[Federal Register Volume 60, Number 213 (Friday, November 3, 1995)]
[Rules and Regulations]
[Pages 55962-55983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27305]
[[Page 55961]]
_______________________________________________________________________
Part VI
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 318, et al.
Poultry Products Produced by Mechanical Separation and Products In
Which Such Poultry Products Are Used; Final Rule
Federal Register / Vol. 60, No. 213 / Friday, November 3, 1995 /
Rules and Regulations
[[Page 55962]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 318, 319, and 381
[Docket No. 93-008F]
RIN 0583-AB68
Poultry Products Produced by Mechanical Separation and Products
In Which Such Poultry Products Are Used
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal poultry products inspection regulations to prescribe: a
definition and standard of identity and composition for the poultry
product that results from the mechanical separation and removal of most
of the bone from skeletal muscle and other tissues of poultry carcasses
and parts of carcasses (``Mechanically Separated (Kind of Poultry)''--
hereafter referred to generically as ``Mechanically Separated Poultry''
(``MSP'')), including requirements for bone solids content (measured as
calcium content) and bone particle size; certain limitations for the
use of MSP; and labeling requirements for MSP, and for poultry products
and meat food products containing MSP as an ingredient. This action
establishes the requirement that products containing MSP as an
ingredient disclose that fact by identifying it in the ingredients
declaration as, in the case of MSP derived from chicken carcasses,
``mechanically separated chicken,'' rather than ``chicken.'' This
action will help ensure that meat and poultry products distributed to
consumers are not labeled in a false or misleading manner and are not
misbranded.
EFFECTIVE DATE: November 4, 1996.
FOR FURTHER INFORMATION CONTACT: John W. McCutcheon, Deputy
Administrator, Regulatory Programs, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC 20250, Area Code (202)
720-2709.
SUPPLEMENTARY INFORMATION:
Purpose of the Final Rule
This final rule amends the regulatory requirements for the poultry
product with a paste-like form and batter-like consistency that results
from the mechanical separation and removal of most of the bone from
attached skeletal muscle and other edible tissues of poultry carcasses
and parts of carcasses, and for the finished poultry products and meat
food products in which this product is used as an ingredient. FSIS
first conducted a rulemaking regarding this product in 1969. Over the
years, the amount of such product being manufactured, and the number
and range of poultry products and meat food products in which it is
used as an ingredient, has increased significantly.
FSIS has gained a great deal of knowledge from its rulemakings
regarding the livestock product resulting from a similar mechanical
separation and removal process which is called ``mechanically separated
beef'' or ``mechanically separated pork'' (or any other species derived
from livestock, such as beef, and lamb), which will be referred to
generically in this document as mechanically separated meat (MSM). MSM
is a livestock product with a paste-like form and batter-like
consistency that results from the mechanical separation and removal of
most of the bone from attached skeletal muscle of livestock carcasses
and parts of carcasses that meets the provisions of 9 CFR 319.5. MSM is
subject to regulatory requirements which include a standard of identity
and composition that defines this product, limits for bone solids
content and bone particle size, and a name that differentiates it from
meat. It is also required to be separately identified in the
ingredients statement of products in which it is used, and is subject
to certain restrictions in its use.
More recently, in a lawsuit, Bob Evans Farms, Inc. et al., v. Mike
Espy, Secretary of Agriculture (D.D.C. Civil Action No. 93-0104),
several red meat sausage manufacturers alleged that, without a
regulatory definition and standard for poultry products produced by
mechanical separation, a disparate situation exists between labeling
MSP, and MSM for which a regulatory definition and standard exist. The
red meat sausage manufacturers have alleged that the disparate labeling
situation poses an unfair advantage for the manufacturers of
mechanically separated poultry products.
In view of these developments, and taking into account the
information and experience acquired since 1969 and current regulatory
policies, the Agency has reviewed and reevaluated the existing
regulations for MSP, particularly in regard to labeling issues about
this product. As a result of its review and reevaluation, the Agency
has concluded that regulatory action to more clearly identify MSP on
product labels, is necessary to prevent the preparation and
distribution in commerce of poultry products and meat food products
which are misbranded or not properly marked, labeled, or packaged. See
sections 4(h) and 8 of the Poultry Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.) and sections 1(n) and 7 of the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.); 21 U.S.C. 453(h), 457
and 601(n), 607. The primary reasons for this action are as follows:
(1) The method of deriving poultry products by the mechanical
separation process results in a product whose physical form and texture
differ materially from those of other boneless poultry products
produced by hand deboning techniques, i.e., hand-held knives.
The process of manufacturing MSP begins with starting materials
that include backs, and whole and half carcasses and parts of carcasses
from which most of the muscle and other tissues have been removed by
hand, leaving bits and pieces of tissue adhering to skeletal frames and
carcass ``shells.'' These starting materials may be raw or cooked, may
contain varying amounts of muscle and/or skin (with or without attached
fat), and may contain kidneys, except when product is made from mature
chickens or turkeys. (Kidneys of mature chickens or turkeys may not be
used as human food according to 9 CFR 381.65(d)). The nature of these
starting materials is such that the muscle and other tissue that
remains on the bones cannot be efficiently or effectively removed using
hand-deboning techniques. This is because (1) the bony structure of the
materials limits the accessibility of knives and obstructs precise hand
removal of edible tissue, (2) hand-removal of the tissues is too time
consuming to make it practical, and (3) the physical movements
necessary to remove the bits and pieces of tissues adhering to bones
have been associated with cumulative trauma disorders (also referred to
as repetitive motion disorders), e.g., Carpal Tunnel Syndrome.
Mechanical separation of the bits and pieces of muscle and other
tissues from the bones to which they are adhering is, however, easily
accomplished using mechanical deboning machines.
Typically, the starting materials have undergone an initial bone
breaking process to enable the machines to operate efficiently. The
starting materials are fed into a mechanical deboning (i.e.,
separation) machine which operates on the differing resistance of bone
and tissue to passage through small holes (i.e., apertures), whether it
employs sieves, screens, or other devices. The starting materials are
pushed under high pressure through the part of the equipment with
apertures. Most of the bone is separated and
[[Page 55963]]
removed. However, the apertures allow a small amount of powdered bone
to pass through with the edible tissues, which, under the high pressure
applied by the machine, become a homogeneous soft tissue mass. The
minute amount of powdered bone (particles much smaller than the size of
pepper and limited to no more than one percent) is also dispersed
throughout the soft tissue mass. The remaining bony residue that has
been separated from the paste-like muscle and other tissues exits from
a separate place on the equipment. Thus, such machines mechanically
separate and remove most of the bone from the starting materials,
resulting in a product with a paste-like form which is comparable in
consistency to a cake batter. The process of manufacturing mechanically
separated poultry results in a product whose form and texture differ
materially from those of other boneless poultry products produced by
traditional hand-deboning. Despite these differences, current FSIS
regulations do not distinguish between poultry products produced by
mechanical separation and poultry products produced by traditional
deboning techniques, i.e., hand-deboning, in terms of product identity
and composition or use. Both are declared on product labels as
``chicken,'' ``turkey,'' or the names of other kinds of poultry.
(2) Mechanically separated poultry is produced by essentially the
same technology and has characteristics (i.e., physical form and
textural consistency) similar to those of the livestock product, MSM,
which is required to be declared on labels as mechanically separated
beef (or pork or other species of livestock).
(3) The mechanical process from which mechanically separated
poultry is derived makes its form and consistency materially different
from that of poultry derived by traditional hand-deboning methods, yet
it is not currently identified in the ingredients statement of a
product in which it is used by a name that distinguishes it from
traditionally deboned poultry. Mechanically separated poultry should be
declared in the ingredients statements of the products in which it is
used by the distinctive term ``mechanically separated (kind of
poultry),'' e.g., ``mechanically separated turkey,'' ``mechanically
separated chicken.''
The product resulting from mechanical separation has certain
textural attributes that are different than hand-deboned poultry, even
if the hand-deboned poultry is further processed through a grinder to
result in ground poultry. The product that directly results from the
mechanical process is paste-like in form and similar to a cake batter
in consistency, and is not the same as chicken or turkey removed from
carcasses or parts of carcasses by hand. Chicken or turkey that results
from hand-deboning is easily recognized as muscle, skin, and other
edible tissues and parts because it retains its natural physical form
and consistency; it has not been subjected to the rigors of crushing
bones and separating bone from muscle and other tissue under high
pressure in separation machinery. The rigors of the mechanical
separation process alter the structure of the muscle fibers, skin, fat,
and other tissues that adhere to the skeletal frames, shells, and other
starting materials so that they become blended and amorphous, and are
no longer recognizable as ``chicken'' and ``turkey.'' These machines
are not available to consumers and, therefore, consumers are not likely
to have the expectation of the resulting batter-like material as
``chicken'' or ``turkey.'' Thus, a separate identity is necessary for
the product that results.
The term ``mechanically separated'' is recognized internationally
by the Codex Alimentarius Commission1 of the United Nations and by
individual countries that trade with the United States, has been upheld
in Court decisions as being appropriate to distinguish the livestock
product derived by mechanical separation machinery2, and
appropriately distinguishes the product from hand-deboned poultry as
one that is derived by a strictly mechanical means. As such, similar
terminology should be applied to poultry products resulting from the
process of mechanical separation and recovery of crushed bone from
muscle and other edible tissues that results in a product with a paste-
like form and cake batter-like consistency.
\1\ Food and Agriculture Organization of the United Nations,
World Health Organization, Codex Alimentarius Commission, Joint FAO/
WHO Food Standards Programme, Codex Alimentarius Commission, Volume
10, Code of Practice for Mechanically Separated Meat and Poultry,
pp. 71-72 (1994) is available for review in the FSIS Docket Clerk's
office.
\2\A copy of the Courts' decisions in Community Nutrition
Institute (CNI) et al. v. Block, No. 82-2009 (D.D.C. Dec. 1, 1982),
aff'd 749 F.2nd 50 (D.C. Cir 1984) is available at the FSIS Docket
Clerk's office for review.
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Therefore, FSIS is amending the poultry products inspection
regulations (9 CFR Part 381) to revise and supplement the requirements
for the manufacture, characteristics, and labeling of poultry products
produced by mechanical separation and the labeling of products in which
they are used as ingredients that result in a product with a paste-like
form and cake batter-like consistency. Under this final rule,
mechanically separated product derived from chicken or turkey would be
labeled as ``mechanically separated chicken,'' or ``mechanically
separated turkey,'' as the case may be, and would be separately
identified by this name in the ingredients statement of products in
which it is used.
The Purpose of An Extended Effective Date
Various commenters suggested that industry should be given a
sufficient amount of time to use most of their already printed labels,
before the final rule's new labeling requirements must be carried out.
FSIS agrees that such a time period should be granted in regard to all
of the new requirements of the final rule. Therefore, an effective date
of one year from the date of publication has been provided for in this
final rule. This time period is intended to allow ample time for an
orderly transition to the new requirements, including the labeling
requirements, and to assure that manufacturers of poultry products
produced by mechanical separation, and of poultry and meat food
products in which the product is used as an ingredient, have ample time
to exhaust current label stock. In this regard, manufacturers will not
be required to dispose of label inventories that were printed or
ordered for printing prior to publication of the rule if they have made
a good faith effort to exhaust current stocks before the effective
date. Requests for use of current labels beyond the effective date will
be considered on a case-by-case basis.
Background
I. Introduction
The technology to mechanically separate and remove most of the bone
from attached skeletal muscle and other tissue of poultry carcasses and
parts of carcasses began in the late 1950's or early 1960's. The
technology is grounded in the desire of poultry manufacturers to
salvage edible, wholesome muscle and other tissue from carcasses and
parts of carcasses (such as skeletal frames and carcass shells) that
cannot be efficiently or effectively removed by hand in order to
provide a source of low-cost protein that is safe and essentially
nutritionally the same as the muscle and other tissue removed from
poultry carcasses and parts of carcasses by hand deboning methods. In
terms of functionality, mechanically separated poultry has the same
functions as hand-deboned chicken or turkey with the added
[[Page 55964]]
benefit of being able to easily form emulsions and bind to other
proteins readily. This is because the muscle and other edible tissues
no longer possess their original tissue structure and the cake-batter
consistency eases blending with other ingredients.
The Agency's initial reaction was to consider the resulting product
adulterated because of the amount of powdered bone present and the
physical size of the bone particles. By the mid-1960's, the industry
had modified and improved the equipment used to produce poultry product
by mechanical separation such that the product contained 1 percent or
less bone solids with an extremely small bone particle size. This
prompted the Agency to reevaluate its position. Widespread commercial
production of products containing mechanically separated poultry began
in the early 1970's. By 1975, poultry product produced by mechanical
separation was being used as an ingredient in poultry and meat food
products such as franks, bologna, salami, and poultry rolls.
Today, the technology for producing poultry products by mechanical
deboning is accepted as a valuable and practical means for salvaging
edible tissue from poultry parts and carcasses from which most of the
muscle and other tissues have been removed by hand. In the current
market, poultry products made with mechanically deboned poultry include
cooked poultry sausages (such as chicken frankfurters, turkey salami,
and turkey bologna), poultry patties and nuggets (such as chicken
patties and nuggets), formed and whole poultry roasts (e.g., oven-
cooked turkey breast), and poultry baby foods. The level at which it is
used has depended in part on technological capabilities. For example,
the level of use has reached 100 percent of the poultry product portion
of a number of cooked poultry sausage products (such as chicken franks)
and greater than 15 percent of the poultry product portion of whole
muscle products, e.g., cooked turkey breast, where it serves the
purpose of binding whole muscle pieces together to make the product.
Poultry product produced by mechanical means is also used at up to 49
percent of the formulations of certain meat food products, e.g., beef
and turkey chili, provided that it is identified in the product name as
``turkey'' or ``chicken,'' and used in meat food products including
cooked sausages, such as frankfurters and bologna, at a level of up to
15 percent of the total ingredients, excluding water (9 CFR 319.180)
without being identified in the product name.
Over the years, the poultry and meat food industries have also
referred to poultry products produced by mechanical means as
``comminuted (i.e., ground) poultry.'' Terminology such as ``finely
comminuted,'' ``finely ground,'' ``mechanically deboned,'' and
``mechanically separated'' have also been used to describe the product
according to 9 CFR 381.117(d). The terms ``finely ground,'' ``ground,''
``finely comminuted,'' and ``comminuted'' have been applied to poultry
produced by mechanical deboning as well as to poultry products produced
using hand-deboning methods as a means of being in accord with 9 CFR
381.117(d).
Poultry products produced by mechanical means are currently subject
to 9 CFR 381.117(d) which relates generically to boneless poultry
products. This regulation requires boneless poultry products to be
labeled in a manner that accurately describes their actual form and
composition. The product name must indicate the form of the product,
e.g., emulsified or finely chopped, and the kind name of the poultry
from which it is derived, e.g., chicken, turkey, etc.. If the product
does not consist of natural proportions of skin and fat, as they occur
in the whole poultry carcass, the product name must also include
terminology that describes the actual composition. If the product is
cooked, it must be so labeled. Section 381.117(d) also limits the bone
solids content of boneless poultry products to 1 percent.
Existing regulations do not distinguish between boneless poultry
products produced by mechanical separation and poultry products
produced by traditional methods, e.g., hand-deboning. As a matter of
practice, poultry product produced by mechanical separation is
currently declared in the ingredients statement of a product in which
it is used, along with any other boneless poultry product used, as
``chicken'' or ``turkey'' where skin and fat are included but not in
excess of their natural proportions, or as ``chicken meat'' or ``turkey
meat'' when skin with attached fat is not included.
II. Report on Health and Safety of Mechanically Deboned Poultry
In 1976, FSIS initiated an analytical program to obtain data on a
number of nutrients and substances of potential health concern in
poultry products produced by mechanical separation. Data were also
gathered from scientific literature, industry, other government
agencies, and university scientists. Details of the analytical program
and a resulting evaluation were published in a June 1979 report
entitled ``Health and Safety Aspects of the Use of Mechanically Deboned
Poultry'' (hereafter referred to as the 1979 Report). An errata
supplement correcting certain items in the report was prepared and
published on August 14, 1979 (44 FR 47576). (The 1979 Report and the
errata supplement are available for public inspection in the FSIS
Docket Clerk's office.) On June 29, 1979, the Agency announced the
availability of this report and encouraged interested members of the
public to comment on its content.
The 1979 Report evaluated the effects on health and safety of use
of mechanically separated poultry and, in particular, examined the
heavy metal, trace element, bone particle, chlorinated hydrocarbon,
cholesterol, fat, essential amino acid, total protein, and purine
contents of MSP, as well its microbiology. The 1979 Report recommended
that (1) potential health risks associated with cadmium in kidneys from
mature chickens would be avoided by not allowing kidneys from mature
chickens in MSP, (2) potential risks to children associated with
fluoride in MSP from fowl could be avoided by not allowing MSP from
fowl in baby foods, (3) MSP should be labeled to show the presence of
cholesterol and calcium for the benefit of people who needed to
restrict their intake of these substances, and (4) mandatory handling
and storage of starting materials used for making MSP should be
considered.
In the same June 29, 1979, announcement on the availability of the
1979 Report, FSIS also notified the public that it was particularly
interested in receiving comments regarding the proper labeling of
products containing poultry product produced by mechanical separation
and what means, if any, should be taken to implement the labeling
recommendations with regard to calcium and cholesterol in the report
(44 FR 37965).
FSIS received 221 comments, most of which were general reactions to
the labeling issues raised in the notice, and health, safety, or
economic concerns. The majority of the commenters expressed a general
opinion on the adequacy of regulations concerning mechanically
separated poultry products and were supportive of the rules at that
time. Some commenters stated that the regulations have effectively
controlled the use of mechanically separated poultry products over many
years with a wide base of consumer acceptance, that such product is not
significantly different from product produced by hand-
[[Page 55965]]
deboning, that these regulations provide truthful labeling, and/or that
the report and scientific literature support the adequacy of current
regulations. Other commenters indicated that mechanically separated
poultry should be regulated the same as mechanically separated meat
(then named mechanically processed (species) product).
III. GAO Report on Mechanically Separated Products
In 1983, the General Accounting Office (GAO) issued a report
recommending that the Secretary of Agriculture direct the Administrator
of FSIS to establish specific standards on poultry products produced by
mechanical separation, and labeling requirements on products made with
such poultry products, as had been done for MSM and products made with
MSM.
IV. Improvements in Machinery for Poultry Products Produced by
Mechanical Separation
The Agency has monitored the advances in the technology for
mechanically separating poultry over the last decade. There have been
improvements in the efficiency of the mechanical separation and removal
of most of the bone from attached skeletal muscle and tissue of poultry
carcasses and parts of poultry carcasses. Today, industry figures
estimate that roughly 1 billion pounds of raw poultry materials are
used to manufacture 700 million pounds of mechanically separated
poultry, which is used, in turn, to formulate approximately 400 million
pounds of poultry sausages (including franks, bologna, and salami), and
300 million pounds of poultry nuggets and poultry patties.3 There
have been major advances in mechanical separation machinery in terms of
the effectiveness of removing the bone which is incorporated by the
process of separation into the skeletal muscle and other tissues of
poultry carcasses and parts of carcasses. This has been accomplished
through enhancements and modifications of the bone-removal devices that
are part of the mechanical deboning machines. There have been continued
refinements of certain operational parameters of the machinery, e.g.,
the ability for operators to adjust the pressure needed to force
crushed poultry bones with adhering muscle and other tissues through
screens to separate muscle and other tissues from bone, and the size of
the apertures in the screens and sieves through which the crushed
bones, muscle, and other tissues are pushed under high pressure. These
improvements have resulted in the ability to easily achieve bone
content limits or decrease the bone solids that are a result of the
mechanical separation process to less than the one percent reflected in
the current poultry products regulations (9 CFR 381.117(d)).
\3\Information provided by industry is available for public
inspection at the FSIS Docket Clerk's Office.
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In 1969, the Agency amended the regulations for poultry and poultry
products inspection to, among other things, provide labeling
requirements for boneless poultry products, as well as a prescribed
bone solids content of not more than 1 percent (34 FR 13991). This
limit was based on an evaluation conducted by FSIS of the operating
results in a series of poultry establishments that used mechanical
deboning equipment. Analyses were made of 485 samples of raw,
mechanically deboned product from nine commercial operations that used
the three types of machines most often used in the process. The
analyses showed that the equipment, at that time, could be operated
under commercial conditions to produce boneless poultry that contained
no more than 1 percent bone solids, on a raw weight basis, and FSIS
concluded that it was demonstrated that it was practical to limit the
bone content in deboned poultry to 1 percent. Moreover, it was deemed
that the one percent maximum bone solids content represents good
manufacturing practices and reflects mechanical separation processes
that are in control.
In light of the improvements that have occurred with regard to the
machinery used to mechanically separate and remove most of the bone
from the muscle and other tissues of poultry carcasses and parts of
carcasses, FSIS recently conducted a study of the bone solids content
of MSP.4 The percentage of bone solids content (determined by
calcium analysis) in boneless poultry products produced by mechanical
separation processes was collected from approximately 50 establishments
during August 1993, and represented a sampling of over 2000 products.
The data indicate that the mean bone solids content of the samples of
these products was approximately 0.6 percent; generally, half of the
samples were above 0.6 percent (but below 1 percent) and half were
below 0.6 percent.
\4\Data available for public inspection at the FSIS Docket
Clerk's Office.
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V. RTI Study
In response to complaints from industry, some of them longstanding,
that the Agency is ``not regulating meat and poultry equitably,'' FSIS
contracted out to the Research Triangle Institute (RTI) a comparison of
the meat and poultry inspection regulations. RTI found many differences
in the two sets of regulations and narrowed down to 12 the areas of the
regulations where significant differences exist.5 FSIS has studied
these areas to determine whether, in the actual conduct of inspection,
they result in an inequitable application of the inspection laws, and,
if so, what might be done to mitigate the inequities.
\5\A copy of the RTI study is available for public inspection in
the FSIS Docket Clerk's office.
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Among the areas identified in the RTI study is mechanically
separated product. It notes that regulations exist on the use of MSM,
but not on the use of mechanically separated poultry. The RTI study
concluded that, in general, ``the regulations covering meat and poultry
have been designed with the same intent--to protect `the health and
welfare of consumers by assuring that meat and meat food products [or
poultry products] are wholesome, not adulterated, and properly marked,
labeled, and packaged' (21 U.S.C. 602 and 451). Although the intent of
the regulations remains the same, the actual requirements are quite
different.'' The study further concludes that the bases for no
comparable regulation for mechanically separated poultry are
``unfavorable consumer perceptions and court decisions resulting in
label and use restrictions for MSM; poultry has no definitional
requirements (e.g., it can be defined as `chicken' or `turkey').''
Mechanically separated meat (i.e., beef or pork) product became the
subject of consumer criticism in the mid-l970's after USDA proposed to
allow its use as ingredients in meat products and to allow it to be
labeled as meat (i.e., ``beef'' or ``pork''). USDA also issued an
interim rule that included standards for the use of mechanically
separated red meat product. A lawsuit soon followed in which the Court
found that this product is not ``meat'' as traditionally defined in the
Federal Meat Inspection Act regulations. The Court further found that
USDA had not considered adequately the health and safety effects of the
mechanically separated red meat product.
To respond to questions on health and safety raised by the Court, a
panel of government scientists was convened to examine the questions.
The panel found that scientific studies established no unique health
risks associated with mechanically separated red meat product, but that
the product is
[[Page 55966]]
sufficiently different from muscle tissue meat in composition to
require separate labeling. The panel recommended, among other things,
that usage limitations be placed on this product.6
\6\The panel's conclusions and recommendations were published in
reports titled ``Health and Safety Aspects of the Use of
Mechanically Deboned Meat, Volume I--Final Report and
Recommendations, Select Panel'' and ``Health and Safety Aspects of
the Use of Mechanically Deboned Meat, Volume II--Background
Materials and Details of Data.'' These reports are available for
public review in the FSIS Docket Clerk's office.
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The panel reports, among other things, led FSIS to issue final
regulations on June 20, 1978, that established preparation,
composition, usage, and labeling requirements for mechanically
separated red meat product, which was named mechanically processed
species product (MP(S)P) and required that it be produced only under a
quality control program approved by the Agency (43 FR 26416). This rule
established a definition and standard of identity for this product that
necessitated it being listed separately from meat in the ingredients
statement of a product in which it was used. In 1981, the Agency
proposed that this product be distinctly identified as ``mechanically
separated (species) (MS(S))'' (where ``species'' refers to beef, pork,
or other species of livestock) based on data, information, and
arguments accumulated by and submitted to FSIS since the regulations
for the product were originally promulgated on June 20, 1978 (46 FR
39274). FSIS proposed to amend the definition and standard for MP(S)P
by deleting the term ``product'' from the product name and by
considering terminology such as ``mechanically separated,''
``mechanically deboned,'' and ``mechanically recovered'' as an
alternative to ``mechanically processed'' to continue distinguishing
the product from ``meat.'' Comments on the proposal indicated that the
term ``mechanically separated'' was more descriptive of the product
than the other terms listed in the proposal, that it was favored
because of its use in other countries and adoption by the Codex
Alimentarius Committee on Processed Meat and Poultry Products (1978),
and that it did not have negative connotations associated with the
other terms. Some commenters on the proposal stated that the term was
truthful and understandable. Additional rulemaking on June 29, 1982 (47
FR 28214), reaffirmed the Agency's position that the product is not
``meat'' as traditionally defined, and that ``mechanically separated
(species) (MS(S))'' is the name that will provide a more meaningful and
concise description of the product's characteristics than
``mechanically processed (species) product.''
During this same period, mechanically separated poultry underwent
product development separately from mechanically separated red meat
product without similar FSIS regulations. Early distinctions in
regulatory treatment were largely due to historical differences in how
the two industries used these products and the way in which they came
to public attention. One significant difference is that mechanically
separated red meat product was being considered for use in products
that had previously contained muscle meat. The use of mechanically
separated poultry in poultry hot-dogs created less controversy because
poultry hot-dogs, bologna, and similar products did not exist before
they were made with mechanically separated poultry. Thus, consumers had
no prior expectations about the formulation.
Differences in regulatory treatment of MSM and mechanically
separated poultry have continued since that time. The meat industry
claims that the effect of those differences has been a reluctance on
the part of processors to use MSM, while MSP use has expanded. In
response to the early rulemakings on MSM, the meat industry claimed
that consumers would not buy products if ``mechanically separated beef
(or pork, or other livestock species)'' is listed on the label.
Similarly, in responding to the March 1994 advance notice of proposed
rulemaking (ANPR) on MSP (discussed later in this document), the
poultry industry claimed that, if they had to label MSP as a poultry
ingredient, consumers would be misled into thinking that they are
purchasing products inferior to what they have historically purchased
or that the product has changed.
The Agency's regulation on the use of MSM and the absence of
regulation on the use of mechanically separated poultry have raised two
major policy issues. The first is whether current regulations are
adequately protecting consumers. The second is whether different
regulatory treatment for these similar products is justified. FSIS is
not promulgating this regulation merely because of the current
differences in the regulatory treatment of mechanically separated
poultry and MSM, but rather because one of the basic statutory missions
of the Federal Meat Inspection Act, under which MSM, such as
``mechanically separated beef (or pork),'' is regulated, and of the
Poultry Products Inspection Act (PPIA), under which MSP is regulated,
is to assure that products bear labeling that is truthful and not
misleading. Here, for MSP, as FSIS did for MSM, FSIS has determined
that a standard of identity and composition is needed for this product,
along with an ingredient labeling requirement, and other requirements
in order to carry out one of the statutory missions of the PPIA, as has
been done in regard to the FMIA for MSM, by assuring that consumers are
accurately informed about the ingredients of products they purchase,
which in this case is an ingredient whose form and consistency
materially differ from those of other boneless poultry products
produced by hand-deboning.
VI. Advance Notices of Proposed Rulemaking
On June 15, 1993, FSIS published an advance notice of proposed
rulemaking (ANPR) (58 FR 33040) soliciting comments, information,
scientific data, and recommendations regarding the need for labeling of
poultry product produced by mechanical separation and products in which
such poultry product is used. FSIS received 2744 comments in response
to the ANPR, most of which were general reactions to labeling issues.
The majority of commenters responded to whether there was a need to
identify mechanically separated poultry in the ingredients statement on
the labels of meat and poultry products in which it is used as an
ingredient. Roughly half the commenters supported identifying
mechanically separated poultry in the ingredients statement because,
the commenters stated that, among other things, consumers have ``a
right to know'' it is an ingredient. The majority of the other
commenters did not support identifying mechanically separated poultry
in the ingredients statement, citing, in part, their belief that
current policies are satisfactory and that labeling MSP would mislead
consumers into thinking that they are purchasing products that are
inferior or different than the product they have historically
purchased. FSIS concluded that there is a ``truth-in-labeling'' issue
that is founded in the mandate under which the Agency operates, viz.,
protecting consumers from misbranded poultry and meat products.
Subsequently, on March 3, 1994, FSIS published another ANPR (59 FR
10230), which solicited comments and information from the meat and
poultry industries and industry-related organizations, the scientific
community, academia, consumers and consumer groups, and other
interested parties. FSIS sought comments on its tentative positions
regarding defining and standardizing, or establishing other
[[Page 55967]]
requirements for poultry products produced by mechanical separation,
including possible provisions for the composition, characteristics, and
use of such products, and requirements for manufacturing and labeling
such products. In the March 1994 ANPR, FSIS considered, among other
things, that certain poultry products produced by mechanical
separation, i.e., those with greater than 0.6 percent bone solids
content, but no more than 1 percent bone solids content, be separately
identified on the labels of products in which they are used as
ingredients by a distinct name. However, because of the improvements
that were previously discussed in separating and removing the bone from
skeletal muscle and other edible tissues of poultry carcasses and parts
of carcasses, FSIS considered that some poultry products derived from
mechanical separation machinery, i.e., those with 0.6 percent or less
bone solids, be identified on the label of products in which they are
used as poultry or poultry meat, e.g., ``chicken'' and ``turkey meat.''
FSIS received 106 comments in response to the March 1994 ANPR. The
majority of the comments did not support the ANPR. The commenters
strongly disagreed with the tentative position that only product with
0.6 percent or less bone solids content could be labeled ``(Kind)'' or
``(Kind) meat,'' without the reference to ``mechanically separated.''
The commenters also disagreed with the need for handling requirements,
protein quality requirements, and quality control for boneless poultry
products produced by mechanical separation. Further, commenters
disagreed with establishing a minimum protein content and a maximum fat
content requirement for poultry product produced by mechanical
separation with greater than 0.6 percent bone solids content. They also
disagreed with restricting the bone particle size to a maximum of less
than 1.5 millimeter (mm) in the greatest dimension and limiting the use
of mechanically separated poultry when used as an ingredient in other
products. Many commenters stated that FSIS should continue allowing the
declaration of mechanically separated poultry on product labeling as
``(Kind)'' or ``(Kind) meat'' (i.e., ``chicken,'' ``chicken meat,''
``turkey,'' and ``turkey meat'') when it is used as an ingredient in
poultry or meat food products.
FSIS generally agreed with the commenters with regard to protein
quality, and protein and fat contents, and concluded that the tentative
positions on protein quality, and minimum protein and maximum fat
contents were unnecessary. Protein quality is not a health issue today,
and information regarding protein and fat contents is generally
available on the Nutrition Facts panel on most processed foods where
mechanically separated poultry might be used as an ingredient.
Furthermore, it was decided that the positions on quality control and
handling requirements would be better addressed as part of larger
regulatory efforts that were planned to consider ways of reducing the
potential for situations that would render any poultry or meat food
product adulterated, unwholesome, and/or misbranded. Therefore, the
Agency concluded that it was premature to address the need for
mandatory quality control or handling requirements for this one
distinct category of poultry product. However, the Agency was not in
agreement with the commenters on the other issues raised in the ANPR.
The Agency maintained that a bone solids content requirement is
necessary because one of the characteristics that distinguishes
mechanically separated poultry from hand-deboned poultry is the method
of mechanical processing that results in a product which is safe in
terms of composition, but one in which there is greater potential for
the incorporation of powdered bone. The bone solids content of MSP is a
direct result of the manufacturing process which involves the crushing
of starting materials which consist of skeletal frames and carcass
shells on which bits and pieces of muscle and other edible tissue
remain after most of the muscle and other tissues have been removed by
hand. Thus, there is the need for controlling the process of
incorporating powdered bone into MSP so that it does not exceed the
level of one percent which is considered a ``good manufacturing
practice.'' The other distinguishing features that make mechanically
separated poultry different than hand-deboned poultry are physical form
and consistency. Informing consumers of such differences by a distinct
and separate labeling of the presence of mechanically separated poultry
in products in which it is used, is supported by the statutory
responsibility of FSIS to assure that all labels on poultry and meat
food products are accurate and not false or misleading.
The Agency did agree that its tentative labeling approach to
identifying two types of mechanically separated poultry, based on the
level of bone solids, i.e., above or below 0.6 percent, which was
suggested in its March 1994 ANPR, appear to be in conflict. The
mechanical separation process results in a product that is materially
different than hand-deboned poultry in terms of its paste-like form and
batter-like consistency, regardless of the level of bone solids
present. The Agency tentatively concluded, after further review of the
approach presented in the March 1994 ANPR and the comments received in
response to it (and the prior June 15, 1993, ANPR), that continuation
of the present labeling policy, even for those finished products with
mechanically separated poultry that has a bone solids content of less
than 0.6 percent, does not inform the consumer that these products
contain the distinct ingredient mechanically separated poultry and that
this may result in misleading labeling. The Agency also maintained that
there is a need for bone particle size restrictions to augment the
measurement of bone solids content as an assurance that mechanical
separation processes are operating under good manufacturing practices
that prevent the inclusion of unacceptable large fragments in
mechanically separated poultry. The Agency also believed that in order
to show that the process of manufacturing MSP was in control, i.e.,
operating under good manufacturing practices, records should be kept.
The Agency disagreed with commenters' objections to the tentative
positions taken in the March 1994 ANPR on restricting the uses of
mechanically separated poultry as an ingredient in certain products,
e.g., in baby foods where there was a potential health effect
associated with fluoride in mechanically separated poultry made from
fowl, and where the textural characteristics of mechanically separated
poultry altered the basic nature of the product to which it may be
added, such as products represented as being composed of whole muscle.
FSIS maintained the position that such restrictions were necessary for
health reasons (in the case of the fluoride issue) or to protect the
consumer from misleading labeling.
The Agency's positions on these major issues led to the publication
of the December 6, 1994 proposed rule.
VII. Proposed Rule
On December 6, 1994, FSIS published a proposed rule to amend the
Federal meat and poultry products inspection regulations to define and
standardize, and establish other requirements for poultry products
produced by mechanical separation, including provisions for the
composition and use of such products, and requirements for
manufacturing and labeling such
[[Page 55968]]
products (59 FR 62629). The proposal prescribed a definition and
standard of identity for poultry products produced by mechanical
separation with 1 percent or less bone solids content, that required
compliance with certain criteria, e.g., bone solids content (measured
as calcium content) and bone particle size. The proposal also provided
recordkeeping and labeling requirements, and limitations on use of
poultry products produced by mechanical separation.
A. Product Definition and Standard
FSIS proposed to prescribe a definition and standard of identity
and composition for the poultry product with a paste-like form and
batter-like consistency that results from the mechanical separation of
and removal of most of the bone from attached skeletal muscle and other
tissue of poultry carcasses and parts of carcasses which has a bone
solids content of 1 percent or less. This product is commonly known in
the poultry industry as mechanically separated or deboned poultry.
FSIS proposed that the boneless poultry products regulations
described in 9 CFR 381.117(d) no longer apply to MSP. FSIS indicated
that the current restriction on bone solids content in this regulation,
as enforced by limiting calcium content, would be included with other
compositional requirements in an MSP standard. Moreover, as a
standardized product, MSP would be differentiated from other poultry
product ingredients and it would be designated in the ingredients
statements on finished product labels by the name specified in its
definition and standard, in accordance with 9 CFR 317.2(c)(2) and
(f)(1) and 381.118(a). Product failing to meet the bone solids content
or bone particle size restrictions of the standard must be labeled as
``Mechanically Separated (Kind) For Further Processing'' and may only
be used in producing poultry extractives, including fats, stocks, and
broths because the manufacturing process completely removes the bone
solids and bone particles.
1. Product name. FSIS proposed to define the standardized product
that results from the mechanical separation and removal of most of the
bone from poultry carcasses and parts of carcasses by a distinctive
name. FSIS proposed that such product be called ``mechanically
separated chicken'' or ``mechanically separated turkey,'' for example.
FSIS indicated that this product differs significantly from boneless
poultry products produced by traditional hand-deboning techniques in
its spread-like form and consistency such that it should be regulated
as a separate, standardized ingredient. FSIS indicated that it would
welcome comments on other names that accurately reflected the process
from which this product was derived, as well as its form and
consistency.
2. Bone solids content. FSIS proposed that the definition and
standard for MSP incorporate the existing restriction on the bone
solids content of mechanically separated poultry products of not more
than 1 percent (9 CFR 381.117(d)). FSIS also proposed that the
definition and standard include maximum calcium content levels of not
more than 0.235 percent in product made from turkeys or mature chickens
or 0.175 percent in product made from other poultry, as a measure of
bone solids content based on the weight of product that has not been
heat treated.
3. Bone particle size. FSIS proposed that at least 98 percent of
the bone particles present in MSP be restricted to a maximum size no
greater than 1.5 millimeters (mm) in their greatest dimension and that
no bone particles could be larger than 2.0 millimeters in their
greatest dimension.
4. Recordkeeping. FSIS also proposed that establishments that
manufactured MSP maintain records of bone solids content and bone
particle size as a measure of process control. These records had to be
made available to the inspector and any other duly authorized
representative of the Secretary upon request.
B. Limitations on Use
FSIS proposed certain limitations with respect to the use of MSP in
the formulation of poultry and meat food products. FSIS proposed such
restrictions based on the potential fluoride contribution of MSP made
from fowl (i.e., mature female chickens) and the characteristics of
MSP, including the kind of poultry from which it is made and its form
and consistency. FSIS also proposed that MSP may be used, except in
certain cases, in any product defined by regulatory standards or Agency
policies whereby ``(Kind)'' or ``(Kind) Meat'' (e.g., ``turkey,''
``turkey meat'') are being used, provided that it is identified as
``Mechanically Separated (Kind)'' and conforms to requirements
regarding the presence of skin within natural proportions (9 CFR
381.117(d)).
1. Kind of product limitation. FSIS proposed that when a poultry
product is required to be prepared from a particular kind or kinds of
poultry, (e.g., chicken), use of MSP of any other kind (e.g.,
mechanically separated turkey), would not be permitted. This provision
assures that the kind of MSP used in a poultry product, such as
mechanically separated chicken, is the same kind as is represented in
the product name or other labeling. For example, product named
``chicken bologna'' could not be composed of mechanically separated
turkey because such action could, among other things, result in false
or misleading labeling by implying that the bologna was made with a
chicken ingredient, when, in fact, it contained a turkey ingredient.
2. Limitations on product made from fowl. FSIS proposed that the
use of mechanically separated chicken made, in whole or in part, from
fowl (i.e., mature female chickens, as defined in 9 CFR
381.170(a)(1)(vi)) not be permitted in baby, junior, or toddler foods.
The Agency based these restrictions on the potential fluoride
contribution of product made from fowl to dietary intakes of young
children.
The Agency noted that this position was supported by the 1979
Report, which was the best data available. FSIS recognized, however,
that views on fluoride consumption have changed in the last few years,
and in particular, recent views on the benefits of fluoride in the
diet, including the diets of children. Comments were invited on this
issue that would have an impact on the current validity of the proposed
restriction on use of MSP from fowl .
3. Poultry product limitations. FSIS proposed that MSP not be
allowed in poultry products that are composed of whole poultry muscle,
and expected to be as such by consumers, except that it may be used for
binding purposes at a level that is sufficient for purpose. However,
FSIS would allow MSP in the sauce portion or any dressing of poultry
products.
FSIS also proposed that MSP not be permitted in poultry products
that have been processed only to the extent of cutting or grinding
because it considers its use to be inconsistent with the basic whole-
muscle character associated with such products. The Agency also would
not permit MSP to be used in poultry products that are processed,
convenience versions of ready-to-cook poultry or cuts or solid pieces
of poultry or poultry meat for the reason stated above.
FSIS proposed no restrictions on the amount of MSP that can be used
in poultry products, or meat food products, in which it is a permitted
ingredient. However, prevailing standards of identity and composition
for particular products may contain quantitative limits (e.g., a limit
on the amount of poultry product ingredients permitted in cooked
sausages such as frankfurters
[[Page 55969]]
and bologna (9 CFR 319.180)) or other restrictions on the quantity of
various poultry product ingredients.
C. Labeling
FSIS proposed special provisions for the labels of MSP. If adopted,
these provisions would supplement other, more general requirements for
such labels (see 9 CFR parts 317 and 381, subpart N). The provisions
are discussed below.
1. The product. FSIS proposed the following labeling provisions for
MSP: (1) the name of the product (e.g., ``Mechanically Separated
(Kind)'' (where ``kind'' refers to chicken, turkey, or other poultry)
must be followed immediately by the phrase(s) ``made from fowl'' unless
it is not made, in whole or part, from mature female chickens, and
``with excess skin'' unless it is made from poultry product that does
not include skin in excess of the natural proportion present on the
whole carcass; and (2) there must be appropriate descriptive
terminology in the labeling of MSP if heat treatment has been used in
the preparation of such product, e.g., ``cooked.'' Because the
characteristics described in (1) and (2) above are ones which would
affect the use of MSP, FSIS proposed that, in order to assure
compliance with regulatory requirements and thereby prevent the
adulteration and misbranding of finished poultry products and meat food
products, such characteristics had to be clearly identified on the
label of MSP when MSP left the establishment at which it was
manufactured.
2. Finished poultry products and meat food products. FSIS proposed
that the standardized paste-like product that results from the
mechanical separation and removal of most of the bone from the skeletal
muscle and other edible tissue of poultry carcasses and parts of
carcasses be defined by its own name, e.g., ``Mechanically Separated
(Kind),'' which would be declared in the ingredients statements on
finished product labels by the name specified in its definition and
standard.
VIII. Discussion of Comments
FSIS received 2420 comments in response to its December 6, 1994,
proposed rule. The majority of the comments (over 95 percent) were
submitted by individuals and food manufacturers and distributors; a few
(less than 5 percent) were submitted by trade associations, consumer
advocate organizations, academia, developers of machinery, food
retailers, food consultants, law firms, an agency of the Federal
government, and a foreign government. The majority of the comments
related to product name. The comments are summarized below.
A. Product Definition and Standard Product Name
Nearly all of the comments were in response to the proposed
requirement regarding the product name for MSP which established a
distinct name for this product, mechanically separated (kind), where
``kind'' represents the kind of poultry, such as chicken or turkey,
from which the product was made. Of these, roughly one-quarter agreed
with defining the product by the distinctive name of ``Mechanically
Separated (Kind) (MS(K)).'' Most of the commenters supporting the
proposal stated that MSP is different from hand-deboned poultry and the
product label should inform consumers of which type product they are
getting. Further, the commenters asserted that ``they have a right to
know'' if mechanically separated poultry is being used because
mechanically separated poultry ``has more bone particles, calcium, and
cholesterol'' (than hand-deboned poultry) because of the way it is
processed. The commenters said that if the name is not changed to MSP,
i.e., mechanically separated (kind), consumers might think that they
are getting a product that has no bone particles and is identical to
hand-deboned poultry. Several commenters also suggested that it is
unfair for FSIS to treat mechanically separated poultry differently
than mechanically separated meat with regard to its labeling and that
this proposed rule will create parity between the poultry and red meat
industries.
The majority of the other commenters disagreed with the proposed
position to define the product by the name MSP. The commenters stated
that: (1) Poultry that is mechanically deboned is the same as any other
poultry and should be treated and labeled like any other poultry, i.e.,
hand-deboned; (2) current labeling is truthful and accurate, unlike the
term ``mechanically separated,'' which suggests it is different because
mechanical equipment is used; (3) labeling MSP differently than it is
currently labeled will confuse and mislead consumers into believing
that the product has undergone a change and is somehow different; (4)
the proposed labeling terminology will force manufacturers to undertake
numerous unnecessary product reformulations and promote new labeling
nomenclature that is both unappealing and unnatural in context; (5) the
common or usual name of finely ground turkey or chicken is ``turkey or
chicken,'' by virtue of consistent, widespread and long-term usage of
the term by the industry; (6) the addition of the words ``mechanically
separated'' to the ingredients statement unnecessarily contributes to
the general cluttering of limited label space; (7) ingredient labeling
should be based upon product characteristics not on the manufacturing
method, because most, if not all, ingredients in all food products are
mechanically processed at some point, e.g., ``pitted cherries are
mechanically pitted but do not require mechanically pitted on the
label'' or ``orange juice squeezed by a machine is not required to be
labeled as mechanically squeezed orange juice;'' and (8) the term will
frustrate technological innovation by establishing a false dichotomy
between mechanical and ``natural'' processes.
Commenters also suggested that any further regulation or change of
ingredient declaration for this product is unnecessary and not based on
consumer expectations or scientific determination. Commenters stated
that there is no adequate justification for setting a new standard of
identity for this product. They stated that FSIS has not provided any
research, consumer studies, or marketing data to support the need for
this labeling change and that no new evidence has been presented by
FSIS to refute that mechanically separated poultry is materially the
same as poultry derived from hand-deboning. Commenters also questioned
placing additional requirements on a product that is already accepted
by consumers. Another commenter stated that the only reason FSIS was
initiating a change to the name for MSP was because of the lawsuit by
the red meat sausage manufacturers (i.e., Bob Evans Farm, Inc. et al.,
v. Espy).
Further, one commenter alleged that the reason given by FSIS for
proposing this rule, which is to prevent mislabeling of products and
misleading consumers, is invalid. This commenter was the only one to
offer consumer data7 regarding consumer reactions to labeling MSP.
The commenter contracted out a consumer study to measure consumers'
preferences for the terms ``chicken,'' ``turkey,'' ``mechanically
separated chicken or turkey,'' and ``finely ground chicken or turkey.''
The commenter concluded that the consumer research shows that ``the
majority of consumers consistently report no preference to change from
current labeling practices.'' According to the commenter, ``less than 2
in 10
[[Page 55970]]
consumers in their study expressed the opinion that `mechanically
separated' is an appropriate labeling term for comminuted poultry,''
and that, if a change is made to current policies, ``finely ground''
would be a more preferred term. The commenter concluded that the
results of the research were applicable to consumers in general.
Several other commenters cited the consumer research presented by this
commenter and also asserted that, if any change is made with respect to
the product name, ``finely ground (Kind)'' is much more informative
than ``MSP.'' Other commenters suggested other names such as
``ground,'' ``finely textured,'' and ``finely comminuted'' poultry.
\7\Comment submitted by the National Turkey Federation is
available for public review at the FSIS Docket Clerk's office.
---------------------------------------------------------------------------
FSIS has concluded that the name mechanically separated poultry,
i.e., ``mechanically separated (kind of poultry) (MSP)'' (e.g.,
mechanically separated chicken) should be adopted as the product name
and that a separate standard of identity should be established for this
product to reflect its name and set forth appropriate parameters for
the product. FSIS has determined that the name ``mechanically separated
(kind of poultry)'' is an appropriate, nonmisleading name for this
product based on comments received in this rulemaking, an examination
of the process by which MSP is made, the distinct paste-like form and
batter-like consistency of MSP, the need to distinguish MSP's
differences from hand-deboned poultry on labeling to comply with FSIS'
statutory consumer protection responsibilities to assure that labels of
meat and poultry products are accurate, and a review of product name
issues raised in the rulemaking for mechanically separated meat, a red
meat product produced in a mechanical manner similar to MSP.
As will be discussed more fully below, FSIS does not agree with
various assertions of some commenters that establishing the name MSP
for this product is unnecessary and unjustified. The name mechanically
separated (kind of poultry)'' clearly and precisely describes the
manner by which the product is made. The process by which MSP is made
along with the type of starting materials used to make it, which
contain only bits and pieces of muscle tissue and other edible tissues,
such as skin and fat, are what causes this product to be different from
hand-deboned poultry. Consumers will be misled if they are not informed
that this product is materially different from hand-deboned poultry,
and the appropriate way to inform them of this difference is to
establish a name for MSP that distinguishes it from hand-deboned
poultry. As FSIS recognized in its rulemaking on MSM, the ability of
any name to convey in only a few words the nature of a product is
limited. However, FSIS has determined that the term MSP will
appropriately notify consumers that the product they are purchasing
contains a distinct ingredient that results from the mechanical
separation process.
FSIS received various comments that suggested alternative names for
the product, if it was concluded that more descriptive labeling was
necessary, such as ``ground (kind of poultry),'' ``finely ground (kind
of poultry),'' ``comminuted (kind of poultry),'' and ``finely textured
(kind of poultry).'' FSIS has concluded that these names do not provide
a concise and accurate description of the product because the usage of
the terms is not unique to MSP, and these terms convey the impression
that the product has the same form and consistency as product with
defined particles of meat, skin, and fat, rather than, as here, one
that has a paste and batter-like consistency. FSIS has concluded here,
as it did for its previous rulemaking on MSM (47 FR 28214, 28224), a
similar product produced by a mechanical separation process that has a
paste and batter-like consistency, that the name of the product should
include the term ``mechanically'' to indicate the nature of the process
used in making the product. When FSIS adopted the name ``mechanically
separated'' in its 1982 rulemaking on MSM to describe mechanically
separated livestock product such as ``beef'' or ``pork,'' the adoption
of this name was challenged in a lawsuit. The name was upheld by the
Courts in Community Nutrition Institute (CNI) v. Block, No. 82-2009
(D.D.C. Dec. 1, 1982), aff'd 749 F.2nd 50 (D.C. Cir. 1984). As also has
been previously noted, the term ``mechanically separated'' is
recognized internationally by the Codex Alimentarius Commission of the
United Nations and by individual countries that trade with the United
States.
In its proposed rule, FSIS proposed the term ``Mechanically
Separated'' (Kind) for MSP. As a point of clarification, FSIS would
like to make it clear that ``kind'' refers to the ``kind of poultry,''
such as chicken, turkey, etc., used in a product. FSIS feels that the
name for this ingredient should be clear about this fact, and,
therefore, has clarified its regulations to reflect this fact.
FSIS also wishes to clarify the scope of its definition and
standard for MSP. As with FSIS' definition and standard for MSM, the
standard and definition for MSP are intended to only cover the product
with a paste-like form and batter-like consistency manufactured by
machinery that operates on the differing resistance of hard bone and
soft tissue to pass through small openings, whether it employs sieves,
screens, or other devices or whether or not bones are pre-broken before
being fed into such equipment. This regulation, however, is not
intended to cover whole pieces of muscles that are mechanically
separated from poultry carcasses or parts of carcasses. FSIS has
clarified its regulation in this regard by indicating that the product
that FSIS is regulating is the one that results from the mechanical
separation process that has a paste-like form.
In response to the commenters who suggested that there is no
difference between MSP and hand-deboned poultry and, that therefore,
they should be labeled the same, FSIS disagrees with this comment. The
method of obtaining poultry products by the mechanical separation
process results in a product whose form and consistency materially
differ from that of poultry derived by traditional hand-deboning
methods.
MSP is a poultry product that results from the mechanical
separation and removal of most of the bone from the skeletal muscle and
other edible tissues, such as skin with attached fat, of poultry
carcasses and parts of carcasses. The process of manufacturing MSP
begins with starting materials from which most of the muscle and other
tissue has already been removed by hand, on which only bits and pieces
of tissue remain. The process involves the crushing of the bones (i.e.,
the starting material) with adhering tissue and the removal of the bone
using high pressure which forces the mass of tissue through holes in
the equipment, allowing a small amount of powdered bone to pass along
with the edible tissue. This results in a product with a paste-like
form and cake batter-like consistency, that no longer resembles
``chicken'' or ``turkey.'' The rigors of the mechanical separation
process alter the structure of the muscle fibers, skin, fat, and other
tissues of the starting materials so that they become a blended and
amorphous paste-like mass that is no longer recognizable as ``chicken''
or ``turkey.'' On the other hand, ``hand-deboned poultry'' is a
boneless poultry product that is a result of removing whole muscle and
other edible tissue (e.g., skin with attached fat) from poultry
carcasses and parts of carcasses, using hand-deboning methods, e.g.,
hand-held knives. Such product is easily recognized as the kind of
boneless muscle and tissue that would be gotten by a person who used
[[Page 55971]]
a knife in their own kitchen to cut off pieces from a poultry carcass
or parts of poultry, such as drumsticks, thighs, and breasts, because
there is not a substantial disruption of the physical form of the
product by hand-deboning. With hand-deboning, the muscle fibers are
visible and maintain much of their original configuration.
Understandably, hand-deboned muscle and other tissue may be
subsequently processed through a grinder, flaking machine, or dicer to
yield poultry in ground, flaked, or diced form, but such product still
exhibits a physical character associated with ``chicken'' and
``turkey,'' rather than a cake batter. This is because the rigors of
these processes which occur after hand-removal of muscle and other
tissue do not alter the physical nature of the tissues to the degree
that mechanical separation does.
In response to the comments regarding consumers being confused or
misled by labeling MSP differently than is currently labeled, i.e., as
``chicken'' or ``turkey,'' the Agency is not aware of reliable or
conclusive data that support the assertion that consumers will be
confused or will believe that the products in which MSP has been used
are different from the products they purchase after the final rule is
effective. The Agency does not agree with one commenter's assertion,
the American Meat Institute, that a report of a study it
submitted8 on an evaluation of mechanically separated red meat
issues support its view that the required labeling for MSP has ``a
great affirmative potential to mislead.'' The report cannot be relied
upon as support for this conclusion for a number of reasons, including
the following discussed here. The report indicates it used focus group
sessions to, among other things, explore consumer reaction to and
understanding of the term ``mechanically separated meat.'' As noted
previously, MSM is a red meat product produced by a mechanical
separation process similar to that by which MSP is made. However, very
little of this product has been made and used in products with which
consumers are familiar, and it is not surprising that consumers might
not be aware of the product the term ``mechanically separated meat''
represented. Therefore, reactions to labels for products containing
mechanically separated meat would not necessarily be applicable to the
labels for mechanically separated poultry. Furthermore, as the study
itself states, the focus group method used does not ``produce precise,
absolute measures,'' ``its findings must be seen as hypotheses,'' and
``findings from focus group sessions are not projectable to a larger
population.'' Moreover, the study also sought consumers' reactions to
other labeling issues and the multiplicity of issues raised could bias
the responses made to the mechanically separated meat labeling issue
and, in turn, the validity of applying the finding to labeling of
mechanically separated poultry.
\8\A copy of the comment and the report are available for review
in the FSIS Docket Clerk's office.
---------------------------------------------------------------------------
In the Agency's opinion, the declaration of MSP as ``chicken'' or
``turkey,'' rather than by a distinctive name in the ingredients
statement of a product in which it used, is misleading. ``Chicken'' and
``turkey'' are terms associated with boneless poultry products derived
by hand from starting materials that consist of whole and half
carcasses, and parts of carcasses, on which whole muscle and other
edible tissues substantially exist. FSIS believes that MSP differs
significantly from boneless poultry produced by hand-deboning
techniques because of its paste-like form and batter-like consistency.
The form and consistency of MSP is a direct result of the mechanical
machinery (i.e., process) from which it is derived which involves the
removal of bits and pieces of muscle tissue and other edible tissues
from boned-out materials, i.e., skeletal frames and carcass shells.
Therefore, FSIS has concluded that MSP should be regulated as a
separate, standardized ingredient, and that the characteristics of this
ingredient are sufficiently different from the characteristics of hand-
deboned poultry that it should be identified on product labels in a way
that distinguishes it from hand-deboned ingredients. Such labeling will
help further inform consumers about the content of the products they
are purchasing. FSIS believes that such a labeling requirement is
necessary in order to fulfill its statutory responsibility under the
FMIA and PPIA to protect consumers by assuring that the labels of
poultry and meat food products are accurate and not false or
misleading.
If the commenters believe that consumers will be misled into
thinking that they are purchasing products that are different from what
they have historically purchased or that the product has changed, the
industry would have a full year before the rule becomes effective, to
educate consumers that the products they will be purchasing that
reflect the name MSP in the ingredients statement are what they have
historically purchased. FSIS, itself, also believes it is important to
inform consumers about this product. Therefore, it intends to review
its public information program and incorporate into it appropriate
explanatory material on the process used to make MSP, its
characteristics, its wholesomeness, its safety, and its nutritional
qualities. The Agency believes that consumers will be misled if
mechanically separated poultry is not separately and distinctly listed
as an ingredient, because of the differences previously discussed
between it and hand-deboned poultry. The Agency's responsibility under
its consumer protection mission is to assure that labeling information
is accurate and helps consumers make informed food purchasing
decisions.
In response to the comments that asserted that the requirement for
labeling ``MSP'' will result in a need for manufacturers to reformulate
products that currently contain MSP, and ``promote new labeling
nomenclature that is both unappealing and unnatural in context,'' the
Agency is not certain as to why such changes will be necessary. There
were no reliable or conclusive data submitted in support of these
comments that show a potential negative impact on poultry or meat food
product formulations. It is the Agency's belief that MSP continues to
be a wholesome and safe, low-cost source of protein, with nutritional
attributes comparable to ``chicken'' and ``turkey.'' The paste-like
form and batter-like consistency of MSP that results from the
mechanical separation process provide unique functional characteristics
that are a key benefit for its use in the variety of poultry and meat
food products (especially emulsion-type products like hot dogs) in
which it is currently used. This benefit seems likely to ensure
continued use of the ingredient in products that are meeting the
demands of consumers who purchase the products.
Further, in response to comments about a negative impact labeling
will have on consumers' acceptance of products labeled with ``MSP,''
there were no persuasive arguments made that support this as an
outcome. The majority of the comments that disagreed with the proposed
identity of the products as ``MSP'' did not provide data, but offered
opinions on the consumers' view of the proposed name. The data that
were presented by the one commenter that pursued consumer research were
not compelling because of shortcomings in the study design.
The report of consumer research submitted by the commenter tested
consumer preferences for the terms ``mechanically separated,'' ``finely
ground,'' and ``chicken'' and ``turkey,''
[[Page 55972]]
as names for MSP. The report concluded that the majority of consumers,
if given the choice between names such as ``mechanically separated
chicken or turkey,'' and ``turkey'' or ``chicken,'' preferred labeling
to stay as it is, ``turkey'' or ``chicken.'' If, however, a change in
the name is made, the report concluded that ``finely ground'' is
overwhelmingly preferred to ``mechanically separated.'' The commenter
concluded that the data show that a labeling change to ``mechanically
separated'' is unjustified and that consumers gain no salient
information from the use of such a term. They indicated that the data
were gathered from consumers who were informed as to the Agency's
concerns regarding the presence of ``powdered bone'' and a change in
texture of finely comminuted poultry.
The survey data's conclusions were based upon 300 interviews of
people in five states, who were given a questionnaire, after reading an
informational handout. The commenter indicated that the survey
participants had used cold cuts, luncheon meats, hot dogs, or smoked
sausage, in the past three months, and were heads of households and
primary or co-primary food purchasers between the ages of 21-69, 80%
who were female and 20% who were men.
The Agency has reviewed the survey conducted by the commenter and
has determined that the survey's findings are not reliable. The
informational handout given to survey participants to read before they
answered the survey questions did not tell those interviewed the
following information which they needed to have in order to make
informed responses to the questions posed to them: (1) a description of
the difference between the form and consistency of MSP and hand deboned
poultry; (2) descriptions of how the mechanical separation process
works and what the product is like that comes from it; (3) a
description of the difference in the nature of the starting materials
for hand-deboned poultry and MSP, and (4) a clear idea of the types of
products in which MSP is used. Further, the interviewees were not shown
any samples of MSP and hand-deboned poultry and, thus, did not view
these products and see the differences in form and consistency between
the products.
Moreover, the content of the handout was slanted in the sense that
it described only certain aspects of MSP and used confusing names for
MSP which obscured the difference between MSP and hand deboned poultry,
thus making any considered labeling change appear to be unnecessary.
For example, the informational handout indicates that the way MSP is
made is that ``new machinery was invented that could separate poultry
meat from bone without the need of hand deboning.'' This, however, is
only a partial description and is, thus, misleading. As has been
previously stated in this docket, the new machinery does not completely
separate meat from bone. Rather a small amount of powdered bone that
results from the fact that the machines crush the bone of the starting
materials from which the MSP is made, becomes mixed together with the
other material, such as muscle tissue and skin removed from the
starting materials. Another example is that the handout states that
``in either case,'' referring to MSP and hand deboned poultry, ``the
original form of the poultry is changed when it is used as an
ingredient in making hot dogs, bologna, and other processed meat.''
This is misleading because, as has been previously noted, MSP is an
amorphous and paste-like mass that is not recognizable as bits and
pieces of chicken and turkey, and even if hand-deboned chicken or
turkey was further processed by grinding, it would still exhibit a
physical character associated with chicken or turkey.
Moreover, the handout indicated that both mechanically separated
and hand deboned poultry may contain up to 1% bone, and that the
powdered bone in MSP ``provides nutritionally available calcium.''
However, whether the powdered bone in MSP provides a nutrient that
consumers want has nothing to do with the issue of what the name should
be of this product. Many types of products provide calcium but they are
appropriately described by different names because they are distinct
types of products. The handout also stated that ``in its raw, fresh
form, consumers are familiar with ground turkey which may be made using
the same equipment.'' This statement is misleading because the
important aspect of the way the machinery operates to produce a product
with a paste-like form and batter-like consistency is not presented.
Moreover, it is misleading to conclude that switching to the term
``mechanically separated'' would likely result in substantial decrease
in consumption of this products, when the interviewees were not told
that it was the distinct character of this product, rather than a
question of the wholesomeness of the product, that was a basis for
FSIS' proposed labeling change. Further, the interviewees also were not
told that product made without MSP could possibly cost more to purchase
than one made with MSP.
The conclusions reached by the commenter from the research are also
not valid because the study design did not account for possible errors
that may make the information gathered unreliable. The study used a
mall intercept survey approach and involved soliciting reactions on the
terms from 300 shoppers in shopping malls. The sample is not
statistically representative of a national population because of the
way the participants were selected. Although the commenter claimed that
they have data from ``true consumers,'' the participants represent a
population who happened to be able to shop in the mall, and on the day
of the survey. A concern with the usefulness of the results stems from
the non-probability, quota sampling approach. Non- probability samples
do not permit an estimate of sampling error. With smaller samples, the
range any reported percentage can take can be relatively large. Since a
sample of 300 respondents is smaller than most national level consumer
surveys, comparisons which look different may not be statistically
different when inferred to the population of primary food buyers. For
example, the difference between the 10 percent of respondents reporting
they will probably buy more product labeled as ``finely ground'' versus
the 6 percent that reported they will probably buy less could be due to
sampling error. Additionally, the approach to sampling tends to under-
represent persons who are difficult to contact or reluctant to
participate. In this case, under representation of certain persons with
different views is likely to yield underestimates of respondents who
report that the issue is of no importance to them.
In response to the comments that stated that the term
``mechanically separated'' is misleading because it suggests the
product is different because mechanical equipment is used, FSIS
believes that the use of mechanical equipment is, in fact, the very
reason MSP differs from hand-deboned poultry. The process of removing
bits and pieces of edible muscle and other tissues from starting
materials consisting of skeletal frames and shells is far different
than the process of removing muscle and other tissue from bone by hand.
The process of manufacturing MSP results in a paste-like product which
no longer resembles the consumer's expectation of ``chicken'' or
``turkey.'' The examples provided by the commenter of other products
that are ``mechanically'' processed, and which do not reflect this in
their names, are not comparable
[[Page 55973]]
because the form and consistency of the products mentioned would not
differ significantly whether the products were processed by hand or
machine.
Therefore, the Agency believes that MSP accurately and concisely
describes the poultry product produced by mechanical deboning,
indicating the nature of the process by which and the kind of poultry
from which it is made, and distinguishing it from poultry product
ingredients produced by traditional hand-deboning techniques. The name
includes ``(Kind of poultry)'' rather than ``poultry'' to make it clear
that the kind of poultry (9 CFR 381.1(b)(40)) from which the product is
made must be specified (e.g., ``Mechanically Separated Chicken'').
In response to comments that suggested the term ``mechanically
separated'' will frustrate technological innovation by creating a false
dichotomy between mechanical and ``natural'' processes, the Agency
stresses that the mere application of the mechanical means of
separating bone from muscle and other tissues does result in a
materially different product than that which is derived by hand. The
action of mechanical separation of bone from poultry tissue involves
crushing bones on which bits and pieces of meat, skin, and fat remain
after hand removal of the majority of edible tissue. The bones with
adhering tissue are forced under high pressure through screens or
sieves in the machinery to result in a paste-like and batter-like
composite of tissues that had been adhering to the bones, that also
contains a minute amount of powdered bone. The physical action of the
mechanical process cannot be duplicated by hand-deboning methods to
result in a similar product.
MSP has been referred to as ``Mechanically Separated'' Poultry
within the meat and poultry industries to specify the form and
derivation of the product. FSIS is aware that other descriptions have
been associated with poultry product produced by mechanical separation,
such as ``mechanically deboned'' poultry, ``finely ground'' poultry,
and ``finely comminuted'' poultry. There are reasons why these other
terms do not appropriately convey the identity of MSP.
FSIS believes that where a primary distinguishing characteristic of
a standardized product is its bone content, it would be inappropriate
to define it by a name that includes the term ``deboned'' and use of
this term in labeling might mislead consumers by implying that such
product contains no bone. This was also concluded in the final rule
that defined and standardized MSM (47 FR 28214). Although consumer
focus group research reported in the MSM proposed rule (46 FR 39274)
suggested that consumers thought that ``mechanically deboned'' is a
term that is more acceptable than ``mechanically processed,''
``mechanically separated,'' and ``mechanically recovered,'' the Agency
in its final rule for MSM rejected the term ``mechanically deboned'' in
lieu of ``mechanically separated.'' The basis was that it was believed
that ``mechanically deboned'' would incorrectly represent to consumers
that the product does not contain bone.
With regard to other terms that refer to the form or consistency of
poultry products, e.g., ``finely comminuted,'' ``comminuted,'' ``finely
ground,'' ``ground,'' and ``finely textured,'' the Agency does not view
such terms as truly reflective of the form and consistency of MSP. MSP
is paste-like in form and like a cake-batter in consistency. When it
emerges from the mechanical separation machinery, it is an amorphous
blend of the tissues removed from the skeletal frames and shells that
were the starting materials. The process uses high pressure and
incorporates a minute amount of powdered bone into the product in the
operation of removing bone from the tissue. Terms such as those
mentioned are used to reflect products with a more defined particulate
size and would be perceived that way by consumers, e.g., as products
with a form and consistency comparable to ground beef. Additionally,
terms such as ``comminuted'' are not readily understood by many
consumers and only have a common usage and understanding among those
involved in the meat and poultry industry. Terms such as ``finely
ground'' and ``comminuted'' have also been used by industry
interchangeably to describe ground poultry, i.e., poultry with defined
muscle particles. Moreover, the terms cited above have been used
indiscriminately to refer to MSP, and although they relate to form and
consistency, do not sufficiently inform consumers that MSP is an
ingredient in the products they purchase. Therefore, these terms are
limited in their ability to effectively meet the Agency's communication
objective of conveying distinctly the presence of MSP on the labels of
products. Furthermore, there were not any comments received that
offered other, novel terms that could be applied to MSP.
Regarding the comments that cited the long-term use of the terms
``chicken,'' ``turkey,'' etc., to refer to mechanically separated
poultry, as the reason for not changing the name of MSP, the Agency has
taken into account the information and experience acquired since the
first regulatory action on MSP in 1969 and current regulatory policies,
and has reviewed and reevaluated the existing regulations, particularly
in light of the labeling issues. As a result of its review and
reevaluation, the Agency has concluded that the distinct declaration of
``MSP'' is necessary after a careful review of (1) the process of
manufacturing MSP which results in a product with a paste-like form and
cake-batter-like consistency, (2) the characteristics (i.e., form and
consistency) of MSP which are significantly different from those
expected of ``chicken,'' ``turkey,'' etc., which are derived by hand-
deboning, (3) the issues raised in rulemakings and court decisions that
resulted in the distinct identity of the livestock product similar to
MSP as ``MS(S),'' because (in part) of the form and consistency of that
product, and (4) the statutory responsibilities to protect the public
and prevent the preparation and distribution in commerce of poultry
products and meat food products which are misbranded or not properly
marked, labeled, or packaged.
Bone Solids Content
FSIS stated in the proposed rule that the definition and standard
for MSP would incorporate the existing restriction on the bone solids
content of mechanically separated poultry products of not more than 1
percent. All of the 26 commenters responding to this issue expressed
strong support for restricting the bone solids content to no greater
than 1 percent. After evaluating data on substances of potential
concern that may tend to concentrate in bone, the 1979 report on health
and safety aspects of the use of mechanically separated poultry did not
recommend any change in the existing bone solids limit. FSIS continues
to believe that the requirement of no more than one percent bone solids
content is reflective of good manufacturing practices that result in
wholesome and safe boneless poultry products.
Therefore, this final rule will restrict the bone solids content to
no greater than 1 percent, as represented by calcium content to a
maximum level of not more than 0.235 percent in product made from
turkeys or mature chickens or 0.175 percent in product made from other
poultry, as a measure of bone solids content based on the weight of
uncooked product (i.e., product that has not been heat treated). The
differences in the calcium value between turkeys and mature chickens,
and the value for
[[Page 55974]]
other poultry, are attributable to the higher level of calcium found in
turkey bones which are typically larger than other poultry bones, and
due to more calcium being deposited over the lifetime of older
chickens.
Bone Particle Size
Twenty-six commenters responded to the proposed bone particle size
requirement which restricts at least 98 percent of bone particles to a
maximum size no greater than 1.5 millimeters (mm) in their greatest
dimension and allows no bone particles to be larger than 2.0
millimeters in their greatest dimension. About half of the 26
commenters supported the restriction of bone particle size. One of the
commenters stated that the bone particle requirement provides consumers
with sufficient protection from any hard bone particles and also, from
any constituents which might not normally be found in items
manufactured from muscle tissue using the traditional hand-deboning
process.
The other half of the commenters opposed setting limits on bone
particle size stating that for more than 20 years of use of MSP, bone
particles have not been a significant problem. The commenters believe
that the nature of the separation process itself, with the comminution
of product which is pushed through screens under pressure, minimizes
the likelihood of large bone particles. Furthermore, the relative
softness of poultry bones due to their age and size make them unlikely
to present a physical hazard. One commenter stated that the American
Dental Association Health Foundation found no health problems
associated with poultry bone particles and that the Michigan State
University has reported no digestibility problems of issue. Other
commenters cited the 1979 Report's conclusion that ``bone particles in
MSP will not present any health hazard because of size or hardness,
provided that bone particle size is controlled.'' Commenters also
suggested that requiring standardized bone particle limitations will
result in increased analytical costs to the processor without improving
or otherwise positively effecting food safety. Other commenters pointed
out that the proposed rule did not suggest a method by which bone
particle testing can be conducted.
FSIS believes that a bone particle size limitation augments the
bone solids content restriction and is a meaningful indicator of a
mechanical separation operation that effectively removes bone from
muscle and other tissue. The mechanical separation process involves
bone crushing and screening out bone from soft tissue, thereby
providing a mechanism for limiting the amount of bone in the product.
The mechanism of separating bone from tissue does not necessarily make
the remaining bone particles uniform in size. Bone is an unexpected
ingredient and the process of mechanical separation should be operated
to avoid the likelihood of large bone particles occurring. If bone were
present in such a particle size as to be readily apparent to the taste
or touch, it would be identifiable as bone and might be reason to
consider the product adulterated. The 1979 Report recommended that bone
particle size be controlled to ensure that equipment type or processing
does not result in unacceptably large bone fragments in mechanically
separated poultry. There were no new data submitted by commenters that
refute the data in the 1979 Report and, thus, they appear to indicate
the reasonable limits, i.e., good manufacturing practices, by which
manufacturers are operating. FSIS agrees with the recommendation in the
1979 Report and is, therefore, requiring that at least 98 percent of
the bone particles present in mechanically separated poultry have a
maximum size no greater than 1.5 mm in their greatest dimension and
that no bone particles be greater than 2.0 mm in their greatest
dimension.
Recordkeeping of Calcium and Bone Particle Size
The proposed recordkeeping requirements required that manufacturers
of MSP maintain records to support the fact that the MSP met the
proposed bone solids content requirement for MSP and the proposed bone
particle size requirement for this product. The majority of the
comments received in response to this requirement supported the
requirement. The commenters believed that establishments should
maintain records of bone solids content and bone particle size because
it assists in compliance and provides an incentive for good process
control. A number of commenters argued that mandatory recordkeeping for
bone particles would have operational costs associated with it, which
are proven to be unnecessary, particularly in light of the fact that
there is no food safety issue of concern.
FSIS has reconsidered the need for establishments' keeping records
on bone solids content (measured as calcium) and bone particle size in
light of the comments that stated that a recordkeeping requirement was
unnecessary. The Agency wishes to be cooperative to ease burdens on
industry, in appropriate situations, and allow flexibility in the
manner in which requirements can be carried out, where it can do so and
still carry out its statutory missions to prevent the distribution of
adulterated and misbranded meat and poultry products. Consistent with
this effort, the Agency in its proposal for MSP did not require the
industry to either carry out any prescribed tests for bone solids
content or bone particle size of the MSP produced, or to carry out any
type or amount of sampling of the MSP produced. The agency has now
concluded that removal of the recordkeeping requirement for bone solids
content and bone particle size will appropriately allow producers even
more flexibility in meeting these requirements. FSIS, of course,
expects producers of MSP to comply with the bone solids content and
bone particle size requirements, and it will implement spot checks in
order to verify that such compliance is occurring by producers of MSP.
If during these spot checks, or during any other inspection or
compliance review, FSIS finds a problem, it believes, however, that any
records producers have maintained in regard to compliance with these
requirements, will be helpful to FSIS and, in turn, to the industry, in
evaluating the company's control of bone solids content and bone
particle size.
B. Use Limitations and Restrictions
Most of the commenters responding to the issue regarding
limitations on the use of MSP disagreed with the Agency's position that
limitations of use in products composed of whole muscle or of MSP made
from fowl are needed. The commenters believe that there should be no
limitations on use because there are no safety or health concerns
regarding MSP. They also believe that use levels of MSP should not be
restricted because the marketplace is a better judge of the quality of
poultry products that are composed of MSP than FSIS. However, two
commenters agreed in part with the proposed limitations. The two
commenters agreed that where a poultry product is required to be
prepared from a particular Kind or Kinds of poultry (e.g., chicken),
use of MSP of any other kind (e.g., mechanically separated turkey)
should not be permitted.
FSIS also received 11 comments regarding the fluoride content of
MSP made from fowl and the use of MSP made from fowl in baby food. All
of the commenters disagreed with the proposed limitation on the use of
product made from fowl in baby foods because of potential health
implications associated with over-consumption of
[[Page 55975]]
fluoride in infants' diets. One commenter stated that based on
discussions with baby food companies, a local children's dentist,
experts from Duke University Medical Center, the University of North
Carolina School of Dentistry, and the American Academy of Pediatrics,
there is not one known documented or suspected case of fluoride
problems related to chicken in baby food. Furthermore, the commenter
stated that these people had very encouraging remarks for the positive
effects that fluoride from all food sources has had on the overall
dental health of the children in our country.
FSIS continues to believe that the use of MSP should be limited in
certain poultry products. In response to the commenters that said where
a poultry product is required to be prepared from a particular kind or
kinds of poultry (e.g., chicken), use of MSP of any other kind (e.g.,
mechanically separated turkey) should not be permitted, FSIS agrees.
This provision assures that MSP made from a certain kind of poultry is
not used in a poultry product represented as containing ingredients
from a different kind or kinds of poultry, thus avoiding situations of
misbranding.
The Agency however, agrees with comments on the proposed use
restrictions of MSP in processed products composed of whole poultry
muscle that suggested a restriction was unnecessary because the use of
MSP in a product formulation is an issue of product quality. The Agency
recognizes the increasing market popularity of convenient, ready-to-
cook or ready-to-eat products that are composed of whole poultry muscle
to which a portion of MSP is added. MSP benefits the manufacture of
such products because it is batter-like and can be molded to form a
desired product shape, and fill voids or spaces to make product shapes
uniform. The level of use of MSP that is associated with these products
exceeds the level that is used for strictly binding muscle pieces
together--an allowance that was acknowledged in the proposal. The
presence of MSP will be declared in the ingredients statement according
to the requirements in this final rule. Therefore, regardless of the
level of MSP used, consumers will have the information necessary to
make an informed purchase decision.
The Agency is also keenly aware that with the allowance for the
addition of MSP (and other highly comminuted boneless poultry products)
to products composed of whole poultry muscle there is presented an
issue regarding truthful and non-misleading product names. The names
for these products should also convey to the consumer that the product
is not composed of entirely intact, whole muscle, perhaps through the
use of a qualifying statement. It is expected that the names for
products composed of whole poultry muscle and portions of MSP, or other
boneless, comminuted poultry, would reflect this fact in their names to
make them truthful and accurate. The Agency will be assessing for
possible future policy development the broad issue of the appropriate
naming of products composed of MSP or other boneless poultry to convey
to consumers that they are not composed of intact, whole muscle, as may
be expected.
FSIS agrees with the commenters views that there is no need for a
requirement that would impose restrictions based on the potential
fluoride contribution of MSP made from fowl (i.e., mature female
chickens). In the proposed rule, FSIS proposed restricting the use of
MSP made from fowl in baby, junior, and toddler foods, citing its
concern for the potential effect of fluorosis in the susceptible
population of babies, infants, and toddlers. MSP made from fowl has
higher amounts of fluoride because the bones of older female chickens
contain more fluoride than younger chickens. In the proposal, the
Agency cited the conclusions of the 1993 National Academy of Science's
(NAS) Subcommittee on Health Effects of Ingested Fluoride (NAS Fluoride
Report)\9\ which indicated that the most effective approach to
controlling the prevalence of dental fluorosis, without jeopardizing
the benefits of fluoride to oral health, is likely to come from more
judicious control of fluoride in foods, especially those items used by
young children. The Agency requested that commenters provide any
information that would either reaffirm or contradict the conclusions
reached in the 1979 health and safety report regarding fluoride.
\9\This report is available for public review in the FSIS Docket
Clerk's office.
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After reviewing the information submitted by commenters, and
reevaluating the findings of the NAS Fluoride Report, FSIS no longer
has a concern regarding the potential effect of fluorosis. Most
noteworthy among the information FSIS considered in withdrawing the
proposed limitation on MSP from fowl are reports of the changing
sources of fluoride ingestion, the positive effects of increased
fluoride intake on reduction of dental caries in the 1990's, and the
decrease in the ingestion of fluoride from infant formulas since 1979.
Therefore, FSIS will not impose a restriction on the use of MSP from
fowl in baby, junior, or toddler foods. Because the Agency has
concluded that MSP made from fowl should not be restricted in baby
foods, there is no longer a need to require the labeling of MSP from
fowl, as ``mechanically separated chicken, made from fowl,'' as
proposed.
In addition, in response to comments seeking clarification on the
uses of MSP, FSIS will not prohibit the use of MSP in cooked sausage
products, such as frankfurters, franks, furter, hot dogs, vienna,
bologna, garlic bologna, knockwurst, and similar products. The Agency
will permit MSP to be used alone or in combination with poultry meat in
cooked sausage products identified in 9 CFR 319.180, however, not in
excess of 15 percent of the total ingredients, not including water.
FSIS is amending 9 CFR 319.180 to allow for such use. FSIS
inadvertently omitted such a provision in the proposed regulations.
C. Labeling
Commenters had varying opinions regarding the labeling of poultry
product produced by mechanical separation as ``MSP.'' Of the 14
commenters responding to this issue, three stated that poultry product
produced by mechanical separation should be labeled as ``mechanically
separated (chicken, turkey, or other kind of poultry) with skin,''
because consumers have a ``right-to-know'' that skin and other ``by-
products'' are present. Two stated that MSP should be listed in the
ingredients statement on a product's label. Other commenters also
suggested that there should be full disclosure of all ``ingredients''
resulting from the mechanical deboning process, including bone
particles, marrow, kidneys, sex glands and lungs. Another commenter
disagreed with the Agency's proposed requirement to label MSP from fowl
as such.
In response to comments that stated that MSP should be labeled to
reflect the presence of skin, skin is a naturally existing edible
component of poultry. Consumers have historically accepted and
purchased whole poultry carcasses (e.g., ``basted young turkey'') and
parts of carcasses (e.g., ``chicken drumsticks'') with skin, as well as
cooked poultry products, e.g., fried chicken, without the presence of
skin being specifically reflected on the product's label. FSIS believes
that the presence of skin should be labeled only when it is present in
excess of natural proportions because this would be a condition in
conflict with what a consumer expects poultry to be. If skin is added
to a product and
[[Page 55976]]
is present in an amount that exceeds that found naturally on the
carcass or the part of a carcass according to the figures presented in
the regulations (9 CFR 381.117(d)), the label must reflect the presence
of skin. FSIS has determined that the name of the product (e.g.,
``Mechanically Separated (Kind of Poultry) (MSP))'' must be followed
immediately by the phrase ``with excess skin'' unless it is made from
poultry product that does not include skin in excess of the natural
proportion present on the whole carcass, as presented in the
regulations.
Furthermore, there must be appropriate descriptive terminology on
the labeling of MSP (with or without skin in excess of natural
proportions) if heat treatment has been used in the preparation of such
product, e.g., ``cooked mechanically separated (kind of poultry).''
Because cooking would affect the use of MSP, FSIS is requiring that
such characteristic be clearly identified on the label when MSP leaves
the establishment at which it is manufactured. The poultry products
inspection regulations already require that information on use,
including deviations from the natural whole carcass proportion of skin
as well as the fact of cooking, appear on the label of boneless poultry
products produced by mechanical separation (9 CFR 381.117 (d)). The
presence of skin or its presence in excess of the natural whole carcass
proportion would continue to affect product use if the regulations are
amended. The use of heat treatment in the preparation of the product
also would be of continuing relevance (9 CFR 381.157(a)). FSIS is
requiring the labeling for excess skin in MSP and for heat treatment of
MSP in order to assure consistency with regulatory requirements in 9
CFR 381.117 (d) for boneless poultry products and, thereby, to prevent
the adulteration and misbranding of finished poultry products and meat
food products.
In response to other comments on the need for disclosure of the
potential constituents of the starting materials from which MSP results
(i.e., bones with muscle tissue and other edible tissue, with or
without skin), FSIS has certain regulatory requirements in this final
rule or currently in the regulations that address bone particles,
kidneys, sex glands, and lungs that negate the need for specific
labeling of these constituents.
This final rule will continue the current limit of 1 percent bone
solids (measured as calcium) that has been applied to all boneless
poultry products since 1969. The size of bone particles has been
limited by this final rule as a process control criterion to ensure
that the process of mechanical separation is operating in accord with
good manufacturing practices. There are no health or safety issues
concerning the bone content or bone particle size criteria being
established by this rule. Furthermore, the requirement that processed
poultry (and meat food) products bear nutrition labeling that includes
a calcium declaration in the Nutrition Facts panel will provide
meaningful information to consumers who wish to monitor their calcium
intake and will reflect the calcium contributed to a product from bone.
For these reasons, specific labeling that addresses the presence of
bone and bone particles is not necessary.
In regard to the comments on the need to label the presence of bone
marrow, no factual basis was provided that would justify such labeling.
As explained below, the Agency believes such labeling is unnecessary
due to the extremely small amount of marrow that is potentially
present, the composition of marrow, the lack of any health or safety
concerns about bone marrow from poultry bones, and the role of
nutritional labeling in disclosing any potential nutritional impact
from the presence of bone marrow in a product. Discussions with poultry
scientists, physiologists and geneticists at a variety of universities
and research organizations support this conclusion. Based on the
limited available data and the discussions with these experts, the
following response to the comments on the need for labeling bone marrow
in MSP is offered.
Most of the ready-to-cook poultry marketed today are raw, uncooked
young poultry carcasses. The bones with attached edible tissue of this
class of poultry represent the bulk of the starting materials from
which MSP is produced. Young chickens, i.e., broilers, are typically
less than 7 weeks of age (although the poultry products inspection
regulations, 9 CFR 381.170, define them as being under 13 weeks). Young
turkeys are typically less than 8 months of age according to the
poultry products inspection regulations (9 CFR 381.170). The young age
at which these birds are marketed does not provide time for the
production of substantial bone content and, thus, bones from such
poultry would not contain much marrow. Moreover, the physiology of
poultry is such that, in order for the birds to fly, their bones cannot
be dense with tissue and most of the bones could be categorized as
being composed mostly of air with minimal tissue (marrow) content. In
fact, references10 indicate that the bones of most birds are
porous; many are filled with air, not marrow, and are connected to the
respiratory organs. The bones with some marrow are mostly the larger
ones, e.g., the leg bones, and are involved in blood production, the
function of ``marrow.'' In actuality, the bone marrow represents part
of the bird's vascular system.
\10\Terres, J.K., 1991. The Audubon Society Encyclopedia of
North American Birds, Wings Books, New York. A copy of this
reference is available for review in the FSIS Docket Clerk's office.
---------------------------------------------------------------------------
Information on the actual amount of marrow in poultry bones is
lacking. According to the 1979 report entitled ``Health and Safety
Aspects of the Use of Mechanically Deboned Poultry,'' marrow content
varies in amount with age of the bird, and varies between different
bones from the same bird. Determining the actual amount of marrow is
difficult because it is difficult to separate marrow from the inner
surfaces of bones, and to determine what proportion of the separated
tissue is actually ``marrow.'' Moreover, because bone marrow is
composed of fat, heme pigments, blood cells, and other constituents
normally found in the edible tissue of poultry, it would be difficult
to distinguish it from the other edible tissue comprising MSP to
determine the minimal amount that may actually be contributed to MSP.
However, with regard to the minimal contribution of bone marrow to
MSP that may be possible, it has not been reported to be a health or
safety concern. The 1979 Report, the most comprehensive review of MSP
to-date, is reliable today as an information source because the basic
composition of poultry that would be the starting materials for MSP has
not changed since the report was prepared. The 1979 Report made no
recommendations regarding the presence of marrow and the need for
specifically labeling bone marrow.
Therefore, because it has been estimated that there would be an
extremely small marrow constituent in MSP, so small and so similar in
composition to other components of MSP that it would be difficult to
quantify it, and that there are no known health or safety issues with
regard to bone marrow, there is no basis for the specific labeling of
bone marrow in MSP. If data on the quantity of bone marrow in MSP
become available at some point in the future that would present a basis
to reconsider this position, the Agency would certainly reconsider it.
[[Page 55977]]
The 1979 Report did, however, suggest that bone marrow is a
potential source of cholesterol in MSP, in addition to that contributed
by skin and muscle tissue. The 1979 Report recommended that because of
the potential contribution of cholesterol in MSP to foods, which may be
of importance to people who have the hereditary condition known as
hypercholesterolemia, it is desirable to identify products that contain
MSP. This final rule requires that the MSP in a product be labeled and,
thus, the recommendation of the 1979 Report has been accepted. More
importantly, recent regulations on nutrition labeling address the issue
of the potential contribution of cholesterol to the diet from any food.
Thus, the potential minimal contribution of marrow to the cholesterol
content of a product would be reflected in the mandatory labeling of
cholesterol, which is reflected in the Nutrition Facts panel of a
product's labeling.
As noted, raw, uncooked young poultry carcasses make up the
majority of the ready-to-cook poultry marketed today. Young poultry
carcasses are currently sold with kidneys and have been historically
sold in this manner. The presence of kidneys in young poultry does not
pose a health or safety concern because there are no constituents,
e.g., heavy metals, known to be present in these kidneys that are of
potential concern. Kidneys from young poultry can be present in the
poultry purchased at the supermarket and in the poultry products
consumed at retail fast food outlets.
FSIS does, however, require the removal of kidneys of mature
turkeys and chickens from their carcasses before completion of the
eviscerating operations during the slaughtering process (9 CFR
381.65(d)). Kidneys of mature poultry pose a potential health concern
because of the possibility of the presence of certain constituents in
these organs, e.g., heavy metals, such as cadmium, which are deposited
in the kidneys of older birds over time.
Since kidneys of young poultry pose no health or safety concern and
have been historically accepted in ready-to-cook poultry, there is no
basis to require specific labeling of these on a product's label.
Furthermore, since kidneys from mature poultry must be removed, there
is no basis for requiring labeling of kidneys from mature poultry.
In response to comments on the presence of sex glands in MSP,
mature reproductive organs (or sex glands) are precluded from being
present in ready-to-cook poultry, i.e., poultry subsequent to the
slaughtering process, by the poultry products inspection regulations (9
CFR 381.1(b)(44)). Therefore, mature sex glands cannot be present as
part of the carcasses or parts of carcasses that are the starting
materials from which MSP is made. Mature male sex glands are, however,
marketed as an edible poultry product known as ``chicken or turkey
fries'' in various regions of the United States.
There are no prohibitions on the presence of immature sex glands,
however, in poultry carcasses or parts of carcasses sold to the
consumer, or in ready-to-cook poultry used as starting materials for
MSP. Immature sex glands have historically been present in these
products because they are considered to be an indistinguishable part of
the edible tissue of poultry. The young age at which most chickens and
turkeys are marketed (as previously noted) does not provide ample time
for the development of reproductive organs, e.g., in chickens, sexual
maturity of the testes and ova does not begin until about 20 weeks of
age. At 6 or 7 weeks of age, the age at which most broilers (the source
of most starting materials for MSP) are marketed, the sex glands are
merely a thin membrane covering over undefined tissue which is no
different in biological or chemical function than other, edible tissue
of the carcass. At 6 or 7 weeks, the weight of the barely
distinguishable, inert tissue that will later become the sex glands has
been estimated to be less than a tenth of a percent of the weight of
the raw, uncooked broiler. There are no health or safety concerns
related to immature sex glands. Thus, because the tissue of immature
sex glands is virtually indistinguishable from other edible poultry
tissue and there are no health or safety concerns related to immature
sex glands, there is no need to require specific labeling of their
presence in a product.
With regard to poultry lungs, poultry lungs must be removed during
the processing of ready-to-cook poultry. Lungs are not defined as part
of the edible portion of ready-to-cook poultry and must be removed
according to the poultry products inspection regulations (9 CFR
381.1(b)(44)). Therefore, specific labeling regarding the presence of
lungs is not needed, since lungs are removed before the starting
materials used for MSP are obtained.
As noted, a comment was received on the need for the proposed
labeling requirement for MSP made from fowl. Because FSIS is not
restricting the use of MSP made from fowl, it is eliminating the
proposed labeling requirement which requires products made with
mechanically separated chicken from fowl to contain on the label the
phrase ``made from fowl'' after the product name (e.g., ``mechanically
separated chicken (made from fowl)).''
D. Nutrition
Although FSIS did not propose any specific requirements that
addressed nutrition, the Agency did receive several comments related to
``Nutrition Facts'' and cholesterol. Fifteen commenters stated that the
``Nutrition Facts'' on product labels is a reflection of the product
formula that will satisfy consumers concerning poultry product produced
by mechanical separation. Three other commenters stated that
cholesterol is not an issue in poultry product produced by mechanical
separation.
FSIS recognizes that a recommendation in the 1979 Report was to
label products containing MSP with cholesterol content information.
This recommendation was based on the evaluation of cholesterol contents
of different MSP products that showed they were nearly double the
contents in hand-deboned poultry. However, it was stated that, based on
consumption estimates, daily increases in cholesterol consumption from
use of MSP would be negligible on a per capita basis, and would not
pose a health hazard for the general public. It was noted that, for a
small segment of the population which must limit their intake of
cholesterol for health reasons, foods containing MSP should be
specifically labeled to show its presence. However, specifically
labeling cholesterol on products containing MSP is not an issue because
the provisions of the nutrition labeling regulations (58 FR 632)
published by FSIS, which were effective July 6, 1994, would be a means
of educating consumers regarding certain nutrients and other components
of processed meat and poultry products produced by mechanical deboning,
including cholesterol.
E. Safety Concern Regarding Poultry Products Produced by Mechanical
Separation
FSIS received 1426 comments regarding the safety of poultry product
produced by mechanical separation. Fourteen hundred and twenty
commenters stated that there are no safety concerns regarding the use
of poultry product produced by mechanical separation. Some of the
commenters stated that there are no bone particles of a size that would
pose a health concern. Five of the commenters believe that Hazard
Analysis and Critical Control Point (HACCP) addresses the needs for
process controls that would be related to
[[Page 55978]]
poultry product produced by mechanical separation. One commenter
suggested that the proposed rule has no conceivable relationship with
health or safety, and is a timely example of unnecessary regulation.
In addition, one commenter stated that there are microbiological
concerns specific to poultry product produced by mechanical separation.
The commenter pointed out that the skin of poultry, including pin
feathers, feather particles, and hair are sources of potential
microbiological contamination.
FSIS agrees with the commenters that there are no unique safety or
health concerns regarding the use of poultry products produced by
mechanical separation. Although the data reviewed in the 1979 Report
indicate that poultry products produced by mechanical separation
generally are acceptable from a microbiological standpoint, the data
also show that, where bacterial loads tend to be higher, it can be
attributed to the starting material used. This is not unique to poultry
products produced by mechanical separation; it can be applied to other
finely comminuted and comminuted products as well. FSIS is currently
developing a separate rulemaking on HACCP and pathogen reduction
efforts that will deal with this issue more fully for all poultry and
meat products, including poultry products produced by mechanical
separation, and the material from which they are manufactured.
F. Economic and Market Impact
FSIS received 1720 comments on the economic and market impact of
the proposed rule on industry. The comments fell into four general
categories: (1) The Agency's economic analysis was not sufficient; (2)
the new labeling requirement would reduce the demand for products
containing MSP; (3) the labeling costs are underestimated; and, (4) the
meat industry has been hurt by a similar labeling requirement. These
comments are presented and responded to below.
Adequacy of the Agency's Analysis on Economic Impacts
The Small Business Administration (SBA), citing many of the
industry objections to the proposed rule, advises that it does not
concur in the Administrator's conclusion that the proposed rule will
not have a ``significant economic impact on a substantial number of
small entities,'' and that, therefore, under the Regulatory Flexibility
Act, a more substantial economic analysis is required to support
continued rulemaking in this matter. SBA states its belief that further
analysis would reveal significant additional costs to industry and
disproportionate impacts on small entities, and would disclose other,
less burdensome regulatory options.
Others made comments similar to those of the SBA, namely, that the
economic analysis of the proposed rule was inadequate and that the
proposal constitutes a major rule requiring a far more detailed
economic analysis prior to final rulemaking.
Neither the SBA comment nor any other comment received provides
data or other evidence that would cause the Agency to alter its
estimate of the impacts outlined in the proposal or the economic
assumptions upon which they are based. No new evidence has been
provided that suggests that this rule will have a disproportionate, or
even a significant, economic impact on a substantial number of small
entities. Moreover, FSIS believes that the 12-month period prior to
implementation of the final rule and its requirements, including the
labeling requirements, will render the attendant costs to
manufacturers, including small businesses, negligible.
Proposed Requirement Would Reduce Demand for Product
Several commenters believe that the effect of the labeling
requirements will be a significant economic and market impact on
manufacturers of MSP and that the impact has not been adequately
considered by the Agency. It is their belief that this impact would
come from the fact that the new label would be unappealing to consumers
and would lead commenters to believe that the product is inferior to
what they are used to buying, or that something new has been added to
the product, or that the product has undergone other changes. This
confusion would, they believe, adversely affect demand for products
containing MSP.
One commenter indicated that many manufacturers may choose to avoid
the misleading connotations of the proposed labeling and reformulate
their products with other, more costly ingredients. The commenter
further stated that if only 25 percent of the usage of this ingredient
were curtailed on this basis, net costs to consumers from such
manufacturing decisions would exceed $134 million dollars per year.
Another commenter provided the information that the current market
price quotes for raw comminuted turkey meat (frozen, 20% skin) are less
than current price quotes for hand-deboned breast and scapula trim meat
and boneless, skinless thighs by about $0.50/lb. to $1.00/lb., in order
to illustrate that reduced purchases due to the proposed labeling would
force industry to use higher cost ingredients such as hand-deboned and
boneless meats and that such costs would be directly passed on to the
consumer.
Another commenter raised the same issue, indicating that companies
that are apprehensive about the labeling change and that fear that
their brands will be damaged by the potential negative connotation will
reformulate products with higher cost materials. According to this
commenter, reformulation will have the effect of increasing the cost of
raw materials for both poultry and red meat, ultimately raising the
consumer's cost to purchase these products. The commenter stated that
the proposal did not address the cost of replacement raw materials and
the effect on the raw materials market and believes that if these
factors were included in the economic impact, the cost would be between
$150 and $200 million.
FSIS has not acquired any reliable data to support the assertion
that this rule's labeling requirements will adversely affect the demand
for products containing MSP. FSIS believes, however, that if the rule's
labeling requirements do reduce demand to some extent for the product
or products containing MSP, then it is difficult to draw any conclusion
other than that the consumer has been misled by the absence of such
labeling.
The primary objective of the Agency's labeling authority is to
facilitate informed purchasing decisions. If, as a result of labeling
requirements, some consumers will not want the products such evidence
would strongly suggest that such labeling is needed. It is the
responsibility of FSIS to help ensure that labeling is not deceptive or
misleading, and it would be contrary to the Agency's statutory
objectives to permit misleading labeling.
The Agency does not believe, however, that it is likely that
consumers will face less choice in the market and be forced to buy
similar products with higher-cost ingredients because of this rule. In
an industry as competitive as the poultry industry, the products
demanded by the consumer will be produced. Price is an important factor
in selling products, and consumers are unlikely to abandon a popularly-
priced, high-quality product which they have found to be satisfactory
simply because it has a more informative label. Further, if some
consumers shift to their purchases to higher-priced products, it is
difficult to see why this would not be a favorable outcome for both the
consumer and the industry. The Agency
[[Page 55979]]
believes that the poultry industry is a mature and sophisticated
industry that is capable of producing and marketing any array of
products for which there is a demand, and that this rule will not
restrict or hamper the industry's ability to meet the needs and desires
of its customers.
The Red Meat Experience With Similar Labeling
One commenter stated that the meat industry's experience in a
comparable regulatory situation strongly, if not conclusively, suggests
that assumptions made in the economic analysis are invalid.
The Agency assumes this commenter is referring to the widely held
belief that product labeled as ``Mechanically Separated (Species),''
here referred to as MSM, has not been a highly profitable undertaking
for the red meat industry. The Agency has no data to confirm or refute
this proposition. It does believe, however, that the red meat and the
poultry situations are not comparable from an economic point of view.
The red meat industry never had an established market for MSM, and
it would be difficult to attribute the asserted lack of success to the
required label rather than to the decision not to try and build that
market. Further, it is not obvious that the MSM label is solely
responsible for the decision not to try to build the market. Numerous
other factors, particularly the marketing expense of launching new
products with an unknown demand, could have been a determining factor
in the decision not to try to build a new market for MSM products.
The poultry industry, on the other hand, has established markets
and satisfied consumers for products that have always been made with
MSP. Its position is, therefore, not comparable to that of the red meat
industry which would have to take a chance on new products with an
unknown consumer reception.
Labeling Costs
One commenter stated that his company would have more than 250
labels affected by this rule. The company believes that it will cost a
minimum of $1,000 for each label change, which includes internal
management time, printing costs, and obsolete label inventory.
The cost of labeling changes can be significantly reduced by
allowing companies to use up their old stocks, which the rule has
provided for by making the rule not effective until one year from its
publication date.
G. Finished Poultry Products and Meat Food Products
Several commenters disagreed with the Agency's proposed position to
regulate MSP as a distinctive ingredient with standardized
characteristics that is defined by its own name, e.g., ``Mechanically
Separated (Kind of Poultry)'' which must be declared in the ingredients
statement of finished product labels. One commenter noted that the
Agency has provided no evidence of salient differences between what
they refer to as ``finely ground poultry'' and hand-deboned poultry to
suggest that mechanically separated poultry should be regulated as
proposed. The commenter further stated that the Agency has provided no
legitimate reasons for treating mechanically separated poultry and MSM
similarly and for regulating the final products based on the process
used to make them. The commenter noted that the poultry industry uses
raw materials containing greater proportions of meat and produces a
product much lower in bone content, which is analytically similar to
whole muscle cuts from the same species.
In addition, another commenter suggested that since calcium and
cholesterol nutrition information is fully disclosed in the Nutrition
Facts panel, which is a reflection of the product formula, the term
``mechanically separated'' is not needed in the ingredients statement.
FSIS believes that such a labeling requirement is necessary to
fulfill its statutory responsibility to protect consumers by assuring
that the labels of finished poultry products and meat food products are
accurate. MSP is materially different in form and texture as compared
to hand-deboned poultry, and this is a direct result of the mechanical
separation process and the types of starting materials used to make
MSP. MSM is a similar red meat product, resulting from a similar
process. FSIS has concluded that MSP should be defined by its own name,
i.e., ``Mechanically Separated (Kind of Poultry),'' and should be
declared in the ingredients statements on finished product labels.
The starting materials used to make MSP may vary in the amount of
edible tissue remaining on the poultry bones after hand-deboning, but
the variance is minimal because a substantial portion of the muscle and
other edible tissues has already been removed by hand-deboning methods.
That a significant amount of muscle remains on the bones is not likely
because the process of mechanical separation for both poultry and
livestock has been designed to salvage the tissue left on the bones to
produce a wholesome, low-cost, and functional poultry product. The
comparison made by a commenter regarding the amount of tissue on
starting materials for making MSP and materials used to make MSM is
irrelevant. It is the fact that the process starts with bones on which
a minimal amount of tissue remains and that both processes are designed
to salvage muscle and other edible tissues, and both processes result
in a paste-like and batter-like product in terms of form and
consistency, that warrant their distinct declaration.
H. Ergonomic Impact
FSIS received several comments regarding the ergonomic impact of
this rule. According to the commenters, mechanical deboning systems
have substantially lowered the risk of cumulative trauma disorders
(CTD) resulting from repetitive hand, arm, and wrist motions. However,
the commenters indicated that industry may be forced to use more hand-
deboned products in lieu of this wholesome mechanically separated
product due to this rule. The commenters believe the rule negatively
impacts the industry's ability to use mechanical deboning and other
``mechanical'' means in harvesting meat from turkey and chicken parts
and carcasses. They indicated this is because the labeling requirements
will diminish sales and production of products containing MSP and make
the industry revert to using hand-deboned poultry.
FSIS agrees that it is likely that mechanical separation systems
have substantially lowered the risk of cumulative trauma disorders,
although there were no data supplied to document this conclusion.
However, FSIS does not agree with the assertion that this rule will
force industry to use more hand-deboned products, in lieu of
mechanically separated product, because of the requirement that use of
MSP in a product be separately reflected in a product's ingredients
statement. This assertion appears to be based on the assumption that it
would be economically feasible to hand debone the materials from which
MSP is made. However, FSIS does not believe that it would be
economically feasible for the industry to hand debone, as opposed to
mechanically separate, the bits and pieces of poultry that remain on
poultry carcasses, and parts of carcasses from which mechanically
separated product is obtained.
[[Page 55980]]
I. Miscellaneous
FSIS received other miscellaneous comments which addressed the
following issues: (1) use of MSP in the manufacture of a flavoring
should not require a separate and distinct listing of MSP as an
ingredient of the flavoring in the ingredients statement of the product
in which it is used, (2) an extension of the comment period for 30 days
should be granted, and (3) industry should be given sufficient time to
use up most of its printed labels before the final rule's new labeling
requirements become effective.
FSIS is familiar with the issue raised by the commenters that MSP
is frequently used as a protein source for ``reaction'' (or process)
flavors produced under the jurisdiction of the Food and Drug
Administration (FDA) and may currently be labeled as ``(kind) flavor''
according to the guidelines on reaction flavors established by the
Agency. FSIS does not intend to change these policies because the
chemical reactions involved in manufacturing process flavors involves
the removal of the soluble flavoring components of the poultry
ingredients and does not include the solid portion of the poultry
ingredients.
At the request of commenters, FSIS extended the comment period for
the proposed rule an additional 30 days to March 6, 1995. FSIS
considered these requests to have additional time to study and develop
information relating to the proposal to be reasonable. Also, as
discussed previously, FSIS has made its final rule effective one year
from its date of publication, which should allow ample time to use up
label stocks.
Executive Order 12866
This final rule has been determined to be significant and has been
reviewed by the Office of Management and Budget under Executive Order
12866.
Total federally inspected broiler and turkey meat production in the
United States in 1993 was about 27 billion pounds on a ready-to-cook
basis (i.e., subsequent to the slaughtering step in processing).
(Broilers represent the majority of chickens grown and slaughtered in
the U.S.) Broiler production was 22.2 billion pounds and turkey 4.8
billion pounds. Continued growth in poultry production has resulted in
large increases in the volume of poultry meat going into further
processed products such as bologna, hot dogs, fritters, patties, and
luncheon meats, many of which use MSP. FSIS has estimated that 1
billion pounds of poultry product is processed annually into MSP, with
a yield of 70%, or 700 million pounds of MSP product for human use.
(Industry sources suggest that a larger amount of MSP product is
produced annually.) FSIS estimated that 400 million pounds are used in
sausage products and 300 million pounds in patties and nuggets. In any
case, size of the market does not directly affect the cost of this rule
(see below).
The Broiler Council estimates that broiler meat is produced in
about 200 establishments, of which 50 are further processing
establishments. MSP is produced in about 108 establishments. About 25-
30 of these establishments with MSP equipment produce hot dogs. The
product from the other 75-80 establishments is sold to establishments
that further process poultry or to red meat processors. Industry
sources indicate that some small firms specialize in MSP production,
buying carcasses from poultry slaughter establishments for further
processing.
Based on inspection task records, FSIS estimated that 108
establishments produce (or are capable of producing) MSP. An assessment
of MSP production by establishment size is not available. However,
total further processed product production by size of establishments
shows 7 establishments with production less than 10,000 pounds of MSP
annually. The average production of the 108 establishments is 51
million pounds of all further processed products.
Under this rule, products containing mechanically separated poultry
are required to separately label ``Mechanically Separated (Kind of
Poultry)'' in the list of ingredients. There is no precise information
on the total number of products that currently contain MSP because MSP
may appear simply as ``chicken'' or ``turkey'' in product formulations
in which it is an ingredient. However, an estimate of the number of
products containing MSP can be made by estimating the number of labels
for MSP and for categories of products to which it is frequently added.
These estimates were made by using the database of label information
that is maintained by FSIS' Food Labeling Division, as part of the
Agency's prior label approval system. There are 602,000 approved labels
for poultry and meat, not all of which are necessarily in use. These
include 529 labels for MSP itself. There is also an unknown number of
labels for products containing MSP, such as frankfurters, chili,
bologna, poultry baby foods, chicken nuggets or patties. FSIS estimates
that, in total, about 5,000 products would require relabeling. There is
no currently available data on the size breakdown of the establishments
producing products containing MSP.
Costs and Benefits of the Rule
Analysis of the economic impact of a rule requires consideration of
all significant costs and benefits.
Benefits
The benefits are the values consumers place on the ability to make
a more informed purchase based on more accurate labeling. Informed
purchases, which in this case result from accurate labeling, are an
essential principle of the free market in which meat and poultry
products trade and one of the principal justifications for the
regulation of labels. FSIS has a statutory mandate to avoid false and
misleading labeling. Therefore, if, as the Agency has determined here,
a label is misleading or false, the Agency has a responsibility to
correct that situation.
As discussed earlier in the preamble to this rule, several
commenters suggested that the labeling requirements of the rule would
adversely affect demand for products made with MSP. FSIS has not
acquired any data that can be used to estimate the impact this rule
will have on the demand for MSP. However, the Agency's experience is
that consumers do distinguish between muscle meat and more finely
comminuted product. It is also apparent that there are texture
differences in these two types of products. The public comments on this
action have reinforced this belief. Many commenters have stated that
they believe consumers will not buy the product if it is labeled under
the new requirement. Further, the producers of a similar red meat
product, which already requires labeling of the type promulgated by
this rule, claim that the required labeling keeps the public from
buying their product. The Agency has not quantified the magnitude of
change in consumer demand under the present rule, but it does recognize
that these comments demonstrate there is widespread recognition that
comminuted product could be viewed less favorably than muscle meat by
the consumer.
Furthermore, as also discussed earlier in the preamble to this
rule, the Agency has concluded that use of the term ``mechanically
separated'' truthfully describes the nature of the product and that
purchases of MSP using this label will accurately reflect the real
value placed on it by consumers.
As a result of the current labeling practices, consumers are being
misled and are possibly consuming more MSP than they otherwise would if
they had better information. The extent to which
[[Page 55981]]
consumers reduce their demand for this product as a result of the
labeling change will reflect the level to which consumers have been
misled. The increased value placed by consumers on inaccurately labeled
MSP products represents a welfare loss to consumers and society. The
misdirected purchasing power placed on inaccurately labeled MSP
products could be used to purchase other products of higher value to
consumers. The greater the change value placed on this product by
consumers, the greater the benefits of the rule. Revenue losses
producers experience due to this shift in consumer demand are not
social welfare losses, but instead represent resources misallocated
toward the excess production of products containing MSP. To the extent
that market prices for products containing MSP decline in response to
shifts in consumer demand, losses experienced by producers represent
gains to consumers and, thus, are in fact transfer payments from
producers to consumers.
Taking into account consumer experience with MSP leads the Agency
to believe that any change in consumer behavior will be negligible, and
FSIS has not acquired any data to show any negative impact on poultry
or poultry products made with MSP. The Agency also believes that MSP
should continue to be a wholesome and safe low-cost source of protein
with nutritional attributes comparable to ``chicken'' or ``turkey.'' As
discussed earlier, MSP has certain desirable attributes that will
ensure its continued use as an ingredient in many products.
Costs
The Agency recognizes that it has a responsibility to keep the cost
impact of this rule to a minimum to keep the burden of regulation as
low as possible on the industry. It has done this by giving sufficient
time for most businesses to use up their inventory of labels, thus
substantially reducing the cost associated with the rule.
Possible sources of costs associated with the rule include the
following items:
A. Labeling Changes and Inventory
Under the final rule, finished products containing mechanically
separated poultry are required to have ingredient statement labeling of
the mechanically separated poultry as ``Mechanically Separated (Kind of
Poultry).'' As reported in the proposed rule, estimates range from $200
to $3,000 per product for a simple product ingredient statement label
change depending on the type of label. Comments in response to the
March 1994 ANPR indicate that changes to the ingredients statement of
most labels to which the final rule will apply would fall in the lower
end of this range (about $600). FSIS previously reported in the
proposal that, assuming an average cost of $1,000 per product, the cost
of relabeling would be $5 million ($1,000 times 5,000 products). These
estimated costs that were reported in the proposed rule assumed a
typical 30-day effective date for implementation of the final rule and
its requirements.
However, by establishing the one-year period from publication to
the effective date for implementation of the final rule, labeling costs
would be substantially reduced. The cost of relabeling would be
negligible because the mandated MSP label changes can be coordinated
with other label changes planned or required during the year-long
period prior to the effective date of the MSP rule. Many firms
routinely make label changes for existing products. For example, about
50% of the 180,000 labels submitted to FSIS each year for approval are
for label changes on existing products. These label changes are made
for various reasons that reflect the kinetic nature of the food
industry and, in particular, the fast-paced research and development of
new and modified meat and poultry products, e.g., changes to
incorporate less costly, new, or more effective ingredients that extend
shelf-life, improve taste or texture, or replace fat; changes to add
recipes or consumer purchase incentives to labeling; changes to make
new or different claims about a product's nutrient content or
performance; changes to alter features such as net weight or logos; or
changes to modify the color or size of print. These new MSP labeling
requirements, therefore, can be worked in with other routine label
changes. The modest costs associated with the MSP labeling change are
nonetheless necessary to assure that consumers receive meat and poultry
products with informative and nonmisleading ingredients statements.
Some firms may discard non-compliant labels when the final rule
goes into effect. A survey of meat and poultry companies for the
nutritional labeling rule indicated that firms carry an average label
inventory of 5 to 6 months. Knowing this, FSIS established a 12-month
period to allow ample time for an orderly transition to the new
requirements of the rule, including the labeling requirements, and to
assure that manufacturers of MSP, and of poultry and meat food products
in which MSP is used as an ingredient, have ample time to exhaust
current label stock. Therefore, it is not anticipated that
manufacturers will have to dispose of label inventories that were
printed or ordered for printing prior to publication of the rule. Thus,
with the 12-month compliance period, inventory losses, if any, would be
minor.
B. Bone Particle Size
A new requirement limits maximum bone particle size. FSIS believes
bone particle size will not have a significant effect on actual
production and is a measure that augments the current requirement of
one percent or less bone solids to show that the process of separating
bone from meat is operating effectively. As previously stated, FSIS did
not in its proposal, nor is it in this final rule, requirement testing
or sampling for bone particle size in MSP. The Agency has concluded
that manufacturers should have the flexibility to decide how best to
assure compliance with the bone particle size requirement.
Furthermore, the Agency agreed with commenters, as stated
previously, that the requirements for keeping records on bone particle
size (and bone solids) should not be mandated and, in this respect,
will permit flexibility in meeting the rule's requirements. Thus,
additional potential costs have been eliminated.
C. Other Costs
The Agency does not agree with the view presented by many
commenters that any reduction in income from the reduction of
consumption of MSP product labeled under the new requirement should be
considered a cost of this rule. To the extent that purchasers reduce
their consumption of MSP products because of the new labeling, the
revenue received by the industry from such purchases is really revenue
derived rom an inaccurate and misleading label, and are not properly
considered as costs attributable to this rule given the statutory
mandate.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing with respect to the premises,
facilities, and operations of federally inspected establishments any
requirements that are in addition to, or different than, those imposed
under the FMIA or PPIA. States and local jurisdictions may, however,
impose recordkeeping and other requirements within the scope of section
202 of the
[[Page 55982]]
FMIA and section 11 of the PPIA, if consistent therewith, with respect
to any such federally inspected establishment. States and local
jurisdictions are also preempted under the FMIA and the PPIA from
imposing any marking, labeling, packaging, or ingredient requirements
on federally inspected meat and poultry products that are in addition
to, or different than, those imposed under the FMIA and PPIA. States
and local jurisdictions may, however, exercise concurrent jurisdiction
over meat and poultry products that are outside official establishments
for the purpose of preventing the distribution of meat and poultry
products that are misbranded or adulterated under the FMIA or PPIA, or,
in the case of imported articles, which are not at such an
establishment, after their entry into the United States. Under the FMIA
and PPIA, States that maintain meat and poultry inspection programs
must impose requirements that are at least equal to those required
under the FMIA and PPIA. The States may, however, impose more stringent
requirements on such State inspected products and establishments.
No retroactive effect will be given to this final rule. The
administrative procedures specified in 9 CFR 306.5 and 381.35 must be
exhausted prior to any judicial challenge to the provisions of this
final rule, if the challenge involves any decision of a program
official. The administrative procedures specified in 9 CFR parts 335
and 381, subpart W, must be exhausted prior to any judicial challenge
to the application of the provisions of this rule with respect to
labeling decisions.
Effect on Small Entities
The Administrator has determined that this final rule will not have
a significant economic impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
Because the implementation date for this final rule provides ample time
for transition to the new requirements, including the labeling
requirements, producers with smaller lot size than large producers will
not have higher compliance costs per pound of product because of
relabeling costs attributable to the rule. By establishing the one-year
effective date for implementation of the final rule, new labeling costs
will be substantially reduced. The cost of relabeling would be
negligible because the mandated MSP label changes can be coordinated
with other label changes planned or required during the year-long
period prior to the effective date and implementation of this rule.
Paperwork Requirements
This final rule will allow establishments to voluntarily maintain
records of bone solids content and bone particle size as a measure of
process control. FSIS will allow manufacturers flexibility to determine
the best methods for compliance with these requirements, provided such
procedures and methods are in accord with good manufacturing practices.
This final rule will also require labels of poultry products
produced by mechanical separation (i.e., products currently termed
mechanically deboned poultry or MDP) or products containing this
ingredient to be revised to include in the ingredients statements the
term ``Mechanically Separated (Kind of Poultry)'' and be submitted to
FSIS for approval. However, by providing a one-year period between
publication of this rule and the effective date for implementation,
labeling costs will be substantially reduced. The cost of relabeling
would be negligible because the mandated MSP label changes can be
coordinated with other label changes planned or required to meet other
regulatory tenets during the year-long period of promulgation of the
MSP rule and its enforcement.
The paperwork requirements contained in this final rule have been
approved by the Office of Management and Budget under control number
0583-0101.
List of Subjects
9 CFR Part 318
Meat inspection.
9 CFR Part 319
Meat inspection, Standards of identity
9 CFR Part 381
Food labeling, Poultry and poultry products, Standards of identity.
Final Rule
For the reasons set forth in the preamble, FSIS is amending 9 CFR
parts 318, 319, and 381 of the Federal meat and poultry inspection
regulations as follows:
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS: REINSPECTION AND
PREPARATION OF PRODUCTS
1. The authority citation for part 318 continues to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.
601-695; 7 CFR 2.17, 2.55.
2. Section 318.6 is amended by adding a new paragraph (b)(13) to
read as follows:
Sec. 318.6 Requirements concerning ingredients and other articles used
in preparation of products.
* * * * *
(b) * * *
(13) Use of ``Mechanically Separated (Kind of Poultry),'' as
defined in Sec. 381.173 of this chapter, in the preparation of meat
food products shall accord with Sec. 381.174 and all other applicable
provisions of this subchapter.
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
3. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
4. Section 319.180 is amended by revising the sixth sentence of
paragraph (a) and the seventh sentence of paragraph (b).
Sec. 319.180 Frankfurter, frank, furter, hot dog, weiner, vienna,
bologna, garlic bologna, knockwurst, and similar products.
(a) * * *. Such products may contain raw or cooked poultry meat
and/or Mechanically Separated (Kind of Poultry) without skin and
without kidneys and sex glands used in accordance with Sec. 381.174,
not in excess of 15 percent of the total ingredients, excluding water,
in the sausage, and Mechanically Separated (Species) used in accordance
with Sec. 319.6. * * *
(b) * * *. These sausage products may contain poultry products and/
or Mechanically Separated (Kind of Poultry) used in accordance with
Sec. 381.174, individually or in combination, not in excess of 15
percent of the total ingredients, excluding water, in the sausage, and
may contain Mechanically Separated (Species) used in accordance with
Sec. 319.6. * * *.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR
2.17, 2.55.
4. Section 381.15 is amended by revising paragraphs (a)(1), (a)(2),
(b)(2), and (c)(1) to read as follows:
Sec. 381.15 Exemption from definition of ``poultry product'' of
certain human food products containing poultry.
* * * * *
(a) * * *
(1) It contains less than 2 percent cooked poultry meat (deboned
white or dark poultry meat, or both) and/or
[[Page 55983]]
``Mechanically Separated (Kind of Poultry)'' as defined in
Sec. 381.173;
(2) It contains less than 10 percent of cooked poultry skins,
giblets, or fat, separately, and less than 10 percent of cooked poultry
skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1)
of this section) or ``Mechanically Separated (Kind of Poultry)'' as
defined in Sec. 381.173, in any combination;
* * * * *
(b) * * *
(2) It contains less than 15 percent cooked poultry meat (deboned
white or dark poultry meat or both) and/or ``Mechanically Separated
(Kind of Poultry) `` as defined in Sec. 381.173, computed on the basis
of the moist deboned, cooked poultry meat and/or ``Mechanically
Separated (Kind of Poultry)'' in such product; and
(3) * * *
(c) * * *
(1) They contain poultry meat and/or ``Mechanically Separated (Kind
of Poultry) `` as defined in Sec. 381.173 or poultry fat only in
condimental quantities;
* * * * *
5. Section 381.117 is amended by revising the section title and
adding a new paragraph (e) to read as follows:
Sec. 381.117 Name of product and other labeling.
* * * * *
(e) On the label of any ``Mechanically Separated (Kind of Poultry)
`` described in Sec. 381.173, the name of such product shall be
followed immediately by the phrase: ``with excess skin'' unless such
product is made from poultry product that does not include skin in
excess of the natural proportion of skin present on the whole carcass,
as specified in paragraph (d) of this section. Appropriate terminology
on the label shall indicate if heat treatment has been used in the
preparation of the product. The labeling information described in this
paragraph shall be identified on the label before the product leaves
the establishment at which it is manufactured.
6. Subpart P is amended by adding new Secs. 381.173, and 381.174 to
read as follows:
Sec. 381.173 Mechanically Separated (Kind of Poultry) .
(a) ``Mechanically Separated (Kind of Poultry)'' is any product
resulting from the mechanical separation and removal of most of the
bone from attached skeletal muscle and other tissue of poultry
carcasses and parts of carcasses that has a paste-like form and
consistency, that may or may not contain skin with attached fat and
meeting the other provisions of this section. Examples of such product
are ``Mechanically Separated Chicken'' and ``Mechanically Separated
Turkey.''
(b) ``Mechanically Separated (Kind of Poultry)'' shall not have a
bone solids content of more than 1 percent. At least 98 percent of the
bone particles present in ``Mechanically Separated (Kind of Poultry) ``
shall have a maximum size no greater than 1.5 mm (millimeter) in their
greatest dimension and there shall be no bone particles larger than 2.0
mm in their greatest dimension.
(c) ``Mechanically Separated (Kind of Poultry)'' shall not have a
calcium content exceeding 0.235 percent when made from mature chickens
or from turkeys as defined in Sec. 381.170(a)(l)(vi) and (vii) and
(a)(2), respectively, or 0.175 percent when made from other poultry,
based on the weight of product that has not been heat treated, as a
measure of a bone solids content of not more than 1 percent.
(d) ``Mechanically Separated (Kind of Poultry)'' may be used in the
formulation of poultry products in accordance with Sec. 381.174 and
meat food products in accordance with subchapter A of this chapter.
(e) Product resulting from the mechanical separation process that
fails to meet the bone particle size or calcium content requirements
for ``Mechanically Separated (Kind of Poultry)'' shall be used only in
producing poultry extractives, including fats, stocks, and broths and
labeled as ``Mechanically Separated (Kind of Poultry) for Further
Processing.''
Sec. 381.174 Limitations with respect to use of Mechanically Separated
(Kind of Poultry).
(a) A poultry product required to be prepared from a particular
kind of poultry (e.g., chicken) shall not contain ``Mechanically
Separated (Kind of Poultry)'' described in Sec. 381.173, that is made
from any other kind of poultry (e.g., Mechanically Separated Turkey).
(b) ``Mechanically Separated (Kind of Poultry)'' described in
Sec. 381.173 may be used in the formulation of any poultry or meat food
product, provided such use conforms with any applicable requirements of
the definitions and standards of identity or composition in this
subchapter or part 319 of this chapter, and provided that it is
identified as ``Mechanically Separated (Kind of Poultry).''
Done at Washington, DC, on: October 30, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-27305 Filed 11-1-95; 8:45 am]
BILLING CODE 3410-DM-P