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SOR/2017-16 February 13, 2017

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (Food Irradiation)

P.C. 2017-111 February 13, 2017

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), makes the annexed Regulations Amending the Food and Drug Regulations (Food Irradiation).

Regulations Amending the Food and Drug Regulations (Food Irradiation)

Amendments

1 (1) Subsections B.01.035(1), (2), (4), (6) and (9) of the Food and Drug Regulations (see footnote 1) 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:

Interprétation

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:

TABLE

Item

Column 1



Food

Column 2


Type and Source of Ionizing Radiation

Column 3



Purpose of Irradiation

Column 4

Minimum Absorbed Dose (kGy)

Column 5

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:

     
   
  • (a) 7.5 MeV when the target material is tantalum or gold;
  • (a) To reduce microbial load, including pathogens;
  • (a) 1.0
  • (a) 4.5
   
  • (b) 5 MeV in any other case.
  • (b) To reduce microbial load, including pathogens.
  • (b) 1.0
  • (b) 4.5

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:

     
   
  • (a) 7.5 MeV when the target material is tantalum or gold;
  • (a) To reduce microbial load, including pathogens;
  • (a) 1.5
  • (a) 7.0
   
  • (b) 5 MeV in any other case.
  • (b) To reduce microbial load, including pathogens.
  • (b) 1.5
  • (b) 7.0

Coming into Force

8 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

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 2) recommended that Health Canada (the Department) 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 3) released in May 2013, recommended that the beef industry submit a proposal to the Department to approve irradiation as “an effective food safety intervention” and that the Department, 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 (1) the efficacy and microbiological safety; (2) the nutritional safety and quality; (3) the toxicological safety; and (4) the technical aspects of its irradiation, focussing 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 4)

Regulatory amendments to the Food and Drug Regulations (FDR) are required to permit the sale of irradiated fresh and frozen raw ground beef.

Background

Food irradiation

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 5), (see footnote 6) Irradiation is not meant to be used by food producers as the sole food safety measure, but rather it can be used to supplement food 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 requires 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 7) 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 at the point of purchase.

International context

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 8) 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 [1990], Netherlands [1992], United Kingdom [1992], Belgium [2004] and Czech Republic [2004]). Australia and New Zealand, like the EU, do not currently permit the irradiation of ground beef.

Regulatory amendments are required to permit the sale of irradiated fresh and frozen raw 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 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 are required. These amendments permit, but do not require, the beef industry to use this important additional food safety technology. As with other irradiated foods, irradiated ground beef is 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 will easily be able to identify it on store shelves.

Objectives

The 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.

Description

The amendments allow, but do not require, the beef industry to use irradiation as an additional tool to improve the safety of their products. Like all other irradiated foods, irradiated ground beef is required to be clearly labelled as such.

The sale of irradiated ground beef is permitted by amending the table to Division 26 of the FDR to add fresh and frozen raw ground beef in column 1 of the table. Additionally, the table is also 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 are 1.0 kilogray (kGy) and 4.5 kGy, respectively. For frozen raw ground beef, the minimum and maximum absorbed dose levels of ionizing radiation are 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 amendments to the table to Division 26 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 amendments are brought forth following the Department’s conclusion that ground beef treated with ionizing radiation does not pose a food safety concern under the specific conditions that are 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 9) 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 levels have been studied extensively and permitted by the United States Food and Drug Administration for irradiated ground beef since 1997.

The definition of “ionizing radiation” set out in section B.26.001 of the FDR is repealed since both the types and sources of ionizing radiation are now set out in column 2 of the table to Division 26. Only the definition of “irradiation” remains in Division 26 (i.e. treatment with ionizing radiation).

The amendments 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 amendments change the column numbers set out in the table to Division 26 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 are amended to reflect this change.

Existing labelling and packaging requirements for irradiated foods 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 has been made. Previously, the heading of column IV of the table to Division 26 was titled “Permitted Absorbed Dose.” Under these amendments, the heading of column 4 is now “Minimum Absorbed Dose (kGy)” and the heading of a new column 5 is “Maximum Absorbed Dose (kGy).” Therefore, the relevant labelling requirement in Part B, Division 1 no longer refers to “maximum permitted absorbed dose set out in column IV,” but rather refer to the “maximum absorbed dose set out in column 5.”

“One-for-One” Rule

The “One-for-One” Rule does not apply to the amendments, as there is no change in administrative costs to business.

Small business lens

The small business lens does not apply to the amendments, as there are no costs to small business associated with these regulatory amendments. Businesses are not required to comply with the new Regulations; the Regulations only apply if a beef producer chooses to sell irradiated ground beef.

Consultation

Stakeholder views — past

In 1998, the Department received submissions requesting approval to extend the 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 concerns about irradiated food products and scepticism surrounding the science and safety of irradiation. However, 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 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 10) commissioned by Agriculture and Agri-Food Canada (AAFC) and conducted by Ipsos Reid, 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 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). The Department discussed the Canadian Cattlemen Association’s submission requesting permission to irradiate ground beef at the Council of Chief Medical Officers of Health in May 2013, and provinces and territories did not express any concerns with the safety of irradiation.

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, and 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 the proposal.

Prepublication in the Canada Gazette, Part I, and summary of comments

On June 18, 2016, a proposal for regulatory amendments to permit the sale in Canada of irradiated fresh and frozen raw ground beef was published in the Canada Gazette, Part I, followed by a 75-day consultation period ending on September 1, 2016. Health Canada received 18 written comments during the consultation. Thirteen out of 18 stakeholders (72%) expressed their support. Stakeholders who were supportive were consumers (3), industry (3), industry associations (3), consultants (2), and government (2). They were generally supportive for the following reasons:

  • the scientific evidence supports the safety and efficacy of irradiation;
  • the technology’s potential to increase food safety and improve public health (reduce potential for foodborne illness);
  • other irradiated foods are already permitted on the market;
  • food irradiation facilities are currently in place in Canada (straightforward implementation);
  • it is a technology endorsed by the World Health Organization and the Food and Agriculture Organization of the United Nations;
  • internationally, irradiation is already permitted for various products, including beef;
  • this regulatory proposal aligns with U.S. regulations; and
  • irradiation provides an additional choice for consumers, and labelling will allow informed choice and potentially increase public confidence in the food supply.

Other stakeholders (5/18 or 28%) were opposed to the proposal for various reasons which are outlined below. Of the five stakeholders who expressed opposition to the current regulatory proposal, three were consumers, one was industry and one was an industry association.

A summary of the suggestions and comments received for consideration with respect to the proposal and Health Canada’s responses are as follows:

Consumer education campaign

It was suggested that the Government of Canada (GoC) consider developing a consumer education campaign to enhance consumer understanding and acceptance of food irradiation.

The GoC provides information on its website to enhance Canadians’ understanding of the science-based safety rationales for food irradiation; however, the promotion of food irradiation to facilitate consumer acceptance and marketability of irradiated foods is not within Health Canada’s mandate.

Allowing irradiation of other food products

One comment received proposed that Health Canada consider permitting the irradiation of additional food products including the other food products permitted to be irradiated in the United States. It was also suggested that the Department use a regulatory instrument, such as Incorporation by Reference (IbR), to allow updates to the list of approved irradiated food products in a timely fashion.

New foods and uses of irradiation can only be permitted if Health Canada receives an application that contains supporting safety and efficacy data and Health Canada determines that the irradiation process does not negatively alter the nutritional quality or safety of the food.

The Department is considering other ways of modernizing the regulatory framework for food irradiation which could include the incorporation by reference of the table to Division 26 of permitted irradiated foods in Canada. Analysis is underway and a decision to move forward with incorporation by reference would be made available through the Departmental Forward Regulatory Plan.

Labelling

A number of comments were provided related to the labelling of irradiated beef, including the use of labelling as a means of supporting consumer choice, labelling in food establishments such as restaurants and using synonyms for “irradiated” such as “ionization” or “ionized” to alleviate public concerns about the safety of food irradiation.

The general labelling requirements for irradiated food and general labelling requirements in food establishments are outside the scope of the regulatory amendment given that it is intended to specifically address a pre-market submission requesting that ground beef be added to Canada’s list of foods that may be irradiated. General labelling requirements for irradiated foods are currently set out in Division 1 (B.01.035 — labelling of irradiated foods) and no changes to those requirements are being made as part of this amendment.

Under the current regulatory framework, no provision exists in the FDR to require the food service and restaurant industry to identify when irradiated foods have been used. Restaurants have the ability to advertise their use of non-irradiated ground beef as a voluntary consumer-value claim, as long as they are truthful and not misleading. If consumers have questions about how the food was produced, they should speak with the food service establishment directly.

The terminology used in the FDR (“treated with radiation,” “treated by irradiation” or “irradiated”) mirrors that of internationally recognized guidance and standards such as the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), as well as regulatory authorities and industry around the world. Health Canada believes that the use of terms such as “ionization” or “ionized” could be problematic if it is unclear that these terms are synonymous with “irradiated.”

Packaging

While generally supportive of the proposal, one stakeholder noted that it may be possible for the beef industry not to irradiate the final package containing the meat intended to be sold at retail, and that packing or processing companies could mix small amounts of irradiated ground beef with untreated beef which could result in recontamination and pose a health risk to consumers.

Health Canada understands that the expectation is that irradiated raw ground beef is to be sold in the packaging in which it was irradiated to avoid possible recontamination. While the regulatory amendments do not prevent repackaging of irradiated ground beef before sale, doing so does not have any clear benefit to the processor, would not be aligned with Good Manufacturing Practices (GMPs), which processors are expected to meet, and would only create additional risk.

In addition, if a raw ground beef product that was labelled as “irradiated” was found to contain human pathogens at levels that would not be expected in an irradiated food, this could be a possible indication of poor manufacturing practices, in which case, the food seller would be subject to investigation and possible compliance action.

Justification for the use of irradiation to treat ground beef

One respondent felt that the low number of annual reported incidents of E. coli contamination did not justify the use of ground beef irradiation.

Despite the number of reported cases, health consequences of foodborne illness outbreaks are serious, particularly for vulnerable populations, such as children, elderly people, and people with weakened immune systems. Allowing industry to use irradiation could help prevent such outbreaks in the future. As outlined in the Independent Review of XL Foods Inc. Beef Recall 2012, one of its food safety recommendations to Health Canada was to give prompt consideration to any application 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, in addition to safety measures already in place.

Impacts on industry

Concerns were raised regarding potential impacts on industry, including larger beef packing companies gaining a competitive advantage over small and medium sized enterprises (SMEs) because of their financial ability to purchase food irradiation equipment; Canadian beef slaughterhouses and processing plants would need to reduce costs and potentially cause food safety issues to worsen due to the United States importing cheaper irradiated beef; and ground beef irradiation may hinder Canada’s beef exports to major importing partners that do not allow beef irradiation.

Health Canada acknowledges the concerns about the possible impact that the proposal could have on SMEs. However, the objective of the amendments is to improve food safety by allowing the sale in Canada of irradiated fresh or frozen raw ground beef.

Beef slaughterhouses and processing plants, including those using high-line speeds, are subjected to a Hazard Analysis Critical Control Point (HACCP)–like system (which includes a series of steps designed to minimize the bacterial contamination of beef products) and they must be able to show trained and qualified inspectors from the Canadian Food Inspection Agency (CFIA) that their HACCP system is effective. They are also responsible for the proper handling of beef products according to Good Manufacturing Practices (GMPs). These obligations would continue to apply to processors and beef slaughterhouses that choose to use irradiation to treat ground beef and would therefore not change as a result of this regulatory amendment.

With regards to the impact that the amendments would have on beef exports, exported beef must meet the importing country’s requirements: this regulation does not prevent that from happening.

Safety concerns relating to irradiated beef

Some concerns were raised related to the safety of irradiated beef, including food processors using this technology in place of sanitary conditions and use of existing food safety practices; ground beef irradiation may give consumers a false sense of safety given bacterial toxins are not eliminated by irradiation, noting that food safety incidents related to beef continue to occur in the United States even though ground beef irradiation has been permitted since 1997. Another concern that was raised was that ground beef may pose a risk to the public due to the production of hydrogen peroxide and cyclobutanones, as well as with radioactive waste as a result of the irradiation process and transportation of such waste.

Irradiation is another technology that will complement and strengthen, not replace, current food safety practices. Regardless of whether irradiation is applied to ground beef, federally registered beef slaughterhouses and processing establishments are required to have a HACCP system and be able to show the CFIA that their HACCP system is effective. The rules of safe food handling, including proper sanitation, packaging, storage and preparation also still need to be followed by industry and consumers.

Processors are required to handle all beef products, including ground beef, according to GMPs and maintain refrigeration of the product at all times. This minimizes the growth of bacteria. When raw ground beef is properly refrigerated and handled, the possibility of toxin production by some specific strains of bacteria in the food is extremely low.

When irradiated, the water found in meat can form hydrogen peroxide. However, hydrogen peroxide is relatively unstable (i.e. it decomposes easily) and any residues that may remain on the meat after irradiation are expected to readily break down to water and oxygen during post-irradiation storage.

Alkylcyclobutanones are products referred to as “Unique Radiolytic Products” (URPs) that are derived from fat when irradiated and, therefore, their presence is directly related to the fat content of the food. These URPs are found in extremely small quantities in irradiated foods, in the order of parts per billion. The overall weight of evidence indicates that the very low levels of these compounds found in irradiated beef do not pose a risk to human health.

The technologies approved for irradiation of beef were selected to ensure radioactive waste would not be produced as a by-product of food irradiation. Isotope-based irradiators, however, will require radioactive sources to be replaced as they age. For food irradiation, the isotopes involved would be cobalt-60 and cesium-137. The exchange of sources is performed by qualified service providers licensed by the Canadian Nuclear Safety Commission (CNSC). The used sources are transferred safely to designated facilities regulated and licensed by the CNSC. The CNSC regulates and licenses these facilities, in order to protect the health, safety and security of Canadians and the environment. As part of all CNSC-licensed activities in Canada, the waste producers are required to manage waste in a safe and secure manner and to make arrangements for the long-term management of the waste, which is considered by the CNSC during the review process for any licensed activity or facility.

The transport of nuclear substances, including radioactive waste, is a joint responsibility between the CNSC and Transport Canada. The CNSC issues transport licences for nuclear substances only once it is convinced that the shipment will be completed safely, without posing risks to the health, safety and security of Canadians and the environment. Recycling radioactive waste is one of the strategies used by the licensee to minimize the volume of radioactive waste. Methods used to reduce, reuse and recycle radioactive waste must always ensure that the health and safety of persons and the environment are protected.

Online petition

An online petition to “stop the proposed legislation in Canada allowing the irradiation of beef products” has been gathering electronic signatures. The originator of this petition, “Dr. Feelgood Health Centre Inc.,” has indicated the intention to deliver it to the Chief Public Health Officer of Canada and to the Minister of Health if it reaches 25 000 signatures. As of November 24, 2016, the petition had reached 18 791 signatures. The concerns raised by the petition cover the following: the impact of irradiation on the quality of food; the safety of a long-term diet of irradiated foods on human health; the use of irradiation to compensate for other food safety issues; the necessity of labelling to allow consumer choice; the potential future use of nuclear energy to irradiate food; that radioactive material is an environmental hazard; that irradiation does not result in “clean” food; and that irradiation does not change how food is grown and produced.

Rationale

The regulatory amendments permit the sale of irradiated ground beef, which provides manufacturers with another technology that can be used to help ensure that food sold in Canada is safe to eat. It can 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; therefore, provincial and territorial governments responsible for healthcare stand to benefit as well.

Canadian beef producers will also benefit from the availability of this food safety technology. 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 2012 Independent Review of XL Foods Inc. Beef Recall 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 amendments 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 application 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 11) 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 the 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 provides guidance to the CFIA in respect of health risks and the implementation of the amendments.

In addition, the Canadian Nuclear Safety Commission will 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.

Contact

Bruno Rodrigue
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Canada
Address Locator: 3000A
Holland Cross, Tower A, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Email: LRM_MLR_consultations@hc-sc.gc.ca