51554 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 

(iii) Ipeco SB Number 063–25–10, Revision 

00; dated May 31, 2016. 

(3) For Ipeco service information identified 

in this AD, contact Ipeco Holdings Ltd., 

Aviation Way, Southend on Sea, SS2 6UN, 

United Kingdom; phone: 44 1702 549371; fax: 

44 1702 540782; email: sales@Ipeco.com. 

(4) You may view this service information 

at FAA, Engine and Propeller Standards 

Branch, Policy and Innovation Division, 1200 

District Avenue, Burlington, MA. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Burlington, Massachusetts, on 

October 19, 2017. 

Karen M. Grant, 

Acting Manager, Engine and Propeller 

Standards Branch, Aircraft Certification 

Service. 

[FR Doc. 2017–24127 Filed 11–6–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2016–C–2767] 

Listing of Color Additives Exempt 

From Certification; Calcium Carbonate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the color additive regulations 

to provide for the safe use of calcium 

carbonate to color hard and soft candy, 

mints, and chewing gum. We are taking 

this action in response to a color 

additive petition submitted by the Wm. 

Wrigley Jr. Company. 

DATES: This rule is effective December 8, 

2017. See section X for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing on 

the final rule by December 7, 2017. The 

incorporation by reference of certain 

publications listed in the rule is 

approved by the Director of the Federal 

Register as of December 7, 2017. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. 

Electronic objections must be submitted 

on or before December 7, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of December 7, 2017. Objections 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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– 

2016–C–2767 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 with the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• 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 

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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Judith Kidwell, Center for Food Safety 

and Applied Nutrition (CFSAN) (HFS– 

265), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740–3835, 240–402–1071. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register on October 7, 

2016 (81 FR 69740), we announced that 

we filed a color additive petition (CAP 

6C0307) submitted by Wm. Wrigley Jr. 

Company (petitioner), c/o Exponent, 

1150 Connecticut Ave. NW., Suite 1100, 

Washington, DC 20036. The petition 

proposed to amend the color additive 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 51555 

regulations in part 73 (21 CFR part 73) 

Listing of Color Additives Exempt from 

Certification to provide for the safe use 

of calcium carbonate to color hard and 

soft candy, mints, and chewing gum. 

The proposed use excludes chocolate or 

the chocolate portion of candy, as the 

current standards of identity for 

chocolate do not allow for the addition 

of color additives (see 21 CFR 163.123, 

163.124, 163.130, 163.135, 163.140, 

163.145, 163.153, 163.155). After the 

petition was filed, the petitioner 

clarified that calcium carbonate is 

intended for use only in ink applied to 

the surface of the chewing gum. 

II. Background 

Calcium carbonate is obtained from 

ground limestone or produced 

synthetically through a precipitation 

process using calcium oxide, water, and 

carbon dioxide. Calcium is abundant in 

the human body and is an integral 

component of bones, teeth, and other 

biological structures. Calcium 

constantly diffuses in and out of the 

bone and is resorbed by the kidney. 

Excess intake of calcium may result in 

hypercalcemia, hypercalciuria, 

gastrointestinal issues, kidney stones, 

interference with iron and zinc 

absorption, possible vascular and soft 

tissue calcification, and renal and 

cardiovascular damage. Carbonate is 

present in the human body as a critical 

component of the pH buffering system. 

The components of carbonate (carbon 

and oxygen) are ubiquitous in the 

human diet and body, and carbonate 

itself does not belong to a class of 

structures that is associated with any 

adverse effects or toxicity. 

Calcium carbonate that is 

pharmaceutical grade is currently 

approved under § 73.1070 for use as a 

color additive in drugs in amounts 

consistent with good manufacturing 

practices (GMP). 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 

§ 184.1191 and § 184.1409 (21 CFR 

184.1191 and 184.1409), respectively. 

These regulations do not include 

limitations for use in food other than 

current GMP. The petitioner proposed 

that to ensure that only food grade 

calcium carbonate is used to color hard 

and soft candy, mints, and chewing 

gum, the substance must meet the 

specifications of the Food Chemicals 

Codex, 10th edition (FCC 10). We have 

reviewed these specifications and agree 

that they should be incorporated into 

the regulation as set forth in this 

document. The petitioner proposed to 

use calcium carbonate to color soft and 

hard candy, mints, and chewing gum in 

amounts consistent with GMP. The 

maximum GMP use level for calcium 

carbonate in hard and soft candy, mints, 

and chewing gum will be determined by 

the desired coloring effect. We have 

determined that the amount of calcium 

carbonate used in these foods is selflimiting because the addition of the 

color additive above a certain level will 

not achieve the desired coloring effect 

and negatively interferes with 

organoleptic properties, such as taste 

and texture. Because the amount of the 

color additive used in these foods is 

self-limiting, we have determined that 

there is no need for a specific upper 

limit on the percent by weight of 

calcium carbonate in hard and soft 

candy, mints, and chewing gum (Ref. 1). 

III. Safety Evaluation 

Under section 721(b)(4) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 379e(b)(4)), a color 

additive cannot be listed for a particular 

use unless the data and information 

available to FDA establish that the color 

additive is safe for that use. 

Furthermore, under section 721(b)(4) of 

the FD&C Act, a color additive is 

deemed to be suitable and safe for the 

purpose of listing for use generally in or 

on food, while there is in effect a 

published finding declaring such 

substance exempt from the term ‘‘food 

additive’’ because of its being generally 

recognized by qualified experts as safe 

for its intended use, as provided in 

section 201(s) of the FD&C Act (21 

U.S.C. 321(s)). FDA’s color additive 

regulations in 21 CFR 70.3(i) define 

‘‘safe’’ to mean that there is convincing 

evidence that establishes 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 

an individual’s estimated exposure, or 

estimated daily intake (EDI), of the color 

additive from all food sources to an 

acceptable daily intake 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 or drugs 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. 

A. Estimated Dietary Exposure 

The petitioner indicated that, given 

the types of candies to be colored and 

the variable conditions under which 

calcium carbonate would be used, the 

use of the assumption that all candies 

would contain calcium carbonate at the 

maximum GMP level would lead to an 

overestimate of exposure. However, 

because only hard and soft candy, 

mints, and chewing gum that are 

colored white would result in a 

potential exposure to calcium carbonate 

from the proposed use, the petitioner 

reviewed the 2009–2012 National 

Health and Examination Survey 

(NHANES) food codes and identified 51 

food codes in which calcium carbonate 

could potentially be used as a color 

additive that represent the intended use 

in hard and soft candy, mints, and 

chewing gum. Although we identified 

additional food codes that could contain 

calcium carbonate, these codes were 

intentionally excluded by the petitioner 

because there were no associated eating 

occasions for these additional food 

codes over the survey years. We agree 

with the selected 51 food codes and the 

exclusion of the other food codes (Ref. 

2). Furthermore, the petitioner used 

market data to refine their exposure 

estimate; however, these data were 

limited to those products that were 

introduced in the last 5 years and may 

not fully represent the market. 

Therefore, to be conservative, we 

estimated exposure to calcium 

carbonate using 2-day food 

consumption data from the 2009–2012 

NHANES for the identified 51 food 

codes at the GMP use levels and made 

no adjustment for market data. Exposure 

to calcium carbonate and to calcium 

was estimated for the U.S. population 2 

years of age and older and children 2 to 

5 years of age (Ref. 2). 

For the U.S. population 2 years of age 

and older, exposure estimates for 

calcium carbonate at the mean and 90th 

percentile from the proposed uses were 

170 milligrams/person/day (mg/p/d) 

and 400 mg/p/d, respectively. For 

children 2 to 5 years of age, exposure 

estimates for calcium carbonate at the 

mean and 90th percentile were 125 mg/ 

p/d and 270 mg/p/d, respectively. 

Calcium carbonate is a source of 

calcium for the consumer once ingested 

and metabolized by the body. Therefore, 

as part of our evaluation, we also 

estimated exposure to calcium from the 

petitioned uses of calcium carbonate by 

assuming that the amount of calcium 

provided by calcium carbonate as a 

color additive is 40 percent of the total 

weight of calcium carbonate. For the 

U.S. population 2 years of age and older, 


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51556 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 

estimated exposure to calcium from the 

proposed uses of calcium carbonate at 

the mean and 90th percentile were 70 

mg/p/d and 160 mg/p/d, respectively. 

For children 2 to 5 years of age, 

estimated exposure to calcium at the 

mean and 90th percentile were 50 mg/ 

p/d and 110 mg/p/d, respectively. 

Additionally, we estimated exposure 

to calcium from background dietary 

sources, drugs, and dietary supplements 

using 2-day food consumption data for 

all foods and nutrient data for calcium 

in those foods based on the U.S. 

Department of Agriculture’s National 

Nutrient Database for Standard 

Reference. This estimate also included 

exposure to calcium from dietary 

supplements (including nonprescription antacids that contain 

calcium) based on NHANES 2-day 

survey data (Ref. 2). 

For the U.S. population 2 years of age 

and older, exposure to calcium from 

background dietary sources, drugs, and 

dietary supplements at the mean and 

90th percentile were estimated to be 

1,125 mg/p/d and 1,900 mg/p/d, 

respectively. For children 2 to 5 years of 

age, exposure estimates at the mean and 

90th percentile were 1,000 mg/p/d and 

1,600 mg/p/d, respectively. Because our 

exposure estimates for dietary 

supplements include calcium from all 

sources, not just calcium carbonate, we 

believe that this exposure estimate is 

sufficiently conservative to include any 

exposure to calcium from the use of 

calcium carbonate to color drugs (Ref. 

2). 

We estimated exposure to calcium 

from background dietary sources, drugs, 

dietary supplements and the proposed 

uses of calcium carbonate at the mean 

and 90th percentile for the U.S. 

population 2 years of age and older and 

children 2 to 5 years of age. Based on 

these calculations, exposure estimates 

for calcium for the U.S. population 2 

years of age and older at the mean and 

90th percentile were 1,150 mg/p/d and 

1,925 mg/p/d, respectively. For children 

2 to 5 years of age, exposure estimates 

for calcium at the mean and 90th 

percentile were 1,025 mg/p/d and 1,625 

mg/p/d, respectively (Ref. 2). 

B. Safety of the Petitioned Uses of 

Calcium Carbonate 

To support the safety of the petitioned 

use of calcium carbonate, the petitioner 

referenced safety information on 

calcium from the 2011 Institute of 

Medicine (IOM) Report on Dietary 

Reference Intakes for Calcium and 

Vitamin D (Ref. 3) and the European 

Food Safety Authority (EFSA) Panel on 

Dietetic Products, Nutrition and 

Allergies’ reevaluation of the safety of 

calcium (Ref. 4). In 2011, the Standing 

Committee on the Scientific Evaluation 

of Dietary Reference Intakes of the Food 

and Nutrition Board of the IOM 

conducted an extensive review of 

relevant published scientific literature 

on calcium to update current dietary 

reference intakes and Upper Tolerable 

Intake Levels (UL). In their 2011 

assessment of calcium, the IOM 

established a UL of 1,000 mg/p/d for 

infants 0 to 6 months of age and 1,500 

mg/p/d for infants 6 to 12 months of 

age. For children 1 to 8 years of age, 

IOM did not change the UL of 2,500 mg/ 

p/d from the previous IOM report in 

1997. For children 9 to 18 years of age, 

IOM increased the UL to 3,000 mg/p/d. 

For adults 19 to 50 years of age, the IOM 

established a UL of 2,500 mg/p/d; for 

adults 51 years and older, the IOM 

established a UL of 2,000 mg/p/d. 

The IOM considers the UL as the 

highest average daily intake level of a 

nutrient that poses no risk of adverse 

effects when the nutrient is consumed 

over long periods of time. The UL is 

determined using a risk assessment 

model developed specifically for 

nutrients. The dose-response 

assessment, which concludes with an 

estimate of the UL, is built upon three 

toxicological concepts commonly used 

in assessing the risk of exposures to 

chemical substances: No-observedadverse-effect level, lowest-observedeffect level, and application of an 

uncertainty factor. We considered the 

ULs established by the IOM relative to 

the exposure estimates for calcium as 

the primary basis for assessing the safety 

of the petitioned uses of calcium 

carbonate. 

The estimated dietary exposure to 

calcium from the petitioned uses, 

dietary sources, and dietary 

supplements at the 90th percentile for 

the U.S. population 2 years of age and 

older is estimated to be 1,925 mg/p/d, 

which is below the IOM’s UL of 2,000– 

3,000 mg/p/d. For children 2 to 5 years 

of age, the exposure estimate at the 90th 

percentile is 1,625 mg/p/d, which also 

is below the IOM’s UL of 2,500 mg/p/ 

d for this age group. Additionally, the 

body of literature on calcium carbonate 

and calcium does not present evidence 

of safety concerns at the expected 

dietary exposures discussed above. 

Thus, we conclude that the petitioned 

use of calcium carbonate as a color 

additive in soft and hard candy, mints, 

and chewing gum is safe (Ref. 5). 

IV. Incorporation by Reference 

FDA is incorporating by reference the 

Food Chemicals Codex, 10th ed. (2016), 

pp. 213–214 (calcium carbonate) and p. 

754 (limestone, ground), which was 

approved by the Office of the Federal 

Register. You may purchase a copy of 

the material from the United States 

Pharmacopeial Convention, 12601 

Twinbrook Pkwy., Rockville, MD 20852 

(http://www.usp.org). Copies also may 

be examined at FDA’s Main Library, 

10903 New Hampshire Ave., Bldg. 2, 

Third Floor, Silver Spring, MD 20993, 

301–796–2039. 

The FCC is a compendium of 

internationally recognized standards for 

the purity and identity of food 

ingredients. To ensure that only food 

grade calcium carbonate and ground 

limestone (consisting of not less than 94 

percent calcium carbonate) are used in 

hard and soft candy, mints, and 

chewing gum, the additive must meet 

the specifications and identity in the 

appropriate FCC monograph. 

V. Conclusion 

FDA reviewed the data and 

information in the petition and other 

available relevant material and 

determined the use of calcium carbonate 

to color hard and soft candy, mints, and 

chewing gum at GMP levels is safe. We 

further conclude that the additive will 

achieve its intended technical effect and 

is suitable for the petitioned uses. We 

note that these uses do not extend to 

chocolate or the chocolate portion of 

candy because the standards of identity 

for chocolate do not allow for the 

addition of color additives (see 21 CFR 

163.123, 163.124, 163.130, 163.135, 

163.140, 163.145, 163.153, 163.155). 

Based on the available information, we 

are amending the color additive 

regulations in part 73 as set forth in this 

document. In addition, based on the 

factors listed in 21 CFR 71.20(b), we 

conclude that certification of calcium 

carbonate to color hard and soft candy, 

mints, and chewing gum is not 

necessary for the protection of public 

health (Ref. 1). 

VI. Public Disclosure 

In accordance with § 71.15 (21 CFR 

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 (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 71.15, we will delete from the 

documents any materials that are not 

available for public disclosure. 

VII. Analysis of Environmental Impact 

We previously considered the 

environmental effects of this rule, as 

stated in the October 7, 2016, Federal 

Register notice of petition for CAP 

6C0307 (81 FR 69740). We stated that 

we had determined, under 21 CFR 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 51557 

25.32(k), that this action ‘‘is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment’’ such that 

neither an environmental assessment 

nor an environmental impact statement 

is required. We have not received any 

new information or comments that 

would affect our previous 

determination. 

VIII. 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. 

IX. Section 301(ll) of the Federal Food, 

Drug, and Cosmetic 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 (ll)(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. 

X. 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 at 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. 

XI. References 

The following references are on 

display with 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 also are available 

electronically at https://

www.regulations.gov. References that 

are published articles and books are not 

on display. 

1. Memorandum from N. Hepp, Color 

Technology Team, Office of Cosmetics 

and Colors (OCAC), CFSAN, FDA to C. 

Johnston, Division of Petition Review, 

Office of Food Additive Safety (OFAS), 

CFSAN, FDA, October 27, 2016. 

2. Memorandum from D. Doell, Division of 

Petition Review, OFAS, CFSAN, FDA to 

J. Kidwell, Division of Petition Review, 

OFAS, CFSAN, FDA, February 16, 2017. 

3. 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. 

4. European Food Safety Authority (EFSA). 

‘‘Scientific Opinion on the Tolerable 

Upper Intake Level of Calcium.’’ EFSA 

Journal, vol. 10(7), p. 2814, 2012. 

5. Memorandum from T. Thurmond, Division 

of Petition Review, OFAS, CFSAN, FDA 

to J. Kidwell, Division of Petition 

Review, OFAS, CFSAN, FDA, February 

17, 2017. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Incorporation by reference, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 73 is 

amended as follows: 

PART 73—LISTING OF COLOR 

ADDITIVES EXEMPT FROM 

CERTIFICATION 

■ 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. 

■ 2. Section 73.70 is added to subpart A 

to read as follows: 

§ 73.70 Calcium carbonate. 

(a) Identity. (1) The color additive 

calcium carbonate is a fine, white 

powder consisting essentially of 

calcium carbonate (CaCO3) prepared 

either by grinding naturally occurring 

limestone or synthetically, by 

precipitation. 

(2) Color additive mixtures for food 

use made with calcium carbonate may 

contain only those diluents that are 

suitable and that are listed in this 

subpart as safe for use in color additive 

mixtures for coloring foods. 

(b) Specifications. The color additive 

meets the specifications of the Food 

Chemicals Codex, 10th ed. (2016), pp. 

213–214 (calcium carbonate) and p. 754 

(limestone, ground), which is 

incorporated by reference. The Director 

of the Office of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain copies 

from the United States Pharmacopeial 

Convention, 12601 Twinbrook Pkwy., 

Rockville, MD 20852 (internet address 

http://www.usp.org). Copies may be 

examined at the Food and Drug 

Administration’s Main Library, 10903 

New Hampshire Ave., Bldg. 2, Third 

Floor, Silver Spring, MD 20993, 301– 

796–2039, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, or go to: http://www.archives.gov/ 

federal_register/code_of_federal_

regulations/cfr/ibr_locations.html. 

(c) Uses and restrictions. Calcium 

carbonate may be safely used in 

amounts consistent with good 

manufacturing practice to color 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, 


nshattuck on DSK9F9SC42PROD with RULES
51558 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 

and Cosmetic Act unless added color is 

authorized by such standards. 

(d) Labeling requirements. The label 

of the color additive and of any 

mixtures prepared therefrom intended 

solely or in part for coloring purposes 

must conform to the requirements of 

§ 70.25 of this chapter. 

(e) Exemption from certification. 

Certification of this color additive is not 

necessary for the protection of the 

public health, and, therefore, batches 

thereof are exempt from the certification 

requirements of section 721(c) of the 

Federal Food, Drug, and Cosmetic Act. 

Dated: November 1, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24194 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2017–N–4394] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Total 25- 

Hydroxyvitamin D Mass Spectrometry 

Test System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is classifying the total 25- 

hydroxyvitamin D mass spectrometry 

test system into class II (special 

controls). The special controls that 

apply to the device type are identified 

in this order and will be part of the 

codified language for the total 25- 

hydroxyvitamin D mass spectrometry 

test system’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices, in part by reducing regulatory 

burdens. 

DATES: This order is effective November 

7, 2017. The classification was 

applicable on May 18, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866, 

steven.tjoe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

total 25-hydroxyvitamin D mass 

spectrometry test system as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or PMA in order to 

market a substantially equivalent device 

(see 21 U.S.C. 360c(i), defining 

‘‘substantial equivalence’’). Instead, 

sponsors can use the less-burdensome 

510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On March 20, 2017, AB Sciex LLC 

submitted a request for De Novo 

classification of the Vitamin D 200M 

Assay for the Topaz System. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the generals controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 


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