Federal Register, Volume 74, Number 2, January 5, 2009, Pages 201-392 Page: 210
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Federal Register/Vol. 74, No. 2/Monday, January 5, 2009 /Rules and Regulations
use of foods containing them,
information regarding their origin is not
considered "material"; therefore,
declaration on the label is not required.
(Comment) FDA received several
comments about the effective date for
the final rule. A few comments
recommended that it be sooner than
proposed, and several comments
suggested that FDA use the current
uniform effective date, January 1, 2010.
Another comment favored using the
current uniform effective date for food,
but only if it provided at least 2 years
for compliance. One comment requested
that the effective date be 36 months after
the date that the final rule is published.
(Response) FDA is adopting the
proposed effective date of 24 months
after date of publication for compliance
with the final rule. Many manufacturers
may have significant inventories of
labels. Some manufacturers may incur
costs, including those related to loss and
disposal of obsolete packaging
inventories, product in obsolete
packages, and new printing plates,
which would be passed on to
consumers. For the reasons discussed in
section IV.C.3 of this document, the
agency has concluded that 24 months
will minimize these labeling costs and,
at the same time, avoid unnecessarily
delaying the benefits of this final rule to
the public health.
Although the effective date of the
final rule is some time away, FDA
encourages manufacturers to have new
labels printed that are in compliance
with these final rules so they may be
used as soon as current inventories are
exhausted to ensure a smooth and
timely changeover. The agency will not
object to voluntary compliance
immediately upon publication of the
final rule.
Given the absence of convincing
evidence or information submitted in
response to the proposed rule, FDA is
adopting the proposed rule, without
change, to require that all food and
cosmetic products disclose the presence
of cochineal extract and carmine by
name.
III. Legal Authority
The legal authority for the regulations
prescribing the safe use of color
additives in foods, drugs, and cosmetics
comes from section 721(b) of the act.
Under section 721(b) of the act, FDA has
the authority to prescribe conditions,
including labeling requirements, under
which a color additive may be safely
used. Products containing color
additives that are not used in
compliance with the color additive
regulations are adulterated undersections 402(c) (foods), 501(a)(4) (drugs),
or 601(e) (cosmetics) of the act (21
U.S.C. 342(c), 351(a)(4), and 361(e),
respectively). FDA has concluded that
cochineal extract and carmine may
cause potentially severe allergic
responses in humans. Thus, the agency
has determined that label information
about the presence of these color
additives in all foods and cosmetics is
necessary to ensure their safe use. We
note that, with respect to OTC drugs,
declaration of inactive ingredients is
already required under 21 CFR
201.66(c)(8), and FDA plans to initiate
rulemaking to implement the FDAMA
provisions that require declaration of
inactive ingredients for drugs, including
prescription drugs.
Additional legal authority for
requiring disclosure of a coloring that is,
or that bears or contains, a food allergen
comes from section 403(x) of the act.
Under that section, a coloring
determined by regulation to be, or to
bear or contain, a food allergen must be
disclosed in a manner specified by
regulation.
Finally, the provisions of section
701(e) of the act (21 U.S.C. 371(e)) apply
to the issuance, amendment, or repeal of
any regulation listing a color additive or
the certification of a color additive for
foods, drugs, and cosmetics, subject to
the provisions of section 721(b)(5)(C) of
the act. Under section 721(d) of the act,
the provisions of section 701(e) of the
act apply to 73.100 and 73.2087.
Section 701(e) of the act directs the
Secretary of Health and Human Services
to initiate through proposed rulemaking
the issuance, amendment, or repeal of
such regulation that is based on a
petition of any interested persons
showing reasonable grounds. Any
person who is adversely affected by the
final rule may file within 30 days of the
issuance of the final rule, objections
with FDA, specifying with particularity
the provision of the final rule deemed
objectionable, stating the grounds for
the objections, and requesting a public
hearing upon such objections.
IV. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
FDA has examined the impacts of the
final rule amending 21 CFR 101.22,
which is not subject to formal
rulemaking, under Executive Order
12866, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104-4). The amendments to part 73
that are subject to formal rulemaking are
exempt from review under Executive
Order 12866. Executive Order 12866
directs agencies to assess all costs andalternatives 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). The agency
believes that this final rule is not a
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. We find that this final rule may
have a significant economic impact on
a substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing "any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year." The current threshold
after adjustment for inflation is $130
million, using the most current (2007)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
B. Need for Regulation
We did not receive any comments on
the discussion of the need for this
regulation in our analysis of the
proposed rule (71 FR 4839 at 4846).
C. Regulatory Options
We considered the following
regulatory options in the analysis of the
proposed rule: (1) Take no action; (2)
take the proposed action; (3) take the
proposed action, but make the effective
date later; (4) take the proposed action,
but make the effective date sooner; and
(5) ban cochineal extract and carmine.
The comments on the proposed rule
suggested a number of other regulatory
options. We add those options as
follows: (6) Take the proposed action,
but also require labeling of the origin of
cochineal extract and carmine and (7)
take the proposed action, but do not
change the labeling requirements for
cosmetics.
1. Option One: Take No Action
We did not receive any comments on
this option.
2. Option Two: Take the Proposed
Action.benefits of available regulatory
210
a. Costs
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United States. Office of the Federal Register. Federal Register, Volume 74, Number 2, January 5, 2009, Pages 201-392, periodical, January 5, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132864/m1/17/: accessed April 25, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.