[Federal Register Volume 59, Number 42 (Thursday, March 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4892]


[[Page Unknown]]

[Federal Register: March 3, 1994]


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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Part 381




Poultry Products Produced by Mechanical Deboning and Products in Which 
Such Poultry Products Are Used; Proposed Rule
DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. 93-008N]
RIN 0583-AB68

 
Poultry Products Produced by Mechanical Deboning and Products in 
Which Such Poultry Products Are Used

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food Safety and Inspection Service (FSIS) has decided 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 deboning, 
including possible provisions for the composition, characteristics, and 
use of such products, and requirements for manufacturing and labeling 
such products. FSIS has formed tentative positions on the provisions of 
such amendments. FSIS needs additional public input on the general 
approach and parameters of such rulemaking in order to help the 
regulation development process. FSIS is interested in receiving 
information from the meat and poultry industries and industry-related 
organizations, the scientific community, academia, consumers and 
consumer groups, and other interested parties prior to undertaking any 
such proposed rulemaking.

DATES: Comments must be received on or before May 2, 1994.

ADDRESSES: Written comments to: Policy Office, Attn: Diane Moore, FSIS 
Hearing 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:

Comments

    Interested persons are invited to submit written comments 
concerning this notice. Written comments should be sent to the Policy 
Office at the address shown above and should refer to Docket No. 93-
008N. 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 Office from 9 a.m. to 12:30 p.m., and from 1:30 p.m. to 4 p.m., 
Monday through Friday.

Background

Introduction

    Poultry products produced by 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 
Department'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 
deboning such that product contained less than 1\1/2\ percent bone 
solids with an extremely small bone particle size. This prompted the 
Department to reevaluate its position. Widespread commercial production 
of products containing mechanically deboned poultry began in the early 
1970's. By 1975, poultry product produced by mechanical deboning was 
being used as an ingredient in poultry and meat food products such as 
franks, bologna, salami, and rolls.
    Today, poultry products produced by mechanical deboning are used in 
a wide variety of poultry products, including 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,'' ``chicken,'' etc., 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).
    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 of the product 
according to 9 CFR 381.117(d).
    Poultry products produced by mechanical means are 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 one percent.
    Poultry products produced by mechanical deboning also are subject 
to 9 CFR 381.47(e). This regulation requires that rooms or compartments 
containing mechanical deboning equipment must be maintained at 50 deg. 
F or less during the mechanical deboning of raw poultry.
    Existing regulations do not distinguish between boneless poultry 
products produced by mechanical deboning and poultry products produced 
by traditional methods, e.g., hand-deboning using high-speed knives. 
Poultry product produced by mechanical deboning is declared in the 
ingredients statement of a product in which it is used, along with any 
other boneless chicken product used, as ``chicken'' where skin and fat 
are included but not in excess of their natural proportions, or as 
``chicken meat'' when such components are not included.
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 deboning. 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 health and safety report). 
An errata supplement correcting certain items in the report was 
prepared and published on August 14, 1979 (44 FR 47576). (The June 1979 
report and the errata supplement are available for public inspection in 
the FSIS Hearing Clerk's office.) On June 29, 1979, the Department 
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 deboning 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 
commenter stated that the regulations have effectively controlled the 
use of product produced by mechanically deboning 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).
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 deboning 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.
Improvements in Machinery for the Poultry Products Produced by 
Mechanical Deboning
    The Agency has monitored the advances in the technology for 
mechanically deboning poultry products 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 700 million pounds of raw poultry materials are 
used to manufacture mechanically deboned poultry which is used, in 
turn, to formulate approximately 400 million pounds of poultry sausages 
(including franks, bologna, and salami), and 300 million pounds of 
poultry nuggets and poultry patties.\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 
traditional 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. These improvements 
have resulted in the ability to decrease the bone solids that are a 
result of the mechanical deboning process for poultry to less than the 
one percent reflected in the current poultry products regulations (9 
CFR 381.117(d)).
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    \1\Information provided by industry available for public 
inspection at the FSIS Hearing Clerk's office.
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    In 1969, the Department amended the regulations for poultry and 
poultry products inspection to, among other things, provide labeling 
requirements for boneless poultry products, including a prescribed bone 
solids content of not more than one percent (34 FR 13991). This limit 
was based on an evaluation conducted by the Department of the operating 
results in a series of poultry plants 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 one 
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 one 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 deboned poultry.\2\ The percentage of bone solids 
content (determined by calcium analysis) in boneless poultry products 
produced by mechanically deboning was collected from approximately 50 
plants 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 percentages 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 Hearing 
Clerk's office.
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Prior Advance Notice of Proposed Rulemaking (ANPR)
    On June 15, 1993, FSIS published an advance notice of proposed 
rulemaking (58 FR 33040) soliciting comments, information, scientific 
data, and recommendations regarding the consideration of the need for 
labeling of poultry product produced by mechanical deboning and 
products in which such poultry product is used. FSIS indicated it was 
considering the need for rulemaking that would establish regulations on 
the labeling of poultry product produced by mechanical deboning and 
products in which such poultry product is used.
Discussions of Comments on the ANPR
    FSIS received 2744 comments in response to the ANPR, most of which 
were general reactions to the labeling issues. Two thousand five 
hundred and ninety comments were submitted by consumers, 113 by food 
manufacturers/distributors, 17 by food retailers, 14 by trade 
associations, 4 by individuals from the Federal government, 3 by 
academia, 2 by food consultants, and 1 by a law firm. The majority of 
the commenters responded to whether there was a need to identify 
mechanically deboned poultry (MDP) in the ingredients statement on the 
labels of meat and poultry products in which it is used as an 
ingredient.
    One thousand four hundred and eighty-seven commenters supported 
identifying MDP in the ingredients statement on the labels of meat and 
poultry products in which it is used. These commenters include 1452 
consumers, 8 food manufacturers/distributors, 17 food retailers, 4 
trade associations, 4 individuals, one food consultant, and one law 
firm representative. The commenters provided the following general 
reasons why MDP should be identified on a finished meat or poultry 
product label. They stated that: (1) Consumers have a right to know 
that MDP is present in a product, (2) meat and poultry products should 
be labeled the same, i.e., there should be parity in labeling 
regulations, (3) MDP contains higher amounts of ``calcium,'' 
``cholesterol,'' and/or ``bone particles'' and, therefore, should be 
identified, and (4) MDP should be identified because there is ``a 
difference'' between MDP and hand-deboned poultry. The eight food 
manufacturers/distributors and four consumers also stated that 
consumers should be made aware (through labeling) that MDP contains 
``kidneys,'' ``sex glands,'' and ``lungs.'' The food manufacturers/
distributors also pointed out that mechanical deboning processes that 
crush or grind bones should be labeled as such, regardless of kind 
(i.e., species). Most of the food manufacturers/distributors encouraged 
FSIS to work with industry's scientific experts and the meat community 
to define ``meat'' and ``poultry'' through standards of ``product 
safety and nutritional composition.''
    The remaining 1,257 commenters did not support identifying MDP in 
the ingredients statement on the labels of finished meat and poultry 
products for the following reasons: (1) The Agency's current policy 
should continue and MDP has a history of safe use for 25-plus years 
without labeling it as anything other than ``chicken,'' ``turkey 
meat,'' etc., (2) nutrition labeling will be a means of educating 
consumers about product composition and will address any concerns with 
regard to the nutrient qualities of the products they purchase, (3) 
listing MDP separately in the ingredients statement would mislead 
consumers into thinking they are purchasing products that are inferior 
to what they have (historically) purchased, (4) any changes in labeling 
regulations on MDP would only serve to confuse consumers into believing 
something ``has been added to their products'' when, in fact, no 
changes have been made, and (5) a change in labeling would result in a 
severe negative economic impact ``on the entire poultry industry and 
U.S. economy, as well as many U.S. trading partners that now use these 
items as a food source.'' One food manufacturer stated that beef and 
pork are different species with obvious differences in bone mass, 
skeletal size, amount of calcification, and bone hardness, and, 
therefore, MDP should not be labeled the same as MS(S), which 
incorporates bone and the constituents of bone in the product. Some of 
the trade associations recommended that if MS(S) meets the same 
criteria for MDP in 9 CFR 381.117, it should be entitled to analogous 
labeling. Some of the trade associations also believe that MDP and 
MS(S) should not be defined by the process used to make them.
    The academicians stated that the method of removal of meat tissue 
from bones of carcasses should not become part of the name of the 
product, and, as long as the end products are comparable and meet the 
``rules'' for starting materials, composition, sanitation, etc., the 
method of processing should not become part of the product name. The 
commenters also stated that MDP is an excellent source of protein and 
calcium.
FSIS's Response to the Comments on the June 15, 1993, ANPR and Issues 
Regarding Poultry Products Produced by Mechanical Deboning
    In its June 15, 1993, ANPR, FSIS solicited comments, information, 
scientific data, and recommendations regarding the consideration of the 
need for labeling of poultry product produced by mechanical deboning 
and products in which such poultry product is based. FSIS did not 
receive any new data regarding the health and safety aspects of the use 
of such products, and, therefore, FSIS believes that there are no new 
health and safety concerns.
    Although, many of the commenters of the June 15, 1993, ANPR raised 
concerns regarding the labeling of calcium and cholesterol contents of 
poultry product produced by mechanical deboning, the provisions of the 
nutrition labeling regulations (58 FR 632) published by FSIS, which are 
to be effective July 6, 1994, would be a means of educating consumers 
regarding certain nutrients and other components of processed meat and 
poultry products containing poultry product produced by mechanical 
deboning, including calcium and cholesterol. Calcium and cholesterol 
declaration becomes necessary on the labeling of most multi-ingredient 
poultry and meat products upon the effective date. These regulations 
also establish a voluntary nutrition labeling program for single-
ingredient, raw products, and specify that FSIS will evaluate 
significant participation of the voluntary program. If significant 
participation is not found, FSIS shall initiate rulemaking to require 
nutrition labeling on those products under the voluntary program. 
Therefore, with certain exceptions, consumers will have complete 
information about the nutrients in poultry products. Such information 
will ensure that consumers are not mislead about the composition of 
products containing poultry products produced by mechanical deboning.
    FSIS recognizes that not all products sold to consumers at the 
retail level will carry nutrition labeling. FSIS's final regulation on 
nutrition labeling provided for certain exemptions including products 
produced by small businesses and products in individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information. 
However, labeling will be required on most processed products purchased 
by consumers in retail stores so that, together with the voluntary 
program for retail store information on single-ingredient, raw 
products, consumers will have information on calcium and cholesterol 
for most products purchased for consumption at home.
    Regarding the comments FSIS received in response to its June 15, 
1993, ANPR on the presence of kidneys in poultry products produced by 
mechanical deboning, FSIS requires the removal of kidneys of mature 
turkeys and chickens from their carcasses before the eviscerating 
operations during the slaughtering process (9 CFR 381.65(d)). Kidneys 
of mature poultry pose a potential health concern because of the 
possibility of the presence of certain heavy metals. Further, in regard 
to the comments made about lungs and sex glands, these are precluded 
from being present in ``ready-to-cook'' poultry (i.e., poultry 
subsequent to the slaughtering process) by the poultry products 
inspection regulations (9 CFR 381.1(b)(44)).
    FSIS acknowledges that many of the reasons provided by commenters 
for maintaining the Agency's current policy on labeling poultry 
products produced by mechanical deboning are valid. However, a 
substantial number of comments reflect the consumer's ``right to know'' 
that poultry product produced by mechanical deboning is in their food 
because of the unexpected presence of bone. FSIS believes that these 
comments refer to the boneless poultry product produced by mechanical 
deboning which has greater than 0.6 bone solids content, but no more 
than one percent bone solids content.
    FSIS is now considering issues in regard to the lack of a 
regulatory definition and standard for certain poultry products 
produced by mechanical deboning--products which are deemed to be 
similar to mechanically separated (species) (MS(S)), for which a 
regulatory definition and standard exist (9 CFR 319.5). (``Species'' 
refers to the species of livestock, e.g., beef or pork.) MS(S) is 
defined as ``any 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'' and 
meeting the other provisions specified in 9 CFR 319.5. Provisions in 
the Federal meat inspection regulations provide, among other things, a 
definition and standard that classifies MS(S) as a meat food product 
and a requirement that MS(S) be separately identified in the 
ingredients statement of a meat food product in which it is used as an 
ingredient (9 CFR 317.2 (c) and (f), 319.1, and 319.5). FSIS's 1982 
final rulemaking on MS(S) (47 FR 28214) indicates that the Agency 
determined that material differences in the consistency and the 
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. As such, it should be identified by a name that 
adequately differentiates it from meat, viz., MS(S). When MS(S) is used 
in meat food products, it must be separately listed in the ingredients 
statement by its standardized name, e.g., ``mechanically separated beef 
(or pork).''
    Over the years, the meat and poultry industries have referred to 
poultry produced by mechanical deboning as ``mechanically deboned 
poultry'' and ``comminuted poultry,'' and have declared the product as 
poultry or poultry meat (e.g., ``chicken'' and ``turkey meat'') in the 
ingredients statement of the labels of products in which it is used as 
ingredients. Several red meat sausage manufacturers have alleged that, 
without a regulatory definition and standard for poultry products 
produced by mechanical deboning, a disparate situation exists between 
labeling certain poultry products produced by mechanical deboning and 
MS(S) which poses an unfair advantage for the manufacturers of poultry 
products and may deny consumers useful information.
    FSIS has considered the appropriate course for addressing these 
issues, and has initiated two actions in response to them. FSIS is 
contemplating proposing regulations on poultry products produced by 
mechanical deboning, and is soliciting comments and requesting data on 
various tentative positions in this advance notice of proposed 
rulemaking. The other action is a proposal found elsewhere in this 
issue of the Federal Register which amends the Federal meat inspection 
regulations by amending the definition of meat to include, as meat, 
product derived from the advances in meat/bone separation machinery and 
recovery systems that do not crush, grind, or pulverize bones to remove 
attached skeletal tissue of livestock carcasses and parts of carcasses 
from livestock bones.
    Purpose of the ANPR: FSIS's Intent 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 Deboning, Including Possible Provisions 
for Composition, Characteristics, and Use, and Requirements for 
Manufacturing and Labeling Such Products.
    FSIS is considering, among other things, that certain poultry 
products produced by mechanical deboning, i.e., those with greater than 
0.6 percent bone solids content, but no more than one 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 is 
considering, among other things, that some boneless poultry products 
derived from mechanical deboning 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.'' Until the Agency receives further data and information 
to support this position, it cannot take a firm position on the content 
of a proposed regulation on this topic. Therefore, FSIS is issuing this 
ANPR that provides an in-depth discussion, which follows, on the 
labeling of MDP, as well as other issues related to boneless poultry 
product produced by mechanical deboning, and expresses the Agency's 
tentative positions regarding these issues. It is FSIS's intent to 
obtain the information and data necessary to solidify its position 
regarding the labeling, use, and production of poultry products 
produced by mechanical deboning.
Tentative Positions
    I. Boneless poultry products produced by mechanical deboning with 
greater than 0.6 percent bone solids content (Boneless poultry products 
produced by mechanical deboning with greater than 0.6 percent bone 
solids content are hereafter referred to as ``MDP.'')
    A. Tentative position: Definition and standard of identity and 
composition. FSIS's tentative position is to prescribe a definition and 
standard of identity 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 greater than 0.6 percent 
bone solids content. 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. This product is commonly known in the 
poultry industry as mechanically deboned poultry or MDP.
    The changes under consideration would include (1) amending the 
Federal poultry products inspection regulations by defining MDP as 
``mechanically separated (kind),'' or another appropriate term, using 
limits for bone solids content and bone particle size, and criteria for 
protein quality, and requirements for labeling of the product in 
products in which it is used as an ingredient, and (2) amending the 
poultry products inspection regulations to require that such poultry 
products produced by mechanical deboning be kept at temperatures of 40 
degrees F or below within 2 hours of the deboning operation. The 
resulting product differs from poultry products produced by traditional 
deboning techniques in its highly comminuted and spread-like 
consistency and in its content of bone and associated tissue, as well 
as muscle, skin, and fat. These differences have a potential 
consequence for finished product microbiological quality and, thus, for 
health and safety. Therefore, certain handling requirements may be 
needed.
    In view of the differences between MDP and boneless poultry derived 
by traditional methods (e.g., hand-deboning), it appears inappropriate 
to continue to include MDP within the category of ``boneless poultry 
products'' (9 CFR 381.117(d)). Instead, FSIS is considering defining it 
as a distinct poultry product ingredient and standardizing its 
characteristics under Subpart P of the poultry products inspection 
regulations (9 CFR part 381, subpart P).
    FSIS's tentative position is that the boneless poultry products 
regulation (9 CFR 381.117(d)) no longer would apply to MDP. 
Consequently, the current restriction on bone solids content in this 
regulation--as enforced by limiting calcium content--would be included 
with other compositional requirements in a MDP standard. Product 
failing to meet the bone particle size, or protein quality requirements 
of the standard could be used only in producing poultry extractives, 
including fats, stocks, and broths, (i.e., processors would be 
permitted to employ acceptable procedures for extracting components 
such as fat, but such product resulting from the mechanical separation 
and removal process could only be used for further processing). 
Mechanically deboned poultry with a protein content of less than 14 
percent and/or a fat content of more than 25 percent would be deemed to 
be product for processing. Moreover, as a standardized product, MDP 
would be differentiated from other poultry product ingredients; and it 
would be designated in the ingredient 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).
    (1) Tentative position: Product name. FSIS's tentative position is 
to consider amending the Federal poultry products inspection 
regulations to define the standardized product that results from the 
mechanical separation and removal of most of the bone from poultry 
carcasses and parts of carcasses by a distinctive name. FSIS is 
tentatively considering that ``Mechanically Separated (Kind) (MS(K))'' 
is an appropriate, nonmisleading name for this product. It appears to 
accurately and concisely describe the product, indicating the nature of 
the process by which and the kind of poultry from which it is made, 
distinguishing it from poultry product ingredients produced by 
traditional hand-deboning techniques. The name under consideration 
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'').
    As previously indicated, FSIS believes that MDP differs 
sufficiently from boneless poultry products produced by traditional 
hand-deboning techniques that it should be regulated as a separate, 
standardized ingredient. As such, this product would be defined by its 
own, distinctive name, and it would be referred to by that name in 
relevant regulations and in labeling. In this regard, FSIS is 
requesting public input on other names that would accurately and 
appropriately describe MDP as a distinct ingredient.
    FSIS is aware that other descriptions have been associated with 
poultry products produced by mechanically deboning. 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 primary 
distinguishing characteristic of a standardized product is its bone 
content, it would be inappropriate to define it by a name that includes 
the term ``deboned'' and use of this term in labeling might mislead 
consumers by implying such product contains no bone.
    Persons commenting on this portion of the ANPR should be aware that 
FSIS does not consider that current familiarity with terminology or its 
appeal to consumers is dispositive on the question of what terminology 
is most likely to achieve its objectives for the name of a standardized 
product: instantaneous consumer familiarity and acceptance cannot and 
should not be expected when labels declare the presence of a product 
for the first time. However, consumer perceptions are important in 
determining whether or not terminology that is technically accurate 
nevertheless may be confusing or even misleading. When FSIS establishes 
a definition and standard for a product with respect to which a 
specified name is deemed appropriate, the product must be called by 
that name in labeling.
    (2) Tentative position: Bone solids content. FSIS is considering 
that a definition and standard for MDP would incorporate the existing 
restriction on the bone solids content of mechanically deboned poultry 
products, viz., not more than one percent (9 CFR 381.117(d)). Because 
this restriction is enforced by limiting calcium content, FSIS is 
considering that the definition and standard for MDP 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 prepared with heat 
treatment.
    As previously discussed, FSIS adopted the one percent bone solids 
restriction after appraising the operating results in a series of 
poultry plants 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, 13992). When processors applied the mechanical 
deboning technology to poultry products such as fowl frames that have 
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 has not occurred; and the adjusted level may 
not exceed one percent. The ``Chemistry Laboratory Guidebook,'' U.S. 
Department of Agriculture (section 6.010F, page 6-33),\3\ 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.
---------------------------------------------------------------------------

    \3\Document is available for public inspection at the FSIS 
Hearing 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. (The report did, however, 
recommend limitations on the use of product made from fowl because of 
bone constituents like fluoride; FSIS's tentative position is to amend 
the poultry products inspection regulations accordingly, as discussed 
below.) Because enforcement is based on calcium content analyses, 
rather than direct measurements of bone solids, FSIS is considering 
that an amended regulation would include the maximum amount of calcium 
permitted in determining whether mechanically deboned poultry is in 
compliance. As discussed below, FSIS is also considering that 
production under an approved quality control program is needed to 
assure that such product is manufactured to comply with regulatory 
requirements on a consistent basis and that implementation of a quality 
control program would increase the effectiveness of enforcement of the 
restriction on bone solids content.
    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 one percent restriction 
on product made from young chickens. Both of these calcium levels are 
equivalent to one percent bone solids using the conversion formulas for 
calculating bone solids from calcium on a weight basis.\4\
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    \4\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 Hearing Clerk's office.
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    Since FSIS is considering proposing a definition and standard that 
includes potential types of mechanically deboned product, FSIS's 
tentative position is to allow 0.175 percent calcium as the maximum for 
all MDP that is made from poultry other than turkeys or mature 
chickens. FSIS is interested in receiving comments regarding the 
calcium levels applicable to MDP made from other kinds of poultry, 
e.g., ducks, geese, and guineas, especially calcium levels applicable 
to mature poultry.
    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 deboned product made only 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. FSIS is considering, as 
discussed below, that production of MDP under an approved quality 
control program is necessary to assure consistent compliance with 
regulatory requirements, including the calcium content requirement 
utilized in restricting bone solids content. Therefore, as the 
discussion of the proposed quality control provision indicates, FSIS's 
tentative position is that, if mechanically deboned chicken is made 
from a combination of young and mature chickens, the application of any 
intermediate value between 0.175 and 0.235 percent in verifying 
compliance would be contingent upon an establishment's program for 
quality control including methods that support such value's 
appropriateness as a measure of a bone solids content to not more than 
one percent; and without such methods, the 0.175 percent limit should 
apply. FSIS wishes to receive comments on the determination of the 
calcium levels associated with MDP made from a combination of young and 
mature poultry.
    The inclusion of these calcium content levels in the definition and 
standard FSIS is considering 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 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.
    (3) Tentative position: Bone particle size. FSIS is considering 
restricting the size of the bone particles in MDP to a maximum of less 
than 1.5 millimeter (mm) in the greatest dimension, but permitting up 
to 5 bone particles per 50 grams of MDP to be from 1.5 mm to less to 
2.0 mm in the greatest dimension. The need to limit the size of bone 
particles in MDP has been acknowledged since the poultry industry began 
to use mechanical methods for manufacturing this product.
    In the 1979 health and safety report, it was recommended that bone 
particle size be controlled to ensure that equipment type of processing 
does not result in unacceptably large fragments and concluded that, 
provided this is done, the bone particles in the product will not 
present any health hazard because of size or hardness.
    FSIS is considering that it is appropriate to permit up to 5 
particles per 50 grams of product to be from 1.5 mm to less than 2.0 mm 
as an acceptable defect in complying product. FSIS is requesting 
comments and information on the extent to which manufacturers should be 
required to control the production of mechanically separated poultry 
product to limit the size of bone particles. FSIS will consider any 
information submitted during the comment period on the size and 
distribution of bone particles that may occur with various mechanical 
deboning procedures conducted in accordance with good manufacturing 
practices (e.g., the extent to which deviations or nonconforming 
particles occur, and data substantiating the absence of potential 
health or finished product quality problems with such particles).
    (4) Tentative position: Protein quality. FSIS is considering 
requiring that MDP meet a minimum protein quality requirement--a 
protein digestibility-corrected amino acid score of not less than 40 
expressed as a percent and to accept as evidence of compliance with 
this requirement an alternative measurement--the content of 7 essential 
amino acids being at least 33 percent of the total of 17 amino acids 
present. Protein quality is a measure of the content, proportion, and 
availability of essential amino acids in food protein and a measure of 
the ability of the food protein to support human growth and body 
protein maintenance.
    When the regulation on MS(S) (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) was published in 1982 (47 FR 
28214), one of the methods specified for measuring protein quality was 
the Protein Efficiency Ratio (PER) procedure. The PER method measures 
the ability of a protein source to support growth in young growing 
rats, and is an expensive and time-consuming assay. FSIS adopted a 
newer method for measuring protein quality, in order to assure the 
value of the protein contributed by meat and poultry to human dietary 
needs, in its final regulations on nutrition labeling of meat and 
poultry products published in the Federal Register on January 6, 1993 
(58 FR 632). The newer procedure, termed the protein digestibility--
corrected amino acid score method, is contained in ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1990 (PDCAAS method).\5\ The protein 
digestibility--corrected amino acid score method is based on human 
amino acid requirements and, therefore, is more appropriate for 
evaluating the protein quality of foods for human consumption that the 
PER which is based on amino acid requirements of rats. The protein 
digestibility-corrected amino acid score method measures the ability of 
amino acids in food proteins to meet the dietary protein needs of 
humans.
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    \5\A copy of the document is available for public inspection in 
the FSIS Hearing Clerk's office.
---------------------------------------------------------------------------

    FSIS is considering proposing a requirement that the protein in MDP 
have a protein quality value that is a protein digestibility-corrected 
amino acid score of not less than 40 expressed as a percent. This value 
is consistent with nutrition labeling requirements for protein in foods 
for children older than one but less than four years of age, as 
provided in 21 CFR 101.9(c)(7), which is cross-referenced in its final 
nutrition regulations (58 CFR 632) in 9 CFR 317.309(b). FSIS believes 
this value protects the young consumer from inadequate nutrition and 
from the use of poor quality protein (i.e., protein that does not meet 
the dietary needs for growth), and in turn, protects people other than 
young consumers. FSIS also believes that it may be appropriate to 
assure comparability of MDP with boneless poultry and poultry that is 
derived by hand-deboning in terms of the protein contributed to human 
dietary needs to maintain the quality and integrity of the poultry 
products supply.
    FSIS is proposing to permit an alternative measurement to the 
protein digestibility-corrected amino acid score method, which requires 
a digestibility measurement in addition to an amino acid analysis, to 
control the cost of monitoring compliance with the protein quality 
requirement. FSIS is considering proposing that, for the purpose of 
measuring the protein quality of MDP, an alternative measurement of 
protein quality would be allowed that is comparable to the protein 
digestibility-corrected amino acid score. This measure would be based 
on a comparison between the ``essential amino acid content of MDP'' and 
``total amino acids present in MDP.'' Essential amino acid content 
includes isoleucine, leucine, lysine, methionine, phenylalanine, 
threonine, and valine content, and the total amino acids present 
including isoleucine, leucine, lysine, methionine, phenylalanine, 
threonine, valine, tyrosine, arginine, histidine, alanine, aspartic 
acid, glutamic acid, glycine, proline, serine, and hydroxyproline 
content. It is being considered that the essential amino acid content 
would be determined by methods given in the ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation.''
    FSIS believes that MDP found to be in compliance by the proposed 
amino acid content measurement would have protein of high quality. This 
belief is supported by the 1982-83 evaluation of an Expert Work Group 
that was organized by the Department's Agricultural Research Service, 
in cooperation with the University of Maryland, to develop 
recommendations based on available scientific knowledge for 
consideration in policy decisions regarding the protein quality of 
meat, poultry, and their products.\6\
---------------------------------------------------------------------------

    \6\``The Protein Nutritional Quality of Meat and Poultry 
Products: Scientific Basis for Regulation'' is the final report of 
the Expert Working group, with accompanying background papers. C.E. 
Bodwell, ed., American Journal of Clinical Nutrition, 40(3): 671-
742, supplement, September 1984. A copy of the report is available 
for public inspection in the FSIS Hearing Clerk's office.
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    The public should be aware that FSIS continues to have interest in 
investigations of protein quality which include among their objectives 
the identification of improved methods for determining protein quality. 
In evaluating the possible use of alternative approaches to assuring 
protein quality, FSIS will consider data and other comments submitted 
by the public.
    (5) Tentative position: Protein and fat contents. FSIS is 
considering allowing for two categories of MDP for use in the 
formulation of poultry products and meat food products: (1) A category 
which meets minimum protein and maximum fat content requirements of not 
less than 14 percent and not more than 25 percent, respectively, and 
(2) a category designated ``for processing'' for which there are no 
protein or fat content requirements. As discussed below, it is 
contemplated that a wider range of use would be permitted for product 
containing not less than 14 percent protein and not more than 25 
percent fat, than for product for processing.
    Poultry products produced by traditional deboning techniques vary 
significantly in fat content, largely depending on the extent to which 
they include skin (with attached fatty tissue) and/or separable fat--
the major sources of fat in poultry. A similar pattern was evident in 
the data on mechanically deboned poultry products reviewed in the 1979 
health and safety report, although mechanically deboned product tended 
to contain more fat. This tendency is not surprising since mechanically 
deboned product frequently is prepared from necks, which have a higher 
skin content than other poultry parts, and/or backs, which have a 
higher skin content than other poultry parts, and because it can 
include bone marrow, which contains as much or more fat than skin.
    While, as with fat content, there is considerable variability in 
the protein content of both mechanically deboned poultry and poultry 
products produced by traditional deboning techniques, in the data 
reviewed in the 1979 health and safety report on MDP, MDP generally 
contained less protein. In addition, the 1979 report found much higher 
moisture to protein ratios in mechanically deboned poultry, indicating 
considerable dilution of poultry product, possibly by ice.
    Currently, the poultry products inspection regulations do not 
directly control the fat or protein content of poultry product 
ingredients. However, they do differentiate between ``poultry meat'' 
and ``poultry,'' i.e., chicken meat and chicken, with the latter 
encompassing edible parts such as skin and fat not in excess of their 
natural proportions in addition to poultry meat. As skin (with attached 
fatty tissue) and separable fat are the places in which most of the fat 
in poultry products is found and poultry products are composed 
essentially of fat, protein, and moisture, these definitions have 
served, to some extent, to distinguish among poultry products in terms 
of their relative fat and protein contents. Moreover, these 
differentiations in fat and protein have consequences for the use of 
poultry product ingredients, since many of the standards of identity or 
composition for finished poultry products include minimum poultry meat 
requirements (9 CFR 381.167) and others limit skin and fat to natural 
proportions (9 CFR 381.160).
    The goal FSIS is considering is to develop a regulatory approach 
that fulfills its responsibility to protect the public by maintaining 
the quality and integrity of the poultry and meat food product supply 
while continuing to permit flexibility in the composition of 
mechanically deboned poultry product, as well as in its use at various 
levels in a broad range of products. In FSIS's view, its responsibility 
to the public includes the objectives of preventing increases in the 
fat content of this portion of the food supply and preventing poultry 
product dilution that could result in the public no longer being able 
to rely on poultry products and meat food products as reasonably good 
sources of high quality dietary protein.
    FSIS is considering that MDP should have a fat content of not more 
than 25 percent and a protein content of not less than 14 percent or it 
shall be deemed to be product for processing. If these views are 
adopted, the effect of this provision would be to impose no maximum on 
the fat content or minimum on the protein content of this ingredient 
where other regulatory provisions assure that the fat content of 
finished products does not exceed appropriate limits and protect 
against decreases in their protein content by establishing finished 
product content requirements. In such a product, it is contemplated 
that MDP could be used, regardless of its fat or protein content, in 
ingredient mixtures that accord with the standard for the finished 
product.
    (6) Tentative position: Quality control. FSIS is considering that a 
quality control program is necessary to assure that establishments 
manufacture mechanically deboned poultry product that complies 
consistently with the tentative definition and standard that is being 
considered by FSIS. Utilization of such a program in producing the 
ingredient MDP would be a prerequisite for the approval of labels for 
products consisting of or containing MDP. The function of plant quality 
control is to restrict potential variability within the limits of the 
tentative requirements FSIS is considering by controlling the factors 
that can affect the resulting product's characteristics.
    FSIS expects to require that MDP be produced under an approved 
plant quality control program. Also, FSIS is considering a requirement 
that the plant quality control program provide the controls and 
information necessary to assure that MDP manufactured under such a 
program meets any requirements established and that it will enable 
establishment personnel and FSIS to monitor it for effectiveness. FSIS 
is focusing on methods that will minimize inter-lot variation by 
maintaining the uniformity of starting materials and controlling the 
handling and processing of starting materials and resulting product.
    Because it appears that this goal can be achieved effectively and 
efficiently where a program for quality control incorporates 
appropriate methods and monitoring techniques and adheres to good 
manufacturing practice, FSIS contemplates requiring that an 
establishment conduct only limited analyses for protein quality and 
fat, and for MDP represented as containing not less than 14 percent 
protein and not more than 25 percent fat, to confirm that production 
is, in fact, under control. After it has been demonstrated that the 
quality control program is able to yield complying product, 
confirmatory analyses would be required only periodically, as long as 
the product is in compliance.
    FSIS anticipates establishing basic parameters for the chemical 
analyses that must be performed to verify compliance with the 
requirements, e.g., defining production lots and sampling schedules, 
and the accepted methodology for performing analyses. FSIS wishes to 
receive comments on the parameters necessary for an adequate quality 
control program.
    B. Tentative position: Handling requirements. Current regulatory 
requirements, including provisions for sanitation, operating 
procedures, and heat processing (9 CFR part 381, subpart H and I, and 
Sec. 381.150), already provide the basic controls necessary to prevent 
spoilage and assure poultry product wholesomeness. However, because the 
mechanical deboning process presents greater opportunities for 
bacterial growth than traditional poultry product processing, FSIS is 
considering amending the poultry products inspection regulations to 
more specifically address the requirements for the various starting 
materials used for MDP and the resulting product.
    Although the data reviewed in the 1979 health and safety report 
indicate that MDP products 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 surprising as common starting materials for 
mechanical deboning 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 in MDP have been associated with the 
time and conditions of holding such starting materials.
    Mechanically deboned poultry itself also presents opportunities for 
excessive microbiological growth because it consists 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.
    FSIS believes that potential bacterial hazards are diminished as 
long as handling accords with good manufacturing practices. FSIS is, 
therefore, considering that processing and storage requirements are 
warranted for the raw materials used to make the product and for the 
product itself.
    FSIS is considering proposing handling requirements that would 
provide that material to be processed into MDP be processed 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. Within 2 hours of the mechanical deboning operation, 
FSIS is also considering proposing that MDP be chilled to 40  deg.F (4 
deg.C) or less, frozen at 0  deg.F (-18  deg.C) or less, or cooked. 
FSIS is further considering proposing that MDP be used as an ingredient 
in a poultry or meat food product directly after being processed, 
except that it may 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.
    FSIS recognizes that different starting materials will be processed 
into MDP, i.e., poultry carcasses or parts of carcasses chilled and 
maintained in accordance with 9 CFR 381.66; unchilled poultry carcasses 
or parts of carcasses; and heat-treated poultry carcasses or parts of 
carcasses, and such carcasses or parts from which a substantial portion 
of skeletal muscle or other tissue has been removed. FSIS wishes to 
receive comments on whether specific handling requirements other than 
those being considered are appropriate for specific types of starting 
materials.
    In addition, in order to avoid confusion about the parts or 
physical state of poultry that may be processed into MDP, FSIS is 
considering providing a definition of ``poultry carcasses or parts of 
carcasses.'' The terms ``poultry carcasses'' or ``parts of carcasses'' 
would apply to whole carcasses or disjointed portions of such carcasses 
that are ``ready-to-cook poultry'' within the meaning of 9 CFR 
381.1(b)(44) of the poultry products inspection regulations. In other 
words, the head, feet, crop, oil gland, trachea, esophagus, entrails, 
mature reproductive organs, and lungs of the slaughtered poultry have 
been removed and such poultry is free from protruding pinfeathers and 
vestigial feathers and suitable for cooking without need of further 
processing.
    FSIS is considering that adoption of the handling requirements 
discussed above 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. 
Thus, if the requirements FSIS is considering are adopted, FSIS would 
need to rescind 9 CFR 381.47(e).
    C. Tentative position: Limitations on use. FSIS's tentative 
position is to establish and codify limitations with respect to use of 
MDP in the formulation of poultry and meat food products. FSIS is 
contemplating imposing such restrictions based on the potential 
fluoride contribution of MDP made from fowl (i.e., mature female 
chickens) and the characteristics of MDP, including the kind of poultry 
from which it is made, its consistency, and its protein and fat 
contents. 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.
    (1) Tentative position: Kind of product limitation. FSIS is 
considering that when a poultry product is required to be prepared from 
a particular kind or kinds of poultry (e.g., chickens), use of MDP of 
any other kind (e.g., mechanically deboned turkey) should not be 
permitted. This provision would assure that MDP 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 tentative definition and standard for MDP that FSIS is 
considering covers MDP prepared from any kind of poultry. FSIS is not 
considering, however, to permit use of MDP 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 interpretations 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 in considering to amend the 
poultry products inspection regulations to provide for the use of MDP 
as a distinctive poultry product ingredient, this consideration should 
not abrogate this type of requirement (e.g., to permit use of 
mechanically deboned chicken in turkey patties).
    (2) Tentative position: Limitations on product made from fowl. FSIS 
is considering that the use of mechanically deboned chicken made, in 
whole or part, from fowl (i.e., mature female chickens, as defined in 9 
CFR 381.170(a)(1)(vi)) should not be permitted in baby, junior, or 
toddler foods. Also, FSIS is considering that it should not be 
permitted in combination with MS(S) to constitute more than 20 percent 
of the livestock and poultry product portion of any other poultry 
product or meat food product. 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 MDP made from poultry other 
than fowl and that of poultry products produced by traditional deboning 
techniques, but considerably higher amounts in MDP made from fowl.
    FSIS believes that, in addition to prohibiting use of MDP made from 
fowl in baby (i.e., strained), junior, and toddler foods, MDP also 
should be limited in other foods, because infants also consume table 
foods, with most eating adult-type foods by age 2. This would limit the 
potential fluoride contribution to dietary intakes of other young 
children in high fluoride areas. FSIS believes that MDP made from fowl 
should be limited to a maximum of 20 percent of the livestock and 
poultry product portion of any poultry or meat food product.
    (3) Tentative position: Poultry product limitations. FSIS is 
considering that the use of MDP should be limited in certain poultry 
products. FSIS is considering allowing MDP in the sauce portion or any 
dressing of poultry products and is soliciting comments on this use. 
FSIS is also soliciting comments on whether MDP should be allowed in 
poultry products for which there are standards of identity or 
composition (e.g., Boned (Kind)--Solid Pack, Boned (Kind) with Natural 
Juices, Shredded (Kind), (Kind) burgers, (Kind) A La Kiev and (Kind) 
Steak or Fillet).
    MDP is a finely comminuted ingredient 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 chicken burgers, or shredded 
chicken. FSIS also considers its 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 an la Kiev, and turkey ham. FSIS recognizes, 
however, that these types of products sometimes are prepared with 
components the characteristics of which are not inconsistent with those 
of MDP.
    It is poultry meat--particular muscle(s)--that characterize 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 deboning of accompanying bones. MDP does not, in 
FSIS's 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 of the 
poultry carcass, whether the muscle from that part is essentially 
intact or has been processed only to the extent of cutting or grinding, 
to include this finely comminuted ingredient.
    The same preparation procedures used in making a turkey ham product 
can be applied to other cuts, such as turkey breast, for which 
definitions and standards have not been prescribed in subpart P of part 
381 of the poultry products inspection regulations (9 CFR part 381, 
subpart P). Cured turkey breast and turkey ham products have in common 
their method of preparation and their association with a particular cut 
of poultry. They differ only in the cut of poultry product used. As 
this difference is not relevant to whether inclusion of MDP would be 
appropriate, FSIS believes that use of MDP should not be permitted in 
these products nor in products that are similar.
    FSIS is interested in receiving comments on its views as to the 
products in which use of MDP or its use in anything but sauces and 
dressings should be prohibited as inconsistent with their basic 
characteristics, including data and other information on the effects of 
using MDP on the characteristics and quality of specific products. 
Persons who support allowing use of MDP in any of the poultry products 
covered in the above discussion should be aware that FSIS is interested 
in their views.
    (4) Tentative position: Limitations on product ``for processing.'' 
FSIS is considering that, in addition to complying with any applicable 
limitations discussed with regard to the requirements of the 
definitions and standards of identity or composition for particular 
poultry products and meat food products (9 CFR parts 319 and 381, 
subpart P thereto), use of MDP ``for processing,'' i.e., MDP that has a 
protein content of less than 14 percent and/or a fat content of more 
than 25 percent, not be permitted in the formulation of a poultry 
product or meat food product at levels above 2 or 3 percent because of 
the effect on finished product quality. FSIS is requesting comments 
regarding this approach and possible conditions for exceptions, e.g., 
when poultry and meat food products are subject to a regulatory 
definition and standard which establishes a minimum requirement for 
protein content and a maximum limit on fat content which ensure 
finished product quality.
    FSIS also recognizes that MDP ``for processing'' may be used at 
very low levels (2 or 3 percent) as a binder--i.e., for a technological 
or functional purpose. FSIS is particularly interested in receiving 
comments on whether such product should be permitted for this purpose 
and, if so, in what products and under what conditions. For example, 
would it be adequate and appropriate to permit this type of use so long 
as it is limited to the 3 percent level in formulating processed 
product?
    D. Tentative position: Labeling. FSIS expects to include special 
provisions for the labels of MDP and products in which it is used as an 
ingredient. If adopted, these provisions would supplement other, more 
general requirements for such labels (see 9 CFR parts 317 and 381, 
subpart N).
    (1) Tentative position: The product. FSIS is considering the 
following possible labeling provisions for MDP: (a) The name of the 
product (e.g., ``Mechanically Separated (Kind),'' must be followed 
immediately by the phrase(s) ``for processing'' unless it has a protein 
content of not less than 14 percent and a fat content of not more than 
25 percent, ``made from fowl'' unless it is not made, in whole or part, 
from mature female chickens (see 9 CFR 381.170(a)(1)(vi)), 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 (see 9 CFR 381.117(d)); (b) after any such required 
information, the name of the product may be followed by ``without 
skin'' and/or ``without kidneys and sex glands'' if it is made from 
poultry product that does not include skin and/or that does not include 
kidneys or sex glands; and (c) there must be appropriate descriptive 
terminology if heat treatment has been used in the preparation of such 
product. Because the characteristics specified are ones which would 
affect use of MDP, FSIS is considering that, in order to assure 
compliance with regulatory requirements and thereby prevent the 
adulteration and misbranding of finished poultry products and meat food 
products, it is necessary to provide for their clear identification on 
the label when MDP leaves the establishment at which it is manufactured 
(see 9 CFR 381.115).
    As indicated previously, the regulations already require that 
information bearing on use--including deviations from the natural whole 
carcass proportion of skin as well as the fact of cooking--appear on 
the label of mechanically separated poultry product (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 MDP 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 and product for 
processing.
    (2) Tentative position: Finished poultry products and meat food 
products. As indicated above in the discussion of FSIS's tentative 
position regarding the definition and standard for MDP, FSIS is 
considering that in view of the differences between MDP and poultry 
products produced by traditional hand-deboning techniques and the 
developments since its introduction, MDP should be regulated as a 
distinctive ingredient with standardized characteristics. Therefore, it 
is FSIS's tentative position to define such product by its own name, 
e.g., ``Mechanically Separated (Kind),'' that would be declared in the 
ingredient 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 MDP to consumers who, according to the 
comments received on the June 15, 1993, ANPR, indicated a desire to 
know of the presence of calcium and cholesterol. FSIS wishes to point 
out that the effective date for its mandatory nutrition labeling 
regulations (9 CFR 317.309, 381.409) is July 6, 1994. These rules 
require mandatory declaration of calcium and cholesterol content on 
most processed meat and poultry products which will address this 
particular labeling concern. FSIS believes that nutrition labeling is 
the most appropriate vehicle for conveying a product's nutrient 
content, which includes calcium, cholesterol as well as other nutrient 
information.
Tentative Position
    II. Boneless poultry products produced by mechanical deboning with 
0.6 percent or less bone solids. FSIS is considering amending its 
current boneless poultry regulations to allow boneless poultry products 
produced by mechanical deboning with 0.6 percent or less bone solids to 
be classified as poultry or poultry meat if produced under the 
provisions of a quality control program that would require compliance 
with certain criteria for this product, e.g., protein quality, bone 
solids (calcium), and bone particle size. FSIS is also considering 
having handling requirements and limitations on use of boneless poultry 
products with 0.6 percent or less bone solids in certain products. 
Further, FSIS is considering that protein and fat content requirements 
would not be necessary, for such products, because protein and fat are 
nutrients whose declaration becomes mandatory on the labeling of most 
multi-ingredient meat and poultry products when FSIS's nutrition 
labeling regulations become effective on July 6, 1994.
    A. Tentative position: Product name and labeling. FSIS is 
contemplating amending the labeling regulations on boneless poultry 
products to change the allowable bone content for products currently 
labeled as poultry or poultry meat. The mechanical deboning machinery 
used to produce boneless poultry products has undergone significant 
changes since 1969. Over the years, there have been continued 
refinements in certain parameters, e.g., the ability to adjust the 
pressure and aperture size, resulting in far less than current 
allowance of no more than one percent bone solids for mechanically 
deboned poultry. According to an August 1993 study done by FSIS\7\ 
regarding bone content of boneless poultry products produced by 
mechanical deboning, the average bone solids content was approximately 
0.6 percent. The changes in mechanical deboning machinery have resulted 
in improved manufacturing processes. We believe it results in products 
which are comparable to ``poultry'' and ``poultry meat'' derived from 
hand-deboning.
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    \7\A summary report of the study is available for public 
inspection at the FSIS Hearing Clerk's office.
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    FSIS is considering provisions that will enable boneless poultry 
products with 0.6 percent or less bone solids to be classified as 
poultry or poultry meat and labeled accordingly. It is FSIS's tentative 
view that these products need not be labeled to describe their form 
(i.e., consistency) by terms such as ``emulsified'' and ``finely 
chopped.'' FSIS believes that the form of the product may not be 
important because these products are primarily used as ingredients in 
poultry and meat products, such as poultry sausages, which are 
themselves categorized as finished products that are ``emulsified,'' 
``finely chopped,'' etc., in terms of texture. Therefore, FSIS wishes 
to receive comments on whether there is a need to include the term used 
to describe the form of the boneless poultry products with 0.6 percent 
or less bone solids, e.g., ``emulsified,'' ``finely ground,'' etc., in 
the ingredients statement of the product in which such product is used 
as an ingredient and whether these terms are important to the consumer.
    (1) Tentative position: Bone solids content. FSIS is considering 
having the bone solids content of boneless poultry product with 0.6 
percent or less bone solids be measured by calcium analysis with a 
maximum calcium content of not more than 0.147 percent in product made 
from turkeys or mature chickens or 0.111 percent in product made from 
other poultry. Both of these levels account for the fact that poultry 
tissues, other than bone, contain some calcium and that turkeys and 
mature chickens contain more calcium naturally than other poultry.
    FSIS is considering, as discussed below, that production of 
boneless poultry products with 0.6 percent or less bone solids under an 
approved quality control program is necessary to assure consistent 
compliance with regulatory requirements, including the calcium content 
requirement utilized in restricting bone solids content.
    The inclusion of these calcium content levels 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 considers that, even assuming all further processed 
poultry were comprised of boneless poultry with 0.6 percent or less 
bone solids, the projected calcium contribution of such product 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. For the new boneless poultry products with 0.6 
percent or less bone solids, the calcium level would be significantly 
lower than mechanically deboned poultry.
    (2) Tentative position: Bone particle size. FSIS is considering 
that the size of the bone particles in boneless poultry products with 
0.6 percent or less bone solids should be restricted to a maximum of 
less than 1.5 millimeter (mm) in the greatest dimension, but permitting 
up to 5 bone particles per 50 grams of boneless poultry products with 
0.6 percent or less bone solids to be from 1.5 mm to less than 2.0 mm 
in the greatest dimension.
    FSIS's objective is that the limitation imposed be adequate to 
prevent any digestibility problems while not restricting the operation 
of equipment in accordance with the improved good manufacturing 
practices more than is necessary for this purpose or to protect 
finished product quality. Bone particle size should be controlled to 
ensure that equipment type or processing does not result in 
unacceptably large fragments and, provided this is done, the bone 
particles in the product will not present any health hazard because of 
size or hardness.
    FSIS is considering that it is appropriate to permit up to 5 
particles per 50 grams of product to be from 1.5 mm to less than 2.0 mm 
as an acceptable defect in complying product. FSIS is requesting 
comments and information on the extent to which manufacturers should be 
required to control the production of boneless poultry products 
produced by mechanical deboning that have 0.6 percent or less bone 
solids to limit the size of bone particles. FSIS will consider any 
information submitted during the comment period on the size and 
distribution of bone particles that may occur with various mechanical 
deboning procedures conducted in accordance with improved good 
manufacturing practices (e.g., the extent to which deviations or 
nonconforming particles occur, and data substantiating the absence of 
potential health or finished product quality problems with such 
particles).
    (3) FSIS tentative: Protein quality. FSIS is considering proposing 
to require that boneless poultry products with 0.6 percent or less bone 
solids meet a minimum protein quality requirement--a protein 
digestibility-corrected amino acid score of not less than 40 expressed 
as a percent and to accept as evidence of compliance with this 
requirement an alternative measurement--the content of 7 essential 
amino acids being at least 33 percent of the total of 17 amino acids 
present. Protein quality is a measure of the content, proportion, and 
availability of essential amino acids in food protein and a measure of 
the ability of the food protein to support human growth and body 
protein maintenance.
    When the regulations on MS(S) were published in 1982 (47 FR 28214), 
one of the methods specified for measuring protein quality was the 
Protein Efficiency Ratio (PER) procedure. The PER method measures the 
ability of a protein source to support growth in young growing rats, 
and is an expensive and time-consuming assay. FSIS adopted a newer 
method for measuring protein quality, in order to assure the value of 
the protein contributed by meat and poultry to human dietary needs, in 
its final regulations on nutrition labeling of meat and poultry 
products published in the Federal Register on January 6, 1993 (58 FR 
632). The newer procedure, termed the protein digestibility-corrected 
amino acid score method, is contained in ``Protein Quality Evaluation, 
Report of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' Rome, 1990 (PDCAAS method).\8\ The protein digestibility-
corrected amino acid score method is based on human amino acid 
requirements and, therefore, is more appropriate for evaluating the 
protein quality of foods for human consumption than the PER which is 
based on amino acid requirements of rats. The protein digestibility-
corrected amino acid score method measures the ability of amino acids 
in food proteins to meet the dietary protein needs of humans.
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    \8\A copy of the document is available for public inspection in 
the FSIS Hearing Clerk's office.
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    FSIS is considering proposing a requirement that the protein in 
boneless poultry products with 0.6 percent or less bone solids have a 
protein quality value that is a protein digestibility-corrected amino 
acid score of not less than 40 expressed as a percent. This value is 
consistent with nutrition labeling requirements for protein in foods 
for children older than one but less than four years of age, as 
provided in 21 CFR 101.9(c)(7), which is cross-referenced in its final 
nutrition regulations (58 CFR 632) in 9 CFR 317.309(b). FSIS believes 
this value protects the young consumer from inadequate nutrition and 
from the use of poor quality protein (i.e., protein that does not meet 
the dietary needs for growth), and in turn, protects people other than 
young consumers. FSIS is also considering that it is appropriate to 
assure comparability of boneless poultry products with 0.6 percent or 
less bone solids with poultry that is derived by hand-deboning in terms 
of the protein contributed to human dietary needs to maintain the 
quality and integrity of the poultry products supply.
    FSIS is proposing to permit an alternative measurement to the 
protein digestibility-corrected amino acid score method, which requires 
a digestibility measurement in addition to an amino acid analysis, to 
control the cost of monitoring compliance with the protein quality 
requirement. FSIS is considering proposing that, for the purpose of 
measuring the protein quality of boneless poultry with 0.6 or less bone 
solids, an alternative measurement of protein quality would be allowed 
that is comparable to the protein digestibility-corrected amino acid 
score. This measure would be based on a comparison between the 
``essential amino acid content of boneless poultry'' and ``total amino 
acids present in boneless poultry.'' Essential amino acid content 
includes isoleucine, leucine, lysine, methionine, phenylalanine, 
threonine, and valine content, and the total amino acids present 
including isoleucine, leucine, lysine, methionine, phenylalanine, 
threonine, valine, tyrosine, arginine, histidine, alanine, aspartic 
acid, glutamic acid, glycine, proline, serine, and hydroxyproline 
content. It is being considered that the essential amino acid content 
would be determined by methods given in the ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation.''
    FSIS believes that boneless poultry with 0.6 percent or less bone 
solids found to be in compliance by the proposed amino acid content 
measurement would have protein of high quality. This belief is 
supported by the 1982-83 evaluation of an Expert Work Group that was 
organized by the Department's Agricultural Research Service, in 
cooperation with the University of Maryland, to develop recommendations 
based on available scientific knowledge for consideration in policy 
decisions regarding the protein quality of meat, poultry, and their 
products.\9\
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    \9\``The Protein Nutritional Quality of Meat and Poultry 
Products: Scientific Basis for Regulation'' is the final report of 
the expert Working group, with accompanying background papers. C.E. 
Bodwell, ed., American Journal of Clinical Nutrition, 40(3): 671-
742, supplement, September 1984. A copy of the report is available 
for public inspection in the FSIS Hearing Clerk's office.
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    The public should be aware that FSIS continues to have interest in 
investigations of protein quality which include among their objectives 
the identification of improved methods for determining protein quality. 
In evaluating the possible use of alternative approaches to assuring 
protein quality, FSIS will consider data and other comments submitted 
by the public.
    (4) FSIS tentative position: Protein and fat contents. FSIS is 
considering whether there is a need to establish minimum protein and/or 
maximum fat content(s) for boneless poultry products with 0.6 percent 
or less bone solids. FSIS has concluded that such action is not 
necessary because protein and fat are nutrients whose declaration 
becomes mandatory on the labeling of most multi-ingredient meat and 
poultry products upon the effective date of the nutrition labeling 
regulations (58 FR 632). These regulations also establish a voluntary 
nutrition labeling program for single-ingredient, raw products, and 
specify that FSIS will evaluate significant participation of the 
voluntary program. If significant participation is not found, FSIS 
shall initiate rulemaking to require nutrition labeling on those 
products under the voluntary program. Therefore, with certain 
exceptions, consumers will have complete information about the 
nutrients in poultry products.
    FSIS recognizes that not all products sold to consumers at the 
retail level will carry nutrition labeling. FSIS's final regulation on 
nutrition labeling provided for certain exceptions including products 
produced by small businesses and products in small packages of less 
than \1/2\ ounce net weight, provided that the labels for these 
products bear no nutrition claims or nutrition information. However, 
labeling will be required on most processed products purchased by 
consumers in retail stores so that, together with the voluntary program 
for retail store information on single-ingredient raw products, 
consumers will have information on protein and fat for most products 
purchased for consumption at home. Based on these considerations, FSIS 
maintains that there is no need to establish minimum protein and/or 
maximum fat contents for boneless poultry products produced by 
mechanical deboning with 0.6 percent or less bone solids.
    (5) Tentative position: Quality control. FSIS believes that a 
quality control program is necessary to assure that establishments that 
manufacture boneless poultry products with 0.6 percent or less bone 
solids comply consistently with the criteria being considered. 
Utilization of such a quality control program in producing the boneless 
poultry products with 0.6 percent or less bone solids would be a 
prerequisite for the approval of labels for products consisting of or 
containing boneless poultry. The function of a quality control program 
is to restrict potential variability within the limits of FSIS's 
tentative requirements by controlling the factors that can affect the 
resulting product's characteristics.
    FSIS expects to require that boneless poultry products with 0.6 
percent or less bone solids be produced under an approved quality 
control program. Also, FSIS expects to require that the quality control 
program provide the controls and information necessary to assure 
boneless poultry with 0.6 percent or less bone solids will meet each of 
the requirements under consideration and will enable establishment 
personnel and FSIS to monitor it for effectiveness. FSIS is focusing on 
methods that will minimize inter-lot variation by maintaining the 
uniformity of starting materials and controlling the handling and 
processing of starting materials and resulting product.
    Because it appears that this goal can be achieved effectively and 
efficiently where a program for quality control incorporates 
appropriate methods and monitoring techniques and adheres to good 
manufacturing practices, FSIS plans to require that an establishment 
conduct only limited analyses for calcium, protein quality, and bone 
particles for boneless poultry products with 0.6 percent or less bone 
solids to confirm that production is, in fact, under control. After it 
has been demonstrated that the quality control program is able to yield 
complying product, confirmatory analyses would be required only 
periodically, as long as the product is in compliance.
    FSIS anticipates establishing basic parameters for the chemical 
analyses that must be performed to verify compliance with the 
requirements, e.g., defining production lots and sampling schedules, 
and the accepted methodology for performing analyses. FSIS wishes to 
receive comments on the parameters necessary for an adequate quality 
control program.
    B. Tentative position: Handling requirements. Current regulatory 
requirements, including provisions for sanitation, operating 
procedures, and heat processing (9 CFR part 381, subpart H and I, and 
Sec. 381.150), already provide the basic controls necessary to prevent 
spoilage and assure poultry product wholesomeness. However, because the 
mechanical deboning process presents greater opportunities for 
bacterial growth than traditional poultry product processing, FSIS is 
considering amending the poultry products inspection regulations to 
more specifically address the requirements for the various starting 
materials used to manufacture boneless poultry products produced by 
mechanical deboning with 0.6 percent or less bone solids and the 
resulting boneless poultry product.
    FSIS believes that potential bacterial hazards are diminished as 
long as handling accords with good manufacturing practices. FSIS is, 
therefore, considering that processing and storage requirements are 
warranted for the raw materials used to make the product and for the 
product itself.
    FSIS is considering proposing handling requirements that would 
provide that material to be processed into boneless poultry products 
produced by mechanical deboning with 0.6 percent or less bone solids be 
processed 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 a 0  deg.F (-18  deg.C) or less. Within 2 hours of 
the mechanical deboning operation, FSIS is also considering proposing 
that boneless poultry with 0.6 percent or less bone solids be chilled 
to 40  deg.F (4  deg.C) or less, frozen to 0  deg.F (-18  deg.C) or 
less, or cooked. FSIS is further considering proposing that boneless 
poultry with 0.6 percent or less bone solids be used as an ingredient 
in a poultry or meat food product directly after being processed, 
except that it may 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.
    FSIS wishes to receive comments on whether specific handling 
requirements other than those being considered are appropriate for 
specific types of starting materials. In addition, in order to avoid 
confusion about the parts or physical state of poultry that may be 
processed into boneless poultry with 0.6 percent or less bone solids, 
FSIS intends to provide a definition of ``poultry carcasses or parts of 
carcasses.'' The terms ``poultry carcasses'' or ``parts of carcasses'' 
would apply to whole carcasses or disjointed portions of such carcasses 
that are ``ready-to-cook poultry'' within the meaning of 9 CFR 
381.1(b)(44) of the poultry products inspection regulations. In other 
words, the head, feet, crop, oil gland, trachea, esophagus, entrails, 
mature reproductive organs, and lungs of the slaughtered poultry have 
been removed and such poultry is free from protruding pinfeathers and 
vestigial feathers and suitable for cooking without need of further 
processing.
    FSIS is considering that adoption of the handling requirements 
discussed above 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. Thus, if the requirements FSIS is considering are adopted, FSIS 
would need to rescind 9 CFR 381.47(e).
    C. Tentative position: Limitations on Use. At a level of 0.6 
percent or less bone solids content there is no need for consumer 
concern regarding potential fluoride contribution of mechanically 
separated product made from fowl (i.e., mature female chickens).
    (1) Tentative position: Kind of product limitation. FSIS's 
tentative position on amending the poultry products produced by 
mechanical deboning with 0.6 percent or less bone solids covers such 
product prepared from any kind of poultry. It is not, however, FSIS's 
intention to permit use of boneless poultry products with 0.6 percent 
or less bone solids 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 
interpretations and could, among other things, result in false or 
misleading labeling.
    FSIS intends to provide that when a poultry product is required to 
be prepared from a particular kind of kinds of poultry (e.g., 
chickens), use of boneless poultry products with 0.6 percent or less 
bone solids of any other kind (e.g., poultry product made from turkey) 
should not be permitted. This provision would assure that boneless 
poultry product 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.
    (2) Tentative position: Limitation on product made from fowl. In 
the past, the Agency has had a policy of discouraging the use of MDP 
containing 1.0 percent or less bone solids content for use in baby, 
junior, and toddler foods because of concern for higher levels of 
fluoride present in the bones of mature poultry. However, FSIS believes 
that at the low level of 0.6 percent or less bone solids content there 
would be no reason to place a restriction on boneless poultry products 
with 0.6 percent or less bone solids for use in baby, junior, and 
toddler foods based on the potential fluoride contribution of product 
made from fowl to dietary intakes. Furthermore, there is research to 
indicate a very poor absorption of fluorine from bone particles coupled 
with a large body of research indicating beneficial effects of fluoride 
at lower levels. With the restriction of 0.6 percent or less bone 
solids content, levels of fluoride present would not present a health 
and safety concern.
    FSIS anticipates permitting the use of boneless poultry products 
with 0.6 percent or less bone solids made, in whole or part, from fowl 
(mature female chickens, as defined in 9 CFR 381.170(a)(1)(vi)) in 
baby, junior, or toddler foods. The Agency is interested in receiving 
comments and supporting scientific documentation if there are valid, 
scientific findings contradicting this view.
    (3) Tentative position: Poultry product limitations. Because 
boneless poultry products with 0.6 percent or less bone solids is 
comminuted, i.e., finely ground, in form, FSIS is considering 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 chicken burgers or shredded 
chicken. FSIS also considers its 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 interested 
in receiving comments on its views as to the products in which use of 
boneless poultry product produced by mechanical deboning with 0.6 
percent or less bone solids or its use in anything but sauces and 
dressings should be prohibited as inconsistent with their basic 
characteristics.
    FSIS's tentative position on limitations of use is intended to 
provide a mechanism for assuring that boneless poultry products with 
0.6 percent or less bone solids is not an ingredient in products 
marketed as classes or cuts of raw poultry which have undergone 
additional preparation such as boning and/or cooking where regulatory 
standards currently do not address their poultry or poultry meat 
content (e.g., boneless turkey breasts), as well as where they do.
    FSIS does not anticipate adopting any restrictions on the amount of 
boneless poultry products with 0.6 percent or less bone solids that can 
be used in poultry products, or meat food products, in which it is a 
permitted ingredient. However, 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 way in which 
various poultry product ingredients may be used.
    (4) Tentative position: Finished poultry products and meat food 
products. As indicated previously, FSIS is considering proposing that 
boneless poultry product with 0.6 percent or less bone solids should be 
classified as ``poultry'' or ``poultry meat'' and that it should be 
described accordingly. Although boneless poultry product with 0.6 
percent or less bone solids is finely ground in form, it is expected 
that this product would be used as an ingredient in products which are, 
themselves, categorized as finely ground in texture, e.g., frankfurters 
and bologna. Therefore, FSIS is considering that when boneless poultry 
product with 0.6 percent or less bone solids is used as ingredient in a 
poultry or meat product, it should be declared by terms that accurately 
describe it as a poultry or poultry meat product, e.g., ``chicken'' and 
``turkey meat.''
    FSIS's tentative position is not to require special declaration of 
calcium and/or cholesterol content on labeling of a poultry or meat 
food product containing boneless poultry products with 0.6 percent or 
less bone solids because calcium and cholesterol declaration becomes 
necessary on the labeling of most multi-ingredient poultry and meat 
products upon the effective date of FSIS's nutrition labeling 
regulations (58 FR 632).
    FSIS's tentative labeling provisions reflect FSIS's belief that 
nutrition labeling is the most appropriate place for calcium and 
cholesterol content information by requiring that the declaration of 
calcium and/or cholesterol content appear as part of any nutrition 
labeling that a poultry product or meat food product bears.

    Authority: 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.

    Done at Washington, DC on: February 25, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-4892 Filed 3-2-94; 8:45 am]
BILLING CODE 3410-DM-M