Food Standards: Requirements for Processed Meat and Poultry Products Named by Use of an Expressed Nutrient Content Claim and a Standardized Term

DEPARTMENT OF AGRICULTURE

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR PART 319 and 381

[Docket No. 92-024P]

RIN: 0583-AB51

Food Standards: Requirements for Processed Meat and Poultry

Products Named by Use of an Expressed Nutrient Content Claim and a

Standardized Term

AGENCY: Food Safety and Inspection Service, USDA.

[[Page 67475]]

ACTION: Proposed rule.

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

amend the Federal meat and poultry products inspection regulations to

establish a general definition and standard of identity for

standardized meat food and poultry food products that have been

modified to qualify for use of an expressed nutrient content claim in

their product name. These products would be identified by an expressed

nutrient content claim, such as ``Fat Free,'' ``Low Fat,'' and

``Light,'' in conjunction with an appropriate standardized product

name. FSIS is taking this action to: (1) Assist consumers in

maintaining healthy dietary practices by providing for substitute

versions of standardized processed meat food and poultry food products

that have reductions of certain constituents that are of health concern

to consumers, such as fat and cholesterol, (2) increase regulatory

flexibility and support product innovation in accord with Executive

Orders 12861 and 12866 and with President Clinton's Memorandum to Heads

of Departments and Agencies, ``Regulatory Reinvention Initiative,''

dated March 4, 1995, and (3) provide consumers with an informative

nutrition labeling system.

DATES: Comments must be received on or before February 27, 1996.

ADDRESSES: Written comments should be sent in triplicate to, Policy,

Evaluation and Planning Office, Attn: FSIS Docket Clerk, DOCKET No. 92-

024P, Room 4352, South Building, Food Safety and Inspection Service,

U.S. Department of Agriculture, Washington, DC 20250. Oral comments as

provided by the Poultry Products Inspection Act should be directed to

Mr. Charles R. Edwards, Director, Product Assessment Division, at (202)

254-2565. (See also ``Comments'' under Supplementary Information.)

FOR FURTHER INFORMATION CONTACT: Mr. Charles R. Edwards, Director,

Product Assessment Division, Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of Agriculture, Washington, DC

20250, (202) 254-2565.

SUPPLEMENTARY INFORMATION:

Background

I. Introduction

The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and

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

authorize the Secretary of Agriculture to establish and maintain

inspection programs designed to assure consumers that meat and poultry

products distributed in commerce or within designated States are

wholesome, not adulterated, and are properly marked, labeled and

packaged.

Under section 7(c) of the FMIA (21 U.S.C. 607 (c)) and section 8(b)

of the PPIA (21 U.S.C. 457(b)), FSIS develops and promulgates

regulations that prescribe definitions and standards of identity and

composition for meat and poultry products (9 CFR parts 319 and 381,

subpart P). FSIS also promulgates regulations that prescribe the

content and design of labels for meat and poultry products (9 CFR parts

317 and 381, subpart N). Food and Drug Administration (FDA) has

responsibility for all other food products.

Food standards have existed in various forms since food was first

produced for distribution in commerce to people. In fact, the U.S.

Department of Agriculture, which was established in 1862, promulgated

about 200 ``standards of purity'' by 1906, which included definitions

of adulteration and misbranding. Meat and poultry standards have been

developed for various reasons, including (1) to prevent nutritional and

economic dilution (i.e., economic adulteration) of the expected,

characterizing, or valued components of meat and poultry products, such

as the amount of beef needed for a product to be considered a ``beef

stew,'' and (2) to establish standardized names for products, such as

``frankfurter,'' ``bologna,'' ``hamburger,'' ``chili con carne,'' and

``corned beef hash,'' that consumers can understand and, in turn, to

establish standardized requirements for the composition of these

products to assure, in general, that the products will contain certain

expected compositional components. For example, a product named

``corned beef hash'' is expected to contain cured beef, potatoes, and

seasonings. Providing standards for meat and poultry products serves

the needs of industry to produce, and the desires of consumers to

purchase products that contain the characteristics and ingredients that

are expected in a product represented by a particular name.

Parts 319 and 381, subpart P, of the meat and poultry inspection

regulations (9 CFR parts 319 and 381, subpart P, respectively) contain

standards of identity or composition for about 60 meat and poultry

product categories. Standards of identity and composition can be like a

recipe and may establish specific requirements for a product such as

the kind of ingredients and/or the amount of ingredients allowed in it;

and/or the methods by which the product must be prepared; and/or the

criteria the finished product must meet, such as a specified salt

content of 4 percent that can affect the wholesomeness or shelf-life of

a product, such as a dried ham.

The standard for ``pizza'' (9 CFR 319.600), for example, defines

the product ``pizza with meat'' as ``a bread base meat food product

with tomato sauce, cheese, and meat topping,'' and indicates the

minimum amount of the meat it must be made from, which is not less than

15 percent raw meat. The standard for corned beef hash (9 CFR 319.303)

sets the minimum amount of meat (i.e., meat content) that this product

must contain, and in addition, lists other required and optional

ingredients for the product. The standard for ``Country Ham'' (9 CFR

319.106) states that this product is an uncooked, cured, dried, smoked

or unsmoked meat food product made up of a single piece of meat from a

pork ``ham'' (i.e., hind leg of a hog) or pork shoulder. This standard

also states that a ``Country Ham'' must be prepared using a dry

application of salt and curing agents in order to have a prescribed

salt, brine concentration, or water activity in the finished product.

The standard for ``meat pies'' (9 CFR 319.500), for example, a beef or

pork pie, requires that the product have not less than 25 percent meat

based on the amount of all the product's ingredients. Hereafter, in

this document, ``standards'' will refer to both the meat and poultry

product standards of identity or composition codified in 9 CFR parts

319 and 381, subpart P.1

\1\ FSIS has also established policy guides in its Standards and

Labeling Policy Book for many processed meat and poultry food

products for which there are no specific regulatory standards, e.g.,

``Chinese Pepper Steak.'' These policy guides address the criteria,

the characteristics, and/or the expected composition of a particular

poultry or meat food product that is associated with a particular

product name. These policy guides may identify minimum meat and/or

poultry contents, maximum fat and water contents, methods of

processing or cooking, expected or characterizing ingredients, and/

or finished product criteria (such as salt content or cooking yield)

for various meat or poultry products. A copy of the Standards and

Labeling Policy Book is available for inspection in the FSIS Docket

Clerk's Office, Room 4352, South Agriculture Building, Washington,

DC 20250.

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Meat and poultry products that are subject to FSIS' regulatory

standards make up a substantial portion of the nation's food supply.

The Agency believes that there is a desire among consumers to be able

to purchase healthful, alternative standardized meat and poultry food

products that have been modified to reduce the level of constituents

that are of health concern to some people, such as fat, cholesterol, or

sodium, below that which occurs under existing FSIS regulatory

[[Page 67476]]

standards. Industry has previously petitioned FSIS for permission to

market these products. The Agency's objective, through this proposal,

is to help facilitate the industry's ability to produce these

substitute standardized products and, in turn, to facilitate consumers'

selections of a variety of alternative products that are wholesome and

properly labeled, as required by the FMIA and the PPIA.

II. IOM Report

Federal regulatory agencies responsible for food safety and food

labeling have been interested in modernizing labeling and food

standards for some time. In 1989, FSIS and the Public Health Service,

U.S. Department of Health and Human Services, which includes FDA,

jointly sponsored a study by the Institute of Medicine (IOM) of the

National Academy of Sciences (NAS), to provide options for improving

food labeling. The NAS in its 1990 final report, Nutrition Labeling,

Issues and Directions for the 1990's 2 (IOM Report), expressed the

concern that some of FDA's standards of identity impeded a

manufacturer's ability to offer more nutritious foods.

\2\ This report is available for public inspection in the FSIS

Docket Clerk's office.

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Although both FSIS and FDA were encouraged to review their food

standards, the IOM Report pointed out that there was a distinct

difference between FDA standards and those of FSIS. FDA standards for

certain products in which fat has traditionally been considered a

valuable or characterizing ingredient require a minimum amount of fat

to be present in a product before the product can be identified by the

standardized name established in FDA regulations. On the other hand,

generally speaking, FSIS standards set maximum limits on fat, water, or

other added substances that can be present in a product in order to use

the name established by the standards. For example, in FDA's standards,

a product using the name ``ice cream'' is required by regulation (21

CFR 135.110) to have a minimum of 10 percent milkfat in order to bear

that name. However, FSIS standards for products identified by the names

``Frankfurter,'' ``Wieners,'' or ``Hot Dog'' (9 CFR 319.180(b)), for

example, limit the combination of fat and added water to no more than

40 percent of the product's formulation. The IOM Report noted that,

historically, a high milkfat content was considered a desirable

characteristic in dairy products, whereas, in meat and poultry

products, an excess amount of fat, water, and other added substances

were considered to dilute the protein contributed by the meat or

poultry portion (which was the ``valued'' component of a meat and

poultry product).

The Agency agrees with the IOM Report, which stated, ``In 1990,

less skepticism exists about consumers' abilities, aided by informative

labeling, to protect themselves against debased or diluted products * *

* Attention is now focused on the consumption of too much fat rather

than the possibility that some products will be made using less of an

ingredient [less fat] than was historically considered a valuable

constituent. Accordingly, it seems clear to the [IOM] Committee that

any system that significantly impedes the marketing of reduced-, low-,

and non- or no-fat substitutes should be examined and, presumably,

changed.''

Processed meat and poultry products are important sources of many

nutrients, especially protein, vitamin B-6, vitamin B-12, iron, and

zinc. Meat is rich in heme iron, which is more readily absorbed by the

body than is iron from many other foods. Heme iron also enhances the

absorption of iron from other sources. Meat and poultry products will

continue to be an important part of the total American diet. FSIS

believes that it is appropriate to provide consumers with the largest

variety of processed meat and poultry products that can be made

available to them, from which consumers can then make healthful food

purchasing choices. Therefore, FSIS believes that reform of labeling

for meat and poultry products and reform of regulatory standards for

these products should include implementing the regulatory changes

needed to provide the meat and poultry industry the flexibility

necessary to create and market an increased variety of healthful

processed meat and poultry products, such as those lower in fat, which

have the beneficial nutrients, flavor, texture and appearance desired

by consumers.

III. NLEA and Regulatory Actions

As a result of increased interest in the benefits of more healthful

diets, consumer groups, Congress, the FDA, and FSIS began to actively

focus on food label reform during the late 1980's and early 1990's. In

November 1990, Congress passed the ``Nutrition Labeling and Education

Act of 1990'' (NLEA). The NLEA, which applies to foods under FDA's

jurisdiction, gave legislative emphasis to an already on-going effort

by the FDA and FSIS to reform food labeling. It included direction for

improving ingredient labeling and addressing issues concerning

standards of identity reform.

The NLEA addressed food labeling only for foods under the

jurisdiction of the FDA. However, in the interest of providing

consumers with uniform nutrition labeling for all foods, FSIS published

an advance notice of proposed rulemaking (ANPR) in the Federal Register

on April 2, 1991 (56 FR 13564), advising of its intent to publish a

proposed rule for nutrition labeling of meat and poultry products. In

regard to meat and poultry product standards of identity, FSIS stated

that it would reassess this issue after completing its rulemaking on

nutrition labeling.

Final nutrition labeling rules for food under the jurisdiction of

FDA and FSIS were published in the January 6, 1993, Federal Register.

The January 6, 1993 Federal Register contained final rules for

nutrition labeling for most meat and poultry products under FSIS'

jurisdiction (58 FR 632), and FDA final nutrition labeling rules for

most food products under its jurisdiction. The nutrition labeling rules

were comprehensive. They addressed both required nutrients and food

components which were to be listed in the ``Nutrition Facts'' panel of

food products, as well as optional nutrient and food components that

could be listed on the panel. Rules were also issued that specified

food product labeling formats and food category serving sizes, as well

as defined nutrient content claims such as ``Low,'' ``Light,'' and

``Free.''

In the same Federal Register (58 FR 2431), FDA published a final

rule that affected many FDA standardized foods. Section 130.10 (21 CFR

130.10), prescribes conditions under which foods that substitute for a

standardized food can deviate from the standard of identity and still

use the standardized name as part of the product name. Provisions in 21

CFR 130.10 prescribe a general definition and standard of identity for

foods that substitute for FDA-regulated standardized foods and use the

name of the standardized food in their statement of identity but do not

comply with the standard of identity because of a deviation that is

described by an expressed nutrient content claim defined by FDA's

regulations. These foods are named by use of an expressed nutrient

content claim, such as ``Fat Free'' ``Light,'' and ``Lean,'' in

conjunction with an applicable standardized name. Based on an informal

market review conducted by FSIS, FDA's rule has resulted in the

appearance in supermarkets of an array of new food products that

qualify for use of an expressed nutrient content

[[Page 67477]]

claim and standardized names, e.g., ``Fat Free Ice Cream,'' ``Low Fat

Cheddar Cheese,'' and ``Reduced Fat Egg Nog,'' because of allowable

deviations from FDA food standards permitted by 21 CFR 130.10.

The FDA regulation requires that the performance characteristics of

the substitute standardized food be similar to those of the

standardized food, except as discussed below. Performance

characteristics are the physical properties (e.g., the ability to

freeze), flavor, functional properties (e.g., spreadability), and

shelf-life (i.e., the time the product exists in a wholesome condition

under acceptable handling practices) of a food. If, however, there are

any significant differences in the performance characteristics of the

modified version of the standardized food that materially limit the

uses of the food, as compared to the uses of the standardized food,

these must be disclosed on the product's labeling. For example, if a

``Fat Free Cream Cheese'' cannot be used in baking, that fact must be

stated on the product's labeling, e.g., ``not recommended for baking.''

The FDA regulation also provides that the ingredients used in the

substitute food product must be those ingredients provided for by the

standard, except that safe and suitable ingredients may be used to

improve texture, add flavor, prevent syneresis, extend shelf life,

improve appearance, or add sweetness so that the product is not

inferior in performance characteristics to the standardized food. The

FDA regulation also requires that ingredients not provided for, and

ingredients used in excess of those levels provided for by the

standards, must be identified by an asterisk in the ingredients

statement of a product and the meaning of the asterisk must be

explained immediately following the ingredients statement.

The FDA regulation facilitated new markets and new opportunities

for FDA-regulated food companies to develop modified versions of

standardized foods. Although 21 CFR 130.10 addressed only FDA-regulated

foods, meat and poultry food manufacturers were quick to respond to the

potential market for modified standardized meat and poultry products.

According to the meat and poultry industries, they intensified their

research and development activities in order to be able to respond to

potential consumer demands for meat and poultry products with

reductions in various constituents, such as fat and cholesterol, where

current standards may limit the marketing of such products.

Technological developments and new ingredient uses now allow the

industry to develop new meat and poultry products, including substitute

standardized products with decreased amounts of fat, such as, ``Fat

Free Bologna.''

Manufacturers of these new meat and poultry products wanted to

market them without labeling them by what they considered to be

pejorative terms such as ``alternative,'' ``replacement,'' and

``substitute.'' The manufacturers indicated that such products were not

of lesser value compared to their traditional standardized

counterparts. They asserted that these products, including new lower

fat products, were better and should be allowed to be identified with

an appropriate nutrient content descriptor and a commonly understood

standardized name that would be familiar to consumers. They requested

that FSIS allow labeling for these products similar to that provided

for in FDA's general standard of identity in 21 CFR 130.10 for modified

standardized products.

FSIS responded to this request by issuing Policy Memo 123 3

(dated January 20, 1995) as an interim policy to allow some

standardized or traditional meat and poultry food products that have

been formulated to reduce their fat content to enter the marketplace

while appropriate regulatory actions related to the modernization of

standards were developed. Policy Memo 123 allowed modified versions of

cooked sausage (e.g., frankfurters), fermented sausages (e.g.,

pepperoni, salami) and breakfast sausage products to be identified by a

nutrient content claim that reflected a reduction in fat content in

conjunction with a standardized or traditional name, e.g., ``Fat Free

Bologna,'' ``Low Fat Pepperoni.'' Policy Memo 123 included provisions

for labeling which were similar to those established by FDA's general

standard of identity in 21 CFR 130.10. In a prior related policy, on

May 10, 1991, FSIS issued Policy Memo 121, ``Labeling of Low Fat Ground

Beef and Low Fat Hamburger Containing Added Ingredients.'' Policy Memo

121 allowed for such products to be named with a standardized name

along with other descriptive labeling, e.g., ``Low Fat Hamburger With a

X% Solution of Water and Carrageenan'' or ``Low Fat Hamburger, Water

and Carrageenan Product.'' Policy Memo 121 has been updated (See Policy

Memo 121B, dated January 20, 1995) 4 to reflect current changes in

nutrition labeling regulations.

\3\ This paper is available for public inspection in the FSIS

Docket Clerk's office.

\4\ This paper is available for public inspection in the FSIS

Docket Clerk's office.

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Both Policy Memo 121B and Policy Memo 123 were issued as interim

policies intended to accommodate certain lower fat substitute meat and

poultry products until such time that rulemaking was completed. Both of

these policy memoranda will be rescinded if provisions proposed in 9

CFR 319.10 and 381.172 become final rules.

FSIS is now, in this rulemaking, proposing to establish a general

regulatory standard of identity for modified meat and poultry products

which substitute for meat and poultry food products defined by a

regulatory standard of identity or composition in 9 CFR parts 319 and

381, subpart P. FSIS believes that this general standard of identity

will be beneficial to consumers because it will (1) assist consumers by

providing for substitute versions of standardized processed meat and

poultry products that have reductions of certain constituents that are

of health concern to consumers, such as fat and cholesterol, and which

bear accurate descriptive names that are meaningful to consumers, (2)

increase regulatory flexibility and support product innovation in

accord with Executive Orders 12861 and 12866 and with President

Clinton's Memorandum to Heads of Departments and Agencies, entitled

``Regulatory Reinvention Initiative,'' dated March 4, 1995, and (3)

provide consumers with an informative nutrition labeling system that

will parallel, to a significant extent, the nutrition food labeling

initiatives of FDA. FSIS believes that this proposed general standard

of identity is fully consistent with FSIS's statutory responsibilities

under the FMIA and PPIA to assure that the labeling of meat and poultry

products is accurate and truthful and not false or misleading. The

substitute meat food and poultry food products covered by this proposal

will be identified by familiar product names and will be labeled to

inform consumers about their general compositional changes from

standardized products by use of a nutrient content claim as part of the

product's name.

IV. Discussion of Regulatory Proposal

FSIS is proposing to amend the Federal meat and poultry products

inspection regulations to establish a definition and general standard

of identity for modified versions of standardized meat and poultry food

products, i.e., ``substitute standardized products.'' These products

will be formulated and processed with ingredients otherwise not in or

in

[[Page 67478]]

amounts greater than that allowed by FSIS regulatory food standards in

9 CFR parts 319 and 381, subpart P, in order that the product's make-up

is consistent with the nutrient content claim made about the product.

The names of these products will be composed of an expressed nutrient

content claim that, in general, reflects the necessary ingredient

modifications made for the product to be accurately identified by such

a claim, along with an established appropriate standardized term.

This proposed rule would: (1) Define ``substitute processed meat or

poultry food products''; (2) allow an expressed nutrient content claim

to be used to identify substitute meat and poultry products, in

conjunction with the name of a standardized product; (3) require

substitute processed meat and poultry food products to have similar

performance characteristics such as physical and functional properties

to the standardized products for which they substitute, except for

significant differences that materially limit the use of the product as

compared to the use of the standardized food, which will be allowed if

the differences are identified by special labeling statements next to

the product's name; (4) require that ingredients used in substitute

standardized products be those provided for use by the regulatory

standard for which the product is a substitute, except that safe and

suitable ingredients approved for use in meat and poultry food products

will be allowed to be used at the minimum level necessary to improve

texture and prevent syneresis, in order that the product does not have

inferior performance characteristics to the standardized product it

modifies; (5) require other ingredient requirements for the substitute

product including not replacing or exchanging an ingredient

specifically required by the standard with a similar ingredient from

another source and requiring such required ingredients to be present in

the same amounts as required by the standard; (6) prescribe

nomenclature for identifying substitute standardized processed meat and

poultry products; and (7) establish labeling requirements for

identifying ingredients used in the substitute standardized processed

meat and poultry products that are not provided for or are used in

excess of the level provided for by the standard for which the product

substitutes.

FSIS believes that this proposed action is needed to provide

consumers with accurate, descriptive, and fully informative labeling

that will promote honesty and fair dealing in the distribution of

products of interest to consumers. This proposed rule is needed to

facilitate the development and availability of substitute processed

meat and poultry products that have reductions in constituents that are

of health concern to some people, e.g, fat, cholesterol, and sodium.

The proposed rule would enable FSIS to rely more on labeling

requirements, and less on recipe-type standards that are restrictive,

in carrying out its mandate to assure that the labels of meat and

poultry food products are accurate and not misleading to consumers.

FSIS believes that today's consumer is better able to evaluate the

merits of standardized processed meat and poultry food products when

provided with labeling that is guided by rules that require, for most

products (1) a commonly recognized product name, (2) nutritional

information about what one serving of the food contains (i.e.,

Nutrition Facts), and (3) a listing of ingredients in the order of

predominance by weight used to make the product (i.e., the ingredients

statement).

Meat and poultry food products that satisfy the criteria for use of

nutrient content claims defined in 9 CFR parts 317 and 381 can also

make claims other than those that reflect reductions of constituents of

health concern to some people, such as ``high in'' or ``good source

of.'' FSIS believes current meat and poultry product standards do not

preclude the making and marketing of substitute products that qualify

to use these claims. Therefore, FSIS is not, in this proposal,

proposing regulations to provide for the production and distribution of

these products, since it believes new regulations are not needed for

these products to be manufactured and distributed. FSIS would, however,

like comments from members of the public, including consumers,

industry, and scientists as to whether or not current regulatory

standards prevent the distribution of products with nutrient content

claims, other than those that reflect a reduction of constituents of

health concern to some people. If after a review of this issue, FSIS

determines its standards impede the development of these products, FSIS

will consider amending the scope of coverage in its proposal.

A. General Standard

FSIS recognizes that valuable and helpful information concerning

the nutrient content of meat and poultry food products can be conveyed

to consumers if defined nutrient content claims can be used in a

consistent and accurate manner in the names of certain substitute meat

and poultry food products. Substitute meat and poultry products are

defined in FSIS nutrition labeling regulations in 9 CFR 317.313(d) and

381.413(d), respectively. These products are defined as a product that

may be used interchangeably with another product that it resembles,

i.e., that it is organoleptically, physically, and functionally

(including shelf-life) similar to, and that it is not nutritionally

inferior to unless it is labeled as an ``imitation.'' Those same

regulations provide that products that have performance characteristics

that materially limit the use of the product may still be considered a

substitute product if the label of the product includes a disclaimer

informing the consumer of such a difference, such as ``not suitable for

frying.''

As part of its nutrition labeling regulations (9 CFR parts 317 and

381, subpart Y), the Agency defined the terms for certain expressed

nutrient content claims, including terms such as ``free,'' ``low,''

``reduced,'' and ``light'' (9 CFR 317.313, 317.356, 317.361, 317.362,

381.413, 381.456, 381.461, and 381.462) that are associated with

reductions in constituents of health concern to some people. These

claims are useful in helping consumers choose a healthy diet.

Manufacturers that wish to use other nutrient content claims on labels

of meat and poultry products that are not currently defined by FSIS

regulations can utilize the procedures set forth in 9 CFR 317.369 and

381.469, ``Labeling Applications for Nutrient Content Claims,''

respectively to seek permission to use other nutrient content claims on

labels of meat and poultry products.

Given these developments, FSIS believes that it is now appropriate

to set forth general requirements governing the establishment of a

general standard of identity for substitute meat and poultry food

products. The proposed general requirements in 9 CFR 319.10 and 381.172

specify the conditions under which names of standardized foods set

forth in 9 CFR parts 319 and 381, subpart P, and appropriate expressed

nutrient content claims may be used to identify new substitute

standardized meat and poultry food products.

FSIS recognizes that the establishment of individual new standards

may, in some cases, be necessary for certain meat and poultry food

products, but, it believes, that in general, the promulgation of a

large number of individual regulations for substitute meat and poultry

food products would be an unnecessarily wasteful use of the Agency's

resources. FSIS believes that the development of a

[[Page 67479]]

general standard applicable to the vast majority of substitute meat and

poultry food products offers the most reasonable and effective

regulatory approach for substitute products that contain reductions of

constituents of health concern for various people. Proposed provisions

9 CFR 319.10 and 381.172 describe the conditions under which a variety

of substitute meat and poultry food products may use expressed nutrient

content claims and standardized terms.

B. Substitute Meat and Poultry Food Products Defined by This Proposal

FSIS is proposing to define substitute processed meat and poultry

products as: any processed meat and/or poultry product whose

formulation has been minimally modified to enable it to be used as a

substitute for another meat and/or poultry product that it resembles

and which has a standard of identity in the regulations (9 CFR parts

319 and 381, subpart P). The substitute meat or poultry food product

would be eligible to use an expressed nutrient content claim to

identify it; would resemble the standardized product in appearance,

form, taste, and texture; and, would use safe, suitable, and approved

substitute ingredients at proper levels and functions, i.e., the lowest

level necessary to satisfy the criteria for use of the expressed

nutrient content claim provided in regulations.

The substitute meat or poultry product will substantially meet the

regulatory requirements and consumer expectations of the standardized

product for which it substitutes (i.e., the product will not be

dissimilar in general appearance, form, taste, and texture and will be

prepared with the ingredients used in the standard of identity or

composition identified in 9 CFR parts 319 and 381, subpart P), unless

the product is labeled in a manner that conveys allowable ingredient

differences to consumers. The ingredient differences that will be

allowed relate to the use of ingredients needed to make a product that

complies with the specific expressed nutrient content claim related to

a reduction in a constituent that has negative health implications that

is used, i.e., fat, cholesterol, and sodium. The substitute meat or

poultry food product will be allowed to be named using a standardized

term because it either will be similar to the standardized product in

its performance characteristics and the ingredients used, or it will,

through appropriate labeling terminology, describe how it differs from

the standardized product for which it substitutes. The Agency believes

that consumers will be protected from false or misleading labeling by

requiring labeling for the substitute product that reflects its

deviations from the standardized product for which it substitutes.

When a Product Will Not Be Considered a Substitute Standardized

Product. There are certain aspects of the standards that are essential

to the identity of the standardized product and deviations from these

aspects would result in products that would not meet FSIS's definition

of substitute products set forth in 9 CFR 317.313(d) and 381.413(d). In

this regard, some of the standards in 9 CFR parts 319 and 381, subpart

P, specify that the standardized product must be prepared using meat or

poultry from a specific anatomical location and/or of a specific kind

and/or amount, and must undergo specified processing procedures that

are essential to the identity of the product. Deviations from these

types of requirements would result in a product that does not come

within the established definition for substitute products because they

would result in a product that is physically dissimilar and, thus, not

a substitute product. Therefore, modified versions of standardized

products which purport to be substitutes of them must adhere to the

original regulatory standards requirements set forth in parts 319 and

381, subpart P regarding the use of meat and poultry from specified

anatomical locations, the use of a specific kind and/or amount of meat

or poultry tissue to prepare the product, and the use of specified

processing procedures. It is FSIS' belief that deviation from these

specified meat or poultry requirements and processing procedures would

result in products that do not meet the definition of substitute

products. To allow such products to affirmatively represent themselves

as substitute standardized products would be false and misleading

labeling in violation of the provisions of the FMIA and PPIA.

For example, in 9 CFR 319.304, beef stew must contain at least 25

percent meat (i.e., beef). Since the meat or poultry content of such a

product is integral to its identity, the label for a substitute of this

product would be false or misleading if the substitute was named, in

part, by a standardized term, but contained less than the amount of

meat and/or poultry required by the standard. Consumers have come to

expect certain meat and/or poultry contents of products they purchase

that bear a standardized term. For example, a product identified with

the standardized name ``Chicken A-La-King'' is required to contain a

minimum of 20% cooked chicken meat and a substitute for this product

would also be required to contain the same amount of chicken meat.

Furthermore, a product identified with the standardized name ``Beef

Stew'' would continue to be required to contain not less than 25% meat

computed on the weight of the fresh meat. In addition, for example, in

9 CFR 381.171, ``Turkey Ham'' must be made from turkey thigh meat and

be cured, and in 9 CFR 319.107, ``Bacon'' must be made from pork

bellies and be cured and substitute products would be required to be

made from those same anatomical parts and by the same processing

procedures.

Although this proposal would not alter the minimum meat and poultry

content requirements in current FSIS standards, FSIS is considering

broader reform of its standards system that would provide firms greater

flexibility in product formulation while fully informing consumers

regarding the meat or poultry content of the product. FSIS plans to

invite comment on possible alternative regulatory approaches in this

area in an ANPR to be published in the Federal Register.

C. Expressed Nutrient Content Claims

FSIS believes that an issue of importance to many consumers is the

lowering of the amount of fat, cholesterol, and/or sodium in meat and

poultry food products. FSIS has the responsibility, under the FMIA and

PPIA to assure that meat and poultry products with reduced amounts of

such constituents are accurately and truthfully labeled. FSIS is,

therefore, proposing in 9 CFR 319.10 and 381.172 the conditions under

which substitute meat and poultry products (as defined in 9 CFR

317.313(d) and 381.469(d)) that do not comply with a standard of

identity in 9 CFR parts 319 and 381, subpart P, because of a deviation

that is described by an expressed nutrient content claim, that

represents reductions in constituents associated with negative health

implications, i.e., fat, cholesterol, and sodium, may be named using an

expressed nutrient content claim and a standardized term.

Final FSIS nutrition labeling regulations published in the January

6, 1993, Federal Register (58 FR 632) provided definitions for various

nutrient content claims that can be used on the label of meat and

poultry products, e.g., ``Fat Free,'' ``Low Fat,'' and ``Low

Cholesterol.'' Those same regulations, which were recodified in January

3, 1995, (60 FR 174), define an expressed nutrient content claim as any

direct statement about the level (or range) of a nutrient in the

product, e.g., ``low fat''

[[Page 67480]]

or ``reduced fat turkey ham.'' Since the proposed product name of a

substitute standardized product is intended to distinguish it from the

standardized product based on its improved nutritional attribute, a

nutrient content claim along with a standardized term must be used to

name the substitute products in order for consumers to understand how

the modified product differs from the standardized product. FSIS is

proposing that only expressed nutrient content claims, i.e., claims

that have been defined and are related to reductions in constituents

having negative health implications, be permitted in conjunction with

the standardized name, in the name of the substitute meat and poultry

products provided for in this proposal. Because such products cannot be

formulated under some existing regulatory standards, FSIS is proposing

to allow additional flexibility for industry to manufacture meat and

poultry products whose compositions has been modified to qualify for

use of an expressed nutrient content claim that asserts that a

constituent of a product, of health concern to some people, has been

reduced in amount. Examples of the applicable nutrient content claims

are: ``low,'' ``lower,'' ``lite,'' ``reduced,'' ``lean,'' ``extra

lean,'' and ``free,'' as defined in 9 CFR 317.313, 317.356, 317.361,

317.362, 381.413, 381.456, 381.461, and 381.462.

D. Performance Characteristics of Substitute Foods

FSIS believes that in order for a product that bears a standardized

name to be considered to be accurately labeled it must not only

resemble the traditional standardized meat and poultry food product but

also must perform similarly to the traditional standardized products

unless, the product is specifically labeled to show any significant

performance usage differences it has, such as a frankfurter not being

suitable for freezing. Unless this is done, consumers might assume that

the substitute product could be used interchangeably with the

traditional standardized food in all applications.

Therefore, in order not to mislead consumers, FSIS is proposing in

9 CFR 319.10(b) and 381.172(b) to require that a substitute

standardized product that bears a standardized name have similar

performance characteristics to the standardized meat and poultry food

product defined in 9 CFR parts 319 and 381, subpart P for which it

substitutes, except as discussed below. FSIS is proposing that the

performance characteristics by which a substitute food be judged in

terms of its similarity include its physical properties (e.g., texture,

cooking qualities, freezing qualities, its functional properties (e.g.,

body, spreadability), and shelf-life.

FSIS recognizes, however, that when a standardized product is

modified so that its composition accurately supports the nutrient

content claim intended to be made, it may not be possible, in all

cases, to produce a substitute product that performs similarly in

regard to all uses of the regulated standardized meat or poultry food

product of which it is a modification. The product would be considered

a substitute product allowed under this proposal if the limitation on

use does not affect the fundamental nature of the product and is

disclosed in labeling.

The FMIA and PPIA require that the label or labeling of a meat or

poultry food product must be accurate and not misleading and that such

labels and labeling must accurately disclose to consumers what they are

buying when they purchase any meat and poultry food product.

Information disclosing differences in use performance characteristics

(e.g., cooking quality, freezing quality, spreadability of product, and

shelf-life) of substitute standardized products is a fact FSIS believes

should be specifically disclosed on labels of substitute products

identified partially by a standardized term because without such

labeling consumers would be misled about the uses the product has in

comparison to the standardized product for which it substitutes.

Accordingly, this information must be communicated to consumers on the

product's label, or the label would be misleading, and the product

would be misbranded under the FMIA and PPIA.

Therefore, the provision in proposed 9 CFR 319.10(d) and 381.172(d)

that requires disclosure of material differences in uses in regard to

the performance characteristics between the substitute product and the

standardized product for which it is a substitute is fully consistent

with FSIS statutory responsibility under the FMIA and PPIA to prevent

false or misleading labeling. If there is a difference in performance

characteristics that materially limits the use of the product, the

product may still be considered a substitute if the label includes a

disclaimer adjacent to the most prominent claim in accordance with 9

CFR 317.313(d) (1) and (2) and 381.413(d) (1) and (2), informing the

consumer of such difference. The statement must appear on the label

with such conspicuousness and in such terms as to render it likely to

be read and understood by the consumer under customary conditions of

purchase and use, in accordance with requirements of 9 CFR 317.313(d)

(1) and (2) and 381.413(d) (1) and (2).

For example, according to the provisions of this proposal, a

product identified as a ``fat free frankfurter'' would have to meet the

criteria for using the nutrient content claim ``fat free'' and would

have to have similar performance characteristics to a ``frankfurter,''

unless a statement of any difference(s) in uses appears on the label of

the substitute frankfurter product; and if it does not, the product

would be considered to be misbranded. A ``frankfurter'' produced

according to the standard for frankfurters would be expected by

consumers to have certain physical and functional characteristics, such

as a ``link'' form, a cured pink color, a spongy texture, and the

ability for refrigeration or freezing for an appropriate time period to

keep the product wholesome. It would also be expected that it could be

prepared in a variety of ways, i.e., by boiling, broiling, grilling,

and frying.

When fat, however, in a frankfurter or another standardized product

is replaced by one or more other ingredients, it may not be possible,

in all cases, to produce substitute products that perform identically

to the traditional standardized meat and poultry products. Successful

fat reduction in meat and/or poultry products requires a firm

understanding of the functions of fat in a product, i.e., to provide

texture, flavor, and palatability, and how those functions can be

replicated with nonfat ingredients. Fats exhibit unique physical

properties in meat and poultry products, e.g., their ability to combine

with protein to form emulsions and their ability to enhance tenderness.

In order to make a substitute product that qualifies for a ``fat free''

nutrient content claim, it may be necessary to replace fat with water

and binders (i.e., additives that hold water and protein) which may

result in a substitute meat or poultry food product with limitations in

performance related to product uses because water and binders may not

provide all of the physical and functional properties related to

product use that are associated with fat, e.g., ability to be stored

frozen. In products such as frankfurters, the increase in moisture

which may be a direct result of fat replacement, and the way water is

held by binders and dispersed in the product, can lead to the formation

of large ice crystals because a higher level of available moisture

makes the product less stable when thawed from the frozen state, i.e.,

water leaks from the product. Therefore, if a ``fat free frankfurter''

does

[[Page 67481]]

not tolerate frozen storage for long periods of time, because the

ingredients needed to make the substitute product do not withstand the

same conditions of storage as the standardized product for which it is

a substitute, a non-performance statement would inform the consumer of

that fact, e.g, ``Do Not Freeze.''

E. Ingredients Used in Substitute Products

1. Ingredients Provided for by Proposed Regulation. FSIS believes

that the ingredients used in a substitute version of a standardized

product should be those ingredients provided for by the traditional

standard with only those deviations necessary to attain an acceptable

substitute product that meets the requirements of the expressed

nutrient content claim that is intended to be used to reflect a

reduction in a constituent that has negative health implication, e.g.

fat, cholesterol, and sodium. Therefore, FSIS is proposing in 9 CFR

319.10(c) and 381.172(c) that ingredients used in a substitute product

be those ingredients provided for by the traditional standard except

that, in addition, ``safe and suitable'' ingredients, as defined in 9

CFR 318.7 and 381.147, may be used to improve texture and prevent

syneresis so that the product has similar characteristics to the

traditional standardized meat or poultry food product, e.g., taste and

appearance.

This proposed rule would have the most significant impact on the

use of water and binders as a ``fat replacement system'' for substitute

products intending to use nutrient content claims related to reductions

in fat and cholesterol. FSIS is providing the following list as

examples of ``fat replacing'' binders, i.e., ingredients or additives

historically classified as binders by food scientists, to aid

commenters in understanding the types of ingredients the Agency

believes are applicable to making substitute products that have

reductions in fat and associated cholesterol. These ingredients have

typically been restricted in standardized meat and poultry food product

formulations, but will now be allowed in substitute products under the

conditions described in this proposal. Examples of these substances

are: Agar-agar; Algin; Sodium alginate; calcium carbonate, lactic acid,

and calcium lactate (or glucono delta-lactone); Calcium reduced dried

skim milk; Carrageenan; Carboxymethyl cellulose (Cellulose gum); Dried

milk; Enzyme (rennet)-treated calcium reduced dried skim milk and

calcium lactate; Food starch modified; Gelatin; Guar gum; Methyl

cellulose; Isolated soy protein; Sodium caseinate; Dry or dried whey;

Reduced lactose whey; Reduced minerals whey; Whey protein concentrate;

Starchy vegetable flour (e.g., potato flour, rice flour, and pea

flour); Vegetable starch (e.g., corn starch, potato starch, and wheat

starch); Wheat gluten; Tapioca dextrin; Soy flour; Soy protein

concentrate; and Xanthan gum.

Emulsifying agents also aid water and binders in replacing fat and

associated cholesterol by holding water, binders, and muscle tissue

together. Therefore, they will be permitted in combination with water

and binders as part of a fat-replacement system. Emulsifying agents

identified in 9 CFR 318.7(c)(4) and 381.147(f)(4), e.g., lecithin, mono

and diglycerides, and polyglycerol esters of fatty acids, commonly used

as emulsifying agents in shortenings and margarines, can be used as

part of the fat-replacement system in combination with approved binders

and water, but are not considered to be ``fat replacing'' ingredients

when used alone. This is because such substances are derived from fat

and do not, themselves, mimic fat. However, emulsifying agents approved

for use in meat and poultry products can be used in amounts consistent

with the regulations, in combination with approved binders and water,

and functioning as part of the ``fat replacing system.''

Humectants are another class of substances that assist water and

binders to mimic fat. They are substances that attract and hold water,

e.g., glycerine and corn syrup solids. Humectants would not be

considered by themselves to be fat replacers, but would be allowed as

part of a ``fat-replacement system.'' Humectants do not by themselves

mimic the functions of fat, but assist in fat-replacement systems by

enhancing water binding.

2. Use of Similar Ingredients. The provision for the use of safe

and suitable ingredients in substitute standardized meat and poultry

products, which is proposed in 9 CFR 319.10(c)(1) and 381.172(c)(1), is

not intended to allow for replacement or exchange of any required

ingredients or component of a required ingredient in the standardized

product with functionally similar ingredients from other sources not

provided for by the standard. This intent is reflected in the

provisions proposed in 9 CFR 319.10(c)(2) and 381.172(c)(2).

For example, FSIS believes that replacing the expected meat or

poultry ingredient(s) of a standardized product with textured vegetable

protein (TVP) to meet the requirements of a lower fat nutrient content

claim of a substitute standardized product should not be allowed

because it would be misleading since such food ingredients are meat

analogues. FSIS believes that consumers expect the meat or poultry in a

meat or poultry product to be its primary source of protein and they

view the meat as the valued component in a meat or poultry product. The

Agency views textured vegetable protein as a ``meat or poultry

replacer.'' A multitude of ``meat substitute'' or ``meat alternative''

foods are currently marketed, e.g., ``Veggie Burgers,'' ``Veggie

Patties,'' ``Garden Links,'' and ``Vegetarian Meat Loaf,'' and are

primarily composed of textured vegetable protein. Textured vegetable

protein is used as a meat or poultry alternative because it looks like

and has texture like meat or poultry, and is virtually

indistinguishable from meat or poultry in mixtures. FSIS believes that

the use of textured vegetable protein as a ``fat replacing'' ingredient

in a substitute product would be inappropriate because its use in such

a product would change the nature of the product to such an extent that

it would no longer be a substitute product within the parameters of

this regulatory proposal.

In a similar manner, FSIS also considers foods, such as bread,

rice, potatoes, cheese, fruits, and vegetables, to be characterizing

ingredients that replace or exchange meat or poultry ingredients in

meat or poultry food products. The Agency is aware that products

currently exist that use such food ingredients because they blend in

with the meat or poultry component of the product and ``look like'' the

meat or poultry component. For example, cherries or beets used in a

fresh ground beef mixture would have the appearance of lean beef. Rice

or grits used in a ground sausage product would give the appearance of

fat. Because these food ingredients have virtually no fat, their

presence in products would result in a finished product with a lowered

fat content. However, the lowered fat content would be a result of the

food ``filling'' or ``extending'' the product rather than as a result

of the food merely functioning as a fat replacer.

3. Ingredients Prohibited by the Standard. Ingredients that are

prohibited from use in standardized products identified in 9 CFR parts

319 and 381, subpart P, would also be prohibited from use in substitute

meat and poultry food products, e.g., poultry kidneys or sex glands are

prohibited from use in certain cooked sausages (9 CFR 319.180(b)) and

would likewise be prohibited for modified versions of traditional

standardized products.

[[Page 67482]]

Ingredients that are restricted from use in formulating any meat or

poultry food product, as addressed in 9 CFR 318.7 and 381.147, would

continue to be prohibited in substitute meat and poultry food products

because they are not approved as safe or suitable for use in meat and

poultry. For example, 9 CFR 318.7(d)(2) prohibits sorbic acid and its

salts from use in formulating meat products and, thus, would continue

to be prohibited in substitute products.

F. Nomenclature

How Substitute Meat and Poultry Food Products are Named. FSIS is

proposing in 9 CFR 319.10(d) and 381.172(d) that the name of a

substitute meat or poultry food product that complies with 9 CFR 319.10

and 381.172 will be an appropriate expressed nutrient content claim, in

conjunction with (i.e., next to) the respective appropriate

standardized term (e.g., fat free bologna). If a food meets the

requirements of 9 CFR 319.10 and 381.172, it is itself a standardized

food. Therefore, even though it does not meet all of the requirements

of the standard underlying the term included in its name, its name will

not be required to contain the term ``substitute'' or ``alternate.''

These meat and poultry food products will not purport to be the

traditional standardized meat or poultry food product currently defined

in 9 CFR parts 319 and 381, subpart P. Rather, these products will

purport to be a food that satisfies the requirement of the standard in

9 CFR 319.10 and 381.172. Thus, these products will be appropriately

named by use of an expressed nutrient content claim and the appropriate

standardized term.

FSIS believes that the labeling for substitute meat and poultry

food products should distinguish them from traditional standardized

products for which they are substitutes in order to provide consumers

with accurate and nonmisleading information, as required by the FMIA

and PPIA, with which to make a purchase decision. Because the

substitute product's identity is the expressed nutrient content claim

adjacent to the standardized term, these words must be presented in the

same style, color, and size of type, to further distinguish the

substitute meat and poultry food product from other products that bear

nutrient content claims, but that are not substitute meat and poultry

products meeting the requirements presented in this proposal.

Furthermore, the substitute product must comply with general labeling

provisions established by regulations in 9 CFR 317 and 381, subpart N

in order to assure that its labeling is not false or misleading.

G. Ingredient Labeling

FSIS is proposing in 9 CFR 319.10(e) and 381.172(e) that each of

the ingredients used in the substitute meat and poultry food product

shall be declared on the label as required by applicable regulations in

9 CFR parts 317 and 381, subpart N. Under 9 CFR parts 317 and 381,

subpart N, in general, all ingredients must be listed by common or

usual name in descending order of predominance by weight on either the

principal display panel or the information panel.

To assist the consumer in differentiating between the traditional

standardized meat or poultry food product and the substitute version of

the traditional standardized product, FSIS is proposing in 9 CFR

319.10(e) and 381.172(e) that all ``safe and suitable'' ingredients not

provided for by the traditional standard, as well as permitted

ingredients added at levels in excess of those allowed by the

traditional standard, must be appropriately identified as such with an

asterisk in the ingredients statement to assure that the labeling of

the substitute product will not be false or misleading. Therefore, the

statement ``Ingredients not in regular (name of the traditional

standardized food),'' or ``Ingredients in excess of amount permitted in

regular (name of the traditional standardized food),'' or both

statements as appropriate, shall immediately follow the ingredients

statement in the same type size. The asterisk statements must clearly

distinguish between ``those ingredients not permitted in'' and ``those

ingredients used in excess of amounts permitted'' in a standardized

product.

FSIS believes that the product name on the principal display panel

of the substitute meat and poultry food product, as well as its

ingredients statement, are the pertinent labeling features that

identify the difference between the traditional standardized product

and the modified version bearing the standardized name. The following

simplified label sketches illustrate how labeling of a standardized

product (Figure 1, GROUND BEEF) would differ from labeling of a

substitute version (Figure 2, LOW FAT GROUND BEEF) and how labeling of

a standardized product (Figure 3, BEEF FRANKS) would differ from a

substitute version (Figure 4, REDUCED FAT BEEF FRANKS) according to

provisions proposed by this rule.

BILLING CODE 3410-DM-P

[[Page 67483]]

Figure 1.--Illustration of a Label for a Standardized Product--

GROUND BEEF, according to 9 CFR 319.15

[GRAPHIC][TIFF OMITTED]TP29DE95.006

Figure 2.--Illustration of Label for Substitute Product--LOW FAT

GROUND BEEF, according to Proposed 9 CFR 319.10

[GRAPHIC][TIFF OMITTED]TP29DE95.007

Figure 3.--Illustration of Label for a Standardized Product--BEEF

FRANKS, according to 9 CFR 319.180

[GRAPHIC][TIFF OMITTED]TP29DE95.008

[[Page 67484]]

Figure 4.--Illustration of Label for Substitute Product--REDUCED

FAT BEEF FRANKS, according to Proposed 9 CFR 319.10

[GRAPHIC][TIFF OMITTED]TP29DE95.009

BILLING CODE 3410-DM-C

Nutrition labeling and the listing of ingredients in order of

predominance for substitute products, along with its product name and

special ingredient labeling for certain differences between it and a

traditional standardized product will allow consumers to be able to

evaluate the merits of substitute meat and poultry food products using

an expressed nutrient content claim and a standardized name. As

discussed, this labeling approach for establishing a general standard

of identity is similar to the labeling scheme established by FDA in

final rules (21 CFR 130.10) published January 6, 1993 (58 FR 2431).

V. Advance Notice of Proposed Rulemaking on Standards Reform

The Agency is planning to publish an ANPR that explores alternative

approaches to defining and standardizing meat and poultry products to

assure that they bear truthful and accurate names, are labeled in a

manner that is not false or misleading, and contain only safe and

suitable ingredients. The ANPR will consider the broader issues

concerning the role regulatory standards of identity and composition

should play in today's market.

Executive Order 12866

This proposed rule has been determined to be significant for

purposes of Executive Order 12866. This proposed rule would allow for

substitute meat and poultry food products to deviate from current

standards, provided certain conditions are met.

FSIS issued Policy Memo 121B and Policy Memo 123 as interim

policies to accommodate development and distribution of certain lower

fat substitute meat and poultry products while undergoing this

rulemaking process. To date, industry already has taken advantage of

this policy by introducing new products. This rule is necessary to

encourage and continue the development of more meat and poultry

products with reductions in food constituents having health

implications, e.g., lower in fat and cholesterol.

Today's consumers are looking for versions of popular standardized

processed meat and poultry food products that have reductions in fat

and cholesterol. To take advantage of advances in ingredient and

processing technologies, meat and poultry food processors would be

provided with the flexibility to formulate and market new meat and

poultry products with reductions in fat content, cholesterol, and

sodium--constituents which are of concern to today's health conscious

consumers--and identify them by an expressed nutrient content claim and

by names that are familiar to consumers.

If the proposed rule encourages firms to market a greater variety

of nutritious meat and poultry products, then consumers will enjoy the

benefit of greater product choices. Consumers will also benefit from a

healthier diet by the availability of products with lower fat and

cholesterol contents if the market is sufficiently strong to sustain

increased sales of these products. Research conducted by the Economic

Research Service of the U.S. Department of Agriculture has shown that

when healthier diets lead to reductions in incidence of heart disease,

cancer, stroke, diabetes, or other health problems, then economic

benefits accrue in the form of reduced medical costs and productivity

losses due to medical infirmity and premature death. While it is not

yet possible to determine the extent to which the rule would lead to

healthier diets and lower medical costs, there could be a benefit to

society.

This proposed rule would not mandate any changes to the way meat

and poultry products must be labeled, but would provide the meat and

poultry industry with the option of producing

[[Page 67485]]

substitute meat and poultry food products. Therefore, any cost incurred

would be voluntary.

If firms chose to make ingredient substitutions to bring newer,

healthful products to market, they may incur some short run costs.

However, these are the normal costs of marketing and production. If

they are incurred, they arise because a firm expects the new product to

be profitable. The costs of bringing these new products to market

would, in the long run, be less than the benefits to firms of increased

sales and profits. If the market for substitute foods is substantial

enough for firms to successfully market these new products, then there

may be a net economic benefit to the industry.

The net effect of the proposed rule would be beneficial to the meat

and poultry industry as a whole and would provide consumers with a

greater diversity of meat and poultry products. Consumers would benefit

from the proposed rule because it is expected to increase the variety

of processed meat and poultry products that would be available from

which to make the most healthful dietary choices for each individual.

At the same time, the proposed rule would safeguard the integrity of

traditional standardized meat and poultry food products that have

served the market well and for which there is expected to continue to

be a strong demand. Consumers would be informed by the product labeling

of the differences between the traditional standardized product and the

modified version.

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 any marking, labeling, packaging,

or ingredient requirement on federally inspected meat and poultry

products that are in addition to, or different than, those imposed

under the FMIA or 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 of the application of the

provisions of this proposed rule, if the challenge involves any

decision of an inspector relating to inspection services provided under

the FMIA or PPIA. The administrative procedures specified in 9 CFR

parts 335 and 381, subpart W, must be exhausted prior to any judicial

challenge of the application of the provisions of this proposed rule

with respect to labeling decisions.

Effect on Small Entities

The Administrator, FSIS, has made an initial determination 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). Small manufacturers would be provided

the flexibility to create more meat and poultry products that have

reductions in certain food constituents that have health implications.

Small businesses who choose to market the new substitute meat and

poultry food products would be required to design new labels or make

certain revisions to their existing product labels, thereby, incurring

some costs. These costs could be outweighed by the potential revenue

increases from sales of the new substitute products.

Paperwork Requirements

Abstract: FSIS has reviewed the paperwork and recordkeeping

requirements in this proposed rule in accordance with the Paperwork

Reduction Act. This proposed rule would require manufacturers producing

new meat and poultry products in accordance with the definition and

general standard of identity for modified processed meat and poultry

products to design their new product labels and submit such labeling to

FSIS for approval.

Estimate of Burden: Meat and poultry establishments must develop

product labels in accordance with the regulations. To receive approval

of the labels, establishments must complete FSIS Form 7234-1. FSIS

program employees review FSIS Form 7234-1 to ensure that information on

the labels complies with the regulations. FSIS estimates that it will

take 60 minutes to design and develop modified product labels in

accordance with the proposed regulations and 15 minutes to prepare FSIS

Form 7234-1 and submit it, along with the label, to FSIS or to a label

expediter who will deliver the form and label to FSIS.

Respondents: Meat and poultry product establishments.

Estimated Number of Respondents: FSIS estimates that at this time

100 establishments would have to develop new labels.

Estimated Number of Responses per Respondent: FSIS estimates that

each establishment would modify about 5 product labels.

Estimated Total Annual Burden on Respondents: 625 hours.

Copies of this information collection assessment can be obtained

from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection

Service, USDA, South Agriculture Building, Room 3812, Washington, DC

20250.

Comments regarding the need for and usefulness of the proposed

requirements, the accuracy of FSIS's burden hour estimate, ways to

minimize the estimated burden, including through the use of automated

collection techniques or other forms of information collection

technology, or any other aspect of this collection of information

discussion, to Lee Puricelli, Paperwork Specialist, at the address

above.

All responses to this notice will be summarized and included in

FSIS's request for the Office Management and Budget (OMB) approval of

the proposed regulation's paperwork requirements. All comments

submitted will also become a matter of public record.

Comments

Interested persons may submit an original and two copies of written

comments concerning this proposed rule to: FSIS Docket Clerk, DOCKET

#92-024P, Room 4352, South Building, Food Safety and Inspection

Service, U.S. Department of Agriculture, Washington, DC 20250. Any

person desiring an opportunity for an oral presentation of views should

make such a request to Mr. Charles R. Edwards 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

proposal will be available for public inspection in the FSIS Docket

Room, Room 4352, South Building, Food Safety and Inspection Service,

U.S. Department of Agriculture, Washington, DC 20250, 8:30 a.m. to 1:00

p.m., and from 2:00 p.m. to 4:30 p.m., Monday through Friday.

[[Page 67486]]

List of Subjects

9 CFR Part 319

Food grades and standards, Meat inspection.

9 CFR Part 381

Food grades and standards, Meat inspection, Poultry and poultry

products.

Proposed Rule

For the reasons discussed in the preamble, FSIS is proposing to

amend 9 CFR parts 319 and 381 as follows:

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

1. The authority citation for part 319 would continue to read as

follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR

2.18, 2.53.

2. Part 319, Subpart A would be amended by adding a new Sec. 319.10

to read as follows:

Sec. 319.10 Requirements for substitute processed meat food products

named by use of an expressed nutrient content claim and a standardized

term.

(a) Description. The meat food products prescribed by this general

definition and standard of identity are those products that substitute,

in accordance with Sec. 317.313(d) for a standardized food defined in

this part and use the name of that standardized food in their statement

of identity, but that do not comply with the established standard

because of a compositional deviation that results from reduction of a

constituent that is described by an expressed nutrient content claim

that has been defined by regulation in part 317, subpart B of this

subchapter. The expressed nutrient content claim shall comply with the

requirements of Sec. 317.313 of this subchapter and with the

requirements of part 317, subpart B of this subchapter that define the

particular nutrient content claim that is used. The meat food product

shall comply with the relevant standard in this part in all other

respects, except as provided in paragraphs (b) and (c) of this section.

(b) Performance characteristics. The performance characteristics,

such as physical properties, functional properties and shelf-life, of

the meat food product shall be similar to those of the standardized

meat food product produced under this part. If there is a significant

difference in performance characteristics that materially limits the

uses of the food compared to the uses of the standardized food defined

in this part, the label shall include, adjacent to the product name, a

statement in accordance with Sec. 317.313(d) (1) and (2) of this

subchapter, informing the consumer of such differences (e.g., if

appropriate, ``not recommended for frozen storage'' or ``not suitable

for roller grilling''). Deviations from ingredient provisions of the

standard that must be the minimum necessary to qualify for the nutrient

content claim, while maintaining similar performance characteristics.

(c) Ingredients Used in Substitute Foods. (1) Ingredients used in

the product shall be those ingredients provided for by the standard as

defined in this part, except that safe and suitable ingredients

approved for use in meat food products as described in Sec. 318.7 of

this subchapter may be used at the minimum level necessary to improve

texture and prevent syneresis, so that the substitute product is not

inferior in performance characteristics from the standardized product

defined in this part for which it is a substitute.

(2) An ingredient or component of an ingredient that is

specifically required by the standard prescribed in this part shall not

be replaced or exchanged with a similar ingredient from another source,

for example, textured vegetable protein shall not replace meat, and

turnips shall not replace potatoes in corned beef hash.

(3) An ingredient or component of an ingredient that is

specifically prohibited from use in any meat food product by this part

shall not be added to the substitute meat food product under this

section.

(4) All ingredients that are specifically required by a standard of

identity or composition as defined in this part shall be present in the

substitute product in the same amounts as required by the standard for

which the product is a substitute. The meat portion of the substitute

product must come from the same anatomical location, be of the same

kind and amount, and undergo the same basic processing procedures as

the standardized product in this part for which it substitutes.

(5) Water and fat-replacers (i.e., binders), in combination, may be

added to replace fat in accordance with paragraph (c) of this section.

(d) Nomenclature. The name of a substitute meat food product that

complies with this section is the appropriate expressed nutrient

content claim and the applicable standardized term, which shall be in

the same style, color, and size of type.

(e) Label declaration. (1) Each of the ingredients used in the

substitute meat food product shall be declared on the label as required

by this section and part 317 of this subchapter.

(2) Ingredients not provided for, and ingredients used in excess of

those levels provided for, by the standard as defined in this part,

shall be identified as such with an asterisk in the ingredients

statement. The statement ``*Ingredient(s) not in regular XXXX''

(The blank shall be filled in with the name of the traditional

standardized product) or ``**Ingredient(s) in excess of amounts

permitted in regular ________'' (The blank shall be filled in with the

name of the traditional standardized product), or both as appropriate

shall immediately follow the ingredients statement in the same type and

size.

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; 450, 21 U.S.C. 451-470, 7 CFR 2.18,

2.53.

4. Part 381, subpart P would be amended by adding a new

Sec. 381.172 to read as follows:

Sec. 381.172 Requirements for substitute processed poultry food

products named by use of an expressed nutrient content claim and a

standardized term.

(a) Description. The poultry food products prescribed by this

general definition and standard of identity are those products that

substitute in accordance with Sec. 381.413(d) for a standardized food

defined in this subpart and use the name of that standardized food in

their statement of identity, but that do not comply with the

established standard because of a compositional deviation that results

from reduction of a constituent that is described by an expressed

nutrient content claim that has been defined by regulation in this

subpart. The expressed nutrient content claim shall comply with the

requirements of Sec. 381.413 and with the requirements in subpart Y of

this part that define the particular nutrient content claim that is

used. The poultry food product shall comply with the relevant standard

in this part in all other respects, except as provided in paragraphs

(b) and (c) of this section.

(b) Performance characteristics. The performance characteristics,

such as physical properties, functional properties and shelf-life, of

the poultry food product shall be similar, except in regard to uses, to

those of the standardized poultry food product produced under subpart P

of this part. If there is a significant difference in performance

characteristics that

[[Page 67487]]

materially limits the use of the food compared to the use of the

standardized food defined in subpart P of this part, the label shall

include, adjacent to the product name, a statement in accordance with

Sec. 317.313(d) (1) and (2) of this part, informing the consumer of

such differences (e.g., if appropriate, ``not recommended for frozen

storage'' or ``not suitable for roller grilling''). Deviations from

ingredient provisions of the standard that must be the minimum

necessary to qualify for the nutrient content claim, while maintaining

similar performance characteristics.

(c) Ingredients Used in Substitute Foods. (1) Ingredients used in

the product shall be those ingredients provided for by the standard as

defined in subpart P of this part, except that safe and suitable

ingredients approved for use in poultry food products as described in

Sec. 381.147 of this part may be used at the minimum level necessary to

improve texture and prevent syneresis, so that the substitute product

is not inferior in performance characteristics from the standardized

product defined in subpart P of this part, for which it is a

substitute.

(2) An ingredient or component of an ingredient that is

specifically required by the standard prescribed in subpart P of this

part shall not be replaced or exchanged with a similar ingredient from

another source, for example, textured vegetable protein shall not

replace poultry, and turnips shall not replace potatoes in corned beef

hash.

(3) An ingredient or component of an ingredient that is

specifically prohibited from use in any poultry food product by subpart

P of this part shall not be added to the substitute poultry food

product under this section.

(4) All ingredients that are specifically required by a standard of

identity or composition as defined in subpart P of this part shall be

present in the substitute product in the same amounts as required by

the standard for which the product is a substitute. The poultry portion

of the substitute product must come from the same anatomical location,

be of the same kind and amount, and undergo the same basic processing

procedures as the standardized in subpart P of this part product for

which it substitutes.

(5) Water and fat-replacers (i.e., binders), in combination, may be

added to replace fat in accordance with paragraph (c) of this section.

(d) Nomenclature. The name of a substitute poultry food product

that complies with this section is the appropriate expressed nutrient

content claim and the applicable standardized term, which shall be in

the same style, color, and size of type.

(e) Label declaration. (1) Each of the ingredients used in the

substitute poultry food product shall be declared on the label as

required by this section and subpart N of this part.

(2) Ingredients not provided for, and ingredients used in excess of

those levels provided for, by the standard as defined in subpart P of

this part, shall be identified as such with an asterisk in the

ingredients statement. The statement ``*Ingredient(s) not in regular

________'' (The blank shall be filled in with the name of the

traditional standardized product) or ``**Ingredient(s) in excess of

amounts permitted in regular ________'' (The blank shall be filled in

with the name of the traditional standardized product), or both as

appropriate shall immediately follow the ingredients statement in the

same type and size.

Done at Washington, DC, on: December 21, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95-31391 Filed 12-26-95; 3:36 pm]

BILLING CODE 3410-DM-P