[Federal Register Volume 59, Number 233 (Tuesday, December 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29901]


[[Page Unknown]]

[Federal Register: December 6, 1994]


  
  
  
  
  
  
  
  
  
  
  
                                                   VOL. 59, NO. 233

                                          Tuesday, December 6, 1994

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318 and 381

[Docket No. 93-008P]
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: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the Federal poultry products inspection regulations to prescribe 
a definition and standard of identity and composition for the finely 
comminuted poultry product that results from the mechanical separation 
and removal of most of the bone from poultry carcasses and parts of 
carcasses (``Mechanically Separated (Kind) (MS(K))'' including 
requirements for bone solids content (measured as calcium content) and 
bone particle size; specify certain limitations for the use of MS(K); 
establish recordkeeping requirements for bone solids content and bone 
particle size; and establish labeling requirements for MS(K), and for 
poultry products and meat food products containing MS(K) as an 
ingredient. This proposed action is intended to establish the Agency's 
requirements with respect to poultry products produced by mechanical 
separation, including the requirement that they be labeled as, in the 
case of MS(K) derived from chicken carcasses, ``mechanically separated 
chicken.'' Such action would help ensure that meat and poultry products 
distributed to consumers are not labeled in a false or misleading 
manner and are not misbranded.

DATES: Comments must be received on or before February 6, 1995.

ADDRESSES: Written comments to: Policy, Evaluation and Planning Office, 
Attn: Diane Moore, FSIS Docket Clerk, Room 3171, South Building, Food 
Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250. Oral comments should be directed to Mr. John W. 
McCutcheon, (202) 720-2709. (See also ``Comments'' under 
``Supplementary Information.'')

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 Proposal

    This proposal would amend the regulatory requirements for the 
finely comminuted poultry product resulting from the mechanical 
separation and removal of most of the bone from 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. The Department 
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. Moreover, the Department 
has gained a great deal of knowledge from its rulemakings regarding the 
livestock product resulting from the mechanical separation and removal 
process which is called Mechanically Separated (Species) (MS(S)). More 
recently, in a lawsuit, Bob Evans Farm, 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 mechanically 
separated poultry and the livestock product resulting from the 
mechanical separation and removal process 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 reviewed and reevaluated the existing regulations, 
particularly in light of the labeling issues. As a result of its review 
and reevaluation, the Agency believes that further regulatory action is 
necessary pursuant to its 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. 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. In 
particular, the Department now believes:
    (1) The method of deriving poultry products by the mechanical 
separation and removal of most of the bone from the meat and other 
tissues of poultry carcasses and parts of carcasses results in a 
product whose physical form and texture differ materially from those of 
other boneless poultry products produced by traditional deboning 
techniques. Mechanically separated poultry is derived using a machine 
that operates on the differing resistance of bone and tissue to passage 
through small openings, whether it employs sieves, screens, or other 
devices. Such machines mechanically separate and remove most of the 
bone from poultry carcasses and parts of carcasses resulting in a 
finely comminuted, paste-like product. The starting materials, which 
may have undergone an initial bone breaking process, are pushed under 
high pressure through equipment with apertures that allow a small 
amount of powdered bone to pass through with the soft tissue. This is 
different than boneless poultry derived by traditional means, i.e., 
hand-deboning, and such differences have potential consequences for 
consumer expectations. FSIS has statutory responsibilities under the 
PPIA and FMIA to assure that consumers receive poultry and meat food 
products that are not adulterated and that bear labeling that is not 
false or misleading. Despite this, the 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.
    (2) Mechanically separated poultry is produced by essentially the 
same technology and has characteristics (i.e., physical form and 
texture) similar to those of the livestock product, MS(S). Yet, the 
regulatory requirements for labeling these two products currently are 
inconsistent with one another.
    Therefore, the Department is proposing to amend 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. Under this 
proposal, mechanically separated product derived from chicken or turkey 
would be labeled as ``mechanically separated chicken'' or 
``mechanically separated turkey,'' as the case may be.

Background

I. Introduction

    Poultry products produced by mechanical separation, also referred 
to as mechanical deboning, are characteristically finely comminuted 
(i.e., finely ground) in form and result 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. The products are 
prepared from various materials, including necks, backs, and whole 
carcasses. These starting materials may be raw or cooked, may contain 
varying amounts of muscle and/or skin, and may contain kidneys, except 
when product is made from mature chickens or mature turkeys. Kidneys of 
mature chickens or turkeys may not be used as human food (9 CFR 
381.65(d)).
    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 
Agency's initial reaction was to consider the resulting product 
adulterated because of the amount of 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 rolls.
    Today, poultry products made with poultry produced by mechanical 
separation include cooked poultry sausages (such as chicken 
frankfurters, turkey salami, and turkey bologna), poultry patties and 
nuggets (such as chicken patties and nuggets), and poultry baby foods. 
The level at which it is used has depended in part on technological 
capabilities and has reached 100 percent of the poultry product portion 
of a number of cooked poultry sausage products. 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,'' and ``mechanically deboned'' have been 
used on poultry product labels to describe the form (i.e., physical 
appearance) and composition of the product according to 9 CFR 
381.117(d).
    Poultry products produced by mechanical means are currently subject 
to 9 CFR 381.117(d) relating 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. If the product does not consist of natural proportions of skin 
and fat, as they occur in the whole 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. Poultry product 
produced by mechanical separation is 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, the Department 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 Department 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 in the report (44 FR 
37965).
    The Department received 221 comments, most of which were general 
reactions to the labeling issues raised in the notice, and health, 
safety, or economic concerns. Of the 187 commenters that expressed a 
general opinion on the adequacy of the regulations concerning 
mechanically deboned poultry products, 175 were supportive. Some 
commenters stated that the regulations have effectively controlled the 
use of product produced by mechanical separation over many years with a 
wide base of consumer acceptance, that such product is not 
significantly different from product produced by hand-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 deboned poultry should be 
regulated the same as mechanically separated (species) (MS(S)) (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 MS(S) and products made with 
MS(S). MS(S) is a finely comminuted product resulting 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.

IV. Improvements in Machinery for Poultry Products Produced by 
Mechanical Separation

    The Agency has monitored the advances in the technology for 
mechanically separating poultry, also referred to as mechanical 
deboning, 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, it has been estimated that roughly 1 
billion pounds of raw poultry materials are used to manufacture 700 
million pounds of mechanically separated poultry, also referred to as 
mechanically deboned poultry (MDP), 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.\1\ There have been major advances 
in mechanical deboning machinery in terms of the effectiveness of bone 
removal from 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 ground poultry bones 
with adhering muscle and other tissues through screens to separate 
muscle and other tissues from bone, and the size of the apertures 
(i.e., holes) in the screens and sieves through which the ground bones, 
muscle, and other tissues are pushed.
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    \1\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 the Department 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 the 
Department concluded that it was demonstrated that it was practical to 
limit the bone content in deboned poultry to 1 percent.
    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 mechanically separated poultry.\2\ The percentage of bone solids 
content (determined by calcium analysis) in boneless poultry products 
produced by mechanical deboning 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 and half were below 0.6 
percent.
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    \2\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.\3\ 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.
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    \3\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 MS(S), 
but not on the use of MDP. 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 MDP 
are ``unfavorable consumer perceptions and court decisions resulting in 
label and use restrictions for MS(S); poultry has no definitional 
requirements for MS(S) (e.g., can be defined as `chicken' or 
`turkey').''
    Mechanically separated red meat food product became the subject of 
consumer criticism in the mid-1970's after USDA proposed to allow its 
use 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 within the scope of the Federal Meat Inspection 
Act. The court further found that USDA had not considered adequately 
the health and safety effects of mechanically separated red meat food 
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 food product, but 
that the product is sufficiently different from muscle tissue meat in 
consistency and composition to require separate labeling. The panel 
recommended, among other things, that usage limitations be placed on 
this product.4
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    \4\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 food product 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. Additional 
rulemaking on June 29, 1982, reaffirmed the Agency's position that the 
product, now called MS(S), is not ``meat'' as traditionally defined (47 
FR 28214).
    During this same period, MDP underwent product development 
separately from mechanically separated red meat food product without 
similar FSIS regulation. 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 food 
product was being considered for use in products that had previously 
contained muscle meat. The use of MDP in poultry hotdogs created less 
controversy. Poultry hotdogs did not exist before they were made with 
MDP. Thus, consumers had no prior expectations about the formulation.
    Differences in regulatory treatment of the product, now called 
MS(S), and MDP 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 MS(S), while MDP use has expanded. In response to 
the early rulemakings on MS(S), the meat industry claimed that 
consumers would not buy products if MS(S) is listed on the label. 
Similarly, in responding to the March 1994 advance notice of proposed 
rulemaking (ANPR) on MDP (discussed later in this document), the 
poultry industry claimed that, if they had to label MDP 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. If the industry believes that 
consumers will be misled into thinking the product has changed, it 
should find some way other than inaccurate labeling to assure them it 
is the same product. The Agency believes that if the current labeling 
is misleading, it has no choice but to assure that the ingredients 
statement accurately informs the consumer what is in the product. If 
consumers would behave differently with different information, then 
that is itself evidence that the information is important to them. It 
is the Agency's responsibility under its consumer protection mission to 
assure the information is accurate and not misleading.
    The Agency's regulation on the use of MS(S) and the absence of 
regulation on the use of MDP 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 proposing this 
regulation because of the current differences in the regulatory 
treatment of MDP and MS(S), but rather because its basic statutory 
mission is to assure that products bear labeling that is truthful and 
not misleading. Accordingly, FSIS has determined that providing this 
assurance requires the regulation of MDP.

V. 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 consideration of 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. One thousand four hundred eighty-
seven 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. 
One thousand two hundred fifty-seven commenters did not support 
identifying mechanically separated poultry in the ingredients 
statement, citing, in part, that current policies are satisfactory and 
that labeling it 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, FSIS decided to obtain the information and data 
necessary to pursue the development of amendments to the Federal 
poultry products inspection regulations to define and standardize, or 
establish other 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. 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 on its 
tentative positions regarding poultry products produced by mechanical 
separation and products in which such poultry products are used.
    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 in separating the bone from muscle 
and other 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.''

VI. Discussion of Comments on March 1994 ANPR

    FSIS received 106 comments in response to the March 1994 ANPR. 
Fifty-one comments were submitted by food manufacturers/distributors, 
44 comments by consumers, 7 by trade associations, 2 by academia, 1 by 
a law firm, and 1 by a developer of machinery. The majority of the 
comments did not support the ANPR. The comments are summarized below.
    A. Bone Solids Content and Labeling. According to the tentative 
positions presented in the March 1994 ANPR, the tentative provisions 
for poultry product produced by mechanical separation would classify or 
``categorize'' such product by bone solids content (as measured by 
calcium content). Mechanically separated poultry with 0.6 percent or 
less bone solids content would be termed ``(Kind)'' or ``(Kind) meat,'' 
where ``kind'' refers to chicken or turkey. Mechanically separated 
poultry with greater than 0.6 percent bone solids content (but not 
greater than 1 percent) would be termed ``Mechanically Separated 
(Kind).''
    Eighty-one commenters addressed the issue regarding the 
classification of poultry products produced by mechanical separation 
according to bone solids content. Of the 81 commenters, 78 disagreed 
with the requirements discussed in the ANPR which tentatively 
considered 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 stated that the 
establishment of a 0.6 percent bone solids content demarcation between 
what would be labeled as ``(kind)'' or ``(kind) meat,'' and 
``mechanically separated (kind),'' based on data collected in August 
1993 (data presented by FSIS in the report entitled ``Determination of 
Acceptable Limits of Percent Bone Solids in Ground Poultry Products'') 
would basically eliminate half of the currently produced product and 
reduce the available amount of this low cost poultry ingredient for 
further processed poultry and meat food products by 60 to 70 percent. 
Moreover, commenters further emphasized that, to operate within the 
current 1 percent bone solids content limit for boneless poultry, most 
processors must target their operations at about 0.6 percent bone 
solids content. The commenters indicated that achievement of the low 
levels of percent bone solids content that were reported by FSIS in the 
report of the August 1993 data occurred because it is necessary for 
producers to target well below the current 1 percent limit in order to 
consistently meet and not exceed the 1 percent requirement. Thus, 
setting a requirement at 0.6 percent for what could be called 
``(kind)'' or ``(kind) meat'' would require producers to aim at 
significantly lower levels of bone solids content which would present 
an unreasonable burden on the industry. Manufacturers would have to 
adjust their mechanical deboning machines to adjust the pressure needed 
to force ground poultry bones with adhering muscle and other tissues 
through screens in the mechanical deboning equipment to eliminate more 
bone from the finished product, thereby reducing product yield. 
According to the commenters, in order to label a product as ``chicken'' 
or ``turkey meat,'' i.e., to meet the ``upper control limit'' of 0.6 
percent, a processor would have to target a 0.3 percent bone solids 
content level to qualify for that product category because of the lack 
of precise controls in the operation of the deboning equipment.
    One commenter claimed that industry data submitted to the Agency 
``shows, under the principles of statistical process control, a 
controlled process that targets 0.6 percent bone solids will result in 
a product that meets the 1 percent bone solids requirement 99.5 percent 
of the time.'' Another commenter claimed that the industry data 
presented indicate that the average percent bone solids content is 0.57 
percent with a standard deviation of 0.227 percent, so that ``at the 99 
percent confidence limit, evidence that a process may not be running 
efficiently is when an individual sample analysis is greater than 1.15 
percent.'' Therefore, according to the commenters, the Agency is wrong 
to advocate an average bone solids content of 0.6 percent as the 
current measure of good manufacturing practices for poultry products 
produced by mechanical separation. The same commenters criticized the 
FSIS report on bone solids content stating that ``no statistical 
analysis, factorial or otherwise, was done to describe the two 
categories of mechanically separated poultry based on bone solids 
content to determine if, in fact, they are different and/or whether 
members of the populations were in fact similar.'' The commenters 
further asserted that the data presented by FSIS did not actually 
demonstrate that two ``categories'' of mechanically separated poultry 
exist. The commenters asserted that such an analysis may show that the 
only difference was due to the type of starting materials (e.g., necks 
versus carcass frames versus backs) or that there are, in fact, no 
separable populations.
    Further, it was asserted by several commenters that the usual 
practice in quality control is to use 3 standard deviations above a 
target criteria as a control limit, rather than the standard deviation 
of 2.33 (corresponding to a 99 percent confidence that the process is 
not in control), as was suggested by FSIS in its report of the 1993 
study. One commenter provided an example of how the 3 standard 
deviations approach would be applied. It was explained that since the 
mean percent bone solids content presented in the report of the 1993 
study was 0.68 percent and that the average standard deviation by 
establishment was 0.138, then 3 standard deviations above the mean 
control limit would be approximately 1.1 percent bone solids content.
    As a general response to the comments on bone solids content and 
labeling, FSIS first reiterates its reasons for having considered in 
the March 1994 ANPR the defining of a product standard for poultry 
products produced by mechanical separation based, in part, on percent 
bone solids content. In 1969, the Agency promulgated rules on deboned 
poultry products specifying that no more than 1 percent bone solids 
content would be allowed for this product. As indicated previously, 
this decision was based on the Agency's careful appraisal 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 products from nine commercial operations, 
representing three makes of machines most often used in this process. 
The analyses demonstrated that it is practical and acceptable to limit 
the bone ``residue'' in mechanically deboned poultry and that the 
equipment for manufacturing such product can be operated under 
commercial conditions to produce poultry product that contains no more 
than 1 percent of bone. This provision of the 1969 amendments was 
promulgated to assure that deboned poultry products are wholesome in 
accordance with the Poultry Products Inspection Act.
    Also, it is important to note that at the time of the 1969 
regulation, the mechanical separation process was new and FSIS had 
limited information concerning the consequences of it. FSIS conducted 
extensive studies on mechanically deboned poultry products during the 
1970's and monitored the technology improvements during the 1980's. The 
results of these studies and the information considered during 
rulemakings, or other documents considering the need for rulemaking, 
regarding poultry and livestock products produced by mechanical 
separation over the past 2 decades have shown that there are 
differences between the mechanically deboned product and traditionally 
deboned products (i.e., hand-deboned). The principal characteristics 
that distinguish mechanically separated poultry product and boneless 
poultry produced by traditional methods are bone solids content, and 
its physical form and consistency. Informing consumers of such 
differences via the distinct labeling of the presence of poultry 
product produced by mechanical means is supported by the statutory 
responsibility of FSIS to assure that all labels on poultry and meat 
food products are not false or misleading. FSIS received comments that 
expressed this sentiment in response to its solicitations for public 
input in the June 1993 ANPR and the March 1994 ANPR.
    In the March 1994 ANPR, FSIS suggested that, because of the 
differences in percent bone solids content among mechanically separated 
poultry products, which were shown in the data presented in the FSIS 
report ``Determination of Acceptable Limits of Percent Bone Solids in 
Ground Poultry Products,'' the Agency would regulate poultry products 
produced by mechanical separation so that producers of a product with a 
low percent bone solids content that met the established limitation 
would be able to label such products without a reference to the 
mechanical means of processing.
    In review of the tentative approach presented in the March 1994 
ANPR and the comments received in response to this ANPR and the prior 
June 15, 1993, ANPR, FSIS now believes that the continuation of the 
present labeling policy, even for those finished products with 
mechanically separated poultry that has a low bone solids contents, 
does not inform the consumer that these products contain mechanically 
separated poultry as an ingredient and that this may result in 
misleading labeling. The statutes under which FSIS operates provide the 
authority to protect the public and prevent the distribution in 
commerce of products that are misbranded and are not properly marked, 
labeled, or packaged. FSIS believes that the labeling of poultry and 
meat food products containing poultry product produced by mechanical 
separation as an ingredient must inform the consumer of its contents, 
unless it is clearly demonstrated that any omitted information would 
not mislead the consumer or otherwise render the product misbranded. 
This labeling position must be adhered to consistently across all types 
of poultry and meat food products containing mechanically separated 
poultry as an ingredient.
    FSIS's tentative consideration in the March 1994 ANPR was to define 
and standardize certain mechanically separated poultry by concentrating 
on the product characteristics that the Agency believes distinguishes 
this product from poultry produced by traditional deboning methods, 
i.e., hand-deboning. A different way of defining and standardizing this 
product based on starting materials was suggested by one commenter. It 
was suggested that a certain type of statistical analysis (factorial 
analysis) be performed in order to identify a relationship between 
percent bone solids content and types of starting materials used to 
manufacture mechanically separated poultry. By suggesting this type of 
statistical analysis, the commenter supported a procedure for 
establishing a standard that would account for the materials used, and 
percent bone solids content limits would vary by the processing 
procedure employed by the processor. However, it was never the 
intention of the March 1994 ANPR to suggest possibly defining and 
standardizing mechanically separated poultry by starting materials 
used. The data collected by FSIS in 1993 and used in the report 
previously cited, came from industry records. Information was collected 
on starting materials but not on the percentages of use nor on 
processing parameters, e.g., pressures, settings, used during 
processing. Thus, data could not be used for establishing process 
control parameters or for determining the relationship between bone 
solids content and other product characteristics, the materials used, 
and processing parameters employed by establishments in the study. The 
purpose of collecting the data was to examine the levels of bone solids 
in mechanically separated poultry produced today, and to get an idea of 
the variability of the percentage of bone solids contents within an 
establishment. Information on starting materials was collected to 
ensure that the sample of establishments represented the different 
types of materials used to manufacture mechanically separated poultry. 
If in establishing standards for the product, the Agency had intended 
to use explicit starting materials to manufacture poultry product 
produced by mechanical separation, then more data would need to be 
collected under known or controlled conditions. FSIS believes that any 
standard established for mechanically separated poultry should not 
preclude a manufacturer from using any type of starting materials so 
long as the requirements of the standard are satisfied.
    Further, in response to comments about the application of an 
acceptable tolerance for meeting bone solids content criteria based on 
statistical variation, FSIS agrees that the establishment of such a 
tolerance should be considered. However, because this issue requires 
indepth technical review, FSIS will consider it for possible rulemaking 
in the future.
    B. Handling Requirements. The tentative position presented in the 
March 1994 ANPR indicated that FSIS was tentatively considering that 
starting material to be processed into poultry product produced by 
mechanical separation be processed into this product within 2 hours 
from the time it is separated from the bones of poultry carcasses or 
parts of carcasses, except that such product may be held for no more 
than 72 hours at 40 deg. F (4 deg. C) or less, or held indefinitely at 
0 deg. F (-18 deg. C) or less. Additionally, the ANPR indicated that 
FSIS was considering proposing that mechanically separated poultry be 
chilled to 40 deg. F (4 deg. C) or less within 2 hours of the 
mechanical deboning operation, or frozen at 0 deg. F (-18 deg. C) or 
less, or cooked. Furthermore, it was indicated that FSIS was 
considering proposing that such product be used as an ingredient in a 
poultry or meat food product directly after being processed, except 
that it might be held prior to such use for no more than 72 hours at 
40 deg. F (4 deg. C) or less or indefinitely at 0 deg. F (-18 deg. C) 
or less.
    Twenty-seven commenters addressed the issue of handling 
requirements for poultry products produced by mechanical separation. 
All of the commenters disagreed with the need for handling requirements 
and, specifically, the need for a time constraint by which the raw 
material used to manufacture poultry product produced by mechanical 
separation has to be processed into such product. Commenters stated 
that chicken can be held for varying times and still be safe depending 
on manufacturing practices, and that the raw materials used need to be 
organoleptically evaluated and not set up on a time schedule, i.e., 
processed within 72 hours.
    The commenters also stated that there are already adequate 
regulations on handling and storage, and any additional handling 
requirements should be handled in a more inclusive way, e.g., as part 
of a Hazard Analysis Critical Control Point (HACCP) effort.
    FSIS believes that handling requirements are necessary to produce a 
safe and wholesome product, and that potential bacterial hazards are 
diminished as long as handling accords with good manufacturing 
practices. FSIS believes that it is the manufacturer's responsibility, 
in concert with FSIS', to assure that wholesome materials are used in 
the manufacture of its product within sound timeframes, and the safety 
of such product is not negatively affected.
    Although the data reviewed in the 1979 Health and Safety 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. Common starting 
materials for mechanical separated and other comminuted products are 
products that remain after the removal of a substantial portion of 
skeletal muscle or other tissue (e.g., skin) from poultry carcasses or 
parts of carcasses. As a result, the resistance of the exposed surface 
area to microbial penetration has been reduced and the ratio of the 
surface area to the volume of total product which is exposed to 
contaminating influences has been increased. Higher microbial counts 
have been associated with the conditions of holding such starting 
materials.
    Poultry products produced by mechanical separation are not unique; 
all finely comminuted and comminuted products present opportunities for 
excessive microbiological growth because they consist of small 
particles which have a greater surface area than most poultry products 
and because during its preparation any microorganisms that are present 
are distributed throughout the product. Therefore, FSIS agrees with the 
commenters that there is a general need to address the issue of 
handling requirements for all poultry products, including finely 
comminuted and comminuted products. FSIS is currently developing a 
separate rulemaking that will deal with this issue more fully and that 
will include handling requirements for poultry products produced by 
mechanical separation, and the materials from which they are 
manufactured. Therefore, FSIS will not propose handling requirements 
for poultry products produced by mechanical separation in this 
rulemaking.
    FSIS believes that the promulgation of handling requirements for 
all comminuted poultry, including mechanically separated poultry 
products, and the starting materials from which they are made, would 
eliminate the need to require that the temperature of rooms or 
compartments in which equipment for mechanical deboning of raw poultry 
is operated be maintained at 50 deg. F or less (9 CFR 381.47(e)). When 
such requirements are promulgated, FSIS will address the need to 
rescind 9 CFR 381.47(e).
    C. Protein Quality. Twenty-five commenters addressed the issue of 
protein quality for boneless poultry products produced by mechanical 
separation. Of the 25 comments, 24 disagreed with the need to have a 
protein quality requirement for any mechanically separated poultry 
product with up to 1 percent bone solids. The commenters stated the 
following reasons for their disagreement: (1) the typical U.S. diet 
provides for an adequate intake of sufficiently high quality protein, 
therefore, protein quality is not a public health concern in the U.S.; 
(2) the U.S. is not a protein-deficient society which requires every 
protein source to be the highest ``quality''; a typical diet consists 
of proteins from a variety of sources and of varying quality; (3) the 
Nutrition Labeling Education Act (NLEA) of 1990 indicated that a daily 
value requirement for protein quality is not necessary; (4) over a 20-
plus year history of producing mechanically separated poultry, there 
has never been a problem identified with the protein quality of 
products manufactured from this low cost ingredient; (5) processors 
have no control over the amino acid content of the chicken parts used 
to manufacture mechanically separated poultry--it is determined by 
genetics and not processing equipment; and (6) the protein quality 
testing requirements suggested in the ANPR for mechanically separated 
poultry are expensive, burdensome, and unnecessary.
    After careful review of the comments, FSIS is in agreement with 
commenters that oppose the tentative position that poultry products 
produced by mechanical separation must meet a minimum protein quality 
requirement, i.e., a protein digestibility corrected amino acid score 
of not less than 40 expressed as a percent or the alternative 
measurement of essential amino acids being at least 33 percent of the 
total 17 amino acids present. The lack of the need for a protein 
quality requirement is founded on scientific literature provided and 
cited by comments from academia and statements made by other commenters 
regarding the status of the quality of protein in diets of individuals 
in the U.S. The literature stated that the protein quality of 
mechanically deboned poultry is comparable to hand-deboned 
poultry.5 Therefore, mechanically deboned poultry can be used in 
poultry and meat food products without sacrificing protein quality. 
According to the literature, during the 20 to 30-year history of the 
use of MDP in many food products, there has not been an indication of 
problems identified with protein quality. Furthermore, consumption of 
enough high-quality protein by humans in the U.S. is not a problem. In 
the preamble of the final nutrition labeling regulations, both FSIS and 
the Food and Drug Administration (FDA) stated that current evidence 
suggests that the diet typically consumed in the U.S. provides for an 
adequate protein intake of sufficiently high quality to meet the 
nutritional needs of adults and children 4 or more years of age (58 FR 
632 and 2079). Furthermore, since there are no outstanding health 
implications requiring the establishment of protein quality criteria 
for food products, in general, it would be unnecessary to require such 
criteria for a specific poultry product, viz., mechanically deboned 
poultry.
---------------------------------------------------------------------------

    \5\ Public comment, including attached research article, 
submitted by R.A. Field, University of Wyoming, is available for 
review in the FSIS Docket Clerk's office.
---------------------------------------------------------------------------

    D. Quality Control. Twenty-one commenters addressed the issue of 
quality control for all poultry products produced by mechanical 
separation. Nineteen of the 21 commenters did not believe that a 
mandatory quality control program was needed for the production of such 
products. The commenters stated that (1) quality control programs, 
including partial quality control programs (PQC), should remain 
voluntary programs, and (2) that FSIS should focus compliance program 
efforts on issues of health and safety of products and allow 
manufacturers to determine quality parameters. The commenters also 
noted that they operate under PQC programs for manufacturing 
mechanically deboned poultry that are approved by FSIS, and any 
additional concerns for assuring their processes are in conformance 
with current regulations should be incorporated into their present PQC 
programs rather than by issuance of a formal requirement through 
rulemaking.
    FSIS believes that establishments manufacturing poultry products 
that are mechanically separated must have controls in place to assure 
that such products comply with the Agency's proposed definition, 
standard, and other criteria. However, after reviewing the comments and 
re-examining the Agency's current regulatory agenda, FSIS believes that 
because there are efforts underway within the Agency to study and 
address ways of reducing the potential for situations that would render 
any poultry or meat food product adulterated, unwholesome, and/or 
misbranded it is premature to address the need for a mandatory quality 
control program for this one distinct category of poultry product. FSIS 
does, however, believe that records of achieving compliance with 
parameters established for mechanically separated poultry product, 
e.g., bone solids content and bone particle size criteria, should be 
maintained to substantiate that boneless poultry criteria meets the 
proposed regulatory manufacturing practices.
    E. Protein/Fat. Nineteen commenters responded to the tentative 
position on 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. All 
nineteen commenters disagreed with FSIS' position on establishing such 
a protein and fat content requirement for this mechanically separated 
poultry. The commenters stated that poultry product produced by 
mechanical separation is used as an ingredient in ready-to-consume 
products of which most have established protein and/or fat standards. 
Furthermore, the commenters stated that most poultry and meat food 
products are now required to have nutrition labeling.
    FSIS does not agree that ``most ready-to-consume'' poultry and meat 
food products have established protein and fat standards, as asserted 
by the commenters. Standards of identity and composition for poultry 
and meat food products generally do not include minimum protein content 
requirements. Of the products for which standards stipulate a maximum 
fat content, most are sausages composed of meat from livestock. There 
are no fat limitations associated with sausages made from poultry, 
according to FSIS policies.
    FSIS does agree, however, with the comments regarding the benefits 
of fat and protein content information provided by nutrition labeling. 
Since the products that typically contain mechanically separated 
poultry, e.g., poultry sausages, are composed of this ingredient as the 
majority of their formulation, the nutrition labeling for such product 
will primarily reflect the protein and fat contributed by the 
mechanically separated poultry component. For this reason, a minimum 
protein content and a maximum fat content requirement for poultry 
products produced by mechanical separation are not needed, given the 
implementation of the Department's nutrition labeling regulations on 
July 6, 1994 (58 FR 632). The nutrition labeling regulations require 
the declaration of protein and fat on the labeling (i.e., the Nutrition 
Facts panel) of most multi-ingredient meat and poultry products. 
Nutrition labeling is now required on most processed products purchased 
by consumers in retail stores, and this, together with the Department's 
voluntary nutrition labeling program established for retail store 
information on single-ingredient raw products, makes FSIS believe that 
consumers will have sufficient information on protein and fat for most 
products purchased for consumption at home.
    FSIS further believes that the need to establish a fat and protein 
requirement is minimized because current regulatory controls will limit 
the amount of skin or fat that may be used in formulating poultry 
products with mechanically separated poultry. According to the poultry 
regulations, viz., 9 CFR 381.117, raw materials used to manufacture 
boneless poultry, e.g., ``mechanically separated chicken'' and 
``mechanically separated turkey,'' must be labeled to reflect the 
presence of skin and attached fat when the proportions of skin and 
attached fat are in excess of that which occurs naturally on a whole 
carcass. Therefore, products currently labeled as ``mechanically 
separated chicken'' or ``mechanically separated turkey'' contain no 
more skin with attached fat than that which occurs naturally on a whole 
carcass, for which there is no maximum fat content established. 
Furthermore, like all other animal products, poultry (e.g., whole 
carcasses and parts of carcasses) is composed of water, fat, protein, 
and inorganic matter (i.e., ash). If the fat content is controlled, the 
proportion of the other components, including protein, should remain 
the same as that which occurs naturally.
    F. Bone Particle Size. Fourteen commenters addressed the issue of 
bone particle size in poultry product produced by mechanical 
separation. Twelve of the 14 commenters disagreed with restricting the 
size of the bone particles present in poultry product produced by 
mechanical separation to a maximum of less than 1.5 millimeter (mm) in 
the greatest dimension. Furthermore, commenters sought clarification of 
the quantity of particles of acceptable dimension that would be 
permitted. The commenters also stated that there is no justification 
for requiring standardized bone particle size limitations; such a 
criteria will result in increased analytical costs to the processor 
without improving food safety. Other commenters cited the 1979 report 
on ``Health and Safety Aspects of the Use of Mechanically Deboned 
Poultry'' which states that over 90 percent of the bone particles found 
in mechanically deboned poultry are less than 150 microns (0.15 mm) in 
size and only 1 percent were greater than 400 microns (0.4 mm).
    FSIS believes that a bone particle size limitation augments the 
bone solids content restriction, and is a meaningful indication of a 
poultry deboning operation that effectively controls bone breakage. The 
1979 health and safety 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 deboned poultry. 
FSIS agrees with this recommendation and continues to support its 
tentative position of restricting the bone particle size in poultry 
products produced by mechanical separation. However, FSIS is in 
agreement with the comments that reflected a need to clarify the 
parameters for such a restriction. In order to simplify such a 
requirement for mechanically separated poultry products, FSIS is 
proposing that at least 98 percent of the bone particles present in 
mechanically separated poultry should have a maximum size no greater 
than 1.5 mm and no bone particles should be greater than 2.0 mm in 
their greatest dimension. These parameters are similar to the 
requirements for bone particle size for MS(S), a similar livestock 
product.
    G. Limitations on Use. In the March 1994, ANPR, FSIS tentatively 
proposed that, in certain cases, poultry product produced by mechanical 
separation should be restricted from use as an ingredient in other 
products. It was considered that imposing such restrictions was 
necessary for mechanically separated poultry because of the potential 
fluoride contribution of mechanically separated poultry made from fowl 
(i.e., mature female chickens). It was also tentatively suggested that 
use restrictions for all poultry product produced by mechanical 
separation be considered (i.e., any product with bone solids not 
greater than 1 percent) based on the characteristics of such product, 
including the kind of poultry from which it is made, and its 
consistency.
    Thirteen commenters addressed the issue of limitation on use of 
poultry product produced by mechanical separation, in general, as an 
ingredient in other products. Twelve of the commenters disagreed with 
the general premise of establishing any use limitations on mechanically 
separated poultry products because there are no safety or health 
concerns regarding poultry product produced by mechanical separation. 
The commenters also stated that the marketplace is a much better judge 
of quality (i.e., use levels of poultry product produced by mechanical 
separation) than FSIS.
    FSIS believes that poultry products that are mechanically separated 
should not be used in poultry products that are represented as being 
composed of whole poultry muscle, other than where it is used as a 
binding agent (i.e., a substance that holds muscle pieces together) at 
a level that is sufficient for this purpose. When used as a binder, it 
is FSIS' belief that, without the declaration of mechanically separated 
poultry as an ingredient on the labels of the poultry and meat food 
products that purport to be intact, whole muscle products, the labels 
of such products would be misbranded.
    It is poultry meat, particularly muscle(s), that characterizes 
parts and cuts of poultry. The physical and sensory characteristics 
(i.e., mouthfeel, texture, color) associated with a part or cut of 
poultry can be retained when trimmings removed during processing are 
reincorporated; and the characteristics associated with the cut remains 
when there is chunking, chopping, or grinding of the muscle as in 
versions of turkey ham product (9 CFR 381.171). FSIS regards these 
processes as different than using product made by the mechanical 
separation of bones with attached poultry tissue. Poultry product 
produced by mechanical separation does not, in FSIS' view, retain the 
characteristics of the cuts themselves. It appears inconsistent with 
the basic characteristics expected of products represented as having 
been made from a particular part or cut of the poultry carcass, to 
include this finely comminuted ingredient, especially when the muscle 
from that part is essentially intact or has been processed only to the 
extent of cutting or grinding. Therefore, FSIS continues to support its 
tentative position stated in the March 1994 ANPR that poultry product 
produced by mechanical separation not be permitted in products expected 
to be composed of whole muscle or pieces of muscle, e.g., ``(Kind) 
steak or (Kind) fillet'' (9 CFR 381.162).
    FSIS agrees with commenters that, except for the potential health 
effects associated with the fluoride content of mechanically separated 
chicken from fowl, there are no health and safety concerns regarding 
the use of poultry products produced by mechanical separation. Issues 
raised in the past concerning cholesterol and calcium content are 
addressed by the requirements of the new nutrition labeling. Calcium 
and cholesterol contents of most foods will be required as part of the 
nutrition label. However, FSIS continues to support its consideration, 
as stated in the March 1994 ANPR, that poultry product produced by 
mechanical separation, i.e., any such product with no greater than 1 
percent bone solids, 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 basis for this is that 
the fluoride content associated with mechanically separated chicken 
made from fowl has potential health implications. There were no data 
submitted in response to the ANPR to support opposition to this aspect 
of use limitations for mechanically separated poultry.
    H. Product Name and Labeling. The majority of the commenters 
(primarily food manufacturers) stated that FSIS should continue with 
its current labeling policy regarding mechanically separated poultry 
that allows the declaration of mechanically separated poultry as 
``(Kind)'' or ``(Kind) meat'' when used as an ingredient in a poultry 
or meat food product. The commenters suggested that any changes in the 
current policy will have a severe economic impact on both the poultry 
and meat industries. Many of the commenters stated that, ``since there 
are no health or safety issues regarding the use of mechanically 
separated poultry, nutrition labeling satisfies the remaining issue of 
the consumer's right to know'' that mechanically separated poultry is 
in the foods they consume. Therefore, the majority of commenters 
supported continuance of the current policy regarding the product name 
and labeling of mechanically separated poultry (e.g., as ``chicken'' or 
``turkey meat''). On the other hand, a few commenters stated that meat 
and poultry products should be labeled the same as Mechanically 
Separated (Species) (MS(S)).
    FSIS must decide whether, under its statutory authorities, 
consumers would be protected from misbranded and improperly labeled 
poultry and meat food products without the separate declaration of 
mechanically separated poultry by a regulated term. The intent of 
nutrition labeling is to assist consumers in making sound choices in 
terms of nutrients in the diet. FSIS believes that nutrition labeling 
provides some of the information about a food that is important to the 
consumer in planning a healthful diet; however, it does fully inform 
the consumer about the ingredients used to formulate a food product. 
Rather, it is the ingredients statement on the label of a product that 
is the labeling feature that informs the consumer of the ingredients 
used to formulate a poultry or meat food product. Therefore, FSIS 
believes that nutrition labeling, coupled with an ingredients statement 
that accurately reflects the ingredients that are used to formulate a 
product, is necessary to protect the consumer from misbranded meat and 
poultry products, i.e., improperly labeled meat and poultry products.
    FSIS evaluated the comments that opposed the establishment of a 
labeling requirement for mechanically separated poultry based on the 
``adverse economic impact'' of identifying this product by a specific 
product name in the ingredients statements of products in which it is 
used as an ingredient, i.e., as ``Mechanically Separated (Kind).'' The 
comments opposing the declaration of mechanically separated poultry by 
a specific name associated with a standard did not fully elaborate why 
consumers would be concerned about its presence in the products they 
consume. It was suggested by a few commenters that the name suggested 
in the tentative position presented by FSIS was pejorative and that 
consumers would think that the product they had purchased previously 
was now formulated with another ingredient, and would not purchase the 
product again because it was different or inferior. However, FSIS 
believes that such a labeling requirement is necessary in order to 
fulfill its statutory responsibility to protect consumers by assuring 
that the labels of poultry and meat food products are not false or 
misleading. FSIS also believes that its continued support of the 
tentative position stated in the March 1994 ANPR to establish a 
standardized name for mechanically separated poultry would be 
consistent with past Court decisions and regulatory actions regarding 
MS(S), a similar product made from livestock, which was determined to 
be materially different than ``meat.'' Consumers had the opportunity to 
provide views on the importance of knowing that MS(S) is an ingredient 
in their food during rulemaking actions on MS(S). FSIS' 1982 final 
rulemaking on MS(S) (47 FR 28214) indicates that material differences 
in the consistency and composition of MS(S) place it outside the scope 
of the product traditionally defined as meat (9 CFR 301.2 (rr)), and 
that its differences are such that it should be defined as a 
distinctive standardized product. Thus, MS(S) must be identified as a 
distinct meat food product, e.g., ``mechanically separated pork (or 
beef),'' and labeled as such on the products in which it is used as an 
ingredient (9 CFR 317.2(c) and (f), 319.1, and 319.5) in order to 
assure that the labeling of such products is accurate and not 
misleading.
    Currently, products that contain mechanically separated poultry are 
marketed using trade names that identify any poultry ingredient they 
are made up of only by the kind name of the poultry used (e.g., 
``Chicken Nuggets'' and ``Turkey Franks''). FSIS believes that it is 
appropriate to allow these products to continue to be marketed under 
such names. These names have a long and uniform history of use. 
Revocation of these familiar trade names may be a disservice to 
consumers if they are mislead to believe that the products they have 
been purchasing have changed. Although these products contain tissues 
other than whole skeletal muscle tissue, FSIS does not believe that 
consumers will be mislead by trade names which only include the name of 
the kind of poultry from which the poultry ingredients are mechanically 
separated since any mechanically separated poultry ingredients will be 
clearly identified as ``mechanically separated (kind)'' in the 
ingredients statement. FSIS believes that the ingredients statement is 
the appropriate labeling feature to inform consumers of the ingredients 
used to formulate a product. However, FSIS welcomes comments on the 
names under which products containing mechanically separated poultry 
are marketed.
    VI. The Proposal
    FSIS is proposing 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 products. The proposal 
would prescribe a definition and standard of identity for poultry 
products produced by mechanical separation with 1 percent or less bone 
solids content, that requires compliance with certain criteria; e.g., 
bone solids content (measured as calcium content) and bone particle 
size. The proposal also would provide recordkeeping and labeling 
requirements, and limitations on use of poultry products produced by 
mechanical separation. Poultry product produced by mechanical 
separation is hereafter referred to as ``MS(K).''
A. Product Definition and Standard
    FSIS is proposing to prescribe a definition and standard of 
identity and composition for the finely comminuted poultry 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 which has a bone solids content of 1 
percent or less. This product is commonly known in the poultry industry 
as mechanically deboned poultry or MDP. While whole carcasses sometimes 
are used, the starting materials for this type of processing frequently 
are parts of carcasses, such as frames, backs and necks, which contain 
relatively low proportions of skeletal muscle, or parts, such as breast 
frames, from which most of the skeletal muscle already has been removed 
by traditional deboning techniques. The starting materials, which may 
have undergone an initial bone breaking process, are pushed under high 
pressure through equipment with apertures that allow a small amount of 
powdered bone to pass through with the soft tissue. Such starting 
material is in natural proportion with regard to skin and attached fat; 
if skin and fat is in excess of proportions found naturally on a whole 
carcass, the product is labeled to reflect the presence of skin and fat 
according to 9 CFR 381.117(d).
    MS(K) differs from poultry products produced by traditional 
deboning techniques (e.g., hand-deboning) in its highly comminuted and 
spread-like consistency and in its content of bone and associated 
tissue, as well as muscle, skin, and fat. In view of the differences 
between MS(K) and boneless poultry derived by traditional methods 
(e.g., hand-deboning), it appears inappropriate to continue to include 
MS(K) within the category of ``boneless poultry products'' (9 CFR 
381.117(d)). Instead, FSIS is proposing to define it as a distinct 
poultry product ingredient and standardize its characteristics under 
subpart P of the poultry products inspection regulations (9 CFR 381, 
subpart P).
    FSIS is proposing that the boneless poultry products regulation (9 
CFR 381.117(d)) no longer apply to MS(K). Consequently, the current 
restriction on bone solids content in this regulation, as enforced by 
limiting calcium content, will be included with other compositional 
requirements in an MS(K) standard. Moreover, as a standardized product, 
MS(K) 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 is proposing to define the standardized 
product that is finely comminuted and results from the mechanical 
separation and removal of most of the bone from poultry carcasses and 
parts of carcasses by a distinctive name. FSIS is proposing that such 
product be called ``Mechanically Separated (Kind) (MS(K)).'' It appears 
to accurately and concisely describe the product that materially 
differs in composition and consistency from traditional hand-deboned 
product, indicating the nature of the process by which and the kind of 
poultry from which it is made. The proposed name includes ``(Kind)'' 
rather than ``poultry'' to make it clear that the kind of poultry (9 
CFR 381.1(b)(40)) from which the product is made is specified (e.g., 
``Mechanically Separated Chicken''). By including ``(Kind)'' in the 
proposed name, FSIS is acknowledging that skin and attached fat may be 
present such that the proportion is consistent with that which occurs 
naturally on a whole poultry carcass. If skin and attached fat are 
present at levels exceeding natural proportions, as defined for 
boneless poultry products (9 CFR 381.117(d)), it must be labeled.
    As previously indicated, FSIS believes that MS(K) differs 
sufficiently from boneless poultry products produced by traditional 
hand-deboning techniques that it should be regulated as separate, 
standardized ingredients. FSIS is aware that other descriptions have 
been associated with poultry products produced by mechanically 
separation. In addition to the use of terminology such as ``finely 
comminuted'' poultry to specify the form of the product and 
``mechanically deboned'' poultry, such product has been referred to as 
``mechanically separated' poultry within the meat and poultry 
industries. FSIS believes that where a distinguishing characteristic of 
a standardized product is, its bone solids 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 
such product contains no bone. FSIS will, however, welcome comments on 
other names that accurately reflect the process from which this product 
is derived, as well as its form and consistency.
    2. Bone solids content. FSIS is proposing that the definition and 
standard for MS(K) 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)). Because this restriction is enforced 
by measuring calcium content, FSIS believes the definition and standard 
for MS(K) should 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.
    As previously discussed, FSIS adopted the 1 percent bone solids 
restriction after appraising the operating results in a series of 
poultry establishments using mechanical deboning equipment, analyzing 
485 samples of raw product, and concluding that existing equipment can 
be operated under commercial conditions to produce product which meets 
this limit (34 FR 13991). When processors applied the mechanical 
deboning technology to poultry products such as fowl frames that had 
been heat treated using various cooking methods, FSIS modified its 
procedures to take into account weight loss that can occur with 
cooking. Thus, the practice has been to permit an allowance for weight 
loss in order to reflect the bone solids content that would have been 
present if heat treatment had not occurred; and the adjusted level may 
not exceed 1 percent. The ``Chemistry Laboratory Guidebook,'' U.S. 
Department of Agriculture (section 6.010F, page 6-33),6 currently 
includes procedures for different degrees of adjustment depending on 
whether conventional cooking methods (i.e., open kettle) or other heat 
treatment (e.g., pressure cooking) are used.
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    \6\Document is available for public inspection at the FSIS 
Docket Clerk's office.
---------------------------------------------------------------------------

    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 deboned poultry did not recommend 
any change in the existing bone solids limit. Because enforcement is 
based on calcium content analyses; however, rather than direct 
measurements of bone solids, FSIS believes that an amended poultry 
products inspection regulation should include the maximum amount of 
calcium permitted in determining whether mechanically separated poultry 
is in compliance.
    FSIS has developed two different calcium content levels for this 
purpose. Both of these levels account for the fact that poultry 
tissues, other than bone, contain some calcium. The higher level--0.235 
percent--reflects the greater proportion of calcium in the bones of 
mature chickens and turkeys as compared with young chickens (i.e., the 
lower ratio of bone solids to calcium). The lower level--0.175 
percent--has been used by FSIS in enforcing the 1 percent restriction 
on product made from young chickens. Both of these calcium levels are 
equivalent to 1 percent bone solids using the conversion formulas for 
calculating bone solids from calcium on a weight basis.7
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    \7\The formula for calculating bone solids from calcium for 
poultry products is in the ``Chemistry Laboratory Guidebook,'' U.S. 
Department of Agriculture (6.010F, page 6-33), and is available for 
public inspection at the FSIS Docket Clerk's office.
---------------------------------------------------------------------------

    Since FSIS is proposing a definition and standard that includes 
potential types of mechanically separated product, FSIS would allow 
0.175 percent calcium as the maximum for all MS(K) that is made from 
poultry other than turkeys or mature chickens.
    The inclusion of these calcium content levels in the proposed 
definition and standard should not be misinterpreted as indicating a 
concern about the amount of the essential nutrient calcium that is 
provided by poultry and meat food products. FSIS agrees with the 
findings in the 1979 health and safety report that, even assuming all 
further processed poultry were made with mechanically deboned poultry 
(i.e., a far greater level of production and use than actually occurs), 
the projected calcium contribution of such products would represent 
only a negligible increase in per capita daily intakes and cannot be 
considered hazardous, particularly since the dietary intake of a large 
sector of the population may be below the recommended level of calcium 
consumption.
    In addition, the ``Chemistry Laboratory Guidebook'' (section 
6.010F, page 6-33) has been revised to include a procedure that could 
be applied to mechanically separated product made in part from mature 
chickens. That procedure involves a determination of the relative 
mature and young chicken proportions when product is made from a 
combination of young and mature chickens.
    3. Bone particle size. FSIS is proposing that at least 98 percent 
of the bone particles present in MS(K) be restricted to a maximum size 
no greater than 1.5 millimeter (mm) in their greatest dimension and no 
bone particles shall be larger than 2.0 millimeter in their greatest 
dimension. The need to limit the size of bone particles in MS(K) has 
been acknowledged since the poultry industry began to use mechanical 
methods for manufacturing this product.
    FSIS' objective is that the limitation imposed be adequate to 
prevent any digestibility problems while not restricting the operation 
of equipment in accordance with good manufacturing practices more than 
is necessary for this purpose or to protect finished product quality. 
In the 1979 health and safety report, it was recommended that bone 
particle size be controlled to ensure that equipment type or processing 
does not result in unacceptably large fragments. The report concluded 
that, provided this is done, the bone particles in the product will not 
present any health hazard because of size or hardness.
    4. Recordkeeping. FSIS is also proposing that establishments that 
manufacture MS(K) maintain records of bone solids content and bone 
particle size as a measure of process control. These records must be 
made available to the inspector and any other duly authorized 
representative of the Secretary upon request.
    B. Limitations on Use
    FSIS is proposing certain limitations with respect to the use of 
MS(K) in the formulation of poultry and meat food products. FSIS is 
proposing such restrictions based on the potential fluoride 
contribution of MS(K) made from fowl (i.e., mature female chickens) and 
the characteristics of MS(K), including the kind of poultry from which 
it is made and its consistency. FSIS believes that such requirements 
are necessary to prevent potential health and safety problems, and to 
maintain the quality and integrity of the poultry and meat food product 
supply. FSIS is also proposing that MS(K) may be used, except in 
certain cases, in any product defined by regulatory standards or Agency 
policies whereby ``(Kind)'' or ``(Kind) Meat'' are being used, provided 
that it is identified as ``Mechanically Separated (Kind).''
    1. Kind of product limitation. FSIS is proposing that when a 
poultry product is required to be prepared from a particular Kind or 
Kinds of poultry (e.g., chickens), use of MS(K) of any other kind 
(e.g., mechanically separated turkey) would not be permitted. This 
provision would assure that MS(K) made from a different kind of poultry 
is not used in a poultry product represented as containing ingredients 
from a particular kind or kinds of poultry.
    The proposed definition and standard for MS(K) covers MS(K) 
prepared from any kind of poultry. FSIS would not permit use of MS(K) 
as an ingredient in any given poultry product regardless of the kind of 
poultry from which it is made. Such action would be inconsistent with 
existing regulatory requirements and could, among other things, result 
in false or misleading labeling. For example, the definition and 
standard for ``(Kind) patties'' (9 CFR 381.160) requires that poultry 
product ingredients be ``of the kind indicated'' (e.g., turkey products 
in turkey patties). FSIS believes that proposing to provide for the use 
of MS(K) as a distinctive poultry product ingredient should not 
abrogate this requirement (e.g., to not permit use of mechanically 
separated chicken in turkey patties).
    2. Limitations on product made from fowl. FSIS is proposing 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. 
These restrictions are based on the potential fluoride contribution of 
product made from fowl to dietary intakes. The 1979 health and safety 
report found only slight differences between the fluoride content of 
MS(K) made from poultry other than fowl and that of poultry products 
produced by traditional deboning techniques, but considerably higher 
amounts in MS(K) made from fowl.
    FSIS believes that conclusions reached in the 1979 health and 
safety report regarding fluoride content of MS(K) from fowl and MS(K) 
from all other poultry sources have not changed significantly. FSIS 
believes that the data reported in the 1979 health and safety report 
are currently the best available on this subject and the conclusions 
reached are valid. However, FSIS is aware that the benefits of fluoride 
in the diet continues to be studied by the scientific community and 
that more information is available today on the subject than in 1979 
when the Agency published the health and safety report.
    The 1993 National Academy of Sciences' Subcommittee on Health 
Effects of Ingested Fluoride report titled, ``Health Effects of 
Ingested Fluoride'' (NAS Fluoride Report),8 commissioned by the 
Environmental Protection Agency (EPA) provides current information on 
the complexities of assessing effects of fluoride in the diet and makes 
recommendations for further research. The NAS Fluoride Report cites 
dental products containing fluoride (topical fluoride applications by 
dentists, fluoride supplementation, and ingestion of fluoride 
dentifrices), beverages made with water containing fluoride (tea and 
coffee, as well as manufactured drinks), and foods as being the major 
sources of ingested fluoride. The NAS Fluoride Report points out that, 
while ingestion of fluoride from some sources may have gone up, some 
food sources of fluoride have gone down. For example, ingestion of 
fluoride from infant formulas (a source of dietary fluoride considered 
in the 1979 health and safety report) has gone down because of the 
agreement among the producers of infant formulas to use only water low 
in fluoride for all their products. The changing sources of fluoride 
ingestion makes assessing intakes and effects on populations inherently 
difficult. In the modern U.S. environment, people are exposed to 
fluoride from food, beverages, toothpaste, and a variety of prescribed 
or over-the-counter dental products.
---------------------------------------------------------------------------

    \8\This report is available for public inspection in the FSIS 
Docket Clerk's office.
---------------------------------------------------------------------------

    While the NAS Fluoride Report reiterates the positive effects of 
increased fluoride intake on reduction of dental caries in the 1990's 
as compared to the 1950's, it also cites the side effect of dental 
fluorosis, e.g., too much fluoride ingested in early childhood while 
teeth are forming. Dental fluorosis occurs when the enamel covering of 
the teeth fails to crystallize properly, leading to defects that range 
from barely discernible to severe brown stain, surface pitting, and 
brittleness. The report states that ``the most effective approach to 
controlling the prevalence of severity of dental fluorosis, without 
jeopardizing the benefits of fluoride to oral health, is likely to come 
from more judicious control of fluoride in foods, processed beverages, 
and dental products, especially those items used by young children.''
    FSIS agrees with this conclusion and maintains its concern for the 
potential effect of fluorosis in the susceptible population of babies, 
infants, and toddlers. Therefore, FSIS believes that the tentative 
position set forth in its March 1994 ANPR previously discussed, to 
restrict the use of MS(K) made from fowl in baby (i.e., strained), 
junior, and toddler foods is prudent. However, FSIS is requesting that 
commenters provide to the Agency any information that would either 
reaffirm or contradict the conclusions reached in the 1979 health and 
safety report. FSIS intends to reassess and update the 1979 health and 
safety report regarding fluoride in light of information submitted in 
response to this proposal.
    3. Poultry product limitations. FSIS believes that the use of MS(K) 
should be limited in certain poultry products. FSIS is proposing that 
MS(K) should 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 will allow MS(K) in the sauce portion or any 
dressing of poultry products.
    MS(K) is a highly comminuted ingredient with a spread-like 
consistency and FSIS considers its use to be inconsistent with the 
basic characteristics associated with poultry products that have been 
processed only to the extent of cutting or grinding or that are made 
from poultry products so processed, such as chicken breasts, turkey 
fillets, and shredded chicken. FSIS also considers their use to be 
inconsistent with the basic characteristics associated with poultry 
products that are processed, convenience versions of ready-to-cook 
poultry or cuts or solid pieces of poultry or poultry meat, such as 
roasted chicken, boned turkey with natural juices, chicken a la Kiev, 
and turkey ham. FSIS is proposing that the use of MS(K) not be 
permitted in these products. FSIS recognizes, however, that these types 
of products sometimes are prepared with components the characteristics 
of which are not inconsistent with those of MS(K).
    It is poultry meat, particularly muscle(s), that characterizes 
parts and cuts of poultry. The characteristics associated with a cut 
can be retained when trimmings removed during processing are 
reincorporated; and the association with the cut remains when there is 
chunking, chopping, or grinding of the muscle as in versions of turkey 
ham product (9 CFR 381.171). FSIS regards these processes as different 
than using product made by the mechanical separation of bones with 
attached poultry tissue. MS(K) does not, in FSIS' view, retain the 
characteristics of the cuts themselves. It appears inconsistent with 
the basic characteristics expected of products represented as having 
been made from a particular part or cut of the poultry carcass, to 
include this finely comminuted ingredient, except as discussed above, 
especially when the muscle from that part is essentially intact or has 
been processed only to the extent of cutting or grinding.
    FSIS is proposing no restrictions on the amount of MS(K) that can 
be used in poultry products, or meat food products, in which it is a 
permitted ingredient. However, prevailing standards for particular 
products may contain quantitative limits (e.g., the limit on the amount 
of poultry product ingredients permitted in cooked sausages such as 
frankfurters and bologna (9 CFR 319.180)) or other restrictions on the 
quantity of various poultry product ingredients.
C. Labeling
    FSIS is proposing special provisions for the labels of MS(K). 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 is proposing the following labeling provisions 
for MS(K): (1) the name of the product (e.g., ``Mechanically Separated 
(Kind)'' 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 MS(K) 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 MS(K), FSIS is proposing 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 must be clearly identified on the label 
when MS(K) leaves the establishment at which it is manufactured.
    As indicated previously, the 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, as discussed previously, 
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)). In addition, since the 
presence of poultry kidneys or sex glands can affect use (9 CFR 
319.180(b)), a number of manufacturers of MS(K) not containing these 
parts currently choose to note this fact on the label. The other 
information that would be required is identification of product made 
from fowl.
    2. Finished poultry products and meat food products. As indicated 
above in the discussion of FSIS' proposed definition and standard for 
MS(K), FSIS is proposing that in view of the differences between MS(K) 
and poultry products produced by traditional hand-deboning techniques, 
MS(K) should be regulated as a distinctive ingredient with standardized 
characteristics. Therefore, FSIS is proposing to define such product by 
its own name, e.g., ``Mechanically Separated (Kind),'' that would be 
declared in the ingredients statements on finished product labels by 
the name specified in its definition and standard.
    FSIS recognizes the importance of the identification of the calcium 
and cholesterol content of MS(K) to consumers who, according to the 
comments received on the June 15, 1993, ANPR (58 FR 33040), indicated a 
desire to know of the presence of calcium and cholesterol. The 
nutrition labeling regulations, effective July 6, 1994, require 
mandatory declaration of calcium and cholesterol content on most 
processed meat and poultry products which addresses this particular 
labeling concern. FSIS believes that nutrition labeling is the most 
appropriate vehicle for conveying a product's nutrient content, which 
includes calcium and cholesterol, as well as other nutrient 
information.

Executive Order 12866

    This proposed 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 
U.S. in 1993 was about 27 billion pounds on a ready to cook basis. 
(Broiler represents 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, many of which use MS(K).
    FSIS has estimated that 1 billion pounds of poultry product is 
processed annually into MS(K), with a yield of 70%, or 700 million 
pounds of MS(K) product for human use. (Industry sources suggest that a 
larger amount of MS(K) product is produced annually.) FSIS estimated 
that 400 million pounds is used in sausage products and 300 million 
pounds in patties and nuggets. The estimated size of the market does 
not directly affect the cost estimates below because these depend on 
the number of label changes.
    The Broiler Council estimates that broiler meat is produced in 
around 200 establishments, of which 50 are further processing 
establishments. MS(K) is produced in around 108 establishments. About 
25-30 of these establishments with MS(K) equipment produce hot dogs. 
The product from the other 75-80 establishments is sold to poultry 
further processors or to red meat processors. Industry sources indicate 
that some small firms specialize in MS(K) production, buying carcasses 
from poultry slaughter establishments for further processing.
    Based on inspection task records, FSIS estimates that 108 
establishments produced (or are capable of producing) poultry MS(K). 
MS(K) production by establishment size is not available from FSIS. 
However, total further processed product production by size of 
establishments shows 7 establishments with production less than 10,000 
pounds of MS(K) annually. The average production of the 108 
establishments is 51 million pounds of all further processed products.
    Under the proposed rule, products containing mechanically separated 
poultry would require that it be labeled as ``Mechanically Separated 
(Kind)'' in the list of ingredients. There is no precise information on 
the total number of products that contain MS(K). FSIS indicated there 
are 602,000 approved labels for poultry and meat, not all of which are 
necessarily in use. These include 529 labels for specific MS(K). There 
is also an unknown number of labels for products containing MS(K) such 
as frankfurters, chili, bologna, poultry baby foods, chicken nuggets or 
patties. FSIS estimates that in a total about 5,000 products would 
require relabeling. There is no currently available data on the size 
breakdown of the establishments producing products containing MS(K).

Possible Economic Impacts From Proposed Rule

    Possible sources of costs associated with the proposed rule:

A. Labeling

    Under the proposed rule, final products containing mechanically 
separated poultry would require ingredient statement labeling of the 
mechanically separated poultry as ``Mechanically Separated (Kind).'' 
Estimates range from $200 to $3,000 per product for a simple product 
ingredient label change depending on the type of label. Comments in 
response to the March 1994 ANPR indicate that most labels would fall in 
the lower end of this range (about $600). Assuming an average cost of 
$1,000 per product, the cost of relabeling would be $5 million ($1,000 
times 5,000 products). Doubling the average cost per product to $2,000 
increases the labeling cost to $10 million.
    Labeling costs could be reduced to the extent mandated MS(K) label 
changes can be coordinated with other label changes planned or required 
during the period of promulgation of the MS(K) rule and its 
enforcement. 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. 
Also, a FSIS policy directive effective July 25, 1994 requires 
widespread changes in meat and poultry ingredient statement labeling by 
August 8, 1995. To the extent MS(K) label changes could be worked in 
with these changes, less additional cost would be incurred.

B. Label Inventory Costs

    Some firms may discard non-compliant labels when the proposed 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. Thus, inventory losses would be minor under 
a 12 month or longer compliance period. Assuming an average inventory 
discard cost of $30 per product results in an estimated inventory 
transition cost of $150,000 ($30 times 5,000 products).

C. 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. For an establishment already performing bone content tests, 
FSIS believes an additional 5 minutes per test is sufficient to add the 
bone particle size test and record results. Good manufacturing 
practices would require that such tests be conducted at least once per 
day per shift.
    Annual costs to perform and record test results for the 108 
establishments are estimated at $74,000. This assumes an average of 
1.75 shifts per day establishment, 260 operating days per year, 5 
additional minutes per test, and a labor cost of $18 per hour.

D. Records Management and Maintenance

    Information from industry indicates that many establishments 
currently maintain records for bone solids content so minimal 
additional burden is added by the proposed recordkeeping requirement. 
New recordkeeping requirements would apply to bone particle size 
testing. FSIS estimates that each establishment will average an 
additional 15 minutes per day on records maintenance. Annual costs of 
additional records maintenance for the 108 establishments are estimated 
at $84,000. This assumes 260 operating days per year and a labor cost 
of $12 per hour.

E. Benefits

    Benefits derived from the proposed regulation arise from consumers 
being assured that labeling for products containing MS(K) would not be 
false or misleading. The description of ingredients will change, but 
the physical product itself will remain unchanged. The Agency does not 
expect any market-wide effects. No estimates exist regarding how 
consumers value such information. However, the Agency believes the 
value of avoiding false and misleading information exceeds the cost of 
labeling. The Agency is seeking additional information and data from 
commenters on the impact this proposal could have on markets and the 
value consumers place on this type of labeling information.

                        Annual Cost Summary Table                       
------------------------------------------------------------------------
                                                         Million dollars
------------------------------------------------------------------------
1. Cost of relabeling.................................      5.000-10.000
2. Label inventory costs..............................              .150
3. Bone particle tests................................              .074
4. Records maintenance................................              .084
5. Consumer reaction (no estimate)....................                  
    Total cost........................................      5.308-10.308
------------------------------------------------------------------------

Executive Order 12778

    This proposed 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 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 proposed 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 
proposed 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 proposed rule with respect 
to labeling decisions.

Effect on Small Entities

    The Administrator has determined that this proposed rule would 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). 
It is likely that producers with smaller lot sizes would have higher 
compliance costs per pound of product because some costs such as 
testing and recordkeeping occur on a lot basis. Any relabeling costs 
also would be lower per pound for products with large annual 
production. No data is available which gives the establishment size 
breakdown for establishments producing products containing MS(K).

Paperwork Requirements

    This proposed rule would require establishments to maintain records 
of bone solids content and bone particle size as a measure of process 
control, and to make such records available to any duly authorized 
representative of the Secretary. This proposed rule would 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 regulated term ``Mechanically Separated 
(Kind)'' and be submitted to FSIS for approval.
    The paperwork requirements contained in this proposed rule have 
been submitted to the Office of Management and Budget for approval 
under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

Comments

    Interested persons are invited to submit written comments 
concerning this notice. Submit comments in triplicate to Diane Moore, 
Docket Clerk, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 3171-S, Washington, DC 20250. Any person desiring an 
opportunity for an oral presentation of views should make such request 
to Mr. John W. McCutcheon so that arrangements can be made for such 
views to be presented. A record will be made of all views orally 
presented. All comments submitted in response to this notice will be 
available for public inspection in the Policy, Evaluation and Planning 
Office from 8:30 a.m. to 1:00 p.m., and from 2:00 p.m. to 4:30 p.m., 
Monday through Friday.

List of Subjects

9 CFR Part 318

    Meat inspection.

9 CFR Part 381

    Food labeling, Poultry and poultry products, Standards of identity.

Proposed Rule

    For the reasons set forth in the preamble, FSIS is proposing to 
amend 9 CFR parts 318 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 would continue 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 would be 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),'' 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 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 would continue 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 would be 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 ``Mechanically Separated 
(Kind)'' 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)'' 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)'' as defined in Sec. 381.173, computed on the basis of the moist 
deboned, cooked poultry meat and/or ``Mechanically Separated (Kind)'' 
in such product; and
    (3) * * *
    (c) * * *
    (1) They contain poultry meat and/or ``Mechanically Separated 
(Kind)'' as defined in Sec. 381.173 or poultry fat only in condimental 
quantities;
* * * * *
    5. Section 381.117 would be 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)'' described 
in Sec. 381.173, the name of such product shall be followed immediately 
and in the following order by the phrase(s): ``made from fowl'' unless 
such product is not made, in whole or part, from mature female chickens 
as defined in Sec. 381.170(a)(1)(vi), and ``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 would be amended by adding new Secs. 381.173, and 
381.174 to read as follows:


Sec. 381.173   Mechanically Separated (Kind).

    (a) ``Mechanically Separated (Kind)'' is any finely comminuted 
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 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)'' 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)'' 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)'' 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)'' 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 separating process that 
fails to meet the bone particle size or calcium content requirements 
for ``Mechanically Separated (Kind)'' shall be used only in producing 
poultry extractives, including fats, stocks, and broths and labeled as 
``Mechanically Separated (Kind) for Further Processing.''
    (f) The management of the establishment that produces 
``Mechanically Separated (Kind)'' shall maintain records to support the 
validity of bone solids content and bone particle size of 
``Mechanically Separated (Kind).'' Such records shall be made available 
to the inspector or any other duly authorized representative of the 
Secretary upon request.


Sec. 381.174   Limitations with respect to use of Mechanically 
Separated (Kind).

    (a) A poultry product required to be prepared from a particular 
kind of poultry (e.g., chicken) shall not contain ``Mechanically 
Separated (Kind)'' described in Sec. 381.173, that is made from any 
other kind of poultry (e.g., Mechanically Separated Turkey).
    (b) Mechanically Separated Chicken described in Sec. 381.173, that 
is made, in whole or in part, from fowl as defined in 
Sec. 381.170(a)(l)(vi), shall not be used in baby, junior, or toddler 
foods.
    (c) ``Mechanically Separated (Kind)'' described in Sec. 381.173 
shall not be used in poultry products that are composed of whole or 
intact poultry muscle and expected to be as such by consumers (e.g., 
chicken steaks, chicken fillets, and cured turkey thighs), except that 
it may be used for binding purposes (i.e., to hold poultry muscle 
together) at a level that is sufficient for that purpose.
    (d) ``Mechanically Separated (Kind)'' or ``Mechanically Separated 
(Kind) Meat'' described in Sec. 381.173 shall not be used in the 
formulation of a poultry product or meat food product, unless 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.
    (e) Other than ``Mechanically Separated (Kind)'' made from fowl, 
Mechanically Separated (Kind)'' may be used in any product defined by 
regulatory standards of identity and composition, except those products 
identified in paragraph (c) of this section, whereby ``Kind'' or ``Kind 
Meat'' is being used, provided that it is identified as ``Mechanically 
Separated (Kind).''
    7. Section 381.175 would be amended by adding a new paragraph 
(b)(6) to read as follows:


Sec. 381.175   Records required to be kept.

* * * * *
    (b) * * *
    (6) Records of bone solids content and bone particle size as 
required by Sec. 381.173 of this subchapter.

    Done at Washington, DC, on November 30, 1994.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 94-29901 Filed 12-2-94; 8:45 am]
BILLING CODE 3410-DM-P