Regulator turns down hearing request on irradiation levels

The FDA this week said it would not hold any hearings on the objections to the limit submitted by various parties. Instead the FDA submitted as a final rule an amendment to the food additive regulations that establishes a new maximum permitted energy level of x-rays for treating food at 7.5 million electron volts (MeV). The FDA is fighting a rearguard action due to the lobbying of consumer groups over the perceived dangers of irradiation when used to rid foods of microbes. The level is valid for x-rays generated from machine sources that use tantalum or gold as the target material. There is no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. The level was originally published in a notice in the Federal Register of March 13, 2003 when it announced the filing of food additive petition by Ion Beam Applications. The petion sought to amend the food additive regulations by increasing the maximum permitted energy level of x-rays for treating food to 7.5 MeV from from 5 MeV. The rights to the petition were subsequently transferred to Sterigenics International. In response to the petition, the FDA issued a final rule on December 23, 2004. Following publication of the 7.5 MeV x-ray final rule, the FDA said it received about 100 objections within the 30-day objection period. All but one of the submissions expressed general opposition to increasing the maximum permitted energy level of x-rays used to irradiate food and to food irradiation. Most of these objections were form letters, the FDA stated. "While most of these objections requested a hearing, no evidence was submitted in support of these objections that could be considered in an evidentiary hearing,"​ the FDA stated. Earlier this month the FDA made a proposals to revise labeling regulations for irradiated foods and supplements, suggesting that some could be labeled as "pasteurized". The proposed rule would provide consumers with "more useful" information than the current regulation, the FDA claimed. Irradiation works by exposing foods to ionizing radiation that kills insects, moulds and bacterium. The technology, which can kill up to 99 per cent of pathogens, is seen by the industry as a means of ensuring food safety. However public concerns over the health effects of the technology has meant global food companies have had to deal with a confusing thicket of legislation and restrictions when making and marketing their products. The US currently requires all single-ingredient irradiated foods sold in stores to be labeled as "treated with irradiation" and to carry the 'radura' symbol. Under the FDA's proposed labeling revisions, only those irradiated foods in which the irradiation causes a material change in the food, would bear the radura logo and the term "irradiated" or a derivative thereof, in conjunction with a description of the change in the food. The agency said it is using the term 'material change' to refer to a change in the organoleptic, nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling. FDA is also proposing to allow a firm to petition for use of an alternate term to "irradiation" (other than "pasteurized"). In addition, FDA is proposing to permit a firm to use the term "pasteurized" in place of "irradiated", provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term "pasteurized" in the Federal Food, Drug, and Cosmetic Act.