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Vol. 136, No. 22 — June 1, 2002 Regulations Amending the Food and Drug Regulations (1304 — Propiconazole)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT ANALYSIS STATEMENT Description Propiconazole is registered under the Pest Control Products Act as a fungicide for the control of various fungi on apricots, barley, cherries, corn, cranberries, oats, peaches/nectarines, plums, rapeseed (canola), rutabagas, Saskatoon serviceberries and wheat. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of propiconazole and its metabolites resulting from these uses at 1 part per million (p.p.m.) in apricots, cherries, peaches/nectarines and plums, and at 0.05 p.p.m. in barley, oats and wheat. An MRL has also been established at 2 p.p.m. in liver and kidney of cattle to cover residues in food derived from animals fed with crops treated with propiconazole. By virtue of subsection B.15.002(1) of the Food and Drug Regulations (the Regulations), the MRL for other foods is 0.1 p.p.m. The Pest Management Regulatory Agency (PMRA) of Health Canada has recently approved an application to amend the registration of propiconazole in order to allow its use for the control of mummyberry on blueberries and for the control of rust on asparagus. This proposed regulatory amendment would establish MRLs for residues of propiconazole and its metabolites resulting from these uses in blueberries and asparagus, in order to permit the sale of food containing these residues. Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value, and the human health and environmental risks associated with its proposed use are acceptable. The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor that has no observable adverse effect level or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future. After the review of all available data, the PMRA has determined that MRLs for propiconazole, and its metabolites, of 0.15 p.p.m. in dried blueberries, 0.1 p.p.m. in asparagus, and 0.02 p.p.m. in blueberries would not pose an unacceptable health risk to the public. Alternatives Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. Also under the Food and Drugs Act, the sale of food containing residues of pest control products at a level less than or equal to 0.1 p.p.m. is permitted unless a lower MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of propiconazole, establishment of MRLs for blueberries and dried blueberries is necessary to support the additional use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. Even though the sale of food containing residues of pest control products at a level greater than 0.1 p.p.m. would already be prohibited by virtue of subsection B.15.002(1) of the Food and Drug Regulations, the establishment of an MRL of 0.1 p.p.m. in Table II, Division 15, of the Regulations, for residues of propiconazole in asparagus would provide more clarity regarding the applicable MRL and would clearly indicate that the appropriate risk assessment has been completed. This is in keeping with current trends towards increased openness and transparency of regulatory processes and is consistent with current practices of most pesticide regulatory agencies throughout the world. Benefits and Costs The use of propiconazole on asparagus and blueberries will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues. Some costs may be incurred related to the implementation of analytical methods for analysis of propiconazole and its metabolites in the foods mentioned above. Resources required are not expected to result in significant costs to the Government. Consultation Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organisation for Economic Co-operation 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 propiconazole are adopted. Contact Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1304 — Propiconazole). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (Tel.: (613) 736-3692; Fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, May 30, 2002
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1304 — PROPICONAZOLE) AMENDMENT 1. The portion of item P.7 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:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. [22-1-o] Regulations Amending the Food and Drug Regulations (1310 — Sulfosulfuron)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) sulfosulfuron as a herbicide for the control of a variety of grassy and broadleaf weeds in wheat 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 sulfosulfuron and its metabolites resulting from this use in wheat, in order to permit the sale of food containing these residues. Before making a registration decision regarding a new pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. Pest control products will be registered if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable. The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor that has no observable adverse effect level or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future. After the review of all available data, the PMRA has determined that an MRL for sulfosulfuron, including its metabolites, of 0.02 parts per million (p.p.m.) in wheat would not pose an unacceptable health risk to the public. This new MRL harmonizes with the one established by the United States Environmental Protection Agency. Alternatives Under the Food and Drugs Act, the sale of food containing residues of pest control products at a level less than or equal to 0.1 p.p.m. is permitted unless a lower MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of sulfosulfuron, establishment of an MRL for wheat is necessary to support the use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. Benefits and Costs The use of sulfosulfuron on wheat will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues. Some costs may be incurred related to the implementation of analytical methods for analysis of sulfosulfuron and its metabolites in the food mentioned above. Resources required are not expected to result in significant costs to the Government. Consultation Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organisation for Economic Co-operation 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 sulfosulfuron is adopted. Contact Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote b) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1310 — Sulfosulfuron). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (tel.: (613) 736-3692; fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, May 30, 2002
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1310 — SULFOSULFURON) 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 S.3:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. [22-1-o] Regulations Amending the Food and Drug Regulations (1324 — Florasulam)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) florasulam as a herbicide for the control of broadleaf weeds in barley, oats and wheat 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 florasulam resulting from this use in barley, oats and wheat, in order to permit the sale of food containing these residues. Before making a registration decision regarding a new pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. Pest control products will be registered if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value, and the human health and environmental risks associated with its proposed use are acceptable. The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a no observable adverse effect level or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future. After the review of all available data, the PMRA has determined that an MRL for florasulam of 0.01 parts per million (p.p.m.) in barley, oats and wheat would not pose an unacceptable health risk to the public. 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 florasulam, establishment of an MRL for barley, oats and wheat is necessary to support the use of a pest control product that has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. Benefits and Costs The use of florasulam on barley, oats and wheat will provide joint benefits to consumers and the agricultural industry as a result of improved management of pests. In addition, this proposed regulatory amendment will contribute to a safe, abundant and affordable food supply by allowing the importation and sale of food commodities containing acceptable levels of pesticide residues. Some costs may be incurred related to the implementation of analytical methods for analysis of florasulam in the foods mentioned above. Resources required are not expected to result in significant costs to the Government. Consultation Registration decisions, including dietary risk assessments, made by the PMRA are based on internationally recognized risk management principles, which are largely harmonized among member countries of the Organisation for Economic Co-operation 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 florasulam is adopted. Contact Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote c) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1324 — Florasulam). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (tel.: (613) 736-3692; fax: (613) 736-3659; e-mail: geraldine_graham@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, May 30, 2002
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1324 — FLORASULAM) 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 F.1.1:
COMING INTO FORCE 2. These Regulations come into force on the day on which they are registered. [22-1-o] Regulations Amending the Employment Insurance RegulationsStatutory Authority Employment Insurance Act Sponsoring Department Department of Human Resources Development REGULATORY IMPACT ANALYSIS STATEMENT Description One of the important reforms made to the Employment Insurance (EI) program in 1996 was the change from a system based on weeks of insurable employment to a system based on hours of insurable employment. The Government's intent was, and still is, to consider that a person has worked in insurable employment for the number of hours that the person has both worked and been remunerated. This basic principle governs the determination of all insurable hours of employment. However, a court decision made by the Federal Court of Appeal (Murphy A-402-99) has challenged the basic principle on which the calculation of hours of insurable employment is based. The Court decided that under the current Regulations, standby hours are insurable if they are paid even if they are not worked. It is not the Government's intention to reform the methods used to determine the number of hours of insurable employment. Therefore, the proposed amendments to sections 10 and 10.2 of the Employment Insurance Regulations are necessary and only clarify the position adopted in 1996 when the current EI system was developed. Alternatives The amendment is necessary in order to restate the Government's intent and to clarify the concept of hours of insurable employment. Consequently, no alternatives have been proposed. Benefits and Costs If this amendment is not made, access to Employment Insurance benefits will become much easier and the cost of administering the employment insurance system will increase accordingly. Since this change only clarifies the existing rules, no significant financial impact is expected, either in the case of administrative costs or costs to the Employment Insurance Fund. Consultation The amendments were prepared by Human Resources Development Canada (HRDC) Insurance Policy in cooperation with Strategic Policy, Legal Services, Insurance Program Services and Headquarters Systems, Canadian Customs and Revenue Agency and the Department of Justice. All the parties involved support the proposal. This proposal was also approved in principle by the Canada Employment Insurance Commission. Compliance and Enforcement HRDC's and Canada Customs and Revenue Agency's usual compliance mechanisms will ensure that the amendments are correctly applied. Contact Stéphane Tremblay, Senior Policy Advisor, Human Resources Development Canada, Policy and Legislation Development, Insurance Policy, 140 Promenade du Portage, 9th Floor, Ottawa, Ontario K1A 0J9, (819) 997-8600 (Telephone), (819) 953-9381 (Facsimile). PROPOSED REGULATORY TEXT Notice is hereby given that the Canada Employment Insurance Commission, with the approval of the Governor in Council, proposes, pursuant to section 55 of the Employment Insurance Act (see footnote d) , to make the annexed Regulations Amending the Employment Insurance Regulations. Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Stéphane Tremblay, Policy and Legislation Development, Insurance Branch, Human Resources Development Canada, 9th Floor, 140 Promenade du Portage, Ottawa, Ontario K1A 0J9. Ottawa, May 30, 2002
EILEEN BOYD
REGULATIONS AMENDING THE EMPLOYMENT INSURANCE REGULATIONS AMENDMENTS 1. Subsection 10(2) of the Employment Insurance Regulations (see footnote 6) is replaced by the following: (2) Except where subsection (1) and section 9.1 apply, if the employer cannot establish with certainty the actual number of hours of work performed by a worker or by a group of workers and for which they were remunerated, the employer and the worker or group of workers may, subject to subsection (3) and as is reasonable in the circumstances, agree on the number of hours of work that would normally be required to gain the earnings referred to in subsection (1), and, where they do so, each worker is deemed to have worked that number of hours in insurable employment. 2. The Regulations are amended by adding the following after section 10: 10.01 (1) If a person is required under their contract of employment to be available for a certain period awaiting a request from their employer to work, the hours during that period are deemed to be hours of insurable employment if the person is paid for those hours at a rate equivalent or superior to the remuneration that would be paid if the person had actually worked during that period. (2) Despite subsection (1), if a person is required by their employer under their contract of employment to be present at the employer's premises for a certain period in case their services are required, the hours during that period are deemed to be hours of insurable employment if the person is paid for those hours. 3. The portion of section 10.2 of the Regulations before paragraph (a) is replaced by the following: 10.2 For the purposes of sections 9.1, 10, 10.01, 10.1 and 22, COMING INTO FORCE 4. These Regulations come into force on the day on which they are registered. [22-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 SOR/2000-351 SOR/2000-351 S.C. 1999, c. 347 C.R.C., c. 870 S.C. 1999, c. 33, s. 347 C.R.C., c. 870 S.C. 1996, c. 23 SOR/96-332 |
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