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[Federal Register Volume 74, Number 176 (Monday, September 14, 2009)]
[Proposed Rules]
[Pages 46951-46957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22036]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. FSIS 2006-0040A]

Product Labeling: Use of the Voluntary Claim ``Natural'' in the 
Labeling of Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing this 
Advance Notice of Proposed Rulemaking (ANPR) to assist the Agency in 
defining the conditions under which it will permit the voluntary claim 
``natural'' to be used in the labeling of meat and poultry products. 
After considering comments on the ``natural'' claim submitted by the 
public in response to a Federal Register notice that the Agency issued 
on December 5, 2006, and the comments presented at a public meeting 
held by the Agency on December 12, 2006, FSIS has decided to solicit 
additional public input. FSIS has concluded that a further solicitation 
of comments could produce information that would help to clarify and 
resolve the issues surrounding the ``natural'' claim. Moreover, 
additional comment will help FSIS to assess how best to coordinate its 
regulation of ``natural'' claims with the standards for voluntary 
marketing claims developed by the Agricultural Marketing Service (AMS), 
particularly with AMS's ``naturally raised'' marketing claim standard.

DATES: Comments are due by November 13, 2009.

ADDRESSES: Comments may be submitted by one of the following methods:
    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.regulations.gov 
and, in the ``Search for Open Regulations'' box, select ``Food Safety 
and Inspection Service'' from the agency drop-down menu, and then click 
on ``Submit.'' In the Docket ID column, select FDMS Docket Number FSIS-
2006-0040A to submit or view public comments and to view supporting and 
related material available electronically. This docket can be viewed 
using the ``Advanced Search'' function in Regulations.gov.
    Mail, including floppy disks or CD-ROMs, and hand or courier-
delivered items: Send to FSIS, OPPD, Docket Room, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 5601 Sunnyside Avenue, 
Room 2-2127, Beltsville, Maryland 20705.
    All submissions received by mail and electronic mail must include 
the Agency name and docket number FSIS-2006-0040A. All comments 
submitted in response to this notice 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. The comments also will 
be posted to the regulations.gov Web site and on the Agency's Web site 
at: http://www.fsis.usda.gov/regulations_&_policies/2009_Notices_Index/index.asp.

FOR FURTHER INFORMATION CONTACT: Sally Jones, Acting Director, Labeling 
and Program Delivery Division, Office of Policy and Program Development 
USDA, FSIS, 5601 Sunnyside Avenue, Beltsville, Maryland 20705, (202) 
205-0623, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 46952]]

I. Background

    FSIS is the public health regulatory agency in the USDA that is 
responsible for ensuring that the nation's commercial supply of meat, 
poultry, and egg products is safe, wholesome, and accurately labeled 
and packaged. FSIS develops and implements regulations and policies to 
ensure that meat, poultry, and egg product labeling is not false or 
misleading. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
601, 607) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 
451, 457), the labels of meat and poultry products must be approved by 
the Secretary of Agriculture, who has delegated this authority to FSIS, 
before these products can enter commerce.
    Pursuant to its authority under the FMIA and PPIA, FSIS has 
established a framework of regulations and policies within which to 
judge whether labels and other labeling of meat and poultry products 
are not false or misleading.
    To guide manufacturers in the development of labeling that FSIS is 
likely to determine to be not false or misleading with regard to the 
voluntary claim ``natural,'' FSIS first issued policy guidance in the 
form of Standards and Labeling Policy Memorandum (Memo) 055, dated 
November 22, 1982. Policy Memo 055 stated that the term ``natural'' may 
be used in the labeling of meat 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, to preserve it, or to make it safe 
for human consumption, e.g., smoking, roasting, freezing, drying, 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 constitute more than minimal processing.
    Policy Memo 055 also provided that the use of an ingredient that 
has undergone more than minimal processing in general precludes a 
product in which the ingredient is used from bearing an unqualified 
``natural'' claim. Policy Memo 055 stated that FSIS will evaluate label 
submissions on a case-by-case basis, however, and may approve a label 
if the manufacturer of the product demonstrates that the use of such an 
ingredient does not significantly change the character of the product 
provided the ``natural'' claim is clearly and conspicuously qualified 
to identify the ingredient.
    Policy Memo 055 also provided that all products that claim 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. In addition, 
the 1982 policy also stated that 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 that a product 
is a ``natural'' food, e.g., ``natural'' chili, would be unacceptable 
for a product that contains beet powder, an ingredient that has a 
``natural'' source but that artificially colors the finished product. 
However, ``all natural ingredients'' might be an acceptable claim for 
such a product.
    Since 1982, FSIS has updated its guidance on the use of ``natural'' 
claims to reflect case-by-case decisions made by the Agency and to 
revise references to regulations. In August 2005, FSIS rescinded Policy 
Memo 055 and incorporated its policy on ``natural'' claims into an 
entry in its Food Standards and Labeling Policy Book (the Policy Book) 
(available on the FSIS Web site at: http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf. The 2005 Policy Book 
entry modified FSIS's ``natural'' policy to add a note that 
acknowledged that ``[s]ugar, sodium lactate (from a corn source) [at 
certain levels], and natural flavorings from oleoresins or extractives 
are acceptable for `all natural' claims.''
    In late 2006, FSIS received information that raised questions about 
its initial judgment that the use of sodium lactate at levels 
consistent with those approved for flavoring (i.e., up to two percent 
of product formulation) was consistent with the meaning of ``natural.'' 
More specifically, the information provided to the Agency indicated 
that sodium lactate, as well as potassium lactate and calcium lactate, 
may provide an antimicrobial effect at levels that have been approved 
for flavoring. The Agency concluded that listing ``sodium lactate (from 
a corn source)'' in the 2005 entry may have been in error. In December 
2006, FSIS modified the ``natural'' claims entry in the Policy Book to 
remove the 2005 reference to sodium lactate. The current entry in the 
Policy Book provides that the use of sodium lactate or any ingredient 
known to have multiple technical effects in products labeled as 
``natural'' will be evaluated on a case-by-case basis at the time of 
label approval to assess whether the intended use, level of use, and 
technical function of the ingredient are consistent with the 1982 
policy.

II. Hormel Petition

    On October 9, 2006, Hormel Foods submitted a petition to FSIS 
requesting that the Agency initiate rulemaking to establish a codified 
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 petition requests that, consistent with FSIS's 
longstanding policy on ``natural,'' 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 issues 
of consumer confidence and consistency in labeling dictate that 
exceptions for specific chemical preservatives and synthetic 
ingredients should not be allowed. The petition focused on the 2005 
Policy Book entry's references to the use of sodium lactate (from a 
corn source).
    A copy of the 2006 Hormel petition is available for viewing by the 
public in the FSIS docket room and on the FSIS Web site at: http://www.fsis.usda.gov/Regulations_&_Policies/Petition_Natural_Label_Claims/index.asp.

III. Federal Register Notice and Public Meeting

    The use of the claim ``natural'' is a marketing issue of 
significant interest to FSIS, to industry, and to the public. 
Therefore, on December 5, 2006, FSIS published in the Federal Register 
a notice to inform the public of the October 2006 petition from Hormel 
and to announce a public meeting to discuss the petition (71 FR 70503). 
The notice also requested comments on the petition and on the use of 
the claim ``natural'' in general. The notice explained that FSIS had 
removed the 2005 reference to sodium lactate (from a corn source) from 
its ``natural'' claims policy and that with respect to ``natural'' 
claims FSIS would consider the use of sodium lactate and other 
ingredients with multiple

[[Page 46953]]

functional effects on a case-by-case basis at the time of label 
evaluation.
    The public meeting on ``natural'' was held on December 12, 2006, in 
Washington, DC (transcripts available for viewing by the public in the 
FSIS docket room and on the FSIS Web site at http://www.fsis.usda.gov/PDF/Natural_Claims_Transcripts.pdf). The comment period on the 
petition and the claim ``natural'' closed on January 11, 2007, but FSIS 
re-opened and extended the comment period to March 5, 2007 (72 FR 
2257).

IV. Issues Raised by the Comments and Other Issues Associated With 
FSIS's ``Natural'' Policy

    FSIS received over 12,000 comments on issues discussed in the 
December 2006 Federal Register notice and at the December 2006 public 
meeting. The Agency also received petitions requesting that it take 
action with regard to ``natural'' claims that differ from the action 
requested in the Hormel petition. Because the actions requested in 
these petitions raise the same issues as those raised by the comments, 
FSIS will address these petitions as if they were comments.
    Most of the comments were identical letters submitted 
electronically by individuals that identified themselves as members of 
the Truthful Labeling Coalition (TLC), a coalition of chicken producers 
and private citizens concerned about the labeling of fresh poultry. 
These comments objected to the use of flavoring, tenderizing, and 
seasoning solutions to enhance poultry products bearing the ``natural'' 
claim. The TLC also submitted a petition dated July 27, 2007, that 
requests that FSIS take immediate action to prohibit the use of 
``natural'' claims on the labels on poultry products enhanced with 
flavorings and other solutions.
    FSIS received 92 comments and three petitions that raised 
additional issues associated with ``natural'' claims. The comments and 
petitions were submitted by industry, trade associations representing 
industry, animal welfare advocacy organizations, private citizens, 
consumer advocacy organizations, researchers, consultants, and law 
firms representing industry.
    The comments expressed divergent views on what the claim 
``natural'' as applied to meat and poultry products should mean and, in 
general, focused on particular ingredients, processing methods, and 
animal production practices that individual commenters felt should or 
should not be permitted for meat or poultry products labeled as 
``natural.'' In addition, several comments disagreed with the request 
in the Hormel petition that FSIS establish a codified definition for 
``natural.'' These comments suggested alternative approaches for 
addressing issues surrounding ``natural'' claims.
    The comments indicate that there is an overall lack of consensus on 
both the general or common understanding of what the claim ``natural'' 
means to the industry and to the public and on the approach that FSIS 
should take to address issues associated with the use of ``natural'' 
claims on the labels of meat and poultry products. Nonetheless, FSIS 
has concluded that a further solicitation of comments could produce 
information that would help to clarify and resolve the issues 
surrounding the ``natural'' claim. Therefore, to better focus the 
public input submitted in response to this ANPR, FSIS is requesting 
comments on the issues described below.

1. The Need for Rulemaking

    The comments submitted in response to the December 2006 Federal 
Register notice and presented at the 2006 public meeting indicate that 
there is significant disagreement on whether FSIS should resolve issues 
surrounding ``natural'' claims through the rulemaking process.
    Some comments agreed with the Hormel petition and supported 
rulemaking to clarify and codify requirements for the use of 
``natural'' claims. The comments stated that the only way to resolve 
issues associated with ``natural'' claims is to issue clear rules that 
can be applied consistently. Some comments stated that issues on 
whether certain ingredients should be allowed in meat or poultry 
products labeled as ``natural'' should be resolved through a 
transparent rulemaking process.
    Other comments objected to rulemaking to address issues associated 
with ``natural'' claims. Several comments suggested that FSIS decline 
to codify the definition of ``natural,'' as requested in the Hormel 
petition, and maintain a flexible policy on the use of ``natural'' 
claims instead. Sara Lee, a manufacturer of meat and poultry products, 
submitted a petition requesting that FSIS adopt a flexible policy on 
``natural'' claims that provides for case-by-case consideration of the 
use of the claims on the labeling of meat and poultry products as 
opposed to a static, fixed definition adopted through notice-and-
comment rulemaking.
    The comments that opposed rulemaking stated that determining 
whether a ``natural'' claim on the label of a meat or poultry product 
is not false or misleading often depends on the context in which the 
claim is used. According to the comments, because the number of uses of 
the claim ``natural'' that are not false or misleading cannot be 
captured in a single, static regulation, FSIS must maintain a flexible 
policy that will allow the Agency to evaluate a proposed use of the 
claim on a case-by-case basis.
    Some comments stated that a codified definition of ``natural'' is 
unnecessary and would restrict FSIS's ability to update its ``natural'' 
claims policy to address new technologies and changes in consumer 
expectations. Several comments noted that prior attempts by other 
Federal agencies to establish regulations to define ``natural'' as it 
applies to foods have proven unsuccessful.
    To address these concerns, it would be possible for FSIS to 
continue to resolve issues surrounding ``natural'' claims by 
maintaining its current approach based on the current, or a revised, 
guidance document.
    As many of the comments noted above indicate, determining whether a 
``natural'' claim on the label of a meat or poultry product is not 
false or misleading may often depend on the context in which the claim 
is used. Thus, these comments seem to suggest that FSIS should not 
define natural by adopting a rigid, static definition, but instead 
consider an approach that would allow manufacturers of meat and poultry 
products to use the ``natural'' claim on their labels in a manner 
consistent with Agency guidance as long as they explain clearly on the 
label why their proposed use of a ``natural'' claim appropriately 
applies to their particular product. The ``natural'' claim and 
explanation would continue to be subject to premarket, case-by-case 
approval by FSIS.
    This approach would give manufacturers of meat and poultry products 
flexibility to use a ``natural'' claim to reflect specific 
characteristics of different products, so long as they accurately 
explain on the label why this term fairly characterizes their product. 
The information provided on the product label would allow consumers to 
determine whether the ``natural'' claim, as explained or qualified by 
the product label, is consistent with the characteristics that the 
consumer expects from a ``natural'' meat or poultry product.

2. Sodium Lactate and Other ``Multi-Functional'' Ingredients and Food 
Safety

    FSIS received several comments on the use of sodium lactate and 
other multi-functional ingredients in ``natural'' meat and poultry 
products. As discussed above, in late 2006, FSIS

[[Page 46954]]

received information to indicate that sodium lactate, as well as 
potassium lactate and calcium lactate, may provide antimicrobial 
effects at levels approved for their flavoring effect. FSIS also 
received comments suggesting that additional multi-functional 
ingredients, such as sodium citrate, distilled vinegar, fruit juice 
concentrates, and sea salt, may present similar issues for the Agency's 
``natural'' policy. Like sodium lactate, these substances serve 
technical purposes that at certain levels and under certain conditions 
would preclude the use of ``natural'' labeling under the Agency's 
policy on the claim.
    Several comments stated that FSIS should not preclude products 
containing ingredients that have multi-functional effects from 
qualifying for the ``natural'' claim. The comments maintained that the 
term ``chemical preservative'' as used in FSIS's natural policy refers 
to synthetic or artificial preservative, not natural ingredients with 
preservative effects. The comments asserted that sodium lactate (from a 
corn source) and certain other lactates are ``natural'' ingredients 
that should be permitted in meat and poultry products labeled as 
``natural'' regardless of their technical effects.
    Some comments stated that ingredients that have both flavoring and 
antimicrobial effects are greatly needed in the manufacturing of large 
food quantities to enhance both food safety and quality. The comments 
stated that ingredients that have both flavoring and antimicrobial 
effects provide food processors with interventions that are needed to 
help ensure public health. Other comments acknowledged that while 
antimicrobial agents can serve important food safety purposes, these 
ingredients nonetheless raise concerns as to whether they can be used 
in products labeled as ``natural.''
    An issue raised by the comments, therefore, is whether it would be 
appropriate in approving ``natural'' claims to distinguish ingredients 
used for their antimicrobial effects to inhibit the growth of 
pathogenic organisms, such as Listeria monocytogenes, from those used 
for preservative effects. This distinction is implicit in the 
definition of ``chemical preservative'' in 21 CFR 101.22(a)(5) and in 
FSIS's definition of ``chemical preservative'' in 9 CFR 301.2, which 
provide that a ``chemical preservative'' is ``any chemical that, when 
added to a food, tends to prevent or retard deterioration thereof * * * 
.''
    The preservative technical effect is to retard or prevent 
deterioration of food, and this effect is achieved by preventing the 
outgrowth of microorganisms that produce off-odors and discolor food as 
the food ages. Based on data that FSIS has received, however, some 
companies add substances with antimicrobial effects to their products 
not to achieve effects on spoilage organisms but to impart flavor and 
to inhibit the outgrowth of the pathogen Listeria monocytogenes that 
may be present in the product.
    These companies submitted data to demonstrate that the ingredient's 
primary purpose is for flavoring, with a potential added benefit of 
preventing the outgrowth of Listeria monocytogenes, and not to prevent 
or retard deterioration of the product. The data submitted show that 
products containing the ingredient have the same ``sell by/use by'' 
date as products with the same formulation except the antimicrobial 
ingredient, and that both products have a similar outgrowth of spoilage 
organisms over time. These companies have argued, therefore, that under 
these circumstances, the product should be eligible to bear the 
``natural'' claim.
    While FSIS evaluates this and other issues discussed in this notice 
and the comments submitted in response to it, the Agency will continue 
to evaluate and approve ``natural'' claims in the labeling of products 
that contain multi-functional ingredients on a case-by-case basis. 
Firms seeking FSIS approval of a ``natural'' claim for a product that 
includes a multi-functional ingredient like sodium lactate would need 
to substantiate the claim with, among other evidence, a showing that 
the ingredient is not being used to extend the product's shelf life.

3. Separate Claims for ``Natural'' Products and ``Natural Ingredients''

    Several comments suggested that FSIS establish criteria for 
separate and distinct claims for (a) ``natural'' products and (b) 
products with ``natural ingredients.'' According to these comments, 
meat and poultry products that meet the conditions specified in the 
``natural'' claims entry in the Policy Book should be permitted to bear 
the claim ``natural'' on their labels, while meat and poultry products 
that simply contain no artificial or synthetic ingredients should be 
permitted to bear the claim ``natural ingredients'' on their labels. 
Some comments suggested that FSIS permit meat and poultry products that 
contain ingredients that comply with FDA's definition of ``natural 
flavor'' or ``natural flavoring'' in 21 CFR 101.22(a)(3) to bear the 
claim ``natural ingredients'' regardless of the ingredient's technical 
effects or whether the ingredient is considered to be ``minimally 
processed.''

4. ``Non-Traditional'' Food Processing Methods

    Several comments noted that many types of processing methods that 
are in use today did not exist 25 years ago when FSIS first established 
its policy on ``natural.'' The comments stated that many of these 
processing methods, such as steam pasteurization, ultra pasteurization, 
modified atmosphere packaging, and high pressure processing, enhance 
the safety and quality of meat and poultry product without altering the 
basic nature of the food and thus should be permitted to be used on 
products labeled as ``natural.'' The comments suggested that FSIS 
consider a meat or poultry product to be ``minimally processed'' based 
on the processing method's impact on the food rather than the 
complexity of the processing technology and equipment. Several comments 
supported allowing the use of high pressure processing on meat and 
poultry products labeled as ``natural.''
    Other comments questioned whether advanced processing technologies, 
such as high-pressure pasteurization, should be considered minimally 
processed regardless of their effects on the composition of the 
finished product. Some comments presented results from focus groups and 
consumer surveys that, according to the comments, indicate that the 
consumers do not have a clear understanding of what ``minimally 
processed'' means. The comments suggested that FSIS either clarify what 
minimally processed means or eliminate the minimal processing component 
of its ``natural'' claims policy.
    While it considers the comments submitted on this issue, FSIS will 
continue to evaluate the use of ``non-traditional'' processing methods 
on products labeled as ``natural'' on a case-by-case basis. FSIS is 
likely to find that a product that has undergone a ``non-traditional'' 
processing method to be ``minimally processed'' if the manufacturer of 
the product demonstrates: (1) That the processing method functions in a 
manner that is similar to one of the traditional processes described in 
``natural'' claims entry of the Policy Book, and (2) that a meat or 
poultry product that has been subjected to the non-traditional process 
has the same basic characteristics as a product that has not undergone 
such a process.

5. ``Enhanced'' Products

    FSIS received over 12,000 electronic form letters from individuals 
stating that they are members of the TLC that

[[Page 46955]]

expressed the view that poultry products containing added solutions 
(i.e., ``enhanced'' poultry) should not be labeled as ``natural'' 
because, according to the comments, ``natural'' products are not 
injected with solutions containing water, salt, flavorings, seasonings, 
tenderizing agents, and water-binding ingredients, such as the seaweed 
extract carrageenan. As noted above, the TLC also submitted a petition 
dated July 27, 2007, requesting that FSIS take immediate action to 
prohibit the use of ``natural'' claims on the labels of ``enhanced'' 
poultry products. The petition includes results from consumer surveys 
that, according to the petition, demonstrate that a majority of 
consumers believe that ``enhanced'' products should not be labeled as 
``natural.''
    Other comments suggested that FSIS establish two categories for 
``natural'' claims associated with raw poultry products. The comments 
proposed that raw, single-ingredient poultry products that are not 
otherwise marinated, seasoned, injected, or otherwise ``enhanced'' 
could be labeled as ``natural,'' while raw poultry products that have 
been enhanced with ``natural'' ingredients could bear claims such as 
``Made with All Natural Ingredients'' or ``Enhanced with All Natural 
Ingredients.''
    ``Enhanced'' products are products to which marinades/flavoring/
tenderizing solutions have been added. Enhanced poultry products are 
widely sold and may bear ``natural'' claims because all of their 
ingredients are ``natural.'' On a commercial scale, manufacturers of 
poultry products are not likely to use a bowl, pan, or any of the other 
common household methods used by consumers to marinate poultry.
    For years, meat and poultry product manufacturers have used various 
techniques to infuse marinade and other solutions containing 
flavorings, seasonings, tenderizing agents, water, salt, and other 
ingredients, such as starches and seaweed extractives, that help hold 
the moisture in the product. FSIS labeling policies have been updated 
over time in light of techniques in commercial operations where 
flavoring and seasoning marinades and solutions are added to poultry 
and meat products using tumbling and ``needling'' mechanisms. For 
example, to ensure that the labeling of meat and poultry products to 
which solutions are added bears a truthful, descriptive product 
designation as provided in 9 CFR 317.2(c)(1) and 9 CFR 381.117(a), the 
traditional product name must be supplemented with an adjacent 
qualifier that informs the consumer of the presence of the solution in 
the product. Examples of such statements are ``Chicken Breast with up 
to 15% of a Flavoring Solution'' and ``Turkey Cutlets Enhanced with 10% 
of water, salt, spices, and carrageenan.'' In addition, FSIS's 
regulations require that all ingredients added to poultry and meat 
products be listed in the ingredients statement on labeling (9 CFR 
317.2, 9 CFR 381.118).
    Thus, the labels of ``enhanced'' meat and poultry products are 
required to contain information to inform consumers that the product 
contains added solutions. However, many comments submitted on this 
issue, as well as the TLC petition, maintain that this required 
supplemental labeling feature does little to prevent consumers from 
believing that they are purchasing fresh, single-ingredient chicken 
because it is typically not prominently displayed on the product label.

6. ``Natural'' and Animal Production Conditions

    Several comments stated that ``natural'' claims on the labels of 
meat and poultry products should reflect the conditions under which 
animals used to produce these products were raised. Most of these 
comments stated that meat and poultry products from animals that have 
been genetically altered, treated with hormones, or fed prophylactic 
antibiotics should not qualify to be labeled as ``natural.'' The 
comments also asserted that products from animals raised under 
intensive confinements that were unable to engage in their natural 
behavior should not be labeled as ``natural.'' FSIS received these 
types of comments from both consumers and producers of meat and poultry 
products.
    In addition, Farm Sanctuary, a farm animal advocacy organization, 
petitioned the Agency to prohibit the claim ``natural'' on all meat and 
poultry products or, in the alternative, to work with USDA's 
Agricultural Marketing Service (AMS) to codify an expanded definition 
of ``natural'' that addresses the treatment and living conditions of 
animal raised for food before their slaughter. The petition includes 
the results of a nation-wide consumer survey that, according to the 
petition, indicates that consumers are confused about what ``natural'' 
claims on the labels of meat and poultry products mean and believe that 
the claim relates to the treatment of an animal while alive.
    Several comments suggested that FSIS work with USDA's AMS to 
develop a ``naturally raised'' claim for meat and poultry products that 
reflects the animal production practices. Other comments, as well as 
the Farm Sanctuary petition, asserted that establishing separate claims 
for ``natural'' and ``naturally raised'' would be confusing to 
consumers, and that FSIS, in consultation with AMS, should establish a 
single ``natural'' claim that encompasses the treatment and living 
conditions of animals raised for food prior to slaughter, as well as 
post-slaughter processing.
    FSIS has regarded the claim ``natural,'' when used on the labels of 
meat and poultry products, as one that is intended to reflect the 
characteristics of the finished product and, unlike the claim 
``naturally raised,'' one that is not intended to encompass animal 
production practices. AMS as well has viewed ``natural'' as a distinct 
and different claim from its ``naturally raised'' marketing claim 
because ``natural'' has been considered as a post-harvest processing 
claim, while ``naturally raised'' has been viewed as a claim that 
pertains to pre-harvest production practices.
    On January 21, 2009, AMS published in the Federal Register, a 
voluntary standard for ``naturally raised'' livestock and meat 
marketing claims (74 FR 3541). The standard addresses the circumstances 
in which a ``naturally raised'' claim could be made for the production 
of livestock used in meat and meat products. The naturally raised 
marketing claim standard states that livestock used for the production 
of meat and meat products have been raised entirely without growth 
promotants and antibiotics (except ionophores used as a coccidiostatic 
for parasite control), and have never been fed animal by-products 
derived from the slaughter/harvest process or from animal waste.
    AMS and FSIS are carefully evaluating the comments submitted to 
FSIS and AMS addressing this issue, including the views expressed at 
the recent public meeting on animal raising claims (73 FR 60228, 
October 10, 2008). Several participants at the public meeting urged the 
agencies to work together on labeling claims such as ``natural'' and 
``naturally raised,'' and AMS and FSIS are, in fact, collaborating to 
achieve a consistent USDA approach to these issues.
    AMS' voluntary standard for ``naturally raised livestock'' was 
adopted to establish conditions for the raising of livestock that AMS 
will verify to increase the value of the livestock and of the meat and 
meat products derived from them. After consideration of the comments 
received with regard to the AMS ``naturally raised'' standard and of 
the views expressed at the public

[[Page 46956]]

meeting on ``raising'' claims held by the two agencies, AMS and FSIS 
have mutually determined that the application of the ``naturally 
raised'' claim to meat and meat products warrants further evaluation by 
the agencies as well as further input from all interested parties. 
FSIS, in cooperation with AMS, will evaluate the ``naturally raised'' 
claim in the context of its consideration of the broader issues 
presented by ``natural'' claims on meat and poultry products. 
Accordingly, FSIS does not intend, at this time, to approve ``naturally 
raised livestock'' claims for meat or meat products based solely on the 
AMS certification to its ``naturally raised'' standard. Nonetheless, 
FSIS will evaluate all requests for ``naturally raised'' claims on a 
case-by case basis.
    AMS and FSIS continue to believe that certification by AMS to the 
``naturally raised'' standard provides appropriate support for claims 
for livestock and thus can enhance the value of such livestock when 
marketed by producers. Accordingly, AMS will continue to offer 
livestock producers the opportunity to use the ``naturally raised'' 
claim, verified by AMS, to market their animals.

7. Establish a Uniform Federal Definition of ``Natural''

    Many comments, as well as the petition submitted by Sara Lee, 
suggested that USDA and FDA work together to create a consistent 
meaning for the ``natural'' claim for both agencies. Some comments 
proposed that both FSIS and FDA define ``natural'' based on the 
conditions that were first described in FSIS Policy Memo 055. Other 
comments proposed that FSIS model its ``natural'' policy after FDA's 
definition of ``natural flavor'' in 21 CFR 101.22(a), which does not 
include a ``minimally processed'' component. One comment encouraged 
FSIS to coordinate with FDA in the development of its ``natural'' 
claims policy but stated that it is not imperative for the two agencies 
to have the same policy. One comment also suggested that FSIS work with 
the Alcohol and Tobacco Trade and Taxation Bureau (ATTB), in 
consultation with the Federal Trade Commission (FTC), to develop a 
single working definition of the term ``natural'' for food and beverage 
products.

8. Carbon Monoxide

    Although FSIS did not receive comments on this issue, some 
processing establishments and producers have expressed interest in 
using carbon monoxide in modified atmosphere packaging systems for meat 
products labeled as ``natural.'' Carbon monoxide is used to stabilize 
the naturally occurring red color pigment of meat. Proponents of this 
technology have expressed support for the use of carbon monoxide in 
``natural'' products because carbon monoxide is a naturally occurring 
gas and acts to form a naturally occurring red meat color that 
dissipates after the product is removed from packaging.
    Although carbon monoxide is a Generally Recognized as Safe (GRAS) 
and suitable substance in modified packaging systems, FSIS considers 
the use of this technology as inconsistent with its policy on 
``natural.'' The Agency's view has been that the process used to add 
carbon monoxide to product packages represents more than minimal 
processing. FSIS continues to believe that the control system required 
in modified atmosphere processing using carbon monoxide, such that no 
more than 0.4% carbon monoxide is added, is too complex to support a 
``natural'' claim.

V. Issues for Comment

    FSIS issued the December 5, 2006, Federal Register notice and held 
the December 12, 2006 public meeting, to solicit public comments on 
what the voluntary labeling claim ``natural'' should mean when applied 
to meat and poultry products to inform the development of a proposed 
rule regarding the ``natural'' claim. However, the comments demonstrate 
that there is a lack of industry and public consensus on the meaning of 
``natural.'' Therefore, FSIS is not prepared at this time to issue a 
proposed rule to establish a regulatory definition for the claim. 
Instead, the Agency is publishing this ANPR to solicit further public 
comment. During the pendency of this process, the Agency will continue 
to apply its ``natural'' claims policy described in the Policy Book.
    To inform this process, FSIS requests comments on the following 
issues raised in this document.

1. Alternatives to Rulemaking

     In light of the concerns expressed by the comments that 
disagreed that FSIS should establish a codified definition for 
``natural,'' the Agency requests comments on whether it should proceed 
to develop a proposed regulation, or use this proceeding to develop an 
updated ``natural'' claims policy.
     If commenters think that FSIS should not promulgate a rule 
to define ``natural,'' the Agency requests comments on whether it 
should continue to resolve issues associated with ``natural'' claims by 
relying on the existing or a revised policy document on ``natural'' 
claims, and if so, whether it should consider adopting the more 
flexible approach described earlier in this document in which, instead 
of defining ``natural,'' the Agency would approve the labels of meat or 
poultry products bearing a ``natural'' claim if the claim is 
accompanied on the label by a truthful statement that clearly explains 
what ``natural'' means as applied to a particular product.

2. Sodium Lactate and Other Multifunctional Ingredients

     FSIS requests comments on whether it should develop a 
policy on ``natural'' claims in which the Agency would continue to 
distinguish products that use ingredients for their antimicrobial 
effects to inhibit the growth of pathogenic organisms, such as Listeria 
monocytogenes, from products that use the same ingredients for 
preservative effects when evaluating labels that contain ``natural'' 
claims.
     FSIS also requests comments on whether it would be more 
appropriate for the labeling of a meat or poultry product that contains 
multi-functional ingredients derived from ``natural'' sources, such as 
sodium lactate from a corn source, to bear an ``all natural 
ingredients'' claim rather than a ``natural'' claim.

3. ``Non-Traditional'' Food Processing Methods

     Given the advances in food processing and packaging 
technologies that have occurred since Policy Memo 055 was first issued, 
FSIS requests comments on whether it should continue to permit more 
complex processes to be used on meat and poultry products labeled as 
``natural'' if the process does not change the basic characteristics of 
the product.
     The Agency also requests comments on whether some of the 
more complex processes qualify as ``minimal processing'' under the 
Agency's established ``natural'' policy, and, if not, whether the 
Agency should revise the policy to allow the use of such processes on 
products labeled as ``natural.''

4. ``Enhanced'' Products

     Given the significant interest in the use of ``natural'' 
claims in the labeling of ``enhanced'' products, FSIS requests comments 
on whether it should approve a ``natural'' claim on meat and poultry 
products that have been enhanced with solutions that contain 
``natural'' ingredients.
     FSIS also requests comments on whether it would be more 
appropriate

[[Page 46957]]

for raw meat and poultry products enhanced with ``natural'' ingredients 
to be allowed to bear an ``all natural ingredients'' claim instead of a 
``natural'' product claim.
     Finally, because of the large number of comments that 
objected to the addition of ingredients to meat and poultry products 
labeled as ``natural,'' FSIS requests comments on whether the claim 
``natural'' should refer only to raw, single-ingredient meat and 
poultry products, i.e., cuts of meat and poultry and ground meat and 
poultry.

5. Natural and Naturally Raised

     Given the number of comments that suggested that the claim 
``natural'' as applied to meat and poultry products should encompass 
the conditions under which the source animals for these products were 
raised, FSIS requests comments on the issue and on how FSIS and AMS can 
best achieve a consistent approach to the claims ``natural'' and 
``naturally raised.''
     FSIS also requests comment on whether the Agency should 
adhere to its traditional view that the claim ``natural'' relates only 
to the finished meat or poultry product and not factor in how the 
source livestock or poultry are raised.

6. Carbon Monoxide

     FSIS requests comments on whether the Agency's position 
regarding the use of carbon monoxide in the packaging of meat products 
is appropriate and should continue to be applied in evaluating requests 
for approval of ``natural'' claims.

7. Economic Effects

     FSIS requests comments on the potential economic effects 
and burdens of the various approaches on the use of ``natural'' claims 
that were presented in this document.
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 
document, FSIS will announce it online through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/2009_Notices_Index/index.asp. 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, health 
professionals, and other individuals who have asked to be included. The 
Update is available on the FSIS Web page. Through the Listserv and the 
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 that 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 accounts.

    Done at Washington, DC, on September 9, 2009.
Alfred V. Almanza,
Administrator.
[FR Doc. E9-22036 Filed 9-11-09; 8:45 am]
BILLING CODE 3410-DM-P
```