[Federal Register Volume 62, Number 36 (Monday, February 24, 1997)]
[Notices]
[Pages 8248-8252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96D-0513]


Guidance on Labeling of Foods That Need Refrigeration by 
Consumers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

SUPPLEMENTARY INFORMATION:

I. Background

    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 
foodborne illness.
    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 
<ls-thn-eq> 4.6), use of preservatives, such as salt, and low water 
activity (a<INF>w <ls-thn-eq> 0.85). Barriers used individually, or in 
combination with each other, may reduce or retard pathogenic microbial 
growth.
    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 
airtight

[[Page 8249]]

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 
stored unrefrigerated.
    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 
labeling.
    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 
opening'' statements.
    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 
different

[[Page 8250]]

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 
hazardous foods.

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 
KEPT REFRIGERATED''.
    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

[[Page 8251]]

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 a<INF>w > 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:


                                                                                                                                                        
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  ........  IMPORTANT  Must Be Kept Refrigerated To Maintain Safety                                                                                     
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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 a<INF>w > 
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:


                                                                                                                                                        
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  ........  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 <ls-thn-eq> 4.6 to inhibit 
the outgrowth and toxin production of C. botulinum; or (2) water 
activity a<INF>w <ls-thn-eq> 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

[[Page 8252]]

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.

V. References

    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, 
1990.
    2. Guidelines for the Development, Production, Distribution, and 
Handling of Refrigerated Foods, National Food Processors 
Association, 1989.
    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