Revocation of Certain Regulations Affecting Food

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.

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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-by-page 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 Sec. 172.345

which is

[[Page 27772]]

effective June 3, 1996. Written objections and requests for a hearing

for part 105 and Sec. 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-by-page 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``eliminate or revise those that are outdated or otherwise in need of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 red-dyed 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., Secs. 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., Sec. 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 Sec. 100.160 are useful because they have

been universally adopted. This comment expressed concern that any

change in the

[[Page 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

Sec. 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 Sec. 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

Sec. 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 Sec. 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

Sec. 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

Sec. 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 Sec. 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 Sec. 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, Sec. 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 Sec. 105.67 are outdated

and misleading. Consequently, the agency is deleting section

Sec. 105.67 as proposed.

[[Page 27774]]

Because Sec. 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 Sec. 105.67,

expressed concern that deleting Sec. 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 Sec. 105.67 that label statements such as

``diabetic'' or ``for diabetics'' are no longer allowed.

FDA points out that Sec. 105.67(c) pertained only to the prominence

of terms such as ``diabetic.'' Based on FDA's conclusion that

Sec. 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 Sec. 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

[[Page 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 Sec. 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 (Sec. 137.230), enriched corn

grits (Sec. 137.235), quick grits (Sec. 137.240), and yellow grits

(Sec. 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

(Sec. 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

Sec. 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 Sec. 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 (Sec. 163.153(b)(2)), while the standard for sweet

chocolate (Sec. 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

Sec. 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

[[Page 27776]]

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

Sec. 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 chocolate-coated 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

[[Page 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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,

[[Page 27778]]

provide information on a wide variety of product characteristics.

In addition, deletion of Sec. 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).

Sec. 100.120 [Removed]

2. Section 100.120 Artificially red-dyed yellow varieties of sweet

potatoes is removed.

Sec. 100.130 [Removed]

3. Section 100.130 Combinations of nutritive and nonnutritive

sweeteners in ``diet beverages'' is removed.

Sec. 100.135 [Removed]

4. Section 100.135 Disposition of incubator reject eggs is removed.

Sec. 100.140 [Removed]

5. Section 100.140 Label declaration of salt in frozen vegetables

is removed.

Sec. 100.145 [Removed]

6. Section 100.145 Notice to packers of comminuted tomato products

is removed.

Sec. 100.150 [Removed]

7. Section 100.150 Notice to packers and shippers of shelled

peanuts is removed.

Sec. 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,

[[Page 27779]]

701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331,

342, 343, 348, 371).

Sec. 101.33 [Removed]

10. Section 101.33 Label declaration of D-erythroascorbic acid when

it is an ingredient of a fabricated food is removed.

Sec. 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)).

Sec. 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).

Sec. 105.67 [Removed]

16. Section 105.67 Label statement relating to food for use in the

diet of diabetics is removed.

Sec. 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 FOOD-PACKAGING 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).

Sec. 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).

Sec. 137.230 [Removed]

21. Section 137.230 Corn grits is removed.

Sec. 137.235 [Removed]

22. Section 137.235 Enriched corn grits is removed.

Sec. 137.240 [Removed]

23. Section 137.240 Quick grits is removed.

Sec. 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).

Sec. 161.131 [Removed]

26. Section 161.131 Extra large oysters is removed.

Sec. 161.132 [Removed]

27. Section 161.132 Large oysters is removed.

Sec. 161.133 [Removed]

28. Section 161.133 Medium oysters is removed.

Sec. 161.134 [Removed]

29. Section 161.134 Small oysters is removed.

Sec. 161.135 [Removed]

30. Section 161.135 Very small oysters is removed.

Sec. 161.137 [Removed]

31. Section 161.137 Large Pacific oysters is removed.

Sec. 161.138 [Removed]

32. Section 161.138 Medium Pacific oysters is removed.

Sec. 161.139 [Removed]

33. Section 161.139 Small Pacific oysters is removed.

Sec. 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:

Sec. 172.345 Folic acid (folacin).

* * * * *

(d) Folic acid may be added, at levels not to exceed 400 micrograms

(g) per serving, to breakfast cereals, as defined under

Sec. 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 Secs. 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).

Sec. 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).

Sec. 700.10 [Removed]

43. Section 700.10 Shampoo preparations containing eggs as one of

the ingredients is removed.

[[Page 27780]]

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