The positions range from expanding on the labeling that is currently required for irradiated food, to eliminating labeling requirements altogether.
Food irradiation for mushrooms: A review | SpringerLink
Because of the diverse positions that fuel controversy, FDA continues to solicit comment, striving to identify a consensus position on labeling that is legally supportable. At the heart of the irradiation labeling controversy is a legal question: is the fact that food has been irradiated a "material fact" that must be disclosed under Sections a and n of the Federal Food, Drug, and Cosmetic Act.
Section a of the act deems food misbranded if its labeling is false or misleading in any particular. Section n of the act identifies the factors FDA will consider when determining whether labeling is misleading; one factor is the extent to which the labeling fails to reveal material facts. According to FDA, in the case of irradiation, "the standard for misbranding under sections a and n of the Act is whether the changes brought about by the safe use of irradiation are material facts in light of representations made to consumers, including the failure to reveal material facts, about such foods" 51 Fed.
FDA has stated previously that because "[i]rradiation may not change the food visually Because irradiation may cause organoleptic changes or changes in storage characteristics, FDA's position has been that irradiated finished foods should bear labeling to notify the customer that the food has been irradiated 53 Fed. However, for multi-ingredient foods that contain ingredients that have been irradiated but that have not been irradiated in finished form, FDA has not required irradiation labeling because foods with multiple ingredients obviously have been processed 51 Fed.
In this case, labeling of the finished food is not required because the consumer is already on notice that processing has occurred. FDA currently requires that the "label and labeling of retail packages of foods irradiated in conformance with [the regulations] The regulation also requires that the radura logo be in a prominent and conspicuous place on the label in conjunction with the radiation disclosure statement Id.
FDA's position on irradiation labeling requirements has come under scrutiny recently as a result of Congressional interest in the labeling of irradiated foods. One provision added Section C to the Federal Food, Drug, and Cosmetic Act, which states that Sections n , a , and may not be construed to require a radiation disclosure statement that is more prominent than the declaration of ingredients on the food label. Specifically, the report directs FDA to solicit comment "on whether the regulations should be amended to revise the prescribed nomenclature for the labeling of irradiated foods and on whether such labeling requirements should expire at a specified date in the future" H.
The report also states that the irradiation disclosure statement should be "of a type and character such that it would not be perceived to be a warning or give rise to inappropriate consumer anxiety" Id. In addition, the report called for final regulations to be issued not more than 12 months after the enactment of FDAMA Id. These provisions of FDAMA and the conference committee report prompted FDA to solicit comment on irradiation labeling in its advance notice of proposed rulemaking 64 Fed.
FDA did not issue final regulations on irradiation labeling within 12 months of FDAMA's enactment as called for by the conference committee report. However, in its Program Priority List for fiscal year which ends September 30, , FDA's Center for Food Safety and Applied Nutrition projected progress on the development of a proposed rule on irradiation labeling in this fiscal year, with completion of the proposed rule expected for fiscal year With recent Congressional interest in irradiation and the agency's activities designed to develop regulations, irradiation labeling has, once again, become one of the more controversial areas in food law.
In a January report to Congress, then-Commissioner Jane Henney stated that comments submitted in response to the Federal Register notice on irradiation labeling failed to produce a consensus position. This is not surprising, given the scope of the controversy surrounding irradiation labeling. Irradiation labeling is controversial, in part, because a number of groups hold strong opinions on the type of labeling that is appropriate for irradiated foods. Reaching consensus among these groups is made even more difficult because the positions taken by these groups are so diverse that they cover the entire spectrum—labeling proponents want to enhance the current labeling requirements while opponents are interested in eliminating labeling requirements entirely.
To provide examples of the wide range of opinions on labeling, several of these positions are described below. The groups interested in expanding the current requirements include those who disagree with the agency's scientific conclusions that irradiated foods are safe; they consider labeling necessary to warn consumers of the alleged danger.
Several of the suggestions from these proponents include requiring permanent labeling with no expiration date for the labeling requirement, retaining the mandatory use of the radura logo, and requiring labels for irradiated foods to state that irradiation causes vitamin loss. This group of labeling proponents also would like FDA to require labeling for multi-ingredient foods that contain ingredients that have been irradiated, even where the food has not been irradiated in finished form.
Another group of labeling proponents views the Federal Food, Drug, and Cosmetic Act as a consumer-right-to-know act; as the agency with the authority to implement the act, this group maintains, FDA should require labeling of irradiated foods to inform consumers. Labeling proponents have also requested that the Federal Trade Commission take action on labeling of irradiated foods where, the proponents allege, consumers are not adequately informed that the foods have been irradiated.
The groups that agree with FDA that irradiated foods are safe, seek labeling that reflects that irradiated food has been processed, but does so without alarming consumers. Over the years, FDA and industry have proposed alternative language to describe the process of irradiation and develop labeling that is not misleading.
The size and shape of containers that may be used for irradiation treatment are determined, in part, by the operating characteristics of the irradiation facility.
These characteristics include the product transport systems and the irradiation source, as they affect the dose distribution within the container. The safety of materials used for the packaging of foods is controlled under Division 23 of Part B of the Food and Drug Regulations. Packaging materials used for foods subjected to irradiation treatment should be assessed in advance for suitability.
When the packaging material used for an irradiated food is not listed for this purpose within the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemicals published by the Canadian Food Inspection Agency, 4 the processor should seek an advisory opinion on the acceptability of the material from Health Canada 5 prior to using the material. Facilities which carry out the irradiation of food products must meet relevant standards for environmental and occupational safety and food hygiene conditions, including:.
In order to achieve inventory control, there should be provision in both the design and operation of the establishment to keep irradiated and non-irradiated food products separate. This segregation can be accomplished by controlled single-direction movement of the food products through the plant and by separated storage areas for irradiated and non-irradiated food products.
- Food irradiation - Wikipedia.
- U.S. Food and Drug Administration.
- Network Computing and Information Security: Second International Conference, NCIS 2012, Shanghai, China, December 7-9, 2012. Proceedings.
Just as retorts deliver an absorbed thermal energy range to batches of canned foods, industrial irradiators deliver an absorbed ionizing energy dose range to irradiated products. Radiation facilities should be designed to provide an absorbed dose in the food product within minimum and maximum limits in accordance with process specifications and government regulatory requirements. For economic and technical reasons e. In general, as described in the Food and Drug Regulations , the following sources of ionizing radiation may be used in food irradiation:. Constraints on the sources that may be used and energy levels that may be employed may be established in the Table to Division 26 of the Food and Drug Regulations for specific food irradiation applications.
Food processing establishments are constructed and operated in accordance with legislative and regulatory requirements in order to ensure the safety of processed foods for consumption, occupational safety of the plant personnel and protection of the environment.
Food Irradiation: A Public Health Opportunity
A food irradiation facility is also subject to these requirements and should be designed, constructed and operated in compliance with relevant legislation and regulations. These include the licensing, certification or registration requirements under the Nuclear Safety and Control Act administered by the Canadian Nuclear Safety Commission and the registration requirements for establishments regulated by the Canadian Food Inspection Agency under the Fish Inspection Act, Meat Inspection Act , etc.
The staff at an irradiation facility is subject to relevant sections of the Codex General Principles of Food Hygiene for personal hygiene recommendations and also to the Codex General Standard for Irradiated Foods for recommendations regarding the need for an adequate, trained and competent personnel to control the radiation process.
- Irradiation Services at Eurofins.
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- Food Irradiation | Center for Consumer Research;
See Section 9, Staff Competency. The manager of a food irradiation facility should maintain records which document the training received by staff.
For example, procedures for measuring the dose and monitoring of the physical parameters of the process are essential for process control. The need for adequate record keeping, including records of quantitative dosimetry, is also emphasized in the Codex General Standard. As for other physical methods of food processing, records are essential means for the regulatory control of processing by ionizing radiation.
Evidence for correct processing, including adherence to any legal or technological dose limits, depends on the maintenance of full and accurate records by the irradiation facility. The facility's records link all the information from several sources to the irradiated food products. Such records are mandatory under the requirements of section B.
These records must be kept for the 2-year period required by the Regulations. Only foods listed in the Table to Division 26 of the Food and Drug Regulations may be irradiated subject to any constraints in that table opposite the entry for that food regarding permitted sources, dose, conditions, and purpose of irradiation. The effectiveness of the irradiation process depends on proper application of the dose and on dose measurement.
Dose distribution measurements should be carried out to characterize the process for each food product; and thereafter dosimeters should be used routinely to monitor correct execution of the process in accordance with internationally accepted procedures. For certain public health or quarantine applications, such as to control pathogens in poultry or for quarantine treatments to control insect infestation in imported fruits, there may be specific requirements to regulate the minimum absorbed dose in order to ensure that the desired technological effect is achieved.
Plant design and administrative procedures must ensure that it is impossible to mix irradiated and non-irradiated food products. Incoming products should be logged and given a code number to identify the packages at each step in its path through the irradiation plant. All relevant parameters such as date, time, source strength, minimum and maximum dose, temperature, etc. It is not possible to distinguish irradiated from non-irradiated product by visual inspection.
Therefore, it is essential that appropriate means, such as physical barriers, be employed for keeping irradiated and non-irradiated product separate. Affixing colour change indicator labels on each package, where applicable, provides another means of distinguishing irradiated and nonirradiated product. The irradiation of food is justified only when it fulfils a technological need or benefit to consumers or where it serves a food hygiene purpose and only those foods listed in the Table to Division 26 may be irradiated, subject to any constraints specified therein.
The process cannot be used to substitute for good manufacturing practices in the production and handling of food. Only top quality foods should be chosen for irradiation treatment. It is important that all steps in the determination of process procedures are documented to: a ensure that the application of the process complies with relevant regulatory requirements; b establish a clear statement for the technological objectives of the process; c estimate the dose range to be applied to achieve the technological objective based on appropriate knowledge of the food product; d demonstrate that irradiation of test samples has been carried out to confirm the estimated dose range under practical production conditions; e ensure that it is possible to meet the technological requirements, e.
Successful irradiation practice depends on the ability of the processor to measure the absorbed dose delivered to each point in the food product and in the production lot, and to control the radiation process once production begins. Various techniques for dosimetry pertinent to radionuclide and machine sources are available in an international publication 7.
The calibration of the dosimetry system used in irradiation treatment should be traceable i. In order to implement these irradiation practices, facilities should be adequately staffed by competent personnel trained in dosimetry and its application in irradiation treatment.
Dosimeters are devices that are capable of providing a quantitative and reproducible measurement of dose through a change in one or more of the physical properties of the dosimeters in response to the exposure to ionizing radiation energy. A dosimetry system consists of dosimeters, measurement instruments and their associated reference standards, and procedures for the system's use. The selection of an appropriate dosimetry system for irradiation of food will depend on a variety of factors, including the dose range needed to achieve a particular technological objective, cost, availability, and ease of use.
A variety of dosimetry systems are available. In food irradiation, the key measurement that governs the process is the absorbed dose. It is influenced by various parameters, such as: radiation source type, strength and geometry; conveyor speed or dwell time; food product density and loading configuration; and carrier size and shape The overall influence of these latter parameters on dose distribution must be taken into account to ensure that the intended technological objective is achieved throughout the production lot.
The minimum and maximum radiation doses absorbed by a food product are important process controls. If the required minimum dose is not applied, the intended technical effect may not be achieved e. There are also situations where the application of too high a dose would impair the quality of the treated food e. In this regard, the process may be described as being self-regulating in a technological or economic sense. Record requirements for the irradiation of food are specified in Section B. Irradiation processors must maintain adequate records listing the type of food processed; the purpose and date of the treatment; the quantity and lot numbers of the food; the absorbed dose; the type of irradiator and radiation source; dosimetry results including types of dosimeters and their calibration ; and records of any previous radiation treatment.
All product documentation shall be available to authorized personnel and accessible for at least two years after the date of irradiation by food control authorities. For example, facilities irradiating products such as meat, poultry or seafoods for the purpose of reducing pathogens should operate in accordance with a recognized safety control program e. This plan should be consistent with the regulatory requirements for the commodity.
In the overall HACCP context, irradiation is a means of reducing hazards associated with infectious parasites and microbial contamination of foods and may be used as a method of control, but not as a substitute for the essential principles of food hygiene and good manufacturing practices. In subsection B. These two sections highlight the fact that re-irradiation is not allowed unless specifically authorized in the Table to Division For instance, there might be situations where it is beneficial technologically to apply and authorize application of the irradiation in two or more stages and in such instances, specific authorization would be inscribed in the Table to Division
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