[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
revoke.
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\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.
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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
crabmeat.''
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
example:
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
flavored.''
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
consistently?
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
flavored.''
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
requirements.
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
stated:
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
public
[[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
processed.
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
vessels.
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]
BILLING CODE 4160-01-F
