0495 Supporting Statement 2016

Food Contact Substance Notification Program
OMB Control No. 0910-0495
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(h))
establishes a premarket notification process for food contact substances. Section 409(h)(6) of the
FD&C Act defines a “food contact substance” as “any substance intended for use as a component of
materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not
intended to have any technical effect in such food.” Section 409(h)(3) of the FD&C Act requires
that the notification process be used for authorizing the marketing of food contact substances except
when: (1) FDA determines that the submission and premarket review of a food additive petition
(FAP) under section 409(b) of the FD&C Act is necessary to provide adequate assurance of safety
or (2) FDA and the manufacturer or supplier agree that an FAP should be submitted. Section
409(h)(1) of the FD&C Act requires that a notification include: (1) information on the identity and
the intended use of the food contact substance and (2) the basis for the manufacturer’s or supplier’s
determination that the food contact substance is safe under the intended conditions of use.
Sections 170.101 and 170.106 of FDA’s regulations (21 CFR 170.101 and 170.106) specify the
information that a notification must contain and require that: (1) a food contact substance
notification (FCN) include a completed and signed Form FDA 3480 and (2) a notification for a food
contact substance formulation include a completed and signed Form FDA 3479. These forms serve
to summarize pertinent information in the notification. The forms facilitate both preparation and
review of notifications because the forms serve to organize information necessary to support the
safety of the use of the food contact substance. The burden of filling out the appropriate form has
been included in the burden estimate for the notification.
Currently, interested persons transmit an FCN submission to the Office of Food Additive Safety in
the Center for Food Safety and Applied Nutrition using Form FDA 3480, whether it is submitted in
electronic or paper format. In addition to its required use with FCNs, Form FDA 3480 is
recommended to be used to organize information within a Pre-notification Consultation or Master
File submitted in support of an FCN 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 contact substance authorizations.
FDA recommends using Form FDA 3480A entitled, “Amendment to an Existing Food Contact
Substance Notification, a Pre-Notification Consultation, or a Food Master File” for each
submission of additional information (i.e., amendment) to an FCN submission currently under
agency review. The form and elements prepared as attachments to the form can be submitted in
electronic format. Form FDA 3480A helps the respondent organize the submission to focus on the
information needed for FDA’s safety review.

Section 171.1 of FDA’s regulations (21 CFR 171.1) specifies the information respondents must
submit in order to: (1) establish that the proposed use of an indirect food additive is safe and (2)
secure the publication of an indirect food additive regulation in parts 175 through 178 (21 CFR
parts 175 through 178). Parts 175 through 178 describe the conditions under which the additive
may be safely used. In addition, FDA’s guidance document entitled, “Use of Recycled Plastics in
Food Packaging: Chemistry Considerations” provides assistance to manufacturers of food
packaging in evaluating processes for producing packaging from post-consumer recycled plastic.
The recommendations in the guidance address the process by which manufacturers certify to FDA
that their plastic products are safe for food contact.
FDA is requesting, therefore, continued OMB approval for Form FDA 3479; Form FDA 3480;
Form FDA 3480A; and the information collection provisions in the guidance entitled, “Use of
Recycled Plastics in Food Packaging: Chemistry Considerations.”
21 CFR 170.101 - Reporting
An FCN is required to contain information that provides a basis for estimating daily dietary
exposure to the substance resulting from its notified use. Such a notification must also either
contain data from toxicological studies which demonstrate that the daily dietary exposure to the
food contact substance does not pose a safety hazard or must reference such data in FDA files.
Information on the environmental impact that would result from the use and disposal of the
proposed food contact substance must also be presented in the notification.
21 CFR 170.106 - Reporting
A notification for a food contact substance formulation is required to contain information on the
identity, amount, and intended effect of all substances in the formulation and information
documenting that the intended use of each substance in the formulation is authorized.
2. Purpose and Use of the Information Collection
Notifications for food contact substances and formulations submitted by manufacturers are
reviewed by FDA scientific personnel to ascertain that the data establish the identity of the
substance, establish its use in contact with food, and support the notifier’s determination that the
intended use in contact with food is safe. Section 409(h)(4) of the FD&C act requires FDA to keep
confidential any information submitted in a premarket notification for the entire 120-day review
period. If FDA does not object to the notification within 120 days after receipt, the notification
becomes effective and the substance may be legally marketed.
Description of Respondents: Respondents to the information collection are manufacturers of food
contact substances sold in the United States. Respondents are from the private sector (for-profit
businesses).
3. Use of Improved Information Technology and Burden Reduction
Notifications for food contact substances and formulations contain summaries of data and narrative
text. FDA currently accepts this information electronically via the Electronic Submission Gateway

2

(ESG) or electronic media (such as: CD ROM, DVD). The agency estimates that all of the
notifications (100%) will be submitted electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
FDA continues to work with EPA and USDA to eliminate areas of duplicate data collection and
evaluation. USDA has eliminated its approval processes for components of food contact materials
that duplicated FDA’s processes. In addition, the Food Quality Protection Act of 1996 gave sole
jurisdiction to EPA for certain substances formerly regulated by FDA as food additives and by EPA
as pesticide chemicals. Currently there is no significant duplication of data collection and
evaluation for food contact substances among Federal agencies with jurisdiction. In addition, to
avoid unnecessary duplication for individual submissions, existing data would be used whenever
possible by FDA in evaluating notifications for food contact substances.
Because section 409(h)(4) of the act prohibits FDA from disclosing the information in a notification
prior to the completion of the agency’s review, such information would not be available to other
notifiers until FDA’s review is complete. In addition, section 409(h)(2)(C) of the act permits only
the manufacturer identified in the notification to rely on the notification to market legally the food
contact substance. Therefore, the notification process will result in some duplication of review by
FDA if a second manufacturer notifies the agency for the same use of the same food contact
substance. In addition, the notification process for formulations that was requested by the regulated
industry will also represent a small duplication of review. In order to minimize potential
duplication of review, FDA uses an image based document management system to permit the
agency to track effective notifications and to permit the agency to determine if a food contact
substance has already been reviewed by the agency. FDA also maintains on the FDA Internet site a
list of effective notifications.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that ten percent (10 %) of respondents are small businesses. The premarket
notification process for food contact substances may increase the burden on small businesses
because small businesses will be required to notify FDA if they wish to manufacture a food contact
substance, even if the food contact substance was the subject of a previous notification by another
manufacturer. Previously, small businesses would have been able to rely on authorizations
requested by other manufacturers under FDA’s food additive petition process or threshold of
regulation exemption process. Nevertheless, this increased burden will be minimal, because any
information presented to support safety of the food contact substance in previous notifications will
be available under the Freedom of Information Act (FOIA) after such previous notifications are
effective. We place on the FDA Internet site a list of effective notifications. This list includes the
notifier, the identity of the food contact substance, the effective date of the notification, as well as
any appropriate limitations on the use of the food contact substance.
The agency has established the types of data necessary to demonstrate that the use of a food contact
substance is safe under 21 CFR 170.101 and that the components of a formulation are authorized
under 21 CFR 170.106. In addition, FDA has developed guidance documents to assist potential
notifiers in preparing notifications. Whenever possible, individual assistance will be given to
requesters to minimize the likelihood that unnecessary work is performed.

3

FDA aids small businesses in complying with its requirements through the agency’s Regional Small
Business Representatives and through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Failure to provide requirements for notifications would
prevent industry from preparing notifications sufficient to permit new products and would make
Federal programs for notification review inefficient. Companies have a right, granted by law, to
submit notifications for food contact substances in order to permit marketing of a food contact
substance for a new use. Any restriction of this right would decrease the number of new food
contact substances that could be legally marketed. In addition, FDA’s acceptance of notifications
for formulations will facilitate domestic and international trade in packaged foods and food contact
materials.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
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 for public comment in the
Federal Register of October 8, 2015 (80 FR 60911). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
FDA expects that notifications for food contact substances will often contain trade secret and
commercial confidential information. As a result, all files are maintained in a secured area. Form
FDA 3479, Form FDA 3480, and Form FDA 3480A, as well as their instructions, and related
guidance, provide instructions for assisting FDA with protecting confidential information. A
submitter may choose to provide a redacted copy of the notification, identifying that information
that the submitter views as trade secret or as confidential commercial or financial information.
Only information that is releasable under the agency’s regulations in 21 CFR part 20 would be
released to the public. This information is also safeguarded by Section 301(j) of the FD&C act and
would be protected from disclosure under the Freedom of Information Act (FOIA) under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)).
Section 409(h)(4) of the FD&C act prohibits FDA from publicly disclosing information in a
notification while it is under review by the agency. After the review is complete and the FCN has
become effective, we add it to the list of effective notifications on the FDA Internet site. This list
includes the notifier, the identity of the food contact substance, the effective date of the notification,

4

as well as any appropriate limitations on the use of the food contact substance. It does not include
any confidential information.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: The respondents to the information collection are manufacturers of
food contact substances sold in the United States.
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
21 CFR Section or other
category
170.106 2 (Category A)
170.101 3,7 (Category B)
170.101 4,7 (Category C)
170.101 5,7 (Category D)
170.101 6,7 (Category E)
Pre-notification
Consultation or Master
File (concerning a food
contact substance). 8
Amendment to an
existing notification
(170.101), amendment to
a Pre-notification
Consultation, or
amendment to a Master
File (concerning a food
contact substance). 9
171.1 Indirect Food
Additive Petitions
Use of Recycled Plastics
in Food
Packaging: Chemistry
Considerations
Total

FDA Form
No.

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

FDA 3479
FDA 3480
FDA 3480
FDA 3480
FDA 3480
FDA 3480

10
6
6
42
38
190

2
1
2
2
1
1

20
6
12
84
38
190

2
25
120
150
150
0.5

40
150
1,440
12,600
5,700
95

FDA 3480A

100

1

100

0.5

50

N/A

1

1

1

10,995

10,995

N/A

10

1

10

25

250

31,320

1

There are no capital costs or operating and maintenance costs associated with this collection of information.
Notifications for food contact substance formulations and food contact articles. These notifications require the
submission of Form FDA 3479 (“Notification for a Food Contact Substance Formulation”) only.
3
Duplicate notifications for uses of food contact substances.
4
Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive
petitions.
5
Notifications for uses that are the subject of moderately complex food additive petitions.
6
Notifications for uses that are the subject of very complex food additive petitions.
2

5

7

These notifications require the submission of Form FDA 3480.
These notifications recommend the submission of Form FDA 3480.
9
These notifications recommend the submission of Form FDA 3480A.
8

The estimates in Table 1 are based on our current experience with the food contact substance
notification program and informal communication with industry.
Beginning in row 1, we estimate 10 respondents will each submit 2 notifications annually for food
contact substance formulations (Form FDA 3479), for a total of 20 responses. We calculate a
reporting burden of 2 hours per response, for a total of 40 hours. In row 2, we estimate six
respondents. We believe the hourly burden for preparing these notifications will primarily consist
of the manufacturer or supplier completing Form FDA 3480, verifying that a previous notification is
effective, and preparing necessary documentation. We estimate one submission for each
respondent, for a total of six responses. We calculate a reporting burden of 25 hours per response,
for a total of 150 hours.
In rows 3, 4, and 5, we identify three tiers of FCNs that reflect different levels of burden applicable
to the respective information collection items (denoted as Categories C, D, and E). We estimate 6
respondents will each submit 2 Category C submissions annually, for a total of 12 responses. We
calculate a reporting burden of 120 hours per response, for a total burden of 1,440 hours. We
estimate 42 respondents will each submit 2 Category D submissions annually, for a total of 84
responses. We calculate a reporting burden of 150 hours per response, for a total burden of 12,600
hours. We estimate 38 respondents will each submit 1 Category E submission annually, for a total
of 38 responses. We calculate a reporting burden of 150 hours per response, for a total burden of
5,700 hours.
In row 6, we estimate one respondent will submit one indirect food additive petition under § 171.1,
for a total of one response. We calculate a reporting burden of 10,995 hours per response, for a total
burden of 10,995 hours. Finally, in row 7, we estimate 10 respondents will utilize the
recommendations in the guidance document entitled, “Use of Recycled Plastics in Food
Packaging: Chemistry Considerations,” to develop the additional information for one such
submission annually, for a total of 10 responses. We calculate a reporting burden of 25 hours per
response, for a total burden of 250 hours.
In row 8, we estimate 190 respondents will each submit information to a prenotification
consultation or a master file in support of FCN submission using Form FDA 3480. We calculate a
reporting burden of 0.5 hours per response, for a total burden of 95 hours. In row 9, we estimate
100 respondents will each submit an amendment (Form FDA 3480A) to a substantive or
nonsubstantive request of additional information to an incomplete FCN submission, an amendment
to a prenotification consultation, or an amendment to a master file in support of an FCN. We
calculate a reporting burden of 0.5 hours per response, for a total burden of 50 hours.
12 b. Annualized Cost Burden Estimate
Gathering the information discussed here and providing it to the agency requires a team of
professional employees, which may include toxicologists, chemists, environmental scientists, and
lawyers. FDA estimates that the average hourly wage for these employees would be equivalent to a
GS-14/Step-1 level in the locality pay area of Washington-Baltimore in 2016, approximately
$52.17/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly
6

cost to respondents to be $104.34/hour. Thus, the overall estimated cost incurred by the
respondents is $3,267,928.80 (31,320 burden hours x $104.34/hour = 3,267,928.80, rounded to
2,820,831.90). In addition, while FDA does not charge for the use of the ESG, FDA requires
respondents to obtain a public key infrastructure (PKI) certificate in order to set up the account.
This can be obtained in-house or outsourced by purchasing a public key certificate that is valid for 1
year to 3 years. The certificate typically costs from $20-$30.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to Federal Government
The annual cost to the government is $6.04 million dollars (including salaries and other costs).
15. Explanation for Program Changes or Adjustments
This information collection reflects agency adjustments. The total annual number of responses
increased from 237 to 461 responses (an increase of 224 responses) and the total annual hour
burden increased from 27,035 to 31,320 hours (an increase of 4,285 hours). We attribute the
increase to an increase in the number of respondents submitting reports. In turn, this increase
caused the total annual hour burden to increase. Specific adjustments are as follows:
Table 2—Summary of Change in Responses and Hour Burden
IC Number
Change in Responses Change in Hour Burden
IC#1
+15
+30
IC#2
+1
+25
IC#3
+2
+240
IC#4
+18
+2,700
IC#5
+8
+1,200
IC#6
No change
No change
IC#7
No change
No change
IC#8
+130
+65
IC#9
+50
+25
Net Change
+224
+4,285
16. Plans for Tabulation and Publication and Project Time Schedule
No statistics from the information obtained from this data collection will be published. However, as
noted above in Section 10, a list of effective notifications is available on the FDA Internet site. This
list includes the notifier, the identity of the food contact substance, the effective date of the
notification, as well as any appropriate limitations on the use of the food contact substance. It does
not include any confidential information.

7

17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

8