0721 SS Part A 2015

Animal Food Labeling; Declaration of Certifiable Color Additives
OMB Control No. 0910-0721
Supporting Statement Part A
Justification
1. Circumstances Making the Collection of Information Necessary
The 1990 amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) amended
section 403(i) to require that certified color additives used in or on a food must be declared by their
common or usual names and not be designated by the collective term “colorings.” Section 210(f) of
the FD&C Act defines “food” as any article used for food or drink for man or other animals, and
thus the 1990 Amendments apply to both human and animal foods. Accordingly, the agency
promulgated regulations regarding the declaration of color additives on human and animal food
labels. FDA is therefore requesting to extend its approval for the information collection
requirements set forth in 21 CFR section 501.22 detailing how certified color additives used in
animal foods should be declared in the ingredient list and suggesting how noncertified color
additives may be declared in the ingredient list.
2. Purpose and Use of the Information Collection
This information collection is associated with requirements under 21 CFR 501.22(k) in which
animal food manufacturers must declare the presence of certified and noncertified color additives in
their animal food products on the product label. Respondents to this collection are manufacturers of
pet food that contain color additives who must disclose information on their product labeling.
3. Improved Information Technology and Burden Reduction
In the vast majority of cases (>90%), animal feed companies revise their product labels without
sending their draft labels to FDA for review. Having become effective November 18, 2013, the
agency estimates that the burden associated with the labeling requirements under 21 CFR 501.22(k)
apply only to new product labels. Because the vast majority of animal food products that contain
certified color additives are pet foods, we limit our burden estimate to reviewing labels for the use
of certified color additives to pet food manufacturers subject to this regulation. For the small
number of companies that will be sending their draft labels to FDA for review or with questions
concerning this Animal Food Labeling rule, about 90% will be by e-mail and 10% by mail.
4. Efforts to Identify Duplication and Use of Similar Information
This information is not otherwise collected and thus there duplication is unlikely.
5. Impact on Small Businesses or Other Small Entities
FDA believes that its requirements for the declaration of certifiable color additives in animal food
labeling impose the minimal burden necessary; however, the regulations apply to all businesses
alike.

6. Consequences of Collection the Information Less Frequently
This information is collected and updated only when a product label is changed. In the absence of
the information the agency is not able to ensure the safety of the regulated products entering the
marketplace.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In the Federal Register of April 1, 2015 (80 FR 17445) FDA published a 60-day notice requesting
public comment on the proposed collection of information. One comment was received but did not
respond to any of the four information collection topics solicited and is therefore not addressed by
the Agency.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
This information will be publicly disclosed on the label of animal foods.
11. Justification for Sensitive Questions
This collection of information does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
FDA estimates the burden for this collection of information as follows:
Table 1. -- Estimated Annual Third-party Disclosure Burden1
21 CFR Section;
Activity

No. of
Respondents

No. of Disclosures
per Respondent

Total Annual Avg. Burden per
Disclosures
Disclosure

Total
Hours

501.22(k); labeling of
3,120
0.83
2,587
.25
647
color additive or lake of
color additive; labeling
of color additives not
subject to certification
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2

Based on A.C. Nielsen Data, FDA estimates that the number of animal food product units subject to
21 CFR 501.22(k) for which sales of the products are greater than zero is 25,874. Assuming that
the flow of new products is 10 percent per year, then 2,587 new animal food products subject to 21
CFR 501.22(k) will come on the market each year. FDA also estimates that there are about 3,120
manufacturers of pet food subject to either 21 CFR 501.22(k)(1) or (k)(2). Assuming the
approximately 2,587 new products are split equally among the firms, then each firm would prepare
labels for approximately 0.83 new products per year (2,587 new products/3,120 firms is
approximately 0.83 labels per firm).
The agency expects that firms prepare the required labeling for their products in a manner that takes
into account at one time all information required to be disclosed on their product labels. Based on
our experience with reviewing pet food labeling, FDA estimates that firms would require less than
0.25 hour (15 minutes) per product to comply with the requirement to include the color additive
information pursuant to 21 CFR 501.22(k). The total burden of this activity is 647 hours (2,587
labels x 0.25 hour/label is approximately 647 hours).
12b. Annualized Cost Burden to Respondents
Type of Respondent
Industrial Production
Manager
1

Total Burden
Hours
647

Hourly Wage
Rate1
$58.31

Total Respondent
Cost
37,727

Bureau of Labor Statistics 2014 Data

FDA estimates the cost of the information collection request to industry to be $37,727 (rounded to
the nearest whole dollar). This figure was calculated by multiplying the hourly wage rate for an
industrial production manager by the total number of burden hours (647).
13. Estimates of Other Total Annual Costs and/or Recordkeepers/Capital Costs
There are no start-up or other costs associated with this collection of information.
14. Annualized Cost to the Federal Government
FDA estimates the cost to the Federal Government for this information collection to be $1,098.
This estimate was calculated by multiplying the time the agency expends to review product labeling
(approximately 30 hours) by the hourly wage for a GS-12 step 1 employee ($36.60).
15. Explanation for Program Changes or Burden Adjustments
Now that implementation of the final rule supporting this information collection has been realized,
the agency has significantly lowered its burden estimate. We have also consolidated the two
individual information collections into one. The result of these adjustments is a decrease in the
annual number of responses to this collection by 12,871 with a corresponding decrease in hourly
burden by 3,218 and cost decrease of $4,608,153.

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16. Plans for Tabulation and Publication and Project Time Schedule
This information will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt display of the expiration date for OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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