[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29701-29708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14888]



Food and Drug Administration

21 CFR Parts 70, 71, 80, 101, 107, 170, 172, 173, 174, 175, 177, 
178, 184, and 1250

[Docket No. 96N-0149]

Food Standards; Reinvention of Regulations Needing Revisions; 
Request for Comments on Certain Existing Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.


SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to review its human food labeling regulations pertaining to: 
The exemption for soft drinks from requirements for the type size and 
placement of certain information on the information panel, requirements 
for listing ``statements of identity,'' and requirements for flavor 
labeling; its infant formula regulations to ensure that they fully 
reflect the Federal Food, Drug, and Cosmetic Act (the act); and its 
regulations pertaining to the discharge of waste aboard casino ships, 
passenger ships, and ferries. The agency is also conducting a review of 
its food additive regulations to consolidate existing regulations. As 
part of this review of agency regulations, the agency is soliciting 
comments from all interested persons on whether the above regulations 
should be retained, revised, or revoked. FDA solicits comments on the 
benefits or lack of benefits of such regulations in facilitating 
domestic, as well as international, commerce and on the value of these 
regulations to consumers. The agency also solicits comments on 
alternative means of accomplishing the statutory objectives that led to 
the adoption of the subject regulations. This review is in response to 
the Administration's ``Reinventing Government'' initiative which seeks 
to ease the burden on regulated industry and consumers.
DATES: Written comments by September 10,1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Corinne L. Howley, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4272.


I. Background

    On March 4, 1995, President Clinton announced plans for the reform 
of the Federal regulatory system as part of the Administration's 
``Reinventing Government'' initiative. In his March 4 directive, the 
President ordered all Federal agencies to conduct a page-by-page review 
of all of their regulations 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; 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). The agency has completed the review 
of its food regulations in response to the President's initiative and 
as a result is publishing two documents elsewhere in this issue of the 
Federal Register. This document is an ANPRM to review regulations that 
the agency believes may need to be revised. In addition to requesting 
information on the following issues, FDA requests any other comments 
relevant to the regulations discussed herein that would assist the 
agency in fulfilling its mission to protect the interest of consumers.

II. Soft Drinks

    Elsewhere in this issue of the Federal Register, FDA is proposing a 
number of changes in Sec. 101.2 (21 CFR 101.2) pertaining to 
information that must appear on the information panel of the label. FDA 
explains in that document that it considers a number of exemptions from 
the type size and placement requirements in Sec. 101.2 to be obsolete, 
and the agency is proposing to remove them. \1\ The exemptions that FDA 
is proposing to remove appear in Sec. 101.2(c), but that paragraph also 
contains a number of exemptions that the agency is not proposing to 

    \1\ The type size and location requirements apply to all 
information required to appear on the label of any package of food 
under certain regulations that are referenced in Sec. 101.2. The 
information must appear either on the principal display panel or the 
information panel unless otherwise specified in the regulations. 
Section 101.2(a) defines the term ``information panel'' as it 
applies to packaged food, and Sec. 101.2(b) identifies referenced 
regulations. Section 101.2(c) requires that information required by 
the referenced regulations be in letters or numbers of at least one-
sixteenth inch in height, unless otherwise exempted by regulation.

    Among the latter exemptions is a provision for soft drinks in 
Sec. 101.2(c)(4). FDA is undecided about whether to retain this 
provision because the agency does not know enough about nationwide 
packing practices for these products. For example, this provision 
exempts soft drink bottles that were manufactured before October 31, 
1975, from the type size and placement requirements. The agency does 
not know, however, whether any bottles manufactured before that date 
are still in use. If not, this exemption is obsolete and should be 
removed. Other soft drink exemptions may also be obsolete, or in need 
of revision, to respond more efficiently to changes in labeling 
practices that have resulted from the Nutrition Labeling and Education 
Act (the 1990 amendments). The agency needs to know more about how 
firms are presenting newly required information to consumers on labels 
and on labeling materials other than labels (e.g., counter cards, 
posters), as well as whether they are encountering any difficulties 
associated with such presentation, before it can determine whether it 
should pursue further rulemaking activities for soft drinks. For 
example, where soft drink manufacturers are using posters for some 
label information, there may be ample free space to present ingredient

[[Page 29702]]

information in relatively large type size. Would consumers be better 
informed by such a presentation of this information than they would 
with smaller type size on the soft drink package itself? If FDA were to 
permit alternative labeling locations for information required to 
appear on the information panel, would the current soft drink 
exemptions still be needed? FDA requests comments on these issues from 
all interested parties.

III. Statements of Identity

    Section 101.3(a) and (b) (21 CFR 101.3(a) and (b)) requires that 
the principal display panel of the label of food in package form bear a 
statement of identity of the food product. Specifically, Sec. 101.3 
requires that the statement of identity be in terms of the name of the 
food as required by Federal law or regulation or, in the absence of 
such, of the common or usual name for the food. If no such common or 
usual name has been established, the statement of identity must be an 
appropriately descriptive term. When the nature of the food is obvious, 
however, a fanciful name commonly used by the public for the food may 
be used.
    This regulation also requires, among other things, that where the 
food is marketed in optional forms (whole, slices, diced), the 
particular form be considered a necessary part of the name 
(Sec. 101.3(c)). This provision does not affect the required 
declarations of identity under definitions and standards of identity 
for foods that specify other ways of declaring the optional forms of 
the food.
    Section 101.3(d) requires that the statement of identity be 
presented in bold type on the principal display panel of the label, be 
in a type size that is reasonably related to the most prominent printed 
matter on such panel, and be in lines generally parallel to the base on 
which the package rests as it is designed to be displayed. These 
provisions were established to meet the prominence and conspicuousness 
requirements of section 403(f) of the act (21 U.S.C. 343(f)).
    The requirement that the type size in which the statement of 
identity appears be reasonably related to the largest type size used on 
the principal display panel has been informally interpreted by FDA to 
mean that the statement of identity must appear in type not less than 
one-half the size of the largest printed matter on the principal 
display panel. However, the agency has observed that brand name 
identifications and flavor declarations often appear many times larger 
than the statement of identity on the food label. The agency requests 
comments on whether the statements of identity are sufficiently 
conspicuous in light of other representations on the principal display 
panel. If they are not, how should the regulation be changed to ensure 
that the type size used for the statement of identity will be adequate? 
For example, should FDA's informal guidance be established as a 
requirement in a regulation? Should a different criterion be 
established, perhaps related to the area of the principal display 
panel, similar to the requirement for net contents declaration?
    FDA is also aware that some identity statements are not placed 
parallel to the base on which the container rests. Does this create 
problems for consumers in reading labels? Are there specific needs for 
variations from this requirement that should be provided for by special 
exemptions? For example, do advancements in packaging foods and in 
displaying them justify exemptions for certain types of packaging?
    Section 101.3(e) defines the term ``imitation'' and how it is to be 
used in the labeling of foods. This provision states that a food shall 
be deemed to be an imitation, and thus subject to the requirements of 
section 403(c) of the act, if it is a substitute for and resembles 
another food but is nutritionally inferior to that food. If the food is 
an imitation, as so defined, then the label of the food must bear in 
type of uniform size and prominence, the word ``imitation'' and, 
immediately thereafter, the name of the food imitated.
    When section 403(c) of the act was adopted in 1938, Congress was 
seeking to protect the consumer from the uninformed purchase of an 
inferior substitute product that could be mistaken for a traditional 
food product (38 FR 2138, January 19, 1973). In 1973, in proposed 
regulations pertaining to imitation foods, the agency noted that vast 
strides in food technology had taken place since section 403(c) of the 
act was enacted, and that since 1938 many new wholesome and nutritious 
food products had entered the marketplace, some of which resembled and 
substituted for traditional foods (38 FR 2138). The agency stated that 
it was no longer the case that such products were necessarily 
substandard compared to the traditional foods for which they 
substituted. However, FDA still believed that the consumer must be 
protected from the unwitting purchase of a product that is different 
from what he or she may reasonably expect (38 FR 2138). FDA proposed 
that the term ``imitation'' only be applied to substitute foods that 
are nutritionally inferior to the foods for which they substitute (38 
FR 2143 at 2148). In its final regulation (38 FR 20703, August 2, 
1973), FDA confirmed this view and defined nutritional inferiority as 
any reduction in the content of an essential nutrient that is present 
in a measurable amount.
    Over the years, FDA has received questions as to when a food is 
considered to resemble and substitute for a traditional food, so that 
it is subject to the provisions of this regulation. The agency has 
advised that where there is no standard of identity for the food in 
parts 130 through 169 (21 CFR parts 130 through 169), no common or 
usual name regulation in part 102 (21 CFR part 102), or no provision 
for the food in the nutritional quality guideline that appears in part 
104 (21 CFR part 104), the product must be evaluated in terms of 
whether it resembles or purports to be (has similar functional, 
physical, and organoleptic properties), and whether it substitutes for, 
a food product that has a commonly understood identity or common or 
usual name. For example, there are products on the market that are 
textured, colored, flavored, and shaped to resemble crabmeat. These 
products resemble and substitute for crabmeat, and when they are 
nutritionally inferior to crabmeat, they must be labeled ``imitation 
    In addition, manufacturers have often sought advice on how a food 
should be labeled when it resembles and substitutes for a traditional 
food but is not nutritionally inferior to the traditional food. In some 
cases, the agency has recommended the use of the term ``substitute'' as 
part of the name of such a food. For example, the agency has advised 
that a beverage made by replacing the milkfat in milk with vegetable 
oil, and which is not nutritionally inferior to milk, could be labeled 
as a ``milk substitute.'' The agency stated that the name would be 
followed by a descriptive phrase, such as ``made with skim milk and 
vegetable oil'' or ``contains 3 percent soybean oil to replace the 
milkfat,'' to inform the consumer as to the difference between the milk 
substitute and milk.
    In view of these questions, the agency is seeking comment on 
whether it should develop more in-depth guidance to assist 
manufacturers in naming new food products. If so, how should this be 
accomplished: through revision of the regulations in Secs. 101.3 or 
102.5 (common or usual
 name), a Compliance Policy Guide, or other less formal guidance, such 
as an addendum to FDA's Food Labeling Guide? In developing comments on 
this issue, interested parties should keep in mind that FDA has 
published an ANPRM seeking comment on whether

[[Page 29703]]

and how standards of identity and common or usual name regulations 
should be revised (60 FR 67492). Many, though not all, of the foods 
subject to Sec. 101.3(e) resemble and substitute for foods subject to 
those regulations. FDA will evaluate any proposed changes in its policy 
on labeling of imitation foods in light of any changes it ultimately 
decides to make in its approach to standards of identity and common or 
usual name regulations.
    In Sec. 101.3(e)(4), FDA has defined nutritional inferiority to 
include any reduction in the content of an essential nutrient that is 
present in a measurable amount. A measurable amount of an essential 
nutrient under this regulation is 2 percent or more of the Daily 
Reference Value of protein listed under Sec. 101.9(c)(7)(iii) (21 CFR 
101.9(c)(7)(iii)) and of potassium listed under Sec. 101.9(c)(9) and of 
the Reference Daily Intake (RDI) of any vitamin or mineral listed under 
Sec. 101.9(c)(8)(iv). In the Federal Register of December 28, 1995 (60 
FR 67164), FDA established RDI's for several nutrients and revised the 
definition of nutritional inferiority to accommodate those new RDI's 
where practicable. The agency stated that as substitute products 
proliferate, it is important to ensure that these products contain 
essential nutrients in amounts consistent with the reference food, so 
that consumers can continue to have confidence that a varied diet will 
supply adequate nutrition (60 FR 67164 at 67169).
    The agency is requesting comment on the appropriateness of the 
current definition of nutritional inferiority for the purpose of 
determining whether a food is an imitation. Fat and calories are 
currently excluded from the nutrients to be considered when determining 
nutritional inferiority. The agency did not reevaluate this provision 
when it revised the definition of nutritional inferiority in the 
December 28, 1995, final rule. Nonetheless, it now seeks comment on 
whether that definition should be further revised. Should the 
definition be changed to take into account current dietary guidelines? 
For example, should sodium, saturated fat, and cholesterol be excluded 
from the nutrients to be considered? On the other hand, if a substitute 
food is modified to achieve a nutrition goal, such as a reduction in 
the sodium content of the diet, and as a consequence the fat or calorie 
content of the food is increased to achieve a more palatable product, 
should such a product be considered to be nutritionally inferior? Is 
there some other way of highlighting such a change on the label?
    FDA notes that the concept of nutritional inferiority is widely 
used in the agency's regulations and interpretations. For example, FDA 
relies on this concept in the definition of the term ``substitute'' 
food in Sec. 101.13 Nutrient content claims--general principles. 
Section 101.13(d) states that a ``substitute'' food is one that may be 
used interchangeably with another food that it resembles, i.e., to 
which it is organoleptically, physically, and functionally (including 
shelf life) similar, and to which it is not nutritionally inferior, 
unless it is labeled as an ``imitation.'' In addition, the general 
standard of identity, Sec. 130.10 Requirements for foods named by use 
of a nutrient content claim and a standardized term (21 CFR 130.10), 
explains how to derive statements of identity for foods that substitute 
for and resemble traditional standardized foods. This regulation 
specifically references Sec. 101.3(e) and provides for the addition of 
nutrients to the new food so that it will not be nutritionally inferior 
to the traditional standardized food that is named in the statement of 
identity. Thus, comments that suggest changes in the definition of 
nutritional inferiority in Sec. 101.3(e) should also consider the 
effect of such changes on the labeling of foods covered by other 
regulations such as those mentioned here.

IV. Flavors

    FDA's flavor labeling regulation, Sec. 101.22 (21 CFR 101.22), has 
generated many questions over the years. Some representatives of the 
food industry have complained that this regulation is so complex that 
it is subject to a multitude of differing interpretations. In light of 
such complaints, FDA believes that it should attempt to revise this 
regulation to make it more user friendly and, at the same time, to make 
flavor designations on food labels more meaningful to consumers. 
Comments on the existing regulation will help the agency to achieve 
this goal.
    Section 101.22 lists a variety of characteristics that would make 
the flavoring used in a food either ``artificial'' or ``natural.'' The 
regulation does not, however, contain an adequate definition for either 
term. Before a firm can decide how to describe the flavoring used in 
its product, it may have to engage in a rather arduous analysis. For 
    In Sec. 101.22(a), FDA defines an ``artificial flavor'' or 
``artificial flavoring'' as any substance, the function of which is to 
impart flavor, which is not derived from a spice, fruit or fruit juice, 
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, 
leaf, or similar plant material, meat, fish, poultry, eggs, dairy 
products, or fermentation products thereof.  The term ``artificial 
flavor'' also includes those synthetic flavoring substances and 
adjuvants listed in Secs. 172.515(b) and 182.60 (21 CFR 172.515(b) and 
182.60) except where the flavors are derived from natural sources.
    This definition would be simpler if FDA could state that the term 
``artificial flavor'' generally connotes a synthetic source. However, 
the agency has traditionally viewed this term as having wider 
application than simply to synthetic substances. For example, FDA has 
advised that when a flavor from a natural source is used in a food 
product to simulate a flavor of a food other than the one from which 
the flavor is derived, the food to which the flavor is added must be 
labeled as ``artificially flavored'' (38 FR 20718, August 2, 1973). 
Thus, a ``lemon'' type pie, made with natural flavor derived 
predominantly from citrus products, could not be identified simply as 
``lemon pie'' without misleading the consumer. It must be labeled as 
``citrus pie'' or ``artificially flavored lemon pie.'' This position 
has led to considerable confusion because often manufacturers do not 
consider the end use of the flavoring, in addition to its source, in 
determining whether the food should be labeled as being ``artificially 
    Further, the exception in the definition of ``artificial flavor'' 
that permits substances that are listed as synthetic flavoring 
substances and adjuvants in Secs. 172.515(b) and 182.60 to be 
designated as ``natural'' when they are derived from ``natural 
sources'' has resulted in a very broad category of substances labeled 
as ``natural flavor.'' There is confusion regarding the interpretation 
of ``natural source'' in this context. Should this provision be 
retained? If so, how should it be phrased so that it can be interpreted 
    The agency's definition for ``natural flavor'' is also very 
complex. In Sec. 101.22(a)(3), FDA defines ``natural flavor'' or 
``natural flavoring'' as the essential oil, oleoresin, essence or 
extractive, protein hydrolysate, distillate, or any product of 
roasting, heating or enzymolysis, that contains the flavoring 
constituents derived from a spice, fruit or fruit juice, vegetable or 
vegetable juice, edible yeast, herb, bark, bud, root, leaf, or similar 
plant material, meat, seafood, poultry, eggs, dairy products, or 
fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors include natural 
essence or extractives obtained from plants

[[Page 29704]]

listed in 21 CFR 182.10, 182.20, 182.40, and 182.50 and part 184 (21 
CFR part 184) and such substances listed in 21 CFR 172.510.
    Recognizing that, with advances being made in the technology of 
flavor development, the distinctions established in its regulations and 
policy statements may need to be modified, FDA requests comments on 
whether and, if so, how the definitions of natural and artificial 
flavor should be revised. For example, if a substance from a natural 
source is used to produce an intermediate product that is further 
reacted with another substance from a natural source, e.g., hydrolyzed 
by use of enzymes or other substances, should the resultant flavor, 
which obviously differs from its original natural source, be permitted 
to be labeled as ``natural,'' or should the new flavoring compound be 
considered to be ``an artificial flavor'' because the new flavor is not 
native to the natural sources? Should hydrolysates and their reaction 
products continue to be considered as natural flavors? What about 
flavors produced by the Maillard reaction? Would it be better to define 
``natural flavor'' and simply provide that ``artificial flavor'' 
constitutes all flavor that does not fall within that definition, or 
vice versa? Does it make sense to simply abandon the distinction 
between ``artificial'' and ``natural'' flavoring as no longer being 
relevant to the interests and understanding of consumers and to simply 
provide for the use of the term ``flavor added'' on the principal 
display panel and as part of the ingredient list?
    In addition, FDA would like to focus attention on the designation 
of characterizing flavors on food labels in accordance with 
Sec. 101.22(i). This matter has provided another source of confusion. 
Section 101.22(i) provides that if the label or labeling or advertising 
makes any direct or indirect representations with respect to the 
primary recognizable flavors of a food, by word, vignette (e.g., by 
depiction of a fruit) or other means, or if for any reason the 
manufacturer or distributor of the food wishes to designate the type of 
flavor in the food other than through the statement of ingredients, 
such flavor shall be considered to be the characterizing flavor and 
shall be designated in the following way:
    1. If the food contains no artificial flavor that simulates, 
resembles, or reinforces the characterizing flavor, the name of the 
food on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor, 
e.g., ``vanilla,'' in letters not less than one-half the height of the 
letters used in the name of the food.
    2. If the food is one that is commonly expected to contain a 
characterizing food ingredient, e.g., strawberries in ``strawberry 
shortcake,'' and the food contains natural flavor derived from such 
ingredient, but the amount of the characterizing ingredient is 
insufficient to independently characterize the food, or the food 
contains no such ingredient, the name of the characterizing flavor may 
be immediately preceded by the word ``natural'' and shall be 
immediately followed by the word ``flavored'' in letters not less than 
one-half the height of the letters in the name of the characterizing 
flavor, e.g., ``natural strawberry flavored shortcake'' or ``strawberry 
flavored shortcake.'' --
    3. If none of the natural flavor used in the food is derived from 
the product whose flavor is simulated, the food in which the flavor is 
used shall be labeled either with the flavor of the product from which 
the flavor is derived or as ``artificially flavored.''
    4. If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor that 
simulates, resembles, or reinforces the characterizing flavor, the name 
of the food shall be immediately followed by the words ``with other 
natural flavor'' in letters not less than one-half the height of the 
letters used in the name of the characterizing flavor.
    5. If the food contains any artificial flavor that simulates, 
resembles, or reinforces the characterizing flavor, the name of the 
food on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor, 
in letters not less than one-half the height of the letters used in the 
name of the food, and the name of the characterizing flavor shall be 
accompanied by the words ``artificial'' or ``artificially flavored,'' 
in letters not less than one-half the height of the letters in the name 
of the characterizing flavor, e.g., ``artificial vanilla,'' 
``artificially flavored strawberry,'' or ``grape artificially 
    6. Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by Sec. 101.22(i) shall immediately and conspicuously 
precede or follow such name, without any intervening written, printed, 
or graphic matter, with certain exceptions.
    These provisions are so complex that it is not surprising that they 
have frequently been the cause of confusion and varying interpretations 
by both manufacturers and regulators. The regulation needs to be 
clarified. In addition, developments in food processing since the 
regulation was adopted have resulted in the manufacture of more diverse 
products using natural and artificial flavors.
    The agency requests comment on how the use of flavors should be 
declared on the food label. Some manufacturers have contended that 
declaration of natural and artificial flavors in the ingredient list is 
sufficient to inform consumers of their role in the food. FDA's 
position has been that consumers can be misled unless the 
characterizing flavor of the food is described as ``flavored'' when 
flavoring substances are needed to characterize the food. The agency's 
position has been that the term ``artificial'' should be used to 
describe the flavor unless it is a natural flavor and is from the same 
source as the flavor of the food.
    What is the best way to inform the consumer of the use and the role 
of a flavoring substance in a food? How should a combination of natural 
and artificial flavors be declared? The agency requests suggestions for 
revisions of Sec. 101.22(i) and substantiating information regarding 
why the suggested revisions are appropriate, and how they would affect 
marketing practices.
    Further, Sec. 101.22(i) requires that the flavor supplier certify, 
in writing, that any flavor it supplies that is designated as 
containing no artificial flavor does not, to the best of the supplier's 
knowledge and belief, contain any artificial flavor, and that the 
supplier has not added any artificial flavor to it. Although the agency 
is not aware of any concerns about labeling of flavors supplied to 
manufacturers, it requests comments on the suitability of these 

V. Infant Formula

    Part 107 (21 CFR part 107) provides for labeling of infant 
formulas, for terms and conditions that a manufacturer must meet with 
respect to exempt infant formulas, for required levels of nutrients in 
infant formulas as prescribed by statute, and for recalls of infant 
formulas in appropriate circumstances. Congress passed the Infant 
Formula Act of 1980 (the 1980 act) (Pub. L. 96-359), which amended the 
act to add section 412 (21 U.S.C. 350a). In 1985, FDA partially 
implemented the 1980 act by establishing subparts B, C, and D in part 
107 regarding the labeling of infant formula, exempt infant formulas, 
and nutrient requirements for infant

[[Page 29705]]

formula, respectively (50 FR 1833, January 14, 1985; 50 FR 48183, 
November 22, 1985; and 50 FR 45106, October 30, 1985). In 1986, 
Congress, as part of the Drug Enforcement, Education, and Control Act 
of 1986 (the 1986 amendments) (Pub. L. 99-570), completely revamped 
section 412 of the act to address concerns that had been expressed by 
Congress and consumers about the 1980 act and FDA's implementation of 
those provisions.
    In 1990, Congress passed the 1990 amendments which amended the act 
to add paragraphs (q) and (r) to section 403. While the 1990 amendments 
exempt infant formulas subject to section 412 of the act from the 
nutrition labeling provisions of section 403(q) of the act, only infant 
formulas subject to section 412(h) of the act (exempt infant formulas) 
are exempt from the nutrient content and health claims provisions of 
section 403(r).
    The agency is considering what changes need to be made to part 107 
in light of the 1986 and 1990 amendments to the act. Subpart D of part 
107-- Nutrient Requirements was not affected by either the 1986 or 1990 
amendments and is not being reconsidered under this review. In 1989, 
the agency responded to the provisions of the 1986 amendments on 
recalls by establishing subpart E in part 107--Infant Formula Recalls 
(54 FR 4006, January 27, 1989). To assist in the update of subparts B 
(Labeling) and C (Exempt Infant Formulas) of part 107, the agency 
requests comments on what matters need to be addressed.
    Section 412(h)(1) of the act states that ``any infant formula which 
is represented and labeled for use by an infant--(A) who has an inborn 
error of metabolism or a low birth weight, or (B) who otherwise has an 
unusual medical or dietary problem, is exempt from the requirements of 
* * *'' section 412(a) (adulteration provisions of the act for failure 
to meet the nutrient requirements of the act, failure to meet the 
quality factor requirements, and failure to process the infant formula 
in compliance with the good manufacturing practices and quality control 
procedures), (b) (quality factors and good manufacturing requirements 
including quality control procedures), and (c) (registration, 
submission, and notification requirements). Section 412(h)(2) of the 
act provides that the Secretary of Health and Human Services (and by 
delegation FDA) may by regulation establish terms and conditions for 
the exemption of an infant formula from the requirements of section 
412(a), (b), and (c).
    In 1980, the House Committee on Interstate and Foreign Commerce 
    The Committee recognizes the need to make special formulas 
available without the imposition of cumbersome regulations which may 
discourage formula manufacturers from committing resources into this 
vital public service. Conditions on exemptions promulgated under 
this authority should not make access to special formulas difficult. 
Instead, they should insure that such formulas are manufactured to 
the same high standards of quality required of formulas for normal 
infants. The Committee recognizes the importance of these products 
and the continued need to make them and new products like them, 
readily available to the public.
(H. Rept. 96-936, 96th Cong., 2d sess., 1980, p.10.)
    The agency is soliciting comment on what terms and conditions 
should be set for the exemption of an infant formula from the 
requirements of section 412(a), (b), and (c) of the act.
    In the past, FDA and infant formula manufacturers have disagreed on 
how to interpret section 412(h) of the act in light of the current 
regulations on exempt infant formula in Sec. 107.50. One manufacturer 
stated that the statute and regulations do not envision a premarket 
designation or clearance for exempt formulas. Another manufacturer 
asserted that section 412(h)(1) of the act exempts these formulas from 
section 412(c) (registration and submissions), and that 
Sec. 107.50(b)(4) only requires notification to FDA of any change in 
ingredients or processes that may result in an adverse impact on the 
levels of nutrients or on the availability of nutrients before the 
first processing of the infant formula. This manufacturer argued that, 
consequently, there is no requirement to give notice to the agency 90 
days before marketing any exempt infant formula that has been changed 
in formulation or processing.
    The agency has deep reservations about both of these industry 
assertions. The first would mean that infants who need an exempt 
formula, and who are by definition among the most vulnerable, would 
receive the least protection from the law. The second would raise 
significant questions about the agency's ability to carry out its 
mandate to ``insure that such formulas are manufactured to the same 
high standards of quality required of formulas for normal infants.'' 
The agency would be unable to do so unless it receives notification of 
``major changes'' in exempt infant formula at least 90 days before the 
marketing of the changed formula. The agency requests comment on what 
terms and conditions should be set for the exemption of an infant 
formula from the requirements of section 412(c) of the act 
(registration and submissions).
    Problems also have occurred in the regulation of infant formulas 
that meet the statutory definition of an exempt infant formula, i.e., 
formulas that are intended for infants who have an inborn error of 
metabolism or a low birth weight, or who otherwise have an unusual 
medical or dietary problem, but that do not need an exemption from any 
of the nutrient, quality factor, or good manufacturing requirements 
(including quality control procedures) of the act. In 1980, the House 
Committee on Interstate and Foreign Commerce stated that it recognized 
that infants suffering from special medical disorders, such as 
phenylketonuria, or severe kidney diseases, require formulas tailored 
specifically to their medical needs. The Committee recognized also the 
need to exempt these formulas from the nutritional standards applicable 
to formulas intended for normal, fullterm infants. (Id.)
However, infant formulas are now being developed that meet the 
nutritional standards applicable to formulas for normal, fullterm 
infants, i.e, the nutrient requirements of Sec. 107.100, but that are 
for infants with low birth weight or with unusual medical or dietary 
problems. Thus, these formulas apparently are exempt infant formulas 
under section 412(h) of the act. The agency requests comment on what 
terms and conditions should be set for the exemption of an infant 
formula from the requirements of section 412(a) of the act. Should 
infant formulas that are intended for special populations of infants 
but that meet the nutrient requirements of the act be exempted from 
being deemed to be adulterated if they do not meet the same quality 
factor requirements or good manufacturing practices and quality control 
procedures that are required of infant formulas for normal, fullterm 
infants? Should infant formulas that meet the definition in the act for 
an ``exempt infant formula'' be exempted from meeting the quality 
factor and good manufacturing practice requirements when they are fully 
capable of meeting these requirements?
    Current Sec. 107.50(b)(3) requires the submission of the label and 
other labeling in the notification required to retain the exempt status 
of an infant formula. Current Sec. 107.50(b)(3) further states that FDA 
will review the submitted information under Sec. 107.50(d), and current 
Sec. 107.50(d)(4) lists the criteria that FDA will use to determine 
whether a deviation from the requirements of subpart C of part 107 
(Exempt Infant Formulas) is necessary and will adequately protect the 

[[Page 29706]]

health. One such criterion is whether a deviation from the labeling 
requirements of subpart B of part 107 is necessary because, without an 
exemption, the label information, including pictograms and symbols, 
could lead to inappropriate use of the infant formula 
(Sec. 107.50(d)(4)(iii)).
    FDA has held that, for an exempt infant formula to be eligible to 
make label claims that deviate in any way from the requirements of 
subpart B of part 107, a firm must show that the labeling claims are 
necessary to ensure appropriate use of the product 
(Sec. 107.50(d)(4)(iii)), and that the public health will be adequately 
protected if these claims are made (Sec. 107.50(d)(4)). This showing 
must be made based on a persuasive medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies) (Sec. 107.50(b)(5)). The agency has held that failure 
to submit information that supports that an exemption is necessary to 
ensure the proper use of a formula, and failure to show that the public 
health will be adequately protected if such an exemption is continued, 
provide grounds for revoking the exempt status of a formula. Revoking 
the exempt status of a formula would mean that its label could not 
deviate in any way from the labeling requirements of subpart B of part 
107, and thus it would not be able to bear the claims in question. The 
agency solicits comments on any changes that need to be made to 
Sec. 107.50 (exempt infant formulas) to ensure that the labeling of 
these products will be consistent with the public health and will not 
lead to the inappropriate use of the product.
    The agency also solicits comments on any changes to subpart B of 
part 107 (Labeling) that may be necessary to ensure that exempt infant 
formulas are labeled appropriately. Further, the agency solicits 
comments on any changes that it needs to make in the regulations 
governing the labeling of exempt infant formulas to ensure that the 
representations made for these products are truthful and not 
misleading. The 1990 amendments exclude exempt infant formulas from the 
requirements on nutrition labeling, nutrient content claims, and health 
claims (section 403(q)(5)(A)(iii) and (r)(5)(A) of the act). The 
regulations issued in response to the 1990 amendments reflect this fact 
(Sec. 101.9(j)(7) (nutrition labeling), Sec. 101.13(q)(4) (nutrient 
content claims), and (Sec. 101.14(f)(1) (health claims)). The agency 
solicits comments on any changes that should be made to subpart B of 
part 107 (Labeling) to ensure that exempt infant formulas are labeled 
in a manner that will adequately protect the public health and that 
will ensure appropriate use of the product.

VI. Food Additive Regulations

    The agency has identified the following candidates for changes to 
make the regulations on food ingredients easier to understand and to 
consolidate certain existing regulations under a single listing to 
minimize redundancy.

A. Carrageenan, Carrageenan With Polysorbate 80, Salts of Carrageenan, 
Furcelleran, and Salts of Furcelleran

    In the Federal Register of October 6, 1961 (26 FR 9411 and 9412), 
FDA published final rules permitting the use of the food additives 
carrageenan, salts of carrageenan, furcelleran, and salts of 
furcelleran in food. The agency later published an additional final 
rule permitting the use of carrageenan processed with polysorbate 80 in 
food. The original food additive petitions requesting the use of 
carrageenan and furcelleran in food were submitted to FDA by competing 
producers of these two additives. Thus, the agency issued separate 
regulations for these additives even though there are similarities in 
the structure and functionality of carrageenan and furcelleran. It may 
now be appropriate to combine the regulations on carrageenan, salts of 
carrageenan, furcelleran, salts of furcelleran, and carrageenan with 
polysorbate 80 into a single regulation.
    Carrageenan and furcelleran are refined hydrocolloids that are 
produced by extraction of certain species of red seaweed in aqueous 
alkali, and they are regulated for use as emulsifiers, thickeners, and 
stabilizers in food under Secs. 172.620 and 172.660 (21 CFR 172.620 and 
172.660). The functional properties of carrageenan derive from the 
sulfated polysaccharide that is the major component of the additive. 
This polysaccharide is composed of galactose and anhydrogalactose 
hexose units.
    The primary difference between carrageenan as regulated under 
Sec. 172.620 and furcelleran as regulated under Sec. 172.660 is the 
degree of sulfation of the hexose units composing the polysaccharide. 
Furcelleran has a sulfate range of 8 to 19 percent on a dry weight 
basis, while carrageenan may have a sulfate content of between 20 and 
40 weight percent. The degree of sulfation of the additive is believed 
to be the determining factor regarding the additive's ability to bind 
to proteins and thus determines the additive's functionality in certain 
food applications, including dairy applications. In addition, the 
functionality of the carrageenan complying with Sec. 172.620 is known 
to vary with the seaweed species used to produce the additive and with 
the dominant cation in aqueous solutions of the additive. This 
variation reflects the level of three principal polysaccharide types in 
commercial carrageenan. These are known as kappa, iota, and lambda 
carrageenan and differ in the number and location of the sulfate groups 
on the hexose units.
    In commerce, carrageenan may consist of a relatively pure form of 
one of the three polysaccharides or a mixture of kappa, lambda, and 
iota polysaccharides along with cellulosic material, protein, and 
inorganic salts. The relative amounts of polysaccharides can vary 
naturally based on their content in the native seaweed, or carrageenan 
can be formulated from relatively pure kappa, lambda, and iota 
carrageenan either by processing or by seaweed choice. The ability to 
produce carrageenan consisting of relatively pure forms of one or the 
other of the polysaccharides facilitates the production of carrageenans 
with a wide variation in properties. Thus, the industry is able to 
develop carrageenans with specific properties for specific applications 
in food.
    The only distinguishing characteristics that FDA incorporated into 
the regulations for furcelleran and carrageenan were a limitation on 
the degree of sulfation for the polysaccharide that is the functional 
component of each additive and a listing of the different seaweed 
sources of the additives. The differing specifications (sulfate content 
and seaweed source) incorporated into the regulations for carrageenan 
and furcelleran were included solely to differentiate between these two 
similar additives. There is no safety concern regarding the sulfate 
content of the respective additives. Given this fact, there is no 
reason to distinguish between the additives on the basis of sulfate 
content, and no reason why the sulfate specifications for the two 
additives could not be combined in one regulation.
    The first detailed specifications that FDA adopted for furcelleran 
and carrageenan were the specifications included in the first edition 
of the Food Chemicals Codex (FCC). The specifications for furcelleran 
in the first edition of the FCC were identical to those for carrageenan 
except for the percent sulfate content of the additive and the listed 
seaweed sources. Subsequent editions of the FCC did not include a 
separate specification for

[[Page 29707]]

furcelleran, in part because the additive was so similar to carrageenan 
that it was generally considered as a form of carrageenan, and in part 
because the total use level of furcelleran was only a fraction of the 
use level of carrageenan. Indeed, the current specification for 
carrageenan adopted by the Food and Agriculture Organization/World 
Health Organization Joint Expert Committee on Food Additives (JECFA) 
includes the additive regulated in the United States as furcelleran. 
Therefore, inclusion of furcelleran under the U.S. regulation for 
carrageenan would be a step toward harmonizing U.S. regulations with 
the JECFA specification recognized internationally.
    When FDA issued separate regulations for salts of carrageenan and 
salts of furcelleran, the agency was primarily concerned about the 
possibility of economic deception resulting from an artificial increase 
of one or more of the inorganic salts that are typically components of 
these additives. In addition, the agency's concern in issuing a 
separate regulation for carrageenan with polysorbate 80 was to ensure 
that carrageenan processed with polysorbate 80 would be properly 
labeled. At the time the regulations for carrageenan, furcelleran, 
salts of carrageenan, salts of furcelleran, and carrageenan with 
polysorbate 80 were issued, the chemistry of carrageenan and of 
furcelleran was well known. At that time, it was known that the 
addition of salts containing one or another cation would alter 
significantly the gelation properties of given forms of the additive.
    The level of sophistication with which carrageenan and carrageenan-
like substances such as furcelleran are developed, marketed, and used 
reflects a high degree of understanding in the industry regarding the 
identity and functionality when used in food. Therefore, it may well be 
advantageous to simplify the regulation of salts of carrageenan, 
furcelleran, salts of furcelleran, and carrageenan with polysorbate 80 
by eliminating the separate regulations for these substances and by 
providing for all of them to be marketed as carrageenan. The agency is 
specifically soliciting comments regarding whether such a change should 
be made, and, if so, what changes to existing specifications, and what 
additional specifications, may be required in a regulation to permit 
the combining of referenced regulations.

B. Use of Metals in Contact With Food

    FDA is considering publishing a proposal to list, in 21 CFR part 
182, certain metals as generally recognized as safe (GRAS) for use in 
contact with food. In addition, FDA is considering ways to make 
publicly available those uses of metals that have been the subject of a 
favorable opinion letter issued by agency employees because of the 
insignificant potential for the metals to migrate into food.
    Historically, the use of metals as components of food-contact 
articles has generally resulted in low dietary exposure. The chemical 
inertness and hardness of many metals is such that there is little or 
no likelihood that the metal will migrate to food in other than 
insignificant amounts. In addition, because metals are typically used 
in the manufacture of repeat-use articles, the concentration of any 
migrant would be extremely low because of the large volume of food 
    While FDA employees have issued opinion letters over the past three 
decades on the agency's lack of safety concern about the low exposure 
from such uses of metals, this information has not been made publicly 
available in any sort of systematic and widespread way. As a result, 
the agency continues to receive inquiries on the same metals that have 
been previously found to be acceptable for use in contact with food, 
either because their use is GRAS, or because the potential for them to 
migrate to food is insignificant.
    To help alleviate this situation, the agency is considering whether 
to list in part 182 those metals that FDA has stated in opinion letters 
are GRAS for use as indirect food additives. FDA has reviewed its files 
and is aware of opinion letters stating that the following metals are 
GRAS for use in contact with food: Aluminum and aluminum foil; 
stainless steel (grades 302, 303, 304, 304F, 316, 321); 416 and 440C 
stainless steel for use as a ring on filter bags; tin plate; and iron 
for food contact use in breweries.
    The agency is interested in information on whether other metals are 
GRAS when used in contact with food and the basis for such a finding.
    In addition to the metals listed above, the agency is aware of 
opinion letters that have been written by agency employees on various 
metals agreeing that their use as a component of food-contact articles 
would not require a food additive petition or regulation because of an 
insignificant potential for migration to food. FDA has considered that, 
in some cases, the composition of some of the metal alloys that have 
been the subject of such letters may be confidential information. The 
agency is interested in comments on what procedures for making such 
letters publicly available would be most effective as well as in 
information that would help it to determine whether data in such 
letters, such as the composition of alloys, are confidential, and thus 
not releasable, or are common information that can be made public.
    FDA invites public comment on all of these matters.

VII. Interstate Conveyance Sanitation (21 CFR Part 1250)

    FDA regulates the construction and operation of conveyances 
(trains, planes, buses, and vessels) in interstate traffic under parts 
1240 and 1250 (21 CFR parts 1240 and 1250) of its regulations. These 
regulations cover environmental health and food safety requirements for 
the conveyances themselves, including their water and waste systems. 
They also cover the conveyance servicing areas and vehicles used for 
boarding drinking water and food and for offloading wastes.
    In Sec. 1250.93, FDA focuses on vessels operating in fresh water 
lakes and rivers and specifically prohibits the discharge of sewage and 
ballast or bilge water within areas adjacent to domestic water intakes.

C. Concerns

    1. FDA regulates vessels in interstate traffic that operate in both 
fresh and salt waters.
    2. These vessels generate several waste streams involving both 
liquid and solid wastes. Improper disposal of some of these wastes have 
important public health implications beyond the possible contamination 
of public drinking water supplies addressed by the existing regulation. 
One example is the possible contamination of molluscan shellfish 
growing and harvesting areas, which is of concern because shellfish are 
often consumed raw.
    3. The National Research Council's Marine Board and its Committee 
on Shipborne Wastes, on September 6, 1995, released a new report 
entitled ``Clean Ships, Clean Ports, Clean Oceans: Controlling Garbage 
and Plastic Wastes at Sea.'' The report concludes that U.S. activities 
to implement the provisions of the International Convention for the 
Prevention of Pollution from Ships (1973) and its 1978 protocol are far 
from complete and effective.
    The report recommends interagency cooperation among relevant 
Federal agencies to promote a systems approach to enhance total 
management and control of vessel wastes in nine specific maritime 
sectors. One of these sectors is passenger day boats, casino ships, and 
ferries, over which FDA has regulatory

[[Page 29708]]

responsibility under the Public Health Service Act.
    Lead Federal agencies in the matter of controlling shipborne wastes 
include the U. S. Coast Guard and the Environmental Protection Agency. 
Other Federal agencies involved include the Department of State, the 
National Oceanic and Atmospheric Administration and its National Marine 
Fisheries Service, the United States Department of Agriculture's Animal 
and Plant Health Inspection Service, and the Maritime Administration.

D. Request for Information

    FDA is considering proposing to revise Sec. 1250.93 of the 
Interstate Travel Sanitation regulations to prohibit discharges that 
would pollute salt water and shellfish growing areas as well as fresh 
water. Other agency objectives include harmonizing FDA's vessel waste 
control requirements with those of other Federal agencies and 
contributing to meeting U. S. obligations under ratified international 
agreements. FDA requests information on what changes could be made to 
Sec. 1250.93 to assist the agency in establishing standards for 
discharges of waste from passenger boats, casino ships, and ferries. 
The agency requests information on the effects that any suggested 
changes would have on the waste discharge practices of affected 

VIII. Comments

    Interested persons may, on or before September 10, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this ANPRM. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-14888 Filed 6-7-96; 12:17 pm]