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 Department of Health and Human Services Food and Drug Administration 21 CFR Part 101
[Docket No. 00N-1351]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Announcement of meeting.
 SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to discuss the use of the term “fresh” in the labeling of foods processed with alternative nonthermal technologies. The purpose of the meeting is to determine whether the use of the term “fresh” is truthful and not misleading on foods processed with these alternative technologies and to determine what type of criteria FDA should use when considering the use of the term with future technologies.
 DATES: The public meeting will be held on July 21, 2000, from 8:30 a.m. to 4 p.m. Please preregister by July 14, 2000. Late registrations will be accepted contingent on space availability. Comments must be submitted no later than August 21, 2000.
 ADDRESSES: The meeting will be held at the Holiday Inn City Centre, 300 East Ohio St., Chicago, IL, 312-787-6100. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. You may also send comments to the Dockets Management Branch at the following e-mail address: FDADockets@oc.fda.gov or on the FDA website at http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​comments/​commentdocket.cfm.
 FOR FURTHER INFORMATION CONTACT: For registration: Kimberly Phillips or Darlene M. Bailey, Office of Public Affairs (HFR-CE645), Food and Drug Administration, 300 South Riverside Plaza, suite 550 South, Chicago, IL 60606, 312-353-7126 or FAX 312-886-3280. 
                        ( print page 41030) For general information: Geraldine A. June, Center for Food Safety and Nutrition, Food and Drug Administration (HFS-822), 200 C St. SW., Washington, DC 20204, 202-205-4168 or FAX 202-205-5295.


SUPPLEMENTARY INFORMATION: I. Background In the 
                    **Federal Register**
                     of January 6, 1993 (58 FR 2302 at 2401), FDA published a final rule that established labeling regulations that govern the use of the terms “fresh,” “freshly
                    XXX
                    ” (e.g., “freshly baked”) and “fresh frozen” as they appear on the labeling of foods, including the use of these terms in brand names and as sensory modifiers. As discussed in the final rule, we issued this regulation because of the continued misuse of the term “fresh” and related terms in the marketplace. We concluded at that time that it was necessary to establish a definition for “fresh” to preclude the type of misuse that we encountered most often, i.e., use of the term to imply that a food is unprocessed, when in fact it has been processed. Thus, provisions in § 101.95 (21 CFR 101.95) govern the use of the term “fresh” when used on the labels or in labeling of foods to suggest or imply that the food is unprocessed. Generally, the appearance of the term “fresh” on a label or in labeling means that the food in its raw state or finished form has not been frozen or subjected to any form of thermal processing or any other form of preservation. However, we provided that the following treatments do not preclude the food from bearing the term “fresh”: (1) The addition of approved waxes or coatings, (2) the post-harvest use of approved pesticides, (3) the application of a mild chlorine wash or mild acid wash on produce, or (4) the treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1 kiloGray. The regulation also notes that use of the term “fresh” is not precluded when it does not imply that the food is unprocessed, e.g., “fresh” may be used to describe pasteurized whole milk because consumers understand that almost all milk is pasteurized and, therefore, there is no misleading implication. Recently, manufacturers have developed new alternative food processing technologies to control pathogens in foods while minimizing the thermal component of the process. Such processes include, but are not limited to, high pressure processing, pulsed electric field, pulsed light, submerged arc, and filtration. FDA contracted with the Institute of Food Technologists (IFT) to review and evaluate the scientific information available on these new alternative technologies and to assist us in evaluating each technology's effectiveness in reducing and inactivating pathogens of public health concern. Where information on these technologies was too limited for a thorough evaluation and conclusion, IFT identified research needs. The final report of this work, entitled “Kinetics of Microbial Inactivation for Alternative Food Processing Technologies” (Ref. 1), is available on FDA's website at www.cfsan.fda.gov. Manufacturers using these processes contend that their products maintain the same “fresh” characteristics as unprocessed products. Thus, these manufacturers have asked FDA if they may label these products with the term “fresh.” We are interested in obtaining the views of interested parties on the use of the term “fresh” for foods processed with these technologies. Thus, we have decided to hold a public meeting to engage interested parties in discussion on this issue. We will use information gathered at this meeting, as well as other information available to FDA, in considering whether to initiate rulemaking to amend § 101.95. In this notice, we are announcing a public meeting to discuss the use of the term “fresh” in the labeling of foods processed with the alternative technologies. We are soliciting public comment on whether the use of the term “fresh” is truthful and not misleading on foods processed with these alternative technologies and on what type of criteria FDA should use when considering the use of the term with future technologies. Specifically, we invite comment on the following questions: 1. Do consumers associate the term “fresh” with organoleptic characteristics, nutritional characteristics, or some other characteristics? 2. Do consumers want a way to identify foods that taste and look fresh but have been processed to control pathogens? 3. What does industry think the term “fresh” means? 4. Is the term “fresh” when applied to foods processed with the new technologies misleading to consumers? 5. Do the new technologies preserve the foods? 6. Are the new technologies truly nonthermal? 7. Are there quantifiable parameters, e.g., level of nutrients, vitamins etc., that could be measured to determine if a food is “fresh?” 8. Is there a term other than “fresh” that can be used for foods processed with the new technologies? 9. Would consumers understand a new term? 10. What is the economic impact of allowing use of the term “fresh” for foods processed with the new technologies? 11. Would allowing the term “fresh” on foods processed with new technologies place small firms not able to use these technologies at an economic disadvantage? At the public meeting, we will be addressing whether the use of alternative processing technologies should preclude the use of the term “fresh.” Therefore, the public meeting will be restricted to the discussion of whether these processes fit the criteria for the use of the term “fresh” and not whether other aspects of the provisions in § 101.95 should be reopened. II. Registration and Requests to Make Oral Presentations If you would like to attend the meeting, you must preregister in writing with the contact person for registration (address above) by July 14, 2000, by providing your name, title, business affiliation, address, telephone and fax number. Preregistered persons should check in before the meeting between 8 a.m. and 8:30 a.m. Persons who have not preregistered may register before the meeting between 8 a.m. and 8:30 a.m., dependent on space availability. To expedite processing, this registration information also may be sent to the contact person by FAX to 312-886-3280. If you need special accommodations due to disability (e.g., sign language interpreter), please inform the contact person when you register. If, in addition to attending, you wish to make an oral presentation during the meeting, you must so inform the contact person and submit: (1) A brief written statement of the general nature of the views you wish to present and (2) the names and addresses of the persons who will give the presentation. Depending on the number of people who register to make presentations, we will limit the time allotted for each presentation. We anticipate that, if time permits, those attending the meeting will have the opportunity to ask questions during the meeting. III. Comments Interested persons may, on or before August 21, 2000, submit written comments to the Dockets Management Branch (address above). You may also 
                    ( print page 41031)
                    send comments to the Dockets Management Branch at the following e-mail address: FDADockets@oc.fda.gov or to the FDA website at http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​comments/​commentdocket.cfm. Please address your comments to the docket number given at the beginning of this notice. You must submit two copies of comments, identified with the docket number found in brackets in the heading of this document, except that you may submit one copy if you are an individual. You may review received comments in the Dockets Management Branch between 9 a.m. and 4 p.m. Monday through Friday. IV. Transcripts You may request a transcript of the meeting from the Freedom of Information Office (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, approximately 15 working days after the meeting, at a cost of 10 cents per page. You may also examine the transcript of the meeting after August 11, 2000, at the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA website at http://www.fda.gov. V. Reference We have placed the following reference on display in the Dockets Management Branch. You may see it at that office between 9 a.m. and 4 p.m., Monday through Friday. 1. Institute of Food Technologists, “Kinetics of Microbial Inactivation for Alternative Food Processing Technologies,” A report of the Institute of Food Technologists for the Food and Drug Administration of the United States Department of Health and Human Services, June 2, 2000. **Registration Form**
Public Meeting on Use of the Term “Fresh” on FoodsProcessed with Alternative Nonthermal TechnologiesInstructions: To register, complete this form and mail it to theaddress of the contact person(s) for registration or fax it to312-886-3280 by July 14, 2000.
 Name, 
                    XXXXXXXXXX Title, 
                    XXXXXXXXXX Company, 
                    XXXXXXXXXXX Address, 
                    XXXXXXXXXX Telephone, 
                    XXXXXXXXXXX Fax, 
                    XXXXXXXXXXXX E-mail, 
                    XXXXXXXXXXX Please indicate the type of organization that you represent: Industry 
                    XX Government 
                    XX Consumer Organization 
                    XX Media 
                    XX Law Firm 
                    XX Educational Organization 
                    XX Other (specify) 
                    XX Do you wish to make an oral presentation? Yes
                    XX No 
                    XX If yes, you must also submit the following: 1. A brief statement of the general nature of the views you wish to present, 2. The names and addresses of all persons who will participate in the presentation, and depending on the number of people who register to make presentations, we will limit the time allotted for each presentation. Dated: June 27, 2000. Margaret M. Dotzel, Associate Commissioner for Policy.


[FR Doc. 00-16716 Filed 6-28-00; 1:38 pm] BILLING CODE 4160-01-F