0546 Supporting Statement 2016

Food Additive Petitions and Investigational
Food Additive Exemptions – 21 CFR 571 and 570.17
OMB Control No. 0910-0546
SUPPORTING STATEMENT
A. Justification
1. Circumstances Which Make This Collection of Information Necessary
Section 409(a) of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 409(a))
provides that a food additive shall be deemed to be unsafe unless its use is permitted by a
regulation which prescribes the condition(s) under which it may safely be used, or unless it is
exempted by regulation for investigational use. Section 409(b) of FFDCA specifies the
information that must be submitted by a petition in order to establish the safety of a food additive
and to secure the issuance of a regulation permitting its use.
To implement the provisions of Section 409, procedural regulations have been issued under Part
571 of 21 CFR for food additives intended for animal consumption. This information collection
supports these regulations, specifically:
21 CFR 571.1; Petition
21 CFR 571.6; Amendment of Petitions
2. Purpose and Use of the Information Collection
Food additive petitions, submitted by food manufacturers or food additive manufacturers, are
reviewed by FDA scientific personnel to ascertain if the data establish the identity of the
substance, justify its intended effect in/on the food, and establish that its intended use in/on food
is safe. The petitions themselves may contain privileged information that will not be made
public and will not be directly published. However, favorable action on the petition by the
Agency requires publication of a regulation in the Federal Register establishing the conditions
under which the additive may be safely used in animal food.
The labeling information for animal food, such as proper name of the product, the name and
address of the manufacturer of the product, and other requirements such as net contents
statements, are specifically required by FFDCA and other Acts enforced by FDA. Labeling
information for foods consumed by animals often includes specific directions for use.
Food additive petitions provide the only method for approval of food additives to bring new food
additives for animal consumption to market.
3. Use of Improved Information Technology and Reduction Burden
FDA expects that food additive petitions under 21 CFR 571.1 and Part 573 do not prohibit the
use of improved technology that may be appropriate to satisfy the labeling requirements for food

additives. FDA regulations (21 CFR Part 571) provide a standard format for food additive
petitions in order to facilitate the processing of the petition and hence the issuance of a regulation
for animal food use as required by FFDCA.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection. FDA continues to work with EPA
and USDA to eliminate areas of duplicate data collection and evaluation. Memoranda of
understanding have been reached with EPA in the areas of pesticides and water treatment. Also,
EPA establishes a tolerance, or exemption from tolerance, for pesticide chemicals and residues
of such chemicals in food, and FDA enforces the tolerance or exemption.
5. Impact on Small Businesses and Other Small Entities
There is no impact on small business or other small entities.
6. Consequences of Collecting The Information Less Frequently
Companies have a right, granted by law, to submit food additive petitions in order to obtain
approval to market a new food additive or to expand the use of a currently regulated approved
food additive for use in animal food. Restriction of this right would lower the number of food
additives being cleared for use but would have no detrimental effects on Federal activities. The
consequence of discontinuing labeling requirements would be the possible misuse of food
additives, resulting in the introduction of unsafe animal food into interstate commerce. Each
container of a food additive must be properly labeled to assure safe use of the additive and to
safeguard the public health. Additionally, food must be identified on the label of retail packages
of animal foods.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for the collection of the information requirements.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice soliciting public comment
regarding the collection of information in the Federal Register of October 21, 2015 (80 FR
63795). No comments were received.
The regulations in 21 CFR regarding the submission of food additive petitions were subject to
notice and comment rulemaking at the time they were promulgated (1959). All regulations
published in response to food additive petitions are also subject to notice and comments from the
public. Also, the agency meets regularly with petitioners prior to the official submission of a
petition and during petition review to ensure that data collected are those necessary and sufficient
to reach a decision on a petition.

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In general, the public sector has no involvement with data developed for food additive petitions.
However, opportunity for public comment on a food additive is given at the time a filing notice
is published in the Federal Register and the public may, within 30 days of the publication of a
regulation authorizing a new food additive, submit objections. Additionally, all data and
information submitted, except for trade secret information, are subject to release under the
Freedom of Information Act after the food additive petition has been filed.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provide to Respondents
Because food additive petitions often contain trade secret information, all files are maintained in
a secured area. Confidentiality of data and information in food additive petitions is regulated
under 21 CFR 571.1. The information is also safeguarded by Section 301 (j) of FFDCA.
11. Justification for Sensitive Questions
This information does not contain questions pertaining to sex behavior, attitude, religious beliefs,
or any other matter commonly considered private or of a sensitive nature. There are no questions
of a sensitive nature in the food additive petition requirements.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden
FDA estimates the burden of this collection of information as follows:
We base our estimate of the total annual responses on submissions received during fiscal years
2014 and 2015. We base our estimate of the hours per response upon our experience with the
petition and filing processes.
Table 1 – Estimated Annual Reporting Burden; Food Additive Petitions1
21 CFR Section

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Avg.
Burden per
Response

Total
Hours

571.1(c) moderate category

12

1

12

3,000

36,000

571.1(c) complex category
571.6 amendment of
petition
Total

12
2

1
1

12
2

10,000
1,300

120,000
2,600

1

158,600

There are no capital costs or operating and maintenance costs associated with this collection of information.

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571.1(c) moderate category: For a food additive petition without complex chemistry,
manufacturing, efficacy or safety issues, the estimated time requirement per petition is
approximately 3,000 hours. We estimate that, annually, 12 respondents will each submit 1 such
petition, for a total of 36,000 hours.
571.1(c) complex category: For a food additive petition with complex chemistry, manufacturing,
efficacy and/or safety issues, the estimated time requirement per petition is approximately 10,000
hours. We estimate that, annually, 12 respondents will each submit 1 such petition, for a total of
120,000 hours.
571.6 amendment of petition: For a food additive petition amendment, the estimated time
requirement per petition is approximately 1,300 hours. We estimate that, annually, 2
respondents will each submit 1 such amendment, for a total of 2,600 hours.
Table 2 – Estimated Annual Reporting Burden; Investigational Food Additive Files1
Authority

570.17; Moderate Category
570.17; Complex Category
Total
1

No. of
Responses
per
Respondent

No. of
Respondents

4
5

Total
Annual
Responses

1
1

4
5

Avg.
Burden
per
Response

1,500
5,000

Total
Hours

6,000
25,000
31,000

There are no capital costs or operating and maintenance costs associated with this collection of information.

570.17 moderate category: For an investigational food additive file without complex chemistry,
manufacturing, efficacy or safety issues, the estimated time requirement per file is approximately
1,500 hours. We estimate that, annually, 4 respondents will each submit 1 such file, for a total of
6,000 hours.
570.17 complex category: For an investigational food additive file with complex chemistry,
manufacturing, efficacy and/or safety issues, the estimated time requirement per file is
approximately 5,000 hours. We estimate that, annually, 5 respondents will each submit 1 such
file, for a total of 25,000 hours.
12b. Annualized Cost Burden Estimate
Type of Respondent

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Compliance Officer

51,700

$47.00

$2,429,900

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital or start-up costs to respondents.

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14. Annual Cost Estimate to the Federal Government
The annualized cost to the federal government of processing petitions is derived by multiplying
the hourly rate for the GS grade of the employee by the total hourly burden. We anticipate that
the review of a food additive petition will require the services of a GS-13-3 review scientist for
1000 hours at an hourly rate of $47.10 per hour. The cost for the one-time review would be
$47,100.
15. Explanation of Program Changes or Adjustments
This information collection reflects adjustments. The agency attributes these adjustments to
industry trends.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no results to publish for this information collection. Food additive petitions are
submitted for regulatory purposes and the data in these petitions are not intended for statistical
use.
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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