[Federal Register Volume 62, Number 36 (Monday, February 24, 1997)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4364]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96D-0513]
Guidance on Labeling of Foods That Need Refrigeration by
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is providing guidance
on labeling of foods that need refrigeration by consumers to maintain
safety or quality. This guidance, which represents FDA's policy on
adequate safe handling instructions for food, should reduce the
likelihood of temperature abuse of certain foods by consumers, and it
is intended to reduce the potential for foodborne illness and death.
The guidance also responds to the recommendations of the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF), the
National Food Processors Association (NFPA), the Association of Food
and Drug Officials (AFDO), and the Centers for Disease Control and
Prevention (CDC) for labeling foods needing refrigeration. FDA is
soliciting comments on this guidance.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written comments on this guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
Refrigeration has long been used to retard deterioration of the
flavor, color, and texture of foods. More importantly, refrigeration
helps maintain the microbiological safety of potentially hazardous
foods. Temperature abuse, i.e., failure to maintain foods at
appropriate temperatures, may result in the outgrowth of microorganisms
that may have contaminated the foods before, or at the time of, harvest
or during processing, handling, or storage. The rate of growth of these
microorganisms is reduced as the storage temperature is lowered. Proper
refrigeration, therefore, prevents or slows the growth of human
pathogens and spoilage microorganisms and reduces the likelihood of
Refrigeration is only one of many individual factors, called
barriers, that can be used to control microbiological risks. It is, for
many foods, the only practicable barrier to reduce or prevent pathogen
growth. Examples of other types of barriers include acidification (pH
4.6), use of preservatives, such as salt, and low water
activity (aw 0.85). Barriers used individually, or in
combination with each other, may reduce or retard pathogenic microbial
In the past, consumers could generally tell if a product were
perishable by its packaging or lack of packaging. Products in a can or
a jar were generally considered to be shelf-stable (i.e., products that
can be stored on the shelf without spoilage), at least until opened.
However, today's new packaging technologies have changed this
situation. Many liquids or semi-liquids in flexible packages have
liners and are shelf-stable. Vacuum packed foods or foods packaged in
modified (oxygen reduced) atmospheres, which are shelf-stable, may
appear to the consumer to be safe to eat, even if they have been
temperature abused. These foods may not have developed organoleptic
signs (such as deterioration of color, flavor, texture, etc.) that
consumers associate with spoiled or unsafe foods. However, foods in
these packages may present a potential hazard if, once opened, they are
Recently, there have been reports of botulism food poisonings
resulting from consumption of food that had been temperature abused by
consumers, even though the products were labeled ``keep refrigerated.''
FDA is concerned that such foods are not labeled adequately or
conspicuously enough to advise consumers that the product must be
refrigerated to maintain its safety. The specific foods implicated in
the botulism poisonings were clam chowder and black bean dip. Packaging
for both of these products could have made the food appear shelf-stable
to the consumer.
The potential for foodborne illness from temperature abused foods
is widely recognized. Efforts to reduce this health risk in potentially
hazardous foods that need refrigeration to ensure their safety and
quality have included voluntary use of label statements such as ``keep
refrigerated'' and ``refrigerate after opening.'' Use of such label
statements no longer provides meaningful consumer information because
the same label statements appear both on foods needing refrigeration to
ensure safety and foods needing refrigeration to maintain quality.
NACMCF has made specific recommendations for label statements on
potentially hazardous foods (Ref. 1) to address this problem. NFPA has
developed guidelines for the food industry for voluntary label
statements using the language in the NACMCF recommendation (Ref. 2).
AFDO has endorsed the guidelines developed by NFPA (Ref. 3) and has
recommended them to State regulatory agencies to assist those agencies
in requiring and enforcing improved labeling (Ref. 4). Finally, CDC
sent FDA a memorandum expressing concern about the recent botulism
outbreaks and recommending, among other things, better labeling for
foods requiring refrigeration (Ref. 5).
II. Inadequacy of Current Labeling
Because of the recent reports of botulism food poisonings from
consumption of foods that had been temperature abused by consumers, FDA
has evaluated the labeling on foods that must be refrigerated to
prevent outgrowth of pathogens and has found that most of this labeling
does not adequately advise the consumer of the need to keep the food
refrigerated or of the health risk if it is not. For example, the
packaging for the clam chowder and black bean dip that were implicated
in the recent botulism poisonings made the foods appear shelf-stable.
The clam chowder was packaged in a plastic bag inside a cardboard
carton. The bean dip was packaged in a resealable plastic tub. These
items were displayed in refrigerated cases in the supermarket. While
both items had a ``keep refrigerated'' statement on their labels,
consumers failed to maintain these products under refrigeration.
Most consumers seem to understand that foods that are displayed
only in the refrigerated section of a grocery store, such as dairy
products, eggs, cold cuts, fresh meats, poultry, and seafood, must be
refrigerated to maintain their quality. While it is unlikely that a
majority of consumers are aware of the hazards and food safety issues
that temperature abuse of these products can present, it is likely that
most consumers will refrigerate these foods even in the absence of
labeling instructions to do so for safety. Therefore, the fact that
these foods are refrigerated does not really provide evidence of the
effectiveness of the ``keep refrigerated'' instructions in their
Foods such as mustard, salad dressings, jams, jellies, salsa, and
spaghetti sauce bear a statement advising refrigeration once the
product is opened to retard deterioration in the quality of the food.
Nonetheless, consumers often do not refrigerate these foods. Although
consumers may notice a deterioration in flavor, color, or texture over
time, they may not associate foodborne illness with consumption of
these products. Therefore, consumers do not seem to associate safety
concerns with the ``keep refrigerated'' or ``refrigerate after
The agency is concerned that consumers may not be aware that some
newer, less traditional, packaged foods need refrigeration to maintain
their safety. Some examples are fresh cut fruits and vegetables, food
packaged in cardboard containers resembling shelf-stable packages (such
as the previously mentioned clam chowder and bean dip), and vacuum or
modified (reduced oxygen) atmosphere packaged products in clear
flexible packaging. Consumer understanding of the significance or
reason for advising that a product be kept refrigerated is likely
hampered by the rapidly expanding marketing of foods having convenient
preparation and ``close to fresh'' product characteristics.
In addition, as previously mentioned, the food industry is
developing new types of foods with extended shelf life (i.e., the
length of time that a product may be stored without deterioration) that
have to be refrigerated. Foods known as ``partially processed'' or
``minimally processed'' may have received a heat process or other
preservation treatment during manufacturing that reduces the
microbiological load in the food but that does not render the food
``commercially sterile.'' These partially processed foods share the
hazard common to all potentially hazardous foods, i.e., ability to
support the growth of pathogens, unless they are refrigerated. Thus, if
only a ``keep refrigerated'' label appears on these types of foods, and
consumers choose not to pay attention to it, the consumers would be
taking a significant risk.
The agency is also concerned about the potential abuse of a
category of products (e.g., low acid canned foods that are not
otherwise preserved) that need refrigeration after being opened. The
potential for temperature abuse of these products may be even greater
than that for foods that need constant refrigeration. These products
are generally displayed in a section of the store that is not
refrigerated, and these products are provided in packaging similar to
foods that do not need refrigeration even after opening. Even though
these shelf-stable foods may bear storage instructions for the unused
portion, the need for refrigeration is frequently not conveyed on the
label, or not conveyed in a way that consumers can see and understand.
Current labeling of shelf-stable packaged foods is not adequate
because the same label statements, e.g., ``keep refrigerated'' or
``refrigerate after opening,'' appear both on foods that are
potentially hazardous and on foods that do not pose a hazard but that
are refrigerated to retard deterioration in quality. The labeling of
potentially hazardous foods that need refrigeration should distinguish
these products from products for which refrigeration is only to protect
quality. FDA is concerned that, without adequate labeling on these
potentially hazardous products, efforts by the food industry to develop
new types of foods with extended shelf life prior to being refrigerated
and while under refrigeration will result in more illnesses.
Further, different formulations and processing methods for
versions of the same food, such as pumpkin pie, may or may not need
refrigeration for safety. In addition, different versions of these
foods can be displayed in different sections of the retail store, with
the ``keep refrigerated'' statement on the version of the food that
needs refrigeration as the only indication that there is a difference
in safety considerations among the versions of the product.
Furthermore, the ``keep refrigerated'' statement often appears in small
print and is placed on an obscure part of the label. Therefore, the
consumer may not understand or interpret the ``keep refrigerated''
statement as an instruction about what must be done to maintain the
safety of the product.
Moreover, ``keep refrigerated'' or ``refrigerate after opening''
statements generally do not include the reason the product is to be
refrigerated. The agency regards it as unlikely that most consumers
know and are able to distinguish the underlying reasons for a ``keep
refrigerated'' label statement when comparing products that bear that
statement to maintain microbiological safety with products that bear
that statement for maintaining quality. Therefore, consumers would have
no reason to consider one such statement any more important for product
safety than another. Thus, the statements ``keep refrigerated'' or
``refrigerate after opening'' alone are not adequate to appropriately
alert consumers to the importance of properly handling potentially
III. Labeling Options Considered
The agency has considered the recommendations offered by CDC,
NACMCF, AFDO, and NFPA. In a memorandum dated February 14, 1995 (Ref.
5), CDC recommended that food labels advising refrigeration should be
reviewed. CDC maintained that labels advising ``keep refrigerated'' may
not be sufficient to warn consumers about the health risks associated
with noncompliance. Further, CDC advised that for foods for which
refrigeration is the only barrier to prevent growth of C. botulinum,
the label should identify the risks of botulism if mishandled.
FDA has also considered the labeling recommendations for foods
requiring refrigeration by consumers that have been offered by NACMCF,
NFPA, and AFDO (Refs. 1, 2, and 4). NACMCF maintained that consumers
have difficulty distinguishing the differences among various label
statements and their relationship to product safety. Therefore, it
recommended that the following label statement be used on packaged food
that poses a safety hazard if temperature abused: ``IMPORTANT MUST BE
Recommendations from NFPA and AFDO recognize two categories of
foods. Group A foods are potentially hazardous, packaged, processed
foods that must be refrigerated for safety reasons, and Group B foods
are products that are intended to be refrigerated but that do not pose
a safety hazard if temperature abused. The recommended label statement
for Group A foods is: ``IMPORTANT: Must Be Kept Refrigerated''.
The recommended label statement for Group B foods is ``keep
refrigerated,'' although such products would be allowed to utilize the
Group A suggested label statement.
A. Analysis of Options
FDA agrees with CDC that the label statement ``keep refrigerated''
may not be sufficient to warn consumers about a health risk. However,
the agency does not agree that the label should specifically identify
the risk of botulism because it is not the only risk if foods that need
refrigeration are temperature abused.
While FDA finds considerable merit in the labeling recommendations
of NACMCF, NFPA, and AFDO, the agency is concerned that these
recommendations do not inform consumers of the reasons for
refrigeration of foods and do not fully differentiate the types of
foods that should bear a ``keep refrigerated'' label. Moreover, the
suggested label statements will not eliminate the confusion generated
by the current voluntary label statements used on foods to be
refrigerated, especially if foods that do not pose a safety hazard are
permitted to bear the same labeling statements as those that do pose a
safety hazard if not refrigerated.
Having considered these recommendations, the agency is recommending
an approach that is somewhat different than those suggested in the
recommendations that it has received. In the agency's view, labeling
will be more effective if it is more specific to the types of hazards
that are presented, and to the types of storage conditions that are
necessary, after the product is opened. In FDA's view, this specificity
is provided if foods that need refrigeration are divided into three
groups. The first group, Group A, are the foods that were in NFPA's and
AFDO's Group A foods that are potentially hazardous and that must be
kept refrigerated for safety reasons. Group B includes foods that are
shelf-stable but that need refrigeration after opening for safety.
Group C (described as Group B foods in the NFPA and AFDO
recommendations) include foods that are refrigerated only to retard
deterioration in quality.
FDA has sought to craft label statements that will help consumers
to differentiate among these types of foods. Phrases such as ``to
maintain safety'' and ``for quality'' are essential in drawing a
distinction between Groups A and B on the one hand and Group C on the
other. Furthermore, the agency agrees with the recommendations of
NACMCF, NFPA, and AFDO that the term ``Important'' would help to
underscore this distinction and to indicate the significance of the
statement. The phrase ``after opening,'' or some similar statement, is
essential to distinguish Group B from Group A.
Thus, the agency considers that the statement ``Important must be
kept refrigerated to maintain safety'' for Group A foods is appropriate
because it can adequately convey to consumers that continued
refrigeration is mandatory to reduce safety risks. Similarly, the
agency considers ``Important must be refrigerated after opening to
maintain safety'' an appropriate label statement for Group B foods
because such foods are shelf-stable and may pose a health hazard only
after opening. In contrast, ``refrigerate for quality'' or ``keep
refrigerated for quality'' for Group C foods is sufficient, in the
agency's opinion, to distinguish this category from Groups A and B and
to inform consumers that refrigeration is only necessary to retard
deterioration in product quality.
B. Labeling Placement and Prominence
In addition to label statements that are focused on the type of
product and the risk it represents, placing the statements on the label
in a way that gives them appropriate prominence is critical to ensuring
that the label statements will be seen, read, and understood. The
placement and prominence guidelines suggested by NFPA are particularly
useful and helpful in this regard. NFPA recommended that the label
statements be set off by the use of hairlines at the top and bottom of
the statement area. The type should: (1) Be on a contrasting
background; (2) utilize a single, easy-to-read style and size; (3) have
at least one point leading (space between two lines of text); and (4)
ensure that letters never touch. On Group A and B foods, the word
``IMPORTANT'' should be in all capital letters, while the remaining
words should use uppercase and lowercase letters, with the first letter
in each word capitalized. The hairlined area should appear on the label
prominently and conspicuously as compared to other words, statements,
designs, or devices. FDA strongly agrees and urges all firms to follow
these recommendations. In addition, the agency notes that its general
approach to type size of label information is that it should be not
less than one-sixteenth inch unless the package is too small to
accommodate this type size. The agency encourages placement of this
statement on the principal display panels, at least for group A and B
foods. If the statement does not fit on the principal display, it
should be placed on the information panel.
C. FDA Labeling Policy
To clarify this guidance, the agency has delineated each of the
three groups and developed model statements for each:
1. Group A Foods
Group A foods are potentially hazardous foods, which, if subjected
to temperature abuse, will support the growth of infectious or
toxigenic microorganisms that may be present. Outgrowth of these
microorganisms would render the food unsafe. Foods that must be
refrigerated for food safety possess the following characteristics: (1)
Product pH > 4.6; (2) water activity aw > 0.85; (3) do not receive
a thermal process or other treatment in the final package that is
adequate to destroy foodborne pathogens that can grow under conditions
of temperature abuse during storage and distribution; and (4) have no
barriers (e.g., preservatives such as benzoates, salt, acidification),
built into the product formulation that prevent the growth of foodborne
pathogens that can grow under conditions of temperature abuse during
storage and distribution.
The appropriate label statement for Group A foods is:
........ IMPORTANT Must Be Kept Refrigerated To Maintain Safety
2. Group B Foods
Group B includes those foods that are shelf-stable as a result of
processing, but once opened, the unused portion is potentially
hazardous unless refrigerated. These foods possess the following
characteristics: (1) Product pH > 4.6; (2) water activity aw >
0.85; (3) receive a thermal process or other treatment that is adequate
to destroy or inactivate foodborne pathogens in the unopened package,
but after opening, surviving or contaminating microorganisms can grow
and render the product unsafe; and (4) have no barriers (for example,
preservatives such as benzoates, salt, acidification) built into the
product formulation to prevent the growth of foodborne pathogens after
opening and subsequent storage under temperature abuse conditions.
The appropriate label statement for Group B foods is:
........ IMPORTANT Must Be Refrigerated After Opening To Maintain Safety
3. Group C Foods
Group C are those foods that do not pose a safety hazard even after
opening if temperature abused, but that may experience a more rapid
deterioration in quality over time if not refrigerated. The
manufacturer determines whether to include on the label a statement
that refrigeration is needed to maintain the quality characteristics of
the product to maximize acceptance by the consumer. These foods do not
pose a safety problem. Foods in this group possess one or more of the
following characteristics to ensure that the food does not present a
hazard if temperature abused: (1) Product pH 4.6 to inhibit
the outgrowth and toxin production of C. botulinum; or (2) water
activity aw 0.85; or (3) have barriers built into the
formulation (for example, preservative systems such as benzoates, salt,
acidification) to prevent the growth of foodborne pathogens if the
product is temperature abused.
The suggested optional label statement for Group C foods is:
``Refrigerate for Quality''
or some other statement that explains to the consumer that the storage
conditions are recommended to protect the quality of the product. To
avoid confusion between refrigeration for safety purposes and
refrigeration for quality reasons, Group A and Group B statements
should not be used on Group C foods.
The agency is publishing this document to provide this guidance by
the quickest means to as many manufacturers as possible, so that they
may begin using the label statements. If manufacturers follow this
guidance, the consumer will have clear, concise, and prominent labeling
information for maintaining the safety of potentially hazardous food
products. Inclusion of these statements in the labeling of appropriate
foods will help the consumer recognize when appropriate storage
temperatures are needed to maintain the safety or quality of those
foods. Such information will reduce the likelihood of temperature abuse
of the food and, consequently, reduce the potential for foodborne
illness and death.
While this guidance is primarily intended to address the need for
safe handling of potentially hazardous foods by consumers, the agency
recognizes that there also is a need for safe handling during the
transportation and distribution of these foods. The Food Safety and
Inspection Service of the U.S. Department of Agriculture and FDA have
jointly published an advance notice of proposed rulemaking in the
Federal Register of November 22, 1996 (61 FR 59372) to solicit comments
on approaches that the two agencies may take to foster safety
improvements in the storage and transportation of potentially hazardous
foods. Therefore, this guidance does not address how foods that need
refrigeration during transportation and storage should be labeled.
IV. Consumer Education
Most consumers are not aware of the hazards associated with
temperature abuse of foods needing refrigeration, especially foods that
use newer, less traditional means of packaging. If firms follow the
guidance set out in this document, it will help consumers to recognize
the difference between the messages, ``refrigerate for safety'' and
``refrigerate for quality.'' The agency recognizes, however, that a
coordinated public education campaign is needed to ensure that
consumers understand the
significance of the differences in these messages. Given the
significance of the underlying problem, FDA intends to undertake an
educational effort, including press releases and consumer pamphlets.
The agency requests the cooperation and assistance of industry and
other private groups in this effort. The agency also requests comments
on additional ways to educate the consumer.
The guidance represented here reflects FDA's current thinking on
safe handling labeling for foods that need refrigeration by the
consumer. This document does not bind FDA and does not create or confer
any rights, privileges, benefits, or immunities for or on any persons.
Interested persons may submit written comments on the guidance to
the Dockets Management Branch (address above). Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in the
brackets in the heading of this document. The guidance and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Recommendations of the National Advisory Committee on
Microbiological Criteria for Foods for Refrigerated Foods Containing
Cooked, Uncured Meat or Poultry Products that are Packaged for
Extended Refrigerated Shelf Life and that are Ready-To-Eat or
Prepared with Little or No Additional Heat Treatment, January 31,
2. Guidelines for the Development, Production, Distribution, and
Handling of Refrigerated Foods, National Food Processors
3. Letter from J. Corby, New York Department of Agriculture and
Markets to A. Dell'Aria, Virginia Department of Agriculture,
September 8, 1995.
4. Memorandum from A. Dell'Aria, AFDO, December 20, 1995.
5. Letter from P. Griffin and R. Tauxe, CDC to K. Wachsmuth,
FDA, February 14, 1995.
Dated: February 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4364 Filed 2-21-97; 8:45 am]
BILLING CODE 4160-01-F