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Vol. 135, No. 18 — May 5, 2001
Regulations Amending the Food and Drug Regulations (1138 — Bentazon)
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) bentazon as a herbicide for the control of broadleaf weeds in various crops. This proposed regulatory amendment would establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for residues of bentazon and its metabolites resulting from this use in beans, blueberries, corn, peanuts, peas, soybeans and wheat, and in imported barley, leeks, onions and rice, 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 bentazon, including its metabolites, of 3 parts per million (p.p.m.) in peas; 0.5 p.p.m. in beans; 0.1 p.p.m. in barley, leeks, onions and wheat; and 0.05 p.p.m. in blueberries, corn, peanuts, rice and soybeans 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 bentazon, establishment of MRLs for beans, blueberries, corn, peanuts, peas, rice and soybeans 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 bentazon in barley, leeks, onions and wheat 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
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 bentazon 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 bentazon 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 (1138 — Bentazon).
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, May 2, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1138 — BENTAZON)
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 before item B.1:
| item | I | II | III | IV |
|---|---|---|---|---|
| Item No. | Common Chemical Name | Chemical Name of Substance | Maximum Residue Limit p.p.m. | Foods |
| B.01 | bentazon | 3-(1-methylethyl)-1H-2,1,3-benzothiadiazin- 4(3H)-one 2,2-dioxide including the metabolites 6-hydroxy-3-(1-methylethyl)-1H-2,1,3- benzothiadiazin-4(3H)-one 2,2-dioxide and 8-hydroxy-3-(1-methylethyl)-1H-2,1,3- benzothiadiazin-4(3H)-one 2,2-dioxide |
3 |
Peas |
| 0.5 | Beans | |||
| 0.1 | Barley, leeks, onions, wheat | |||
| 0.05 | Blueberries, corn, peanuts, rice, soybeans |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[18-1-o]
Regulations Amending the Food and Drug Regulations (1157 — Clethodim)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Clethodim is registered under the Pest Control Products Act as a herbicide for the control of annual and perennial grasses in various crops as a post-emergent treatment. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of clethodim and its metabolites resulting from this use at 10 parts per million (p.p.m.) in soybeans, 0.5 p.p.m. in lentils, peas (dry) and potatoes, 0.4 p.p.m. in mustard seed, 0.3 p.p.m. in flaxseed, 0.2 p.p.m. in sunflower (including sunola) seeds and 0.05 p.p.m. in rapeseed (canola). 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 clethodim in order to allow its use for the control of annual and perennial grasses in beans, chickpeas and onions as a post-emergent treatment. This proposed regulatory amendment would establish MRLs for residues of clethodim and its metabolites resulting from this use in beans, chickpeas and onions, 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 clethodim, including its metabolites, of 0.5 p.p.m. in beans and chickpeas; and 0.2 p.p.m. in onions would not pose an unacceptable health risk to the public. This proposed regulatory amendment would also amend the chemical name of clethodim in order to comply with international nomenclature conventions.
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 clethodim, establishment of MRLs for beans, chickpeas and onions 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 clethodim on beans, chickpeas and onions 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 clethodim 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 clethodim 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 (1157 — Clethodim).
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, May 2, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1157 — CLETHODIM)
AMENDMENT
1. The portion of item C.10.1.1 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 2) in columns II (see footnote 3) to IV (see footnote 4) is replaced by the following:
| item | II | III | IV |
|---|---|---|---|
Item No. |
Common Chemical Name |
Maximum Residue Limit p.p.m. |
Foods |
| C.10.1.1 | (E,E)-(±)-2-[1-[[-3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one including its metabolites containing the 2-cyclohex-1-enone moiety | 10 |
Soybeans |
| 0.5 | Beans, chickpeas, lentils, peas (dry), potatoes |
||
| 0.4 | Mustard seed |
||
| 0.3 | Flaxseed | ||
| 0.2 | Onions, sunflower (including sunola) seeds | ||
| 0.05 | Rapeseed (canola) |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[18-1-o]
Regulations Amending the Food and Drug Regulations (1200 — Imidacloprid)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Imidacloprid is registered under the Pest Control Products Act as an insecticide for the control of Colorado potato beetles, flea beetles, aphids and other insect pests on apples, potatoes and tomatoes. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of imidacloprid and its metabolites resulting from this use at 6 parts per million (p.p.m.) in tomato paste, 3 p.p.m. in tomato purée, 1 p.p.m. in tomatoes and tomato juice, 0.5 p.p.m. in apples and 0.3 p.p.m. in potatoes. MRLs have also been established at 3.5 p.p.m. in brassica crops and lettuce, 1.5 p.p.m. in grapes, 1 p.p.m. in peppers, 0.6 p.p.m. in pears, 0.2 p.p.m. in mangoes and 0.05 p.p.m. in canola oil and cottonseed oil, imported into Canada, in order to permit the sale of food containing these residues. 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 approved applications to amend the registration of imidacloprid in order to allow its use for the control of flea beetles on mustard as a seed treatment and its use for the control of aphids and whiteflies on cucumbers. This proposed regulatory amendment would establish MRLs for residues of imidacloprid and its metabolites resulting from this use in mustard seed and cucumbers, and in imported citrus fruits and pecans, 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 imidacloprid, including its metabolites, of 1 p.p.m. in citrus fruits, 0.5 p.p.m. in cucumbers and 0.05 p.p.m. in mustard seed and pecans would not pose an unacceptable health risk to the public.
This proposed regulatory amendment would also amend the chemical name of imidacloprid in order to comply with international nomenclature conventions and change the name of the food canola oil to rapeseed (canola) in order to be consistent with current conventions for food descriptors. By virtue of subsection B.15.002(3) of the Food and Drug Regulations, the MRL for rapeseed (canola) will still apply to canola oil.
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 imidacloprid, establishment of MRLs for citrus fruits, cucumbers, mustard seed and pecans 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.
As a means to improve responsiveness of the regulatory system, Interim Marketing Authorizations (IMAs) were issued on August 28, 1999, and May 27, 2000, to permit the immediate sale of cucumbers and citrus fruits containing residues of imidacloprid with MRLs of 0.5 p.p.m. and 1 p.p.m., respectively, while the regulatory process to formally amend the regulation 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 imidacloprid 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 imidacloprid 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 (1200 — Imidacloprid).
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, May 2, 2001
RENNIE M. MARCOUX
Acting Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1200 — IMIDACLOPRID)
AMENDMENT
1. The portion of item I.2.1 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 5) in columns II (see footnote 6) to IV (see footnote 7) is replaced by the following:
| item | II | III | IV |
|---|---|---|---|
Item No. |
Chemical Name of Substance |
Maximum Residue Limit p.p.m. |
Foods |
| I.2.1 | 1-[(6-chloro-3-pyridinyl)methyl]4,5-dihydro-N-nitro-1H-imidazol-2-amine
including metabolites containing the 6-chloropicolyl moiety |
6 | Tomato paste |
| 3.5 | Brassica crops, lettuce | ||
| 3 | Tomato purée | ||
| 1.5 | Grapes | ||
| 1 | Citrus fruits, peppers, tomatoes, tomato juice |
||
| 0.6 | Pears | ||
| 0.5 | Apples, cucumbers | ||
| 0.3 | Potatoes | ||
| 0.2 | Mangoes | ||
| 0.05 | Cottonseed oil, mustard seed, pecans, rapeseed (canola) |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[18-1-o]
a S.C. 1999, c. 33, s. 347
1 C.R.C., c. 870
a S.C. 1999, c. 33, s. 347
1 C.R.C., ch. 870
2 SOR/99-287
2 SOR/99-287
a S.C. 1999, c. 33, s. 347
1 C.R.C., c. 870
2 SOR/99-287
2 SOR/99-287
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