0016 Food Petitions SSA 2020 EXT

UNITED STATES FOOD AND DRUG ADMINISTRATION
Submission of Petitions:
Food Additive, Color Additive (Including Labeling), Submission of
Information to a Master File in Support of Petitions, and
Electronic Submission Using Food and Drug Administration Form 3503
OMB Control No. 0910-0016
SUPPORTING STATEMENT
Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA or we) regulations as
discussed below:
Food Additive Petitions and Labeling Requirements
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(a))
provides that a food additive shall be deemed to be unsafe, unless: (1) The additive and its use,
or intended use, are in conformity with a regulation issued under section 409 of the FD&C Act
that describes the condition(s) under which the additive may be safely used; (2) the additive and
its use, or intended use, conform to the terms of an exemption for investigational use; or (3) a
food contact notification submitted under section 409(h) of the FD&C Act is effective. Food
additive petitions (FAPs) are submitted by individuals or companies to obtain approval of a new
food additive or to amend the conditions of use permitted under an existing food additive
regulation. Section 171.1 of FDA’s regulations (21 CFR 171.1) specifies the information that a
petitioner must submit in order to establish that the proposed use of a food additive is safe and to
secure the publication of a food additive regulation describing the conditions under which the
additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180)
contain labeling requirements for certain food additives to ensure their safe use. The labeling
regulations are considered by FDA to be cross-referenced to § 171.1.
Color Additive Petitions and Labeling Requirements
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a color additive shall be
deemed to be unsafe unless the additive and its use are in conformity with a regulation that
describes the condition(s) under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued under section 721(f) of
the FD&C Act. Color additive petitions (CAPs) are submitted by individuals or companies to
obtain approval of a new color additive or a change in the conditions of use permitted for a color
additive that is already approved. Section 71.1 of our regulations (21 CFR 71.1) specifies the
information that a petitioner must submit to establish the safety of a color additive and to secure
the issuance of a regulation permitting its use. FDA’s color additive labeling requirements in §
70.25 (21 CFR 70.25) require that color additives that are to be used in food, drugs, medical
devices, or cosmetics be labeled with sufficient information to ensure their safe use.

FDA Form 3503 and Master File
Respondents may transmit FAP or CAP regulatory submissions in electronic format or paper
format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition
using Form FDA 3503. Form FDA 3503 helps the respondent organize their submission to focus
on the information needed for FDA’s safety review. Form FDA 3503 can also be used to
organize information within food or color master files (master files) submitted in support of
petitions according to the items listed on the form. Master files can be used as repositories for
information that can be referenced in multiple submissions to the agency, thus minimizing
paperwork burden for food and color additive approvals.
We, therefore request extension of OMB approval of the information collection provisions found
in this collection of information and in Form FDA 3503.
2. Purpose and Use of the Information Collection
FDA scientific personnel reviews FAPs to ensure the safety of the intended use of the additive in
or on food, or that may be present in food as a result of its use in articles that contact food.
Likewise, FDA personnel review CAPs to ensure the safety of the color additive prior to its use
in food, drugs, medical devices, or cosmetics.
Description of Respondents: Respondents are typically businesses engaged in the manufacture
or sale of food, food ingredients, color additives, or substances used in materials that come into
contact with food. Respondents are typically from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
As part of the agency’s ongoing modernization efforts, we have replaced our electronic
submission system (the FDA Unified Registration Listing System, also known as FURLS) with a
new electronic submission system, the CFSAN Online Submission Module (COSM).
Information submitted to COSM will be the same information that is submitted to the FURLS
system. Respondents may transmit regulatory submissions in electronic format via the COSM
system or paper format on Form FDA 3503. Electronic Form FDA 3503 also can be used to
organize information within a master file submitted in support of petitions according to the items
listed on the form.
We estimate that 80% of the respondents will electronically submit the information being
collected via COSM or on a physical media (e.g., CD-ROM or DVD).
4. Efforts to Identify Duplication and Use of Similar Information
We continue to work with Environmental Protection Agency (EPA) and the U.S. Department of
Agriculture (USDA) to eliminate areas of duplicate data collection and evaluation. There is no
duplication of FDA labeling requirements by other U.S. government agencies. Memoranda of
understanding have been reached with EPA in the areas of pesticides and water treatment. EPA
establishes a tolerance, or exemption from tolerance, for pesticide chemicals and residues of such
chemicals in food, and we enforce the tolerance or exemption.

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Under the Meat and Poultry Inspection Acts (21 U.S.C. 601(m)(2) and 21 U.S.C. 453(g)(2)), the
USDA Food Safety and Inspection Service (FSIS) has regulatory authority to determine the
suitability and regulate the use of ingredients and sources of radiation in or on meat and poultry
products in federally inspected facilities. FDA’s regulations listed in §§ 71.1 and 171.1 permit
an efficient joint review by both FDA and FSIS of petitions for approval to use a food ingredient
or source of radiation in or on meat or poultry products. Applicants petitioning for approval for
the use of substances in meat and poultry products provide four copies of the petition to FDA.
We then forward a copy of the petition or relevant portions of the petition to FSIS so that both
agencies can perform the necessary reviews simultaneously, thus reducing the time it takes to
authorize an ingredient for use in meat and poultry products.
5. Impact on Small Businesses or Other Small Entities
We are unaware of ways to minimize the burdens on a small business wishing to petition for a
new food or color additive or a new use of a regulated food or color additive. The agency has
established criteria for the type of data necessary to demonstrate the safety of a food or color
additive. Where possible, assistance is given (in fact, a significant percentage of agency time is
spent in assistance activities), but we do not have the resources to conduct a firm’s analytical
studies or the animal feeding studies necessary to demonstrate the safety of a new additive. The
labeling requirements for a specific food additive or color additive are the same regardless of the
size of the firm. However, to reduce the burden on all businesses, we provide assistance to
requestors to minimize the likelihood that unnecessary work is performed. We aid small
businesses in complying with the petition process and labeling requirements through the
agency’s Regional Small Business Representatives and through the administrative and scientific
staffs within the agency. We have provided a Small Business Guide on the agency’s website at
https://www.fda.gov/industry/small-business-assistance.
We estimate that no small businesses are involved in this information collection.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. If the collection is not conducted or is conducted less
frequently, manufacturers would not be in compliance with §§ 409(a), 201(s) and 721 of the
FD&C Act. Without FDA review and approval of food and color additive petitions as required
by law, it would not be possible to protect the nation’s food supply.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
FDA’s regulations at 21 CFR 71.1 and 171.1 require a firm to submit four copies of its petition
when the firm states that the substance is intended for use in the production of meat and poultry
products. We then forward the fourth copy of the petition or relevant portions of the petition to
FSIS so that both agencies can perform the necessary reviews simultaneously, thus reducing the
time it takes to authorize an ingredient for use in meat and poultry products. OMB previously
approved this fourth copy when the regulations were amended.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of March 17, 2020 (85 FR 15188.) No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents.

10. Assurance of Confidentiality Provided to Respondents
Food additive and color additive petitions often contain trade secret and commercial confidential
information. Confidential commercial information is protected from disclosure under the
Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), by
section 301(j) of the FD&C Act, and by part 20 of the agency’s regulations (21 CFR part 20).
Thus, we make no assurance of confidentiality regarding information contained in these
petitions.
Privacy Act
This information collection request (ICR) is collecting personally identifiable information (PII)
or other data of a personal nature. PII is collected in the context of the individuals’ professional
capacity. Information is collected via Form FDA 3503 (Food Additive Petition, Color Additive
Petition, Food Master File, Color Master File). The PII collected is name, title, address,
telephone number, fax number, and email address.
We determined that although PII is collected, the collection is not subject to the Privacy Act of
1974 and the particular notice and other requirements of the Act do not apply. Specifically, we
do not use name or any other personal identifier to routinely retrieve records from the
information collected.
In preparing this supporting statement, FDA staff consulted with the FDA Privacy Office to
ensure appropriate handling of information collected.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature in the data requirements for food additive or color
additive petitions.

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12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden
21 CFR
Section/Form
FDA

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

Total
Operating
and
Maintenance
Costs

Color Additive Petitions
70.25, 71.1

2

1

2

1,337

2,674

$5,600

Food Additive Petitions
171.1

3

1

3

7,093

21,279

0

6

1

6

1

6

0

23,959

$5,600

Form FDA
3503
Total

The estimate on burden for food additives and color additive petitions is based on FDA’s
experience with the petition process. We retain our estimate of the number of color additive
and food additive petitions received because the average number of petitions received
annually has varied little over the past 10 years. The figures for hours per response are based
on estimates from experienced persons in the agency and in industry. Although the estimated
hour burden varies with the type of petition submitted, an average petition involves analytical
work and appropriate toxicological studies, as well as the work of drafting the petition itself.
The burden varies depending on the complexity of the petition, including the amount and
types of data needed for scientific analysis.
The labeling requirements for food and color additives were designed to specify the
minimum information needed for labeling in order that food and color manufacturers may
comply with all applicable provisions of the FD&C Act and other specific labeling acts
administered by FDA. Label information does not require any additional information
gathering beyond what is already required to assure conformance with all specifications and
limitations in any given food or color additive regulation. Label information does not have
any specific recordkeeping requirements unique to preparing the label. Therefore, because
labeling requirements under § 70.25 for a particular color additive involve information
required as part of the CAP safety review process, the estimate for number of respondents is
the same for § 70.25 and § 71.1, and the burden hours for labeling are included in the
estimate for § 71.1. Also, because labeling requirements under parts 172, 173, 179, and 180
for particular food additives involve information required as part of the FAP safety review
process under § 171.1, the burden hours for labeling are included in the estimate for § 171.1.

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12b. Annualized Cost Burden Estimate
We estimate that the average hourly wage for respondents is equivalent to a GS-14, step 4 level
in the locality pay area of Washington-Baltimore in 2020, approximately $63.94/hour. Doubling
this wage to account for overhead costs, we estimate the average hourly cost to respondents to be
$127.88/hour. The overall estimated cost incurred by the respondents is $3,063,876.92 (23,959
burden hours x $127.88/hour).
Type of Respondent
Manufacturers or sellers
of food

Total Burden
Hourly Wage Rate
Total Respondent
Hours
Costs
23,959
$127.88
$3,063,876.92

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
Color additives are subject to payment of fees for the petitioning process. The listing fee for a
color additive petition ranges from $1,600 to $3,000, depending on the intended use of the color
additive and the scope of the requested amendment. A complete schedule of fees is set forth in
21 CFR 70.19. An average of one Category A and one Category B color additive petition is
expected per year. The maximum color additive petition fee for a Category A petition is $2,600
and the maximum color additive petition fee for a Category B petition is $3,000. Since an
average of two color additive petitions are expected per calendar year, the estimated total annual
cost burden to petitioners for this start-up cost would be less than or equal to $5,600 ($2,600
(Category A petition) + $3,000 (Category B petition)).
14. Annualized Cost to the Federal Government
We estimate an allocation of 5 full-time employees (FTE) annually for the review of petitions
received under this information collection. The annualized cost to the Federal Government of
processing petitions is calculated by multiplying FTEs used in processing petitions by the dollar
value per supported position. FDA consumer safety officers review submitted petitions with
input from technical reviewers. The dollar estimate for FDA consumer safety officer wages
corresponds roughly to a GS-13, step 6 level in the locality pay area of Washington-Baltimore in
2020, which is $119,775 annually. Doubling this amount to account for overhead costs, we
estimate an average cost of $239,550 per fully supported position. Thus, the total cost to the
Federal Government is estimated at $1,197,750 (5 FTEs x $239,550).
15. Explanation for Program Changes or Adjustments
The burden for this information collection has not changed since the last OMB approval.
16. Plans for Tabulation and Publication and Project Time Schedule
We publish a notice in the Federal Register when a food additive or color additive petition is
filed (21 CFR 71.2 or 171.1) or when a food additive or color additive regulation has been
promulgated (21 CFR 71.20 or 171.100). Otherwise, the agency has no plans for publication of
information from this information collection.
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17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the OMB expiration date would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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