[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
(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
