[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Proposed Rules]
[Pages 29708-29711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14887]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 101 and 730
[Docket No. 96N-0174]
RIN 0910-AA69
Food and Cosmetic Labeling; Revocation of Certain Regulations;
Opportunity for Public Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke
certain regulations that appear to be obsolete. These regulations have
been identified for revocation as a result of a page-by-page review of
the agency's regulations that FDA conducted in response to the Clinton
administration's ``Reinventing Government'' initiative, which seeks to
streamline Government to ease the burden on regulated industry and
consumers. The agency is providing an opportunity for comments on this
proposed rule.
DATES: Written comments by August 26, 1996. The agency is proposing
that any final rule that may issue based upon this proposal become
effective 75 days following date of publication of the final rule.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
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, 1995, 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are outdated or otherwise in need of reform.''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 (see, e.g., 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
its review of its food and cosmetic regulations in response to the
President's initiative and as a result is publishing two documents in
this issue of the Federal Register. This document announces additional
regulations that FDA is proposing to eliminate or revise, and the
second document is an ANPRM that seeks information on other food and
cosmetic regulations that appear to be in need of revision.
II. The Proposal
A. Food Labeling Regulations
FDA has identified several food labeling regulations in part 101
(21 CFR part 101) as candidates for revocation or revision and is
seeking comments from interested parties regarding its tentative
conclusions on these matters. The following is a list of those
regulations and the agency's tentative conclusions concerning the
needed changes:
1. Section 101.2 Information panel of package form food
In Sec. 101.2, paragraph (a) defines the term ``information panel''
as it applies to packaged food, and in paragraph (b), the regulation
provides that all information required to appear on the label of any
package of food under certain referenced regulations appear either on
the principal display panel or on the information panel unless
otherwise specified in the regulations. The referenced regulations are:
Sec. 101.4 Food; designation of ingredients, Sec. 101.5 Food; name and
place of business of manufacturer, packer, or distributor), Sec. 101.8
Labeling of food with number of servings, Sec. 101.9 Nutrition labeling
of food, Sec. 101.12 Reference amounts customarily consumed per eating
occasion, Sec. 101.13 Nutrient content claims general principles,
Sec. 101.17 Food labeling warning and notice statements, Part 101--
Subpart D--Specific requirements for nutrient content claims, and Part
105--Foods for special dietary use (21 CFR 105). Paragraph (c) of
Sec. 101.2 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. Paragraph (c) of
Sec. 101.2 also provides exemptions to this type size requirement. FDA
tentatively concludes that certain of these exemptions are obsolete.
a. Exemptions for small packages
There are exemptions in paragraphs (c)(1) through (c)(3) of
Sec. 101.2 for small packages (defined according to the surface area
available to bear labeling). These exemptions were established before
the enactment of the Nutrition Labeling and Education Act of 1990 (the
1990 amendments) (Pub. L. 101-535). They were designed to encourage
firms to provide nutrition information in accordance with Sec. 101.9,
as well as a full list of ingredients in accordance with the
regulations in Sec. 101.4 and the agency's policy regarding declaration
of ingredients on standardized foods as set out in Sec. 101.6 (see 39
FR 15268, May 2, 1974). Before the enactment of the 1990
[[Page 29709]]
amendments, nutrition information was voluntary unless a nutrient was
added to the food or a claim about the nutrient content of the food was
made in its labeling. The agency also did not have authority under the
Federal Food, Drug, and Cosmetic Act (the act) to require that all
ingredients used in standardized foods be declared on the label.
The 1990 amendments amended the act to provide for, among other
things, mandatory nutrition labeling of foods and complete ingredient
listing on all foods. As a result, FDA amended its nutrition labeling
regulations in a number of significant respects, including specifying
minimum type sizes and formats for presenting the nutrition information
on the label (Sec. 101.9). The amended nutrition labeling regulations
include exemptions from the new minimum type size requirements,
depending on the particular format being used and the label space
available to bear the information.
Also, in response to the 1990 amendments, FDA revised the
definitions and standards of identity for foods in parts 131 to 169 (21
CFR parts 131 to 169) to reflect the requirement that all food
ingredients, including the mandatory ingredients of standardized foods,
be listed on the label and Sec. 101.6 be revoked (58 FR 2850 and 2888,
January 6, 1993).
Because the purpose of Sec. 101.2(c)(1), (c)(2), and (c)(3) was to
encourage voluntary declaration of ingredients and nutrition
information on food, FDA has tentatively concluded that they are no
longer needed. Nutrition labeling is now required on most foods, and
the regulations now in effect provide for flexibility in presentation
of the information where space is limited. Declaration of all
ingredients in standardized foods is also required. Because the
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) are obsolete, FDA is
proposing to revoke them. If any interested person believes that there
is a need to retain any of the exemptions, he or she should submit
comments explaining that need in response to this proposal. Comments
supporting retention of any of these exemptions should include
information on specific products for which other type size exemptions
are inadequate.
b. Nonretail Individual Serving Size Packages
Section 101.2(c)(5) provides that individual serving size packages
of food served with meals in restaurants, institutions, and on board
passenger carriers, and not intended for sale at retail, are exempt
from the type-size requirements of Sec. 101.2(c) under the following
conditions:
(i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of one-sixteenth inch in
height;
(iii) The label information includes a full list of ingredients in
accordance with regulations in part 101 and the policy expressed in
Sec. 101.6; and
(iv) The information required by Sec. 101.2 (b) appears on the
label in accordance with the provisions of this paragraph, except that
the type size is not less than one thirty-second inch in height.
Because declaration of all ingredients in standardized foods is now
required, and Sec. 101.6 has been revoked, reference to Sec. 101.6 is
no longer meaningful. Therefore, FDA is proposing to delete that
reference from Sec. 101.2(c)(5). Specifically, FDA is proposing to
revoke paragraph Sec. 101.2(c)(5)(iii) and redesignate paragraph
(5)(iv) as (5)(iii).
2. Section 101.8 Labeling of foods with number of servings
Section 101.8(a) requires that any package of food that bears a
representation as to the number of servings contained in such package
bear in immediate conjunction with such statement, and in the same size
type as is used for such statement, a statement of the net quantity (in
terms of weight, measure, or numerical count) of each such serving.
However, such statement may be expressed in terms that differ from the
terms used in the required statement of net quantity of contents (for
example, in cups or tablespoons rather than in avoirdupois ounces) when
such differing term is common to cookery and describes a constant
quantity. This paragraph also requires that the statement not be
misleading in any particular. It goes on to state that where nutrition
labeling information is required in accordance with the provisions of
Sec. 101.9, the statement of the net quantity of each serving shall be
consistent with the requirements for serving size expression set forth
in that section (e.g., 10 1-cup (240 milliliters) servings). The
provision also states that a statement of the number of units in a
package is not in itself a statement of the number of servings.
Paragraph (b) of this regulation (Sec. 101.8(b)) provides that, if
there exists a voluntary product standard issued by the Department of
Commerce under the procedures found in 15 CFR part 10, that
quantitatively defines the meaning of the term ``serving'' with respect
to a particular food, then any label representation as to the number of
servings in such packaged food shall correspond with such quantitative
definition. It also states that, ``Copies of published standards are
available upon request from the National Bureau of Standards,
Department of Commerce, Washington, DC 20234.''
The agency has tentatively concluded, based on two factors, that
this regulation is obsolete. The first factor is that the description
of how serving size information should appear on food labels in
Sec. 101.8(a) has been obviated by the recent extensive changes in
FDA's regulations governing mandatory nutrition labeling of foods that
the agency adopted in response to the 1990 amendments. Section 101.9
requires that quantitative nutrition information be declared in
relation to a serving of the food as defined in paragraph (b)(1) of
that section. Section 101.9(b)(1) defines a ``serving'' or ``serving
size'' for the purpose of these regulations as the amount of food,
expressed in a common household measure that is appropriate for the
food, customarily consumed per eating occasion by persons 4 years of
age and older. When the food is specially formulated or processed for
use by infants or by toddlers, a serving or serving size means an
amount of food customarily consumed per eating occasion by infants up
to 12 months of age or by children 1 through 3 years of age,
respectively. Section 101.9(b) also provides specific guidance as to
how the serving or serving size is to be determined for various food
products. Section Sec. 101.12 specifies the reference amount
customarily consumed per eating occasion for 139 food product
categories and requires the declaration of the serving in terms of
metric units and familiar household measures. Among other things, the
serving size regulation provides criteria for determining the serving
size based on the reference amount for the food category, thereby
ensuring that reasonable and uniform serving sizes will be used in
product labeling. Such uniformity in food labeling enhances consumers'
ability to make nutrition comparisons among foods. With Sec. 101.8(a),
however, there is not the same specificity for determining appropriate
serving sizes. Consequently, there is far less assurance under
Sec. 101.8(a) than under Sec. 101.9 that uniform serving sizes will
appear on similar products. Therefore, FDA is proposing to revoke
Sec. 101.8(a).
The second factor is that FDA is aware of no need to continue the
reference in Sec. 101.8(b) to ``voluntary product standards issued by
the
[[Page 29710]]
National Bureau of Standards of the Department of Commerce (DOC)'' that
quantitatively define the meaning of the term ``serving.'' (The agency
notes that the National Bureau of Standards is now known as the
National Institute of Standards and Technology (NIST)). NIST has
advised (Ref. 1) FDA that it no longer issues voluntary product
standards, and it has been withdrawing its voluntary serving size
standards for FDA-regulated food products for some time. NIST stated
that its only standard for an FDA-regulated commodity is one for
carbonated soft drink bottles and that standard is about to be
withdrawn. Therefore, FDA is proposing to revoke Sec. 101.8(b).
3. Section 101.29 Labeling of kosher and kosher-style foods
Section 101.29 is a statement of informal agency policy regarding
the use of the terms ``kosher'' and ``kosher style'' in the labeling of
food products. This policy was excerpted from agency correspondence and
codified in part 101 (formerly codified as Sec. 3.302, see 22 FR 9593
at page 9594, November 30, 1957) because the agency believed that it
was of general interest to the public. Because it was not established
through rulemaking procedures, this provision serves only as guidance
and does not have the force and effect of law. If these terms are used
in a manner that would render the product misbranded, the agency could
take action against such products under section 403(a) of the act (21
U.S.C. 343(a)). Although Sec. 101.29 could be removed without notice
and comment rulemaking, FDA is proposing to remove it in this document
to ensure that its decision is as informed as possible. The agency also
solicits comments on whether it should prepare a Compliance Policy
Guide that reflects the policy that has been codified in Sec. 101.29.
Compliance Policy Guides are used by FDA as informal guidance in
evaluating products and accompanying label statements and in
recommending regulatory actions for efficient enforcement of the act.
B. Cosmetic Regulations (Part 730--21 CFR 730)
Parts 710, 720, and 730 (21 CFR parts 710, 720, and 730) of FDA's
regulations provide for the Voluntary Cosmetic Reporting Program (VCRP)
for the voluntary submission of information relating to cosmetic
products. Part 730 of this program provides for the voluntary filing of
cosmetic product experience reports (VCPE) by the cosmetics industry.
In the Federal Register of October 17, 1973 (38 FR 28914), FDA, in
response to a petition from the Cosmetic, Toiletry and Fragrance
Association, Inc. (CTFA), issued regulations for the voluntary filing
of cosmetic product experiences. The petitioner believed that the VCPE
would serve: ``(1) To provide reliable baseline information against
which to assess or evaluate products or their ingredients, and (2)
prompt information where specific public health questions may be
presented.'' The regulation was implemented in 1974 as the Voluntary
Cosmetic Experience Program. FDA recodified these regulations in 1974
(39 FR 10054, 10062, March 15, 1974) and modified them in 1981 (46 FR
38073, July 24, 1981) and 1986 (51 FR 25687, July 16, 1986).
During the 23 years the CVRP has been in place, companies have
submitted information about adverse reactions that consumers have
reported to them. FDA has performed a statistical assessment of the
data to calculate the ``baseline'' adverse reactions (expected number
of reactions per million units distributed) that occur for the
different cosmetic product categories identified in the program.
While the VCPE has provided useful information regarding relative
adverse reaction baseline rates, it has suffered from some serious
limitations. Industry participation in this portion of the program has
historically been very limited and selective, the reports lack
sufficient details to be useful, and annual reports are sent in long
after the occurrence of an adverse reaction. This limited participation
has persisted even though the program has been modified several times
over the years to make it easier for companies to participate. In this
regard, the VCPE provides a false impression about the ability of the
voluntary program to ensure the safety of cosmetics. Thus, the VCPE
program no longer provides any new information about cosmetic adverse
reactions, and it no longer serves the important purpose of helping to
find harmful cosmetics and to remove them from the marketplace.
With current budgetary constraints on FDA, it is difficult to
justify the continuation of a program that does not contribute directly
to increasing the safety of cosmetics or protecting the public health.
Adding data to the information that FDA has obtained over 20 years
about baseline adverse reaction rates will be unlikely to have any
value. Thus, FDA is proposing to revoke part 730. FDA intends to
perform a thorough evaluation of information received over the years
and will prepare an in-depth report that will be useful to both the
cosmetic industry and the public in understanding adverse reaction
trends for different product categories and the baseline rates of
adverse reactions. Companies will be able to use this in-depth report
for assessing their own individual products without having to report
their information to FDA.
The agency is interested in comments on whether the VCPE should be
eliminated in its entirety, reduced in scope, or some other
alternative. For example, one alternative would be to revoke part 730
but maintain the availability of reporting forms or other means of
access ( e.g., electronic). These forms could be used for the prompt
reporting of any unusually severe adverse reactions or for reporting an
unusually high number of adverse reactions of moderate severity. In
addition to comments on the issues discussed in this proposal, FDA
requests comments on any other related matters that would assist FDA in
fulfilling its mission to protect the interests of consumers.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) and (a)(8),
respectively, that the actions to revoke or revise several food
labeling regulations in part 101, and to eliminate or modify part 730
of the cosmetic regulations, are of a type that do not individually or
cumulatively have a significant effect on the environment. Therefore,
neither an environmental assessment nor an environmental impact
statement is required.
IV. Economic Impact
FDA has examined the economic impact of the proposed rule as
required by Executive Order 12866 and the Regulatory Flexibility Act
(Pub. L. 96-354). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health, safety, distributive, and equity effects). The Regulatory
Flexibility Act requires analyzing options for regulatory relief for
small businesses. FDA finds that the proposed rule does not constitute
a major rule as defined by Executive Order 12866. FDA also finds that
the proposed rule will not have a significant impact on small
businesses.
The proposed rule will remove or revise several provisions in part
101 and all of part 730. The proposed removals include: (1) Certain
type-size exemptions, (2) the labeling of foods with number of servings
other than as specified in the 1990 amendments, (3) guidance on use of
the term ``kosher'',
[[Page 29711]]
and (4) elimination of the Voluntary Cosmetic Experience Program.
Except for the ``kosher'' guidance, all of the targeted provisions have
been rendered obsolete or counterproductive by more recent regulations
and other changes. The ``kosher'' guidance is not obsolete, but, as
mentioned earlier in this preamble, because it does not have the force
and effect of law, it is not necessary for it to be codified in Title
21.
FDA anticipates that the labeling provisions of the proposed rule
will not change the availability of health and safety information to
consumers. Although some labels may change as a result of revising
Sec. 101.2(c) and removing Sec. 101.8, the main effect of the proposal
will be to make FDA's regulations less complicated and easier to
follow. Removing the kosher labeling guidance in Sec. 101.29 should not
affect information used for religious purposes because the agency will
still be providing the same guidance but most likely in the form of an
FDA Compliance Policy Guide. Any information loss that might result
would likely arise from recognition by the affected industry that the
policy does not carry the force and effect of law. Nevertheless, such a
loss would not affect health or safety.
FDA estimates the economic effects of labeling with a general model
described in the November 27, 1991 Federal Register (56 FR 60856). The
net benefits of labeling rules are the difference between the benefits
to consumers of the information on labels and the cost to producers
(and, ultimately, to consumers) of providing that information. The
benefits from labeling can be estimated to be the monetary value of the
health and safety improvements that can be attributed to better-
informed consumers. The costs of labeling regulations include
administrative, analytical, printing, inventory, and product
reformulation costs. FDA believes that the proposed labeling revisions
will not reduce the nutrition and safety information available to
consumers. The health and safety benefits from the labeling rules in
part 101 therefore will not change.
The primary economic effect of the proposal will be changes in
costs. FDA expects compliance costs of labeling to decline, mainly
because the proposed rule will reduce administrative costs. The
administrative costs include interpreting labeling regulations and
determining how they apply to individual products. The more complicated
and confusing the regulations, the more costly it is to interpret them.
For example, the existence of type size exemptions in Sec. 101.2(c)
that differ from those in Sec. 101.9 forces firms to study both
sections before determining how the rules apply to their products. Even
if there were no differences in labeling requirements between sections,
firms would have to interpret both sections to assure themselves
perhaps at considerable cost, that no differences exist.
By streamlining and consolidating labeling rules, the labeling
directions in part 101 will be more user friendly, which in turn will
substantially reduce compliance costs. Although FDA does not possess
enough data to quantify the reduction in costs, the agency is confident
that the compliance cost of labeling regulations will indeed fall as a
result of the proposal.
Eliminating voluntary cosmetic experience reporting will generate
net benefits by reducing costs. FDA receives an average of 125
submissions annually from firms in the industry. The annual cost to FDA
of reviewing, evaluating, summarizing, and storing the experience
reports is approximately $12,000. The annual cost to participating
firms is approximately $12,000. Eliminating the program would therefore
reduce annual agency and industry costs by approximately $24,000,
without affecting public health. FDA tentatively concludes that because
it will reduce the costs but not the benefits of labeling and voluntary
reporting regulations, the proposed rule will generate positive net
benefits. FDA finds no reason to expect the proposal to impose burdens
on small businesses, whose compliance costs could fall.
V. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling or other third party disclosure
requirements. Thus there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is asking for comment on
whether this proposed rule to revoke certain regulations that it
believes are obsolete imposes any paperwork burden.
IV. References
The following reference has been placed on display in the Dockets
Management Brance (HFA-305, Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum to James Taylor, Center for Food Safety and
Applied Nutrition, FDA, from Joan Roenig, the National Institutes of
Standards and Technology, April 2, 1996.
List of Subjects
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
21 CFR Part 730
Cosmetics, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 101 and 730 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.2 Information panel of package form food is amended
by removing paragraphs (c)(1) through (c)(3) and (c)(5)(iii); and by
redesignating paragraphs (c)(4) and (c)(5) as paragraphs (c)(1) and
(c)(2) respectively.
Sec. 101.8 [Removed]
3. Section 101.8 Labeling of food with number of servings is
removed.
Sec. 101.29 [Removed]
4. Section 101.29 Labeling kosher and kosher-style foods is
removed.
PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES
Part 730 [Removed]
5. Part 730 is amended by removing it in its entirety.
Dated: May 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-14887 Filed 6-10-96; 12:17 pm]
BILLING CODE 4160-01-F
