[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Pages 67474-67487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31391]



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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