[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
[[Page 47456]]
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