[Federal Register Volume 65, Number 128 (Monday, July 3, 2000)]
[Proposed Rules]
[Pages 41029-41031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 00N-1351]


Food Labeling; Use of the Term ``Fresh'' for Foods Processed With 
Alternative Nonthermal Technologies; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of meeting.

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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: <a href="/cdn-cgi/l/email-protection#22646663664d4149475651624d410c4446430c454d54"><span class="__cf_email__" data-cfemail="ffb9bbbebb909c949a8b8cbf909cd1999b9ed1989089">[email protected]</span></a> 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.

[[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______'' (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 
Sec. 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 Sec. 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 
Sec. 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

[[Page 41031]]

send comments to the Dockets Management Branch at the following e-mail 
address: <a href="/cdn-cgi/l/email-protection#3c7a787d78535f5759484f7c535f125a585d125b534a"><span class="__cf_email__" data-cfemail="e8aeaca9ac878b838d9c9ba8878bc68e8c89c68f879e">[email protected]</span></a> 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 Foods
           Processed with Alternative Nonthermal Technologies
 
    Instructions: To register, complete this form and mail it to the
     address of the contact person(s) for registration or fax it to
                     312-886-3280 by July 14, 2000.
 

    Name, ____________________
    Title, ____________________
    Company, ______________________
    Address, ____________________
    Telephone, ______________________
    Fax, ________________________
    E-mail, ______________________
    Please indicate the type of organization that you represent:
    Industry ____
    Government ____
    Consumer Organization ____
    Media ____
    Law Firm ____
    Educational Organization ____
    Other (specify) ____
    Do you wish to make an oral presentation?
    Yes____
    No ____
    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


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