[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Pages 67492-67503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31492]




DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 102, 130, 131, 133, 135, 136, 137, 139, 145, 146, 150, 
152, 155, 156, 158, 160, 161, 163, 164, 165, 166, 168, and 169

[Docket No. 95N-0294]


Food Standards of Identity, Quality and Fill of Container; Common 
or Usual Name Regulations; Request for Comments on Existing Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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[[Page 67493]]


SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to review its regulations pertaining to identity, quality, and 
fill of container for standardized foods and its common or usual name 
regulations for nonstandardized foods. As part of this review, the 
agency is soliciting comments from all interested parties on whether 
these regulations should be retained, revised, or revoked. FDA solicits 
comments on the benefits or lack of benefits of such regulations in 
facilitating domestic, as well as international, commerce and on the 
value of these regulations to consumers. The agency also solicits 
comments on alternative means of accomplishing the statutory objective 
of food standards, i.e., to promote honesty and fair dealing in the 
interest of consumers in the manufacture and sale of food products 
covered by these regulations. This review responds in part to President 
Clinton's memorandum to heads of departments and agencies, entitled 
``Regulatory Reinvention Initiative,'' dated March 4, 1995.

DATES: Written comments by April 29, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Nannie H. Rainey, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    On March 4, 1995, the President issued a memorandum to heads of 
departments and agencies, entitled ``Regulatory Reinvention 
Initiative'' (RRI memorandum) that, among other things, directed them 
to continue to work toward making Government more effective. In the RRI 
memorandum, the President noted that all Americans want the benefits of 
effective regulation, such as clean water, safe work places, wholesome 
food, and sound financial institutions, but stated that too often the 
rules are drafted with such detailed lists of do's and don'ts that the 
objectives they seek to achieve are undermined. Thus, the RRI 
memorandum directed that departments and agencies conduct a page-by-
page review of all of their regulations and eliminate or revise those 
that are outdated or otherwise in need of reform.
    A prime focus of FDA's review under the RRI memorandum has been the 
agency's food standard and common or usual name regulations. These 
provisions, which cover approximately 260 pages in the Code of Federal 
Regulations, appear to be exactly the kind of regulations that need 
reform. Intended to protect the integrity of the food supply, these 
regulations provide detailed definitions of various types of food, 
ranging from milk to canned fruits and vegetables to seafood cocktails. 
Some are extremely detailed and have the potential to limit 
technological advances. Virtually all of these regulations were adopted 
before the passage of the Nutrition Labeling and Education Act of 1990 
(Pub. L. 101-535) (the 1990 amendments) and, thus, were developed 
without reference to the significant informational function that the 
food label can play. Therefore, the food standards and common or usual 
name regulations are a candidate for revision or reform.
    As a result of its page-by-page review of its regulations in 
response to the RRI memorandum, FDA tentatively concluded that several 
food standards of identity should be revoked for various reasons 
including that they are obsolete, or that their provisions are being 
adequately covered by other regulations. On November 9, 1995 (60 FR 
56513), FDA published a final rule repealing a stayed standard (canned 
fruit nectars, formerly codified as Sec. 146.113 (21 CFR 146.113)). In 
that same issue of the Federal Register (60 FR 56541), the agency 
published a proposed rule to revoke the standards of identity for 
certain lower-fat milk, sour cream, and yogurt products in part 131 (21 
CFR part 131) and the standard of identity for lowfat cottage cheese in 
part 133 (21 CFR part 133) so that these foods can be produced and 
labeled under the general standard in Sec. 130.10 (21 CFR 130.10). That 
proposal also would amend the nutrient content claims regulations in 
Sec. 101.62 (21 CFR part 101.62) to provide for ``skim'' as a synonym 
for ``nonfat,'' thereby allowing the use of the names ``skim milk,'' 
``acidified skim milk,'' ``cultured skim milk,'' and ``sweetened 
condensed skim milk.'' In addition, FDA has proposed (60 FR 53480, 
October 13, 1995) to revoke a number of regulations because they are 
obsolete or of no current interest to industry or consumers. Among 
those regulations are several standards of identity in part 161 (21 CFR 
part 161) that specify sizes for certain oyster products, the standards 
of identity in part 163 (21 CFR part 163) for coatings made from cocoa, 
sweet chocolate, or milk chocolate and vegetable fats other than cacao 
fat, and the standards of identity in part 137 (21 CFR part 137) for 
the corn grits products (i.e., corn grits, enriched corn grits, quick 
grits, and yellow grits).
    The agency's review of the remaining food standards in parts 130 
through 169 (21 CFR parts 130 through 169) and the common or usual name 
regulations in part 102 (21 CFR part 102) forms the basis of this 
advanced notice of proposed rulemaking.

B. History: Pre-1938

    In providing for standards of identity, quality, and fill of 
container in section 401 of the Federal Food, Drug, and Cosmetic Act of 
1938 (the act) (21 U.S.C. 341), Congress sought to correct a deficiency 
in the 1906 Food and Drugs Act (the 1906 act). The 1906 act established 
definitions for adulteration and misbranding and subjected foods to 
seizure if they were found to be in violation of these definitions. 
Section 7 of the 1906 act was intended to prevent adulteration in the 
form of dilution or substitution of a valuable ingredient, concealment 
of inferiority, or use of harmful ingredients in foods. It deemed that 
a food was adulterated if, among other things, the food's strength or 
quality had been lowered, or if it had been cheapened. However, the 
1906 act contained no provision requiring foods to bear a statement of 
ingredients on the label and, thus, offered no means of comparing foods 
to determine whether dilution or substitution had occurred.
    The misbranding provisions of the 1906 act actually contributed to 
the proliferation of cheap or debased foods that could be sold legally 
by reason of its so called ``distinctive name proviso.'' This provision 
permitted the marketing of foods that would have been adulterated and 
misbranded if sold under the name of the food they purported to be by 
allowing their sale under meaningless ``distinctive'' names such as 
``Bred-Spred.'' Bred-Spred products were made in imitation of fruit 
preserves produced by adding acid and pectin to about 15 percent fruit. 
This quantity of fruit was far less than that used by the homemaker or 
by reputable manufacturers to make fruit preserves at that time.
    The lack of a provision to establish mandatory standards under the 
1906 act handicapped the Government in its attempts to maintain the 
integrity of the food supply by making it difficult for the Government 
to proceed against a debased food product, particularly a fabricated 
food. (See U.S. v. 10 Cases ``Bred-Spred,'' 49 F.2d 87 (8th Cir. 
1931).) 

[[Page 67494]]

    Under the 1906 act, the Government established advisory definitions 
and standards for use in food inspections. However, these definitions 
and standards had no effect on the enforcement of the law. To establish 
a violation of law, the Government had to introduce testimony showing 
that an undeclared variation was not one expected by consumers in an 
article bearing the name of the food. It was also necessary for the 
Government to show that the variation was not the prevailing good 
commercial practice. Without standards or guidelines, judgments under 
the 1906 act varied widely. Manufacturers could not be assured that 
their products would not be found to be violative, nor were consumers' 
interests effectively protected. Manufacturers were not protected 
against disreputable competitors who could affect competitive pressures 
and, more importantly, reduce consumer confidence in the food supply.
    Eventually, the Government and the industry came to the conclusion 
that a new statute was needed to ensure the integrity of food by 
keeping economically adulterated foods off the market. This recognition 
resulted in inclusion of three key provisions (sections 401, 403, and 
701 of the act (21 U.S.C. 341, 343, and 371) for standardization of 
foods.

C. History: Post-1938

1. The 1938 Act
    a. Authority to establish standards. The authority to establish 
standards is set forth in section 401 of the act. This section provides 
that:

    Whenever in the judgment of the Secretary 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, and/or reasonable standards of fill of container: Provided, 
That no definition and standard of identity and no standard of 
quality shall be established for fresh or dried fruits, fresh or 
dried vegetables, or butter, except that definitions and standards 
of identity may be established for avocados, cantaloupes, citrus 
fruits, and melons. * * *
    Early standards of identity established under the act were 
primarily ``recipe standards,'' defining in considerable detail the 
specific ingredients (both mandatory and optional ingredients) to be 
used and, in many instances, the procedure to be followed in 
manufacturing the food, much like home recipes. In addition, they 
provided assurance that only ``harmless'' ingredients would be used in 
the food and designated which optional ingredients must be declared on 
the label.
    Standards were intended to prevent economic deception. They were 
intended to protect consumers from receiving debased or watered down 
food products in which water or other fillers had been substituted for 
more valuable constituents. For example, the early standards for flour 
products established a maximum level of not more than 15 percent 
moisture in these foods. They also included a referenced method of 
analysis for moisture content to allow the manufacturer to use the same 
procedure as the Government inspector in testing the food for 
compliance with the standard.
    In defining the composition of foods, the definitions and standards 
of identity provided an added measure of assurance that the food supply 
would be safe. The standards designated the specific ingredients that 
should be used by name or limited them as ``harmless ingredients'' 
where class names were used. For example, only harmless and assimilable 
forms of iron or calcium salts could be added to enrich farina, and, in 
the case of vitamin D addition, only harmless carriers that do not 
impair the enriched farina could be used (Sec. 137.305). Because the 
statute did not have in place, at that time, a mechanism for 
preclearance of food additives or other functional optional ingredients 
that were used in foods, inclusion of such a limitation on ingredients 
provided further assurance that the foods would be wholesome and not 
adulterated.
    b. Misbranding provisions of the act. To ensure compliance with the 
definitions and standards established under section 401 of the act, 
Congress included two paragraphs under the misbranding provisions that 
effect food standards.
    Section 403(g) of the act, states that a food shall be deemed to be 
misbranded:

    If it purports to be or is represented as a food for which a 
definition and standard of identity has been prescribed by 
regulations as provided by section 401, unless: (1) It conforms to 
such definition and standard, and (2) its label bears the name of 
the food specified in the definition and standard, and, insofar as 
may be required by such regulations, the common names of optional 
ingredients (other than spices, flavoring, and coloring) present in 
such food.

In addition, section 403(i) of the act, as originally enacted, provided 
that a nonstandardized food (i.e., ``If it is not subject to the 
provisions of paragraph (g) of this section) was misbranded * * * 
unless its label bears (1) the common or usual name of the food, if any 
there be, and (2) in case it is fabricated from two or more 
ingredients, the common or usual name of each such ingredient; * * *.''
    Thus, the act, as originally enacted, required that foods 
purporting to be, or represented as, the standardized food comply with 
the compositional provisions of the applicable standard and bear the 
name designated in the definition and standard for the food. However, 
the act only provided for label declaration of the optional ingredients 
used in standardized foods and not the mandatory ingredients. 
Nonstandardized foods, on the other hand, had to list all ingredients 
used in the food, except that ``spices,'' ``flavorings,'' and 
``colorings'' could be declared collectively using those terms.
    c. The standards setting process. As enacted in 1938, section 701 
of the act (21 U.S.C. 371) provided in paragraph (e)(1) and (e)(2) that 
``any action for the issuance, amendment, or repeal'' of any standard 
of identity must be accomplished under formal rule making procedures 
where interested persons are given an opportunity to participate in a 
trial-type hearing.
    d. Preemption. As enacted in 1938, the act contained no provision 
providing that Federal food standards preempt State laws. While the 
standards provided a minimum below which the States could not go, it 
did not prevent the States from adopting more stringent standards. (See 
Grocery Manufacturers of America v. Gevace, 581 F. Supp. 658 (S.D.N.Y. 
1984), aff'd in part and rev'd in part, 75S F.2d 993 (2d Cir.), cert. 
denied 474 U.S. 820 (1985).)
2. Agency Implementation of the Standards Provisions
    a. Standards of identity. FDA has implemented section 401 of the 
act by adopting over 280 standards of identity. These 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). Standards may specify minimum levels of the 
valuable constituents and maximum levels for fillers and water. They 
may also designate the manufacturing process when that process has a 
bearing on the identity of the finished food. Finally, 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. 

[[Page 67495]]

    Individual 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 in them. For example, the 
standard of identity for fruit preserves and jams (Sec. 150.160) states 
that these foods must contain a minimum of 45 parts or 47 parts of 
fruit (depending on the type of fruit used) to each 55 parts of sugar 
or other sweetener, and that they may contain other ingredients such as 
pectin, acidifying agents, buffering agents, preservatives, and 
antifoaming agents. In this way, the standard ensures that when 
consumers purchase ``jam,'' they receive a product that contains a 
level of fruit that meets their expectations.
    Other foods standards focus on compositional characteristics of the 
food, rather than on the specific ingredients. The standards of 
identity for fruit juice products in part 146, for example, define 
these juices in terms of minimum juice soluble solids contents rather 
than on the ingredients used to make the food. Thus, the standard of 
identity for orange juice from concentrate (Sec. 146.145) requires that 
the food contain not less than 11.8 percent orange juice soluble 
solids, exclusive of any added sweetener. In this way, the standard 
helps to ensure that all products marketed as ``orange juice'' 
approximate, in the most important respects, the juice that comes 
directly from the fruit, and that consumers will receive a consistent 
orange juice product.
    The standards of identity for milk products in part 131 list the 
minimum milkfat and minimum milk solids not fat levels that must be 
contained in these foods. These specific compositional requirements 
protect against addition of water or other substances that could dilute 
the value of the nutrients in the food. In the case of certain 
dehydrated products, such as lowfat dry milk, the standard of identity 
(Sec. 131.123) specifies a maximum moisture level to protect against 
microbiological growth and to enhance the overall keeping quality of 
the product. To ensure that these compositional requirements are met, 
the standards reference specific methods of analysis.
    Other foods owe their distinctive characteristics to the manner in 
which they are produced. Thus, the standards for these foods reflect 
this fact. Standards of identity for some cheeses in part 133, for 
example, specify the manufacturing process, in addition to establishing 
minimum milkfat and maximum moisture requirements, to distinguish one 
cheese from another. These standards may also prescribe a curing 
process or specific species of mold to be used on or in the cheese to 
ensure that the finished cheese has the characteristic organoleptic 
properties commonly associated with that cheese.
    Some foods are defined by the physical characteristics of the food 
itself. For example, the particle size is an important factor in 
distinguishing cracked wheat from crushed wheat. Thus, the standards of 
identity for cracked wheat in Sec. 137.190 and crushed wheat in 
Sec. 137.195 include methods of analysis for the determination of the 
particle size of these foods. The test methods are used by 
manufacturers and regulators to ensure that foods labeled with these 
standardized names will possess the same physical properties from 
purchase to purchase. They also ensure that bakers will not have to do 
additional particle sizing of the ingredients before they are used for 
a specific baking operation. Similarly, standards of identity for flour 
(Sec. 137.105), instantized flour (Sec. 137.170), and whole wheat flour 
(Sec. 137.200) rely in part on the particle size determination as a 
distinguishing feature of these foods. Although the primary purpose of 
the particle size designation is to aid in establishing the identity of 
the food, it also serves as a quality factor and ensures that consumers 
will receive the same physical characteristics in all of these cereal 
grain products, regardless of where they are purchased or by whom they 
are produced.
    The distinctive property of other foods is provided by their 
nutrient levels. For example, the standards of identity for certain 
juices provide for the addition of vitamin C, some for milk products 
provide for the addition of vitamins A and D, while standards of 
identity for certain bakery products, enriched bread, rolls and buns, 
and cereal products, such as enriched macaroni and noodle products, 
enriched flours, and enriched corn meals provide for addition of 
thiamin, riboflavin, niacin, iron, and calcium. The enriched cereal 
grain products also provide for the optional addition of vitamin D. 
Such standards provide for consistency in fortification levels when 
nutrients are added to these foods and also serve as guidance to 
industry on what the agency believes are reasonable target levels for 
these nutrients in foods.
    b. Standards of quality and fill of container. Standards of quality 
set minimum specifications for such factors as tenderness, color, and 
freedom from defects in canned fruits and vegetables. Quality 
standards, established primarily for canned foods, place limits on 
defects, such as limits on the amounts of peel in canned peeled 
tomatoes, or on the number of pit fragments that may be in canned 
peaches, on the levels of seriously blemished (shriveled, hard, 
discolored, etc.) peas in canned peas, and on the number of pits in 
pitted canned cherries. 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 of a can). In the case of certain juice products, they may also 
establish criteria for percent juice soluble solids and maximum acidity 
to ensure that the juice product will have an acceptable flavor 
profile.
    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. The types of fill requirements differ for various products, 
depending on the characteristics of the food. Some fill-of-container 
standards specify minimum weights of solid food that must be present 
after the drainable liquid has been poured off (referred to as 
``minimum drained weight''). For example, the fill of container for 
canned corn in Sec. 155.130(c) is not less than 61 percent of the water 
capacity of the container. Other standards provide a simple stipulation 
that the container, with or without added liquid, must be filled with 
solid ingredients to a maximum that will still permit the lid to be 
attached and the food processed by heat to prevent spoilage, without 
crushing or breaking the solid ingredients. This type of standard was 
established for several canned fruits, i.e., apricots, cherries, 
peaches, and pears (see Secs. 145.115(c), 145.125(c), 145.170(c), and 
145.175(c), respectively), because the size, shape or textural 
properties of the foods will affect the fill of the raw food and the 
drained weight of the finished product. For example, the firmness, 
size, and shape of the peach or pear pieces (e.g., halves, slices, 
chunks) before heat processing in the container makes them difficult to 
pack to uniform fill-in weights. The fill of container for such foods 
is further complicated by the tendency of the pieces to soften on 
cooking and ``pack down,'' giving the appearance of a slack-filled 
container.
    The minimum fill-of-container requirements in standards provide 
guidance to the manufacturer, as well as 

[[Page 67496]]
to the food inspector, as to what constitutes a well-filled container. 
For some products, such as crushed pineapple, applesauce, pineapple 
juice, and packed nuts, where the consistency of the product is more 
uniform, or where there is no added packing medium that could serve to 
dilute the product contents, the required minimum fill of container is 
the total food contents, expressed as a percentage of the capacity of 
the container.
    In the case of canned tuna (Sec. 161.190), which may be packed in 
oil or water, FDA has established minimum fill of container 
requirements, expressed in terms of the pressed cake weight, in ounces, 
depending on the size of the container used to pack the tuna. The 
minimum pressed cake weight requirement assures consumers that they 
will obtain a minimum amount of tuna flesh in each can. The measure of 
tuna obtained in the laboratory by the pressed cake weight procedure 
described in the standard approximates the measure that the homemaker 
would observe when the lid of the tuna can is removed and is used to 
press the tuna and drain the liquid. In the case of canned Pacific 
salmon (Sec. 161.170), in which no packing medium is added, the minimum 
fill of container is expressed in terms of a minimum net weight of 
salmon for each container size. The minimum net weight requirements 
established in the standard are slightly less than the water capacity 
of the container, thereby taking into account the irregular shapes of 
the salmon pieces, but at the same time, providing assurance that the 
containers will not be underfilled.
    FDA regulations require that consumers be informed when foods do 
not comply with the applicable standard of quality or fill of 
container. Under Sec. 130.14 (21 CFR 130.14), foods that fail to comply 
with the quality standards must bear bold label statements, such as 
``BELOW STANDARD IN QUALITY,'' followed by a statement such as ``GOOD 
FOOD--NOT HIGH GRADE,'' or in the case of products that are substandard 
in fill, the statement ``BELOW STANDARD IN FILL,'' wherever the name of 
the food or any pictorial representation of the food appears so 
conspicuously as to be easily seen under customary conditions of 
purchase. The individual quality standards provide for an alternate 
label statement of the quality factor which makes the food substandard, 
such as ``EXCESSIVE COB'' on canned corn or ``EXCESSIVELY MEALY'' in 
canned peas instead of the general label statement, ``GOOD FOOD-- NOT 
HIGH GRADE.''
    Both the standards of quality and of fill of container provide 
detailed methodology for determining compliance. Because most of the 
methods included in the standards pertain only to the specific food 
identified by that standard, the agency has been of the opinion that 
this is the most efficient way to provide for such methods, e.g., the 
pressed cake weight method of analysis that pertains only to canned 
tuna. In some cases where the same method is used for multiple 
products, for example, the drained weight method of analysis for 
certain vegetables, FDA has simply referenced the method without 
repeating it in each of the standards (see Sec. 155.3(a)). However, in 
the case of canned fruit cocktail, the drained weight method of 
analysis is incorporated in the standard of fill of container 
(Sec. 145.135(c)).
    c. Temporary marketing permits. Under the agency's food standards 
program, FDA established a regulation providing for the issuance of 
temporary marketing permits (TMP's) in Sec. 130.17. TMP's allow 
manufacturers to make products that deviate from applicable standards 
in specified ways and to test consumer acceptance of those foods in the 
marketplace. TMP's allow the manufacturer to market the product in 
interstate commerce to obtain data on the commercial viability of a 
change in a standard of identity before petitioning the agency to amend 
the applicable standard to provide for the deviation. Products marketed 
under temporary permits must be labeled in a manner whereby the 
consumer can distinguish between the food being tested and the food 
complying with the applicable standard.
    FDA usually grants permits for a period not to exceed 15 months. 
However, with good reason, the agency may provide for a longer initial 
test market. Notice of the issuance of a permit, including a 
description of the deviations from the standardized food and the 
marketing conditions, is published in the Federal Register.
    Under Sec. 130.17, the TMP applicant may request an extension of 
the firm's permit, when such extension is necessary to obtain 
sufficient data to evaluate the test product. Requests for extensions 
must be accompanied by a description of the experiments conducted thus 
far under the permit, tentative conclusions reached, and reasons why 
further experimental shipments are considered to be necessary. Such 
requests must also be accompanied by a petition to amend the applicable 
standard to provide for the deviation.
    If FDA concludes, based on the information supplied, that extension 
of the time for test marketing the product is in the interest of 
consumers, the agency publishes a notice in the Federal Register 
stating this fact and inviting other interested firms to participate in 
the test market under the same conditions as set forth for the original 
applicant, except that the designated distribution area for the test 
product would not apply. These extensions usually continue until FDA 
publishes a final regulation either modifying the standard of identity 
in the manner sought or terminating the proposed rulemaking, whichever 
is the case.
    This procedure has worked well in providing manufacturers the 
flexibility to test the commercial viability of new, reformulated 
versions of traditional standardized foods. It has also served 
consumers well, allowing new and nutritionally advantageous products to 
be marketed before rulemaking. The data generated under TMP's also 
assist the agency in its rulemaking decisions. For example, before the 
passage of the 1990 amendments, the agency responded to more than 100 
applications for TMP's for modified dairy products, such as nonfat sour 
cream, nonfat cottage cheese, and light eggnog. The success of these 
test products assured the agency that these nutritionally modified 
foods were viable products, which could be made to resemble and 
substitute for the traditional standardized food and in a manner so as 
not to be nutritionally inferior to the traditional standardized food. 
Recently, FDA has issued TMP's for white chocolate, a food that 
deviates from the cacao product standards in part 163 because it 
contains none on the nonfat cacao solids usually present in chocolate 
products.
    3. Developments Affecting the Food Standard Regulations
    a. Safe and suitable policy. Passage of the Food Additives 
Amendment of 1958 and the Color Additive Amendments of 1960 instituted 
premarket approval of new food and color additives. These amendments 
allowed FDA to develop its ``safe and suitable'' policy, codified in 
Sec. 130.3(d), concerning functional ingredients used in foods. This 
policy provides that ingredients used in food must be listed food or 
color additives, or generally recognized as safe (GRAS) substances, and 
used at levels no higher than necessary to accomplish their intended 
functional effect in the food.
    FDA first used this policy in 1961 in the standard of identity for 
frozen raw breaded shrimp (Sec. 161.175). At that time, it represented 
a significant change in the manner in which permitted 

[[Page 67497]]
ingredients were designated in food standards. The standard simply 
provided for ``safe and suitable batter and breading ingredients,'' 
without listing the names of the specific permitted ingredients. This 
departure from the traditional food standards concept provided 
manufacturers with considerably more flexibility in the selection of 
ingredients to be used in the food. Along with this provision, the 
agency also required that each such safe and suitable optional 
ingredient used in the food be declared on the label.
    Since the establishment of this policy, the agency has revised most 
of its standards to provide for the use of safe and suitable 
ingredients, by category, that perform the needed technical effect in 
the food, e.g., safe and suitable emulsifiers. However, a few of the 
standards have not been so updated to increase flexibility in the 
manufacture of those foods. These standards include the standards of 
identity for certain cheese products (e.g., Secs. 133.169, 133.173, 
133.179, 133.187, and 133.188), which specify antimycotics by name 
(e.g., sorbic acid, potassium sorbate, sodium sorbate, calcium 
propionate, and sodium propionate) and the levels at which they may be 
used in the food, and the standards of identity for artificially 
sweetened fruit products (e.g., Secs. 145.116, 145.126, 145.131, 
145.136, 145.171, 145.176, and 145.181), which designate the specific 
artificial sweeteners (saccharin and sodium saccharin) that may be 
used.
    b. The 1990 amendments--i. Ingredient labeling. In the 1990 
amendments Congress amended the ingredient labeling provisions in 
section 403(i) of the act by removing the language that limited full 
ingredient labeling to nonstandardized foods. The 1990 amendments also 
amended section 403(i) to require that certified color additives be 
declared by their common or usual names, rather than by the collective 
term ``colorings.'' The framers of the act in 1938 apparently believed 
that consumers would know what mandatory ingredients would be used in 
staple food products covered by standards of identity and, thus, only 
provided that the optional ingredients used in such food would need to 
be declared on the label. However, with advance in food product 
formulation and processing, the ingredients used in standardized foods 
in the 1990's are more varied, and many are less familiar to consumers 
than the ingredients that were being used in 1938. This fact, along 
with consumers' desire to know the nature of all ingredients used in 
foods, led to the amendment of section 403(i). In response, the agency 
amended the food standards, as necessary, in parts 131 through 169 to 
require label declaration of each ingredient used in these foods (58 FR 
2850 at 2876 through 2887; and 58 FR 2888 at 2890 through 2896, January 
6, 1993).
    ii. The standard setting process. The 1990 amendments removed most 
section 401 proceedings from the list of rulemakings in which formal 
rulemaking is required under section 701(e) of the act. As a result, 
proceedings to establish, amend, or repeal food standards are subject 
to the requirements of informal notice and comment rulemaking. The only 
exception to this change is for actions to amend or repeal standards of 
identity for dairy products.
    iii. Preemption. The 1990 amendments added section 403A(a)(1) to 
the act (21 U.S.C. 343-1(a)(1)). Under this provision, a State may not 
establish or continue in effect a standard of identity for a food that 
is the subject of a standard of identity under section 401 of the act 
if the standard is not identical to the Federal standard. One of 
Congress' goals in passing this provision was to provide industry with 
some relief from State requirements that interfere with its ability to 
market products in all 50 States in an efficient and cost effective 
manner (statement of Rep. Madigan, 136 Congressional Record H12954 
(October 26, 1990)). Thus, as a result of the 1990 amendments, FDA's 
food standards are preemptive of State standards.
    iv. Other changes. In addition to these provisions that bear 
directly on food standards, Congress made a number of fundamental 
changes in how virtually all foods are labeled that bear directly on 
the issue of the continuing need for some or all food standards. The 
1990 amendments require that virtually all foods bear nutrition 
labeling. This information, plus the full ingredient list that is now 
required, ensures that consumers will have vastly more information 
about the make-up of a particular food product than was available in 
1938. This information should make it immediately apparent if a 
marketer is attempting to sell a debased or watered down food. Because 
the standards were originally intended to prevent this type of economic 
deception, the nutrition labeling requirement raises a question as to 
whether food standards are still necessary.
    The 1990 amendments also provide authority for FDA to adopt 
regulations defining nutrient content claims, such as ``reduced fat,'' 
``low fat,'' and ``fat free'' in Sec. 101.62 (January 6, 1993, 58 FR 
2302 at 2418). Having established uniform definitions for these terms, 
the agency was able to establish a general definition and standard of 
identity in Sec. 130.10, which permits the modification of a 
traditional standardized food to achieve a nutrition goal, such as a 
reduction in fat or calories. Such modified foods, complying with the 
requirements of Sec. 130.10, may be named by the use of a nutrient 
content claim defined by FDA in part 101, such as ``reduced fat,'' and 
a standardized term, such as ``cheddar cheese'' (i.e., reduced fat 
cheddar cheese).
    This general definition and standard of identity requires that the 
modified food: (1) Not be nutritionally inferior to the traditional 
standardized food that it resembles and for which it substitutes, (2) 
possess performance characteristics that are similar to the reference 
food, (3) contain a significant amount of any mandatory ingredient that 
is required to be in the traditional standardized food, and (4) not 
contain an ingredient that is prohibited in the traditional 
standardized food. However, under Sec. 130.10, safe and suitable 
ingredients not specifically provided for in the standard for the 
traditional food may be added to ensure that the modified food will not 
be inferior in performance characteristics (e.g., physical properties, 
flavor characteristics, and shelf life) when compared to those of the 
traditional food. This one standard (Sec. 130.10) has provided enormous 
flexibility in the manufacture of foods that deviate from the 
traditional standards and in providing many healthful and informatively 
labeled food products to consumers. It has also eliminated the need for 
use of complex alternative names for foods, as well as the need for the 
industry to request establishment of new standards or TMP's to deviate 
from existing standards to make new foods to meet consumers' needs and 
desires.
    In the past, many dairy products were defined by the level of 
milkfat in the food. Milkfat was considered to be one of the valuable 
constituents in the food, and if the minimum established level for 
milkfat was not met in the finished food, the product was deemed to be 
misbranded under section 403(g) of the act and adulterated under 
section 402(b) of the act. However, with the increased concern about 
fat and cholesterol in the diet, many consumers view milkfat in some 
dairy products as a negative factor or a constituent to be avoided 
rather than one that is sought after or highly valued. Under the 
general standard in Sec. 130.10, manufacturers are able to meet 
consumers demands for reduced fat dairy products. Many new foods, e.g, 

[[Page 67498]]
nonfat sour cream, reduced fat cheeses, and light or reduced fat ice 
cream products, to name a few, have been made available to consumers 
throughout the country in the past few years.
    To assist manufacturers in producing informatively labeled reduced 
fat ice cream products, FDA published a final rule in the Federal 
Register of September 14, 1994 (59 FR 47072) that removed the standard 
of identity for ice milk and goat's milk ice milk. Products formerly 
labeled as ice milk may be labeled as ``reduced fat'' or ``lowfat ice 
cream,'' depending on the total fat content of the food. Manufacturers 
may make other versions of ice cream, such as ``nonfat ice cream'' or 
``light ice cream.'' In that final rule, FDA also extended the optional 
sweeteners provision in the ice cream standard to include use of 
alternative sweeteners in reduced calorie ice cream products. For the 
next 3 years, until September 14, 1998, FDA is requiring that the name 
of the alternative sweeteners used in an ice cream be declared as part 
of the name of the food.

    When Congress issued the 1990 amendments, it recognized that some 
standards of identity contained nutrient content claims as a part of 
their names and specifically exempted them from regulations 
implementing the requirements of the amendments. To ensure consistency 
in the use of such claims on food labels, the agency announced that it 
intended to amend as soon as possible those standards of identity that 
require that the use of the claim in the name of the standardized food 
be consistent with use of the claim on nonstandardized food labels. 
Elsewhere in this issue of the Federal Register, to effect that intent, 
FDA is proposing to rescind virtually every standard for a dairy 
product whose name includes a ``low fat'' or ``no fat'' claim.

D. Common or Usual Name Regulations

    In the Federal Register of March 14, 1973 (38 FR 6964), FDA issued 
regulations in part 102 governing the establishment of ``common or 
usual names for nonstandardized foods.'' The agency stated in the 
preamble to the final rule that standards of identity are appropriate 
and useful where there is a need to prescribe the entire compositional 
requirement for a food, in addition to the name of the food. Often, 
however, the agency pointed out, there is a need simply to establish a 
uniform and informative name for food without the compositional aspects 
of a food standard.
    In issuing this regulation, FDA did not intend to establish common 
or usual names for all foods. Many foods already have established 
names, for example, apples, carrots, or potatoes and the diced, sliced, 
dehydrated, or frozen versions of these foods. There is no need for 
regulations to define the nature of these foods. If these foods are 
labeled inappropriately or in a misleading manner, it is a simple 
violation of the misbranding provisions of the act. However, when these 
foods are fabricated with other ingredients or modified in ways that 
are unfamiliar to consumers, and when the same formulated products are 
being marketed with different names by different firms, the nature of 
the foods may become less obvious, and there may be need for regulation 
to ensure that consumers are not misled or deceived.

    In the early 1970's, FDA received a petition requesting that it 
establish a regulation stating that onion rings were made from fresh 
onion bulbs, sliced and separated into rings, coated with batter or 
breading, and fried in a suitable fat or oil bath. The purpose of this 
regulation was to distinguish onion rings, so prepared, from an onion 
ring product that is made from fresh or dehydrated chopped onion, 
shaped by an extruder into ring shapes, breaded, and fried. This 
petition led to the establishment of the common or usual name 
regulation for ``onion rings made from diced onion'' in Sec. 102.39. 
This regulation distinguishes onion rings made from comminuted onions 
from those made with intact slices. It also requires that, if the onion 
ingredient has been dehydrated, the name include this fact, i.e., 
``onion rings made from dried diced onions.'' FDA received similar 
petitions for potato chips made from comminuted potatoes or dehydrated 
potato products leading to the establishment of another common or usual 
name regulation in Sec. 102.41, ``potato chips made from dried 
potatoes.''
    The 1969 White House Conference on Food, Nutrition, and Health had 
recommended that the agency establish by regulation uniform common or 
usual names for foods that accurately reflect the reasonable 
expectations of consumers. The Conference recommendation focused on 
concern that the amount of the characterizing ingredient, if any, be 
represented on the label in percentage form or some other uniform 
method. In the preamble to the final rule, FDA acknowledged that 
disclosure of the amount of a characterizing ingredient is often 
necessary for the consumer to choose between two competing products 
when the amount of the ingredient is important to the value of the 
food.
    Part 102 consists of general principles for common or usual names 
for classes or subclasses of foods and several regulations that set 
requirements for naming specific nonstandardized foods. The general 
principles in Sec. 102.5 require that the common or usual name of a 
food accurately describe, in as simple and direct terms as possible, 
the basic nature of the food or its characterizing properties or 
ingredients. The name must include the percentage of a characterizing 
ingredient or component or a statement of its presence or absence when 
the portion of that substance has material bearing on the value of the 
food, or when the appearance of the food might otherwise mislead the 
consumer as to the amount of the substance present.
    FDA has issued common or usual name regulations for nonstandardized 
foods only when necessary to fully inform consumers, or where different 
names were being used for the same product by different manufacturers. 
The first common or usual name regulation that required percentage 
declaration of the valuable characterizing ingredient was for seafood 
cocktails consisting of two or more seafood constituents or for 
cocktails with one seafood constituent. FDA had received consumer 
complaints concerning both the amount of seafood present in such 
cocktails and the use of labeling that suggested a greater proportion 
of seafood than was present. The common or usual name sought to correct 
this situation. Because the proportion of the seafood in such cocktails 
has material bearing on price and consumer acceptance, this regulation 
allowed consumers to make better purchasing decisions.
    At the time they were established, one of the benefits of the 
common or usual name provisions in part 102 was that names of new 
products could be established by regulation using informal notice and 
comment rulemaking procedures, rather than the lengthy formal 
rulemaking procedures required for food standards. With passage of the 
1990 amendments, however, as explained above, new standards of identity 
also may be established by notice and comment rulemaking proceedings. 
In view of this change in the act, the agency requests comments on the 
need to retain the dual mechanisms of standards and common or usual 
name regulations for establishing the definition of a food. Comments 
who support retention of both should describe the circumstances in 
which common or usual names should be chosen over standards of 

[[Page 67499]]

identity. If standards of identity are deemed more appropriate, the 
agency requests comments on whether the common or usual name 
regulations for specific foods in part 102 should be retained in that 
part, transferred to the appropriate food standards parts, or repealed.

II. Reinventing Government

    Congress directed FDA to establish and implement food standards 
because there was a real need to protect consumers from economic fraud 
and to promote honesty and fair dealing in the interest of consumers. 
Food standards have been beneficial through their long history of 
providing assurance to consumers of product uniformity, with the 
resulting expectation and belief by consumers that all products bearing 
a particular name will possess the same characteristics irrespective of 
where they are purchased, or by whom they are manufactured or 
distributed. Food standards have also been an efficient mechanism for 
addressing public health problems through mandatory fortification 
requirements. In addition, standards have provided manufacturers with 
guidance in the production, naming, and labeling of products and with 
assurance that competitors will have to meet the same guidelines for 
the same foods.
    However, the agency recognizes that food standards may serve as an 
impediment to the food industry to the degree to which they fail to 
reflect advances in food science and technology. New ingredients and 
plant varieties that allow manufacturers to enhance a food's 
organoleptic or functional properties, alter its nutritional profile, 
or extend its shelf life, are being developed and used in 
nonstandardized food products. Incorporation of these advances into 
standardized foods may be difficult or impossible without laborious 
amendment of the relevant standard. FDA believes that manufacturers of 
standardized foods should have the ability to make use of advances in 
food technology, provided the basic nature of the food remains 
essentially the same.
    Also, consumer expectations may have changed dramatically in the 
past two decades. Busy, active consumers put a premium on convenience 
when purchasing foods, and this emphasis may have also altered their 
expectations relative to basic, staple food products. Additionally, 
with the growing body of scientific evidence linking diet and health, 
consumers are demanding modified versions of traditional products that 
have lower amounts of constituents associated with negative health 
implications, such as fat, saturated fat, cholesterol, and sodium.
    Some critics have suggested that the agency revoke all food 
standards and allow market forces to control the composition of the 
products that are currently regulated by standards. On the other hand, 
industry and consumer spokespersons have expressed support for 
standards, believing them necessary to ensure that all manufacturers 
operate in a spirit of fairness and to ensure consistency in the 
products consumers are purchasing. They also state that standards 
promote consistency in labeling and to serve as a basis for nutrient 
content claims. For example, standards for traditional dairy products 
with established minimum fat levels can be used as the bases for 
``reduced fat'' claims on labels of modified versions of these foods.
    FDA believes that the two actions described previously, namely: (1) 
Amending standards to provide for the use of ``safe and suitable'' 
ingredients rather than explicit designation of all ingredients and (2) 
establishment of the general standard in Sec. 130.10 for foods named by 
the use of a nutrient content claim and a standardized term, have 
lifted some of the restrictiveness of standards. However, the agency is 
considering further steps for providing flexibility in how foods are 
formulated and named, including, if appropriate, eliminating food 
standards, while continuing to promote honesty and fair dealing in the 
interest of consumers, and while continuing to ensure that food is not 
adulterated or misbranded. In light of the President's memorandum, FDA 
is looking critically at food standards.
    The agency notes that the Food Safety and Inspection Service (FSIS) 
of the U.S. Department of Agriculture has established a number of food 
standards, under the authority of the acts that it administers. Many of 
these standards define the nature of meat and poultry products in a 
manner similar to FDA standards described previously. In a separate 
document, FSIS is announcing that it too is critically reviewing its 
standards in accordance with President Clinton's directive. Comments to 
this document are urged to consider, and provide comments separately 
to, FSIS's document.

III. International Standards

    The United States is a charter member (dating back to 1963) and 
strong supporter of the Codex Alimentarius Commission (Codex) and its 
food standards program. The aim of the Codex, which is sponsored 
jointly by the United Nations' Food and Agriculture Organization (FAO) 
and World Health Organization (WHO), is to promote the health and 
economic interests of consumers, while encouraging fair international 
trade in food. One of the general provisions of FDA's food standards 
program is the review of Codex food standards, following the procedure 
described in Sec. 130.6(a): ``All food standards adopted by the Codex 
Alimentarius Commission will be reviewed by the Food and Drug 
Administration and will be accepted without change, accepted with 
change, or not accepted.''
    It has been FDA's policy to publish new Codex food standards in an 
advance notice of proposed rulemaking in the Federal Register for 
review and informal comment. If the comments support adoption of the 
Codex standard or amendment of an existing standard to incorporate 
changes based on the Codex standard, FDA publishes a proposal in the 
Federal Register to adopt the Codex standard's provisions insofar as 
practicable. A proposal of this type could also be begun on the 
agency's own initiative. These procedures are described in Sec. 130.6. 
To date, the agency has considered 83 Codex standards for adoption. (As 
a part of its initiative on international harmonization, FDA is 
considering a separate rulemaking to amend and update procedures in 
Sec. 130.6 to make them more consistent with current Codex policies.)
    FDA notes that U.S. delegates participating in the development of 
the international standards at Codex Committee meetings have often 
relied upon criteria established in the U.S. food standards in deciding 
on compositional requirements to be included in Codex standards. The 
agency believes that this procedure is a reasonable course of action 
because the U.S. standards, for the most part, reflect current 
commercial practice in this country. In the absence of U.S. food 
standards, would the position of the U.S. delegates in the Codex 
Committee meetings be weakened? How important is it to exporters and 
importers that the compositional provisions of the U.S. food standards 
be reflected in international specifications such as those established 
by the Codex Alimentarius?

IV. Economic Issues

    Executive Order 12866 directs FDA to maximize the net benefits 
(benefits minus costs) of its regulations. The agency generally 
considers the following seven factors in determining the net benefits 
of a food standard:
    1. Net benefits are likely to be higher for standards involving the 
product 

[[Page 67500]]
characteristics about which consumers are most concerned. FDA has no 
formal method of determining the level of consumer concern about 
various characteristics, however and, thus, seeks information on this 
issue. In particular, consumer concerns may change over time. FDA 
requests comments on how it should factor changing consumer concerns 
into the economic assessments that it does for any rulemaking that may 
result from this advance notice of proposed rulemaking.
    2. Net benefits are likely to be higher for standards that 
consumers are best able to understand and interpret. Thus, it becomes 
significant if there are any cases in which standards of identity 
produce confusion rather than provide information. FDA requests 
comments as to whether any such standards exist. For example, might 
consumers believe that products similar to standardized products but 
which fail to meet the standard are necessarily inferior to products 
that meet the standard? Such confusion may deter consumers from 
purchasing nonconforming products, even though those products may have 
all the characteristics some consumers usually associate with that type 
of product or all the characteristics desired by consumers. This 
confusion could lead to a reduction in the development of new products, 
a reduction in competition between similar products, and a reduction in 
product variety. FDA requests comments and information on whether 
consumers may be confused when comparing standardized foods to other 
foods and on the importance of product variety in particular markets.
    3. Net benefits are likely to be higher for standards dealing with 
characteristics that are least amenable to direct informational 
labeling, including both labeling required by FDA and voluntary 
labeling by manufacturers. Characteristics that are not amenable to 
direct informational labeling are those for which direct labeling would 
be particularly complex or lengthy, such as the relative proportion of 
various ingredients, particular functional or organoleptic 
characteristics, or particular methods of manufacture. Other 
characteristics, such as the presence of particular ingredients, 
nutritional facts, and the contents of containers, are now labeled for 
most products. FDA requests comments on which characteristics are most 
and least amenable to direct labeling.
    4. Net benefits are likely to be higher for standards involving 
product characteristics that cannot be detected after purchase. 
Although information on characteristics that can be detected after, but 
not before, purchase can prevent post-purchase dissatisfaction, the 
value of this information is likely to be less. If a consumer purchases 
a brand name product and is not satisfied with that product, that 
consumer will purchase a different brand name in the future. Thus, food 
manufacturers have an economic incentive to produce products with the 
characteristics consumers desire, and that they can ensure are present. 
The agency believes that information about characteristics that cannot 
be detected after purchase is more valuable because consumers cannot 
acquire this information on their own. FDA requests comments on how 
much value the consumer places on being able to detect product 
characteristics before purchase so as to avoid post-purchase 
dissatisfaction.
    5. Net benefits of federally established standards are likely to be 
higher for those standards least amenable to implementation by private 
organizations. If consumers are willing to pay for assurances that 
products have certain characteristics, it may be possible for private 
organizations to certify the presence of those characteristics in some 
cases.
    6. Net benefits are likely to be higher for standards that are 
short, simple, and flexible. The lengthier and more complex a given 
standard, the more difficult it is likely to be for FDA to issue, and 
it may be more difficult to enforce. Shorter and less complex standards 
are also less costly for manufacturers to interpret and comply with. 
The more flexible a standard, the less likely FDA will have to revise 
or amend that standard in the future, and the less costly it will 
likely be for manufacturers to comply with that standard. FDA requests 
comments on the proper degree of flexibility for particular standards.
    7. The net benefits of particular Federal standards may be larger 
or smaller than those of State standards preempted by those Federal 
standards. Conflicting State standards generate compliance costs 
because manufacturers selling products under conflicting standards must 
either provide alternative product formulations or labeling for those 
products. However, Federal standards are not necessarily superior to 
State standards because Federal and State standards may have different 
costs or benefits with respect to any of the factors listed previously, 
that is, State standards may provide more or less information than 
Federal standards, may restrict competition to a greater or lesser 
degree than Federal standards, and so on. Consumers in different 
States, however, may have conflicting ideas over the proper definition 
of various products, and some State standards may provide some 
consumers with better information on the characteristics that most 
concerned them. The benefits and costs of harmonizing Federal or State 
standards with international standards can be analyzed in the same 
manner as the benefits and costs of harmonizing State standards through 
the use of Federal standards.

V. Request for Information

    Given this background on past standards activities and the agency's 
commitment to review all of its standards, FDA is soliciting comments 
on the following issues, as well as any other ideas that would assist 
the agency in fulfilling its mission to protect the interest of 
consumers. FDA particularly requests comments that reflect the 
following concerns of broad segments of industry, food manufacturers, 
and distributors, including importers and exporters, individuals and 
consumer groups, academia, State and local governments, and the 
international community:

A. Overall Operation of Food Standards

1. Utility of the System
    a. Some persons have argued that there should be a partial or total 
dissolution of food standards. Do you agree? If so, why? What, if 
anything, should take their place? Are some standards obsolete? Are 
there different types of standards, some of which are more meaningful 
than others? Could the objective of food standards, ``to promote 
honesty and fair dealing in the interest of consumers,'' be 
accomplished by other, more effective means? If so, how would it be 
accomplished within the limits of current and anticipated FDA 
resources?
    b. Are there any data that indicate whether consumers find the 
current system of standards meaningful, or whether significant 
alteration of standards would significantly affect consumers' ideas 
about the integrity of food products?
    c. Does industry need compositional standards for orderly marketing 
of foods? Are food standards needed to control the composition of 
fabricated foods such as cheeses, ice cream, and enriched cereal and 
bakery products?
2. Naming Conventions
    a. Food standards of identity are a means of defining the 
composition of a food that is marketed under a designated common or 
usual name. What criteria should be used for determining when a food 
standard is 

[[Page 67501]]
appropriate? How should FDA interpret the phrase in section 401 of the 
act ``to promote honesty and fair dealing in the interest of 
consumers''? Should evidence of the existence of consumer confusion or 
dissatisfaction be required as a precondition before FDA undertakes the 
standards setting process?
    b. In which markets does the potential misinterpretation of 
standards of identity generate a significant tradeoff between 
consumers' desire for product consistency and product variety? Given 
that standards define the trade-off between product consistency and 
product variety, for which products or characteristics is variety least 
important to consumers, and, hence, which products or characteristics 
are most appropriate to be standardized?
    c. In section II.A. of this document, FDA discussed the different 
kinds of defining characteristics that serve as the basis for a 
standard of identity. Are food standards distinguishable by these 
characteristics? Can they be divided into categories, and should these 
categories be evaluated separately? For example, should standards for 
foods defined by physical characteristics, such as cracked wheat, be 
retained? Should they be revised by retaining the criterion for the 
defining characteristic, e.g., particle size, and removing the specific 
instructions for measuring the defining characteristic? Can the 
criterion be used effectively if the method to be used for measuring it 
is not specified? How can FDA best determinethe characteristics of food 
with which consumers are most concerned?
    d. In addition to promoting honesty and fair dealing, standards 
also promote the health and safety of the general public. As noted 
above, in section I.C.2.a. of this document, a number of the standards 
of identity contain provisions for restoration of nutrients which may 
be lost during processing of the food or addition of nutrients to 
correct a nutritional deficiency, such as the addition of certain B 
vitamins and iron in cereal grain products. The agency requests 
comments on whether food standards are the best means of providing for 
the addition of such nutrients, and, if not, on what those other means 
are.
3. Products Sold to Manufacturers
    Some standards of identity govern products that are sold primarily 
to other manufacturers, such as the standards for lactose in 
Sec. 168.122 and dried glucose sirup in Sec. 168.121. These standards 
define the purity of these ingredients. The agency requests comments on 
the need to retain these standards. Are standards that govern products 
that are sold primarily to manufacturers for use as ingredients in 
formulating other foods necessary to promote honesty and fair dealing 
in the interest of consumers? Would purity specifications for products, 
such as lactose, be more properly provided in food additive 
regulations, GRAS affirmation regulations, or other nonregulation 
sources such as the Food Chemicals Codex?
4. Test Marketing of Products
    Should the agency continue to issue temporary marketing permits? Is 
there another way that the food industry could label, for test 
marketing purposes, products that deviate from the applicable standard 
of identity that would ensure that consumers will not be misled about 
the nature of the food and alert the consumer that the food is not the 
traditional standardized food? For example, could a product be labeled 
with a bold statement that ``this food deviates from the standard of 
identity established by the Food and Drug Administration because 
____________________,'' and not be considered to be misleading to 
consumers? Would such a statement be meaningful to consumers? Can such 
a system be reconciled with section 403(g) of the act?
5. Methods of Analysis
    FDA often provides detailed methods of analysis in its standards of 
identity, quality, and fill of container. Given that Federal food 
standards are preemptive, FDA believes that providing such detail for 
specific products in the standards appears to be an efficient way to 
convey to state and local enforcement agencies, as well as the food 
industry, information on the procedures the agency will use in its 
enforcement actions. In some of the food standards, where the same 
analytical method is used across many different foods, the agency may 
reference the method in a text such as the International AOAC's 
Official Methods of Analysis or a method that appears elsewhere in the 
Code of Federal Regulations. However, in the interest of having less 
complex standards, the agency requests comments on the need to continue 
to incorporate specific methods of analysis in food standards. Would 
incorporation of these methods in a separate manual or section of the 
Code of Federal Regulations be preferable to the current procedures? 
Are there other procedures that would provide for easier updating of 
the methods than amendment of the standards of identity? FDA points out 
that its current policy is to require that the methods it uses for 
enforcement of the provisions of the standards go through the 
rulemaking procedures applicable to all other provisions of the 
standards. Any change in how methods of analysis are dealt with must 
take into consideration the legal status of the resultant 
specification.
6. Elimination of Federal Preemption; Impact on State Jurisdiction
    FDA specifically requests comments on the preemption aspects of 
standards of identity. If Federal standards of identity were 
discontinued, the States would be able to establish their own 
compositional requirements, a situation that would be contrary to the 
congressional move toward national uniformity in food standards and 
labeling. Is this desirable? How significant are costs associated with 
conflicting state regulations to firms marketing products interstate 
commerce?
    In light of the preemption provisions of section 403A of the act, 
the agency requests comments as to whether it is in the interest of the 
general public that the agency retain a Federal food standards program. 
If so, should the operation of that program deviate from the existing 
system of standards of identity and common or usual names regulations? 
If it is not deemed to be in the interest of the public, what changes 
should be made in the act and in the regulations to effect the 
necessary changes in food regulation? Comments should be supported by 
data where available on the issues relating to the economics of 
production and marketing of commodities currently covered by food 
standards or common or usual name regulations, including the costs and 
benefits to consumers, industry, and international trade.
7. Impact on International Trade
    a. How significant are the costs associated with State or Federal 
standards of identity that do not conform to international food 
standards?
    b. In recommending an alternative to the current system of 
regulating the manufacture and sale of food using standards of identity 
and common or usual name regulations, comments should take into account 
the impact of the alternative on FDA's ability to participate in the 
development and harmonization of international standards. For example, 
how effective would U.S. delegates be in debating the merits of 
specific provisions in a Codex standard if the United States had no 
comparable standards? 

[[Page 67502]]

8. FDA-FSIS Harmonization
    FDA recognizes the need for consistency between FDA and FSIS in the 
development and implementation of food standards that set forth minimum 
compositional requirements. The agency believes that manufacturers will 
be better able to comply with the requirements of both agencies if 
similar approaches are used. Thus, to the extent possible, one of the 
agency's goals is to harmonize its regulations with those of FSIS. The 
agency requests comments on how this goal might be accomplished. Is 
consistency in the two agencies' policies sufficient harmonization to 
make regulations easier to use, or should the standards established by 
both agencies be listed together and in similar formats? For example, 
would codification of the FSIS and FDA standards of identity in the 
same Title of the Code of Federal Regulations be beneficial to users of 
these regulations? Commenters responding to this issue should consider 
the different authorities granted to FDA under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 et seq.) and to FSIS under the Federal 
Meat Inspection Act (21 U.S.C. 601 et seq.) and the Poultry Products 
Inspection Act (21 U.S.C. 451 et seq.) in promulgation and enforcement 
of the standards, particularly the premarket clearance and inspection 
authority that is available to FSIS and not to FDA.
    FDA regulations cover a wider range of food products than those of 
FSIS. In addition, FDA standards appear in a number of different 
formats, some of which also encompass quality and fill of container 
requirements. Should these differences continue, or should the two 
agencies strive to have a consistent format for their food standards?
9. Agency Budget Constraints
    Because of budget constraints, FDA must prioritize its resources. 
In such a situation, matters affecting food safety and public health 
take precedence over those concerning issues of economic deception, 
such as the development and revision of food standards. If comments 
support a continuance of the existing food standards program, FDA 
requests comments on where resources for the program would be obtained. 
Should it be changed to a fee supported program in which petitioners 
for new standards or amendments to existing standards, including 
applicants for temporary marketing permits, would pay a filing fee that 
would cover the agency's cost of petition or application review and 
evaluation and the subsequent Federal Register document preparation?
10. Imitation Foods
    A related matter that would arise should FDA decide to retain food 
standards in some form or another is the question of whether FDA should 
modify its treatment of imitation foods. Under Sec. 101.3(e), a food 
shall be deemed to be an imitation, and thus subject to the 
requirements of section 403(c) of the act, if it is a substitute for 
and resembles another food but is nutritionally inferior to that food. 
If a food is an imitation, then the label of the food shall bear the 
word ``imitation'' and, immediately thereafter, the name of the food 
imitated. FDA requests comments on whether, if it retains food 
standards, it should modify its treatment of imitation foods in any 
way.

B. Alternatives

1. Regulate All Foods as Nonstandardized Foods
    Revoke the existing food standards. Under this alternative, all 
foods would be labeled as nonstandardized foods in accordance with the 
regulations in parts 101 and 102. This alternative would provide 
maximum flexibility to manufacturers and would provide for a wider 
variety of foods to consumers. At the same time, it would mean that 
consumers would no longer be able to rely on the definitions of 
familiar foods established by foodstandards. FDA requests comment on 
the value of this alternative.
2. Declaration of Percentage of All Major Ingredients
    Some persons have suggested label declaration in the ingredients 
list of the percentage of all ingredients used in a food as an 
alternative to minimum compositional requirements in food standards. 
Historically, FDA has not required such quantitative labeling of 
ingredients.
    FDA now seeks comment on whether such quantitative ingredient 
labeling is a desirable and feasible alternative to food standards. If 
it is, how extensive should this labeling be? Should the percentages of 
all ingredients be listed? Should the declarations be limited to only 
the major ingredients in the food or to those ingredients that are 
present at a level greater than a certain designated limit, for 
example, 2 percent or more? What impact would this have on industry's 
ability to be flexible in its formulations if the labels must specify 
accurately the percentage of each ingredient or of each major 
ingredient? Would percentage ingredient labeling be adequate to allow 
consumers to distinguish between products with similar appearance? How 
important is percentage declaration of ingredients now that nutrition 
labeling of foods is mandatory? In considering the alternatives to the 
current system of standards of identity and common or usual name 
regulations, the agency requests that commenters consider the costs to 
industry, enforcement agencies, and consumers, as well as the benefits, 
of the alternatives.
3. Percentage Labeling of Characterizing Ingredients in the Food Name
    Could a simpler system of nomenclature be established such as one 
based on a percentage declaration of the valuable characterizing 
ingredient in the food, for example, ``strawberry jelly, 30% 
strawberries,'' or ``peanut butter, 80% peanuts?''. (FDA standards for 
these foods require that strawberry jelly contain not less than 45 
parts strawberries and 55 parts sweetener and that peanut butter 
contain not less than 90 percent peanut ingredient.) This approach 
would allow manufacturers to include greater or lesser amounts of the 
characterizing ingredients with the consumer being the ultimate 
decisionmaker regarding the product's acceptability. Would such a 
system be similar to common or usual name regulations in Part 102? 
Should a level be established below which a product could not be called 
by the traditional name? For example, should a product labeled as 
containing 5 percent strawberries be allowed to be called ``strawberry 
jelly,'' if the percentage of strawberries is declared as part of the 
name? Should this approach be limited to only certain types of foods? 
If so, what types of FDA regulated food products would be amenable to 
this type of labeling?
    In multicomponent, fabricated food products, what determines the 
components whose percentage would be declared? Should the percentage of 
more than one component be declared? For example, in an egg noodle 
product, should the percentage of the flour and the egg be declared as 
part of the name of the food? Should the amount of milk used in the 
formulation or manufacture of a cheese be declared on the label even 
though not all of the components of the milk remain in the cheese? 
Would a declaration of the percentage of certain constituents of the 
finished food, e.g., the fat and protein contents of the cheese, be 
more informative than the percentage of the ingredients used to make 
the food?
4. Compositional Standard for the Parent Product
    If percentage characterizing ingredient declaration were adopted 
for traditional 

[[Page 67503]]
foods, such as fruit jellies, jams, and preserves, would it be 
necessary to identify a ``parent'' product, for example, a standardized 
jam or jelly that complies with minimum compositional requirements 
established by regulation, to avoid misleading use of the percentage 
declaration on the food label? For example, if products with less than 
45 parts fruit were allowed to be called ``jam'' or ``preserves,'' 
provided the percentage of fruit were required to be declared, would a 
standard of identity for jam and preserves specifying the types of 
ingredients the foods contain and requiring a minimum fruit content, 
minimum sweetener content, or minimum soluble solids in the finished 
product be necessary? If so, would it be desirable that the standard of 
identity also require declaration of the percentage of fruit in the 
parent product for comparison purposes?
5. Establishment of Generic Food Standards
    FDA has established several generic food standards, such as the 
class standards of identity in part 133 for certain types of cheeses 
for which the agency has not established individual varietal standards 
(e.g., Sec. 133.150 Hard cheeses, and Sec. 133.193 Spiced, flavored 
standardized cheeses) and the generic standard for nutritionally 
modified versions of traditional standardized foods in Sec. 130.10 
Requirements for foods named by the use of a nutrient content claim and 
a standardized term. Could the generic food standard concept be 
extended to other classes of food standards, e.g., canned fruits and 
canned fruit juices? Could these standards be written as 
``performance'' standards rather than as recipes? If so, provide 
illustrative examples.
6. Private Certification of Food Products
    Which characteristics of food products are most amenable to 
certification by private organizations rather than by local, State, or 
Federal government? Which factors render private certification 
impractical or inappropriate?
7. Labeling Qualifications That Product Differs From Government 
Standard
    a. Should products that do not conform to FDA quality standards be 
labeled ``BELOW STANDARD IN QUALITY--GOOD FOOD, NOT HIGH GRADE?'' Is 
there better labeling that would provide more useful distinctions? 
Would alternative labeling be more readily interpreted in the case of 
substandard fill labeling?
    b. FDA notes that most of the previous questions are directed 
primarily at standards of identity or common or usual name regulations. 
However, the agency requests that commenters also consider the need for 
standards of fill of container and standards of quality. How important 
are these regulations to consumers and the food industry? As in the 
case of standards of identity, FDA requests comments on whether these 
standards should be retained, revised, or revoked. Some of the quality 
factors of the standards were based on acceptance of the Codex 
Alimentarius international food standards and others on good commercial 
practice in this country. Thus, comments should consider as part of 
their analysis the impact of such standards relative to exported and 
imported food, as well as food produced and sold domestically.
8. Moratorium on Food Standards
    FDA requests comment on whether, if it institutes a broad 
rulemaking on foods standards, a moratorium on foods standards actions, 
e.g., issuance of temporary marketing permits and the development of 
regulations to amend, repeal, or establish new standards, would be 
appropriate.
9. Are There Any Other Ideas?
    a. Is there a better way to protect consumer expectations about 
food products without the market entry delays and demands on agency 
resources that frequently occur under the current system? If the 
existing system of standards is deemed to be outdated and no longer 
serving a useful purpose in the marketplace, is there a middle ground? 
Is there a different system for standards that would be useful? What, 
if anything, should be done about section 401 of the act? If this 
provision is not repealed, the agency will continue to receive 
petitions to issue standards of identity, quality, and fill of 
container.
    b. The agency is particularly interested in the cost/benefit 
aspects of food standards. Do the benefits of standards of identity, 
quality, and fill of container to consumers and to the regulated 
industry outweigh the costs of such regulations? 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?
    c. What factors affect the benefits and costs of food standards, 
other than the factors listed previously? Are there considerations 
relating to the cost/benefit factors listed above that have not been 
acknowledged? How can FDA best estimate the benefits and costs of 
particular standards? Which standards are particularly beneficial or 
costly, and why?
    Interested persons may, on or before April 29, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this advanced notice of proposed rulemaking. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 22, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31492 Filed 12-26-95; 3:37 pm]
BILLING CODE 4160-01-P