[Federal Register Volume 62, Number 155 (Tuesday, August 12, 1997)]
[Rules and Regulations]
[Pages 43071-43075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 101 and 730
[Docket No. 96N-0174]
RIN 0910-AA69
Food and Cosmetic Labeling; Revocation of Certain Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revoking certain
regulations that are obsolete. These regulations have been identified
for revocation as the result of a page-by-page review of the agency's
regulations. This review is in response to the Administration's
``Reinventing Government'' initiative which seeks to streamline
Government to ease the burden on regulated industry and consumers.
DATES: This final rule will become effective September 11, 1997.
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: Felicia B. Satchell, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of 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outdated or otherwise in need of reform.''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 has revoked a number of
regulations through notice and comment rulemaking (e.g., 61 FR 58991,
November 20, 1996; 61 FR 27771, June 3, 1996) and issued proposals to
revoke additional regulations (e.g., 60 FR 53480, October 13, 1995; 60
FR 56513 and 56541, November 9, 1995; and 61 FR 29708, June 12, 1996).
FDA has also issued two advance notices of proposed rulemaking to
review standards of identity and other existing regulations to
determine whether these regulations should also be considered for
revocation or revision (e.g., 60 FR 67492, December 29, 1995; and 61 FR
29701, June 12, 1996). This document responds to comments submitted to
its proposal entitled ``Food and Cosmetic Labeling; Revocation of
Certain Regulations; Opportunity for Public Comment,'' which published
in the Federal Register of June 12, 1996 (61 FR 29708) (hereinafter
referred to as the June 12 revocation proposal).
FDA received 11 letters in response to the June 12 revocation
proposal. Each letter contained one or more comments. The letters were
from industry trade associations, academia, and consumer organizations.
Some comments supported various provisions of the proposal. Other
comments objected to the revocation of certain regulations. A summary
of the comments and the agency's responses to the comments follow.
II. Food Labeling Regulations
A. Information Panel of Package Form Food (Sec. 101.2)
This regulation, in paragraph (a), defines the term ``information
panel'' as it applies to packaged food, and in paragraph (b) provides
that all information required to appear on the label of any package of
food under certain referenced regulations shall appear either on the
principal display panel or on the information panel, unless otherwise
specified in the regulations. The referenced regulations are in part
101 (21 CFR part 101) and part 105 (21 CFR part 105) and are as
follows: 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, subpart D of part 101, Specific Requirements for Nutrient
Content Claims, and Part 105--Foods for Special Dietary Use. 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. However, Sec. 101.2(c)
also contains exemptions to this type-size requirement. FDA tentatively
concluded in the June 12 revocation proposal that several of the
exemptions are now obsolete and should be revoked.
1. Exemptions for Small Packages
Specifically, FDA proposed to revoke Sec. 101.2(c)(1), (c)(2), and
(c)(3). The exemptions set out in these paragraphs are for small
packages (defined according to the surface area available to bear
labeling) and were established before the enactment of the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). As fully discussed in the June 12 revocation proposal, these
exemptions were designed to encourage firms to voluntarily provide
nutrition information in accordance with Sec. 101.9 and a full list of
ingredients in accordance with the regulations in part 101, which was
voluntary on some standardized foods before the enactment of the 1990
amendments. However, as a result of the 1990 amendments, nutrition
labeling and full ingredient labeling is now required on most foods,
and the agency has made specific provision for flexibility in the
presentation of this information where space is limited.
For these reasons, the agency tentatively concluded in the June 12
revocation proposal that the exemptions in Sec. 101.2(c)(1), (c)(2),
and (c)(3) were now obsolete and should be revoked. Also in that
document, FDA solicited comments on the need to retain any of these
exemptions and stated that comments supporting retention of any of
these exemptions should include information on specific products for
which other type size exemptions are inadequate.
1. Two comments addressed the proposed revocation of
Sec. 101.2(c)(1), (c)(2), and (c)(3). One of these comments supported
revocation of the exemptions.
[[Page 43072]]
The other comment opposed revocation of the exemptions and disagreed
with the rationale the agency presented in the proposal for revoking
them. The comment contended that nutrition labeling has been mandatory
for many food products since the early 1970's, often because of the
addition of a nutrient or use of a nutrition claim. Further, the
comment argued that the impact of making the disclosure of ingredients
in standardized food mandatory rather than voluntary has been
exceedingly small. The comment also pointed out that the type size
exemptions issued under the 1990 amendments apply only to nutrition
labeling and not to the other mandatory label information, such as
ingredient labeling. Consequently, the comment argued, unless the
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) are retained,
mandatory information other than nutrition labeling will be required to
appear in one-sixteenth inch type, even where this cannot realistically
be accomplished. The comment urged the agency to retain the type-size
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3).
The agency has not been persuaded by the latter comment that the
exemptions in Sec. 101.2(c)(1), (c)(2), and (c)(3) should be retained.
The comment did not provide any information, as requested in the June
12 revocation proposal, on specific products for which the other type
size exemptions provided in FDA's regulations (e.g., Sec. 101.2(c)(5))
are inadequate. Nor did the comment point to any specific products that
could not realistically bear the mandatory information in one-sixteenth
inch type. Furthermore, the agency has not been presented with
information suggesting that revocation of these exemptions would cause
an economic burden on the industry because of the need to redesign
packaging or print new labels. In the absence of such information, and
for the reasons cited in the proposal, the agency concludes that the
exemptions are now obsolete. Accordingly, FDA is revoking
Sec. 101.2(c)(1), (c)(2), and (c)(3), as proposed.
2. 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 certain
described conditions. Because declaration of all ingredients in
standardized foods is now required, reference to Sec. 101.6 is no
longer appropriate. Consequently, FDA proposed to revise Sec. 101.2 by
revoking paragraph (c)(5)(iii).
2. The comments addressing this issue supported revocation of
Sec. 101.2(c)(5)(iii). Accordingly, FDA is revoking
Sec. 101.2(c)(5)(iii) and redesignating paragraph (c)(5)(iv) as
paragraph (c)(5)(iii). The agency points out that revocation of
existing Sec. 101.2(c)(5)(iii) would not eliminate any ingredient
listing requirements for nonretail individual serving size packages
because this proposal does not pertain to any provisions of Sec. 101.4.
B. Labeling of Foods With Number of Servings (Sec. 101.8)
The regulation in Sec. 101.8(a) requires, among other things, that
any package of a food that bears a representation as to the number of
servings contained in the 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, the latter
statement may be expressed in terms that differ from the terms used in
the required statement of net quantity of contents (for example, cups,
tablespoons) when such differing term is common to cookery and
describes a constant quantity.
FDA tentatively concluded in the June 12 revocation proposal that
this regulation was obsolete in light of the mandatory nutrition
labeling provisions in Sec. 101.9. As discussed in the June 12
revocation proposal, Sec. 101.9 defines a ``serving'' or ``serving
size'' for the purpose of nutrition labeling 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. Section 101.9 also gives guidance for determining
serving size when the food is specially formulated or processed for use
by infants or by toddlers. Thus, FDA proposed to revoke Sec. 101.8.
3. All of the comments responding to this issue agreed that FDA's
regulations governing mandatory nutrition labeling of foods which, in
Sec. 101.12, establish serving sizes for foods based on the reference
amounts customarily consumed per eating occasion, render the provisions
in Sec. 101.8 obsolete. Accordingly, as proposed, FDA is revoking
Sec. 101.8. FDA advises, however, that manufacturers are expected to
continue to adhere to its guidance that statements concerning the
number of servings in a package that are presented in locations other
than as part of the nutrition information be in the same terms as those
that are used to express the serving size as part of the nutrition
information. To do otherwise may render the labeling information
misleading to consumers.
To conform its regulations to the revocation of Sec. 101.8, FDA is
removing the reference to Sec. 101.8 in Sec. 101.2(b) and (f).
C. Labeling of Kosher and Kosher-Style Foods (Sec. 101.29)
Section 101.29 of FDA's regulations is a statement of informal
agency policy regarding the use of the terms ``kosher'' and ``kosher-
style'' in the labeling of food products. Because this section only
provides guidance and was not established through rulemaking, it does
not have the force and effect of law. Furthermore, because the use of
the terms ``kosher'' and ``kosher-style'' is, in fact, governed under
the general misbranding provisions of the act, FDA proposed in the June
12 revocation proposal to remove this section. In addition, the agency
solicited comments on whether it should prepare a Compliance Policy
Guide (CPG) (an FDA informal guidance document used for efficient
enforcement of the act) that reflects the policy that has been codified
in Sec. 101.29.
4. Six comments addressed the proposed revocation of Sec. 101.29.
Two of these comments supported the removal of Sec. 101.29. Both
comments noted that FDA has not traditionally sought to regulate kosher
food labeling. These comments opined that religious authorities are
well-equipped to police the use of ``kosher'' and other religious
terminology in food labeling. Furthermore, these two comments
questioned the constitutionality of any FDA action in this area.
Finally, the comments urged that the agency not republish Sec. 101.29
or any other policy regarding kosher labeling as a CPG.
Several other comments supported maintaining a written policy on
the use of these terms. These comments contended that it is appropriate
for the agency to concern itself with the proper use of the terms
``kosher'' and ``kosher-style'' on food labels because without such
guidance, the potential for misuse of these terms would undoubtedly
increase, resulting in significant consumer deception. Two of these
comments supported retaining this policy in the form of a CPG. Further,
one comment suggested that even as a CPG, Sec. 101.29 did not go far
enough in providing guidance to the industry or in providing adequate
information to the consumer. Accordingly, the comment requested that as
a part of a CPG, FDA create and maintain a certificate for
[[Page 43073]]
domestic and imported products that contains information regarding the
manufacturer, certifying Rabbi and organization, effective dates of the
certificate, and symbols used in product labeling. The comment opined
that such a certificate, publicly available upon request, could greatly
assist consumers in deciding whether the food in question meets their
personal needs, because they would have access to information
identifying not only the manufacturer but also the certifying
organization. The comment further suggested that having a certificate
on file could reduce difficulties currently experienced by persons
wishing to import kosher products into the United States.
Another comment argued that the proper course for FDA is not to
remove from the Code of Federal Regulations (CFR) its only
pronouncement on kosher labeling but to assume a higher profile and
initiate rulemaking that explicitly states its enforcement authority
with regard to use of the terms ``kosher'' and ``kosher-style,''
thereby providing the kosher food consumer with effective and
meaningful protection. The comment contended that such action was
needed because misbranding of kosher foods is not uncommon. The comment
further argued that such a regulation should prohibit the use of
``kosher-style'' on all food items, whether or not they conform to
religious dietary standards. The comment stated, however, that if FDA
would not prohibit the use of the term ``kosher-style,'' then FDA
should establish a regulation consistent with the U.S. Department of
Agriculture's (USDA's) policy and allow use of the term ``kosher-
style'' only when the product is produced under ``rabbinical
supervision.'' A second alternative suggested by the comment to
prohibiting the term is to permit the term but require that the product
label also bear a disclaimer if the product does not conform to
religious dietary standards. The comment argued that such a regulation
is necessary to adequately protect the kosher consumer and to reduce
the potential for misbranding, fraud, error, and confusion as the
kosher food industry grows.
FDA has evaluated the comments and finds that, while there is
support for maintaining specific guidance on use of the terms
``kosher'' and ``kosher-style,'' FDA is not persuaded by the comments
that such guidance should be retained in the CFR. The comments
presented no compelling reason why this statement of policy should not
be converted to a CPG, the form in which most agency policy statements
are maintained. The goal of the President's Initiative is to develop a
more efficient regulatory regime, and that goal is advanced by
minimizing the number of policy statements in the CFR.
Nor have the comments persuaded the agency that a rulemaking on the
use of the terms ``kosher'' and ``kosher-style'' is warranted. The use
of the terms ``kosher,'' ``kosher-style,'' and any other term
suggesting that a food has been prepared in accordance with certain
religious practices is subject to the general misbranding provisions of
section 403(a) of the act (21 U.S.C. 343(a)). Aside from providing this
basic level of protection, FDA has no role in determining what food is
kosher.
In light of the issues raised in the comments, however, the agency
is concerned that if it did not maintain some statement on kosher
labeling, there would be confusion and misinformation in the kosher
food industry, which could result in a proliferation of misbranded
products, and thus consumers could be adversely affected. Therefore,
FDA will maintain a statement of its policy on labeling foods that
conform to religious dietary laws but do so through the use of a CPG.
Accordingly, FDA is revoking Sec. 101.29 as proposed. It intends to
prepare a CPG in accordance with the Good Guidance Principles published
in the Federal Register of February 27, 1997 (62 FR 8961). In
developing the CPG, the agency will fully consider the alternatives
suggested in the comments and will provide an opportunity for comment.
The agency believes that this approach will provide the kosher food
industry with the guidance needed to minimize false or misleading
labels.
III. Cosmetic Regulations
Parts 710 and 720 (21 CFR parts 710 and 720) of FDA's regulations
provide for the Voluntary Cosmetic Reporting Program (VCRP) under which
cosmetic firms voluntarily register cosmetic product establishments
(part 710) and cosmetic product ingredient and raw material composition
statements (part 720). Part 730 (21 CFR part 730) provides for the
voluntary filing of cosmetic product experience reports (VCPE) by the
cosmetics industry.
During the 23 years the VCPE 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. As fully discussed in the June 12 revocation proposal,
this 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. Thus, FDA proposed to revoke part 730. However, the agency
solicited comments on whether this section should be eliminated in its
entirety, reduced in scope, or some other alternative.
5. Three comments addressed the proposed revocation of part 730.
Two comments supported the proposal to revoke this part in its
entirety. One comment suggested, however, that FDA replace the
voluntary program by: (1) Enhancing its MEDWATCH program to include
cosmetic adverse reactions; (2) referring consumers with adverse
reactions directly to the cosmetic company; and (3) maintaining a
process for voluntary industry analysis of product experience and
reporting of any serious reactions to FDA.
The third comment asserted that, although the VCPE program had
failed, part 730 should not be revoked but completely revised to
require cosmetic companies to file with FDA all consumer adverse
reaction reports. The comment suggested that a mandatory reporting
system would provide data that would be useful in increasing the safety
of cosmetics and protecting the public health. Further, the comment
recommended that FDA mandate the registration of cosmetic manufacturing
establishments and product formulations, continue with the
establishment of a toll-free telephone hotline for consumers to report
adverse reactions, and enhance its MEDWATCH program to include cosmetic
products.
The agency rejects the assertion in the latter comment that the
VCPE has failed. During the years that this program has been in effect,
it has provided FDA with useful information and data. Using these data,
FDA has been able to establish baseline adverse reaction rates. Thus,
the function for which the program was intended has been achieved, and
from the point of view of establishing a baseline level, any further
data would be of little value. The comment has not persuaded the agency
to change this view. Accordingly, FDA is revoking part 730 in its
entirety.
However, the agency recognizes that there may be some merit to the
other arguments made in this and another comment. As suggested by one
[[Page 43074]]
comment, the agency will consider enhancing its MEDWATCH program to
include cosmetic products and will maintain the availability of adverse
reaction reporting forms, which may be submitted to the agency.
Further, FDA intends to perform a thorough evaluation of the cosmetic
adverse reaction information that it has received over the years and to
prepare an indepth 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. However, the comment did not provide a factual basis for
making an adverse reaction reporting system or a registration system
mandatory for cosmetics.
IV. 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.
V. Benefit-Cost Analysis
FDA has examined the economic implications of this final rule as
required by Executive Order 12866. 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 and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including: Having an annual effect on the economy of $100
million; adversely affecting some sector of the economy in a material
way; adversely affecting jobs or competition; or raising novel legal or
policy issues.
In the proposal, FDA based the economic impact analysis on the
effects of revoking the following: Certain type-size exemptions,
labeling with number of servings other than as specified in the 1990
amendments, the statement of informal agency policy regarding the terms
``kosher'' and ``kosher-style,'' and the Voluntary Cosmetic Experience
Program. None of the comments on the proposal directly addressed the
economic impact analysis. The one comment that opposed revocation of
the current minimum type-size exemptions did not mention costs
directly, but implied (``can not realistically be accomplished'') that
the revocation could impose additional labeling costs for some
products. The net effect of revoking the type-size and serving-size
exemptions will be to reduce compliance costs for businesses. In the
absence of evidence that the revocation would impose significant
labeling costs, the agency has not altered its conclusion that the net
economic benefits of this final rule are positive.
FDA finds that this final rule does not constitute a significant
rule as defined by Executive Order 12866. Furthermore, it has been
determined that this final rule is not a major rule for purposes of
Congressional Review (Pub. L. 104-121).
VI. Small Business Analysis
FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities.
No comments dealt with the proposal's statement that the rule would
not have a significant impact on a substantial number of small
businesses. One comment that came from an organization representing
entrepreneurial cosmetic firms supported terminating the Voluntary
Cosmetic Experience Program. The comment agreed with the agency's
conclusion that the program's benefits had already been realized.
Terminating the program will impose no costs on participating small
firms.
Although it is possible that revoking the type-size exemptions
could impose costs on some small entities, the reduced costs of
interpreting labeling regulations and determining how they apply to
individual products will more likely, if anything, reduce the costs of
labeling for small entities. The removal of the kosher and kosher-style
labeling guidance, because it is a guidance, will impose no additional
costs on small entities.
FDA finds that under the Regulatory Flexibility Act, this final
rule will not have a significant economic impact on a substantial
number of small entities. Accordingly, under the Regulatory Flexibility
Act (5 U.S.C. 605(b)), the Commissioner of Food and Drugs certifies
that this final rule will not have a significant economic impact on a
substantial number of small entities.
VII. The Paperwork Reduction Act of 1995
In the June 12 revocation proposal, FDA solicited comment on
whether the proposed rule to revoke certain regulations that the agency
believes are obsolete imposes any paperwork burden. FDA did not receive
any comments on this issue. Thus, FDA concludes that this final 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.
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, 21 CFR parts
101 and 730 are 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).
Sec. 101.2 [Amended]
2. Section 101.2 Information panel of package form food is amended
in paragraphs (b) and (f) by removing the reference to Sec. 101.8; by
removing paragraphs (c)(1) through (c)(3) and paragraph (c)(5)(iii); by
redesignating paragraph (c)(5)(iv) as paragraph (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 of kosher and kosher-style foods is
removed.
PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES
PART 730--[REMOVED]
5. Part 730 is removed.
[[Page 43075]]
Dated: July 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-21156 Filed 8-11-97; 8:45 am]
BILLING CODE 4160-01-F
