[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]]

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Part VI





Department of Agriculture





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Food Safety and Inspection Service



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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.
---------------------------------------------------------------------------

    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