29708 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

responsibility under the Public Health

Service Act.

Lead Federal agencies in the matter of

controlling shipborne wastes include

the U. S. Coast Guard and the

Environmental Protection Agency.

Other Federal agencies involved include

the Department of State, the National

Oceanic and Atmospheric

Administration and its National Marine

Fisheries Service, the United States

Department of Agriculture’s Animal and

Plant Health Inspection Service, and the

Maritime Administration.

D. Request for Information

FDA is considering proposing to

revise § 1250.93 of the Interstate Travel

Sanitation regulations to prohibit

discharges that would pollute salt water

and shellfish growing areas as well as

fresh water. Other agency objectives

include harmonizing FDA’s vessel waste

control requirements with those of other

Federal agencies and contributing to

meeting U. S. obligations under ratified

international agreements. FDA requests

information on what changes could be

made to § 1250.93 to assist the agency

in establishing standards for discharges

of waste from passenger boats, casino

ships, and ferries. The agency requests

information on the effects that any

suggested changes would have on the

waste discharge practices of affected

vessels.

VIII. Comments

Interested persons may, on or before

September 10, 1996, submit to the

Dockets Management Branch (address

above) written comments regarding this

ANPRM. 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: May 31, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–14888 Filed 6–7–96; 12:17 pm]

BILLING CODE 4160–01–F

21 CFR Parts 101 and 730

[Docket No. 96N–0174]

RIN 0910–AA69

Food and Cosmetic Labeling;

Revocation of Certain Regulations;

Opportunity for Public Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revoke certain regulations that appear to

be obsolete. These regulations have been

identified for revocation as a result of a

page-by-page review of the agency’s

regulations that FDA conducted in

response to the Clinton administration’s

‘‘Reinventing Government’’ initiative,

which seeks to streamline Government

to ease the burden on regulated industry

and consumers. The agency is providing

an opportunity for comments on this

proposed rule.

DATES: Written comments by August 26,

1996. The agency is proposing that any

final rule that may issue based upon this

proposal become effective 75 days

following date of publication of the final

rule.

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:

Corinne L. Howley, Center for Food

Safety and Applied Nutrition (HFS–24),

Food and Drug Administration, 200 C

St., SW., Washington, DC 20204, 202–

205–4272.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton

announced plans for the reform of the

Federal regulatory system as part of the

administration’s ‘‘Reinventing

Government’’ initiative. In his March 4,

1995, directive, the President ordered

all Federal agencies to conduct a pageby-page review of all of their regulations

to ‘‘eliminate or revise those that are

outdated or otherwise in need of

reform.’’

In response to this directive, FDA

issued proposals to revoke a number of

regulations (see, e.g., 60 FR 53480,

October 13, 1995; 60 FR 56513 and

56541, November 9, 1995) and an

advance notice of proposed rulemaking

(ANPRM) to review standards of

identity, quality, and fill of container

(60 FR 67492, December 29, 1995). The

agency has completed its review of its

food and cosmetic regulations in

response to the President’s initiative

and as a result is publishing two

documents in this issue of the Federal

Register. This document announces

additional regulations that FDA is

proposing to eliminate or revise, and the

second document is an ANPRM that

seeks information on other food and

cosmetic regulations that appear to be in

need of revision.

II. The Proposal

A. Food Labeling Regulations

FDA has identified several food

labeling regulations in part 101 (21 CFR

part 101) as candidates for revocation or

revision and is seeking comments from

interested parties regarding its tentative

conclusions on these matters. The

following is a list of those regulations

and the agency’s tentative conclusions

concerning the needed changes:

1. Section 101.2 Information panel of

package form food

In § 101.2, paragraph (a) defines the

term ‘‘information panel’’ as it applies

to packaged food, and in paragraph (b),

the regulation provides that all

information required to appear on the

label of any package of food under

certain referenced regulations appear

either on the principal display panel or

on the information panel unless

otherwise specified in the regulations.

The referenced regulations are: § 101.4

Food; designation of ingredients, § 101.5

Food; name and place of business of

manufacturer, packer, or distributor),

§ 101.8 Labeling of food with number of

servings, § 101.9 Nutrition labeling of

food, § 101.12 Reference amounts

customarily consumed per eating

occasion, § 101.13 Nutrient content

claims general principles, § 101.17 Food

labeling warning and notice statements,

Part 101—Subpart D—Specific

requirements for nutrient content

claims, and Part 105—Foods for special

dietary use (21 CFR 105). Paragraph (c)

of § 101.2 requires that information

required by the referenced regulations

be in letters or numbers of at least onesixteenth inch in height, unless

otherwise exempted by regulation.

Paragraph (c) of § 101.2 also provides

exemptions to this type size

requirement. FDA tentatively concludes

that certain of these exemptions are

obsolete.

a. Exemptions for small packages

There are exemptions in paragraphs

(c)(1) through (c)(3) of § 101.2 for small

packages (defined according to the

surface area available to bear labeling).

These exemptions were established

before the enactment of the Nutrition

Labeling and Education Act of 1990 (the

1990 amendments) (Pub. L. 101–535).

They were designed to encourage firms

to provide nutrition information in

accordance with § 101.9, as well as a

full list of ingredients in accordance

with the regulations in § 101.4 and the

agency’s policy regarding declaration of

ingredients on standardized foods as set

out in § 101.6 (see 39 FR 15268, May 2,

1974). Before the enactment of the 1990
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29709

amendments, nutrition information was

voluntary unless a nutrient was added

to the food or a claim about the nutrient

content of the food was made in its

labeling. The agency also did not have

authority under the Federal Food, Drug,

and Cosmetic Act (the act) to require

that all ingredients used in standardized

foods be declared on the label.

The 1990 amendments amended the

act to provide for, among other things,

mandatory nutrition labeling of foods

and complete ingredient listing on all

foods. As a result, FDA amended its

nutrition labeling regulations in a

number of significant respects,

including specifying minimum type

sizes and formats for presenting the

nutrition information on the label

(§ 101.9). The amended nutrition

labeling regulations include exemptions

from the new minimum type size

requirements, depending on the

particular format being used and the

label space available to bear the

information.

Also, in response to the 1990

amendments, FDA revised the

definitions and standards of identity for

foods in parts 131 to 169 (21 CFR parts

131 to 169) to reflect the requirement

that all food ingredients, including the

mandatory ingredients of standardized

foods, be listed on the label and § 101.6

be revoked (58 FR 2850 and 2888,

January 6, 1993).

Because the purpose of § 101.2(c)(1),

(c)(2), and (c)(3) was to encourage

voluntary declaration of ingredients and

nutrition information on food, FDA has

tentatively concluded that they are no

longer needed. Nutrition labeling is now

required on most foods, and the

regulations now in effect provide for

flexibility in presentation of the

information where space is limited.

Declaration of all ingredients in

standardized foods is also required.

Because the exemptions in § 101.2(c)(1),

(c)(2), and (c)(3) are obsolete, FDA is

proposing to revoke them. If any

interested person believes that there is

a need to retain any of the exemptions,

he or she should submit comments

explaining that need in response to this

proposal. Comments supporting

retention of any of these exemptions

should include information on specific

products for which other type size

exemptions are inadequate.

b. Nonretail Individual Serving Size

Packages

Section 101.2(c)(5) provides that

individual serving size packages of food

served with meals in restaurants,

institutions, and on board passenger

carriers, and not intended for sale at

retail, are exempt from the type-size

requirements of § 101.2(c) under the

following conditions:

(i) The package has a total area of 3

square inches or less available to bear

labeling;

(ii) There is insufficient area on the

package available to print all required

information in a type size of onesixteenth inch in height;

(iii) The label information includes a

full list of ingredients in accordance

with regulations in part 101 and the

policy expressed in § 101.6; and

(iv) The information required by

§ 101.2 (b) appears on the label in

accordance with the provisions of this

paragraph, except that the type size is

not less than one thirty-second inch in

height.

Because declaration of all ingredients

in standardized foods is now required,

and § 101.6 has been revoked, reference

to § 101.6 is no longer meaningful.

Therefore, FDA is proposing to delete

that reference from § 101.2(c)(5).

Specifically, FDA is proposing to revoke

paragraph § 101.2(c)(5)(iii) and

redesignate paragraph (5)(iv) as (5)(iii).

2. Section 101.8 Labeling of foods with

number of servings

Section 101.8(a) requires that any

package of food that bears a

representation as to the number of

servings contained in such package bear

in immediate conjunction with such

statement, and in the same size type as

is used for such statement, a statement

of the net quantity (in terms of weight,

measure, or numerical count) of each

such serving. However, such statement

may be expressed in terms that differ

from the terms used in the required

statement of net quantity of contents (for

example, in cups or tablespoons rather

than in avoirdupois ounces) when such

differing term is common to cookery

and describes a constant quantity. This

paragraph also requires that the

statement not be misleading in any

particular. It goes on to state that where

nutrition labeling information is

required in accordance with the

provisions of § 101.9, the statement of

the net quantity of each serving shall be

consistent with the requirements for

serving size expression set forth in that

section (e.g., 10 1-cup (240 milliliters)

servings). The provision also states that

a statement of the number of units in a

package is not in itself a statement of the

number of servings.

Paragraph (b) of this regulation

(§ 101.8(b)) provides that, if there exists

a voluntary product standard issued by

the Department of Commerce under the

procedures found in 15 CFR part 10,

that quantitatively defines the meaning

of the term ‘‘serving’’ with respect to a

particular food, then any label

representation as to the number of

servings in such packaged food shall

correspond with such quantitative

definition. It also states that, ‘‘Copies of

published standards are available upon

request from the National Bureau of

Standards, Department of Commerce,

Washington, DC 20234.’’

The agency has tentatively concluded,

based on two factors, that this regulation

is obsolete. The first factor is that the

description of how serving size

information should appear on food

labels in § 101.8(a) has been obviated by

the recent extensive changes in FDA’s

regulations governing mandatory

nutrition labeling of foods that the

agency adopted in response to the 1990

amendments. Section 101.9 requires

that quantitative nutrition information

be declared in relation to a serving of

the food as defined in paragraph (b)(1)

of that section. Section 101.9(b)(1)

defines a ‘‘serving’’ or ‘‘serving size’’ for

the purpose of these regulations as the

amount of food, expressed in a common

household measure that is appropriate

for the food, customarily consumed per

eating occasion by persons 4 years of

age and older. When the food is

specially formulated or processed for

use by infants or by toddlers, a serving

or serving size means an amount of food

customarily consumed per eating

occasion by infants up to 12 months of

age or by children 1 through 3 years of

age, respectively. Section 101.9(b) also

provides specific guidance as to how the

serving or serving size is to be

determined for various food products.

Section § 101.12 specifies the reference

amount customarily consumed per

eating occasion for 139 food product

categories and requires the declaration

of the serving in terms of metric units

and familiar household measures.

Among other things, the serving size

regulation provides criteria for

determining the serving size based on

the reference amount for the food

category, thereby ensuring that

reasonable and uniform serving sizes

will be used in product labeling. Such

uniformity in food labeling enhances

consumers’ ability to make nutrition

comparisons among foods. With

§ 101.8(a), however, there is not the

same specificity for determining

appropriate serving sizes. Consequently,

there is far less assurance under

§ 101.8(a) than under § 101.9 that

uniform serving sizes will appear on

similar products. Therefore, FDA is

proposing to revoke § 101.8(a).

The second factor is that FDA is

aware of no need to continue the

reference in § 101.8(b) to ‘‘voluntary

product standards issued by the
29710 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

National Bureau of Standards of the

Department of Commerce (DOC)’’ that

quantitatively define the meaning of the

term ‘‘serving.’’ (The agency notes that

the National Bureau of Standards is now

known as the National Institute of

Standards and Technology (NIST)).

NIST has advised (Ref. 1) FDA that it no

longer issues voluntary product

standards, and it has been withdrawing

its voluntary serving size standards for

FDA-regulated food products for some

time. NIST stated that its only standard

for an FDA-regulated commodity is one

for carbonated soft drink bottles and

that standard is about to be withdrawn.

Therefore, FDA is proposing to revoke

§ 101.8(b).

3. Section 101.29 Labeling of kosher and

kosher-style foods

Section 101.29 is a statement of

informal agency policy regarding the

use of the terms ‘‘kosher’’ and ‘‘kosher

style’’ in the labeling of food products.

This policy was excerpted from agency

correspondence and codified in part 101

(formerly codified as § 3.302, see 22 FR

9593 at page 9594, November 30, 1957)

because the agency believed that it was

of general interest to the public. Because

it was not established through

rulemaking procedures, this provision

serves only as guidance and does not

have the force and effect of law. If these

terms are used in a manner that would

render the product misbranded, the

agency could take action against such

products under section 403(a) of the act

(21 U.S.C. 343(a)). Although § 101.29

could be removed without notice and

comment rulemaking, FDA is proposing

to remove it in this document to ensure

that its decision is as informed as

possible. The agency also solicits

comments on whether it should prepare

a Compliance Policy Guide that reflects

the policy that has been codified in

§ 101.29. Compliance Policy Guides are

used by FDA as informal guidance in

evaluating products and accompanying

label statements and in recommending

regulatory actions for efficient

enforcement of the act.

B. Cosmetic Regulations (Part 730—21

CFR 730)

Parts 710, 720, and 730 (21 CFR parts

710, 720, and 730) of FDA’s regulations

provide for the Voluntary Cosmetic

Reporting Program (VCRP) for the

voluntary submission of information

relating to cosmetic products. Part 730

of this program provides for the

voluntary filing of cosmetic product

experience reports (VCPE) by the

cosmetics industry. In the Federal

Register of October 17, 1973 (38 FR

28914), FDA, in response to a petition

from the Cosmetic, Toiletry and

Fragrance Association, Inc. (CTFA),

issued regulations for the voluntary

filing of cosmetic product experiences.

The petitioner believed that the VCPE

would serve: ‘‘(1) To provide reliable

baseline information against which to

assess or evaluate products or their

ingredients, and (2) prompt information

where specific public health questions

may be presented.’’ The regulation was

implemented in 1974 as the Voluntary

Cosmetic Experience Program. FDA

recodified these regulations in 1974 (39

FR 10054, 10062, March 15, 1974) and

modified them in 1981 (46 FR 38073,

July 24, 1981) and 1986 (51 FR 25687,

July 16, 1986).

During the 23 years the CVRP has

been in place, companies have

submitted information about adverse

reactions that consumers have reported

to them. FDA has performed a statistical

assessment of the data to calculate the

‘‘baseline’’ adverse reactions (expected

number of reactions per million units

distributed) that occur for the different

cosmetic product categories identified

in the program.

While the VCPE has provided useful

information regarding relative adverse

reaction baseline rates, it has suffered

from some serious limitations. Industry

participation in this portion of the

program has historically been very

limited and selective, the reports lack

sufficient details to be useful, and

annual reports are sent in long after the

occurrence of an adverse reaction. This

limited participation has persisted even

though the program has been modified

several times over the years to make it

easier for companies to participate. In

this regard, the VCPE provides a false

impression about the ability of the

voluntary program to ensure the safety

of cosmetics. Thus, the VCPE program

no longer provides any new information

about cosmetic adverse reactions, and it

no longer serves the important purpose

of helping to find harmful cosmetics

and to remove them from the

marketplace.

With current budgetary constraints on

FDA, it is difficult to justify the

continuation of a program that does not

contribute directly to increasing the

safety of cosmetics or protecting the

public health. Adding data to the

information that FDA has obtained over

20 years about baseline adverse reaction

rates will be unlikely to have any value.

Thus, FDA is proposing to revoke part

730. FDA intends to perform a thorough

evaluation of information received over

the years and will prepare an in-depth

report that will be useful to both the

cosmetic industry and the public in

understanding adverse reaction trends

for different product categories and the

baseline rates of adverse reactions.

Companies will be able to use this indepth report for assessing their own

individual products without having to

report their information to FDA.

The agency is interested in comments

on whether the VCPE should be

eliminated in its entirety, reduced in

scope, or some other alternative. For

example, one alternative would be to

revoke part 730 but maintain the

availability of reporting forms or other

means of access ( e.g., electronic). These

forms could be used for the prompt

reporting of any unusually severe

adverse reactions or for reporting an

unusually high number of adverse

reactions of moderate severity. In

addition to comments on the issues

discussed in this proposal, FDA

requests comments on any other related

matters that would assist FDA in

fulfilling its mission to protect the

interests of consumers.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) and (a)(8),

respectively, that the actions to revoke

or revise several food labeling

regulations in part 101, and to eliminate

or modify part 730 of the cosmetic

regulations, are of a type that do not

individually or cumulatively have a

significant effect on the environment.

Therefore, neither an environmental

assessment nor an environmental

impact statement is required.

IV. Economic Impact

FDA has examined the economic

impact of the proposed rule as required

by Executive Order 12866 and the

Regulatory Flexibility Act (Pub. L. 96–

354). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health,

safety, distributive, and equity effects).

The Regulatory Flexibility Act requires

analyzing options for regulatory relief

for small businesses. FDA finds that the

proposed rule does not constitute a

major rule as defined by Executive

Order 12866. FDA also finds that the

proposed rule will not have a significant

impact on small businesses.

The proposed rule will remove or

revise several provisions in part 101 and

all of part 730. The proposed removals

include: (1) Certain type-size

exemptions, (2) the labeling of foods

with number of servings other than as

specified in the 1990 amendments, (3)

guidance on use of the term ‘‘kosher’’,
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29711

and (4) elimination of the Voluntary

Cosmetic Experience Program. Except

for the ‘‘kosher’’ guidance, all of the

targeted provisions have been rendered

obsolete or counterproductive by more

recent regulations and other changes.

The ‘‘kosher’’ guidance is not obsolete,

but, as mentioned earlier in this

preamble, because it does not have the

force and effect of law, it is not

necessary for it to be codified in Title

21.

FDA anticipates that the labeling

provisions of the proposed rule will not

change the availability of health and

safety information to consumers.

Although some labels may change as a

result of revising § 101.2(c) and

removing § 101.8, the main effect of the

proposal will be to make FDA’s

regulations less complicated and easier

to follow. Removing the kosher labeling

guidance in § 101.29 should not affect

information used for religious purposes

because the agency will still be

providing the same guidance but most

likely in the form of an FDA

Compliance Policy Guide. Any

information loss that might result would

likely arise from recognition by the

affected industry that the policy does

not carry the force and effect of law.

Nevertheless, such a loss would not

affect health or safety.

FDA estimates the economic effects of

labeling with a general model described

in the November 27, 1991 Federal

Register (56 FR 60856). The net benefits

of labeling rules are the difference

between the benefits to consumers of

the information on labels and the cost

to producers (and, ultimately, to

consumers) of providing that

information. The benefits from labeling

can be estimated to be the monetary

value of the health and safety

improvements that can be attributed to

better-informed consumers. The costs of

labeling regulations include

administrative, analytical, printing,

inventory, and product reformulation

costs. FDA believes that the proposed

labeling revisions will not reduce the

nutrition and safety information

available to consumers. The health and

safety benefits from the labeling rules in

part 101 therefore will not change.

The primary economic effect of the

proposal will be changes in costs. FDA

expects compliance costs of labeling to

decline, mainly because the proposed

rule will reduce administrative costs.

The administrative costs include

interpreting labeling regulations and

determining how they apply to

individual products. The more

complicated and confusing the

regulations, the more costly it is to

interpret them. For example, the

existence of type size exemptions in

§ 101.2(c) that differ from those in

§ 101.9 forces firms to study both

sections before determining how the

rules apply to their products. Even if

there were no differences in labeling

requirements between sections, firms

would have to interpret both sections to

assure themselves perhaps at

considerable cost, that no differences

exist.

By streamlining and consolidating

labeling rules, the labeling directions in

part 101 will be more user friendly,

which in turn will substantially reduce

compliance costs. Although FDA does

not possess enough data to quantify the

reduction in costs, the agency is

confident that the compliance cost of

labeling regulations will indeed fall as

a result of the proposal.

Eliminating voluntary cosmetic

experience reporting will generate net

benefits by reducing costs. FDA receives

an average of 125 submissions annually

from firms in the industry. The annual

cost to FDA of reviewing, evaluating,

summarizing, and storing the

experience reports is approximately

$12,000. The annual cost to

participating firms is approximately

$12,000. Eliminating the program would

therefore reduce annual agency and

industry costs by approximately

$24,000, without affecting public health.

FDA tentatively concludes that because

it will reduce the costs but not the

benefits of labeling and voluntary

reporting regulations, the proposed rule

will generate positive net benefits. FDA

finds no reason to expect the proposal

to impose burdens on small businesses,

whose compliance costs could fall.

V. Paperwork Reduction Act

FDA tentatively concludes that this

proposed rule contains no reporting,

recordkeeping, labeling or other third

party disclosure requirements. Thus

there is no ‘‘information collection’’

necessitating clearance by the Office of

Management and Budget. However, to

ensure the accuracy of this tentative

conclusion, FDA is asking for comment

on whether this proposed rule to revoke

certain regulations that it believes are

obsolete imposes any paperwork

burden.

IV. References

The following reference has been

placed on display in the Dockets

Management Brance (HFA–305, Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, and may be seen by interested

persons between 9 a.m. and 4 p.m.,

Monday through Friday.

1. Memorandum to James Taylor, Center

for Food Safety and Applied Nutrition, FDA,

from Joan Roenig, the National Institutes of

Standards and Technology, April 2, 1996.

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

21 CFR Part 730

Cosmetics, Reporting and

recordkeeping requirements.

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 101 and 730 be amended

as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.2 Information panel of

package form food is amended by

removing paragraphs (c)(1) through

(c)(3) and (c)(5)(iii); and by

redesignating paragraphs (c)(4) and

(c)(5) as paragraphs (c)(1) and (c)(2)

respectively.

§ 101.8 [Removed]

3. Section 101.8 Labeling of food with

number of servings is removed.

§ 101.29 [Removed]

4. Section 101.29 Labeling kosher and

kosher-style foods is removed.

PART 730—VOLUNTARY FILING OF

COSMETIC PRODUCT EXPERIENCES

Part 730 [Removed]

5. Part 730 is amended by removing

it in its entirety.

Dated: May 31, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–14887 Filed 6–10–96; 12:17 pm]

BILLING CODE 4160–01–F

21 CFR Parts 170, 171, 172, 173, 175,

176, 177, 178, 182, and 184

[Docket 96N–0177]

RIN 0910–AA58

Reinvention of Certain Food Additive

Regulations

AGENCY: Food and Drug Administration,

HHS.