USDA Proposes Allowing Irradiation of Meat Products

The U.S. Department of Agriculture (USDA)--through its Food Safety and Inspection Service (FSIS)--is proposing to amend its meat inspection regulations to permit the use of radiation for treating refrigerated and frozen meat products to help reduce levels of food borne pathogens and extend shelf life.

USDA's proposal follows a final rule published by the Food and Drug Administration (FDA) in December 1997 that also allowed the use of ionizing radiation to treat the same meat products. Until USDA issues its proposal in final, meat products in the U.S. are not allowed to be irradiated.

Part of HACCP Program

In this proposal, USDA confirms FDA's findings that the use of irradiation to kill food borne pathogens is safe and effective. This comes as no surprise since such evidence has been publicly recognized by USDA for quite some time. Indeed, FSIS already permits the use of ionizing radiation for fresh or previously frozen cuts of pork and in fresh or frozen, uncooked, packaged poultry products. In fact, the Agency is also using this rulemaking to update its pork and poultry radiation regulations.

In permitting the use of radiation treatment, USDA wants meat and poultry facilities to make it part of their Hazard Analysis and Critical Control Points (HACCP) program. HACCP is a process control system designed to improve the safety of meat and poultry products. Accordingly, USDA says that it's trying to provide as much flexibility as possible and is proposing only requirements necessary to ensure product safety.

Thus, there are no minimum dose requirements, no restrictions on the specific function of irradiation as a critical control point within a HACCP system and no special handling or packaging requirements for irradiated meat products.

However, the Agency does include specific requirements and procedures concerning dosimetry and requires appropriate documentation regarding licensing and registration of equipment with the Nuclear Regulatory Commission and the Occupational Safety and Health Administration.

The Agency also requires certification of training for supervisory and operational personnel. Smaller establishments which have not yet adopted HACCP must develop a process schedule that is approved by a "process authority" for safety and efficacy. Although the Agency defines a "process authority," it does not list the individuals or organizations it considers acceptable for providing this approval.

Packaging Requirements

Although USDA maintains it has no special packaging requirements for irradiated food, it requires meat and poultry facilities to have on file guarantees from the suppliers of all food-contact packaging materials that may be subject to irradiation, that those materials comply with the Federal Food, Drug and Cosmetic Act and with FDA regulations specified in 21 C.F.R. 179.45 for food irradiation processing.

The tenor of USDA's proposal suggests that, unless a particular material complies specifically with Section 179.45 of the regulations, it will not be permitted for use with irradiated food under USDA regulations. This section of the food additive regulations lists specific packaging materials to be used with prepackaged irradiated food.

We have previously taken the position that FDA should consider "deregulating" packaging materials for irradiated foods and allow suppliers of such materials to determine suitability. (See Regulatory Update, March 1998.) Any material that has an acceptable regulatory status for use in contact with food under the intended conditions of time and temperature 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, FDA should see this as a Good Manufacturing Practice question instead of one that requires material suppliers to seek explicit FDA approval for each packaging material intended to be used in contact with irradiated foods.

The reason flexibility is required in this instance is because current FDA regulations limit the types of materials that are permitted in use with irradiated food products. Even if USDA adopts its proposed regulation sometime in the near future, meat and poultry facilities will still be substantially hampered by the few packaging materials actually available for them to use in irradiating meat and poultry products.

Labeling Rules

Labeling requirements for irradiated foods have always been a hot issue because the radura symbol used on such products is often seen as a warning and not just an informational statement. Unfortunately, USDA must continue to follow FDA's lead with respect to these labeling regulations. Thus, the radura symbol and a statement indicating that the product was treated with irradiation must appear on package labels. The Agency also wants similar labeling for unpackaged meat food products that are sold in bulk.

Additionally, USDA wants ingredient statements on multi-ingredient food products to declare the presence of irradiated meat. For example, sausage containing irradiated pork would have to include an entry such as "irradiated pork" or "pork, treated by irradiation." In contrast, FDA does not require such a statement for ingredients of food products.

On the other hand, USDA is considering permitting label statements for food products to indicate the use of radiation to eliminate or reduce certain pathogens. The Agency already permits the use of such qualifiers for irradiated poultry and appears inclined to do so for other products as well. Of course, the Agency will require substantiation of such claims.

More information on the proposal can be found at 64 Federal Register 9089 (February 24, 1999) or by checking USDA's website at www.USDA.gov.

Comments are due by April 26, 1999.

By George Misko, Partner, Keller & Heckman

Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

COPYRIGHT 1999 Stagnito Communications
COPYRIGHT 2004 Gale Group