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Vol. 135, No 35 — September 1, 2001
Regulations Amending the Food and Drug Regulations (1134 — Metsulfuron-methyl)
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) metsulfuron-methyl as a herbicide for the control of snowberry, wild rose and broadleaf weeds in pasture, rangeland rough turf and non-crop areas as a post-emergent treatment. This proposed regulatory amendment would establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for fat, kidney, meat and meat by-products of cattle, goats and hogs, and milk to cover residues in food derived from animals fed with crops treated with metsulfuron-methyl 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 no observable adverse effect level 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 MRLs for metsulfuron-methyl, including its metabolite, of 0.5 parts per million (p.p.m.) in kidney of cattle, goats and hogs; 0.1 p.p.m. in fat, meat and meat by-products of cattle, goats and hogs; and 0.05 p.p.m. in milk 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. 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 metsulfuron-methyl, establishment of MRLs for kidney of cattle, goats and hogs and for milk 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.
Even though the sale of food containing residues of pest control products at a level greater than 0.1 p.p.m. would already be prohibited by virtue of subsection B.15.002(1) of the Food and Drug Regulations, the establishment of an MRL of 0.1 p.p.m. in Table II, Division 15, of the Regulations, for residues of metsulfuron-methyl in fat, meat and meat by-products of cattle, goats and hogs would provide more clarity regarding the applicable MRL and would clearly indicate that the appropriate risk assessment has been completed. This is in keeping with current trends towards increased openness and transparency of regulatory processes and is consistent with current practices of most pesticide regulatory agencies throughout the world.
Benefits and Costs
The use of metsulfuron-methyl on forage crops 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 metsulfuron-methyl and its metabolite 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 metsulfuron-methyl 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 a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1134 — Metsulfuron-methyl).
Interested persons may make representations with respect to the proposed Regulations within 60 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, August 28, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1134 — METSULFURON-METHYL)
AMENDMENT
1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) is amended by adding the following after item M.8:
| item | I | II | III | IV |
|---|---|---|---|---|
Item No. |
Common Chemical Name |
Chemical Name of Substance |
Maximum Residue Limit p.p.m. |
Foods |
| M.8.1 | metsulfuron-methyl | methyl 2-[[[[(4-methoxy-6- methyl-1,3,5-triazin-2-yl) amino]carbony]amino]sulfonyl] benzoate including the metabolite methyl 2-[[[[(4- methoxy-6-methyl-1,3,5-triazin- 2-yl)amino]carbonyl]amino]sulfonyl] 4-hydroxybenzoate |
0.5 | Kidney of cattle, goats and hogs |
| 0.1 | Fat, meat and meat by-products of cattle, goats and hogs | |||
| 0.05 | Milk |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[35-1-o]
Regulations Amending the Food and Drug Regulations (1223 — Azoxystrobin)
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) azoxystrobin as a fungicide for the control of fungal plant pathogens on grapes and rapeseed (canola) as a post-emergent treatment. This proposed regulatory amendment would establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for residues of azoxystrobin and its isomer resulting from this use in grapes and rapeseed (canola), and in imported bananas, peaches/nectarines, peanut oil, peanuts, pecans, tomatoes and tomato paste, in order to permit the sale of food containing these residues. This proposed amendment would also establish MRLs in kidney, liver, meat and meat by-products of cattle, hogs, horses and sheep to cover residues in food derived from animals fed with crops treated with azoxystrobin.
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 no observable adverse effect level 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 MRLs for azoxystrobin, including its isomer, of 3 parts per million (p.p.m.) on grapes, 1 p.p.m. on bananas and rapeseed (canola), 0.8 p.p.m. on peaches/nectarines, 0.6 p.p.m. in tomato paste, 0.3 p.p.m. in liver of cattle, hogs, horses and sheep, 0.2 p.p.m. on tomatoes, 0.06 p.p.m. in kidney of cattle, hogs, horses and sheep, 0.03 p.p.m. in peanut oil and 0.01 p.p.m. in meat and meat by-products of cattle, hogs, horses and sheep, peanuts and pecans 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. 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 azoxystrobin, establishment of MRLs for bananas, grapes, kidney, liver, meat and meat by-products of cattle, hogs, horses and sheep, peaches/nectarines, peanut oil, peanuts, pecans, rapeseed (canola), tomatoes and tomato paste 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
This proposed regulatory amendment will provide joint benefits to consumers, the agricultural industry and importers of agricultural products as a result of improved management of pests and 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 azoxystrobin and its isomer 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 azoxystrobin 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 b) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1223 — Azoxystrobin).
Interested persons may make representations with respect to the proposed Regulations within 60 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, August 28, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1223 — AZOXYSTROBIN)
AMENDMENT
1. Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 2) is amended by adding the following after item A.3:
| item | I | II | III | IV |
|---|---|---|---|---|
| Item No. | Common Chemical Name | Chemical Name of Substance |
Maximum Residue Limit p.p.m. | Foods |
| A.4 | azoxystrobin | (aE)-methyl 2-[[6- (2-cyanophenoxy) -4-pyrimidinyl]oxy]-a- (methoxymethylene) benzeneacetate including the isomer (Z)-methyl 2-[[6- (2-cyanophenoxy)-4- pyrimidinyl]oxy]-a-(methoxymethylene) benzeneacetate |
3 |
Grapes |
| 1 | Bananas, rapeseed (canola) | |||
| 0.8 | Peaches/ nectarines |
|||
| 0.6 | Tomato paste | |||
| 0.3 | Liver of cattle, hogs, horses and sheep | |||
| 0.2 | Tomatoes | |||
| 0.06 | Kidney of cattle, hogs, horses and sheep | |||
| 0.03 | Peanut oil | |||
| 0.01 | Meat and meat by-products of cattle, hogs, horses and sheep, peanuts, pecans |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[35-1-o]
Regulations Amending the Food and Drug Regulations (1250 — Myclobutanil)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Myclobutanil is registered under the Pest Control Products Act as a fungicide for the control of black rot, brown rot, cedar apple rust, gummy stem blight, leaf spot, powdery mildew, quince rust, rust and scab on apples, asparagus, cherries, cucumbers, grapes, peaches/nectarines, Saskatoon berries and tomatoes for pre-harvest management. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of myclobutanil and its metabolites resulting from this use at 10 parts per million (p.p.m.) in raisins, 1 p.p.m. in cherries, grapes, grape juice, peaches/nectarines and wine, and 0.5 p.p.m. in apples and apple juice. MRLs have also been established at 0.3 p.p.m. in liver of cattle, goats, hogs, horses and sheep; 0.05 p.p.m. in fat, meat and meat by-products of cattle, goats, hogs, horses and sheep, and milk; and 0.02 p.p.m. in eggs, fat, meat and meat by-products of poultry to cover residues in food derived from animals fed with crops treated with myclobutanil. 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 myclobutanil in order to allow its use for the control of brown rot, leaf spot and powdery mildew on peppers for pre-harvest management. This proposed regulatory amendment would establish MRLs for residues of myclobutanil and its metabolites resulting from this use in peppers. This proposed amendment would also establish MRLs in dried cherries and dried peaches/nectarines, and in imported bananas, cucurbits (balsam apples, balsam pears, bitter melons, cantaloupes, casabas, chayotes, Chinese cucumbers, Chinese waxgourds, citron melons, crenshaw melons, cucumbers, golden pershaw melons, gourds (edible), honey balls, honeydew melons, mango melons, Persian melons, pineapple melons, pumpkins, Santa Claus melons, snake melons, summer squash, watermelons and winter squash) and strawberries, 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 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 MRLs for myclobutanil, including its metabolites, of 7 p.p.m. in dried peaches/nectarines, 4 p.p.m. in dried cherries, 2 p.p.m. in bananas, 1 p.p.m. in peppers, 0.5 p.p.m. in strawberries and 0.3 p.p.m. in cucurbits 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 myclobutanil, establishment of MRLs for bananas, dried cherries, cucurbits, dried peaches/nectarines, peppers and strawberries 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.
As a means to improve responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) was issued on February 10, 2001, to permit the immediate sale of peppers containing residues of myclobutanil with an MRL of 1 p.p.m. while the regulatory process to formally amend the Regulations is undertaken.
Benefits and Costs
This proposed regulatory amendment will provide joint benefits to consumers, the agricultural industry and importers of agricultural products as a result of improved management of pests and 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 myclobutanil 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 myclobutanil 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 c) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1250 — Myclobutanil).
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 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, August 28, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1250 — MYCLOBUTANIL)
AMENDMENT
1. The portion of item M.11 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 3) in columns II to IV (see footnote 4) is replaced by the following:
| item | II | III | IV |
|---|---|---|---|
Item No. |
Chemical Name of Substance |
Maximum Residue Limit p.p.m. | Foods |
| M.11 | a-butyl-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile, including the metabolites a-(3-hydroxybutyl)-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile and a-(butyl-3-one)-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile |
10 |
Raisins |
| 7 | Dried peaches/nectarines | ||
| 4 | Dried cherries | ||
| 2 | Bananas | ||
| 1 | Cherries, grapes, grape juice, peaches/nectarines, peppers, wine | ||
| 0.5 | Apples, apple juice, strawberries | ||
| 0.3 | Balsam apples, balsam pears, bitter melons, cantaloupes, casaba melons, chayotes, Chinese cucumbers, Chinese waxgourds, citron melons, crenshaw melons, cucumbers, golden pershaw melons, gourds (edible), honey balls, honeydew melons, mango melons, Persian melons, pineapple melons, pumpkins, Santa Claus melons, snake melons, summer squash, watermelons, winter squash | ||
| a-butyl-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile, including the metabolites a-(3-hydroxybutyl)-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile, a-(butyl-3-one)-a-(4- chlorophenyl)-1H-1,2,4- triazole-1-propanenitrile and a-(4-chlorophenyl)-a- (2-formylethyl)-1H-1,2,4- triazole-1-propane nitrile |
0.3 |
Liver of cattle, goats, hogs, horses and sheep | |
| 0.05 | Fat, meat and meat by-products of cattle, goats, hogs, horses and sheep, milk | ||
| 0.02 | Eggs, fat, meat and meat by-products of poultry |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[35-1-o]
Regulations Amending the Food and Drug Regulations (1254 — Tribenuron-methyl)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Tribenuron-methyl is registered under the Pest Control Products Act as a herbicide for the control of grassy and broadleaf weeds in barley, blueberries, oats and wheat as a post-emergent treatment. A Maximum Residue Limit (MRL) has been established under the Food and Drugs Act for residues of tribenuron-methyl resulting from this use at 0.05 parts per million (p.p.m.) in barley and wheat. An MRL has also been established at 0.01 p.p.m. in milk to cover residues in food derived from animals fed with crops treated with tribenuron-methyl. By virtue of subsection B.15.002(1) of the Food and Drug Regulations (the 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 tribenuron-methyl in order to allow its use for the control of grassy and broadleaf weeds in flax, oats and rapeseed (canola) as a post-emergent treatment. This proposed regulatory amendment would establish an MRL for residues of tribenuron-methyl resulting from this use in flax, oats and rapeseed (canola), 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 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 MRLs for tribenuron-methyl of 0.05 p.p.m. in oats and 0.02 p.p.m. in flax and rapeseed (canola) would not pose an unacceptable health risk to the public. This proposed regulatory amendment would also amend the French common name, and the English and French chemical names of tribenuron-methyl in order to comply with international nomenclature conventions.
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 tribenuron-methyl, establishment of MRLs for flax, oats and rapeseed (canola) is necessary to support the additional 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 tribenuron-methyl on flax, oats and rapeseed (canola) 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 tribenuron-methyl 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 tribenuron-methyl 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 (1254 — Tribenuron-methyl).
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 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, August 28, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1254 — TRIBENURON-METHYL)
AMENDMENT
1. Item T.7 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 5) is replaced by the following:
| item | I | II | III | IV |
|---|---|---|---|---|
Item No. |
Common Chemical Name |
Chemical Name of Substance |
Maximum Residue Limit p.p.m. |
Foods |
| T.7 | tribenuron-methyl | methyl 2-[[[[(4-methoxy-6-methyl- 1,3,5-triazin-2-yl)methylamino ]carbonyl]amino]sulfonyl]benzoate |
0.05 | Barley, oats, wheat |
| 0.02 | Flax, rapeseed (canola) | |||
| 0.01 | Milk |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[35-1-o]
S.C. 1999, c. 33, s. 347
C.R.C., c. 870
S.C. 1999, c. 33, s. 347
C.R.C., c. 870
S.C. 1999, c. 33, s. 347
C.R.C., c. 870
SOR/92-723; SOR/97-133; SOR/99-420
S.C. 1999, c. 33, s. 347
C.R.C., c. 870
NOTICE:
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