[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