Food Irradiation Labeling: The Controversy Continues
By Keller and Heckman LLP’s Packaging Practice Group
The continuing controversy surrounding the labeling of irradiated food is inhibiting the commercial spread of irradiation, and limiting what could be a significant market for new types of packaging materials.
While labeling issues are not always on the radar screens of packaging material suppliers, any company interested in this developing market should be aware of labeling and other consumer issues surrounding the use of irradiation, in order to properly evaluate the opportunities in this area. (As a general matter, labeling issues are beyond the scope of this Web site, although Keller and Heckman LLP has a very substantial practice concerning the labeling of food and other products, as evidenced by our responses to some of the questions posted to the site).
In 1981, the U.S. Food and Drug Administration published an advance notice of proposed rulemaking (ANPR) to announce that it was considering establishing procedures for regulating irradiated foods (46 Fed. Reg. 18992 (Mar. 27, 1981)). In that notice, FDA solicited comment on a number of issues relating to the use of irradiation in the production, processing, and handling of food. With regard to labeling of irradiated foods, FDA specifically asked for comment on whether a need exists for labeling to distinguish irradiated foods from foods that have not been irradiated.
Almost 20 years later, FDA again published an ANPR requesting comment on special labeling for irradiated foods (64 Fed. Reg. 7834 (Feb. 17, 1999)). Just as in 1981, FDA solicited comment on what type of labeling is appropriate for irradiated foods.
Why are the same questions being asked after almost 20 years? Why is FDA still collecting public comment on the issue of labeling of irradiated foods?
The short answer is that "FDA is not aware of a consensus regarding specific changes in the labeling of irradiated food" that would accommodate the various positions on the issue taken by the most vocal stakeholders: consumer rights groups, Congress, and industry. (See 64 Fed. Reg. at 7835.) The positions range from expanding on the labeling that is currently required for irradiated food, to eliminating labeling requirements altogether. 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.
Legal and Regulatory Background
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 403(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act. Section 403(a) of the act deems food misbranded if its labeling is false or misleading in any particular. Section 201(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 403(a) and 201(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. Reg. 13376, 13388 (April 18, 1986)). FDA has stated previously that because "[i]rradiation may not change the food visually... in the absence of a statement that a food has been irradiated, the implied representation is that the food has not been processed" (Id.). 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. Reg. 53176, 53205 (Dec. 30, 1988)). 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. Reg. at 13389). 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] ... bear the [radura] logo along with either the statement 'Treated with radiation' or the statement 'Treated by irradiation'" (21 C.F.R. § 179.26(c)). 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. In 1997, Congress passed the Food and Drug Administration Modernization Act of 1997 (FDAMA), an act covering many topics under FDA's jurisdiction. One provision added Section 403C to the Federal Food, Drug, and Cosmetic Act, which states that Sections 201(n), 403(a), and 409 may not be construed to require a radiation disclosure statement that is more prominent than the declaration of ingredients on the food label. The FDAMA conference committee report also contains direction from Congress on FDA's activities on irradiation labeling. 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. Rep. No. 105-399, 105th Cong., 1st Sess., at 98-99). 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 1999 advance notice of proposed rulemaking (64 Fed. Reg. at 7834). 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 2001 (which ends September 30, 2001), 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 2002. 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.
Positions on Labeling
In a January 2001 report to Congress, then-Commissioner Jane Henney stated that comments submitted in response to the 1999 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.
For example, one proposal was to label irradiated foods as "treated with ionizing energy" or subject to "picowave treatment." FDA has also considered language that combines the disclosure of irradiation with a description of one of the benefits of irradiation: "treated with radiation to prolong shelf life to [insert a certain date]." In addition, FDA has received proposals to eliminate the radura logo and keep the disclosure statement, or eliminate the disclosure statement and keep the radura logo. To some industry members, the radura logo suggests danger; other members want to use the radura logo, which is internationally recognized, and drop the separate disclosure statement.
Recently, interest has shifted to use of the terms "electronically pasteurized" or "cold pasteurized" to describe food that has been irradiated. Both of these options notify the consumer that processing has taken place, but use a term—"pasteurized"—that is accepted by consumers to convey the message that food has been processed.
In the last few weeks, reports about focus group research that FDA has conducted on consumers' understanding of the various proposals for labeling irradiated foods indicate that consumers do not prefer terms like "electronically pasteurized" to describe irradiation. Although the agency has not yet released a report on the focus group research, the preliminary reports suggest that the focus group research may not lead FDA to a clear consensus position, as the agency may have hoped.
[Editor's note: On June 28, Joseph Levitt, chief of the FDA's Center for Food Safety and Applied Nutrition, met with public interest group representatives to discuss labeling issues, including whether labeling should explain the function of the irradiation, such as "irradiated for food safety."]
As demonstrated by the wide range of positions described above, FDA will continue to experience difficulty in identifying a consensus position on irradiation labeling. Although committed to publishing new regulations on irradiation labeling, it is unlikely that the regulations will put an end to the labeling controversy.
Many government officials and industry members have commented that the most effective way to diminish the controversy and develop a consensus position is to educate the public about the safety and the benefits of food irradiation. Once consumers understand what food irradiation actually is and what the food safety benefits associated with this technology are, crafting the appropriate language for a label that will not be perceived as a warning or give rise to inappropriate consumer anxiety will become a far less difficult task for FDA.
On the other hand, the labeling issue is driven to some extent by consumer groups opposed to the use of irradiation on food at all, who advocate labeling that alarms the public and thereby may limit acceptance of the technology. The degree of ultimate consumer acceptance of irradiated food remains unclear and, in turn, clouds the market prospects for the treated food and its associated packaging.