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.
29712 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is seeking public

comment on possible ways to streamline

various food additive regulations as the

result of a page-by-page review of the

agency’s regulations. This regulatory

review is part of the administration’s

‘‘Reinventing Government’’ initiative

which seeks to streamline Government

and to ease the burden on regulated

industry and consumers.

DATES: Written comments by September

10, 1996.

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:

Regarding information concerning the

regulations: George H. Pauli, Center

for Food Safety and Applied

Nutrition (HFS–205), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–

3090.

Regarding general information on

FDA’s ‘‘reinventing initiative’’: Lisa

M. Helmanis, Regulations Policy

and Management Staff (HF–26),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–3480.

SUPPLEMENTARY INFORMATION: On March

4, 1995, President Clinton announced

plans for reforming the Federal

regulatory system as part of his

‘‘Reinventing Government’’ initiative. In

his March 4 directive, the President

ordered all Federal agencies to conduct

a page-by-page review of all of their

regulations and to ‘‘eliminate or revise

those that are outdated or otherwise in

need of reform.’’ This notice, which

seeks public comment on possible

‘‘reinventions’’, represents FDA’s

continuing effort to implement the

President’s plan. In previous issues of

the Federal Register, FDA proposed

revoking or revising other regulations,

and the agency expects to issue future

reinvention proposals in upcoming

issues.

In this document, FDA is seeking

comments on ways in which the

following food additive regulations

could be updated or revised in order to

make them more understandable. The

agency is also seeking any other

comments regarding parts 170–184 that

would assist FDA in fulfilling its

mission to protect the interest of

consumers. The following is a sectionby-section analysis of the regulations

that FDA is considering ‘‘reinventing.’’

I. Section-by-Section Analysis:

The agency’s section-by-section

analysis of the regulations listed in parts

170, 171, 172, 173, 175, 176, 177, 178,

182, and 184 (21 CFR parts 170, 171,

172, 173, 175, 176, 177, 178, 182, and

184) has identified candidate

regulations to be considered for change,

according to the similarity of the

regulatory action. The consolidation of

multiple listings under one heading

would be intended to make the

regulations easier to find and use by the

regulated industry. Eliminating required

analytical methodology would allow

more flexibility to use improved

methods. Rewriting some sections

would be intended to make the

regulations easier to understand.

The agency recognizes, however, that

apparently simple revisions can

inadvertently change the original intent

of a regulation. Therefore, care must be

taken when revising language to avoid

unintended changes. Also, while

revising the regulations would not entail

reevaluation of the scientific data

underlying an approval, it would

require agency resources that would

otherwise be spent on reviewing

petitions and promulgating regulations

authorizing uses of other food additives.

Additionally, the agency recognizes that

while simplification or shortening of the

regulations is a useful goal, some users

may prefer the detail currently in the

regulations. Therefore, before

committing further resources to develop

proposed changes, FDA is seeking

comment on the importance to the

regulated community of the various

actions under consideration so that the

agency can establish appropriate

priorities for its reform efforts. The

agency is interested in comments both

on whether the regulatory actions

should be pursued and, for those

changes that are needed, any

recommendations regarding the specific

changes to be made in the regulation

and the relative importance of these

revisions to interested persons. The

agency notes that, due to their technical

nature, some of the changes suggested

below could be accomplished in a final

rule; others may require both a proposed

rule and a final rule stage. In some

instances, the agency has suggested a

reinvention approach.

II. Consolidate and Delete Regulations

The following additives have been

selected as candidates possible for

single listing to minimize redundancy.

A. Food Additives

Glycine is listed in §§ 170.50 Glycine

(aminoacetic acid) in food for human

consumption, 172.320 Amino acids, and

172.812 Glycine. Should these

regulations be consolidated and, if so,

how?

B. Food Additives Permitted for Direct

Addition to Food for Human

Consumption

Sections 172.836 Polysorbate 60,

172.838 Polysorbate 65, 172.840

Polysorbate 80, and 172.842 Sorbitan

monostearate could be simplified by

deleting references to specific

combinations of entries of substances

listed within the regulation.

Sections 172.860 Fatty acids, 172.862

Oleic acid derived from tall oil fatty

acids, and 172.863 Salts of fatty acids

could be combined and simplified

under one section. Tests and methods

could also be simplified.

Section 172.866 Synthetic glycerin

produced by the hydrogenolysis of

carbohydrates could be combined with

§ 182.1320 to eliminate the apparent

redundancy.

C. Secondary Direct Food Additives

Permitted in Food for Human

Consumption

Sections 173.160 Candida

guilliermondii and 173.165 Candida

lipolytica could be combined and

simplified under one section.

D. Indirect Food Additives: Adhesives

and Components of Coatings

Sections 175.360 Vinylidene chloride

copolymer coatings for nylon film and

175.365 Vinylidene chloride copolymer

coatings for polycarbonate film could be

combined and simplified under one

section.

E. Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

Section 178.2010 Antioxidants and/or

stabilizers for polymers contains a

listing of antioxidants. Thus the

information in § 178.2550 4-

Hydroxymethyl-2,6-di-tert-butylphenol

could be added to the listing in

§ 178.2010.

Sections 178.3530 Isoparaffinic

petroleum hydrocarbons, synthetic and

178.3650 Odorless light petroleum

hydrocarbons are related substances

which could be combined under one

section.

Section 178.3600 Methyl glucosidecoconut oil ester could be deleted and

the substance listed as a processing aid

under 21 CFR 172.816 and 178.3520.

Sections 178.3610 Methylstyrenevinyltoluene resin, hydrogenated and

178.3930 Terpene resins could be

deleted and the substances listed as

components for use in olefin polymers

under § 177.1520.
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules 29713

Sections 178.3700 Petrolatum,

178.3710 Petroleum wax and 178.3720

Petroleum wax synthetic could be

simplified and combined under one

section.

Section 178.3860 Release agents

contains a listing of release agents.

Thus, the information in 21 CFR

178.3290 could be added to the listing

in § 178.3860.

F. Direct Food Substances Affirmed as

Generally Recognized as Safe

Sections 184.1271 L-Cysteine and

184.1272 L-Cysteine monohydrochloride

could be simplified under one section.

III. Proposed Deletion of Descriptions of

Analytical Methods

Lengthy descriptions of the analytical

methods may not be necessary. Each

reference to a method could state that

copies are available from the Center for

Food Safety and Applied Nutrition

(CFSAN) and could also specify that

equivalent methods are acceptable.

Thus, the descriptions of methods could

be deleted from the following

regulations:

A. Indirect Food Additives: Paper and

Paperboard Components

Section 176.170 Components of Paper

and Paperboard in Contact with

Aqueous and Fatty Foods.

B. Indirect Food Additives: Polymers

Section 177.1010 Acrylic and

modified acrylic plastics, semirigid and

rigid.

Section 177.1050 Acrylonitrile/styrene

copolymer modified with butadiene/

styrene elastomer.

Section 177.1315 Ethylene-1, 4-

cyclohexylene dimethylene

terephthalate copolymers.

Section 177.1330 Ionomeric resins.

Section 177.1500 Nylon resins.

Section 177.1520 Olefin polymers.

Section 177.1640 Polystyrene and

rubber-modified polystyrene.

Section 177.1950 Vinyl chlorideethylene copolymers.

Section 177.1970 Vinyl chloridelauryl vinyl ether copolymers.

Section 177.1980 Vinyl chloridepropylene copolymers.

C. Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

Section 178.1010 Sanitizing solutions.

Section 178.3620 Mineral oil.

Section 178.3770 Polyhydric alcohol

esters of oxidatively refined (Gersthofen

process) montan wax acids.

Section 178.3910 Surface lubricants

used in the manufacture of metallic

articles.

IV. Methodology

The methodology in the following

regulations could be simplified.

A. Food Additives Permitted for Direct

Addition to Food for Human

Consumption

The method and descriptions in

§ 172.133 Dimethyl dicarbonate could

be simplified.

The analytical specification in

§ 172.250 Petroleum naphtha could be

simplified.

In § 172.695 Xanthan gum, the tests as

specified in paragraph (d) could be

eliminated.

In § 172.820 Polyethylene glycol

(mean molecular weight 200–9,500), the

analytical method referenced for

determining ethylene glycol and

diethylene glycol could be simplified.

Section 172.859 Sucrose fatty acid

esters could be rewritten to clarify

preparation and methods.

In § 172.864 Synthetic fatty alcohols

paragraphs (a) and (c) could be revised,

and refer to analytical methods that are

available from CFSAN.

Section 172.886 Petroleum wax could

be simplified and refer to the analytical

procedures that are available from

CFSAN.

B. Secondary Direct Food Additives

Permitted in Food for Human

Consumption

Section 173.350 Combustion product

gas could be simplified and could state

that analytical procedures were

available from CFSAN.

V. General provisions applicable to

indirect additives

The statement on good manufacturing

practice and the general list of

acceptable components in articles that

contact food, as referenced in § 174.5,

are applicable to indirect food additives

in general. Therefore, similar statements

could be deleted in the following

individual regulations:

A. Indirect Food Additives: Adhesives

and Components of Coatings

Section 175.105 Adhesives.

Section 175.125 Pressure-sensitive

adhesives.

Section 175.230 Hot-melt strippable

food coatings.

Section 175.300 Resinous and

polymeric coatings.

Section 175.320 Resinous and

polymeric coatings for polyolefin films.

Section 175.350 Vinyl acetate/

crotonic acid copolymer.

Section 175.390 Zinc-silicon dioxide

matrix coatings.

B. Indirect Food Additives: Paper and

Paperboard Components

Section 176.130 Anti-offset

substances.

Section 176.170 Components of paper

and paperboard in contact with aqueous

and fatty foods.

Section 176.200 Defoaming agents

used in coatings.

Section 176.210 Defoaming agents

used in the manufacture of paper and

paperboard.

Section 176.300 Slimicides.

C. Indirect Food Additives: Polymers

Section 177.1010 Acrylic and

modified acrylic plastics, semirigid and

rigid.

Section 177.1030 Acrylonitrile/

butadiene/styrene/methyl methacrylate

copolymer.

Seciton 177.1040 Acrylonitrile/styrene

copolymer.

Section 177.1200 Cellophane.

Section 177.1210 Closures with

sealing gaskets for food containers.

Section 177.1240 1,4-Cyclohexylene

dimethylene terephthalate and 1,4-

cyclohexylene dimethylene isophthalate

copolymer.

Section 177.1310 Ethylene-acrylic

acid copolymers.

Section 177.1320 Ethylene-ethyl

acrylate copolymers.

Section 177.1350 Ethylene-vinyl

acetate copolymers.

Section 177.1400 Hydroxyethyl

cellulose film, water-insoluble.

Section 177.1520 Olefin polymers.

Section 177.1550 Perfluorocarbon

resins.

Section 177.1630 Polyethylene

phthalate polymers.

Section 177.1635 Poly(pmethylstyrene) and rubber-modified

poly(p-methylstyrene).

Section 177.1640 Polystyrene and

rubber-modified polystyrene.

Section 177.1650 Polysulfide

polymer-polyepoxy resins.

Section 177.1660 Poly(tetramethylene

terephthalate).

Section 177.1970 Vinyl chloridelauryl vinyl ether copolymers.

Section 177.1980 Vinyl chloridepropylene copolymers.

Section 177.1990 Vinylidene chloride/

methyl acrylate copolymers.

Section 177.2000 Vinylidene chloride/

methyl acrylate/methyl methacrylate

polymers.

Section 177.2400 Perfluorocarbon

cured elastomers.

Section 177.2460 Poly(2,6-dimethyl1,4-phenylene) oxide resins.

Section 177.2470 Polyoxymethylene

copolymer.

Section 177.2480 Polyoxymethylene

homopolymer.
29714 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Proposed Rules

Section 177.2550 Reverse osmosis

membranes.

Section 177.2600 Rubber articles

intended for repeated use.

Section 177.2800 Textiles and textile

fibers.

D. Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

Section 178.1005 Hydrogen peroxide

solution.

Section 178.3120 Animal glue.

Section 178.3570 Lubricants with

incidental food contact.

Section 178.3850 Reinforced wax.

VI. Regulations Reinvented for Clarity

The agency has noted that some of its

food additive regulations could be

rewritten to provide clearer guidance.

A. Food Additives Permitted for Direct

Addition to Food for Human

Consumption

The labeling directions in § 172.725

Gibberellic acid and its potassium salt

could be rewritten for clarity.

Section 172.177 Sodium nitrite used

in processing smoked chub could be

revised to achieve greater consistency

with 21 CFR 172.175.

B. Secondary Direct Food Additives

Permitted in Food for Human

Consumption

Section 173.357 Materials used as

fixing agents in the immobilization of

enzyme preparations could be revised to

give a clearer statement of components

that may be safely used.

Section 173.395 Trifluoromethane

sulfonic acid could be revised for

clarity.

C. Indirect Food Additives: General

Section 174.5 General provisions

applicable to indirect food additives

could be revised to achieve greater

clarity in paragraph (d)(l) and in the

restrictions placed on GRAS substances

authorized for use in this part.

D. Indirect Food Additives: Polymers

In § 177.1560 Polyarylsulfone resins,

the agency could add a definition for

‘‘normal baking temperature.’’

In § 177.2490 Polyphenylene sulfide

resins, the agency could add a definition

for ‘‘normal baking and frying

temperature.’’

E. Direct Food Substances Affirmed as

Generally Recognized as Safe

In §§ 184.1257 Clove and its

derivatives and 184.1259 Cocoa butter

substitute primarily from palm oil, the

description of the additives could be

simplified.

Section 184.1287 Enzyme-modified

fats does not contain general

requirements for enzyme preparations.

FDA could reinvent this section to be

consistent with the agency’s general

enzyme provisions.

In § 184.1333 Gum ghatti, the agency

could eliminate the specifications under

paragraph (b) and incorporate by

reference the specifications in the Food

Chemicals Codex.

In § 184.1408 Licorice and licorice

derivatives could be revised to achieve

greater clarity and the regulation could

state that methods of analysis are

available from CFSAN.

The description of the additives in

§ 184.1685 Rennet (animal-derived) and

chymosin preparation (fermentationderived) could be simplified.

VII. Request for Comments

Interested persons may, on or before,

September 10, 1996, submit to the

Dockets Management Branch (address

above) written comments regarding this

notice. 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: June 6, 1996.

William B. Schultz,

Deputy Commissioner for Policy

[FR Doc. 96–14889 Filed 6–7–96; 3:02 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 26

[PS–22–96]

RIN 1545–AU26

Generation-Skipping Transfer Tax

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: This document contains

proposed regulations relating to the

final generation-skipping transfer (GST)

tax regulations under chapter 13 of the

Internal Revenue Code (Code). This

document proposes a change to the final

regulations and is necessary to provide

guidance to taxpayers so that they may

comply with chapter 13 of the Code.

DATES: Written comments and requests

for a public hearing must be received by

September 10, 1996.

ADDRESSES: Send submissions to:

CC:DOM:CORP:R (PS–22–96), room

5228, Internal Revenue Service, POB

7604, Ben Franklin Station, Washington,

DC 20044. In the alternative,

submissions may be hand delivered

between the hours of 8 a.m. and 5 p.m.

to: CC:DOM:CORP:R (PS–22–96),

Courier’s Desk, Internal Revenue

Service, 1111 Constitution NW.,

Washington, DC 20224.

FOR FURTHER INFORMATION CONTACT:

Concerning the proposed regulation,

James F. Hogan, (202) 622–3090 (not a

toll-free number); concerning

submissions, Christina Vasquez, (202)

622–7180, (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

On December 24, 1992, the IRS

published a notice of proposed

rulemaking in the Federal Register (57

FR 61356) containing proposed

regulations under sections 2611, 2612,

2613, 2632, 2641, 2642, 2652, 2653,

2654, and 2663. On December 27, 1995,

the IRS published final regulations in

the Federal Register (60 FR 66898)

under sections 2611, 2612, 2613, 2632,

2641, 2642, 2652, 2653, 2654, and 2663.

This proposed regulation will delete

§ 26.2652–1(a)(4) and two related

examples.

Explanation of Provision

Section 2652(a)(1) provides generally,

that the term transferor means—(A) in

the case of any property subject to the

tax imposed by chapter 11, the

decedent, and (B) in the case of any

property subject to the tax imposed by

chapter 12, the donor. An individual is

treated as transferring any property with

respect to which the individual is the

transferor. Under § 26.2652–1(a)(2), a

transfer is subject to Federal gift tax if

a gift tax is imposed under section

2501(a) and is subject to Federal estate

tax if the value of the property is

includable in the decedent’s gross estate

determined under section 2031 or

section 2103. Under § 26.2652–1(a)(4),

the exercise of a power of appointment

that is not a general power of

appointment is also treated as a transfer

subject to Federal estate or gift tax by

the holder of the power if the power is

exercised in a manner that may

postpone or suspend the vesting,

absolute ownership, or power of

alienation of an interest in property for

a period, measured from the date of the

creation of the trust, extending beyond

any specified life in being at the date of

creation of the trust plus a period of 21

years plus, if necessary, a reasonable

period of gestation.

The purpose of the rule in § 26.2652–

1(a)(4) was to apply the GST tax when