While the U.S. Department of Agriculture is trying to put a wrap on the final rule allowing the sale of irradiated red meats, the Food & Drug Administration is meeting with packagers in an effort to quickly approve new packaging for ground beef, stew meat and steaks. A major powwow was scheduled for February between top FDA regulatory officials and members of a coalition that is in the process of being pulled together by the National Center for Food Safety & Technology. The Center is partly funded by the FDA, partly by industry. It is operated from the Illinois Institute of Technology in Chicago. The coalition is likely to include packaging manufacturers such as Cryovac (Duncan, SC) and Printpack (Atlanta, GA) and meat and poultry producers such as Cargill and Hormel. Irradiation of poultry is already legal. Dane Bernard, vice president of food safety programs for the National Food Processors Assn., says the actual decision to form a coalition has not been made. "It is not a done deal," he notes. "But I am confident things will move forward." The group would jointly fund migration studies of resins that are not currently approved for irradiated beef or poultry. The idea is to get the FDA to approve a particular resin class. Then individual companies would develop proprietary packaging using that approved resin. In the past, the FDA has approved a material in a particular form, such as polystyrene sheet. When Amoco wanted to sell a foamed PS tray, for example, it had to apply to the FDA for a threshold of regulation (TOR) exemption to do so. Some materials approved A select number of packages already comply with FDA requirements for irradiated food. The problem is that most of these packages were approved in the late 1950s and '60s for use with army field rations, to extend their shelf life. Only one, an ethylene vinyl acetate (EVA) copolymer, can be used with electron-beam radiation. The list of materials already approved for gamma-irradiated foods is significantly longer, including polyethylene, polyvinylidene chloride, nylon 6 and polyester films. Food processors are anxious to add to that list such "new" copolymers as ethylene vinyl alcohol (EVOH), rigid polystyrene and ionomers like DuPont's Surlyn®. Surlyn, for example, is used as a packaging layer for medical devices that have been sterilized with radiation, and for meats and poultry that have not been irradiated. Surlyn is usually the polymer layer touching the meat or poultry. Many packagers feel its strongest advantage is its seal integrity. Andy Rimes, senior development program manager at DuPont's Packaging and Industrial Polymers Div. (Wilmington, DE), says there is no migration of chemicals from the Surlyn to the meat, whether radiation is used or not. "There are no additives to migrate," he explains. But he adds that the company has not done any migration studies. TOR exemptions needed Patricia Hansen, an official with the FDA's division of product policy at the Center for Food Safety and Applied Nutrition, says her agency is very willing to work with industry, either en masse or with individual companies, to get additional TOR exemptions approved for materials currently used on non-irradiated foods. TOR exemptions have recently been made available for most resins, and are supposed to be quicker to receive than approval for a full-blown food additive petition. "Judging by the lack of petitions, people have been reluctant to invest the time and money in getting new packaging materials approved," Hansen explains. "We are willing to work with industry to figure out whether they need a petition or a TOR exemption, and what data would be needed in either case." There are a couple of reasons why new packaging is needed. To begin with, irradiated meat and poultry overwrapped with currently approved films can give off an odor when the plastic film is removed. For example, gamma-irradiated meats packaged in film containing EVA can produce a vinegary smell when opened, according to Norm Bornstein, global director for product regulatory compliance at Cryovac. Also, some of the currently approved materials can be used only in a specific form. For example, a material may be approved as a bag, but a meat or poultry processor might prefer to use a tray. "Unless the consortium is successful, we would have to change a number of our formulations for our currently available packages to make them acceptable to the FDA for use on irradiated foods," says Bornstein. Not so fast! The silver lining here is that packagers have some time. Even though the FDA gave its okay to the use of radiation on refrigerated and frozen uncooked meat, meat byproducts and ground beef last December 3, those products cannot be sold yet. The regulatory meat grinder is still working. The Food Safety and Inspection Service has to publish a final implementation rule before irradiated meat can be marketed. As of 1998, the FSIS had not even put out a proposed rule. Once that comes out, there will have to be a 60- to 90-day public comment period. Dan Engeljohn, branch chief for standards development at the FSIS, says an optimistic reading of future developments puts publication of the final rule in mid-1998. The odds on that are about the same as the Chicago Cubs winning the National League pennant. A more realistic estimate would be very late 1998 or early 1999. The final rule will have to resolve two key issues. The first is procedural: how to fit the use of irradiation for both beef and poultry into a HACCP (Hazard Analysis and Critical Control Point) environment. The FSIS's HACCP program went into effect in January 1998. The other somewhat controversial issue will be the requirements for labeling of irradiated foods. There is already a requirement for labeling irradiated poultry. But Engeljohn says he expects pressure from food companies to keep the labeling requirements for meat as simple and unobtrusive as possible.
