0495 Food Contact Substances SSA 2019 Rev

UNITED STATES FOOD & DRUG ADMINISTRATION
Food Contact Substance Notification Program
OMB Control No. 0910-0495
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration’s (FDA, us or we)
food contact substance notification program. 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.

We recommend 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.
Our guidance documents entitled: (1) “Preparation of Food Contact Notifications:
Administrative,” (2) “Preparation of Food Contact Notifications and Food Additive
Petitions for Food Contact Substances: Chemistry Recommendations,” and (3)
“Preparation of Food Contact Notifications for Food Contact Substances: Toxicology
Recommendations” provide assistance to industry regarding the preparation of an FCN and a
petition for a food contact substances (FCSs). These guidance documents are already
considered within the burden analysis. We have also developed a draft guidance entitled,
“Preparation of Food Contact Notifications for Food Contact Substances in Contact with
Infant Formula and/or Human Milk.” Once finalized, the guidance will provide our current
thinking on how to prepare an FCN for FDA review and evaluation of the safety of FCSs
used in contact with infant formula and/or human milk. The guidance documents may be
found on our internet site and accessed through our food contact substances review page:
https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/Notifications/ucm
2006854.htm
Section 171.1 of FDA 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, our 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.
We are requesting, therefore, continued OMB approval for Form FDA 3479; Form FDA
3480; Form FDA 3480A; as well as the information collection provisions found in the
associated guidance documents discussed in this supporting statement.
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

2

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
As discussed above, we have developed a number of guidance documents to assist
respondents with the information collection requirements found in the applicable
regulations. Notifications for food contact substances and formulations contain summaries
of data and narrative text. We currently accept this information electronically via the
Electronic Submission Gateway (ESG) or electronic media (such as: CD ROM, DVD). We
estimate that all notifications (100%) will be submitted electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We continue 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 FD&C 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 FD&C 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, we use an image-based document management system to permit the
agency to track effective notifications and determine if a food contact substance has already
been reviewed by the agency.
5. Impact on Small Businesses or Other Small Entities
We estimate 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 us if they wish to manufacture a food

3

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 the 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 a list of effective
notifications on our 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.
We have 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.
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), we published a 60-day notice requesting public
comment on the proposed collection of information in the Federal Register of September 13,
2018 (83 FR 46493). One comment was received unrelated to the information collection
and therefore was not addressed.

4

9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provide to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
We expect 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. Respondents 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 our 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, as well as any appropriate limitations on the use of the food contact
substance. It does not include any confidential information.
Privacy Act Review
This ICR does not request any personally identifiable information per the definition
provided by OMB Circular No. A-130. This ICR does contain forms, but they do not
require a Privacy Act Statement as defined in 5 U.S.C. §552a(e)(3)).
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
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

5

21 CFR Section or other
category

170.1062 (Category A)
170.1013, 7 (Category B)
170.1014, 7 (Category C)
170.1015, 7 (Category D)
170.1016, 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 Prenotification 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
Preparation of Food
Contact Notifications for
Food Contact Substances
in Contact with Infant
Formula and/or Human
Milk.
Total

Table 1. --Estimated Annual Reporting Burden1
Form
No. of
No. of
Total
FDA
Respondents Responses
Annual
No.
per
Responses
Respondent
3479
10
2
20
3480
6
1
6
3480
6
2
12
3480
42
2
84
3480
38
1
38
3480
190
1
190

3480A

Average
Burden
per
Response

Total
Hours

2
25
120
150
150
0.5

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

100

1

100

0.5

50

N/A

1

1

1

10,995

10,995

N/A

10

1

10

25

250

N/A

2

1

2

5

10

31,330

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 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 contact
substance notifications.
5 Notifications for uses that are the subject of moderately complex food contact substance notifications.
6 Notifications for uses that are the subject of very complex food contact substance notifications.
7 These notifications require the submission of Form FDA 3480.
8 These notifications recommend the submission of Form FDA 3480.
9 These notifications recommend the submission of Form FDA 3480A.

6

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 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
7, 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. In row 8, 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.
In row 9, 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.
Finally, in row 10, we estimate 2 respondents will utilize the recommendations in the
guidance document entitled, “Preparation of Food Contact Notifications for Food Contact
Substances in Contact with Infant Formula and/or Human Milk,” to submit information
regarding the preparation of food contact notifications for food contact substances in contact
with infant formula and/or human milk. We calculate a reporting burden of 5 hours per
response, for a total burden of 10 hours.

7

12b. 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 WashingtonBaltimore in 2019, approximately $54.91/hour. Doubling this wage to account for overhead
costs, FDA estimates the average hourly cost to respondents to be $109.82/hour. Thus, the
overall estimated cost incurred by the respondents is $3,440,660.60 (31,330 burden hours x
$109.82/hour = $3,440,660.60, rounded to $3,440,661). 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.
Type of Respondent

Total Burden
Hours

Hourly Wage Rate

Manufacturers of food contact
substances sold in the United States.

31,330

$109.82

Total
Respondent
Costs
$3,440,661

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 the Federal Government
The annual cost to the government is $6.36 million dollars (including salaries and other
costs), based on current FTE allocations in support of the program.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustment and revision. We have increased the
reporting burden by 10 hours (from 31,320), with a corresponding increase of 2 annual
responses. We attribute the increase to recommendations found in agency guidance entitled,
“Preparation of Food Contact Notifications for Food Contact Substances in Contact with
Infant Formula and/or Human Milk,” associated with the submission of FCNs. The
collection is being revised to account for burden that may be attributable to activities
associated with recommendations found in agency guidance. Specifically, and as discussed
previously under Question 1, we are including reference to chemistry and toxicology
guidance that discuss testing recommendations with regard to food contact substances.

8

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.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

9