67492 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

21 CFR Part 170

Administrative practice and

procedure, Food additives, Reporting

and recordkeeping requirements.

21 CFR Part 171

Administrative practice and

procedure, Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 71, 170, and 171 be

amended as follows:

PART 71—COLOR ADDITIVE

PETITIONS

1. The authority citation for 21 CFR

part 71 continues to read as follows:

Authority: Secs. 201, 402, 409, 501, 505,

506, 507, 510, 512–516, 518–520, 601, 701,

721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 342, 348, 351,

355, 356, 357, 360, 360b–360f, 360h–360j,

361, 371, 379e, 381); secs. 215, 351 of the

Public Health Service Act (42 U.S.C. 216,

262).

2. Section 71.1 is amended in

paragraph (c) in the petition by revising

the introductory paragraph preceding

paragraph A., and by adding new

paragraph (j) to read as follows:

§ 71.1 Petitions.

* * * * *

(c) * * *

Attached hereto in triplicate

(quadruplicate, if intended uses include use

in meat, meat food product, or poultry

product), and constituting a part of this

petition are the following:

* * * * *

(j)(1) If intended uses of the color

additive include uses in meat, meat food

product, or poultry product subject to

regulation by the U.S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) or Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(2) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

3.Section 71.20 is amended by adding

new paragraph (a)(3) to read as follows:

§ 71.20 Publication of regulation.

* * * * *

(a) * * *

(3) The regulation shall list any use or

uses in meat, meat food product, or

poultry product subject to the Federal

Meat Inspection Act (FMIA)(21 U.S.C.

601 et seq.) or Poultry Products

Inspection (PPIA)(21 U.S.C. 451 et seq.)

for which the color additive has been

found suitable and for which it may

safely be employed.

* * * * *

PART 170—FOOD ADDITIVES

4. The authority citation for 21 CFR

part 170 continues to read as follows:

Authority: Secs. 201, 401, 402, 408, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 346a, 348, 371).

5. Section 170.35 is amended by

redesignating paragraphs (c)(3) through

(c)(6) as paragraphs (c)(4) through (c)(7),

respectively, and by adding new

paragraph (c)(3) to read as follows:

§ 170.35 Affirmation of generally

recognized as safe (GRAS) status.

* * * * *

(c) * * *

(3)(i) If intended uses of the substance

include uses in meat, meat food

product, or poultry product subject to

regulation by the U. S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451 et seq.) or Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(ii) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

* * * * *

PART 171—FOOD ADDITIVE

PETITIONS

6. The authority citation for 21 CFR

part 171 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

7. Section 171.1 is amended in

paragraph (c) in the petition by revising

the introductory paragraph preceding

paragraph A., and by adding new

paragraph (n) to read as follows:

§ 171.1 Petitions.

* * * * *

(c) * * *

Attached hereto, in triplicate

(quadruplicate, if intended uses include use

in meat, meat food product, or poultry

product), and constituting a part of this

petition, are the following:

* * * * *

(n) (1) If intended uses of the food

additive include uses in meat, meat food

product, or poultry product subject to

regulation by the U.S. Department of

Agriculture (USDA) under the Poultry

Products Inspection Act (PPIA) (21

U.S.C. 451, et seq.) or Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601, et

seq.), FDA shall, upon filing of the

petition, forward a copy of the petition

or relevant portions thereof to the Food

Safety and Inspection Service, USDA,

for simultaneous review under the PPIA

and FMIA.

(2) FDA will ask USDA to advise

whether the proposed meat and poultry

uses comply with the FMIA and PPIA,

or if not, whether use of the substance

would be permitted in products under

USDA jurisdiction under specified

conditions or restrictions.

8. Section 171.100 is amended by

redesignating paragraph (b) as paragraph

(c) and by adding new paragraph (b) to

read as follows:

§ 171.100 Regulation based on petition.

* * * * *

(b) The regulation shall describe the

conditions under which the substance

may be safely used in any meat product,

meat food product, or poultry product

subject to the Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601 et seq.) or the

Poultry Products Inspection Act (PPIA)

(21 U.S.C. 451 et seq.).

* * * * *

Dated: October 11, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–31491 Filed 12–26–95; 3:37 pm]

BILLING CODE 4160–01–F

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.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 § 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 § 130.10 (21 CFR 130.10).

That proposal also would amend the

nutrient content claims regulations in

§ 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).)
67494 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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 (§ 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.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 (§ 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 (§ 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

(§ 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 § 137.190 and crushed

wheat in § 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

(§ 137.105), instantized flour

(§ 137.170), and whole wheat flour

(§ 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 § 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 §§ 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
67496 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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 (§ 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 (§ 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

§ 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 § 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 (§ 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 § 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 § 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 § 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 (§ 161.175). At that

time, it represented a significant change

in the manner in which permitted
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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., §§ 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., §§ 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 § 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

§ 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

§ 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

§ 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

(§ 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

§ 130.10, manufacturers are able to meet

consumers demands for reduced fat

dairy products. Many new foods, e.g,
67498 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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 § 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 § 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 § 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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 § 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

§ 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 § 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 § 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
67500 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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 § 168.122 and dried glucose

sirup in § 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

llllllllll,’’ 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?
67502 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules

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

§ 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
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Proposed Rules 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., § 133.150 Hard

cheeses, and § 133.193 Spiced, flavored

standardized cheeses) and the generic

standard for nutritionally modified

versions of traditional standardized

foods in § 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