Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations 27771

REVISIONS TO MINIMUM ENROUTE IFR ALTITUDES AND CHANGEOVER POINTS—Continued

[Amendment 396 Effective Date, June 20, 1996]

From To MEA

Atlantic Routes

AR 7

Is Amended To Delete

Bimini/DCMSND, BF NDB ............................................................ Vally, FL FIX ................................................................................. 2000

A301

Is Amended To Read in Part

Bimini, BF VORTAC ..................................................................... Bkene, BF FIX .............................................................................. 4000

Bkene, BF FIX .............................................................................. Fowee, FL FIX .............................................................................. 4000

Fowee, FL FIX .............................................................................. Zolla, OA FIX ................................................................................ 8000

Zolla, OA FIX ................................................................................ Ursus, OA FIX .............................................................................. 10000

A555

Is Amended by Adding

Bimini, BF VORTAC *11000–MRA ............................................... *Rajay, BF FIX ............................................................................. 4000

Rajay, BF FIX ............................................................................... Nassau, BF VOR/DME ................................................................. 4000

Nassau, BF VOR/DME ................................................................. Victs, BF FIX ................................................................................ 3000

Victs, BF FIX ................................................................................. Gerot, OA FIX .............................................................................. 3000

Is Amended To Read in Part

Gerot, OA FIX ............................................................................... Stella Maris, BF NDB ................................................................... 3000

A636

Is Amended by Adding

Great Inagua, BF NDB ................................................................. Albee, BF FIX ............................................................................... 4000

§ 95.6003 VOR Federal Airway 3 Is Amended To Read in Part

Palm Beach, FL VORTAC *2000–MOCA ..................................... Vero Beach, FL VORTAC ............................................................ *3000

§ 95.6055 VOR Federal Airway 55 Is Amended To Read in Part

Siren, WI VOR/DME ..................................................................... Brainerd, MN VORTAC ................................................................ 3000

MAA–1400

§ 95.6082 VOR Federal Airway 82 Is Amended To Read in Part

Brainerd, MN VORTAC ................................................................. Gopher, MN VORTAC .................................................................. 3000

§ 95.6133 VOR Federal Airway 133 Is Amended To Read in Part

Marquette, MI VOR/DME *3000–MOCA ...................................... Bride, MI FIX ................................................................................ *3600

§ 95.6161 VOR Federal Airway 161 Is Amended To Read in Part

Gopher, MN VORTAC .................................................................. Brainerd, MN VORTAC ................................................................ 3000

§ 95.6210 VOR Federal Airway 210 Is Amended To Read in Part

Mingg, OK FIX *4200–MRA **2500–MOCA ................................. *Loboe, OK FIX ............................................................................ **4000

§ 95.6218 VOR Federal Airway 218 Is Amended To Read in Part

Grand Rapids, MN VOR/DME *3000–MOCA ............................... Gopher, MN VORTAC .................................................................. *5500

§ 95.6266 VOR Federal Airway 266 Is Amended To Read in Part

Mazon, VA FIX *1500–MOCA ...................................................... Sunns, NC FIX ............................................................................. *2000

Sunns, NC FIX .............................................................................. Elizabeth City, NC VOR/DME ...................................................... *5000

§ 95.6492 VOR Federal Airway 492 Is Amended To Read in Part

La Belle, FL VORTAC *1500–MOCA ........................................... Palm Beach, FL VORTAC ........................................................... *2000

[FR Doc. 96–13776 Filed 5–31–96; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 100, 101, 103, 104, 105,

109, 137, 161, 163, 172, 182, 186, 197,

and 700

[Docket No. 95N–310F]

Revocation of Certain Regulations

Affecting Food

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking

certain regulations that it has

determined are obsolete, no longer in

use, or in conflict with applicable law.

These regulations have been identified

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

that cover food and cosmetics. This

regulatory review is in response to the

administration’s ‘‘Reinventing

Government’’ initiative that seeks to

streamline Government to ease the

burden on regulated industry and

consumers. This document also is

amending the food additive listing for

folic acid (folicin) to reflect the fact that

grits are now a nonstandardized food.

DATES: Effective July 3, 1996, except for

the amendment to § 172.345 which is
27772 Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations

effective June 3, 1996. Written

objections and requests for a hearing for

part 105 and § 172.345(d) by July 3,

1996. Any labels or labeling that require

revision as a result of these revocations

shall comply no later than January 1,

1998.

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:

Michelle A. Smith, 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 his

‘‘Reinventing Government’’ initiative.

Part of this reform effort is aimed at

deleting prescriptive regulations which

can sometimes undermine their stated

purpose. In his March 4, 1995, directive,

entitled ‘‘Regulatory Reinvention

Initiative,’’ the President ordered all

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

and 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 (60 FR 53480, October 13,

1995 (hereinafter referred to as the

October 1995 proposal); 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)

(hereinafter referred to as the December

1995 ANPRM). This document is a final

rule that responds to that portion of the

agency’s October 1995 proposal that

described the agency’s intent to revoke

certain regulations that pertain to food

and cosmetics.

II. The Proposal

In the October 1995 proposal, FDA

proposed to eliminate a number of

regulations on various grounds,

including that they were either obsolete,

redundant, of no public interest, or

statements of policy that did not need

to be in the Code of Federal Regulations

(CFR). The agency stated that any

revocation would become effective 30

days after date of publication of a final

rule in the Federal Register. Interested

persons were given until January 11,

1996, to comment on the proposal.

III. Summary of and Response to

Comments to Proposal

FDA received 12 letters from industry

and affected trade associations

containing one or more comments on

the October 1995 proposal. The majority

of comments supported the

administration’s reinventing

Government initiative. Several

comments agreed that certain

regulations are obsolete, unnecessary, or

duplicative and should be revoked.

Some comments agreed with the

proposal in general terms but did not

specifically refer to individual sections

of the CFR, or did not elaborate on why

certain sections should be revoked

beyond the reasons given by the agency

in its October 1995 proposal. A few

comments contained concerns about, or

requested clarification on, the agency’s

proposal to revoke certain sections. A

summary of the comments and the

agency’s responses follows:

A. General Agreement with Proposal to

Revoke

All comments supported, either

generally or specifically, revocation of

the following sections:

1. Section 100.120 Artificially reddyed yellow varieties of sweet potatoes

(21 CFR 100.120).

2. Section 100.130 Combinations of

nutritive and nonnutritive sweeteners in

‘‘diet beverages’’ (21 CFR 100.130).

3. Section 100.135 Disposition of

incubator reject eggs (21 CFR 100.135).

4. Section 100.140 Label declaration

of salt in frozen vegetables (21 CFR

100.140).

5. Section 100.145 Notice to packers

of comminuted tomato products (21

CFR 100.145).

6. Section 100.150 Notice to packers

and shippers of shelled peanuts (21 CFR

100.150).

7. Section 101.33 Label declaration of

D-erythroascorbic acid when it is an

ingredient of a fabricated food (21 CFR

101.33).

8. Section 101.103 Petitions

requesting exemptions from or special

requirements for label declaration of

ingredients (21 CFR 101.103).

9. Part 103—Quality Standards for

Foods With No Identity Standards (21

CFR part 103).

10. Section 104.19 Petitions (21 CFR

104.19).

11. Section 105.69 Foods used to

regulate sodium intake.

12. Section 109.5 Petitions (21 CFR

109.5).

13. Section 161.131 Extra large

oysters (21 CFR 161.131).

14. Section 161.132 Large oysters (21

CFR 161.132).

15. Section 161.133 Medium oysters

(21 CFR 161.133).

16. Section 161.134 Small oysters (21

CFR 161.134).

17. Section 161.135 Very small oysters

(21 CFR 161.135).

18. Section 161.137 Large Pacific

oysters (21 CFR 161.137).

19. Section 161.138 Medium Pacific

oysters (21 CFR 161.138).

20. Section 161.139 Small Pacific

oysters (21 CFR 161.139).

21. Section 161.140 Extra small

Pacific oysters (21 CFR 161.140).

22. Subpart F—Dietary Supplements

of part 182 (21 CFR part 182).

23. Section 186.1025 Caprylic acid (21

CFR 186.1025).

24. Part 197—Seafood Inspection

Program (21 CFR part 197).

25. Section 700.10 Shampoo

preparations containing eggs as one of

the ingredients (21 CFR 700.10).

Thus, in view of the support

expressed by comments on the October

1995 proposal, and given the

Government’s resolve to eliminate

obsolete, redundant, or conflicting

regulations, FDA is revoking these

sections. The agency concludes that this

action will benefit consumers and

industry by eliminating regulations that

are unnecessary and that, therefore,

have the potential to be confusing and,

as a result, burdensome.

FDA advises that where the agency

has determined a section is obsolete,

unnecessary, or duplicative (e.g.,

§§ 100.130 and 100.140), once the

section is revoked, generally, no further

action is required. Where the section

being revoked is a statement of policy

(e.g., § 100.135), the agency may decide

that it is in the public interest to

develop a Compliance Policy Guide

(CPG), or other appropriate means, to

make the public aware of this policy.

FDA will publish a notice in the Federal

Register of the availability of any policy

statements that it develops.

B. Sections About Which Comments

Expressed Concern or Requested

Clarification About the Impact of

Revocation

One or more comments objected to,

expressed concern about, or requested

clarification on, FDA’s proposal to

revoke the following sections:

Section 100.160 Tolerances for moldy

and insect-infested cocoa beans (21 CFR

100.160)

1. FDA received one letter from a

trade association commenting that the

tolerances set out in § 100.160 are useful

because they have been universally

adopted. This comment expressed

concern that any change in the
Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations 27773

tolerances for defective cocoa beans

could have a serious impact on the

market value of warehoused cocoa

beans and on the value of cocoa futures

contracts. The comment maintained

that, because of the value of this market,

any change in the tolerances should be

subject to public scrutiny at open

hearings. Finally, the comment stressed

the need for the tolerances to be widely

known.

In response to this comment, FDA

advises that it did not propose to change

the action levels for defective cocoa

beans set out in § 100.160. Rather, the

agency tentatively concluded that,

because this section is a statement of

policy, it need not appear in the CFR.

Further, the agency cannot envision any

situation where it would be compelled

to change these levels without seeking

input from interested parties. FDA

concludes, therefore, that, because it is

not altering the defect action levels in

the policy statement, the comment’s

concern in this regard is without merit.

In addition, as mentioned in section

III.A. of this document, where the

agency concludes that the policy

statements covered by this review need

not appear in the CFR, but where it

remains necessary to communicate the

policy to interested parties, FDA intends

to set out the policy in a CPG or by other

appropriate means. FDA advises that the

CPG system for assembling and

maintaining statements of policy has

been in place since 1969. The agency

notes that CPG’s have a history of

including statements that contain

regulatory action guidance information

of the type set out in § 100.160 (e.g.,

CPG number 7101.06 ‘‘Green Coffee

Beans—Adulteration with Insects;

Mold’’). In fact, CPG 7105.12 ‘‘Cacao

Beans—Adulteration by Mold, Insect

Infestation, and Mammalian Excreta’’

sets out, among other things, the same

defect action levels for moldy or insect

damaged cacao beans as § 100.160.

On June 20, 1995 (60 FR 32159), the

agency published a notice of availability

for a new, reorganized, and bound

edition of the FDA Compliance Policy

Guides (CPG manual). The purpose of

the CPG manual is to provide to FDA

personnel and to other interested parties

a more convenient and user friendly

system for statements of FDA

compliance policy. In addition, the

agency provides notice in the Federal

Register of the availability of new or

revised CPG’s. Such notices are also

widely reported in trade association

newsletters, other newsletters, and

professional journals.

Accordingly, FDA concludes that

removing § 100.160 from the CFR will

change the location of the information

that it contained, but not the effective

communication of that information. The

agency further concludes that reducing

the number of nonregulatory sections

that appear in the CFR, which, by

definition, is a compendium of Federal

regulations, is consistent with the

administration’s goal of streamlining the

regulatory process. Therefore, FDA is

revoking § 100.160, as proposed.

Section 105.67 Label statement relating

to food for use in the diet of diabetics

In the October 1995 proposal, FDA

noted that this section is not in

accordance with current dietary advice

for persons with diabetes. The agency

tentatively concluded that the

regulations that it had adopted in

response to the Nutrition Labeling and

Education Act of 1990 (the 1990

amendments) (Pub. L. 101–535),

including the new ingredient labeling

regulations, should ensure that food

labels contain sufficient information to

assist diabetics in making educated food

choices.

2. FDA received five letters, from

trade associations, a manufacturer,

health professionals, and a health

professional association, commenting

on its proposal to delete this section.

Some of the comments agreed with the

agency’s tentative conclusion that

§ 105.67 is not consistent with current

dietary advice for persons with diabetes

and should, therefore, be revoked. One

comment noted that healthy eating is

the cornerstone of diabetes self

management, and that it is essential that

persons with diabetes have access to

accurate nutrition information regarding

the foods they eat. Other comments

supported the agency’s conclusion that

nutrition labeling and ingredient

declaration requirements ensure that

consumers have access to the

information necessary to plan a healthy

diet. These comments also maintained

that, because current dietary advice is

based on the premise that no specific

food is either good or bad for persons

with diabetes, label statements

identifying specific foods as being

useful to diabetics would be misleading.

One comment argued that § 105.67

continues the myth that persons with

diabetes should have a restricted diet

insofar as the variety of foods they eat.

The comment noted that this view is

contrary to current evidence and

practice. The comment stated that, for

example, there is no scientific basis for

unnecessarily restricting sucrose and

other sugars in the diet of persons with

diabetes. However, according to the

comment, the predominant use of

§ 105.67 is to make certain foods more

appealing to diabetics relative to sucrose

and sucrose replacements.

Conversely, one comment maintained

that label statements identifying foods

for diabetic use may be useful. The

comment argued that there is no clear

consensus that some foods and

beverages are not better for people with

diabetes, and that, therefore, labeling to

identify foods for diabetic use should be

allowed. The comment maintained that

the conclusion of a health professional

association that polyols (i.e., sugar

alcohols) have no significant advantage

over other nutritive sweeteners is in

error because, according to the

comment, that association’s conclusion

is based on the assumption that polyols

have the same energy value as other

nutritive sweeteners (i.e., 4 calories per

gram). The comment cited the article

entitled ‘‘Helpful Hints: Using the 1995

Exchange Lists for Meal Planning’’ in

Diabetes Spectrum that acknowledges

the reduced caloric values for polyols

and instructs people with diabetes on

how to factor this reduction into meal

planning. The comment also maintained

that products sweetened with polyols

and other low calorie sweeteners cause

a lower glycemic response, and,

consequently, that identifying these

products as, ‘‘useful to diabetics on the

advice of a physician,’’ would assist

persons with diabetes in formulating

meal plans. The comment concluded,

therefore, that such labeling would not

be false or misleading.

The fact that there is not universal

agreement that a statement that a

specific food would be particularly

useful in the diets of diabetics is false

does not mean that it is appropriate for

such a statement to appear in food

labeling. The weight of evidence and

current recommendations by recognized

authorities is that no specific food is, or

is not, more useful than others in the

diets of diabetics. Rather, current

recommendations promote a varied diet

(Ref. 1).

In addition, § 101.9(c)(1)(i)(D) on

nutrition labeling allows manufacturers

to use specific FDA approved food

factors to calculate the energy value of

ingredients such as polyols. Therefore,

the calorie declaration within nutrition

labeling reflects the reduced energy

value of polyols. Accordingly, nutrition

labeling and ingredient declarations

provide persons with diabetes with the

information that they need to determine

how a food fits into their meal plan.

Therefore, consistent with current

dietary advice, FDA concludes that the

provisions for diabetic labeling in

§ 105.67 are outdated and misleading.

Consequently, the agency is deleting

section § 105.67 as proposed.
27774 Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations

Because § 105.67 was adopted under

authority of section 403(j) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

343(j)) (the act), this revocation must be

made in accordance with the formal

rulemaking procedures in section 701(e)

of the act (21 U.S.C. 371(e)). Under these

procedures, there is an opportunity to

object to a final rule and to request a

public hearing based upon such

objection.

3. One comment, while supporting

revocation of § 105.67, expressed

concern that deleting § 105.67(c) (which

contains requirements for how the term

‘‘diabetic’’ is to appear in labeling) may

be seen by some manufacturers as

license to label products as ‘‘diabetic’’

without restriction. The comment urged

FDA to make clear in any final rule

revoking § 105.67 that label statements

such as ‘‘diabetic’’ or ‘‘for diabetics’’ are

no longer allowed.

FDA points out that § 105.67(c)

pertained only to the prominence of

terms such as ‘‘diabetic.’’ Based on

FDA’s conclusion that § 105.67 is

contrary to current dietary

recommendations, and that use of label

statements identifying specific foods as

particularly useful for diabetics is

misleading, the prominence of such

terms is a moot issue. FDA has no

evidence that removal of the specific

restrictions in § 105.67(c), or in any

other paragraph of that section, would

be misinterpreted by manufacturers to

mean that the terms covered therein

could be used without limitation. The

nutrient content and health claim

provisions in section 403(r) of the act

along with section 403(a) should

provide an adequate regulatory

framework to prevent any use of the

term ‘‘diabetic’’ that is not scientifically

valid or that is misleading.

C. Standards of Identity Issues

FDA proposed to revoke several

standards of identity because it

tentatively concluded that they were

obsolete, unnecessary, or no longer in

the public interest. After it published

the October 1995 proposal, but before

the close of the comment period in this

rulemaking, FDA published the

December 1995 ANPRM (60 FR 67492 at

67493) that announced the agency’s

intent to begin a broader review of its

regulations that set out standards of

identity, quality, and fill of container

(hereinafter referred to as the

‘‘reinventing standards initiative’’). In

that document, FDA asked for

comments on the benefit of such

regulations in facilitating domestic and

international commerce and their value

to consumers. The agency also solicited

comment on alternative means of

accomplishing the statutory objectives

of food standards, i.e., to promote

honesty and fair dealing in the interest

of consumers.

Sections 137.230 Corn grits (21 CFR

137.230), 137.235 Enriched corn grits

(21 CFR 137.235), 137.240 Quick grits

(21 CFR 137.240), and 137.245 Yellow

grits (21 CFR 137.245)

The standards for grits describe the

foods as corn (white corn or yellow

corn) that is ground to a particular

fineness. They provide maximum

content requirements for moisture, fat,

and crude fiber. In addition, the

standard for enriched corn grits

specifies minimum and maximum

content requirements for thiamin,

riboflavin, niacin, and iron and optional

levels of vitamin D and calcium. In a

final rule published in the Federal

Register of March 5, 1996 (61 FR 8781)

(hereinafter referred to as the March

1996 final rule), FDA added folate to the

list of nutrients that must be added to

enriched corn grits. The standard for

quick grits specifies that the food is grits

that have been lightly steamed and

compressed to reduce cooking time for

the consumer.

4. FDA received two letters

specifically commenting on its proposal

to revoke the standards of identity for

corn grits, enriched corn grits, quick

grits, and yellow grits (hereinafter

referred to as ‘‘the standards for grits’’).

One comment supported the

administration’s efforts to streamline

Government to ease the burden on

consumers and regulated industries.

The comment argued that the standards

for grits are unneeded and unnecessary,

serve no public health benefit, and

should be revoked. The comment stated

that revoking obsolete and unnecessary

food standards that serve no public

interest, including the standards for

grits, is a positive step towards

achieving the administration’s goals.

According to the comment, the

standards for grits inhibit the

development of new products that may

have benefits for consumers.

Conversely, the second comment

maintained that the need for the

standards for grits is current and

ongoing. The comment expressed

concern about the potential

characteristics of products

manufactured and labeled as ‘‘grits’’ in

the absence of a standard of identity.

The comment noted, for example, that

particle size or other parameters may

change, slowly migrating from the

original, the migration dictated by

economic or other commercial forces. In

addition, the comment stated that the

standard of identity for yellow grits

should be maintained since consumers

have preferences between cereal

products made from white or yellow

corn. The comment argued that

consumers should not be forced to wait

until they get home and open the

package to find out whether the grits

they purchased are white or yellow

grits.

The comment also hypothesized that,

in the absence of a standard of identity,

in a short yellow corn crop, products

labeled as ‘‘yellow grits’’ might be made

from a blend of white and yellow corn.

The comment further suggested that

products labeled as ‘‘yellow grits’’ could

even be white grits made to appear

yellow. According to the comment,

yellow colorant could be added to

products made from white corn but

identified as ‘‘yellow grits’’ so long as

the colorant’s use is listed in the

ingredient declaration.

The comment argued that it is in the

best interest of consumers that products

they have come to trust as a specific

product not be allowed to change

according to economic or market

pressures. In support of maintaining the

standards for enriched corn grits and for

quick grits, the comment cited

consumer reliance on enriched cereal

products and consumer benefit from

quick preparation.

FDA acknowledges the comment’s

concerns that products that have long

enjoyed the protection of standards of

identity may change in the absence of

those standards. They are similar to

concerns raised by some of the early

comments the agency has received in

response to its reinventing standards

initiative.

However, the agency disagrees with

the comment’s contention that the

absence of standards will allow the

proliferation of adulterated or

misbranded products. The names

‘‘grits’’ and ‘‘yellow grits’’ were widely

accepted as the common or usual names

of the corn products to which these

names apply before FDA adopted

standards of identity. In the preamble to

its proposed rule on these standards (12

FR 69 at 70; January 4, 1947)

(hereinafter referred to as the 1947

standards proposal), FDA noted that the

common or usual name of grits milled

from white corn was, as it remains, the

unqualified term ‘‘grits,’’ and that the

names ‘‘hominy grits’’ and ‘‘corn grits’’

were synonyms for ‘‘grits.’’ The agency

further noted that the common name of

the corresponding food made from

yellow corn is ‘‘yellow grits,’’ ‘‘yellow

hominy grits,’’ or ‘‘yellow corn grits.’’

Thus, there is a longstanding common

understanding of what foods can

appropriately be called ‘‘grits.’’ Because
Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations 27775

of this understanding, if the term ‘‘grits’’

is inappropriately applied to a food, that

food will be misbranded under both

section 403(i)(1) of the act (a food shall

be deemed to be misbranded ‘‘Unless its

label bears * * * the common or usual

name of the food, if any there be * * *’’)

and section 403(b) (a food is deemed to

be misbranded ‘‘If it is offered for sale

under the name of another food.’’) Thus,

the comment’s suggestion that

consumers will be left unprotected if the

standard is revoked is without merit.

FDA also disagrees with the

comment’s suggestion that, in the

absence of a standard of identity,

consumers will be unable to tell from

labeling what type of grits they have

purchased. The general principles for

common or usual names in § 102.5 (21

CFR 102.5) require that the common or

usual name of a food accurately describe

the basic nature of a food or its

characterizing properties or ingredients.

Thus, if the food is from yellow corn,

the name must reflect that fact. If the

food is colored to appear yellow, the

name must reflect that fact. If the food

is a mixture of yellow and white corn

but also contains a sufficient amount of

white corn grits to be characterizing, it

must be labeled using an appropriately

descriptive phrase, e.g., ‘‘Mixed grits, a

blend of white and yellow corn grits.’’

In response to the comment’s concern

about changes in particle size, FDA

points out that grits, as evidenced by the

record in the 1947 standard setting

proceeding, are generally understood to

be the coarsest of the products prepared

by grinding corn, which also include

corn meal and corn flour. FDA finds

that migration in particle size will be

limited by two factors. First, corn meal

and corn flour will continue, at least

pending the outcome of FDA’s broader

rulemaking on food standards, to be

subject to standards of identity. Thus,

any attempt to call a too finely ground

product ‘‘grits’’ would misbrand the

food under sections 403(b) and (g) of the

act. Second, grits is a unique food in

that its name directly reflects its

characterizing property, i.e., that it

consists of coarsely ground yet small

particles of corn. As noted in the 1947

standards proposal and recognized by

the comment itself, particle size affects

the eating and cooking properties of the

food. Thus, a product with particles that

are too large will simply not have the

gritty mouth feel that characterizes this

food. Given the well established

character of grits, drift towards a larger

particle size will create a significant

possibility of consumer rejection of the

product. This strong possibility should

serve as a disincentive to migration

towards larger particle size.

Finally, even though FDA is revoking

these standards, manufacturers remain

free to make, and, to the extent they do,

consumers remain free to purchase,

products such as ‘‘quick grits’’ and

‘‘enriched grits.’’ For all these reasons,

FDA has not been convinced by the

comment to retain the standards of

identity for grits. Accordingly, FDA is

revoking the standards for corn grits

(§ 137.230), enriched corn grits

(§ 137.235), quick grits (§ 137.240), and

yellow grits (§ 137.245).

5. One comment expressed concern

about the impact of deleting the

standard for enriched grits on other

enriched products. While the comment

did not specifically agree or disagree

with the proposed revocation of the

standards for grits, it urged the agency

to consider the contribution from all

cereal flour enrichment to the health

and well-being of consumers.

FDA advises that a copy of this

comment has been placed in the docket

for the reinventing standards initiative

(Docket No. 95N–0294) and will be

considered in that rulemaking. FDA also

advises that its decision to revoke the

standard of identity for enriched grits

should have no effect on the health and

well-being of consumers. In the March

1996 final rule on folic acid, the agency

foresaw the possibility that it would

revoke the standard for enriched grits.

In that document, FDA recognized the

dietary significance of enriched cereal

grain products, including grits. FDA

stated that should the enriched grits

standard be revoked, it would amend

the food additive regulation on folic

acid (§ 172.345) to include grits in the

list of nonstandardized foods to which

folic acid may be added. FDA is making

that conforming change in this

document. Therefore, the total amount

of folate available from the diet should

not be affected by the decision to revoke

the standard of identity for enriched

grits.

Removing the standard of identity for

enriched grits does not affect the

agency’s finding that the use of folic

acid in this food is safe. Consequently,

FDA is amending the food additive

regulation in § 172.345(d) to continue

authorization of this use at the level

permitted by the former standard for

enriched grits. Specifically, the agency

is amending § 172.345(d) by adding at

the end of that paragraph ‘‘, and to corn

grits at a level such that each pound of

the corn grits contains not more than 1.0

milligram of folic acid.’’ The agency

advises that, because this amendment

does not change the currently approved

uses of folic acid, it has no effect on the

safe use of folic acid. For this reason,

and because this change was

foreshadowed in the final rule

establishing a folic acid fortification

level for standardized, enriched grain

products, FDA is issuing this

amendment as a final rule.

Section 163.150 Sweet cocoa and

vegetable fat coating, Section 163.153

Sweet chocolate and vegetable fat

coating, and Section 163.155 Milk

chocolate and vegetable fat coating.

The standards for sweet cocoa and

vegetable fat coating, sweet chocolate

and vegetable fat coating, and milk

chocolate and vegetable fat coating

(hereinafter referred to as ‘‘coatings

made with vegetable fat’’) describe foods

that resemble traditional milk chocolate

and sweet chocolate products except for

specified deviations to achieve certain

performance characteristics. The

primary deviation from traditional

chocolate products is that a vegetable

fat, having a higher or lower melting

point than cacao fat, replaces part of the

cacao fat in the food. In addition, the

standards for coatings made with

vegetable fat are somewhat more flexible

in permitting the use of optional

ingredients compared to the standards

of identity for traditional chocolate

products. For example, any safe and

suitable dairy-derived ingredient may be

used in sweet chocolate and vegetable

fat coating (§ 163.153(b)(2)), while the

standard for sweet chocolate

(§ 163.123(b)(4)) provides a list of

specific dairy ingredients (e.g., milk,

cream, or skim milk) that may be used

in the food. Conversely, the standards of

identity for both the traditional

chocolate products and for coatings

made with vegetable fat require that the

foods meet minimum and maximum

milk solids content requirements based

on those dairy ingredients referred to in

§ 163.123(b)(4). Sweet cocoa and

vegetable fat coating resembles sweet

chocolate and vegetable fat coating

except that cocoa may replace all, or

part, of the chocolate liquor in the sweet

chocolate and vegetable fat coating. The

standards of identity for coatings made

with vegetable fat also contain labeling

requirements for the name of the food

and for ingredient declaration.

6. FDA received five letters

specifically commenting on the agency’s

proposal to revoke the standards for

sweet cocoa and vegetable fat coating,

sweet chocolate and vegetable fat

coating, and milk chocolate and

vegetable fat coating. Three comments

supported the proposal, maintaining

that the standards for coatings made

with vegetable fat are unnecessary and

serve no useful function or public

interest. One comment argued that the

standards are not necessary because the
27776 Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations

ingredient declaration would

sufficiently inform consumers about the

nature of these products. Another

comment noted that the current

nomenclature for the products covered

by these standards is so unwieldy and

confusing that inherent marketplace

value normally associated with a

standard of identity is severely

undermined. In fact, most of the

comments on this issue, regardless of

whether or not they supported

revocation, acknowledged that industry

typically uses the term ‘‘chocolate flavor

coating’’ to identify these products

rather than the names provided for in

the standards.

One comment acknowledged that,

technically, this terminology constitutes

misbranding under section 403 of the

act. Another comment maintained that

because of the long history of use of the

term ‘‘chocolate flavor coating’’ to

describe these products, they would be

adequately covered by the common or

usual name regulations in § 101.3 if the

standards were revoked. Finally, these

comments argued that deleting the

standards for coatings made with

vegetable fat would increase flexibility

and innovation, thereby encouraging the

introduction of new products in the

market place. One comment maintained

that, despite the increased flexibility

afforded by 21 CFR 130.10

Requirements for foods named by use of

a nutrient content claim and a

standardized term, eliminating the

standards for coatings made with

vegetable fat would allow greater

flexibility in the use of new

technologies that could result in new

product introductions (e.g., lower fat or

lower calorie products) than is possible

under the constraints of the standards.

On the other hand, two comments

maintained that the standards of

identity for coatings made with

vegetable fat are not obsolete,

unnecessary, or no longer serving the

public interest. One comment argued

that limiting the deviations in these

products has guaranteed that the

products have the same general sensory

and quality characteristics (e.g., meet

the same minimum dairy or cacao solids

content requirements) as traditional

chocolate products. One comment

maintained that the standards for

coatings made with vegetable fat are

every bit as necessary as the standards

for the traditional chocolate products to

prevent the historical economic

adulteration of products labeled

‘‘chocolate.’’ These comments

supported maintaining the standards for

coatings made with vegetable fat but

suggested certain amendments, e.g.,

revising nomenclature, simplifying

provisions, and combining the

standards for sweet cocoa and vegetable

fat coating with sweet chocolate and

vegetable fat coating. One comment

noted the complexity of the

nomenclature issue and stated that FDA

and the industry should work together

to resolve this issue rather than revoking

the standards for coatings made with

vegetable fat.

FDA notes that its proposal to revoke

the standards for coatings made with

vegetable fat was probably the most

contentious issue in this rulemaking.

The agency admits that it was somewhat

surprised by the relatively large number

of comments on this issue and by the

diversity of viewpoints expressed

therein. The proposal to remove these

standards was based, in part, on

findings during the recent rulemaking to

update the standards for cacao products

in part 163 (58 FR 29523 at 29529, May

21, 1993) that the standardized

nomenclature was not being used for

these products. In that rulemaking, FDA

shortened the names from, e.g., ‘‘Sweet

chocolate and vegetable fat other than

cacao fat coating’’ to ‘‘Sweet chocolate

and vegetable fat coating.’’ However, it

was not able to change the names of

these foods to ‘‘chocolate flavor

coating,’’ as requested, because

codifying the term would place

manufacturers of nonstandardized

confectionery products at a serious

disadvantage.

Since that rulemaking, informal

communications with manufacturers

have revealed that at least some

manufacturers would rather see the

standards of identity for coatings made

with vegetable fat eliminated than be

required to label products with the

nomenclature provided for in the

standards (Ref. 2). Thus, in the course

of its page-by-page review of

regulations, the agency questioned

whether there was a need to retain these

standards. The validity of raising the

question was borne out by the

comments that agreed with the agency’s

proposal to revoke the standards.

As noted at the beginning of this

section, a number of comments stated

that revoking these standards would

increase flexibility and foster

innovation. Several comments

expressed frustration about issues that

the agency had not been able to resolve

to the commenters’ satisfaction in the

1993 final rule updating the cacao

standards and suggested that, absent a

resolution of those issues, the standards

were of little benefit and should be

revoked.

Conversely, as noted previously, a

number of comments, particularly a

comment from a trade association

representing chocolate manufacturers,

raised substantive objections to the

agency’s proposal to revoke the

standards for coatings made with

vegetable fat. According to these

comments, the standards for coatings

made with vegetable fat are necessary

for the continued accurate and truthful

labeling of chocolate and chocolatecoated products. As such, the standards

are useful to the industry and to

consumers.

FDA notes that it is not dismissing the

comments that supported revocation.

The agency is committed to increasing

flexibility while continuing to promote

honesty and fair dealing in the interest

of consumers. Although the standards

for coatings made with vegetable fat

were recently updated to keep pace with

advances in technology, to increase

flexibility for manufacturers, and to

improve consumers’ product choices,

some limitations remain. At the same

time, because of the nature of these

foods (i.e., chocolate coatings made with

vegetable fat and cocoa coatings made

with vegetable fat are highly formulated

products, the composition of which

consumers are not likely to be aware),

the standards of identity are a way,

above and beyond other label

information, to ensure that consumers

receive a product with the expected

characteristics.

Because of the complexity of the

issues and because of indications that a

significant proportion of the

confectionery industry favors retaining

these standards in some form, FDA

concludes that it would be premature to

revoke the standards for coatings made

with vegetable fat. To do so at this time

would not be in the best interest of

consumers or of the regulated industry.

Rather, the comment suggesting that the

agency defer any action on these

standards to the broader reinventing

standards initiative has merit.

FDA notes that it proposed to revoke

the standards for coatings made with

vegetable fat before it published the

ANPRM announcing its reinventing

standards initiative. The standards for

the other cacao products in part 163,

including the sweet chocolate and milk

chocolate products that the coatings

made with vegetable fat resemble, are

being reviewed as part of the

reinventing standards initiative. It

makes sense from a resource standpoint

to review all these standards at that

time. Further, it may be possible, under

a revised system of standards, to resolve

some of the issues that the agency was

not able to resolve at the time of the

1993 cacao final rule. If that is the case,

the agency may be able to eliminate or

modify those aspects of the standards
Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations 27777

that comments perceive to be

burdensome. Alternatively, it may be

that under a new standards system,

some or all of these standards will no

longer be necessary, and they could

therefore be revoked.

Consequently, contrary to its

proposal, FDA is not revoking the

standards for coatings made with

vegetable fat.

IV. Filing of Objections and Request for

a Hearing

Any person who will be adversely

affected by the amendments to part 105

or to § 172.345(d) may at any time on or

before July 3, 1996, 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 at the heading of this

document. Any objections received in

response to the revocation may be seen

in the Dockets Management Branch

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

through Friday. If the removal or

amendment of any provisions stayed by,

or as a result of, the filing of proper

objections, FDA will publish timely

notice in the Federal Register.

V. Economic Impact

FDA has examined the impact of this

final rule under Executive Order 12866

and the Regulatory Flexibility Act.

Executive Order 12866 directs Federal

agencies to assess the 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 effects; distributive impacts;

and equity). According to Executive

Order 12866, a regulatory action is

‘‘economically significant’’ if it meets

any one of a number of specified

conditions, including having an annual

effect on the economy of $100 million

or adversely affecting in a material way

a sector of the economy, competition, or

jobs. A regulation is considered

‘‘significant’’ under Executive Order

12866 if it raises novel legal or policy

issues. The Regulatory Flexibility Act

(Pub. L. 96–354) requires Federal

agencies to minimize the economic

impact of their regulations on small

businesses. FDA finds that this final

rule is neither an economically

significant nor significant regulatory

action as defined by Executive Order

12866. In compliance with the

Regulatory Flexibility Act and the

Regulatory Fairness Act of 1996, FDA

certifies that this final rule will not have

a significant impact on a substantial

number of small businesses.

Comments raised a number of issues

relevant to the analysis of the costs and

benefits of this action that were not

addressed in the economic analysis that

accompanied the notice of proposed

rulemaking.

One comment objected to the

revocation of § 100.160, which sets

tolerances for defective cocoa beans at

the time of import. This comment

claimed that this defect action level is

featured in standard contracts for cocoa

beans, and that the value of these

contracts will change if this section is

revoked.

As previously pointed out, FDA is not

revoking the defect action level that is

reflected in § 100.160. However, even if

the agency were to take such an action,

any change in the value of contracts

linked to this provision could not

properly be considered a cost of

revocation because the value of a

contract linked to anything subject to

change during the life of the contract,

such as a Federal regulation, already

reflects the fact that such change may

occur.

One comment objected to the

revocation of the standards of identity

for corn grits, enriched corn grits, quick

grits, and yellow grits. This comment

suggested that the combination of these

product names and the associated

standards of identity convey

information about product

characteristics to consumers, that

consumers are interested in the

information conveyed, and that

consumers might experience difficulty

obtaining this information in the

absence of these standards.

The issues discussed in this comment

involve legitimate potential costs of

eliminating this standard of identity

which were not discussed in the

economic analysis of the proposed rule.

However, these costs are attenuated to

some degree by the fact that the labeling

of nonstandardized products cannot be

false or misleading, and that the name

of the product itself, which can still be

used even if the product is not

standardized, defines its characteristics.

In addition, the elimination of these

standards of identity is associated with

countervailing benefits that were also

not discussed in the economic analysis

of the proposed rule. Eliminating these

standards eliminates the costs that

would be associated with revising these

standards in response to industry

petitions and the costs associated with

preparing and submitting those

petitions. In addition, eliminating these

standards may increase the variety of

grits products offered to consumers and

reduce the costs associated with

adopting new methods of producing

these products. Although the comment

suggested that costs are associated with

the elimination of these standards, the

comment provided no way of

determining the magnitude of these

costs or to compare these costs with the

potential benefits of eliminating these

standards. A more thorough discussion

of the societal benefits and costs is

contained in the December 1995

ANPRM (60 FR 67492 at 67499).

Finally, one comment objected to the

revocation of § 105.67 (label statement

relating to food for use in the diet of

diabetics). This comment did not

dispute the contention that there is no

scientific consensus that the relevant

claims are true but suggested, instead,

that there is also no scientific consensus

that the relevant claims are false. The

point of this comment was probably that

the current scientific consensus is that

these claims are neither clearly true nor

clearly false, but in some third category,

such as possibly but not proven true, or

possibly but not proven false.

If this comment were correct about

the state of the scientific consensus on

these claims, then the phenomena

discussed in this comment would

represent potentially legitimate costs of

this action that were not discussed in

the economic analysis of the proposed

rule. In that case, the deletion of

§ 105.67 would prevent a claim from

appearing on food labels that scientific

consensus did not hold to have been

proven false, and that some consumers

might have wished to use to make food

consumption choices. However, these

costs would be attenuated by the fact

that this type of label claim is not the

only means by which consumers may

identify foods with desired

characteristics. As previously pointed

out, the regulations adopted in response

to the 1990 amendments, including the

new ingredient labeling regulations,
27778 Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations

provide information on a wide variety of

product characteristics.

In addition, deletion of § 105.67, even

under the conditions suggested in the

comment, would be associated with a

countervailing benefit that was also not

discussed in the economic analysis of

the notice of proposed rulemaking. This

benefit is the maintenance of the

relatively high informational content of

label claims made possible by restricting

such claims to those that current

scientific consensus finds to be true

rather than restricting such claims to

those that current scientific consensus

does not find to have been conclusively

proven false. This restriction of

allowable claims reduces the need for

consumers to investigate the basis and

relative credibility of label claims on

their own.

Estimating the benefits and costs of

allowing label claims having various

degrees of scientific plausibility is quite

difficult. However, in general, the

availability of other means of

identifying food with desired

characteristics suggests that the benefit

of maintaining a relatively high

standard for information presented in

label claims probably outweighs the

costs of restricting these claims to those

supported by scientific consensus.

These issues are discussed in more

detail in the regulatory impact analysis

for the final rule to amend the food

labeling regulations in the Federal

Register of January 6, 1993 (58 FR

2927).

In addition, FDA does not agree that

there is no scientific consensus that the

relevant claims are false. Not only is

there no scientific consensus that such

claims are true, but the current scientific

consensus is that such claims are false.

The comment provided no information

on the current state of scientific

consensus to support its contention that

there is no consensus that such claims

are false.

Finally, the cost of the associated

label changes was not addressed in the

economic analysis of the notice of

proposed rulemaking. Affected firms

will have a minimum of 1 year to make

the required label changes because any

required label changes need not be

made until the next uniform effective

date after publication of the final rule in

the Federal Register. In general, the

average cost of changing a label under

a compliance period of 1 year is

estimated to be $1,000 per label, if the

claim is on the principal display panel,

and $425 per label, if the claim is

located elsewhere on the label. FDA has

no information on the number of labels

affected or on the location of the

relevant claims on those labels.

However, the specificity of the relevant

claims suggests the number of affected

labels is probably small.

VI. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(9) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VII. References

The following references has been

placed on display in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, and may be seen by interested

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

Monday through Friday.

1. American Diabetes Association, Position

Statement—Food Labeling, Diabetes Care,

19:543–544, 1996.

2. Smith, M. A., Communications regarding

standards for coatings made with vegetable

fat, memorandum to file, May 29, 1996.

List of Subjects

21 CFR Part 100

Administrative practice and

procedure, Food labeling, Food

packaging, Foods, Intergovernmental

relations.

21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

21 CFR Part 103

Beverages, Bottled water, Food grades

and standards.

21 CFR Part 104

Food grades and standards, Frozen

foods, Nutrition.

21 CFR Part 105

Dietary Foods, Food grades and

standards, Food labeling, Infants and

children.

21 CFR Part 109

Food packaging, Foods,

Polychlorinated biphenyls (PCB’s).

21 CFR Part 137

Cereal(s) (food), Food grades and

standards.

21 CFR Part 161

Food grades and standards, Frozen

foods, Seafood.

21 CFR Part 172

Food additives, Reporting and

recordkeeping requirements.

21 CFR Part 182

Food ingredients, Food packaging,

Spices and flavorings.

21 CFR Part 186

Food ingredients, Food packaging.

21 CFR Part 197

Food grades and standards, Reporting

and recordkeeping requirements,

Seafood.

21 CFR Part 700

Cosmetics, Packaging and containers.

Therefore, under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301

et seq.) and under authority delegated to

the Commissioner of Food and Drugs,

21 CFR parts 100, 101, 103, 104, 105,

109, 137, 161, 172, 182, 186, 197, and

700 are amended as follows:

PART 100—GENERAL

1. The authority citation for 21 CFR

part 100 continues to read as follows:

Authority: Secs. 201, 301, 307, 402, 403,

409, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 337, 342,

343, 348, 371).

§ 100.120 [Removed]

2. Section 100.120 Artificially reddyed yellow varieties of sweet potatoes

is removed.

§ 100.130 [Removed]

3. Section 100.130 Combinations of

nutritive and nonnutritive sweeteners in

‘‘diet beverages’’ is removed.

§ 100.135 [Removed]

4. Section 100.135 Disposition of

incubator reject eggs is removed.

§ 100.140 [Removed]

5. Section 100.140 Label declaration

of salt in frozen vegetables is removed.

§ 100.145 [Removed]

6. Section 100.145 Notice to packers

of comminuted tomato products is

removed.

§ 100.150 [Removed]

7. Section 100.150 Notice to packers

and shippers of shelled peanuts is

removed.

§ 100.160 [Removed]

8. Section 100.160 Tolerances for

moldy and insect-infested cocoa-beans

is removed.

PART 101—FOOD LABELING

9. 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,
Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations 27779

701 of the Federal Food, Drug, and Cosmetic

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

§ 101.33 [Removed]

10. Section 101.33 Label declaration

of D-erythroascorbic acid when it is an

ingredient of a fabricated food is

removed.

§ 101.103 [Removed]

11. Section 101.103 Petitions

requesting exemptions from or special

requirements for label declaration of

ingredients is removed.

PART 103—QUALITY STANDARDS

FOR FOODS WITH NO IDENTITY

STANDARDS

PART 103 [REMOVED]

12. Part 103 is removed.

PART 104—NUTRITIONAL QUALITY

GUIDELINES FOR FOODS

13. The authority citation for 21 CFR

part 104 continues to read as follows:

Authority: Secs. 201, 403, 701(a) of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 343, 371(a)).

§ 104.19 [Removed]

14. Section 104.19 Petitions is

removed.

PART 105—FOODS FOR SPECIAL

DIETARY USE

15. The authority citation for 21 CFR

part 105 continues to read as follows:

Authority: Secs. 201, 401, 403, 409, 411,

701, 721 of the Federal Food, Drug and

Cosmetic Act (21 U.S.C. 321, 341, 343, 348,

350, 371, 379e).

§ 105.67 [Removed]

16. Section 105.67 Label statement

relating to food for use in the diet of

diabetics is removed.

§ 105.69 [Removed]

17. Section 105.69 Foods used to

regulate sodium intake is removed.

PART 109—UNAVOIDABLE

CONTAMINANTS IN FOOD FOR

HUMAN CONSUMPTION AND FOODPACKAGING MATERIAL

18. The authority citation for 21 CFR

part 109 continues to read as follows:

Authority: Secs. 201, 306, 402, 406, 408,

409, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 336, 342, 346,

346a, 348, 371).

§ 109.5 [Removed]

19. Section 109.5 Petitions is

removed.

PART 137—CEREAL FLOURS AND

RELATED PRODUCTS

20. The authority citation for 21 CFR

part 137 continues to read as follows:

Authority: Secs. 201, 401, 403, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

§ 137.230 [Removed]

21. Section 137.230 Corn grits is

removed.

§ 137.235 [Removed]

22. Section 137.235 Enriched corn

grits is removed.

§ 137.240 [Removed]

23. Section 137.240 Quick grits is

removed.

§ 137.245 [Removed]

24. Section 137.245 Yellow grits is

removed.

PART 161—FISH AND SHELLFISH

25. The authority citation for 21 CFR

part 161 continues to read as follows:

Authority: Secs. 201, 401, 403, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

§ 161.131 [Removed]

26. Section 161.131 Extra large

oysters is removed.

§ 161.132 [Removed]

27. Section 161.132 Large oysters is

removed.

§ 161.133 [Removed]

28. Section 161.133 Medium oysters is

removed.

§ 161.134 [Removed]

29. Section 161.134 Small oysters is

removed.

§ 161.135 [Removed]

30. Section 161.135 Very small oysters

is removed.

§ 161.137 [Removed]

31. Section 161.137 Large Pacific

oysters is removed.

§ 161.138 [Removed]

32. Section 161.138 Medium Pacific

oysters is removed.

§ 161.139 [Removed]

33. Section 161.139 Small Pacific

oysters is removed.

§ 161.140 [Removed]

34. Section 161.140 Extra small

Pacific oysters is removed.

PART 172—FOOD ADDITIVES

PERMITTED FOR DIRECT ADDITION

TO FOOD FOR HUMAN

CONSUMPTION

35. The authority citation for 21 CFR

part 172 continues to read as follows:

Authority: Secs. 201, 401, 402, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 348, 371, 379e).

36. Section 172.345 is amended by

revising paragraph (d) to read as

follows:

§ 172.345 Folic acid (folacin).

* * * * *

(d) Folic acid may be added, at levels

not to exceed 400 micrograms (μg) per

serving, to breakfast cereals, as defined

under § 170.3(n)(4) of this chapter, and

to corn grits at a level such that each

pound of the corn grits contains not

more than 1.0 milligram of folic acid.

* * * * *

PART 182—SUBSTANCES

GENERALLY RECOGNIZED AS SAFE

37. The authority citation for 21 CFR

part 182 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).

Subpart F [Removed]

38. Subpart F, consisting of

§§ 182.5013 through 182.5997, is

removed and reserved.

PART 186—INDIRECT FOOD

SUBSTANCES AFFIRMED AS

GENERALLY RECOGNIZED AS SAFE

39. The authority citation for 21 CFR

part 186 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).

§ 186.1025 [Removed]

40. Section 186.1025 Caprylic acid is

removed.

PART 197—SEAFOOD INSPECTION

PROGRAM

Part 197 [Removed]

41. Part 197 is removed.

PART 700—GENERAL

42. The authority citation for 21 CFR

Part 700 continues to read as follows:

Authority: Secs. 201, 301, 502, 505, 601,

602, 701, 704 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 352, 355,

361, 362, 371, 374).

§ 700.10 [Removed]

43. Section 700.10 Shampoo

preparations containing eggs as one of

the ingredients is removed.
27780 Federal Register / Vol. 61, No. 107 / Monday, June 3, 1996 / Rules and Regulations

Dated: May 29, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–13829 Filed 5–30–96; 1:06 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Parts 65, 66, and 76

RIN 1076 AD31

Enrollment of Indians; Removal of

Regulations

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Final rule.

SUMMARY: The Bureau of Indian Affairs

(BIA) is eliminating 25 CFR Parts 65, 66,

and 76 as mandated by Executive Order

12866 to streamline the regulatory

process and enhance the planning and

coordination of new and existing

regulations. The necessity for these

rules no longer exists.

EFFECTIVE DATE: July 3, 1996.

FOR FURTHER INFORMATION CONTACT:

Bettie Rushing, (202) 208–3463.

SUPPLEMENTARY INFORMATION:

Background

The purpose for which these rules

were promulgated has been fulfilled and

the rules are no longer required.

Members of the San Pasqual Band have

been enrolled as required in satisfaction

of judgments of the United States

Claims Court docket 80–A. Members of

the Delaware Tribe of Indiana and the

Absentee Delaware Tribe of Western

Oklahoma have been enrolled as the

basis for distribution of judgment funds

awarded in Indian Claims Commission

dockets 27–A, and 241, 289, 27–B and

338, and 27 E and 202, 27.

The authority to issue rules and

regulations is vested in the Secretary of

the Interior by 5 U.S.C. 301 and sections

463 and 465 of the Revised Statutes, 25

U.S.C. 2 and 9.

Executive Order 12778: The

Department has certified to the Office of

Management and Budget (OMB) that

this rule meets the applicable standards

provided in sections 2(a) and 2(b)(2) of

Executive Order 12778.

Executive Order 12866: This rule is

not a significant regulatory action under

Executive Order 12866 and does not

require review by the Office of

Management and Budget.

Regulatory Flexibility Act: This rule

will not have a significant economic

impact on a substantial number of small

entities under the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.).

Executive Order 12630: The

Department has determined that this

rule does not have ‘‘significant’’ takings

implications. This rule does not pertain

to ‘‘taking’’ of private property interests,

nor does it impact private property. Executive Order 12612: The

Department has determined that this

rule does not have significant federalism

effects because it pertains solely to

Federal-tribal relations and will not

interfere with the roles, rights and

responsibilities of states. NEPA Statement: The Department has

determined that this rule does not

constitute a major Federal action

significantly affecting the quality of the

human environment and that no

detailed statement is required pursuant

to the National Environmental Policy

Act of 1969.

Unfunded Mandates Act of 1995: This

rule imposes no unfunded mandates on

any governmental or private entity and

is in compliance with the provisions of

the Unfunded Mandates Act of 1995.

Paperwork Reduction Act of 1995:

This rule contains no information

collection requirement the elimination

of which would require notification to

the Office of Management and Budget. Drafting Information: The primary

author of this document is Bettie

Rushing, Bureau of Indian Affairs.

List of Subjects in 25 CFR Parts 65, 66

CFR 76.

Indians—enrollment, Indians—

claims.

PARTS 65, 66, 76—[REMOVED]

Under the authority of Executive

Order 12866, and for the reasons stated

above, 25 CFR Parts 65, 66, and 76 are

removed.

Dated: May 22, 1996.

Ada E. Deer,

Assistant Secretary—Indian Affairs.

[FR Doc. 96–13730 Filed 5–31–96; 8:45 am]

BILLING CODE 4310–02–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 62

[CGD–94–091]

RIN 2115–AF14

Conformance of the Western Rivers

Marking System With the United States

Aids to Navigation System

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: As part of the President’s

Regulatory Reinvention Initiative, the

Coast Guard will replace the solid-color

crossing dayboards in the Western

Rivers Marking System (WRMS) with

checkered non-lateral dayboards used in

the United States Aids to Navigation

System (USATONS); the latter

dayboards would have the same

meaning and be the same size and shape

as the former, but would be easier to

see. These changes would help mariners

to better see the crossing dayboards,

making the Western Rivers safer.

DATES: This rule is effective June 3,

1996. The first checkered non-lateral

dayboards will appear on the Western

Rivers no sooner than September 3. The

last solid-color crossing dayboards will

disappear from the Western Rivers not

later than June 3, 1996.

ADDRESSES: Unless otherwise indicated,

documents referred to in this preamble

are available for inspection or copying

at the office of the Executive Secretary,

Marine Safety Council (G–LRA/3406)

(CGD 94–091), U.S. Coast Guard

Headquarters, 2100 Second Street SW.,

Washington, DC 20593–0001, room

3406 at the same address between 8 a.m.

and 3 p.m., Monday through Friday,

except Federal holidays. The telephone

number is (202) 267–1477.

FOR FURTHER INFORMATION CONTACT:

LTJG Chad Asplund, Short Range Aids

to Navigation Division, Telephone: (202)

267–1386.

SUPPLEMENTARY INFORMATION:

Drafting Information

The principle persons involved in

drafting this document are LTJG Chad

Asplund, Project Manager, Short Range

Aids to Navigation Division, and Patrick

J. Murray, Project Counsel, Office of

Chief Counsel.

Regulatory History

On March 27, 1996, the Coast Guard

published an NPRM entitled

Conformance of the Uniform State

Waterway Marking System and the

Western Rivers Marking System with