Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 14839 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5129, 

Silver Spring, MD 20993–0002, 301– 

796–8220, FAX: 301–847–8640, or 

Michael.Ortwerth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Antiviral Drugs Advisory Committee 

was established on October 7, 1980 (see 

45 FR 79025, November 28, 1980). The 

Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of acquired 

immune deficiency syndrome, human 

immunodeficiency virus related 

illnesses, and other viral, fungal and 

mycobacterial infections. The 

Committee is no longer needed and was 

terminated on February 15, 2015. 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the Agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely 

removes the name of the Antiviral Drugs 

Advisory Committee from the list of 

standing advisory committees in 

§ 14.100 (21 CFR 14.100). 

Therefore, the Agency is amending 

§ 14.100(c) as set forth in the regulatory 

text of this document. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155; Pub. L. 113–54. 

§ 14.100 [Amended] 

■ 2. Section 14.100 is amended by 

removing paragraph (c)(3) and 

redesignating paragraphs (c)(4) through 

(18) as paragraphs (c)(3) through (17). 

Dated: March 16, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–06425 Filed 3–19–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2013–C–1008] 

Listing of Color Additives Exempt 

From Certification; Synthetic Iron 

Oxide 

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 expanded safe use of 

synthetic iron oxide as a color additive 

to include use in soft and hard candy, 

mints, and chewing gum. This action is 

in response to a petition filed by Wm. 

Wrigley Jr. Company (Wrigley). 

DATES: This rule is effective April 21, 

2015. See section X for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing by 

April 20, 2015. 

ADDRESSES: You may submit either 

electronic or written objections and 

requests for a hearing, identified by 

Docket No. FDA–2013–C–1008, by any 

of the following methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–C–1008 for this rulemaking. All 

objections received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section. 

Docket: For access to the docket to 

read background documents or 

objections received, go to http://

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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Laura A. Dye, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 240–402–1275. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In a document published in the 

Federal Register of September 17, 2013 

(78 FR 57105), we announced that we 

had filed a color additive petition (CAP 

3C0298) submitted by Wm. Wrigley Jr. 

Company, c/o Exponent Inc., 1150 

Connecticut Ave. NW., Suite 1100, 

Washington, DC 20036 (petitioner). The 

petition proposed to amend the color 

additive regulations in § 73.200 

Synthetic Iron Oxide (21 CFR 73.200) by 

expanding the safe use of synthetic iron 

oxide as a color additive to include use 

in soft and hard candy, mints, and 

chewing gum. The petitioner requested 

that the proposed uses be permitted at 

levels consistent with current good 

manufacturing practice (GMP). The 

petition also proposed to lower the 

specification limit for lead in synthetic 

iron oxide for human food use from 10 

milligrams per kilogram (mg/kg; 10 

parts per million (ppm)) to 5 mg/kg (5 

ppm). 

II. Background 

Currently, synthetic iron oxides and 

their hydrated forms are approved as 

color additives for the following direct 

uses in human food, drugs, and 

cosmetics: (1) In sausage casings 

intended for consumption in an amount 

not exceeding 0.10 percent by weight of 

the finished food (§ 73.200); (2) in 

ingested or topically-applied drugs with 

a limit for ingested drugs of 5 

milligrams, calculated as elemental iron, 

per day for labeled or prescribed 

dosages (21 CFR 73.1200); and (3) in 

cosmetics generally, including 

cosmetics applied to the area of the eye, 

in amounts consistent with GMP (21 

CFR 73.2250). 

Synthetically prepared iron oxides 

and their hydrated forms include red 

iron oxide, yellow iron oxide, black iron 

oxide, and brown iron oxide, which is 

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14840 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 

a blend of various iron oxides. For the 

subject petition, synthetic iron oxides 

are intended to be used in soft and hard 

candy, mints, and chewing gum in 

amounts consistent with GMP. The 

maximum GMP use level for iron oxides 

depends on the color of the iron oxide 

and the application. We have 

determined that the amount of the color 

additive used in these foods is selflimiting (Ref. 1). Therefore, there is no 

need for a specific upper limit on the 

percent by weight of iron oxide in hard 

and soft candies, mints, and chewing 

gum in the regulation for these foods. 

III. Evaluation of Safety 

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 establishes that the 

color additive is safe for that use. 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 food is not 

harmful under its intended conditions 

of use, we consider the estimated 

human dietary exposure to the additive, 

the additive’s toxicological data, and 

other relevant information (such as 

published literature) available to us. We 

compare an individual’s estimated daily 

intake (EDI) of the additive from all 

sources to an acceptable daily intake 

(ADI) established by toxicological data. 

The EDI is determined by projections 

based on the amount of the additive 

proposed for use in particular foods and 

on data regarding the amount consumed 

from all sources of the additive. We 

typically use the EDI for the 90th 

percentile consumer of a color additive 

as a measure of high chronic dietary 

exposure. 

IV. Safety of Petitioned Use of the 

Additive 

To support the safety of the proposed 

uses of synthetic iron oxide, Wrigley 

provided information about iron intake 

expected to result from the proposed 

new uses of synthetic iron oxide, as well 

as intake from other sources of iron. 

There are many dietary sources of iron, 

including from food ingredients, dietary 

supplements, and from food that 

contains naturally occurring iron. 

Specifically, Wrigley submitted detailed 

exposure estimates of iron that took into 

account the following: (1) The proposed 

uses of synthetic iron oxide as a color 

additive in soft and hard candy, mints, 

and chewing gum based on the 

maximum anticipated use levels; (2) the 

current use of synthetic iron oxide to 

color sausage casings; (3) background 

iron from conventional food based on 

the iron content declared on food labels; 

(4) iron from dietary supplements; and 

(5) oral exposure to iron oxides from 

their use as color additives in lipstick. 

These exposure estimates assumed that 

all of the iron that is present is absorbed 

in the gastrointestinal tract. Wrigley also 

provided exposure estimates to iron that 

took into account the bioavailability of 

iron from all current dietary sources, 

proposed uses, and lipstick. Wrigley 

compared these intake estimates to the 

Tolerable Upper Intake Level (UL) for 

iron established by the Institute of 

Medicine (IOM) of the National 

Academies. Based on this and other 

information, Wrigley concluded that the 

proposed use of synthetic iron oxide to 

color soft and hard candy, mints, and 

chewing gum is safe. 

A. Estimated Daily Intake of Iron 

Using food consumption data from 

the 2003–2008 National Health and 

Nutrition Examination Survey 

(NHANES), Wrigley’s estimated 

exposure to iron from the proposed uses 

in soft and hard candy, mints and 

chewing gum for the U.S. population (2 

years of age and older) to be 16.3 mg/ 

p/day (d) for the 90th percentile 

consumer. Wrigley also provided 

dietary exposure estimates to iron for 

children 2 to 5 years of age, children 2 

to 13 years of age, and adolescents and 

adults 14 years of age and older. For 

these population groups, Wrigley 

estimated the exposure to iron from the 

proposed uses at the 90th percentile to 

be 12.2 mg/p/d, 15.6 mg/p/d, and 16.4 

mg/p/d, respectively. Wrigley also 

estimated the cumulative exposure to 

iron from all food sources (current and 

proposed) for the U.S. population (2 

years of age and older) to be 40.6 mg/ 

p/d for the 90th percentile consumer. 

Wrigley also provided dietary exposure 

estimates to iron for children 2 to 5 

years of age, children 2 to 13 years of 

age, and adolescents and adults 14 years 

of age and older. For these population 

groups, Wrigley estimated the exposure 

to iron at the 90th percentile to be 31.2 

mg/p/d, 34.6 mg/p/d, and 41.5 mg/p/d, 

respectively. In addition, Wrigley 

estimated exposure to iron from all food 

sources (current and proposed) and 

lipstick for females 10 to 13 years old, 

and 14 years of age and older. The 

exposure at the 90th percentile for these 

two population groups was 33.8 mg/p/ 

d and 40.2 mg/p/d, respectively. 

Wrigley noted that these exposure 

estimates are conservative and assume 

that all of the iron present is 

bioavailable. We have no further 

questions regarding Wrigley’s exposure 

estimates for iron in food and cosmetics 

and conclude that the petitioner’s 

exposure estimates are sufficiently 

conservative to account for the use of 

iron oxides in ingested drugs (Ref. 2). 

We also conclude that exposure from 

indirect uses of iron oxides, such as for 

colorants for food-contact polymers 

authorized in 21 CFR 178.3297, would 

not significantly contribute to the 

overall exposure to iron oxides. 

To address the bioavailability of iron, 

Wrigley provided information showing 

approximately 18 percent of iron from 

conventional foods and dietary 

supplements is bioavailable, and that 

about 1 percent of iron from synthetic 

iron oxide is bioavailable. Based on this 

information, Wrigley provided exposure 

estimates that take into account the 

bioavailability of iron. Wrigley 

estimated the exposure to bioavailable 

iron from the proposed uses at the 90th 

percentile to be 0.16 mg/p/d, 0.12 mg/ 

p/d, 0.16 mg/p/d, and 0.16 mg/p/d for 

the U.S. population (2 years of age and 

older), children 2 to 5 years of age, 

children 2 to 13 years of age, and 

adolescents and adults 14 years of age 

and older, respectively. Wrigley 

estimated the cumulative exposure to 

bioavailable iron from all food sources 

(current and proposed) at the 90th 

percentile to be 6.02 mg/p/d, 4.68 mg/ 

p/d, 4.99 mg/p/d, and 6.21 mg/p/d for 

the U.S. population (2 years of age and 

older), children 2 to 5 years of age, 

children 2 to 13 years of age, and 

adolescents and adults 14 years of age 

and older, respectively. For females 10 

to 13 years old, and 14 years of age and 

older, Wrigley estimated exposure to 

bioavailable iron from all food sources 

(current and proposed) and lipstick to 

be 5.07 mg/p/d and 6.12 mg/p/d, 

respectively (Ref. 2). 

B. Acceptable Intake Level for Iron 

In 2000, the Standing Committee on 

the Scientific Evaluation of Dietary 

Reference Intakes of the Food and 

Nutrition Board at the IOM conducted 

an extensive review of relevant 

published scientific literature to 

determine dietary reference intakes and 

ULs for iron. The IOM published a 

detailed report that included a UL for 

iron of 40 mg/d for children (2 to 5 years 

of age and 2 to 13 years of age), and a 

UL of 45 mg/d for adolescents and 

adults (14 years of age and older) (Ref. 

3). 

The IOM considers the UL as the 

highest daily intake level of a nutrient 

that poses no risk of adverse effects 

when the nutrient is consumed over 

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Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 14841 

long periods of time. The UL is 

determined using a risk assessment 

model developed specifically for 

nutrients and, generally speaking, may 

consider intake from such sources as 

food, water, nutrient supplements, and 

pharmacological agents. The doseresponse 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 an uncertainty factor. 

We considered the ULs established by 

the IOM relative to the intake estimates 

as the primary basis for assessing the 

safety of iron from the proposed uses of 

synthetic iron oxide. We also reviewed 

scientific articles on the safety of iron 

submitted by Wrigley, as well as other 

relevant published studies available to 

FDA. 

The exposure estimates to iron from 

all food sources, including the proposed 

use of synthetic iron oxide in soft and 

hard candy, mints, and chewing gum, at 

the 90th percentile for children 2 to 5 

years of age and for children 2 to 13 

years of age, without taking into account 

the bioavailability of the iron, is 31.2 

mg/p/d and 34.6 mg/p/d, respectively. 

Both of these exposure estimates are 

below the UL for these age groups. The 

exposure estimate to iron from all food 

sources (current and proposed) and 

lipstick for females 10 to 13 years old 

at the 90th percentile of 33.8 mg/p/d is 

also below the UL established for this 

group. For adolescents and adults 14 

years of age and older, the exposure 

estimate for iron at the 90th percentile 

of 41.5 mg/p/d is below the UL of 45 

mg/p/d for adolescents 14 to 18 years of 

age. Similarly, the exposure estimate to 

iron from all food sources and lipstick 

for females 14 years of age and older of 

40.2 mg/p/d at the 90th percentile is 

below the UL of 45 mg/p/d for 

adolescents and adults (14 years of age 

and older). Because the EDI of iron from 

all current and proposed food sources at 

the 90th percentile for each population 

group, which was estimated using 

conservative assumptions, is below the 

corresponding IOM UL for that 

population group, even without taking 

into account the low bioavailability of 

the iron from the petitioned uses, we 

conclude that there is a reasonable 

certainty of no harm from the proposed 

use of synthetic iron oxide as a color 

additive in soft and hard candy, mints, 

and chewing gum (Ref. 4). 

C. Lead Specification 

As discussed in section I, the 

petitioner proposed to lower the 

specification limit for lead in synthetic 

iron oxide for human food use in 21 

CFR 73.200 from 10 mg/kg to 5 mg/kg. 

To support the lower lead specification, 

the petitioner submitted data on lead 

levels from batch analyses of synthetic 

iron oxide. The data demonstrates that 

the proposed lead limit of 5 ppm is 

achievable with the use of good 

manufacturing practices in the 

production of the color additive (Ref. 5). 

Because the lower specification limit is 

achievable, and also because the lower 

specification limit is consistent with the 

safe use of the color additive, we are 

lowering the lead specification limit for 

lead in synthetic iron oxide for human 

food as proposed. The lower 

specification applies to both the 

petitioned new use of synthetic iron 

oxide to color candy, chewing gum, and 

mints, as well as to the alreadyapproved use of synthetic iron oxide for 

human food use in the coloring of 

sausage casings. 

V. Conclusion 

Based on the data and information in 

the petition and other relevant material, 

we conclude that the petitioned use of 

synthetic iron oxide in soft and hard 

candy, mints, and chewing gum is safe. 

We further conclude that the additive 

will achieve its intended technical effect 

and is suitable for the petitioned use. 

Consequently, we are amending the 

color additive regulations in 21 CFR 

part 73 as set forth in this document. In 

addition, based upon the factors listed 

in 21 CFR 71.20(b), we conclude that 

batch certification of synthetic iron 

oxide is not necessary for the protection 

of public health. 

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. Environmental Impact 

We previously considered the 

environmental effects of this rule as 

stated in the September 17, 2013, notice 

of filing for CAP 3C0298 (78 FR 57105). 

We stated that we had determined, 

under 21 CFR 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 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, 

the Food and Drug Administration 

Amendments Act of 2007, which was 

signed into law on September 27, 2007, 

amended the FD&C Act to, among other 

things, add section 301(ll) of the FD&C 

Act (21 U.S.C. 331(ll)). Section 301(ll) of 

the FD&C Act 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 

products containing this color additive. 

Accordingly, this final rule should not 

be construed to be a statement that a 

product 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 Division of Dockets 

Management (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 to which you object and the 

grounds for your objection. Within each 

numbered objection, you must 

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14842 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 

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. 

It is only necessary to send one set of 

documents. Identify documents with the 

docket number found in brackets in the 

heading of this document. Any 

objections received in response to the 

regulation may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

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 have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses in this reference 

section, but FDA is not responsible for 

any subsequent changes to Web sites 

after this document publishes in the 

Federal Register.) 

1. Memorandum to the File from A. Zajac, 

Division of Petition Review, February 27, 

2015. 

2. Memorandum from D. Doell, Chemistry 

Review Group, Division of Petition 

Review, to L. Dye, Regulatory Group II, 

Division of Petition Review, June 20, 

2014. 

3. Institute of Medicine. Dietary Reference 

Intakes for Vitamin A, Vitamin K, 

Arsenic, Boron, Chromium, Copper, 

Iodine, Iron, Manganese, Molybdenum, 

Nickel, Silicon, Vanadium, and Zinc. 

Washington, DC: The National 

Academies Press, 2001. 

4. Memorandum from S. Thurmond, 

Toxicology Team, Division of Petition 

Review, to L. Dye, Regulatory Group II, 

Division of Petition Review, September 

9, 2014. 

5. Memorandum from N. Hepp, Color 

Technology Team, Office of Cosmetics 

and Colors, to L. Dye, Division of 

Petition Review, September 23, 2013. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

and 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 21 CFR 

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 73.200 is amended by 

revising paragraphs (b)(1) and (c)(1) to 

read as follows: 

§ 73.200 Synthetic iron oxide. 

* * * * * 

(b) * * * 

(1) Synthetic iron oxide for human 

food use shall conform to the following 

specifications: 

Arsenic (as As), not more than 3 

milligrams per kilogram (mg/kg) (3 parts 

per million (ppm)). 

Lead (as Pb), not more than 5 mg/kg 

(5 ppm). 

Mercury (as Hg), not more than 1 mg/ 

kg (1 ppm). 

* * * * * 

(c) * * * 

(1) Synthetic iron oxide may be safely 

used for human food use subject to the 

following restrictions: 

(i) In sausage casings intended for 

human consumption in an amount not 

exceeding 0.10 percent by weight of the 

finished food. 

(ii) In soft and hard candy, mints, and 

chewing gum at levels consistent with 

good manufacturing practice, except 

that it may not be used to color foods 

for which standards of identity have 

been issued under section 401 of the 

Federal Food, Drug, and Cosmetic Act, 

unless the use of the added color is 

authorized by such standards. 

* * * * * 

Dated: March 17, 2015. 

Susan M. Bernard, 

Director, Office of Regulations, Policy and 

Social Sciences, Center for Food Safety and 

Applied Nutrition. 

[FR Doc. 2015–06418 Filed 3–19–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–406] 

Substances Temporarily Controlled 

Under Schedule I of the Controlled 

Substances Act 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: This final rule makes 

technical and conforming amendments 

to the Drug Enforcement Administration 

regulations listing substances 

temporarily controlled under schedule I 

of the Controlled Substances Act. This 

final rule eliminates references to 7 

substances that were previously subject 

to temporary control, but which have 

since been permanently controlled 

under schedule I, and redesignates 23 

other substances that are currently 

temporarily controlled under schedule I. 

This action makes no substantive 

changes to the affected regulation. 

DATES: This rule is effective March 20, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, and are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), chapter II. The CSA 

and its implementing regulations are 

designed to prevent, detect, and 

eliminate the diversion of controlled 

substances and listed chemicals into the 

illicit market while providing for the 

legitimate medical, scientific, research, 

and industrial needs of the United 

States. Controlled substances have the 

potential for abuse and dependence and 

are controlled to protect the public 

health and safety. 

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