SOR/2016-74: Regulations Amending the Food and Drug Regulations (Food — Various Subjects)
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
April 15, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues Pursuant to the Jobs, Growth and Long-term Prosperity Act (Bill C-38), the Department of Health (the Department) has undertaken a number of initiatives to create a more efficient and responsive regulatory framework for foods. The following regulatory amendments implement specific efficiencies enabled by B... (Click for more)
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Published on April 15, 2016
SOR/2016-74: Regulations Amending the Food and Drug Regulations (Food — Various Subjects)
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues Pursuant to the Jobs, Growth and Long-term Prosperity Act (Bill C-38), the Department of Health (the Department) has undertaken a number of initiatives to create a more efficient and responsive regulatory framework for foods. The following regulatory amendments implement specific efficiencies enabled by Bill C-38. Bill C-38 replaced Interim Marketing Authorizations (IMAs) with the more efficient and scientifically responsive Marketing Authorizations (MAs). In light of this change, provisions in the Food and Drug Regulations (FDR) that formerly applied to IMAs are repealed. To fulfill the intention of Bill C-38 to make regulating substances that occur or are used in food more efficient, provisions in the FDR and the regulatory table respecting the maximum residue limits for veterinary drugs are also repealed. Those provisions are no longer needed, as the maximum residue limits are now more efficiently identified in a Marketing Authorization. Similarly, the provisions in the FDR and the regulatory table respecting maximum or trace levels of contaminants and other adulterating substances are repealed and replaced with a single, more scientifically responsive List of Contaminants and Other Adulterating Substances in Foods that is incorporated by reference in the FDR. Provisions in Part E relating to saccharin are repealed in order to enable the inclusion of saccharin as a food additive in table-top sweeteners in the new Marketing Authorization for Food Additives That May Be Used as Sweeteners, as saccharin has been deemed to be safe as a food additive. Background With the enactment of the Jobs, Growth and Long-term Prosperity Act, the Food and Drugs Act (FDA) was amended to give the Minister of Health (the Minister) the authority to issue MAs to establish exemptions from the Regulations. To date, MAs have been issued to permit the presence of specific substances in foods (e.g. food additives and veterinary drug residues) and permit the use of health representations/claims for foods. The amendments also provided an expanded authority to incorporate by reference public documents into MAs, or directly into the FDR. These amendments were intended to allow the Minister to act rapidly on certain science and safety decisions, and to improve efficiency in the food regulatory system, ultimately making it more responsive to emerging health and safety issues. Interim Marketing Authorizations (IMAs) IMAs can no longer be issued because the new authority to issue MAs replaced the authority to issue IMAs in the Food and Drugs Act. As a result, section B.01.056 of the FDR respecting the process for applying for an IMA is no longer relevant. All existing IMAs were grandfathered and kept active until they expired two years after they were issued. Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods On May 22, 2013, the Department issued a Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods, which incorporated by reference the List of Maximum Residue Limits for Veterinary Drugs in Foods. This List is based on the existing Table III of veterinary drug maximum residue limits of Part B, Division 15 of the FDR. The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has written to the Department requesting that it address redundancies and inconsistencies between the list incorporated into the Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods and Table III in Division 15 of the FDR. The SJCSR has stated that industry may potentially be confused as to which rules apply since the documents contain different MRLs in some cases. Consequently, the present amendment addresses the redundancies and inconsistencies by removing Table III from the FDR. Contaminants and other adulterating substances in foods Maximum levels (MLs) pertaining to certain contaminants in foods are presently prescribed as tolerances in Table I of Division 15 of the FDR. Sections B.01.046 and B.01.047 set out prohibitions and exemptions to the prohibitions with respect to adulterants in foods. In pursuing the opportunity to make additional changes to Division 15, beyond those addressing veterinary drug residues in food, to address contaminants and other adulterants in food, amendments are made in order to gain regulatory efficiencies and advance the following policy objectives: “Resetting” the rules set out in sections B.01.046 and B.01.047 and in Table I of Division 15 by bringing together the management of certain substances into a single list that is incorporated by reference into the FDR, and by delegating the authority to make changes from the Governor in Council to the Minister, thus enabling the Department to realize efficiencies in acting on scientific decisions relating to contaminants and other adulterating substances in foods. Providing the greatest possible level of clarity and predictability for industry, consistent with government direction, with respect to compliance and enforcement policy — based on current practice (this will not introduce a policy change, but will increase transparency). Saccharin sweeteners Saccharin was de-listed in the 1970s as a food additive in Canada on the basis of a study suggesting a human health concern about the ingestion of saccharin. However, access to saccharin sweeteners sold under certain restrictions was maintained under Part E of the FDR. A more recent submission to the Department requesting that saccharin be reconsidered as a food additive prompted another safety evaluation, in which it was concluded that the study in question was not relevant to humans. It was also concluded that the body of scientific evidence supported the safety of saccharin as a food additive when it is used under prescribed conditions. This conclusion is consistent with the positions of both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization of the United Nations and the World Health Organization, and the European Commission’s Scientific Committee on Foods. On April 24, 2014, the Department enabled the use of saccharin as a food additive in a number of unstandardized foods and has determined the appropriateness to extend this use to table-top sweeteners. In order to do so, the regulatory restrictions on the sale of saccharin (that were introduced to Part E of the FDR at the time that saccharin was de-listed as a food additive) are removed. Objectives The objectives of these amendments are the following: Remove IMA provisions in the FDR that are no longer valid due to the removal from the FDA of the authority to issue IMAs (replaced by the MA authority pursuant to Bill C-38); Remove redundant provisions in Division 15 of the FDR to prevent possible confusion with respect to MRLs for veterinary drugs in food; Further realize the administrative efficiencies provided by Bill C-38 by bringing together existing rules for contaminants and certain adulterants into a single list that would be incorporated by reference into Division 15 of the FDR; and Repeal provisions respecting the sale of saccharin sweeteners in Part E to allow the Department to enable the use of saccharin as a food additive in table-top sweeteners. Description In keeping with the legislative authorities of the Jobs, Growth and Long-term Prosperity Act, and to achieve efficiency gains, the following amendments to the FDR are made. Interim Marketing Authorizations (IMAs) The amendments made to the FDA through Bill C-38 included the Minister’s new Marketing Authorization authority, which replaced the Minister’s authority to issue IMAs. Existing IMAs were grandfathered; however with the new MA authorities in force, no new IMAs may be issued. Section B.01.056 of the FDR regarding the process to apply for an IMA is therefore no longer relevant and is repealed. Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods The Minister has issued a Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods that incorporates by reference an ambulatory list replicating Table III in Division 15 of the FDR. Therefore, Table III is repealed. Residues of veterinary drugs in food are considered adulterants and foods that contain such residues are subject to paragraph 4(1)(d) of the FDA. The MA exempts a food containing residues of veterinary drugs below set MRLs from paragraphs 4(1)(a) and (d) of the FDA in the same manner that section B.15.003 was used in the FDR. Since the new MA contains the exemption from paragraph 4(1)(d) of the FDA, section B.15.003 is now redundant and is repealed. Amendments are also made to resolve a discrepancy between Part B and Part C of the FDR in relation to the presence in food of drugs listed in subsection B.01.048(2) and paragraph C.01.611(1)(b). Specifically, prior to this amendment, paragraphs B.01.048(1)(b) and (c) prohibited the use of any drug listed in subsection B.01.048(2) in meat, meat by-products, eggs or milk intended for consumption. This provision is amended to prohibit the use of those drugs in any food; the reference to “meat, meat by-products, eggs or milk” is replaced by a reference to “any food.” This amendment is consistent with Part C (section C.01.610.1), which prohibits the sale of the drugs listed in subsection B.01.048(2) for administration to animals that produce food or are consumed as food. Similarly, paragraph C.01.611(1)(a) is amended to replace the reference to “residues within the limits prescribed by these Regulations” with a reference to the maximum residue limits set out in the list referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods, since these limits are no longer set out in the FDR given the repeal of Table III to Division 15. Paragraph C.01.611(1)(b) is also amended to replace the reference to “meat, meat by-products, eggs or milk” with a reference to “food,” in order to reflect the fact that other foods derived from animals can also be set out in the list referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods. Contaminants and other adulterating substances in foods MRLs listed as tolerances in Table I of Division 15 and the rules set out in sections B.01.046 and B.01.047 are consolidated into the List of Contaminants and Other Adulterating Substances in Foods (the List) that is incorporated by reference in section B.15.001 of Division 15 of the FDR. The List incorporated by reference is organized into two parts. Part 1 of the List reflects those rules previously prescribed in B.01.046 which set out various substances or classes of substances that, if present in food at any level, would result in the food being declared as adulterated. Part 2 reflects the tolerances previously prescribed in Table I and in certain paragraphs under B.01.046 and B.01.047. The List will be maintained administratively and published on the Department’s Web site, similar to what is currently being done for food additives and MRLs for veterinary drugs in foods. Consequently, sections B.01.046 and B.01.047 and Table I of Division 15 are repealed from the FDR. The publication of the List on the Department’s Web site will coincide with the publication of the amendments in the Canada Gazette, Part II. This will ensure continuity in the applicability of the existing rules for contaminants and other adulterating substances. Moving forward, changes to the List will be made administratively using the Minister’s authority set out in Bill C-38, following established processes. Saccharin sweeteners On April 24, 2014, saccharin was added to the List of Permitted Sweeteners, thus permitting its use in a number of foods, but not in table-top sweeteners, the only food category in which it could not be authorized until it is removed from Part E of the FDR. Part E of the FDR is amended to eliminate the current conditions of sale applicable to saccharin in table-top sweeteners by removing references to “saccharin sweeteners.” This amendment enables the Department to extend the use of saccharin as a sweetener in table-top sweeteners in the List of Permitted Sweeteners incorporated by reference in the Marketing Authorization for Food Additives That May Be Used as Sweeteners. This list is maintained administratively using the Minister’s authority established in Bill C-38. Miscellaneous amendments Subparagraph B.02.100(b)(iii) of the FDR contains an error in the English version. Language pertaining to subparagraph B.02.100(b)(iv) [“(iv) yeast foods, in accordance with Table XIV to section B.16.100”] was inadvertently added to the above-mentioned provision and the added language is repealed. Section B.14.004 of the FDR contains an error in the French version. An [N] symbol representing a standard is found in the French version when in fact the provision does not prescribe a standard. The English version is correct; the French version is amended to remove the [N] symbol. “One-for-One” Rule The “One-for-One” Rule does not apply to these regulatory amendments, as they do not introduce new or incremental administrative burden costs to business. Small business lens The amendments to the FDR do not impose annual nationwide costs over $1 million, nor do they have a disproportionate impact on any small businesses. As a result, the small business lens does not apply. Consultation The following is a brief summary of consultations on the issues pertaining to these various amendments to the FDR prior to publication of the proposed amendments in the Canada Gazette, Part I. Interim Marketing Authorizations (IMAs) and Marketing Authorizations (MAs) The amendments to replace the IMA authorities with MAs and to permit incorporation by reference were introduced with the Jobs, Growth and Long-term Prosperity Act, and consultations on them were held during the legislative process. Included in the consultations were the next steps the Department would take, including these regulatory amendments, to ensure efficiencies. Industry stakeholders have welcomed and publicly expressed their support for these legislative amendments, as they address their longstanding concern that the process to enable a food additive after scientific review was lengthy and less responsive to emerging food safety concerns. Health and consumer groups have also expressed their support for provisions that allow for more responsiveness regarding health and safety risks, without compromising the rigor of scientific assessment. Maximum Residue Limits (MRLs) for Veterinary Drugs for Foods On February 2, 2013, a Notice of Intent (NOI) was published in the Canada Gazette, Part I, outlining the Minister’s new authority to create a Marketing Authorization (MA) for veterinary drug MRLs. The NOI invited stakeholder comments for 60 days during which time the Department received no comments. Contaminants and other adulterating substances in foods Prior to publication in the Canada Gazette, Part I, on December 13, 2014, consultation had not been held on the amendments to repeal sections B.01.046 and B.01.047 and Table I to Division 15 and to create a List of Contaminants and Other Adulterating Substances in Foods, which will be incorporated by reference in Division 15 of the FDR. Since this was considered a technical amendment to provide a more efficient regulatory process, it was determined that there was no need to proceed with consultations on the rules themselves. Incorporating by reference the List of Contaminants and Other Adulterating Substances in Foods allows the Department to administratively modify the List based on current science and to respond in a timely manner to emerging issues that can have an impact on the health and safety of consumers. The Department will conduct technical consultations on any proposed future modifications to the List as part of an established administrative procedure. Saccharin sweeteners Consultation was undertaken in November 2006 and stakeholders expressed support for the reinstatement of saccharin as a food additive. Some stakeholders requested additional information on the Department’s evaluation, in particular the various studies used by the Department’s scientists to review the safety of saccharin. The Bureau of Chemical Safety in the Department’s Food Directorate provided these stakeholders with an extensive list of studies that had been reviewed during this assessment and the relevant references. Other stakeholders requested clarification pertaining to the use of saccharin during pregnancy and the labelling requirements associated with the use of this additive. The Department responded to these questions by providing an overview of the studies that were conducted to examine possible effects of saccharin on the fetus. These studies provided the scientific evidence to support the conclusion that saccharin can be safely consumed by humans, including pregnant or breastfeeding women. A Notice of Proposal was posted on the Department’s Web site in October 2013 to advise stakeholders of the Department’s intention to enable the use of saccharin, calcium saccharin, potassium saccharin and sodium saccharin as sweeteners in various unstandardized foods with the exception of table-top sweeteners. In response, three comments were received from domestic and foreign industry associations. All three association responses indicated support for the proposal. A fourth was received from a foreign government. One of the associations and the foreign government requested that modifications to the listing be made to allow for broader use of these food additives. In response, the Department indicated that the permitted foods to which the sweeteners can be added and the maximum levels of use are determined by the results of the safety evaluation of the requested maximum levels of use and the requested foods set out in the food additive submission. The Department also indicated that it could consider a new food additive submission requesting an extension of use so that these sweeteners could be added to a new food or be used at a different maximum level. Comments received following publication of the proposed Regulations in the Canada Gazette Part I The Regulations were published in the Canada Gazette, Part I, on December 13, 2014, followed by a 75-day comment period. Comments were received from two stakeholders (food industry associations). Overall, both stakeholders were supportive of the Regulations. One of the stakeholders sought clarification on the process associated with modifications to the List of Contaminants and Other Adulterating Substances in Foods (the List); i.e. the criteria that will be used to accept proposals and evaluate the relevance of new information. This stakeholder also sought clarification regarding when stakeholders would be notified of proposed changes to the List; how much time will they have to comment on proposed changes; what is the amount of time required to update the List on the Health Canada Web site; and what is the accessibility level of archived lists. This request for clarification has been taken into consideration and will be reflected in materials to be posted on the Department’s Web site. The stakeholder also expressed concern regarding the potential zero-tolerance treatment of substances listed in Part 1 of the List. More specifically, the stakeholder expressed concern that, since there are no maximum levels for the substances listed in Part 1, low background levels of a certain substance could be present in food without posing any substantive health risk. The Department has considered this comment and is of the view that the List simply replaces the bulk of the regulatory framework that was formerly set out in sections B.01.046, B.01.047 and Table I to Division 15 of the FDR. The same zero tolerance that applied to certain substances found in section B.01.046 continues to apply in Part 1 of the List. In that respect, there is no impact on industry. Health Canada is aware that certain substances that were listed in section B.01.046 of the FDR and that will now be found in Part I of the List may be detected at low levels due to the sensitivity of modern testing methods. Any changes to the List will be made on a priority basis following a thorough scientific safety assessment and only after thorough consultation with stakeholders. As the aforementioned comments refer specifically to the implementation of the List, no modifications to the regulatory amendments were made. With respect to saccharin, only one of the above mentioned stakeholders provided comments. They were supportive of the Department’s intention to amend Part E of the FDR to eliminate the current conditions of sale applicable to saccharin in table-top sweeteners. Rationale These amendments meet the objective of creating administrative efficiencies, one of the objectives of the Jobs, Growth and Long-term Prosperity Act, and remove redundant provisions in the FDR to prevent possible confusion. With respect to contaminants and other adulterating substances, proceeding with the incorporation by reference of a List of Contaminants and Other Adulterating Substances in Foods strengthens regulatory responsiveness and efficiency by enabling the Department to amend its health and safety rules in response to new science and/or emerging issues in a more timely fashion. Similar regulatory structures are already in place for food additives and veterinary drug MRLs and have proven successful. Furthermore, consolidating rules within a single list facilitates stakeholder comprehension of the rules surrounding the presence of contaminants and other adulterating substances in foods. The removal of the saccharin provisions in Part E benefits to the food industry, as it allows saccharin to be used in table-top sweeteners in a manner consistent with the use of other permitted sweeteners in table-top sweeteners. This also allows for consistency in labelling and at points of sale with other table-top sweeteners. Implementation, enforcement and service standards These amendments will come into force on the day on which they are published. The amendments also include transitional provisions that permit the continued sale of saccharin sweeteners. These provisions will be in place when the new amendments are published to allow continued compliance in accordance with labelling and advertising requirements in Part E of the FDR for one year beginning on the day on which the Regulations come into force. The transitional period will allow time for existing saccharin sweeteners to become compliant with the existing labelling and advertising requirement found in the FDR. These amendments do not alter existing compliance activities under the provisions of the FDA and the FDR, which are enforced by the Canadian Food Inspection Agency. Contact Dana Wang Office of Legislative and Regulatory Modernization Policy, Planning and International Affairs Directorate Health Canada Address Locator: 3105A Holland Cross, Tower B, 5th Floor 1600 Scott Street Ottawa, Ontario K1A 0K9 Email: [email protected] Footnote a S.C. 2012, c. 19, s. 414 Footnote b S.C. 2012, c. 19, s. 416 Footnote c R.S., c. F-27 Footnote 1 C.R.C., c. 870
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