Addressed to Dr. Lane Highbarger, from FDA's Center for Food Safety and Applied Nutrition, the letter requests the petition be denied due to several concerns. AHPA says it became aware of the petition - submitted by Steris Corporation in 2003 - due to a reference to it in FDA's final rule on current Good Manufacturing Practices (GMPs).
The petition proposes food additive regulations "be amended to provide for the safe use of ionizing radiation for the control of microbial contamination on dietary supplements, and ingredients used in the manufacture of dietary supplements, up to a maximum absorbed dose of 30 kGy [kiloGray]."
Among AHPA's concerns is that the level of 30 kGy is in fact three to 30 times higher than what is currently allowed for all but two food categories.
In addition, AHPA posits that the new GMPs for dietary supplement manufacturing are sufficient for safeguarding contamination issues that irradiation seeks to address.
"…proper handling of these ingredients under current good manufacturing practice is usually sufficient to ensure that dietary supplements are not subject to microbial contamination that presents any risk to the health of consumers of these products…," states AHPA's letter.
The trade association has expressed particular concern over the use of this technology for herbal ingredients.
Should the petition be approved, according to AHPA, "the use of ionizing irradiation on herbal dietary ingredients will mask one of the factors that is currently relevant to the determination of ingredient quality."
The group says information about microbial levels and the presence of pathogens or yeasts and molds at any time during the handling of a treated ingredient would be done away with in this process.
AHPA's letter also expressed concern that "the United States will become the dumping ground for poor quality herbal ingredients from around the world, since irradiation of herbal ingredients is not permitted in many countries."