[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Proposed Rules]
[Pages 66116-66120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23844]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. FDA-2022-N-1635]
RIN 0910-AI69


Color Additive Certification; Increase in Fees for Certification 
Services

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend the color additive regulation to increase the fee for 
certification services. The change in fees will allow FDA to continue 
to maintain an adequate color certification program as required by the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). The fees are intended 
to recover the full costs of operation of FDA's color certification 
program.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by January 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-N-1635 for ``Color Additive Certification; Increase in Fees 
for Certification Services.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Bryan Bowes, Office of Cosmetics and 
Colors (HFS-105), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1122; or Carrol Bascus, Center for Food Safety and Applied 
Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Need for the Regulation
III. Description of the Proposed Rule
IV. Proposed Effective Date
V. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

[[Page 66117]]

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule, if finalized, would amend the color additive 
regulation to increase the fee for certification services. The change 
in fees would allow FDA to continue to maintain an adequate color 
certification program as required by the FD&C Act. The fees are 
intended to recover the full costs of operation of FDA's color 
certification program.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule, if finalized, would amend the color additive 
regulation to increase the fees for certification services. The fees 
for straight colors including lakes would be $0.45 per pound ($0.10 per 
pound increase) with a minimum fee of $288. There would be similar 
increases in fees for repacks of certified color additives and color 
additive mixtures.

C. Legal Authority

    We are issuing this proposed rule consistent with our statutory 
which requires that fees necessary to provide, maintain, and equip an 
adequate color additive certification program be specified in our 
regulations. FDA also derives authority to issue this proposed rule 
from the FD&C Act, which authorizes FDA to issue regulations for the 
efficient enforcement of the FD&C Act.

D. Costs and Benefits

    The proposed rule, if finalized, would amend existing color 
additive regulations by increasing fees for certification services. The 
costs of this proposed rule include the cost to read and understand the 
rule. As the increase in fees is not associated with any change in our 
certification program, no economic benefits are expected to result from 
the proposed rule. Similarly, the impact of the increase in 
certification fees on color additive manufacturers is considered a 
transfer, rather than an economic cost. Accordingly, we do not estimate 
economic benefits associated with this proposed rule, and the impact of 
the increase in color certification fees is estimated as an ongoing 
transfer from manufacturers of color additives to the Federal 
Government. The economic burdens of this proposed rule, if finalized, 
would accrue to color additive manufacturers. We estimate a one-time 
cost to read and understand the rule for all color additive 
manufacturers. The present value of this cost is approximately $1,407 
at a 3 percent rate of discount, and $1,354 at a 7 percent rate of 
discount. The annualized value of these costs estimates is 
approximately $165 at a 3 percent discount rate and $193 at a 7 percent 
discount rate.

II. Background

A. Introduction

    Certification of color additives by a self-supporting process has 
been required since the enactment of the FD&C Act. In accordance with 
section 721(a)(1)(B) of the FD&C Act, certain color additives must be 
certified for use by FDA in food, drugs, cosmetics, and medical 
devices. FDA analyzes samples from each batch of color additive 
received from a manufacturer and verifies that it meets composition and 
purity specifications. Certification is performed before the additives 
are permitted to be used in products. Manufacturers pay fees, based on 
the weight of each batch for certification. These fees support FDA's 
color certification program.
    In the Federal Register of March 29, 2005 (70 FR 15755), we issued 
an interim final rule (IFR) amending the color additive regulations by 
increasing the fees for certification services due to a general 
increase in the cost associated with operating the certification 
program. The IFR increased the fees per pound. The fee for straight 
colors including lakes increased from $0.30 to $0.35 per pound (a $0.05 
per pound increase) with a minimum fee increase from $192 to $224. The 
fee for repacks of certified color additives and color additive 
mixtures increased from $30 to $35 for 100 pounds or less, from $30 to 
$35 plus $0.06 \1\ for each pound over 100 pounds up to 1,000 pounds, 
and from $84 to $89 plus $0.02 per pound over 1,000 pounds.
---------------------------------------------------------------------------

    \1\ We had originally specified ``$0.05'' for each pound over 
100 pounds up to 1,000 pounds. Subsequently, in the Federal Register 
of December 7, 2006 (71 FR 70873), we amended the IFR to correct 
this typographical error.
---------------------------------------------------------------------------

B. Need for the Regulation

    The current fee schedule specified in part 80 (21 CFR part 80) 
became effective in 2005 and was amended in 2006. Since 2005, the costs 
of the certification program have significantly increased because of 
general operating expenses, including the purchase and maintenance of 
critical equipment, rent and facility charges, and escalating staff 
payroll. Therefore, we propose to increase the fees for certifying 
color additives to reflect increasing operating costs for the 
certification program. The fee schedule for color additive 
certification, as provided for in our regulations, is designed to cover 
all the costs involved in certifying batches of color additives. This 
includes the cost of specific tests required by the regulations and the 
general costs associated with the certification program, such as costs 
of accounting, reviewing data, issuing certificates, conducting 
research, inspecting establishments, and purchasing and maintaining 
equipment. The current fee schedule is insufficient to provide, equip, 
and maintain an adequate certification program. Consistent with section 
721(e) of the FD&C Act, the proposed increase is necessary to cover 
increasing operating costs and maintain an adequate color certification 
program.

III. Description of the Proposed Rule

    The proposed rule, if finalized, would revise Sec.  80.10 (21 CFR 
80.10), ``Fees for certification services,'' to:
     increase the fee for certification services from $0.35 to 
$0.45 per pound for straight colors including lakes, and change the 
minimum fee from $224 to $288 (proposed Sec.  80.10(a));
     increase the fees for repacks of certified color additives 
and color additive mixtures from $35 for 100 pounds or less to $45 
(proposed Sec.  80.10(b)(1));
     increase the fees for repacks of certified color additives 
and color additive mixtures over 100 pounds, but not over 1,000 pounds, 
from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08 
for each pound over 100 pounds (proposed Sec.  80.10(b)(2)); and
     increase the fees for repacks of certified color additives 
and color additive mixtures over 1,000 pounds from $89 plus $0.02 for 
each pound over 1,000 pounds to $114 plus $0.03 for each pound over 
1,000 pounds (proposed Sec.  80.10(b)(3)).
    Increasing the fees will ensure the viability of the certification 
program and offset the increased costs of maintaining this program.

IV. Proposed Effective Date

    We propose that any final rule resulting from this rulemaking be 
effective 30 days after the final rule's date of publication in the 
Federal Register. We believe that this effective date is appropriate 
because it will provide industry sufficient time to prepare for and 
adjust to the change in fees.

V. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order

[[Page 66118]]

12866, Executive Order 13563, 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 and 13563 direct us to assess all costs and 
benefits 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). We believe 
that this proposed rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the increase in fees for color certification services 
would not significantly increase costs to manufacturers, we propose to 
certify that the proposed 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 costs and benefits, before proposing ``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 $165 million, using the most current (2021) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    This proposed rule, if finalized, would amend existing color 
additive regulations by increasing fees for certification services. The 
fee schedule for color additive certification, as provided for in this 
proposed regulation, is designed to cover all the costs of operation of 
FDA's color certification program. This includes both the cost of 
specific tests required by the regulations and the general costs 
associated with the certification program, such as the costs of 
accounting, reviewing data, issuing certificates, conducting research, 
inspecting establishments, and purchasing and maintaining equipment. 
The fee for certification services of straight colors including lakes 
would increase from $0.35 per pound to $0.45 per pound, with the 
minimum fee increasing from $224 to $288. The fees for repacks of 
certified color additives and color additive mixtures would increase 
from $35 for 100 pounds or less to $45. The fee for repacks of 
certified color additives and color additive mixtures over 100 pounds, 
but not over 1,000 pounds would increase from $35 plus $0.06 for each 
pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds. 
The fee for repacks of certified color additives and color additive 
mixtures over 1,000 pounds would increase from $89 plus $0.02 for each 
pound over 1,000 pounds to $114 plus $0.03 for each pound over 1,000 
pounds.
    The economic burdens of this proposed rule, if finalized, would 
accrue to color additive manufacturers. We estimate a one-time cost to 
read and understand the rule for all color additive manufacturers. The 
present value of this cost is approximately $1,407 at a 3 percent rate 
of discount, and $1,354 at a 7 percent rate of discount. The annualized 
value of these costs estimates is approximately $165 at a 3 percent 
discount rate and $193 at a 7 percent discount rate. Because the value 
of these impacts is small relative to manufacturer revenues, we assume 
that the supply of color additives would not be affected by this 
proposed rule. Consequently, we estimate no other impacts associated 
with this proposed rule.
    As noted in the preamble, the fees are intended to recover the full 
costs of operation of FDA's color certification program. Since 2005, 
the costs of the certification program significantly increased as a 
result of escalating staff payroll, rent and facility charges, as well 
as general operational expenses, including purchasing and maintaining 
equipment. As the increase in fees is not associated with any change in 
our certification program, no economic benefits are expected to result 
from the proposed rule, if finalized. Similarly, the impact of the 
increase in certification fees on color additive manufacturers is 
considered a transfer, rather than an economic cost. Accordingly, we do 
not estimate economic benefits associated with this proposed rule, and 
the impact of the increase in color certification fees is estimated as 
an ongoing transfer from manufacturers of color additives to the 
Federal Government. Our estimates are summarized in table 1.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                  [Millions of 2020 dollars over 10-year time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                               Units
                                                                               ------------------------------------
                 Category                     Primary       Low        High                               Period                    Notes
                                             estimate    estimate    estimate      Year      Discount     covered
                                                                                  dollars    rate  (%)   (yearrs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year...........  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                                     3
    Annualized Quantified.................  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                                     3
    Qualitative:..........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Costs:
    Annualized Monetized $/year...........    $0.00019  ..........  ..........        2020           7          10  ....................................
                                               0.00016                                2020           3          10
    Annualized Quantified.................  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                                     3
    Qualitative...........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Transfers:
    Federal Annualized Monetized $/year...       $2.46  ..........  ..........        2020           7          10  ....................................
                                                  2.46                                2020           3          10
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...............................  From: Manufacturers of color
                                            additives
                                            To: Federal Government              ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 66119]]

 
    Other Annualized Monetized $/year.....  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                                     3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...............................  From:
                                            To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: No
     effect..
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Small Business: The proposed rule, if finalized, would generate costs to small businesses, as well as transfers from small businesses to FDA that we
     treat as costs from the perspective of the small business. On average, these costs amount to approximately 0.2732% of annual average revenues of
     the small firms in the affected industry..
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    We have examined the economic implications of this proposed rule 
for small entities as required by the Regulatory Flexibility Act. If a 
proposed rule would have a significant economic impact on a substantial 
number of small entities, the Regulatory Flexibility Act requires 
Agencies to analyze regulatory options that would lessen the economic 
effect of the proposed rule on small entities. Consequently, this 
analysis, together with other relevant sections of this document and 
the preamble of the proposed rule, serves as the Initial Regulatory 
Flexibility Analysis, as required under the Regulatory Flexibility Act.
    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 1) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. We have concluded, under 21 CFR 25.30(h), that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. FDA invites comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

X. Reference

    The following reference is on display at 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; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

1. FDA, ``Color Additive Certification; Increase in Fees for 
Certification Services'' Preliminary Regulatory Impact Analysis, 
Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform 
Act Analysis. Available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 80

    Color additives, Cosmetics, Drugs, Reporting and recordkeeping 
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 80 be amended as follows:

PART 80--COLOR ADDITIVE CERTIFICATION

0
1. The authority citation for part 80 continues to read as follows:

    Authority: 21 U.S.C. 371, 379e.

0
2. In Sec.  80.10, revise paragraphs (a) and (b) to read as follows:


Sec.  80.10  Fees for certification services.

    (a) Fees for straight colors including lakes. The fee for the 
services provided by the regulations in this part in the case of each 
request for certification submitted in accordance with Sec.  
80.21(j)(1) and (2) shall be $0.45 per pound of the batch covered by 
such requests, but no such fee shall be less than $288.
    (b) Fees for repacks of certified color additives and color 
additive mixtures. The fees for the services provided under the 
regulations in this part in the case of each request for certification 
submitted in accordance with Sec.  80.21(j)(3) and (4) shall be:

[[Page 66120]]

    (1) 100 pounds or less--$45.
    (2) Over 100 pounds but not over 1,000 pounds--$45 plus $0.08 for 
each pound over 100 pounds.
    (3) Over 1,000 pounds--$114 plus $0.03 for each pound over 1,000 
pounds.
* * * * *

    Dated: October 21, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-23844 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P