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Vol. 133, No. 40 — October 2, 1999
Regulations Amending the Food and Drug Regulations (1177 — Metalaxyl)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Metalaxyl is registered under the Pest Control Products Act as a fungicide for the preventive and curative control of various air- and soil-borne fungi on a variety of crops. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of metalaxyl resulting from this use in Canada and in other countries at 10 parts per million (p.p.m.) in onions (green) and spinach; 7 p.p.m. in asparagus; 5 p.p.m. in citrus fruit and lettuce; 4 p.p.m. in avocado; 3 p.p.m. in ginseng and onions (dry); 2 p.p.m. in blueberries, broccoli, cabbage, cauliflower and raisins; 1 p.p.m. in apricots, cantaloupes, cherries, cucumbers, grapes, molasses (sugar beet), peaches, peppers, plums, soybeans, squash, tomatoes and watermelon; 0.5 p.p.m. in almonds, carrots, potatoes, radishes and walnuts; 0.4 p.p.m. in strawberries and 0.2 p.p.m. in beans, peanuts, peas, raspberries and wheat. 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 metalaxyl in order to allow its use for the control of various air- and soil-borne fungi on endives. This proposed regulatory amendment would establish an MRL for residues of metalaxyl resulting from this use in endives, 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. Provided 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 an MRL for metalaxyl of 5 p.p.m. in endives 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 metalaxyl, establishment of an MRL for endives 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 metalaxyl on endives 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 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 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 metalaxyl is adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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 (1177 — Metalaxyl).
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, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1177 — METALAXYL)
AMENDMENT
1. The portion of item M.3 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 | IV |
|---|---|---|
Maximum Residue Limit p.p.m. |
Foods |
|
| M.3 | 10 | Onions (green) and spinach |
| 7 | Asparagus | |
| 5 | Citrus fruit, endives and lettuce | |
| 4 | Avocado | |
| 3 | Ginseng and onions (dry) | |
| 2 | Blueberries, broccoli, cabbage, cauliflower and raisins | |
| 1 | Apricots, cantaloupes, cherries, cucumbers, grapes, molasses (sugar beets), peaches, peppers, plums, soybeans, squash, tomatoes and watermelons |
|
| 0.5 | Almonds, carrots, potatoes, radishes and walnuts | |
| 0.4 | Strawberries | |
| 0.2 | Beans, peanuts, peas, raspberries and wheat |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[40-1-o]
Regulations Amending the Food and Drug Regulations (1181 — Ethylene bisdithiocarbamate fungicides)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Ethylene bisdithiocarbamate fungicides including mancozeb, maneb, metiram and zineb are registered under the Pest Control Products Act. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of ethylene-bisdithiocarbamate fungicides resulting from this use in Canada and in other countries at 7 parts per million (p.p.m.) in apples, broccoli, Brussels sprouts, cabbages, cauliflower, eggplants, grapes, lettuce, mushrooms, onions (green), pears and peppers; at 5 p.p.m. in celery and at 4 p.p.m. in cucumbers and tomatoes. 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 ethylene-bisdithiocarbamate fungicides in order to allow their use on endives. This proposed regulatory amendment would establish an MRL for residues of ethylene-bisdithiocarbamate fungicides resulting from this use in endives, 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 toxico-llogical 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. Provided 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 an MRL for ethylene-bisdithiocarbamate fungicides of 7 p.p.m. in endives 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 ethylene-bisdithiocarbamate fungicides, establishment of an MRL for endives 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 ethylene-bisdithiocarbamate fungicides in endives 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 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 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 ethylene-bisdithiocarbamate fungicides are adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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 (1181 — Ethylene Bisdithiocarbamate fungicides).
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, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1181 — ETHYLENE BISDITHIOCARBAMATE FUNGICIDES)
AMENDMENT
1. Item E.5 of Table II to Division 15 of Part B of the Food and Drug Regulations(see footnote 4) is replaced by the following:
| Item No. | I | II | III | IV |
|---|---|---|---|---|
| Common or (Trade Name) | Chemical Name of Substance | Maximum Residue Limit p.p.m. | Foods | |
| E.5 | ethylene bisdithio- carbamate fungicides |
manganese and zinc ethylenebis (dithiocarbamate) (polymeric) |
7 | Apples, broccoli, Brussels sprouts, cabbages, cauliflower, eggplants, endives, grapes, lettuce, mushrooms, onions (green), pears and peppers |
| 5 | Celery | |||
| 4 | Cucumbers and tomatoes |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[40-1-o]
Regulations Amending the Food and Drug Regulations (1194 — Diflufenzopyr)
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) diflufenzopyr, as a herbicide for the control of many annual and perennial broadleaf weed species in field corn, as a post-emergent treatment. This proposed regulatory amendment would establish a Maximum Residue Limit (MRL) under the Food and Drugs Act for residues of diflufenzopyr and its metabolite M1 resulting from this use in corn, 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. 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. Provided 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 an MRL for diflufenzopyr, including its metabolite M1, of 0.05 parts per million (p.p.m.) in corn would not pose an unacceptable health risk to the public. This new MRL harmonizes with that 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 diflufenzopyr, establishment of an MRL for corn 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 diflufenzopyr on corn 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 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 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 diflufenzopyr is adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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 (1194 — Diflufenzopyr).
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, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1194 — DIFLUFENZOPYR)
AMENDMENT
1. Table II to Division 15 of Part B of the Food and Drug Regulations(see footnote 5) is amended by adding the following after item D.14:
| Item No. | I | II | III | IV |
|---|---|---|---|---|
| Common or (Trade Name) | Chemical Name of Substance | Maximum Residue Limit p.p.m. | Foods | |
| D.14.1 | diflufenzopyr | 2-[1-[[[(3,5-difluorophenyl) amino] carbonyl]hydrazono] ethyl]-3-pyridinecarboxylic acid including its metabolites convertible to M1 (8-methyl-5(6H)-pyrido[2,3-d] pyridazinone) |
0.05 | Corn |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[40-1-o]
Regulations Amending the Food and Drug Regulations (1195 — Diazinon)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Diazinon is registered under the Pest Control Products Act as an insecticide for the control of sucking and chewing insects and mites on a very wide range of crops, including deciduous fruit trees, by soil application. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of diazinon resulting from this use in Canada and in other countries at 0.75 parts per million (p.p.m.) in apples, apricots, beets, broccoli, cabbage, carrots, cauliflower, celery, cherries, endives, grapes, kale, kohlrabi, lettuce, onions, pears, peppers, plums, salsify, spinach, strawberries, tomatoes, turnips (tops); at 0.7 p.p.m. in citrus fruits and peaches; at 0.5 p.p.m. in beans, Brussels sprouts, cucumbers and turnips and at 0.25 p.p.m. in cantaloupes, collards, cranberries, figs, hops, lima beans, muskmelons, parsley, parsnips, radishes, summer squash, Swiss chard, watermelons and winter squash. 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 diazinon in order to allow its use for the control of sucking and chewing insects and mites on wasabi (a member of the Cruciferae or mustard family) by soil application. This proposed regulatory amendment would establish an MRL for residues of diazinon resulting from this use in wasabi, 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. Provided 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 an MRL for diazinon of 0.75 p.p.m. on wasabi 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 diazinon, establishment of an MRL for wasabi 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 diazinon on wasabi 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 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 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 diazinon is adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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 (1195 — Diazinon).
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, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1195 — DIAZINON)
AMENDMENT
1. The portion of item D.7 of Table II to Division 15 of Part B of the Food and Drug Regulations(see footnote 6) in columns III and IV is replaced by the following:
Item No. |
III | IV |
|---|---|---|
Maximum Residue Limit p.p.m. |
Foods |
|
| D.7 | 0.75 |
Apples, apricots, beets, broccoli, cabbage, carrots, cauliflower,
celery, cherries, endives, grapes, kale, kohlrabi, lettuce, onions,
pears, peppers, plums, salsify, spinach, strawberries, tomatoes, turnips (tops) and wasabi |
| 0.7 | Citrus fruits and peaches | |
| 0.5 | Beans, Brussels sprouts, cucumbers and turnips | |
| 0.25 | Cantaloupes, collards, cranberries, figs, hops, lima beans, muskmelons,
parsley, parsnips, radishes, summer squash, Swiss chard, watermelons
and winter squash |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[40-1-o]
Regulations Amending the Food and Drug Regulations (1196 — Chlorothalonil)
Statutory Authority
Food and Drugs Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
Chlorothalonil is registered under the Pest Control Products Act as a fungicide for the control of many fungal diseases on a wide range of crops including beans, blueberries, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, cherries, cranberries, cucumbers, melons, mushrooms, nectarines, onions, parsnips, peaches, peanuts, pumpkins, squash and tomatoes by foliar application. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of chlorothalonil resulting from this use at 15 parts per million (p.p.m.) in celery; 5 p.p.m. in broccoli, Brussels sprouts, cabbage, cauliflower, cucumbers, melons, onions, pumpkins, beans, squash and tomatoes; 2 p.p.m. in cranberries; 1 p.p.m. in carrots, mushrooms and parsnips; 0.6 p.p.m. in blueberries; 0.5 p.p.m. in cherries, nectarines and peaches and 0.3 p.p.m. in peanuts. 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 chlorothalonil in order to allow its use for the control of fungal diseases on wasabi (a member of the Cruciferae or mustard family) by foliar application. This proposed regulatory amendment would establish an MRL for residues of chlorothalonil resulting from this use in wasabi, 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. Provided 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 an MRL for chlorothalonil of 5 p.p.m. in wasabi 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 chlorothalonil, establishment of an MRL for wasabi 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 chlorothalonil on wasabi 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 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 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 wasabi is adopted.
Contact
Geraldine Graham, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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 (1196 — Chlorothalonil).
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, Project Manager, Alternative Strategies and Regulatory Affairs Division, 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, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1196 — CHLOROTHALONIL)
AMENDMENT
1. The portion of item C.9 of Table II to Division 15 of Part B of the Food and Drug Regulations(see footnote 7) in columns III(see footnote 8) and IV(see footnote 9) is replaced by the following:
Item No. |
III | IV |
|---|---|---|
Maximum Residue Limit p.p.m. |
Foods |
|
| C.9 | 15 | Celery |
| 5 | Beans, broccoli, Brussels sprouts, cabbage, cauliflower, cucumbers, melons, onions, pumpkins, squash, tomatoes and wasabi |
|
| 2 | Cranberries | |
| 1 | Carrots, mushrooms and parsnips | |
| 0.6 | Blueberries | |
| 0.5 | Cherries, nectarines and peaches | |
| 0.3 | Peanuts |
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
[40-1-o]
Regulations Amending the Radiation Emitting Devices Regulations
Statutory Authority
Radiation Emitting Devices Act
Sponsoring Department
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
Description
The Radiation Emitting Devices Regulations serve to protect Canadians from injury due to exposure to radiation by prescribing standards that regulate the design, construction and functioning of certain classes of radiation emitting devices.
This amendment will replace the present standard for diagnostic X-ray equipment with a new standard that is compatible with internationally accepted standards and which reflects the current state of diagnostic X-ray equipment design and technology.
The existing Canadian standard on diagnostic X-ray equipment has been in force with only minor amendments since 1981. In its present form, it does not reflect the current state of equipment design and technology that is reflected in United States (U.S.) performance standards (CFR 1020.30) or International Electrotechnical Commission standards (IEC 601-1 series); the standards which are considered to represent the current state of design and technology in diagnostic X-ray equipment.
This results in advanced imported equipment having to undergo unnecessary modification in order to comply with the Canadian standard so that it may be sold in Canada. As Canada imports virtually all of its diagnostic X-ray equipment, such unnecessary modifications result in an unnecessary increase in the cost of equipment to Canadian consumers.
Alternatives
Maintaining the status quo is considered unacceptable as it perpetuates the need for unnecessary equipment modification which translates into increased costs to Canadian consumers of diagnostic X-ray equipment.
Revoking the regulatory standard in favour of either a voluntary standard or no standard, is also considered unacceptable. While most equipment produced in the world meets high standards, there may still be some equipment produced which does not. In the absence of a regulatory standard, Canada would be leaving itself open to becoming a market for equipment that failed to meet foreign regulatory requirements and internationally accepted standards.
Benefits and Costs
The Department estimates that there are approximately 100 firms worldwide that manufacture diagnostic X-ray equipment. There are no Canadian manufacturers of this equipment. The amendment is expected to result in a decrease in costs to any of those firms which market diagnostic X-ray equipment in Canada, which in turn is expected to result in a decrease in costs to Canadian consumers of diagnostic X-ray equipment.
The amendment is not expected to result in any additional costs to the Department.
Consultation
A draft of the proposed Regulations was circulated to manufacturers, provincial regulatory authorities, professional associations, users and hospitals prior to publication in the Canada Gazette, Part I.
Most stakeholders were in agreement that the Canadian standard on diagnostic X-ray equipment should be amended.
Interested parties were provided an opportunity to comment by publication of the draft Regulations in the Canada Gazette, Part I, on November 8, 1997. Comments were received from 13 parties: 1 from the federal government, 5 from provincial governments, 1 from a manufacturer, 1 from a manufacturers' association, 1 from a hospital, and 4 from professional organizations.
Many modifications were proposed and accepted to numerous sections to the draft Regulations. These modifications were aim to improve the harmonizations with U.S. Regulations and International standards. Modifications were also made to the draft to the limits of loading factors, automatic exposure control, air kerma rate in radioscopy, and on other minor and editorial points.
The amended Regulations are being submitted for a re-publication in the Canada Gazette, Part I, with a 30-day comment period to provide interested parties an opportunity to review the modifications and to provide them another opportunity to provide comments prior to final publication in the Canada Gazette, Part II.
Compliance and Enforcement
The amendment does not alter existing compliance mechanisms. Compliance monitoring and enforcement will continue to be undertaken by Health Protection Branch inspectors under the authority of the Radiation Emitting Devices Act and Regulations.
Contact
Mr. Christian Lavoie, P.Eng., Head, Medical X-ray Unit, Address Locator 6301A, 775 Brookfield Road, Ottawa, Ontario K1A 1C1, (613) 954-0323 (Telephone), (613) 941-1734 (Facsimile).
PROPOSED REGULATORY TEXT
Notice is hereby given, pursuant to subsection 13(2) of the Radiation Emitting Devices Act, that the Governor in Council proposes, pursuant to subsection 13(1) of that Act, to make the annexed Regulations Amending the Radiation Emitting Devices Regulations.
Manufacturers, importers, distributors and other interested persons may make representations with respect to the proposed Regulations to Mr. Christian Lavoie, P.Eng., Head, Medical X-ray Unit, Address Locator 6301A, 775 Brookfield Road, Ottawa, Ontario K1A 1C1, within 30 days after the date of publication of this notice. All such representations should cite the Canada Gazette, Part I, and the date of publication of this notice. The representations should stipulate the parts thereof 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 reasons why those parts should not be disclosed and the period during which those parts should remain undisclosed. The representations should also stipulate the parts thereof in respect of which there is consent to disclosure pursuant to the Access to Information Act.
Ottawa, September 29, 1999
MARC O'SULLIVAN
Assistant Clerk of the Privy Council
REGULATIONS AMENDING THE RADIATION EMITTING DEVICES REGULATIONS
AMENDMENTS
1. Item 12(see footnote 10) of Schedule I to the Radiation Emitting Devices Regulations(see footnote 11) is replaced by the following:
12. Diagnostic X-ray equipment, being X-ray devices designed primarily for the examination of the human body but excluding dental X-ray equipment with an extra-oral source, photofluorographic X-ray equipment, radiation therapy simulators and computer-assisted tomographic equipment.
2. Part XII (see footnote 12) of Schedule II to the Regulations is replaced by the following:
PART XII
DIAGNOSTIC X-RAY EQUIPMENT
Interpretation
1. (1) The definitions in this section apply in this Part.
"aluminum" means aluminum of purity 99.99% or higher and density 2.70 g/cm3. (aluminium)
"aluminum equivalent" means the attenuation equivalent expressed in thickness of aluminum. (équivalent en aluminium)
"field emission device" means a device in which the emission of electrons from the cathode is due solely to the action of an electric field. (dispositif d'émission par effet de champ)
"general purpose radiographic equipment" means any stationary equipment other than that designed for the examination of specific anatomical regions. (appareil de radiographie pour usage général)
"loading factors" means factors the value of which influences the X-ray tube load, and includes
(a) for diagnostic X-ray equipment where the X-ray beam is produced by the discharge of the capacitor through an X-ray tube, the X-ray tube voltage and the amount of capacitor charge;
(b) for a field emission device, the X-ray tube voltage and the number of pulses; and
(c) for any other diagnostic X-ray equipment, the X-ray tube voltage and either the X-ray tube current and irradiation time, or the current time product. (paramètres de charge)
"mobile equipment" means diagnostic X-ray equipment that is designed to be moved between periods of use. (appareil mobile)
"radioscopic imaging assembly" means the combination of components in radioscopic equipment that use X-ray photons to produce a radioscopic image. These components usually consist of the X-ray image receptor, X-ray image intensifier, equipment housings, interlocks and protective shielding. (système d'imagerie radioscopique)
"radioscopy" means the technique for producing a continuous or periodic sequence of X-ray patterns and for simultaneously and continuously displaying them in the form of visible images. (radioscopie)
"rectification type" means, with respect to diagnostic X-ray equipment, its type with respect to the way in which high voltage is rectified to produce the X-ray tube voltage. (type de redressement)
"stationary equipment" means diagnostic X-ray equipment that is permanently installed in one location. (appareil fixe)
"X-ray image receptor" means a device that converts incident X-radiation into a visible image or into a form that can be made into a visible image by further transformation. (récepteur d'image radiologique)
(2) Unless otherwise defined, words and expressions used in this Part have the same meaning as in the International Electrotechnical Commission Standard entitled Medical radiology — Terminology, Publication 788, First Edition, 1984.
General Requirements
Information
2. Diagnostic X-ray equipment shall be accompanied by the following information, which shall be provided by the manufacturer:
(a) installation instructions;
(b) the address of the manufacturer;
(c) instructions concerning any radiological safety procedures and additional precautions that are necessary because of unique features of the equipment;
(d) instructions as to the maintenance necessary to keep the equipment in compliance with the requirements of this Part;
(e) the rated line voltage, the maximum line current and the line voltage regulation for operation of the equipment at the maximum line current;
(f) the loading factors that constitute the maximum line current condition for the X-ray generator;
(g) for each X-ray tube assembly,
(ii) the cooling curves for the anode and for the X-ray tube housing,
(iii) the X-ray tube rating charts, and
(iv) the method by which the focal spot to image receptor distance can be determined using the elements specified in subparagraph 3(c)(i);
(h) the duty cycles, rectification type and the generator rating of the equipment;
(i) where the equipment is battery powered, the minimum state of charge necessary for it to operate;
(j) the maximum deviation for any selected X-ray tube voltage within the range of values of operating X-ray tube voltages specified for the equipment;
(k) where the equipment is not designed to operate exclusively under automatic exposure control, the accuracy limits of
(ii) the X-ray tube current, and
(iii) the current time product;
(l) where the equipment is designed to operate under automatic exposure control, the accuracy limits of that control; and
(m) the conditions under which the information provided under paragraphs (j) to (l) is valid.
Labelling
3. Diagnostic X-ray equipment shall bear
(a) on the external surface of the main control panel
(A) unauthorized use is prohibited, and
(B) hazardous X-radiation is emitted when the equipment is in operation,
(ii) the X-radiation warning symbol described in section 4, and
(iii) a label setting out, with respect to the X-ray generator,
(B) the model designation,
(C) the serial number,
(D) the date of manufacture, and
(E) the country of manufacture;
(b) on the external surface of the X-ray tube housing, a label setting out, with respect to the X-ray tube assembly,
(ii) the model designation,
(iii) the serial number,
(iv) the date of installation of the X-ray tube in the X-ray tube housing,
(v) the country of manufacture, and
(vi) the minimum permanent filtration in the X-ray beam emitted from the X-ray tube assembly, expressed in millimetres of aluminum equivalent at a specified X-ray tube voltage;
(c) on the external surface of the X-ray tube housing, or on any other suitable structure securely and permanently attached to the X-ray tube housing,
(ii) where the X-ray tube and the high-voltage generator are not located within a common enclosure, marks that clearly indicate the anode and cathode terminals on the X-ray tube housing and on the high-voltage generator; and
(d) on the external surface of any beam limiting device that adds filtration to the X-ray beam, a label setting out the total permanent filtration deliverable by the beam limiting device, expressed in millimetres of aluminum equivalent at a specified X-ray tube voltage.
4. The X-radiation warning symbol shall
(a) be displayed in two contrasting colours;
(b) be clearly visible and identifiable from a distance of 1 m;
(c) have no outer dimension that is less than 2 cm;
(d) bear the words "CAUTION: X-RADIATION — ATTENTION : RAYONNEMENTS X"; and
(e) conform to
(ii) symbol 03-03 in the International Electrotechnical Commission report entitled Graphical symbols for electrical equipment in medical practice, Publication 878, 1988, illustrated as follows:
5. (1) Labels required by this Part shall be securely affixed to or engraved on the equipment and be clearly visible.
(2) Controls, meters, warning lights and other indicators required by this Part shall be clearly labelled as to their function.
Design and Construction Standards
6. Diagnostic X-ray equipment shall be designed and constructed in such a manner that, when installed and maintained in accordance with the instructions referred to in paragraphs 2(a) and (d), it functions in accordance with sections 11 to 21.
7. Diagnostic X-ray equipment shall be designed and constructed to include
(a) where more than one X-ray tube is controlled by one control panel,
(ii) a visual indicator on the control panel that shows which X-ray tubes are connected and ready to be energized;
(b) a means, appropriate to its rectification type, to compensate for variations in X-ray tube voltage caused by line voltage fluctuations;
(c) a visual indicator or audible signal that warns the operator, or a mechanism that prevents X-radiation from being emitted, when the variation in line voltage exceeds the rate set out in section 13;
(d) separate warning lights on the control panel
(ii) the other of which indicates when X-radiation is being emitted;
(e) meters, labels or other indicators, located on the control panel, that
(ii) enable the operator to select, before an irradiation, the loading factors;
(f) where the equipment is battery powered, a visual indicator on the control panel showing whether the battery is adequately charged for proper operation of the equipment;
(g) an irradiation switch, controlling timer or other mechanism to initiate and terminate an irradiation;
(h) an audible signal to indicate termination of an irradiation;
(i) for equipment designed to operate within a range set out in column 1 of an item of the table to this section, radiation filters that result in a measured half-value layer of aluminum of not less than
(ii) in any other case, the value obtained by linear interpolation or extrapolation from that table;
(j) a means to ensure that any necessary additional filtration is in place in an X-ray source assembly that
(ii) is designed to be operated with additional filtration;
(k) where the equipment is designed to move around a patient by remote control, an emergency stop switch that immediately terminates both the motion of the equipment and the emission of X-radiation; and
(l) a beam limiting device.
TABLE
Item |
Column 1 Operating Range (kV) |
Column 2 X-ray Tube Voltage (kV) |
Column 3 Half-value Layer of Aluminum (mm) |
|---|---|---|---|
| 1. | Up to and including 50 | (a) 30 | 0.3 |
| (b) 40 | 0.4 | ||
| (c) 50 | 0.5 | ||
| 2. | 50 up to and including 70 | (a) 50 | 1.2 |
| (b) 60 | 1.3 | ||
| (c) 70 | 1.5 | ||
| 3. | 70 upwards | (a) 70 | 2.1 |
| (b) 80 | 2.3 | ||
| (c) 90 | 2.5 | ||
| (d) 100 | 2.7 | ||
| (e) 110 | 3.0 | ||
| (f) 120 | 3.2 | ||
| (g) 130 | 3.5 | ||
| (h) 140 | 3.8 | ||
| (i) 150 | 4.1 |
8. (1) Where diagnostic X-ray equipment is equipped with an irradiation switch, the switch shall be designed so that
(a) it requires continuous pressure by the operator to emit X-radiation;
(b) where it is a foot switch, any unintended irradiation does not occur if the switch is accidentally overturned; and
(c) for mobile equipment, it allows the operator to stand at least 3 m from the X-radiation source when the X-ray tube is energized.
(2) Where diagnostic X-ray equipment is equipped with a controlling timer, the timer shall be designed so that
(a) it can automatically terminate an irradiation
(ii) on attainment of a preset current time product value, or
(iii) on completion of a preset number of X-radiation pulses;
(b) it permits the operator to terminate an irradiation at any time;
(c) it automatically resets itself to its original setting or to zero on termination of an irradiation; and
(d) when it is at zero, at the off position or at an unmarked setting, an irradiation cannot be initiated.
9. (1) Where an article set out in column 1 of an item of Table 1 to this section is positioned between the patient and the X-ray image receptor, the aluminum equivalent of the article shall not exceed the amount set out in column 2 of that item, as determined using an X-ray beam that, for mammographic equipment
(a) is generated at an X-ray tube voltage of 30 kV;
(b) has a maximum ripple of 10 per cent; and
(c) has a half-value layer of aluminum of 0.3 mm.
(2) Where an article set out in column 1 of an item of Table 2 to this section is positioned between the patient and the X-ray image receptor, the aluminum equivalent of the article shall not exceed the amount set out in column 2 of that item, as determined using an X-ray beam that, for any diagnostic X-ray equipment other than mammographic equipment
(a) is generated at an X-ray tube voltage of 100 kV;
(b) has a maximum ripple of 10 per cent; and
(c) has a half-value layer of aluminum of 3.7 mm.
(3) For the purposes of subsections (1) and (2), any sensor used in automatic exposure control is considered to be a part of the X-ray image receptor.
TABLE 1
MAMMOGRAPHIC EQUIPMENT
Item |
Column 1 Article |
Column 2 Aluminum Equivalent (mm) |
|---|---|---|
| 1. | Support table (total of all layers) | 0.3 |
TABLE 2
EQUIPMENT OTHER THAN MAMMOGRAPHIC EQUIPMENT
Item |
Column 1 Article |
Column 2 Aluminum Equivalent (mm) |
|---|---|---|
| 1. | Front panel of cassette holder (total of all layers) | 1.2 |
| 2. | Front panel of film changer (total of all layers) | 1.2 |
| 3. | Cradle | 2.3 |
| 4. | Patient support, stationary, without articulated joints | 1.2 |
| 5. | Patient support, moveable, without articulated joints (including stationary layers) | 1.7 |
| 6. | Patient support, with radiolucent panel having one articulated joint | 1.7 |
| 7. | Patient support, with radiolucent panel having two or more articulated joints | 2.3 |
| 8. | Patient support, cantilevered | 2.3 |
10. Diagnostic X-ray equipment shall be designed and constructed in such a manner that
(a) the X-ray tube is securely affixed to and aligned within the X-ray tube housing;
(b) the radiation filters are securely affixed to the exit port of the X-ray tube housing or beam limiting device, or both; and
(c) the X-ray source assembly maintains its required position or movement without drift or vibration during operation.
Functioning Standards
11. Diagnostic X-ray equipment that is fully assembled for use shall function in the manner set out in sections 12 to 21, when operated under normal conditions of use.
12. (1) The definitions in this subsection apply in this section.
"coefficient of variation" means the ratio of the standard deviation to the mean value of a series of measurements calculated by using the following equation:
where
C is the coefficient of variation;
S is the estimated standard deviation;
Xi is the value of the ith measurement;
X is the mean value of the measurements; and
n is the number of measurements. (coefficient de variation)
"radiation exposure to the X-ray image receptor" means the amount of radiation, registered by one or more detectors located in a fixed position in proximity to the X-ray image receptor, that is necessary to produce a radiogram of the desired overall density. (dose d'irradiation au récepteur d'image radiologique)
(2) For any combination of X-ray tube voltage, X-ray tube current and irradiation time, or for any selected radiation exposure to the X-ray image receptor, when the line voltage for each measurement is accurate to within one per cent of the mean line voltage value of all the measurements, and when all variable controls for the loading factors are adjusted to alternate settings and reset to the test setting before each measurement,
(a) the coefficient of variation of any 10 consecutive air kerma (exposure) measurements, taken at the same point along the X-ray beam axis within a period of one hour, shall be no greater than 0.05; and
(b) each of the 10 measurements taken under paragraph (a) shall be within 15 per cent of the mean value of those 10 measurements.
(3) For the purposes of subsection (2), diagnostic X-ray equipment with automatic exposure control must have attenuating material in the X-ray beam thick enough that the loading factors can be adjusted to provide individual irradiations of at least
(a) 12 pulses in the case of a field emission device designed for pulsed operation; or
(b) 0.1 s per irradiation in the case of any other diagnostic X-ray equipment.
13. (1) This section applies in respect of diagnostic X-ray equipment where
(a) the high-voltage generator is not a stored energy highvoltage generator;
(b) no loading factors are changed automatically to compensate for unintentional variations in X-ray tube voltage; and
(c) the irradiation time is at least 0.1 s and the current time product is at least 5 mAs.
(2) For any line voltage regulation in the diagnostic X-ray equipment not exceeding 6 per cent, for any combination of loading factors
(a) the X-ray tube voltage shall not deviate from the selected value by more than 5 per cent in the case of mammographic equipment, or 10 per cent in any other case;
(b) the loading time shall not deviate from the selected value by more than 10 per cent plus 1 ms;
(c) the X-ray tube current shall not deviate from the selected value by more than 20 per cent; and
(d) the current time product shall not deviate from the selected value by more than 10 per cent plus 0.2 mAs.
14. (1) The controlling timer or automatic exposure control device shall be capable of controlling irradiations of 1/60 s or of the time required to deliver 5 mAs, whichever is greater.
(2) To obtain the values of optical densities in accordance with subsection (3), the thickness of an irradiated object that is made of water or other tissue equivalent material shall reflect the patient thickness specified for the X-ray equipment.
(3) The automatic exposure control device shall perform in such a way that the variation of optical density in the resultant radiograms does not exceed the value of
(a) 0.15 when the X-ray tube voltage is variable and the thickness of the irradiated object is constant;
(b) 0.20 when the thickness of the irradiated object is variable and the X-ray tube voltage is constant;
(c) 0.20 when the thickness of the irradiated object and the X-ray tube voltage are both variable; and
(d) 0.10 when the thickness of the irradiated object and the X-ray tube voltage are both constant.
15. (1) For any preselected value of X-ray tube voltage within a range determined in accordance with subsection (2), the average ratios of air kerma (exposure) to current time product, obtained in accordance with subsection (3), shall not differ by more than 0.10 times their sum, that is,
where X1 and X2 are average air kermas (exposures) per current time product.
(2) The range referred to in subsection (1) is the smaller of
(a) the range from 40 per cent to 90 per cent of the maximum available X-ray tube voltage, and
(b) the range specified for the diagnostic X-ray equipment by the manufacturer.
(3) The average ratios of air kerma (exposure) to current time product referred to in subsection (1) shall be obtained at
(a) any two consecutive X-ray tube current settings, where the X-ray tube current is selected in discrete steps;
(b) any two X-ray tube current settings differing by a factor not greater than 2, where the X-ray tube current selection is continuous; or
(c) any two focal spot sizes greater than 0.45 mm, or any two focal spot sizes smaller or equal to 0.45mm.
16. (1) This section applies in respect of mammographic equipment that is operated
(a) at the maximum X-ray field and the minimum focal spot to image receptor distance for which it is designed; and
(b) at the maximum available X-ray tube voltage and the maximum available current time product.
(2) Where mammographic equipment is operated in accordance with subsection (1), the residual radiation behind the image receptor supporting device referred to in paragraph 27(1)(b) shall not result in an air kerma that exceeds 1.0 µGy (exposure of 0.115 mR) per irradiation.
(3) For the purposes of subsection (2), the air kerma (exposure) shall be averaged over a detection area that is
(a) 100 cm2, with no linear dimension greater than 20 cm; and
(b) centred at 5 cm from any accessible surface beyond the image receptor supporting device.
17. (1) Except during the time that radioscopic images are being recorded, radioscopic equipment shall not be operable at any combination of X-ray tube voltage and X-ray tube current that will result in an air kerma (exposure) rate that exceeds
(a) 50 mGy/min (5.75 R/min), if the equipment is not equipped with automatic intensity control;
(b) 100 mGy/min (11.5 R/min), if the equipment is equipped with automatic intensity control; and
(c) 150 mGy/min (17.25 R/min), if the equipment is equipped with automatic intensity control and high level control, and the high level control is activated.
(2) For the purposes of subsection (1), the air kerma (exposure) rate shall be measured at a point along the X-ray beam axis that is
(a) 1 cm above the table, where the X-radiation source is below the table;
(b) 30 cm above the table, with the X-radiation source positioned as closely as possible to the point of measurement, where the X-radiation source is above the table;
(c) 30 cm from the input surface of the radioscopic imaging assembly, where the equipment is a C-arm radioscope;
(d) 15 cm from the centreline of the table in the direction of the X-ray source with the X-ray source assembly positioned as closely as possible to the point of measurement for all positions of the table, where the equipment is a lateral type radioscope; or
(e) 1 cm from end of the beam limiting device or spacer, where the equipment is used with the high level control activated.
18. The leakage radiation from the X-ray source assembly shall not exceed an air kerma (exposure) rate of 1.0 mGy/h (115 mR/h), when the assembly is operated at the nominal X-ray tube conditions of loading corresponding to the maximum specified energy input in one hour, when averaged over a detection area that
(a) is 100 cm2, with no linear dimension greater than 20 cm; and
(b) is centred 1 m from the focal spot.
19. (1) This section applies where there is a possibility of a high voltage appearing across the X-ray tube without the automatic exposure control or the irradiation switch being activated.
(2) The emission of X-radiation from the X-ray source assembly, with the beam limiting device fully open, shall not result in an air kerma (exposure) rate that exceeds 20.0 µGy/h (2.3 mR/h), when averaged over a detection area that is
(a) 10 cm2, with no linear dimension greater than 5 cm; and
(b) centred at 5 cm from any accessible surface of the X-ray source assembly.
20. The emission of X-radiation from any component other than the X-ray source assembly shall not result in an air kerma (exposure) rate that exceeds 20.0 µGy/h (2.3 mR/h), under any operating conditions, when averaged over a detection area that is
(a) 10 cm2, with no linear dimension greater than 5 cm; and
(b) centred at 5 cm from any accessible surface of the component.
21. (1) In this section, "attenuation block" means a block of aluminum having dimensions 20 cm by 20 cm by 3.8 cm.
(2) In the case of radioscopic equipment, the air kerma (exposure) rate, where the X-radiation is due to transmission of the X-ray beam through, or scattering from, the entrance window of the radioscopic imaging assembly, shall not exceed 2 mGy/h (2 mR/h), for each air kerma rate of 1 Gy/min (1 R/min) of entrance air kerma (exposure) rate, measured
(a) at a point specified in subsection 17(2), depending on the type of equipment; and
(b) with the attenuation block positioned between the point of entrance air kerma (exposure) measurement and the image reception area of the radioscopic imaging assembly.
(3) For the purposes of subsection (2), the air kerma (exposure) rate shall be averaged over a detection area that
(a) is 100 cm2; and
(b) is 10 cm from any accessible surface of the radioscopic imaging assembly beyond the image receptor plane.
Radiographic Equipment
22. Radiographic equipment equipped with automatic exposure control shall be designed and constructed to include
(a) a visual indicator on the control panel that shows when the automatic exposure control has been selected;
(b) where the operating X-ray tube voltage is 50 kV or greater, a minimum irradiation time capability that is equal to or less than
(ii) 1/60 s or the time required to deliver 5 mAs, whichever is greater, in the case of any other radiographic equipment;
(c) a means to ensure that
(ii) where the X-ray tube voltage is 50 kV or more,
(B) the product of the X-ray tube voltage, X-ray tube current and irradiation time does not exceed 60 kVAs per irradiation; and
(d) where termination of an irradiation under automatic exposure control occurs because the limits specified in paragraph (c) have been reached,
(ii) a reset control that must be activated manually before another irradiation under automatic exposure control can be made.
23. (1) General purpose radiographic equipment shall be designed and constructed to include
(a) a beam limiting device that provides for
(ii) a minimum X-ray field that does not exceed 5 cm by 5 cm at a focal spot to image receptor distance of 100 cm;
(b) a light field-indicator or other means that visually defines the X-ray field such that the delimitation is visible under normal lighting conditions in the X-ray room;
(c) a means to indicate when the X-ray beam axis is perpendicular to the image receptor plane;
(d) a means to align the centre of the X-ray field with the centre of the image reception area to within 2 per cent of the focal spot to image receptor distance; and
(e) a means to indicate the focal spot to image receptor distance to within 2 per cent of that distance.
(2) The light field-indicator referred to in paragraph (1)(b) shall be designed such that, when the X-ray beam axis is perpendicular to the image receptor plane, the light field-indicator visually defines the X-ray field in accordance with the following requirements:
(a) misalignment of the edges of the visually defined field with the edges of the X-ray field does not exceed 2 per cent of the focal spot to image receptor distance; and
(b) the dimensions of the X-ray field are indicated at selected distances and the indicated dimensions are accurate to within 2 per cent of the focal spot to image receptor distance.
(3) The light field-indicator referred to in paragraph (1)(b) shall be designed such that the average illumination within the light field is at least 100 lux when measured from the lesser of
(a) a distance of 100 cm from the X-radiation source, and
(b) the maximum focal spot to image receptor distance.
(4) For the purposes of subsection (3), "light field" means the area of light that
(a) is circumscribed by the beam limiting device; and
(b) has as its perimeter the locus of points at which illumination is one fourth of the maximum illumination in the area.
24. (1) Where general purpose radiographic equipment is equipped with a positive beam limiting system, the system shall
(a) provide for stepless adjustment of the size of the X-ray field;
(b) provide for a minimum X-ray field size that does not exceed 5 cm by 5 cm at a focal spot to image receptor distance of 100 cm;
(c) provide for adjustment of the size of the X-ray field to dimensions smaller than those of the image reception area;
(d) automatically return to the mode described in paragraph (e) on any change to
(ii) the focal spot to image receptor distance, if the change would result in failure to meet the requirements of paragraph (e); and
(e) under the conditions of operation specified in subsection (2),
(ii) prevent the emission of X-radiation until the beam limiting device is manually adjusted so that
(B) the size of the X-ray field does not exceed the size of the image reception area, or a preselected portion of that area, by more than 3 per cent of the focal spot to image receptor distance, and
(C) the sum of the absolute values of the length and width differences between the X-ray field size and the image reception area, or a preselected portion of that area, does not exceed 4 per cent of the focal spot to image receptor distance.
(2) For the purposes of paragraph (1)(e), the conditions of operation are as follows:
(a) the image receptor is inserted into a permanently mounted cassette holder;
(b) neither the length nor the width of the image reception area exceeds 50 cm;
(c) the X-ray beam axis is perpendicular to the image receptor plane to within 3 degrees;
(d) the X-ray beam axis is accurate to
(ii) within 3 degrees of vertical when the focal spot to image receptor distance is not less than 90 cm and not more than 130 cm; and
(e) neither tomography nor stereoscopic radiography is being performed.
25. (1) Subject to section 26, radiographic equipment, other than general purpose radiographic equipment and mammography equipment, shall be designed and constructed to include an assortment of removable, fixed-aperture beam limiting devices that, for every combination of image reception area and focal spot to image receptor distance for which the equipment is designed,
(a) provide a means of aligning the centre of the X-ray field with the centre of the image reception area to within 2 per cent of the focal spot to image receptor distance; and
(b) provide a means to ensure that the X-ray field does not extend beyond any edge of the image reception area.
(2) Each beam limiting device shall bear a label setting out the dimensions of the image reception area and the focal spot to image receptor distance for which it is designed.
26. Mobile equipment that does not meet the requirements of section 25 shall be designed and constructed to include
(a) a beam limiting device that provides for
(ii) a minimum X-ray field size that does not exceed 5 cm by 5 cm at a focal spot to image receptor distance of 100 cm;
(b) a light field-indicator or other means referred to in paragraph 23(1)(b) that, where the X-ray beam axis is perpendicular to the image receptor plane, visually defines the X-ray field and where the misalignment of the edges of the visually defined field with the edges of the X-ray field does not exceed 2 per cent of the focal spot to image receptor distance, and
(c) a means to indicate the focal spot to image receptor distance to within 2 per cent of that distance.
27. (1) Mammographic equipment shall be designed and constructed to include
(a) a beam limiting device that limits the size of the X-ray beam so that, at any focal spot to image receptor distance for which the equipment is designed, the X-ray field does not extend beyond
(ii) any other edge of the image reception area by more than 2 per cent of the focal spot to image receptor distance;
(b) an image receptor supporting device that
(ii) is designed to extend to the patient's chest wall, and
(iii) extends beyond the X-ray field by at least one per cent of the focal spot to image receptor distance; and
(c) a breast compression device that
(ii) provides a means for fine adjustment of motion during the compression,
(iii) provides a means for rapid decompression,
(iv) has motion adjustment controls on both sides of where the patient is positioned, and
(v) allows the portion of the compression plate in contact with the breast to be brought to within 10 mm of the surface of the patient support.
(2) Where mammographic equipment is equipped with a removable, fixed-aperture beam limiting device, the device shall bear on its external surface a label that sets out
(a) the dimensions of the image reception area; and
(b) the focal spot to image receptor distance for which the equipment is designed.
28. Radioscopic equipment that is equipped with a spotfilm device shall be designed and constructed to include
(a) where the angle of the image receptor plane or of the X-ray source assembly can be adjusted by the operator, a means to indicate when the X-ray beam axis is perpendicular to the image receptor plane;
(b) a mechanism that ensures that, with the X-ray beam axis perpendicular to the image receptor plane,
(ii) when the size of the X-ray field is smaller than the size of a preselected portion of the image reception area, the option of adjusting the field size is available only to the operator,
(iii) when the edges of the X-ray field are aligned with the edges of a preselected portion of the image reception area,
(B) the sum of the absolute values of the length and width differences between the X-ray field size and the image reception area does not exceed 4 per cent of the focal spot to image receptor distance, and
(iv) the centre of the X-ray field is aligned with the centre of the preselected portion of the image reception area to within 2 per cent of the focal spot to image receptor distance;
(c) a mechanism for adjusting the size of the X-ray field to dimensions smaller than those of the preselected portion of the image reception area, such that
(ii) when the X-ray beam axis is perpendicular to the image receptor plane, the requirements set out in subparagraph (b)(iv) are met; and
(d) where a means is provided for the operator, in the case of failure of the automatic X-ray field size adjustment, to override it, a visual indicator at the operator's position that shows when the override is activated.
29. Radiographic equipment, other than equipment described in sections 22 to 28, shall be designed and constructed to include a beam limiting device that, when the axis of the X-ray beam is perpendicular to the image receptor plane, provides a means of
(a) aligning the centre of the X-ray field with the centre of the image reception area to within 2 per cent of the focal spot to image receptor distance; and
(b) adjusting the edges of the X-ray field such that they do not extend beyond the corresponding edges of the image reception area by more than 2 per cent of the focal spot to image receptor distance.
Radioscopic Equipment
30. Radioscopic equipment shall be designed and constructed to include
(a) an X-ray image intensifier that includes protective shielding such that
(ii) the X-ray beam and scattered radiation from the image intensifier that would otherwise reach the operator are intercepted,
(iii) the radioscopic X-ray tube is not capable of emitting X-radiation unless protective shielding is in place to intercept the X-ray beam, and
(iv) the attenuation of X-radiation transmitted through or scattered from the entrance window of the radioscopic imaging assembly is sufficient to ensure that the equipment meets the standard of functioning prescribed by section 21;
(b) for mobile equipment, an X-ray image intensifier that is an integral part of the equipment or is interlocked in such a manner that its removal prevents X-radiation from being produced;
(c) for stationary equipment, a means to prevent the X-ray tube from producing X-radiation when there is no image receptor in place to intercept the X-ray beam;
(d) for stationary equipment not equipped with remote control,
(ii) a means to remove the protective means referred to in subparagraph (i) where it would interfere with the performance of specialized diagnostic procedures;
(e) an irradiation switch of a type that
(ii) enables the operator to terminate the recording of serial radioscopic images at any time;
(f) a chronometer that
(ii) can be reset to zero or any other selected value;
(g) a positive beam limiting system such that, when the X-ray beam axis is perpendicular to the image receptor plane,
(ii) the sum of the excess length and excess width does not exceed 4 per cent of the focal spot to image receptor distance;
(h) meters or other visual indicators that provide a continuous indication of X-ray tube voltage and X-ray tube current; and
(i) a device that limits the focal spot to skin distance to not less than
(ii) 38 cm, for stationary equipment,
(iii) 20 cm, for radioscopic equipment fitted with an X-ray image intensifier and designed for special applications that would be impossible at the minimum focal spot to skin distances specified in subparagraphs (i) and (ii), or
(iv) in the case of small-format, low-intensity radioscopic equipment, the distance at which the equipment is capable of delivering an air kerma (exposure) rate of 50 mGy/min (5.75 R/min).
31. Radioscopic equipment that is designed for cineradiography shall be equipped with meters or other visual indicators that provide a continuous indication of the X-ray tube voltage and X-ray tube current.
32. Where a high level control is part of the radioscopic equipment, the control shall
(a) require a separate means to activate it;
(b) require continuous pressure by the operator for it to emit X-radiation; and
(c) include a continuous audible signal, or an intermittent signal with silent periods not longer than one second, to indicate that a high level control is being employed.
COMING INTO FORCE
3. These Regulations come into force on the day on which they are registered.
[40-1-o]
C.R.C., c. 870
SOR/96-97
SOR/96-97
C.R.C., c. 870
C.R.C., c. 870
C.R.C., c. 870
C.R.C., c. 870
SOR/97-189
SOR/97-189
SOR/81-23
C.R.C., c. 1370
SOR/85-705
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