0298 Food contact threshold reg SSA Ext 2019

UNITED STATES FOOD & DRUG ADMINISTRATION
Threshold of Regulation for Substances Used in Food-Contact Articles
OMB Control No. 0910-0298
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 348(a)), the use of a food additive is deemed unsafe unless one of the following is
applicable: (1) it conforms to an exemption for investigational use under section 409(j) of
the FD&C Act; (2) it conforms to the terms of a regulation prescribing its use; or (3) in
the case of a food additive which meets the definition of a food-contact substance in
section 409(h)(6) of the FD&C Act, there is either a regulation authorizing its use in
accordance with section 409(a)(3)(A) or an effective notification in accordance with
section 409(a)(3)(B). The regulations in § 170.39 (21 CFR 170.39) established a process
that provides the manufacturer with an opportunity to demonstrate that the likelihood or
extent of migration to food of a substance used in a food-contact article is so trivial that
the use need not be the subject of a food additive listing regulation or an effective
notification. The Food and Drug Administration (FDA, the agency, us or we) has
established two thresholds for the regulation of substances used in food-contact articles.
The first exempts those substances used in food-contact articles where the resulting
dietary concentration would be at or below 0.5 part per billion (ppb). The second
exempts regulated direct food additives for use in food-contact articles where the
resulting dietary exposure is 1 percent or less of the acceptable daily intake for these
substances.
In order to determine whether the intended use of a substance in a food-contact article
meets the threshold criteria, certain information specified in § 170.39(c) must be
submitted to FDA. This information includes the following components: (1) the
chemical composition of the substance for which the request is made; (2) detailed
information on the conditions of use of the substance; (3) a clear statement of the basis
for the request for exemption from regulation as a food additive; (4) data that will enable
FDA to estimate the daily dietary concentration resulting from the proposed use of the
substance; (5) results of a literature search for toxicological data on the substance and its
impurities; and (6) information on the environmental impact that would result from the
proposed use.
We therefore request extension of OMB approval for the information collection
requirements found in 21 CFR 170.39 pertaining to exemptions from the food additive
petition process for food-contact articles.

2. Purpose and Use of the Information Collection
We use the information to determine whether the food-contact article meets the threshold
criteria. Requests for exemptions from the food additive listing regulation requirement
are letter-type submissions from manufacturers of food packaging and food processing
equipment. These submissions are reviewed by FDA personnel to ascertain if the
substance(s) is adequately identified and if the proposed use meets the criteria specified
in 21 CFR 170.39 for an exemption. If the data are sufficient to support an exemption
under 21 CFR 170.39, the agency informs the requestor by letter that the intended use of
the substance in a food-contact article is not required to be the subject of a food additive
listing regulation or a food contact notification.
Description of Respondents: Respondents to this information collection are individual
manufacturers and suppliers of substances used in food-contact articles (i.e., food
packaging and food processing equipment) or of the articles themselves. Respondents
are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Information is submitted by respondents through the Electronic Submissions Gateway
(ESG). The EST is our central transmission point for receiving regulatory submissions.
The ESG does not open or review submissions, but routes them to the proper FDA center
or office, and notifies that center or office of delivery. To facilitate that process for
certain food-related submissions, our Center for Food Safety and Applied Nutrition
(CFSAN) developed the CFSAN Online Submission Module (COSM). COSM provides
a real-time user interface to assist respondents who make submissions required for
CFSAN-regulated products. We estimate nearly 75% of respondents are utilizing
electronic means to fulfill the information collection.
4. Efforts to Identify Duplication and Use of Similar Information
A critical element in FDA’s Threshold of Regulation Policy is that the use of a substance
exempted by the agency is not limited to only the manufacturer who submitted the
request for an exemption. Other manufacturers may use exempted substances in foodcontact articles as long as the conditions of use (e.g., use levels, temperature, type of food
contacted, etc.) are those for which the exemption was issued. Manufacturers and other
interested persons can easily access an up-to-date list of exempted substances which is on
display at FDA’s Division of Dockets Management and is also available on the Internet at
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm. A
list of exempted substances can also be obtained by contacting FDA’s Office of Food
Additive Safety (HFS-200), 5001 Campus Drive, College Park, MD 20740. This list
includes the name of the company that made the request, the chemical name of the
exempted substance, and the specific use for which it has been exempted, as well as any
appropriate limitations. Having the list of exempted substances publicly available also
decreases the likelihood that a company would submit a food additive petition or a food

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contact substance notification for the use of a substance for which the agency has
previously granted an exemption from the food additive listing regulation requirement.
To avoid unnecessary duplication, existing data are used whenever possible by FDA in
evaluating requests for exemption of components of food-contact articles under 21 CFR
170.39. This includes data in FDA files as well as data available in the scientific
literature. For example, existing data in FDA files on the migration of components of
food-contact articles into food or food simulating solvents can often be used to predict the
level of migration resulting from similar uses of other components of food-contact
articles. However, because the extent of migration of a component of a food-contact
article into food depends on a number of factors (e.g., the chemical nature of the
substance, the temperature of use, the type of food contacted, the length of time in contact
with food, the amount of food contacted over the lifetime of a repeat-use article), and
because substances used in the manufacture of food-contact articles possess a wide range
of chemical and physical properties and are used under a variety of conditions, additional
information is often needed to determine whether a particular use of a specific substance
results in a dietary concentration that is below the “threshold of regulation.”
5. Impact on Small Businesses or Other Small Entities
We estimate ten percent (10%) of respondents are small businesses. FDA’s threshold of
regulation process minimizes the burden on all businesses by providing a procedure that
is less burdensome than the current food additive petition process. Because agency
reviews made under this process require significantly less resources than petition reviews,
decisions authorizing the marketing of a product are issued relatively quickly (i.e., within
4-5 months as opposed to the 1-4 years required for the review of a petition and the
issuance of a regulation). As a result, components of food-contact articles that are found
to be exempt from the food additive listing regulation requirement can be marketed
sooner than those authorized by the petition process. Because the types of information
needed for approval under the premarket notification process for those uses of foodcontact articles involving dietary concentrations of 0.5 ppb or less is identical to that
required under 21 CFR 170.39, the burden on industry for the preparation of a premarket
notification would be similar to the burden for the preparation of a request submitted
under the existing threshold of regulation process.
The agency has established the types of data necessary to demonstrate that the use of a
component of a food-contact article meets the criteria for an exemption under 21 CFR
170.39. However, the agency does not have the resources to generate the data needed to
support a request for an exemption under this policy. Whenever possible, assistance will
be given to requestors to minimize the likelihood that unnecessary work is performed.
FDA aids small businesses in dealing with the requirements through the Division of
Education and Communication in the Center for Food Safety and Applied Nutrition
(CFSAN) and through the scientific and administrative staffs of the agency.
Whenever possible, to reduce the burden on all businesses, FDA will provide assistance
to requestors to minimize the likelihood that unnecessary work is performed. CFSAN’s

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Division of Education and Communication will also aid small businesses in dealing with
the submission requirements specified in 21 CFR 170.39. It should be emphasized that
the Threshold of Regulation Policy itself is, in part, a response to representatives of the
food packaging and processing industries who have proposed, both informally and
formally (Petition submitted by the Society of Plastics Industries; Docket No. 77-0122)
that FDA establish a Threshold of Regulation Policy for food-contact articles.
6. Consequences of Collecting the Information Less Frequently
Respondents will submit the required information on an occasional basis, as required by
21 CFR 170.39. Any restriction of the right to require certain types of data for requests
submitted under this policy would significantly decrease the number of food contact
substances exempted from the requirement that they be the subject of food additive
petitions or food contact substance notifications. Exemptions would be restricted to those
situations which involve substances which are generally recognized as safe (GRAS)
substances whose use was sanctioned prior to January 1, 1958, and substances approved
for investigational use under section 409(j) of the FD&C Act. All other components of
food-contact articles whose use results in or which may reasonably be expected to result
in migration into food, even in trivial amounts, would require premarket approval via the
food additive petition process or the notification process.
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 for public comment
in the Federal Register of June 21, 2019 (84 FR 29209). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Requests for exemptions of components of food-contact articles from the food additive
listing regulation requirement often contain trade secret and commercial confidential
information. Only information that is releasable under the agency’s 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 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)).

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A list of substances exempted under 21 CFR 170.39 is placed on display at the Division
of Dockets Management and is also available on the Internet at
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm.
This list includes the name of the company that made the request, the chemical name of
the exempted substance and the specific use for which it has been exempted, as well as
any appropriate limitations. It does not include any trade names or other confidential
information. The agency’s finding of no significant environmental impact and the
evidence supporting that finding, contained in an environmental assessment, are also
available for public inspection at the Division of Dockets Management.
Privacy Act
This ICR is not requesting any personally identifiable information per the definition of
PII in OMB Circular No. A-130 and does not include a form that requires a Privacy Act
Statement under 5 U.S.C. §552a(e)(3)).
This information collection request (ICR) is not collecting personally identifiable
information (PII) or other data of a personal nature. Information is collected to determine
whether the intended use of a substance in a food-contact article meets the threshold
criteria not to be subject to the food additive listing regulation of substances used in foodcontact articles. This information collected includes the following components: (1) the
chemical composition of the substance for which the request is made; (2) detailed
information on the conditions of use of the substance; (3) a clear statement of the basis
for the request for exemption from regulation as a food additive; (4) data that will enable
FDA to estimate the daily dietary concentration resulting from the proposed use of the
substance; (5) results of a literature search for toxicological data on the substance and its
impurities; and (6) information on the environmental impact that would result from the
proposed use.
In preparing this supporting statement, FDA staff consulted with the FDA Privacy Office
to ensure appropriate handling of information collected. FDA determined that personally
identifiable information (PII) is not collected and the Privacy Act of 1974 does not apply.
11. Justification for Sensitive Questions
There are no questions of a personally sensitive nature in the data requirements for
requests for exemptions under the FDA’s Threshold of Regulation Policy.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

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Table 1.--Estimated Annual Reporting Burden 1
21 CFR 170.39
No. of
No. of
Total
Respondents
Responses per
Annual
Respondent
Responses
Threshold of regulation 7
1
7
for substances used in
food contact articles
1

Average
Burden per
Response
48

Total
Hours
336

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

Based on a review of the information collection since our last request for OMB approval,
we have made no adjustments. We estimate that approximately 7 requests per year will
be submitted under the threshold of regulation exemption process of § 170.39, for a total
of 336 hours. In the Federal Register of June 21, 2019 (84 FR 29209), we estimated 4
requests per year. In reconsideration of the 2-3 requests that were received but did not
become effective, we retain our previous estimate of 7 requests per year, with 4 of those
requests becoming effective.
The threshold of regulation process offers an advantage over the premarket notification
process for food-contact substances established by section 409(h) of FD&C Act (OMB
control number 0910-0495) in that the use of a substance exempted by FDA is not limited
to only the manufacturer or supplier who submitted the request for an exemption. Other
manufacturers or suppliers may use exempted substances in food-contact articles as long
as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are
those for which the exemption was issued. As a result, the overall burden on both the
agency and the regulated industry would be significantly less in that other manufacturers
and suppliers would not have to prepare, and we would not have to review, similar
submissions for identical components of food-contact articles used under identical
conditions.
Manufacturers and other interested persons can easily access an up-to-date list of
exempted substances which is on display at FDA’s Dockets Management Staff and on the
internet at https://www.fda.gov/food/packaging-food-contact-substances-fcs/thresholdregulation-exemptions-substances-used-food-contact-articles. Having the list of
exempted substances publicly available decreases the likelihood that a company would
submit a food additive petition or a notification for the same type of food-contact
application of a substance for which FDA has previously granted an exemption from the
food additive listing regulation requirement.
12b. Annualized Cost Burden Estimate
Based on information provided to FDA, the annualized cost for the collection of
information and preparation of a simple request for review under the proposed Threshold
of Regulation Policy would range from $5,000-$25,000 depending on the complexity of
the project. If analytical studies are required to show that the dietary exposure resulting
from the proposed use is below the threshold of regulation, we estimate that the
additional cost would vary from $10,000 to $75,000 depending on the complexity of the
project (i.e., the number of substances and food simulating solvents involved, the method

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of analysis). Based on these estimates, the total cost to the respondent to submit requests
under FDA’s Threshold of Regulation Policy would vary from $5,000-$100,000.
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
We estimate that we will receive an average of 7 requests per year for review under the
Threshold of Regulation Policy. An abbreviated review of the chemistry, toxicology, and
environmental impact information requires an average of 25 hours to review.
We estimate the hourly cost for review to be $52.27 per hour, the GS-13/Step-4 rate for
the Washington-Baltimore locality pay area for the year 2019. To account for overhead,
this cost is increased by 100 percent, making the total cost $104.54 per hour. We
estimate the cost to the Federal Government for the review of records to be $2,613.50 per
review ($104.54/hour x 25 hours). Thus, we estimate that the annual cost to the Federal
Government would be $18,294.50 ($2,613.50 x 7 requests).
15. Explanation for Program Changes or Adjustments
Our estimated burden for the information collection is unchanged. However, we note
implementation of newly developed IT, as discussed more fully at Question 3, to
facilitate submission. As we gain experience with the new technology we will include a
discussion of our review in future submissions to OMB. Also, as we consider other
changes or enhancements to the collection method or instruments, we will include a fuller
discussion in our PRA notice so that we can include any specific feedback on respondent
experience in our evaluation.
16. Plans for Tabulation and Publication and Project Time Schedule
The agency does not publish information from this information collection other than, as
noted above, by making available a list of substances exempted under 21 CFR 170.39 at
the Division of Dockets Management and on the Internet at
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm.
This list includes the name of the company that made the request, the chemical name of
the exempted substance and the specific use for which it has been exempted, as well as
any appropriate limitations. It does not include any trade names or other confidential
information. The agency’s finding of no significant environmental impact and the
evidence supporting that finding, contained in an environmental assessment, are also
available for public inspection at the Division of Dockets Management.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
We will display the OMB expiration date as required by 5 CFR 1320.5. 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.

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