[Federal Register Volume 61, Number 107 (Monday, June 3, 1996)]
[Rules and Regulations]
[Pages 27771-27780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13829]



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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 
(<greek-m>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