Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations 43071

Point of Origin and the 315° bearing, 30 NM

position from the Point of Origin, thence

west along that line until the point of

beginning.

Area H. That airspace extending upward

from 6,000 feet MSL to and including 11,000

feet MSL beginning at the 293° bearing, 30

NM position from the Point of Origin, thence

southeast on the 293° bearing from the Point

of Origin until the 26–NM arc from the Point

of Origin, extending counterclockwise on the

26–NM arc from the Point of Origin until

SH–377, thence southwest on SH–377 until

the 30–NM arc from the Point of Origin, and

extending clockwise on the 30–NM arc from

the Point of Origin until the point of

beginning.

* * * * *

Issued in Washington, DC, on August 7,

1997.

John S. Walker,

Program Director for Air Traffic,

Airspace Management.

[FR Doc. 97–21410 Filed 8–11–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101 and 730

[Docket No. 96N–0174]

RIN 0910–AA69

Food and Cosmetic Labeling;

Revocation of Certain Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking

certain regulations that are obsolete.

These regulations have been identified

for revocation as the result of a page-bypage review of the agency’s regulations.

This review is in response to the

Administration’s ‘‘Reinventing

Government’’ initiative which seeks to

streamline Government to ease the

burden on regulated industry and

consumers.

DATES: This final rule will become

effective September 11, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Felicia B. Satchell, 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

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

directive, the President ordered all

Federal agencies to conduct a page-bypage 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outdated or otherwise in need of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 has

revoked a number of regulations

through notice and comment

rulemaking (e.g., 61 FR 58991,

November 20, 1996; 61 FR 27771, June

3, 1996) and issued proposals to revoke

additional regulations (e.g., 60 FR

53480, October 13, 1995; 60 FR 56513

and 56541, November 9, 1995; and 61

FR 29708, June 12, 1996). FDA has also

issued two advance notices of proposed

rulemaking to review standards of

identity and other existing regulations

to determine whether these regulations

should also be considered for revocation

or revision (e.g., 60 FR 67492, December

29, 1995; and 61 FR 29701, June 12,

1996). This document responds to

comments submitted to its proposal

entitled ‘‘Food and Cosmetic Labeling;

Revocation of Certain Regulations;

Opportunity for Public Comment,’’

which published in the Federal Register

of June 12, 1996 (61 FR 29708)

(hereinafter referred to as the June 12

revocation proposal).

FDA received 11 letters in response to

the June 12 revocation proposal. Each

letter contained one or more comments.

The letters were from industry trade

associations, academia, and consumer

organizations. Some comments

supported various provisions of the

proposal. Other comments objected to

the revocation of certain regulations. A

summary of the comments and the

agency’s responses to the comments

follow.

II. Food Labeling Regulations

A. Information Panel of Package Form

Food (§ 101.2)

This regulation, in paragraph (a),

defines the term ‘‘information panel’’ as

it applies to packaged food, and in

paragraph (b) provides that all

information required to appear on the

label of any package of food under

certain referenced regulations shall

appear either on the principal display

panel or on the information panel,

unless otherwise specified in the

regulations. The referenced regulations

are in part 101 (21 CFR part 101) and

part 105 (21 CFR part 105) and are as

follows: § 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, subpart

D of part 101, Specific Requirements for

Nutrient Content Claims, and Part 105—

Foods for Special Dietary Use. Section

101.2(c) 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.

However, § 101.2(c) also contains

exemptions to this type-size

requirement. FDA tentatively concluded

in the June 12 revocation proposal that

several of the exemptions are now

obsolete and should be revoked.

1. Exemptions for Small Packages

Specifically, FDA proposed to revoke

§ 101.2(c)(1), (c)(2), and (c)(3). The

exemptions set out in these paragraphs

are for small packages (defined

according to the surface area available to

bear labeling) and were established

before the enactment of the Nutrition

Labeling and Education Act of 1990 (the

1990 amendments) (Pub. L. 101–535).

As fully discussed in the June 12

revocation proposal, these exemptions

were designed to encourage firms to

voluntarily provide nutrition

information in accordance with § 101.9

and a full list of ingredients in

accordance with the regulations in part

101, which was voluntary on some

standardized foods before the enactment

of the 1990 amendments. However, as a

result of the 1990 amendments,

nutrition labeling and full ingredient

labeling is now required on most foods,

and the agency has made specific

provision for flexibility in the

presentation of this information where

space is limited.

For these reasons, the agency

tentatively concluded in the June 12

revocation proposal that the exemptions

in § 101.2(c)(1), (c)(2), and (c)(3) were

now obsolete and should be revoked.

Also in that document, FDA solicited

comments on the need to retain any of

these exemptions and stated that

comments supporting retention of any

of these exemptions should include

information on specific products for

which other type size exemptions are

inadequate.

1. Two comments addressed the

proposed revocation of § 101.2(c)(1),

(c)(2), and (c)(3). One of these comments

supported revocation of the exemptions.
43072 Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations

The other comment opposed revocation

of the exemptions and disagreed with

the rationale the agency presented in the

proposal for revoking them. The

comment contended that nutrition

labeling has been mandatory for many

food products since the early 1970’s,

often because of the addition of a

nutrient or use of a nutrition claim.

Further, the comment argued that the

impact of making the disclosure of

ingredients in standardized food

mandatory rather than voluntary has

been exceedingly small. The comment

also pointed out that the type size

exemptions issued under the 1990

amendments apply only to nutrition

labeling and not to the other mandatory

label information, such as ingredient

labeling. Consequently, the comment

argued, unless the exemptions in

§ 101.2(c)(1), (c)(2), and (c)(3) are

retained, mandatory information other

than nutrition labeling will be required

to appear in one-sixteenth inch type,

even where this cannot realistically be

accomplished. The comment urged the

agency to retain the type-size

exemptions in § 101.2(c)(1), (c)(2), and

(c)(3).

The agency has not been persuaded

by the latter comment that the

exemptions in § 101.2(c)(1), (c)(2), and

(c)(3) should be retained. The comment

did not provide any information, as

requested in the June 12 revocation

proposal, on specific products for which

the other type size exemptions provided

in FDA’s regulations (e.g., § 101.2(c)(5))

are inadequate. Nor did the comment

point to any specific products that could

not realistically bear the mandatory

information in one-sixteenth inch type.

Furthermore, the agency has not been

presented with information suggesting

that revocation of these exemptions

would cause an economic burden on the

industry because of the need to redesign

packaging or print new labels. In the

absence of such information, and for the

reasons cited in the proposal, the agency

concludes that the exemptions are now

obsolete. Accordingly, FDA is revoking

§ 101.2(c)(1), (c)(2), and (c)(3), as

proposed.

2. 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 certain

described conditions. Because

declaration of all ingredients in

standardized foods is now required,

reference to § 101.6 is no longer

appropriate. Consequently, FDA

proposed to revise § 101.2 by revoking

paragraph (c)(5)(iii).

2. The comments addressing this

issue supported revocation of

§ 101.2(c)(5)(iii). Accordingly, FDA is

revoking § 101.2(c)(5)(iii) and

redesignating paragraph (c)(5)(iv) as

paragraph (c)(5)(iii). The agency points

out that revocation of existing

§ 101.2(c)(5)(iii) would not eliminate

any ingredient listing requirements for

nonretail individual serving size

packages because this proposal does not

pertain to any provisions of § 101.4.

B. Labeling of Foods With Number of

Servings (§ 101.8)

The regulation in § 101.8(a) requires,

among other things, that any package of

a food that bears a representation as to

the number of servings contained in the

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, the latter

statement may be expressed in terms

that differ from the terms used in the

required statement of net quantity of

contents (for example, cups,

tablespoons) when such differing term

is common to cookery and describes a

constant quantity.

FDA tentatively concluded in the June

12 revocation proposal that this

regulation was obsolete in light of the

mandatory nutrition labeling provisions

in § 101.9. As discussed in the June 12

revocation proposal, § 101.9 defines a

‘‘serving’’ or ‘‘serving size’’ for the

purpose of nutrition labeling 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. Section 101.9 also gives

guidance for determining serving size

when the food is specially formulated or

processed for use by infants or by

toddlers. Thus, FDA proposed to revoke

§ 101.8.

3. All of the comments responding to

this issue agreed that FDA’s regulations

governing mandatory nutrition labeling

of foods which, in § 101.12, establish

serving sizes for foods based on the

reference amounts customarily

consumed per eating occasion, render

the provisions in § 101.8 obsolete.

Accordingly, as proposed, FDA is

revoking § 101.8. FDA advises, however,

that manufacturers are expected to

continue to adhere to its guidance that

statements concerning the number of

servings in a package that are presented

in locations other than as part of the

nutrition information be in the same

terms as those that are used to express

the serving size as part of the nutrition

information. To do otherwise may

render the labeling information

misleading to consumers.

To conform its regulations to the

revocation of § 101.8, FDA is removing

the reference to § 101.8 in § 101.2(b) and

(f).

C. Labeling of Kosher and Kosher-Style

Foods (§ 101.29)

Section 101.29 of FDA’s regulations is

a statement of informal agency policy

regarding the use of the terms ‘‘kosher’’

and ‘‘kosher-style’’ in the labeling of

food products. Because this section only

provides guidance and was not

established through rulemaking, it does

not have the force and effect of law.

Furthermore, because the use of the

terms ‘‘kosher’’ and ‘‘kosher-style’’ is, in

fact, governed under the general

misbranding provisions of the act, FDA

proposed in the June 12 revocation

proposal to remove this section. In

addition, the agency solicited comments

on whether it should prepare a

Compliance Policy Guide (CPG) (an

FDA informal guidance document used

for efficient enforcement of the act) that

reflects the policy that has been codified

in § 101.29.

4. Six comments addressed the

proposed revocation of § 101.29. Two of

these comments supported the removal

of § 101.29. Both comments noted that

FDA has not traditionally sought to

regulate kosher food labeling. These

comments opined that religious

authorities are well-equipped to police

the use of ‘‘kosher’’ and other religious

terminology in food labeling.

Furthermore, these two comments

questioned the constitutionality of any

FDA action in this area. Finally, the

comments urged that the agency not

republish § 101.29 or any other policy

regarding kosher labeling as a CPG.

Several other comments supported

maintaining a written policy on the use

of these terms. These comments

contended that it is appropriate for the

agency to concern itself with the proper

use of the terms ‘‘kosher’’ and ‘‘kosherstyle’’ on food labels because without

such guidance, the potential for misuse

of these terms would undoubtedly

increase, resulting in significant

consumer deception. Two of these

comments supported retaining this

policy in the form of a CPG. Further,

one comment suggested that even as a

CPG, § 101.29 did not go far enough in

providing guidance to the industry or in

providing adequate information to the

consumer. Accordingly, the comment

requested that as a part of a CPG, FDA

create and maintain a certificate for
Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations 43073

domestic and imported products that

contains information regarding the

manufacturer, certifying Rabbi and

organization, effective dates of the

certificate, and symbols used in product

labeling. The comment opined that such

a certificate, publicly available upon

request, could greatly assist consumers

in deciding whether the food in

question meets their personal needs,

because they would have access to

information identifying not only the

manufacturer but also the certifying

organization. The comment further

suggested that having a certificate on

file could reduce difficulties currently

experienced by persons wishing to

import kosher products into the United

States.

Another comment argued that the

proper course for FDA is not to remove

from the Code of Federal Regulations

(CFR) its only pronouncement on kosher

labeling but to assume a higher profile

and initiate rulemaking that explicitly

states its enforcement authority with

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

‘‘kosher-style,’’ thereby providing the

kosher food consumer with effective

and meaningful protection. The

comment contended that such action

was needed because misbranding of

kosher foods is not uncommon. The

comment further argued that such a

regulation should prohibit the use of

‘‘kosher-style’’ on all food items,

whether or not they conform to religious

dietary standards. The comment stated,

however, that if FDA would not prohibit

the use of the term ‘‘kosher-style,’’ then

FDA should establish a regulation

consistent with the U.S. Department of

Agriculture’s (USDA’s) policy and allow

use of the term ‘‘kosher-style’’ only

when the product is produced under

‘‘rabbinical supervision.’’ A second

alternative suggested by the comment to

prohibiting the term is to permit the

term but require that the product label

also bear a disclaimer if the product

does not conform to religious dietary

standards. The comment argued that

such a regulation is necessary to

adequately protect the kosher consumer

and to reduce the potential for

misbranding, fraud, error, and confusion

as the kosher food industry grows.

FDA has evaluated the comments and

finds that, while there is support for

maintaining specific guidance on use of

the terms ‘‘kosher’’ and ‘‘kosher-style,’’

FDA is not persuaded by the comments

that such guidance should be retained

in the CFR. The comments presented no

compelling reason why this statement of

policy should not be converted to a

CPG, the form in which most agency

policy statements are maintained. The

goal of the President’s Initiative is to

develop a more efficient regulatory

regime, and that goal is advanced by

minimizing the number of policy

statements in the CFR.

Nor have the comments persuaded the

agency that a rulemaking on the use of

the terms ‘‘kosher’’ and ‘‘kosher-style’’

is warranted. The use of the terms

‘‘kosher,’’ ‘‘kosher-style,’’ and any other

term suggesting that a food has been

prepared in accordance with certain

religious practices is subject to the

general misbranding provisions of

section 403(a) of the act (21 U.S.C.

343(a)). Aside from providing this basic

level of protection, FDA has no role in

determining what food is kosher.

In light of the issues raised in the

comments, however, the agency is

concerned that if it did not maintain

some statement on kosher labeling,

there would be confusion and

misinformation in the kosher food

industry, which could result in a

proliferation of misbranded products,

and thus consumers could be adversely

affected. Therefore, FDA will maintain a

statement of its policy on labeling foods

that conform to religious dietary laws

but do so through the use of a CPG.

Accordingly, FDA is revoking

§ 101.29 as proposed. It intends to

prepare a CPG in accordance with the

Good Guidance Principles published in

the Federal Register of February 27,

1997 (62 FR 8961). In developing the

CPG, the agency will fully consider the

alternatives suggested in the comments

and will provide an opportunity for

comment. The agency believes that this

approach will provide the kosher food

industry with the guidance needed to

minimize false or misleading labels.

III. Cosmetic Regulations

Parts 710 and 720 (21 CFR parts 710

and 720) of FDA’s regulations provide

for the Voluntary Cosmetic Reporting

Program (VCRP) under which cosmetic

firms voluntarily register cosmetic

product establishments (part 710) and

cosmetic product ingredient and raw

material composition statements (part

720). Part 730 (21 CFR part 730)

provides for the voluntary filing of

cosmetic product experience reports

(VCPE) by the cosmetics industry.

During the 23 years the VCPE 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. As fully

discussed in the June 12 revocation

proposal, this 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.

Thus, FDA proposed to revoke part 730.

However, the agency solicited

comments on whether this section

should be eliminated in its entirety,

reduced in scope, or some other

alternative.

5. Three comments addressed the

proposed revocation of part 730. Two

comments supported the proposal to

revoke this part in its entirety. One

comment suggested, however, that FDA

replace the voluntary program by: (1)

Enhancing its MEDWATCH program to

include cosmetic adverse reactions; (2)

referring consumers with adverse

reactions directly to the cosmetic

company; and (3) maintaining a process

for voluntary industry analysis of

product experience and reporting of any

serious reactions to FDA.

The third comment asserted that,

although the VCPE program had failed,

part 730 should not be revoked but

completely revised to require cosmetic

companies to file with FDA all

consumer adverse reaction reports. The

comment suggested that a mandatory

reporting system would provide data

that would be useful in increasing the

safety of cosmetics and protecting the

public health. Further, the comment

recommended that FDA mandate the

registration of cosmetic manufacturing

establishments and product

formulations, continue with the

establishment of a toll-free telephone

hotline for consumers to report adverse

reactions, and enhance its MEDWATCH

program to include cosmetic products.

The agency rejects the assertion in the

latter comment that the VCPE has failed.

During the years that this program has

been in effect, it has provided FDA with

useful information and data. Using these

data, FDA has been able to establish

baseline adverse reaction rates. Thus,

the function for which the program was

intended has been achieved, and from

the point of view of establishing a

baseline level, any further data would

be of little value. The comment has not

persuaded the agency to change this

view. Accordingly, FDA is revoking part

730 in its entirety.

However, the agency recognizes that

there may be some merit to the other

arguments made in this and another

comment. As suggested by one
43074 Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations

comment, the agency will consider

enhancing its MEDWATCH program to

include cosmetic products and will

maintain the availability of adverse

reaction reporting forms, which may be

submitted to the agency. Further, FDA

intends to perform a thorough

evaluation of the cosmetic adverse

reaction information that it has received

over the years and to prepare an indepth

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.

However, the comment did not provide

a factual basis for making an adverse

reaction reporting system or a

registration system mandatory for

cosmetics.

IV. 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.

V. Benefit-Cost Analysis

FDA has examined the economic

implications of this final rule as

required by Executive Order 12866.

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

and safety, and other advantages;

distributive impacts; and equity).

Executive Order 12866 classifies a rule

as significant if it meets any one of a

number of specified conditions,

including: Having an annual effect on

the economy of $100 million; adversely

affecting some sector of the economy in

a material way; adversely affecting jobs

or competition; or raising novel legal or

policy issues.

In the proposal, FDA based the

economic impact analysis on the effects

of revoking the following: Certain typesize exemptions, labeling with number

of servings other than as specified in the

1990 amendments, the statement of

informal agency policy regarding the

terms ‘‘kosher’’ and ‘‘kosher-style,’’ and

the Voluntary Cosmetic Experience

Program. None of the comments on the

proposal directly addressed the

economic impact analysis. The one

comment that opposed revocation of the

current minimum type-size exemptions

did not mention costs directly, but

implied (‘‘can not realistically be

accomplished’’) that the revocation

could impose additional labeling costs

for some products. The net effect of

revoking the type-size and serving-size

exemptions will be to reduce

compliance costs for businesses. In the

absence of evidence that the revocation

would impose significant labeling costs,

the agency has not altered its conclusion

that the net economic benefits of this

final rule are positive.

FDA finds that this final rule does not

constitute a significant rule as defined

by Executive Order 12866. Furthermore,

it has been determined that this final

rule is not a major rule for purposes of

Congressional Review (Pub. L. 104–

121).

VI. Small Business Analysis

FDA has examined the economic

implications of this final rule as

required by the Regulatory Flexibility

Act (5 U.S.C. 601–612). If a rule has a

significant economic impact on a

substantial number of small entities, the

Regulatory Flexibility Act requires

agencies to analyze regulatory options

that would lessen the economic effect of

the rule on small entities.

No comments dealt with the

proposal’s statement that the rule would

not have a significant impact on a

substantial number of small businesses.

One comment that came from an

organization representing

entrepreneurial cosmetic firms

supported terminating the Voluntary

Cosmetic Experience Program. The

comment agreed with the agency’s

conclusion that the program’s benefits

had already been realized. Terminating

the program will impose no costs on

participating small firms.

Although it is possible that revoking

the type-size exemptions could impose

costs on some small entities, the

reduced costs of interpreting labeling

regulations and determining how they

apply to individual products will more

likely, if anything, reduce the costs of

labeling for small entities. The removal

of the kosher and kosher-style labeling

guidance, because it is a guidance, will

impose no additional costs on small

entities.

FDA finds that under the Regulatory

Flexibility Act, this final rule will not

have a significant economic impact on

a substantial number of small entities.

Accordingly, under the Regulatory

Flexibility Act (5 U.S.C. 605(b)), the

Commissioner of Food and Drugs

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

VII. The Paperwork Reduction Act of

1995

In the June 12 revocation proposal,

FDA solicited comment on whether the

proposed rule to revoke certain

regulations that the agency believes are

obsolete imposes any paperwork

burden. FDA did not receive any

comments on this issue. Thus, FDA

concludes that this final 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.

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, 21 CFR parts 101

and 730 are 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).

§ 101.2 [Amended]

2. Section 101.2 Information panel of

package form food is amended in

paragraphs (b) and (f) by removing the

reference to § 101.8; by removing

paragraphs (c)(1) through (c)(3) and

paragraph (c)(5)(iii); by redesignating

paragraph (c)(5)(iv) as paragraph

(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 of kosher

and kosher-style foods is removed.

PART 730—VOLUNTARY FILING OF

COSMETIC PRODUCT EXPERIENCES

PART 730—[REMOVED]

5. Part 730 is removed.
Federal Register / Vol. 62, No. 155 / Tuesday, August 12, 1997 / Rules and Regulations 43075

Dated: July 10, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–21156 Filed 8-11-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 92F–0261]

Indirect Food Additives: Adhesives

and Components of Coatings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of 3-pentadecenyl phenol

mixture (obtained from cashew nutshell

liquid) reacted with formaldehyde and

ethylenediamine in a ratio of 1:2:2 as an

epoxy curing agent in resins and

coatings intended for contact with food.

This action is in response to a petition

filed by Cardolite Corp.

DATES: The regulation is effective

August 12, 1997. Submit written

objections and requests for a hearing by

september 11, 1997.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 21, 1992 (57 FR 32226), FDA

announced that a food additive petition

(FAP 2B4326) had been filed by

Cardolite Corp., c/o 1414 Fenwick Lane,

Silver Spring, MD 20910 (now c/o

Regulatory Assistance Corp., 17

Clearview Circle, Hopewell Junction, NJ

12533). The petition proposed to amend

the food additive regulations in

§ 175.300 Resinous and polymeric

coatings (21 CFR 175.300) to provide for

the safe use of 3-pentadecenyl phenol

mixture (obtained from cashew nutshell

liquid) reacted with formaldehyde and

ethylenediamine in a ratio of 1:2:2 (CAS

Reg. No. 68413–28–5) as an epoxy

curing agent in resins and coatings

intended for contact with food.

FDA’s review of the subject petition

indicates that the additive may contain

trace amounts of formaldehyde and

ethylenediamine as impurities. The

potential carcinogenicity of

formaldehyde and ethylenediamine was

reviewed by the Cancer Assessment

Committee (the Committee) of FDA’s

Center for Food Safety and Applied

Nutrition.

The Committee noted that for many

years formaldehyde has been known to

be a carcinogen by the inhalation route,

but it concluded that these inhalation

studies are not appropriate for assessing

the potential carcinogenicity of

formaldehyde in food. The Committee’s

conclusion was based on the fact that

the route of administration (inhalation)

is not relevant to the safety of

formaldehyde residues in food and the

fact that tumors were observed only

locally at the portal of entry (nasal

turbinates). In addition, the agency has

received literature reports of two

drinking water studies on

formaldehyde: (1) A preliminary report

of a carcinogenicity study purported to

be positive by Soffritti et al. (1989),

conducted in Bologna, Italy (Ref. 1) and

(2) a negative study by Til, et al. (1989),

conducted in The Netherlands (Ref. 2).

The Committee reviewed both studies

and concluded, concerning the Soffritti

study, ‘‘ * * * that the data reported

were unreliable and could not be used

in the assessment of the oral

carcinogenicity of formaldehyde’’ (Ref.

3). This conclusion is based on a lack

of critical details in the study,

questionable histopathologic

conclusions, and the use of unusual

nomenclature to describe the tumors.

Based on the Committee’s evaluation,

the agency has determined that there is

no basis to conclude that formaldehyde

is a carcinogen when ingested.

The Committee also evaluated the

results of a 2-year study submitted by

the petitioner on ethylenediamine

dihydrochloride (EDA•2HCl) in Fisher

344 rats (Ref. 4). The committee

concluded that data from this study do

not demonstrate carcinogenic potential

for (EDA•2HCl) in Fisher 344 rats (Ref.

5). Based on the Committee’s

evaluation, the agency has determined

that based upon the available data and

information, there is no basis to

conclude that ethylenediamine is a

carcinogen.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive is safe, that the additive

will have its intended technical effect,

and therefore, that the regulations in

§ 175.300 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before September 11, 1997,

file with the Dockets Management

Branch (address above) written

objections thereto. Each objection shall

be separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons