[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