67474 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

TABLE 1.—REGULATIONS THAT ARE CANDIDATES FOR REVISION OR REMOVAL PRIOR TO HACCP IMPLEMENTATION—

Continued

Regulations—FMIA, PPIA Subject Possible action

Eliminate command-and-control type requirements for the use

of nitrite and sodium ascorbate or erythorbate in bacon;

convert these requirements to performance standards and

clarify role of inspection program employees. (See

§ 318.7(b).)

Convert requirements for the treatment of pork and pork products to destroy trichinae in to performance standards; supplement with guidelines as needed. (See § 318.10.)

Convert requirements for preparing articles not for use as

human food (e.g., dog food) to performance standards; clarify role of inspection program employees; eliminate command-and-control type requirements. (See §§ 318.12 and

381.152.)

Eliminate redundancy with other provisions (mixtures containing product that are not classed as meat food products).

(See § 318.13.)

Convert procedure for handling product adulterated by polluted water to performance standards and decision criteria;

supplement with guidelines as needed. (See §§ 318.14 and

381.151.)

Convert requirements for tagging chemicals, preservatives,

cereals, spices, etc., to performance standards; clarify role

of inspection program employees. (See § 318.15.)

Convert rules for substances such as pesticide chemical residues, food additives, and color additives to performance

standards and role of inspection program employees. (See

§ 318.16.)

Make requirements for handling of certain material for mechanical deboning consistent with any new time-temperature requirements. (See § 318.18.)

Convert compliance procedures for meat derived from advanced meat/bone separation machinery and recovery systems to performance standards and clarify role of inspection

program employees. (See § 318.24.)

Convert requirements for canning and canned products to

performance standards and clarify role of inspection program employees. (See §§ 318.300–318.311 and 381.300–

381.311.)

325, 381, Subpart S ......... Transportation ................................................... Eliminate obsolete provisions; focus on and clarify policies

and performance standards.

IV. Request for Comments

This ANPR is intended to elicit

comments, suggestions, and information

that will enable FSIS to provide more

efficient and effective service and to

focus its organizational resources more

closely on health and safety matters,

which are of vital concern to all

Americans. FSIS specifically requests

comment on its efforts to transform its

regulations from heavy reliance on

command-and-control approaches to

greater reliance on performance

standards, and solicits detailed

suggestions concerning which existing

regulations need to be changed to be

consistent with HACCP, and how those

regulations should be changed. The

Agency notes that several individuals

and groups, including at least one trade

association, responded to a similar

request in the February 3, 1995,

proposal. FSIS would also appreciate

comments on the economic burdens and

the paperwork, recordkeeping, or other

information collection burdens

associated with the regulations

discussed in this document.

Comments supported by scientific or

other data on the impacts, such as the

public health effects, of changing or

eliminating existing regulations, would

be especially valuable.

Executive Order 12866

This advance notice of proposed

rulemaking has been reviewed under

Executive Order 12866. This rule has

been determined to be significant for the

purposes of Executive Order 12866 and,

therefore, has been reviewed by the

Office of Management and Budget. FSIS does not have data necessary to

assess how the regulatory changes

discussed in this document might affect

various sectors of the meat and poultry

industries. Therefore, the Agency

invites comment on potential effects,

including economic costs or benefits, of

any specific changes that may be

suggested.

Done, at Washington, D.C., on December

21, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95–31393 Filed 12–26–95; 3:36 pm]

BILLING CODE 3410–DM–P

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.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67475

1FSIS 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.

ACTION: Proposed rule.

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

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
67476 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

2This report is available for public inspection in

the FSIS Docket Clerk’s office.

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.

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 ongoing 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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67477

3This paper is available for public inspection in

the FSIS Docket Clerk’s office.

4This paper is available for public inspection in

the FSIS Docket Clerk’s office.

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 FDAregulated 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.

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
67478 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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-LaKing’’ 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’’
67480 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 nonperformance 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 fatreplacement 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.
67482 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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.

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Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 67483

Figure 1.—Illustration of a Label for a Standardized Product—GROUND BEEF, according to 9 CFR 319.15

Figure 2.—Illustration of Label for Substitute Product—LOW FAT GROUND BEEF, according to Proposed 9 CFR 319.10

Figure 3.—Illustration of Label for a Standardized Product—BEEF FRANKS, according to 9 CFR 319.180
67484 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

Figure 4.—Illustration of Label for Substitute Product—REDUCED FAT BEEF FRANKS, according to Proposed 9 CFR

319.10

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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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.
67486 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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 § 319.10 to

read as follows:

§ 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 § 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

§ 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 § 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 § 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 llll’’

(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 § 381.172 to

read as follows:

§ 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 § 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

§ 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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 § 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 § 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 llll’’

(The blank shall be filled in with the

name of the traditional standardized

product) or ‘‘**Ingredient(s) in excess of

amounts permitted in regular llll’’

(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]

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