ARCHIVED — Vol. 148, No. 11 — May 21, 2014

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Registration

SOR/2014-99 May 2, 2014

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (Mechanically Tenderized Beef)

P.C. 2014-478 May 1, 2014

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

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (MECHANICALLY TENDERIZED BEEF)

AMENDMENTS

1. Subsection B.01.001(1) of the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

“mechanically tenderized beef” means uncooked solid cut beef that is prepared in either of the following ways:

  • (a) the integrity of the surface of the beef is compromised by being pierced by blades, needles or other similar instruments; or
  • (b) the beef is injected with a marinade or other tenderizing solution. (bœuf attendri mécaniquement)

2. The Regulations are amended by adding the following after section B.14.021:

B.14.022. No person shall sell mechanically tenderized beef unless

  • (a) the beef is identified as mechanically tenderized when it is offered or exposed for sale; and
  • (b) the beef has a label on it with a principal display panel that, subject to section B.01.012, includes all of the following information:
    • (i) in type at least as legible and prominent as that of the common name,
      • (A) the expression “mechanically tenderized” in the English version of the label, and
      • (B) the expression “attendri mécaniquement”, with any necessary grammatical modifications, in the French version of the label, and
    • (ii) in type at least as legible and prominent as that of any other information other than the common name,
      • (A) in the English version of the label,
        • (I) the message “Cook to a minimum internal temperature of 63°C (145°F).”, and
        • (II) in the case of steak, the additional message “Turn steak over at least twice during cooking.”, and
      • (B) in the French version of the label,
        • (I) the message “Faire cuire jusqu’à ce que la température interne atteigne au moins 63 °C (145 °F).”, and
        • (II) in the case of steak, the additional message “Retourner le bifteck au moins deux fois durant la cuisson.”.

COMING INTO FORCE

3. These Regulations come into force three months after 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.)

Executive summary

Issues: Recent events of food-borne illness derived from mechanically tenderized beef (MTB) have identified the need for consistent and enhanced food labelling to provide consumers with information to support the identification of MTB products and provide instructions for safe cooking.

Description: These Regulations will amend the Food and Drug Regulations by introducing the following elements: a definition of MTB, a requirement that all MTB sold in Canada must clearly be labelled with information that it has been mechanically tenderized and safe cooking instructions.

Cost-benefit statement: These Regulations will provide a net benefit of an estimated $418,800 over a 10-year period. Based on a 95% rate of coverage, (see footnote 2) a one-time compliance cost, estimated to be $114,700, would be attributable to label changes. Further, clear safe cooking instructions on the label will provide consumers with important information to prevent food-borne illnesses, monetized at about $110,800 annually.

“One-for-One” Rule and small business lens: The “One-for-One” Rule is not applicable, as most, if not all, of the incremental costs associated with the proposal would be considered compliance cost.

Based on data from Industry Canada, there are an estimated 815 slaughterhouses and meat processing facilities (excluding those for poultry) in the country, of which small business constitutes 93% and 98% of the respective business sectors. Although data on the number of small retail outlets engaged in mechanical meat tenderization is not available, it is believed to be a small proportion.

Overall, the estimated incremental cost to industry would not be substantial. Nevertheless, the small business lens would still apply due to the demographic nature of the industry.

Domestic and international coordination and cooperation: These Regulations focus on MTB sold in Canada. All MTB imported into Canada must comply with the requirements under the Meat Inspection Act and its Regulations. Coordination and cooperation will focus mainly on enforcement activities with the Canadian Food Inspection Agency.

Background

In 2012, 18 cases of food-borne illness caused by Escherichia coli 0157 (E. coli 0157) were reported as part of a Canadian outbreak associated with contaminated XL Foods Inc. beef. During the food safety investigation following the outbreak, several cases were considered to be likely associated with the consumption of mechanically tenderized beef (MTB) produced at the retail level. Health Canada decided to initiate a risk assessment of MTB and to make known recommendations concerning the handling of the MTB.

Mechanical tenderization of meat is a common practice and has been used by processors, food services and retailers for many years to improve the tenderness and flavour of cooked beef. The process of mechanically tenderizing meat involves using instruments such as needles or blades to break down, penetrate or pierce its surface, or injecting it with a marinade or tenderizing solution. It is not apparent by just looking at the meat product whether if it has undergone this process. Further, this process can increase the risk posed to consumers if the surface of the meat is contaminated with bacteria, which can then be transferred from the surface to the centre of the meat during tenderization. This can also occur at home, as tenderizing tools intended for home use are also available to Canadian consumers.

Following the 2012 outbreak, Health Canada along with the Public Health Agency of Canada released an interim recommendation encouraging Canadians to cook mechanically tenderized steak and beef cuts to an internal temperature of at least 71°C (160°F). There is now new scientific research specific to MTB that supports new cooking recommendations to achieve better protection for consumers of MTB products. These include cooking MTB products to a minimal internal temperature of 63°C (145°F) and flipping steaks at least twice during cooking to achieve a consistent temperature throughout.

An independent review of XL Foods Inc. beef recall, (Independent Review of XL Foods Inc. Beef Recall 2012) was conducted and concluded in 2013. The review included a recommendation to Health Canada to complete its risk assessment of MTB and make known its recommendations concerning the handling of the product.

In May 2013, Health Canada completed the health risk assessment on E. coli 0157 in MTB. The results from the assessment showed a fivefold increase in risk from MTB products when compared to intact cuts of beef. The presence of the E.coli 0157 strain is known to make people sick, causing severe stomach cramps, diarrhea and vomiting. Furthermore, serious complications of an E. coli 0157 infection can include kidney failure. The assessment also identified that without labels, it is difficult for Canadians to identify which products have been mechanically tenderized.

The health risk assessment, Findings of the Health Risk Assessment of Escherichia coli 0157 in Mechanically Tenderized Beef Products in Canada, which was published on May 28, 2013, is available at the following Web site: www.intechopen.com/journals/international_food_risk_analysis_journal/findings-of-the-health-risk-assessment-of-escherichia-coli-o157-in-mechanically-tenderized-beef-prod.

On May 17, 2013, as part of the Safe Food for Canadians Action Plan, the Government of Canada announced plans to implement mandatory labelling requirements for all MTB products sold in Canada. Following this announcement, the CFIA amended its Meat Hygiene Manual of Procedures (MOP) under the Meat Inspection Regulations, 1990 (MIR) to mandate federally registered plants that produce MTB cuts to label those products as “mechanically tenderized” and with cooking instructions. Consequently, federally registered processors and many national retailers are complying with the requirements, but non-federally registered processors and small grocery retailers, including butcher shops are not included. The proposal is intended to address this regulatory gap.

In addition, the Minister of Health released the Healthy and Safe Food for Canadians Framework, which outlines how the Government is working to inform consumers about healthy and safe food choices, to minimize food safety risks, and to protect Canadians when unsafe foods enter the marketplace. The regulatory proposal is part of this work, as it will provide the information Canadians need to make informed decisions and promotes safe food preparation.

Internationally, the United States Department of Agriculture — Food Safety Inspection Service (USDA-FSIS) announced on June 10, 2013, a regulatory proposal to require the use of the descriptive designation “mechanically tenderized” on the labels of mechanically tenderized beef products. The proposed regulations also require that cooking instructions be provided to consumers on the product label.

The United States appears to be the only country to indicate a mandatory cooking temperature specific to MTB and the only other country to propose a requirement for MTB labelling with cooking instructions.

Issues

Recent Canadian events of food-borne illness associated with E. coli 0157 contamination in MTB products have identified the need for enhanced food labelling. Such labelling would provide consumers with information to support identification of MTB and instructions for safe cooking.

Following these outbreaks, Health Canada conducted a health risk assessment. The results indicated that there is a fivefold increase of risk from MTB products when compared to intact cuts of beef and that without proper labelling it is difficult for Canadians to identify which products have been mechanically tenderized.

Currently, the CFIA has authority over the federally registered processors under the MIR that require mandatory labelling of MTB. However, a consumer may purchase meat products at the retail level that come from sources other than a federally registered meat processing facility and meat products can also be further processed, cut, tenderized and packaged at a retail level or by non-federally registered processors. Hence, these products are not subject to the rules under the mandatory labelling requirements of MIR.

Objectives

The objectives of the Regulations are to assist consumers in identifying MTB products and to provide them with safe cooking instructions to help minimize the potential risk of food-borne illness.

These Regulations further commitments the Government has made under the Safe Food for Canadians Action Plan and the Healthy and Safe Food for Canadians Framework, which support consistent labelling of all MTB products sold in Canada with important information to make informed decisions and promote safe cooking.

These Regulations will also address a gap between the labelling requirements for federally registered and non-federally registered facilities for MTB products, and will bring a consistent approach to managing the potential risk of food-borne illness associated with all MTB for Canadians.

Description

These Regulations will amend the Food and Drug Regulations (FDR), Part B Foods to

  • add a definition of “mechanically tenderized beef;”
  • prohibit the sale of MTB in Canada unless it is identified as “mechanically tenderized;”
  • follow the labelling requirements set out in section B.01.012;
  • clearly label on the packages’ principle display panel
    • that is it “mechanically tenderized;”
    • that it contains instructions regarding cooking to a minimum internal temperature of 63°C; and
    • that if the MTB is in the form of a steak, it must contain an additional cooking instruction to turn the steak over at least twice during cooking.

These amendments will come into force three months after publication in the Canada Gazette, Part II.

Regulatory and non-regulatory options considered

Regulatory option
Mandatory labelling

The regulatory amendment to the FDR to mandate labelling of all MTB products is considered the instrument of choice, as there is no means to enforce compliance with the current voluntary standards. As MTB products cannot be identified by consumers without clear labelling, mandatory labelling will provide important safe cooking instructions on packages.

Further, without mandatory labelling there would be an inconsistency in how the food safety rules are being applied to federally registered and non-federally registered facilities, presenting a vulnerability to the Canadian food safety system.

Non-regulatory option
Voluntary labelling — Non-federally registered facilities

The non-regulatory option of voluntarily labelling would apply only to non-federally registered facilities, given that federally registered facilities are now required to label according to the recently amended MOP. This option would not address the inconsistency in food safety rules for federally registered and non-federally registered facilities that provide the same food product.

Health promotion and prevention efforts — Public health notices and consumer education efforts

There are federally supported programs to educate consumers about health risks. For example, Health Canada and the Public Health Agency of Canada have published recommendations to Canadians regarding the safe cooking of meat products. Most consumers would become aware of such recommendations and public health notices mainly through the media. However, this does not have the same effect as important safety information provided on the product label itself that is visible to the consumer each time a product is selected for purchase. Also, in comparison with education efforts for products that consumers can easily recognize, such as ground meats, promotion and prevention efforts for MTB are not currently effective because consumers cannot easily identify the products in the marketplace in the absence of labelling.

Benefits and costs

Cost-benefit statement
Quantified impacts
  Base Year Final Year Total (PV) Average Annual

Benefits

Health care system — reduction of illnesses

$110,800 $110,800 $533,500 $110,800

Cost

Label change for non-federally registered facilities

$114,700 $0 $114,700 $16,500 (see footnote 3)
Net benefits $418,800 $94,300
Qualitative impacts
  • Industry should benefit from reduced risks for the number of recalls (see footnote 4) relating to tenderized beef products, which may be rare in occurrence but could be significant in financial impact, particularly to small businesses;
  • Canadians would benefit from the proper cooking instructions and temperature information for MTB to reduce the possibility of food-borne illnesses; and
  • Consumers would gain from the transparency provided by the label requirement to make informed choices about beef products.
Benefits
Canadian consumers

These Regulations will benefit Canadians in several ways. First, they will provide the necessary information to consumers regarding proper cooking instructions for tenderized beef products. Second, they will provide transparency to consumers in differentiating between cuts of beef that have been tenderized from those that have not, which will facilitate informed choice.

Industry

These Regulations should reduce the number of recalls (see footnote 5) for tenderized beef products which may be rare in occurrence, but that could be financially significant, particularly to small business.

Health care system and the provincial and territorial governments

Based on the analysis carried out by the USDA-FSIS for a similar proposal in the United States, it is expected that the MTB labelling proposal would prevent 460 cases of food-borne illnesses, with a lower bound of 133 and an upper bound of 1 497 cases annually in the United States. (see footnote 6) In monetary terms, this represents an expected benefit of $1,511,000 with a range of $121,000 to $11,641,000.

Taken into account of consumption pattern, and with approximately 10% of the United States population, a similar proposal in Canada could expect to reduce 34 cases of food-borne illnesses annually, with a lower bound of 10 and an upper bound of 110 cases. In monetary terms, this could translate into an expected value of $110,800, with a range of $31,000 to $361,000 for Canada.

As the provincial and territorial governments are primarily responsible for managing the health care system, they would also be the major recipients of any benefits from illness prevention.

Cost
Industry

Meat processing facilities engaged in beef tenderizing

Based on Industry Canada data, there are approximately 815 slaughtering houses and meat processing facilities in Canada (excluding those for poultry). These Regulations will have a different impact on beef processing facilities depending on whether they are federally registered or not.

There are approximately 426 federally registered facilities, of which 41 conduct beef tenderizing activities. (see footnote 7) As federally registered facilities are already required to label mechanically tenderized products under the CFIA’s MOP, there would be no incremental cost to these establishments. Furthermore, the nil cost implication would extend to beef importers since they must be federally registered and imported meat would be required to be labelled according to Canadian requirements. Federally registered facilities consist of comparatively larger establishments with national distribution capacities.

On the other hand, non-federally registered processing facilities operate solely within provincial borders and are not required to meet the label requirement under MOP and may incur incremental cost as a result of this proposal if they engage in tenderizing beef. These facilities are mostly smaller establishments registered and inspected provincially and can only sell their products within provincial borders.

It is estimated that there are approximately 389 non-federally registered establishments (see footnote 8) in Canada. Because meat processing is typically a high volume–low profit margin business, smaller enterprises potentially need to find a niche market, where there is not a significant volume to attract the bigger rivals, to maintain reasonable profit margins to survive.

Given that tenderized beef has been estimated to range between 20% to 37% of overall beef production, it would not fall under the low volume category.

If the same ratio of meat processors were engaged in tenderizing beef at the provincial level as at the national level, the estimated number would be 37 facilities. (see footnote 9)

The United States (USDA-FSIS) estimated that the cost per label change is $310 and assumed 10 labels would require change per affected business.

The estimated cost for label change seems reasonable in light of computer and printing technological advancements. For example, electronic scale with label printing capability requires minimal intervention to accommodate label change. Nevertheless, this would apply only to those establishments with sufficient volume to justify and afford the investment. Further consultations, in particular with small businesses, will be needed to determine their circumstances.

If the United States calculation is applied to the non-federally registered facilities in Canada, assuming 37 establishments are engaged in tenderizing beef, the one-time incremental cost would be about $114,700. (see footnote 10)

Retailers

Grocery retailers could vary in size from multinational and national chain stores to local butcher shops with various cost structure.

There are at least three scenarios to consider for retailers:

  1. In the case of meat processing facilities that ship their products in consumer packages (e.g. steaks in a wrapped trap pack), retailers would not incur incremental cost;
  2. In cases of meat processing facilities that ship the tenderized beef in bulk containers and allow the retailers to repackage the products for consumers, the retailers would incur the incremental cost of relabelling; and
  3. In the case of retailers that tenderize and package the beef themselves, the retailers would incur the incremental cost of labelling.

According to the U.S. report, Expert Elicitation on the Market Shares for Raw Meat and Poultry Products Containing Added Solutions and Mechanically Tenderized Raw Meat and Poultry Products, 5% of mechanically tenderized or enhanced beef products were packaged in retail operations.

Due to the lack of data available at this time, Health Canada cannot estimate the number of retail facilities that would engage in packaging or repackaging of tenderized beef products. However, the Department has initiated consultations with the appropriate stakeholder groups for their input on the incremental costs to retailers.

Government

The CFIA will enforce the MTB labelling requirement as part of its existing food labelling enforcement activities.

The full cost-benefit analysis is available upon request.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these Regulations, as there is no change in administrative cost to business.

Small business lens

Based on data from Industry Canada, there are an estimated 290 slaughtering houses and 525 meat processors in Canada, of which small business constitutes 93% and 98% of the respective business segments.

The number of small retail businesses that would be affected is not known. According to census data, 87% of butchers and meat cutters (both retail and wholesale) were employed in food stores (some 12 000 Canadians in total). Of those, only 24% were employed in specialty stores, the remainder were employed in grocery stores or wholesale food distributors. Since not all retail establishments tenderize beef mechanically, it can be assumed that the number of small retail outlets affected would be significantly fewer than the number of butchers employed in small retail shops (www.servicecanada.gc.ca/eng/qc/job_futures/statistics/6251shtml#outlook).

As a result, while the estimated incremental cost to industry may not be significant, the small business lens would nevertheless apply because of the demographic nature of the industry.

Further, larger association members representing non-federally registered processors and retailers have been made aware of the Department’s intent to improve labelling for MTB, through invitations to consultations, the Government’s recent announcement and amendments to CFIA’s policies regarding mandatory labelling for federally registered processors in July 2013.

Regulatory flexibility analysis statement

The initial option considered will require all businesses to comply with labelling requirements three months following publication in the Canada Gazette, Part II.

A flexible alternative option would be a further delayed implementation period of six months or longer for all industry. However, due to food safety concerns, a shorter implementation period was determined. In addition, the primary cost would be associated with new labelling activities, which may not be significantly reduced by deferring implementation.

By changing the requirement to include the term “mechanically tenderized beef” anywhere on the principal display panel of a label instead of the “common name,” the Regulations provide flexibility to industry with regards to labelling. The industry will be able to control the location of the term “mechanically tenderized beef” on their labels as long as it meets the requirements of legibility and prominence on the principal display panel. As a result, this will minimize the costs associated with changing labels and reduce the amount of time required to come into compliance.

In addition, minimizing administrative or compliance costs for small businesses cannot be at the expense of the greater health and safety concerns of Canadians. For this reason, the Department has not chosen the flexible alternative option and is proposing implementation three months after publication.

Consultation

Prior to the Government of Canada announcement on May 17, 2013, Health Canada held meetings with key stakeholders, such as the Canadian Restaurant and Food Services Association (CRFA), the Canadian Meat Council (CMC), the North American Meat Association (NAMA), the Canadian Federation of Independent Grocers (CFIG) and the Retail Council of Canada (RCC). The discussion included requiring mandatory labelling requirements for MTB and gathering information on the various stakeholder opinions on this path forward. Most stakeholders were supportive of mandatory labelling if Health Canada determined it contributed to consumer health and safety.

An association representing small grocers and retailers opposed to the mandatory labelling option, as they felt there was a disproportionate impact on their members. They suggested the option of counter signage or a voluntary policy instead.

On June 6, 2013, Health Canada held a meeting with meat and microbiology experts, including representatives from academia (Kansas State University), industry (the Canadian Cattlemen Association [CCA], the CMC, the RCC, the CRFA, and the CFIG) as well as both American and Canadian government bodies (the USDA, the CFIA, and Agriculture and Agri-Food Canada [AAFC]) to discuss the factors which would need to be considered in making potential cooking recommendations for MTB.

On July 24, 2013, Health Canada held a meeting regarding the mandatory labelling of MTB with various meat and microbiology experts and stakeholders to discuss the proposed labelling options and any issues. This meeting included representatives from the CFIA, AAFC, the CMC, the RCC, the CRFA, the NAMA, as well as academic experts from the University of Manitoba, Alberta and British Colombia. The attendees were presented with proposed options and were asked to provide their input. The following is a summary of the input received:

  • an outreach strategy including consumer education activities (other than the label) to inform consumers on the risks associated with MTB and provide more prescriptive cooking instructions and specific advice will likely be important;
  • alignment with the American MTB labelling approach would be desirable for industry;
  • use of the term “flip/flipping” in reference to cooking steaks may need to be included in the label text;
  • label text directed to consumers for use at home may be different than those directed towards chefs/restaurants; and
  • there should be consistency of suggested texts among various Government of Canada (Health Canada and CFIA) policies regarding food safety with respect to level of detail.

Most recently, in early December 2013, Health Canada contacted the key stakeholders (the CCA and AAFC) involved with recent scientific studies which tested the effects of various cooking procedures on contaminated steaks. Health Canada has confirmed with the CCA that this study concludes that turning over steaks during cooking greatly assists in achieving a consistent temperature throughout the steak.

As a result of these consultations, Health Canada narrowed down the number of proposed label text options and revised proposed wording.

Comments received following publication of the Regulations in the Canada Gazette, Part I

Following publication in the Canada Gazette, Part I, on February 15, 2014, 18 stakeholders submitted their comments during the 30-day comment period. Overall, stakeholders were supportive of the Regulations, but expressed some concerns over the labelling requirements. One stakeholder did not support the Regulations and proposed that the Department should withdraw the proposal until detailed research and risk assessment are done using current data.

The comments received and Health Canada’s responses are summarized below.

Definition of “mechanically tenderized beef”

Six stakeholders expressed concerns with the definition of “mechanically tenderized beef,” and believe that it is too broad and will capture products tenderized by methods that do not translocate bacteria into deeper tissues where pathogens might survive, such as “massaging,” “tumbling” and “other similar process.” In addition, two stakeholders believe the definition should not capture meat cuts that are less than 1.3 cm thick, such as minute/fast fry steaks.

Health Canada agrees with the analysis that the tenderizing methods, such as “massaging,” “tumbling” and “other similar process,” will not affect deeper tissues causing pathogens to survive, and will therefore remove those terms from the definition of “mechanically tenderized beef.” In addition, Health Canada believes that all meat cuts should be included in the definition since the risk exists regardless of the thickness of the meat cut.

Three stakeholders expressed concerns over the term “mechanically tenderized” and did not believe that the term “mechanically” should be included on a label since it will be negatively viewed by consumers. They recommended using the term “blade tenderized” as an alternative.

While these concerns were taken into consideration, Health Canada believes that the term “mechanically tenderized” is the most effective with consumers and will meet the safety objectives of these Regulations.

Cost of changing labels

The Department received two comments relating to the cost of changing labels to conform to the proposed Regulations. Specifically, a comment was received from one retailer indicating that it might cost them an estimated $2.5 million to change labels and equipment so they can come into compliance with the new Regulations.

Health Canada has changed the labelling requirements and will allow flexibility in the location of the term “mechanically tenderized.” Since some stakeholders are currently voluntarily labelling according to our requirements with the exception of the term “mechanically tenderized,” a slight modification in the label will not result in increased costs as previously reported.

To provide flexibility, the Department has decided to change the requirements to include the term “mechanically tenderized” in the common name, and instead require the term to be included in the principal display panel.

Alignment with other federal government regulations

The CFIA expressed concerns with wording used in the proposed Regulations which included the term “product name” and “conspicuous.” They recommended that we change the terms to “common name” and “prominent,” respectively, to align with CFIA regulations.

Health Canada agrees with the CFIA’s comments and will change the terms to align with CFIA regulations.

Coming into force

Two stakeholders requested that the coming-into-force date be changed to six months after the Regulations are registered in order to account for small-scale operators. A six months coming-into-force date could reduce financial burden by permitting the use of existing labels for a period of six months or until reprinting of labels is required, whichever is less.

Flexibility in labelling requirements will allow stakeholders to use current labels and make small modifications to come into compliance with the new Regulations. Therefore, Health Canada believes that the three month coming into force is sufficient time to allow for reprinting of labels.

Regulatory cooperation

As these Regulations focus on labelling for MTB sold in Canada, regulatory cooperation will mainly be related to enforcement activities with the CFIA. These Regulations will also support initiatives under the Safe Foods for Canadians Action Plan regarding consistent application of MTB labelling requirements across federally and non-federally registered sectors.

These Regulations will potentially align and minimize any regulatory differences with the mandatory MTB labelling efforts underway in the United States.

Rationale

Mandatory labelling for MTB will help to address ongoing concerns regarding incidences of food-borne illness in Canada. It will address the lack of transparency for consumers regarding information on identifying MTB products and provide important safe cooking instructions, which has been identified by the Government and industry partners as a preferable risk management option.

Although voluntary guidelines are available, there is no incentive for the non-federally registered sector to follow them and no means for the federal government to enforce compliance.

Implementation, enforcement and service standards

Health Canada is proposing a three-month transitional period for the coming into force of the proposed amendments.

These amendments do not alter existing compliance mechanisms under the provisions of the Food and Drug Act (FDA) and its Regulations or other applicable food-related legislation enforced by the CFIA.

Consumer education and awareness efforts will be a part of the implementation strategy in order to inform consumers that the nature of MTB is not the same as that of an intact cut of beef, and the consequence of the tenderization process may include the intake of bacteria. MTB may therefore carry a higher risk than intact products and that MTB products should be cooked to a minimum internal temperature of 63°C.

Performance measurement and evaluation

Health Canada is proposing a three-month coming into force of the amendment following final approval. This delayed implementation period is intended to provide time for industry to plan for and adjust to the new regulatory requirements.

Health Canada will develop guidance documents and make them available to aid regulated parties to be in compliance.

These amendments will not alter existing compliance mechanisms under the provisions of the FDA and its Regulations or other food-related legislation enforced by the CFIA.

Contact

Dionne Saul-Hamilton
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Canada
1600 Scott Street, Holland Cross
Tower B, 5th Floor
Address locator: 3105A
Telephone: 613-960-6851
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca

Small Business Lens Checklist

1. Name of the sponsoring regulatory organization:

Health Canada

2. Title of the regulatory proposal:

Regulations Amending the Food and Drug Regulations (Mechanically Tenderized Beef)

3. Is the checklist submitted with a RIAS for the Canada Gazette, Part I or Part II?

Box without checkmark. Canada Gazette, Part I Box with checkmark. Canada Gazette, Part II

A. Small business regulatory design
I Communication and transparency Yes No N/A
1. Are the proposed Regulations or requirements easily understandable in everyday language? Box with checkmark. Box without checkmark. Box without checkmark.
2. Is there a clear connection between the requirements and the purpose (or intent) of the proposed Regulations? Box with checkmark. Box without checkmark. Box without checkmark.
3. Will there be an implementation plan that includes communications and compliance promotion activities, that informs small business of a regulatory change and guides them on how to comply with it (e.g. information sessions, sample assessments, toolkits, Web sites)? Box with checkmark. Box without checkmark. Box without checkmark.
4. If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No new forms or reports will be required from small businesses. Label requirements will not differ in format, and the design will be developed by the individual businesses.
II Simplification and streamlining Yes No N/A
1. Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: Health Canada does not plan on implementing streamlined processes to collect information from small businesses.
2. Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed? Box with checkmark. Box without checkmark. Box without checkmark.
3. Has the impact of the proposed Regulations on international or interprovincial trade been assessed? Box with checkmark. Box without checkmark. Box without checkmark.
4. If the data or information, other than personal information, required to comply with the proposed Regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department’s or agency’s ATIP office or legal services unit.) Box with checkmark. Box without checkmark. Box without checkmark.
5. Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant’s personal particulars such as contact information, date, etc. when that information is already available to the department.) Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No forms will be necessary to implement labelling requirements proposed under this regulatory amendment.
6. Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No electronic reporting will be used or proposed under this regulatory amendment.
7. Will reporting, if required by the proposed Regulations, be aligned with generally used business processes or international standards if possible? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No electronic reporting will be used or proposed under this regulatory amendment.
8. If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No additional forms will be necessary to implement labelling requirements proposed under this regulatory amendment.
III Implementation, compliance and service standards Yes No N/A
1. Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet? Box without checkmark. Box with checkmark. Box without checkmark.
Explanatory Note: This regulatory proposal does not require access to high-speed Internet, and, as a result, special consideration has not been given to small businesses in remote areas.
2. If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service? Box without checkmark. Box without checkmark. Box with checkmark.
Explanatory Note: No regulatory authorizations will be required to implement labelling requirements proposed under this regulatory amendment.
3. Is there a clearly identified contact point or help desk for small businesses and other stakeholders? Box with checkmark. Box without checkmark. Box without checkmark.
B. Regulatory flexibility analysis and reverse onus
IV Regulatory flexibility analysis Yes No N/A
1.

Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section?

Examples of flexible options to minimize costs are as follows:

  • Longer time periods to comply with the requirements, longer transition periods or temporary exemptions;
  • Performance-based standards;
  • Partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option);
  • Reduced compliance costs;
  • Reduced fees or other charges or penalties;
  • Use of market incentives;
  • A range of options to comply with requirements, including lower-cost options;
  • Simplified and less frequent reporting obligations and inspections; and
  • Licences granted on a permanent basis or renewed less frequently.
Box with checkmark. Box without checkmark. Box without checkmark.
2. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option?
  • Use the Regulatory Cost Calculator to quantify and monetize administrative and compliance costs and include the completed calculator in your submission to TBS-RAS.
Box with checkmark. Box without checkmark. Box without checkmark.
3. Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security or safety or create environmental risks for Canadians.) Box with checkmark. Box without checkmark. Box without checkmark.
4. Does the RIAS include a summary of feedback provided by small business during consultations? Box with checkmark. Box without checkmark. Box without checkmark.
V Reverse onus Yes No N/A
1. If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS? Box with checkmark. Box without checkmark. Box without checkmark.
  • Footnote a
    S.C. 2012, c. 19, ss. 414 and 415
  • Footnote b
    R.S., c. F-27
  • Footnote 1
    C.R.C., c. 870
  • Footnote 2
    It is estimated that retailers package and repackage approximately 5% of tenderized beef. The analysis did not include the cost to retailers due to insufficient data. Health Canada has initiated consultation with the stakeholder groups, and preliminary feedback indicated that the cost would be minimal.
  • Footnote 3
    Calculated with a discounted rate of 7% as recommended by the Treasury Board Secretariat.
  • Footnote 4
    Recalls are often triggered by illnesses reported by consumers and health care institutions. Thus, preventing more food-borne illnesses will potentially lead to fewer recalls.
  • Footnote 5
    Ibid.
  • Footnote 6
    www.fsis.usda.gov/OPPDE/rdad/FRPubs/2008-0017.pdf
  • Footnote 7
    Source: Canadian Food Inspection Agency.
  • Footnote 8
    According to Industry Canada data, there are 815 slaughtering houses and meat processors in Canada. According to the CFIA, there are 426 federally registered establishments. As a result, the non-federally registered facilities = 815 – 426 = 389.
  • Footnote 9
    Percentage of federally registered facilities which tenderize beef = 41 ÷ 426 ≈ 9.6%; same ratio applies to non-federally registered facilities = 9.6% × 389 = 37.
  • Footnote 10
    $310 × 10 labels × 37 facilities.