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

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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that are outdated or otherwise in need of reform.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).)

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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.

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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

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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

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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