Canada Gazette, Part I, Volume 150, Number 25: Regulations Amending the Food and Drug Regulations (Food Irradiation)
June 18, 2016
Food and Drugs Act
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Recent high profile cases of foodborne illness resulting from Canadian meat products led to comprehensive reviews of the factors that contributed to the illnesses and of how outbreaks could be prevented in the future. The Report of the Independent Investigator into the 2008 Listeriosis Outbreak (Weatherill report, 2009) (see footnote 1) recommended that Health Canada fast-track new technologies that have the potential to contribute to food safety, giving particular attention to those that have been scientifically validated in other jurisdictions. The Independent Review of XL Foods Inc. Beef Recall 2012,(see footnote 2) released in May 2013, recommended that the beef industry submit a proposal to Health Canada to approve irradiation as “an effective food safety intervention” and that Health Canada, in turn, give prompt consideration to any such application.
On May 3, 2013, the Department received a request from the Canadian Cattlemen's Association to reactivate an earlier application submitted in 1998 to permit the sale of irradiated ground beef, with minor changes to the previously requested conditions of the irradiation. Along with the review of the information that was submitted in the request, the Department completed an updated scientific assessment of irradiated fresh and frozen raw ground beef which considered the following: (1) the efficacy and microbiological safety; (2) the nutritional safety and quality; (3) the toxicological safety; and (4) the technical aspects of its irradiation. This evaluation focused on new information that has become available since 2002 and the requested changes from the original submission. The Department concluded that the irradiation of ground beef within the parameters requested is safe, effective, and does not significantly impact the nutritional quality of the beef any more than cooking would. (see footnote 3)
Regulatory amendments to the Food and Drug Regulations (FDR) would be needed to permit the sale of irradiated fresh and frozen raw ground beef.
Food irradiation is a method used in food production whereby food is treated with ionizing radiation to reduce levels of bacteria that cause food poisoning and spoilage, to inhibit the germination of root crops, or to prevent insect infestation in stored agricultural commodities, without affecting the nutritional quality of the food. Extensive research and testing have demonstrated that irradiated food is as safe for human health as cooked or canned food. (see footnote 4) (see footnote 5) Irradiation is not meant to be used by food producers as the sole food safety measure, but rather it could be used to supplement safety measures already in place.
Currently, only the following irradiated foods are permitted for sale in Canada: (1) potatoes; (2) onions; (3) wheat, flour, whole wheat flour; and (4) whole or ground spices and dehydrated seasoning preparations. The FDR set out the conditions that must be met in order for an irradiated food to be sold in Canada. The FDR also require all prepackaged irradiated food products to be labelled with the statement “treated with radiation,” “treated by irradiation” or “irradiated” and to display the international symbol identifying irradiated foods, the radura, (see footnote 6) on the principal display panel of their label. When an irradiated food is not sold in prepackaged form, a sign displaying the radura symbol must be located immediately next to the food.
International bodies, such as the World Health Organization and the Food and Agriculture Organization of the United Nations, recognize the irradiation process as one way of safely reducing levels of microorganisms that cause foodborne illness, such as Salmonella and E. coli, in food products. (see footnote 7) Approximately 60 countries worldwide permit the irradiation of certain foods.
Although irradiated ground beef is not presently permitted for sale in Canada, the United States has permitted the irradiation of ground beef products since 1997; 23 other foreign governments, including South Africa, Saudi Arabia, Russia and Brazil, also permit the irradiation of meat.
The European Union (EU) currently does not permit the irradiation of ground beef, but some EU member-states do permit the irradiation of chicken meat and poultry (France , Netherlands , United Kingdom , Belgium  and Czech Republic ). Australia and New Zealand, like the EU, do not currently permit the irradiation of ground beef.
Regulatory amendments would be needed to permit the sale of irradiated ground beef
Currently, subsection B.26.003(1) of the FDR prohibits the sale of a food that has been irradiated. This prohibition is subject to the exceptions that are set out in subsection B.26.003(2), which include the following four irradiated food products: (1) potatoes; (2) onions; (3) wheat, flour, whole wheat flour; and (4) whole or ground spices and dehydrated seasoning preparations. Therefore, in order to permit the sale of irradiated fresh or frozen raw ground beef in Canada, amendments to the FDR would be needed. The proposed amendments would permit, but not require, the beef industry to use this important additional food safety technology. As with other irradiated foods, irradiated ground beef would be required to be clearly labelled in accordance with the requirements set out in section B.01.035 of the FDR; consumers wishing to purchase irradiated ground beef would easily be able to identify it on store shelves.
The proposed amendments have the objective of permitting the sale of irradiated fresh and frozen raw ground beef products in Canada for the purpose of reducing its bacterial count and improving its safety.
The proposed amendments would enable regulations that allow, but not require, the beef industry to use irradiation as an additional tool to improve the safety of its products. Like all other irradiated foods, irradiated ground beef would need to be clearly labelled as such.
The sale of irradiated ground beef would be permitted following the amendments to the table to Division 26 of the FDR to add fresh and frozen raw ground beef in column 1 of the table. The table would also be amended to set out the corresponding permitted types and sources of ionizing radiation, the purpose of irradiation, and the permitted minimum and maximum absorbed dose levels of ionizing irradiation.
For fresh raw ground beef, the minimum and maximum absorbed dose levels of ionizing radiation would be 1.0 kilogray (kGy) and 4.5 kGy, respectively. For frozen raw ground beef, the minimum and maximum absorbed dose levels of ionizing radiation would be 1.5 kGy and 7.0 kGy, respectively. These absorbed dose levels of ionizing radiation have been determined based on the range of absorbed doses of ionizing radiation shown to be able to treat pathogens in ground beef without negatively affecting the food itself.
The proposed amendments to the table to Division 26 would set out the following as permitted types and sources of ionizing radiation for both fresh and frozen raw ground beef: gamma radiation from either cobalt-60 or cesium-137; electrons from machine sources operated at or below 10 megaelectron volt (MeV); and X-rays from machine sources operated at or below either 5 MeV or 7.5 MeV, depending on the target material used by the machine source to generate the X-rays.
These proposed amendments are recommended following the Department's conclusion that ground beef treated with ionizing radiation does not pose a food safety concern under the proposed specific conditions that would be set out in the FDR. This conclusion is based on the Department's safety evaluation of the original 1998 submission and its evaluation of the scientific information that has become available since the previous evaluation.
The Department also considered the potential for radioactive isotopes to be formed in irradiated food and concluded that any induced activity in ground beef irradiated with X-rays generated at an energy level of 7.5 MeV would be significantly lower than the natural radioactivity in the food. This conclusion is consistent with that of the United States Food and Drug Administration, which identified no safety concerns with a maximum energy level of 7.5 MeV for machine sources that use tantalum or gold as a target material when generating X-rays. (see footnote 8) The Canadian Nuclear Safety Commission (CNSC) has also concluded that increasing the operating energy to 7.5 MeV for X-ray machine sources (when the target material is tantalum or gold) would not significantly increase the background radioactivity of food. These proposed levels have been studied extensively and permitted by the United States Food and Drug Administration for irradiated ground beef since 1997.
It is proposed that the definition of “ionizing radiation” set out in section B.26.001 be repealed since both the types and sources of ionizing radiation would be set out in column 2 of the table to Division 26. Therefore, the current definition would no longer be needed. Only the definition of “irradiation” would remain in Division 26 (i.e. “treatment with ionizing radiation”).
These proposed amendments would permit the sale of irradiated fresh and frozen raw ground beef under the specific conditions set out in the FDR.
As part of ongoing modernization of the regulatory language, the column numbers set out in the table to Division 26 would be changed from roman numerals (I, II, III, IV) to arabic numerals (1, 2, 3, 4). Consequently, all references to column numbers elsewhere in Division 26 as well as in section B.01.035 of the FDR would be amended to reflect this change.
Existing labelling and packaging requirements for irradiated foods would apply to irradiated fresh and frozen raw ground beef. However, one minor amendment to the labelling requirements in Part B, Division 1, of the FDR would be required. In the current table to Division 26, the heading of Column IV is “Permitted Absorbed Dose.” Under the proposed amendments, the heading of column 4 would be “Minimum Absorbed Dose (kGy)” and the heading of a new column 5 would be “Maximum Absorbed Dose (kGy).” Therefore, the relevant labelling requirement in Part B, Division 1, would no longer refer to “maximum permitted absorbed dose set out in Column IV”, but rather would refer to the “maximum absorbed dose set out in column 5.”
The “One-for-One” Rule does not apply to this proposal, as there is no change in administrative costs to business.
Small business lens
The small business lens does not apply to this proposal, as there are no costs to small business associated with these proposed regulatory amendments. Businesses would not be required to comply with the new regulations; the regulations would only apply if a beef producer chose to sell irradiated ground beef.
Stakeholder views — past
In 1998, the Department received submissions requesting approval to extend the possible use of food irradiation to new food products, including fresh and frozen raw ground beef. Following its safety assessment, the Department concluded that the irradiation of ground beef products was safe and effective under the proposed conditions. Proposed regulatory amendments that would have enabled the sale of irradiated ground beef were published in 2002 in the Canada Gazette, Part I. The proposal generated a wide range of comments from the public and various stakeholder groups (over 1 700 comments were received). At that time, the majority of stakeholders (mostly individual Canadians and consumer associations) did not support the proposal because of misconceptions about irradiated food products and scepticism surrounding the science and safety of irradiation. However, approximately 75% of other stakeholder groups, such as domestic and foreign industry as well as other governments, were for the most part supportive of the proposal. Due to the complexity and controversy surrounding food irradiation at the time, the FDR were never amended to permit the sale of any new irradiated food products.
Stakeholder views — present
A March/April 2014 online survey, “Consumer Perceptions of Food, Wave 4” (see footnote 9) commissioned by Agriculture and Agri-Food Canada (AAFC) and conducted by Ipsos Reid, has revealed a positive shift in public attitudes towards food safety measures such as food irradiation. Approximately 3 000 respondents participated. The results specific to food irradiation indicated that although the vast majority of respondents (72%) had not heard of food irradiation, overall perceptions of food irradiation were slightly more positive (30%) than negative (21%) when respondents were informed that irradiation is a food safety measure that reduces levels of bacteria that cause food poisoning and food spoilage. Consumers overwhelmingly agreed (83%) that irradiated food should be labelled as such.
The Department has also received a number of letters supporting the sale of irradiated ground beef from academia (the University of Saskatchewan) and the food industry (the Saskatchewan Stock Growers Association, the Canadian Meat Council, and the Canadian Poultry and Egg Processors Council). At the Council of Chief Medical Officers of Health in May 2013, the Department discussed the submission from the Canadian Cattlemen's Association requesting permission to irradiate ground beef, and provinces and territories did not express any concerns.
Consultation period prior to proposal prepublication in the Canada Gazette, Part I
In May 2015, the Department conducted a limited targeted consultation with key stakeholders within industry, public health associations and academia to assess their views on the advancement of a proposal to allow beef irradiation. All stakeholders consulted at the time responded positively to the advancement of a proposal given that the decision to do so was science-based. Leading up to the publication of the proposal in the Canada Gazette, Part I, the Department conducted another round of consultations with the stakeholders contacted in 2015 to reaffirm their support, but also broadened this consultation to other key industry, public health associations as well as consumer associations. This targeted consultation was completed in April 2016 and yielded only positive views on the advancement of this proposal.
The regulatory proposal to permit the sale of irradiated ground beef would provide manufacturers with another tool that could be used to help ensure that food sold in Canada is safe to eat. It could also contribute to a reduction in disease incidence and, consequently, result in an associated reduction in public and personal health costs. Canadian consumers who chose to purchase irradiated ground beef would have added confidence that their ground beef is safe, as irradiation has been shown to reduce the levels of bacteria, such as E. coli and Salmonella, which can cause foodborne illness. Potentially reducing occurrences of foodborne illness related to these bacteria means fewer patients requiring treatment or hospitalization; thus, provincial and territorial governments responsible for health care stand to benefit as well.
Canadian beef producers would also benefit from the availability of this food safety tool. Because food recalls are often triggered following reports of foodborne illness, the availability and consumption of irradiated beef could potentially help reduce the number of ground beef recalls resulting from foodborne illness. As a consequence, beef producers may benefit from having to issue fewer ground beef recalls, which can be very costly to the beef industry (e.g. the Independent Review of XL Foods Inc. Beef Recall 2012 reported that the XL recall of E. coli–contaminated beef products resulted in an estimated loss to the beef industry of between $16 million and $27 million).
The proposed amendments to permit the sale of irradiated ground beef are also consistent with and fulfill the Report of the Independent Investigator into the 2008 Listeriosis Outbreak (Weatherill report, 2009) recommendation that Health Canada should fast-track new technologies that have the potential to contribute to food safety. It also addresses the Independent Review of XL Foods Inc. Beef Recall 2012 food safety recommendation for Health Canada to give prompt consideration to any consideration from the beef industry to approve irradiation as an effective food safety technology for the purpose of reducing the levels of harmful bacteria in beef products, (see footnote 10) in addition to safety measures already in place.
Implementation, enforcement and service standards
The Canadian Food Inspection Agency (CFIA) is responsible for the enforcement of the Food and Drugs Act and its regulations as they relate to food. While it is the responsibility of industry to comply with regulatory requirements, compliance would be monitored by the CFIA as part of its ongoing domestic and import inspection programs, in keeping with the CFIA's existing enforcement and compliance verification resources. This includes verification that regulated parties have implemented appropriate processing controls and sampling of meat products to test for irradiation and to ensure that other regulatory requirements such as labelling are met. The Department would provide guidance to the CFIA in respect of health risks and the implementation of these proposed regulatory amendments.
In addition, the Canadian Nuclear Safety Commission would include any new food irradiation facilities in its licensing, monitoring and inspection programs. At this time, however, no new facilities are expected to be built for the purpose of only irradiating ground beef products.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Address Locator: 3105A
Holland Cross, Tower B, 5th Floor
1600 Scott Street
PROPOSED REGULATORY TEXT
Notice is given that the Governor in Council, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Food and Drug Regulations (Food Irradiation).
Interested persons may make representations concerning 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 Bruno Rodrigue, Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Postal Locator: 3105A, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Ottawa, Ontario K1A 0K9 (email: LRM_MLR_consultations@hc-sc.gc.ca).
Ottawa, June 9, 2016
Assistant Clerk of the Privy Council
Regulations Amending the Food and Drug Regulations (Food Irradiation)
1 (1) Subsections B.01.035(1), (2), (4), (6) and (9) of the Food and Drug Regulations (see footnote 11) are amended by replacing “Column I” with “column 1”.
(2) Subsection B.01.035(7) of the Regulations is replaced by the following:
(7) The label attached to a shipping container that contains a food set out in column 1 of the table to Division 26 that has been subjected to the maximum absorbed dose set out in column 5 shall carry the statement that is required by subsection (3) and the statement “Do not irradiate again.”.
2 The heading “Définitions” before section B.26.001 of the French version of the Regulations is replaced by the following:
3 Section B.26.001 of the Regulations is replaced by the following:
B.26.001 In this Division, irradiation means treatment with ionizing radiation.
4 Subsection B.26.003(2) of the Regulations is replaced by the following:
(2) A food that is set out in column 1 of the table to this Division that has been irradiated may be sold if both of the following requirements are met:
- (a) the ionizing radiation is of a type and from a source set out in column 2 for the purpose of irradiation set out in column 3; and
- (b) the ionizing radiation that is absorbed by the food is either within the range set out in columns 4 and 5 or, if there is no minimum absorbed dose set out in column 4, is not more than the maximum absorbed dose set out in column 5.
5 Section B.26.004 of the Regulations is replaced by the following:
B.26.004 (1) A manufacturer who sells a food that has been irradiated shall keep on their premises, for at least two years after the date of the irradiation, a record that contains all of the following information:
- (a) the name of the food that was irradiated and the quantity and lot numbers of the food;
- (b) the purpose of the irradiation;
- (c) the date of the irradiation;
- (d) the dose of ionizing radiation that was absorbed by the food;
- (e) the type and source of the ionizing radiation;
- (f) a statement that indicates whether the food was previously irradiated and, if it was previously irradiated, the information referred to in paragraphs (a) to (e) in respect of that previous irradiation.
(2) A person who imports a food for sale in Canada that has been irradiated shall keep on their premises, for at least two years after the date of importation, a record of the information required by subsection (1).
6 Paragraph B.26.005(a) of the Regulations is replaced by the following:
- (a) the purpose and details of the proposed irradiation — including the type and source of the ionizing radiation — and the proposed number of treatments and the minimum and maximum absorbed doses of the ionizing radiation;
7 The table to Division 26 of the Regulations is replaced by the following:
Type and Source of Ionizing Radiation
Purpose of Irradiation
Minimum Absorbed Dose (kGy)
Maximum Absorbed Dose (kGy)
|1||Potatoes (Solanum tuberosum L.)||Gamma radiation from cobalt-60||To inhibit sprouting during storage||0.15|
|2||Onions (Allium cepa)||Gamma radiation from cobalt-60||To inhibit sprouting during storage||0.15|
|3||Wheat, flour, whole wheat flour (Triticum spp.)||Gamma radiation from cobalt-60||To control insect infestation in stored food||0.75|
|4||Whole or ground spices and dehydrated seasoning preparations||(1) Gamma radiation from cobalt-60||(1) To reduce microbial load||(1) 10.0 (total overall average dose)|
|(2) Gamma radiation from cesium-137||(2) To reduce microbial load||(2) 10.0 (total overall average dose)|
|(3) Electrons from machine sources operated at or below 3 MeV||(3) To reduce microbial load||(3) 10.0 (total overall average dose)|
|5||Fresh raw ground beef||(1) Gamma radiation from cobalt-60||(1) To reduce microbial load, including pathogens||(1) 1.0||(1) 4.5|
|(2) Gamma radiation from cesium-137||(2) To reduce microbial load, including pathogens||(2) 1.0||(2) 4.5|
|(3) Electrons from machine sources operated at or below 10 MeV||(3) To reduce microbial load, including pathogens||(3) 1.0||(3) 4.5|
|(4) X-rays from machine sources operated at or below one of the following:|
|6||Frozen raw ground beef||(1) Gamma radiation from cobalt-60||(1) To reduce microbial load, including pathogens||(1) 1.5||(1) 7.0|
|(2) Gamma radiation from cesium-137||(2) To reduce microbial load, including pathogens||(2) 1.5||(2) 7.0|
|(3) Electrons from machine sources operated at or below 10 MeV||(3) To reduce microbial load, including pathogens||(3) 1.5||(3) 7.0|
|(4) X-rays from machine sources operated at or below one of the following:|
Coming into Force
8 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.