26356 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 

1The original petition did not specify that the 

color additive is to be used in sutures that are nonabsorbable. Therefore, our March 6, 2017, notice of 

filing did not specify that the color additive is 

intended for use in non-absorbable sutures. 

However, petitioner’s subsequent submissions to 

FDA indicated that the intended use of the additive 

is for sutures that are non-absorbable. 

Dated: June 1, 2018. 

Pamela M. Bush, 

Commission Secretary. 

[FR Doc. 2018–12258 Filed 6–6–18; 8:45 am] 

BILLING CODE 6360–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 74 

[Docket No. FDA–2017–C–0935] 

Listing of Color Additives Subject to 

Certification; D&C Black No. 4 

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 D&C Black 

No. 4 for coloring ultra-high molecular 

weight polyethylene (UHMWPE) nonabsorbable sutures for use in general 

surgery. This action is in response to a 

color additive petition (CAP) submitted 

by DSM Biomedical. 

DATES: This rule is effective July 10, 

2018. See section VIII for further 

information on the filing of objections. 

Submit either electronic or written 

objections and requests for a hearing on 

the final rule by July 9, 2018. 

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 July 9, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of July 

9, 2018. 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– 

2017–C–0935 for ‘‘Listing of Color 

Additives Subject to Certification; D&C 

Black No. 4.’’ 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. 

• 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: 

Joseph M. Thomas, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740–3835, 301–796–9465. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register on March 6, 

2017 (82 FR 12531), we announced that 

we filed a color additive petition (CAP 

7C0310) submitted by DSM Biomedical 

(petitioner), 735 Pennsylvania Dr., 

Exton, PA 19341. The petition proposed 

to amend the color additive regulations 

in part 73 (21 CFR part 73), Listing of 

Color Additives Exempt from 

Certification, to provide for the safe use 

of high-purity carbon black for coloring 

UHMWPE non-absorbable sutures for 

use in general surgery.1 After the 

petition was filed and during our 

review, we determined that the color 

additive will require batch certification 

by FDA. We intend to give each certified 

batch of the subject color additive the 

name D&C Black No. 4. Therefore, this 

color additive will be identified as D&C 

Black No. 4 and will be listed in part 74 

(21 CFR part 74), Listing of Color 

Additives Subject to Certification. 

II. Identity and Specifications 

D&C Black No. 4 is a high-purity 

carbon black prepared by the oil furnace 

process. It is manufactured by injecting 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 26357 

a heated aromatic petroleum feedstock 

into the combustion zone of a natural 

gas-fired furnace to produce carbon 

black. The reaction is quenched with 

water and the carbon particles are 

further cooled and separated by a filter. 

The recovered high-purity carbon black 

is dried and pelletized to produce the 

final D&C Black No. 4 commercial 

product, consisting of aggregated 

particles with a surface area ranging 

from 50 to 260 meters squared per gram 

(m2/g). D&C Black No. 4 is mechanically 

mixed at a maximum level of 1 percent 

by weight with the UHMWPE suture 

raw materials to form a homogenous 

suspension, absent of chemical reaction 

between components, and extruded to 

form black colored sutures. 

As explained in section III, the color 

additive D&C Black No. 4 may contain 

low levels of potentially carcinogenic 

polycyclic aromatic hydrocarbon (PAH) 

contaminants. To limit the amounts of 

these contaminants in the color 

additive, FDA is setting specifications 

for total PAHs, as well as for the 

individual PAH species benzo[a]pyrene 

(B[a]P) and dibenz[a,h]anthracene. 

These specifications are consistent with 

specifications for other high-purity 

carbon blacks approved by FDA, 

including the color additive D&C Black 

No. 2 (§ 74.2052 (21 CFR 74.2052)), 

which is approved for use in certain 

cosmetics, including cosmetics for use 

in the area of the eye (i.e., eyeliner, 

brush-on-brow, eye shadow, mascara), 

and high-purity furnace black, which is 

approved for use in food-contact 

polymers (§ 178.3297 (21 CFR 

178.3297)). These specifications are also 

supported by the safety information 

reviewed as a part of this petition (see 

section III). In addition, to ensure 

compliance with these specifications, 

FDA is requiring that D&C Black No. 4 

for use in UHMWPE non-absorbable 

sutures be from a batch of the color 

additive certified by FDA. 

The identity for D&C Black No. 4 is 

the same as D&C Black No. 2, except for 

the surface area. For D&C Black No. 2, 

we set specifications for arsenic, lead, 

and mercury, total color (as carbon), 

total sulfur, ash content, surface area, 

and weight loss on heating, in addition 

to the specifications for total PAHs, 

benzo[a]pyrene (B[a]P), and 

dibenz[a,h]anthracene. We are setting 

the same specifications that were 

established for D&C Black No. 2 for D&C 

Black No. 4 for these parameters with 

the exception of surface area 

specification, which is broader for D&C 

Black No. 4. 

III. Safety Evaluation 

A. Determination of Safety 

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 cannot be listed for a particular 

use unless a fair evaluation of the data 

and information available to FDA 

establish that the color additive is safe 

under the intended conditions of use. 

Furthermore, under 21 CFR 70.5(c), a 

color additive intended for use in a 

surgical suture must have a listing 

specifically providing for this 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. 

Section 721(b)(5)(B)(ii) of the FD&C 

Act provides that for any use of a color 

additive that will not result in ingestion 

of any part of such additive, the color 

additive shall be deemed to be unsafe 

and shall not be listed if, after tests that 

are appropriate for the evaluation of the 

safety of additives for such use, or after 

other relevant exposure of man or 

animal to such additive, it is found to 

induce cancer in man or animal. 

Importantly, however, section 

721(b)(5)(B) of the FD&C Act applies to 

the additive itself and not to impurities 

in the additive. That is, where an 

additive itself has not been shown to 

cause cancer, but contains a 

carcinogenic impurity, the additive is 

properly evaluated under the general 

safety standard using risk assessment 

procedures to determine whether there 

is a reasonable certainty that no harm 

will result from the intended use of the 

additive (Scott v. FDA, 728 F.2d 322 

(6th Cir. 1984)). 

B. Safety of the Petitioned Use of D&C 

Black No. 4 

In evaluating the safety of a color 

additive, FDA customarily reviews the 

available data on each relevant chemical 

impurity to determine whether the 

chemical induces tumors in animals or 

humans. If FDA concludes that the 

chemical impurity causes cancer in 

animals or humans, the Agency 

calculates the unit cancer risk for the 

chemical and the upper bound limit of 

lifetime human cancer risk from the 

chemical’s presence in the additive. To 

establish with reasonable certainty that 

D&C Black No. 4 intended to color 

UHMWPE non-absorbable sutures is not 

harmful under the intended conditions 

of use, we have considered the exposure 

to the color additive and its impurities, 

the additive’s toxicological data, and 

other relevant information (such as 

published literature) available to us. 

The petitioner incorporated safety 

information that was previously 

submitted to FDA on behalf of Cabot 

Corp. in Food Additive Petition 5B4464 

by reference to support the safety of 

high-purity furnace black as a colorant 

for polymers in food-contact 

applications. D&C Black No. 4 is 

manufactured in the same manner as the 

referenced high-purity furnace black. 

The petitioner also submitted data 

from an extraction study testing the 

migration of D&C Black No. 4 from 

UHMWPE sutures and provided data 

from two studies demonstrating 

biocompatibility of UHMWPE sutures 

along with other information. The 

petitioner’s data from the extraction 

study indicated that D&C Black No. 4, 

when added to UHMWPE nonabsorbable sutures at the maximum 

level of 1 percent, remains physically 

embedded in the suture matrix resulting 

in the color additive not being detected 

in the extracts at the limit of 

quantitation. This study evaluated the 

amount of non-volatile residue (NVR) 

and any extractables that could migrate 

from the suture. The study was 

performed with water, hexane, and 

ethanol at 50 °C for 24 hours and 

demonstrated that D&C Black No. 4 does 

not migrate from the suture following 

exposure to solvents with varying 

polarities and exposure to heat. The 

study also yielded NVRs not able to be 

analyzed. To estimate potential 

exposure from D&C Black No. 4, the 

petitioner used data from the extraction 

study and the conservative assumption 

that all of the NVR that was extracted 

and not able to be analyzed was D&C 

Black No. 4. The petitioner derived an 

estimate for the mass amount of D&C 

Black No. 4 expected to migrate over a 

lifetime, expressed as the mean daily 

exposure, based on its proposed use 

level in surgical sutures, and using data 

for the maximum NVR extracted and the 

surface area of the tested sutures. 

While FDA agrees with using the 

conservative assumption that all NVR 

extracted was D&C Black No. 4, the 

petitioner’s exposure estimate 

represents the scenario where D&C 

Black No. 4 would migrate from the 

sutures 1 day post-implantation. 

However, since non-absorbable sutures 

are intended to be left in the body 

indefinitely post-implantation, it is 

necessary to average the petitioner’s 

exposure estimate over an individual’s 

lifetime post-implantation (assumed to 

be 70 years) to estimate the lifetime 

average exposure to D&C Black No. 4. In 

this manner, we estimated the lifetime 

average exposure to D&C Black No. 4 to 


sradovich on DSK3GMQ082PROD with RULES
26358 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 

be 15.3 nanograms per person per day 

(ng/p/d). However, as carbon black is 

known to be thermally stable, inert, and 

insoluble in water and common 

solvents, we agree with the petitioner’s 

conclusion that D&C Black No. 4 is 

firmly embedded and does not migrate 

from the suture matrix, resulting in no 

potential exposure to D&C Black No. 4 

from sutures that are in contact with the 

body (Ref. 1). 

As discussed in section II, D&C Black 

No. 4 has been shown to contain low 

levels of PAH impurities, some of which 

are carcinogenic. We have previously 

considered the safe use of high-purity 

carbon black as a color additive in 

cosmetics (D&C Black No. 2; § 74.2052) 

and as a colorant in food-contact 

polymers (high-purity furnace black; 

§ 178.3297) and set limits for PAHs in 

these high-purity carbon blacks to 

minimize exposure. We are setting 

similar limits for PAHs in D&C Black 

No. 4 as those established for D&C Black 

No. 2: Total PAHs (not more than 0.5 

milligrams per kilogram (mg/kg) (500 

parts per billion)); B[a]P (not more than 

0.005 mg/kg (5 parts per billion)); and 

dibenz[a,h]anthracene (not more than 

0.005 mg/kg (5 parts per billion)). 

There were no detectable PAHs at the 

limit of quantitation resulting from the 

petitioner’s extraction study. The 

petitioner stated that the trace levels of 

PAHs in the color additive, as limited 

by specifications, are strongly bound to 

the surface of D&C Black No. 4 carbon 

particles due to the powerful adsorption 

capabilities of the color additive. FDA 

concurs that any PAH impurities are not 

expected to migrate under the proposed 

specifications and conditions of use 

(Ref. 1). In calculating the lifetime 

average exposure to PAHs from the use 

of D&C Black No. 4 in sutures, we used 

the conservative assumption that total 

PAHs, B[a]P, and dibenz[a,h]anthracene 

are present in the color additive at their 

specification limits. These assumptions, 

along with the assumption that all NVR 

extracted from the sutures is D&C Black 

No. 4, calculated over a 70-year lifespan, 

results in a conservative estimated 

lifetime average exposure of total PAHs 

of 7.7 × 10¥6 ng/p/d, B[a]P of 7.7 × 10¥8

ng/p/d, and dibenz[a,h]anthracene of 

7.7 × 10¥8 ng/p/d (Ref. 1). 

Current data have shown B[a]P to be 

a high contributor to the total 

carcinogenic potential for the PAH 

family (Ref. 2). To assess the risk from 

exposure to PAHs, FDA has used a 

worst-case assumption that all PAHs are 

present in D&C Black No. 4 as B[a]P. We 

used data from a carcinogenesis 

bioassay on B[a]P, conducted by H. 

Brune, et al., to estimate the upperbound limit of lifetime human risk from 

exposure to B[a]P equivalents resulting 

from the petitioned use of the color 

additive (Ref. 3). The authors reported 

treatment-related benign forestomach 

tumors or esophageal tumors in male 

rats exposed to B[a]P. Using a linear-atlow-dose extrapolation method and 

tumor incidence data from the H. Brune, 

et al. study, we estimated the unit 

cancer risk (UCR) for B[a]P to be 1.75 

(milligrams per kilogram bodyweight 

per day (mg/kg bw/day))¥1 (Ref. 4). The 

UCR represents the derived cancer risk 

calculated per unit dose of the additive. 

This same UCR was used to assess the 

risk from exposure to PAHs for D&C 

Black No. 2 (69 FR 44927, July 28, 2004) 

and high-purity furnace black (Ref. 5). 

The lifetime cancer risk (LCR) was 

calculated by multiplying the UCR for 

B[a]P by the estimated lifetime average 

exposures. This results in LCRs of 2.24 

× 10¥15 and 2.24 × 10¥13 for B[a]P and 

total PAHs, respectively. Because of the 

conservative assumptions we used to 

calculate the exposure estimate and the 

carcinogenic potency of PAHs in the 

color additive, and the fact that PAHs 

bind tightly to carbon black and are not 

expected to migrate, the lifetimeaveraged individual exposure to PAHs 

is likely to be substantially less than our 

worst-case exposure estimate. Thus, the 

probable lifetime human risk would be 

less than the estimated LCR. Therefore, 

we conclude that there is reasonable 

certainty that no harm from exposure to 

PAHs will result from the petitioned use 

of the additive (Refs. 1 and 3). 

IV. Conclusion 

Based on the data and information in 

the petition and other available relevant 

material, FDA concludes that the 

petitioned use of D&C Black No. 4 for 

coloring UHMWPE non-absorbable 

sutures for use in general surgery is safe. 

We further conclude that the additive 

will achieve its intended technical effect 

and is suitable for the petitioned uses. 

Based on the available information, we 

are amending the color additive 

regulations in part 74 as set forth in this 

document. In addition, in accordance 

with 21 CFR 71.20(b), we conclude that 

batch certification of D&C Black No. 4 

is necessary for the protection of public 

health because of the need to limit the 

levels of PAHs, some of which have 

been shown to be carcinogenic. 

Therefore, part 74 should be amended 

as set forth in this document. 

V. 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. 

VI. Analysis of Environmental Impact 

We previously considered the 

environmental effects of this rule, as 

stated in the notice of petition 

published in the Federal Register of 

March 6, 2017. We stated that we had 

determined, under 21 CFR 25.32(l), 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. 

VII. 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. 

VIII. 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 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations 26359 

have received or lack thereof in the 

Federal Register. 

IX. 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 H. Lee, Division of 

Petition Review, Office of Food Additive 

Safety (OFAS), CFSAN, FDA to J. 

Thomas, Division of Petition Review, 

OFAS, CFSAN, FDA, dated April 27, 

2018. 

2. Choi H, R. Harrison, H. Komulainen, et al., 

‘‘Polycyclic Aromatic Hydrocarbons.’’ 

WHO Guidelines for Indoor Air Quality: 

Selected Pollutants. Geneva: World 

Health Organization; 2010. 

3. Brune H., R. P. Deutsch-Wenzel, M. Habs, 

et al., ‘‘Investigation of the Tumorigenic 

Response to Benzo(a)pyrene in Aqueous 

Caffeine Solution Applied Orally to 

Sprague-Dawley Rats,’’ Journal of Cancer 

Research and Clinical Oncology, 

102(2):153–157, 1981. 

4. Memorandum from N. Anyangwe, Division 

of Petition Review, OFAS, CFSAN, FDA 

to J. Thomas, Division of Petition 

Review, OFAS, CFSAN, FDA, dated 

April 27, 2018. 

5. Memorandum from the Indirect Additives 

Branch, FDA, to the Executive Secretary, 

Quantitative Risk Assessment 

Committee, FDA, concerning 

‘‘Estimation of the Upper-bound Lifetime 

Risk from Polynuclear Aromatic 

Hydrocarbons (PAH’s) in High-Purity 

Furnace Black (HPFB): subject of Food 

Additive Petition No. 5B4464 (Cabot 

Corp.),’’ dated May 9, 1996. 

List of Subjects in 21 CFR Part 74 

Color additives, Cosmetics, Drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 74 is 

amended as follows: 

PART 74—LISTING OF COLOR 

ADDITIVES SUBJECT TO 

CERTIFICATION 

■ 1. The authority citation for part 74 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

■ 2. Section 74.3054 is added to subpart 

D to read as follows: 

§ 74.3054 D&C Black No. 4. 

(a) Identity. The color additive D&C 

Black No. 4 is a high-purity carbon 

black prepared by the oil furnace 

process. It is manufactured by the 

combustion of aromatic petroleum oil 

feedstock and consists essentially of 

pure carbon, formed as aggregated fine 

particles with a surface area range of 50 

to 260 meters (m)2/gram. 

(b) Specifications. D&C Black No. 4 

must conform to the following 

specifications and must be free from 

impurities other than those named to 

the extent that such other impurities 

may be avoided by good manufacturing 

practice: 

(1) Surface area by nitrogen BET 

(Brunauer, Emmett, Teller) method, 50 

to 260 m2/gram. 

(2) Weight loss on heating at 950 °C 

for 7 minutes (predried for 1 hour at 125 

°C), not more than 2 percent. 

(3) Ash content, not more than 0.15 

percent. 

(4) Arsenic (total), not more than 3 

milligrams per kilogram (mg/kg) (3 parts 

per million). 

(5) Lead (total), not more than 10 mg/ 

kg (10 parts per million). 

(6) Mercury (total), not more than 1 

mg/kg (1 part per million). 

(7) Total sulfur, not more than 0.65 

percent. 

(8) Total polycyclic aromatic 

hydrocarbons (PAHs), not more than 0.5 

mg/kg (500 parts per billion). 

(9) Benzo[a]pyrene, not more than 

0.005 mg/kg (5 parts per billion). 

(10) Dibenz[a,h]anthracene, not more 

than 0.005 mg/kg (5 parts per billion). 

(11) Total color (as carbon), not less 

than 95 percent. 

(c) Uses and restrictions. (1) D&C 

Black No. 4 may be safely used at a level 

not to exceed 1.0 percent by weight of 

the suture material for coloring ultrahigh molecular weight polyethylene 

non-absorbable sutures for general 

surgical use. 

(2) Authorization and compliance 

with this use must not be construed as 

waiving any of the requirements of 

sections 510(k), 515, and 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

with respect to the ultra-high molecular 

weight polyethylene surgical sutures in 

which D&C Black No. 4 is used. 

(d) Labeling. The label of the color 

additive must conform to the 

requirements of § 70.25 of this chapter. 

(e) Certification. All batches of D&C 

Black No. 4 must be certified in 

accordance with regulations in part 80 

of this chapter. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12218 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 1, 8, 16, and 40 

[Docket No. FR–6102–F–01] 

RIN 2501–AD88 

Removal of Cross References to 

Previously Removed Appendices and 

Subpart 

AGENCY: Office of General Counsel, 

HUD. 

ACTION: Final rule. 

SUMMARY: This final rule corrects HUD’s 

regulations by removing cross references 

to appendices and a subpart that were 

removed by earlier rulemakings. In 

1995, HUD removed several appendices 

throughout HUD’s regulations deemed 

unnecessary or obsolete. In 1996, HUD 

consolidated its hearing procedures for 

nondiscrimination and equal 

opportunity matters in a new CFR part 

and removed the subpart of another. 

Cross-references to the removed 

appendices and subpart were not 

removed, however. This final rule 

corrects HUD’s regulations by removing 

cross references to these nonexistent 

appendices and subpart. 

DATES: Effective July 9, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Ariel Pereira, Associate General 

Counsel, Office of Legislation and 

Regulations, Department of Housing and 

Urban Development, 451 7th Street SW, 

Room 10282, Washington, DC 20410; 

telephone number 202–402–5138 (this 

is not a toll-free number). Persons with 

hearing or speech impairments may 

access this number through TTY by 

calling the Federal Relay Service at 800– 

877–8339 (this is a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 11, 1995 (60 FR 47260), 

HUD published a final rule entitled, 

‘‘Elimination of Obsolete Parts’’ which 

removed from 24 CFR several 

appendices deemed obsolete and 

unnecessary. HUD undertook the 

regulation consistent with the 

‘‘Regulatory Reinvention Initiative,’’ 

which required federal agencies to 

eliminate outdated regulations and 

modify others to reduce regulatory 

burden. Among the provisions removed 

were appendix A in 24 CFR part 1, 

appendices A and B in 24 CFR part 8, 

appendix A in 24 CFR part 16, and 

appendix A in 24 CFR part 40. 

On October 4, 1996 (61 FR 52216), 

HUD published a final rule entitled, 

‘‘Consolidated HUD Hearing Procedures 

for Civil Rights Matters,’’ which revised 


sradovich on DSK3GMQ082PROD with RULES