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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Backgrounders
February 1999
The Food Safety and Inspection Service (FSIS) is proposing to amend its meat inspection regulations to permit the use of ionizing radiation for treating refrigerated or frozen uncooked meat to reduce levels of foodborne pathogens. FSIS is proposing this action in light of the Food and Drug Administration’s December 1997 final rule that amended its food additive regulations to provide for the safe use of ionizing irradiation sources to treat meat. The FSIS proposal will specify the same maximum absorbed dose levels for refrigerated and frozen meat as did the FDA final rule (i.e., 4.5 kGy and 7.0 kGy, respectively).
FSIS also is proposing to revise the regulations governing the irradiation of poultry so that they will be as consistent as possible with the proposed regulations for the irradiation of meat food products.
The public is invited to submit comments on any aspect of the proposal. FSIS is asking for input on specific issues, such as labeling claims for Escherichia coli O157:H7-free meat, as well as ingredient labeling of products that have irradiated meat as part of the product formulation.
Food irradiation is the process of exposing food to radiant energy in order to reduce or eliminate bacteria. Forms of radiant energy include: microwave and infrared radiation, which heat food during cooking; visible light or ultraviolet light, which are used to dry food or kill surface microorganisms; and ionizing radiation, which penetrates deeply into food, killing microorganisms without raising the temperature of the food significantly. Food is most often irradiated commercially to reduce the numbers of pathogenic microorganisms, to extend shelf-life, or to eliminate insect pests. Food irradiation for these purposes is practiced in many countries, including the United States.
Pathogenic microorganisms are the most significant cause of foodborne illness. Ionizing radiation will reduce, and in some circumstances eliminate, pathogenic microorganisms in or on meat and poultry. FSIS therefore recognizes irradiation as an important technology for helping to ensure the safety of meat and poultry. FSIS already has included ionizing radiation as an approved additive in pork carcasses and fresh or previously frozen cuts of pork carcasses, that have not been cured or heat-processed for the control of Trichinella spiralis, which causes trichinosis. Ionizing irradiation is also recognized as an approved additive in fresh or frozen, uncooked, packaged poultry products and mechanically separated poultry for the purpose of reducing pathogenic microorganisms. In fact, FSIS originally petitioned FDA to allow the irradiation of poultry.
Treating product with the maximum safe dose of irradiation allowed by the rule could result in a significant reduction or even the elimination of certain pathogens. Available scientific data indicate that ionizing radiation can significantly reduce the levels of many of the pathogenic microorganisms of concern in meat food products, including various species of Salmonella; E. coli O157:H7; Clostridium perfringens; Staphylococcus aureus; Listeria monocytogenes; Campylobacter jejuni; and the protozoan parasite Toxoplasma gondii.
Available reports and published articles indicate that the radiation dose necessary to reduce the amount of many pathogens by more than 90 percent is well below the maximum dose of irradiation authorized by FDA and proposed by FSIS in this rule for refrigerated and frozen meat food products. Treating the product with the maximum allowed dose of irradiation, therefore, could result in a significant reduction, or even elimination, of certain pathogens.
FSIS also is proposing to require that any establishment irradiating meat food products have in place a dosimetry system. Dosimetry is the process of measuring an absorbed dose of radiation. FSIS is proposing to require establishments to implement a dosimetry system to ensure that each lot of treated product has received the dose defined in the process schedule or Hazard Analysis and Critical Control Point (HACCP) plan.
On July 25, 1996, FSIS published a final rule that requires every meat and poultry establishment to develop and implement HACCP, a science-based process control system designed to improve the safety of meat and poultry products. Under this final rule, meat and poultry establishments are responsible for developing and implementing HACCP plans incorporating the controls determined by the establishment to be necessary and appropriate to produce safe products. HACCP is a flexible system that enables establishments to tailor their control systems to their specific needs.
Irradiation can be used within a HACCP system by poultry establishments and, if FSIS finalizes this rule, by meat establishments. Establishments that irradiate product probably would establish critical limits such as radiation dosage, product temperature, and ambient oxygen level. By ensuring that specific limits for each of these parameters are met, establishments could be reasonably sure that a predetermined reduction in pathogens has been achieved within the irradiated product.
The proposed rule requires labeling of irradiated meat and meat products sold at retail. For meat and meat products irradiated in their entirety, the Agency is proposing that package labels contain the radura symbol and a statement indicating that the product was treated by irradiation. The symbol contains simple petals (representing the food) in a broken circle (representing the rays from the energy source).
The symbol would have to be placed prominently and conspicuously in conjunction with the required statement. The statement would have to appear as a qualifier contiguous to the product name. For unpackaged meat food products irradiated in their entirety, the Agency is proposing that the required logo and a statement must be prominently and conspicuously displayed to purchasers either through labeling on a bulk container or some other appropriate device.
Under this proposal, establishments could also use irradiated meat food products as ingredients in multi-ingredient meat food products. FSIS is proposing to require that the ingredient statement on such products reflect the inclusion of irradiated meat food product ingredients. For example, an ingredient statement for a sausage product containing irradiated pork would be required to include an entry such as, "irradiated pork" or "pork, treated by irradiation."
FSIS would consider approving labeling statements for meat food products indicating the elimination or reduction of certain pathogens. FSIS already allows qualifiers on labels of irradiated poultry, e.g., "Treated by irradiation to reduce Salmonella and other pathogens." The prerequisite for such labeling statements on meat and poultry products would be a HACCP plan or process schedule validated as achieving, through irradiation, the specific elimination or reduction in pathogens indicated by the labeling. FSIS is proposing to require that labeling statements indicating a specific reduction in microbial pathogens be substantiated by processing documentation.
Currently, FSIS does not have the scientific data necessary to propose regulations that specifically address the necessary preconditions for an "E. coli O157:H7 free" label or similar labels indicating the elimination of other pathogens. Based upon comments and other data FSIS receives, FSIS would consider a modified version of the proposed labeling requirements that would allow the labeling of meat products as being free of E. coli O157:H7 or other pathogens.
FSIS is proposing changes to the poultry regulations, which were provided for in the FDA regulation, to make them as consistent as possible with the meat regulations and with HACCP. FSIS is proposing to eliminate the minimum dose that it currently requires for poultry. FSIS wants to allow poultry establishments, similar to meat establishments, to determine what level of irradiation (subject to a maximum level) and consequent reduction of pathogens is appropriate within their HACCP systems.
FSIS also is proposing to revise the packaging requirements of irradiated poultry to maximize processing flexibility and innovation.
For Further Information Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-3897
Fax: (202) 720-5704
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