[Federal Register: July 3, 2000 (Volume 65, Number 128)]
[Proposed Rules]
[Page 41029-41031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy00-38]

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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: 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.

[[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: 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 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