
[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Proposed Rules]               
[Page 61068-61074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no09-20]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 501

[Docket No. FDA-2009-N-0025]
RIN 0910-AG02

 
Animal Food Labeling; Declaration of Certifiable Color Additives

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations regarding the declaration of certified color additives 
on the labels of animal food including animal feeds and pet foods. FDA 
is proposing this amendment in response to the Nutrition Labeling and 
Education Act of 1990 (the 1990 amendments), which amended the Federal 
Food, Drug, and Cosmetic Act (the act) by requiring, among other 
things, the listing on food labels of the common or usual names of all 
color additives required to be certified by FDA. An additional purpose 
of this amendment is to make these regulations consistent with the 
regulations regarding the declaration of certified color additives on 
the labels of human food. The proposed rule also suggests appropriate 
terminology for the declaration of certification-exempt color additives 
on the labels of animal food.

DATES:  Submit written or electronic comments on the proposed rule by 
February 22, 2010. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by December 23, 2009, (see 
the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0025 and/or RIN number 0910-AG02, by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 must be submitted to the Office of 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).
Electronic Submissions
    Submit electronic comments 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 comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to  http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to  http://www.regulations.gov and insert the 
docket number(s), 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: John P. Machado, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6854; e-mail:  john.machado@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Before passage of the 1990 amendments, the act provided that 
colorings could be declared collectively on food product labels using 
the term ``colorings.'' However, the 1990 amendments amended section 
403(i) of the act (21 U.S.C. 343(i)) to require that certified color 
additives be declared by their common or usual names and not be 
designated by the term ``colorings.'' As a result of this change in the 
statute, each certified color additive (e.g., FD&C

[[Page 61069]]

Blue No. 2, FD&C Red No. 40) used in or on a food must be declared on 
labeling by its common or usual name, but color additives exempt from 
certification (e.g., caramel, paprika, and beet juice) may still be 
declared collectively.
    In response to this statutory requirement, FDA issued a final rule 
on January 6, 1993 (58 FR 2850), which was codified in title 21 of the 
Code of Federal Regulations, Sec.  101.22 (21 CFR 101.22). 
Specifically, Sec.  101.22(k) details how color additives used in human 
foods are to be declared in the ingredient list. The agency also 
permitted the use of abbreviated names (e.g., Blue 2, Red 40) for 
certified color additives.
    Although the 1990 amendments apply both to human and animal foods, 
the regulations pertaining to animal foods have not yet been issued. 
Nonetheless, the provisions of the 1990 amendments that amend section 
403(i) of the act are self-executing and apply to animal food labels 
even in the absence of issued regulations under this authority. Because 
FDA has not published regulations applicable to animal food under the 
1990 amendments, FDA has generally exercised enforcement discretion 
with regard to the requirements of this provision of the act as they 
pertain to animal food labels. Because of this exercise of enforcement 
discretion, as well as the decision to provide an opportunity to 
deplete the current stock of animal food labels prior to enforcing the 
requirements with regard to animal food products, a final rule issued 
based on this proposed rule would have a 2-year effective date.
    This proposed rule adds a paragraph to Sec.  501.22 (21 CFR 
501.22), detailing how certified color additives used in or on animal 
foods must be declared in the ingredient list. In addition, the 
proposed rule sets out different ways a manufacturer can comply with 
the requirement that color additives not subject to certification under 
the act be declared collectively on the label.

II. Description of the Proposed Rule

    The 1990 amendments amended section 403(i) of the act to require 
that certified color additives used in or on a food be declared by 
their common or usual names. Because section 201(f) of the act (21 
U.S.C. 321(f)) defines ``food'' as any article used for food or drink 
for man or other animals, the changes made to section 403(i) by the 
1990 amendments apply to both human and animal foods. In response to 
this new statutory amendment, FDA revised its human food labeling 
regulations by adding paragraph (k) to Sec.  101.22. These regulations 
were published in the Federal Register on June 21, 1991 (56 FR 28592) 
(proposed rule) and January 6, 1993 (final rule). However, the 
regulations pertaining to animal foods have not yet been issued.
    The changes FDA is proposing for animal food labels are similar to 
the ones made in Sec.  101.22 for human food labels. Specifically, this 
proposed regulation adds paragraph (k) to the animal food labeling 
regulations at Sec.  501.22, detailing how certified color additives 
used in animal foods must be declared in the ingredient list, and sets 
out the various ways that manufacturers may collectively declare 
certified-exempt color additives in the ingredient list.
    New Sec.  501.22(k) proposes that a color additive or the lake of a 
color additive subject to certification under section 721(c) of the act 
(21 U.S.C. 379(c)) shall be declared by the common or usual name of the 
color additive as listed in the applicable regulation in part 74 (21 
CFR part 74) or part 82 (21 CFR part 82), except that it is not 
necessary to include the ``FD&C'' prefix or the term ``No.'' in the 
declaration. However, the term ``Lake'' shall be included in the 
declaration for the lake of a certified color additive (e.g., Blue 1 
Lake). Manufacturers may parenthetically declare an appropriate 
alternative name of the certified color additive following its common 
or usual name as specified in part 74 or part 82. The new provision 
also provides a number of options for collectively declaring the 
presence in food of the certified-exempt color additives that are 
listed in part 73 (21 CFR part 73). Color additives not subject to 
certification 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 
with the name of the color additive listed in the applicable regulation 
in part 73.

III. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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). In accordance with 
Executive Order 12866, FDA has carefully analyzed the economic effects 
of this proposal and has determined that the final rule, if issued, 
will not be a significant regulatory action as defined by the Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. As discussed more fully in section IV of this 
document, we have prepared an initial regulatory flexibility analysis. 
Our initial analysis indicates that at every establishment size, the 
expected cost of compliance would likely be significantly less than 1 
percent of revenues for each label requiring new labeling. We have, 
therefore, determined that the compliance costs of the proposed rule 
are unlikely to 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 $133 million, using the most current (2008) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. Purpose of Rule

    This proposed rule would require that the common or usual name of 
all color additives that are required to be certified by FDA be listed 
on the label of animal foods. This change would amend FDA's animal food 
regulations to include certain requirements of the 1990 amendments, as 
was previously done with the human food regulations. Additionally, the 
proposed rule suggests how color additives not certified by FDA should 
be declared on the ingredient list of animal foods. As stated 
previously in this document, the 1990 amendments require that all food 
labels list the common or usual names of all color additives that are 
required to be certified by FDA. Therefore, the agency lacks a great 
deal of flexibility in the development of this rule.

[[Page 61070]]

B. Benefits

    The principal benefit of this rule is that it would provide 
additional consumer information for purchasers of pet food and other 
animal food products to consider in making their buying decisions for 
those animal food products that are not currently labeled in accordance 
with the provisions of this proposed rule. The agency does not have any 
data with which to quantify the extent to which having this additional 
information would result in more informed buying decisions by 
consumers. The rule also would provide some voluntary options for all 
animal food manufacturers, including options for terminology they can 
use when declaring certification-exempt color additives on their 
product labels.

C. Costs

    The rule proposes that the effectiveness date be 2 years from the 
date of publication of the final rule. This time is intended to allow 
animal food manufacturers some time to deplete their current label 
inventories as they make the transition to the new label. We do not 
consider this proposal to require a major label redesign because it 
would likely only necessitate minor changes in wording on the 
ingredient list. Many animal food manufacturers are already declaring 
certified color additives in their labeling by their common or usual 
name.
    The rule would impose some review costs on those animal food 
manufacturers that use or intend to use certified color additives. 
Because the vast majority of animal food products that contain 
certified color additives are pet foods, we limit the costs to review 
labels for the use of certified color additives to pet food 
manufacturers. Each of these manufacturers would need to review the 
labels of its pet food products to determine the current level of 
compliance with the proposed rule. Those manufacturers determined not 
to be in compliance with the proposed rule would incur additional costs 
under Sec.  501.22(k)(1) to change the wording of their labels.
    Animal feeds for a limited number of production animals, such as 
animal feeds for certain farm-raised fish and poultry, also contain 
color additives. However, we believe the color additives used in animal 
feeds for fish and poultry are generally certification-exempt, because 
such color additives can produce the desired colors in edible tissues 
of these animals more efficiently than certified color additives; 
currently, no certified color additive is approved to alter the color 
of the edible tissue of these animals. We invite public comment and 
data on the use of color additives in animal feeds for production 
animals in general, and in particular, on the use of certified color 
additives in fish and poultry feeds.
    Animal food manufacturers using certification-exempt color 
additives in their products would only incur additional relabeling 
costs under Sec.  501.22(k)(2) if they were to revise their labels to 
use one of the specific terminology options set forth in that 
provision. Although Sec.  501.22(k)(2) lists specific terms that 
manufacturers can use when declaring color additives that are exempt 
from certification (e.g., ``Artificial Color'' or ``Color Added''), the 
provision also would permit such color additives to be declared using 
other equally informative terms that make clear that a color additive 
has been used in the food. FDA believes that most manufacturers of 
animal food products containing certification-exempt color additives 
are already declaring the presence of these ingredients in a manner 
that complies with proposed Sec.  501.22(k)(2). We are not aware of any 
private incentives that would lead these manufacturers to voluntarily 
change their labels solely for the purpose of adopting one of the terms 
identified in proposed Sec.  501.22(k)(2), although it is conceivable 
that some may make such a change as part of a larger effort to change 
their labels for other reasons, such as to comply with Sec.  
501.22(k)(1) or as part of scheduled labeling changes. Because use of 
the terminology specified in proposed Sec.  501.22(k)(2) is optional 
and the presence of certification-exempt color additives can instead be 
declared in other equally informative ways, we do not expect proposed 
Sec.  501.22(k)(2) to impose any new compliance costs on animal food 
manufacturers.
Pet food labeling costs
    We do not have data sources that can be used to precisely estimate 
the number of pet food products. For the purpose of this analysis we 
assume, based on an industry source, that there are approximately 
15,000 different brands of pet foods.\1\ Further, we lack extensive 
data on pet food labels to confidently estimate the number of such 
labels that are currently consistent with the provisions of the 
proposed rule. An informal survey of pet food products for dogs, cats, 
rabbits and guinea pigs, however, found that only 13 of the 68 products 
surveyed had labels that listed color ingredients in a manner that 
might be determined not to be in compliance in the event the proposed 
rule becomes final.\2\ Only 1 of the 13 products would definitely be 
considered out of compliance with the rule, and that was due to its 
failure to individually identify which of the identified certified 
color additives were the colors requiring certification and which were 
the lakes colors requiring certification.
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    \1\ Veterinary News Network, http://www.myvnn.com, accessed May 
21, 2007. (FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    \2\ Informal survey of pet foods brands taken on April 20, 2007 
at one grocery store and one drug store in Anne Arundel County, MD 
by FDA personnel.
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    On many of the other 12 product labels, the phrase ``and other 
color(s)'' or similar language followed immediately after a list of FDC 
colors requiring certification. In these cases, we believe it is likely 
that the phrase is being used to designate colors that do not require 
certification. However, because we could not rule out the possibility 
that the phrase ``and other color(s)'' or a similar phrase was being 
used to declare colors requiring certification that therefore would 
need to be listed individually by their common or usual name, we 
included them in the group of pet food product labels that would 
possibly be out of compliance. Based on the previous reasoning, we 
project the midpoint of the 12 possible cases of noncompliance 
represent actual cases of noncompliance with the proposed rule. 
Therefore, we project an upper end of the estimated noncompliance range 
at 7 of the 68 cases in the sample (6 of the possibly noncompliant 
cases plus the 1 case that is almost certainly out of compliance), or 
about 10 percent.
    Due to the uncertainty surrounding pet food products in other 
market niches as well as those that are imported (all or almost all of 
those in the informal sample are products that were produced in the 
United States, although some ingredients may have been imported), it 
may be proper to account for these products by increasing the possible 
non-compliance level. However, because of the arguments mentioned 
previously concerning our likely overestimation of the upper range of 
our estimate in our informal survey, we have only increased our high-
end estimate of products that would not be in compliance with the 
proposed rule to 15 percent. Although only 1.5 percent of the sample 
would definitely be out of compliance, to account for some uncertainty 
we have increased the low end of our compliance range to 5 percent. We 
estimate current product labeling that would not be in compliance with 
the proposed rule to range from 750 to 2,250

[[Page 61071]]

products, or 5 to 15 percent of the estimated 15,000 different brands 
of pet food products. We request comment and additional data on the 
number of existing pet food product labels that would need to be 
modified if this proposed rule becomes final.
    We have estimated a cost for the combined effort by pet food 
industry management to become familiar with the requirements of the 
rule, plus the effort to determine the compliance status of each of the 
approximately 15,000 products. We project that, on average, the 
compliance status of each product could be determined within 15 minutes 
by an industry compliance officer. In some instances, notably those 
involving companies with fewer products, the average may be longer due 
to the additional time spent on general education and awareness of the 
rule's requirements being apportioned over fewer products. For those 
companies with tens or hundreds of product labels, however, the average 
time to review an individual pet food ingredient label could easily be 
less than our estimate of 15 minutes per label. In any case, at 15 
minutes per label, the one-time effort to review the 15,000 labels 
would amount to 3,750 hours. Using the median wage rate of $32.77 per 
hour for an industrial production manager (adding 35 percent to account 
for benefits results in a cost of $44.24 per hour), the cost of this 
label review would amount to about $166,000.\3\
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    \3\ U.S. Department of Labor, Bureau of Labor Statistics, 
Occupational Employment Statistics NAICS 311100--Animal Food 
Manufacturing (http://www.bls.gov/oes/current/naics4_311100.htm).
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    FDA's Labeling Cost Model presents low, medium, and high cost 
estimates for all aspects of the label manufacturing process, from the 
administrative efforts through physical creation of the label, as well 
as an estimate for the loss of current label inventory\4\. We do not 
have specific data on the frequency of scheduled label changes for the 
pet food industry, but believe it would be similar to the human food 
industry. The model also includes a field that attempts to show to what 
extent human food labeling changes can be coordinated with scheduled 
labeling changes based on the time period within which the additional 
changes must be made. The model suggests parameters that lead to cost 
estimates that fall exponentially with the time allowed for labeling 
changes. The default or suggested percentages in the human foods model 
for a 2-year effectiveness date are 33 percent for private label 
products and 67 percent for brand name products. For pet foods, we 
believe the large majority of products are branded, implying that our 
estimate of all pet food labels that would have a scheduled label 
change within the 2-year effectiveness date should be closer to 67 
percent than 33 percent (the Labeling Cost Model does not include data 
for products made by the pet food industry). Further, the general 
conclusion of a discussion with an industry association was that 1.5 to 
2 years is a reasonable estimate for the life of a pet food label 
order, and for large manufacturers it is likely less than 1 year.\5\ 
Based on these insights and lacking any other data source, we estimate 
that 60 percent of the pet food ingredient labeling changes could be 
coordinated with scheduled labeling changes. We invite public comment 
and data on the extent to which pet food ingredient labeling changes 
can be coordinated with scheduled labeling changes. (See the COMMENTS 
section of this document.)
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    \4\ http://www.foodrisk.org/lcm.htm. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes 
to the Web site after this document publishes in the Federal 
Register.)
    \5\ E-mail communication between industry association and FDA 
personnel on March 8, 2007.
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    We ran the model with several different human food items as proxies 
for pet foods, including canned seafood, cereal, flour meal, and bagged 
snack food, assuming a 2-year effectiveness date for the rule. The 
resulting total costs (which include label inventory loss) per 
stockkeeping unit (SKU) varied from low cost estimates for all but the 
canned seafood around $800, and with high cost estimates for canned 
seafood approaching $4,750. For the purpose of this analysis, we 
propose to use the median cost estimates from the cereal and canned 
seafood model results, or a range from about $1,250 per SKU to about 
$3,550 per SKU.
    We project that only 300 to 900 pet food SKUs would be required to 
undertake an earlier labeling change as a result of this rule. This 
represents the 40 percent of SKUs that would not be able to coordinate 
the label change required by this rule with regularly scheduled label 
changes multiplied by the 750 to 2,250 SKUs that are not expected to be 
in compliance with the rule. Based on the range of per SKU costs 
described previously, the additional one-time labeling costs (including 
inventory loss) would range from $375,000 to about $3.2 million. 
Discounting these costs until the end of the 2-year transition period 
(at a 7-percent discount rate) results in one-time costs of about 
$328,000 to $2.8 million (at a 3-percent rate, the one-time cost would 
range from $353,000 to $3.0 million).
    We estimate total pet food industry one-time costs (discounted at 7 
percent) to range from about $500,000 to $3 million, including both the 
effort to determine compliance with the proposed rule and the labeling 
costs for those SKUs that would remain out of compliance after 2 years 
from the date of publication of the final rule. We do not project any 
additional annual reporting costs.
Analysis of Alternatives
    Because section 403(i) of the act as amended by the 1990 amendments 
specifically requires certified color additives used in food to be 
declared by their common or usual names, we lacked the flexibility to 
consider other ways to declare certified color additives on the labels 
of animal food products. Based on the 2-year effectiveness date 
included in this proposal, total discounted one-time compliance costs 
would range from about $500,000 to $3 million. As indicated earlier, 
the 2-year effective date is to allow for an orderly transition from 
current label inventory without a significant, additional cost to the 
animal food products industry. FDA seeks comment on this issue.

IV. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to prepare a 
regulatory flexibility analysis if a rule is expected to have a 
significant economic impact on a substantial number of small entities. 
Although we believe it is unlikely that significant economic impacts 
would occur, we cannot rule out the possibility completely because of 
uncertainty in the distribution of the affected products among 
establishments producing animal food products. The following 
constitutes the initial regulatory flexibility analysis.
    One requirement of the Regulatory Flexibility Act is a succinct 
statement of any objectives of the rule. As stated previously in this 
analysis, the agency intends to amend the ingredient labeling 
regulations for animal feeds and pet foods to require that the common 
or usual name of all color additives that are required to be certified 
by FDA be listed on the label. This change would codify in FDA's animal 
food labeling regulations the requirements of the 1990 amendments, as 
was previously done for the food product labels for humans.
    The Regulatory Flexibility Act also requires a description of the 
small entities that would be affected by the rule, and an estimate of 
the number of small entities to which the rule would apply. Dog and cat 
food manufacturers are classified in the North American

[[Page 61072]]

Industrial Classification System (NAICS) under industry code 311111--
Dog and Cat Food Manufacturing. Census data from 2002 in this category 
shows that 175 companies with 242 establishments make dog and cat foods 
in the United States.
    NAICS industry code 311119 is identified as Other Animal Food 
Manufacturing. The 2002 census data for this category reported a total 
of 1,042 companies with 1,567 establishments. At least 629 of these 
establishments, however, prepared feeds for beef cattle, dairy cattle, 
swine, poultry (other than chickens and turkeys) and other minor 
production animal species. These establishments manufacture animal feed 
for production animals such as cattle and swine that ordinarily would 
not include any color additives in their products. This reduces the 
number of establishments in industry code 311119 that are subject to 
Sec.  501.22(k)(1) to 938.
    We have not reduced the number of establishments any further to 
account for the 350 establishments that manufacture feed or feed 
ingredients for chickens and turkeys, fish species and other minor 
species, which are the types of products that we believe are more 
likely to contain a color additive to aid in their marketability. Based 
on our understanding that feed or feed ingredients for chickens and 
turkeys, fish, and some other minor species typically do not contain 
color additives requiring certification, we believe that manufacturers 
of these products would only be minimally affected by proposed Sec.  
501.22(k)(1), if at all. However, because we cannot rule out the 
possibility that they would, at some point in the future, use a color 
additive requiring certification, we do not exclude them from the total 
of 938 establishments. Thus, using the 2002 census data, we estimate 
that the total number of establishments manufacturing dog, cat, and 
production animal foods that could be affected by Sec.  501.22(k)(1) 
may be as large as 1,180 establishments (242 + 938).
    The Small Business Administration defines businesses in NAICS 
categories 311111 and 311119 as small entities if they employ less than 
500 employees. Census data shows that only 1 establishment with NAICS 
code 311111 employs 500 or more employees and that no establishments 
within NAICS code 311119 employ 500 or more employees. The existence of 
some multi-establishment companies in each NAICS classification would 
likely increase the number of companies that would not meet the 
definition of a small entity because companies comprised of more than 
one establishment are likely to have more employees. Nonetheless, we 
would expect that a large number of the 1,180 establishments that 
manufacture dog food, cat food, or other animal food that might contain 
a color additive requiring certification would meet the criteria to be 
considered small businesses.
    Census data on industry shipments for dog and cat food 
manufacturers is not available for establishments with one to four 
employees in 2002. For those establishments with 5 to 9 employees, and 
those with 10 to 19 employees, the average annual value of shipments 
ranges from $3.37 to $4.16 million. For all establishments with 20 or 
more employees, it is much greater. If a manufacturer composed of only 
one establishment of five to nine employees had to undertake one 
product relabeling due to this rule, the one-time cost of this effort 
would represent only about 0.11 percent of average annual revenues. 
Those establishments with 10 to 19 employees could have 11 SKUs needing 
relabeling before their one-time costs equal 1 percent of average 
annual revenues, while establishments with 20 or more employees could 
have more than 50 SKUs needing relabeling before their one-time costs 
equal 1 percent of average annual revenues.
    For those establishments with one to four employees that 
manufacture other animal foods, the average annual value of shipments 
is about $950,000. The average value of shipments for establishments in 
this industry with five or more employees is greater than $3.8 million. 
An average company composed of one establishment with one to four 
employees would expend 0.37 percent of its revenues for the cost of 
relabeling one SKU as a result of this rule. Establishments with 5 to 9 
employees and those with 10 to 19 employees could have 11 and 24 SKUs 
requiring relabeling after 2 years, respectively, before their one-time 
costs would account for 1 percent of average annual revenues. All 
larger establishments could have 100 or more SKUs requiring relabeling 
after 2 years before their one-time costs would account for 1 percent 
of average annual revenues.
    Although the data show that the cost for relabeling one SKU would 
not likely represent a significant burden on a substantial number of 
small companies, we do not have data on either the number of affected 
animal food products manufactured by establishments or firms of any 
size, or the distribution of those animal food products that would not 
have met the requirements of the rule within 2 years of the publication 
of the final rule. That being the case, we must allow for the 
possibility, however unlikely, that the rule could have a significant 
impact on a substantial number of small firms.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The analysis above shows that at every establishment 
size, the expected cost of compliance would be significantly less than 
1 percent of revenues for each SKU requiring new labeling. The 
estimated number of SKUs requiring new labeling makes it unlikely that 
their distribution among establishments would result in any 
establishment incurring compliance costs greater than 1 percent of 
revenues. The agency believes, therefore, that this proposed rule would 
be unlikely to have a significant economic impact on a substantial 
number of small entities. FDA requests comment on this issue.

V. Environmental Impact

    The agency has determined that establishment of this labeling 
requirement would not increase the existing levels of use or change the 
intended uses of color additives or their substitutes. Therefore, under 
21 CFR 25.30(k), this proposed rule is determined to be categorically 
excluded from the need to prepare an environmental assessment or an 
environmental impact statement.

VI. Federalism

    FDA has analyzed this proposed 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 law conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts ``any requirement for the labeling of food of the type 
required by * * * [21 U.S.C. 343(i)(2)] * * * that is not identical to 
the requirements of such section * * *'' 21 U.S.C. 343-1(a)(2). This 
proposed rule, if made final, would create requirements for declaring 
the presence of certified color additives on the labels of animal food, 
including animal feeds and pet foods under 21 U.S.C. 343(i)(2).

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB), 
under

[[Page 61073]]

the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). A 
description of these provisions is given in table 1 of this document 
with an estimate of the annual reporting burden. Included in the 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques and other 
forms of information technology.
Title: Animal Food Labeling; Declaration of Certifiable Color 
Additives.
Description: FDA is proposing this amendment in response to the 1990 
amendments, which amended the act by requiring, among other things, the 
listing on food labels of the common or usual names of all color 
additives required to be certified by FDA. An additional purpose of 
this amendment is to make these regulations consistent with the 
regulations regarding the declaration of certified color additives on 
the labels of human food. The proposed rule also suggests appropriate 
terminology for the declaration of certified-exempt color additives on 
the labels of animal food.
Description of Respondents: Animal feed industry, which also includes 
those establishments manufacturing pet foods.
    Thus, FDA estimates the burden for this collection of information 
as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    No. of       Annual Frequency     Total Annual    Hours per    Total      Total Capital
                21 CFR Section                   Respondents       per Response        Responses       Response    Hours          Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
501.22 (k)(1)                                            1,180              12.71             15,000        .25      3,750     $3,000,0002\2\  .........
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no operating and maintenance costs associated with this collection of information.
\2\Because the range was $500,000 to $3 million, FDA has chosen to show the high figure here.

    The numbers for Sec.  501.22(k)(1) in table 1 of this document were 
taken from section III of this document. As discussed in section IV of 
this document, the total number of establishments manufacturing dog, 
cat, and other non-production animal foods is estimated at 1,180. The 
annual frequency per response (12.71) is derived by dividing the 15,000 
annual responses (i.e., labels) by the number of establishments 
(1,180). The total hours (3,750) is derived by multiplying the number 
of total annual responses (15,000) by 15 minutes (.25) per response. 
Due to the proposed 2-year delay in the effective date of the final 
rule, the total capital costs range from $500,000 to $3 million, and 
operating and maintenance costs were estimated to be zero.
    New Sec.  501.22(k)(2) proposes appropriate terminology for the 
declaration of certification-exempt color additives on the ingredient 
list of labels of animal food. Color additives not subject to 
certification 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 
with the name of the color additive listed in the applicable regulation 
in part 73 of this chapter. Although the suggested appropriate 
terminology for labels for declaration of colors exempt from 
certification is optional and offers some flexibility to a manufacturer 
in terms of how to declare such color additives on its ingredient 
label, it is possible that some may voluntarily adopt the language 
specified in Sec.  501.22(k)(2) when they are already relabeling their 
animal food products for other reasons such as for marketing purposes. 
The census data shows that up to 938 establishments produce animal 
feeds that may contain color additives exempt from certification. These 
additives may also be used at the 242 dog and cat food establishments 
in the United States. We do not have data that can be used to estimate 
the number of product labels that will be voluntarily changed at the 
1,180 establishments as a result of proposed Sec.  501.22(k)(2). 
However, our analysis of the required changes for proposed Sec.  
501.22(k)(1) estimated that about 6 percent of the products would 
require label changes after the 2-year effectiveness date has passed 
(15 percent of labels that are currently out of compliance with 
proposed Sec.  501.22(k)(1) times the 40 percent of these that would 
remain out of compliance after regular label changes occurring over 2 
years). We assume that management would choose to make fewer voluntary 
label changes than required label changes. For our analysis, we assume 
that only one-half as much, or 3 percent of these products, undergo 
voluntary label changes as proposed in Sec.  501.22(k)(2). This would 
result in 0.38 label changes per establishment for proposed Sec.  
501.22(k)(2), or 450 label changes over the 1,180 establishments.
    The hours per response for label review to determine compliance 
with the rule and the appropriate language to put on the label is 
estimated at .25 hour, which compares to the time allotted for animal 
food labels containing certified colors. The annual cost of label 
review is the hourly wage of an industrial production manager ($44.24) 
times .25 hours per response times the number of labels.
    The upper-bound estimate of relabeling costs for the remaining 
labels (i.e., those reviewed for compliance with the proposed rule), is 
$3,350 per SKU. The total one-time cost of Sec.  501.22(k)(2) would 
therefore be the cost of label review plus the cost of changing 450 
labels as part of normal business practices, for an estimated total of 
about $1.5 million. The total hours spent, as shown in Table 1 of this 
document, are 112.5 (450 times .25).
    The information collection provisions of this proposed rule have 
been submitted to OMB for review. Interested persons are requested to 
fax comments regarding information collection to the Office of 
Information and Regulatory Affairs, OMB (see the DATES section of this 
document). To ensure that comments on information collection are 
received, OMB recommends that written

[[Page 61074]]

comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

VIII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 501

    Animal food labeling, Specific animal food labeling requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 501 be amended as follows:

PART 501--ANIMAL FOOD LABELING

    1. The authority citation for 21 CFR part 501 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.
    2. Section 501.22 is amended by adding paragraph (k) to read as 
follows:


Sec.  501.22  Animal foods; labeling of spices, flavorings, colorings, 
and chemical preservatives.

* * * * *
    (k) The label of an animal food to which any coloring has been 
added shall declare the coloring in the statement of ingredients in the 
manner specified in paragraphs (k)(1) and (k)(2) of this section.
    (1) A color additive or the lake of a color additive subject to 
certification under section 721(c) of the act shall be declared by the 
name of the color additive listed in the applicable regulation in part 
74 or part 82 of this chapter, except that it is not necessary to 
include the ``FD&C'' prefix or the term ``No.'' in the declaration, but 
the term ``Lake'' shall be included in the declaration of the lake of 
the certified color additive (e.g., Blue 1 Lake). Manufacturers may 
parenthetically declare an appropriate alternative name of the 
certified color additive following its common or usual name as 
specified in part 74 or part 82 of this chapter.
    (2) Color additives not subject to certification 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 with the name of the color 
additive listed in the applicable regulation in part 73 of this 
chapter.

    Dated: November 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27984 Filed 11-20-09; 8:45 am]

BILLING CODE 4160-01-S
