New Substances Fees Regulations

New Substances Fees Regulations Whereas, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999a, the Minister of the Environment published in the Canada Gazette, Part I, on June 30, 2001 a copy of the proposed New Substances Fees Regulations, substantially in the form set out in the annexed Regulations, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection; S.C. 1999, c. 33 Whereas, pursuant to subsection 328(3) of that Act, the fees that are prescribed by the annexed Regulations for services provided do not exceed the cost to Her Majesty in right of Canada of providing those services; And whereas, pursuant to section 329 of that Act, the Minister of the Environment and the Minister of Health have consulted with those persons and organizations that the Minister of the Environment and the Minister of Health consider to be interested in the matter; Therefore, the Minister of the Environment and the Minister of Health, on the recommendation of the Treasury Board, pursuant to section 328 of the Canadian Environmental Protection Act, 1999a, hereby make the annexed New Substances Fees Regulations. Ottawa, September 3, 2002 David Anderson Minister of the Environment Ottawa, October 11, 2002 A. Anne McLellan Minister of Health The definitions in this section apply in these Regulations. Act means the Canadian Environmental Protection Act, 1999. (Loi) assessment means the assessment of information in respect of a new substance for the purpose of determining, under section 83 of the Act, whether the new substance is toxic or capable of becoming toxic. (évaluation) DSL means the Domestic Substances List maintained by the Minister under subsection 66(1) of the Act. (liste intérieure) Minister means the Minister of the Environment. (ministre) NDSL means the Non-Domestic Substances List maintained by the Minister under subsection 66(2) of the Act. (liste intérieure) new substance means any substance that is not on the DSL. (substance nouvelle) notifier means any person who manufactures or imports a new substance, or who intends to do so, and who provides, in accordance with paragraph 81(1)(a) of the Act, the information required under a schedule to the New Substances Notification Regulations (Chemicals and Polymers). (déclarant) These Regulations do not apply to biochemicals, biopolymers and research and development substances regulated under the New Substances Notification Regulations (Chemicals and Polymers); and organisms regulated under the New Substances Notification Regulations (Organisms). These Regulations do not apply to the notifier of a new substance that is manufactured or imported for a use that is regulated under any other Act of Parliament, including the Food and Drugs Act, the Fisheries Act and the Health of Animals Act. Subject to section 5 and the reductions provided for in sections 6 and 7, a notifier of a new substance who for the first time provides the information required under any schedule to the New Substances Notification Regulations (Chemicals and Polymers) set out in column 1 of Schedule 1 to these Regulations shall pay for the assessment of that substance the amount set out in column 2 under the heading corresponding to the notifier’s annual sales in Canada. Subject to section 5 and the reductions provided for in sections 6 and 7, a notifier of a new substance who has provided with respect to that substance the information required under any schedule to the New Substances Notification Regulations (Chemicals and Polymers), and who subsequently provides, with respect to the same substance, information required by another schedule to those Regulations set out in column 1 of Schedule 1 to these Regulations, shall pay for the assessment of that substance in respect of that other schedule the amount set out in column 2 under the heading corresponding to the notifier’s annual sales in Canada, reduced by any amount previously paid for the assessment of that substance in respect of any other schedule to the New Substances Notification Regulations (Chemicals and Polymers), but the reduction may not result in a negative amount. Subject to the reductions provided for in sections 6 and 7, a notifier of a new substance who provides the information required under Schedule 5 or 9 to the New Substances Notification Regulations (Chemicals and Polymers), and who is not required under those Regulations to provide subsequent information with respect to the same substance, shall pay for the assessment of that substance the amount set out in column 2 of Schedule 2 to these Regulations under the heading corresponding to the notifier’s annual sales in Canada, reduced by any amount previously paid for the assessment of that substance in respect of any other schedule to the New Substances Notification Regulations (Chemicals and Polymers), if applicable, but the reduction may not result in a negative amount. A notifier of a new substance who requests of the Department of the Environment the use of information that was previously provided by another notifier with respect to the same substance, which notification is known as a matched notification, is not required to pay an amount under section 3, 4 or 5, but shall pay an amount of $200 for the assessment of that substance. A notifier of a maximum of six new substances of the same class, where the information provided under the schedules to the New Substances Notification Regulations (Chemicals and Polymers) for each substance is identical, which notification is known as a consolidated notification, shall pay the amount required under section 3, 4 or 5 for the assessment of one of those substances and an amount of $250 for the assessment of each other of those substances. Despite sections 3 to 5, the maximum fees payable for the assessment of a new substance on the basis of the information required under the schedules to the New Substances Notification Regulations (Chemicals and Polymers) is $2,625, where the notifier’s annual sales in Canada are less than $40 million, and $3,500, in any other case. The fee payable for a service set out in column 1 of Schedule 3 to these Regulations is the fee set out in column 2 under the heading corresponding to the annual sales in Canada of the person for whom the service is provided. A person who requests that fees payable under these Regulations be based on the person’s annual sales in Canada shall provide to the Minister the person’s sales reports for Canada according to the person’s financial statements for the previous fiscal period prepared in accordance with generally accepted accounting principles and certified as true and correct by that person or, in the case of a corporation, by the manager responsible for the corporation’s financial affairs. Despite any other provision of these Regulations, if the information relating to annual sales in Canada is not provided, fees payable shall be based on annual sales above $40 million. The fees payable under sections 3 to 9 shall be paid at the time the service is requested by certified cheque or money order to the Receiver General; or credit card in respect of which the notifier is either the cardholder or an authorized user, if the issuer of the credit card has entered into an agreement with the Government of Canada establishing the conditions of its acceptance and use. These Regulations come into force on January 1, 2003. > 13 ≤ 26 > 26 ≤ 40 Schedule to the New Substances Notification Regulations (Chemicals and Polymers). Search of substances appearing on the DSL or NDSL that have been published under masked names. Application for a masked name, as defined in the Masked Name Regulations, for a new substance. Application for a service under the Agreement for Sharing of Information Between the U.S. Environmental Protection Agency (USEPA), and Environment Canada (EC) and Health Canada (HC) (the “Four Corners Agreement”).