[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Rules and Regulations]
[Pages 58445-58449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-6238]


Listing of Color Additives Exempt From Certification; Calcium 
Carbonate

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
color additive regulations to provide for the safe use of calcium 
carbonate in dietary supplement tablets and capsules. We are taking 
this action in response to a color additive petition (CAP) submitted by 
Colorcon, Inc. (Colorcon or petitioner).

DATES: This rule is effective October 28, 2022. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by October 27, 2022. See section XI for further information 
on the filing of objections. The incorporation of reference of certain 
material listed in this rule is approved by the Director of the Federal 
Register as of October 27, 2022.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections 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 
October 27, 2022. Objections 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 objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection 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 objections submitted to the Dockets 
Management Staff, FDA will post your objection, 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-2017-C-6238 for ``Listing of Color Additives Exempt from 
Certification; Calcium Carbonate.'' Received objections, 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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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

[[Page 58446]]

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: Christopher Kampmeyer, Office of Food 
Additive Safety (HFS-255), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740-3835, 240-402-1255; or Alexandra Jurewitz, Office of 
Regulations and Policy (HFS-024), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notification published in the Federal Register on November 20, 
2020 (85 FR 74304), we announced that we filed a color additive 
petition (CAP 0C0318) submitted by Colorcon, Inc., 275 Ruth Rd., 
Harleysville, PA 19438. The petition proposed to amend the color 
additive regulations in Sec.  73.70 ``Calcium Carbonate,'' by expanding 
the permitted uses of calcium carbonate to include use in dietary 
supplement tablets and capsules, including coatings and printing inks, 
in amounts consistent with good manufacturing practice.

II. Background

    Calcium carbonate (CAS 471-34-1) is a fine, white powder prepared 
either by grinding naturally occurring limestone or produced 
synthetically through a precipitation process using heat, water, and 
carbon dioxide. Calcium carbonate is slightly soluble in water and 
dissociates into calcium and carbonate ions in an aqueous environment. 
Calcium is abundant in the human body and is an integral component of 
bones, teeth, and other biological structures. Carbonate is also 
present in the human body, e.g., as a critical component of the pH 
buffering system.
    Calcium carbonate is authorized under Sec.  73.70 for use as a 
color additive in soft and hard candies, mints, and in inks used on the 
surface of chewing gum, in amounts consistent with good manufacturing 
practice, except that it may not be used to color chocolate or the 
chocolate portion of candy, as the standards of identity for chocolate 
do not provide for the use of color additives. Calcium carbonate is 
also authorized under Sec.  73.1070 for use as a color additive in 
drugs; generally, in amounts consistent with good manufacturing 
practice. Additionally, food grade calcium carbonate and ground 
limestone (consisting of not less than 94 percent calcium carbonate) 
are affirmed as generally recognized as safe in 21 CFR 184.1191 and 
184.1409, respectively. These two regulations do not include 
limitations for use in food other than current good manufacturing 
practice, which our regulations define at Sec.  184.1(b).
    The petitioner stated that calcium carbonate complies with the 
specifications in the 10th edition of the Food Chemicals Codex (FCC 
10), which was incorporated by reference into Sec.  73.70 (82 FR 51554, 
November 7, 2017). Since this regulation became effective, the 13th 
edition of the FCC (FCC 13) has published. The specifications for 
calcium carbonate and ground limestone are the same in both FCC 10 and 
FCC 13. Therefore, we are updating our incorporation by reference to 
FCC 13. In an email dated May 26, 2022, the petitioner concurred with 
updating the FCC reference from FCC 10 to FCC 13.
    The petitioner concluded that the amount of calcium carbonate 
petitioned for use in dietary supplement tablets and capsules is self-
limiting because the addition of the color additive above a certain 
level would be uneconomical and/or have adverse consequences on the 
quality of the dietary supplements. Because the petitioner concluded 
that the amount of calcium carbonate used as a color additive in 
dietary supplement tablets and capsules would be self-limiting, they 
did not propose any tolerances or other limitations. We determined 
there is no need for a specific upper limit for this use of calcium 
carbonate (Ref. 1).

III. Safety Evaluation

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed 
for a particular use unless the data and information available to FDA 
establish that the color additive is safe for that use. Our color 
additive regulations at 21 CFR 70.3(i) define ``safe'' to mean that 
there is convincing evidence establishing with reasonable certainty 
that no harm will result from the intended use of the color additive.
    To establish with reasonable certainty that a color additive 
intended for use in foods is not harmful under its intended conditions 
of use, we consider the projected human dietary exposure to the color 
additive; the additive's toxicological data; and other relevant 
information (such as published literature) available to us. We compare 
the estimated dietary exposure, or estimated daily intake (EDI), of the 
color additive from all dietary sources to an acceptable daily intake 
(ADI) level established by toxicological data. The EDI is determined by 
projections based on the amount of the color additive proposed for use 
in particular foods and on data regarding the amount consumed from all 
sources of the color additive. We commonly use the EDI for the 90th 
percentile consumer of a color additive as a measure of high chronic 
exposure.

IV. Safety of the Petitioned Use of the Color Additive

A. Dietary Exposure Estimate

    The petitioner estimates that the amount of calcium carbonate as a 
color additive in dietary supplements would not exceed 24 milligrams 
(mg) per dietary supplement (Ref. 2). The petitioner used data for 
dietary supplements from the 2011-2014 National Health and Nutrition 
Examination Survey (NHANES) to estimate dietary exposure to calcium 
carbonate and elemental calcium from the proposed use. From the NHANES 
data, the petitioner determined that the U.S. population aged 2 years 
and older consumes two dietary supplements in a 24-hour period at the 
mean and five at the 90th percentile. We note that these values could 
represent two or five of the same or different dietary supplements. In 
estimating dietary exposure, the petitioner assumed that all dietary 
supplements consumed would contain calcium carbonate as a color 
additive and that each dietary supplement consumed contains 24 mg 
calcium carbonate. This results in a dietary exposure estimate to 
calcium carbonate of 48 milligrams/person/day (mg/p/d) at the mean and 
120 mg/p/d at the 90th percentile. Because calcium carbonate is 
comprised of 40 percent calcium, the petitioner noted that the maximum 
dietary exposure to calcium from this use of calcium carbonate is 
estimated to be 19 mg/p/d at the mean and 48 mg/p/d at the 90th 
percentile.
    The petitioner stated that the maximum amount of calcium carbonate 
deposited as a printing ink on the surface of the dietary supplement 
would

[[Page 58447]]

be 0.009 mg, which corresponds to approximately 0.004 mg of calcium per 
dietary supplement. The petitioner concluded that the contribution to 
the dietary exposure from use in printing ink on the surface of dietary 
supplements is accounted for in the dietary exposure estimate for the 
use of calcium carbonate as a color additive at the maximum proposed 
use level in dietary supplements. FDA concurred with this approach 
regarding the dietary exposure estimate for calcium and calcium 
carbonate from the petitioned uses of calcium carbonate (Ref. 2).
    FDA previously determined the cumulative estimated dietary intake 
(CEDI) for calcium from all sources to be 1,150 mg/p/d at the mean and 
1,925 mg/p/d at the 90th percentile for the U.S. population aged 2 
years and older (Ref. 3). The petitioner summed FDA's mean cumulative 
dietary exposure to calcium (1,150 mg/p/d) (Ref. 3) with the mean 
dietary exposure to calcium from the petitioned uses (19 mg/p/d) (Ref. 
2) to estimate a revised mean CEDI for elemental calcium from the 
existing uses as well as the petitioned use of calcium carbonate as a 
color additive in dietary supplement tablets and capsules, including 
coatings and printing inks. This resulted in a mean CEDI for calcium of 
1,169 mg/p/d for the U.S. population aged 2 years and older. Using an 
analogous approach, the 90th percentile CEDI for calcium, determined 
previously (1,925 mg/p/d; Ref. 3), was summed with the 90th percentile 
value (48 mg/p/d) from the petitioned uses to derive an upper bound 
90th percentile CEDI for calcium of <2,000 mg/p/d for the U.S. 
population aged 2 years and older (Ref. 2).

B. Toxicological Considerations

    To support the safety of the petitioned use of calcium carbonate, 
the petitioner noted that calcium carbonate and ground limestone are 
affirmed as generally recognized as safe under Sec. Sec.  184.1191 and 
184.1409, respectively. The petition referenced FDA's safety review of 
calcium carbonate in CAP 6C0307 (Ref. 4), which resulted in FDA's 
listing of calcium carbonate in Sec.  73.70. Calcium carbonate can 
dissociate into calcium and carbonate ions in aqueous environments, 
making those two ions relevant to a safety evaluation of ingested 
calcium carbonate. Based on carbonate's chemical structure and 
physiological functions, no further safety analysis of carbonate 
exposure was necessary (Ref. 4). FDA also considered safety evaluations 
by the Institute of Medicine (IOM) and safety information resulting 
from a search of the published literature (Ref. 4). In the IOM's 2011 
report on dietary reference intakes for calcium and vitamin D, the IOM 
updated recommended tolerable upper limits (ULs) for calcium ranging 
from 2,000 to 3,000 mg/p/d for the U.S. population aged 1 year and 
older, based on a comprehensive literature review (Ref. 5). The IOM 
considered the UL as the highest average daily exposure that is likely 
to pose no risk of adverse effects to almost all individuals in the 
general population (Ref. 5).
    We conducted a search of the literature from January 2016 until 
December 2021 to identify publications germane to our safety evaluation 
using several different databases (i.e., PubMed, Web of Science and 
ToxNet). We reviewed the articles found in this search and other 
relevant studies available to FDA on the safety of calcium and calcium 
carbonate (Ref. 6). We also noted that in our previous safety review 
(Ref. 4) we determined that no further safety analysis of carbonate was 
necessary, based on its chemical structure and physiological functions 
(Ref. 6).
    Based on our review, we considered the UL established by IOM for 
calcium (2,000 mg/p/d) to remain an appropriate benchmark for assessing 
the safety of dietary exposure to calcium from the petitioned use of 
calcium carbonate (Ref. 6). For the U.S. population aged 2 years and 
older, the dietary exposure estimate at the 90th percentile is below 
the IOM's UL of 2,000 mg/p/d. Additionally, the body of literature on 
calcium carbonate and calcium does not present evidence of safety 
concerns at the expected dietary exposure (Ref. 6). Based on our review 
of the recently published literature, and because the 90th percentile 
dietary exposure to calcium from all dietary sources, including the 
petitioned uses of calcium carbonate, is less than the UL determined by 
IOM, the dietary exposure to calcium from the proposed use of calcium 
carbonate as a color additive in dietary supplement tablets and 
capsules, including coatings and printing inks, does not raise safety 
concerns (Ref. 6). Therefore, we conclude that there is a reasonable 
certainty of no harm from this proposed use as a color additive.

V. Incorporation by Reference

    FDA is incorporating by reference the monographs for calcium 
carbonate and limestone, ground from the Food Chemicals Codex, 13th 
ed., 2022, which was approved by the Office of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may purchase a 
copy of the material from the United States Pharmacopeial Convention, 
12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, https://www.usp.org. You may inspect a copy at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday 
through Friday. Because materials incorporated by reference will no 
longer be available at FDA's main library, we are revising Sec.  73.70 
to update the location where referenced materials cited in FDA 
regulations can be found; the new location will be at the Dockets 
Management Staff.
    The FCC monographs establish a standard for purity and identity for 
calcium carbonate. The monographs provide specifications and analytical 
methodologies used to identify the substance and establish acceptable 
purity criteria. The current color additive regulation for the use of 
calcium carbonate (Sec.  73.70) indicates that the additive must meet 
the specifications in the FCC 10. The most current version of the FCC 
is the FCC 13, and the specifications for calcium carbonate in FCC 13 
are identical to those in FCC 10. Therefore, we are amending Sec.  
73.70 by adopting, and incorporating by reference, the specifications 
for calcium carbonate and ground limestone in FCC 13 in place of FCC 
10.

VI. Conclusion

    Based on the data and information in the petition and other 
available relevant information, we conclude that the petitioned use of 
calcium carbonate for use as a color additive in dietary supplement 
tablets and capsules, including coatings and printing inks, is safe. We 
further conclude that the color additive will achieve its intended 
technical effect and is suitable for the petitioned use. Therefore, we 
are amending the color additive regulations in part 73 to provide for 
the safe use of this color additive as set forth in this document. In 
addition, based on the factors in 21 CFR 71.20(b), we conclude that 
batch certification of calcium carbonate, proposed for use as a color 
additive in dietary supplement tablets and capsules, including coatings 
and printing inks, is not necessary for the protection of public health 
(Ref. 1).

VII. Public Disclosure

    In accordance with Sec.  71.15, the petition and the documents that 
we considered and relied upon in reaching our decision to approve the 
petition will be made available for public disclosure

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(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we 
will delete from the documents any materials that are not available for 
public disclosure.

VIII. Analysis of Environmental Impact

    As stated in the November 20, 2020, Federal Register notification 
of filing, the petitioner claimed that this action is categorically 
excluded under Sec.  25.32(k) because the substance is intended to 
remain in food through ingestion by consumers and is not intended to 
replace macronutrients in food. We further stated that if FDA 
determines a categorical exclusion applies, neither an environmental 
assessment nor an environmental impact statement is required. We did 
not receive any new information or comments regarding this claim of 
categorical exclusion. We considered the petitioner's claim of 
categorical exclusion and determined that this action is categorically 
excluded under Sec.  25.32(k). Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final 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.

X. Section 301(ll) of the FD&C Act

    Our review of this petition was limited to section 721 of the FD&C 
Act. This final rule is not a statement regarding compliance with other 
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act 
(21 U.S.C. 331(ll)) prohibits the introduction or delivery for 
introduction into interstate commerce of any food that contains a drug 
approved under section 505 of the FD&C Act (21 U.S.C. 355), a 
biological product licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262), or a drug or biological product for which 
substantial clinical investigations have been instituted and their 
existence has been made public, unless one of the exemptions in section 
301(ll)(1) to (4) of the FD&C Act applies. In our review of this 
petition, we did not consider whether section 301(ll) of the FD&C Act 
or any of its exemptions apply to food containing this color additive. 
Accordingly, this final rule should not be construed to be a statement 
that a food containing this color additive, if introduced or delivered 
for introduction into interstate commerce, would not violate section 
301(ll) of the FD&C Act. Furthermore, this language is included in all 
color additive final rules that pertain to food and therefore should 
not be construed to be a statement of the likelihood that section 
301(ll) of the FD&C Act applies.

XI. Objections

    This rule is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Dockets Management Staff (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are 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. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. 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. Memorandum from N. Hepp, Color Technology Branch, Office of 
Cosmetics and Colors, Center for Food Safety and Applied Nutrition 
(CFSAN), FDA to C. Kampmeyer, Division of Food Ingredients (DFI), 
Office of Food Additive Safety (OFAS), CFSAN, FDA, May 11, 2022.
* 2. Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS, 
CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11, 2022.
* 3. Memorandum from D. Doell, Division of Petition Review (DPR), 
OFAS, CFSAN, FDA to J. Kidwell, DPR, OFAS, CFSAN, FDA, February 16, 
2017.
* 4. Memorandum from T.S. Thurmond, DPR, OFAS, CFSAN, FDA to J. 
Kidwell, DPR, OFAS, CFSAN, FDA, February 17, 2017.
5. Committee to Review Dietary Reference Intakes for Vitamin D and 
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary 
Reference Intakes for Calcium and Vitamin D,'' National Academies 
Press, Washington, DC 2011. Available at https://www.nap.edu/read/13050/chapter/1 (accessed July 27, 2021).
* 6. Memorandum from R. Chanderbhan, Toxicology Review Team, DFI, 
OFAS, CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11, 
2022.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Incorporation by 
reference, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


0
2. Amend Sec.  73.70 by revising paragraphs (b) and (c) and adding 
paragraph (f) to read as follows:


Sec.  73.70   Calcium carbonate.

* * * * *
    (b) Specifications. Calcium carbonate must meet the specifications 
given in calcium carbonate (FCC 13) and limestone, ground (FCC 13).
    (c) Uses and restrictions. Calcium carbonate may be safely used in 
amounts consistent with good manufacturing practice to color dietary 
supplement tablets and capsules (including coatings and printing inks), 
soft and hard candies and mints, and in inks used on the surface of 
chewing gum, except that it may not be used to color chocolate for 
which standards of identity have been promulgated under section 401 of 
the Federal Food, Drug,

[[Page 58449]]

and Cosmetic Act unless added color is authorized by such standards.
* * * * *
    (f) Incorporation by reference. Material listed in this paragraph 
(f) is incorporated by reference into this section with the approval of 
the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR 
part 51. All approved material is available for inspection at the Food 
and Drug Administration and at the National Archives and Records 
Administration (NARA). Contact the Food and Drug Administration between 
9 a.m. and 4 p.m., Monday through Friday at: Dockets Management Staff, 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. For information on the availability 
of this material at NARA, email: [email protected]; website: 
www.archives.gov/federal-register/cfr/ibr-locations.html. You may 
obtain the material from the U.S. Pharmacopeial Convention, 12601 
Twinbrook Pkwy., Rockville, MD 20852; website: www.usp.org.
    (1) Limestone, Ground, Food Chemicals Codex, 13th edition, 
effective June 1, 2022 (FCC 13).
    (2) Calcium Carbonate, Food Chemicals Codex, 13th edition, 
effective June 1, 2022 (FCC 13).

    Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20819 Filed 9-26-22; 8:45 am]
BILLING CODE 4164-01-P