ARCHIVED - Irradiation of Poultry: Summary of Submission Process

A. Summary Of Situation

(a) The Requests

Two submissions have been received for the irradiation of fresh and frozen poultry and prepared poultry products. Both submissions are based on substantially the same information.

First Submission (I)

This submission is for the irradiation of fresh and frozen poultry, prepared poultry products and mechanically separated poultry meat. "Poultry" includes chicken, turkey, fowl, duck, pheasant, geese and Cornish hens.

Second Submission (II)

This submission advocates the irradiation of raw, fresh chilled, refrigerated and pre-frozen intact poultry and the comminuted edible tissue of the skeletal muscle and edible viscera.

"Poultry" includes all raw edible tissue of domesticated avian human food sources, specifically chicken, turkey, ducks and geese.

(b) Divisions of the Food Directorate Responsible for Evaluating these Submissions

Chemical Health Hazard Assessment Division, Bureau of Chemical Safety (Coordinating Division; also evaluates toxicological safety, chemical safety and dosimetry portions of submissions)

Evaluation Division, Bureau of Microbial Hazards (evaluates efficacy and microbial safety aspects)

Nutrition Evaluation Division, Bureau of Nutritional Sciences (evaluates nutritional effects)

B. Evaluation Summary

(a) Purpose, Source of Radiation and (Absorbed) Dose

Submission I:

The purpose of irradiation is to (1) reduce or eliminate bacterial pathogens e.g. Salmonella, and Campylobacter, and (2) to extend refrigerator shelf-life by reducing spoilage bacteria.

The proposed source of ionizing (gamma-) radiation is Cobalt-60.

The proposed dosages are as follows:

Fresh Poultry: Absorbed dose minimum 1.5 kGy and maximum 3.0 kGy. Expected total overall average absorbed dose in commercial irradiation: 2.75 kGy.

Frozen Poultry: Absorbed dose minimum 2.0 kGy and maximum 5.0 kGy.
Expected total overall average absorbed dose in commercial irradiation: 3.5 kGy.

Submission II:

The purpose¹ of irradiation is to (1) control microbial pathogens and infectious parasites and (2) to extend the edible-marketable chilled and refrigerated fresh life of poultry by concomitantly reducing the number of spoilage organisms.

The primary pathogenic organisms of concern include members of the Enterobacteriaceae (e.g., Salmonella spp., Escherichia coli, Shigella spp., Yersinia spp.), non-spore forming gram-positive bacteria (e.g. Staphylococcus aureus, Lysteria monocytogenes), infectious parasites (e.g. Cryptosporidium) and vegetative forms of spore-forming pathogens (e.g, Clostridium perfringens, Bacillus cereus).

The spoilage organisms of concern include the coliforms, pseudomonads and other related non-fermentative gram-positive species.

The proposed source of irradiation is Cobalt-60, Cesium-137, electrons or X-rays from machine sources.

The proposed dosages are as follows:

Chilled, refrigerated poultry: Absorbed dose maximum 3.0 kGy.
Hard frozen (minus 18°C during irradiation): Absorbed dose maximum 5.0 kGy.

(b) Efficacy

Microbiological evaluators have no objection to the use of ionizing radiation up to a maximum dose of 5.0 kGy for frozen poultry. However, it recommended that the dose level be limited to a maximum of 3.0 kGy for fresh poultry since there are insufficient data to assess the risk posed by the growth of, and toxin production by, non-proteolytic C. botulinum type E at irradiation levels higher than 3.0 KGy. The first petitioner has concurred with this recommendation.

If specific claims are made such as "pathogen free" or "Salmonella free" or "shelf-life extended by x days", additional data to substantiate the claim would have to be submitted for evaluation.

There appears to be no increased microbiological food safety concern when poultry products are irradiated at the proposed dose levels. The effectiveness of the irradiation process is site and product specific and will require the application of HACCP principles

and GMP. The log reduction of pathogens of concern should be monitored continuously to ensure the anticipated log reduction has been achieved and continues to be achieved.

There is enough evidence in the scientific literature including that cited by the petitioners, to support the conclusion that irradiation is an effective means of reducing and, in some cases eliminating, certain food borne pathogens (Salmonella, Listeria, E. coli, Campylobacter) from fresh or frozen poultry products. The proposed irradiation process should reduce the levels of Salmonella in poultry products by about 2 logs.

In order that the irradiated poultry and poultry products made available to the consumer have the best microbiological quality, it is essential that appropriate good manufacturing practices for minimizing bacterial contamination and growth during processing be strictly followed. A suggested process is described in IAEA-TECDOC-688. The Irradiation Protocol (Appendix I), proposed by the first petitioner covers (1) pre-irradiation handling and packaging, (2) irradiation processing requirements and conditions, (3) dosimetry and process control, and (4) post irradiation handling and storage.

The first petitioner, a manufacturer and supplier of irradiation equipment, indicated that it would assist Canadian processors in the design of the facility and preparing documentation for its licensing by the Atomic Energy Control Board (now called the Canadian Nuclear Safety Commission).

Packaging

It is important that the poultry be packaged appropriately to withstand normal handling during and after the irradiation treatment until it reaches the consumer. The U. S. regulation requires that the packaging material be permeable to oxygen because it was felt that oxygen would be an additional factor that would inhibit the growth and toxin production by spores of C. botulinum type E under conditions of mild temperature abuse. However, subsequent research has shown that neither the inclusion of oxygen in the head-space gas², nor the use of oxygen permeable film³ are acceptable control measures for the growth of C. Botulinum. Staff microbiologists have advised that the use of oxygen permeable films is considered unnecessary if the maximum absorbed dose does not exceed 3.0 kGy.

(c) Dosimetry

For dosimetry practices, both petitioners cite methodology published by the American Society for Testing Materials (ASTM) (1988; 1993)⁴, Codex Alimentarius Commission

(1992)⁵, the International Consultative Group on Food Irradiation (ICGFI) (1988)⁶ and Chadwick and Osterheert (1986).⁷

(d) Alteration of Chemical, Physical and Microbiological Characteristics

i. Odour:

The literature indicates that, subsequent to irradiation (-1 to 4.4°C), up to an absorbed dose of 5.0 kGy, a slight "irradiation" odour is noted in fresh, raw chicken meat. The odour is sufficient to distinguish the irradiated chicken from controls; the odour appears to last for 2-4 days, but disappears upon cooking (oven roasting 177°C). It has also been shown that the odour is more likely to be noted by experienced judges than by the average consumer.

At doses higher than 5.0 kGy, (7.5kGy -10.0 kGy), an unpleasant flavour with an after-taste develops. The changes are more evident in breast meat than in leg meat. These changes would be minimized with the restriction of the absorbed dose maximum to 3.0 kGy for raw chicken. [See CONSULTATION section).

ii. Appearance/Colour:

Non-irradiated chicken carcasses develop a dull greyish discolouration after 8 days of storage (-1 to 4.4°C). Chicken breasts irradiated at 2.5 kGy develop a very slight pink colouration, noticeable to a trained eye, for up to 18 days. In treatments at 5.0 kGy, the pink colour is more intense. Again, the upper constraint of 3.0 kGy will minimize this phenomenon.

iii. Shelf-life (Raw Chicken):

Based on the organoleptic criteria (flavour and odour), the shelf-life of chicken irradiated at the proposed dose levels, and stored at refrigeration temperatures, seems to be in the range of 14-22 days. According to the petitioners this is an extension of shelf-life by a factor of 2 to 3.

iv. Chemical:

The main chemical change is the formation of small amounts of radiolytic products (RPs), some of which are volatile. The RPs formed as a result of irradiation have received extensive study and evaluation over the past several years . However, it is of value here to review the quality and quantity of RPs formed during the irradiation of chicken at the proposed dose levels.

Key work on radiolytic products, undertaken by Merritt⁸ for the U.S.Army Natick Research Laboratories, was appropriated and published by the USDA in 1984 and examined by staff chemists in 1985. The following discussion, limited to chicken, summarizes the key findings.

Merritt's work, on one hand, represents a "worst case" scenario because (1) the chicken (rolls:82% light/dark meat and 18% skin) contained 0.7% salt and 0.3% sodium triphosphate, (2) the chicken was enzyme-inactivated in a cookhouse by heating to an internal temperature of at least 68°C and not more than 74°C; (3) the dose ranged from 46 to 68 kGy, and (4) the meat products were not heated after irradiation treatment. On the other hand, the products were irradiated in the frozen state which tends to minimize chemical alteration.

The average total amount of radiolytic compounds found in irradiated chicken was 3.6 mg/kg (estimated at 10 kGy). The levels of individual compounds ranged from 0.001-0.366 mg/kg (1-366 ppb). Hydrocarbons accounted for the largest percentage of the total weight of radiolytic products (92.7%). The alkanes predominated and exceeded the total of alkenes and alkynes by a factor of 1.8 and the aromatics by a factor of 48.

Some products of toxicological interest noted in chicken when analysed directly after the various treatments employed were xylene, chloroform and ethane nitrile. Xylene was not found in (enzyme-inactivated) frozen control chicken, but was in thermally-sterilized chicken at 6 ppb and at 2 ppb in Co-60 irradiated chicken. Chloroform was found at roughly the same level in the frozen control (11 ppb), the thermally-sterilized (12 ppb) and the Co-60 irradiated (12 ppb). Ethane nitrile was not found in either the frozen control chicken or the thermally-sterilized, but a trace (<1 ppb) was found in Co-60 irradiated. Investigators suggested that the chloroform found in chicken in connection with this work, and indeed, these other compounds, were adventitious. The level of chloroform and xylene was found to be independent of radiation dose and the concentrations for these compounds either stayed constant or decreased with increasing dose of up to 120 kGy. This lends credence to their adventitious presence.

As part of the first petitioner's submission, a consultant to the petitioner reviewed the work of Merritt, as well as that of Nawar et al.⁹ and Spiegelberg et al.¹⁰ on the radiolytic products of chicken. Using other data published by Merritt and co-workers¹¹ on the yield of radiolytic products versus temperature and the yield versus dose, the consultant was able to re-calculate the Natick data and make estimations of yields in chicken at temperatures of -20°C and 5°C at the more realistic dose of 5 kGy being suggested in these two submissions by the petitioners. The consultant also calculated the Probable Daily Intakes (PDIs) for radiolytic compounds based on an intake of 62.1 g¹² chicken per day and has presented a detailed overview of the significance of the presence of each of the compounds or their calculated intakes in relation to known toxicological indices, where available.

All available evidence suggests that the products formed on irradiation of meat at 0-5°C and in the frozen state are similar. There is no evidence of any significant differences in the identities of the products formed as a result of irradiation at the two temperature ranges. The yields of the products however, are generally lower in the frozen meats. Some hydrocarbons viz. pentene, hexene and heptadecene have shown higher yields at frozen conditions. The yields are also dose related.^{13, 14, 15, 16, 17}

(e) Packaging

With regard to specific packaging materials that may be used on foods offered for sale in Canada, letters of opinion are offered upon request to packaging material manufacturers

upon submission of appropriate technical data, including extraction data. The same voluntary procedure is followed in the case of materials intended to package foods to be irradiated. In all cases, the letters of opinion consider the requirements of Section B.23.001 of the Regulations which states that "No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food."

(f) Nutritional Aspects

Nutrition evaluators reviewed the reports submitted by the petitioners, and also other scientific literature, obtained by an independent literature search, on the effects of irradiation on the content and composition of lipids, proteins and amino acids, and the content of vitamins and minerals in poultry (mainly chicken). The effects of irradiation treatment were evaluated with respect to the contribution of chicken and other poultry products to the intake of specific nutrients. Also, the effects of irradiation were contrasted with effects of other processes for which data were available and discussed with respect to the relationship between irradiation and other types of processing likely to be applied to poultry. A list of studies reviewed by the Nutrition Evaluation Division appears as Appendix II.

The nutrients which poultry contains in significant quantities are riboflavin, niacin, pantothenic acid, pyridoxine, vitamin B12, magnesium, phosphorus, zinc, as well as protein and fat. The only one of them however which was found consistently to be degraded by irradiation treatment within the dose range proposed in this submission was thiamin. The thiamin contribution of a reasonable daily intake of cooked chicken, however, is limited to about 5% of the weighted recommended nutrient intake (WRNI)¹⁸ for thiamin.

There was some indication that riboflavin could be destroyed to some extent but the data are not consistent. Data related to effects of irradiation of poultry on certain other nutrients, in particular some of the B vitamins, were relatively limited. Taking the evidence regarding effects of irradiation on these nutrients as a whole, including studies on the impact of irradiation on nutrients in other food systems, it was concluded that no losses of B vitamins other than thiamin would be expected as a result of the irradiation doses that are the subject of this submission.

Staff nutritionists conclude that, while thiamin loss is significant in proportion to the initial amounts found, the relative importance of that loss, when the contribution of poultry to dietary thiamin intake in Canada is considered, is insignificant. At the same time, since thiamin is partially destroyed by irradiation and there are indications, albeit limited, that the combined effects of cooking and irradiation, both destructive to thiamin on their own, may be worse than the sum of the two, every effort should be made to limit losses of thiamin through use of the lowest possible effective radiation dose, low oxygen environments and low product temperature during irradiation.

If significantly higher irradiation dose levels or higher product temperatures during irradiation (above refrigeration) are proposed at any time in the future, reconsideration of this recommendation may be necessary.

(g) Toxicological Studies

Over the past 30 years several toxicological studies on irradiated poultry have been evaluated by the Health Protection Branch. The studies included long term and short term feeding studies with rats, mice, dogs, hamsters and rabbits; multi-generation and chronic feeding studies on rats; genetic and carcinogenicity studies in mice; and mutagenicity studies. A detailed list of studies and internal reports of evaluation appears as Appendix III.

In 1983, staff toxicologists concluded that irradiation of chicken with doses lower than 10 kGy would lead to safe products and therefore no further toxicological studies were suggested. This conclusion was in response to a proposal to irradiate chicken at a dose ranging from 3.0-7.0 kGy. In memoranda dated June 1993 and October 1993, the Toxicological Evaluation Division concluded that, except for chicken, there was insufficient information to provide a toxicological opinion on irradiated turkey, fowl, pheasant, geese, etc., but if the composition of these other poultry species was shown to be similar to chicken, a need for wide-range toxicological studies on each species could be reduced or eliminated. Additional information on the similarity of composition of carcasses from the different poultry species was subsequently provided by the first petitioner in the form of a review by a researcher at the University of Guelph in which the composition of poultry meat products was compared.

This review of the composition of various poultry species was thorough. Basically, the researcher concluded that, considering the variance found in the composition of chicken products, it is illogical to consider the composition of other poultry species as being different. The composition of amino acids, vitamins and minerals is similar across species and seems to be little affected by genetics, nutrition or on-farm management. The carcasses of waterfowl species contain more fat and less protein compared with carcasses of chickens of the same age and weight. Nonetheless, the range of fat seen in the carcass of chickens is the same magnitude as that seen in other poultry species. The composition of the fat is also similar, but this is dependent upon the birds' diet. Based on these observations, the conclusion was accepted that the chemical composition of carcasses from the various poultry species is similar, or to use a term borrowed from OECD when examining novel foods, "substantially equivalent."

The key summary tables from this researcher's work were reviewed by staff toxicologists. These evaluators concurred with the conclusion that the chemical composition of carcasses from the various poultry species was similar (i.e. "substantially equivalent"). Based on these facts, it was concluded that irradiation of any of these species up to 10 kGy would not result in any significant differences in comparison to those observed and evaluated for chicken. Staff toxicologists see no need for additional toxicological studies in other poultry species.

The consultant to the petitioner also noted that the vast majority of volatile radiolytic products are formed from fat and it has been shown that the volatiles increase linearly in concentration with the fat content. Based on the values given in the researcher's report, they would all be within a factor of 2 with those of chicken, taking into account the large variation in the data for chicken. Such an increase in the yields would not lead to any

change in the conclusions about the safety of the poultry.

C. Proposed Amendment

New items

19

proposed for addition to the Table in Division 26 are as follows:

D. Consultation:

Consultation was undertaken to assess the safety and nutritional quality of chicken and chicken products and the efficacy of the irradiation treatments at the proposed dose levels with the following, as noted above:

• The Toxicological Evaluation Section, Chemical Health Hazard Assessment Division
• Evaluation Division, Bureau of Microbial Hazards
• Nutrition Evaluation Division, Bureau of Nutritional Sciences.

Canadian Food Inspection Agency Consultation

The Food of Animal Origin Division of the Canadian Food Inspection Agency was consulted on the proposal to allow irradiation of poultry meat and indicated that it had no objection and looked forward to further consultation on issues arising from the recommendation, especially labelling issues and the incorporation of irradiation processes into HACCP plans. CFIA also suggested that "the approach taken by the Food and Drug Administration and USDA be compared to any recommendations to minimize any trade issues.

Note: The labelling of irradiated foods is based on the consumer's "right to know," and not on heath and safety considerations, and therefore such matters fall under the jurisdiction of the Canadian Food Inspection Agency. This department could, however, be partially involved if claims involving the destruction of pathogens were made and required verification.

External Support and Testimonials

Two trade organizations representing poultry/egg and turkey interests have supported these submissions and have called for the irradiation of poultry:

The former commented that no labelling should be necessary.

The latter noted the former's labelling position but recognized that it may be demanded by the consumer.

E. Interdisciplinary Impact

The Canadian Food Inspection Agency (CFIA) might have to develop enforcement methodology and will have to ensure that irradiation of poultry is conducted as part of an overall GMP/HACCP program. There will also be issues of "best before" dates for irradiated vs non-irradiated poultry to consider. CFIA will also be faced with labelling issues involving use of the symbol and the label statement "Treated by Irradiation" on poultry and poultry parts packaged on the premises of a retail supermarket/meat market.

Finally labelling issues involving proposed positive, promotional label statements and claims will undoubtedly have to be evaluated for truthfulness by labelling specialists, possibly with input from Health Canada food microbiologists.

Food Directorate
Health Products and Food Branch
Health Canada
October 29, 2002.

Appendix I:

The proposed Poultry Irradiation Protocol

Appendix II:

A list of relevant studies reviewed by the Nutrition Evaluation Division

Appendix III:

A list of toxicological studies reviewed by the Health Protection Branch (1968-1980)

Appendix I

Irradiation Protocol For Poultry

1.0 Preliminary Requirements

1.1 General

It should be understood by the processor that irradiation is aimed at 'further reduction' of the microbial load of the poultry processed according to current protocols, to make it an even safer product. It is not a substitute for any of the steps being taken now (GMP) to maintain low microbial loads on the processed poultry.

1.2 Pre-irradiation handling

Relevant standards of GMP should be followed to ensure that the initial quality of fresh poultry is satisfactory. This includes slaughter of only healthy birds, sanitary dressing and other processing operations; the steps being taken now to keep the microbial load of the processed poultry as low as possible, should continue. The processed poultry should be promptly cooled to below 4 °C (but above freezing) during storage and transport.

Poultry for freezing should first be chilled and the storage time before freezing should be minimized. The temperature of the frozen poultry should be -18°C or lower, during storage and transport. It is important to package poultry prior to freezing, to protect it against freezer burn.

1.3 Packaging

It is important that the poultry be packaged appropriately to withstand normal handling during irradiation, transport, and prior to its use (e.g., during its retail sale). Irradiation results in essentially pathogen-free poultry. However, if the packaging breaks, the poultry can be re-contaminated thus negating the effect of irradiation.

It is necessary that the packaging material used for poultry be approved for this purpose. A list of the packaging materials for which Health and Welfare Canada had issued "Letters of No Objection" is given in the enclosed paper by Chuaqui-Offermans (1991). For further revision of this list, the Health Products and Food Branch should be consulted. The present petition is for irradiation of poultry in the presence of air. It is therefore also important that the packaging material selected is permeable to oxygen.

2.0 Irradiation Requirements and Conditions (Good Manufacturing Practice, GMP & Good Radiation Practice, GRP)

The irradiator for poultry irradiation, and its operation, should meet the International recommendations as given in the Codex General Standard for Irradiated Foods, and in the Recommended International Code of Practice for the Operation of Irradiation Facilities used for the Treatment of Foods. It should also meet the requirements of the Canadian Atomic Energy Control Board, and should be duly licensed by it. (MDS Nordion would assist Canadian processors in the design of the facility, and in preparing documentation for its licensing by the Canadian Atomic Energy Control Board). If a processor uses a service irradiator for irradiation of poultry, the service irradiator should meet the same requirements and should be duly licensed. In addition, safety must be a top priority of the facility operation.

2.1 Control Aspects

All operational variables which affect dose distribution must be monitored and maintained within a range which assures that the delivered range of doses fully complies with regulations. The main variables

include: source specifications, source-target geometry, density of product, exposure interval times, and conveyor speed, as appropriate.

The processor should detail procedures that identify all the steps involved from the time of arrival of the poultry for irradiation to the time of the shipment of the irradiated poultry, and do test runs to ensure that the procedures decided upon are adequate to irradiate the poultry within the specified dose limits, and at the required temperature. Prior to irradiation of any product in routine production, it is necessary to map the absorbed dose throughout the volume of the particular packaging configurations to be used for production. Each particular configuration, specified by product size, density, arrangement, source-product geometry and dwell times or conveyor speed, as appropriate, must be dose mapped. The purpose of this mapping is to ensure that the dose extremes actually delivered in production are within the permitted limits. In essence, dosimetric commissioning constitutes an essential part of the validation of the specific treatment protocol to be used for the product under consideration.

These test runs should be documented in detail and should remain part of a permanent record at the irradiator (and with the processor, if a service irradiator is being used). Whenever there are any significant changes at the irradiator, e.g., changes in the source strength (other than normal decay of Co-60, which is very accurately known) or modification of the poultry handling system within the irradiator target area, or changes in the poultry package sizes, appropriate portions of the tests should be redone and documented in detail. The procedures established at the irradiator for the irradiation of poultry should be consistent with the relevant GMP or GRP requirements. Useful guidance for such tests is provided in ASTM E-1204-93 under sections 8 and 9.

2.2 Training

Operating personnel at a commercial food irradiation facility must be adequately trained. In Canada, MDS Nordion operates a pilot scale irradiator at Laval, which would be offered for training of the personnel to operate commercial food irradiation facilities.

2.3 Identification Aspects

Treated product must be kept physically separate from untreated product, in such a manner that there is no possibility of mixing irradiated and unirradiated product containers. Adequate records of product treatment must be kept to permit identification, and traceability if required, of specific treatment lots, and to ascertain all of the pertinent details of their treatment. For example, the irradiated packages/boxes may be labelled/stamped irradiated, as they complete their irradiation period inside the irradiator target room. Use could also be made of the labels that change colour on irradiation (see ASTM E 1593-96, enclosed). The irradiated product should also be adequately labelled as per the Canadian regulation B.26.001 of the Food and Drugs Act, and procedures should be established so that the product cannot be irradiated more than once.

3.0 Dosimetry and Process Control

3.1 General

Delivered dose is the most important treatment parameter in the irradiation process. Dosimetry is the means of ensuring that the correct dose for the intended purpose is delivered to the product. Dosimetry procedures are essential and must be carried out according to approved specifications, and should be in accordance with appropriate accepted international standards. References for dosimetry have been given in the original petition submission (of 1993 May 5). The processor should also consult the updated versions of the dosimetry procedures, in particular ASTM E 1204-93, ASTM E 1261-88, ASTM E 1431-91, ASTM E 1539-93 and ASTM E 1707-95 (copies enclosed).

3.2 Effective and limiting dose

Effective dose is the minimum dose, delivered to a product, required to effect the desired technical benefit (1.5 kGy for poultry). The limiting dose is the maximum dose that can be tolerated by the product with good quality retention, or else as specified by regulation (3 kGy, for poultry).

3.3 Routine Dosimetry

Routine dosimetry should be performed during industrial irradiations, to ensure that the irradiation process is within the desired /regulated specifications. Dosimeters should be placed at critical reference points within the production lots, in such a way that the dose at the chosen reference location(s) has a known, well defined relationship to the known maximum and minimum doses for the particular configuration in effect. The measured dose at the chosen reference location should be used for process control. Routine dosimetry has been discussed in section 10 of ASTM E 1204-93. A complete record of all dosimetry measurements, including calibrations of the dosimeters, must be maintained.

4.0 Post-Irradiation Handling and Storage 4.1 Freshly chilled poultry and poultry parts

Poultry temperature should continuously be kept below 4°C, but above freezing, all along the distribution chain, until it reaches the consumer. Care should be exercised not to exceed the period of shelf-life extension which has been established for the product. Package integrity must be maintained to prevent the possibility of re-contamination.

4.2 Freshly frozen poultry and poultry parts

Temperature of frozen poultry should be continuously maintained at -18°C or lower. No changes from the usual handling practices for frozen product are required.

4.3 End Product Specifications

Freshly chilled poultry irradiated for pathogen control and product shelf-life extension should be described as 'radiation pasteurized'. This should be taken to mean that the microbiological burden of that product has been significantly reduced, relative to unirradiated but otherwise comparable product, but that the product is not sterile. Thus such product still requires refrigeration and adherence to other handling guidelines. Radiation pasteurized poultry should be essentially free of pathogens.

Frozen poultry irradiated for pathogen control should be described as 'radiation pasteurized', with all the implications of that term.

Appendix II

Poultry Irradiation: Relevant studies reviewed by the Bureau of Nutritional Sciences.

1. American Council on Science and Health, Irradiated Foods, 2^nd Edition, July 1985.
2. Basson, R.A., Advances in Radiation Chemistry of Food and Food Components - An Overview, in Recent Advances in Food Irradiation, Elias, P.S. and Cohen, A.J. (Eds), Elsevier Biomedical, 1983.
3. Council for Agricultural Science and Technology, Report #109, Ionizing Energy in Food Processing and Pest Control, I. Wholesomeness of Food Treated with Ionizing Energy, 1986.
4. Codex Alimentarius Commission, (Vol. 4), "General Principles for the Addition of Essential Nutrients to Foods", CAC/GL 09-1987 (1994).
5. Diehl, J.F., Effects of combination processes on the nutritive value of food, in Combination Processes in Food Irradiation, IAEA Symposium Proceedings, IAEA, Vienna, 1981, p. 349-366.
6. Diehl, J.F., International Status of Food Irradiation, Food Technology in Australia, 36(8): 356, p. 358-366, 1984.
7. Diehl, J.F., Safety of Irradiated Foods, 2nd ed., Marcel Dekker, Inc., p. 273, 1995.
8. de Groot, A.P., van der Mijll Dekker, Slump, P., Vos, H.J., and Willems, J.J.L., Composition and Nutritive Value of Radiation-Pasteurized Chicken, Report # R3787, Central Institute for Nutrition and Food Research, The Netherlands, 1972.
9. Délincée, H., Recent advances in radiation chemistry of proteins, in Recent Advances in Food Irradiation, ed. P.S. Elias and A.J. Cohen, Elsevier Biomedical Press, 1983.
10. FAO/IAEA/WHO (Food and Agriculture Organisation/International Atomic Energy Agency/World Health Organisation) Joint Expert Committee, Wholesomeness of Irradiated Foods, WHO Technical Report Series #659, 1981.
11. Fox, J.B., jr., Lakritz, L., Thayer, D.W., Effect of reductant level in skeletal muscle and liver on the rate of loss of thiamin due to gamma-radiation, Int. J. Radiat. Biol., 64(3), p. 305-309, 1993.
12. Fox, J.B., Jr., Thayer, D.W., Jenkins, R.K., Phillips, J.G., Ackerman, S.A., Beecher, E.R., Holden, J.M., Morrows, F.D., and Quirbach, D.M., Effect of Gamma Irradiation on the B Vitamins of Pork Chops and Chicken Breasts, Int. J. Radiat. Biol., 55(4), p. 689-703, 1989.
13. Fox, J.B., Jr., L. Lakritz, J. Hampson, R. Richardson, K. Ward, and D.W. Thayer, Gamma irradiation effects on thiamin and riboflavin in beef, lamb, pork, and turkey, J. Food Science, 60 (3):596-598, 603, 1995.
14. Gallien, Cl. L., Paqiun, J., Ferradini, C. and Sadat, T., Electron Beam Processing in Food Industry - Technology and Costs, Radiat. Phys. Chem., 25(1-3), p.81-96, 1985.
15. Gruiz, K. and Kiss, I., Effect of Ionizing Radiation on the Lipids in Frozen Poultry, I. Fatty Acids and Hydrocarbons, Acta Alimentaria, 16(2), p.111-127, 1987.
16. Hampson, J.W., Fox, J.B., Lakrtiz, L., and Thayer, D.W., Effect of Low Dose Gamma Radiation on Lipids in Five Different Meats, Meat Science, 42 (3), p.271-276, 1996.
17. Hanis, T., Jelen, P., Klir, P., Mnukova, J., Perez, B. and Pesek, M., Poultry Meat Irradiation - Effect of Temperature on Chemical Changes and Inactivation of Microorganisms, J. Food Protection, 52(1), p.26-29, 1989.
18. Health Canada, Canadian Nutrient File, 1997.
19. Ibrahim, S., El-Said, F., and Ahmed, A.K., Gamma irradiation of fats and fatty oils. Part II. Effect of gamma radiation on the fatty peroxy compounds and on the stability of fats, Bull. Fac. Pharm., Cairo Univ. 7, p. 11-25, 1968.
20. Josephson, E.S., Thomas, N.H. and Calhoun, W.K., Nutritional aspects of food irradiation: An overview, J. Food Proc. Pres. 2, p.299-313, 1978.
21. Kanatt, S.R., Paul, P., D'Souza, S.F., and Thomas, P., Effect of Gamma Irradiation on the Lipid Peroxidation in Chicken, Lamb and Buffalo Meat During Chilled Storage, J. Food Safety, 17, p.283-294, 1997.
22. Katta, S.R., Rao, D.R., Sunki, G.R., and Chawan, C.B., Effect of Gamma Irradiation of Whole Chicken Carcasses on Bacterial Loads and Fatty Acids, J. Food Sci., 56(2), p.371-372, 1991.
23. Kraybill, H.F., Effect of processing on nutritive value of food: Irradiation, in Handbook of Nutritive Value of Processed Food, Vol. I, M. Rechcigl Jr., (ed.), CRC Press, Boca Raton, Fl., 1982, p. 181-208.
24. Lorenz, Klaus, Irradiation of cereal grains and cereal grain products, Critical Reviews in Food Science and Nutrition,, Vol. 6 (4), p. 317-382, 1975.
25. Mast, M.G. and Clouser, C.S., The Effect of Further Processing on the Nutritive Value of Poultry Products, World Poultry Science Association, 7th European Symposium on Meat Quality, p.219-234, 1985.
26. Maxwell, R.J., and Rady, A.H., Effect of Gamma Irradiation at Various Temperatures on Air and Vacuum Packed Chicken Tissues II. Fatty Acid Profiles of Neutral and Polar Lipids Separated from Muscle and Skin Irradiated at 2-5°C, Radiat. Phys. Chem., 34 (5), p.791-796, 1989.
27. Meister, K.A., Irradiated Foods, American Council on Science and Health, 1985.
28. Mills, S., Issues in Food Irradiation, Discussion Paper, Science Council of Canada, 1987.
29. Murray, T.K., Nutritional aspects of food irradiation, in Recent Advances in Food Irradiation, Elias, P.J. and A.J. Cohen, eds., Elsevier Biomedical Press, Amsterdam, p. 203-216, 1983.
30. Nawar, W.W., Radiolysis of Non-Aqueous Components of Foods, in Preservation of Food by Ionizing Radiation, Vol. II, Josephson, E.S. and Peterson, M.S. (eds), CRC Press, 1983.
31. Nova Scotia Heart Health Program, Report of the Nova Scotia Nutrition Survey, 1993.
32. Rady, A.H., Maxwell, R.J. Wierbecki, E., and Phillips, J.G., Effect of Gamma Irradiation at Various Temperatures and Packaging Conditions on Chicken Tissues I. Fatty Acid Profiles of Neutral and Polar Lipids Separated from Muscle Irradiated at -20°C, Radiat. Phys. Chem., 31 (1-3), p.195-202, 1988.
33. Sadat, T. and Vassenaix, M., Use of a Linear Accelerator for Decontamination of Deboned Poultry Meat, Radiat. Phys. Chem., 36(5), p.661-665, 1990.
34. Santé Québec, Rapport de l'Enquête québécoise sur la nutrition, 1990, Gouvernement du Québec, 1995.
35. Shamsuzzaman, K., Chuaqui-Offermanns, N., Lucht, L., McDougall, T. and Borsa, J., Microbiological and Other Characteristics of Chicken Breast Meat Following Electron-Beam and Sous-Vide Treatments, J. Food Protection, 55(7), p. 528-533, 1992.
36. Skala, J.H., McGown, E.L. and Waring, P.P., Wholesomeness of Irradiated Foods, J. Food Protection, p.150-160, 1987.
37. Thomas, M.H. and Josephson, E.S., Radiation preservation of foods and its effects on nutrients, Sci. Teacher 37, p. 59-63, 1970.
38. U.K. Advisory Committee on Irradiated and Novel Foods, Report on the safety and wholesomeness of irradiated foods, Department of Health and Social Security, Ministry of Agriculture, Fisheries and Food, U.K., 1984.
39. U.S. Federal Register, 55(85), Rules and Regulations, p. 18538-18544, 1990.
40. Urbain, W.M., Radiation Chemistry of Proteins, Chapter 4 in Radiation Chemistry of Major Food Components, ed. P.S. Elias and A.J. Cohen, Elsevier, New York, 1977.
41. Wood, B.F., A research project to demonstrate the efficacy of controlling microorganisms in poultry and poultry products by gamma irradiation - part of the Processing, Distribution, and Retailing (PDR) program. Food Research Institute, Research Branch, Agriculture Canada, Ottawa, 1986.
42. World Health Organization, Safety and Nutritional Adequacy of Irradiated Food, p.139, 1994..

Appendix III

Poultry Irradiation: List of Toxicological Studies reviewed by Health Protection Branch (1968-1980)

Evaluated August 14,1968

1. 2-Year dog-feeding study on radiation-sterilized chicken stew [Clive McCay, Cornell University]
2. 2-Year rat-feeding study on radiation-sterilized chicken stew [A.W. Phillips, H.R. Newcomb and D. Shanklin]
3. Pathological evaluation of study reported above [Ross, Barner and Hood (AFIP)]
4. 2-Year Dog Feeding Study on Irradiated Chicken [F.R. Blood]
5. 2-Year rat-feeding study on irradiated chicken [L.R. Richardson]
6. 2-Year mouse-feeding carcinogenicity test on irradiated chicken stew [Calandra and Kay]
7. Mouse-feeding experiment on irradiated chicken.[Monsen]

Evaluated March 7, 1973

1. Short-term human feeding studies of foods sterilized by gamma-radiation and stored at room temperature [U.S. Army Medical Nutrition Laboratory, Report No. 22, lst July 1958; Vol. 5, Ref. No. 1]
2. Short-term rat feeding trial on low-dose irradiated chicken [C.M. McLeod and F.A. Farmer, Canadian Inst. Fd. Tech. J., 1: 104 (1968)]
3. Long-term feeding studies on irradiated chicken stew and irradiated cabbage [A.W. Phillips, H.R. Newcomb and D.R. Shanklin, Toxicol. and Appl. Pharmacol., 5: 273 (1963)]
4. A Long-term feeding study of irradiated foods using rats as experimental animals [L.R. Richardson,S.J. Ritchey and R.H. Rigdon, Fed. Proc., 19: 1023 (1960)]
5. Multi-generation study in rats with radiation-pasteurized chicken [A. Knecht van Eekelen, H.C. van den Meuler, H.P. Till and A.P. de Groot, Report #3622 of the Central Institute of Nutrition and Food Research, Zeist, The Netherlands]
6. Long-term dog-feeding experiment with irradiated chicken, beef and jam [F.R. Blood et al., Final Report from the Departments of Biochemistry and Pathology, School of Medicine, Vanderbilt University, Nashville, Tennesee]. (Later published as Blood, F.R., Wright, M.S., Darby, W.J., and Elliott, G.A. 1966. Feeding of irradiated chicken, beef and pineapple jam to dogs. Tox. Appl. Pharm., 8: 241-246.)
7. Effect of ionized radiation on the nutritive value of food (chicken stew) as determined by growth, reproduction and lactation studies with dogs [C.M. McCay and G.L. Rumsay, Final Report from the Department of Animal Husbandry, Cornell University, Ithaca, New York, 1960]
8. The carcinogenic properties of irradiated foods [J.C. Calandra and J.H. Kay, Final Report from Industrial Biotest Laboratories, Northbrook, Illinois, 1961]
9. A study of the carcinogenicity of irradiated chicken in the mouse [B.G. Proctor, G. Rona and C.I. Chappel, Bio-Research Laboratories, Project No. 245, 1971]
10. One year feeding study with low-dose irradiated chicken [International Project in the Field of Food Irradiation, Karlsruhe, Germany; Study undertaken at the Central Institute for Nutrition and Food Research, Zeist, The Netherlands]
11. Chronic (two-year) feeding study in rats with irradiation-pasteurized chicken [same sponsor as #10 above]
12. Multi-generation study in rats with radiation-pasteurized chicken [same sponsor as #10 above]

In addition, several other studies to assess wholesomeness and nutritive value were examined.

Evaluated August 23,1979

1. 4-Week feeding study of irradiated chicken in rats [MacLeod and Farmer]

2. 1-Year feeding study of irradiated chicken in dogs [Til et al., 1971]

3. 80-Week feeding study of irradiated chicken in mice [Proctor et al., 1971]

4. 2-Year feeding study of irradiated chicken to rats [de Knecht van Eekelen et al., 1972]

5. 3-Generation reproduction study in rats [de Knecht van Eekelen et al., 1971]

In addition, some studies on wholesomeness and nutritive value were also assessed.

Evaluated January 29, 1985

1. Chronic toxicity, oncogenicity study using CD-1 mice to evaluate frozen, thermally sterilized, cobalt 60 irradiated, and 10 MeV electron irradiated chicken meat. (Report No. PB84-187012, June 1983.

Reports Investigating Potential Toxicity of Chicken (Data not Published in the Scientific Literature)

1. Blood, F.R. et al., 1961. Long-term dog-feeding experiment with irradiated chicken, beef and jam. Biochemistry and Pathology, Vanderbilt University School of Medicine, Nashville, Tennesee. Final Contract Report. U.S. Army Contract No. DA-49-007-MD 779.

2. Composition and nutritive value of radiation pasteurized chicken. Report No. R3787, Central Institute for Nutrition and Food Research, The Netherlands.

3. McCay, C.M. and G.L. Rumsey, 1960. Effect of ionized radiation on the nutritive value of food (chicken stew) as determined by growth, reproduction and lactation studies with dogs. Department of the Army, Office of the Surgeon General. Contract No. AA-49-007-MD600.

4. Reber, E.F., 1968. Biological evaluation of protein quality of radiation pasteurized chicken. AEC Contract No. AT(30-1)3461. School of Home Economics, University of Massachusetts.

5. Richardson, L.R., 1960. A long-term feeding study of irradiated chicken and green beans using the rat as the experimental animal. Texas Agricultural Experimental Station, Texas. Contract No. DA-49-007-MD582.

Studies Used in the Assessment of Irradiated Foods by Health Protection Branch

1. Blood, F.R., Wright, M.S., Darby, W.J.,. Elliott, G.A. 1966. Feeding of irradiated chicken, beef and pineapple jam to dogs. Tox. Appl. Pharm., 8: 241-246.
2. Chapple, F.E. and Schedt, A. 1980. Reproductive performance of dogs fed radappertized chicken for three-years or more. Proceedings of the 26th European Meeting of Meat Research Workers. pp. 183-185, August 31-September 5, 1980.
3. Chronic toxicity, oncogenicity and multigeneration reproduction study using CD-1 mice to evaluate frozen, thermally-sterilized, Cobalt-60 irradiated, and 10 MeV-electron irradiated chicken meat (Final Report, PB84-187012, ERR-ARS Document Nos. 41-54, 10; 328 pages). Available from NTIS.
4. De Groot, A.P. 1975. To assess the wholesomeness of feeding irradiated chicken to albino rats. Fd. Irr. Inf. (5) FAO/IAEA Suppl. p.83.
5. De Groot, A.P. 1975. To assess the toxicological safety of feeding irradiated chicken to dogs. Fd. Irr. Inf. (5) FAO/IAEA Suppl. p.81.
6. De Knecht, van Eekelen, A., Feron, V.J., Til, H.P., and de Groot, A.P. 1972. Chronic (two-year) feeding study in rats with radiationpasteurized chicken. Central Institute for Nutrition and Food Research, The Netherlands, Technical Report. No. R3773.
7. De Knecht, van Eekelen, A., van der Mueller, H.C., Til, H.P., and de Groot, A.P. 1971. Multi-generation study in rats with radiation-pasteurized chicken. Central Institute for Nutrition and Food Research, The Netherlands, Technical Report No. R3622.
8. Genetic studies: Dominant lethal study, sex linked recessive lethal, Ames mutagenicity, and heritable translocation test of thermal processed, frozen, electron-irradiated, and gamma-irradiated chicken (Final Report PB84-187053, ERRC-ARS Document Nos. 68, 70, 72 and 74; 406 pages). Available from NTIS.
9. Hamster, mouse, rabbit and rat teratology studies of irradiation-sterilized chicken products (Final Report PB 844-187-46, ERRC-ARS Document Nos. 65, 66,.67, and 69; 835 pages). Available from NTIS.
10. McCay, C.M. and Rumsey, G.L. 1960. Effect of ionizing radiation on the nutritive value of food (chicken stew) as determined by growth reproduction and lactation studies with dogs. (Final Contract Report, Army Contract No. DA-49-007-MD-600, 1960)
11. McGown, E.L., Lewis, C.M., and Waring, P.P. 1979. Investigation of possible anti-thiamine properties in irradiation-sterilized chicken. Final Contract Report, Army Contract No. D6-47.
12. Phillips, A.W., Newcomb, R., Shanklin, D. 1961. Long-term rat feeding studies: Irradiated chicken stew and cabbage. U.S. Army Contract No. DA-49-007-MD-783.
13. Phillips, B.J., Kranz, E., Elias, P.S. and Münzner, R. 1980. An investigation of the genetic toxicology of irradiated foodstuffs using short-term test systems. 1. Digestion in vitro and the testing of digests in the Salmonella typhimurium reverse mutation test. Fd. Cosmet. Toxicol. 18: 371-375.
14. Phillips, B.J., Kranz, E. and Elias, P.S. 1980. An investigation of the genetic toxicology of irradiated foodstuffs using short-term test systems. II. Sister chromatid exchange and mutation assays in cultured Chinese hamster ovary cells. Fd. Cosmet. Toxicol. 18: 471-475.
15. Proctor, B.G. 1971. Study of the carcinogenicity of irradiated chicken in the mouse. Bio-Research Laboratories, Project No. 245, Technical Report to the AEC, Canada.
16. Proctor, B.G. 1974. To determine the presence of carcinogenic substances in irradiated chicken by oral administration of the test food to mice throughout their entire lifespan. Fd. Irr. Inf. (3) IAEA, Suppl. p.18.
17. Renner, H.W. 1980. In vivo mutagenicity testing of irradiated chicken, fish and dates. Final Contract Report 78/1, WHO Irradiated Dates Monograph.
18. Richardson, L.R. 1960. A long-term feeding study of irradiated chicken and green beans using the rat as the experimental animal. Contract Report - Army No. DA-49-007-MD-582.
19. Ronning, D.C. 1980. Animal feeding studies protocol for irradiated sterilized chicken. Final Report: dominant lethal study. Contract Final Report, Army Contract No. DAMD 17-76-C-6047.
20. Til, H.P., Willems, M.I., Huismans, J.W., and de Groot, A.P. 1971. One-year feeding study with low-dose irradiated chicken in beagle dogs. Central Institute for Nutrition and Food Research, The Netherlands, Technical Report No. R3443, IFIP.

¹ The specified purpose of the submission is "to provide the legal authority to establish a commercial facility, which may be licensed to provide irradiation of domestically sold poultry........". Although establishing an irradiation facility does not come under the authority of the Food and Drugs Act and Regulations, the Table of positive listings in Division 26 of the Regulations would have to be amended if the food is to be sold in Canada. However, no amendment is required for irradiating poultry and meat in Canada for export purposes.

² Lambert, A. D. Smith, J. P. and Dodds, K. L. Effect of initial 0₂ and CO₂ and low dose irradiation of toxin production by Clostridium boulinum in MAP fresh pork, 1991, J of Food Production 54: 939-944.

³ Communication, Bureau of Microbial Hazards, September, 1996.

⁴ Standard Practice for application of Dosimetry in the Characterization and operation of a Gamma Irradiation Facility for Food Processing (Designation E 1204-87) in Annual Book of ASTM Standards, Vol. 12.02, 1987; Standard Guide for selection and application of Dosimetry Systems for Radiation Processing of Food (Designation E 1261-88) in Annual Book of ASTM Standards, Vol. 12.0, 1988; Standard Practice for Dosimetry and Bremsstralung Irradiation Facilities for Food Processing (Designation E 1431-91) in Annual Book of ASTM Standards, Vol. 12.02, 1991; and Standard Guide for the Irradiation of Fresh and Frozen Meats and Poultry (to control pathogens) (Designation F 1356-91) in Annual Book of ASTM Standards, Vol. 12.02, 1993.

⁵ Codex General Standard for Irradiated Foods, CODEX STAN 106-1983, in Codex Alimentarius, Vol. 1, Section 8 (Rome: FAO/WHO, 1992, pp. 311-315. Recommended international code of practice for the operation of radiation facilities used in the treatment of foods, CAC/RCP 19-1979 (Rev. 1) in Codex Alimentarius, Vol. 1, Section 8.1 (Rome: FAO/WHO 1992 pp. 317-323.

⁶ International Consultative Group on Food Irradiation. 1988. Provisional guidelines for the irradiation of fresh and frozen Red Meats and Poultry.

⁷ Chadwick, K. H. and Oosterheert, W. F. 1986. Dosimetry concepts and measurement in food irradiation processing Int. J. Rad. Appl. Instr.(Part A), 37(1), 47-52.

⁸ Merritt, C. Jr., 1984 Radiolysis compounds in chicken and bacon. Final Report. September 18, 1981 - September 20, 1982. EERC/ARS-83. NTIS Order No. PB84-187095.

⁹ Nawar,W.W., Z.R.Zhu and Yoo, Y.J. 1990, Radiolytic products of lipids as markers for the detection of irradiated meats. In Food Irradiation and the Chemist Eds., D.E.Johnston and M.H. Stevenson (Cambridge, U.K : Royal Society of Chemistry Special Publication Vol 86: 13-24.

¹⁰ Spiegelberg, A., Schulzki, G., Helle, N, Bogl, K.W., and Schreiber, G.A. 1984. Methods of routine control of irradiated food: optimization of a method for the detection of radiation- induced hydrocarbons and its application to various foods, 43: 433-444.

¹¹ Merritt, C. Jr., Angelini, P. and Graham, R.A. 1978. Effect of radiation parameters on the formation of radiolysis products in meat and meat substances. J. Agric. Fd. Chem.,26(1): 29-35.

¹² Derived from a consumption of 22.66 kg/person/year (Statistics Canada, 1993 Publication # 32-229).

¹³ Merritt. C, Jr.,Angelini, P. and Graham , R. A. 1978. J. Agri. Food Chem.,26, 29.

¹⁴ Merritt, C., Jr. 1984. Radiolysis Compounds in Bacon and Chicken; USDA Report PB 84-187095.

¹⁵ Nawar, W, W, and Balboni, J. J. 1970. J. Assoc.Analyt. Chem., 53, 726.

¹⁶ Nawar, W. W. 1986. Food Reviews International, 21, 45.

¹⁷ Spiegelberg, A., Schulzki, G., Helle, N., Bogl, K. W. and Schreiber, G. A. 1994. Radiat. Phys. Chem., 43, 433.

¹⁸ The Weighted Recommended Nutrient Intakes are listed in the Food and Drug Regulations, in Table II of Part D, Division 1 (vitamins) and Table II of Part D, Division 2 (minerals)

¹⁹ Item 5 is reserved for mangoes