Proposed Rule2022-23844
Color Additive Certification; Increase in Fees for Certification Services
Primary source
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Published
November 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 211 (Wednesday, November 2, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23844]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
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\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.
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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:
<bullet> 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));
<bullet> 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));
<bullet> 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
<bullet> 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]
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Units
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Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (yearrs)
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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
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From/To............................... From: Manufacturers of color
additives
To: Federal Government ..........
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[[Page 66119]]
Other Annualized Monetized $/year..... .......... .......... .......... .......... 7 .......... ....................................
3
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From/To............................... From:
To: ..........
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Effects:
State, Local, or Tribal Government: No
effect..
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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..
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Wages: No effect....................................................................................................................................
Growth: No effect...................................................................................................................................
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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 <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
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
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