Canada Gazette
www.gazette.gc.ca
Common menu bar links
Vol. 133, No. 27 — July 3, 1999
Regulations Amending the Food and Drug Regulations (1113 — Glufosinate-ammonium)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Glufosinate-ammonium is registered under the Pest Control Products Act as a herbicide for the control of a wide range of annual and biannual weeds and as a post-harvest treatment on many crops. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of glufosinate-ammonium, and its metabolite, in lentils, rapeseed (canola), dry white beans, potatoes and in the liver and kidney of cattle, goats, hogs, poultry and sheep resulting from this use. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other crops is 0.1 parts per million (ppm).
The Pest Management Regulatory Agency (PMRA) of Health Canada, has recently approved applications to amend the registration of glufosinate-ammonium in order to allow its use for the control of weeds on peas, wheat and corn. This proposed regulatory amendment would establish MRLs for residues of glufosinate-ammonium and its metabolite in dry peas, wheat and corn resulting from this use 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. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to the no observable adverse effect level determined through extensive toxicological studies. 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. As long as the PDI does not exceed the ADI or ARD for any subpopulation or age group, 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 when MRLs are originally established, additional MRLs for the pest control product may be added in the future, provided the new PDI would still not exceed the ADI or ARD.
After the review of all available data, the PMRA has determined that MRLs for glufosinate-ammonium, including its metabolites, of 3 ppm in dry peas and 0.2 ppm in wheat and in corn would not pose an unacceptable health risk to the public.
Because these residues would not pose unacceptable health risks, the PMRA approved a request for an Interim Marketing Authorization (IMA) on January 21, 1999, to permit the immediate sale of dry peas and wheat with residues of glufosinate-ammonium, including its metabolite, at a level not to exceed 3 ppm and 0.2 ppm, respectively, while the regulatory process to amend the Regulations is underway.
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 ppm unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of glufosinate-ammonium, establishment of MRLs for dry peas, wheat and corn is necessary to support additional uses 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 glufosinate-ammonium on peas, wheat and corn will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this use will contribute to a safe, abundant and affordable food supply.
The cost of administering this amendment to the Regulations will not be greater than that of administering the existing Regulations, since monitoring for residues of pest control products, whether or not MRLs have been established, is performed on an ongoing basis. Adequate analytical methodology for analysis of the compound is available.
Consultation
Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among the 29 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 glufosinate-ammonium are adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@pmra-arla.hc-sc.gc.ca (Electronic mail).
PROPOSED REGULATORY TEXT
Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1113 — Glufosinate-ammonium).
Interested persons may make representations with respect to the proposed Regulations within 15 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, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham @pmra-arla.hc-sc.gc.ca (Electronic mail).
The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.
Ottawa, June 23, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1113 — GLUFOSINATE-AMMONIUM)
AMENDMENT
1. The portion of item G.1 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:
Item No. |
III Maximum Residue Limit p.p.m. |
IV Foods |
|---|---|---|
| G.1 | 6 | Lentils |
| 3 | Dry peas, rapeseed (canola) | |
| 1 | Liver and kidney of cattle, goats, hogs, poultry and sheep | |
| 0.5 | Dry white beans | |
| 0.4 | Potatoes | |
| 0.2 | Corn, wheat |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[27-1-o]
Regulations Amending the Food and Drug Regulations (1150 Pyrimethanil)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
This proposed regulatory amendment would establish Maximum Residue Limits (MRLs) under the Food and Drugs Act for residues of pyrimethanil in raisins and grapes, in order to permit the import and sale of food containing these residues. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other crops is 0.1 parts per million (ppm).
In order to determine whether proposed MRLs are safe, the Pest Management Regulatory Agency (PMRA) of Health Canada conducts a dietary risk assessment. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to the no observable adverse effect level determined through extensive toxicological studies. The potential daily intake (PDI) is calculated from the amount of residue that remains on each imported food when the pest control product is used according to use instructions in the country of origin and the intake of that food from imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. As long as the PDI does not exceed the ADI or ARD for any subpopulation or age group, 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 when MRLs are originally established, additional MRLs for the pest control product may be added in the future, provided the new PDI would still not exceed the ADI or ARD.
After the review of all available data, the PMRA has determined that MRLs of 8 ppm for pyrimethanil in raisins and 5 ppm in grapes 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 ppm unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of pyrimethanil, establishment of MRLs for raisins and grapes is necessary to support the import of food containing residues that have been shown to be safe, while at the same time preventing the sale of food with unacceptable residues.
Benefits and Costs
This proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation of food commodities containing acceptable levels of pesticide residues.
The cost of administering this proposed amendment to the Regulations will not be greater than that of administering the existing Regulations, since monitoring for residues of pest control products, whether or not MRLs have been established, is performed on an ongoing basis. Adequate analytical methodology for analysis of the compound is available.
Consultation
Dietary risk assessments conducted by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among the 29 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 pyrimethanil are adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D, 2250 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) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1150 — Pyrimethanil).
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, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@ hc-sc.gc.ca (Electronic mail).
The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.
Ottawa, June 22, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1150 — PYRIMETHANIL)
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 P.8:
Item No. |
I Common or (Trade Name) |
II Chemical Name of Substance |
III Maximum Residue Limit p.p.m. |
IV Foods |
|---|---|---|---|---|
| P.8.1 | pyrimethanil | N-(4,6-dimethylpyrimidin-2-yl)aniline | 8 | Raisins |
| 5 | Grapes |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[27-1-o]
Regulations Amending the Food and Drug Regulations (1176 — Tebufenozide)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Tebufenozide is registered under the Pest Control Products Act as an insecticide for the control of caterpillars and worms in apples. A Maximum Residue Limit (MRL) of 1 part per million (ppm) has been established under the Food and Drugs Act for residues of tebufenozide in apples resulting from this use. By virtue of subsection B.15.002(1) of the Food and Drug Regulations, the MRL for other crops is 0.1 ppm. This proposed regulatory amendment would establish MRLs for residues of tebufenozide in raisins, kiwi fruit and grapes, in order to permit the import and sale of food containing these residues.
In order to determine whether proposed MRLs are safe, the Pest Management Regulatory Agency (PMRA) of Health Canada conducts a dietary risk assessment. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to the no observable adverse effect level determined through extensive toxicological studies. 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 use instructions in Canada or the country of origin and the intake of that food in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. As long as the PDI does not exceed the ADI or ARD for any subpopulation or age group, 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 when MRLs are originally established, additional MRLs for the pest control product may be added in the future, provided the new PDI would still not exceed the ADI or ARD.
After the review of all available data, the PMRA has determined that MRLs of 2.5 ppm for tebufenozide in raisins and 0.5 ppm in kiwi fruit and grapes 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 ppm unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of tebufenozide, establishment of MRLs for raisins, kiwi fruit and grapes is necessary to support the import of food containing residues that have been shown to be safe, while at the same time preventing the sale of food with unacceptable residues.
Benefits and Costs
This proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation of food commodities containing acceptable levels of pesticide residues.
The cost of administering this proposed amendment to the Regulations will not be greater than that of administering the existing Regulations, since monitoring for residues of pest control products, whether or not MRLs have been established, is performed on an ongoing basis. Adequate analytical methodology for analysis of the compound is available.
Consultation
Dietary risk assessments conducted by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among the 29 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 tebufenozide are adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D, 2250 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) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1176 — Tebufenozide).
Interested persons may make representations with respect to the proposed Regulations within 15 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, Project Manager, Alternative Strategies and Regulatory Affairs, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D, 2250 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@ hc-sc.gc.ca (Electronic mail).
The representations should stipulate those parts of the representations that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.
Ottawa, June 23, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1176 — TEBUFENOZIDE)
AMENDMENT
1. The portion of item T.01 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:
Item No. |
III Maximum Residue Limit p.p.m. |
IV Foods |
|---|---|---|
| T.01 | 2.5 | Raisins |
| 1 | Apples | |
| 0.5 | Kiwi fruit and grapes |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[27-1-o]
C.R.C., c. 870
SOR/94-183
SOR/94-183
C.R.C., c. 870
C.R.C., c. 870
SOR/97-404
SOR/97-404
NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).
