Overcoming the Packaging Hurdle to Producing Irradiated Foods

Food safety issues have been a dominant issue in the news media for several years now, and even merited President Clinton's attention in his State of the Union address. "Millions of Pounds of Beef Recalled," "Food Poisoning Outbreak Traced to Restaurant" and similar headlines are not unusual at all these days and with good reason. The Food and Drug Administration (FDA) estimates that outbreaks associated with E. coli 0157:H7, a particularly virulent pathogen, have increased from four in 1992 to 30 in 1994. Deaths from foodborne illnesses are estimated at 9,000 a year in the United States with more than a million people becoming sick each year.

Many of these illnesses and deaths are no doubt the result of improper food storage and handling at the consumer level and not due to any inherent shortcoming at the processing stage. However, if food processors can reduce the potential for microbiological contamination of food products, they should consider it since consumers are increasingly clamoring for it.

Safe, Effective ... But Unpopular

The use of radiation to kill foodborne pathogens has long been hailed as both safe and highly effective. FDA recently confirmed this conclusion once again with publication of a regulation clearing the use of irradiation to treat refrigerated and frozen uncooked meat, meat byproducts and certain meat food products to control foodborne pathogens and extend product shelf life (See 62 Fed. Reg. 64107, Dec. 3, 1997.) Going as far back as 1963, FDA has previously approved the use of radiation for several other foods, including wheat and wheat flour, spices, pork, poultry, and fruits and vegetables.

Although irradiation treatment for food has been found safe and effective, some consumers have evinced an almost pathological fear of it, as if the product itself becomes radioactive. This fear is clearly irrational and available studies suggest that it may be quelled with appropriate education programs.

Unfortunately, as food processors and packagers explore the possibilities of producing irradiated food products and dealing with consumer concerns, they will also find another major problem: the lack of packaging materials that have been cleared by FDA for use with pre-packaged, irradiated food.

Of course, if FDA could complete review of a food additive petition within a reasonable time, that wouldn't be a problem. Unfortunately, time and time again, this is just not the case.

FDA should consider "deregulating" packaging materials for irradiated foods. The agency should allow material suppliers to determine on their own whether films already accepted by FDA as safe for use with food are also safe for use with irradiated food.

Radiation as a Food Additive

We usually think of a food additive as a substance that is added to food directly, such as a sweetening agent, or indirectly, such as a component of a packaging material that migrates to food.

Under Section 201(s) of the Federal Food, Drug and Cosmetic Act, sources of radiation are considered food additives even though they are treatment methods for food and are not intended to add anything to the food. Nonetheless, like all food additives, radiation is not permitted to be used with food unless it is the subject of a food additive regulation, is generally recognized as safe or is otherwise exempt from regulation. This is why FDA promulgated the recent regulation permitting beef products to be irradiated.

FDA has also traditionally taken the position that packaging materials that will be subject to radiation incidental to the irradiation of pre-packaged food must also be cleared for this use. Thus, under Section 179.45 of the food additive regulations, FDA lists specific packaging materials to be used with pre-packaged irradiated food.

The Agency's primary concerns are to (1) ensure that the material does not undergo some major change when subjected to irradiation and (2) more importantly, to ensure that the irradiation does not produce low molecular weight (volatile) species or radiolytic products in the material that might migrate to food.

But is this a reason for FDA to specifically regulate materials to be used with pre-packaged irradiated foods? We think not. FDA activities on packaging materials demonstrate that Section 179.45 is superfluous.

Regulation Not Needed

First, FDA has taken the position that pre-clearance is not needed for packaging materials that are irradiated prior to food-contact. Here, FDA has stated that irradiated material may be tested to see whether it is changed by radiation and otherwise complies with the regulations. If it does, no additional regulation is required.

In our view, there is no basis for the Agency to permit a company to test its packaging to assess compliance with existing regulations where the package is empty, and not permit the same for packaging that holds food when irradiated. Since testing can be conducted that addresses FDA's legitimate concerns about the creation and migration to food of low molecular weight materials, the same "self-testing/self-determination of compliance" paradigm should apply to "pre-packaged" foods as to packaging alone.

Second, in the preamble to its 1995 final rule to allow the irradiation of frozen, packaged meats for use in the National Aeronautics and Space Administration (NASA) space flight program, FDA concluded that the packaging materials need not comply with Section 179.45, "provided that their use is otherwise permitted by applicable regulation[s]."

In discussing its evaluation of the safety of irradiated frozen, packaged meats for the NASA spaceflight programs, FDA concluded that "the total amount of radiolytic products that could be formed in the packaging materials during irradiation processing, and then migrate to the food and subsequently be consumed by individuals in the spaceflight programs, is too small to be of any toxicological significance."

FDA's determination for astronauts was made easy by the very low dietary consumption of irradiated foods that could be expected. However, even if use is more widespread, if testing conducted on a material demonstrates that irradiation of the material, when filled with food, produces no radiolytic products that might become components of the packaged food, a similar conclusion should be available, that is, the amount of radiolytic products, if any, that could be consumed is too small to be of toxicological significance and pre-clearance of packaging materials should not be required.

Finally, in a 1996 letter to the Amoco Corp., FDA again indicated that an explicit listing under Section 179.45 is not required if there is no reason for concern. In this instance, FDA cleared Amoco's request for an exemption under the Threshold of Regulation policy, permitting Amoco to market its uncolored polystyrene foam trays for use with pre-packaged irradiated foods. The Agency's decision was supported by data demonstrating that migration to food as a result of irradiation resulted in a dietary concentration below the 0.5 part per billion threshold of regulation.

In all three of the above instances--the preamble to the 1986 irradiation rulemaking, the preamble to the NASA irradiation rule and the 1996 Agency threshold letter to Amoco--FDA acknowledges that it is appropriate to determine the suitability of irradiation of pre-packaged foods by demonstrating that the packaging prior to and after irradiation has not changed in any respect and that no additional migrants are produced during the course of irradiation.

Bottom Line: Food Safety

Given FDA's public views on prepackaged foods that are subsequently irradiated, any additive that is the subject of an applicable food additive regulation--or otherwise has an acceptable regulatory status for use in contact with food under the intended conditions of use (such as time, temperature and type of food contact)--should be available for use in packaging food to be irradiated, provided that the radiation of the packaging does not (a) change the additive's chemical nature, (b) result in additional migrants or (c) otherwise create any degradation products (including volatiles that could be trapped in the packaging) that pose a safety problem.

In other words, the Agency should view this as a good manufacturing practice question that could reside with packaging materials suppliers instead of requiring food additive petitions or threshold of regulation submissions.

If FDA were to adopt such a position, it would end the time lags companies would encounter in qualifying appropriate materials for use in packaging food intended to be irradiated--and more quickly achieve the Clinton Administration's objective in reducing food safety concerns.

Food processors and the packaging industry are now attempting to form a consortium to deal with this food packaging question. Acting through the National Center for Food Safety and Technology, this consortium should provide an appropriate forum for gathering data necessary to establish whether FDA has any reason for concern here at all. For more information or to get involved, call George Sadler at (708) 563-8170.

George Misko, Partner, Keller & Heckman

Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC20001; phone (202) 434-4100 or fax (202) 434-4646.

COPYRIGHT 1998 Stagnito Communications
COPYRIGHT 2004 Gale Group