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Vol. 136, No. 22 — June 1, 2002 Regulations Amending the Food and Drug Regulations (1197 — Sethoxydim)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT ANALYSIS STATEMENT Description Sethoxydim is registered under the Pest Control Products Act as a herbicide for the control of grasses in broadleaf crops as a post-emergent treatment. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of sethoxydim and its metabolites resulting from this use at 15 parts per million (p.p.m.) in tomato paste, 10 p.p.m. in dry beans and peas, 5 p.p.m. in beans and soybeans, 4 p.p.m. in lentils, potatoes and tomatoes, 2 p.p.m. in cabbage and mustard greens, 1 p.p.m. in cucumbers and squash, 0.5 p.p.m. in broccoli, corn and cranberries, and 0.2 p.p.m. in onions, and at 2 p.p.m. in artichokes, cantaloupes, eggplants and spinach, and 1 p.p.m. in celery and lettuce imported into Canada. MRLs have also been established at 2 p.p.m. in eggs, 0.5 p.p.m. in liver of poultry and 0.2 p.p.m. in meat of poultry to cover residues in food derived from animals fed with crops treated with sethoxydim. 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 approved an application to amend the registration of sethoxydim in order to allow its use for the control of grasses in asparagus, blueberries, carrots, flax, peppers, pumpkins, raspberries, strawberries, sunflowers and turnips as a post-emergent treatment. This proposed regulatory amendment would establish MRLs for residues of sethoxydim and its metabolites resulting from these uses in asparagus, blueberries, carrots, flax, peppers, pumpkins, raspberries, strawberries, sunflowers and turnips, establish an MRL for mustard, and increase the MRLs for cranberries and lentils, in order to permit the sale of food containing these residues. The MRL for cranberries is being increased from 0.5 p.p.m. to 2 p.p.m. in conjunction with a decision to decrease the minimum time between application of sethoxydim and harvest. The MRL for lentils is being increased from 4 p.p.m. to 30 p.p.m. in order to harmonize with the one established by the United States Environmental Protection Agency. 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 following conditions are met: 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 that 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 sethoxydim, including its metabolites, of 30 p.p.m. in lentils, 10 p.p.m. in strawberries, 7 p.p.m. in sunflowers, 5 p.p.m. in raspberries, 4 p.p.m. in blueberries, 2 p.p.m. in cranberries and mustard, 1 p.p.m. in pumpkins, 0.5 p.p.m. in asparagus and peppers, 0.2 p.p.m. in flax and turnips, and 0.1 p.p.m. in carrots would not pose an unacceptable health risk to the public. This proposed regulatory amendment would also amend the chemical name of sethoxydim in order to comply with international nomenclature conventions. Alternatives Under the Food and Drugs Act, it is prohibited to sell food containing residues of pest control products at a level greater than 0.1 p.p.m. unless a higher MRL has been established in Table II, Division 15, of the Food and Drug Regulations. In the case of sethoxydim, increasing the MRL for lentils and cranberries, and the establishment of MRLs for asparagus, blueberries, flax, mustard, peppers, pumpkins, raspberries, strawberries, sunflowers and turnips are necessary to support the additional use of a pest control product which has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. 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 sethoxydim in carrots 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 sethoxydim on the crops listed above 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 sethoxydim 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 sethoxydim 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 (1197 — Sethoxydim). 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 (1197 — SETHOXYDIM) AMENDMENT 1. The portion of item S.1 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) in columns II (see footnote 2) to 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 (1240 — Nicotine)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT ANALYSIS STATEMENT Description Part I of Schedule F of the Food and Drug Regulations lists substances intended for human or veterinary use which require a prescription to be sold in Canada. Schedule F includes nicotine as a drug substance except when sold in natural substances or in a gum or transdermal patch. Products in gum and patch form are commonly used in smoking cessation therapy to relieve nicotine withdrawal symptoms. The nonprescription nicotine replacement therapies (NRTs) presently available on the Canadian market were initially approved as prescription drugs. These products are nicotine 2 mg chewing gum (nonprescription since 1992), nicotine 4 mg chewing gum (nonprescription since 1997) and nicotine transdermal patches (nonprescription since 1998). This regulatory amendment proposes to remove from Schedule F, nicotine, when administered by an oral inhalation device. The current proposal differs from previous prescription to nonprescription switch proposals because the product has not been sold in Canada as a prescription drug. The proposal would allow the new inhalation dosage form for nicotine to be sold as a nonprescription drug immediately upon approval by Health Canada. Rationale — The proposal to remove nicotine inhaler from Schedule F is based on a review of the clinical evidence and safety data provided in a New Drug Submission. A general review of the known pharmacological and toxicological properties of nicotine, reported adverse drug reactions, abuse potential studies and available literature has also been undertaken. — According to the federal government's Tobacco Demand Reduction Strategy included in the National Action Plan to Combat Smuggling in Canada, measures which safely assist the cessation of smoking should be encouraged. — In 1997, the United Nations Focal Point on Tobacco or Health recommended that less hazardous nicotine devices should be as or more easily available than cigarettes. — Nicotine in an oral inhaler dosage form has been available internationally since 1996. It is a nonprescription drug in 13 countries including Denmark, Sweden and the United Kingdom. There is no evidence from the post-market data that this product is being abused by either children or non-smokers. There have been no reports of inappropriate use, overdose or product dependence. — Two studies have been completed in the United States which confirm that: (a) the safety and effectiveness of the product is not reduced when used in a nonprescription setting.
Alternatives Prescription status The alternative option would be to leave nicotine inhaler on Schedule F. This option was not considered to be an appropriate risk management tool. Prescription status would unnecessarily restrict the availability of a safe and effective smoking cessation product. The benefits of having nicotine inhaler available as a nonprescription drug clearly outweigh the risks. Benefits and Costs
The proposed amendment would impact on the following sectors:
The availability of the nicotine inhaler as a nonprescription product would provide consumers with the convenience of self-medication. It would also provide consumers with a greater choice of nonprescription aids for smoking cessation. This may encourage more Canadians to try to quit smoking. Product labels would be required to include directions for use and applicable cautionary statements. This would help to provide information to the public about the product's safe and proper use. The public would be required to pay directly for the product as nonprescription products are not usually covered by drug insurance plans. — Pharmaceutical Industry The nonprescription availability of the nicotine inhaler could impact on the sales of the other nonprescription NRT dosage forms that are already on the market. — Provincial Health Care Systems There would be no anticipated cost to publicly funded drug benefit plans since most do not cover the cost of nonprescription drugs. An increased number of smokers quitting their use of tobacco products could lead to fewer patients with smoking-related diseases and reduced costs to the health care system. Consultation Direct mailing of this regulatory proposal was sent on November 14, 2000, to the provincial Ministries of Health, medical and pharmacy licensing bodies and pharmaceutical industry with a 30-day comment period. Responses were received from four stakeholders. Three respondents supported the proposal. One respondent objected to the proposal and expressed the concerns summarized below: Comment No. 1 The proposal to exempt nicotine inhalers from the Food and Drug Regulations is too broad. Only one nicotine inhaler is currently proposed for marketing in Canada, yet the regulatory proposal is to exempt all inhalers. Response The proposed amendment would remove nicotine inhaler from Schedule F. It would not exempt nicotine inhaler from other requirements of the Food and Drug Regulations. Any proposal to market a different nicotine inhaler would require a New Drug Submission (NDS). The NDS would be required to include safety and efficacy data. Clinical trial data would be required to demonstrate efficacy. Safety data would include adverse drug reaction reports and abuse-potential studies. Each submission would be evaluated on a case-by-case basis before a Notice of Compliance would be issued. Comment No. 2 The early consultation letter issued by Health Canada makes reference to the conclusion "that the benefits of having nicotine inhaler available as a nonprescription drug clearly outweigh the risks." There is no available risk-benefit analysis on which to make this decision. Response Studies have shown that the nicotine inhaler is as effective for smoking cessation therapy as other nonprescription NRTs currently available in Canada. In four out of six studies, people using a nicotine inhaler had significantly higher smoking cessation success rates than those who used a placebo. The nicotine released from the inhaler is absorbed primarily through the mouth and throat into the bloodstream. The amount of nicotine that ends up in the blood is sufficient to relieve symptoms of nicotine withdrawal, but with a low risk of adverse events. The abuse potential of the nicotine inhaler is no higher than that of other available NRTs. Comment No. 3 There is little evidence that increased availability of nicotine products increases successful quit attempts. Nicotine products have been available on a nonprescription basis in several jurisdictions including Canada for a number of years. This has provided an opportunity to establish, through post-market studies, whether the anticipated benefit is being realized. Health Canada should demand such evidence be provided before increasing the availability of nicotine in a form with abuse potential. Response It is acknowledged that the relapse rate for all NRTs is high. However, on a public health level, any NRT that increases the probability of smoking cessation is considered to reduce the overall health hazards and diseases associated with continued smoking. Some smokers may transfer their nicotine dependence to a NRT. In these cases, the NRT does not cause the dependence. NRT dependence is considered to be less harmful than tobacco dependence. Comment No. 4 Health Canada's proposal appears to rely on the UN Focal Point on Tobacco or Health recommendation. It does not identify the influence and financing of this initiative by the pharmaceutical companies which benefit from this recommendation. Health Canada's proposal does not address the need for promotional constraints on nicotine. The proposed regulatory change would remove from the public sphere any form of constraint on the promotion of nicotine inhalers. Response The availability of the nicotine inhaler as a nonprescription drug is not expected to result in a new group of nicotine addicts. The nicotine inhaler studies included only smokers as participants, not former smokers or nonsmokers. However, in studies with the gum, patch and nasal spray, former smokers or nonsmokers generally had a strong dislike for nicotine obtained from such products. Advertising for nonprescription drug products must comply with the Food and Drugs Act and Regulations and related guidelines and policies. Information provided in an advertisement must agree with the approved product monograph or product labelling. Comment No. 5 No evidence has been forwarded to suggest an absence of abuse of nicotine inhalers. Response Since none of the six studies with the inhaler allowed participants to use the inhaler beyond six months, definitive data on the percentage of people who would use the inhaler long term is unknown. Experience with the nicotine gum suggests that even if long-term use were to occur, most users (approximately 98 percent) would cease using the inhaler within one to two years. Even if long-term use with the inhaler were to occur, the health risk with continued smoking would be considerably greater. The nicotine inhaler is expected to have an abuse/dependence potential similar to that of nicotine gum. This potential is much less than that of cigarettes. This conclusion is based on the following findings: — The inhaler produces blood levels of nicotine that are lower and more consistent than those produced by smoking. — The nicotine from an inhaler is absorbed into the blood stream more slowly than from smoking. — In the studies, only 11 percent of smokers were still using the inhaler at 6 months. — Only one participant out of the 730 who used inhalers containing nicotine reported possible dependence on the inhaler. In the same studies, three participants who used inhalers containing a placebo mentioned similar feelings of dependence. — The number of nicotine inhalers used per day declines over time. This is not the usual pattern for drugs of abuse. With typical drugs of abuse, the amount of drug used often increases over time. With addicted smokers, the number of cigarettes per day does not usually decline but remains fairly consistent. Compliance and Enforcement This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations, enforced by the Health Products and Food Branch Inspectorate. Indirect enforcement is provided through complaints from the medical profession and competitors. Inspection mechanisms at both the federal and provincial levels would be maintained. Contact Karen Ash, Bureau of Policy and Coordination, Therapeutic Products Directorate, Holland Cross, Tower 'B', 1600 Scott Street, 2nd Floor, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 957-0372 (Telephone), (613) 941-6458 (Facsimile), karen_ash@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 (1240 — Nicotine). 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 Karen Ash, Therapeutic Products Directorate, Health Canada, Address Locator No. 3102C5, 1600 Scott Street, 2nd floor, Tower B, Ottawa, Ontario K1A 1B6 (Fax: (613) 941-6458; E-mail: karen_ash@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 (1240 — NICOTINE) AMENDMENTS 1. The reference to Nicotine and its salts (except in natural substances or when sold as a chewing gum containing not more than the equivalent of 4 mg of nicotine per dosage unit or when sold as a transdermal patch with a delivery rate of not more than the equivalent of 22 mg of nicotine per day) Nicotine et ses sels (sauf dans les substances naturelles ou s'ils sont vendus sous forme de gomme à mâcher contenant au plus l'équivalent de 4 mg de nicotine par unité posologique ou sous forme de timbre cutané ayant un taux de libération de 22 mg ou moins de nicotine par jour) (see footnote 4) in Part I of Schedule F to the Food and Drug Regulations (see footnote 5) is replaced by the following: Nicotine and its salts, for human use, except
(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit; (c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day; or (d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit
b) sous forme de gomme à mâcher contenant 4 mg ou moins de nicotine par unité posologique; c) sous forme de timbre cutané ayant un taux de libération de 22 mg ou moins de nicotine par jour; d) sous une forme destinée à être administrée par voie orale au moyen d'un inhalateur libérant 4 mg ou moins de nicotine par unité posologique Nicotine and its salts COMING INTO FORCE 3. These Regulations come into force on the day on which they are registered. [22-1-o] Regulations Amending the Food and Drug Regulations (1296 — Tebufenozide)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT ANALYSIS STATEMENT Description Tebufenozide is registered under the Pest Control Products Act as an insecticide for the control of various insects on apples and for the control of European corn borer on peppers. Maximum Residue Limits (MRLs) have been established under the Food and Drugs Act for residues of tebufenozide resulting from this use at 1 part per million (p.p.m.) in apples and 0.2 p.p.m. in peppers, and at 2.5 p.p.m. in raisins and 0.5 p.p.m. in grapes and kiwi fruit imported into Canada. 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 tebufenozide in order to allow its use for the control of blackheaded fireworm, cutworms, and fruitworm on cranberries, the control of Looper on lettuce and tomatoes, and the control of codling moth, oblique-banded leafroller and three-lined leafroller on pears. This proposed regulatory amendment would establish MRLs for residues of tebufenozide resulting from this use in cranberries, dried cranberries, lettuce, pears and tomatoes, in order to permit the sale of food containing these residues. Before making a registration decision regarding a new use of a pest control product, the PMRA conducts the appropriate assessment of the risks and value of the product specific to its proposed use. The registration of the pest control product will be amended if the data requirements for assessing value and safety have been adequately addressed, the evaluation indicates that the product has merit and value and the human health and environmental risks associated with its proposed use are acceptable. The human health risk assessment includes an assessment of dietary risks posed by expected residues of the pest control product, as determined through extensive toxicological studies. An acceptable daily intake (ADI) and/or acute reference dose (ARD) is calculated by applying a safety factor to a no observable adverse effect level or, in appropriate cases, by applying a risk factor which is calculated based on a linear low-dose extrapolation. The potential daily intake (PDI) is calculated from the amount of residue that remains on each food when the pest control product is used according to the proposed label and the intake of that food from both domestic and imported sources in the diet. PDIs are established for various Canadian subpopulations and age groups, including infants, toddlers, children, adolescents and adults. Provided the PDI does not exceed the ADI or ARD for any subpopulation or age group, and the lifetime risk is acceptable, the expected residue levels are established as MRLs under the Food and Drugs Act to prevent the sale of food with higher residue levels. Since, in most cases, the PDI is well below the ADI and lifetime risks are very low when MRLs are originally established, additional MRLs for the pest control product may be added in the future. After the review of all available data, the PMRA has determined that MRLs for tebufenozide of 6 p.p.m. in lettuce, 5 p.p.m. in dried cranberries, 2 p.p.m. in tomatoes and 1 p.p.m. in cranberries and pears 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 tebufenozide, establishment of MRLs for cranberries, dried cranberries, lettuce, pears and tomatoes is necessary to support the additional use of a pest control product which has been shown to be both safe and effective, while at the same time preventing the sale of food with unacceptable residues. As a means to improve responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) was issued on August 4, 2001, to permit the immediate sale of lettuce, dried cranberries and cranberries containing residues of tebufenozide with MRLs of 6 p.p.m., 5 p.p.m. and 1 p.p.m. respectively, while the regulatory process to formally amend the regulation is undertaken. A second IMA was issued on November 17, 2001, to permit the immediate sale of tomatoes containing residues of tebufenozide with an MRL of 2 p.p.m. while the regulatory process to formally amend the Regulations is undertaken. A third IMA was issued on February 9, 2002, to permit the immediate sale of pears containing residues of tebufenozide with an MRL of 1 p.p.m. while the regulatory process to formally amend the Regulations is undertaken. Benefits and Costs The use of tebufenozide on cranberries, lettuce, pears and tomatoes 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 tebufenozide 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 tebufenozide are adopted. Contact Geraldine Graham, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9, (613) 736-3692 (Telephone), (613) 736-3659 (Facsimile), geraldine_graham@hc-sc.gc.ca (Electronic mail). PROPOSED REGULATORY TEXT Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote c) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1296 — Tebufenozide). 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 (1296 — TEBUFENOZIDE) AMENDMENT 1. The portion of item T.01 of Table II to Division 15 of Part B of the Food and Drug Regulations (see footnote 7) in columns III (see footnote 8) and IV (see footnote 9) 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] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 SOR/97-413 SOR/97-413 S.C. 1999, c. 33, s. 347 SOR/98-294 C.R.C., c. 870 SOR/97-410 S.C. 1999, c. 33, s. 347 C.R.C., c. 870 SOR/2001-460 SOR/2001-460 |
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