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

SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to

amend the Federal poultry products inspection regulations to prescribe

a definition and standard of identity and composition for the finely

comminuted poultry product that results from the mechanical separation

and removal of most of the bone from poultry carcasses and parts of

carcasses (``Mechanically Separated (Kind) (MS(K))'' including

requirements for bone solids content (measured as calcium content) and

bone particle size; specify certain limitations for the use of MS(K);

establish recordkeeping requirements for bone solids content and bone

particle size; and establish labeling requirements for MS(K), and for

poultry products and meat food products containing MS(K) as an

ingredient. This proposed action is intended to establish the Agency's

requirements with respect to poultry products produced by mechanical

separation, including the requirement that they be labeled as, in the

case of MS(K) derived from chicken carcasses, ``mechanically separated

chicken.'' Such action would help ensure that meat and poultry products

distributed to consumers are not labeled in a false or misleading

manner and are not misbranded.

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

ADDRESSES: Written comments to: Policy, Evaluation and Planning Office,

Attn: Diane Moore, FSIS Docket Clerk, Room 3171, South Building, Food

Safety and Inspection Service, U.S. Department of Agriculture,

Washington, DC 20250. Oral comments should be directed to Mr. John W.

McCutcheon, (202) 720-2709. (See also ``Comments'' under

``Supplementary Information.'')

FOR FURTHER INFORMATION CONTACT: John W. McCutcheon, Deputy

Administrator, Regulatory Programs, Food Safety and Inspection Service,

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

720-2709.

SUPPLEMENTARY INFORMATION:

Purpose of the Proposal

This proposal would amend the regulatory requirements for the

finely comminuted poultry product resulting from the mechanical

separation and removal of most of the bone from poultry carcasses and

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

products in which this product is used as an ingredient. The Department

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

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

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

an ingredient, has increased significantly. Moreover, the Department

has gained a great deal of knowledge from its rulemakings regarding the

livestock product resulting from the mechanical separation and removal

process which is called Mechanically Separated (Species) (MS(S)). More

recently, in a lawsuit, Bob Evans Farm, Inc. et al., v. Mike Espy,

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

meat sausage manufacturers alleged that, without a regulatory

definition and standard for poultry products produced by mechanical

separation, a disparate situation exists between labeling mechanically

separated poultry and the livestock product resulting from the

mechanical separation and removal process for which a regulatory

definition and standard exist. The red meat sausage manufacturers have

alleged that the disparate labeling situation poses an unfair advantage

for the manufacturers of mechanically separated poultry products.

In view of these developments, and taking into account the

information and experience acquired since 1969 and current regulatory

policies, the Agency reviewed and reevaluated the existing regulations,

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

and reevaluation, the Agency believes that further regulatory action is

necessary pursuant to its statutory responsibilities to protect the

public and prevent the preparation and distribution in commerce of

poultry products and meat food products which are misbranded or not

properly marked, labeled, or packaged. See sections 4(h) and 8 of the

Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) and

sections 1(n) and 7 of the Federal Meat Inspection Act (FMIA) (21

U.S.C. 601 et seq.); 21 U.S.C. 453(h), 457 and 601(n), 607. In

particular, the Department now believes:

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

separation and removal of most of the bone from the meat and other

tissues of poultry carcasses and parts of carcasses results in a

product whose physical form and texture differ materially from those of

other boneless poultry products produced by traditional deboning

techniques. Mechanically separated poultry is derived using a machine

that operates on the differing resistance of bone and tissue to passage

through small openings, whether it employs sieves, screens, or other

devices. Such machines mechanically separate and remove most of the

bone from poultry carcasses and parts of carcasses resulting in a

finely comminuted, paste-like product. The starting materials, which

may have undergone an initial bone breaking process, are pushed under

high pressure through equipment with apertures that allow a small

amount of powdered bone to pass through with the soft tissue. This is

different than boneless poultry derived by traditional means, i.e.,

hand-deboning, and such differences have potential consequences for

consumer expectations. FSIS has statutory responsibilities under the

PPIA and FMIA to assure that consumers receive poultry and meat food

products that are not adulterated and that bear labeling that is not

false or misleading. Despite this, the regulations do not distinguish

between poultry products produced by mechanical separation and poultry

products produced by traditional deboning techniques, i.e., hand-

deboning, in terms of product identity and composition or use.

(2) Mechanically separated poultry is produced by essentially the

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

texture) similar to those of the livestock product, MS(S). Yet, the

regulatory requirements for labeling these two products currently are

inconsistent with one another.

Therefore, the Department is proposing to amend the poultry

products inspection regulations (9 CFR Part 381) to revise and

supplement the requirements for the manufacture, characteristics, and

labeling of poultry products produced by mechanical separation and the

labeling of products in which they are used as ingredients. Under this

proposal, mechanically separated product derived from chicken or turkey

would be labeled as ``mechanically separated chicken'' or

``mechanically separated turkey,'' as the case may be.

Background

I. Introduction

Poultry products produced by mechanical separation, also referred

to as mechanical deboning, are characteristically finely comminuted

(i.e., finely ground) in form and result from the mechanical separation

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

tissue of poultry carcasses and parts of carcasses. The products are

prepared from various materials, including necks, backs, and whole

carcasses. These starting materials may be raw or cooked, may contain

varying amounts of muscle and/or skin, and may contain kidneys, except

when product is made from mature chickens or mature turkeys. Kidneys of

mature chickens or turkeys may not be used as human food (9 CFR

381.65(d)).

The technology to mechanically separate and remove most of the bone

from attached skeletal muscle and other tissue of poultry carcasses and

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

Agency's initial reaction was to consider the resulting product

adulterated because of the amount of bone present and the physical size

of the bone particles. By the mid-1960's, the industry had modified and

improved the equipment used to produce poultry product by mechanical

separation such that the product contained 1 percent or less bone

solids with an extremely small bone particle size. This prompted the

Agency to reevaluate its position. Widespread commercial production of

products containing mechanically separated poultry began in the early

1970's. By 1975, poultry product produced by mechanical separation was

being used as an ingredient in poultry and meat food products such as

franks, bologna, salami, and rolls.

Today, poultry products made with poultry produced by mechanical

separation include cooked poultry sausages (such as chicken

frankfurters, turkey salami, and turkey bologna), poultry patties and

nuggets (such as chicken patties and nuggets), and poultry baby foods.

The level at which it is used has depended in part on technological

capabilities and has reached 100 percent of the poultry product portion

of a number of cooked poultry sausage products. Poultry product

produced by mechanical means is also used at up to 49 percent of the

formulations of certain meat food products, e.g., beef and turkey

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

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

sausages, such as frankfurters and bologna, at a level of up to 15

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

without being identified in the product name.

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

referred to poultry products produced by mechanical means as

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

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

used on poultry product labels to describe the form (i.e., physical

appearance) and composition of the product according to 9 CFR

381.117(d).

Poultry products produced by mechanical means are currently subject

to 9 CFR 381.117(d) relating to boneless poultry products. This

regulation requires boneless poultry products to be labeled in a manner

that accurately describes their actual form and composition. The

product name must indicate the form of the product, e.g., emulsified or

finely chopped, and the kind name of the poultry from which it is

derived. If the product does not consist of natural proportions of skin

and fat, as they occur in the whole carcass, the product name must also

include terminology that describes the actual composition. If the

product is cooked, it must be so labeled. Section 381.117(d) also

limits the bone solids content of boneless poultry products to 1

percent.

Existing regulations do not distinguish between boneless poultry

products produced by mechanical separation and poultry products

produced by traditional methods, e.g., hand-deboning. Poultry product

produced by mechanical separation is declared in the ingredients

statement of a product in which it is used, along with any other

boneless poultry product used, as ``chicken'' or ``turkey'' where skin

and fat are included but not in excess of their natural proportions, or

as ``chicken meat'' or ``turkey meat'' when skin with attached fat is

not included.

II. Report on Health and Safety of Mechanically Deboned Poultry

In 1976, the Department initiated an analytical program to obtain

data on a number of nutrients and substances of potential health

concern in poultry products produced by mechanical separation. Data

were also gathered from scientific literature, industry, other

government agencies, and university scientists. Details of the

analytical program and a resulting evaluation were published in a June

1979 report entitled ``Health and Safety Aspects of the Use of

Mechanically Deboned Poultry'' (hereafter referred to as the 1979

Report). An errata supplement correcting certain items in the report

was prepared and published on August 14, 1979 (44 FR 47576). (The 1979

Report and the errata supplement are available for public inspection in

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

the availability of this report and encouraged interested members of

the public to comment on its content. The Department also notified the

public that it was particularly interested in receiving comments

regarding the proper labeling of products containing poultry product

produced by mechanical separation and what means, if any, should be

taken to implement the labeling recommendations in the report (44 FR

37965).

The Department received 221 comments, most of which were general

reactions to the labeling issues raised in the notice, and health,

safety, or economic concerns. Of the 187 commenters that expressed a

general opinion on the adequacy of the regulations concerning

mechanically deboned poultry products, 175 were supportive. Some

commenters stated that the regulations have effectively controlled the

use of product produced by mechanical separation over many years with a

wide base of consumer acceptance, that such product is not

significantly different from product produced by hand-deboning, that

these regulations provide truthful labeling, and/or that the report and

scientific literature support the adequacy of current regulations.

Other commenters indicated that mechanically deboned poultry should be

regulated the same as mechanically separated (species) (MS(S)) (then

named mechanically processed (species) product).

III. GAO Report on Mechanically Separated Products

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

recommending that the Secretary of Agriculture direct the Administrator

of FSIS to establish specific standards on poultry products produced by

mechanical separation and labeling requirements on products made with

such poultry products as had been done for MS(S) and products made with

MS(S). MS(S) is a finely comminuted product resulting from the

mechanical separation and removal of most of the bone from attached

skeletal muscle of livestock carcasses and parts of carcasses that

meets the provisions of 9 CFR 319.5.

IV. Improvements in Machinery for Poultry Products Produced by

Mechanical Separation

The Agency has monitored the advances in the technology for

mechanically separating poultry, also referred to as mechanical

deboning, over the last decade. There have been improvements in the

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

from attached skeletal muscle and tissue of poultry carcasses and parts

of poultry carcasses. Today, it has been estimated that roughly 1

billion pounds of raw poultry materials are used to manufacture 700

million pounds of mechanically separated poultry, also referred to as

mechanically deboned poultry (MDP), which is used, in turn, to

formulate approximately 400 million pounds of poultry sausages

(including franks, bologna, and salami), and 300 million pounds of

poultry nuggets and poultry patties.\1\ There have been major advances

in mechanical deboning machinery in terms of the effectiveness of bone

removal from skeletal muscle and other tissues of poultry carcasses and

parts of carcasses. This has been accomplished through enhancements and

modifications of the bone-removal devices that are part of the

mechanical deboning machines. There have been continued refinements of

certain operational parameters of the machinery, e.g., the ability for

operators to adjust the pressure needed to force ground poultry bones

with adhering muscle and other tissues through screens to separate

muscle and other tissues from bone, and the size of the apertures

(i.e., holes) in the screens and sieves through which the ground bones,

muscle, and other tissues are pushed.

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

\1\Information provided by industry is available for public

inspection at the FSIS Docket Clerk's office.

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

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

products inspection to, among other things, provide labeling

requirements for boneless poultry products, as well as a prescribed

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

limit was based on an evaluation conducted by the Department of the

operating results in a series of poultry establishments that used

mechanical deboning equipment. Analyses were made of 485 samples of

raw, mechanically deboned product from nine commercial operations that

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

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

under commercial conditions to produce boneless poultry that contained

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

Department concluded that it was demonstrated that it was practical to

limit the bone content in deboned poultry to 1 percent.

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

machinery used to mechanically separate and remove most of the bone

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

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

of mechanically separated poultry.\2\ The percentage of bone solids

content (determined by calcium analysis) in boneless poultry products

produced by mechanical deboning was collected from approximately 50

establishments during August 1993, and represented a sampling of over

2000 products. The data indicate that the mean bone solids content of

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

half of the samples were above 0.6 percent and half were below 0.6

percent.

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

\2\Data available for public inspection at the FSIS Docket

Clerk's Office.

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

V. RTI Study

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

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

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

the meat and poultry inspection regulations. RTI found many differences

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

regulations where significant differences exist.\3\ FSIS has studied

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

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

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

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

\3\A copy of the RTI study is available for public inspection in

the FSIS Docket Clerk's office.

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

Among the areas identified in the RTI study is mechanically

separated product. It notes that regulations exist on the use of MS(S),

but not on the use of MDP. The RTI study concluded that, in general,

``the regulations covering meat and poultry have been designed with the

same intent--to protect `the health and welfare of consumers by

assuring that meat and meat food products [or poultry products] are

wholesome, not adulterated, and properly marked, labeled, and packaged'

(21 U.S.C. 602 and 451). Although the intent of the regulations remains

the same, the actual requirements are quite different.'' The study

further concludes that the bases for no comparable regulation for MDP

are ``unfavorable consumer perceptions and court decisions resulting in

label and use restrictions for MS(S); poultry has no definitional

requirements for MS(S) (e.g., can be defined as `chicken' or

`turkey').''

Mechanically separated red meat food product became the subject of

consumer criticism in the mid-1970's after USDA proposed to allow its

use in meat products and to allow it to be labeled as meat (i.e., beef

or pork). USDA also issued an interim rule that included standards for

the use of mechanically separated red meat product. A lawsuit soon

followed in which the court found that this product is not ``meat'' as

traditionally defined within the scope of the Federal Meat Inspection

Act. The court further found that USDA had not considered adequately

the health and safety effects of mechanically separated red meat food

product.

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

panel of government scientists was convened to examine the questions.

The panel found that scientific studies established no unique health

risks associated with mechanically separated red meat food product, but

that the product is sufficiently different from muscle tissue meat in

consistency and composition to require separate labeling. The panel

recommended, among other things, that usage limitations be placed on

this product.4

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

\4\The panel's conclusions and recommendations were published in

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

Mechanically Deboned Meat, Volume I--Final Report and

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

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

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

public review in the FSIS Docket Clerk's office.

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

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

regulations on June 20, 1978, that established preparation,

composition, usage, and labeling requirements for mechanically

separated red meat food product and required that it be produced only

under a quality control program approved by the Agency (43 FR 26416).

This rule established a definition and standard of identity for this

product that necessitated it being listed separately from meat in the

ingredients statement of a product in which it was used. Additional

rulemaking on June 29, 1982, reaffirmed the Agency's position that the

product, now called MS(S), is not ``meat'' as traditionally defined (47

FR 28214).

During this same period, MDP underwent product development

separately from mechanically separated red meat food product without

similar FSIS regulation. Early distinctions in regulatory treatment

were largely due to historical differences in how the two industries

used these products and the way in which they came to public attention.

One significant difference is that mechanically separated red meat food

product was being considered for use in products that had previously

contained muscle meat. The use of MDP in poultry hotdogs created less

controversy. Poultry hotdogs did not exist before they were made with

MDP. Thus, consumers had no prior expectations about the formulation.

Differences in regulatory treatment of the product, now called

MS(S), and MDP have continued since that time. The meat industry claims

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

of processors to use MS(S), while MDP use has expanded. In response to

the early rulemakings on MS(S), the meat industry claimed that

consumers would not buy products if MS(S) is listed on the label.

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

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

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

ingredient, consumers would be misled into thinking that they are

purchasing products inferior to what they have historically purchased

or that the product has changed. If the industry believes that

consumers will be misled into thinking the product has changed, it

should find some way other than inaccurate labeling to assure them it

is the same product. The Agency believes that if the current labeling

is misleading, it has no choice but to assure that the ingredients

statement accurately informs the consumer what is in the product. If

consumers would behave differently with different information, then

that is itself evidence that the information is important to them. It

is the Agency's responsibility under its consumer protection mission to

assure the information is accurate and not misleading.

The Agency's regulation on the use of MS(S) and the absence of

regulation on the use of MDP have raised two major policy issues. The

first is whether current regulations are adequately protecting

consumers. The second is whether different regulatory treatment for

these similar products is justified. FSIS is not proposing this

regulation because of the current differences in the regulatory

treatment of MDP and MS(S), but rather because its basic statutory

mission is to assure that products bear labeling that is truthful and

not misleading. Accordingly, FSIS has determined that providing this

assurance requires the regulation of MDP.

V. Advance Notices of Proposed Rulemaking

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

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

scientific data, and recommendations regarding the consideration of the

need for labeling of poultry product produced by mechanical separation

and products in which such poultry product is used. FSIS received 2744

comments in response to the ANPR, most of which were general reactions

to labeling issues. The majority of commenters responded to whether

there was a need to identify mechanically separated poultry in the

ingredients statement on the labels of meat and poultry products in

which it is used as an ingredient. One thousand four hundred eighty-

seven commenters supported identifying mechanically separated poultry

in the ingredients statement because, the commenters stated that, among

other things, consumers have ``a right to know'' it is an ingredient.

One thousand two hundred fifty-seven commenters did not support

identifying mechanically separated poultry in the ingredients

statement, citing, in part, that current policies are satisfactory and

that labeling it would mislead consumers into thinking that they are

purchasing products that are inferior or different than the product

they have historically purchased. FSIS concluded that there is a

``truth-in-labeling'' issue that is founded in the mandate under which

the Agency operates, viz., protecting consumers from misbranded poultry

and meat products.

Subsequently, FSIS decided to obtain the information and data

necessary to pursue the development of amendments to the Federal

poultry products inspection regulations to define and standardize, or

establish other requirements for poultry products produced by

mechanical separation, including possible provisions for the

composition, characteristics, and use of such products, and

requirements for manufacturing and labeling such products. On March 3,

1994, FSIS published another ANPR (59 FR 10230) which solicited

comments and information from the meat and poultry industries and

industry-related organizations, the scientific community, academia,

consumers and consumer groups, and other interested parties on its

tentative positions regarding poultry products produced by mechanical

separation and products in which such poultry products are used.

In the March 1994 ANPR, FSIS considered, among other things, that

certain poultry products produced by mechanical separation, i.e., those

with greater than 0.6 percent bone solids content, but no more than 1

percent bone solids content be separately identified on the labels of

products in which they are used as ingredients by a distinct name.

However, because of the improvements in separating the bone from muscle

and other tissues of poultry carcasses and parts of carcasses, FSIS

considered that some poultry products derived from mechanical

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

be identified on the label of products in which they are used as

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

VI. Discussion of Comments on March 1994 ANPR

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

Fifty-one comments were submitted by food manufacturers/distributors,

44 comments by consumers, 7 by trade associations, 2 by academia, 1 by

a law firm, and 1 by a developer of machinery. The majority of the

comments did not support the ANPR. The comments are summarized below.

A. Bone Solids Content and Labeling. According to the tentative

positions presented in the March 1994 ANPR, the tentative provisions

for poultry product produced by mechanical separation would classify or

``categorize'' such product by bone solids content (as measured by

calcium content). Mechanically separated poultry with 0.6 percent or

less bone solids content would be termed ``(Kind)'' or ``(Kind) meat,''

where ``kind'' refers to chicken or turkey. Mechanically separated

poultry with greater than 0.6 percent bone solids content (but not

greater than 1 percent) would be termed ``Mechanically Separated

(Kind).''

Eighty-one commenters addressed the issue regarding the

classification of poultry products produced by mechanical separation

according to bone solids content. Of the 81 commenters, 78 disagreed

with the requirements discussed in the ANPR which tentatively

considered that only product with 0.6 percent or less bone solids

content could be labeled ``(kind)'' or ``(kind) meat,'' without the

reference to ``mechanically separated.'' The commenters stated that the

establishment of a 0.6 percent bone solids content demarcation between

what would be labeled as ``(kind)'' or ``(kind) meat,'' and

``mechanically separated (kind),'' based on data collected in August

1993 (data presented by FSIS in the report entitled ``Determination of

Acceptable Limits of Percent Bone Solids in Ground Poultry Products'')

would basically eliminate half of the currently produced product and

reduce the available amount of this low cost poultry ingredient for

further processed poultry and meat food products by 60 to 70 percent.

Moreover, commenters further emphasized that, to operate within the

current 1 percent bone solids content limit for boneless poultry, most

processors must target their operations at about 0.6 percent bone

solids content. The commenters indicated that achievement of the low

levels of percent bone solids content that were reported by FSIS in the

report of the August 1993 data occurred because it is necessary for

producers to target well below the current 1 percent limit in order to

consistently meet and not exceed the 1 percent requirement. Thus,

setting a requirement at 0.6 percent for what could be called

``(kind)'' or ``(kind) meat'' would require producers to aim at

significantly lower levels of bone solids content which would present

an unreasonable burden on the industry. Manufacturers would have to

adjust their mechanical deboning machines to adjust the pressure needed

to force ground poultry bones with adhering muscle and other tissues

through screens in the mechanical deboning equipment to eliminate more

bone from the finished product, thereby reducing product yield.

According to the commenters, in order to label a product as ``chicken''

or ``turkey meat,'' i.e., to meet the ``upper control limit'' of 0.6

percent, a processor would have to target a 0.3 percent bone solids

content level to qualify for that product category because of the lack

of precise controls in the operation of the deboning equipment.

One commenter claimed that industry data submitted to the Agency

``shows, under the principles of statistical process control, a

controlled process that targets 0.6 percent bone solids will result in

a product that meets the 1 percent bone solids requirement 99.5 percent

of the time.'' Another commenter claimed that the industry data

presented indicate that the average percent bone solids content is 0.57

percent with a standard deviation of 0.227 percent, so that ``at the 99

percent confidence limit, evidence that a process may not be running

efficiently is when an individual sample analysis is greater than 1.15

percent.'' Therefore, according to the commenters, the Agency is wrong

to advocate an average bone solids content of 0.6 percent as the

current measure of good manufacturing practices for poultry products

produced by mechanical separation. The same commenters criticized the

FSIS report on bone solids content stating that ``no statistical

analysis, factorial or otherwise, was done to describe the two

categories of mechanically separated poultry based on bone solids

content to determine if, in fact, they are different and/or whether

members of the populations were in fact similar.'' The commenters

further asserted that the data presented by FSIS did not actually

demonstrate that two ``categories'' of mechanically separated poultry

exist. The commenters asserted that such an analysis may show that the

only difference was due to the type of starting materials (e.g., necks

versus carcass frames versus backs) or that there are, in fact, no

separable populations.

Further, it was asserted by several commenters that the usual

practice in quality control is to use 3 standard deviations above a

target criteria as a control limit, rather than the standard deviation

of 2.33 (corresponding to a 99 percent confidence that the process is

not in control), as was suggested by FSIS in its report of the 1993

study. One commenter provided an example of how the 3 standard

deviations approach would be applied. It was explained that since the

mean percent bone solids content presented in the report of the 1993

study was 0.68 percent and that the average standard deviation by

establishment was 0.138, then 3 standard deviations above the mean

control limit would be approximately 1.1 percent bone solids content.

As a general response to the comments on bone solids content and

labeling, FSIS first reiterates its reasons for having considered in

the March 1994 ANPR the defining of a product standard for poultry

products produced by mechanical separation based, in part, on percent

bone solids content. In 1969, the Agency promulgated rules on deboned

poultry products specifying that no more than 1 percent bone solids

content would be allowed for this product. As indicated previously,

this decision was based on the Agency's careful appraisal of the

operating results in a series of poultry establishments that used

mechanical deboning equipment. Analyses were made of 485 samples of

raw, mechanically deboned products from nine commercial operations,

representing three makes of machines most often used in this process.

The analyses demonstrated that it is practical and acceptable to limit

the bone ``residue'' in mechanically deboned poultry and that the

equipment for manufacturing such product can be operated under

commercial conditions to produce poultry product that contains no more

than 1 percent of bone. This provision of the 1969 amendments was

promulgated to assure that deboned poultry products are wholesome in

accordance with the Poultry Products Inspection Act.

Also, it is important to note that at the time of the 1969

regulation, the mechanical separation process was new and FSIS had

limited information concerning the consequences of it. FSIS conducted

extensive studies on mechanically deboned poultry products during the

1970's and monitored the technology improvements during the 1980's. The

results of these studies and the information considered during

rulemakings, or other documents considering the need for rulemaking,

regarding poultry and livestock products produced by mechanical

separation over the past 2 decades have shown that there are

differences between the mechanically deboned product and traditionally

deboned products (i.e., hand-deboned). The principal characteristics

that distinguish mechanically separated poultry product and boneless

poultry produced by traditional methods are bone solids content, and

its physical form and consistency. Informing consumers of such

differences via the distinct labeling of the presence of poultry

product produced by mechanical means is supported by the statutory

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

food products are not false or misleading. FSIS received comments that

expressed this sentiment in response to its solicitations for public

input in the June 1993 ANPR and the March 1994 ANPR.

In the March 1994 ANPR, FSIS suggested that, because of the

differences in percent bone solids content among mechanically separated

poultry products, which were shown in the data presented in the FSIS

report ``Determination of Acceptable Limits of Percent Bone Solids in

Ground Poultry Products,'' the Agency would regulate poultry products

produced by mechanical separation so that producers of a product with a

low percent bone solids content that met the established limitation

would be able to label such products without a reference to the

mechanical means of processing.

In review of the tentative approach presented in the March 1994

ANPR and the comments received in response to this ANPR and the prior

June 15, 1993, ANPR, FSIS now believes that the continuation of the

present labeling policy, even for those finished products with

mechanically separated poultry that has a low bone solids contents,

does not inform the consumer that these products contain mechanically

separated poultry as an ingredient and that this may result in

misleading labeling. The statutes under which FSIS operates provide the

authority to protect the public and prevent the distribution in

commerce of products that are misbranded and are not properly marked,

labeled, or packaged. FSIS believes that the labeling of poultry and

meat food products containing poultry product produced by mechanical

separation as an ingredient must inform the consumer of its contents,

unless it is clearly demonstrated that any omitted information would

not mislead the consumer or otherwise render the product misbranded.

This labeling position must be adhered to consistently across all types

of poultry and meat food products containing mechanically separated

poultry as an ingredient.

FSIS's tentative consideration in the March 1994 ANPR was to define

and standardize certain mechanically separated poultry by concentrating

on the product characteristics that the Agency believes distinguishes

this product from poultry produced by traditional deboning methods,

i.e., hand-deboning. A different way of defining and standardizing this

product based on starting materials was suggested by one commenter. It

was suggested that a certain type of statistical analysis (factorial

analysis) be performed in order to identify a relationship between

percent bone solids content and types of starting materials used to

manufacture mechanically separated poultry. By suggesting this type of

statistical analysis, the commenter supported a procedure for

establishing a standard that would account for the materials used, and

percent bone solids content limits would vary by the processing

procedure employed by the processor. However, it was never the

intention of the March 1994 ANPR to suggest possibly defining and

standardizing mechanically separated poultry by starting materials

used. The data collected by FSIS in 1993 and used in the report

previously cited, came from industry records. Information was collected

on starting materials but not on the percentages of use nor on

processing parameters, e.g., pressures, settings, used during

processing. Thus, data could not be used for establishing process

control parameters or for determining the relationship between bone

solids content and other product characteristics, the materials used,

and processing parameters employed by establishments in the study. The

purpose of collecting the data was to examine the levels of bone solids

in mechanically separated poultry produced today, and to get an idea of

the variability of the percentage of bone solids contents within an

establishment. Information on starting materials was collected to

ensure that the sample of establishments represented the different

types of materials used to manufacture mechanically separated poultry.

If in establishing standards for the product, the Agency had intended

to use explicit starting materials to manufacture poultry product

produced by mechanical separation, then more data would need to be

collected under known or controlled conditions. FSIS believes that any

standard established for mechanically separated poultry should not

preclude a manufacturer from using any type of starting materials so

long as the requirements of the standard are satisfied.

Further, in response to comments about the application of an

acceptable tolerance for meeting bone solids content criteria based on

statistical variation, FSIS agrees that the establishment of such a

tolerance should be considered. However, because this issue requires

indepth technical review, FSIS will consider it for possible rulemaking

in the future.

B. Handling Requirements. The tentative position presented in the

March 1994 ANPR indicated that FSIS was tentatively considering that

starting material to be processed into poultry product produced by

mechanical separation be processed into this product within 2 hours

from the time it is separated from the bones of poultry carcasses or

parts of carcasses, except that such product may be held for no more

than 72 hours at 40 deg. F (4 deg. C) or less, or held indefinitely at

0 deg. F (-18 deg. C) or less. Additionally, the ANPR indicated that

FSIS was considering proposing that mechanically separated poultry be

chilled to 40 deg. F (4 deg. C) or less within 2 hours of the

mechanical deboning operation, or frozen at 0 deg. F (-18 deg. C) or

less, or cooked. Furthermore, it was indicated that FSIS was

considering proposing that such product be used as an ingredient in a

poultry or meat food product directly after being processed, except

that it might be held prior to such use for no more than 72 hours at

40 deg. F (4 deg. C) or less or indefinitely at 0 deg. F (-18 deg. C)

or less.

Twenty-seven commenters addressed the issue of handling

requirements for poultry products produced by mechanical separation.

All of the commenters disagreed with the need for handling requirements

and, specifically, the need for a time constraint by which the raw

material used to manufacture poultry product produced by mechanical

separation has to be processed into such product. Commenters stated

that chicken can be held for varying times and still be safe depending

on manufacturing practices, and that the raw materials used need to be

organoleptically evaluated and not set up on a time schedule, i.e.,

processed within 72 hours.

The commenters also stated that there are already adequate

regulations on handling and storage, and any additional handling

requirements should be handled in a more inclusive way, e.g., as part

of a Hazard Analysis Critical Control Point (HACCP) effort.

FSIS believes that handling requirements are necessary to produce a

safe and wholesome product, and that potential bacterial hazards are

diminished as long as handling accords with good manufacturing

practices. FSIS believes that it is the manufacturer's responsibility,

in concert with FSIS', to assure that wholesome materials are used in

the manufacture of its product within sound timeframes, and the safety

of such product is not negatively affected.

Although the data reviewed in the 1979 Health and Safety Report

indicate that poultry products produced by mechanical separation

generally are acceptable from a microbiological standpoint, the data

also show that where bacterial loads tend to be higher, it can be

attributed to the starting material used. This is not unique to poultry

products produced by mechanical separation; it can be applied to other

finely comminuted and comminuted products as well. Common starting

materials for mechanical separated and other comminuted products are

products that remain after the removal of a substantial portion of

skeletal muscle or other tissue (e.g., skin) from poultry carcasses or

parts of carcasses. As a result, the resistance of the exposed surface

area to microbial penetration has been reduced and the ratio of the

surface area to the volume of total product which is exposed to

contaminating influences has been increased. Higher microbial counts

have been associated with the conditions of holding such starting

materials.

Poultry products produced by mechanical separation are not unique;

all finely comminuted and comminuted products present opportunities for

excessive microbiological growth because they consist of small

particles which have a greater surface area than most poultry products

and because during its preparation any microorganisms that are present

are distributed throughout the product. Therefore, FSIS agrees with the

commenters that there is a general need to address the issue of

handling requirements for all poultry products, including finely

comminuted and comminuted products. FSIS is currently developing a

separate rulemaking that will deal with this issue more fully and that

will include handling requirements for poultry products produced by

mechanical separation, and the materials from which they are

manufactured. Therefore, FSIS will not propose handling requirements

for poultry products produced by mechanical separation in this

rulemaking.

FSIS believes that the promulgation of handling requirements for

all comminuted poultry, including mechanically separated poultry

products, and the starting materials from which they are made, would

eliminate the need to require that the temperature of rooms or

compartments in which equipment for mechanical deboning of raw poultry

is operated be maintained at 50 deg. F or less (9 CFR 381.47(e)). When

such requirements are promulgated, FSIS will address the need to

rescind 9 CFR 381.47(e).

C. Protein Quality. Twenty-five commenters addressed the issue of

protein quality for boneless poultry products produced by mechanical

separation. Of the 25 comments, 24 disagreed with the need to have a

protein quality requirement for any mechanically separated poultry

product with up to 1 percent bone solids. The commenters stated the

following reasons for their disagreement: (1) the typical U.S. diet

provides for an adequate intake of sufficiently high quality protein,

therefore, protein quality is not a public health concern in the U.S.;

(2) the U.S. is not a protein-deficient society which requires every

protein source to be the highest ``quality''; a typical diet consists

of proteins from a variety of sources and of varying quality; (3) the

Nutrition Labeling Education Act (NLEA) of 1990 indicated that a daily

value requirement for protein quality is not necessary; (4) over a 20-

plus year history of producing mechanically separated poultry, there

has never been a problem identified with the protein quality of

products manufactured from this low cost ingredient; (5) processors

have no control over the amino acid content of the chicken parts used

to manufacture mechanically separated poultry--it is determined by

genetics and not processing equipment; and (6) the protein quality

testing requirements suggested in the ANPR for mechanically separated

poultry are expensive, burdensome, and unnecessary.

After careful review of the comments, FSIS is in agreement with

commenters that oppose the tentative position that poultry products

produced by mechanical separation must meet a minimum protein quality

requirement, i.e., a protein digestibility corrected amino acid score

of not less than 40 expressed as a percent or the alternative

measurement of essential amino acids being at least 33 percent of the

total 17 amino acids present. The lack of the need for a protein

quality requirement is founded on scientific literature provided and

cited by comments from academia and statements made by other commenters

regarding the status of the quality of protein in diets of individuals

in the U.S. The literature stated that the protein quality of

mechanically deboned poultry is comparable to hand-deboned

poultry.5 Therefore, mechanically deboned poultry can be used in

poultry and meat food products without sacrificing protein quality.

According to the literature, during the 20 to 30-year history of the

use of MDP in many food products, there has not been an indication of

problems identified with protein quality. Furthermore, consumption of

enough high-quality protein by humans in the U.S. is not a problem. In

the preamble of the final nutrition labeling regulations, both FSIS and

the Food and Drug Administration (FDA) stated that current evidence

suggests that the diet typically consumed in the U.S. provides for an

adequate protein intake of sufficiently high quality to meet the

nutritional needs of adults and children 4 or more years of age (58 FR

632 and 2079). Furthermore, since there are no outstanding health

implications requiring the establishment of protein quality criteria

for food products, in general, it would be unnecessary to require such

criteria for a specific poultry product, viz., mechanically deboned

poultry.

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

\5\ Public comment, including attached research article,

submitted by R.A. Field, University of Wyoming, is available for

review in the FSIS Docket Clerk's office.

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

D. Quality Control. Twenty-one commenters addressed the issue of

quality control for all poultry products produced by mechanical

separation. Nineteen of the 21 commenters did not believe that a

mandatory quality control program was needed for the production of such

products. The commenters stated that (1) quality control programs,

including partial quality control programs (PQC), should remain

voluntary programs, and (2) that FSIS should focus compliance program

efforts on issues of health and safety of products and allow

manufacturers to determine quality parameters. The commenters also

noted that they operate under PQC programs for manufacturing

mechanically deboned poultry that are approved by FSIS, and any

additional concerns for assuring their processes are in conformance

with current regulations should be incorporated into their present PQC

programs rather than by issuance of a formal requirement through

rulemaking.

FSIS believes that establishments manufacturing poultry products

that are mechanically separated must have controls in place to assure

that such products comply with the Agency's proposed definition,

standard, and other criteria. However, after reviewing the comments and

re-examining the Agency's current regulatory agenda, FSIS believes that

because there are efforts underway within the Agency to study and

address ways of reducing the potential for situations that would render

any poultry or meat food product adulterated, unwholesome, and/or

misbranded it is premature to address the need for a mandatory quality

control program for this one distinct category of poultry product. FSIS

does, however, believe that records of achieving compliance with

parameters established for mechanically separated poultry product,

e.g., bone solids content and bone particle size criteria, should be

maintained to substantiate that boneless poultry criteria meets the

proposed regulatory manufacturing practices.

E. Protein/Fat. Nineteen commenters responded to the tentative

position on establishing a minimum protein content and a maximum fat

content requirement for poultry product produced by mechanical

separation with greater than 0.6 percent bone solids content. All

nineteen commenters disagreed with FSIS' position on establishing such

a protein and fat content requirement for this mechanically separated

poultry. The commenters stated that poultry product produced by

mechanical separation is used as an ingredient in ready-to-consume

products of which most have established protein and/or fat standards.

Furthermore, the commenters stated that most poultry and meat food

products are now required to have nutrition labeling.

FSIS does not agree that ``most ready-to-consume'' poultry and meat

food products have established protein and fat standards, as asserted

by the commenters. Standards of identity and composition for poultry

and meat food products generally do not include minimum protein content

requirements. Of the products for which standards stipulate a maximum

fat content, most are sausages composed of meat from livestock. There

are no fat limitations associated with sausages made from poultry,

according to FSIS policies.

FSIS does agree, however, with the comments regarding the benefits

of fat and protein content information provided by nutrition labeling.

Since the products that typically contain mechanically separated

poultry, e.g., poultry sausages, are composed of this ingredient as the

majority of their formulation, the nutrition labeling for such product

will primarily reflect the protein and fat contributed by the

mechanically separated poultry component. For this reason, a minimum

protein content and a maximum fat content requirement for poultry

products produced by mechanical separation are not needed, given the

implementation of the Department's nutrition labeling regulations on

July 6, 1994 (58 FR 632). The nutrition labeling regulations require

the declaration of protein and fat on the labeling (i.e., the Nutrition

Facts panel) of most multi-ingredient meat and poultry products.

Nutrition labeling is now required on most processed products purchased

by consumers in retail stores, and this, together with the Department's

voluntary nutrition labeling program established for retail store

information on single-ingredient raw products, makes FSIS believe that

consumers will have sufficient information on protein and fat for most

products purchased for consumption at home.

FSIS further believes that the need to establish a fat and protein

requirement is minimized because current regulatory controls will limit

the amount of skin or fat that may be used in formulating poultry

products with mechanically separated poultry. According to the poultry

regulations, viz., 9 CFR 381.117, raw materials used to manufacture

boneless poultry, e.g., ``mechanically separated chicken'' and

``mechanically separated turkey,'' must be labeled to reflect the

presence of skin and attached fat when the proportions of skin and

attached fat are in excess of that which occurs naturally on a whole

carcass. Therefore, products currently labeled as ``mechanically

separated chicken'' or ``mechanically separated turkey'' contain no

more skin with attached fat than that which occurs naturally on a whole

carcass, for which there is no maximum fat content established.

Furthermore, like all other animal products, poultry (e.g., whole

carcasses and parts of carcasses) is composed of water, fat, protein,

and inorganic matter (i.e., ash). If the fat content is controlled, the

proportion of the other components, including protein, should remain

the same as that which occurs naturally.

F. Bone Particle Size. Fourteen commenters addressed the issue of

bone particle size in poultry product produced by mechanical

separation. Twelve of the 14 commenters disagreed with restricting the

size of the bone particles present in poultry product produced by

mechanical separation to a maximum of less than 1.5 millimeter (mm) in

the greatest dimension. Furthermore, commenters sought clarification of

the quantity of particles of acceptable dimension that would be

permitted. The commenters also stated that there is no justification

for requiring standardized bone particle size limitations; such a

criteria will result in increased analytical costs to the processor

without improving food safety. Other commenters cited the 1979 report

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

Poultry'' which states that over 90 percent of the bone particles found

in mechanically deboned poultry are less than 150 microns (0.15 mm) in

size and only 1 percent were greater than 400 microns (0.4 mm).

FSIS believes that a bone particle size limitation augments the

bone solids content restriction, and is a meaningful indication of a

poultry deboning operation that effectively controls bone breakage. The

1979 health and safety report recommended that bone particle size be

controlled to ensure that equipment type or processing does not result

in unacceptably large bone fragments in mechanically deboned poultry.

FSIS agrees with this recommendation and continues to support its

tentative position of restricting the bone particle size in poultry

products produced by mechanical separation. However, FSIS is in

agreement with the comments that reflected a need to clarify the

parameters for such a restriction. In order to simplify such a

requirement for mechanically separated poultry products, FSIS is

proposing that at least 98 percent of the bone particles present in

mechanically separated poultry should have a maximum size no greater

than 1.5 mm and no bone particles should be greater than 2.0 mm in

their greatest dimension. These parameters are similar to the

requirements for bone particle size for MS(S), a similar livestock

product.

G. Limitations on Use. In the March 1994, ANPR, FSIS tentatively

proposed that, in certain cases, poultry product produced by mechanical

separation should be restricted from use as an ingredient in other

products. It was considered that imposing such restrictions was

necessary for mechanically separated poultry because of the potential

fluoride contribution of mechanically separated poultry made from fowl

(i.e., mature female chickens). It was also tentatively suggested that

use restrictions for all poultry product produced by mechanical

separation be considered (i.e., any product with bone solids not

greater than 1 percent) based on the characteristics of such product,

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

consistency.

Thirteen commenters addressed the issue of limitation on use of

poultry product produced by mechanical separation, in general, as an

ingredient in other products. Twelve of the commenters disagreed with

the general premise of establishing any use limitations on mechanically

separated poultry products because there are no safety or health

concerns regarding poultry product produced by mechanical separation.

The commenters also stated that the marketplace is a much better judge

of quality (i.e., use levels of poultry product produced by mechanical

separation) than FSIS.

FSIS believes that poultry products that are mechanically separated

should not be used in poultry products that are represented as being

composed of whole poultry muscle, other than where it is used as a

binding agent (i.e., a substance that holds muscle pieces together) at

a level that is sufficient for this purpose. When used as a binder, it

is FSIS' belief that, without the declaration of mechanically separated

poultry as an ingredient on the labels of the poultry and meat food

products that purport to be intact, whole muscle products, the labels

of such products would be misbranded.

It is poultry meat, particularly muscle(s), that characterizes

parts and cuts of poultry. The physical and sensory characteristics

(i.e., mouthfeel, texture, color) associated with a part or cut of

poultry can be retained when trimmings removed during processing are

reincorporated; and the characteristics associated with the cut remains

when there is chunking, chopping, or grinding of the muscle as in

versions of turkey ham product (9 CFR 381.171). FSIS regards these

processes as different than using product made by the mechanical

separation of bones with attached poultry tissue. Poultry product

produced by mechanical separation does not, in FSIS' view, retain the

characteristics of the cuts themselves. It appears inconsistent with

the basic characteristics expected of products represented as having

been made from a particular part or cut of the poultry carcass, to

include this finely comminuted ingredient, especially when the muscle

from that part is essentially intact or has been processed only to the

extent of cutting or grinding. Therefore, FSIS continues to support its

tentative position stated in the March 1994 ANPR that poultry product

produced by mechanical separation not be permitted in products expected

to be composed of whole muscle or pieces of muscle, e.g., ``(Kind)

steak or (Kind) fillet'' (9 CFR 381.162).

FSIS agrees with commenters that, except for the potential health

effects associated with the fluoride content of mechanically separated

chicken from fowl, there are no health and safety concerns regarding

the use of poultry products produced by mechanical separation. Issues

raised in the past concerning cholesterol and calcium content are

addressed by the requirements of the new nutrition labeling. Calcium

and cholesterol contents of most foods will be required as part of the

nutrition label. However, FSIS continues to support its consideration,

as stated in the March 1994 ANPR, that poultry product produced by

mechanical separation, i.e., any such product with no greater than 1

percent bone solids, made, in whole or in part, from fowl (i.e., mature

female chickens, as defined in 9 CFR 381.170(a)(1)(vi)) not be

permitted in baby, junior, or toddler foods. The basis for this is that

the fluoride content associated with mechanically separated chicken

made from fowl has potential health implications. There were no data

submitted in response to the ANPR to support opposition to this aspect

of use limitations for mechanically separated poultry.

H. Product Name and Labeling. The majority of the commenters

(primarily food manufacturers) stated that FSIS should continue with

its current labeling policy regarding mechanically separated poultry

that allows the declaration of mechanically separated poultry as

``(Kind)'' or ``(Kind) meat'' when used as an ingredient in a poultry

or meat food product. The commenters suggested that any changes in the

current policy will have a severe economic impact on both the poultry

and meat industries. Many of the commenters stated that, ``since there

are no health or safety issues regarding the use of mechanically

separated poultry, nutrition labeling satisfies the remaining issue of

the consumer's right to know'' that mechanically separated poultry is

in the foods they consume. Therefore, the majority of commenters

supported continuance of the current policy regarding the product name

and labeling of mechanically separated poultry (e.g., as ``chicken'' or

``turkey meat''). On the other hand, a few commenters stated that meat

and poultry products should be labeled the same as Mechanically

Separated (Species) (MS(S)).

FSIS must decide whether, under its statutory authorities,

consumers would be protected from misbranded and improperly labeled

poultry and meat food products without the separate declaration of

mechanically separated poultry by a regulated term. The intent of

nutrition labeling is to assist consumers in making sound choices in

terms of nutrients in the diet. FSIS believes that nutrition labeling

provides some of the information about a food that is important to the

consumer in planning a healthful diet; however, it does fully inform

the consumer about the ingredients used to formulate a food product.

Rather, it is the ingredients statement on the label of a product that

is the labeling feature that informs the consumer of the ingredients

used to formulate a poultry or meat food product. Therefore, FSIS

believes that nutrition labeling, coupled with an ingredients statement

that accurately reflects the ingredients that are used to formulate a

product, is necessary to protect the consumer from misbranded meat and

poultry products, i.e., improperly labeled meat and poultry products.

FSIS evaluated the comments that opposed the establishment of a

labeling requirement for mechanically separated poultry based on the

``adverse economic impact'' of identifying this product by a specific

product name in the ingredients statements of products in which it is

used as an ingredient, i.e., as ``Mechanically Separated (Kind).'' The

comments opposing the declaration of mechanically separated poultry by

a specific name associated with a standard did not fully elaborate why

consumers would be concerned about its presence in the products they

consume. It was suggested by a few commenters that the name suggested

in the tentative position presented by FSIS was pejorative and that

consumers would think that the product they had purchased previously

was now formulated with another ingredient, and would not purchase the

product again because it was different or inferior. However, FSIS

believes that such a labeling requirement is necessary in order to

fulfill its statutory responsibility to protect consumers by assuring

that the labels of poultry and meat food products are not false or

misleading. FSIS also believes that its continued support of the

tentative position stated in the March 1994 ANPR to establish a

standardized name for mechanically separated poultry would be

consistent with past Court decisions and regulatory actions regarding

MS(S), a similar product made from livestock, which was determined to

be materially different than ``meat.'' Consumers had the opportunity to

provide views on the importance of knowing that MS(S) is an ingredient

in their food during rulemaking actions on MS(S). FSIS' 1982 final

rulemaking on MS(S) (47 FR 28214) indicates that material differences

in the consistency and composition of MS(S) place it outside the scope

of the product traditionally defined as meat (9 CFR 301.2 (rr)), and

that its differences are such that it should be defined as a

distinctive standardized product. Thus, MS(S) must be identified as a

distinct meat food product, e.g., ``mechanically separated pork (or

beef),'' and labeled as such on the products in which it is used as an

ingredient (9 CFR 317.2(c) and (f), 319.1, and 319.5) in order to

assure that the labeling of such products is accurate and not

misleading.

Currently, products that contain mechanically separated poultry are

marketed using trade names that identify any poultry ingredient they

are made up of only by the kind name of the poultry used (e.g.,

``Chicken Nuggets'' and ``Turkey Franks''). FSIS believes that it is

appropriate to allow these products to continue to be marketed under

such names. These names have a long and uniform history of use.

Revocation of these familiar trade names may be a disservice to

consumers if they are mislead to believe that the products they have

been purchasing have changed. Although these products contain tissues

other than whole skeletal muscle tissue, FSIS does not believe that

consumers will be mislead by trade names which only include the name of

the kind of poultry from which the poultry ingredients are mechanically

separated since any mechanically separated poultry ingredients will be

clearly identified as ``mechanically separated (kind)'' in the

ingredients statement. FSIS believes that the ingredients statement is

the appropriate labeling feature to inform consumers of the ingredients

used to formulate a product. However, FSIS welcomes comments on the

names under which products containing mechanically separated poultry

are marketed.

VI. The Proposal

FSIS is proposing to amend the Federal meat and poultry products

inspection regulations to define and standardize, and establish other

requirements for poultry products produced by mechanical separation,

including provisions for the composition and use of such products, and

requirements for manufacturing and labeling such products. The proposal

would prescribe a definition and standard of identity for poultry

products produced by mechanical separation with 1 percent or less bone

solids content, that requires compliance with certain criteria; e.g.,

bone solids content (measured as calcium content) and bone particle

size. The proposal also would provide recordkeeping and labeling

requirements, and limitations on use of poultry products produced by

mechanical separation. Poultry product produced by mechanical

separation is hereafter referred to as ``MS(K).''

A. Product Definition and Standard

FSIS is proposing to prescribe a definition and standard of

identity and composition for the finely comminuted poultry product

resulting from the mechanical separation and removal of most of the

bone from attached skeletal muscle and other tissue of poultry

carcasses and parts of carcasses which has a bone solids content of 1

percent or less. This product is commonly known in the poultry industry

as mechanically deboned poultry or MDP. While whole carcasses sometimes

are used, the starting materials for this type of processing frequently

are parts of carcasses, such as frames, backs and necks, which contain

relatively low proportions of skeletal muscle, or parts, such as breast

frames, from which most of the skeletal muscle already has been removed

by traditional deboning techniques. The starting materials, which may

have undergone an initial bone breaking process, are pushed under high

pressure through equipment with apertures that allow a small amount of

powdered bone to pass through with the soft tissue. Such starting

material is in natural proportion with regard to skin and attached fat;

if skin and fat is in excess of proportions found naturally on a whole

carcass, the product is labeled to reflect the presence of skin and fat

according to 9 CFR 381.117(d).

MS(K) differs from poultry products produced by traditional

deboning techniques (e.g., hand-deboning) in its highly comminuted and

spread-like consistency and in its content of bone and associated

tissue, as well as muscle, skin, and fat. In view of the differences

between MS(K) and boneless poultry derived by traditional methods

(e.g., hand-deboning), it appears inappropriate to continue to include

MS(K) within the category of ``boneless poultry products'' (9 CFR

381.117(d)). Instead, FSIS is proposing to define it as a distinct

poultry product ingredient and standardize its characteristics under

subpart P of the poultry products inspection regulations (9 CFR 381,

subpart P).

FSIS is proposing that the boneless poultry products regulation (9

CFR 381.117(d)) no longer apply to MS(K). Consequently, the current

restriction on bone solids content in this regulation, as enforced by

limiting calcium content, will be included with other compositional

requirements in an MS(K) standard. Moreover, as a standardized product,

MS(K) would be differentiated from other poultry product ingredients

and it would be designated in the ingredients statements on finished

product labels by the name specified in its definition and standard, in

accordance with 9 CFR 317.2(c)(2) and (f)(1) and 381.118(a). Product

failing to meet the bone solids content or bone particle size

restrictions of the standard must be labeled as ``Mechanically

Separated (Kind) For Further Processing'' and may only be used in

producing poultry extractives, including fats, stocks, and broths

because the manufacturing process completely removes the bone solids

and bone particles.

1. Product name. FSIS is proposing to define the standardized

product that is finely comminuted and results from the mechanical

separation and removal of most of the bone from poultry carcasses and

parts of carcasses by a distinctive name. FSIS is proposing that such

product be called ``Mechanically Separated (Kind) (MS(K)).'' It appears

to accurately and concisely describe the product that materially

differs in composition and consistency from traditional hand-deboned

product, indicating the nature of the process by which and the kind of

poultry from which it is made. The proposed name includes ``(Kind)''

rather than ``poultry'' to make it clear that the kind of poultry (9

CFR 381.1(b)(40)) from which the product is made is specified (e.g.,

``Mechanically Separated Chicken''). By including ``(Kind)'' in the

proposed name, FSIS is acknowledging that skin and attached fat may be

present such that the proportion is consistent with that which occurs

naturally on a whole poultry carcass. If skin and attached fat are

present at levels exceeding natural proportions, as defined for

boneless poultry products (9 CFR 381.117(d)), it must be labeled.

As previously indicated, FSIS believes that MS(K) differs

sufficiently from boneless poultry products produced by traditional

hand-deboning techniques that it should be regulated as separate,

standardized ingredients. FSIS is aware that other descriptions have

been associated with poultry products produced by mechanically

separation. In addition to the use of terminology such as ``finely

comminuted'' poultry to specify the form of the product and

``mechanically deboned'' poultry, such product has been referred to as

``mechanically separated' poultry within the meat and poultry

industries. FSIS believes that where a distinguishing characteristic of

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

inappropriate to define it by a name that includes the term ``deboned''

and use of this term in labeling might mislead consumers by implying

such product contains no bone. FSIS will, however, welcome comments on

other names that accurately reflect the process from which this product

is derived, as well as its form and consistency.

2. Bone solids content. FSIS is proposing that the definition and

standard for MS(K) incorporate the existing restriction on the bone

solids content of mechanically separated poultry products of not more

than 1 percent (9 CFR 381.117(d)). Because this restriction is enforced

by measuring calcium content, FSIS believes the definition and standard

for MS(K) should include maximum calcium content levels of not more

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

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

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

treated.

As previously discussed, FSIS adopted the 1 percent bone solids

restriction after appraising the operating results in a series of

poultry establishments using mechanical deboning equipment, analyzing

485 samples of raw product, and concluding that existing equipment can

be operated under commercial conditions to produce product which meets

this limit (34 FR 13991). When processors applied the mechanical

deboning technology to poultry products such as fowl frames that had

been heat treated using various cooking methods, FSIS modified its

procedures to take into account weight loss that can occur with

cooking. Thus, the practice has been to permit an allowance for weight

loss in order to reflect the bone solids content that would have been

present if heat treatment had not occurred; and the adjusted level may

not exceed 1 percent. The ``Chemistry Laboratory Guidebook,'' U.S.

Department of Agriculture (section 6.010F, page 6-33),6 currently

includes procedures for different degrees of adjustment depending on

whether conventional cooking methods (i.e., open kettle) or other heat

treatment (e.g., pressure cooking) are used.

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

\6\Document is available for public inspection at the FSIS

Docket Clerk's office.

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

After evaluating data on substances of potential concern that may

tend to concentrate in bone, the 1979 report on health and safety

aspects of the use of mechanically deboned poultry did not recommend

any change in the existing bone solids limit. Because enforcement is

based on calcium content analyses; however, rather than direct

measurements of bone solids, FSIS believes that an amended poultry

products inspection regulation should include the maximum amount of

calcium permitted in determining whether mechanically separated poultry

is in compliance.

FSIS has developed two different calcium content levels for this

purpose. Both of these levels account for the fact that poultry

tissues, other than bone, contain some calcium. The higher level--0.235

percent--reflects the greater proportion of calcium in the bones of

mature chickens and turkeys as compared with young chickens (i.e., the

lower ratio of bone solids to calcium). The lower level--0.175

percent--has been used by FSIS in enforcing the 1 percent restriction

on product made from young chickens. Both of these calcium levels are

equivalent to 1 percent bone solids using the conversion formulas for

calculating bone solids from calcium on a weight basis.7

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

\7\The formula for calculating bone solids from calcium for

poultry products is in the ``Chemistry Laboratory Guidebook,'' U.S.

Department of Agriculture (6.010F, page 6-33), and is available for

public inspection at the FSIS Docket Clerk's office.

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

Since FSIS is proposing a definition and standard that includes

potential types of mechanically separated product, FSIS would allow

0.175 percent calcium as the maximum for all MS(K) that is made from

poultry other than turkeys or mature chickens.

The inclusion of these calcium content levels in the proposed

definition and standard should not be misinterpreted as indicating a

concern about the amount of the essential nutrient calcium that is

provided by poultry and meat food products. FSIS agrees with the

findings in the 1979 health and safety report that, even assuming all

further processed poultry were made with mechanically deboned poultry

(i.e., a far greater level of production and use than actually occurs),

the projected calcium contribution of such products would represent

only a negligible increase in per capita daily intakes and cannot be

considered hazardous, particularly since the dietary intake of a large

sector of the population may be below the recommended level of calcium

consumption.

In addition, the ``Chemistry Laboratory Guidebook'' (section

6.010F, page 6-33) has been revised to include a procedure that could

be applied to mechanically separated product made in part from mature

chickens. That procedure involves a determination of the relative

mature and young chicken proportions when product is made from a

combination of young and mature chickens.

3. Bone particle size. FSIS is proposing that at least 98 percent

of the bone particles present in MS(K) be restricted to a maximum size

no greater than 1.5 millimeter (mm) in their greatest dimension and no

bone particles shall be larger than 2.0 millimeter in their greatest

dimension. The need to limit the size of bone particles in MS(K) has

been acknowledged since the poultry industry began to use mechanical

methods for manufacturing this product.

FSIS' objective is that the limitation imposed be adequate to

prevent any digestibility problems while not restricting the operation

of equipment in accordance with good manufacturing practices more than

is necessary for this purpose or to protect finished product quality.

In the 1979 health and safety report, it was recommended that bone

particle size be controlled to ensure that equipment type or processing

does not result in unacceptably large fragments. The report concluded

that, provided this is done, the bone particles in the product will not

present any health hazard because of size or hardness.

4. Recordkeeping. FSIS is also proposing that establishments that

manufacture MS(K) maintain records of bone solids content and bone

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

made available to the inspector and any other duly authorized

representative of the Secretary upon request.

B. Limitations on Use

FSIS is proposing certain limitations with respect to the use of

MS(K) in the formulation of poultry and meat food products. FSIS is

proposing such restrictions based on the potential fluoride

contribution of MS(K) made from fowl (i.e., mature female chickens) and

the characteristics of MS(K), including the kind of poultry from which

it is made and its consistency. FSIS believes that such requirements

are necessary to prevent potential health and safety problems, and to

maintain the quality and integrity of the poultry and meat food product

supply. FSIS is also proposing that MS(K) may be used, except in

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

policies whereby ``(Kind)'' or ``(Kind) Meat'' are being used, provided

that it is identified as ``Mechanically Separated (Kind).''

1. Kind of product limitation. FSIS is proposing that when a

poultry product is required to be prepared from a particular Kind or

Kinds of poultry (e.g., chickens), use of MS(K) of any other kind

(e.g., mechanically separated turkey) would not be permitted. This

provision would assure that MS(K) made from a different kind of poultry

is not used in a poultry product represented as containing ingredients

from a particular kind or kinds of poultry.

The proposed definition and standard for MS(K) covers MS(K)

prepared from any kind of poultry. FSIS would not permit use of MS(K)

as an ingredient in any given poultry product regardless of the kind of

poultry from which it is made. Such action would be inconsistent with

existing regulatory requirements and could, among other things, result

in false or misleading labeling. For example, the definition and

standard for ``(Kind) patties'' (9 CFR 381.160) requires that poultry

product ingredients be ``of the kind indicated'' (e.g., turkey products

in turkey patties). FSIS believes that proposing to provide for the use

of MS(K) as a distinctive poultry product ingredient should not

abrogate this requirement (e.g., to not permit use of mechanically

separated chicken in turkey patties).

2. Limitations on product made from fowl. FSIS is proposing that

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

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

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

These restrictions are based on the potential fluoride contribution of

product made from fowl to dietary intakes. The 1979 health and safety

report found only slight differences between the fluoride content of

MS(K) made from poultry other than fowl and that of poultry products

produced by traditional deboning techniques, but considerably higher

amounts in MS(K) made from fowl.

FSIS believes that conclusions reached in the 1979 health and

safety report regarding fluoride content of MS(K) from fowl and MS(K)

from all other poultry sources have not changed significantly. FSIS

believes that the data reported in the 1979 health and safety report

are currently the best available on this subject and the conclusions

reached are valid. However, FSIS is aware that the benefits of fluoride

in the diet continues to be studied by the scientific community and

that more information is available today on the subject than in 1979

when the Agency published the health and safety report.

The 1993 National Academy of Sciences' Subcommittee on Health

Effects of Ingested Fluoride report titled, ``Health Effects of

Ingested Fluoride'' (NAS Fluoride Report),8 commissioned by the

Environmental Protection Agency (EPA) provides current information on

the complexities of assessing effects of fluoride in the diet and makes

recommendations for further research. The NAS Fluoride Report cites

dental products containing fluoride (topical fluoride applications by

dentists, fluoride supplementation, and ingestion of fluoride

dentifrices), beverages made with water containing fluoride (tea and

coffee, as well as manufactured drinks), and foods as being the major

sources of ingested fluoride. The NAS Fluoride Report points out that,

while ingestion of fluoride from some sources may have gone up, some

food sources of fluoride have gone down. For example, ingestion of

fluoride from infant formulas (a source of dietary fluoride considered

in the 1979 health and safety report) has gone down because of the

agreement among the producers of infant formulas to use only water low

in fluoride for all their products. The changing sources of fluoride

ingestion makes assessing intakes and effects on populations inherently

difficult. In the modern U.S. environment, people are exposed to

fluoride from food, beverages, toothpaste, and a variety of prescribed

or over-the-counter dental products.

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

\8\This report is available for public inspection in the FSIS

Docket Clerk's office.

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

While the NAS Fluoride Report reiterates the positive effects of

increased fluoride intake on reduction of dental caries in the 1990's

as compared to the 1950's, it also cites the side effect of dental

fluorosis, e.g., too much fluoride ingested in early childhood while

teeth are forming. Dental fluorosis occurs when the enamel covering of

the teeth fails to crystallize properly, leading to defects that range

from barely discernible to severe brown stain, surface pitting, and

brittleness. The report states that ``the most effective approach to

controlling the prevalence of severity of dental fluorosis, without

jeopardizing the benefits of fluoride to oral health, is likely to come

from more judicious control of fluoride in foods, processed beverages,

and dental products, especially those items used by young children.''

FSIS agrees with this conclusion and maintains its concern for the

potential effect of fluorosis in the susceptible population of babies,

infants, and toddlers. Therefore, FSIS believes that the tentative

position set forth in its March 1994 ANPR previously discussed, to

restrict the use of MS(K) made from fowl in baby (i.e., strained),

junior, and toddler foods is prudent. However, FSIS is requesting that

commenters provide to the Agency any information that would either

reaffirm or contradict the conclusions reached in the 1979 health and

safety report. FSIS intends to reassess and update the 1979 health and

safety report regarding fluoride in light of information submitted in

response to this proposal.

3. Poultry product limitations. FSIS believes that the use of MS(K)

should be limited in certain poultry products. FSIS is proposing that

MS(K) should not be allowed in poultry products that are composed of

whole poultry muscle, and expected to be as such by consumers, except

that it may be used for binding purposes at a level that is sufficient

for purpose. However, FSIS will allow MS(K) in the sauce portion or any

dressing of poultry products.

MS(K) is a highly comminuted ingredient with a spread-like

consistency and FSIS considers its use to be inconsistent with the

basic characteristics associated with poultry products that have been

processed only to the extent of cutting or grinding or that are made

from poultry products so processed, such as chicken breasts, turkey

fillets, and shredded chicken. FSIS also considers their use to be

inconsistent with the basic characteristics associated with poultry

products that are processed, convenience versions of ready-to-cook

poultry or cuts or solid pieces of poultry or poultry meat, such as

roasted chicken, boned turkey with natural juices, chicken a la Kiev,

and turkey ham. FSIS is proposing that the use of MS(K) not be

permitted in these products. FSIS recognizes, however, that these types

of products sometimes are prepared with components the characteristics

of which are not inconsistent with those of MS(K).

It is poultry meat, particularly muscle(s), that characterizes

parts and cuts of poultry. The characteristics associated with a cut

can be retained when trimmings removed during processing are

reincorporated; and the association with the cut remains when there is

chunking, chopping, or grinding of the muscle as in versions of turkey

ham product (9 CFR 381.171). FSIS regards these processes as different

than using product made by the mechanical separation of bones with

attached poultry tissue. MS(K) does not, in FSIS' view, retain the

characteristics of the cuts themselves. It appears inconsistent with

the basic characteristics expected of products represented as having

been made from a particular part or cut of the poultry carcass, to

include this finely comminuted ingredient, except as discussed above,

especially when the muscle from that part is essentially intact or has

been processed only to the extent of cutting or grinding.

FSIS is proposing no restrictions on the amount of MS(K) that can

be used in poultry products, or meat food products, in which it is a

permitted ingredient. However, prevailing standards for particular

products may contain quantitative limits (e.g., the limit on the amount

of poultry product ingredients permitted in cooked sausages such as

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

quantity of various poultry product ingredients.

C. Labeling

FSIS is proposing special provisions for the labels of MS(K). If

adopted, these provisions would supplement other, more general

requirements for such labels (see 9 CFR Parts 317 and 381, Subpart N).

The provisions are discussed below.

1. The product. FSIS is proposing the following labeling provisions

for MS(K): (1) the name of the product (e.g., ``Mechanically Separated

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

fowl'' unless it is not made, in whole or part, from mature female

chickens, and ``with excess skin'' unless it is made from poultry

product that does not include skin in excess of the natural proportion

present on the whole carcass; and (2) there must be appropriate

descriptive terminology in the labeling of MS(K) if heat treatment has

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

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

affect the use of MS(K), FSIS is proposing that, in order to assure

compliance with regulatory requirements and thereby prevent the

adulteration and misbranding of finished poultry products and meat food

products, such characteristics must be clearly identified on the label

when MS(K) leaves the establishment at which it is manufactured.

As indicated previously, the regulations already require that

information on use, including deviations from the natural whole carcass

proportion of skin as well as the fact of cooking, appear on the label

of boneless poultry products produced by mechanical separation (9 CFR

381.117(d)). The presence of skin or its presence in excess of the

natural whole carcass proportion would, as discussed previously,

continue to affect product use if the regulations are amended. The use

of heat treatment in the preparation of the product also would be of

continuing relevance (9 CFR 381.157(a)). In addition, since the

presence of poultry kidneys or sex glands can affect use (9 CFR

319.180(b)), a number of manufacturers of MS(K) not containing these

parts currently choose to note this fact on the label. The other

information that would be required is identification of product made

from fowl.

2. Finished poultry products and meat food products. As indicated

above in the discussion of FSIS' proposed definition and standard for

MS(K), FSIS is proposing that in view of the differences between MS(K)

and poultry products produced by traditional hand-deboning techniques,

MS(K) should be regulated as a distinctive ingredient with standardized

characteristics. Therefore, FSIS is proposing to define such product by

its own name, e.g., ``Mechanically Separated (Kind),'' that would be

declared in the ingredients statements on finished product labels by

the name specified in its definition and standard.

FSIS recognizes the importance of the identification of the calcium

and cholesterol content of MS(K) to consumers who, according to the

comments received on the June 15, 1993, ANPR (58 FR 33040), indicated a

desire to know of the presence of calcium and cholesterol. The

nutrition labeling regulations, effective July 6, 1994, require

mandatory declaration of calcium and cholesterol content on most

processed meat and poultry products which addresses this particular

labeling concern. FSIS believes that nutrition labeling is the most

appropriate vehicle for conveying a product's nutrient content, which

includes calcium and cholesterol, as well as other nutrient

information.

Executive Order 12866

This proposed rule has been determined to be significant and has

been reviewed by the Office of Management and Budget under Executive

Order 12866.

Total federally inspected broiler and turkey meat production in the

U.S. in 1993 was about 27 billion pounds on a ready to cook basis.

(Broiler represents the majority of chickens grown and slaughtered in

the U.S.) Broiler production was 22.2 billion pounds and turkey 4.8

billion pounds. Continued growth in poultry production has resulted in

large increases in the volume of poultry meat going into further

processed products, many of which use MS(K).

FSIS has estimated that 1 billion pounds of poultry product is

processed annually into MS(K), with a yield of 70%, or 700 million

pounds of MS(K) product for human use. (Industry sources suggest that a

larger amount of MS(K) product is produced annually.) FSIS estimated

that 400 million pounds is used in sausage products and 300 million

pounds in patties and nuggets. The estimated size of the market does

not directly affect the cost estimates below because these depend on

the number of label changes.

The Broiler Council estimates that broiler meat is produced in

around 200 establishments, of which 50 are further processing

establishments. MS(K) is produced in around 108 establishments. About

25-30 of these establishments with MS(K) equipment produce hot dogs.

The product from the other 75-80 establishments is sold to poultry

further processors or to red meat processors. Industry sources indicate

that some small firms specialize in MS(K) production, buying carcasses

from poultry slaughter establishments for further processing.

Based on inspection task records, FSIS estimates that 108

establishments produced (or are capable of producing) poultry MS(K).

MS(K) production by establishment size is not available from FSIS.

However, total further processed product production by size of

establishments shows 7 establishments with production less than 10,000

pounds of MS(K) annually. The average production of the 108

establishments is 51 million pounds of all further processed products.

Under the proposed rule, products containing mechanically separated

poultry would require that it be labeled as ``Mechanically Separated

(Kind)'' in the list of ingredients. There is no precise information on

the total number of products that contain MS(K). FSIS indicated there

are 602,000 approved labels for poultry and meat, not all of which are

necessarily in use. These include 529 labels for specific MS(K). There

is also an unknown number of labels for products containing MS(K) such

as frankfurters, chili, bologna, poultry baby foods, chicken nuggets or

patties. FSIS estimates that in a total about 5,000 products would

require relabeling. There is no currently available data on the size

breakdown of the establishments producing products containing MS(K).

Possible Economic Impacts From Proposed Rule

Possible sources of costs associated with the proposed rule:

A. Labeling

Under the proposed rule, final products containing mechanically

separated poultry would require ingredient statement labeling of the

mechanically separated poultry as ``Mechanically Separated (Kind).''

Estimates range from $200 to $3,000 per product for a simple product

ingredient label change depending on the type of label. Comments in

response to the March 1994 ANPR indicate that most labels would fall in

the lower end of this range (about $600). Assuming an average cost of

$1,000 per product, the cost of relabeling would be $5 million ($1,000

times 5,000 products). Doubling the average cost per product to $2,000

increases the labeling cost to $10 million.

Labeling costs could be reduced to the extent mandated MS(K) label

changes can be coordinated with other label changes planned or required

during the period of promulgation of the MS(K) rule and its

enforcement. Many firms routinely make label changes for existing

products. For example, about 50% of the 180,000 labels submitted to

FSIS each year for approval are for label changes on existing products.

Also, a FSIS policy directive effective July 25, 1994 requires

widespread changes in meat and poultry ingredient statement labeling by

August 8, 1995. To the extent MS(K) label changes could be worked in

with these changes, less additional cost would be incurred.

B. Label Inventory Costs

Some firms may discard non-compliant labels when the proposed rule

goes into effect. A survey of meat and poultry companies for the

nutritional labeling rule indicated that firms carry an average label

inventory of 5 to 6 months. Thus, inventory losses would be minor under

a 12 month or longer compliance period. Assuming an average inventory

discard cost of $30 per product results in an estimated inventory

transition cost of $150,000 ($30 times 5,000 products).

C. Bone Particle Size

A new requirement limits maximum bone particle size. FSIS believes

bone particle size will not have a significant effect on actual

production. For an establishment already performing bone content tests,

FSIS believes an additional 5 minutes per test is sufficient to add the

bone particle size test and record results. Good manufacturing

practices would require that such tests be conducted at least once per

day per shift.

Annual costs to perform and record test results for the 108

establishments are estimated at $74,000. This assumes an average of

1.75 shifts per day establishment, 260 operating days per year, 5

additional minutes per test, and a labor cost of $18 per hour.

D. Records Management and Maintenance

Information from industry indicates that many establishments

currently maintain records for bone solids content so minimal

additional burden is added by the proposed recordkeeping requirement.

New recordkeeping requirements would apply to bone particle size

testing. FSIS estimates that each establishment will average an

additional 15 minutes per day on records maintenance. Annual costs of

additional records maintenance for the 108 establishments are estimated

at $84,000. This assumes 260 operating days per year and a labor cost

of $12 per hour.

E. Benefits

Benefits derived from the proposed regulation arise from consumers

being assured that labeling for products containing MS(K) would not be

false or misleading. The description of ingredients will change, but

the physical product itself will remain unchanged. The Agency does not

expect any market-wide effects. No estimates exist regarding how

consumers value such information. However, the Agency believes the

value of avoiding false and misleading information exceeds the cost of

labeling. The Agency is seeking additional information and data from

commenters on the impact this proposal could have on markets and the

value consumers place on this type of labeling information.

Annual Cost Summary Table

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

Million dollars

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

1. Cost of relabeling................................. 5.000-10.000

2. Label inventory costs.............................. .150

3. Bone particle tests................................ .074

4. Records maintenance................................ .084

5. Consumer reaction (no estimate)....................

Total cost........................................ 5.308-10.308

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

Executive Order 12778

This proposed rule has been reviewed under Executive Order 12778,

Civil Justice Reform. States and local jurisdictions are preempted

under the Federal Meat Inspection Act (FMIA) and the Poultry Products

Inspection Act (PPIA) from imposing with respect to the premises,

facilities, and operations of federally inspected establishments any

requirements that are in addition to, or different than, those imposed

under the FMIA or PPIA. States and local jurisdictions may, however,

impose recordkeeping and other requirements within the scope of section

202 of the FMIA and section 11 of the PPIA, if consistent therewith,

with respect to any such federally inspected establishment. States and

local jurisdictions are also preempted under the FMIA and the PPIA from

imposing any marking, labeling, packaging, or ingredient requirements

on federally inspected meat and poultry products that are in addition

to, or different than, those imposed under the FMIA and PPIA. States

and local jurisdictions may, however, exercise concurrent jurisdiction

over meat and poultry products that are outside official establishments

for the purpose of preventing the distribution of meat and poultry

products that are misbranded or adulterated under the FMIA or PPIA, or,

in the case of imported articles, which are not at such an

establishment, after their entry into the United States. Under the FMIA

and PPIA, States that maintain meat and poultry inspection programs

must impose requirements that are at least equal to those required

under the FMIA and PPIA. The States may, however, impose more stringent

requirements on such State inspected products and establishments.

No retroactive effect will be given to this proposed rule. The

administrative procedures specified in 9 CFR 306.5 and 381.35 must be

exhausted prior to any judicial challenge to the provisions of this

proposed rule, if the challenge involves any decision of a program

official. The administrative procedures specified in 9 CFR parts 335

and 381, subpart W, must be exhausted prior to any judicial challenge

to the application of the provisions of this proposed rule with respect

to labeling decisions.

Effect on Small Entities

The Administrator has determined that this proposed rule would not

have a significant economic impact on a substantial number of small

entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).

It is likely that producers with smaller lot sizes would have higher

compliance costs per pound of product because some costs such as

testing and recordkeeping occur on a lot basis. Any relabeling costs

also would be lower per pound for products with large annual

production. No data is available which gives the establishment size

breakdown for establishments producing products containing MS(K).

Paperwork Requirements

This proposed rule would require establishments to maintain records

of bone solids content and bone particle size as a measure of process

control, and to make such records available to any duly authorized

representative of the Secretary. This proposed rule would also require

labels of poultry products produced by mechanical separation (i.e.,

products currently termed mechanically deboned poultry or MDP) or

products containing this ingredient to be revised to include in the

ingredients statements the regulated term ``Mechanically Separated

(Kind)'' and be submitted to FSIS for approval.

The paperwork requirements contained in this proposed rule have

been submitted to the Office of Management and Budget for approval

under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

Comments

Interested persons are invited to submit written comments

concerning this notice. Submit comments in triplicate to Diane Moore,

Docket Clerk, Food Safety and Inspection Service, U.S. Department of

Agriculture, Room 3171-S, Washington, DC 20250. Any person desiring an

opportunity for an oral presentation of views should make such request

to Mr. John W. McCutcheon so that arrangements can be made for such

views to be presented. A record will be made of all views orally

presented. All comments submitted in response to this notice will be

available for public inspection in the Policy, Evaluation and Planning

Office from 8:30 a.m. to 1:00 p.m., and from 2:00 p.m. to 4:30 p.m.,

Monday through Friday.

List of Subjects

9 CFR Part 318

Meat inspection.

9 CFR Part 381

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

Proposed Rule

For the reasons set forth in the preamble, FSIS is proposing to

amend 9 CFR parts 318 and 381 of the Federal meat and poultry

inspection regulations as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS: REINSPECTION AND

PREPARATION OF PRODUCTS

1. The authority citation for part 318 would continue to read as

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.

601-695; 7 CFR 2.17, 2.55.

2. Section 318.6 would be amended by adding a new paragraph (b)(13)

to read as follows:

Sec. 318.6 Requirements concerning ingredients and other articles used

in preparation of products.

* * * * *

(b) * * *

(13) Use of ``Mechanically Separated (Kind),'' as defined in

Sec. 381.173 of this chapter, in the preparation of meat food products

shall accord with Sec. 381.174 and all other applicable provisions of

this subchapter.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for part 381 would continue to read as

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR

2.17, 2.55.

4. Section 381.15 would be amended by revising paragraphs (a)(1),

(a)(2), (b)(2), and (c)(1) to read as follows:

Sec. 381.15 Exemption from definition of ``poultry product'' of

certain human food products containing poultry.

(a) * * *

(1) It contains less than 2 percent cooked poultry meat (deboned

white or dark poultry meat, or both) and/or ``Mechanically Separated

(Kind)'' as defined in Sec. 381.173;

(2) It contains less than 10 percent of cooked poultry skins,

giblets, or fat, separately, and less than 10 percent of cooked poultry

skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1)

of this section) or ``Mechanically Separated (Kind)'' as defined in

Sec. 381.173, in any combination;

* * * * *

(b) * * *

(2) It contains less than 15 percent cooked poultry meat (deboned

white or dark poultry meat or both) and/or ``Mechanically Separated

(Kind)'' as defined in Sec. 381.173, computed on the basis of the moist

deboned, cooked poultry meat and/or ``Mechanically Separated (Kind)''

in such product; and

(3) * * *

(c) * * *

(1) They contain poultry meat and/or ``Mechanically Separated

(Kind)'' as defined in Sec. 381.173 or poultry fat only in condimental

quantities;

* * * * *

5. Section 381.117 would be amended by revising the section title

and adding a new paragraph (e) to read as follows:

Sec. 381.117 Name of product and other labeling.

* * * * *

(e) On the label of any ``Mechanically Separated (Kind)'' described

in Sec. 381.173, the name of such product shall be followed immediately

and in the following order by the phrase(s): ``made from fowl'' unless

such product is not made, in whole or part, from mature female chickens

as defined in Sec. 381.170(a)(1)(vi), and ``with excess skin'' unless

such product is made from poultry product that does not include skin in

excess of the natural proportion of skin present on the whole carcass,

as specified in paragraph (d) of this section. Appropriate terminology

on the label shall indicate if heat treatment has been used in the

preparation of the product. The labeling information described in this

paragraph shall be identified on the label before the product leaves

the establishment at which it is manufactured.

6. Subpart P would be amended by adding new Secs. 381.173, and

381.174 to read as follows:

Sec. 381.173 Mechanically Separated (Kind).

(a) ``Mechanically Separated (Kind)'' is any finely comminuted

product resulting from the mechanical separation and removal of most of

the bone from attached skeletal muscle and other tissue of poultry

carcasses and parts of carcasses that may or may not contain skin with

attached fat and meeting the other provisions of this section. Examples

of such product are ``Mechanically Separated Chicken'' and

``Mechanically Separated Turkey.''

(b) ``Mechanically Separated (Kind)'' shall not have a bone solids

content of more than 1 percent. At least 98 percent of the bone

particles present in ``Mechanically Separated (Kind)'' shall have a

maximum size no greater than 1.5 mm (millimeter) in their greatest

dimension and there shall be no bone particles larger than 2.0 mm in

their greatest dimension.

(c) ``Mechanically Separated (Kind)'' shall not have a calcium

content exceeding 0.235 percent when made from mature chickens or from

turkeys as defined in Sec. 381.170(a)(l) (vi) and (vii) and (a)(2),

respectively, or 0.175 percent when made from other poultry, based on

the weight of product that has not been heat treated, as a measure of a

bone solids content of not more than 1 percent.

(d) ``Mechanically Separated (Kind)'' may be used in the

formulation of poultry products in accordance with Sec. 381.174 and

meat food products in accordance with subchapter A of this chapter.

(e) Product resulting from the mechanical separating process that

fails to meet the bone particle size or calcium content requirements

for ``Mechanically Separated (Kind)'' shall be used only in producing

poultry extractives, including fats, stocks, and broths and labeled as

``Mechanically Separated (Kind) for Further Processing.''

(f) The management of the establishment that produces

``Mechanically Separated (Kind)'' shall maintain records to support the

validity of bone solids content and bone particle size of

``Mechanically Separated (Kind).'' Such records shall be made available

to the inspector or any other duly authorized representative of the

Secretary upon request.

Sec. 381.174 Limitations with respect to use of Mechanically

Separated (Kind).

(a) A poultry product required to be prepared from a particular

kind of poultry (e.g., chicken) shall not contain ``Mechanically

Separated (Kind)'' described in Sec. 381.173, that is made from any

other kind of poultry (e.g., Mechanically Separated Turkey).

(b) Mechanically Separated Chicken described in Sec. 381.173, that

is made, in whole or in part, from fowl as defined in

Sec. 381.170(a)(l)(vi), shall not be used in baby, junior, or toddler

foods.

(c) ``Mechanically Separated (Kind)'' described in Sec. 381.173

shall not be used in poultry products that are composed of whole or

intact poultry muscle and expected to be as such by consumers (e.g.,

chicken steaks, chicken fillets, and cured turkey thighs), except that

it may be used for binding purposes (i.e., to hold poultry muscle

together) at a level that is sufficient for that purpose.

(d) ``Mechanically Separated (Kind)'' or ``Mechanically Separated

(Kind) Meat'' described in Sec. 381.173 shall not be used in the

formulation of a poultry product or meat food product, unless such use

conforms with any applicable requirements of the definitions and

standards of identity or composition in this subchapter or part 319 of

this chapter.

(e) Other than ``Mechanically Separated (Kind)'' made from fowl,

Mechanically Separated (Kind)'' may be used in any product defined by

regulatory standards of identity and composition, except those products

identified in paragraph (c) of this section, whereby ``Kind'' or ``Kind

Meat'' is being used, provided that it is identified as ``Mechanically

Separated (Kind).''

7. Section 381.175 would be amended by adding a new paragraph

(b)(6) to read as follows:

Sec. 381.175 Records required to be kept.

* * * * *

(b) * * *

(6) Records of bone solids content and bone particle size as

required by Sec. 381.173 of this subchapter.

Done at Washington, DC, on November 30, 1994.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 94-29901 Filed 12-2-94; 8:45 am]

BILLING CODE 3410-DM-P