Food Standards; General Principles and Food Standards Modernization, 29214-29235 [05-9958]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service
• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Proposed Rules]
[Pages 29214-29235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9958]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 410

[Docket No. 95-051P]
RIN 0583-AC72

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 130

[Docket No. 1995N-0294]
RIN 0910-AC54


Food Standards; General Principles and Food Standards 
Modernization

AGENCIES: Food Safety and Inspection Service, USDA; Food and Drug 
Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and 
Drug Administration (FDA) (we, our, the agencies) are proposing to 
establish a set of general principles for food standards. The adherence 
to these principles will result in standards that will better promote 
honesty and fair dealing in the interest of consumers and protect the 
public, allow for technological advances in food production, be 
consistent with international food standards to the extent feasible, 
and be clear, simple, and easy to use for both manufacturers and the 
agencies that enforce compliance with the standards. The proposed 
general principles will establish the criteria that the agencies will 
use in considering whether a petition to establish, revise, or 
eliminate a food standard will be the basis for a proposed rule. In 
addition, each agency may propose to establish, revise, or eliminate a 
food standard on its own initiative or may propose revisions to a food 
standard in addition to those a petitioner has requested. These 
proposed general principles are the agencies' first step in instituting 
a process to modernize their standards of identity (and any 
accompanying standards of quality and fill of container) and standards 
of composition.

DATES: Submit written or electronic comments by August 18, 2005.

ADDRESSES: You may submit comments to FSIS, identified by Docket No. 
95-051P, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM 
submissions):
    Send an original and two copies of comments to: FSIS Docket Clerk, 
Docket No. 95-051P, rm. 102, Cotton Annex Bldg., 300 12th St. SW., 
Washington, DC 20250-3700.
    Instructions: All submissions received must include the agency name 
and Docket No. 95-051P or regulatory information number (RIN) 0583-
AC72.
    Other Information: All comments submitted in response to this 
proposal, as well as research and background information used by FSIS 
in developing this document, will be available for public inspection in 
the FSIS Docket Room at the address listed above between 8:30 a.m. and 
4:30 p.m., Monday through Friday. The comments also will be posted on 
the Agency's Web site at https://www.fsis.usda.gov/OPPDE/rdad/
FRDockets.htm.
    You may submit comments to FDA, identified by Docket No. 1995N-0294 
and/or RIN 0910-AC54, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 1995N-
0294 and/or RIN 0910-AC54 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM 
submissions):

[[Page 29215]]

    Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. 1995N-0294 or RIN 0910-AC54. All comments received will 
be posted without change to https://www.fda.gov/ohrms/dockets/
default.htm, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FSIS: Robert C. Post, Labeling and 
Consumer Protection Staff, rm. 602, Cotton Annex Bldg., 1400 
Independence Ave. SW., Washington, DC 20250-3700, 202-205-0279.
    FDA: Ritu Nalubola, Center for Food Safety and Applied Nutrition 
(HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. FSIS Food Standards
    B. FDA Food Standards
    C. Advance Notices of Proposed Rulemaking
    D. Comments to the ANPRMs
    E. Options in the Food Standards Modernization Process
    F. Consumer Research
II. The Proposed General Principles
III. FSIS and FDA Requests for Information
IV. Executive Order 12866: Cost Benefit Analysis
    A. Need for the Rule
    B. Regulatory Options
V. Regulatory Flexibility Analysis
VI. Executive Order 12988: Civil Justice Reform
VII. Executive Order 13132: Federalism
VIII. Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Additional Public Notification
XI. Comments
XII. References

I. Background

    FSIS and FDA share responsibility for ensuring that food labels are 
truthful and not misleading. FSIS has the authority to regulate the 
labeling of meat and poultry products, and FDA has the authority to 
regulate the labeling of all other foods. Some foods, such as eggs, are 
regulated by both agencies. Food standards are used to ensure that 
products sold under particular names have the characteristics expected 
by consumers.

A. FSIS Food Standards

    Meat and poultry product standards of identity or composition are 
codified in title 9 of the Code of Federal Regulations (CFR). FSIS has 
established by regulation approximately 80 meat and poultry product 
standards of identity or composition (9 CFR parts 319 and 381, subpart 
P, for meat and poultry products, respectively) under its authorities 
in the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) (21 U.S.C. 607(c) and 457(b)). These sections 
provide:
    The Secretary [of Agriculture], whenever he determines such 
action is necessary for the protection of the public, may prescribe 
* * * definitions and standards of identity or composition for 
articles subject to [the FMIA and PPIA] and standards of fill of 
container for such articles not inconsistent with any such standards 
established under the Federal Food, Drug, and Cosmetic Act [act] (21 
U.S.C. 301 et seq. ) and there shall be consultation between the 
Secretary [of Agriculture] and the Secretary of Health and Human 
Services prior to the issuance of such standards under [the FMIA, 
PPIA, or act] relating to articles subject to this chapter to avoid 
inconsistency in such standards and possible impairment of the 
coordinated effective administration of [the FMIA, PPIA and the 
act]. There shall also be consultation between the Secretary [of 
Agriculture] and an appropriate advisory committee provided for in 
[21 U.S.C. 454 and 661] prior to the issuance of such standards * * 
* to avoid, insofar as feasible, inconsistency between Federal and 
State standards.
    Consistent with the statutes, FSIS has consulted with FDA regarding 
the proposed general principles. In addition, FSIS consulted with the 
National Advisory Committee on Meat and Poultry Inspection about this 
proposed rule in November 2001, and incorporated their comments in this 
document. FSIS's food standards regulations cover many different foods. 
The contents of individual food standards or groups of food standards 
are extremely varied, depending on the complexity of the food and the 
level of detail necessary to define the characterizing features of the 
food. Some food standards are relatively simple, consisting of only a 
sentence or two (e.g., beef stew, 9 CFR 319.304), or a paragraph or two 
(e.g., deviled ham, 9 CFR 319.760). Other food standards are extremely 
detailed and prescriptive. For example, the standard for frankfurter, 
frank, furter, hotdog, weiner, vienna, bologna, garlic bologna, 
knockwurst and similar products describes the form of the product, the 
expected ingredients, and the allowable meat and nonmeat ingredients 
and poultry products that can be used in these products (9 CFR 
319.180). There are more standards for meat products than for poultry 
products because processed meat products have been in existence longer 
and have been consumed more widely than processed poultry products. 
Although the FMIA and PPIA authorized standards of fill, FSIS has not 
established any standards of fill in regulations.
    FSIS standards of identity generally require the presence of 
certain expected ingredients in a food product or mandate how a product 
is to be formulated or prepared. For example, a poultry product labeled 
``(kind) a la Kiev'' is required to be stuffed with butter, which may 
be seasoned (9 CFR 381.161). In the poultry products inspection 
regulations, the term ``kind'' refers to the type of poultry used. In 
this standard of identity, butter is an expected ingredient, and the 
standard also requires that the product be prepared by stuffing the 
butter in the poultry. The standard of identity for barbecued meats 
requires that barbecued meats be cooked by the direct action of dry 
heat resulting from the burning of hard wood or the hot coals therefrom 
for a sufficient period to assume the usual characteristics of a 
barbecued article, which include the formation of a brown crust on the 
surface and the rendering of surface fat (9 CFR 319.80). This standard 
of identity specifies exactly how the product must be prepared and also 
includes a description of the defining characteristics of products that 
meet the standard.
    Standards of composition specify the minimum or maximum amount of 
ingredients in a product. Many of these standards for meat products 
establish a minimum amount of meat or a maximum amount of fat in the 
product. For example, the standards of composition for ground beef, 
chopped beef, hamburger, and fabricated steaks require that the product 
contain no more than 30 percent fat (9 CFR 319.15). Several of the 
poultry standards of composition specify minimum poultry levels and 
maximum added liquid levels. For example, canned boned poultry, 
labeled, ``boned (kind)'' must

[[Page 29216]]

contain at least 90 percent cooked, deboned poultry meat of the kind 
indicated on the label, with skin, fat and seasoning, and may contain 
no more than 10 percent added liquid (9 CFR 381.157). The standards of 
composition for mechanically separated (species) (9 CFR 319.5) and 
mechanically separated (kind) (9 CFR 381.173) limit the amount and size 
of bone particles that the product may contain.
    Some FSIS standards require that product be labeled with a specific 
name, such as ``hamburger'' (9 CFR 319.15(b)) or ``(kind) patties'' (9 
CFR 381.160), while other standards provide examples of terms that can 
be used to label the products but do not prescribe the exact terms or 
phrases that must be used to label the product. For example, numerous 
phrases may be used in labeling fabricated steaks, including ``beef 
steak, chopped, shaped, frozen,'' ``minute steak, formed, wafer sliced, 
frozen,'' or ``veal steaks, beef added, choppedmolded- cubed-frozen, 
hydrolyzed plant protein, and flavoring'' (9 CFR 319.15(d)). Fabricated 
steaks also may be labeled with other terms not specified in the 
regulations.
    In addition, some FSIS standards require specific label 
information. For example, Italian sausage products that are cooked must 
be labeled with the word ``cooked'' in the product name (9 CFR 
319.145(c)), and cooked sausages, such as frankfurters, franks, 
furters, or hotdogs, that are prepared with meat from a single species 
of cattle, sheep, swine, or goats must be labeled with the term 
designating the particular species in conjunction with the generic name 
of the sausage (9 CFR 319.180(c)). The standard for poultry rolls 
requires that when binding agents are added in excess of 3 percent for 
cooked rolls and 2 percent for raw rolls, the common name of the agent 
or the term ``binders added'' must be included in the name of the 
product (9 CFR 381.159(a)).
    Under FSIS's food standards regulations, products that do not 
conform to a standard may not represent themselves as the standardized 
food. However, such products still may be sold under another name. For 
example, a beef stew that contains less than 25 percent beef can be 
marketed as ``gravy, vegetables, and beef'' or ``chunky beef soup,'' 
but can not be identified as ``beef stew'' because the food standard 
for meat stew requires that the product contain not less than 25 
percent of meat of the species named on the label (9 CFR 319.304). A 
product that does not meet the sausage standard (9 CFR 319.140) because 
it contains more than 10 percent of added water in the finished product 
may be marketed under another name, such as ``pork, water, and soy 
protein concentrate link.''
    Finally, in addition to its food standards regulations, FSIS has 
established numerous informal or ``policy'' food standards for meat and 
poultry products in the FSIS ``Food Standards and Labeling Policy 
Book'' (Policy Book).

B. FDA Food Standards

    FDA has established over 280 food standards of identity, some of 
which include standards of quality and fill of container, under the 
authority set forth in section 401 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 341). This section provides in part:
    Whenever in the judgment of the Secretary [of Health and Human 
Services] such action will promote honesty and fair dealing in the 
interest of consumers, he shall promulgate regulations fixing and 
establishing for any food, under its common or usual name so far as 
practicable, a reasonable definition and standard of identity, a 
reasonable standard of quality, or reasonable standards of fill of 
container.
    The standards of identity, quality, and fill of container for foods 
regulated by FDA are codified in title 21, parts 130 to 169 (21 CFR 130 
to 169). FDA food standards establish the common or usual name for a 
food and define the nature of the food, generally in terms of the types 
of ingredients that it must contain (i.e., mandatory ingredients), and 
that it may contain (i.e., optional ingredients). FDA food standards 
may specify minimum levels of the valuable constituents and maximum 
levels for fillers and water. They also may describe the manufacturing 
process when that process has a bearing on the identity of the finished 
food. Finally, FDA food standards provide for label declaration of 
ingredients used in the food and may require other specific labeling, 
such as the declaration of the form of the food, packing medium, and 
flavorings or other characterizing ingredients, as part of the name of 
the food or elsewhere on the principal display panel of the label.
    Individual FDA food standards vary widely in their content. These 
variations have developed because of the different aspects of food 
technology that are responsible for providing the defining 
characteristics of a food. Some foods are defined and distinguished by 
their ingredients. The standards for these foods set specific limits on 
the levels of ingredients that must be used. For example, the standard 
of identity for fruit preserves and jams (Sec.  150.160 (21 CFR 
150.160)) lists the minimum amount of fruit and sugar that these foods 
must contain. Other food standards focus on compositional 
characteristics of the food, rather than on the specific ingredients. 
For example, the standards of identity for milk products (part 131) 
list the minimum levels of milkfat and milk solids (excluding fat) that 
must be contained in these foods. Still other foods owe their 
distinctive characteristics to the manner in which they are produced, 
and the standards for these foods reflect this fact. For example, the 
standards of identity for cheese products (part 133) specify the 
manufacturing process, in addition to compositional characteristics, to 
distinguish one cheese from another. Some other foods are defined by 
their physical characteristics. For example, particle size is an 
important factor in distinguishing cracked wheat from crushed wheat, 
and the standards of identity for these foods (Sec.  137.190 and 
137.195, respectively) include methods of analysis for the 
determination of the particle size of these foods. Depending on the 
level of detail necessary to define the characteristics of the food, 
some food standards of identity consist of only a few paragraphs (e.g., 
sap sago cheese in Sec.  133.186), while others are longer. For 
example, the canned tuna standard (Sec.  161.190) covers approximately 
eight pages in the CFR and prescribes the vegetables that must be used 
if the tuna is seasoned with vegetable broth.
    FDA's food standards of quality set minimum specifications for such 
factors as tenderness, color, and freedom from defects for canned 
fruits and vegetables. Such characteristics would not be readily 
apparent to the purchaser of these foods because of the nature of the 
foods and the manner in which they are presented to the consumer 
(inside a can). FDA food standards of fill of container set out 
requirements as to how much food must be in a container. These 
requirements are particularly important when foods are packed in 
liquids and sealed in opaque containers.
    In a manner similar to the FSIS food standard regulations, FDA's 
food standard regulations do not permit products that do not conform to 
a standard to be represented as the standardized food; such products, 
however, may be sold under other nonstandardized names. For example, a 
fruit product that does not meet the standard of identity for fruit 
preserves and jams (Sec.  150.160), because its fruit content is lower 
than the standard requires, may be marketed under another name, such as 
``fruit topping.''

[[Page 29217]]

C. Advance Notices of Proposed Rulemaking

    In 1995, FSIS and FDA began reviewing our regulatory procedures and 
requirements for food standards to determine whether food standards 
were still needed, and if so, whether they should be modified or 
streamlined. To initiate this review, we published advance notices of 
proposed rulemaking (ANPRMs) on food standards (60 FR 67492, December 
29, 1995 (FDA), and 61 FR 47453, September 9, 1996 (FSIS)). These 
ANPRMs discussed regulations and policy governing food standards, the 
history of food standards, and the possible need to revise the food 
standards.
    In the ANPRMs, we identified problems with existing food standards. 
Specifically, we stated that some food standards might impede 
technological innovation in the food industry. FSIS stated that the 
existing food standards also may prevent the food industry from 
producing products that have lower amounts of constituents associated 
with negative health implications, such as fat, saturated fat, 
cholesterol, and sodium (61 FR 47453). FDA stated that manufacturers of 
nonstandardized foods are developing new ingredients and plant 
varieties to enhance a food's organoleptic or functional properties, 
alter its nutritional profile, or extend shelf life. Incorporation of 
these advances into standardized foods may be difficult without the 
laborious amendment of the relevant standard (60 FR 67492).
    In the ANPRMs, FDA and FSIS presented alternatives to the existing 
food standards. The alternatives presented by FSIS included permitting 
the use of a lesser amount of meat or poultry in standardized products 
provided the product's label contained a declaration of the percentage 
of the meat or poultry content in the product; establishing a general 
standard of identity for standardized products that would provide for 
deviations from current ingredient allowances and restrictions 
(deviations would be highlighted in the ingredient statement on the 
product label); establishing categories of meat or poultry products and 
corresponding recommendations for expected meat and poultry contents; 
amending the statutes to allow private organizations to certify that 
food products meet consumer expectations; and revoking existing food 
standards and regulating all foods as nonstandardized foods (61 FR 
47453).
    The alternatives presented by FDA included revoking existing food 
standards and regulating all foods as nonstandardized foods; requiring 
that products declare the percentage of all major ingredients on the 
label; requiring that products declare the percentage of characterizing 
ingredients in the food name; identifying ``parent'' products with 
minimum compositional requirements (for example, creating a standard 
for jam or jelly that specifies minimum fruit content requirements) to 
avoid misleading use of percentage declaration on the food label; 
establishing generic food standards (such as the standards of identity 
for hard cheeses (Sec.  133.150) and spiced, flavored standardized 
cheeses (Sec.  133.193)); amending the statute to allow private 
organizations to certify that food products meet consumer expectations; 
and requiring appropriate labeling of foods that deviate from 
government quality standards (60 FR 67492).
    In the ANPRMs, the agencies asked for comments on the benefits or 
lack of benefits of the food standards regulations in facilitating 
domestic and international commerce and on the benefits of the food 
standards regulations to consumers. We asked how the food standards 
could be revised to grant the flexibility necessary for timely 
development and marketing of products that meet consumer needs, while 
at the same time providing consumer protection. We also asked for 
comments on the alternatives to the food standards presented in the 
ANPRMs and whether to coordinate efforts to revise the food standards 
regulations.

D. Comments to the ANPRMs

    FSIS received 28 letters, each containing one or more comments, 
from industry, consumers, a consumer group, and the U.S. Department of 
Agriculture (USDA) Food and Consumer Service (FCS) (now known as Food, 
Nutrition, and Consumer Services) in response to its ANPRM. FDA 
received 95 letters, each containing 1 or more comments, from industry, 
consumers, consumer groups, and the USDA FCS in response to its ANPRM. 
Most comments to both ANPRMs strongly supported the concept of food 
standards, while a few requested that standards be eliminated. However, 
very few comments to both ANPRMs supported the existing food standards 
as currently written. The types of concerns expressed in the comments 
to the ANPRMs follow.
    Many of the comments that supported retaining food standards stated 
that they protect consumers from fraudulent and substandard products by 
establishing the basis upon which similar products are formulated. 
Others argued that food standards ensure that products meet consumers' 
nutritional expectations and needs. Several comments from industry, a 
consumer, and two consumer groups stated that nutrition labeling and 
ingredient declarations cannot substitute for food standards, as 
reliance on nutrition labeling and ingredient declarations would be a 
burden to consumers.
    Several industry comments that supported food standards also stated 
that the Federal food standards ensure a level playing field for 
industry because they provide direction to industry members producing 
standardized products. Several industry comments and one comment from 
the USDA FCS also stated that, in the absence of Federal food 
standards, the States would be able to establish their own food 
standards and manufacturers would be confronted with the challenge of 
meeting different States' requirements. In addition, many industry 
comments stated that the food standards provide a basis for 
negotiations related to the international harmonization of standards 
and facilitate international trade. One comment stated that, without a 
U.S. food standards system, food standards development could shift to 
international bodies, which may not be sensitive to the American 
consumer or industry. Another comment stated that the absence of food 
standards could pose a barrier to exports and international markets.
    Although most comments supported retaining food standards in some 
form, they requested that food standards be simplified, be made more 
flexible, or be clarified. For example, one industry comment stated 
that food standards should not include manufacturing methods, 
prohibitions regarding classes of ingredients, or product-specific 
labeling (other than the acceptable product name). This comment also 
stated that standardized and nonstandardized food product labeling 
should be the same. Similarly, other industry comments requested that 
the food standards be made more flexible to allow for alternative safe 
and suitable ingredients and alternative technologies that do not 
change the basic nature or basic characteristics of the food. Several 
industry comments recommended limiting food standards to the name of 
the product and the essential characterizing properties of the product. 
Several industry comments to FSIS's ANPRM recommended that food 
standards be limited to meat and poultry content requirements. 
Conversely, other industry comments to FSIS's ANPRM recommended that

[[Page 29218]]

industry be given the flexibility to reduce the percentage of meat in 
standardized products.
    Several industry comments and a consumer comment to FDA's ANPRM 
recommended that FDA revise certain specific food standards (e.g., 
jams, jellies, preserves, milk chocolate, and sweetened condensed milk) 
to provide more flexibility in food technology and ingredient options.
    In response to FSIS's and FDA's requests for suggestions as to how 
they should revise food standards, several comments from industry and 
from a consumer group recommended rescinding or modifying them on a 
case-by-case basis. Some comments from industry recommended instituting 
advisory committees, contracting with independent groups, or forming 
nongovernment groups to revise the food standards. Further, several 
industry comments recommended establishing general or ``guiding'' 
principles or a fundamental philosophy for reviewing food standards and 
revising them. Other industry comments and a consumer group suggested 
that revisions to standards should be initiated by petitions and 
supported by adequate data. Finally, several comments to both ANPRMs 
stated that FSIS and FDA food standards should be consistent, and that 
we should attempt to harmonize our efforts to revise the food 
standards.
    Comments to FSIS's alternatives: Few comments supported the 
alternatives to food standards that FSIS presented in its ANPRM. A 
consumer organization was opposed to all of the alternatives presented 
in the ANPRM. Several trade groups specifically stated their opposition 
to percentage labeling. One of these groups stated that products would 
be cheapened if this alternative were allowed. The USDA FCS comment 
stated that percentage labeling had merit, but that this alternative 
does not address all the factors that might make a product inferior in 
quality. The USDA FCS comment-and several industry comments that 
generally opposed the other alternatives presented in the ANPRM-
expressed support for the general standard alternative that would 
provide for deviations from current ingredient allowances and 
restrictions. These comments stated that this approach would allow 
consumers to discern differences between the standardized product and 
the modified version. One of these comments stated that this approach 
may not allow enough ingredient deviations in standardized products. 
Another of these comments stated that a general standard's approach 
should expressly permit reduction of meat and poultry content in 
standardized products. Many of the industry comments opposed private 
certification that food products meet consumer expectations.
    Comments to FDA's alternatives: Several comments opposed the 
alternatives presented in FDA's ANPRM. One trade association stated 
that percentage labeling was not an adequate substitute for standards. 
One industry comment stated that percentage labeling might be 
acceptable if it provided for the marketing of ``heavily breaded 
shrimp'' without requiring ``imitation'' labeling but that any other 
use of percentage labeling would be too cumbersome and could give away 
proprietary information. The USDA FCS comment stated that percentage 
labeling has merit but does not address all of the factors that could 
make a product inferior in quality. Another alternative that was 
presented in conjunction with percentage characterizing ingredient 
labeling was to identify a ``parent'' product, for example, a 
standardized jam or jelly that complies with minimum compositional 
requirements, to avoid misleading use of the percentage declaration on 
a food label. In response, one industry comment stated that this 
approach might be useful, but would not be adequate to replace all 
standards. Another industry comment stated that minimal compositional 
standards are necessary to provide a benchmark to ensure product 
integrity and to satisfy consumer expectations. Comments also opposed 
the alternative of extending the generic food standard concept (such as 
the existing standard of identity for hard cheeses (Sec.  133.150) or 
the generic standard for nutritionally modified versions of traditional 
standardized foods in Sec.  130.10 (21 CFR 130.10)) to other classes of 
food standards. Two industry comments stated that generic food 
standards should not be used to create standards for nonstandardized 
foods, while another industry comment stated that the current generic 
standards in Sec.  130.10 were adequate. On the other hand, an industry 
comment stated that generic standards in addition to those covered in 
Sec.  130.10 could be beneficial to maintain product characteristics. 
Similarly, the USDA FCS stated that the generic standards approach has 
merit. With regard to the alternative of requiring that foods that 
deviate from government quality standards be labeled appropriately, one 
comment stated that foods that deviate from standards should be named 
so that they are readily distinguishable from the standardized food. 
Another comment stated that current labeling requirements provide 
sufficient information concerning deviation from standards. While two 
industry comments supported private certification of foods that meet 
consumer expectations, most comments opposed this alternative.

E. Options in the Food Standards Modernization Process

    As noted previously, several comments recommended that FDA and FSIS 
establish general principles or a fundamental philosophy for reviewing 
food standards and revising them. The agencies agree with these 
comments supporting the development of general principles for reviewing 
and revising food standards regulations and also agree with the 
comments that stated that the agencies should work in concert to 
develop consistent food standards regulations.
    On September 12, 1996, FDA convened an internal agency task force 
to discuss the current and future role of food standards and to draft a 
set of principles for reviewing and revising FDA's food standards 
regulations. The task force agreed that the food standards should 
protect consumers without unduly inhibiting technological advances in 
food production and marketing.
    To ensure that FSIS and FDA were consistent as the food standards 
reform process continued, in January 1997, a joint FDA and FSIS Food 
Standards Work Group (the Work Group) was convened, chaired by the 
Director of the FDA's former Office of Food Labeling (now incorporated 
into the Office of Nutritional Products, Labeling, and Dietary 
Supplements) and the Director of the FSIS Labeling and Compounds Review 
Division (now the Labeling and Consumer Protection Staff). The Work 
Group revised the principles that the FDA task force had developed to 
reflect the goals and needs of both agencies.
    In addition to developing these general principles, the Work Group 
considered five options, as the next step in the process of food 
standards reform, and analyzed the advantages and disadvantages of each 
option. The first option the Work Group considered was not proceeding 
any further with the review of the food standards regulations. The 
advantage of this option is that, in the short run, it would require 
little or no increase in the agencies' use of resources.
    A major disadvantage of this option is that there is very little 
industry or consumer support for it. As noted previously, the majority 
of comments supported revising the existing system of food standards to 
simplify them and

[[Page 29219]]

to make them more flexible. In addition, even if this first option were 
adopted, we would need to continue to expend resources interpreting and 
enforcing food standards that may be outdated. Additionally, a system 
of food standards that does not allow technological advancement in food 
production may not be in the long-term interest of consumers. If we do 
not revise the food standards, FDA would need to continue to devote 
resources to temporary marketing permit (TMP) applications, which allow 
companies to sell products that deviate from established food standards 
while testing the marketplace for consumer acceptance of the new 
product (Sec.  130.17), and both agencies would need to devote 
resources to keeping their respective standards systems functioning. In 
the long run, demands on each agency's resources would likely increase 
as technological and marketing advances conflict with the requirements 
in the existing food standards regulations. However, if food standards 
were revised to provide flexibility in manufacturing, the number of TMP 
applications would be reduced and agencies' resources conserved. 
Finally, not reviewing or revising food standards to ensure that they 
are current with international food standards, as appropriate, could 
create difficulties in international negotiations and trade.
    The second option the Work Group considered was removing all food 
standards from the regulations and treating all foods as 
nonstandardized foods. One advantage of this option is that, in most 
cases, fewer agency resources would be required to eliminate food 
standards than to review and revise them. Also, under this option, we 
no longer would devote resources to responding to petitions requesting 
an amendment to an existing standard or the establishment of a new food 
standard.
    As with the first option, however, very few comments on the ANPRMs 
supported eliminating food standards completely. We agree with the 
comments that stated that States might establish their own food 
standards in the absence of Federal food standards. For meat and 
poultry products, if there were no Federal standards, States with their 
own meat and poultry inspection programs could have State standards for 
meat and poultry products and these would only apply to products 
produced at establishments within the State that are distributed within 
the State. Such food standards for meat and poultry products could 
differ from State to State. For FDA-regulated food products, if there 
were no Federal food standards, States would be free to create their 
own standards which might differ from each other, making compliance by 
manufacturers more difficult. Without Federal food standards, there 
would be no reference point for ensuring consistency of products for 
national commodity programs or feeding programs, such as the National 
School Lunch Program. In addition, as comments stated, without Federal 
food standards, the United States would have no reference point for 
negotiating international food standards, or facilitating international 
trade.
    Another disadvantage of this option is the loss of enforcement 
efficiency. Without food standards, we would have to rely solely on the 
general adulteration and misbranding provisions of our statutes rather 
than upon the specified requirements of a food standard to determine if 
a product were economically adulterated (i.e., adulterated under Sec.  
402(b)(1)) or misbranded. This would likely require more enforcement 
resources than a food standards system would require.
    The third option the Work Group considered was using our resources 
to review and revise food standards to make them internally consistent, 
more flexible for manufacturers and consumers, and easier to 
administer. The majority of comments supported this option and several 
provided specific suggestions concerning regulatory revisions. If we 
were to revise the food standards, we would ensure that the revisions 
reduced the burden on industry and ensured adequate protection of 
consumers. The disadvantage of this option is competing priorities 
would make it unlikely we could do this in a timely manner.
    The fourth option the Work Group considered was to request external 
industry groups to review, revise, and administer the food standards 
(private certification). This option would require little or no use of 
the agencies' resources. In addition, the revised food standards would 
provide the level of flexibility that industry desires. However, for 
private organizations to review, revise, and administer the food 
standards, the act, FMIA, and PPIA would have to be amended, so that 
these standards would have the force of law.
    Although a few industry comments supported private certification of 
food standards, most comments to the ANPRMs opposed private 
certification. In addition, the Work Group determined that this option 
might not provide a mechanism for consumer input, unless required by 
legislation. Therefore, consumers' interests would not necessarily be 
reflected in the revised food standards, which might result in the 
standards failing to promote honesty and fair dealing in the interest 
of consumers or to protect the public. Also, food standards for which 
industry was unwilling to commit resources would not be revised. Under 
this option, there might be no mechanism for resolving conflict, should 
it arise, among industry segments, unless legislative changes provided 
such a mechanism. Furthermore, we determined that food standards 
established and maintained by industry would be voluntary, not 
mandatory, unless legislative changes authorized industry to establish 
and maintain the standards.
    The fifth option the Work Group considered was to rely on external 
groups-consumer, industry, commodity, or other groups-to draft 
recommended revisions to existing Federal food standards but retain the 
agencies' authority to establish the final food standards. Under this 
option, we would continue to codify the food standards in our 
respective regulations. The external groups would use the general 
principles put forward by us to draft new food standards and would 
submit these in petitions. Similarly, external groups would use the 
general principles to draft revised food standards or to propose 
eliminating existing food standards. We would review any petitions 
submitted to ensure that they were consistent with the general 
principles. Under this option, if we determined that a petition to 
establish, revise, or eliminate a standard was consistent with the 
general principles, and provided adequate data and support for the 
suggested change, we would more quickly propose and, when appropriate, 
finalize a new or revised and simplified standard or the elimination of 
a standard.
    One major advantage of this option is that it would require the use 
of fewer of our agencies' resources than would be required if we were 
to review and propose amendments to the food standards without the 
benefit of petitions. In addition, this option allows for the 
participation of consumer groups and an opportunity for them to express 
interest through the petition process and through the submission of 
comments in response to proposed rules on new or revised food 
standards. Because we would have ultimate authority and jurisdiction 
over the final food standard established or eliminated, we would ensure 
that consumer interests were protected. Another advantage of this 
option is that it would rely largely on information from those groups 
that have the most interest in, and knowledge of, the particular food 
standards being

[[Page 29220]]

considered for revision. These groups could draw on technical experts 
with knowledge of current production practices and marketing trends who 
could suggest which aspects of a specific standard are necessary to 
define the essential characteristics of a particular food. This 
approach would also likely result in consistent food standards because 
the general principles would govern all changes that are made to the 
standards.
    The disadvantage to this fifth option is that, if a consumer, 
industry, or commodity group does not feel strongly about revising a 
particular group of food standards, we might not receive a petition and 
would then need to commit resources to reviewing the food standards 
without the benefit of a petition. However, comments to the ANPRMs and 
informal communications with external groups following publication of 
the ANPRMs indicate the willingness of consumer, industry, and 
commodity groups to submit for our consideration complete and thorough 
revisions for many food standards. In the event we do not receive a 
petition requesting that we revise, revoke, or establish a food 
standard, we, on our own initiative, may, when appropriate, propose to 
revise, revoke, or establish a standard.
    For the reasons discussed previously, we have tentatively 
determined that the fifth option is the most appropriate course of 
action. The Work Group preliminarily determined that we could rely on 
external groups to suggest new food standards, revisions to existing 
food standards, or elimination of certain food standards that are 
consistent with the proposed general principles. The general principles 
approach would allow us to chart the basic course of food standards 
review and modernization. Moreover, it would allow consumer and 
industry groups to participate in the development of new and revised 
food standards and to identify food standards that should be 
eliminated. In addition, it would provide an opportunity for consumer 
and industry groups to submit data to support any claims made in 
petitions relating to consumer expectations or beliefs, and hence, 
protect consumer interests.

F. Consumer Research

    To gain a preliminary understanding of current consumer attitudes 
toward Federal food standards of identity and the usefulness of food 
standards to consumers, we funded a series of focus group discussions 
(FGDs) that were conducted by the Research Triangle Institute, North 
Carolina. A total of 64 household grocery shoppers were recruited to 
participate in 8 FGDs held, 2 each in 4 cities: Raleigh, NC; San Diego, 
CA; Philadelphia, PA; and St. Louis, MO. Male and female participants 
were selected to represent diversity in age, level of education, and 
race. The purpose of this research was to collect the following 
information on consumers: (1) Attitudes toward arguments for and 
against standards of identity regulations; (2) preferences for 
standards of identity regulations for different types of food products; 
(3) preferences for various types of requirements in standards of 
identity regulations; (4) preferences for possible alternatives to 
standards of identity regulations; and (5) attitudes towards the 
standards setting process and suggestions for improving it.
    The FGDs revealed that the opinion of participants on standards of 
identity varied widely ranging from those who felt that such standards 
are always necessary to those who felt that such standards are never 
necessary. However, the FGDs did not generate sufficient data to 
explain the basis for these differences. The majority of participants 
at these FGDs supported the need for food standards to ensure product 
quality and protect consumers, and opined that food standards should 
not be eliminated. Some participants stated that standards were 
necessary to ensure that products are named and labeled appropriately, 
and that food standards would allow consumers to base purchase 
decisions simply on the name of the product. Some participants also 
stated that standards should be based on consumers' beliefs about 
minimum acceptable levels of product characteristics and were concerned 
that a lack of standards would lead to increased shopping time and 
costs associated with trying different brands of a particular food to 
find one that meets their expectations. A majority of participants also 
indicated that food standards help ensure a certain degree of product 
uniformity.
    However, some participants did not support the use of food 
standards. A few participants in the FGDs questioned the need for 
standards. With respect to quality provisions in standards, some 
participants stated that they prefer variety over a set standard 
quality of a food product; they also felt that some consumers might 
value the ability to choose a product of lower quality at a reduced 
price. These participants believed that standards were not necessary 
because consumer expectations of essential product characteristics and 
product quality can vary, and normal market forces, including the 
ability of a product to meet consumers' expectations, will determine 
whether it stays on the market. Therefore, they maintained that 
government oversight over product quality and uniformity was not 
needed. Some of these participants asserted that food standards do not 
serve consumers because they do not reflect the diversity of consumer 
expectations and beliefs, and restrict product choice and innovation.
    In addition to being asked whether they support or oppose the need 
for food standards, participants were asked which food products or 
characteristics of food products it was most important to standardize 
and monitor. In response, participants stated that they considered food 
standards to be most necessary for foods with multiple, unrecognizable 
ingredients (e.g., cheeses or hot dogs) and least necessary for foods 
with a single, recognizable ingredient (e.g., milk or canned corn). 
Many participants identified requirements for the types and amounts of 
ingredients and the quality of a product as the most important ones of 
a food standard, while the physical characteristics of a food were 
stated as least important.
    Additionally, several participants suggested that we review food 
standards periodically and revise them as needed on a case-by-case 
basis to accommodate changes in consumer preferences and reflect 
advances in processing and ingredient technologies. Finally, 
participants expressed the need for FSIS and FDA to obtain input from 
consumers during the process of establishing and revising food 
standards so consumers' preferences and beliefs are accurately 
reflected in food standards (Refs. 1 and 2).
    Overall, although the opinion of participants on standards of 
identity varied widely, some tentative conclusions can be drawn. Many 
participants found standards of identity to be valuable. Participants 
stated that having uniform product names for products with certain 
defined characteristics makes shopping easier. Many participants also 
felt that standards of identity help ensure a product has its expected 
characteristics. Most participants did not agree that standards hinder 
the variety of products available on the market. In general, 
participants felt that it was more important for standards to address 
characteristics that participants could not readily observe (such as 
ingredients in products with multiple, unrecognizable ingredients) 
rather than characteristics they could observe (such as appearance, 
size, or number). Participants also stated that standards of

[[Page 29221]]

identity should be based on consumer beliefs and expectations about the 
product that are implied by a product's name and its minimum acceptable 
characteristics. In addition, participants believed that standards 
should be periodically revised to accommodate changes in consumer 
beliefs and technological advances. Most participants also expressed 
the desire for consumers to play a role in the development or revision 
of standards and did not feel that the government should rely solely on 
input from industry. Although tentative, and drawn from the limited 
focus group research data that is available, these conclusions provide 
support for the general principles discussed in section II of this 
document.

II. The Proposed General Principles

    We are proposing general principles for establishing new food 
standards and for revising or eliminating existing food standards. In 
the list of proposed general principles for both of our agencies, the 
first four state the purpose or function of a food standard, and the 
remaining principles state how the requirements of a food standard 
should be written and what should be incorporated, in general, in the 
standard. Although the general principles have been developed to be 
consistent between our two agencies, they are not identical. Because 
FSIS and FDA regulate different products, principles that are specific 
to a particular agency were developed to reflect that agency's 
regulatory needs and perspectives.
    FSIS is proposing to establish 9 CFR 410.1(a) and FDA is proposing 
to amend 21 CFR 130.5(b) to include these new general principles. Under 
this proposed rule, the agencies will deny a petition to establish a 
food standard if the proposed food standard is not consistent with all 
of the general principles that apply to the proposed standard. The 
agencies recognize that not all of the general principles will be 
applicable to every food standard. The agencies will deny a petition to 
revise an existing standard if the proposed revision is inconsistent 
with any of the general principles that apply to the proposed revision. 
Under this proposed rule, when proposing a revision to a standard, 
petitioners will not be required to propose all the revisions that 
might be needed to modernize the entire existing standard. Rather, the 
petitioner may propose only limited changes to existing standards, 
provided the proposed revisions are consistent with the general 
principles that apply to them.
    The first four general principles state the purpose or function of 
a food standard. These principles are the most fundamental principles 
addressing consumer protection from an economic standpoint. Therefore, 
the agencies are proposing to deny a petition to eliminate a food 
standard if the petition does not demonstrate how the standard proposed 
to be eliminated is inconsistent with any one of the first four general 
principles. As stated in section I.B of this document, the act 
explicitly states that regulations establishing food standards of 
identity shall be issued when such action will ``promote honesty and 
fair dealing in the interest of consumers'' (21 U.S.C. 341). In 
addition, as stated in section I.A of this document, the FMIA and PPIA 
require that standards of identity or composition established under 
these acts be consistent with standards of identity, quality, or fill 
of container established under the act. Also, as stated previously, the 
FMIA and PPIA authorize the Secretary of Agriculture, after 
consultation with the Secretary of Health and Human Services, to 
prescribe definitions and standards of identity or composition for meat 
and poultry products whenever he or she determines that such action is 
necessary for the protection of the public. Therefore, all of the 
general principles set forth in this proposal have been designed to 
achieve the goals of promoting honesty and fair dealing in the interest 
of consumers and protecting the public. This is further explained as 
each individual or group of general principles is discussed below. 
Consistent with section 401 of the act, section 457(b) of the PPIA, and 
section 607(c) of the FMIA, the first four proposed general principles 
primarily address consumer protection from an economic standpoint. 
These first four principles are consistent with the findings of the 
focus group studies where a majority of participants maintained that 
food standards are needed to ensure product quality and uniformity and 
to protect consumers from economic deception. The first general 
principle listed under proposed 9 CFR 410.1(a)(1) and 21 CFR 
130.5(b)(1) makes it explicit that FSIS' purpose for a food standard is 
to protect the public and FDA's is to promote honesty and fair dealing 
in the interest of consumers. Food standards would provide a system by 
which consumer interests are protected and consumer expectations of a 
food are met. Historically, food standards have been beneficial because 
they provide assurance to consumers of product uniformity with respect 
to certain significant characteristics of standardized foods, resulting 
in the expectation and belief of consumers that all products bearing a 
particular name will possess the same essential characteristics, 
irrespective of where they are purchased, or by whom they are 
manufactured or distributed. Thus, to ensure that consumers are not 
misled by the name of the food, to meet consumers' expectations of 
product characteristics and uniformity, and, in turn, to promote 
honesty and fair dealing in the interest of consumers and to protect 
the public, a food standard should, as stated in proposed 9 CFR 
410.1(a)(2) and 21 CFR 130.5(b)(2), describe the basic nature of the 
food. The basic nature of the food is directly related to consumer 
expectations and beliefs about the food.
    Also, to promote honesty and fair dealing in the interest of 
consumers and to protect the public, proposed 9 CFR 410.1(a)(3) and 21 
CFR 130.5(b)(3) would state that the food standard should reflect the 
essential characteristics of the food. While the basic nature of a food 
is directly related to consumer expectations and beliefs about the 
food, the essential characteristics are the attributes of a food that 
make the food what it is even though they may not be readily apparent 
to the consumer. The essential characteristics of a food are those that 
define or distinguish a food or describe the distinctive properties of 
a food. Further, the essential characteristics of a food may contribute 
to achieving the basic nature of the food or may reflect relevant 
consumer expectations of a food product. Foods may be defined or 
distinguished by their ingredients, compositional characteristics, 
physical characteristics, levels of certain nutrients, or the manner in 
which they are produced--all of which are the essential characteristics 
of a food. For example, the essential characteristics of a hotdog 
include a certain fat and moisture content, and the use of water or ice 
to form an emulsion, whereas the basic nature of a hotdog is that it is 
a comminuted, semisolid sausage prepared from one or more kinds of raw 
skeletal muscle meat and/or cooked poultry meat. Similarly, the 
essential characteristics of a particular type of cheese may include 
the bacterial culture used, the processing method, and the fat and 
moisture content that contribute to the unique characteristics of that 
cheese and the basic nature of that cheese is that it is a milk-derived 
food of a certain form and consistency. Likewise, the essential 
characteristics of wheat flour

[[Page 29222]]

include granulation requirements (the percentage of flour that has to 
pass through a certain sieve size), its moisture content, and its ash 
content, whereas the basic nature of wheat flour is that it is a ground 
product of cleaned wheat grain. Therefore, although the essential 
characteristics of a food may contribute to achieving the basic nature 
of that food or may be relevant to meeting certain consumer 
expectations about the food, they differ from the basic nature of the 
food in that consumers may not be aware of the essential 
characteristics that make the food what it is.
    Preserving the basic nature and essential characteristics of a food 
would promote honesty and fair dealing in the interest of consumers and 
protect the public by ensuring that consumer expectations of the 
economic and nutritional value of a food are met. Historically, food 
standards have been adopted to protect consumers of traditional foods 
from deceptive, inferior quality products of lesser economic value. 
Current food standards ensure the economic value of a food. For 
example, the standards of identity for cheeses (part 133) specify milk 
solids or milkfat content requirements to prevent the substitution of 
less valuable ingredients for more valuable ingredients.
    In addition to ensuring the economic value of a food, FDA food 
standards, on occasion, also may serve to ensure the nutritional 
quality of a food by imposing requirements in addition to the labeling 
requirements in part 101 (21 CFR part 101). For example, the 
requirements for mandatory addition of vitamin D to evaporated milk and 
of vitamin A to margarine are specified within the standards of 
identity for these foods (Sec. Sec.  131.130 and 166.110, 
respectively). These nutritional requirements are an integral part of 
the standards of identity of these two foods and are not regulated 
under FDA's other nutritional quality provisions, such as its nutrient 
content claims regulations (part 101). The use of food standards as 
vehicles to improve the nutritional quality of the food supply has 
always been based on documented public health need and substantiated 
with sound science to ensure that, within the context of the total 
diet, the food is suitable for its intended use with reasonable 
assurance of effectiveness and safety in achieving the nutritional 
goals. FDA will continue to apply this standard for any future use of 
standardized foods or any other food as a vehicle to improve the 
nutritional quality of the food supply.
    Numerous FSIS standards specify the minimum amounts of meat and 
poultry and maximum amounts of fat or other ingredients a product may 
contain. These provisions ensure both the economic value and 
nutritional quality of standard meat and poultry products.
    Therefore, proposed 9 CFR 410.1(a)(4) and 21 CFR 130.5(b)(4) state 
that the food standard should ensure that the food does not appear to 
be better or of a greater value than it is. Additionally, the food 
standard may be used as a vehicle to improve the overall nutritional 
quality of the food supply.
    In addition to protecting the consumer, the next three proposed 
general principles would promote clear and straightforward requirements 
for food manufacturers. They would also promote, to the extent 
feasible, flexibility in food technology.
    Regulatory requirements written in plain and simple language 
facilitate the manufacture of foods that comply with the regulations 
and, thereby, help reduce manufacturers' costs of compliance and 
government costs of enforcement. Lowered costs of producing foods that 
meet the standards may potentially benefit consumers in the form of 
lowered prices of products in the marketplace. Therefore, proposed 9 
CFR 410.1(a)(5) and 21 CFR 130.5(b)(5) state that the food standard 
should contain clear and easily understood requirements to facilitate 
compliance by food manufacturers.
    Establishing regulations that do not stifle innovations in food 
technology and allow for technological alternatives and advancements in 
food processing would improve manufacturing efficiency and lessen costs 
which may be passed on to the consumer. Improved technologies may 
additionally benefit product quality and diversity. Increased diversity 
in, and potentially lower costs of, food products in the marketplace 
that continue to meet consumer expectations would promote honesty and 
fair dealing in the interest of consumers and protect the public. 
Therefore, proposed 9 CFR 410.1(a)(6) and 21 CFR 130.5(b)(6) provide 
that the food standard should permit maximum flexibility in the food 
technology used to prepare the standardized food, so long as that 
technology does not alter the basic nature or essential 
characteristics, or adversely affect the nutritional quality, or safety 
of the food. In addition, these provisions would state that the food 
standard should provide for any suitable, alternative manufacturing 
process that accomplishes the desired effect and should describe 
ingredients as broadly and generically as feasible.
    We are proposing the provision concerning flexibility in food 
technology to ensure that any requirement of a standard accomplishes 
its purpose without impeding technological advances that are not in 
conflict with the intent of the requirement. For example, in FSIS's 
current regulations, the standard for barbecued meats requires that 
products such as ``beef barbecue'' or ``barbecued pork'' be cooked by 
the direct action of dry heat (9 CFR 319.80). However, there may be 
other cooking methods that result in the same product characteristics 
that the direct action of dry heat achieves, such as infrared heating. 
During FGDs, consumers expressed the need to revise food standards to 
reflect current advances in food manufacturing technology, and we 
believe that this general principle provides an avenue to keep food 
standards current with technological advances.
    In addition to addressing flexibility in food technology, proposed 
9 CFR 410.1(a)(6) and 21 CFR 130.5(b)(6) would also state that the food 
standard should provide for any suitable, alternative manufacturing 
process that accomplishes the desired effect and should describe 
ingredients as broadly and generically as possible. Examples of 
standards that would permit flexibility in manufacturing processes 
would be those that provided for any suitable procedure for removing 
glucose from dried eggs, for instantizing flours, or for low-
temperature rendering of meat. We proposed that any food standard that 
includes a specific manufacturing process should allow for alternative 
procedures. If the manufacturing process specified in a food standard 
is essential to the character of the food, the food standard should 
allow for the use of any alternative procedure that yields a product 
with the same physical, nutritional, and sensory characteristics as the 
food made according to the traditional procedure specified in existing 
food standards.
    To allow for flexibility in ingredients used to formulate 
standardized products, the ingredients for frozen raw breaded shrimp, 
for example, might be described to be ``batter and breading 
ingredients'' (Sec.  161.175) and those in frankfurters, frank, furter, 
hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and 
similar products might be described to be ``byproducts and variety 
meats'' (9 CFR 319.180). If it is necessary to specify ingredients, the 
standard should specify these ingredients by functional use category, 
e.g., ``stabilizers and thickeners'' or ``texturizers,'' rather than by 
listing specific ingredients. Also, where appropriate, in accordance 
with current

[[Page 29223]]

regulations, the specific levels of ingredients that can be used may be 
modified if they reflect safe and suitable levels or those levels that 
reflect good manufacturing practices.
    The general principles would also promote uniformity between 
Federal food standards and any international standards for the same 
food. With the rising trend in globalization and increased 
accessibility of U.S. goods to other nations' markets, efforts to 
harmonize U.S. food standards with international f