[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.
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\3\Document is available for public inspection at the FSIS
Hearing Clerk's office.
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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.
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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\
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\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