Poultry Products Produced by Mechanical Separation and Products In Which Such Poultry Products Are Used

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

Federal poultry products inspection regulations to prescribe: a

definition and standard of identity and composition for the poultry

product that results from the mechanical separation and removal of most

of the bone from skeletal muscle and other tissues of poultry carcasses

and parts of carcasses (``Mechanically Separated (Kind of Poultry)''--

hereafter referred to generically as ``Mechanically Separated Poultry''

(``MSP'')), including requirements for bone solids content (measured as

calcium content) and bone particle size; certain limitations for the

use of MSP; and labeling requirements for MSP, and for poultry products

and meat food products containing MSP as an ingredient. This action

establishes the requirement that products containing MSP as an

ingredient disclose that fact by identifying it in the ingredients

declaration as, in the case of MSP derived from chicken carcasses,

``mechanically separated chicken,'' rather than ``chicken.'' This

action will help ensure that meat and poultry products distributed to

consumers are not labeled in a false or misleading manner and are not

misbranded.

EFFECTIVE DATE: November 4, 1996.

FOR FURTHER INFORMATION CONTACT: John W. McCutcheon, Deputy

Administrator, Regulatory Programs, Food Safety and Inspection Service,

U.S. Department of Agriculture, Washington, DC 20250, Area Code (202)

720-2709.

SUPPLEMENTARY INFORMATION:

Purpose of the Final Rule

This final rule amends the regulatory requirements for the poultry

product with a paste-like form and batter-like consistency that results

from the mechanical separation and removal of most of the bone from

attached skeletal muscle and other edible tissues of poultry carcasses

and parts of carcasses, and for the finished poultry products and meat

food products in which this product is used as an ingredient. FSIS

first conducted a rulemaking regarding this product in 1969. Over the

years, the amount of such product being manufactured, and the number

and range of poultry products and meat food products in which it is

used as an ingredient, has increased significantly.

FSIS has gained a great deal of knowledge from its rulemakings

regarding the livestock product resulting from a similar mechanical

separation and removal process which is called ``mechanically separated

beef'' or ``mechanically separated pork'' (or any other species derived

from livestock, such as beef, and lamb), which will be referred to

generically in this document as mechanically separated meat (MSM). MSM

is a livestock product with a paste-like form and batter-like

consistency that results from the mechanical separation and removal of

most of the bone from attached skeletal muscle of livestock carcasses

and parts of carcasses that meets the provisions of 9 CFR 319.5. MSM is

subject to regulatory requirements which include a standard of identity

and composition that defines this product, limits for bone solids

content and bone particle size, and a name that differentiates it from

meat. It is also required to be separately identified in the

ingredients statement of products in which it is used, and is subject

to certain restrictions in its use.

More recently, in a lawsuit, Bob Evans Farms, Inc. et al., v. Mike

Espy, Secretary of Agriculture (D.D.C. Civil Action No. 93-0104),

several red meat sausage manufacturers alleged that, without a

regulatory definition and standard for poultry products produced by

mechanical separation, a disparate situation exists between labeling

MSP, and MSM for which a regulatory definition and standard exist. The

red meat sausage manufacturers have alleged that the disparate labeling

situation poses an unfair advantage for the manufacturers of

mechanically separated poultry products.

In view of these developments, and taking into account the

information and experience acquired since 1969 and current regulatory

policies, the Agency has reviewed and reevaluated the existing

regulations for MSP, particularly in regard to labeling issues about

this product. As a result of its review and reevaluation, the Agency

has concluded that regulatory action to more clearly identify MSP on

product labels, is necessary to prevent the preparation and

distribution in commerce of poultry products and meat food products

which are misbranded or not properly marked, labeled, or packaged. See

sections 4(h) and 8 of the Poultry Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) and sections 1(n) and 7 of the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et seq.); 21 U.S.C. 453(h), 457

and 601(n), 607. The primary reasons for this action are as follows:

(1) The method of deriving poultry products by the mechanical

separation process results in a product whose physical form and texture

differ materially from those of other boneless poultry products

produced by hand deboning techniques, i.e., hand-held knives.

The process of manufacturing MSP begins with starting materials

that include backs, and whole and half carcasses and parts of carcasses

from which most of the muscle and other tissues have been removed by

hand, leaving bits and pieces of tissue adhering to skeletal frames and

carcass ``shells.'' These starting materials may be raw or cooked, may

contain varying amounts of muscle and/or skin (with or without attached

fat), and may contain kidneys, except when product is made from mature

chickens or turkeys. (Kidneys of mature chickens or turkeys may not be

used as human food according to 9 CFR 381.65(d)). The nature of these

starting materials is such that the muscle and other tissue that

remains on the bones cannot be efficiently or effectively removed using

hand-deboning techniques. This is because (1) the bony structure of the

materials limits the accessibility of knives and obstructs precise hand

removal of edible tissue, (2) hand-removal of the tissues is too time

consuming to make it practical, and (3) the physical movements

necessary to remove the bits and pieces of tissues adhering to bones

have been associated with cumulative trauma disorders (also referred to

as repetitive motion disorders), e.g., Carpal Tunnel Syndrome.

Mechanical separation of the bits and pieces of muscle and other

tissues from the bones to which they are adhering is, however, easily

accomplished using mechanical deboning machines.

Typically, the starting materials have undergone an initial bone

breaking process to enable the machines to operate efficiently. The

starting materials are fed into a mechanical deboning (i.e.,

separation) machine which operates on the differing resistance of bone

and tissue to passage through small holes (i.e., apertures), whether it

employs sieves, screens, or other devices. The starting materials are

pushed under high pressure through the part of the equipment with

apertures. Most of the bone is separated and

[[Page 55963]]

removed. However, the apertures allow a small amount of powdered bone

to pass through with the edible tissues, which, under the high pressure

applied by the machine, become a homogeneous soft tissue mass. The

minute amount of powdered bone (particles much smaller than the size of

pepper and limited to no more than one percent) is also dispersed

throughout the soft tissue mass. The remaining bony residue that has

been separated from the paste-like muscle and other tissues exits from

a separate place on the equipment. Thus, such machines mechanically

separate and remove most of the bone from the starting materials,

resulting in a product with a paste-like form which is comparable in

consistency to a cake batter. The process of manufacturing mechanically

separated poultry results in a product whose form and texture differ

materially from those of other boneless poultry products produced by

traditional hand-deboning. Despite these differences, current FSIS

regulations do not distinguish between poultry products produced by

mechanical separation and poultry products produced by traditional

deboning techniques, i.e., hand-deboning, in terms of product identity

and composition or use. Both are declared on product labels as

``chicken,'' ``turkey,'' or the names of other kinds of poultry.

(2) Mechanically separated poultry is produced by essentially the

same technology and has characteristics (i.e., physical form and

textural consistency) similar to those of the livestock product, MSM,

which is required to be declared on labels as mechanically separated

beef (or pork or other species of livestock).

(3) The mechanical process from which mechanically separated

poultry is derived makes its form and consistency materially different

from that of poultry derived by traditional hand-deboning methods, yet

it is not currently identified in the ingredients statement of a

product in which it is used by a name that distinguishes it from

traditionally deboned poultry. Mechanically separated poultry should be

declared in the ingredients statements of the products in which it is

used by the distinctive term ``mechanically separated (kind of

poultry),'' e.g., ``mechanically separated turkey,'' ``mechanically

separated chicken.''

The product resulting from mechanical separation has certain

textural attributes that are different than hand-deboned poultry, even

if the hand-deboned poultry is further processed through a grinder to

result in ground poultry. The product that directly results from the

mechanical process is paste-like in form and similar to a cake batter

in consistency, and is not the same as chicken or turkey removed from

carcasses or parts of carcasses by hand. Chicken or turkey that results

from hand-deboning is easily recognized as muscle, skin, and other

edible tissues and parts because it retains its natural physical form

and consistency; it has not been subjected to the rigors of crushing

bones and separating bone from muscle and other tissue under high

pressure in separation machinery. The rigors of the mechanical

separation process alter the structure of the muscle fibers, skin, fat,

and other tissues that adhere to the skeletal frames, shells, and other

starting materials so that they become blended and amorphous, and are

no longer recognizable as ``chicken'' and ``turkey.'' These machines

are not available to consumers and, therefore, consumers are not likely

to have the expectation of the resulting batter-like material as

``chicken'' or ``turkey.'' Thus, a separate identity is necessary for

the product that results.

The term ``mechanically separated'' is recognized internationally

by the Codex Alimentarius Commission1 of the United Nations and by

individual countries that trade with the United States, has been upheld

in Court decisions as being appropriate to distinguish the livestock

product derived by mechanical separation machinery2, and

appropriately distinguishes the product from hand-deboned poultry as

one that is derived by a strictly mechanical means. As such, similar

terminology should be applied to poultry products resulting from the

process of mechanical separation and recovery of crushed bone from

muscle and other edible tissues that results in a product with a paste-

like form and cake batter-like consistency.

\1\ Food and Agriculture Organization of the United Nations,

World Health Organization, Codex Alimentarius Commission, Joint FAO/

WHO Food Standards Programme, Codex Alimentarius Commission, Volume

10, Code of Practice for Mechanically Separated Meat and Poultry,

pp. 71-72 (1994) is available for review in the FSIS Docket Clerk's

office.

\2\A copy of the Courts' decisions in Community Nutrition

Institute (CNI) et al. v. Block, No. 82-2009 (D.D.C. Dec. 1, 1982),

aff'd 749 F.2nd 50 (D.C. Cir 1984) is available at the FSIS Docket

Clerk's office for review.

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Therefore, FSIS is amending the poultry products inspection

regulations (9 CFR Part 381) to revise and supplement the requirements

for the manufacture, characteristics, and labeling of poultry products

produced by mechanical separation and the labeling of products in which

they are used as ingredients that result in a product with a paste-like

form and cake batter-like consistency. Under this final rule,

mechanically separated product derived from chicken or turkey would be

labeled as ``mechanically separated chicken,'' or ``mechanically

separated turkey,'' as the case may be, and would be separately

identified by this name in the ingredients statement of products in

which it is used.

The Purpose of An Extended Effective Date

Various commenters suggested that industry should be given a

sufficient amount of time to use most of their already printed labels,

before the final rule's new labeling requirements must be carried out.

FSIS agrees that such a time period should be granted in regard to all

of the new requirements of the final rule. Therefore, an effective date

of one year from the date of publication has been provided for in this

final rule. This time period is intended to allow ample time for an

orderly transition to the new requirements, including the labeling

requirements, and to assure that manufacturers of poultry products

produced by mechanical separation, and of poultry and meat food

products in which the product is used as an ingredient, have ample time

to exhaust current label stock. In this regard, manufacturers will not

be required to dispose of label inventories that were printed or

ordered for printing prior to publication of the rule if they have made

a good faith effort to exhaust current stocks before the effective

date. Requests for use of current labels beyond the effective date will

be considered on a case-by-case basis.

Background

I. Introduction

The technology to mechanically separate and remove most of the bone

from attached skeletal muscle and other tissue of poultry carcasses and

parts of carcasses began in the late 1950's or early 1960's. The

technology is grounded in the desire of poultry manufacturers to

salvage edible, wholesome muscle and other tissue from carcasses and

parts of carcasses (such as skeletal frames and carcass shells) that

cannot be efficiently or effectively removed by hand in order to

provide a source of low-cost protein that is safe and essentially

nutritionally the same as the muscle and other tissue removed from

poultry carcasses and parts of carcasses by hand deboning methods. In

terms of functionality, mechanically separated poultry has the same

functions as hand-deboned chicken or turkey with the added

[[Page 55964]]

benefit of being able to easily form emulsions and bind to other

proteins readily. This is because the muscle and other edible tissues

no longer possess their original tissue structure and the cake-batter

consistency eases blending with other ingredients.

The Agency's initial reaction was to consider the resulting product

adulterated because of the amount of powdered bone present and the

physical size of the bone particles. By the mid-1960's, the industry

had modified and improved the equipment used to produce poultry product

by mechanical separation such that the product contained 1 percent or

less bone solids with an extremely small bone particle size. This

prompted the Agency to reevaluate its position. Widespread commercial

production of products containing mechanically separated poultry began

in the early 1970's. By 1975, poultry product produced by mechanical

separation was being used as an ingredient in poultry and meat food

products such as franks, bologna, salami, and poultry rolls.

Today, the technology for producing poultry products by mechanical

deboning is accepted as a valuable and practical means for salvaging

edible tissue from poultry parts and carcasses from which most of the

muscle and other tissues have been removed by hand. In the current

market, poultry products made with mechanically deboned poultry include

cooked poultry sausages (such as chicken frankfurters, turkey salami,

and turkey bologna), poultry patties and nuggets (such as chicken

patties and nuggets), formed and whole poultry roasts (e.g., oven-

cooked turkey breast), and poultry baby foods. The level at which it is

used has depended in part on technological capabilities. For example,

the level of use has reached 100 percent of the poultry product portion

of a number of cooked poultry sausage products (such as chicken franks)

and greater than 15 percent of the poultry product portion of whole

muscle products, e.g., cooked turkey breast, where it serves the

purpose of binding whole muscle pieces together to make the product.

Poultry product produced by mechanical means is also used at up to 49

percent of the formulations of certain meat food products, e.g., beef

and turkey chili, provided that it is identified in the product name as

``turkey'' or ``chicken,'' and used in meat food products including

cooked sausages, such as frankfurters and bologna, at a level of up to

15 percent of the total ingredients, excluding water (9 CFR 319.180)

without being identified in the product name.

Over the years, the poultry and meat food industries have also

referred to poultry products produced by mechanical means as

``comminuted (i.e., ground) poultry.'' Terminology such as ``finely

comminuted,'' ``finely ground,'' ``mechanically deboned,'' and

``mechanically separated'' have also been used to describe the product

according to 9 CFR 381.117(d). The terms ``finely ground,'' ``ground,''

``finely comminuted,'' and ``comminuted'' have been applied to poultry

produced by mechanical deboning as well as to poultry products produced

using hand-deboning methods as a means of being in accord with 9 CFR

381.117(d).

Poultry products produced by mechanical means are currently subject

to 9 CFR 381.117(d) which relates generically to boneless poultry

products. This regulation requires boneless poultry products to be

labeled in a manner that accurately describes their actual form and

composition. The product name must indicate the form of the product,

e.g., emulsified or finely chopped, and the kind name of the poultry

from which it is derived, e.g., chicken, turkey, etc.. If the product

does not consist of natural proportions of skin and fat, as they occur

in the whole poultry carcass, the product name must also include

terminology that describes the actual composition. If the product is

cooked, it must be so labeled. Section 381.117(d) also limits the bone

solids content of boneless poultry products to 1 percent.

Existing regulations do not distinguish between boneless poultry

products produced by mechanical separation and poultry products

produced by traditional methods, e.g., hand-deboning. As a matter of

practice, poultry product produced by mechanical separation is

currently declared in the ingredients statement of a product in which

it is used, along with any other boneless poultry product used, as

``chicken'' or ``turkey'' where skin and fat are included but not in

excess of their natural proportions, or as ``chicken meat'' or ``turkey

meat'' when skin with attached fat is not included.

II. Report on Health and Safety of Mechanically Deboned Poultry

In 1976, FSIS initiated an analytical program to obtain data on a

number of nutrients and substances of potential health concern in

poultry products produced by mechanical separation. Data were also

gathered from scientific literature, industry, other government

agencies, and university scientists. Details of the analytical program

and a resulting evaluation were published in a June 1979 report

entitled ``Health and Safety Aspects of the Use of Mechanically Deboned

Poultry'' (hereafter referred to as the 1979 Report). An errata

supplement correcting certain items in the report was prepared and

published on August 14, 1979 (44 FR 47576). (The 1979 Report and the

errata supplement are available for public inspection in the FSIS

Docket Clerk's office.) On June 29, 1979, the Agency announced the

availability of this report and encouraged interested members of the

public to comment on its content.

The 1979 Report evaluated the effects on health and safety of use

of mechanically separated poultry and, in particular, examined the

heavy metal, trace element, bone particle, chlorinated hydrocarbon,

cholesterol, fat, essential amino acid, total protein, and purine

contents of MSP, as well its microbiology. The 1979 Report recommended

that (1) potential health risks associated with cadmium in kidneys from

mature chickens would be avoided by not allowing kidneys from mature

chickens in MSP, (2) potential risks to children associated with

fluoride in MSP from fowl could be avoided by not allowing MSP from

fowl in baby foods, (3) MSP should be labeled to show the presence of

cholesterol and calcium for the benefit of people who needed to

restrict their intake of these substances, and (4) mandatory handling

and storage of starting materials used for making MSP should be

considered.

In the same June 29, 1979, announcement on the availability of the

1979 Report, FSIS also notified the public that it was particularly

interested in receiving comments regarding the proper labeling of

products containing poultry product produced by mechanical separation

and what means, if any, should be taken to implement the labeling

recommendations with regard to calcium and cholesterol in the report

(44 FR 37965).

FSIS received 221 comments, most of which were general reactions to

the labeling issues raised in the notice, and health, safety, or

economic concerns. The majority of the commenters expressed a general

opinion on the adequacy of regulations concerning mechanically

separated poultry products and were supportive of the rules at that

time. Some commenters stated that the regulations have effectively

controlled the use of mechanically separated poultry products over many

years with a wide base of consumer acceptance, that such product is not

significantly different from product produced by hand-

[[Page 55965]]

deboning, that these regulations provide truthful labeling, and/or that

the report and scientific literature support the adequacy of current

regulations. Other commenters indicated that mechanically separated

poultry should be regulated the same as mechanically separated meat

(then named mechanically processed (species) product).

III. GAO Report on Mechanically Separated Products

In 1983, the General Accounting Office (GAO) issued a report

recommending that the Secretary of Agriculture direct the Administrator

of FSIS to establish specific standards on poultry products produced by

mechanical separation, and labeling requirements on products made with

such poultry products, as had been done for MSM and products made with

MSM.

IV. Improvements in Machinery for Poultry Products Produced by

Mechanical Separation

The Agency has monitored the advances in the technology for

mechanically separating poultry over the last decade. There have been

improvements in the efficiency of the mechanical separation and removal

of most of the bone from attached skeletal muscle and tissue of poultry

carcasses and parts of poultry carcasses. Today, industry figures

estimate that roughly 1 billion pounds of raw poultry materials are

used to manufacture 700 million pounds of mechanically separated

poultry, which is used, in turn, to formulate approximately 400 million

pounds of poultry sausages (including franks, bologna, and salami), and

300 million pounds of poultry nuggets and poultry patties.3 There

have been major advances in mechanical separation machinery in terms of

the effectiveness of removing the bone which is incorporated by the

process of separation into the skeletal muscle and other tissues of

poultry carcasses and parts of carcasses. This has been accomplished

through enhancements and modifications of the bone-removal devices that

are part of the mechanical deboning machines. There have been continued

refinements of certain operational parameters of the machinery, e.g.,

the ability for operators to adjust the pressure needed to force

crushed poultry bones with adhering muscle and other tissues through

screens to separate muscle and other tissues from bone, and the size of

the apertures in the screens and sieves through which the crushed

bones, muscle, and other tissues are pushed under high pressure. These

improvements have resulted in the ability to easily achieve bone

content limits or decrease the bone solids that are a result of the

mechanical separation process to less than the one percent reflected in

the current poultry products regulations (9 CFR 381.117(d)).

\3\Information provided by industry is available for public

inspection at the FSIS Docket Clerk's Office.

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In 1969, the Agency amended the regulations for poultry and poultry

products inspection to, among other things, provide labeling

requirements for boneless poultry products, as well as a prescribed

bone solids content of not more than 1 percent (34 FR 13991). This

limit was based on an evaluation conducted by FSIS of the operating

results in a series of poultry establishments that used mechanical

deboning equipment. Analyses were made of 485 samples of raw,

mechanically deboned product from nine commercial operations that used

the three types of machines most often used in the process. The

analyses showed that the equipment, at that time, could be operated

under commercial conditions to produce boneless poultry that contained

no more than 1 percent bone solids, on a raw weight basis, and FSIS

concluded that it was demonstrated that it was practical to limit the

bone content in deboned poultry to 1 percent. Moreover, it was deemed

that the one percent maximum bone solids content represents good

manufacturing practices and reflects mechanical separation processes

that are in control.

In light of the improvements that have occurred with regard to the

machinery used to mechanically separate and remove most of the bone

from the muscle and other tissues of poultry carcasses and parts of

carcasses, FSIS recently conducted a study of the bone solids content

of MSP.4 The percentage of bone solids content (determined by

calcium analysis) in boneless poultry products produced by mechanical

separation processes was collected from approximately 50 establishments

during August 1993, and represented a sampling of over 2000 products.

The data indicate that the mean bone solids content of the samples of

these products was approximately 0.6 percent; generally, half of the

samples were above 0.6 percent (but below 1 percent) and half were

below 0.6 percent.

\4\Data available for public inspection at the FSIS Docket

Clerk's Office.

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V. RTI Study

In response to complaints from industry, some of them longstanding,

that the Agency is ``not regulating meat and poultry equitably,'' FSIS

contracted out to the Research Triangle Institute (RTI) a comparison of

the meat and poultry inspection regulations. RTI found many differences

in the two sets of regulations and narrowed down to 12 the areas of the

regulations where significant differences exist.5 FSIS has studied

these areas to determine whether, in the actual conduct of inspection,

they result in an inequitable application of the inspection laws, and,

if so, what might be done to mitigate the inequities.

\5\A copy of the RTI study is available for public inspection in

the FSIS Docket Clerk's office.

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Among the areas identified in the RTI study is mechanically

separated product. It notes that regulations exist on the use of MSM,

but not on the use of mechanically separated poultry. The RTI study

concluded that, in general, ``the regulations covering meat and poultry

have been designed with the same intent--to protect `the health and

welfare of consumers by assuring that meat and meat food products [or

poultry products] are wholesome, not adulterated, and properly marked,

labeled, and packaged' (21 U.S.C. 602 and 451). Although the intent of

the regulations remains the same, the actual requirements are quite

different.'' The study further concludes that the bases for no

comparable regulation for mechanically separated poultry are

``unfavorable consumer perceptions and court decisions resulting in

label and use restrictions for MSM; poultry has no definitional

requirements (e.g., it can be defined as `chicken' or `turkey').''

Mechanically separated meat (i.e., beef or pork) product became the

subject of consumer criticism in the mid-l970's after USDA proposed to

allow its use as ingredients in meat products and to allow it to be

labeled as meat (i.e., ``beef'' or ``pork''). USDA also issued an

interim rule that included standards for the use of mechanically

separated red meat product. A lawsuit soon followed in which the Court

found that this product is not ``meat'' as traditionally defined in the

Federal Meat Inspection Act regulations. The Court further found that

USDA had not considered adequately the health and safety effects of the

mechanically separated red meat product.

To respond to questions on health and safety raised by the Court, a

panel of government scientists was convened to examine the questions.

The panel found that scientific studies established no unique health

risks associated with mechanically separated red meat product, but that

the product is

[[Page 55966]]

sufficiently different from muscle tissue meat in composition to

require separate labeling. The panel recommended, among other things,

that usage limitations be placed on this product.6

\6\The panel's conclusions and recommendations were published in

reports titled ``Health and Safety Aspects of the Use of

Mechanically Deboned Meat, Volume I--Final Report and

Recommendations, Select Panel'' and ``Health and Safety Aspects of

the Use of Mechanically Deboned Meat, Volume II--Background

Materials and Details of Data.'' These reports are available for

public review in the FSIS Docket Clerk's office.

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The panel reports, among other things, led FSIS to issue final

regulations on June 20, 1978, that established preparation,

composition, usage, and labeling requirements for mechanically

separated red meat product, which was named mechanically processed

species product (MP(S)P) and required that it be produced only under a

quality control program approved by the Agency (43 FR 26416). This rule

established a definition and standard of identity for this product that

necessitated it being listed separately from meat in the ingredients

statement of a product in which it was used. In 1981, the Agency

proposed that this product be distinctly identified as ``mechanically

separated (species) (MS(S))'' (where ``species'' refers to beef, pork,

or other species of livestock) based on data, information, and

arguments accumulated by and submitted to FSIS since the regulations

for the product were originally promulgated on June 20, 1978 (46 FR

39274). FSIS proposed to amend the definition and standard for MP(S)P

by deleting the term ``product'' from the product name and by

considering terminology such as ``mechanically separated,''

``mechanically deboned,'' and ``mechanically recovered'' as an

alternative to ``mechanically processed'' to continue distinguishing

the product from ``meat.'' Comments on the proposal indicated that the

term ``mechanically separated'' was more descriptive of the product

than the other terms listed in the proposal, that it was favored

because of its use in other countries and adoption by the Codex

Alimentarius Committee on Processed Meat and Poultry Products (1978),

and that it did not have negative connotations associated with the

other terms. Some commenters on the proposal stated that the term was

truthful and understandable. Additional rulemaking on June 29, 1982 (47

FR 28214), reaffirmed the Agency's position that the product is not

``meat'' as traditionally defined, and that ``mechanically separated

(species) (MS(S))'' is the name that will provide a more meaningful and

concise description of the product's characteristics than

``mechanically processed (species) product.''

During this same period, mechanically separated poultry underwent

product development separately from mechanically separated red meat

product without similar FSIS regulations. Early distinctions in

regulatory treatment were largely due to historical differences in how

the two industries used these products and the way in which they came

to public attention. One significant difference is that mechanically

separated red meat product was being considered for use in products

that had previously contained muscle meat. The use of mechanically

separated poultry in poultry hot-dogs created less controversy because

poultry hot-dogs, bologna, and similar products did not exist before

they were made with mechanically separated poultry. Thus, consumers had

no prior expectations about the formulation.

Differences in regulatory treatment of MSM and mechanically

separated poultry have continued since that time. The meat industry

claims that the effect of those differences has been a reluctance on

the part of processors to use MSM, while MSP use has expanded. In

response to the early rulemakings on MSM, the meat industry claimed

that consumers would not buy products if ``mechanically separated beef

(or pork, or other livestock species)'' is listed on the label.

Similarly, in responding to the March 1994 advance notice of proposed

rulemaking (ANPR) on MSP (discussed later in this document), the

poultry industry claimed that, if they had to label MSP as a poultry

ingredient, consumers would be misled into thinking that they are

purchasing products inferior to what they have historically purchased

or that the product has changed.

The Agency's regulation on the use of MSM and the absence of

regulation on the use of mechanically separated poultry have raised two

major policy issues. The first is whether current regulations are

adequately protecting consumers. The second is whether different

regulatory treatment for these similar products is justified. FSIS is

not promulgating this regulation merely because of the current

differences in the regulatory treatment of mechanically separated

poultry and MSM, but rather because one of the basic statutory missions

of the Federal Meat Inspection Act, under which MSM, such as

``mechanically separated beef (or pork),'' is regulated, and of the

Poultry Products Inspection Act (PPIA), under which MSP is regulated,

is to assure that products bear labeling that is truthful and not

misleading. Here, for MSP, as FSIS did for MSM, FSIS has determined

that a standard of identity and composition is needed for this product,

along with an ingredient labeling requirement, and other requirements

in order to carry out one of the statutory missions of the PPIA, as has

been done in regard to the FMIA for MSM, by assuring that consumers are

accurately informed about the ingredients of products they purchase,

which in this case is an ingredient whose form and consistency

materially differ from those of other boneless poultry products

produced by hand-deboning.

VI. Advance Notices of Proposed Rulemaking

On June 15, 1993, FSIS published an advance notice of proposed

rulemaking (ANPR) (58 FR 33040) soliciting comments, information,

scientific data, and recommendations regarding the need for labeling of

poultry product produced by mechanical separation and products in which

such poultry product is used. FSIS received 2744 comments in response

to the ANPR, most of which were general reactions to labeling issues.

The majority of commenters responded to whether there was a need to

identify mechanically separated poultry in the ingredients statement on

the labels of meat and poultry products in which it is used as an

ingredient. Roughly half the commenters supported identifying

mechanically separated poultry in the ingredients statement because,

the commenters stated that, among other things, consumers have ``a

right to know'' it is an ingredient. The majority of the other

commenters did not support identifying mechanically separated poultry

in the ingredients statement, citing, in part, their belief that

current policies are satisfactory and that labeling MSP would mislead

consumers into thinking that they are purchasing products that are

inferior or different than the product they have historically

purchased. FSIS concluded that there is a ``truth-in-labeling'' issue

that is founded in the mandate under which the Agency operates, viz.,

protecting consumers from misbranded poultry and meat products.

Subsequently, on March 3, 1994, FSIS published another ANPR (59 FR

10230), which solicited comments and information from the meat and

poultry industries and industry-related organizations, the scientific

community, academia, consumers and consumer groups, and other

interested parties. FSIS sought comments on its tentative positions

regarding defining and standardizing, or establishing other

[[Page 55967]]

requirements for poultry products produced by mechanical separation,

including possible provisions for the composition, characteristics, and

use of such products, and requirements for manufacturing and labeling

such products. In the March 1994 ANPR, FSIS considered, among other

things, that certain poultry products produced by mechanical

separation, i.e., those with greater than 0.6 percent bone solids

content, but no more than 1 percent bone solids content, be separately

identified on the labels of products in which they are used as

ingredients by a distinct name. However, because of the improvements

that were previously discussed in separating and removing the bone from

skeletal muscle and other edible tissues of poultry carcasses and parts

of carcasses, FSIS considered that some poultry products derived from

mechanical separation machinery, i.e., those with 0.6 percent or less

bone solids, be identified on the label of products in which they are

used as poultry or poultry meat, e.g., ``chicken'' and ``turkey meat.''

FSIS received 106 comments in response to the March 1994 ANPR. The

majority of the comments did not support the ANPR. The commenters

strongly disagreed with the tentative position that only product with

0.6 percent or less bone solids content could be labeled ``(Kind)'' or

``(Kind) meat,'' without the reference to ``mechanically separated.''

The commenters also disagreed with the need for handling requirements,

protein quality requirements, and quality control for boneless poultry

products produced by mechanical separation. Further, commenters

disagreed with establishing a minimum protein content and a maximum fat

content requirement for poultry product produced by mechanical

separation with greater than 0.6 percent bone solids content. They also

disagreed with restricting the bone particle size to a maximum of less

than 1.5 millimeter (mm) in the greatest dimension and limiting the use

of mechanically separated poultry when used as an ingredient in other

products. Many commenters stated that FSIS should continue allowing the

declaration of mechanically separated poultry on product labeling as

``(Kind)'' or ``(Kind) meat'' (i.e., ``chicken,'' ``chicken meat,''

``turkey,'' and ``turkey meat'') when it is used as an ingredient in

poultry or meat food products.

FSIS generally agreed with the commenters with regard to protein

quality, and protein and fat contents, and concluded that the tentative

positions on protein quality, and minimum protein and maximum fat

contents were unnecessary. Protein quality is not a health issue today,

and information regarding protein and fat contents is generally

available on the Nutrition Facts panel on most processed foods where

mechanically separated poultry might be used as an ingredient.

Furthermore, it was decided that the positions on quality control and

handling requirements would be better addressed as part of larger

regulatory efforts that were planned to consider ways of reducing the

potential for situations that would render any poultry or meat food

product adulterated, unwholesome, and/or misbranded. Therefore, the

Agency concluded that it was premature to address the need for

mandatory quality control or handling requirements for this one

distinct category of poultry product. However, the Agency was not in

agreement with the commenters on the other issues raised in the ANPR.

The Agency maintained that a bone solids content requirement is

necessary because one of the characteristics that distinguishes

mechanically separated poultry from hand-deboned poultry is the method

of mechanical processing that results in a product which is safe in

terms of composition, but one in which there is greater potential for

the incorporation of powdered bone. The bone solids content of MSP is a

direct result of the manufacturing process which involves the crushing

of starting materials which consist of skeletal frames and carcass

shells on which bits and pieces of muscle and other edible tissue

remain after most of the muscle and other tissues have been removed by

hand. Thus, there is the need for controlling the process of

incorporating powdered bone into MSP so that it does not exceed the

level of one percent which is considered a ``good manufacturing

practice.'' The other distinguishing features that make mechanically

separated poultry different than hand-deboned poultry are physical form

and consistency. Informing consumers of such differences by a distinct

and separate labeling of the presence of mechanically separated poultry

in products in which it is used, is supported by the statutory

responsibility of FSIS to assure that all labels on poultry and meat

food products are accurate and not false or misleading.

The Agency did agree that its tentative labeling approach to

identifying two types of mechanically separated poultry, based on the

level of bone solids, i.e., above or below 0.6 percent, which was

suggested in its March 1994 ANPR, appear to be in conflict. The

mechanical separation process results in a product that is materially

different than hand-deboned poultry in terms of its paste-like form and

batter-like consistency, regardless of the level of bone solids

present. The Agency tentatively concluded, after further review of the

approach presented in the March 1994 ANPR and the comments received in

response to it (and the prior June 15, 1993, ANPR), that continuation

of the present labeling policy, even for those finished products with

mechanically separated poultry that has a bone solids content of less

than 0.6 percent, does not inform the consumer that these products

contain the distinct ingredient mechanically separated poultry and that

this may result in misleading labeling. The Agency also maintained that

there is a need for bone particle size restrictions to augment the

measurement of bone solids content as an assurance that mechanical

separation processes are operating under good manufacturing practices

that prevent the inclusion of unacceptable large fragments in

mechanically separated poultry. The Agency also believed that in order

to show that the process of manufacturing MSP was in control, i.e.,

operating under good manufacturing practices, records should be kept.

The Agency disagreed with commenters' objections to the tentative

positions taken in the March 1994 ANPR on restricting the uses of

mechanically separated poultry as an ingredient in certain products,

e.g., in baby foods where there was a potential health effect

associated with fluoride in mechanically separated poultry made from

fowl, and where the textural characteristics of mechanically separated

poultry altered the basic nature of the product to which it may be

added, such as products represented as being composed of whole muscle.

FSIS maintained the position that such restrictions were necessary for

health reasons (in the case of the fluoride issue) or to protect the

consumer from misleading labeling.

The Agency's positions on these major issues led to the publication

of the December 6, 1994 proposed rule.

VII. Proposed Rule

On December 6, 1994, FSIS published a proposed rule to amend the

Federal meat and poultry products inspection regulations to define and

standardize, and establish other requirements for poultry products

produced by mechanical separation, including provisions for the

composition and use of such products, and requirements for

manufacturing and labeling such

[[Page 55968]]

products (59 FR 62629). The proposal prescribed a definition and

standard of identity for poultry products produced by mechanical

separation with 1 percent or less bone solids content, that required

compliance with certain criteria, e.g., bone solids content (measured

as calcium content) and bone particle size. The proposal also provided

recordkeeping and labeling requirements, and limitations on use of

poultry products produced by mechanical separation.

A. Product Definition and Standard

FSIS proposed to prescribe a definition and standard of identity

and composition for the poultry product with a paste-like form and

batter-like consistency that results from the mechanical separation of

and removal of most of the bone from attached skeletal muscle and other

tissue of poultry carcasses and parts of carcasses which has a bone

solids content of 1 percent or less. This product is commonly known in

the poultry industry as mechanically separated or deboned poultry.

FSIS proposed that the boneless poultry products regulations

described in 9 CFR 381.117(d) no longer apply to MSP. FSIS indicated

that the current restriction on bone solids content in this regulation,

as enforced by limiting calcium content, would be included with other

compositional requirements in an MSP standard. Moreover, as a

standardized product, MSP would be differentiated from other poultry

product ingredients and it would be designated in the ingredients

statements on finished product labels by the name specified in its

definition and standard, in accordance with 9 CFR 317.2(c)(2) and

(f)(1) and 381.118(a). Product failing to meet the bone solids content

or bone particle size restrictions of the standard must be labeled as

``Mechanically Separated (Kind) For Further Processing'' and may only

be used in producing poultry extractives, including fats, stocks, and

broths because the manufacturing process completely removes the bone

solids and bone particles.

1. Product name. FSIS proposed to define the standardized product

that results from the mechanical separation and removal of most of the

bone from poultry carcasses and parts of carcasses by a distinctive

name. FSIS proposed that such product be called ``mechanically

separated chicken'' or ``mechanically separated turkey,'' for example.

FSIS indicated that this product differs significantly from boneless

poultry products produced by traditional hand-deboning techniques in

its spread-like form and consistency such that it should be regulated

as a separate, standardized ingredient. FSIS indicated that it would

welcome comments on other names that accurately reflected the process

from which this product was derived, as well as its form and

consistency.

2. Bone solids content. FSIS proposed that the definition and

standard for MSP incorporate the existing restriction on the bone

solids content of mechanically separated poultry products of not more

than 1 percent (9 CFR 381.117(d)). FSIS also proposed that the

definition and standard include maximum calcium content levels of not

more than 0.235 percent in product made from turkeys or mature chickens

or 0.175 percent in product made from other poultry, as a measure of

bone solids content based on the weight of product that has not been

heat treated.

3. Bone particle size. FSIS proposed that at least 98 percent of

the bone particles present in MSP be restricted to a maximum size no

greater than 1.5 millimeters (mm) in their greatest dimension and that

no bone particles could be larger than 2.0 millimeters in their

greatest dimension.

4. Recordkeeping. FSIS also proposed that establishments that

manufactured MSP maintain records of bone solids content and bone

particle size as a measure of process control. These records had to be

made available to the inspector and any other duly authorized

representative of the Secretary upon request.

B. Limitations on Use

FSIS proposed certain limitations with respect to the use of MSP in

the formulation of poultry and meat food products. FSIS proposed such

restrictions based on the potential fluoride contribution of MSP made

from fowl (i.e., mature female chickens) and the characteristics of

MSP, including the kind of poultry from which it is made and its form

and consistency. FSIS also proposed that MSP may be used, except in

certain cases, in any product defined by regulatory standards or Agency

policies whereby ``(Kind)'' or ``(Kind) Meat'' (e.g., ``turkey,''

``turkey meat'') are being used, provided that it is identified as

``Mechanically Separated (Kind)'' and conforms to requirements

regarding the presence of skin within natural proportions (9 CFR

381.117(d)).

1. Kind of product limitation. FSIS proposed that when a poultry

product is required to be prepared from a particular kind or kinds of

poultry, (e.g., chicken), use of MSP of any other kind (e.g.,

mechanically separated turkey), would not be permitted. This provision

assures that the kind of MSP used in a poultry product, such as

mechanically separated chicken, is the same kind as is represented in

the product name or other labeling. For example, product named

``chicken bologna'' could not be composed of mechanically separated

turkey because such action could, among other things, result in false

or misleading labeling by implying that the bologna was made with a

chicken ingredient, when, in fact, it contained a turkey ingredient.

2. Limitations on product made from fowl. FSIS proposed that the

use of mechanically separated chicken made, in whole or in part, from

fowl (i.e., mature female chickens, as defined in 9 CFR

381.170(a)(1)(vi)) not be permitted in baby, junior, or toddler foods.

The Agency based these restrictions on the potential fluoride

contribution of product made from fowl to dietary intakes of young

children.

The Agency noted that this position was supported by the 1979

Report, which was the best data available. FSIS recognized, however,

that views on fluoride consumption have changed in the last few years,

and in particular, recent views on the benefits of fluoride in the

diet, including the diets of children. Comments were invited on this

issue that would have an impact on the current validity of the proposed

restriction on use of MSP from fowl .

3. Poultry product limitations. FSIS proposed that MSP not be

allowed in poultry products that are composed of whole poultry muscle,

and expected to be as such by consumers, except that it may be used for

binding purposes at a level that is sufficient for purpose. However,

FSIS would allow MSP in the sauce portion or any dressing of poultry

products.

FSIS also proposed that MSP not be permitted in poultry products

that have been processed only to the extent of cutting or grinding

because it considers its use to be inconsistent with the basic whole-

muscle character associated with such products. The Agency also would

not permit MSP to be used in poultry products that are processed,

convenience versions of ready-to-cook poultry or cuts or solid pieces

of poultry or poultry meat for the reason stated above.

FSIS proposed no restrictions on the amount of MSP that can be used

in poultry products, or meat food products, in which it is a permitted

ingredient. However, prevailing standards of identity and composition

for particular products may contain quantitative limits (e.g., a limit

on the amount of poultry product ingredients permitted in cooked

sausages such as frankfurters

[[Page 55969]]

and bologna (9 CFR 319.180)) or other restrictions on the quantity of

various poultry product ingredients.

C. Labeling

FSIS proposed special provisions for the labels of MSP. If adopted,

these provisions would supplement other, more general requirements for

such labels (see 9 CFR parts 317 and 381, subpart N). The provisions

are discussed below.

1. The product. FSIS proposed the following labeling provisions for

MSP: (1) the name of the product (e.g., ``Mechanically Separated

(Kind)'' (where ``kind'' refers to chicken, turkey, or other poultry)

must be followed immediately by the phrase(s) ``made from fowl'' unless

it is not made, in whole or part, from mature female chickens, and

``with excess skin'' unless it is made from poultry product that does

not include skin in excess of the natural proportion present on the

whole carcass; and (2) there must be appropriate descriptive

terminology in the labeling of MSP if heat treatment has been used in

the preparation of such product, e.g., ``cooked.'' Because the

characteristics described in (1) and (2) above are ones which would

affect the use of MSP, FSIS proposed that, in order to assure

compliance with regulatory requirements and thereby prevent the

adulteration and misbranding of finished poultry products and meat food

products, such characteristics had to be clearly identified on the

label of MSP when MSP left the establishment at which it was

manufactured.

2. Finished poultry products and meat food products. FSIS proposed

that the standardized paste-like product that results from the

mechanical separation and removal of most of the bone from the skeletal

muscle and other edible tissue of poultry carcasses and parts of

carcasses be defined by its own name, e.g., ``Mechanically Separated

(Kind),'' which would be declared in the ingredients statements on

finished product labels by the name specified in its definition and

standard.

VIII. Discussion of Comments

FSIS received 2420 comments in response to its December 6, 1994,

proposed rule. The majority of the comments (over 95 percent) were

submitted by individuals and food manufacturers and distributors; a few

(less than 5 percent) were submitted by trade associations, consumer

advocate organizations, academia, developers of machinery, food

retailers, food consultants, law firms, an agency of the Federal

government, and a foreign government. The majority of the comments

related to product name. The comments are summarized below.

A. Product Definition and Standard Product Name

Nearly all of the comments were in response to the proposed

requirement regarding the product name for MSP which established a

distinct name for this product, mechanically separated (kind), where

``kind'' represents the kind of poultry, such as chicken or turkey,

from which the product was made. Of these, roughly one-quarter agreed

with defining the product by the distinctive name of ``Mechanically

Separated (Kind) (MS(K)).'' Most of the commenters supporting the

proposal stated that MSP is different from hand-deboned poultry and the

product label should inform consumers of which type product they are

getting. Further, the commenters asserted that ``they have a right to

know'' if mechanically separated poultry is being used because

mechanically separated poultry ``has more bone particles, calcium, and

cholesterol'' (than hand-deboned poultry) because of the way it is

processed. The commenters said that if the name is not changed to MSP,

i.e., mechanically separated (kind), consumers might think that they

are getting a product that has no bone particles and is identical to

hand-deboned poultry. Several commenters also suggested that it is

unfair for FSIS to treat mechanically separated poultry differently

than mechanically separated meat with regard to its labeling and that

this proposed rule will create parity between the poultry and red meat

industries.

The majority of the other commenters disagreed with the proposed

position to define the product by the name MSP. The commenters stated

that: (1) Poultry that is mechanically deboned is the same as any other

poultry and should be treated and labeled like any other poultry, i.e.,

hand-deboned; (2) current labeling is truthful and accurate, unlike the

term ``mechanically separated,'' which suggests it is different because

mechanical equipment is used; (3) labeling MSP differently than it is

currently labeled will confuse and mislead consumers into believing

that the product has undergone a change and is somehow different; (4)

the proposed labeling terminology will force manufacturers to undertake

numerous unnecessary product reformulations and promote new labeling

nomenclature that is both unappealing and unnatural in context; (5) the

common or usual name of finely ground turkey or chicken is ``turkey or

chicken,'' by virtue of consistent, widespread and long-term usage of

the term by the industry; (6) the addition of the words ``mechanically

separated'' to the ingredients statement unnecessarily contributes to

the general cluttering of limited label space; (7) ingredient labeling

should be based upon product characteristics not on the manufacturing

method, because most, if not all, ingredients in all food products are

mechanically processed at some point, e.g., ``pitted cherries are

mechanically pitted but do not require mechanically pitted on the

label'' or ``orange juice squeezed by a machine is not required to be

labeled as mechanically squeezed orange juice;'' and (8) the term will

frustrate technological innovation by establishing a false dichotomy

between mechanical and ``natural'' processes.

Commenters also suggested that any further regulation or change of

ingredient declaration for this product is unnecessary and not based on

consumer expectations or scientific determination. Commenters stated

that there is no adequate justification for setting a new standard of

identity for this product. They stated that FSIS has not provided any

research, consumer studies, or marketing data to support the need for

this labeling change and that no new evidence has been presented by

FSIS to refute that mechanically separated poultry is materially the

same as poultry derived from hand-deboning. Commenters also questioned

placing additional requirements on a product that is already accepted

by consumers. Another commenter stated that the only reason FSIS was

initiating a change to the name for MSP was because of the lawsuit by

the red meat sausage manufacturers (i.e., Bob Evans Farm, Inc. et al.,

v. Espy).

Further, one commenter alleged that the reason given by FSIS for

proposing this rule, which is to prevent mislabeling of products and

misleading consumers, is invalid. This commenter was the only one to

offer consumer data7 regarding consumer reactions to labeling MSP.

The commenter contracted out a consumer study to measure consumers'

preferences for the terms ``chicken,'' ``turkey,'' ``mechanically

separated chicken or turkey,'' and ``finely ground chicken or turkey.''

The commenter concluded that the consumer research shows that ``the

majority of consumers consistently report no preference to change from

current labeling practices.'' According to the commenter, ``less than 2

in 10

[[Page 55970]]

consumers in their study expressed the opinion that `mechanically

separated' is an appropriate labeling term for comminuted poultry,''

and that, if a change is made to current policies, ``finely ground''

would be a more preferred term. The commenter concluded that the

results of the research were applicable to consumers in general.

Several other commenters cited the consumer research presented by this

commenter and also asserted that, if any change is made with respect to

the product name, ``finely ground (Kind)'' is much more informative

than ``MSP.'' Other commenters suggested other names such as

``ground,'' ``finely textured,'' and ``finely comminuted'' poultry.

\7\Comment submitted by the National Turkey Federation is

available for public review at the FSIS Docket Clerk's office.

---------------------------------------------------------------------------

FSIS has concluded that the name mechanically separated poultry,

i.e., ``mechanically separated (kind of poultry) (MSP)'' (e.g.,

mechanically separated chicken) should be adopted as the product name

and that a separate standard of identity should be established for this

product to reflect its name and set forth appropriate parameters for

the product. FSIS has determined that the name ``mechanically separated

(kind of poultry)'' is an appropriate, nonmisleading name for this

product based on comments received in this rulemaking, an examination

of the process by which MSP is made, the distinct paste-like form and

batter-like consistency of MSP, the need to distinguish MSP's

differences from hand-deboned poultry on labeling to comply with FSIS'

statutory consumer protection responsibilities to assure that labels of

meat and poultry products are accurate, and a review of product name

issues raised in the rulemaking for mechanically separated meat, a red

meat product produced in a mechanical manner similar to MSP.

As will be discussed more fully below, FSIS does not agree with

various assertions of some commenters that establishing the name MSP

for this product is unnecessary and unjustified. The name mechanically

separated (kind of poultry)'' clearly and precisely describes the

manner by which the product is made. The process by which MSP is made

along with the type of starting materials used to make it, which

contain only bits and pieces of muscle tissue and other edible tissues,

such as skin and fat, are what causes this product to be different from

hand-deboned poultry. Consumers will be misled if they are not informed

that this product is materially different from hand-deboned poultry,

and the appropriate way to inform them of this difference is to

establish a name for MSP that distinguishes it from hand-deboned

poultry. As FSIS recognized in its rulemaking on MSM, the ability of

any name to convey in only a few words the nature of a product is

limited. However, FSIS has determined that the term MSP will

appropriately notify consumers that the product they are purchasing

contains a distinct ingredient that results from the mechanical

separation process.

FSIS received various comments that suggested alternative names for

the product, if it was concluded that more descriptive labeling was

necessary, such as ``ground (kind of poultry),'' ``finely ground (kind

of poultry),'' ``comminuted (kind of poultry),'' and ``finely textured

(kind of poultry).'' FSIS has concluded that these names do not provide

a concise and accurate description of the product because the usage of

the terms is not unique to MSP, and these terms convey the impression

that the product has the same form and consistency as product with

defined particles of meat, skin, and fat, rather than, as here, one

that has a paste and batter-like consistency. FSIS has concluded here,

as it did for its previous rulemaking on MSM (47 FR 28214, 28224), a

similar product produced by a mechanical separation process that has a

paste and batter-like consistency, that the name of the product should

include the term ``mechanically'' to indicate the nature of the process

used in making the product. When FSIS adopted the name ``mechanically

separated'' in its 1982 rulemaking on MSM to describe mechanically

separated livestock product such as ``beef'' or ``pork,'' the adoption

of this name was challenged in a lawsuit. The name was upheld by the

Courts in Community Nutrition Institute (CNI) v. Block, No. 82-2009

(D.D.C. Dec. 1, 1982), aff'd 749 F.2nd 50 (D.C. Cir. 1984). As also has

been previously noted, the term ``mechanically separated'' is

recognized internationally by the Codex Alimentarius Commission of the

United Nations and by individual countries that trade with the United

States.

In its proposed rule, FSIS proposed the term ``Mechanically

Separated'' (Kind) for MSP. As a point of clarification, FSIS would

like to make it clear that ``kind'' refers to the ``kind of poultry,''

such as chicken, turkey, etc., used in a product. FSIS feels that the

name for this ingredient should be clear about this fact, and,

therefore, has clarified its regulations to reflect this fact.

FSIS also wishes to clarify the scope of its definition and

standard for MSP. As with FSIS' definition and standard for MSM, the

standard and definition for MSP are intended to only cover the product

with a paste-like form and batter-like consistency manufactured by

machinery that operates on the differing resistance of hard bone and

soft tissue to pass through small openings, whether it employs sieves,

screens, or other devices or whether or not bones are pre-broken before

being fed into such equipment. This regulation, however, is not

intended to cover whole pieces of muscles that are mechanically

separated from poultry carcasses or parts of carcasses. FSIS has

clarified its regulation in this regard by indicating that the product

that FSIS is regulating is the one that results from the mechanical

separation process that has a paste-like form.

In response to the commenters who suggested that there is no

difference between MSP and hand-deboned poultry and, that therefore,

they should be labeled the same, FSIS disagrees with this comment. The

method of obtaining poultry products by the mechanical separation

process results in a product whose form and consistency materially

differ from that of poultry derived by traditional hand-deboning

methods.

MSP is a poultry product that results from the mechanical

separation and removal of most of the bone from the skeletal muscle and

other edible tissues, such as skin with attached fat, of poultry

carcasses and parts of carcasses. The process of manufacturing MSP

begins with starting materials from which most of the muscle and other

tissue has already been removed by hand, on which only bits and pieces

of tissue remain. The process involves the crushing of the bones (i.e.,

the starting material) with adhering tissue and the removal of the bone

using high pressure which forces the mass of tissue through holes in

the equipment, allowing a small amount of powdered bone to pass along

with the edible tissue. This results in a product with a paste-like

form and cake batter-like consistency, that no longer resembles

``chicken'' or ``turkey.'' The rigors of the mechanical separation

process alter the structure of the muscle fibers, skin, fat, and other

tissues of the starting materials so that they become a blended and

amorphous paste-like mass that is no longer recognizable as ``chicken''

or ``turkey.'' On the other hand, ``hand-deboned poultry'' is a

boneless poultry product that is a result of removing whole muscle and

other edible tissue (e.g., skin with attached fat) from poultry

carcasses and parts of carcasses, using hand-deboning methods, e.g.,

hand-held knives. Such product is easily recognized as the kind of

boneless muscle and tissue that would be gotten by a person who used

[[Page 55971]]

a knife in their own kitchen to cut off pieces from a poultry carcass

or parts of poultry, such as drumsticks, thighs, and breasts, because

there is not a substantial disruption of the physical form of the

product by hand-deboning. With hand-deboning, the muscle fibers are

visible and maintain much of their original configuration.

Understandably, hand-deboned muscle and other tissue may be

subsequently processed through a grinder, flaking machine, or dicer to

yield poultry in ground, flaked, or diced form, but such product still

exhibits a physical character associated with ``chicken'' and

``turkey,'' rather than a cake batter. This is because the rigors of

these processes which occur after hand-removal of muscle and other

tissue do not alter the physical nature of the tissues to the degree

that mechanical separation does.

In response to the comments regarding consumers being confused or

misled by labeling MSP differently than is currently labeled, i.e., as

``chicken'' or ``turkey,'' the Agency is not aware of reliable or

conclusive data that support the assertion that consumers will be

confused or will believe that the products in which MSP has been used

are different from the products they purchase after the final rule is

effective. The Agency does not agree with one commenter's assertion,

the American Meat Institute, that a report of a study it

submitted8 on an evaluation of mechanically separated red meat

issues support its view that the required labeling for MSP has ``a

great affirmative potential to mislead.'' The report cannot be relied

upon as support for this conclusion for a number of reasons, including

the following discussed here. The report indicates it used focus group

sessions to, among other things, explore consumer reaction to and

understanding of the term ``mechanically separated meat.'' As noted

previously, MSM is a red meat product produced by a mechanical

separation process similar to that by which MSP is made. However, very

little of this product has been made and used in products with which

consumers are familiar, and it is not surprising that consumers might

not be aware of the product the term ``mechanically separated meat''

represented. Therefore, reactions to labels for products containing

mechanically separated meat would not necessarily be applicable to the

labels for mechanically separated poultry. Furthermore, as the study

itself states, the focus group method used does not ``produce precise,

absolute measures,'' ``its findings must be seen as hypotheses,'' and

``findings from focus group sessions are not projectable to a larger

population.'' Moreover, the study also sought consumers' reactions to

other labeling issues and the multiplicity of issues raised could bias

the responses made to the mechanically separated meat labeling issue

and, in turn, the validity of applying the finding to labeling of

mechanically separated poultry.

\8\A copy of the comment and the report are available for review

in the FSIS Docket Clerk's office.

---------------------------------------------------------------------------

In the Agency's opinion, the declaration of MSP as ``chicken'' or

``turkey,'' rather than by a distinctive name in the ingredients

statement of a product in which it used, is misleading. ``Chicken'' and

``turkey'' are terms associated with boneless poultry products derived

by hand from starting materials that consist of whole and half

carcasses, and parts of carcasses, on which whole muscle and other

edible tissues substantially exist. FSIS believes that MSP differs

significantly from boneless poultry produced by hand-deboning

techniques because of its paste-like form and batter-like consistency.

The form and consistency of MSP is a direct result of the mechanical

machinery (i.e., process) from which it is derived which involves the

removal of bits and pieces of muscle tissue and other edible tissues

from boned-out materials, i.e., skeletal frames and carcass shells.

Therefore, FSIS has concluded that MSP should be regulated as a

separate, standardized ingredient, and that the characteristics of this

ingredient are sufficiently different from the characteristics of hand-

deboned poultry that it should be identified on product labels in a way

that distinguishes it from hand-deboned ingredients. Such labeling will

help further inform consumers about the content of the products they

are purchasing. FSIS believes that such a labeling requirement is

necessary in order to fulfill its statutory responsibility under the

FMIA and PPIA to protect consumers by assuring that the labels of

poultry and meat food products are accurate and not false or

misleading.

If the commenters believe that consumers will be misled into

thinking that they are purchasing products that are different from what

they have historically purchased or that the product has changed, the

industry would have a full year before the rule becomes effective, to

educate consumers that the products they will be purchasing that

reflect the name MSP in the ingredients statement are what they have

historically purchased. FSIS, itself, also believes it is important to

inform consumers about this product. Therefore, it intends to review

its public information program and incorporate into it appropriate

explanatory material on the process used to make MSP, its

characteristics, its wholesomeness, its safety, and its nutritional

qualities. The Agency believes that consumers will be misled if

mechanically separated poultry is not separately and distinctly listed

as an ingredient, because of the differences previously discussed

between it and hand-deboned poultry. The Agency's responsibility under

its consumer protection mission is to assure that labeling information

is accurate and helps consumers make informed food purchasing

decisions.

In response to the comments that asserted that the requirement for

labeling ``MSP'' will result in a need for manufacturers to reformulate

products that currently contain MSP, and ``promote new labeling

nomenclature that is both unappealing and unnatural in context,'' the

Agency is not certain as to why such changes will be necessary. There

were no reliable or conclusive data submitted in support of these

comments that show a potential negative impact on poultry or meat food

product formulations. It is the Agency's belief that MSP continues to

be a wholesome and safe, low-cost source of protein, with nutritional

attributes comparable to ``chicken'' and ``turkey.'' The paste-like

form and batter-like consistency of MSP that results from the

mechanical separation process provide unique functional characteristics

that are a key benefit for its use in the variety of poultry and meat

food products (especially emulsion-type products like hot dogs) in

which it is currently used. This benefit seems likely to ensure

continued use of the ingredient in products that are meeting the

demands of consumers who purchase the products.

Further, in response to comments about a negative impact labeling

will have on consumers' acceptance of products labeled with ``MSP,''

there were no persuasive arguments made that support this as an

outcome. The majority of the comments that disagreed with the proposed

identity of the products as ``MSP'' did not provide data, but offered

opinions on the consumers' view of the proposed name. The data that

were presented by the one commenter that pursued consumer research were

not compelling because of shortcomings in the study design.

The report of consumer research submitted by the commenter tested

consumer preferences for the terms ``mechanically separated,'' ``finely

ground,'' and ``chicken'' and ``turkey,''

[[Page 55972]]

as names for MSP. The report concluded that the majority of consumers,

if given the choice between names such as ``mechanically separated

chicken or turkey,'' and ``turkey'' or ``chicken,'' preferred labeling

to stay as it is, ``turkey'' or ``chicken.'' If, however, a change in

the name is made, the report concluded that ``finely ground'' is

overwhelmingly preferred to ``mechanically separated.'' The commenter

concluded that the data show that a labeling change to ``mechanically

separated'' is unjustified and that consumers gain no salient

information from the use of such a term. They indicated that the data

were gathered from consumers who were informed as to the Agency's

concerns regarding the presence of ``powdered bone'' and a change in

texture of finely comminuted poultry.

The survey data's conclusions were based upon 300 interviews of

people in five states, who were given a questionnaire, after reading an

informational handout. The commenter indicated that the survey

participants had used cold cuts, luncheon meats, hot dogs, or smoked

sausage, in the past three months, and were heads of households and

primary or co-primary food purchasers between the ages of 21-69, 80%

who were female and 20% who were men.

The Agency has reviewed the survey conducted by the commenter and

has determined that the survey's findings are not reliable. The

informational handout given to survey participants to read before they

answered the survey questions did not tell those interviewed the

following information which they needed to have in order to make

informed responses to the questions posed to them: (1) a description of

the difference between the form and consistency of MSP and hand deboned

poultry; (2) descriptions of how the mechanical separation process

works and what the product is like that comes from it; (3) a

description of the difference in the nature of the starting materials

for hand-deboned poultry and MSP, and (4) a clear idea of the types of

products in which MSP is used. Further, the interviewees were not shown

any samples of MSP and hand-deboned poultry and, thus, did not view

these products and see the differences in form and consistency between

the products.

Moreover, the content of the handout was slanted in the sense that

it described only certain aspects of MSP and used confusing names for

MSP which obscured the difference between MSP and hand deboned poultry,

thus making any considered labeling change appear to be unnecessary.

For example, the informational handout indicates that the way MSP is

made is that ``new machinery was invented that could separate poultry

meat from bone without the need of hand deboning.'' This, however, is

only a partial description and is, thus, misleading. As has been

previously stated in this docket, the new machinery does not completely

separate meat from bone. Rather a small amount of powdered bone that

results from the fact that the machines crush the bone of the starting

materials from which the MSP is made, becomes mixed together with the

other material, such as muscle tissue and skin removed from the

starting materials. Another example is that the handout states that

``in either case,'' referring to MSP and hand deboned poultry, ``the

original form of the poultry is changed when it is used as an

ingredient in making hot dogs, bologna, and other processed meat.''

This is misleading because, as has been previously noted, MSP is an

amorphous and paste-like mass that is not recognizable as bits and

pieces of chicken and turkey, and even if hand-deboned chicken or

turkey was further processed by grinding, it would still exhibit a

physical character associated with chicken or turkey.

Moreover, the handout indicated that both mechanically separated

and hand deboned poultry may contain up to 1% bone, and that the

powdered bone in MSP ``provides nutritionally available calcium.''

However, whether the powdered bone in MSP provides a nutrient that

consumers want has nothing to do with the issue of what the name should

be of this product. Many types of products provide calcium but they are

appropriately described by different names because they are distinct

types of products. The handout also stated that ``in its raw, fresh

form, consumers are familiar with ground turkey which may be made using

the same equipment.'' This statement is misleading because the

important aspect of the way the machinery operates to produce a product

with a paste-like form and batter-like consistency is not presented.

Moreover, it is misleading to conclude that switching to the term

``mechanically separated'' would likely result in substantial decrease

in consumption of this products, when the interviewees were not told

that it was the distinct character of this product, rather than a

question of the wholesomeness of the product, that was a basis for

FSIS' proposed labeling change. Further, the interviewees also were not

told that product made without MSP could possibly cost more to purchase

than one made with MSP.

The conclusions reached by the commenter from the research are also

not valid because the study design did not account for possible errors

that may make the information gathered unreliable. The study used a

mall intercept survey approach and involved soliciting reactions on the

terms from 300 shoppers in shopping malls. The sample is not

statistically representative of a national population because of the

way the participants were selected. Although the commenter claimed that

they have data from ``true consumers,'' the participants represent a

population who happened to be able to shop in the mall, and on the day

of the survey. A concern with the usefulness of the results stems from

the non-probability, quota sampling approach. Non- probability samples

do not permit an estimate of sampling error. With smaller samples, the

range any reported percentage can take can be relatively large. Since a

sample of 300 respondents is smaller than most national level consumer

surveys, comparisons which look different may not be statistically

different when inferred to the population of primary food buyers. For

example, the difference between the 10 percent of respondents reporting

they will probably buy more product labeled as ``finely ground'' versus

the 6 percent that reported they will probably buy less could be due to

sampling error. Additionally, the approach to sampling tends to under-

represent persons who are difficult to contact or reluctant to

participate. In this case, under representation of certain persons with

different views is likely to yield underestimates of respondents who

report that the issue is of no importance to them.

In response to the comments that stated that the term

``mechanically separated'' is misleading because it suggests the

product is different because mechanical equipment is used, FSIS

believes that the use of mechanical equipment is, in fact, the very

reason MSP differs from hand-deboned poultry. The process of removing

bits and pieces of edible muscle and other tissues from starting

materials consisting of skeletal frames and shells is far different

than the process of removing muscle and other tissue from bone by hand.

The process of manufacturing MSP results in a paste-like product which

no longer resembles the consumer's expectation of ``chicken'' or

``turkey.'' The examples provided by the commenter of other products

that are ``mechanically'' processed, and which do not reflect this in

their names, are not comparable

[[Page 55973]]

because the form and consistency of the products mentioned would not

differ significantly whether the products were processed by hand or

machine.

Therefore, the Agency believes that MSP accurately and concisely

describes the poultry product produced by mechanical deboning,

indicating the nature of the process by which and the kind of poultry

from which it is made, and distinguishing it from poultry product

ingredients produced by traditional hand-deboning techniques. The name

includes ``(Kind of poultry)'' rather than ``poultry'' to make it clear

that the kind of poultry (9 CFR 381.1(b)(40)) from which the product is

made must be specified (e.g., ``Mechanically Separated Chicken'').

In response to comments that suggested the term ``mechanically

separated'' will frustrate technological innovation by creating a false

dichotomy between mechanical and ``natural'' processes, the Agency

stresses that the mere application of the mechanical means of

separating bone from muscle and other tissues does result in a

materially different product than that which is derived by hand. The

action of mechanical separation of bone from poultry tissue involves

crushing bones on which bits and pieces of meat, skin, and fat remain

after hand removal of the majority of edible tissue. The bones with

adhering tissue are forced under high pressure through screens or

sieves in the machinery to result in a paste-like and batter-like

composite of tissues that had been adhering to the bones, that also

contains a minute amount of powdered bone. The physical action of the

mechanical process cannot be duplicated by hand-deboning methods to

result in a similar product.

MSP has been referred to as ``Mechanically Separated'' Poultry

within the meat and poultry industries to specify the form and

derivation of the product. FSIS is aware that other descriptions have

been associated with poultry product produced by mechanical separation,

such as ``mechanically deboned'' poultry, ``finely ground'' poultry,

and ``finely comminuted'' poultry. There are reasons why these other

terms do not appropriately convey the identity of MSP.

FSIS believes that where a primary distinguishing characteristic of

a standardized product is its bone content, it would be inappropriate

to define it by a name that includes the term ``deboned'' and use of

this term in labeling might mislead consumers by implying that such

product contains no bone. This was also concluded in the final rule

that defined and standardized MSM (47 FR 28214). Although consumer

focus group research reported in the MSM proposed rule (46 FR 39274)

suggested that consumers thought that ``mechanically deboned'' is a

term that is more acceptable than ``mechanically processed,''

``mechanically separated,'' and ``mechanically recovered,'' the Agency

in its final rule for MSM rejected the term ``mechanically deboned'' in

lieu of ``mechanically separated.'' The basis was that it was believed

that ``mechanically deboned'' would incorrectly represent to consumers

that the product does not contain bone.

With regard to other terms that refer to the form or consistency of

poultry products, e.g., ``finely comminuted,'' ``comminuted,'' ``finely

ground,'' ``ground,'' and ``finely textured,'' the Agency does not view

such terms as truly reflective of the form and consistency of MSP. MSP

is paste-like in form and like a cake-batter in consistency. When it

emerges from the mechanical separation machinery, it is an amorphous

blend of the tissues removed from the skeletal frames and shells that

were the starting materials. The process uses high pressure and

incorporates a minute amount of powdered bone into the product in the

operation of removing bone from the tissue. Terms such as those

mentioned are used to reflect products with a more defined particulate

size and would be perceived that way by consumers, e.g., as products

with a form and consistency comparable to ground beef. Additionally,

terms such as ``comminuted'' are not readily understood by many

consumers and only have a common usage and understanding among those

involved in the meat and poultry industry. Terms such as ``finely

ground'' and ``comminuted'' have also been used by industry

interchangeably to describe ground poultry, i.e., poultry with defined

muscle particles. Moreover, the terms cited above have been used

indiscriminately to refer to MSP, and although they relate to form and

consistency, do not sufficiently inform consumers that MSP is an

ingredient in the products they purchase. Therefore, these terms are

limited in their ability to effectively meet the Agency's communication

objective of conveying distinctly the presence of MSP on the labels of

products. Furthermore, there were not any comments received that

offered other, novel terms that could be applied to MSP.

Regarding the comments that cited the long-term use of the terms

``chicken,'' ``turkey,'' etc., to refer to mechanically separated

poultry, as the reason for not changing the name of MSP, the Agency has

taken into account the information and experience acquired since the

first regulatory action on MSP in 1969 and current regulatory policies,

and has reviewed and reevaluated the existing regulations, particularly

in light of the labeling issues. As a result of its review and

reevaluation, the Agency has concluded that the distinct declaration of

``MSP'' is necessary after a careful review of (1) the process of

manufacturing MSP which results in a product with a paste-like form and

cake-batter-like consistency, (2) the characteristics (i.e., form and

consistency) of MSP which are significantly different from those

expected of ``chicken,'' ``turkey,'' etc., which are derived by hand-

deboning, (3) the issues raised in rulemakings and court decisions that

resulted in the distinct identity of the livestock product similar to

MSP as ``MS(S),'' because (in part) of the form and consistency of that

product, and (4) the statutory responsibilities to protect the public

and prevent the preparation and distribution in commerce of poultry

products and meat food products which are misbranded or not properly

marked, labeled, or packaged.

Bone Solids Content

FSIS stated in the proposed rule that the definition and standard

for MSP would incorporate the existing restriction on the bone solids

content of mechanically separated poultry products of not more than 1

percent. All of the 26 commenters responding to this issue expressed

strong support for restricting the bone solids content to no greater

than 1 percent. After evaluating data on substances of potential

concern that may tend to concentrate in bone, the 1979 report on health

and safety aspects of the use of mechanically separated poultry did not

recommend any change in the existing bone solids limit. FSIS continues

to believe that the requirement of no more than one percent bone solids

content is reflective of good manufacturing practices that result in

wholesome and safe boneless poultry products.

Therefore, this final rule will restrict the bone solids content to

no greater than 1 percent, as represented by calcium content to a

maximum level of not more than 0.235 percent in product made from

turkeys or mature chickens or 0.175 percent in product made from other

poultry, as a measure of bone solids content based on the weight of

uncooked product (i.e., product that has not been heat treated). The

differences in the calcium value between turkeys and mature chickens,

and the value for

[[Page 55974]]

other poultry, are attributable to the higher level of calcium found in

turkey bones which are typically larger than other poultry bones, and

due to more calcium being deposited over the lifetime of older

chickens.

Bone Particle Size

Twenty-six commenters responded to the proposed bone particle size

requirement which restricts at least 98 percent of bone particles to a

maximum size no greater than 1.5 millimeters (mm) in their greatest

dimension and allows no bone particles to be larger than 2.0

millimeters in their greatest dimension. About half of the 26

commenters supported the restriction of bone particle size. One of the

commenters stated that the bone particle requirement provides consumers

with sufficient protection from any hard bone particles and also, from

any constituents which might not normally be found in items

manufactured from muscle tissue using the traditional hand-deboning

process.

The other half of the commenters opposed setting limits on bone

particle size stating that for more than 20 years of use of MSP, bone

particles have not been a significant problem. The commenters believe

that the nature of the separation process itself, with the comminution

of product which is pushed through screens under pressure, minimizes

the likelihood of large bone particles. Furthermore, the relative

softness of poultry bones due to their age and size make them unlikely

to present a physical hazard. One commenter stated that the American

Dental Association Health Foundation found no health problems

associated with poultry bone particles and that the Michigan State

University has reported no digestibility problems of issue. Other

commenters cited the 1979 Report's conclusion that ``bone particles in

MSP will not present any health hazard because of size or hardness,

provided that bone particle size is controlled.'' Commenters also

suggested that requiring standardized bone particle limitations will

result in increased analytical costs to the processor without improving

or otherwise positively effecting food safety. Other commenters pointed

out that the proposed rule did not suggest a method by which bone

particle testing can be conducted.

FSIS believes that a bone particle size limitation augments the

bone solids content restriction and is a meaningful indicator of a

mechanical separation operation that effectively removes bone from

muscle and other tissue. The mechanical separation process involves

bone crushing and screening out bone from soft tissue, thereby

providing a mechanism for limiting the amount of bone in the product.

The mechanism of separating bone from tissue does not necessarily make

the remaining bone particles uniform in size. Bone is an unexpected

ingredient and the process of mechanical separation should be operated

to avoid the likelihood of large bone particles occurring. If bone were

present in such a particle size as to be readily apparent to the taste

or touch, it would be identifiable as bone and might be reason to

consider the product adulterated. The 1979 Report recommended that bone

particle size be controlled to ensure that equipment type or processing

does not result in unacceptably large bone fragments in mechanically

separated poultry. There were no new data submitted by commenters that

refute the data in the 1979 Report and, thus, they appear to indicate

the reasonable limits, i.e., good manufacturing practices, by which

manufacturers are operating. FSIS agrees with the recommendation in the

1979 Report and is, therefore, requiring that at least 98 percent of

the bone particles present in mechanically separated poultry have a

maximum size no greater than 1.5 mm in their greatest dimension and

that no bone particles be greater than 2.0 mm in their greatest

dimension.

Recordkeeping of Calcium and Bone Particle Size

The proposed recordkeeping requirements required that manufacturers

of MSP maintain records to support the fact that the MSP met the

proposed bone solids content requirement for MSP and the proposed bone

particle size requirement for this product. The majority of the

comments received in response to this requirement supported the

requirement. The commenters believed that establishments should

maintain records of bone solids content and bone particle size because

it assists in compliance and provides an incentive for good process

control. A number of commenters argued that mandatory recordkeeping for

bone particles would have operational costs associated with it, which

are proven to be unnecessary, particularly in light of the fact that

there is no food safety issue of concern.

FSIS has reconsidered the need for establishments' keeping records

on bone solids content (measured as calcium) and bone particle size in

light of the comments that stated that a recordkeeping requirement was

unnecessary. The Agency wishes to be cooperative to ease burdens on

industry, in appropriate situations, and allow flexibility in the

manner in which requirements can be carried out, where it can do so and

still carry out its statutory missions to prevent the distribution of

adulterated and misbranded meat and poultry products. Consistent with

this effort, the Agency in its proposal for MSP did not require the

industry to either carry out any prescribed tests for bone solids

content or bone particle size of the MSP produced, or to carry out any

type or amount of sampling of the MSP produced. The agency has now

concluded that removal of the recordkeeping requirement for bone solids

content and bone particle size will appropriately allow producers even

more flexibility in meeting these requirements. FSIS, of course,

expects producers of MSP to comply with the bone solids content and

bone particle size requirements, and it will implement spot checks in

order to verify that such compliance is occurring by producers of MSP.

If during these spot checks, or during any other inspection or

compliance review, FSIS finds a problem, it believes, however, that any

records producers have maintained in regard to compliance with these

requirements, will be helpful to FSIS and, in turn, to the industry, in

evaluating the company's control of bone solids content and bone

particle size.

B. Use Limitations and Restrictions

Most of the commenters responding to the issue regarding

limitations on the use of MSP disagreed with the Agency's position that

limitations of use in products composed of whole muscle or of MSP made

from fowl are needed. The commenters believe that there should be no

limitations on use because there are no safety or health concerns

regarding MSP. They also believe that use levels of MSP should not be

restricted because the marketplace is a better judge of the quality of

poultry products that are composed of MSP than FSIS. However, two

commenters agreed in part with the proposed limitations. The two

commenters agreed that where a poultry product is required to be

prepared from a particular Kind or Kinds of poultry (e.g., chicken),

use of MSP of any other kind (e.g., mechanically separated turkey)

should not be permitted.

FSIS also received 11 comments regarding the fluoride content of

MSP made from fowl and the use of MSP made from fowl in baby food. All

of the commenters disagreed with the proposed limitation on the use of

product made from fowl in baby foods because of potential health

implications associated with over-consumption of

[[Page 55975]]

fluoride in infants' diets. One commenter stated that based on

discussions with baby food companies, a local children's dentist,

experts from Duke University Medical Center, the University of North

Carolina School of Dentistry, and the American Academy of Pediatrics,

there is not one known documented or suspected case of fluoride

problems related to chicken in baby food. Furthermore, the commenter

stated that these people had very encouraging remarks for the positive

effects that fluoride from all food sources has had on the overall

dental health of the children in our country.

FSIS continues to believe that the use of MSP should be limited in

certain poultry products. In response to the commenters that said where

a poultry product is required to be prepared from a particular kind or

kinds of poultry (e.g., chicken), use of MSP of any other kind (e.g.,

mechanically separated turkey) should not be permitted, FSIS agrees.

This provision assures that MSP made from a certain kind of poultry is

not used in a poultry product represented as containing ingredients

from a different kind or kinds of poultry, thus avoiding situations of

misbranding.

The Agency however, agrees with comments on the proposed use

restrictions of MSP in processed products composed of whole poultry

muscle that suggested a restriction was unnecessary because the use of

MSP in a product formulation is an issue of product quality. The Agency

recognizes the increasing market popularity of convenient, ready-to-

cook or ready-to-eat products that are composed of whole poultry muscle

to which a portion of MSP is added. MSP benefits the manufacture of

such products because it is batter-like and can be molded to form a

desired product shape, and fill voids or spaces to make product shapes

uniform. The level of use of MSP that is associated with these products

exceeds the level that is used for strictly binding muscle pieces

together--an allowance that was acknowledged in the proposal. The

presence of MSP will be declared in the ingredients statement according

to the requirements in this final rule. Therefore, regardless of the

level of MSP used, consumers will have the information necessary to

make an informed purchase decision.

The Agency is also keenly aware that with the allowance for the

addition of MSP (and other highly comminuted boneless poultry products)

to products composed of whole poultry muscle there is presented an

issue regarding truthful and non-misleading product names. The names

for these products should also convey to the consumer that the product

is not composed of entirely intact, whole muscle, perhaps through the

use of a qualifying statement. It is expected that the names for

products composed of whole poultry muscle and portions of MSP, or other

boneless, comminuted poultry, would reflect this fact in their names to

make them truthful and accurate. The Agency will be assessing for

possible future policy development the broad issue of the appropriate

naming of products composed of MSP or other boneless poultry to convey

to consumers that they are not composed of intact, whole muscle, as may

be expected.

FSIS agrees with the commenters views that there is no need for a

requirement that would impose restrictions based on the potential

fluoride contribution of MSP made from fowl (i.e., mature female

chickens). In the proposed rule, FSIS proposed restricting the use of

MSP made from fowl in baby, junior, and toddler foods, citing its

concern for the potential effect of fluorosis in the susceptible

population of babies, infants, and toddlers. MSP made from fowl has

higher amounts of fluoride because the bones of older female chickens

contain more fluoride than younger chickens. In the proposal, the

Agency cited the conclusions of the 1993 National Academy of Science's

(NAS) Subcommittee on Health Effects of Ingested Fluoride (NAS Fluoride

Report)\9\ which indicated that the most effective approach to

controlling the prevalence of dental fluorosis, without jeopardizing

the benefits of fluoride to oral health, is likely to come from more

judicious control of fluoride in foods, especially those items used by

young children. The Agency requested that commenters provide any

information that would either reaffirm or contradict the conclusions

reached in the 1979 health and safety report regarding fluoride.

\9\This report is available for public review in the FSIS Docket

Clerk's office.

---------------------------------------------------------------------------

After reviewing the information submitted by commenters, and

reevaluating the findings of the NAS Fluoride Report, FSIS no longer

has a concern regarding the potential effect of fluorosis. Most

noteworthy among the information FSIS considered in withdrawing the

proposed limitation on MSP from fowl are reports of the changing

sources of fluoride ingestion, the positive effects of increased

fluoride intake on reduction of dental caries in the 1990's, and the

decrease in the ingestion of fluoride from infant formulas since 1979.

Therefore, FSIS will not impose a restriction on the use of MSP from

fowl in baby, junior, or toddler foods. Because the Agency has

concluded that MSP made from fowl should not be restricted in baby

foods, there is no longer a need to require the labeling of MSP from

fowl, as ``mechanically separated chicken, made from fowl,'' as

proposed.

In addition, in response to comments seeking clarification on the

uses of MSP, FSIS will not prohibit the use of MSP in cooked sausage

products, such as frankfurters, franks, furter, hot dogs, vienna,

bologna, garlic bologna, knockwurst, and similar products. The Agency

will permit MSP to be used alone or in combination with poultry meat in

cooked sausage products identified in 9 CFR 319.180, however, not in

excess of 15 percent of the total ingredients, not including water.

FSIS is amending 9 CFR 319.180 to allow for such use. FSIS

inadvertently omitted such a provision in the proposed regulations.

C. Labeling

Commenters had varying opinions regarding the labeling of poultry

product produced by mechanical separation as ``MSP.'' Of the 14

commenters responding to this issue, three stated that poultry product

produced by mechanical separation should be labeled as ``mechanically

separated (chicken, turkey, or other kind of poultry) with skin,''

because consumers have a ``right-to-know'' that skin and other ``by-

products'' are present. Two stated that MSP should be listed in the

ingredients statement on a product's label. Other commenters also

suggested that there should be full disclosure of all ``ingredients''

resulting from the mechanical deboning process, including bone

particles, marrow, kidneys, sex glands and lungs. Another commenter

disagreed with the Agency's proposed requirement to label MSP from fowl

as such.

In response to comments that stated that MSP should be labeled to

reflect the presence of skin, skin is a naturally existing edible

component of poultry. Consumers have historically accepted and

purchased whole poultry carcasses (e.g., ``basted young turkey'') and

parts of carcasses (e.g., ``chicken drumsticks'') with skin, as well as

cooked poultry products, e.g., fried chicken, without the presence of

skin being specifically reflected on the product's label. FSIS believes

that the presence of skin should be labeled only when it is present in

excess of natural proportions because this would be a condition in

conflict with what a consumer expects poultry to be. If skin is added

to a product and

[[Page 55976]]

is present in an amount that exceeds that found naturally on the

carcass or the part of a carcass according to the figures presented in

the regulations (9 CFR 381.117(d)), the label must reflect the presence

of skin. FSIS has determined that the name of the product (e.g.,

``Mechanically Separated (Kind of Poultry) (MSP))'' must be followed

immediately by the phrase ``with excess skin'' unless it is made from

poultry product that does not include skin in excess of the natural

proportion present on the whole carcass, as presented in the

regulations.

Furthermore, there must be appropriate descriptive terminology on

the labeling of MSP (with or without skin in excess of natural

proportions) if heat treatment has been used in the preparation of such

product, e.g., ``cooked mechanically separated (kind of poultry).''

Because cooking would affect the use of MSP, FSIS is requiring that

such characteristic be clearly identified on the label when MSP leaves

the establishment at which it is manufactured. The poultry products

inspection regulations already require that information on use,

including deviations from the natural whole carcass proportion of skin

as well as the fact of cooking, appear on the label of boneless poultry

products produced by mechanical separation (9 CFR 381.117 (d)). The

presence of skin or its presence in excess of the natural whole carcass

proportion would continue to affect product use if the regulations are

amended. The use of heat treatment in the preparation of the product

also would be of continuing relevance (9 CFR 381.157(a)). FSIS is

requiring the labeling for excess skin in MSP and for heat treatment of

MSP in order to assure consistency with regulatory requirements in 9

CFR 381.117 (d) for boneless poultry products and, thereby, to prevent

the adulteration and misbranding of finished poultry products and meat

food products.

In response to other comments on the need for disclosure of the

potential constituents of the starting materials from which MSP results

(i.e., bones with muscle tissue and other edible tissue, with or

without skin), FSIS has certain regulatory requirements in this final

rule or currently in the regulations that address bone particles,

kidneys, sex glands, and lungs that negate the need for specific

labeling of these constituents.

This final rule will continue the current limit of 1 percent bone

solids (measured as calcium) that has been applied to all boneless

poultry products since 1969. The size of bone particles has been

limited by this final rule as a process control criterion to ensure

that the process of mechanical separation is operating in accord with

good manufacturing practices. There are no health or safety issues

concerning the bone content or bone particle size criteria being

established by this rule. Furthermore, the requirement that processed

poultry (and meat food) products bear nutrition labeling that includes

a calcium declaration in the Nutrition Facts panel will provide

meaningful information to consumers who wish to monitor their calcium

intake and will reflect the calcium contributed to a product from bone.

For these reasons, specific labeling that addresses the presence of

bone and bone particles is not necessary.

In regard to the comments on the need to label the presence of bone

marrow, no factual basis was provided that would justify such labeling.

As explained below, the Agency believes such labeling is unnecessary

due to the extremely small amount of marrow that is potentially

present, the composition of marrow, the lack of any health or safety

concerns about bone marrow from poultry bones, and the role of

nutritional labeling in disclosing any potential nutritional impact

from the presence of bone marrow in a product. Discussions with poultry

scientists, physiologists and geneticists at a variety of universities

and research organizations support this conclusion. Based on the

limited available data and the discussions with these experts, the

following response to the comments on the need for labeling bone marrow

in MSP is offered.

Most of the ready-to-cook poultry marketed today are raw, uncooked

young poultry carcasses. The bones with attached edible tissue of this

class of poultry represent the bulk of the starting materials from

which MSP is produced. Young chickens, i.e., broilers, are typically

less than 7 weeks of age (although the poultry products inspection

regulations, 9 CFR 381.170, define them as being under 13 weeks). Young

turkeys are typically less than 8 months of age according to the

poultry products inspection regulations (9 CFR 381.170). The young age

at which these birds are marketed does not provide time for the

production of substantial bone content and, thus, bones from such

poultry would not contain much marrow. Moreover, the physiology of

poultry is such that, in order for the birds to fly, their bones cannot

be dense with tissue and most of the bones could be categorized as

being composed mostly of air with minimal tissue (marrow) content. In

fact, references10 indicate that the bones of most birds are

porous; many are filled with air, not marrow, and are connected to the

respiratory organs. The bones with some marrow are mostly the larger

ones, e.g., the leg bones, and are involved in blood production, the

function of ``marrow.'' In actuality, the bone marrow represents part

of the bird's vascular system.

\10\Terres, J.K., 1991. The Audubon Society Encyclopedia of

North American Birds, Wings Books, New York. A copy of this

reference is available for review in the FSIS Docket Clerk's office.

---------------------------------------------------------------------------

Information on the actual amount of marrow in poultry bones is

lacking. According to the 1979 report entitled ``Health and Safety

Aspects of the Use of Mechanically Deboned Poultry,'' marrow content

varies in amount with age of the bird, and varies between different

bones from the same bird. Determining the actual amount of marrow is

difficult because it is difficult to separate marrow from the inner

surfaces of bones, and to determine what proportion of the separated

tissue is actually ``marrow.'' Moreover, because bone marrow is

composed of fat, heme pigments, blood cells, and other constituents

normally found in the edible tissue of poultry, it would be difficult

to distinguish it from the other edible tissue comprising MSP to

determine the minimal amount that may actually be contributed to MSP.

However, with regard to the minimal contribution of bone marrow to

MSP that may be possible, it has not been reported to be a health or

safety concern. The 1979 Report, the most comprehensive review of MSP

to-date, is reliable today as an information source because the basic

composition of poultry that would be the starting materials for MSP has

not changed since the report was prepared. The 1979 Report made no

recommendations regarding the presence of marrow and the need for

specifically labeling bone marrow.

Therefore, because it has been estimated that there would be an

extremely small marrow constituent in MSP, so small and so similar in

composition to other components of MSP that it would be difficult to

quantify it, and that there are no known health or safety issues with

regard to bone marrow, there is no basis for the specific labeling of

bone marrow in MSP. If data on the quantity of bone marrow in MSP

become available at some point in the future that would present a basis

to reconsider this position, the Agency would certainly reconsider it.

[[Page 55977]]

The 1979 Report did, however, suggest that bone marrow is a

potential source of cholesterol in MSP, in addition to that contributed

by skin and muscle tissue. The 1979 Report recommended that because of

the potential contribution of cholesterol in MSP to foods, which may be

of importance to people who have the hereditary condition known as

hypercholesterolemia, it is desirable to identify products that contain

MSP. This final rule requires that the MSP in a product be labeled and,

thus, the recommendation of the 1979 Report has been accepted. More

importantly, recent regulations on nutrition labeling address the issue

of the potential contribution of cholesterol to the diet from any food.

Thus, the potential minimal contribution of marrow to the cholesterol

content of a product would be reflected in the mandatory labeling of

cholesterol, which is reflected in the Nutrition Facts panel of a

product's labeling.

As noted, raw, uncooked young poultry carcasses make up the

majority of the ready-to-cook poultry marketed today. Young poultry

carcasses are currently sold with kidneys and have been historically

sold in this manner. The presence of kidneys in young poultry does not

pose a health or safety concern because there are no constituents,

e.g., heavy metals, known to be present in these kidneys that are of

potential concern. Kidneys from young poultry can be present in the

poultry purchased at the supermarket and in the poultry products

consumed at retail fast food outlets.

FSIS does, however, require the removal of kidneys of mature

turkeys and chickens from their carcasses before completion of the

eviscerating operations during the slaughtering process (9 CFR

381.65(d)). Kidneys of mature poultry pose a potential health concern

because of the possibility of the presence of certain constituents in

these organs, e.g., heavy metals, such as cadmium, which are deposited

in the kidneys of older birds over time.

Since kidneys of young poultry pose no health or safety concern and

have been historically accepted in ready-to-cook poultry, there is no

basis to require specific labeling of these on a product's label.

Furthermore, since kidneys from mature poultry must be removed, there

is no basis for requiring labeling of kidneys from mature poultry.

In response to comments on the presence of sex glands in MSP,

mature reproductive organs (or sex glands) are precluded from being

present in ready-to-cook poultry, i.e., poultry subsequent to the

slaughtering process, by the poultry products inspection regulations (9

CFR 381.1(b)(44)). Therefore, mature sex glands cannot be present as

part of the carcasses or parts of carcasses that are the starting

materials from which MSP is made. Mature male sex glands are, however,

marketed as an edible poultry product known as ``chicken or turkey

fries'' in various regions of the United States.

There are no prohibitions on the presence of immature sex glands,

however, in poultry carcasses or parts of carcasses sold to the

consumer, or in ready-to-cook poultry used as starting materials for

MSP. Immature sex glands have historically been present in these

products because they are considered to be an indistinguishable part of

the edible tissue of poultry. The young age at which most chickens and

turkeys are marketed (as previously noted) does not provide ample time

for the development of reproductive organs, e.g., in chickens, sexual

maturity of the testes and ova does not begin until about 20 weeks of

age. At 6 or 7 weeks of age, the age at which most broilers (the source

of most starting materials for MSP) are marketed, the sex glands are

merely a thin membrane covering over undefined tissue which is no

different in biological or chemical function than other, edible tissue

of the carcass. At 6 or 7 weeks, the weight of the barely

distinguishable, inert tissue that will later become the sex glands has

been estimated to be less than a tenth of a percent of the weight of

the raw, uncooked broiler. There are no health or safety concerns

related to immature sex glands. Thus, because the tissue of immature

sex glands is virtually indistinguishable from other edible poultry

tissue and there are no health or safety concerns related to immature

sex glands, there is no need to require specific labeling of their

presence in a product.

With regard to poultry lungs, poultry lungs must be removed during

the processing of ready-to-cook poultry. Lungs are not defined as part

of the edible portion of ready-to-cook poultry and must be removed

according to the poultry products inspection regulations (9 CFR

381.1(b)(44)). Therefore, specific labeling regarding the presence of

lungs is not needed, since lungs are removed before the starting

materials used for MSP are obtained.

As noted, a comment was received on the need for the proposed

labeling requirement for MSP made from fowl. Because FSIS is not

restricting the use of MSP made from fowl, it is eliminating the

proposed labeling requirement which requires products made with

mechanically separated chicken from fowl to contain on the label the

phrase ``made from fowl'' after the product name (e.g., ``mechanically

separated chicken (made from fowl)).''

D. Nutrition

Although FSIS did not propose any specific requirements that

addressed nutrition, the Agency did receive several comments related to

``Nutrition Facts'' and cholesterol. Fifteen commenters stated that the

``Nutrition Facts'' on product labels is a reflection of the product

formula that will satisfy consumers concerning poultry product produced

by mechanical separation. Three other commenters stated that

cholesterol is not an issue in poultry product produced by mechanical

separation.

FSIS recognizes that a recommendation in the 1979 Report was to

label products containing MSP with cholesterol content information.

This recommendation was based on the evaluation of cholesterol contents

of different MSP products that showed they were nearly double the

contents in hand-deboned poultry. However, it was stated that, based on

consumption estimates, daily increases in cholesterol consumption from

use of MSP would be negligible on a per capita basis, and would not

pose a health hazard for the general public. It was noted that, for a

small segment of the population which must limit their intake of

cholesterol for health reasons, foods containing MSP should be

specifically labeled to show its presence. However, specifically

labeling cholesterol on products containing MSP is not an issue because

the provisions of the nutrition labeling regulations (58 FR 632)

published by FSIS, which were effective July 6, 1994, would be a means

of educating consumers regarding certain nutrients and other components

of processed meat and poultry products produced by mechanical deboning,

including cholesterol.

E. Safety Concern Regarding Poultry Products Produced by Mechanical

Separation

FSIS received 1426 comments regarding the safety of poultry product

produced by mechanical separation. Fourteen hundred and twenty

commenters stated that there are no safety concerns regarding the use

of poultry product produced by mechanical separation. Some of the

commenters stated that there are no bone particles of a size that would

pose a health concern. Five of the commenters believe that Hazard

Analysis and Critical Control Point (HACCP) addresses the needs for

process controls that would be related to

[[Page 55978]]

poultry product produced by mechanical separation. One commenter

suggested that the proposed rule has no conceivable relationship with

health or safety, and is a timely example of unnecessary regulation.

In addition, one commenter stated that there are microbiological

concerns specific to poultry product produced by mechanical separation.

The commenter pointed out that the skin of poultry, including pin

feathers, feather particles, and hair are sources of potential

microbiological contamination.

FSIS agrees with the commenters that there are no unique safety or

health concerns regarding the use of poultry products produced by

mechanical separation. Although the data reviewed in the 1979 Report

indicate that poultry products produced by mechanical separation

generally are acceptable from a microbiological standpoint, the data

also show that, where bacterial loads tend to be higher, it can be

attributed to the starting material used. This is not unique to poultry

products produced by mechanical separation; it can be applied to other

finely comminuted and comminuted products as well. FSIS is currently

developing a separate rulemaking on HACCP and pathogen reduction

efforts that will deal with this issue more fully for all poultry and

meat products, including poultry products produced by mechanical

separation, and the material from which they are manufactured.

F. Economic and Market Impact

FSIS received 1720 comments on the economic and market impact of

the proposed rule on industry. The comments fell into four general

categories: (1) The Agency's economic analysis was not sufficient; (2)

the new labeling requirement would reduce the demand for products

containing MSP; (3) the labeling costs are underestimated; and, (4) the

meat industry has been hurt by a similar labeling requirement. These

comments are presented and responded to below.

Adequacy of the Agency's Analysis on Economic Impacts

The Small Business Administration (SBA), citing many of the

industry objections to the proposed rule, advises that it does not

concur in the Administrator's conclusion that the proposed rule will

not have a ``significant economic impact on a substantial number of

small entities,'' and that, therefore, under the Regulatory Flexibility

Act, a more substantial economic analysis is required to support

continued rulemaking in this matter. SBA states its belief that further

analysis would reveal significant additional costs to industry and

disproportionate impacts on small entities, and would disclose other,

less burdensome regulatory options.

Others made comments similar to those of the SBA, namely, that the

economic analysis of the proposed rule was inadequate and that the

proposal constitutes a major rule requiring a far more detailed

economic analysis prior to final rulemaking.

Neither the SBA comment nor any other comment received provides

data or other evidence that would cause the Agency to alter its

estimate of the impacts outlined in the proposal or the economic

assumptions upon which they are based. No new evidence has been

provided that suggests that this rule will have a disproportionate, or

even a significant, economic impact on a substantial number of small

entities. Moreover, FSIS believes that the 12-month period prior to

implementation of the final rule and its requirements, including the

labeling requirements, will render the attendant costs to

manufacturers, including small businesses, negligible.

Proposed Requirement Would Reduce Demand for Product

Several commenters believe that the effect of the labeling

requirements will be a significant economic and market impact on

manufacturers of MSP and that the impact has not been adequately

considered by the Agency. It is their belief that this impact would

come from the fact that the new label would be unappealing to consumers

and would lead commenters to believe that the product is inferior to

what they are used to buying, or that something new has been added to

the product, or that the product has undergone other changes. This

confusion would, they believe, adversely affect demand for products

containing MSP.

One commenter indicated that many manufacturers may choose to avoid

the misleading connotations of the proposed labeling and reformulate

their products with other, more costly ingredients. The commenter

further stated that if only 25 percent of the usage of this ingredient

were curtailed on this basis, net costs to consumers from such

manufacturing decisions would exceed $134 million dollars per year.

Another commenter provided the information that the current market

price quotes for raw comminuted turkey meat (frozen, 20% skin) are less

than current price quotes for hand-deboned breast and scapula trim meat

and boneless, skinless thighs by about $0.50/lb. to $1.00/lb., in order

to illustrate that reduced purchases due to the proposed labeling would

force industry to use higher cost ingredients such as hand-deboned and

boneless meats and that such costs would be directly passed on to the

consumer.

Another commenter raised the same issue, indicating that companies

that are apprehensive about the labeling change and that fear that

their brands will be damaged by the potential negative connotation will

reformulate products with higher cost materials. According to this

commenter, reformulation will have the effect of increasing the cost of

raw materials for both poultry and red meat, ultimately raising the

consumer's cost to purchase these products. The commenter stated that

the proposal did not address the cost of replacement raw materials and

the effect on the raw materials market and believes that if these

factors were included in the economic impact, the cost would be between

$150 and $200 million.

FSIS has not acquired any reliable data to support the assertion

that this rule's labeling requirements will adversely affect the demand

for products containing MSP. FSIS believes, however, that if the rule's

labeling requirements do reduce demand to some extent for the product

or products containing MSP, then it is difficult to draw any conclusion

other than that the consumer has been misled by the absence of such

labeling.

The primary objective of the Agency's labeling authority is to

facilitate informed purchasing decisions. If, as a result of labeling

requirements, some consumers will not want the products such evidence

would strongly suggest that such labeling is needed. It is the

responsibility of FSIS to help ensure that labeling is not deceptive or

misleading, and it would be contrary to the Agency's statutory

objectives to permit misleading labeling.

The Agency does not believe, however, that it is likely that

consumers will face less choice in the market and be forced to buy

similar products with higher-cost ingredients because of this rule. In

an industry as competitive as the poultry industry, the products

demanded by the consumer will be produced. Price is an important factor

in selling products, and consumers are unlikely to abandon a popularly-

priced, high-quality product which they have found to be satisfactory

simply because it has a more informative label. Further, if some

consumers shift to their purchases to higher-priced products, it is

difficult to see why this would not be a favorable outcome for both the

consumer and the industry. The Agency

[[Page 55979]]

believes that the poultry industry is a mature and sophisticated

industry that is capable of producing and marketing any array of

products for which there is a demand, and that this rule will not

restrict or hamper the industry's ability to meet the needs and desires

of its customers.

The Red Meat Experience With Similar Labeling

One commenter stated that the meat industry's experience in a

comparable regulatory situation strongly, if not conclusively, suggests

that assumptions made in the economic analysis are invalid.

The Agency assumes this commenter is referring to the widely held

belief that product labeled as ``Mechanically Separated (Species),''

here referred to as MSM, has not been a highly profitable undertaking

for the red meat industry. The Agency has no data to confirm or refute

this proposition. It does believe, however, that the red meat and the

poultry situations are not comparable from an economic point of view.

The red meat industry never had an established market for MSM, and

it would be difficult to attribute the asserted lack of success to the

required label rather than to the decision not to try and build that

market. Further, it is not obvious that the MSM label is solely

responsible for the decision not to try to build the market. Numerous

other factors, particularly the marketing expense of launching new

products with an unknown demand, could have been a determining factor

in the decision not to try to build a new market for MSM products.

The poultry industry, on the other hand, has established markets

and satisfied consumers for products that have always been made with

MSP. Its position is, therefore, not comparable to that of the red meat

industry which would have to take a chance on new products with an

unknown consumer reception.

Labeling Costs

One commenter stated that his company would have more than 250

labels affected by this rule. The company believes that it will cost a

minimum of $1,000 for each label change, which includes internal

management time, printing costs, and obsolete label inventory.

The cost of labeling changes can be significantly reduced by

allowing companies to use up their old stocks, which the rule has

provided for by making the rule not effective until one year from its

publication date.

G. Finished Poultry Products and Meat Food Products

Several commenters disagreed with the Agency's proposed position to

regulate MSP as a distinctive ingredient with standardized

characteristics that is defined by its own name, e.g., ``Mechanically

Separated (Kind of Poultry)'' which must be declared in the ingredients

statement of finished product labels. One commenter noted that the

Agency has provided no evidence of salient differences between what

they refer to as ``finely ground poultry'' and hand-deboned poultry to

suggest that mechanically separated poultry should be regulated as

proposed. The commenter further stated that the Agency has provided no

legitimate reasons for treating mechanically separated poultry and MSM

similarly and for regulating the final products based on the process

used to make them. The commenter noted that the poultry industry uses

raw materials containing greater proportions of meat and produces a

product much lower in bone content, which is analytically similar to

whole muscle cuts from the same species.

In addition, another commenter suggested that since calcium and

cholesterol nutrition information is fully disclosed in the Nutrition

Facts panel, which is a reflection of the product formula, the term

``mechanically separated'' is not needed in the ingredients statement.

FSIS believes that such a labeling requirement is necessary to

fulfill its statutory responsibility to protect consumers by assuring

that the labels of finished poultry products and meat food products are

accurate. MSP is materially different in form and texture as compared

to hand-deboned poultry, and this is a direct result of the mechanical

separation process and the types of starting materials used to make

MSP. MSM is a similar red meat product, resulting from a similar

process. FSIS has concluded that MSP should be defined by its own name,

i.e., ``Mechanically Separated (Kind of Poultry),'' and should be

declared in the ingredients statements on finished product labels.

The starting materials used to make MSP may vary in the amount of

edible tissue remaining on the poultry bones after hand-deboning, but

the variance is minimal because a substantial portion of the muscle and

other edible tissues has already been removed by hand-deboning methods.

That a significant amount of muscle remains on the bones is not likely

because the process of mechanical separation for both poultry and

livestock has been designed to salvage the tissue left on the bones to

produce a wholesome, low-cost, and functional poultry product. The

comparison made by a commenter regarding the amount of tissue on

starting materials for making MSP and materials used to make MSM is

irrelevant. It is the fact that the process starts with bones on which

a minimal amount of tissue remains and that both processes are designed

to salvage muscle and other edible tissues, and both processes result

in a paste-like and batter-like product in terms of form and

consistency, that warrant their distinct declaration.

H. Ergonomic Impact

FSIS received several comments regarding the ergonomic impact of

this rule. According to the commenters, mechanical deboning systems

have substantially lowered the risk of cumulative trauma disorders

(CTD) resulting from repetitive hand, arm, and wrist motions. However,

the commenters indicated that industry may be forced to use more hand-

deboned products in lieu of this wholesome mechanically separated

product due to this rule. The commenters believe the rule negatively

impacts the industry's ability to use mechanical deboning and other

``mechanical'' means in harvesting meat from turkey and chicken parts

and carcasses. They indicated this is because the labeling requirements

will diminish sales and production of products containing MSP and make

the industry revert to using hand-deboned poultry.

FSIS agrees that it is likely that mechanical separation systems

have substantially lowered the risk of cumulative trauma disorders,

although there were no data supplied to document this conclusion.

However, FSIS does not agree with the assertion that this rule will

force industry to use more hand-deboned products, in lieu of

mechanically separated product, because of the requirement that use of

MSP in a product be separately reflected in a product's ingredients

statement. This assertion appears to be based on the assumption that it

would be economically feasible to hand debone the materials from which

MSP is made. However, FSIS does not believe that it would be

economically feasible for the industry to hand debone, as opposed to

mechanically separate, the bits and pieces of poultry that remain on

poultry carcasses, and parts of carcasses from which mechanically

separated product is obtained.

[[Page 55980]]

I. Miscellaneous

FSIS received other miscellaneous comments which addressed the

following issues: (1) use of MSP in the manufacture of a flavoring

should not require a separate and distinct listing of MSP as an

ingredient of the flavoring in the ingredients statement of the product

in which it is used, (2) an extension of the comment period for 30 days

should be granted, and (3) industry should be given sufficient time to

use up most of its printed labels before the final rule's new labeling

requirements become effective.

FSIS is familiar with the issue raised by the commenters that MSP

is frequently used as a protein source for ``reaction'' (or process)

flavors produced under the jurisdiction of the Food and Drug

Administration (FDA) and may currently be labeled as ``(kind) flavor''

according to the guidelines on reaction flavors established by the

Agency. FSIS does not intend to change these policies because the

chemical reactions involved in manufacturing process flavors involves

the removal of the soluble flavoring components of the poultry

ingredients and does not include the solid portion of the poultry

ingredients.

At the request of commenters, FSIS extended the comment period for

the proposed rule an additional 30 days to March 6, 1995. FSIS

considered these requests to have additional time to study and develop

information relating to the proposal to be reasonable. Also, as

discussed previously, FSIS has made its final rule effective one year

from its date of publication, which should allow ample time to use up

label stocks.

Executive Order 12866

This final rule has been determined to be significant and has been

reviewed by the Office of Management and Budget under Executive Order

12866.

Total federally inspected broiler and turkey meat production in the

United States in 1993 was about 27 billion pounds on a ready-to-cook

basis (i.e., subsequent to the slaughtering step in processing).

(Broilers represent the majority of chickens grown and slaughtered in

the U.S.) Broiler production was 22.2 billion pounds and turkey 4.8

billion pounds. Continued growth in poultry production has resulted in

large increases in the volume of poultry meat going into further

processed products such as bologna, hot dogs, fritters, patties, and

luncheon meats, many of which use MSP. FSIS has estimated that 1

billion pounds of poultry product is processed annually into MSP, with

a yield of 70%, or 700 million pounds of MSP product for human use.

(Industry sources suggest that a larger amount of MSP product is

produced annually.) FSIS estimated that 400 million pounds are used in

sausage products and 300 million pounds in patties and nuggets. In any

case, size of the market does not directly affect the cost of this rule

(see below).

The Broiler Council estimates that broiler meat is produced in

about 200 establishments, of which 50 are further processing

establishments. MSP is produced in about 108 establishments. About 25-

30 of these establishments with MSP equipment produce hot dogs. The

product from the other 75-80 establishments is sold to establishments

that further process poultry or to red meat processors. Industry

sources indicate that some small firms specialize in MSP production,

buying carcasses from poultry slaughter establishments for further

processing.

Based on inspection task records, FSIS estimated that 108

establishments produce (or are capable of producing) MSP. An assessment

of MSP production by establishment size is not available. However,

total further processed product production by size of establishments

shows 7 establishments with production less than 10,000 pounds of MSP

annually. The average production of the 108 establishments is 51

million pounds of all further processed products.

Under this rule, products containing mechanically separated poultry

are required to separately label ``Mechanically Separated (Kind of

Poultry)'' in the list of ingredients. There is no precise information

on the total number of products that currently contain MSP because MSP

may appear simply as ``chicken'' or ``turkey'' in product formulations

in which it is an ingredient. However, an estimate of the number of

products containing MSP can be made by estimating the number of labels

for MSP and for categories of products to which it is frequently added.

These estimates were made by using the database of label information

that is maintained by FSIS' Food Labeling Division, as part of the

Agency's prior label approval system. There are 602,000 approved labels

for poultry and meat, not all of which are necessarily in use. These

include 529 labels for MSP itself. There is also an unknown number of

labels for products containing MSP, such as frankfurters, chili,

bologna, poultry baby foods, chicken nuggets or patties. FSIS estimates

that, in total, about 5,000 products would require relabeling. There is

no currently available data on the size breakdown of the establishments

producing products containing MSP.

Costs and Benefits of the Rule

Analysis of the economic impact of a rule requires consideration of

all significant costs and benefits.

Benefits

The benefits are the values consumers place on the ability to make

a more informed purchase based on more accurate labeling. Informed

purchases, which in this case result from accurate labeling, are an

essential principle of the free market in which meat and poultry

products trade and one of the principal justifications for the

regulation of labels. FSIS has a statutory mandate to avoid false and

misleading labeling. Therefore, if, as the Agency has determined here,

a label is misleading or false, the Agency has a responsibility to

correct that situation.

As discussed earlier in the preamble to this rule, several

commenters suggested that the labeling requirements of the rule would

adversely affect demand for products made with MSP. FSIS has not

acquired any data that can be used to estimate the impact this rule

will have on the demand for MSP. However, the Agency's experience is

that consumers do distinguish between muscle meat and more finely

comminuted product. It is also apparent that there are texture

differences in these two types of products. The public comments on this

action have reinforced this belief. Many commenters have stated that

they believe consumers will not buy the product if it is labeled under

the new requirement. Further, the producers of a similar red meat

product, which already requires labeling of the type promulgated by

this rule, claim that the required labeling keeps the public from

buying their product. The Agency has not quantified the magnitude of

change in consumer demand under the present rule, but it does recognize

that these comments demonstrate there is widespread recognition that

comminuted product could be viewed less favorably than muscle meat by

the consumer.

Furthermore, as also discussed earlier in the preamble to this

rule, the Agency has concluded that use of the term ``mechanically

separated'' truthfully describes the nature of the product and that

purchases of MSP using this label will accurately reflect the real

value placed on it by consumers.

As a result of the current labeling practices, consumers are being

misled and are possibly consuming more MSP than they otherwise would if

they had better information. The extent to which

[[Page 55981]]

consumers reduce their demand for this product as a result of the

labeling change will reflect the level to which consumers have been

misled. The increased value placed by consumers on inaccurately labeled

MSP products represents a welfare loss to consumers and society. The

misdirected purchasing power placed on inaccurately labeled MSP

products could be used to purchase other products of higher value to

consumers. The greater the change value placed on this product by

consumers, the greater the benefits of the rule. Revenue losses

producers experience due to this shift in consumer demand are not

social welfare losses, but instead represent resources misallocated

toward the excess production of products containing MSP. To the extent

that market prices for products containing MSP decline in response to

shifts in consumer demand, losses experienced by producers represent

gains to consumers and, thus, are in fact transfer payments from

producers to consumers.

Taking into account consumer experience with MSP leads the Agency

to believe that any change in consumer behavior will be negligible, and

FSIS has not acquired any data to show any negative impact on poultry

or poultry products made with MSP. The Agency also believes that MSP

should continue to be a wholesome and safe low-cost source of protein

with nutritional attributes comparable to ``chicken'' or ``turkey.'' As

discussed earlier, MSP has certain desirable attributes that will

ensure its continued use as an ingredient in many products.

Costs

The Agency recognizes that it has a responsibility to keep the cost

impact of this rule to a minimum to keep the burden of regulation as

low as possible on the industry. It has done this by giving sufficient

time for most businesses to use up their inventory of labels, thus

substantially reducing the cost associated with the rule.

Possible sources of costs associated with the rule include the

following items:

A. Labeling Changes and Inventory

Under the final rule, finished products containing mechanically

separated poultry are required to have ingredient statement labeling of

the mechanically separated poultry as ``Mechanically Separated (Kind of

Poultry).'' As reported in the proposed rule, estimates range from $200

to $3,000 per product for a simple product ingredient statement label

change depending on the type of label. Comments in response to the

March 1994 ANPR indicate that changes to the ingredients statement of

most labels to which the final rule will apply would fall in the lower

end of this range (about $600). FSIS previously reported in the

proposal that, assuming an average cost of $1,000 per product, the cost

of relabeling would be $5 million ($1,000 times 5,000 products). These

estimated costs that were reported in the proposed rule assumed a

typical 30-day effective date for implementation of the final rule and

its requirements.

However, by establishing the one-year period from publication to

the effective date for implementation of the final rule, labeling costs

would be substantially reduced. The cost of relabeling would be

negligible because the mandated MSP label changes can be coordinated

with other label changes planned or required during the year-long

period prior to the effective date of the MSP rule. Many firms

routinely make label changes for existing products. For example, about

50% of the 180,000 labels submitted to FSIS each year for approval are

for label changes on existing products. These label changes are made

for various reasons that reflect the kinetic nature of the food

industry and, in particular, the fast-paced research and development of

new and modified meat and poultry products, e.g., changes to

incorporate less costly, new, or more effective ingredients that extend

shelf-life, improve taste or texture, or replace fat; changes to add

recipes or consumer purchase incentives to labeling; changes to make

new or different claims about a product's nutrient content or

performance; changes to alter features such as net weight or logos; or

changes to modify the color or size of print. These new MSP labeling

requirements, therefore, can be worked in with other routine label

changes. The modest costs associated with the MSP labeling change are

nonetheless necessary to assure that consumers receive meat and poultry

products with informative and nonmisleading ingredients statements.

Some firms may discard non-compliant labels when the final rule

goes into effect. A survey of meat and poultry companies for the

nutritional labeling rule indicated that firms carry an average label

inventory of 5 to 6 months. Knowing this, FSIS established a 12-month

period to allow ample time for an orderly transition to the new

requirements of the rule, including the labeling requirements, and to

assure that manufacturers of MSP, and of poultry and meat food products

in which MSP is used as an ingredient, have ample time to exhaust

current label stock. Therefore, it is not anticipated that

manufacturers will have to dispose of label inventories that were

printed or ordered for printing prior to publication of the rule. Thus,

with the 12-month compliance period, inventory losses, if any, would be

minor.

B. Bone Particle Size

A new requirement limits maximum bone particle size. FSIS believes

bone particle size will not have a significant effect on actual

production and is a measure that augments the current requirement of

one percent or less bone solids to show that the process of separating

bone from meat is operating effectively. As previously stated, FSIS did

not in its proposal, nor is it in this final rule, requirement testing

or sampling for bone particle size in MSP. The Agency has concluded

that manufacturers should have the flexibility to decide how best to

assure compliance with the bone particle size requirement.

Furthermore, the Agency agreed with commenters, as stated

previously, that the requirements for keeping records on bone particle

size (and bone solids) should not be mandated and, in this respect,

will permit flexibility in meeting the rule's requirements. Thus,

additional potential costs have been eliminated.

C. Other Costs

The Agency does not agree with the view presented by many

commenters that any reduction in income from the reduction of

consumption of MSP product labeled under the new requirement should be

considered a cost of this rule. To the extent that purchasers reduce

their consumption of MSP products because of the new labeling, the

revenue received by the industry from such purchases is really revenue

derived rom an inaccurate and misleading label, and are not properly

considered as costs attributable to this rule given the statutory

mandate.

Executive Order 12778

This final rule has been reviewed under Executive Order 12778,

Civil Justice Reform. States and local jurisdictions are preempted

under the Federal Meat Inspection Act (FMIA) and the Poultry Products

Inspection Act (PPIA) from imposing with respect to the premises,

facilities, and operations of federally inspected establishments any

requirements that are in addition to, or different than, those imposed

under the FMIA or PPIA. States and local jurisdictions may, however,

impose recordkeeping and other requirements within the scope of section

202 of the

[[Page 55982]]

FMIA and section 11 of the PPIA, if consistent therewith, with respect

to any such federally inspected establishment. States and local

jurisdictions are also preempted under the FMIA and the PPIA from

imposing any marking, labeling, packaging, or ingredient requirements

on federally inspected meat and poultry products that are in addition

to, or different than, those imposed under the FMIA and PPIA. States

and local jurisdictions may, however, exercise concurrent jurisdiction

over meat and poultry products that are outside official establishments

for the purpose of preventing the distribution of meat and poultry

products that are misbranded or adulterated under the FMIA or PPIA, or,

in the case of imported articles, which are not at such an

establishment, after their entry into the United States. Under the FMIA

and PPIA, States that maintain meat and poultry inspection programs

must impose requirements that are at least equal to those required

under the FMIA and PPIA. The States may, however, impose more stringent

requirements on such State inspected products and establishments.

No retroactive effect will be given to this final rule. The

administrative procedures specified in 9 CFR 306.5 and 381.35 must be

exhausted prior to any judicial challenge to the provisions of this

final rule, if the challenge involves any decision of a program

official. The administrative procedures specified in 9 CFR parts 335

and 381, subpart W, must be exhausted prior to any judicial challenge

to the application of the provisions of this rule with respect to

labeling decisions.

Effect on Small Entities

The Administrator has determined that this final rule will not have

a significant economic impact on a substantial number of small

entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).

Because the implementation date for this final rule provides ample time

for transition to the new requirements, including the labeling

requirements, producers with smaller lot size than large producers will

not have higher compliance costs per pound of product because of

relabeling costs attributable to the rule. By establishing the one-year

effective date for implementation of the final rule, new labeling costs

will be substantially reduced. The cost of relabeling would be

negligible because the mandated MSP label changes can be coordinated

with other label changes planned or required during the year-long

period prior to the effective date and implementation of this rule.

Paperwork Requirements

This final rule will allow establishments to voluntarily maintain

records of bone solids content and bone particle size as a measure of

process control. FSIS will allow manufacturers flexibility to determine

the best methods for compliance with these requirements, provided such

procedures and methods are in accord with good manufacturing practices.

This final rule will also require labels of poultry products

produced by mechanical separation (i.e., products currently termed

mechanically deboned poultry or MDP) or products containing this

ingredient to be revised to include in the ingredients statements the

term ``Mechanically Separated (Kind of Poultry)'' and be submitted to

FSIS for approval. However, by providing a one-year period between

publication of this rule and the effective date for implementation,

labeling costs will be substantially reduced. The cost of relabeling

would be negligible because the mandated MSP label changes can be

coordinated with other label changes planned or required to meet other

regulatory tenets during the year-long period of promulgation of the

MSP rule and its enforcement.

The paperwork requirements contained in this final rule have been

approved by the Office of Management and Budget under control number

0583-0101.

List of Subjects

9 CFR Part 318

Meat inspection.

9 CFR Part 319

Meat inspection, Standards of identity

9 CFR Part 381

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

Final Rule

For the reasons set forth in the preamble, FSIS is amending 9 CFR

parts 318, 319, and 381 of the Federal meat and poultry inspection

regulations as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS: REINSPECTION AND

PREPARATION OF PRODUCTS

1. The authority citation for part 318 continues to read as

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.

601-695; 7 CFR 2.17, 2.55.

2. Section 318.6 is amended by adding a new paragraph (b)(13) to

read as follows:

Sec. 318.6 Requirements concerning ingredients and other articles used

in preparation of products.

* * * * *

(b) * * *

(13) Use of ``Mechanically Separated (Kind of Poultry),'' as

defined in Sec. 381.173 of this chapter, in the preparation of meat

food products shall accord with Sec. 381.174 and all other applicable

provisions of this subchapter.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

3. The authority citation for part 319 continues to read as

follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR

2.17, 2.55.

4. Section 319.180 is amended by revising the sixth sentence of

paragraph (a) and the seventh sentence of paragraph (b).

Sec. 319.180 Frankfurter, frank, furter, hot dog, weiner, vienna,

bologna, garlic bologna, knockwurst, and similar products.

(a) * * *. Such products may contain raw or cooked poultry meat

and/or Mechanically Separated (Kind of Poultry) without skin and

without kidneys and sex glands used in accordance with Sec. 381.174,

not in excess of 15 percent of the total ingredients, excluding water,

in the sausage, and Mechanically Separated (Species) used in accordance

with Sec. 319.6. * * *

(b) * * *. These sausage products may contain poultry products and/

or Mechanically Separated (Kind of Poultry) used in accordance with

Sec. 381.174, individually or in combination, not in excess of 15

percent of the total ingredients, excluding water, in the sausage, and

may contain Mechanically Separated (Species) used in accordance with

Sec. 319.6. * * *.

* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for part 381 continues to read as

follows:

Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR

2.17, 2.55.

4. Section 381.15 is amended by revising paragraphs (a)(1), (a)(2),

(b)(2), and (c)(1) to read as follows:

Sec. 381.15 Exemption from definition of ``poultry product'' of

certain human food products containing poultry.

* * * * *

(a) * * *

(1) It contains less than 2 percent cooked poultry meat (deboned

white or dark poultry meat, or both) and/or

[[Page 55983]]

``Mechanically Separated (Kind of Poultry)'' as defined in

Sec. 381.173;

(2) It contains less than 10 percent of cooked poultry skins,

giblets, or fat, separately, and less than 10 percent of cooked poultry

skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1)

of this section) or ``Mechanically Separated (Kind of Poultry)'' as

defined in Sec. 381.173, in any combination;

* * * * *

(b) * * *

(2) It contains less than 15 percent cooked poultry meat (deboned

white or dark poultry meat or both) and/or ``Mechanically Separated

(Kind of Poultry) `` as defined in Sec. 381.173, computed on the basis

of the moist deboned, cooked poultry meat and/or ``Mechanically

Separated (Kind of Poultry)'' in such product; and

(3) * * *

(c) * * *

(1) They contain poultry meat and/or ``Mechanically Separated (Kind

of Poultry) `` as defined in Sec. 381.173 or poultry fat only in

condimental quantities;

* * * * *

5. Section 381.117 is amended by revising the section title and

adding a new paragraph (e) to read as follows:

Sec. 381.117 Name of product and other labeling.

* * * * *

(e) On the label of any ``Mechanically Separated (Kind of Poultry)

`` described in Sec. 381.173, the name of such product shall be

followed immediately by the phrase: ``with excess skin'' unless such

product is made from poultry product that does not include skin in

excess of the natural proportion of skin present on the whole carcass,

as specified in paragraph (d) of this section. Appropriate terminology

on the label shall indicate if heat treatment has been used in the

preparation of the product. The labeling information described in this

paragraph shall be identified on the label before the product leaves

the establishment at which it is manufactured.

6. Subpart P is amended by adding new Secs. 381.173, and 381.174 to

read as follows:

Sec. 381.173 Mechanically Separated (Kind of Poultry) .

(a) ``Mechanically Separated (Kind of Poultry)'' is any product

resulting from the mechanical separation and removal of most of the

bone from attached skeletal muscle and other tissue of poultry

carcasses and parts of carcasses that has a paste-like form and

consistency, that may or may not contain skin with attached fat and

meeting the other provisions of this section. Examples of such product

are ``Mechanically Separated Chicken'' and ``Mechanically Separated

Turkey.''

(b) ``Mechanically Separated (Kind of Poultry)'' shall not have a

bone solids content of more than 1 percent. At least 98 percent of the

bone particles present in ``Mechanically Separated (Kind of Poultry) ``

shall have a maximum size no greater than 1.5 mm (millimeter) in their

greatest dimension and there shall be no bone particles larger than 2.0

mm in their greatest dimension.

(c) ``Mechanically Separated (Kind of Poultry)'' shall not have a

calcium content exceeding 0.235 percent when made from mature chickens

or from turkeys as defined in Sec. 381.170(a)(l)(vi) and (vii) and

(a)(2), respectively, or 0.175 percent when made from other poultry,

based on the weight of product that has not been heat treated, as a

measure of a bone solids content of not more than 1 percent.

(d) ``Mechanically Separated (Kind of Poultry)'' may be used in the

formulation of poultry products in accordance with Sec. 381.174 and

meat food products in accordance with subchapter A of this chapter.

(e) Product resulting from the mechanical separation process that

fails to meet the bone particle size or calcium content requi

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