June 29, 2007
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Rm. 1061
Rockville, MD 20852
RE: Docket # 2005N-0272, “Irradiation in the Production, Processing, and Handling of Food.”
To Whom It May Concern:
Thank you for this opportunity to comment.
The Organic Trade Association (OTA) is a 1600-member North American business association serving all sectors of the organic products industry. OTA’s members who operate certified organic farms and businesses are proud to display the signs of organic process certification, including stickers on fruits and vegetables (cf. Page 16298 of this Proposed Rule).
OTA supports option 1 in the proposed rule’s analysis—no new regulatory action, including maintaining the requirement for the mandatory labeling with the radura logo and the term “irradiated” on all products that are irradiated, regardless of any perceived material, nutritional, functional, or organoleptic effect. OTA strongly opposes the use of an alternate word, especially the word “pasteurized,” to indicate irradiation.
Consumers of organic products count on labels to help them identify products they want to buy and products they prefer not to buy. Consumers of certified organic products know that among the prohibited processes covered by the national organic rule is a prohibition on the use in any organic or non-organic ingredient of ionizing radiation. Mandatory labeling would continue to help these consumers choose according to their preferences because it would clearly identify any product or ingredient that had been subjected to the ionizing radiation process.
Buyers of organic ingredients and minor ingredients that may be used in very small quantities with larger quantities of organic ingredients are prohibited from buying any of these minor ingredients if they have been treated with ionizing radiation (7 CFR 205.105(f)):
§ 205.105 Allowed and prohibited substances, methods, and ingredients in organic
production and handling.
To be sold or labeled as “100 percent organic,” “organic,” or “made with organic
(specified ingredients or food group(s)),” the product must be produced and handled without the use of:
(f) Ionizing radiation, as described in Food and Drug Administration regulation, 21 CFR
The use of the term “pasteurization” has historically specifically referred to a particular treatment of product within a well-understood range of processes. The term “irradiated” is simple, accurate, and recognizable by consumers as descriptive of the ionizing radiation process.
Buyers along with manufacturers of organic product rely on irradiated product being clearly identified. Therefore, the term “irradiation” should be kept, and words, such as pasteurization, that have dual or broad meanings should be disallowed, so buyers of organic ingredients, and all other consumers of products normally labeled as “pasteurized” can avoid the inadvertent purchase of irradiated product.
Finally, FDA should disallow the use of purpose statements for irradiation such as “for extended shelf life” or “for food safety.” In this context, these seem to be merely marketing statements disguised as informational statements and detract from the simple and clear process statement, “irradiated.”
Thank you very much.
Tom HutchesonRegulatory and Policy Manager