[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Rules and Regulations]
[Pages 207-217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31253]


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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.

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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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     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\
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    \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.
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    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

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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

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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

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    (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

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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