Regulatory Impact Analysis

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Food Additives: Food Contact Substance
Notification That Is No Longer Effective
Docket No. FDA-2021-N-0403

Final Regulatory Impact Analysis
Regulatory Flexibility Analysis

Economics Staff
Office of Planning
Office of Policy, Legislation and International Affairs
Office of the Commissioner

Executive Summary
The final rule amends the Food and Drug Administration’s (FDA or we) food additive
regulations relating to premarket notifications for food contact substances (FCNs) and the
procedures by which we determine that an FCN is no longer effective. The final rule will
allow manufacturers or suppliers of food contact substances (FCSs) to request that FDA
determine that an FCN is longer effective for reasons other than safety. Cost savings of
the final rule to manufacturers and suppliers and FDA range from zero to $0.4 million,
with a central estimate of $0.1 million, annualized over ten years at a 2 percent discount
rate. We estimate that there will be little to no costs associated with the final rule.

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Table of Contents

I. Introduction and Summary .............................................................................................. 3
A. Introduction ................................................................................................................ 3
B. Summary of Cost and Benefits .................................................................................. 4
II. Final Regulatory Impact Analysis .................................................................................. 6
A. Need for Regulation ................................................................................................... 6
B. Cost Savings of the Rule ............................................................................................ 7
C. Costs of the Rule ...................................................................................................... 15
D. Uncertainty and Sensitivity Analysis ....................................................................... 15
E. Analysis of Regulatory Alternatives to the Final Rule............................................. 17
III. Small Entity Analysis ................................................................................................. 18
A. Description and Number of Affected Small Entities ............................................... 18
B. Description of the Potential Impacts of the Rule on Small Entities ......................... 20
IV. References................................................................................................................... 21

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I. Introduction and Summary
A. Introduction
We have examined the impacts of the final rule under Executive Order 12866,
Executive Order 13563, Executive Order 14094, the Congressional Review Act/Small
Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs,
and transfers of available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages; distributive impacts; and
equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended
by Executive Order 14094) if they “have an annual effect on the economy of $200
million or more (adjusted every 3 years by the Administrator of [the Office of
Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or
adversely affect in a material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State, local, territorial, or
tribal governments or communities.” OIRA has determined that this final rule is not a
significant regulatory action under Executive Order 12866 Section 3(f)(1).
A rule is “major” under the Congressional Review Act/Small Business Regulatory
Enforcement Fairness Act if it has resulted or is likely to result in an annual effect on the
economy of $100 million or more or meets other criteria specified in the Congressional

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Review Act. OIRA has determined that this final rule is not a major rule under the
Congressional Review Act/Small Business Regulatory Enforcement Fairness Act.
The Regulatory Flexibility Act requires agencies to analyze regulatory options
that would minimize any significant impact of a rule on small entities. Because the final
rule is unlikely to impose a substantial burden on the affected small entities, we certify
that the final rule will not have a significant economic impact on a substantial number of
small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to
prepare a written statement, which includes an assessment of anticipated impacts, before
issuing “any rule that includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one year.” The current
threshold after adjustment for inflation is $183 million, using the most current (2023)
Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule
to result in any 1-year expenditure that will meet or exceed this amount.

B. Summary of Cost and Benefits
We expect the final rule to lead to cost savings for manufacturers and suppliers of
food contact substances and FDA. The final rule would revise FDA’s current process of
determining whether an FCN is no longer effective. The final rule would provide
manufacturers and suppliers the opportunity to demonstrate why an FCN should continue
to be effective before we could determine that an FCN is no longer effective.
Additionally, the final rule would revise the current process to cover situations in which it
is determined that an FCN is no longer effective for reasons other than safety, including
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that a manufacturer or supplier may request that FDA determine that an FCN is no longer
effective on the basis that the manufacturer or supplier no longer produces, supplies, or
uses the food contact substance for the intended use. Cost savings will be incurred by
manufacturers and suppliers of food contact substances (FCS) who will be able to request
that FDA determine the FCN is no longer effective for reasons other than safety. FDA
will also experience cost savings from being able to act more efficiently upon such a
request by the manufacturer or supplier. As the revisions in the final rule would not
require significant additional action to be taken by manufacturers and suppliers, we
expect the costs of the final rule to be minimal.
The estimated total cost savings of the final rule are estimated in 2021 U.S.
dollars and range from zero to $0.4 million, with a central estimate of $0.1 million,
annualized at 2 percent over 10 years. We estimate that the costs of the final rule are
minimal. The cost savings and costs of the final rule are summarized in Table 1.
Table 1. Summary of Cost Savings, Costs, and Distributional Effects of Final Rule
Category

Cost
Savings

Costs

One-time
Monetized
millions/year
Annualized
Quantified
Qualitative

Primary
Estimate

Low
Estimate

High
Estimate

$0.1M

$0

$0.4M

Notes

Units
Year
Dollars

Discount
Rate

Period
Covered

2021

2%

10 years

Annualized
Monetized
millions/year
Annualized
Quantified

Transfers

Qualitative
Federal
Annualized
Monetized
$millions/year

$0

2021

From:

To:

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10 years

Other
Annualized
Monetized
$millions/year
From:

To:

State, Local or Tribal Government:
Effects

Small Business: Increased cost savings of zero to $147.31 per affected small entity
Wages:
Growth:

II. Final Regulatory Impact Analysis
A. Need for Regulation
This rule creates needed administrative procedures that do not currently exist in
our food additive regulations at 21 CFR part 170, subpart D, which provide the process
by which FDA may determine an FCN is no longer effective. Our regulations currently
do not provide reasons other than safety as the basis for FDA to determine that an FCN is
no longer effective. In some cases, a manufacturer may want to stop using an FCS for its
originally intended use or an FCS may become obsolete, but this does not mean the
intended use of the FCS is no longer safe. In other cases, FDA may inform a
manufacturer of potential safety concerns for the intended use of a FCS, and a
manufacturer may choose to stop manufacturing the FCS rather than obtaining
information and data to address FDA’s safety concerns. Responding to FDA’s safety
concerns can be costly and time intensive. In order to respond, manufacturers may
employ lawyers, administrative support staff, and specialized scientists, including
chemists and toxicologists. Similarly, processing submitted information on an intended
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use of an FCS is costly to FDA and requires time-intensive labor of consumer safety
officers, scientists, supervisors, and support staff. The final rule will increase the
efficiency of current FCN review processes by reducing the amount of labor expended by
manufacturers and suppliers as well as FDA to determine that an FCN is no longer
effective while incurring minimal additional costs.

B. Cost Savings of the Rule
The cost savings of the final rule stem from cost savings to FCS manufacturers
and suppliers and cost savings to FDA. Under the final rule, manufacturers and suppliers
will be able to request that FDA determine that an FCN is no longer effective for reasons
other than safety. Such a request would be based on the manufacturer or supplier no
longer producing, using, or supplying the FCS for the intended use, or intending to stop
producing, using, or supplying the FCS for the intended use at a specified date in the
future. Cost savings to manufacturers and suppliers are estimated to be the forgone time
burden of responding to FDA’s safety concerns about the intended use of the FCS. FDA
may deny this request for safety or public health reasons. Cost savings to FDA are
estimated to be the reduced time burden of reviewing whether an intended use of an FCS
is no longer safe.
We have reviewed the FCN submissions data and estimate that the final rule will
lead to between zero and approximately 5 requests by FCS manufacturers and suppliers
per year (Ref. 1). We use these values to estimate low and high estimates of cost savings
to manufacturers and suppliers, using the midpoint of 2.5 FCNs as a central estimate. The
lower bound of zero requests per year takes into consideration the possibility that FCS
manufacturers and suppliers may request that FDA determine the FCN is no longer
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effective for reasons other than safety, such as ceasing production and distribution of an
FCS; such requests would not have an associated reduced time burden, as FCS
manufacturers and suppliers would not incur costs of obtaining information and data to
address safety concerns. Many FCS manufacturers and suppliers outsource the research
and paperwork associated with an FCN submission to an outside agent, usually a law
firm specializing in regulatory law and technical assistance to manufacturers and
suppliers of food contact surfaces. Based on our examination of FCN submissions data,
we estimate that approximately 71.4 percent of FCN submissions received are submitted
by agents on behalf of manufacturers and suppliers. We estimate that the percentage of
manufacturers and suppliers affected by the final rule is also approximately 71.4 percent
and that the annual number of FCN submissions completed by agents ranges from zero (=
0 x 0.714) to approximately 3.6 (= 5 x 0.714), with a central estimate of approximately
1.8 FCN submissions (= 2.5 x 0.71).
Currently, an agent may employ a group of experts to respond to an FDA safety
concern about the intended use of the FCS. Under the final rule, this process may no
longer be necessary if the manufacturer or supplier requests that FDA determine the FCN
is no longer effective for reasons other than safety, resulting in cost savings to
manufacturers and suppliers. We estimate the time burden to manufacturers and suppliers
of completing a response to FDA’s safety concern about the intended use of the FCS that
is the subject of the FCN is greater than the FDA time burden to review the response.
Based on timekeeping records for previous FCN submissions (Ref. 2), we estimate that
FDA spends approximately 3,000 person-hours reviewing a single FCN submission. We
use 3,000 person-hours as an upper estimate of the reduced time burden of the final rule,

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and zero as a lower estimate, with the midpoint of approximately 1,500 person-hours as a
central estimate. We estimate that the time burden to manufacturers and suppliers of
responding to an FDA safety concern about the intended use of an FCS is 1.5 times that
of the time burden to FDA, ranging from zero to approximately 4,500 person-hours (=
3,000 x 1.5), with a central estimate of approximately 2,250 (= 1,500 x 1.5).
We estimate that an agent will employ a lawyer, a food scientist, a biochemist, a
chemist, a legal support staff member, and an administrative assistant to respond to an
FDA safety concern about the intended use of an FCS. Using Bureau of Labor Statistics
(BLS) wage data, we estimate wage rates in 2021 dollars for each employee, adjusting for
100 percent overhead. Fully-loaded hourly mean wage rates are estimated to be $142.34
(= $71.17 x 2) for lawyers (Ref. 3), $80.92 (= $40.46 x 2) for food scientists (Ref. 4),
$109.10 (= $54.55 x 2) for biochemists (Ref. 5), $85.70 (= $42.85 x 2) for chemists (Ref.
6), $70.20 (= $35.10 x 2) for legal support (Ref. 7), and $64.30 (= $32.15 x 2) for
administrative assistants (Ref. 8). We estimate that the time burden of a response to an
FDA safety concern about the intended use of an FCS (i.e., an FCN response submission)
is split between each of these employees, with lawyers bearing approximately 20 percent
of the burden, food scientists bearing approximately 20 percent of the burden,
biochemists bearing approximately 20 percent of the burden, legal support bearing
approximately 10 percent of the burden, and administrative assistants bearing
approximately 10 percent of the burden.
We multiply the time burden per FCN response submission by the hourly wage
for each employee and its associated percentage of time burden and sum to yield
estimated cost savings ranging from zero to approximately $436.8 thousand (= 4,500 x

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$142.34x 0.20 + 4,500 x $80.92 x 0.20 + 4,500 x $109.10 x 0.20 + 4,500 x $85.70 x 0.20
+ 4,500 x $70.20 x 0.10 + 4,500 x $64.30 x 0.10), with a central estimate of
approximately $218.4 thousand (= 2,250 x $142.34x 0.20 + 2,250 x $80.92 x 0.20 +
2,250 x $109.10 x 0.20 + 2,250 x $85.70 x 0.20 + 2,250 x $70.20 x 0.10 + 2,250 x $64.30
x 0.10). We multiple these cost savings by the estimated number of FCN response
submissions completed by agents per year to yield cost savings ranging from zero to
approximately $1.6 million (= 3.6 x $436.8 thousand), with a central estimate of
approximately $390.0 thousand (= 1.8 x $218.4 thousand). The estimated cost savings to
manufacturers and suppliers that utilize agents to complete FCN response submissions
are summarized in Table 2.
Table 2. Annual Cost Savings to FCS Manufacturers and Suppliers That Utilize
Agents (2021$)
Low
Middle
High
Number of affected FCNs per year
0
2.5
5
Percentage of FCNs completed by agents
71.4%
71.4%
71.4%
Number of FCNs completed by agents
0
1.8
3.6
Time burden per FCN
0
2,250
4,500
$142.34
$142.34
Hourly wage of lawyers
$142.34
$80.92
$80.92
$80.92
Hourly wage of food scientists
$109.10
$109.10
$109.10
Hourly wage of biochemists
$85.70
$85.70
Hourly wage of chemists
$85.70
$70.20
$70.20
Hourly wage of legal support
$70.20
$64.30
$64.30
$64.30
Hourly wage of administrative assistants
Percent of time burden for lawyers
20%
20%
20%
Percent of time burden for food scientists
20%
20%
20%
Percent of time burden for biochemists
20%
20%
20%
Percent of time burden for chemists
20%
20%
20%
Percent of time burden for legal support
10%
10%
10%
Percent of time burden for administrative
assistants
10%
10%
10%
Annual cost savings per FCN
$0 $218,390
$436,779
Annual cost savings of manufacturers and
suppliers that utilize agents to complete FCNs
$0 $389,981 $1,559,925

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Because we estimate that approximately 71.4 percent of FCN response
submissions received by FDA are submitted by agents on behalf of manufacturers and
suppliers, we estimate that the remainder (approximately 28.6 percent) of FCN response
submissions are completed by manufacturers and suppliers. Using our previous estimate
of zero to approximately 5 annual FCN response submissions, we estimate that the annual
number of FCN response submissions completed by manufacturers and suppliers that are
affected by the final rule ranges from zero (= 0 x 0.286) to approximately 1.4 (= 5 x
0.286), with a central estimate of approximately 0.7 FCN response submissions (= 2.5 x
0.286). We estimate that the time burden of completing an FCN response submission is
the same for manufacturers and suppliers as the time burden estimated for agents, ranging
from zero to approximately 4,500 hours, with a central estimate of approximately 2,250
hours.
Based on our examination of prior FCN response submissions to FDA’s safety
concerns about the intended use of an FCS, we estimate that manufacturers and suppliers
will employ a group consisting of a lawyer, a biochemist, and an administrative assistant
to complete an FCN response submission. Using BLS wage data, we estimate wage rates
in 2021 dollars for each group, adjusting for 100 percent overhead. Fully-loaded hourly
mean wage rates are estimated to be $142.34 (= $71.17 x 2) for lawyers (Ref. 3), $109.10
(= $54.55 x 2) for biochemists (Ref. 5), and $64.30 (= $32.15 x 2) for administrative
assistants (Ref. 8). We estimate that the time burden associated with an FCN response
submission is split between each of these employees, with lawyers bearing approximately
40 percent of the burden, biochemists bearing approximately 40 percent of the burden,
and administrative assistants bearing approximately 20 percent of the burden. We

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multiply the time burden per FCN response submission by the hourly wage for each
employee and its associated percentage of time burden and sum to yield an estimated cost
saving ranging from zero to approximately $510.5 thousand (= 4,500 x $142.34 x 0.40 +
4,500 x $109.10 x 0.40 + 4,500 x $64.30 x 0.20), with a central estimate of
approximately $255.2 thousand (= 2,250 x $142.34 x 0.40 + 2,250 x $109.10 x 0.40 +
2,250 x $64.30 x 0.20). We multiply these cost savings by the estimated number of
affected FCN response submissions completed by agents per year to yield cost savings
ranging from zero to approximately $729.2 thousand (= 1.4 x $510,462), with a central
estimate of approximately $182.3 thousand (= 0.7 x $255,231). The estimated cost
savings to manufacturers and suppliers that complete FCN response submissions are
summarized in Table 3.
Table 3. Cost Savings to Manufacturers and Suppliers That Complete FCNs
(2021$)
Low
Middle
High
Number of affected FCNs per year
0
2.5
5
Percentage of FCNs completed by manufacturers
or suppliers
28.6%
28.6%
28.6%
Number of FCNs completed by manufacturers or
suppliers
0
0.7
1.4
Time burden per FCN
0
2,250
4,500
$142.34
$142.34
$142.34
Hourly wage of lawyers
$109.10
$109.10
$109.10
Hourly wage of biochemists
$64.30
$64.30
Hourly wage of administrative assistants
$64.30
Percent of time burden for lawyer
40%
40%
40%
Percent of time burden for biochemist
40%
40%
40%
Percent of time burden for administrative assistant
20%
20%
20%
Annual cost savings per FCN
$0 $255,231 $510,462
Annual cost savings to manufacturers and
suppliers that complete FCNs
$0 $182,308 $729,231

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We total the estimated cost savings to manufacturers and suppliers that utilize
agents to complete FCN response submissions and those who do not to estimate the total
cost savings of the final rule to FCS manufacturers and suppliers. We estimate that the
total cost savings range from zero to approximately $2.3 million (= $1.6 million + $729.2
thousand), with a central cost savings estimate of approximately $572.3 thousand (=
$390.0 thousand + $182.3 thousand). The estimated cost savings of the final rule to
manufacturers and suppliers are summarized in Table 4.
Table 4. Cost Savings of the Final Rule to FCS Manufacturers and Suppliers
(2021$)
Low
Middle
High
Annual cost savings to manufacturers and suppliers
that utilize agents to complete FCNs
$0 $389,981 $1,559,925
Annual cost savings to manufacturers and suppliers
that complete FCNs
$0 $182,308
$729,231
Total annual cost savings of the final rule to
manufacturers and suppliers
$0 $572,289 $2,289,156
When this final rule becomes effective, manufacturers and suppliers will be able
to request that FDA determine an FCN is no longer effective for reasons other than
safety. We anticipate that this new process may reduce the time burden to FDA of
determining that an FCS is no longer safe for its intended use, yielding cost savings. We
estimate that the annual number of FCN response submissions affected by this rule is
between zero and approximately 5, with a midpoint of approximately 2.5, and FDA time
burden of reviewing an FCN response submission is between zero and approximately
3,000 hours, with a midpoint of approximately 1,500 hours. We estimate that FDA will
employ consumer safety officers and scientists at the GS-13 and GS-14 levels to review
FCN response submissions. Using the 2021 General Schedule (GS) Locality Pay Table
for the Washington-Baltimore-Arlington pay area (Ref. 9), we calculate the average
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salary for all GS-13 and GS-14 pay steps, divide this average by 2,080, the annual
number of hours worked (= 40 hours x 52 weeks), and double the result to account for
overhead. This yields a composite hourly wage of $125.07 (= $130,076 / 2080 x 2). To
estimate the cost savings of the final rule to FDA, we multiply the estimated time burden
to FDA of reviewing an FCN response submission by the composite hourly wage rate for
FDA reviewers, yielding estimated cost savings ranging from zero to approximately
$375.2 thousand (= 3,000 x $125.07), with a central estimate of approximately $187.6
thousand (= 1,500 x $125.07). We multiply these cost savings by the estimated number of
affected FCN response submissions to yield cost savings ranging from zero to
approximately $1.9 million (= 5 x $375,219), with a central estimate of approximately
$469.0 thousand (= 2.5 x $187,609). The cost savings of the final rule to FDA are
summarized in Table 5.
Table 5. Cost Savings to FDA FCN Reviewers (2021$)
Low
Middle
High
Number of affected FCNs per year
0
2.5
5
FDA time burden per FCN
0
1,500
3,000
$125.07
Hourly wage of FDA FCN reviewers
$125.07 $125.07
Annual FDA cost savings per FCN
$0 $187,609
$375,219
Total annual cost savings to FDA FCN reviewers
$0 $469,024 $1,876,095
We sum the estimated cost savings to manufacturers and suppliers and the
estimated cost savings to FDA to yield total estimated costs of the final rule ranging from
zero to approximately $4.2 million (= $2.3 million + $1.9 million), with a central
estimate of approximately $1.0 million (= $572.3 thousand + $469.0 thousand). The net
present value of the cost savings of the final rule ranges from zero to approximately $4.1
million, with a central estimate of approximately $1.0 million, discounted at 2 percent.
The annualized cost savings over 10 years range from zero to approximately $433.4
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thousand, with a central estimate of approximately $108.3 thousand, discounted at 2
percent. The total estimated cost savings of the final rule are summarized in Table 6.
Table 6. Total Cost Savings of the Final Rule (2021$)
Low
Cost savings to FCS manufacturers and suppliers
Cost savings to FDA FCN reviewers
Total cost savings of the final rule
Net present value of cost savings (2%)
Annualized cost savings (2%)

$0
$0
$0
$0
$0

Middle
$572,289
$469,024
$1,041,313
$1,020,895
$108,342

High
$2,289,156
$1,876,095
$4,165,251
$4,083,580
$433,367

Notes: Cost savings are annualized over 10 years.

C. Costs of the Rule
We estimate that the final rule yields cost savings to manufacturers and suppliers
and FDA with minimal or no costs. The final rule increases the efficiency of the process
by which FDA can determine that an FCN is no longer effective. As a result, a
manufacturer or supplier can request that FDA determine an FCN is no longer effective
for reasons other than safety. We estimate that the time burden to FCS manufacturers and
suppliers responding to FDA’s safety concerns with information that they no longer
produce, use, or supply the FCS for the intended use is minimal and that the time burden
to FDA associated with reviewing such information is minimal.

D. Uncertainty and Sensitivity Analysis
We have identified several sources of uncertainty in our estimation of cost
savings. As part of our uncertainty and sensitivity analysis, we estimate cost savings in
which the values of all sources of uncertainty are decreased and increased. This yields
lower and upper estimates of the estimated cost savings. One source of uncertainty is the
estimated time burden to FCS manufacturers and suppliers of responding to an FDA
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safety concern about the intended use of the FCS that may be forgone under the final
rule, which we calculate as being approximately 150 percent of FDA’s time burden of
reviewing a response to our safety concern (2,250 hours = 1,500 hours x 1.5). We
calculate a lower bound on the manufacturer and supplier time burden by estimating that
the time burden is equal to that of FDA, and we calculate an upper bound on
manufacturer and supplier time burden that is approximately 200 percent of FDA’s time
burden of reviewing a response submission (3,000 = 1,500 hours x 2).
Another source of uncertainty is the percentage of the time burden incurred by
those who create FCN response submissions. As an upper bound of cost savings incurred
by manufacturers and suppliers that utilize agents, we calculate that the time burden of an
FCN response submission is split between an agent’s employees, with lawyers bearing
approximately 25 percent of the burden, food scientists bearing approximately 25 percent
of the burden, biochemists bearing approximately 25 percent of the burden, and chemists
bearing approximately 25 percent of the burden. For manufacturers and suppliers
completing their own FCN response submissions, we calculate that the time burden is
split between a manufacturer’s employees, with lawyers bearing approximately 50
percent of the burden and biochemists bearing approximately 50 percent of the burden.
These calculations result in higher estimated cost savings by shifting the burden of labor
that may be forgone due to the final rule toward employees with higher wages and away
from employees with lower wages.
When costs are estimated with lower values for all sources of uncertainty, we
estimate total cost savings to be approximately $723.4 thousand. Annualized over 10
years, the lower bound of estimated cost savings is approximately $75.3 thousand,

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discounted at 2 percent. When costs are estimated with higher values for all sources of
uncertainty, the total cost savings of the final rule are estimated to be approximately $1.6
million. Annualized over 10 years, we estimate the upper bound of cost savings is
approximately $163.8 thousand, discounted at 2 percent. Our sensitivity analysis and
initial central estimates of cost savings are summarized in Table 7.
Table 7. Sensitivity Analysis of Cost Savings of the Final Rule (thousands 2021$)
Low
Mean
High
Total cost savings
$723.4
$1,041.3
$1,574.8
Annualized cost savings (2%)
$75.3
$108.3
$163.8
Notes: Estimates are based on sensitivity analysis of central cost savings estimates. Cost savings are
annualized over 10 years.

E. Analysis of Regulatory Alternatives to the Final Rule
FDA has identified and assessed regulatory alternatives to the final rule including:
1. No Regulatory Action
In the absence of the final rule, FDA would rely on the existing processes for
FCN submissions and FCS manufacturers and suppliers would be unable to request that
FDA determine an FCN is no longer effective for reasons other than safety. This option
serves as our baseline and we estimate cost savings of the final rule relative to this
baseline. This baseline has no cost savings. The disadvantage of this alternative is that it
forgoes the cost savings and efficiencies we estimate for FCS manufacturers and
suppliers and FDA under the final rule. The estimated cost savings of this alternative to
the final rule are presented in Table 8.
Table 8. Cost Savings of Taking No Regulatory Action
Total cost savings of taking no regulatory action

$0

The estimated cost savings of the final rule and the final alternative are
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summarized in Table 9. Cost savings estimates of the alternative to the final rule range
from zero to approximately $1.0 million. Annualized cost savings range from zero to
approximately $108.3 thousand, discounted at 2 percent over 10 years.
Table 9. Summary of Cost Savings of Regulatory Alternatives to the Final Rule (in
thousands 2021$)
Initial Estimate
No Regulatory
Action
Total cost savings
$1,041.3
$0
Annualized cost savings (2%)
$108.3
$0
Notes: Cost savings are annualized over 10 years.

III. Small Entity Analysis
The Regulatory Flexibility Act requires agencies to analyze regulatory options
that would minimize any significant impact of a rule on small entities. Small entities have
fewer resources to devote to regulatory compliance and, therefore, may be more affected
by regulatory compliance costs. We certify that the final rule will not have a significant
economic impact on a substantial number of small entities.

A. Description and Number of Affected Small Entities
We utilize the Dun & Bradstreet database (Ref. 10) to estimate the number of
small entities that may be affected by the final rule. We examine data for all entities
classified by 8-digit Standard Industrial Code as Paper; coated and laminated packaging
(SIC 26710000), Paper; coated and laminated packaging, nec (SIC 26719900), Bread
wrappers, waxed or laminated: purchased material (SIC 26719901), Paper, coated or
laminated for packaging (SIC 26719902), Plastic film, coated or laminated for packaging
(SIC 26719903), Resinous impregnated paper for packaging (SIC 26719904),
Thermoplastic coated paper for packaging (SIC 26719905), Waxed paper: made from
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purchased material (SIC 26719906), Wrapping paper, waterproof or coated (SIC
26719907), Bags: plastic, laminated, and coated (SIC 26730000), Food storage and trash
bags (plastic) (SIC 26730200), Food storage and frozen food bags, plastic (SIC
26730201), Plastic bags: made from purchased materials (SIC 26730301), Pliofilm bags:
made from purchased materials (SIC 26730302), Bags: plastic, laminated, and coated,
nec (SIC 26739900), Cellophane bags, unprinted: made from purchased materials (SIC
26739901), Unsupported plastics film and sheet (SIC 30810000), Plastics film and sheet
(SIC 30810100), Packing materials, plastics sheet (SIC 30810101), Polyethylene film
(SIC 30810103), Polypropylene film and sheet (SIC 30810104), Polyvinyl film and sheet
(SIC 30810105), Vinyl film and sheet (SIC 30810106), Unsupported plastics film and
sheet, nec (SIC 30819900), Film base, cellulose acetate or nitrocellulose plastics (SIC
30819901), Plastics bottles (SIC 30850000), Plastics products, nec (SIC 30890000),
Plastics containers, except foam (SIC 30890100), Boxes, plastics (SIC 30890102),
Buckets, plastics (SIC 30890103), Cases, plastics (SIC 30890104), Jars, plastics (SIC
30890106), Bottle caps, molded plastics (SIC 30890201), Carafes, plastics (SIC
30890204), Cups, plastics, except foam (SIC 30890207), Dishes, plastics, except foam
(SIC 30890208), Kitchenware, plastics (SIC 30890211), Picnic jugs, plastics (SIC
30890213), Plates, plastics (SIC 30890214), Saucers, plastics (SIC 30890215),
Tableware, plastics (SIC 30890216), Tops: dispenser, shaker, etc.: plastics (SIC
30890218), Trays, plastics (SIC 30890219), and Tumblers, plastics (SIC 30890220).
The Small Business Administration (SBA) defines entities classified under SIC
codes 26719903, 26719904, 26719905, 26719906, 26719907, 26730000, 26730200,
26730201, 26730301, 26730302, 26739900, 26739901, 30810000, 30810100, 30810101,

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30810103, 30810104, 30810105, 30810106, 30819900, and 30819901 as small
businesses if they hire 750 or fewer employees (Ref. 11). The SBA defines entities
classified under SIC code 326160 as small businesses if they hire 1,250 or fewer
employees (Ref. 11). The SBA defines entities classified under SIC codes 30890000,
30890100, 30890102, 30890103, 30890104, 30890106, 30890201, 30890204, 30890207,
30890208, 30890211, 30890213, 30890214, 30890215, 30890216, 30890218, 30890219,
and 30890220 as small businesses if they hire 500 or fewer employees (Ref. 11). We
estimate that there are approximately 4,425 entities that may be potentially affected by
this rule and approximately 51 percent, or 2,250 (= 4,425 x 0.51) are classified as small
businesses by SBA definition. We estimate that the total annual sales volume of all 4,425
entities is approximately $322.5 billion, $25.7 billion of which is attributed to small
entities (approximately 8 percent of the industry total).

B. Description of the Potential Impacts of the Rule on Small Entities
We estimate that small entities are likely to experience cost savings stemming
from the final rule. We estimate that the total cost savings of the final rule range from
zero to approximately $4.2 million, with a central estimate of approximately $1,041.3
thousand, and that these cost savings will be passed to FCS manufacturers and suppliers.
We estimate that the percentage of these cost savings incurred by small entities is
approximately 8 percent, the percentage of total industry sales volume associated with
small entities. This yields total cost savings of the final rule for small entities ranging
from zero to $331.5 thousand (= $4.2 million x 0.0796), with a central estimate of $82.9
thousand (= $1,041.3 thousand x 0.0796). We divide the estimated total cost savings to
small entities by the estimated number of small entities to yield cost savings ranging from
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zero to approximately $147.31 per small entity (= $331.5 thousand / 2,250), with a
central estimate of approximately $36.83 per small entity (= $82.9 thousand / 2,250). The
results of our small entity analysis are summarized in Table 10.
Table 10. Analysis of Impacts of the Final Rule on Small Entities (2021$)
Low
Middle
High
Number of affected entities
4,425
4,425
4,425
Number of affected small entities
2,250
2,250
2,250
Total cost savings of the final rule (millions)
$0
$976,764 $3,907,055
Total sales volume of all entities (millions)
$322,534.4 $322,534.4 $322,534.4
Sales volume of small entities (millions)
$25,665.7 $25,665.7
$25,665.7
Percentage of total sales volume attributed to
small entities
7.96%
7.96%
7.96%
Total cost savings of the final rule to small
entities
$0
$82,863
$331,450
Cost savings of the final rule per small
entity
$0
$36.83
$147.31

IV. References
The following reference is on display in the Dockets Management Staff (see
ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are also available electronically at
https://www.regulations.gov. FDA has verified the website addresses, as of the date this
document publishes in the Federal Register, but websites are subject to change over time.
1. Memo to File, Estimates of the annual number of food contact notification
submissions that will be affected by the Food Additives: Food Contact Substance
Notification That Is No Longer Effective proposed rule, prepared by Christian
Brown, FDA, May 22, 2017.
2. Memo to File, Estimates of FCN submission approval time burdens, prepared by
Christian Brown, FDA, May 22, 2017.
3. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 23-1011 Lawyers,” available at:
http://www.bls.gov/oes/current/oes231011.htm, accessed March 8, 2023.
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4. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 19-1012 Food Scientists and Technologists,” available at:
http://www.bls.gov/oes/current/oes191012.htm, accessed March 8, 2023.
5. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 19-1021 Biochemists and Biophysicists,” available at:
http://www.bls.gov/oes/current/oes191021.htm, accessed March 8, 2023.
6. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 19-2031 Chemists,” available at:
http://www.bls.gov/oes/current/oes192031.htm, accessed March 8, 2023.
7. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 23-2099 Legal Support Workers, All Other,” available at:
http://www.bls.gov/oes/current/oes232099.htm, accessed March 8, 2023.
8. U.S. Bureau of Labor Statistics (BLS), “Occupational Employment and Wages,
May 2021, 43-6011 Executive Secretaries and Executive Administrative
Assistants” available at: http://www.bls.gov/oes/current/oes436011.htm, accessed
March 8, 2023.
9. U.S. Office of Personnel Management (OPM), “Salary Table 2021-DCB
Incorporating the 1% General Schedule Increase and A Locality Payment of
30.48% for the Locality Pay Area of Washington-Baltimore-Arlington, DC-MDVA-WV-PA” available at: https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2021/general-schedule/, accessed March 8, 2023.
10. Dun & Bradstreet, Dun & Bradstreet Global Business Database. 2016
11. U.S. Small Business Administration, “Table of Small Business Size Standards
Matched to North American Industry Classification System Codes,” available at:
https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, accessed
March 8, 2023.

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