Supporting Statement

Final Rule\--Food Contact Substances Notification System

**1. Circumstances Necessitating Information Collection**

In 1958, Congress amended the Federal Food, Drug, and Cosmetic (FD&C)
Act to require premarket authorization of food additives (21 U.S.C.
321(s), 342(a)(2)(C), and 348). A \"food additive,\" as defined in
section 201(s) of the Act, is:

> \* \* \* any substance the intended use of which results or may
> reasonably be expected to result, directly or indirectly, in its
> becoming a component or otherwise affecting the characteristics of any
> food (including any substance intended for use in producing,
> manufacturing, packing, processing, preparing, treating, packaging,
> transporting, or holding food;\*\*\*), if such substance is not
> generally recognized, among experts qualified by scientific training
> and experience to evaluate its safety, as having been shown through
> scientific procedures \*\*\* to be safe under the conditions of its
> intended use\*\*\*.

Because the definition of a food additive includes substances that may
reasonably be expected to \"indirectly\" become a component of food,
food additives that are components of food contact materials require
premarket authorization. In November 1997, section 309 of the Food and
Drug Administration Modernization Act (FDAMA) amended section 409 of the
FD&C Act establishing a premarket notification process for \"food
contact substances\". FDAMA added a definition for a \"food contact
substance\" under section 409(h)(6) of the FD&C Act as follows:

> \*\*\*the term \"food contact substance\" means 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 a technical effect in such food.\*\*\*

Under section 409(h) **(Attachment 1)** of the FD&C Act, manufacturers
and suppliers of food contact substances are required to notify FDA 120
days prior to marketing a food contact substance for a new use. Under
section 409(h)(1), such notifications must include information on the
identity and intended use of the food contact substance, the notifier's
determination that the intended use of the food contact substance is
safe, all information that forms the basis for that determination, and
any information that FDA requires by regulation to be provided.

Under section 409(h)(3)(A) of the FD&C act, premarket notifications for
food contact substances are intended to be the primary method for
authorizing the use of food contact substances. The only other methods
for authorizing a new use of a food contact substance are the food
additive petition process (Section 409(b) of the FD&C Act) and FDA's
threshold of regulation process (21 CFR 170.39) **( Attachment 2).**
These other processes require the same level of information to support
the safe use of a food contact substance that comparable premarket
notifications would require. However, the food additive petition and
threshold of regulation processes are more burdensome on industry than
the notification process, because the petition and threshold processes
do not require automatic authorization within a specific time frame.

This is a request for OMB approval of the information collection
requirements in the following citations:

**21 CFR 170.101** - Information required in a notification for a food
contact substance that provides a basis for estimating daily dietary
exposure to the substance resulting from it's 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** - Information required in a notification for a food
contact substance formulation including information on the identity,
amount, and intended effect of all substances in the formulation and any
information to document that the intended use of each substance in the
formulation is authorized.

**2. How, by Whom, and for What Purpose Information is Used**

Notifications for food contact substances and formulations submitted by
manufacturers are reviewed by FDA scientific personnel to ascertain if
the data establish the identity of the substance, 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. No action is required by FDA for a notification under section
409(h) of the FD&C act to become effective, and FDA is not required by
statute to publish a notice that a notification is effective or to
inform the notifier in writing that a notification has become effective.

**3. Consideration of Information Technology**

In a **Federal Register** notice of March 20, 1997 (65 FR 13429), FDA
published a final rule that would, under certain circumstances, permit
the agency to accept electronic records, electronic signatures, and
handwritten signatures executed to electronic records as generally
equivalent to paper records and handwritten signatures executed on
paper. These proposed regulations would apply to notifications submitted
under section 409(h) of the FD&C Act.

The agency currently has a working local area network (LAN) and optical
scanning system in operation. Current paper files are optically scanned
and placed on the LAN. This is a preliminary step that will complement
the long-range goal of electronic submission of premarket notifications
for food contact substances. FDA is currently developing under contract
a program that notifiers will be able to use to automate assembly of
electronic submissions for food contact notifications. This program is
based on FDA Form 3480 and will build to electronic notification as the
notifier fills out the form. Once available, FDA expects to make the
program available from the Agency's internet site.

The availability of computerized indexing services such as Med-Line and
Tox-line permits requestors to search the scientific literature to
determine if a substance has been the subject of toxicity testing that
is relevant to the safety of its use as a food contact substance. FDA
has also instituted a computerized indexing system (SIREN: Scientific
Information Retrieval and Exchange Network) and an image-based document
management system (FARM: The Food Additives Regulatory Management
System) to permit FDA personnel to easily locate and access data
previously submitted to the agency.

**4. Duplication and Similar Information Already Available**

FDA continues to work with EPA and USDA to eliminate areas of duplicate
data collection and evaluation. Within the past two years 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
notifier's 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 legally market 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 expects to use 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
expects to maintain a listing of effective notifications available on
the agency's internet site.

**5. 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.

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. FDA aids small businesses
in dealing with the requirements through the Office of Small
Manufacturers Assistance and through the scientific and administrative
staffs of the agency.

**6. Consequences of Less Frequent Information Collection**

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**

Data collection for notifications for food contact substances involves
no special circumstances and all information would be collected in
conformance with the Paperwork Reduction Act.

**8. Outside Consultation**

The Draft Guidances for Industry on Food-Contact Substance Notification
System; Availability (60 day notice) was published on November 12, 1999
(64 FR 61648), the 30 day notice was published on May 31, 2000 (65 FR
34713) and the Notice of Proposed Rulemaking was published on July 13,
2000 (65 FR 43269) Attachment 3). No comments were received on the draft
guidances, but three comments were received on the proposed rule.

All three comments request that FDA clarify the relationship of FDA Form
3480 to the recommendations in the Agency's draft guidance documents for
FCNs. Proposed § 170.101(e) (21 CFR 170.101(e)) would require that a
completed and signed FDA Form 3480 be included in an FCN. FDA Form 3480
requires that notifiers list summary toxicology information on the FCS
and its constituents. In addition, the draft guidance on toxicology
information in an FCN advises that notifiers should provide a
comprehensive toxicological profile for the FCS and its constituents.
The comments express uncertainty about the level of detail required in
FDA Form 3480. In addition, the comments express concern about the
potential for duplicate efforts when a manufacturer develops a
comprehensive toxicology profile and the safety narrative, as
recommended in the draft toxicology guidance document, and the
manufacturer's completion of FDA Form 3480. In response to these
comments, FDA has revised FDA Form 3480 to minimize duplication of
effort in developing the toxicology package for FCNs. FDA has also
revised its guidance documents to assist notifiers in completing FDA
Form 3480.

As part of its implementation of the notification process for food
contact substances, FDA held a public meeting on March 12, 1999. FDA
received comments as a result of the public meeting.

-   Some comments from the regulated industry requested that FDA accept
    notifications for complete formulations of food contact materials.
    Notifications for such formulations will only be accepted if each
    component of the formulation is already authorized for its intended
    use. In contrast to other notifications, a notification for a
    formulation of a food contact material is voluntary because all
    components of such a formulation must already be authorized for
    their intended use in the formulation.

-   FDA received comments from industry requesting that the agency
    permit the submission of notifications in electronic format. FDA is
    considering these comments in developing specific guidance for the
    submission of notifications in electronic format. FDA received
    comments from industry requesting that the agency respond in writing
    to the notifier when a notification becomes effective. The comment
    argues that the listing of notifications in FDA's inventory of
    effective notifications on the Agency's internet site may not be
    adequate to inform interested persons regarding the status of an
    FCN. In addition, the comment contends that listing on FDA's
    internet site may not be completed in a timely manner. FDA disagrees
    with this comment. The statute does not require FDA to issue a
    letter at the conclusion of the review of an FCN. Indeed, no action
    is required by FDA for an FCN to become effective. FDA believes that
    issuance of final letters for effective FCNs has some value, but FDA
    is concerned that the issuance of such letters may consume resources
    necessary to complete the timely review of FCNs. Therefore, FDA is
    denying the request to require the Agency to issue a final letter
    for effective notifications. However, as noted above, FDA has been
    reviewing FCNs since the program began to operate and, since that
    time, FDA has consistently issued final letters and listed effective
    notifications on its internet site in a timely manner. Accordingly,
    FDA expects to continue to issue final letters as long as the
    resources necessary to do so do not prevent timely review of
    FCNs**.**

Listed below are persons with whom FDA has consulted to obtain an
estimate of the resources needed to prepare a notification for a new use
of a food contact substance.

[Name]{.underline} [Company]{.underline} [Telephone No.]{.underline}

Banko, Lacy Eastman Chemical 423-229-1051

Michaels, Mary BPAmoco 630-836-5742

Misko, George Keller and Heckman 202-434-4170

Because, the notification process will largely replace the Threshold of
Regulation (TOR) process and a large portion of the food additive
petition process FDA has also used the most recent information gathered
regarding those information collections. The following are the persons
who previously provided information regarding those information
collections:

[Food Additive Petitions]{.underline}

[Name]{.underline} [Firm]{.underline} [Telephone No.]{.underline}

Breder, Charles Keller and Heckman 202-434-4183

Goldenthal, Edwin MPI Research 616-668-3336

Graham, Stuart S.L. Graham 301-249-0295

Harrison, Eliot Lewis & Harrison 301-652-5495

Heckman, Jerome Keller and Heckman 202-434-4100

Misko, George Keller and Heckman 202-434-4170

Olson, William Center for Regulatory 703-620-9175

Services

Schwemmer, Bruce Bruce EnviroExcel Group 908-689-9215

Takeguchi, Clyde Phoenix Regulatory 703-406-0906

Associates

Wang, Wilhelm Ciba-Geigy 914-785-4311

Weaver, Jane Shell Chemical 216-798-6431

Yingling, Gary McKenna and Cuneo 202-789-7645

[Threshold of Regulation Requests]{.underline}

[Name]{.underline} [Company]{.underline} [Telephone No.]{.underline}

Banko, Lacy Eastman Chemical 423-229-1051

Misko, George Keller and Heckman 202-434-4170

Mary, Michaels BPAmoco 630-836-5742

**9. Payment to Respondents**

FDA is not proposing any payment or gift to respondents.

**10. Confidentiality of Information**

FDA expects that notifications for food contact substances will often
contain trade secret and commercial confidential information. 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.
Thereafter, only information that is releasable under the Freedom of
Information Regulations (21 CFR Part 20) would be released to the
public. This information is also safeguarded by Section 301(j) of the
FD&C Act.

A list of effective notifications will be available via the Agency's
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.

**11. Sensitive Questions**

There are no questions of a sensitive nature in the data requirements
for notifications for food contact substances.

**12. Burden Hours and Explanation**

FDA estimates the burden of this information collection as follows:

ESTIMATED ANNUAL REPORTING BURDEN^1^

+-------------+--------------+-------+--------+--------+------+------+
| **21 CFR    | **No. of     | **F   | **     | *      | **H  | **T  |
| Section**   | R            | orm** | Annual | *Total | ours | otal |
|             | espondents** |       | Fre    | Annual | per  | Hou  |
|             |              |       | quency | Respo  | Re   | rs** |
|             |              |       | per    | nses** | spon |      |
|             |              |       | Resp   |        | se** |      |
|             |              |       | onse** |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **1         | **200**      | **FDA | **4**  | *      | *    | *    |
| 70.106^2^** |              | 3     |        | *800** | *2** | *1,6 |
|             |              | 479** |        |        |      | 00** |
| **(Category |              |       |        |        |      |      |
| A)**        |              |       |        |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **170       | **200**      | **FDA | **1**  | *      | **   | *    |
| .101^3,7^** |              | 3     |        | *200** | 25** | *5,0 |
|             |              | 480** |        |        |      | 00** |
| **(Category |              |       |        |        |      |      |
| B)**        |              |       |        |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **170       | **55**       | **FDA | **2**  | *      | **1  | **   |
| .101^4,7^** |              | 3     |        | *110** | 20** | 13,2 |
|             |              | 480** |        |        |      | 00** |
| **(Category |              |       |        |        |      |      |
| C)**        |              |       |        |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **170       | **45**       | **FDA | **2**  | **90** | **1  | **   |
| .101^5,7^** |              | 3     |        |        | 50** | 13,5 |
|             |              | 480** |        |        |      | 00** |
| **(Category |              |       |        |        |      |      |
| D)**        |              |       |        |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **170       | **16**       | **FDA | **1**  | **16** | **1  | *    |
| .101^6,7^** |              | 3     |        |        | 50** | *2,4 |
|             |              | 480** |        |        |      | 00** |
| **(Category |              |       |        |        |      |      |
| E)**        |              |       |        |        |      |      |
+-------------+--------------+-------+--------+--------+------+------+
| **Total**   |              |       |        |        |      | **   |
|             |              |       |        |        |      | 35,7 |
|             |              |       |        |        |      | 00** |
+-------------+--------------+-------+--------+--------+------+------+

^1^There **are no capital costs or operating and maintenance costs
associated with this collection of information.**

**^2^ Notifications for formulations and food contact articles. These
notifications require only FDA form 3479 ("Notification for a Food
Contact Substance Formulation") to be filled out and documentation
attached. (Attachment 5)**

**^3^ Duplicate notifications for uses of food contact substances.**

**^4^ Notifications for uses that would currently be the subject of
exemptions under 21 CFR 170.39 and very simple food additive
petitions.**

**^5^ Notifications for uses that would currently be the subject of
moderately complex food additive petitions.**

**^6^ Notifications for uses that would currently be the subject of very
complex food additive petitions.**

**^7^ These notifications require the submission of FDA form 3480
("Notification for New Use of a Food Contact Substance").**

FDA expects to receive an average of approximately 1216 notifications
for food contact substances and formulations per year. FDA bases this
estimate of the number of notifications expected annually on the highest
number of comparable submissions received by the agency in recent years
(50 food additive petitions and 54 threshold of regulation exemption
requests). FDA also estimated that more notifications will be received
annually than petitions and exemption requests because 1) the
notification process is proprietary so that each company that wishes to
market a food contact substance must separately notify FDA, and 2) the
increased predictability of the notification process is likely to foster
innovation and increase the number of food contact substances that may
be successfully marketed.

The agency estimated that the likely increase in submissions will be
approximately four times the highest recent number of annual submissions
for food contact substances (50 food additive petitions (FAP's) and 54
threshold of regulation (TOR) submissions). Thus, FDA estimates that
approximately 416 premarket notifications will be submitted annually (4
x 50 + 4 x 54).

The agency determined the expected number of notifications for five
categories of notifications for formulations and food contact
substances. The burden of the data collection will vary with the type of
notification submitted. The following examples represent estimates of
information collection for notifications for formulations and food
contact substances.

> ***Category A:*** Notification for a formulation of a food contact
> material. This type of notification requires the least amount of time
> for the collection of information: approximately 2 hours per
> submission to fill out FDA Form No. 3479 **(Attachment 4)** and attach
> documentation. FDA estimates about 800 notifications of this type will
> be submitted annually, resulting in a burden of 1,600 hours.
>
> ***Category B:*** Duplicate notifications for food contact substances.
> Because this type of notification may reference an earlier agency
> review, it also requires a minimal amount of time for collection of
> information: approximately 25 hours per submission to fill out FDA
> form 3480 **(Attachment 4)**, verify that a previous notification is
> applicable, and collect the information necessary to establish that a
> previous notification is applicable. FDA expects approximately 200
> notifications of this type will be submitted annually for a total
> burden of 5,000 hours.
>
> ***Category C:*** Notifications for food contact substances that would
> formerly have been threshold of regulation exemptions and simple
> indirect additive petitions. Such submissions will require notifiers
> to perform literature searches and collect available information
> relevant to the safety of the food contact substance, and in limited
> instances to perform specific toxicity testing or analytical work to
> support the safety of such food contact substances. Therefore, FDA
> expects the burden for collection of information will be minimal:
> approximately 110 of these notifications will be submitted annually
> for a total burden of 13,200 hours. In addition, FDA estimates the
> cost of such testing to be approximately \$12,500 per submission for a
> total cost of testing of \$1.375M.
>
> ***Category D:*** An moderately complex notification consisting of
> analytical work, 90-day feeding studies, toxicological review of study
> data, and internal review and the drafting of the notification,
> requires approximately 150 hours per petition and a total cost of
> necessary testing of approximately \$350,000. Ninety such
> notifications are expected to be submitted on an annual basis,
> resulting in a burden of 13,500 hours and \$31.5M.
>
> ***Category E:*** For a notification with complex analytical problems,
> the estimated time requirement per submission is still approximately
> 150 hours, but the analytical costs rise slightly to \$375,000.
> Sixteen such notifications are expected to be submitted on an annual
> basis, resulting in a burden of 2,400 hours and \$6.0M.

**Costs to respondents:** Furnishing the information required even in a
simple notification for a food contact substance requires a team of
professional employees, which may include toxicologists, chemists,
environmental scientists, and lawyers. According to information provided
by industry trade associations, the collection of information,
analytical work, toxicological review and administrative details
involved in such a notification (category C) average about 120 hours.
Assuming that the aggregate professional hourly cost is \$90, then the
cost for submitting such a notification is \$10,800 (calculated by
multiplying the hourly cost and the total hours).

**13. Annual Cost to Respondents**

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

**14. Annual cost to Government**

The annual costs to the government is \$6.04 million dollars (including
salaries and other costs).

**15. Explanation of Change in Items 13 and 14**

This is a new collection

**16. Statistical Analysis, Publication Plans, and Schedule**

No comprehensive tabulation of the data is planned or anticipated.

**17. Displaying of OMB Expiration Date**

The agency is not seeking to not display the expiration date for OMB
approval of the information collection.

**18. Exceptions to the Certification Statement**

There are no exceptions to the certification statement identified in
Item 19, \"Certification for Paperwork Reduction Act Submissions,\" of
OMB Form 83-I.