Novel Food Information - High Pressure Processing (HPP)-Treated Raw Ground Beef (Fressure- fresh ground beef)

Health Canada has notified Gridpath Solutions Inc., on behalf of Cargill Inc., that it has no objection to the food use of High Pressure Processing (HPP)-treated raw ground beef (trade name: Fressure™ fresh ground beef). The Department conducted a comprehensive assessment of this HPP-treated food product according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.

Background:

The following provides a summary of the notification from Gridpath Solutions Inc. and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

Raw ground beef, with a protein:fat ratio of 73%:19%Footnote 1, is packaged in chub or patty format (patties vertically stacked in packaging) and loaded in batches into a pressure chamber. The chamber is sealed and then pressurized by injecting water into the chamber until a defined pressure, specific for the treated product, is reached. In the case of HPP-treated raw ground beef, the product is held at 87,000 psi/600 MPa for a 1-minute holding time. Upon completion of the treatment holding time, the chamber is depressurized and the product is released. The HPP-treated product still requires refrigeration post-treatment and should be cooked properly (like its untreated equivalent) prior to consumption.

In the event of an incomplete treatment cycle, the petitioner would like the ability to treat their product for an accumulated treatment time of up to 3 minutes to accommodate a restart of the HPP treatment process. As such, the petitioner provided data for their product treated for both a 1-minute, and 3-minute holding time at 87,000 psi/600 MPa.

Fressure™ fresh ground beef is treated with HPP for the purpose of extending the refrigerated shelf life of the product and to inactivate the potential microbial pathogen, Escherichia coli O157:H7. The petitioner has stated that this product is specifically intended for the food service industry and is not available for direct purchase by retail consumersFootnote 2.

The assessment conducted by the Food Directorate considered the intended addition of an HPP treatment to the current manufacturing process, the nutritional composition of both HPP-treated and untreated product, the potential for the HPP treatment to generate any toxic compounds within the product, and the microbiological safety of the finished HPP-treated product. The Directorate also evaluated the efficacy of the HPP treatment to inactivate E. coli O157:H7 cells in raw ground beef. Gridpath Solutions Inc. has provided data which demonstrates that raw ground beef treated at 87,000 psi/600 MPa for a minimum of 1 minute up to a maximum of 3 minutes is as safe as the equivalent untreated product.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Division 28). Raw ground beef treated by high pressure processing (HPP) is considered a novel food under the following part of the definition of novel foods:

"b) a food that has been manufactured, prepared, preserved or packaged by a process that

  1. has not been previously applied to that food, and
  2. causes that food to undergo a major change."

2. Development of the novel food

Gridpath Solutions Inc. has provided information describing the methods and parameters used to assess the impact of the HPP treatment on the nutritional composition, microbiological safety, and toxicological safety of the treated product.

Nutritional and toxicological data were provided for raw ground beef treated with HPP at 87,000 psi/600 MPa for 3 minutes or untreated (negative control). Microbiological data was provided for the finished products treated at 87,000 psi/600 MPa for 1 minute only, with the rationale that additional treatment would not decrease the microbiological safety of these products. The evaluators considered this rationale acceptable.

Samples were treated with HPP using a batch method. Prior to pressurization, the package-sealed samples were loaded onto a tray, which itself was loaded into the pressurization chamber. The chamber was then sealed and pressurized by injecting water into the chamber until the defined pressure (i.e., 87,000 psi/600 MPa) was reached. Treatment pressure was maintained for a single 1- or 3-minute cycle. Control samples were not subjected to HPP treatment. All samples were packaged in materials acceptable for the intended HPP treatment. The HPP-treated food products still required refrigeration.

3. Dietary Exposure

As previously stated, Fressure™ fresh ground beef (i.e., HPP-treated raw ground beef) is not intended for direct sale to the consumer. The treated product is only intended to be used by the food service industry. Therefore, it is expected that HPP-treated raw ground beef would only partially replace untreated raw ground beef destined for the food service industry. The consumption pattern of ground beef is not expected to change due to the introduction of this HPP-treated product.

4. Chemistry

The safety of all packaging materials is regulated under Division 23, Part B of the Food and Drug Regulations. It is the ongoing responsibility of the manufacturer to ensure that the packaging materials used for their product are acceptable for their intended use. A list of all packaging materials (including those acceptable for HPP treatment) accepted by the Canadian Food Inspection Agency (CFIA), for use in federally-registered establishments, is available on the  CFIA website.

To demonstrate the acceptability of the packaging materials used for HPP-treated raw ground beef, the petitioner provided two Letters of No Objection (dated August 12, 2011 and November 7, 2011, respectively) from the Bureau of Chemical Safety addressed to their packaging material supplier, Sealed Air (Canada) Co./Cie. (Mississauga, ON). The first letter states that the Bureau has no objection to the use of a series of materials (specified in the letter) subjected to pressures up to 90,000 psi/620 MPa for a maximum of 10 minutes. The second letter states that the Bureau has no objection to the use of a series of materials subjected to pressures up to 90,000 psi/620 MPa for a maximum of 20 minutes, with a number of treatment cycles not to exceed 10.

5. Microbiology

The petitioner provided analytical data for 13 HPP-treated raw ground beef samples (65 g each) tested on 3 non-consecutive dates (4 samples on December 28, 2012; 5 samples on January 1, 2013; and 4 samples on January 3, 2013). All samples were tested for the presence of E. coli O157:H7 using a gene-based assay, Assurance GDS™ (MFLP-16, Health Canada). The data demonstrated that HPP-treated raw ground beef produced by the petitioner is consistently negative for the presence of E. coli O157:H7.

The petitioner also provided data from a challenge study conducted to demonstrate the efficacy of the HPP treatment to inactivate E. coli O157:H7 cells. In this study, samples of raw ground beef were inoculated with a 5-strain cocktail of E. coli O157:H7 at an approximate concentration of 109 colony forming units (CFU)/ml. The strains were selected from the University of Guelph's private collection. Four of five strains were isolated from known sources (i.e., apple cider, 1 isolate; beef, 1 isolate; water, 2 isolates), while one strain was from an unknown source. No additional information regarding the physiological properties (e.g., pressure resistance) of the strains was provided. The inoculated samples were subjected to HPP treatment at 87,000 psi/600 MPa for either a 1-minute or 3-minute holding time or were untreated (control). The treated and untreated samples were subsequently plated on both non-selective (i.e., tryptic soy agar - TSA) and selective (sorbitol MacConkey agar with cefixime and tellurite - CT-SMAC) media and enumeration of surviving E. coli O157:H7 cells were conducted. The concentration of surviving E. coli O157:H7 cells was calculated for each media type and treatment variable and statistical analysis was conducted to determine if the observed differences between the means were statistically significant. It can be concluded that the HPP treatment of 87,000 psi/600 MPa for both 1 and 3 minutes can reduce the bacterial concentration of the 5 E. coli O157:H7 strains that were tested in raw ground beef by greater than 5-log CFU/g. This reduction is statistically significant at a 5% error level for both recovery methods, where surviving cells were grown on non-selective TSA media or selective CT-SMAC media (designed for the culture of E. coli O157:H7).

However, the efficacy of the HPP treatment is based solely on the 5 E. coli O157:H7 strains of which no information was provided regarding their individual (or collective) resistance to pressure. Pressure resistance has been shown to vary significantly between microbial species, serotypes, and even strains of the same serotype such as E. coli O157:H7. The claim of a greater than 5-log CFU/g reduction is based on these specific strains of E. coli O157:H7. As the data is still very limited at this time, the Bureau of Microbial Hazards is not in a position of issuing an opinion regarding the specific efficacy (i.e., >5-log CFU/g) of this HPP treatment that would apply to all E. coli O157:H7 strains that may be present in raw ground beef. However, the Bureau can state that the HPP treatment reduces the concentration of E. coli O157:H7 cells in raw ground beef with a protein:fat ratio of 73%:19%.

6. Nutrition

The petitioner submitted compositional and nutritional data on raw ground beef (both HPP-treated and untreated) to demonstrate that the HPP treatment (i.e., 87,000 psi/600 MPa for 3 minutes) had little or no effect on the nutritional composition of the product.

Nutritional analysis was performed on 10 samples of raw ground beef per variable (i.e., HPP-treated and untreated). The nutritional markers selected were: fat, protein, moisture, ash, calcium, iron, thiamine, riboflavin, vitamin A, retinol, and beta carotene. These markers are appropriate for raw ground beef. No changes or differences were observed in all the makers analyzed between the HPP-treated and untreated samples.

7. Toxicology

The toxicological data submitted were limited to a chemical analysis of lipid oxidation as determined by the thiobarituric acid test. The test measures the level of a detectable fluorescent product resulting from the reaction of thiobarituric acid and malondialdehyde (an end-product of lipid oxidation). An indication of lipid oxidation would suggest that the HPP treatment causes the product to become rancid and potentially generate mutagenic substances.

The test was performed on 10 raw ground beef samples either HPP-treated or untreated (i.e., 10 samples per variable). The data submitted showed that the levels of lipid oxidation were not significantly affected by the HPP treatment. This finding suggests that under these conditions, HPP-treated raw ground beef does not pose a toxicological concern.

8. Labelling

Exposure to the HPP treatment of 87,000 psi/600 MPa for up to a maximum of 3 minutes does not cause a significant compositional change in the treated food, nor have there been any safety concerns raised regarding the use of this process for raw ground beef with a protein:fat ratio of 73%:19%. On this basis, mandatory labelling requirements are not necessary in this case.

Conclusion:

Health Canada's review of the information presented in support of the food use of raw ground beef (with a protein:fat ratio of 73%:19%), which has been treated at 87,000 psi/600 MPa for a minimum of 1 minute up to a maximum of 3 minutes, concluded that this use does not raise concerns related to food safety. Health Canada is of the opinion that this HPP-treated food product is as safe as its untreated counterpart on the Canadian market.

This opinion is solely with respect to the suitability of sale of this HPP-treated food product. It is the continuing responsibility of the food manufacturer or importer to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to this product which has potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all foods available in the Canadian marketplace. The sale of a food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca

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