[Federal Register: January 5, 2009 (Volume 74, Number 2)]
[Rules and Regulations]
[Page 207-217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja09-5]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73 and 101
[Docket No. FDA-1998-P-0032] (formerly Docket No. 1998P-0724)
RIN 0910-AF12
Listing of Color Additives Exempt From Certification; Food, Drug,
and Cosmetic Labeling: Cochineal Extract and Carmine Declaration
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is revising its
requirements for cochineal extract and carmine by requiring their
declaration by name on the label of all food and cosmetic products that
contain these color additives. This final rule responds to reports of
severe allergic reactions, including anaphylaxis, to cochineal extract-
containing food and carmine-containing food and cosmetics and will
allow consumers who are allergic to these color additives to identify
and thus avoid products that contain these color additives. This action
also responds to a citizen petition submitted by the Center for Science
in the Public Interest (CSPI).
DATES: This regulation is effective January 5, 2011. All affected
products initially introduced or initially delivered for introduction
into interstate commerce on or after this date shall fully comply,
except as to any provisions that may be stayed by the filing of proper
objections. Voluntary compliance with this final regulation, including
making any required labeling changes, may begin immediately. Submit
written or electronic objections and requests for hearing by February
4, 2009. See section IX of the SUPPLEMENTARY INFORMATION section of
this document for information on filing of objections.
ADDRESSES: You may submit written or electronic objections and
requests for a hearing on 21 CFR 73.100 and 73.2087, identified by
Docket No. FDA-1998-P-0724 and RIN number 0910-AF12, by any of the
following methods:
Electronic Submissions
Submit electronic objections in the following way:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using the Federal
eRulemaking Portal, as described in the ADDRESSES portion of this
document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number and Regulatory Information Number (RIN) for this
rulemaking. All objections received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting objections, see the
``Objections'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
[[Page 208]]
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1278.
SUPPLEMENTARY INFORMATION:
I. Background
Cochineal extract is a color additive that is permitted for use in
foods and drugs in the United States. The related color additive
carmine is permitted for use in foods, drugs, and cosmetics. These
certification-exempt color additives and conditions for their safe use
are listed in Sec. Sec. 73.100 (foods), 73.1100 (drugs), and 73.2087
(cosmetics) (21 CFR 73.100, 73.1100, and 73.2087, respectively). In the
Federal Register of January 30, 2006 (71 FR 4839), FDA published a
proposed rule to amend its requirements for cochineal extract and
carmine by requiring their declaration on the label of all food and
cosmetic products that contain these color additives. More
specifically, for food products, FDA proposed to amend the color
additive regulation (Sec. 73.100) that permits the use of cochineal
extract or carmine in foods by adding new paragraph (d)(2) to require
that all foods (including butter, cheese, and ice cream) that contain
cochineal extract or carmine specifically declare the presence of the
color additive by its respective common or usual name, ``cochineal
extract'' or ``carmine,'' in the ingredient statement of the food
label. Because Sec. 101.22(k) (21 CFR 101.22(k)) allows any
certification-exempt color additive to be declared with a general
phrase, such as ``Artificial Color'' or ``Artificial Color Added,''
rather than by its specific common or usual name, FDA also proposed to
amend Sec. 101.22(k) to disallow generic declaration of color
additives for which individual declaration is required by applicable
regulations in part 73 (21 CFR part 73).
For cosmetic products, FDA proposed to amend the color additive
regulation (Sec. 73.2087) permitting the use of carmine in cosmetics
by adding new paragraph (d)(2) to require that cosmetics containing
carmine that are not subject to the requirements of Sec. 701.3 (21 CFR
701.3) specifically declare the presence of carmine prominently and
conspicuously at least once in the labeling. This amendment will cover
all cosmetic products, including those cosmetics that are manufactured
and sold for use only by professionals (e.g., makeup used in
photography studios and by makeup artists for television, movie, and
theater actors/actresses, products intended for use only by
professionals in beauty salons, and camouflage makeup dispensed by
physicians and aestheticians to clients with skin conditions such as
scarring) and those cosmetics that are gifts or free samples. FDA also
proposed to include in Sec. 73.2087, as an example, the following
statement: ``Contains carmine as a color additive.''
As the agency indicated in the proposed rule, it plans to initiate
a separate rulemaking to implement section 412 of the Food and Drug
Administration Modernization Act (FDAMA), which amended the misbranding
provisions of the Federal Food, Drug, and Cosmetic Act (the act) to
require declaration of inactive ingredients for drugs. The FDAMA
provisions have already been implemented for over-the-counter (OTC)
drugs.\1\
---------------------------------------------------------------------------
\1\ The provisions of FDAMA have already been implemented for
OTC drugs. See 64 FR 13254 at 13263 (March 17, 1999). Note also that
current 21 CFR 201.100(b)(5) requires the label of a prescription
drug that is not for oral use (such as a topical or injectable drug)
to bear the names of inactive ingredients, but permits certain color
components to be designated as ``coloring'' rather than being
specifically named.
---------------------------------------------------------------------------
FDA issued the proposed rule in response to reports of severe
allergic reactions, including anaphylaxis, to cochineal extract and
carmine-containing food and cosmetics. The proposed rule also was in
response, in part, to a 1998 citizen petition from CSPI, which asked
FDA to take action to protect consumers who are allergic to cochineal
extract and carmine. FDA did not propose to adopt CSPI requests that
the agency do the following things: (1) Require labeling of animal
(insect) origin of cochineal extract and carmine, (2) undertake or
require scientific reviews or studies, or (3) prohibit, if necessary,
the use of cochineal extract and carmine entirely (71 FR 4839 at 4845).
Interested persons were given until May 1, 2006, to comment on the
proposed rule.
II. Summary of Comments and the Agency's Responses
FDA received a total of 159 responses (including 83 form letters),
each containing one or more comments, to the proposed rule. Responses
were received from industry, trade associations, consumer advocacy
organizations, health care professionals, and consumers. A number of
comments supported the proposed rule generally or supported certain
portions of the proposed rule. Other comments objected to the proposed
rule. Several comments raised issues that were outside the scope of the
proposed rule and will not be discussed here. A summary of the relevant
comments and the agency's responses to the comments follow.
(Comment) One comment requested that FDA not consider cochineal
extract and carmine to be major allergens under the Food Allergen
Labeling and Consumer Protection Act of 2004 (FALCPA).
(Response) Cochineal extract and carmine are not considered to be
``major food allergens'' nor are they derived from one of the eight
foods or food groups identified in FALCPA (i.e., milk, eggs, fish
(e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster,
shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat,
and soybeans).
(Comment) One comment stated that cochineal extract and carmine are
allergens and should be listed under the allergen information on food
labels.
(Response) FDA disagrees. Cochineal extract and carmine are
allergens for a small subset of the allergic population (71 FR 4839 at
4841 through 4843), but they are not ``major food allergens'' under
FALCPA. However, because these additives are allergens, FDA is
requiring that they be labeled by name in the ingredient list.
(Comment) One comment stated that carmine or cochineal extract
could be present in food by virtue of having been an ingredient in a
component of that food. The comment argued that when the color additive
has no technical or functional effect in the food, carmine or cochineal
extract is an incidental additive and should be exempt from labeling
under Sec. 101.100(a) (21 CFR 101.100(a)).
(Response) FDA disagrees. Cochineal extract and carmine are
allergens for a small subset of the allergic population. Section 403(x)
of the act (21 U.S.C. 343(x)) provides FDA the authority to establish
labeling requirements through rulemaking for the disclosure of any food
allergen (other than a major food allergen) that is found in a spice,
flavoring, coloring, or incidental additive. Therefore, because this
regulation requires that cochineal extract and carmine be declared on
labels, these color additives are not exempt from labeling under Sec.
101.100(a).
(Comment) Several comments stated that cochineal extract and
carmine
[[Page 209]]
should be banned. One comment argued that these color additives are not
safe under 21 CFR 70.3(i) because the evidence did not establish with
reasonable certainty that no harm would result from its intended use.
Therefore, the comment stated, FDA is required by section 721(b)(8)(C)
of the act (21 U.S.C. 379e(b)(8)(C)) to take into account the
availability, if any, of other color additives suitable and safe for
one or more of the uses allowed for cochineal extract and carmine. The
comment also argued that the impact on the general population is no
longer the test in the case of allergens because FALCPA was passed even
though only a small percentage of the population then suffered from
food allergies.
(Response) FDA disagrees. Cochineal extract and carmine have both
been determined to be safe when used as specified by the color additive
regulations in part 73 (see 71 FR 4839 at 4845). The comment did not
submit any data demonstrating that this conclusion is incorrect.
Therefore, FDA is not required to take into account the availability of
alternative color additives as a justification for a ban. Section
721(b)(8)(C) applies when, with regard to the aggregate quantity of a
color additive likely to be consumed in the diet or applied to the
human body, FDA finds that the data fail to show that it would be safe
or otherwise permissible to list a color additive for all proposed uses
and at the levels of concentration proposed. Further, FALCPA applies
only to the eight major food allergens and thus does not bear on the
safety of cochineal extract or carmine, which are not major food
allergens.
(Comment) One comment requested that FDA ban cochineal extract and
carmine because doing so would protect those consumers who are not
aware that they are allergic to these ingredients.
(Response) As discussed in the previous paragraphs, FDA has
determined that these additives are safe when used as specified by the
color additive regulations under part 73, and this comment did not
submit any data demonstrating that this conclusion is incorrect. FDA
has concluded that the labeling requirements established by this
regulation will provide consumers adequate information that will enable
them to avoid carmine and cochineal extract. While FDA recognizes that
people who have not been diagnosed with an allergy to these color
additives will not know to avoid these ingredients, as is the case with
any allergen, this fact does not change our conclusion that these color
additives are safe when used as specified by the color additive
regulations under part 73. The labeling required by this regulation
will help consumers and health professionals more quickly identify
people with sensitivities to these color additives.
(Comment) Several comments requested that FDA not require labeling
of cochineal extract and carmine by name in the ingredient list of
foods. The comments argued that there is inadequate scientific support
for finding sensitivity to cochineal extract and carmine.
(Response) FDA disagrees. Cochineal extract and carmine are
allergens for a small subset of the allergic population. The adverse
event reports and published studies clearly demonstrate that a person
may become sensitized and reactive to cochineal extract and carmine
from ingestion, inhalation, or topical exposure to the color additives.
The data also show evidence of immunoglobulin E (IgE)-mediated allergic
reactions to these color additives, including anaphylaxis or other
serious health outcome (71 FR 4839 at 4843). The agency has therefore
concluded that requiring label declaration for these color additives in
foods is necessary so that sensitive individuals may avoid products
containing these color additives.
(Comment) One comment expressed concern that focusing on a single
color additive in a negative manner will confuse consumers and cause
the industry to use artificial color additives that will adversely
affect consumers.
(Response) FDA disagrees that the label declaration of these color
additives would be confusing or intimidating to consumers or would
portray these color additives distastefully. The comment did not
provide information to support its position. The use of another listed
color additive in accordance with the listing regulations would not
adversely affect the public health because such color additives have
been found to be safe.
(Comment) Several comments stated that the proposed labeling
changes for cosmetics are unwarranted due to inadequate scientific
evidence showing allergic sensitization or hypersensitivity reactions
to these color additives in cosmetics. Other comments stated that the
labeling changes would dilute the impact of truly necessary labeling
statements or may cause consumers to avoid the product.
(Response) FDA disagrees that requiring the labeling of carmine on
cosmetic products is unwarranted. Review of consumer adverse event data
supports the comment's contention that these reports do not provide
definitive proof of sensitization to carmine through the skin. However,
there is clear evidence in FDA's Voluntary Cosmetics Registration
Program database (discussed in 71 FR 4839 at 4843) that several
carmine-sensitive individuals had used carmine-containing cosmetics
previously and had noted or reported reproducible allergic-type
reactions at the site where these products were applied. FDA believes
that consumers should be alerted to the presence of carmine in all
cosmetic products because of the allergenicity of the color additive.
Labeling of carmine by name on most cosmetics has been a requirement
for many years under Sec. 701.3 and the agency has no evidence, nor
was any submitted, demonstrating that consumers have been confused or
have avoided these products because they were labeled as containing
carmine.
(Comment) Several comments requested FDA to require disclosure that
cochineal extract and carmine are ``insect (or animal) derived.'' Many
of these comments stated that persons who wish to avoid consuming
animal products need this information in order to avoid such products
and that labeling cochineal extract and carmine by name is not
sufficient.
(Response) FDA disagrees that declaring these color additives by
name provides insufficient information to consumers who choose to avoid
products containing these additives. The origins of cochineal extract
and carmine are clearly described in the color additive regulations. If
consumers desire to avoid products containing these color additives,
they will be able to identify such products by reading the ingredient
list.
(Comment) One comment, which urged FDA not to require that the
color additives are insect-derived, stated that this information is
``not a material fact of the type that would be required to be declared
on a label or in labeling'' under section 201(n) of the act (21 U.S.C.
321(n)).
(Response) FDA agrees that this information is not material under
section 201(n) of the act. Section 201(n) of the act states that, in
determining whether labeling is misleading, the law takes into account
the extent to which the labeling fails to reveal facts material to
consequences which may result from the use of the product as it is
labeled or customarily used. The agency has required special labeling
in cases where information is necessary to ensure that consumers are
aware of special health risks associated with consumption of a
particular product. Because the origin of these color additives has no
bearing on consequences that may result from the
[[Page 210]]
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 under sections 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 Sec. Sec. 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 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). 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.
a. Costs
[[Page 211]]
(Comment) One comment suggested we set the effective date to be the
next uniform compliance date for labeling regulations.
(Response) Setting the effective date to be the next uniform
compliance date for labeling regulations would result in firms having
between 12 months and 36 months to make the proposed labeling changes,
depending on the date of the publication of the final rule. In the
analysis of the proposed rule, we found that changing the effective
date from 24 months to 12 months decreased net benefits. We also found
that we had insufficient information to determine if changing the
effective date from 24 months to 36 months would increase or decrease
net benefits. Therefore, we cannot determine the effect on net benefits
of changing the effective date from 24 months to the next uniform
compliance date for labeling regulations.
b. Benefits
(Comment) Some comments noted that some consumers might prefer not
to consume food containing cochineal extract or carmine even if they
are not allergic to those color additives. These comments specified
various groups of consumers who might wish to avoid these color
additives for non-health reasons, including vegetarians, Jews, Muslims,
and Jains. One comment suggested there was some controversy about the
acceptability of consuming these color additives within the kosher
Jewish community. Other comments were from individuals who did not
belong to any of these groups but who simply preferred not to consume
food containing these color additives.
(Response) In the analysis of the proposed rule, we did not account
for the value of the proposed labeling changes for consumers who wish
to avoid cochineal extract and carmine for non-health reasons. A
significant number of consumers belong to the groups identified in the
comments as potentially wishing to avoid cochineal extract and carmine
for non-health reasons. Therefore, the value of labeling cochineal
extract and carmine for these consumers represents a potentially
significant addition to the benefits we estimated in the analysis of
the proposed rule.
A recent nationwide poll concluded that 2.3 percent of adults in
the United States over the age of 18 were vegetarians in 2006 (Ref. 1).
This poll defined a vegetarian as someone who never eats meat, chicken,
or fish. In 2005, there were 215,246,449 consumers over the age of 18
living in the United States, excluding those living in institutions,
college dormitories, and other group quarters (Ref. 2). The population
in 2006 was larger than in 2005, and some adults living in group
quarters are probably vegetarian. Therefore, the poll we cited
previously in this paragraph suggests there were probably at least
4,950,668 vegetarians over the age of 18 living in the United States in
2006. One study estimated that 5,764,000 Jews; 4,745,200 Muslims; and
7,700 Jains lived in the United States in 2005 (Ref. 3). We do not know
how many Jews, Muslims, or Jains are also vegetarians. Therefore, we
assume that the rate of vegetarianism in these groups is similar to
that in the general population, or 2.3 percent. We also do not know how
many consumers in the specified groups also wish to avoid cochineal
extract and carmine for health reasons. However, few consumers in the
general population are sensitive to these color additives. Therefore,
we assume that only a very small percentage of consumers in these
groups also wish to avoid these color additives for health reasons.
Adding these numbers after subtracting 2.3 percent from each of the
religious groups to avoid double counting with vegetarians, we estimate
that up to approximately 15 million adult consumers in the United
States may wish to avoid cochineal extract and carmine because they are
vegetarian or for religious reasons. However, these comments did not
provide information establishing that these groups actually have
policies in place to encourage their members to avoid these substances,
nor did they provide information establishing that every member of
these groups follows such policies, if they exist. Therefore, the full
range of the number of adults who wish to avoid these substances
because they are vegetarian or for religious reasons is 0 to 15
million. In addition, some consumers who are not vegetarian and who do
not belong to any of the specified religious groups may also wish to
avoid cochineal extract and carmine for non-health reasons. However, we
do not have sufficient information to estimate the potential number of
such consumers.
We do not know how much these consumers would be willing to pay for
the proposed labeling changes. However, any benefit accruing to these
consumers would recur annually and, given the number of consumers
involved, would probably represent significant additional benefits
beyond the quantified benefits involving people who wish to avoid
cochineal extract and carmine for health reasons.
(Comment) One comment said that we made an error in our analysis of
the proposed rule. According to this comment, we said there were 14
adverse events over a 10-year period, and we assumed that only one
percent of adverse events are reported. The comment said that this
implies an estimate of 140 adverse events per year, but we estimated
only 31 adverse events per year.
(Response) In our discussion of Option Two in the analysis of the
proposed rule, we identified three adverse events over an approximately
10-year period that involved products containing carmine or cochineal
extract in which those color additives did not or probably did not
appear on the ingredient list. We based our benefit estimate on these
three cases because the proposed labeling changes could only eliminate
cases in which cochineal extract or carmine did not already appear on
the product label, and the other 11 cases either did not contain
information on how the product that caused the reaction was labeled or
involved products that were labeled as containing carmine or cochineal
extract. We applied a reporting rate of 1 percent to this figure to
obtain our estimate of 31 adverse events per year.
We addressed the remaining 11 adverse events, which involved
products that probably already listed carmine or cochineal extract on
the product label, in our discussion of Option Five in the analysis of
the proposed rule. We noted that it would be easier for consumers or
health care personnel to identify carmine or cochineal extract as the
potential cause of an adverse event in these cases than in cases in
which these color additives did not appear on the product label.
Therefore, we assumed a reporting rate of 10 percent for those cases.
(Comment) One comment said we did not explain why we assumed that
only 1 percent of adverse events are reported rather than assuming that
0.1 percent or 10 percent of adverse events are reported.
(Response) In the analysis of the proposed rule, we cited studies
that found adverse event reporting rates for various products and
reporting systems ranging from less than 1 percent to 10 percent.
Estimating the reporting rate for any particular product, adverse
event, and reporting system is difficult because many factors can
affect adverse event reporting rates, including the severity of the
adverse event, whether the adverse event is unusual or unexpected, the
amount of media attention the cause of the adverse event has received,
and the details of the reporting system involved. We discussed our
bases for assuming an adverse event reporting rate of 1 percent for
products in which cochineal extract
[[Page 212]]
and carmine do not appear on the label. The comment did not provide
sufficient information for us to revise that assumption.
(Comment) One comment was from an organization that said it had
received reports that 32 people had suffered adverse events caused by
products containing carmine or cochineal extract between August 1998
and April 2006. The comment noted that applying a 1 percent reporting
rate to this number of adverse events results in an estimate of
approximately 400 adverse events per year.
(Response) As we discussed elsewhere in this section, we estimated
the number of adverse events reported annually based on the number of
adverse events involving products containing carmine or cochineal
extract in which those color additives did not or probably did not
appear on the label. This comment does not indicate whether any of the
adverse event reports it received involved products that contained
carmine or cochineal extract and did not or probably did not declare
those color additives on product labels. Based on these considerations,
we have not revised our analysis to reflect the information provided in
this comment.
(Comment) Some comments noted that labeling would not prevent
allergic reactions that a consumer experiences before he or she
identifies carmine or cochineal extract as the cause of the allergic
reaction. Some comments were from people who said it had taken them up
to 10 years to identify cochineal extract or carmine as the cause of
their allergic reactions.
(Response) In the analysis of the proposed rule, we acknowledged
that the proposed labeling changes would not prevent adverse events
involving people who do not yet know that they are sensitive to these
color additives. We do not have an estimate of how many people are
allergic to these color additives but are not aware of it. To reflect
this, we assumed that the proposed labeling changes would eliminate
between 10 percent and 90 percent of the adverse events. These comments
did not provide sufficient information for us to revise this estimate.
c. Distributive Impacts
(Comment) One comment argued that the proposed labeling changes
could reduce demand for cochineal extract and carmine. This comment
noted that a drop in the demand for these color additives would reduce
the incomes of people who produce and collect cochineal. The comment
said that 20,000 families in the poorest rural zones of Peru depend
exclusively on the production and collection of cochineal for their
livelihood.
(Response) We discussed potential distributive impacts in the
analysis of the proposed rule under Option Five, which involved banning
cochineal extract and carmine. However, we did not discuss distributive
impacts in the context of Option Two. The proposed labeling changes may
have some effect on the demand for cochineal extract and carmine.
However, any distributive impacts generated by the proposed labeling
changes would be significantly smaller than those generated by a ban
because consumers who wish to avoid products containing cochineal
extract and carmine probably represent only a small fraction of the
total number of consumers of such products. Therefore, we have revised
our discussion of the impacts of this option to add the potential for a
small distributive impact on producers of cochineal extract and
carmine.
d. Summary
The revised estimated costs and benefits of this option are the
same as the original estimated costs and benefits of this option in the
analysis of the proposed rule except for the following changes. We
revised our earlier health benefit estimate of $1 million to $26
million to include the value of the proposed labeling changes for
consumers who wish to avoid cochineal extract and carmine for non-
health reasons. We do not have sufficient information to estimate this
benefit, but it may be significant based on the number of consumers
that might be involved and the fact that any benefit would recur
annually. In addition, we revised the analysis of this option in the
proposed rule to include potential distributive effects on producers of
cochineal extract and carmine due to a possible decline in the demand
for those color additives. These distributive effects would probably be
small because relatively few consumers probably wish to avoid these
substances.
We have not revised the estimate of the costs that we presented in
the analysis of the proposed rule, which consisted of relabeling costs
of $0 million to $3 million plus some small but permanently recurring
costs associated with the loss of otherwise free label space.
Therefore, we estimate total net benefits of -$2 million to $26
million, plus the recurring benefit to consumers who wish to avoid
carmine or cochineal extract for non-health reasons, minus the
recurring costs associated with the loss of otherwise free label space.
3. Option Three: Take the Proposed Action, but Make the Effective Date
Later
(Comment) One comment suggested we make the effective date 36
months after publication of the final rule because this would avoid
problems caused by a large number of firms trying to change their
labels within 24 months.
(Response) In the analysis of the proposed rule, we discussed the
option of setting the effective date at 36 months after publication of
the final rule. We noted that this would reduce costs to a range of $0
million to some amount less than $3 million. The high end of this range
would be lower than the high end of the range that we estimated for the
proposed effective date of 24 months after publication of the final
rule, which was $3 million.
In the analysis of the proposed rule, we also noted that setting
the effective date at 36 months after publication of the final rule
would eliminate the $0 million to $2 million in health benefits that
would have occurred in months 24 to 36 under Option Two, which would
make total quantified benefits approximately $1 million to $24 million.
Reducing the recurring annual stream of benefits that led to the
estimated present value of $1 million by the small amount per year that
rounds to $0 million did not change the overall estimated value of this
stream of recurring benefits, which remained $1 million after rounding.
However, reducing the recurring stream of annual benefits that led to
the estimated present value of $26 million by $2 million in months 24
to 36 reduced the overall estimated value of this stream of recurring
benefits from $26 million to $24 million. We said that we were unable
to make any conclusions about the effect on net benefits of choosing
this option rather than Option Two because of the overlapping changes
in quantified costs and benefits. The revisions to the benefits that we
discussed under Option Two also apply to this option. Therefore, we now
estimate that the benefits that would have occurred in months 24 to 36
under Option Two are $0 million to $2 million plus the recurring
benefits to consumers who wish to avoid cochineal extract and carmine
for non-health reasons. Therefore, total net benefits would be -$2
million to $24 million, plus the recurring benefits to consumers who
wish to avoid cochineal extract and carmine for non-health reasons,
minus the recurring costs associated with the loss of otherwise free
label space. This range overlaps with the range that we estimated for
Option Two, so we are
[[Page 213]]
again unable to draw any conclusion about whether this option would
generate greater net benefits than Option Two.
4. Option Four: Take the Proposed Action, but Make the Effective Date
Sooner
The revisions to the benefits that we discussed under Option Two
also apply to this option. In the analysis of the proposed rule, we
discussed the option of setting the effective date at 12 months after
publication of the final rule rather than the proposed 24 months after
publication of the final rule. We estimated that this option would
increase costs relative to Option Two by $3 million to $52 million,
which means that the total cost of this option relative to the baseline
would be $3 million to $55 million. We also estimated that this option
would increase benefits relative to Option Two by $0 million to $2
million, which means that the total benefits of this option relative to
the baseline would be $1 million to $28 million. Under the revisions to
the benefits that we discussed under Option Two, we now estimate that
the total benefits of this option would be $1 million to $28 million
plus the recurring benefits to consumers who wish to avoid cochineal
extract and carmine for non-health reasons. Therefore, we now estimate
net benefits of -$54 million to $25 million plus the recurring benefits
to consumers who wish to avoid cochineal extract and carmine for non-
health reasons minus the recurring costs associated with the loss of
otherwise free label space. This range overlaps with the range that we
estimated for Option Two. Therefore, we are unable to determine if the
net benefits of this option would be greater than those of Option Two.
5. Option Five: Ban Carmine or Cochineal Extract
In the analysis of the proposed rule, we estimated that the costs
of banning cochineal extract and carmine would be $3 million to $1,390
million and that the total value of the resulting annual stream of
health benefits would be $9 million to $36 million. The revisions to
the benefits that we discussed under Option Two also apply to this
option. Our revised estimate of the benefits of this option is $9
million to $36 million plus the recurring benefits to consumers who
wish to avoid cochineal extract and carmine for non-health reasons.
Therefore, we estimate net benefits of -$1,381 million to $33 million
plus the recurring benefits to consumers who wish to avoid cochineal
extract and carmine for non-health reasons minus the recurring costs
associated with the loss of otherwise free label space. This range
overlaps with the range that we estimated for Option Two. Therefore, we
are unable to determine if the net benefits of this option would be
greater than those of Option Two.
(Comment) One comment said that we ignored the availability of
potential alternative color additives. Another comment argued that
firms would have difficulty using alternative synthetic color additives
to reproduce the colors produced by cochineal extract and carmine.
(Response) We addressed the potential use of alternatives in the
analysis of the proposed rule. The comments did not provide information
that would allow us to revise that analysis.
(Comment) One comment argued that we overestimated the cost of
reformulating products that would result from banning the use of
cochineal extract and carmine. This conclusion was based on two
factors: (1) The modest number of foods that contain carmine or
cochineal extract and (2) the assertion that some foods already contain
alternative color additives.
(Response) The analysis of the proposed rule addressed the fact
that only a modest number of foods contain carmine or cochineal
extract. In addition, the model we used to estimate reformulation costs
addressed the potential use of alternatives. Therefore, we have not
revised our analysis in response to this comment.
(Comment) Some comments argued that no color additives currently on
the market are acceptable replacements for carmine or cochineal
extract.
(Response) In the analysis of the proposed rule, we noted that
potential substitute color additives have technical and functional
characteristics that differ from those of cochineal extract and
carmine. The comment did not provide information establishing that
there are no acceptable substitutes after considering changes in
product formulation that address differences in technical and
functional characteristics.
(Comment) One comment suggested that alternative synthetic color
additives might have genotoxic, teratogenic, or carcinogenic
properties.
(Response) In the analysis of the proposed rule, we did not address
potential genotoxic, teratogenic, or carcinogenic properties of
alternative color additives. Adverse health effects generated by
alternative color additives would represent a cost of banning cochineal
extract and carmine. However, listed color additives are safe when used
for their intended purposes.
6. Option Six: Take the Proposed Action, but Also Require Labeling of
the Origin of Cochineal Extract and Carmine
(Comment) A number of comments suggested that we take the proposed
action but also require labeling indicating that cochineal extract and
carmine are derived from insects or, more broadly, from animals. One
comment argued that consumers who want to avoid eating ingredients
derived from animals, including insects, would not think to look up the
source of cochineal extract and carmine.
(Response) This option would generate the same costs and benefits
as Option Two plus some additional costs and benefits. This option
would result in additional costs because it would require a more
complicated type of label change than the change in the ingredient list
that we discussed under Option Two. In addition, this option would
generate additional loss of otherwise free label space beyond the
amount that we discussed under Option Two.
This option would result in additional benefits because consumers
who are interested in avoiding ingredients derived from insects or
animals would have all the information they need to accomplish their
objective on the product label, so they would not need to learn that
cochineal extract and carmine are derived from insects. Learning that
cochineal extract and carmine come from insects is a one-time cost for
individuals. However, some people would enter the pool of people trying
to avoid ingredients derived from insects or animals every year, so
these learning costs would be an annual cost. Education costs would
probably be relatively low because one can get information on
ingredients derived from animals from a variety of sources such as
books or Web sites dealing with vegetarianism, health, and religious
eating restrictions. We do not have sufficient information to estimate
the number of people who might wish to avoid carmine and cochineal
extract for various reasons, nor do we know how much it would cost them
to learn that cochineal extract and carmine are derived from insects.
Therefore, we cannot estimate the net benefits of this option or
determine if this option would generate greater net benefits than
Option Two.
7. Option Seven: Take the Proposed Action, but Do Not Change the
Labeling Requirements for Cosmetics
(Comment) One comment said that we lacked support for our claim
that cosmetics containing carmine have
[[Page 214]]
caused adverse reactions. This comment also discussed some studies that
ostensibly showed that cosmetics containing this color additive do not
cause allergic reactions. Another comment was from a manufacturer of
cosmetics that contain carmine that said it had never received a
documented adverse event report involving this color additive in these
cosmetics in 40 years of selling these products in various countries.
One comment suggested we take the proposed action with respect to food
but not cosmetics.
(Response) The estimated cost of taking the proposed action but not
changing the labeling requirements for cosmetics is approximately $0
million to $3 million, which is the same as the cost we estimated for
Option Two, plus the recurring costs associated with the loss of
otherwise free label space. This option would also generate the same
benefits as Option Two. The cost of changing cosmetic labels did not
contribute significantly to the total estimated cost of changing labels
in Option Two in the analysis of the proposed rule.
None of the three adverse events involving products that contained
carmine or cochineal extract but did not list those substances on the
product label, which we used to estimate benefits for Option Two,
involved cosmetics. However, some small number of adverse events
involving unlabeled carmine in cosmetics probably occur because some
consumers have reported having adverse reactions to cosmetic products
containing carmine and some cosmetic products containing carmine do not
list those substances on the product label. We do not have sufficient
information to estimate the number of such cases. Therefore, we cannot
estimate the net benefits of this option or determine if this option
would generate greater net benefits than Option Two.
8. Summary
In table 1 of this document, we summarize the quantified costs and
benefits and compare the estimates from our analyses of the proposed
and final rules. We discuss the nonquantified costs and benefits after
table 1.
Table 1.
------------------------------------------------------------------------
Proposed
Final Rule Final Rule Proposed Rule
Option Cost Benefit Rule Cost Benefit
(millions of (millions of (millions (millions
dollars) dollars) of dollars) of dollars)
------------------------------------------------------------------------
Option One: Take Baseline Baseline Baseline Baseline
No Action
------------------------------------------------------------------------
Option Two: Take $0 to $3 $1 to $26 $0 to $3 $1 to $26
the Proposed
Action as Revised
in This Final
Rule
------------------------------------------------------------------------
Option Three: Take $0 to < $3 $1 to $24 $0 to < $3 $1 to $24
the Proposed
Action, but Make
the Effective
Date Later
------------------------------------------------------------------------
Option Four: Take $3 to $55 $1 to $28 $3 to $55 $1 to $28
the Proposed
Action, but Make
the Effective
Date Sooner
------------------------------------------------------------------------
Option Five: Ban $3 to $1,390 $9 to $36 $3 to $9 to $36
Carmine or $1,390
Cochineal Extract
------------------------------------------------------------------------
Option Six: Take $0 to $3 $1 to $26 Not NA
the Proposed applicable
Action, but Also (NA)
Require Labeling
of the Origin of
Cochineal Extract
and Carmine
------------------------------------------------------------------------
Option Seven: Take $0 to $3 $1 to $26 NA NA
the Proposed
Action, but Do
Not Change the
Labeling
Requirements for
Cosmetics
------------------------------------------------------------------------
In addition to quantified costs and benefits, we also have
nonquantified costs and benefits. One nonquantified benefit, which we
discussed in the analysis of the proposed rule, is the value of the
various potential regulatory alternatives that consumers who are
sensitive to cochineal extract and carmine gain from being able to
consume some foods and use some cosmetics that they might currently
avoid because these consumers are uncertain as to whether the products
contain these substances. This benefit occurs under Options Two through
Seven. It is greatest under Option Five (Ban Carmine or Cochineal
Extract). Among the options that involve labeling, this benefit is
somewhat smaller under Option Seven than under the other relevant
options because Option Seven does not apply to cosmetics. Another
nonquantified benefit, which we have introduced in this analysis of the
final rule, is the value to consumers who wish to avoid cochineal
extract and carmine for non-health reasons. This benefit occurs under
Options Two through Seven. It is greatest under Option Five (Ban
Carmine or Cochineal Extract). Among the options that involve labeling,
this benefit is also somewhat greater under Option Six because this
option requires declaration of information on the origin of these
substances and somewhat smaller under Option Seven because this option
does not apply to cosmetics. The one nonquantified cost is a small but
permanently recurring cost from the loss of otherwise free label space.
This nonquantified cost occurs under Options Two through Four and Six
through Seven. This cost is somewhat greater under Option Six because
this option requires additional information to be declared and somewhat
less under Option Seven because this option does not apply to
cosmetics.
D. Small Entity Analysis
We have 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. We find that this final rule may have a significant
economic impact on a substantial
[[Page 215]]
number of small entities. The discussion in this section of the final
rule, as well as data and analysis contained in this rule's regulatory
impact analysis, constitutes our final regulatory flexibility analysis
in compliance with section 604 of the Regulatory Flexibility Act.
The Regulatory Flexibility Act requires that we present a succinct
statement of a rule's objectives. As stated previously in this analysis
and unchanged from the proposed rule, the intent of this rule is to
enable individuals with sensitivities to cochineal extract and carmine
to avoid products containing these color additives, as well as to
enable consumers and healthcare professionals to more quickly identify
sensitivities to these additives.
The Small Business Administration (SBA) publishes definitions of
small businesses by North American Industry Classification System
(NAICS) code. We presented a list of relevant NAICS codes in the
preliminary regulatory impact analysis (71 FR 4839 at 4847). For most
of the relevant NAICS codes, SBA defines a small business as a business
with 500 or fewer employees. The exceptions are NAICS codes 311821 and
312140, for which the cutoff is 750 employees, and 311422, for which
the cutoff is 1,000 employees. We used the 1997 Economic Census to
check the number of firms that would be classified as small businesses
under the SBA definitions. We found that virtually all (98 percent) of
the firms in the relevant NAICS code categories are small businesses
according to the SBA definitions.
Total costs potentially incurred by small businesses will be
virtually equal to the social costs estimated in the initial and final
regulatory impact analyses because the vast majority of the affected
firms discussed in the cost benefit analysis are small businesses.
These costs may or may not be borne by small businesses because firms
may be able to pass on some or all of these costs to consumers in the
form of higher prices, depending on market conditions. If the total
costs accruing to small businesses are proportional to the number of
affected food and cosmetic firms that are small businesses, and if
these firms are unable to pass on any costs to consumers, then we
estimate that the one-time costs accruing to small businesses from
taking the proposed action would be $0 million to $3 million, plus some
small but permanently recurring costs associated with the loss of
otherwise free label space. We described these costs and our method for
estimating these costs in the initial and final regulatory impact
analyses.
All of the regulatory alternatives that we discussed in the initial
regulatory impact analysis would change the potential impact of this
rule on small businesses. Taking no action (Option One) would eliminate
all potential impacts on small businesses. However, it would also
eliminate all potential benefits of this rule. Taking the proposed
action but increasing the compliance period from 24 months to 36 months
(Option Three) would reduce the potential impact on small businesses to
between $0 million and some amount less than $3 million, plus some
small but permanently recurring costs associated with the loss of
otherwise free label space. However, as we discussed in the initial
regulatory impact analysis, extending the compliance period from 24
months to 36 months would also reduce benefits by the amount that would
otherwise have been generated in the first 12 months. Taking the
proposed action but decreasing the compliance period from 24 months to
12 months (Option Four) would substantially increase the potential
impact on small businesses to between $3 million and $55 million, plus
some small but permanently recurring costs associated with the loss of
otherwise free label space. Banning carmine and cochineal extract
(Option Five) would significantly increase the potential costs for
small food and cosmetic firms to between $3 million and $1,390 million.
In addition, a ban would also generate significant distributive effects
on small businesses that manufacture, import, or process these color
additives and do not also handle substitutes. These distributive
effects would also be considered costs from the perspective of the
affected small businesses. Other firms, including small firms, would
benefit from these distributive effects. However, we are unable to
consider positive effects on small businesses for purposes of this
analysis.
We did not receive any comments that require us to revise the
discussion of the five options that we discussed in the analysis of the
proposed rule other than those comments that we have already discussed
in the final regulatory impact analysis. However, we must address the
additional options suggested in the comments. Taking the proposed
action but also requiring labeling of the origin of cochineal extract
and carmine (Option Six) would increase costs for small entities
relative to Option Two because it would require a more complicated type
of label change than the change in the ingredient list that we
discussed under Option Two. Therefore, the range of costs for this
option would be greater than the $0 to $3 million that we estimated for
Option Two. In addition, this option would generate additional loss of
otherwise free label space beyond the amount that we discussed under
Option Two. We do not have sufficient information to determine how much
this option would increase costs for small entities relative to Option
Two. Taking the proposed action but not changing the labeling
requirements for cosmetics (Option Seven) would eliminate costs that
would accrue to small cosmetic firms under Option Two. However, costs
accruing to cosmetic firms did not contribute significantly to the
estimated total costs of Option Two. Therefore, our estimate of the
costs of this option rounds to $0 million to $3 million plus the
recurring costs associated with the loss of otherwise free label space,
which is the same as the costs we estimated for Option Two. This option
would also eliminate all benefits associated with applying this rule to
small cosmetic firms.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
Section 403A of the act (21 U.S.C. 343-1) is an express preemption
provision. Section 403A(a) of the act provides that: ``* * * no State
or political subdivision of a State may directly or indirectly
establish under any authority or continue in effect as to any food in
interstate commerce--* * * (2) any requirement for the labeling of food
of the type required by section * * * 403(x) that is not identical to
the requirement of such section * * *.'' This final rule, among other
things, amends the existing labeling regulations on cochineal extract
and carmine by requiring their declaration by name on the label of all
food products that contain these color additives. Although this rule
has a preemptive effect in that it precludes States from issuing any
food labeling requirements for cochineal extract and carmine that are
not identical to those required by this final rule, this preemptive
effect is consistent with what Congress set forth in section 403A of
the act. Section 403A(a)(2) of
[[Page 216]]
the act displaces both State legislative requirements and State common
law duties (Riegel v. Medtronic, 128 S. Ct. 999 (2008)). In addition,
as with any Federal requirement, if a State law requirement makes
compliance with both Federal law and State law impossible, or would
frustrate Federal objectives, the State requirement would be preempted.
See Geier v. American Honda Co., 529 U.S. 861 (2000); English v.
General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado
Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312
U.S. 52, 67 (1941).
The preemptive effects are the result of existing law set forth in
the statute as interpreted in decisions of the United States Supreme
Court. FDA, therefore, has not sought separate comment on the
preemptive effect of this action because it is not seeking
independently to preempt State law beyond the effects of section
403A(a)(2) of the act or existing case law.
VI. Paperwork Reduction Act of 1995
This final rule contains information collections that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The labeling
requirements in this final rule cross-reference labeling requirements
in other regulations; therefore, FDA is not estimating the burden of
this final rule separately. The burden hours for 21 CFR 70.25 cross-
referenced in Sec. Sec. 73.100(d)(1) and 73.2087(c)(1) have been
estimated and approved under OMB Control Number 0910-0016. The burden
hours for 21 CFR 101.4 cross-referenced in Sec. 73.100(d)(2) have been
estimated and approved under OMB Control Number 0910-0381. The burden
hours for Sec. 701.3 cross-referenced in Sec. 73.2087(c)(2) have been
estimated and approved under OMB Control Number 0910-0599.
VII. Analysis of Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (71 FR 4839). No new
information or comments have been received that would affect the
agency's previous determination that this action has no significant
impact on the human environment and that neither an environmental
assessment nor an environmental impact statement is required.
VIII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Stahler, Charles. How Many Adults are Vegetarian? Vegetarian
Journal. 2006. Issue 4.
2. U.S. Census Bureau. 2005 American Community Survey.
3. The 2005 Annual Megacensus of Religions. (2007). Britannica
Book of the Year, 2006.
IX. Objections
This rule is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) written or electronic objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents are to be
submitted and are to be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will
publish notice of the objections that the agency has received or lack
thereof in the Federal Register.
List of Subjects
21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
73 and 101 are amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
0
2. Section 73.100 is amended by revising paragraph (d) to read as
follows:
Sec. 73.100 Cochineal extract; carmine.
* * * * *
(d) Labeling requirements. (1) The label of the color additives and
any mixtures intended solely or in part for coloring purposes prepared
therefrom shall conform to the requirements of Sec. 70.25 of this
chapter.
(2) The label of food products intended for human use, including
butter, cheese, and ice cream, that contain cochineal extract or
carmine shall specifically declare the presence of the color additive
by listing its respective common or usual name, ``cochineal extract''
or ``carmine,'' in the statement of ingredients in accordance with
Sec. 101.4 of this chapter.
* * * * *
0
3. Section 73.2087 is amended by revising paragraph (c) to read as
follows:
Sec. 73.2087 Carmine.
* * * * *
(c) Labeling. (1) The color additive and any mixture prepared
therefrom intended solely or in part for coloring purposes shall bear,
in addition to any information required by law, labeling in accordance
with the provisions of Sec. 70.25 of this chapter.
(2) Cosmetics containing carmine that are not subject to the
requirements of Sec. 701.3 of this chapter shall specifically declare
the presence of carmine prominently and conspicuously at least once in
the labeling. For example: ``Contains carmine as a color additive.''
* * * * *
PART 101--FOOD LABELING
0
4. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
0
5. Section 101.22 is amended by revising paragraph (k)(2) to read as
follows:
Sec. 101.22 Foods; labeling of spices, flavorings, colorings and
chemical preservatives.
* * * * *
(k) * * *
[[Page 217]]
(2) Color additives not subject to certification and not otherwise
required by applicable regulations in part 73 of this chapter to be
declared by their respective common or usual names may be declared as
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added''
(or by an equally informative term that makes clear that a color
additive has been used in the food). Alternatively, such color
additives may be declared as ``Colored with ----------------'' or ``--
-------------- color,'' the blank to be filled in with the name of the
color additive listed in the applicable regulation in part 73 of this
chapter.
* * * * *
Dated: December 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31253 Filed 1-2-09; 8:45 am]
BILLING CODE 4160-01-S