuddyc@inac.gc.ca.

Ottawa, April 18, 2002

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE TERRITORIAL LANDS REGULATIONS

AMENDMENT

1. Subsection 8(1) (see footnote 9)  of the Territorial Lands Regulations (see footnote 10)  is replaced by the following:

8. (1) Where territorial lands have been inspected and appraised by a valuator appointed by the Minister and the value of the lands is less than $32,000, the lands may be sold by the Minister for not less than the greater of the appraised value and $200.

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[17-1-o]

Footnote a 

S.C. 1999, c. 33, s. 347

Footnote 1 

C.R.C., c. 870

Footnote 2 

SOR/2001-348

Footnote 3 

SOR/2001-348

Footnote b 

S.C. 1999, c. 33, s. 347

Footnote 4 

C.R.C., c. 870

Footnote c 

S.C. 1999, c. 33, s. 347

Footnote 5 

C.R.C., c. 870

Footnote 6 

SOR/2001-223

Footnote 7 

SOR/2001-223

Footnote d 

S.C. 1999, c. 33, s. 347

Footnote 8 

C.R.C., c. 870

Footnote 9 

SOR/96-111

Footnote 10 

C.R.C., c. 1525

 

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