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[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are outdated or otherwise in need of reform.''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
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