ARCHIVED - Use of Multiple-cycle High Pressure Processing (HPP) Treatment of Ready To Eat (RTE) Meat and Poultry Products

Novel Food Information

Health Canada has notified Gridpath Solutions Inc. that it has no objection to the use of Ready To Eat (RTE) meats and poultry that have been treated with up to three consecutive cycles of High Pressure Processing (HPP) treatment. The Department conducted a comprehensive assessment of these RTE meat and poultry according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of novel foods.

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 summerize 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.

High Pressure Processing (HPP) consists of applying a high pressure to a packaged food product via compressed water. Prior to pressurization, packaged Ready To Eat (RTE) meat and poultry products are loaded in a tray, which is itself loaded into the pressure vessel. The vessel is sealed and then pressurized by injecting water into the vessel until a defined pressure specific for the food to be treated is reached. The packaged RTE products are thus immersed in the pressurized water and subjected to high hydrostatic pressure. The proposed process is run in a batch mode for prepackaged foods; other units also exist which can run in a semi-continuous mode, for easily pumped liquid foods (e.g. juices, purees, sauces, etc.).

The length of the HPP treatment determines the efficacy of inactivation of background microflora. The high hydrostatic pressure does not affect any of the structural components of the food itself (e.g. structural proteins, fibres, fats, etc.), nor does it affect the structural integrity of the package used, as the pressure is applied uniformly on the food and on the package.

The process is for use as a post-processing, post-packaging intervention step for the control of Listeria monocytogenes in RTE meats and poultry, and in some cases to extend the shelf life of these products.

For clarity, RTE meats and poultry means meat or poultry products which have already been subjected to a process sufficient to inactivate vegetative pathogenic microorganisms or their toxins and control spores of foodborne pathogenic bacteria so that the meat product does not require further preparation before consumption, except, in certain cases, washing, thawing or exposing to sufficient heat to warm the product without cooking it. It excludes raw meats or meat products requiring further processing before being safely consumed,  Meat Inspection Regulations, 1990, Section 2.

The submission provided by Gridpath Solutions Inc. pertains to the acceptability of RTE meats and poultry that have been treated with up to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle). This petition is an expansion of the previous approval of RTE meats and poultry treated with a single cycle of HPP treatment (87000 psi/600 MPa, for 3 min), Decision Document for the Use of High Hydrostatic Pressure for the Control of L. monocytogenes in Ready To Eat (RTE) Meats and Poultry.

The purpose of this expansion is to make provision for food manufacturers to exercise a deviation procedure in the event of an incomplete HPP treatment cycle. An incomplete HPP cycle can occur as a result of a mechanical error in the system equipment (e.g. failure to achieve the desired pressure within the vessel) or a technical error in the system's supervisory program (e.g. power outage). Gridpath Solutions Inc. has indicated that approximately 5% of all HPP cycles will result in an incomplete cycle, translating to a maximum of 2-3 incomplete cycles on average in a typical 8 h operational shift. When the cycle is incomplete, and based on the design of the system, the pressure vessel (containing the partially treated product) will remain sealed until an approved systems operator manually restarts the treatment cycle or opens the vessel to remove the product. The commonly established deviation procedure entails restarting the process (i.e. 87000 psi/600 MPa for 3 min). The impact of this procedure on the food product is that it is subjected to a repeated, complete cycle(s) of high hydrostatic pressure exposure.

The assessment conducted by the Food Directorate considered the physical properties (e.g. pH, water activity, etc.) of the treated RTE meat or poultry product, the impact of multiple-cycle HPP treatment on the nutritional composition and chemical safety of RTE meat and poultry products, and the impact of extending the treatment duration of a single HPP cycle from 3 min up to 9 min. Gridpath Solutions Inc. has provided data which demonstrates that RTE meat and poultry products subjected to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle) are as safe as the equivalent products subjected to a single cycle of HPP treatment (87000 psi/600 MPa, for 3 min), the standard cycle presently used by the meat industry.

The Food Program has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Part B, Division 28). HPP-treated meats and poultry are considered novel foods, as per B.28.001, as they have been manufactured by a process that has not previously to those foods, and causes the foods to undergo a major change, the major change being, in respect to these foods, a change that places the food outside the accepted limits of natural variations for that food, with regard to microbiological safety.

2. Development of the novel food

Gridpath Solutions Inc. has provided information describing the methods and parameters used to compare the potential effects on RTE meat and poultry products treated by a single cycle or multiple consecutive cycles of HPP.

Data were provided for samples of RTE meat and poultry products with higher (>0.9) water activity (i.e. sliced cooked chicken) and lower (<0.9) water activity (i.e. sliced dry prosciutto ham). Samples were treated to both a single cycle of HPP treatment (87000 psi/600 MPa, with 2, 3, or 9 min per cycle) and three consecutive cycles of HPP treatment (87000 psi/600 MPa, with 2, 3, or 9 min per cycle). All treatment conditions were tested in triplicate for each RTE meat and poultry product.

Samples were treated to high hydrostatic pressure using a batch method. Prior to pressurization, the vacuum-packed samples were loaded unto a tray, which itself was loaded into the pressure vessel. The vessel was sealed and then pressurized by injecting water into the vessel until the defined pressure (i.e. 87000 psi/600 MPa) was reached. Treatment pressure was maintained for 2, 3, or 9 minutes per cycle respectively, followed by depressurization and release of the samples. All samples were packaged in flexible films approved for HPP treatment. The HPP-treated RTE meat and poultry products still required refrigeration.

3. Dietary Exposure

It is expected that RTE meat and poultry products treated with multiple cycles of HPP will be consumed comparatively to their non-treated counterparts. RTE meat and poultry products treated with multiple cycles of HPP can be expected to partially replace non-treated RTE meat and poultry products.

4. Chemistry

The impact of the HPP treatment on the packaging materials used to package RTE meats and poultry has been performed independently of the novel food submission by the Food Packaging Materials & Incidental Additives Section of the Chemical Health Hazard Assessment Division, as per Division 23, Part B of the Food and Drug Regulations.

It should be noted that the packaging material authorization process is independent from the novel food authorization process. The packaging material companies direct any requests concerning the acceptability of packaging materials for HPP treatment to the Canadian Food Inspection Agency (CFIA) to obtain proper clearance. CFIA will contact the Food Packaging Materials & Incidental Additives Section, as necessary, to obtain an opinion on the safety of the packaging material used with a novel process.

5. Microbiology

In the original Novel Food submission regarding the use of HPP for the control of L. monocytogenes in RTE meats and poultry, Decision Document for the Use of High Hydrostatic Pressure for the Control of L. monocytogenes in Ready To Eat (RTE) Meats and Poultry, Health Canada reviewed the data provided regarding the microbiological safety of these HPP-treated products. Based on this information, Health Canada has no objection to the use of RTE meats and poultry which have been subjected to a single cycle of HPP treatment (87000 psi/600 MPa, for 3 min).

Considering that the conditions of a single cycle of HPP treatment (87000 psi/600 MPa, for 3 min) are sufficient to ensure the microbiological safety of treated RTE meats and poultry, it is understood that the microbiological safety of a RTE meat or poultry product treated with additional consecutive cycles is expected to be equivalent or even enhanced by such treatment. From a microbiological standpoint, the Bureau of Microbial Hazards has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle).

6. Nutrition

The petitioner provided data pertaining to the impact of a multiple-cycle HPP treatment on the nutritional composition of RTE meats and poultry. The study design included the measurement of vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), protein, moisture, calcium, iron, vitamin A, retinol, and beta-carotene, for samples of both sliced cooked chicken and sliced dry prosciutto ham subjected to either a single or three consecutive cycles of HPP treatment.

Samples subjected to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle) were nutritionally comparable to those treated with a single cycle (87000 psi/600 MPa, 3 min per cycle).

Based on the assessment of the data provided in the submission and the probable risks associated with HPP, the Bureau of Nutritional Sciences has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle).

7. Toxicology

With respect to the possible generation of toxic compounds from the components of RTE meat and poultry products, the potential for repeated exposure to HPP treatment to cause the breakdown of protein and increase the concentration of nitrites and nitrates than already present in the food was investigated. An increase in the level of nitrites and nitrates would be a concern as nitrites can react with amines in foods to form nitrosamines which are genotoxic carcinogens, and nitrates can be converted to nitrites.

No significant increase in the level of nitrites and nitrates was observed for RTE meat and poultry products exposed to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle) compared to those treated with a single cycle (87000 psi/600 MPa, for 3 min). These results support the conclusion that the multiple-cycle HPP treatment of RTE meat and poultry products does not increase the potential generation of toxic compounds.

On this basis, the Bureau of Chemical Safety has no objection to the use of RTE meats and poultry which have been subjected to up to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle).

8. Labelling

Exposure to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle) does not cause a significant compositional change in the food, nor has there been any safety concerns raised regarding the use of this process for RTE meats and poultry. 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 RTE meats and poultry which have been treated with up to three consecutive cycles of HPP treatment (87000 psi/600 MPa, from 3 min up to 9 min per cycle), concluded that this use does not raise concerns related to food safety. Health Canada is of the opinion that those treated RTE meats and poultry are as safe as other RTE counterparts on the market.

This opinion is solely with respect to the suitability for sale of these RTE meats and poultry. It is the continuing responsibility of the food manufacturer to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to these products which have 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 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, PL2204E
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9

Telephone: (613) 957-1742
Facsimile: (613) 952-6400