[Federal Register: December 5, 2006 (Volume 71, Number 233)]
[Page 70503-70505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. FSIS 2006-0040]

Product Labeling: Definition of the Term ``Natural''

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of petition and public meeting; request for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
receipt of a petition from Hormel Foods to establish a definition for 
the voluntary claim ``natural'' and to delineate the conditions under 
which the claim can be used on the labels of meat and poultry products. 
The use of the claim ``natural'' is an issue of significant interest to 
the Agency, to industry, and to the public. Therefore, the Agency is 
inviting comments on the issue generally and on the petition and, to 
facilitate the comment process, is announcing that it will hold a 
public meeting to discuss the petition. After the comment period 
closes, FSIS will initiate rulemaking on the claim ``natural.'' The 
Agency has decided to initiate rulemaking because it is the most 
appropriate, open, and transparent method to deal with issues 
surrounding the definition and use of the claim ``natural.''

DATES: The public meeting will be held on Tuesday, December 12, 2006, 
from 9 a.m. to 1 p.m. Comments on this notice must be received by 
January 11, 2007.

ADDRESSES: The public meeting will be held in the rear of the 
Cafeteria, South Agriculture Building, United States Department of 
Agriculture (USDA), 1400 Independence Avenue, SW., Washington, DC 
    FSIS invites interested persons to send comments on this notice. 
FSIS will finalize an agenda on or before the meeting date and will 
post it on the FSIS Internet Web page http://www.fsis.usda.gov/News?Meetings_&_Events/.
 The petition discussed in this notice is 

available for viewing by the public in the FSIS Docket Room (see 
address below) and on the FSIS Web site at: http://www.fsis.usda.gov/News?Meetings_&_Events/.
 The official transcript of the meeting will 

be available for viewing by the public in the FSIS docket room and on 
the FSIS Web site http://www.fsis.usda.gov/News?Meetings_&_Events/ 

when it becomes available.
    Comments on this notice may be submitted by any of the following 
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to FSIS Docket Room, Docket Clerk, USDA, 
FSIS, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 
     Electronic mail: fsis.regulationscomments@fsis.usda.gov.
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulation.gov
 and in the ``Search for Open Regulations'' box, 

select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select FDMS 
Docket Number 2006-0040 to submit or view public comments and to view 
supporting and related materials available electronically.
    All submissions received by mail or electronic mail must include 
the Agency name and docket number 2006-0040. All comments sent in 
response to this document, as well as research and background 
information used by FSIS in developing this document, will be available 
for public inspection in the FSIS Docket Room at the address listed 
above between 8:30 a.m. and 4:30 p.m., Monday through Friday. Comments 
will also be posted on the Agency's Web site at http://www.fsis.usda.gov/regulations_&_policies/regulations_directives_&_notices/index.asp

FOR FURTHER INFORMATION CONTACT: For technical information: Dr. Robert 
C. Post, Director, Labeling and Consumer Protection Staff, Office of 
Policy, Program, and Employee Development, USDA, FSIS, 1400 
Independence Avenue, SW., Washington, DC 20250, (202) 205-0279, FAX: 
(202) 205-3625, e-mail: Robert.Post@fsis.usda.gov.
    Pre-registration for this meeting is recommended. To pre-register, 
please contact Diane Jones by telephone at (202) 720-9692 or be e-mail 
at Diane.Jones@fsis.usda.gov. Persons requiring a sign language 
interpreter or special accommodations should contact Ms. Jones as soon 
as possible.



    FSIS is the public health regulatory agency in the USDA responsible 
for ensuring that the nation's commercial supply of meat, poultry, and 
egg products is safe, wholesome, and truthfully labeled and packaged. 
In particular, FSIS develops and implements national policies to ensure 
that meat, poultry, and egg product labeling is truthful and non-

Labeling Guidance on the Voluntary Claim ``Natural''

    To guide manufacturers in the development of labeling that FSIS was 
likely to determine to be truthful and not misleading with regard to 
the voluntary claim ``natural,'' FSIS published policy guidance in the 
form of Standards and Labeling Policy Memorandum (Memo) 055, dated 
November 22, 1982. The policy guide states that the term ``natural'' 
may be used on labeling for meat products and poultry products provided 
that the applicant for such labeling demonstrates that:
    (1) The product does not contain any artificial flavor or 
flavoring, coloring ingredient, or chemical preservative (as defined in 
21 CFR 101.22), or any other artificial or synthetic ingredient; and 
(2) the product and its ingredients are not more than minimally 
processed. Minimal processing may include: (a) Those traditional 
processes used to make food edible or to preserve it or to make it safe 
for human consumption, e.g., smoking, roasting, freezing, drying,

[[Page 70504]]

and fermenting, or (b) those physical processes that do not 
fundamentally alter the raw product or that only separate a whole, 
intact food into component parts, e.g., grinding meat, separating eggs 
into albumen and yolk, and pressing fruits to produce juices. 
Relatively severe processes, e.g., solvent extraction, acid hydrolysis, 
and chemical bleaching, would clearly be considered more than minimal 
processing. Thus, the Policy Memo explained, the use of a flavor or 
flavoring, for example, that has undergone more than minimal processing 
would, in general, mean that a product in which the ingredient is used 
could not be called ``natural.''
    The Policy Memo acknowledged, however, that there are exceptions to 
this general view, and that the presence of an ingredient that has been 
more than minimally processed would not necessarily preclude a product 
from being promoted as ``natural.'' The Policy Memo stated that 
exceptions of this type would be granted on a case-by-case basis if it 
could be demonstrated that the use of such an ingredient would not 
significantly change the character of the product to the point that it 
could no longer be considered a ``natural'' product. In such cases, the 
``natural'' claim would have to be qualified to clearly and 
conspicuously identify the ingredient, e.g., ``all natural ingredients 
except dextrose, modified food starch, etc.''
    Policy Memo 055 further stated that all products claiming to be 
``natural'' or a ``natural'' food should be accompanied by a brief 
statement that explains what is meant by the term ``natural,'' i.e., 
that the product is a ``natural'' food because it contains no 
artificial ingredients and is only minimally processed. This statement 
should appear directly beneath or beside all ``natural'' claims or, if 
elsewhere on the principal display panel of the label, an asterisk 
should be used to tie the explanation to the claim.
    According to the 1982 policy, the decision of the Agency to approve 
or deny the use of a ``natural'' claim may be affected by the specific 
context in which the claim is made. For example, claims indicating that 
a product is ``natural'' food, e.g., ``natural'' chili or ``chili--a 
``natural'' product'' would be unacceptable for a product containing 
beet powder which artificially colors the finished product. However, 
``all natural ingredients'' might be an acceptable claim for such a 
    Since 1982, except for the conditions in points (1) and (2) of the 
Policy Memo stated above, FSIS modified the guidance on occasion to 
make it consistent with prevailing policies, to reflect case-by-case 
decisions made by the Agency, and to update references to regulations. 
In August 2005, FSIS modified the guidance by acknowledging that sugar, 
sodium lactate (from a corn source), and natural flavorings from 
oleoresins or extractives could be acceptable for products bearing 
``natural'' claims.
    The Agency has come to recognize, based on the controversy that has 
arisen about ``natural'' in recent months, that there is significant 
disagreement about aspects of the August 2005 policy modification, 
particularly the recognition of sodium lactate as an ingredient that 
could be included in products that bear a ``natural'' claim. The Agency 
has received information that raises questions about when, and if, a 
food to which sodium lactate has been added would be fairly 
characterized as ``natural.'' The Agency has come to believe that this 
question, like numerous others alluded to in this document, is best 
resolved through a rulemaking process. Therefore, FSIS has removed the 
reference to sodium lactate from the 2005 modification. As the Agency 
moves through the stages of rulemaking on ``natural,'' ``natural'' 
claims for foods in which sodium lactate is used will continue to be 
considered by FSIS on a case-by-case basis, in light of factors such as 
the level used, the claimed technical effect of the sodium lactate, and 
the actual effect that it is having on the product.

Advances in Food Processing

    In recent years, the longstanding policy on ``natural'' has been 
challenged by advances in food processing and in packaging methods, 
e.g., the use of techniques such as high pressure processing, food 
ingredients that are regulated to provide multiple technical effects, 
and modified atmosphere packaging. The value and integrity of the 1982 
policy is challenged further by new uses of ingredients that have 
previously been used for flavoring purposes, for example, as 
antimicrobial agents. While the food safety purpose of using 
antimicrobial agents is important, their effects raise questions as to 
whether they can be used in products labeled ``natural.''


    On October 9, 2006, Hormel Foods submitted a petition to FSIS for 
rulemaking to codify in the Federal meat and poultry inspection 
regulations a definition of ``natural.'' The petitioner requested that 
FSIS begin rulemaking procedures to clarify the circumstances in which 
the claim may be used on the labeling of a meat or poultry product. The 
petition states that, consistent with FSIS's longstanding policy, a 
meat or poultry product should not be labeled as ``natural'' unless (1) 
It does not contain artificial flavorings, artificial coloring 
ingredients, other artificial or synthetic ingredients, or chemical 
preservatives; and (2) it is not more than minimally processed. The 
petition further states that consumer confidence and consistency in 
labeling dictate that exceptions for specific chemical preservatives 
and synthetic ingredients should not be allowed.
    In support of the need for a regulatory definition of ``natural,'' 
the petition explains that consumer interest and concern in natural 
products are rising. Meat and poultry food manufacturers are seeking to 
establish marketing presence in this growing area of labeling. The 
petitioner cites the difficulty in maintaining a level playing field 
among manufacturers wishing to establish a marketing presence with 
FSIS's acceptance of ingredients such as sodium lactate and the AMS 
National Organic Program ``national list'' of food substances as a 
reference to support that such ingredients may be considered 
``natural.'' According to the petition, as a result, there is a 
significant likelihood of inconsistent guidance that provides an 
opportunity for food manufacturers to manipulate exceptions in the 
policy and to undercut the intent for ``natural'' labeling. The 
petitioner requests that the Agency conduct rulemaking regarding the 
claim ``natural'' to provide clarity and certainty in its use of 
product labeling in the interest of consumer protection and consumer 
confidence in labeling.

Public Meeting

    FSIS is holding a public meeting in order to gain public input on 
the use of the ``natural'' claim and the points raised by the petition, 
the ideas set out in this notice, and the impact of possible changes 
discussed herein. Following the public meeting, the Agency intends to 
initiate rulemaking on ``natural'' claims.
    In order to benefit from this public meeting, FSIS seeks input on 
the following questions concerning the petition discussed above:
    1. Considering the types of food processing methods that are 
commonplace today, as opposed to 24 years ago when the policy on 
``natural'' claims was established, is it reasonable to include as part 
of the definition of ``natural'' a stipulation that products, to be 
eligible to bear the claim, can be no more than minimally processed? 
Are there any accommodations necessary to allow for certain operations 

[[Page 70505]]

food processing and packaging techniques for enhancing safety may 
disqualify a product as ``natural?''
    2. What are the implications and conflicts that exist with regard 
to using current and new food processing methods, e.g., chlorine in 
poultry chillers; steam pasteurization of carcasses; high pressure 
processing; and modified atmosphere packaging and uses of certain 
classes of ingredients, e.g., antimicrobial agents, and the meaning of 
the claim ``natural'' on the labels of meat and poultry products?
    3. Are there available data, in addition to the data provided in 
the petition, from consumer studies on views, perceptions, and beliefs 
about what the claim ``natural'' means on the labels of food products, 
including meat and poultry products? What do consumers think that the 
terms ``minimal processing,'' ``artificial and synthetic,'' and 
``preservatives'' mean?
    4. Do food safety and consumer protection benefits of using what 
historically may have been considered more than minimal processing 
techniques and antimicrobial agents outweigh conflicts with the meaning 
of ``natural?'' In recent years, FSIS has put a great deal of emphasis 
on improving food safety. In some ways, however, some definitions of 
``natural'' might unnecessarily undercut this objective. For example, 
some definitions of ``natural'' could discourage the use of 
antimicrobials, which are used to reduce and prevent the growth of 
Listeria monocytogenes in foods. The Agency seeks comment on how it 
best determines an appropriate and rational balance between the need to 
ensure the safety of the food supply and the need to ensure that labels 
are truthful and not misleading.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it on-line through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations/2006_Notices_Index/. FSIS 

will also make copies of this Federal Register publication available 
through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to constituents 
and stakeholders. The update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade and farm 
groups, consumer interest groups, allied health professionals, and 
other individuals who have asked to be included. The update is 
available on the FSIS Web page. Through the Listserv and Web page, FSIS 
is able to provide information to a much broader and more diverse 
audience. In addition, FSIS offers an e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/.
 Options range from recalls to 

export information to regulations, directives, and notices. Customers 
can add or delete subscriptions themselves and have the option to 
password protect their account.

    Done at Washington, DC on: December 1, 2006.
Barbara J. Masters,
[FR Doc. 06-9546 Filed 12-1-06; 2:25 pm]