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Hello. I'm Sharon Elyashiv-Barad.
This presentation will assist you
in the preparation of a food-contact notification,
known as an FCN,
and provide background information
on food-contact substances
and specific information and recommendations
on the submission of notifications for such substances.
The Office of Food Additive Safety, or OFAS,
in FDA's Center of Food Safety and Applied Nutrition
in College Park, Maryland,
is responsible for the evaluation of scientific data
and other information submitted
in support of the safe use of various food substances.
Within OFAS, the Division of Food Contact Notifications
is responsible for administering the FCN program
for the pre-market review of industry submissions
of new components and uses of food-contact materials.
I encourage you to contact FDA
should you have any questions, comments,
or requests for information and/or clarification.
This slide shows an outline of the topics
that are covered in this presentation.
First, I'll provide background information
on the FDA Modernization Act of 1997.
Next, I will discuss various aspects of the FCN program,
including the scope;
information available on the Web,
including guidance documents, inventories,
and information on the format and submission of an FCN;
and FDA actions both during and after the review period.
I will conclude the presentation
with a brief discussion on pre-notification consultations
and Freedom of Information Act requests.
Much of the information that I will cover in this presentation
is also available online at the FDA Website, www.fda.gov,
under the section entitled "Food Contact Substances."
FDA encourages you to review the information on our Website
prior to engagement on this topic.
The FCN program was promulgated
by the FDA Modernization Act of 1997.
FDAMA established the FCN program as the preferred method
to achieve pre-market clearance
of what used to be termed "indirect additives"
but was now folded into a broader term
of "food contact substances," or FCSs.
Compared to the food additive petition process,
the FCN process is more streamlined
and has several important attributes.
Specifically, an FCN approval is proprietary
to the manufacturer or supplier listed in the effective FCN.
An FCN is maintained as confidential
during the review period,
but non-confidential material is releasable
if an agency action occurs on the submission.
And submission actions must be completed
in a 120-day review period.
Importantly, the safety standard
defined under the Federal Food, Drug, and Cosmetic Act
remains unchanged, as defined in 21 CFR section 170.3(i) --
that is, the reasonable certainty of no harm.
The Federal Food, Drug, and Cosmetic Act defines an FCS
as any substance that is intended for use
as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food
if the use is not intended
to have any technical effect in such food.
A food-contact material or article
may be composed of one or more FCSs.
The newly termed "food contact substance"
is much broader than our previously used term
of "indirect additive"
and encompasses food additives,
Generally Recognized as Safe substances,
and prior-sanctioned substances.
As aforementioned,
many food additives that fit the definition of FCS
used to be known as indirect additives
and are so codified
in 21 CFR sections 174 through 179.
There are many examples of FCSs,
several of which are shown on this slide.
It is important to note that the definition of an FCS
includes both polymers, typically the food additive,
as well as the starting monomer or monomers.
Other types of materials
that are traditionally seen in this arena
include coatings on paper and metal,
paper and polymer additives, adhesives, ion-exchange resins,
and food-processing equipment.
Should you find yourself
questioning the regulatory authority of a substance,
please be sure to contact FDA.
The next few slides describe who may submit an FCN,
when an FCN or food additive petition should be submitted,
when more than one FCN is required,
who may rely on an effective FCN,
and when an existing authorized FCS
may require the submission of a new FCN.
When determining the applicability of an FCS,
the first question is often, "Who may submit an FCN?"
This is clearly defined in the law
that a manufacturer or supplier of an FCS
or an agent may submit to FDA
a notification for a new use of an FCS.
Regarding the term "supplier," this has been interpreted
to mean any person supplying the FCS,
including a company supplying the FCS to themselves
for manufacture of a food-contact material.
The next question when planning for use of a new material is,
"When should an FCN be submitted?"
By law, FCNs are only required
for new uses of FCSs that are food additives.
Examples of situations when a new FCN may be required
include the use of an unapproved FCS,
an approved FCS with a modification of use,
a new manufacturing process,
or new or different manufacturer or supplier.
Although a notification is not required
for an FCS that is generally recognized as safe
or prior sanctioned
for its intended use in contact with food,
manufacturers may choose to submit an FCN
to notify FDA of new uses for such FCSs.
Although an FCN is the preferred route for approval,
FDA still has the option to require a food additive petition
in some instances.
These instances are described in 21 CFR section 170.100(c)
and include cases where the new use of the FCS
will increase the cumulative dietary concentration
to greater than or equal to 1 part per million
or, in the case of a biocide, to a level of 200 parts per billion
or when there exists a bioassay on the FCS
that the agency has not reviewed
and the study is not clearly negative for carcinogenicity.
Now you may ask yourself,
"When is one or multiple notifications required?"
As illustrated on this slide, one FCN should be submitted
when there is only one FCS that is a food additive.
For example, consider a new polymer
that is manufactured with a new catalyst.
The polymer is the food additive,
while the catalyst is an FCS
that has no technical effect in the finished polymer.
On the other hand, multiple FCNs should be submitted
when more than one of the FCSs are food additives
that are not permitted for the intended use.
For example, consider a new polymer
that is blended with an antioxidant
that was not previously authorized
for use in the polymer.
The antioxidant is an FCS, but it is also a food additive,
as it has an intended technical effect in the polymer.
Next, you may ask, "Who may rely on an effective FCN?"
Since an FCN is effective only for the manufacturer, substance,
and intended use identified in the notification,
any person wishing to rely on an effective FCN
generally will need to demonstrate
that the FCS being marketed has been manufactured or supplied
by the manufacturer identified in the effective FCN
and that the FCS is being used under the conditions
that are the subject of that effective notification.
Sometimes during the course of product use,
a new notification may need to be submitted
although an effective FCN already exists.
There are numerous situations
when a notifier should submit a new notification
for an already-effective FCS in use --
for example,
if substantive changes are made to an effective FCN,
including changes in the manufacturer,
manufacturing process,
identity of the FCS and/or impurities and impurity levels,
and changes to the specifications,
limitations, and conditions of use.
If new data become available to FDA warranting consideration
that the intended use of the FCS is unsafe,
then a new FCN may need to be submitted
to allow for such a review.
The next section of this presentation
provides an introduction to available guidance, inventories,
submission format, and forms related to the FCN program,
which can be found on FDA's Website at www.fda.gov.
Click on the "Food" link.
Then under the program heading,
select "Food Ingredients and Packaging."
Under the programs area heading, select "Food Contact Substance."
This will direct you to the "Food Contact Substance" page,
where you will find links to various useful FCN documents
and other related information.
Anyone submitting notifications to FDA
should familiarize themselves with our guidance documents,
beginning with the Administrative Guidance.
This document covers many of the topics
already highlighted in this presentation,
such as the scope of the FCN Program
and the format of an FCN,
but also includes information on electronic submissions,
disclosable information in an FCN,
FDA's response to an FCN,
the withdrawal of an FCN without prejudice,
determination that an FCN is no longer effective,
pre-notification consultations,
and the format of a notification
for food-contact substance formulations.
The Chemistry Guidance details information
recommended to confirm the identity, manufacture of,
and impurities in the FCS,
proposed use, intended technical effect,
stability, migration levels in food --
including migration testing and analytical methods --
and consumer exposure.
The Toxicology Guidance
pairs the exposure estimates for the FCS
and any other substances with recommended safety testing.
This document provides guidance
on the format of summarizing the information
regarding the safety of the FCS
and also more detailed summaries on the individual substances
in what are referred to as the safety narrative
and comprehensive toxicology profile, respectively.
In addition, guidance is provided
on consideration or evaluation of the migrants
with structural similarity to known toxicants,
as well as additional toxicological considerations.
Since all FDA actions also require that FDA comply
with the National Environmental Policy Act, or NEPA,
FCNs also have an environmental-review component.
The Environmental Guidance details the requirement
that FCNs must include either an environmental assessment,
also known as an EA,
or a claim of categorical exclusion
from the requirement of an EA.
The Environmental Guidance addresses how to determine
if your FCS is categorically excluded
and how to prepare an EA when necessary.
To assist in this effort,
FDA also provides an Inventory of Environmental Decisions
for Effective FCS Notifications on the Web
that can be used as a resource to anyone submitting an FCN.
In addition to the Inventory of Environmental Decisions
for Effective FCS Notifications,
FDA maintains several inventories
to assist stakeholders in preparing an FCN
or determining if a use is previously authorized.
These include the inventory of effective FCNs,
the list of food-types and conditions of use for FCSs,
which defines several classifications
used in specifying the use of an FCS,
a cumulative exposure database,
the list of Threshold of Regulation exemption requests,
and a list of indirect additives
and their applicable regulations.
In order to submit a complete FCN,
FDA requires notifiers to submit Form 3480.
This form consists of several sections.
Section 1 is for administrative information,
and sections 2 through 5 are for technical information.
The form should be placed at the beginning of any FCN submission
to ensure that the FCN is complete
and the review of the FCN will be efficient.
The FDA sees the use of this form beneficial
since it organizes the FCN
and assists both the notifier and the FDA reviewers
in determining what the necessary data are
for reviewing the safe use of the substance.
The form contains empty fields
for inputting the information required in an FCN.
However, there is often not enough space
to enter all of the required information into Form 3480.
As such, attachments and appendices
can be amended to the form and referenced within the form.
Residual data analyses, toxicology studies,
and environmental assessments are examples of documents
that are frequently amended as attachments or appendices
to FDA Form 3480.
You may also notice a second form available on the Web.
This form, Form 3479, should be used for FCS formulations.
For additional information on this form,
please contact our office.
A notifier currently has two options when submitting an FCN.
There is the paper format and the electronic format.
The paper format can include submitting five paper copies
of the FCN or a CD-ROM of the notification,
along with the five paper copies.
Alternatively, a notifier also has the option
of submitting just one paper copy of the FCN
along with a CD-ROM of the FCN.
At this time, submitting a CD-ROM alone
is not an acceptable option
and will be considered an incomplete submission.
Notifications should be addressed
to the Notification Control Assistant
at the address shown on this slide.
In addition to submitting the original documents,
notifiers should also submit a sanitized version of the FCN
in which the commercial and trade-secret
confidential information has been redacted.
This can be accomplished by drawing a box
around the confidential information
and stamping "confidential" near the box.
The FDA highly recommends that notifiers submit a sanitized FCN
so that information considered confidential will be emphasized
and brought to the attention of the FDA.
An option still in development for FDA
is submitting an FCN via electronic format
or e-filing through the FDA portal.
FDA currently has draft guidance
for the electronic filing of FCN submissions
whereby a notifier can electronically submit
all the information related to the FCN
in a way that is secure, confidential, user-friendly,
and consistent with the current FCN format.
At this time, it is recommended
that notifiers discuss this option with FDA staff
to assist in the process.
Considering the statutory time frame
and the need for efficiency in reviewing FCNs,
FDA has divided the processing of food-contact notifications
into four discrete periods of activity.
The review period for an FCN begins with the receipt
and administrative processing of the FCN,
followed by what is termed the Phase-One review process,
then the Phase-Two review process,
and finally, conclusion with the Final Decision.
Each of these phases will be discussed in more detail
on the following slides.
The receipt date of an FCN is established when the FCN arrives
at the Office of Food Additive Safety at FDA,
not the date of arrival at FDA itself.
The FCN copies are distributed to the reviewers
while the first hard copy
is scanned into FDA's internal electronic portal
and distributed to the consumer safety officer.
The first step of the technical review,
known as a Phase-One meeting,
is scheduled usually within three weeks
from the receipt date.
The first step in the technical review process
is determining if FDA has the information necessary
to perform the review.
This is termed the Phase-One review,
and the goal or decision
is to determine if the FCN is complete administratively.
This determination is based on whether the chemistry,
toxicology, and environmental data requirements have been met.
Based on this review, FDA makes one of three possible decisions.
One, to accept the notification for full review
under the FCN process,
in which case an acknowledgment letter is issued.
Two, to communicate to the notifier
that deficiencies need to be addressed
prior to acceptance of the FCN.
Or, three, to not accept the FCN
based on the Agency's option for a food additive petition,
as previously discussed, or other reasons.
A description of each of these letters
is provided in the following slides.
FDA sends the acknowledgment letter
early in the review process to communicate to the notifier
our understanding of the FCS and proposed use.
The acknowledgment letter is usually sent to the notifier
within 30 days of receipt of the FCN.
This letter provides the initial contact
between FDA and the notifier and assigns an FCN number.
The letter confirms the FCS identity,
manufacturer or supplier, intended use,
and conditions of use, including limitations and specifications.
The acknowledgment letter formally establishes
the 120-day effective date of an FCN
and also provides the notifier with the opportunity
to clarify minor, non-substantive information.
Once the acknowledgment letter is issued,
the notification is considered accepted
and proceeds to a full review within the 120-day review period.
This review is known as a Phase-Two review,
which I will discuss in greater detail
later in this presentation.
The second type of letter that could be generated
after a Phase-One review is a deficiency letter,
which highlights the findings
from FDA's initial or preliminary review of the FCN.
This letter is usually sent to the notifier
within 45 days of receipt of an FCN.
This letter identifies minor and major deficiencies
that should be addressed
in order to ensure that the FCN is complete and acceptable
and serves to formally document the Agency's request for information,
as well as provide the notifier a specific time frame
in which a response is required.
Requests for minor information
include things such as points for clarification
and missing or incorrect pages.
In these cases, FDA would expect the information
to be readily available to the notifier
so that the notifier can easily provide a response.
This is information that should be obtainable
in less than two weeks.
On the other hand, request for major information
includes failure to provide relevant
and/or appropriate studies,
missing raw analytical data and/or environmental component,
and lack of data to support safety conclusions,
safety calculations, technical effect, and/or stability.
In such cases, a complete response may not be possible
within the time allotted.
If the notifier cannot respond within the allotted time frame,
the notifier can voluntarily withdraw the FCN
without prejudice and re-file at a later date,
or FDA may send a non-acceptance letter,
ending the review of the FCN.
As previously noted, FDA will generally provide the notifier
with a brief period of time
to supply the missing information or withdraw the FCN.
If the deficiencies are not adequately addressed
or the FCN is not withdrawn,
a non-acceptance letter is issued.
In addition,
under 21 CFR section 170.100 subparagraph (b),
FDA may choose not to accept a notification
for a use of an FCS that is the subject of a regulation
in Parts 173 through 186
or that is the subject of an exemption
under 21 CFR section 170.39.
As described earlier,
under 21 CFR section 170.100 subparagraph (c),
FDA may choose to not accept a notification
if the proposed use
will increase the dietary concentration
to greater than or equal to 1 part per million
or to a level of 200 parts per billion in the case of a biocide
or when there exists a bioassay on the FCS
that the Agency has not reviewed
and the study is not clearly negative for carcinogenicity.
The issuance of a non-acceptance letter
completes the review of the submission.
If deficiencies in an FCN are addressed in a timely manner,
FDA's determination regarding a time frame
for a path forward on the submission
is based on whether the information
is considered substantive or non-substantive.
Information determined to be substantive
requires that the 120-day review clock
start on the date
when OFAS received a complete notification.
If information is determined to be non-substantive,
the 120-day clock starts
with the original receipt date for the FCN.
The effective date is always communicated to the notifier
in the acknowledgment letter.
During the Phase-Two review,
FDA completes a full safety evaluation on the FCS
and any other substances from the proposed use
as specified in the FCN.
If FDA completes the review of the submission
and agrees that the FCS is safe for the intended use,
a final letter is issued.
This letter is not required by law.
The final letter brings closure to the review process,
lists the authorized notifier, manufacturer, and/or supplier,
and the identity and use of the FCS.
It also includes the effective date of the notification
and provides the Environmental Impact Decision for the FCN.
Alternatively, if, during Phase-Two review,
the Agency determines
that the safe use of the FCS cannot be supported,
these issues are conveyed to the notifier
with the option to withdraw the notification
without prejudice to future filing.
If the notifier chooses not to withdraw,
an objection letter is sent prior to the 120-day time frame.
The content of the objection letter includes a statement
that FDA objects to the marketing of an FCS.
It describes in detail the Agency's basis for objection
and provides details on the additional information required
to support the safety of the FCS for the intended use.
The reasons FDA may object to an FCN
are described under section 409(h) of the Act
and 21 CFR section 170.104 subparagraph (c)
of the regulations
and include that the FCN is incomplete
because it does not comply with the general criteria for an FCN
as described in 21 CFR section 170.100.
FDA may also object to an FCN
because FDA does not agree that the notifier has demonstrated
that the substance is safe under the intended conditions of use.
Finally, FDA may object because a portion of the 120 days
after FDA's receipt of the FCN occurs within a fiscal year
for which the FCN program does not operate.
Other aspects important to the FCN process
include pre-notification consultations,
also known as PNCs,
and Freedom of Information Act, or FOIA, requests.
These have proven to be tools
useful in the preparation of an FCN.
Pre-notification consultations, or PNCs,
are interactions between stakeholders and FDA
prior to the submission of an FCN.
These consultations can take several forms,
such as letters or meetings,
and there are many reasons for submitting a PNC.
A PNC request may be sent to the Agency
via e-mail, fax, or letter.
Some examples are presented on this slide
and include draft FCNs submitted for FDA's comments,
meetings to discuss requirements,
and recommendations to support a future submission,
determining a path forward based on data already developed
and regulatory status.
FDA also receives requests for information
or the need for a discussion
concerning the eligibility of a substance
prior to its being considered for an FCN.
For additional information or to initiate this process,
please contact FDA.
The Freedom of Information Act, known as FOIA,
requires that all federal agencies
make their information publicly available.
A FOIA can request certain information
in previously regulated food additive petitions
or effective food-contact notifications.
All FOIA requests must be in writing and sent by mail or fax.
FDA does not accept FOIA requests sent via e-mail.
For additional information on FOIA requests,
please visit the FDA Website at www.fda.gov.
Select "More Regulatory Information,"
followed by "How to Make a FOIA Request."
FDA will not release or disclose any information in the FCN
during the 120-day review period.
Once the FCN becomes effective after the 120-day review period,
FDA's conclusion is made publicly available
on our Website in the inventory of effective notifications.
However, if the FCN was withdrawn
and does not become effective,
the information in the FCN will not be disclosed.
If FDA objects to the FCN,
the FCN also becomes public knowledge.
With regard to FOIA,
information in the notification is not protected from disclosure
after an FCN becomes effective or if FDA objects to the FCN
unless it is trade-secret
or confidential commercial information.
Once an FCN becomes effective after the 120-day review period
or is objected to,
general information, safety and functionality data,
and information incorporated by reference
may be releasable through a FOIA request.
Please note that trade-secret
and confidential commercial information is not releasable,
even after the FCN is effective.
For additional information
on any of the topics covered in this presentation,
please contact FDA.
Thank you.