[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Proposed Rules]
[Pages 47453-47459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22956]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 319 and 381

[Docket No. 95-051A]
RIN 0583-AC01


Meat and Poultry Standards of Identity and Composition

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking; request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is reviewing the 
standards of identity and composition established over the years for 
meat and poultry food products. These standards define particular 
products or product categories in terms of specified meat or poultry 
contents or other characteristics. As part of its regulatory review 
initiatives, the Agency is considering whether to modify or eliminate 
specific standards, or to modify its overall regulatory approach to 
standardized meat and poultry products. Because of new technologies, 
changing lifestyles, changed consumer expectations, and the information 
now available to consumers through ingredient and nutrition labeling, 
the relevance and general usefulness of standards are in question.
    FSIS recognizes that some of the current standards may impede 
innovation, or slow the introduction into the marketplace of products 
with reductions in certain constituents of health concern to some 
people. The Agency is soliciting information from the public on what 
direction further reform of food standards should take, including 
suggestions on whether to alter, or eliminate entirely, the regulations 
on standardized meat and poultry products. The Agency would like to 
know how product definitions and standards, if needed, can provide 
consumer protection, while at the same time granting the flexibility 
necessary for timely development and marketing of meat and poultry 
products that meet consumer needs. This review responds in part to 
President Clinton's memorandum to heads of departments and agencies, 
titled ``Regulatory Reinvention Initiative,'' dated March 4, 1995.

DATES: Comments must be received on or before November 25, 1996.

ADDRESSES: Please send an original and two copies of written comments 
to Docket Clerk, Room 4352 South Building, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250. Copies 
of reports and handbooks cited in this notice are available for review 
in the FSIS Docket Room.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Post, Chief, Food Standards 
and Ingredients Branch, Product Assessment Division, Regulatory 
Programs, at (202) 254-2588.

SUPPLEMENTARY INFORMATION:

Background

    The Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) prohibit the preparation for, and the sale or 
transportation, in commerce, of meat and poultry products that are 
adulterated or misbranded (21 U.S.C. 610; 21 U.S.C. 458).
    These prohibitions apply to interstate and foreign commerce. They 
also apply to commerce solely within designated states by 
establishments that operate solely within a designated state. A state 
is designated if it does not have or is not effectively enforcing 
requirements at least equal to Title I and IV of the FMIA, and 
specified provisions of the PPIA. Once a state is designated, the 
inspection requirements of the FMIA and PPIA apply to establishments 
that slaughter livestock and poultry and/or prepare or process meat 
and/or poultry products therefrom, solely for distribution within the 
state.
    A meat or poultry product may be considered misbranded if it 
falsely purports to be or falsely represents itself to be a food for 
which a standard of identity or composition has been prescribed by 
regulation, or if its label fails to bear the name of the food 
specified in the standard and, if required, the common or usual names 
of optional ingredients, except for certain specified optional 
ingredients (21 U.S.C. 601(n)(7); 21 U.S.C. 453(h)(7)).
    FSIS has prescribed by regulation 60 meat and poultry standards of 
identity and composition (9 CFR Secs. 319 and 381, Subpart P, for meat 
and poultry products, respectively), under its statutory authorities 
set forth in 21 U.S.C. 607(c) and 457(b). These sections permit the 
Secretary of Agriculture, whenever the Secretary determines such action 
is necessary for the protection of the public, to prescribe definitions 
and

[[Page 47454]]

standards of identity or composition for meat and poultry products. The 
Agency enforces the regulations concerning the standards through prior 
labeling approval, in-plant inspection, and compliance monitoring of 
products in commercial channels. Further, numerous informal standards 
for meat and poultry products are contained in the FSIS Standards and 
Labeling Policy Book.
    The standards have been established to prescribe: (1) Minimum meat 
or poultry contents; (2) maximum fat and water contents; (3) methods of 
processing, cooking, and preparation; (4) permitted safe and suitable 
ingredients; and/or (5) expected or characterizing ingredients. 
Generally speaking, a standard of identity is like a recipe, requiring 
the presence of certain expected ingredients in a food product and/or 
mandating the way the product is formulated and prepared. A standard of 
composition generally specifies the minimum or maximum amount of 
ingredients in a product.

Standards of Identity and Composition and Regulatory Reform

    FSIS has begun a comprehensive review of its regulatory procedures 
and requirements, including those for standards of identity and 
composition, to determine whether any are still needed and, if so, 
which ought to be modified or streamlined. This review is an integral 
part of the FSIS initiative to improve the safety of meat and poultry 
products by modernizing the Agency's system of food safety regulation. 
This review expands upon the page-by-page review of FSIS's regulations 
carried out earlier this year under the President's Reinvention of 
Government Initiative. This initiative directed departments and 
agencies to conduct a page-by-page review of all of their regulations 
and to eliminate or revise those that were outdated or otherwise in 
need of reform. For ones that FSIS determines need simplification or 
modification, FSIS is examining how it can make these regulations 
easier to understand and use, while still maintaining the protection 
they provide for consumers.

History of the Standards

    From its early years, USDA has been concerned with food purity and 
compositional integrity. Beginning in the 1880's, Departmental 
scientists undertook systematic studies of food adulteration with a 
view toward its prevention, and published their results in numerous 
bulletins. By 1906, when the Meat Inspection Act and the Food and Drugs 
Act were passed, the Department had published, in circulars, about 200 
standards of purity for food products, including meat and meat 
products.
    The 1906 Meat Inspection Act and regulations subsequently enacted 
thereunder, prohibited the marketing of meat products that were 
misbranded or adulterated. Early inspection program directives and 
regulations listed permissible ingredients and coloring agents for meat 
products that corresponded to lists prepared by the Department's Bureau 
of Chemistry (predecessor of the Food and Drug Administration [FDA]). 
To assure that labels were truthful and not misleading, the directives 
listed basic requirements for products that were to bear a certain 
name. Thus, ``potted'' or ``deviled'' ham could be so named only if the 
product were made of ham or ham trimmings; if other pork was used, the 
mixture was required to be called ``pork meats'' or ``potted meats.'' A 
product called ``pork sausage'' could be made only from pork. ``Leaf 
lard'' had to be made only from the leaf fat of hogs.
    The meat inspection regulations published in 1914 and 1922 
prescribed product composition standards for products containing more 
than one ingredient. Thus, a pork sausage with beef added could be 
called a ``pork sausage'' only if it contained at least 50-percent pork 
and had to be labeled ``pork sausage, beef added.'' The meat portion of 
veal loaf had to be 100-percent veal. A 20-percent limit was imposed on 
the use of meat byproducts in products bearing a species name, such as 
``beef,'' ``pork,'' or ``veal,'' along with the requirement that the 
presence of the byproducts be indicated in the product name. Percentage 
limitations on the use of ``cereals'' in sausage products were also 
prescribed.
    The Department maintained such requirements for meat products in 
the meat regulations with minor modifications through the 1920's and 
1930's. As the mandatory meat inspection program grew, more policies 
and standards were established for assuring accurate and consistent 
product identity. During the 1940's the Department developed policies 
and standards to prevent economic deception, that is, to protect 
consumers from receiving meat products that did not meet their 
expectations, such as debased food products in which fillers had been 
substituted for more valuable constituents.
    Under the Agricultural Marketing Act of 1946, the Agency also 
promulgated poultry standards to ensure that poultry products would 
meet the expectations of consumers. During this period, the policies 
applied to poultry products were similar to those applied to meat 
products.
    During the 1950's and 1960's, about a dozen prepared meat and 
poultry frozen dinners were marketed, all essentially similar and with 
simple formulations. Among the first regulatory standards of identity 
and composition for a ``further-processed'' poultry product, 
originating in the mid-1950's under the voluntary poultry inspection 
program, was the one specifying the minimum poultry meat content for 
poultry pies, such as ``turkey pies.''
    Since standards for meat and poultry products have been developed 
over time in response to market trends, industry and consumer needs, 
and other developments, such as the advent of new methods of processing 
to yield traditional products, they are diverse in regard to their 
areas of coverage. Some standards define products or specify product 
characteristics and/or contents; others set forth methods of 
processing, preparation, and cooking. Not all of these elements are 
included in every standard.

Product Definitions, Contents, and Characteristics

    Some standards define meat or poultry terms. For example, the 
standards for kinds and classes and cuts of raw poultry (Sec. 381.170) 
identify a Rock Cornish game hen or Cornish game hen as ``a young 
immature chicken (usually 5 to 6 weeks of age) weighing not more than 2 
pounds ready-to-cook weight, which was prepared from a Cornish chicken 
or the progeny of a Cornish chicken crossed with another breed of 
chicken.''
    Other standards require that certain products contain specific 
amounts and/or types of meat or poultry. For example, the standards for 
poultry dishes and specialty items in Sec. 381.167 of the regulations 
require specific, minimum poultry content, calculated on a ready-to-eat 
basis, for certain products: ``Turkey a la King,'' for example, must 
contain 20 percent turkey meat, ``Chicken Tetrazzini'' must contain 15 
percent chicken meat, and ``Chicken Stew'' must contain 12 percent 
chicken meat. There are similar standards for some meat products. For 
example, the regulations in Sec. 319.304 require that meat stews, such 
as ``Beef Stew,'' contain no less than 25% meat of the species named on 
the label, computed on the weight of the fresh meat. Product identified 
as ``Corned Beef'' must, among other requirements, be prepared from 
beef briskets, navels, clods, middle ribs, rounds, rumps, or similar 
cuts (Sec. 319.100).

[[Page 47455]]

    The use of safe and suitable ingredients, such as those additives 
specifically classified as extenders, binders, emulsifiers, coloring 
agents, antioxidants, flavoring agents, and tenderizing agents are 
frequently referenced in standards for meat or poultry products. The 
use of additives in meat and poultry products is essentially controlled 
by the regulations for standards, e.g., Secs. 319 and 381 Subpart P, 
and those that directly address the use of safe and suitable 
ingredients, e.g., Secs. 318.7 and 381.147.
    Some meat and poultry standards specifically reference these safe 
and suitable ingredient regulations when identifying what can and 
cannot be included in a specific standardized product. For example, 
standards for cured meat or cured poultry products contain provisions 
for allowable curing ingredients that have been declared safe and 
suitable at restricted levels (Sec. 318.7 and 381.147). A product 
identified as ``Breakfast Sausage'' (Sec. 319.143) can only contain 
certain kinds of meat ingredients, and has limits on added water, fat 
content of the finished product, and binders or extenders that are to 
be added in accordance with Sec. 318.7(c)(4). The kinds of binders and 
extenders allowed in meat and poultry products and their use 
restrictions can be found in the Tables of Approved Substances 
(Secs. 318.7(c)(4) and 381.147(f)(4)) under ``Class of Substance, 
Binders and Extenders.'' Many other standards also reference the Tables 
of Approved Substances in regard to use of certain ingredients in the 
standardized product.
    When appropriate, characterizing ingredients are also included as 
part of a product standard. For example, the regulations in 
Sec. 319.145 require that a product identified as ``Italian Sausage'' 
contain salt, pepper, and either fennel or anise, or a combination of 
fennel and anise. The standard also requires that ``Italian Sausage'' 
contain at least 85-percent meat, or a combination of meat and fat, 
with the total fat content constituting not more than 35-percent of the 
finished product, as well as optional ingredients.

Methods of Processing, Preparation, and Cookery

    Some standards include processing, preparation, or cooking 
criteria, some of which are relevant to ensuring product safety. For 
instance, the standard for ``Country Ham'' and ``Dry Cured Ham'' 
products (Sec. 319.106) specifies not only the kind of anatomical pork 
cut that is to be used as the starting material, but also requires the 
dry application of salt or salt and optional curing agents. It also 
specifies the length of time required for the salt penetration, the 
finished product weight, and the internal salt content or water 
activity level that must be met. All of these requirements help ensure 
product safety and shelf-stability. The presence and quantity of curing 
agents and salt, for example, and limits on water activity, help 
inhibit microbial growth.
    Other standards specify cooking or processing requirements that 
were developed to ensure that consumer expectations about the nature of 
a product are met. For example, ``Barbecued Chicken'' (Sec. 381.165) 
must be cooked in dry heat and basted with a seasoned sauce. The 
standard for ``Barbecued Beef'' (Sec. 319.80) requires dry heat cooking 
by burning hardwood or hot coals therefrom, and a finished product with 
a brown crust and a yield of not more than 70 percent of the weight of 
the fresh uncooked meat.

Mechanically Separated (Species)

    Most meat product and poultry food product standards identify a 
finished product, such as a ``Turkey Ham'' or ``Chili with Meat.'' 
However, the standard for mechanically separated species (MS(S)), such 
as that in Sec. 319.6 for mechanically separated beef or pork, is 
somewhat different because it defines a meat ingredient that can be 
used with some restrictions in formulating other meat products. MS(S) 
is an ingredient that can be used in certain standardized meat food 
products, such as hot dogs, frankfurters, bologna (Sec. 319.180), meat 
stews (Sec. 319.304), spaghetti with meatballs (Sec. 319.306), pizza 
(Sec. 319.600), and tamales (Sec. 319.305). The level of its use, which 
is restricted, is specifically cited as part of its food product 
standard.

Current Concerns and Need for Review

    The meat and poultry food product standards have provided a 
framework for identifying products and helping to ensure that products 
meet consumer expectations regarding product composition and 
characteristics. In certain instances, standards also have helped to 
ensure product safety. For example, the FSIS policy guide in the 
Standards and Labeling Policy Book for dry, fermented sausages 
prescribes moisture/protein ratios (MPR) that limit moisture content in 
these products, which, in turn, inhibits microbial growth.
    Some manufacturers have complained that standards are too 
restrictive, stifle innovation, and prevent market acceptability of 
products, because they restrict the use of commonly understood product 
names familiar to consumers. Some manufacturers believe that the 
nutrition and ingredient information provided in labeling is adequate 
to enable consumers to distinguish among meat and poultry products and 
make informed choices.
    Many proponents of standards reform contend that a product name has 
little relevance in today's market, which is becoming more and more 
diverse, with the increased manufacturing of new and nontraditional 
products. Because of changing market trends and public perceptions, 
some food manufacturers also believe that prescriptive standards of 
identity and composition impede the introduction of new, innovative, 
and possibly less expensive, products.
    For example, food manufacturers have pointed out that restaurants 
market meatless pizzas consisting of a bread-type product topped with 
fruit or vegetables, olive oil, and seasonings. However, if an FSIS 
inspected establishment wants to prepare and market a nontraditional 
pizza that includes a meat topping of sausage but not cheese, it would 
be in conflict with FSIS's established standards for pizza products 
containing meat. The standard for ``pizza with sausage'' 
(Sec. 319.600(b)), for instance, requires that a product identified as 
``Sausage Pizza'' be a bread-based meat food product with tomato sauce, 
cheese, and meat topping containing not less than 12 percent cooked 
sausage or 10 percent dry sausage (pepperoni).
    Consumer expectations regarding the nutritional composition of 
foods have also changed in recent years. Health-conscious consumers 
looking for convenience and nutritional quality in their food purchases 
have come to play a decisive role in the marketplace. A growing body of 
scientific evidence that links dietary intake to health supports the 
concerns of these consumers, who demand products based upon traditional 
recipes which have been modified to have lower amounts of constituents 
with negative health implications, such as saturated fat and 
cholesterol. Meat and poultry food processors have striven to meet this 
demand by formulating products that resemble traditional products but 
that contain less fat and associated cholesterol.
    In some circumstances, current standards inhibit the marketing of 
products lower in such constituents, because of limits on the types of 
ingredients permitted. FSIS has attempted to ease some of the 
restrictions posed by the existing standards by developing labeling 
approaches to identify the differences between traditional products and 
the

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newer versions. Consequently, some products currently bear health-
related nutrient content claims on their labels, such as, ``low-fat'' 
and ``reduced fat.''
    Consumers' nutritional and health concerns indicate a need to 
review the basis for traditional standards of identity and composition, 
to question the justification for the establishment of new prescriptive 
standards, and to consider the elimination or modification of these 
standards. In fact, the public health rationale for doing so is 
underscored by a 1990 report by the Institute of Medicine, National 
Academy of Sciences (NAS). The report, ``Nutrition Labeling: Issues and 
Directions for the 1990's,'' argues for reexamining and changing any 
system ``that significantly impedes the marketing of reduced-, low-, 
and non- or no-fat substitutes.''
    To begin to address this concern, FSIS has proposed in a separate 
document, ``Food Standards: Requirements for Processed Meat and Poultry 
Products Named by Use of an Expressed Nutrient Content Claim and a 
Standardized Term (60 FR 67474),'' to establish a general standard of 
identity for modified meat and poultry food products that would 
facilitate the development and marketing of, among other things, 
reduced fat substitutes for products currently subject to an FSIS 
standard of identity. The general standard of identity proposed would 
require that a modified meat or poultry product: (1) Not be 
nutritionally inferior to the traditional standardized food that it 
resembles and for which it substitutes, (2) possess performance 
characteristics that are generally similar to the traditional 
standardized food, (3) contain the same amount of any mandatory 
ingredient (i.e., meat or poultry) that is required to be in the 
traditional standardized food, and (4) not contain an ingredient that 
is prohibited in the traditional standardized food. The proposed 
standard (Secs. 319.10 and 381.172, as proposed) also would allow safe 
and suitable ingredients, not specifically provided for in the standard 
or in excess of that provided for in the traditional food, in order 
that the product's makeup is consistent with the nutrient content claim 
made about the product.
    In light of current budget constraints and the need to address high 
priority food safety concerns and redeploy Agency resources, FSIS is 
examining whether any of the Agency's approaches to regulating meat and 
poultry products for economic adulteration and mislabeling should be 
changed. Thus, FSIS is examining whether the current approach to 
promote fair competition and prevent misbranding and economic 
adulteration through developing and enforcing meat and poultry product 
standards continues to be appropriate.
    Many of the standards are based on industry standards and were 
originally suggested by, and in many cases are still supported by, 
industry. Such standards not only reflect consumer expectations, but 
also serve to promote fair competition among manufacturers producing 
similar products. The FMIA, in fact, states that regulation of meat 
products is important, since ``* * * mislabeled, or deceptively 
packaged articles can be sold at lower prices and compete unfairly with 
the wholesome, not adulterated, and properly labeled and packaged 
articles, to the detriment of consumers and the public generally (21 
U.S.C. 602).'' The PPIA also contains a similar provision which 
recognizes that unwholesome, adulterated, or misbranded poultry 
products destroy markets for wholesome, not adulterated, and properly 
marked, labeled, and packaged poultry products (21 U.S.C. 451).
    FSIS is undertaking this comprehensive review of all of its 
existing product standards to determine whether in their present form 
they continue to play a useful role in serving the needs of industry 
and consumers. FSIS is exploring whether alternative approaches could 
be more effective in ensuring that consumers are adequately informed 
about the products they are purchasing and receive what they believe 
they are paying for, while ensuring fair competition. Any alternative 
approach or combination of approaches chosen would of course have to 
comply with the statutory mandates of the FMIA and PPIA with respect to 
misbranding (false or misleading labeling) and economic adulteration, 
provide industry greater flexibility to innovate, and expand consumer 
choices in the marketplace.

Issues for Public Comment

    As part of its comprehensive standards review, FSIS is soliciting 
comments on the following issues, as well as any other comments that 
would assist the Agency in fulfilling its mission to protect the 
interest of consumers by helping to ensure that meat and poultry 
products are correctly labeled and are not adulterated. FSIS requests 
comments from any interested parties such as food manufacturers and 
distributors, including importers and exporters, individuals and 
consumer groups, academia, State and local governments, and the 
international community.

1. Utility of the System

    a. In general, how do consumers and the regulated industry view the 
Agency's role in developing food standards? How would major changes in 
standards of identity affect consumers, producers, and manufacturers?
    b. As discussed above, there are different types of standards. Are 
some more meaningful or useful than others? Could the objectives of 
meat and poultry standards, designed to ensure that products are 
correctly labeled and not economically adulterated, as well as help 
ensure fair competition and market stability for wholesome, properly 
labeled products, be accomplished by other more effective means? If so, 
how could they be accomplished within the limits of current and 
anticipated FSIS resources?
    c. Do standards of identity for meat and poultry products actually 
protect the integrity of the food supply? Are there any data that 
indicate consumers are aware of or rely upon the current standards? If 
so, do consumers find the current system of standards meaningful and 
understandable? Would alteration of the standards significantly affect 
consumers' ideas about the integrity of meat and poultry products?
    d. Does the industry need compositional standards for the orderly 
marketing of foods? Are food standards needed to control the 
composition of fabricated foods such as hot dogs, bologna, pepperoni, 
and potted meats? Depending on the extent of any standards reform, what 
market impact would result if manufacturers were allowed to decrease 
the amounts of meat or poultry used in products?
    e. As previously discussed, some standards contain processing and 
other requirements relevant to food safety. Could food safety 
objectives be achieved by other means?
    f. Are food standards an effective means of ensuring that only safe 
and suitable additives and ingredients are used in the formulation of 
products?

2. Flexibility

    If FSIS continues to maintain a system of standards of identity and 
composition, how could current and future standards be made more 
flexible, to accomodate the needs of industry in a changing market, 
without compromising the Agency's efforts to ensure that meat and 
poultry products are neither misbranded nor economically adulterated?

3. Product Identity

    a. Food standards of identity are a means of defining the 
composition of a

[[Page 47457]]

food that is marketed under a designated common or usual name. What 
criteria should be used for determining when a food standard is 
appropriate? Should evidence of the existence of consumer confusion or 
dissatisfaction be required as a precondition before FSIS undertakes a 
standards setting process?
    b. How should FSIS address differences between the standards of 
identity established for similar meat and poultry products, such as 
those established for ham and turkey ham products, which allow for 
different levels of moisture content? What purpose do such differences 
serve and how do they affect consumers, producers, and processors? 
Also, FSIS requires establishments to indicate through labeling the 
presence of meat byproducts in all processed meat products. Should FSIS 
require disclosure of the presence of detached skin, even in natural 
proportions, in the ingredients statement of processed poultry 
products?
    c. Consumers desire both product consistency and variety among 
products. Given this, how would revision or elimination of the 
standards of identity affect consumers? For which products or 
characteristics is consistency, or standardization, most important to 
consumers?
    d. If there were no meat or poultry product standards, what 
criteria could be used to define ``imitation'' products?
    e. If there were no standards, how would consumers, industry, and 
FSIS judge when a product is identified, by labeling, in a misleading 
way?

4. Federal Preemption: Impact on State Jurisdiction

    a. FSIS specifically requests comments on the preemption aspects of 
Federal standards of identity. If Federal standards of identity were 
discontinued and the preemptive provisions of the FMIA and the PPIA for 
labeling were amended, would the States establish their own 
compositional requirements in the absence of a Federal meat and poultry 
standards program? Would a diverse, multi-State food standards program 
be desirable? What would be the costs and benefits?
    b. If it is not deemed to be in the interest of the public to 
retain Federal food standards for meat and poultry products, what 
changes should be considered in the FMIA and PPIA? Comments should be 
supported by data where possible relating to the economics of 
production and marketing of commodities currently covered by food 
standards, including the costs and benefits to consumers, industry, and 
international trade.

5. Impact on Domestic and International Trade

    a. How are current FSIS standards related to international meat and 
poultry standards and what would be the economic impact of standards 
reform on product development in the United States and international 
markets?
    b. Would there be significant costs for industry if Federal meat 
and poultry standards of identity were conformed to international 
standards for these products, where possible? Also, what would be the 
costs for industry if states were permitted to enforce any type of 
standard requirements that were different from Federal and 
international standards?
    c. In recommending an alternative to the current system of 
standards of identity and common or usual name designation for food, 
commenters should take into account the impact of the alternative on 
FSIS's ability to participate in the development and harmonization of 
international standards.
    The United States participates in the Codex Alimentarius Commission 
(Codex) and its food standards program. Codex is sponsored jointly by 
the United Nations' Food and Agriculture Organization (FAO) and World 
Health Organization (WHO). Its goal is to promote the health and 
economic interests of consumers, while encouraging fair international 
trade in food. All food standards adopted by Codex must be reviewed by 
the FDA (in consultation with FSIS when appropriate) and be accepted 
without change, accepted with change, or not accepted. Procedures 
regarding Codex standard adoption are codified in 21 CFR 130.6.
    U.S. food standards provide an important point of reference when 
international standards are established. How effective would U.S. 
delegates be in debating the merits of specific provisions in Codex 
food standards if the Federal government had no comparable standards? 
How important is it to exporters and importers that the compositional 
provisions of the Federal meat and poultry standards be reflected in 
international standards such as those established by the Codex 
Alimentarius?

6. FSIS and FDA Uniformity and Standards Systems

    The FMIA (section 7(c)(2))(21 U.S.C. 607(c)(2)) and the PPIA 
(section 8(b)(2))(21 U.S.C. 457(b)(2)) provide that the Secretary of 
Agriculture may prescribe definitions and standards of identity or 
composition; that they not be inconsistent with any such standards 
established under the Federal Food, Drug, and Cosmetic Act; and that 
inconsistencies between Federal and State standards be avoided, insofar 
as feasible. To what extent should FSIS harmonize its approach to 
standards reform with FDA?
    On December 29, 1995, FDA published an Advance Notice of Public 
Rulemaking, ``Food Standards of Identity, Quality and Fill of 
Container; Common or Usual Name Regulations; Request for Comment on 
Existing Regulations'' (60 FR 67490). FSIS encourages commenters to 
read the FDA document because it provides useful background information 
on similar FDA standards' issues. A thorough understanding of both 
agencies' food standards programs will help commenters in providing 
comments that will facilitate uniform food standards reform. Commenters 
should submit separate comments to each agency.

7. Agency Budget Constraints and Regulatory Compliance

    Current and anticipated budget constraints compel FSIS to alter the 
way it allocates resources. The Agency must give priority to programs 
affecting food safety and public health, while seeking means to 
continue meeting its responsibilities concerning issues of economic 
adulteration and misbranding. Thus, comments supporting continuance of 
the existing food standards program should discuss possible sources of 
new or additional resources for the program. Further, in light of 
budget constraints, how should the Agency verify compliance with the 
standards in the future? What should be the FSIS inspector's role in a 
modified or streamlined system of standards?

8. Policy Guides

    The Agency has developed policy guides for standards which are 
identified in the Standards and Labeling Policy Book. The Standards and 
Labeling Policy Book serves, in part, to guide industry regarding 
product names, composition, characterizing ingredients, methods of 
preparation related to product names, and such. Do the policy guides as 
embodied in the Standards and Labeling Policy Book, serve a useful 
purpose? If these policy guides serve a useful purpose, do they need 
revision? If so, what revisions are necessary and what data are 
available to support revision?

[[Page 47458]]

9. Standards and Substitute, Modified Meat and Poultry Products

    a. To what extent do FSIS requirements for minimum meat and poultry 
content in the standards impede the development of reduced fat and 
other modified products that can assist consumers in meeting dietary 
needs?
    b. Is there any point at which consumers would feel that 
``substitute, modified foods,'' (i.e., standardized foods with a 
reduction in constituents of concern to consumers) are no longer 
similar to the standardized foods they are intended to resemble and are 
merely imitations of these foods? For further information about 
``substitute, modified foods'' see FSIS's proposed rule, ``Food 
Standards: Requirements for Processed Meat and Poultry Products Named 
by Use of an Expressed Nutrient Content Claim and a Standardized Term'' 
(60 FR 67474).

10. Grandfather or Sunset Provisions

    Is there a need to ``grandfather'' or ``sunset'' current regulatory 
requirements or policy guides?

11. Cost and Benefits to Consumers and Industry

    The Agency is particularly interested in the cost/benefit aspects 
of food standards. It would appreciate receiving comments in response 
to the following questions: Do the benefits of standards to consumers 
and to the regulated industry outweigh the costs of such regulations?; 
What factors affect the benefits and costs of food standards?; How can 
FSIS best estimate the benefits and costs of particular standards?; 
Which standards are particularly beneficial or costly, and why?; and If 
the existing programs need to be restructured, how should this be 
accomplished, and how would such a change affect the costs and benefits 
to consumers?

Alternatives Considered

    FSIS is considering adopting one or more of the following 
alternative approaches, should it continue meat and poultry standards 
in any form. FSIS believes that these approaches increase the 
flexibility of the meat and poultry product standards, while ensuring 
that meat and poultry products are identified in a non-misleading 
manner, and contain only safe and suitable ingredients.

1. Use of Percentage Declaration of Meat and/or Poultry Content in 
Conjunction with Standardized Names

    One approach the Agency is considering would provide greater 
flexibility than currently allowed in the formulation of standardized 
products required to contain a specified minimum amount of meat or 
poultry. FSIS could permit the use of a lesser amount of meat and/or 
poultry in these standardized products, provided the product's label 
contained a declaration of the percentage of the meat or poultry 
content in the product. For example, the standard of identity for meat 
stews, such as ``Beef Stew'' (Sec. 319.304), currently requires the 
product contain ``not less than 25-percent of meat'' of the species 
named on the label.
    Under current FSIS regulations and policy guides, products 
containing less than the prescribed amount of meat or poultry for a 
standardized product may be marketed (1) under names that indicate that 
the product is an ``imitation'' of the standardized food; (2) under 
names that distinguish the product from the standardized product, e.g., 
using a descriptive name such as ``gravy, vegetables, and beef,'' for a 
product that does not meet the ``Beef Stew'' standard; or (3) with 
labels that use a comparative, educational statement in addition to a 
standardized name to reflect the difference in meat or poultry 
contents, when the substitute product is nutritionally equivalent. For 
example, a pizza that contains only 5 percent sausage may be identified 
as ``Pizza with Sausage'' as long as a statement is included on the 
label that indicates the product ``contains 5 percent sausage, whereas 
the standard for 'Pizza with Sausage' requires 12 percent sausage.''
    Under one alternative approach, a manufacturer might produce a 
``Beef Stew'' containing a lesser amount of beef than prescribed in the 
standard, provided the principal display panel of the label bears, in 
conjunction with the name of the food, a declaration of the percentage 
of beef contained in the product, e.g., ``Beef Stew, Contains 10% 
Beef.'' Another option would be to provide the percentage declaration 
in conjunction with the ingredient list on the label.
    Key advantages of such alternatives are that they would expand the 
flexibility available to companies in formulating products bearing the 
standardized name while still providing the consumers with important 
information about the meat or poultry content of the product, that is 
both factual and non-misleading. Information about the percentage of 
meat or poultry in a product, in combination with the nutrition 
information and ingredient labeling provided on labels, would give 
consumers valuable information upon which they could rely in making a 
food choice.
    In considering such alternatives, FSIS recognizes that there may be 
some products that contain such a small amount of meat or poultry that 
the use of a standardized name, even if used in conjunction with a 
statement that indicates the percentage of meat and poultry in the 
product, may not be justified. FSIS will be considering whether 
products that contain an insignificant amount of meat or poultry should 
be permitted to use as standardized name as part of its labeling. FSIS 
would like comments on this issue.
    The Agency has reviewed numerous meat and poultry standards to 
identify categories that may be good candidates for this alternative 
declaration-of-percentage approach to product identity. Obviously, 
candidates include standards that contain a minimum meat, meat food 
product, meat byproduct, and/or poultry content requirement. Such 
standards, found in 9 CFR Part 319 and 381, Subpart P, include scrapple 
(Sec. 319.280); chili con carne (Sec. 319.300); chili con carne with 
beans (Sec. 319.301); hash (Sec. 319.302); corned beef hash (319.303); 
meat stews (319.304); tamales (Sec. 319.305); spaghetti with meatballs 
and sauce--spaghetti with meat and sauce, and similar products 
(Sec. 319.309); spaghetti sauce with meat (Sec. 319.307); beans with 
frankfurters in sauce, sauerkraut with wieners and juice, and similar 
products (Sec. 319.306); lima beans with ham in sauce, beans with ham 
in sauce, beans with bacon in sauce and similar products (Sec. 319.310) 
chow mein vegetables with meat, and chop suey vegetables with meat 
(Sec. 310.311); pork with barbecue sauce and beef with barbecue sauce 
(Sec. 319.312); tongue spread and similar products (Sec. 319.762); 
liver meat food products (Sec. 319.881); poultry dinners (frozen) and 
pies (Sec. 381.158); and ``other poultry dishes and specialty items'' 
(Sec. 381.167).

2. Develop a General Standard of Identity for All Meat and Poultry Food 
Products

    The Agency could propose to establish a general standard of 
identity for the 60 meat and poultry products defined by standards in 
the current regulations. This general standard of identity approach 
would provide for deviations from current ingredient allowances and 
restrictions. The deviations would be highlighted in the ingredient 
statement of the product. This labeling requirement would inform 
consumers of the difference between the standardized products and the 
``modified'' version of the product.
    For example, the current standard for ``Chili Con Carne'' 
(Sec. 319.300) requires

[[Page 47459]]

this product to contain no less than 40-percent meat computed on the 
weight of the fresh meat; allows the use of MS(S) in accordance with 
Sec. 319.6; restricts head meat, cheek meat, and heart meat exclusive 
of the heart cap to no more than 25 percent of the meat ingredients 
under specific declaration on the label; and allows binders and 
extenders as provided in Sec. 318.7(c)(4). Under a general standard of 
identity, a new, ``modified'' ``Chili con carne'' product might contain 
40 percent cheek meat, as long as the ingredients statement highlighted 
this deviation. If the meat component were reduced from 40 percent to 
20 percent, or if the product contained 40 percent textured vegetable 
protein as well as meat, these deviations also would need to be 
highlighted in the ingredients statement.
    FSIS would like to receive comments on whether this approach could 
provide the flexibility desired by manufacturers, while protecting the 
integrity of the food supply by ensuring that consumers receive meat 
and poultry products labeled in an truthful and non-misleading manner.

3. Recommended Meat and Poultry Contents

    Another approach would be to establish categories of meat or 
poultry products, and corresponding recommendations for expected meat 
and poultry contents. For example, FSIS could recommend that ``Beef 
Burgundy'' contain 50-percent beef, that ``Beef Stroganoff'' contain 30 
percent cooked beef, and so forth. Under this approach, establishments 
could deviate from the recommended meat and poultry content. It would 
be expected that the difference be conveyed to the consumer through 
labeling. Recommended amounts of meat and poultry content in products 
would reflect consumer expectations, and, therefore, would serve as 
guidance for food manufacturers.
    FSIS requests public comment on this alternative approach to 
establishing content standards, and would welcome other suggestions for 
establishing product categories, or determining what the meat and/or 
poultry content should be for the various categories. FSIS also 
requests comments on how other requirements in the current standards, 
such as those concerning additives, non-meat ingredients, or 
processing, would be affected by meat and poultry content 
recommendations for the various meat and poultry categories?

4. Private Certification of Food Products

    Provided that amendments are made to the FMIA and PPIA, it may be 
possible for private organizations to certify that meat and poultry 
products meet consumer expectations. These organizations would 
establish criteria for product content and characteristics associated 
with product names.
    FSIS would like to receive comments on the issue of eliminating 
standards of identity and composition including comments in response to 
the following questions: Could national associations that promote or 
address marketing issues for specific products or commodities, such as 
the National Food Processors Association and the National Frozen Pizza 
Association, or other recognized authorities, such as culinary 
societies, schools, or institutes, establish meaningful meat or poultry 
product standards?; How would the fact that products met such standards 
be conveyed in labeling?; Would a labeling statement, such as ``Meets 
standards established by the National Chili Society,'' have meaning in 
labeling?; How would the truthfulness or the accuracy for the statement 
be verified?; How would the credibility or authenticity of the 
certifying body be established?; Which characteristics of meat or 
poultry food products are most amenable to certification by private 
organizations rather than by local, State, or Federal government?; and 
Which factors render private certification impractical or 
inappropriate?

5. Elimination of the Standards of Identity and Composition

    The FMIA and PPIA provide that USDA may promulgate definitions and 
standards of identity and composition for meat and poultry products 
whenever it determines such action is necessary for the protection of 
the public (21 U.S.C. 607(c), 457(b)). These Acts do not require, 
however, that USDA promulgate standards. Therefore, one option for the 
Agency is to eliminate regulations for standards of identity and 
composition and then to discontinue any programs related to the 
standards.
    FSIS would like to receive comments on the issue of eliminating 
standards of identity and composition including comments in response to 
the following questions: In general, what would be the advantages and 
disadvantages to industry and consumers of eliminating the standards of 
identity and composition?; What would be the impact on domestic and 
foreign commerce, and food safety?; How would labeling requirements 
need to be revised if standards of identity were eliminated?; and In 
the absence of standards of identity, should labels specify percentages 
of ingredients?
    Additionally, some standards include processing, preparation, or 
specific cooking requirements that are related to ensuring product 
safety and shelf-stability, such as the standard for ``Country Ham'' 
and ``Dry Cured Ham'' products (Sec. 319.106). FSIS would like comments 
on this issue including responses to the following questions: If such 
standards were eliminated, would remaining regulations be sufficient to 
assure the safety of these products?; and Should the safety provisions 
of these standards be included in other regulations?

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 is seeking the 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.

    Done, at Washington, D.C., on: September 3, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-22956 Filed 9-6-96; 8:45 am]
BILLING CODE 3410-DM-P