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Vol. 139, No. 19 — September 21, 2005 Registration CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999 Regulations Amending the New Substances Fees Regulations Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on October 30, 2004 a copy of the proposed Regulations Amending the New Substances Fees Regulations, substantially in the annexed form, 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; 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, pursuant to section 328 of the Canadian Environmental Protection Act, 1999 (see footnote c), hereby make the annexed Regulations Amending the New Substances Fees Regulations.
REGULATIONS AMENDING THE NEW SUBSTANCES FEES REGULATIONS AMENDMENTS 1. (1) The definitions "LES" and "LIS" in section 1 of the French version of the New Substances Fees Regulations (see footnote 1) are repealed. (2) Section 1 of the French version of the Regulations is amended by adding the following in alphabetical order: « liste extérieure » La liste extérieure des substances tenue à jour par le ministre en application du paragraphe 66(2) de la Loi. (NDSL) « liste intérieure » La liste intérieure des substances tenue à jour par le ministre en application du paragraphe 66(1) de la Loi. (DSL) (3) The expression "(LIS)" at the end of the definition "DSL" in section 1 of the English version of the Regulations is replaced by the expression "(liste intérieure)". (4) The expression "(LES)" at the end of the definition "NDSL" in section 1 of the English version of the Regulations is replaced by the expression "(liste extérieure)". 2. Subsection 2(1) of the Regulations is replaced by the following: 2. (1) These Regulations do not apply to (a) biochemicals, biopolymers and research and development substances regulated under the New Substances Notification Regulations (Chemicals and Polymers); and (b) organisms regulated under the New Substances Notification Regulations (Organisms). 3. Section 5 of the Regulations is replaced by the following: 5. 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. 4. Section 11 of the Regulations is replaced by the following: 11. The fees payable under sections 3 to 9 shall be paid at the time the service is requested by (a) certified cheque or money order to the Receiver General; or (b) 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. 5. Schedules 1 and 2 to the Regulations are replaced by the following: SCHEDULE 1 ASSESSMENT FEES
* Schedule to the New Substances Notification Regulations (Chemicals and Polymers) SCHEDULE 2 ASSESSMENT FEES
* Schedule to the New Substances Notification Regulations (Chemicals and Polymers) 6. The Regulations are amended by replacing the expression "New Substances Notification Regulations" with the expression "New Substances Notification Regulations (Chemicals and Polymers)" wherever it occurs in the following provisions: (a) the definition "notifier" in section 1; (b) sections 3 and 4; and (c) sections 7 and 8. 7. The French version of the Regulations is amended by replacing the expressions "LES" and "LIS" with the expressions "liste extérieure" and "liste intérieure", respectively, wherever they occur in the following provisions: (a) the definition "substance nouvelle" in section 1; and (b) Schedule 3. COMING INTO FORCE 8. These Regulations come into force on the day on which the New Substances Notification Regulations (Chemicals and Polymers) come into force. REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Description The Regulations Amending the New Substances Fees Regulations are necessary to harmonize the New Substances Fees Regulations (NSFR) with the New Substances Notification Regulations (Chemicals and Polymers). Historically, the NSFR have applied to the chemicals and polymers portion of the New Substances Notification Regulations (NSNR). Following extensive multistakeholder consultations regarding the notification of new chemicals and polymers, the NSNR are being repealed and replaced with two distinct regulations pursuant to subsections 89(1) and 114(1) of the Canadian Environmental Protection Act, 1999: the New Substances Notification Regulations (Chemicals and Polymers) (NSNR (Chemicals and Polymers)) and the New Substances Notification Regulations (Organisms) (NSNR (Organisms)). The amended NSFR will apply only to the NSNR (Chemicals and Polymers). Structural changes to the NSNR (Chemicals and Polymers) necessitate these harmonization amendments to the NSFR. These Regulations will come into force on the day on which the NSNR (Chemicals and Polymers) come into force. Background The NSFR, which came into force January 1, 2003, implement a cost recovery scheme for the notification and assessment processes of the NSNR, as recommended following Environment Canada's 1995 Program Review. The purpose of the cost recovery initiative is to improve efficiency and equity by charging clients or beneficiaries who benefit from services beyond those enjoyed by the general public. The NSFR require notifiers of new chemicals and polymers to submit a fee at the time of notification to partially offset the cost of an assessment. There are also fees associated with other services, including: confidential searches, masked name applications, and applications under the Four Corners Arrangement (see footnote 2). All fees are outlined in Schedules to the NSFR (both in the original and amended Regulations), and vary depending on the annual sales of the notifier and the specific service provided by the New Substances Program. It should be noted that the fees do not apply to notifiers of biotechnology products (biochemicals, biopolymers or animate substances) at this time or to notifiers whose substance is for a use that is regulated under another Act of Parliament, whether or not it is listed in Schedule 2 or 4 of the Act. This includes substances whose use is regulated by the Food and Drugs Act, the Fisheries Act and the Health of Animals Act. Amendments to the New Substances Fees Regulations In order to harmonize the NSFR with the NSNR (Chemicals and Polymers), the Schedule references have been updated as follows:
In addition to changes in Schedule references, the regulatory amendments expand payment options for notifiers to include credit cards (i.e. VISA, MasterCard and American Express). This amendment formalizes a payment policy that has been in effect since February 2004. Alternatives No alternatives were considered because even though the amendments are minor administrative adjustments, they are still necessary. Benefits and Costs Because the amendments do not add, remove or alter the fees for services required under the NSFR, there are no significant benefits or costs anticipated for notifiers or the Government of Canada. The NSNR (Chemicals and Polymers) will require notifications for some new chemicals and polymers to be submitted earlier (or later) than under the previous NSNR. Consequently, while the size of fee associated with each type of notification will not change, notifiers may be required to submit their payment earlier (or later) than is currently required. In addition, there may be a small incremental benefit to notifiers associated with the expansion of fee payment options to include credit cards. Consultation Consultation prior to pre-publication of the proposed Regulations in the Canada Gazette, Part I Because the amendments are minor and administrative and the fees remain the same, no consultation was held. The majority of the minor changes to the NSFR are necessary for harmonization with the NSNR (Chemicals and Polymers), which were the outcome of a consensus-based multistakeholder process. The decision to expand payment options to include credit cards was made in response to a request from industry. In spring 2004, Environment Canada conducted a survey to improve service delivery, the results of which indicated that 50 percent of notifiers prefer payment by credit card. Comments received during the comment period following pre-publication in the Canada Gazette, Part I Of the five written responses received following pre-publication of the NSNR (Chemicals and Polymers), NSNR (Organisms) and these amendments to the NSFR in the Canada Gazette, Part I on October 30, 2004, only two submissions contained comments pertaining to the NSFR. Specifically, one comment pointed out that column 2 of Schedule 1 should indicate that the annual sales are less than or equal to $13 million. The departments have corrected the error in order to be consistent with the previous NSFR. The second comment raised the concern that fees should not be charged for the procurement of a general benefit. The comment also disagreed with EC's interpretation that New Substances Notification fees are compliant with the new User Fee Act, which came into force on March 31, 2004. The departments are of the view that at the beginning of the multistakeholder consultations it was agreed that cost recovery would not be a part of the consultation process. Therefore, no changes were made to the structure of the NSFR. Since the User Fee Act was promulgated after the coming into force of the NSFR, the fee regulations are not subject to the User Fee Act. The User Fee Act will only apply to the NSFR if the structure of the fees is revised (increasing or decreasing fees, adding fees for other services). In the same comment EC was asked to provide an opportunity to propose ideas to improve service, to conduct an impact assessment and to explain to notifiers how user fee is determined and identify the cost and revenue element of the user fee. In addition, the establishment of an independent advisory panel to address complaint and performance standards was also requested. The question of how EC intends to comply with the requirements of subsection 4(2) of the Act was also raised. The departments clarified that based on the recommendations from the multistakeholder consultation, EC and HC had conducted a survey in spring 2004 targeting the notifiers. The survey was undertaken by an independent party and followed the Treasury Board mandate for all government to improve the service delivery. This survey provided a good opportunity for the stakeholders to identify what was working and what was not, and also to give ideas on how to improve the service delivery. Based on the results of this survey, a report on the path forward will be available in the future. Performance measurement indicators will also be developed to track improvements. Compliance and Enforcement The amendments will not alter the manner in which the NSFR are enforced. Contacts Bernard Madé Céline Labossière S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 S.C. 1999, c. 33 SOR/2002-374 The Agreement for Sharing of Information Between the United States Environmental Protection Agency, and Environment Canada and Health Canada (the "Four Corners Arrangement") has focused on providing a mechanism to expedite the introduction of substances newly added to the U.S. Inventory onto Canada's Non-Domestic Substances List, and to identify Canadian data requirements that could be waived based on U.S. assessment of the same new substance |
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