Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 57293 

(3) A battery failure sensing and 

warning system with a means for 

automatically disconnecting the battery 

from its charging source in the event of 

battery failure. 

h. Any Li-ion battery installation 

whose function is required for safe 

operation of the airplane, must 

incorporate a monitoring and warning 

feature that will provide an indication 

to the appropriate flightcrew members 

whenever the capacity and State of 

Charge (SOC) of the batteries have fallen 

below levels considered acceptable for 

dispatch of the airplane. 

i. The Instructions for Continued 

Airworthiness (ICA) must contain 

recommended manufacturers 

maintenance and inspection 

requirements to ensure that batteries, 

including single cells, meet a safety 

function level essential to the aircraft’s 

continued airworthiness. 

(1) The ICA must contain operating 

instructions and equipment limitations 

in an installation maintenance manual. 

(2) The ICA must contain installation 

procedures and limitations in a 

maintenance manual, sufficient to 

ensure that cells or batteries, when 

installed according to the installation 

procedures, still meet safety functional 

levels essential to the aircraft’s 

continued airworthiness. The 

limitations must identify any unique 

aspects of the installation. 

(3) The ICA must contain corrective 

maintenance procedures to check 

battery capacity at manufacturers 

recommended inspection intervals. 

(4) The ICA must contain scheduled 

servicing information to replace 

batteries at manufacturers 

recommended replacement time. 

(5) The ICA must contain 

maintenance and inspection 

requirements to check visually for 

battery and/or charger degradation. 

j. Batteries in a rotating stock (spares) 

that have experienced degraded charge 

retention capability or other damage due 

to prolonged storage must be 

functionally checked at manufacturers 

recommended inspection intervals. 

k. The System Safety Assessment 

(SSA) process should address the 

software and complex hardware levels 

for the sensing, monitoring, and 

warning systems if these systems 

contain complex devices. The 

functional hazard assessment (FHA) for 

the system is required based on the 

intended functions described. The 

criticality of the specific functions will 

be determined by the safety assessment 

process for compliance with § 23.1309. 

Advisory Circular 23–1309–1C contains 

acceptable means for accomplishing this 

requirement. For determining the failure 

condition, the criticality of a function 

will include the mitigating factors. The 

failure conditions must address the loss 

of function and improper operations. 

Issued in Kansas City, Missouri, on 

September 14, 2015. 

Mel Johnson, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2015–24164 Filed 9–22–15; 8:45 am] 

BILLING CODE 4910–13–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2011–0489; FRL 9927–44] 

RIN 2070–AJ88 

Significant New Use Rule for 

Hexabromocyclododecane and 

1,2,5,6,9,10-Hexabromocyclododecane 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is promulgating a 

significant new use rule (SNUR) under 

the Toxic Substances Control Act 

(TSCA) for two chemical substances 

collectively referred to as ‘‘HBCD.’’ This 

action requires persons who intend to 

manufacture (including import) or 

process hexabromocyclododecane or 

1,2,5,6,9,10-hexabromocyclododecane 

(HBCD) for use in consumer textiles 

(other than for use in motor vehicles) to 

notify EPA at least 90 days before 

commencing that activity. The required 

notification will provide EPA with the 

opportunity to evaluate the intended 

use and, if appropriate, to prohibit or 

limit that activity before it occurs. In 

this SNUR, the exemption for persons 

importing or processing a chemical 

substance as part of an article does not 

apply to importers and processors of 

HBCD as part of a textile article (e.g., as 

part of a bolt of cloth or part of an 

upholstered chair). EPA is also making 

a technical amendment to the codified 

list of control numbers for approved 

information collection activities so that 

it includes the control number assigned 

by the Office of Management and 

Budget (OMB) to the information 

collection activities contained in this 

rule. 

DATES: This final rule is effective 

November 23, 2015. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0489, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), EPA 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPPT 

Docket is (202) 566–0280. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Sue 

Slotnick, National Program Chemicals 

Division (7404T), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 566–1973; 

email address: slotnick.sue@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import) or process 

hexabromocyclododecane (Chemical 

Abstracts Service Registry Number 

(CASRN) 25637-99-4) or 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194-55-6) for use in consumer textiles 

other than for use in motor vehicles. 

Throughout this final rule preamble, the 

term ‘‘HBCD’’ represents both chemical 

substances, unless a specific CASRN is 

also noted. The North American 

Industrial Classification System 

(NAICS) codes that are identified in this 

unit are not intended to be exhaustive, 

but rather provide a guide to help 

readers determine whether this rule 

applies to them. Potentially affected 

entities may include: 

• Chemical Manufacturing (NAICS 

code 325). 

• Painting and Wall Covering 

Contractors (NAICS code 238320). 

• Textile and Fabric Finishing (except 

Broadwoven Fabric) Mills (NAICS code 

313312). 

• Curtain and Drapery Mills (NAICS 

code 314121). 

• Other Household Textile Product 

Mills (NAICS code 314129). 

• All Other Miscellaneous Textile 

Product Mills (NAICS code 314999). 

• Upholstered Household Furniture 

Manufacturing (NAICS code 337121). 

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57294 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 

1As of August 16, 2011, the Inventory Update 

Rule (IUR) was renamed ‘‘Chemical Data Reporting 

rule (CDR).’’ See the TSCA Inventory Update 

Reporting Modifications; Chemical Data Reporting 

• Household Furniture (except Wood 

and Metal) Manufacturing (NAICS code 

337125). 

• Mattress Manufacturing (NAICS 

code 337910). 

• Blind and Shade Manufacturing 

(NAICS code 337920). 

• Furniture Merchant Wholesalers 

(NAICS code 423210). 

• Home Furnishing Merchant 

Wholesalers (NAICS code 423220). 

• Reupholstery and Furniture Repair 

(NAICS code 811420). 

If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

This action may affect importers and 

exporters of HBCD through pre-existing 

import certification and export 

notification rules under TSCA, 

regardless of the use of the HBCD. 

B. What is the Agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture or 

process the chemical substance for that 

use (15 U.S.C. 2604(a)(1)(B)). As 

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

C. What action is the Agency taking? 

This final rule designates use of 

HBCD in consumer textiles (other than 

for use in motor vehicles) as a 

significant new use. EPA has concluded 

that the only current use of HBCD for 

consumer textiles is in motor vehicles. 

That use and other current uses of 

HBCD (e.g., in non-consumer textiles 

and in building insulation) are not 

covered by this rule, not because EPA 

has determined that these uses are not 

‘‘significant,’’ but because they are 

ongoing and thus not ‘‘new uses.’’ 

This action requires persons who 

intend to manufacture or process HBCD 

as part of consumer textiles (other than 

for use in motor vehicles) to notify EPA 

at least 90 days before commencing that 

activity. The definition of ‘‘consumer 

textile’’ in this rule can include the 

following examples: bolts of cloth and 

draperies, as well as textiles that are 

part of household furniture and 

mattresses. The general provisions for 

SNURs include an exemption for 

persons who import or process chemical 

substances as part of an article (40 CFR 

721.45(f)). However, for this SNUR, EPA 

is making the exemption at 40 CFR 

721.45(f) inapplicable for importers or 

processors of HBCD as part of a textile 

article. Accordingly, importers and 

processors of HBCD as part of a textile 

article (whether or not it is a consumer 

textile) are subject to this SNUR. The 

term ‘‘textile article’’ is intended to be 

read in conjunction with the definition 

of ‘‘consumer textile’’ and includes bolts 

of cloth and draperies, as well as textiles 

that are part of upholstered household 

furniture and mattresses. EPA proposed 

the rule on March 26, 2012 (Ref. 1) and 

received seven public comments. The 

comments and EPA’s responses to them 

(Ref. 2) are in the public docket for this 

rule (EPA–HQ–OPPT–2011–0489) and 

are also summarized below in Unit X. 

The Agency is promulgating the 

SNUR as proposed with two exceptions. 

The first exception is the scope of the 

exemption for persons who import or 

process HBCD as part of an article. EPA 

had proposed to make the exemption at 

40 CFR 721.45(f) completely 

inapplicable in the HBCD SNUR, which 

would have meant that importers and 

processors of HBCD as part of any 

article would be subject to the rule. As 

stated above in this section, the final 

rule makes the exemption inapplicable 

only to importers and processors of 

HBCD as part of textile articles. The 

second change from the proposed rule is 

EPA’s clarification to the proposed 

definition of ‘‘consumer textile.’’ For 

further explanation of both changes, see 

Unit X. 

D. Why is the Agency taking this action? 

This SNUR is necessary to ensure that 

EPA receives timely advance notice of 

any future manufacturing and 

processing of HBCD for new uses that 

may produce changes in human and 

environmental exposures. The rationale 

and objectives for this SNUR are 

explained in Unit III. 

E. What are the estimated incremental 

impacts of this action? 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of the 

chemical substances included in this 

final rule. This analysis, which is 

available in the docket, is discussed in 

Unit IX., and is briefly summarized 

here. In the event that a SNUN is 

submitted, costs are estimated to be less 

than $8,600 per SNUN submission for 

large business submitters and $6,200 per 

SNUN submission for small business 

submitters. These estimates include the 

cost to prepare and submit the SNUN 

and the payment of a user fee. Persons 

that must submit a SNUN under this 

SNUR who are first-time submitters of 

any TSCA section 5 notice must register 

their company and key users with the 

Central Data Exchange reporting tool, 

deliver a CD electronic signature to 

EPA, and establish and use a Pay.gov Epayment account before they may 

submit a SNUN, for a cost of $200 per 

firm. However, these activities are only 

required of first-time submitters of 

section 5 notices. The rule may also 

affect firms that import or process 

articles that may contain HBCD, 

because, while not required by the 

SNUR, these parties may take additional 

steps to determine whether HBCD is 

part of the articles that they are 

considering to import or process. Since 

EPA is unable to predict whether 

anyone might engage in future activities 

that would require reporting, potential 

total costs were not estimated. In 

addition, for persons exporting a 

substance that is the subject of a SNUR, 

a one-time notice must be provided for 

the first export or intended export to a 

particular country, which is estimated 

to cost less than $80 on average per 

notification. 

II. Overview of the Chemical 

Substances Subject to This Rule 

A. What chemicals are included in the 

SNUR? 

This SNUR applies to two chemical 

substances: Hexabromocyclododecane 

(CASRN 25637-99-4) and 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194-55-6). Hexabromocyclododecane is 

manufactured by adding bromine to 

technical grade 1,5,9-cyclododecatriene 

to make a chemical substance where the 

positions of the six bromine atoms are 

not specified on the cyclododecane ring, 

corresponding to CASRN 25637-99-4. 

The specific 1,2,5,6,9,10- 

hexabromocyclododecane isomer 

(CASRN 3194-55-6) is the major 

component of CASRN 25637-99-4. 

B. What is the production volume of 

HBCD? 

The most recent production volume 

submitted to EPA for Chemical Data 

Reporting was in 2012 and was claimed 

as Confidential Business Information 

(CBI). Earlier Inventory Update Rule 

(IUR) 1 submissions to EPA reported 

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Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 57295 

final rule in the Federal Register issue of August 

16, 2011 (76 FR 50816). 

annual U.S. import/production volumes 

of 10–50 million pounds (lbs.) in 2002 

and 2006 for CASRN 3194-55-6 (Ref. 3). 

IUR submissions to EPA reported 

annual U.S. import/production volumes 

of 10,000 to 500,000 lbs. in 2002 for 

CASRN 25637-99-4; no import/

production was reported in 2006 (Ref. 

4). 

C. What are the uses of HBCD? 

The major use of HBCD is in 

polystyrene foam insulation boards used 

in construction. In the IUR data from 

2006, one manufacturer/importer of 

HBCD (CASRN 3194-55-6) reported the 

use of the chemical substance under the 

NAICS code for textile and fabric 

finishing mills. This use constituted less 

than 1 percent of the total production 

volume of the chemical substance. The 

reporting does not distinguish between 

commercial and consumer use (Ref. 4). 

However, as explained below, and in 

greater detail in the Economic Analysis 

for this rule, EPA concluded that HBCD 

is not used in consumer textiles (as 

defined by this regulation) other than 

for use in motor vehicles (Ref. 5). 

Information available to EPA 

indicates that the use of HBCD in 

textiles is as a coating to function as a 

flame retardant. EPA conducted 

research to determine whether HBCD 

was used in textile applications for end 

products sold to consumers. In 2010, an 

HBCD expert with the Consumer 

Product Safety Commission (CPSC) 

expressed to EPA his understanding that 

HBCD is used only in non-consumer 

textiles such as firefighters’ suits (Ref. 

6). In 2011, EPA requested information 

from current and former manufacturers 

of HBCD. The responses indicate that 

only one manufacturer sells HBCD for 

textile uses. The company does not 

know whether the end use of any of 

those textiles is a consumer article (Ref. 

7). Additionally, a representative of 

Herman Miller, a company which 

manufactures commercial and consumer 

furniture, told EPA that HBCD is not in 

its products (Ref. 8). 

EPA also received information from a 

group of textile formulators that the end 

uses of HBCD-containing textiles are for 

military, institutional, and aviation uses 

only (Ref. 9). EPA found that a small 

amount of HBCD is used in motor 

vehicles sold in the United States, 

including in floor mats, headliners, and 

possibly other interior fabrics. EPA 

received a public comment stating that 

although automakers are working 

towards ultimately phasing out the use 

of HBCD in consumer textiles in motor 

vehicles, there is concern about whether 

viable substitutes will be available. 

Thus, after considering the available 

information, EPA concludes that HBCD 

is not used in consumer textiles other 

than for use in motor vehicles. 

D. What are the potential health and 

environmental effects of HBCD? 

This section summarizes results of 

laboratory testing of 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194-55-6). The results are also valid for 

unspecified hexabromocyclododecane 

(CASRN 25637-99-4) and therefore 

relevant to both chemical substances in 

this rule. 

1. Human health effects. Animal 

studies give an indication of potential 

human health effects of HBCD. Repeated 

exposure of HBCD to rats showed 

disturbances in thyroid hormone system 

and effects on the thyroid in males and 

females (Ref. 10). A 2-generation 

reproductive toxicity study in rats 

exposed to HBCD showed a treatmentrelated reproductive effect (a significant 

decrease in the number of primordial 

follicles in the F1 females) (Ref. 11). 

Although this decrease in ovarian 

follicles did not affect any reproductive 

parameters in this study, this effect is 

suggestive of potential reproductive 

toxicity. Developmental effects were 

observed, including delays in eye 

opening in the second (F2) generation 

and transient changes in learning and 

memory in F1 males, but exposure did 

not cause any changes in spontaneous 

behavior. In addition, there was high 

and dose-dependent pup mortality 

during lactation (Ref. 11). 

2. Environmental effects. Laboratory 

studies have shown that HBCD is 

capable of producing adverse effects in 

a variety of organisms including algae, 

fish, invertebrates, and soil-dwelling 

organisms at environmentally relevant 

concentrations. HBCD is toxic to algae 

and acutely toxic to fish embryos (Ref. 

12), (Ref. 13). A number of sub-lethal 

effects (e.g., altered thyroid status, 

protein metabolism, oxidative stress, 

reproductive activity), have also been 

observed in fish (Ref. 14), (Ref. 15), (Ref. 

16), and (Ref. 17). One study reported a 

reduced number and size of daphnid 

offspring in first and second generations 

(Ref. 18). Thyroid hormone-dependent 

developmental effects were observed in 

tadpoles (Xenopus laevis) exposed to 

HBCD (Ref. 19). HBCD has been 

reported to reduce egg production and 

lower biomass in soil dwelling 

organisms (Lumbriculus variegatus) 

(Ref. 20). HBCD administered to chicken 

(Gallus domesticus) embryonic 

hepatocytes in vitro resulted in 

significant alterations in expression of 

genes (mRNA) associated with liver and 

thyroid function (Ref. 21). Thinner egg 

shells were measured in American 

kestrels exposed to a combination of 

polybrominated diphenyl ethers and 

HBCD (Ref. 22). 

E. What are the potential sources and 

routes of exposure to HBCD? 

There is potential for HBCD to be 

released at any point in the lifecycle of 

consumer textiles treated with HBCD. 

There is potential for release when the 

HBCD is being formulated into the 

textile coating, as well as when it is 

applied to the textile material. In 

addition, because HBCD is not 

chemically bound to its substrate (the 

protected textile material), HBCD can be 

released during the service life of the 

textile material containing it, including 

release into water used to wash the 

treated textiles or into the air via dust 

particulates. Workers and the general 

population can be exposed to HBCD 

through direct contact as it migrates 

across land, in air, and in water by 

diffusion or environmental transport. 

Other opportunities for release can 

occur at the end of the lifecycle of 

HBCD-treated textiles when they are 

transported and incinerated or 

landfilled (Ref. 23). Evidence strongly 

suggests there is potential for exposure 

to the general population from HBCD in 

the environment and also from products 

and dust in the home and workplace. 

HBCD is found worldwide in the 

environment and wildlife (Note: Only 

the specific 1,2,5,6,9,10- 

hexabromocyclododecane isomer 

(CASRN 3194–55–6) or the alpha, beta, 

and gamma isomers are monitored in 

biota and the environment, not the 

unspecified hexabromocyclododecane 

(CASRN 25637–99–4)). Human 

exposure is evidenced from its presence 

in breast milk, adipose tissue, and blood 

(Ref. 24). The chemical substances 

bioaccumulate and biomagnify in food 

chains. The frequent detection of HBCD 

over a large geographic area, with 

increasing exposure in remote locations 

such as the Arctic, where no 

demonstrable local sources exist that 

can account for these exposures, suggest 

that HBCD is persistent and undergoes 

long-range transport (Ref. 25). 

To the extent HBCD is present in 

household applications (e.g., building 

foam, furniture upholstery, carpeting), 

children could be exposed, especially 

given children’s increased exposure to 

dust and the hand-to-mouth ingestion 

pathway. In vitro experiments 

conducted to demonstrate leaching of 

HBCD from textiles showed that the 

presence of simulated biological fluids 

(sweat, saliva) and fruit juices enhances 

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57296 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 

the leaching of HBCD from back-coated 

samples (Ref. 26). HBCD exposure 

values for children have been estimated 

from mouthing of textiles and from 

ingestion of dust (Ref. 27). 

HBCD has been measured in air and 

sediment in Scandinavian countries, 

North America and Asia (Ref. 24), (Ref. 

28). HBCD has also been measured in 

marine and Arctic mammals, freshwater 

and marine fish, aquatic invertebrates, 

birds and bird eggs, and one plant 

species (Ref. 24), (Ref. 28), and (Ref. 29). 

For more information on HBCD 

concerning its physical-chemical 

properties, fate, releases, and human 

and environmental exposure, see EPA’s 

HBCD Problem Formulation and Initial 

Assessment dated August 2015 (Ref. 30). 

III. Rationale and Objectives 

A. Rationale 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), EPA’s decision to issue a SNUR 

for a particular chemical use need not 

be based on an extensive evaluation of 

the hazard, exposure, or potential risk 

associated with that use. Rather, the 

Agency’s action is based on EPA’s 

determination that, if the use begins or 

resumes, it may present a risk that EPA 

should evaluate under TSCA before the 

manufacturing or processing for that use 

begins. Since the new use does not 

currently exist, deferring a detailed 

consideration of potential risks or 

hazards related to that use is an effective 

use of resources. If a person decides to 

begin manufacturing or processing the 

chemical for the use, the notice to EPA 

allows EPA to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use. 

As summarized in Units II.D., and 

II.E., EPA has concerns regarding the 

potential exposure to and human health 

and environmental effects of HBCD. 

EPA believes that, in the future, HBCD 

could be manufactured or processed for 

consumer textile uses (in addition to the 

current textiles in motor vehicles). 

Accordingly, EPA wants the 

opportunity to evaluate and control, 

where appropriate, activities associated 

with consumer textile use, if such 

manufacturing or processing were to 

commence in the future. The required 

notification provided by a SNUN will 

provide EPA with the opportunity to 

evaluate activities associated with the 

significant new use and an opportunity 

to protect against potential unreasonable 

risks, if any, from exposure to HBCD. 

B. Objectives 

Based on the considerations described 

in the proposal (Ref. 1), and in the 

response to public comments, EPA 

expects to achieve the following 

objectives with regard to the significant 

new use that is designated in this final 

rule: 

1. EPA will receive notification of any 

person’s intent to manufacture or 

process HBCD for the described 

significant new use before that activity 

begins; 

2. EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing 

HBCD for the described significant new 

use; and 

3. EPA will be able to regulate the 

prospective manufacturing or 

processing of HBCD before the 

described significant new use of the 

chemical substance(s) occurs, provided 

that regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6, or 7. 

IV. Significant New Use Determination 

As required by section 5(a)(2) of 

TSCA, EPA considered the four specific 

factors contained in that section along 

with other relevant factors in making its 

determination of the significant new use 

of HBCD for this rule. The first factor is 

the ‘‘projected volume of manufacturing 

and processing of a chemical substance’’ 

(TSCA section 5(a)(2)(A)). The potential 

increase in volume of this persistent, 

bioaccumulative and toxic chemical 

from consumer textile use weighs in 

favor of determining that consumer 

textile use (other than for use in motor 

vehicles) is a significant new use. The 

second factor is ‘‘the extent to which a 

use changes the type or form of 

exposure of human beings or the 

environment to a chemical substance’’ 

(TSCA section 5(a)(2)(B)). Human 

exposure to consumer textile use may 

differ from exposure to commercial 

textiles and other current uses. The 

third factor is ‘‘the extent to which a use 

increases the magnitude and duration of 

exposure of human beings or the 

environment to a chemical substance’’ 

(TSCA section 5(a)(2)(C)). Because 

HBCD is a persistent, bioaccumulative, 

and toxic chemical that has potential for 

long range transport (Ref. 1), even a 

small increase in the amount that is 

manufactured and processed, and thus 

subsequently used, would have a larger 

impact on potential exposures in terms 

of the number of people exposed and/ 

or the amount of exposure. The 

potential for exposure would last for 

longer periods of time over a significant 

area as compared to a chemical that is 

not persistent and bioaccumulative with 

the potential for long range transport. 

The fourth factor is ‘‘the reasonably 

anticipated manner and methods of 

manufacturing, processing, distribution 

in commerce, and disposal of a 

chemical substance’’ (TSCA section 

5(a)(2)(D)). Should a significant new use 

be planned, EPA anticipates that the 

new use would raise important 

questions such as what the impacts 

would be on consumer exposure, 

worker exposure, user exposure, or 

release of the substance to the 

environment, and what potential 

controls are available to limit such 

exposures and releases (see Unit II. E.). 

In addition to considering the four 

factors in section 5(a)(2) of TSCA, EPA 

considered relevant information about 

the toxicity of HBCD, and likely human 

exposures and environmental releases 

associated with possible uses (see Unit 

II.D. and II.E.). EPA has concluded that 

the factors taken together weigh in favor 

of determining that manufacture or 

processing of HBCD for any consumer 

textile use (other than for use in motor 

vehicles) would be a significant new use 

such that the Agency should have an 

opportunity to analyze the new use 

before such use (and potential 

exposures) occurs. Further explanation 

of EPA’s consideration of those factors 

is contained in the Response to 

Comments document (Ref. 2) in the 

docket for this rule (EPA–HQ–OPPT– 

2011–0489). 

V. Applicability of General Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, and exemptions to 

reporting requirements. 

Provisions relating to user fees appear 

at 40 CFR part 700, subpart C. 

Additional provisions governing SNUN 

submissions appear in 40 CFR part 720, 

which are the notice requirements and 

EPA regulatory procedures that 

submitters of Premanufacture Notices 

(PMNs) under TSCA section 5(a)(1)(A) 

must follow (see 40 CFR 721.1(c)). 

SNUR requirements also include the 

information submission requirements of 

TSCA sections 5(b) and 5(d)(1), and 

companies may wish to consider 

whether they are eligible for the 

exemptions authorized by TSCA 

sections 5(h)(1), (h)(2), (h)(3), and (h)(5). 

Once EPA receives a SNUN, EPA may 

take regulatory action under TSCA 

sections 5(e), 5(f), 6 or 7 to control the 

activities on which it has received the 

SNUN. If EPA does not take action, EPA 

is required under TSCA section 5(g) to 

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explain in a Federal Register notice its 

reasons for not taking action. 

Exemptions from SNUR requirements 

are found at 40 CFR 721.45. For this 

SNUR, 40 CFR 721.45(f), which exempts 

persons who import or process a 

chemical substance as part of an article, 

does not apply to importers and 

processors of HBCD as part of a textile, 

regardless of whether the textile is a 

consumer textile, as further explained in 

Unit X. 

Persons who export or intend to 

export a chemical substance identified 

in a proposed or final SNUR are subject 

to the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. Persons 

who import a chemical substance 

identified in a final SNUR are subject to 

the TSCA section 13 import certification 

requirements, codified at 19 CFR 12.118 

through 12.127 (see also 19 CFR 127.28). 

Those persons must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B (see 40 

CFR 721.20). The TSCA section 13 

import certification requirement applies 

to articles containing a chemical 

substance or mixture if so required by 

the Administrator by a specific rule 

under TSCA. At this time EPA is not 

requiring import certification for these 

chemical substances as part of articles. 

VI. Applicability of the Final Rule to 

Uses Occurring Before the Effective 

Date of the Final Rule 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376) (Ref. 

31), EPA has decided that the intent of 

TSCA section 5(a)(1)(B) is best served by 

designating a use as a significant new 

use as of the date of publication of the 

proposed rule rather than as of the 

effective date of the final rule. If uses 

begun after publication of the proposed 

rule were considered ongoing rather 

than new, it would be difficult for EPA 

to establish SNUR notification 

requirements, because a person could 

defeat the SNUR by initiating the 

proposed significant new use before the 

rule became final, and then argue that 

the use was ongoing as of the effective 

date of the final rule. Thus, persons who 

began commercial manufacture or 

processing of HBCD for a significant 

new use after the publication of the 

proposed rule must cease any such 

activity before the effective date of the 

final rule. To resume their activities, 

these persons must comply with all 

applicable SNUR notification 

requirements and wait until the 

notification review period, including all 

extensions, expires. EPA has 

promulgated provisions (40 CFR 

721.45(h)) to allow persons to comply 

with this SNUR before the effective 

date. If a person meets the conditions of 

advance compliance under 40 CFR 

721.45(h), that person is considered to 

have met the requirements of the final 

SNUR for those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. There are two exceptions: (1) 

Development of test data is required 

where the chemical substance subject to 

the SNUR is also subject to a test rule 

under TSCA section 4 (see TSCA 

section 5(b)(1)); and (2) development of 

test data may be necessary where the 

chemical substance has been listed 

under TSCA section 5(b)(4) (see TSCA 

section 5(b)(2)). In the absence of a 

TSCA section 4 test rule or a TSCA 

section 5(b)(4) listing covering the 

chemical substance, persons are 

required only to submit test data in their 

possession or control and to describe 

any other data known to or reasonably 

ascertainable by them (15 U.S.C. 

2604(d); 40 CFR 720.50 and 40 CFR 

721.25). However, as a general matter, 

EPA recommends that SNUN submitters 

include data that would permit a 

reasoned evaluation of risks posed by 

the chemical substance during its 

manufacture, processing, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN. 

As part of this optional pre-notice 

consultation, EPA would discuss 

specific data it believes may be useful 

in evaluating a significant new use. 

SNUNs submitted for significant new 

uses without any test data may increase 

the likelihood that EPA would take 

action under TSCA section 5(e) to 

prohibit or limit activities associated 

with this chemical. SNUN submitters 

should be aware that EPA will be better 

able to evaluate SNUNs that provide 

detailed information on: 

1. Human exposure and 

environmental releases that may result 

from the significant new use of the 

chemical substance. 

2. Potential benefits of the chemical 

substance. 

3. Information on risks posed by the 

chemical substance compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be on EPA 

Form No. 7710–25, generated using ePMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in 40 CFR 721.25 

and 720.40. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. For 

first-time submitters of a TSCA section 

5 notice, see requirements at Unit I. E. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of HBCD 

in consumer textiles. The evaluation is 

in the ‘‘Economic Analysis of the Final 

Significant New Use Rule for 

Hexabromocyclododecane (HBCD)’’ 

(Ref. 5). It is briefly summarized here 

and is available in the docket for this 

rule (EPA–HQ–OPPT–2011–0489). EPA 

added additional information to the 

economic analysis for HBCD in response 

to public comments. 

A. SNUN Submission 

The costs of submitting a SNUN 

would be incurred when a company 

decides to pursue a significant new use 

of one of these chemicals. In the event 

that a SNUN is submitted, costs are 

estimated at approximately $8,600 per 

SNUN submission for large businesses 

and $6,200 per SNUN submission for 

small businesses, and include the cost 

to prepare and submit the SNUN and 

the payment of a user fee. Businesses 

that submit a SNUN are either subject to 

a $2,500 user fee required by 40 CFR 

700.45(b)(2)(iii), or, if they are a small 

business with annual sales of less than 

$40 million when combined with those 

of the parent company (if any), a 

reduced user fee of $100 (40 CFR 

700.45(b)(1)). In its evaluation of this 

final rule, EPA also considered the 

potential costs a company might incur 

by avoiding or delaying the significant 

new use in the future, but these costs 

have not been quantified. 

B. Import or Processing HBCD as Part of 

a Textile 

Persons who import or process HBCD, 

including as part of a textile article, are 

covered by this rule. As explained in 

Unit X., EPA is making the exemption 

at 40 CFR 721.45(f) inapplicable for 

importers or processors of HBCD as part 

of a textile article. Accordingly, 

importers and processors of HBCD as 

part of textile articles including 

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consumer and non-consumer textile 

articles, are subject to this SNUR. This 

provision is explained in Unit X. 

Some firms have an understanding of 

the contents of the articles they import 

or process. However, EPA acknowledges 

that importers and processors of articles 

may have varying levels of knowledge 

about the chemical content of the 

articles that they import or process. 

These parties may take steps to become 

familiar with the requirements of the 

rule. And, while not required by the 

SNUR, these parties may take additional 

steps to determine whether HBCD is 

part of the articles that they are 

considering importing or processing. 

This determination may involve 

activities such as gathering information 

from suppliers along the supply chain, 

and/or testing samples of the article 

itself. Costs vary across the activities 

chosen. Cost ranges are presented in the 

‘‘Economic Analysis of the Final 

Significant New Use Rule for 

Hexabromocyclododecane (HBCD)’’ 

(Ref. 5). Given existing regulatory 

limitations on HBCD internationally, 

industry-wide processes, and resources 

that support companies in 

understanding and managing their 

supply chains, EPA believes that article 

importers who choose to investigate 

their products would incur costs at the 

lower end of the ranges presented in the 

Economic Analysis as a result of this 

rule. For those companies choosing to 

undertake actions to assess the 

composition of the articles they import 

or process, EPA expects that importers 

and processors would take actions that 

are commensurate with the company’s 

perceived likelihood that a chemical 

substance might be a part of an article, 

and the resources it has available. 

Example activities and their costs are 

provided in the accompanying 

Economic Analysis of this rule. 

C. Export Notification 

EPA regulations under TSCA section 

12(b) (15 U.S.C. 2611(b)) at 40 CFR part 

707, subpart D require that, for 

chemicals subject to a proposed or final 

SNUR, a company must notify EPA of 

the first export or intended export to a 

particular country of an affected 

chemical substance. EPA estimated the 

one-time cost of preparing and 

submitting an export notification to be 

$80. The total costs of export 

notification would vary per chemical, 

depending on the number of required 

notifications (i.e., number of countries 

to which the chemical is exported). 

X. Response to Public Comments 

EPA received seven public comments 

on the proposed SNUR. The comments 

and EPA’s complete response (Ref. 2) 

are available in the docket for this final 

rule (EPA–HQ–OPPT–2011–0489). EPA 

made two changes to the regulatory text 

as a result of issues raised in public 

comments; these changes are explained 

below in Section A of this unit. A 

summary of the remaining issues is in 

Section B of this unit, and the full 

discussion of these comments is in the 

docket. 

A. Changes to Regulatory Text as a 

Result of Public Comments 

Article exemption. Two commenters 

indicated that there was some concern 

regarding the breadth of the lifting of the 

exemption for persons who import or 

process chemical substances as part of 

an article. EPA had proposed to make 

the exemption at 40 CFR 721.45(f) 

inapplicable to this rule. 

The proposal preamble stated that 

‘‘EPA is concerned that exempting 

HBCD as part of articles would render 

the SNUR less effective because of the 

possibility that consumer textile articles 

containing HBCD, the primary concern 

of EPA associated with this proposed 

rule, could be imported or processed for 

uses subject to this proposed SNUR 

without the submission of a SNUN. This 

proposed rule would not include the 

exemption at § 721.45(f).’’ 77 FR 17386, 

17391, March 26, 2012. (Ref. 1) 

Accordingly, the proposed regulatory 

text stated that ‘‘[t]he provisions of 

§ 721.45(f) do not apply to this section. 

A person who imports or processes the 

chemical substances identified in 

paragraph (a)(1) of this section as part of 

an article for the significant new use 

described in paragraph (a)(2) of this 

section must submit a significant new 

use notice (SNUN).’’ 

Although the Agency has the 

authority to lift the exemption for 

importers and processors of HBCD as 

part of all articles, such a broad 

application is not necessary or desirable 

for this rule. This is because there are 

ongoing uses of HBCD as part of articles 

that are unlikely to be diverted to the 

significant new use. 

EPA considered a narrow approach 

that would have made the exemption 

inapplicable to importers and 

processors of HBCD as part of consumer 

textiles only, not all textiles. EPA is 

concerned that if the inapplicability of 

the exemption was limited to consumer 

textiles, undifferentiated textiles (e.g., 

the type of textiles that could be for a 

consumer use or a non-consumer use), 

could be imported or processed and 

distributed in commerce for consumer 

use without notification to the Agency. 

The category ‘‘consumer textiles’’ is 

fully subsumed by the broader category 

of textiles, so by requiring importers and 

processors of all textiles containing 

HBCD to meet the notification 

requirements at 40 CFR 721.5, EPA is 

ensuring that the regulatory 

mechanisms designed to prevent 

significant new uses without notice to 

the Agency will apply to import and 

processing of HBCD-containing articles 

that have the potential to be used as 

consumer textiles. 

Thus, EPA is making the exemption at 

40 CFR 721.45(f) inapplicable for 

importers and processors of HBCD as 

part of a textile article, rather than as 

part of all articles. Accordingly, 

importers and processors of HBCD as 

part of textile articles, regardless of 

whether those textiles are consumer 

textiles, are subject to this final SNUR. 

The term ‘‘textile’’ is intended to be read 

in conjunction with the definition of 

‘‘consumer textile’’ and includes, but is 

not limited to, bolts of cloth and 

draperies, as well as textiles that are 

part of upholstered household furniture 

and mattresses. The definition of 

‘‘consumer textile’’ for this rule is in the 

regulatory text at 40 CFR 721.10281. 

The Agency’s decision to lift the 

exemption for importers and processors 

of HBCD as part of textile articles rather 

than for importers and processors of all 

HBCD-containing articles is specific to 

this SNUR and based on the particular 

significant new use in this SNUR. 

Definition of consumer textile. One of 

the seven commenters stated that the 

definition of ‘‘consumer textile’’ in the 

proposed SNUR is ‘‘rather nuanced . . . 

[and] contains several terms that are not 

self-evident on their face.’’ The 

proposed definition at 77 FR 17386, 

17394, March 26, 2012 was: ‘‘Consumer 

textile means any cloth, fabric, or other 

item produced during the milling 

process (including spinning, weaving, 

knitting, felting, or finishing), consisting 

in whole or as part of a product that is 

sold to or made available to a private 

individual who uses the product in or 

around a permanent or temporary 

household or residence, during 

recreation, or for any personal use or 

enjoyment. Consumer textiles include 

but are not limited to draperies and 

textiles that are part of upholstered 

household furniture and mattresses’’ 

(Ref. 1). The proposal defined 

‘‘consumer textile’’ to distinguish 

consumer textiles from other textiles 

(e.g., commercial, industrial, 

institutional, military). While this rule 

does not use the term ‘‘consumer 

product’’ as defined in 40 CFR 721.3, 

some of the terms and phrases used in 

the consumer textile definition, 

including those that the commenter 

claims are ‘‘not self-evident on their 

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face,’’ are the same as those in the 

consumer product definition. 

However, in the course of considering 

the comments, EPA revisited the 

definition of consumer textile, and 

concluded it could be clarified in 

certain respects. In this final rule, EPA 

is making minor changes to clarify the 

definition, as explained below. The 

changes do not impact the scope of the 

SNUR, as the final definition of 

‘‘consumer textile’’ covers only those 

textiles that the Agency intended to 

cover in the proposal. The final 

definition is: ‘‘Consumer textile means 

any cloth, fabric, or other item produced 

during a milling process for textiles 

(including spinning, weaving, knitting, 

felting, or finishing), that is sold or 

made available either as a product or as 

part of a product, to a private individual 

who uses it in or around a permanent 

or temporary household or residence, 

during recreation, or for any personal 

use or enjoyment. Consumer textiles can 

include, but are not limited to, bolts of 

cloth and draperies, as well as textiles 

that are part of upholstered household 

furniture and mattresses.’’ Because there 

are milling processes that do not relate 

to textiles, the final definition clarifies 

that only items produced during milling 

processes for textiles are covered. The 

final definition also clarifies that the 

textile itself can be a consumer textile 

and that the textile need not be part of 

a larger product like a mattress. This 

clarification is made in two places: By 

changing ‘‘consisting in whole or as part 

of a product’’ to ‘‘as a product or as part 

of a product’’ and by adding ‘‘bolts of 

cloth’’ as an example of a type of textile. 

B. Summary of Response to Remaining 

Public Comments 

Some commenters questioned 

whether EPA has the legal authority to 

regulate articles under TSCA. EPA’s 

response is that TSCA section 5 

provides EPA with authority to regulate 

chemical substances, including 

chemical substances that are part of 

articles. Commenters also stated that 

EPA should establish a policy 

framework by rule for the issuance of 

article SNURs. EPA’s response is that 

development of a ‘‘policy framework’’ is 

not necessary before reaching the 

conclusion, with respect to HBCD, that 

persons who import or process this 

substance as part of consumer textiles 

(other than for use in motor vehicles) 

should be subject to the notification 

provisions of 40 CFR 721.25. 

One commenter objected to the 

wording of the significant new use 

(‘‘consumer textiles, other than for use 

in motor vehicles’’) because it implies 

that a motor vehicle is a consumer 

product as defined by 40 CFR 721.3. 

EPA’s response is that the HBCD SNUR 

does not rely on the definition of 

consumer product as defined by 40 CFR 

721.3. Instead, the rule specifically 

defines ‘‘consumer textile’’ and the 

definition would ordinarily encompass 

textiles used in motor vehicles. Another 

commenter said the proposed exclusion 

for consumer textiles in motor vehicles 

is appropriate but that the proposed 

SNUR appears to be a signal that EPA 

would like HBCD to be phased out of 

use in textiles in vehicles. The 

commenter is concerned that the 

phasing out of HBCD would leave the 

automotive industry without a 

substitute. EPA’s response is that the 

exclusion from this SNUR for 

manufacture and import of HBCD as 

part of textiles in motor vehicles is not 

a signal that EPA would like this use of 

HBCD to be phased out. Use of HBCD 

in textiles in motor vehicles is 

unaffected by this SNUR because the 

use is ongoing. EPA continues to 

evaluate ongoing uses of HBCD as part 

of its TSCA Work Plan chemical 

assessments (see http://www.epa.gov/

oppt/existingchemicals/pubs/

riskassess.html). The remaining three 

commenters supported the proposed 

SNUR. 

XI. References 

The following is a listing of the 

documents that are specifically 

referenced in this action. The docket 

includes these documents and other 

information considered by EPA in 

developing this rule, including 

documents that are referenced within 

the documents that are in the docket, 

even if the referenced document is not 

physically located in the docket. For 

assistance in locating these other 

documents, please consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

1. EPA. Significant New Use Rule for 

Hexabromocyclododecane and 

1,2,5,6,9,10-Hexabromocyclododecane: 

Proposed Rule. Federal Register (77 FR 

17386, March 26, 2012) (FRL–9341–6). 

Available at http://www.gpo.gov/fdsys/

browse/

collection.action?collectionCode=FR. 

2. EPA. Response to Public Comments on 

Proposed Significant New Use Rule for 

Hexabromocyclododecane and 

1,2,5,6,9,10-Hexabromocyclododecane, 

April 24, 2015. 

3. EPA. 2012 Chemical Data Reporting (CDR). 

Chemical Data Access Tool (CDAT). 

Available at: http://java.epa.gov/oppt_

chemical_search/. Accessed May 21, 

2013. Last updated April 4, 2013. 

4. EPA. Inventory Update Reporting (IUR): 

Non-Confidential 2006 TSCA Inventory 

Update Rule (IUR) Records. Available at: 

http://cfpub.epa.gov/iursearch. 

5. EPA Environmental Economics and 

Technology Division (EETD), Economic 

and Policy Analysis Branch (EPAB). 

Economic Analysis of the Final 

Significant New Use Rule for 

Hexabromocyclododecane (HBCD), 

Washington, DC. 2015. 

6. Consumer Product Safety Commission. 

Personal communication with Dr. 

Michael Babich, Chemist, United States 

Consumer Product Safety Commission 

(CPSC). March 16, 2010. 

7. ACC. Personal communication with 

Jackson Morrill, Director of Chemical 

Products of the American Chemistry 

Council (ACC). February 16, 2011. 

8. Herman Miller. Personal communication 

with Gabe Wing of Herman Miller, Inc. 

March 30, 2011. 

9. Eagle Performance Products. Personal 

communication with John Friddle, 

President of Eagle Performance Products. 

March 3, 2011. 

10. Chengelis. An oral (gavage) 90 day 

toxicity study of HBCD in rats. Study No. 

WIL–186012. WIL Research Laboratories, 

Inc. Ashland, Ohio, USA. 2001. 

11. Ema, M., et al. Two-generation 

reproductive toxicity study of the flame 

retardant hexabromocyclododecane in 

rats. Reproductive Toxicology. April 

2008. 25(3), pp. 335–351. 

12. Desjardins, et al. 

Hexabromocyclododecane (HBCD): A 72- 

hour toxicity test with the marine diatom 

(Skeletonema costatum). Final Report. 

Wildlife International, Ltd. Easton, 

Maryland, USA. 2004. p. 66. 

13. Deng, et al. Hexabromocyclododecaneinduced developmental toxicity and 

apoptosis in zebrafish embryos. Aquatic 

Toxicology. June 2009. 93(1), pp. 29–36. 

14. Palace, et al. Biotransformation enzymes 

and thyroid axis disruption in juvenile 

rainbow trout (Oncorhynchus mykiss) 

exposed to hexabromocyclododecane 

diastereoisomers. Environmental Science 

and Technology. February 2008. 42(6), 

pp. 1967–1972. 

15. Kling, et al. Proteomic studies in 

zebrafish liver cells exposed to the 

brominated flame retardants HBCD and 

TBBPA. Ecotoxicology and 

Environmental Safety. November 2009. 

72, pp. 985–1993. 

16. Zhang, et al. Induction of hepatic 

enzymes and oxidative stress in Chinese 

rare minnow (Gobiocypris rarus) 

exposed to waterborne 

hexabromocyclododecane (HBCD). 

Aquatic Toxicology. January 2008. 86(1), 

pp. 4–11. 

17. Ronisz, et al. Sublethal effects of the 

flame retardants 

hexabromocyclododecane (HBCDD), and 

tetrabromobisphenol A (TBBPA), on 

hepatic enzymes and other biomarkers in 

juvenile rainbow trout and feral eelpout. 

Aquatic Toxicology. August 2004. 69(3), 

pp. 229–245. 

18. Drottar, Hexabromocyclododecane 

(HBCD): A flow-through life-cycle 

toxicity test with the cladoceran 

(Daphnia magna). Final Report. 439A– 

108, Wildlife International, Ltd. Easton, 

Maryland, USA. 1998. pp. 78. 

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57300 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 

19. Schriks, et al. Disruption of thyroid 

hormone-mediated Xenopus laevis 

tadpole tail tip regression by 

hexabromocyclododecane (HBCD) and 

2,2′,3,3′,4,4′,5,5′, 6-nona brominated 

diphenyl ether (BDE206). Chemosphere. 

December 2006. 65(10), pp. 1904–1908. 

20. Oetken, et al. Validation of the 

preliminary EU-concept of assessing the 

impact of chemicals to organisms in 

sediment by using selected substances. 

UBA–FB 299 67 411, Institute of 

Hydrobiology, Dresden University of 

Technology, Dresden, Germany. 2001. 

pp. 97. 

21. Crump, et al. Effects of 

hexabromocyclododecane and 

polybrominated diphenyl ethers on 

mRNA expression in chicken (Gallus 

domesticus) hepatocytes. Toxicological 

Sciences. December 2008. 106(2), pp. 

479–487. 

22. Fernie, et al. Environmentally relevant 

concentrations of DE–71 and HBCD alter 

eggshell thickness and reproductive 

success of American kestrels. 

Environmental Science and Technology. 

March 2009. 43(6), pp. 2124–30. 

23. Posner. Survey and technical assessment 

of alternatives to TBBPA and HBCDD. 

Kemi (Kemikalieinspektionen) (Swedish 

Chemicals Agency, Sweden). 

Sundbyberg, Sweden. January, 2006. 

24. Covaci, et al. Hexabromocyclododecanes 

(HBCDs) in the Environment and 

Humans: A Review. Environmental 

Science and Technology. May 2006. 

40(12), pp. 3679–3688. 

25. UNEP. Stockholm Convention on 

Persistent Organic Pollutants. Persistent 

Organic Pollutants Review Committee, 

Third meeting, Geneva. pp. 19–23, 

November 2007, Item 7 of the 

provisional agenda, Presentation on 

environmental transport and modeling. 

The OECD screening tool for overall 

persistence and long-range transport 

potential. UNEP/POPS/POPRC.3/INF/7. 

26. Ghanem, R. Kinetics of Thermal and 

Photolytic Segregation of 

Hexabromocyclododecane in Backcoated 

Textile Samples. Jordan Journal of 

Chemistry. April 2009. 4(2), pp. 171–181. 

27. European Commission (EC). Risk 

Assessment: Hexabromocyclododecane 

CAS-No.: 25637–99–4 EINECS-No.: 247– 

148–4, Final Report. Office for Official 

Publications of the European 

Communities: Luxembourg. May 2008. 

28. Arnot, et al. An evaluation of 

hexabromocyclododecane (HBCD) for 

Persistent Organic Pollutant (POP) 

properties and the potential for adverse 

effects in the environment. Submitted to 

European Brominated Flame Retardant 

Industry Panel (EBFRIP). May 2009. 

29. UNEP. Stockholm Convention on 

Persistent Organic Pollutants. Summary 

of the proposal for the listing of 

hexabromocyclododecane (HBCDD) in 

Annex A to the Convention. July 2009. 

30. EPA. TSCA Work Plan Chemical Problem 

Formulation and Initial Assessment, 

Cyclic Aliphatic Bromides Cluster, 

Flame Retardants. August 2015. 

Available at http://www.epa.gov/oppt/

existingchemicals/pubs/riskassess.html. 

31. EPA. Significant New Uses of Certain 

Chemical Substances, Final Rule. 

Federal Register (55 FR 17376, April 24, 

1990) (FRL–3658–5). 

32. EPA. Modification of Significant New Use 

Rules for Certain Substances, Final Rule. 

Federal Register (62 FR 42690, August 8, 

1997) (FRL–5735–4). 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This final rule is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866 (58 FR 51735, 

October 4, 1993) and is therefore not 

subject to review under Executive 

Orders 12866 and 13563, entitled 

‘‘Improving Regulation and Regulatory 

Review’’ (76 FR 3821, January 21, 2011). 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

information collection burden under the 

PRA, 44 U.S.C. 3501 et seq. Burden is 

defined in 5 CFR 1320.3(b). The 

information collection activities 

associated with existing chemical 

SNURs are already approved by OMB 

under OMB control number 2070–0038 

(EPA ICR No. 1188), and the 

information collection activities 

associated with export notifications are 

already approved by OMB under OMB 

control number 2070–0030 (EPA ICR 

No. 0795). If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to be less than 100 hours 

per response, and the estimated burden 

for an export notification is less than 1.5 

hours per notification. In both cases, 

burden is estimated to be reduced for 

submitters who have already registered 

to use the electronic submission system. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

that requires OMB approval under the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in Title 

40 of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9 and included on the related 

collection instrument, or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list this SNUR. This 

listing of the OMB control numbers and 

their subsequent codification in the CFR 

satisfies the display requirements of the 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. Since 

the existing OMB approval was 

previously subject to public notice and 

comment before OMB approval, and 

given the technical nature of the table, 

EPA finds that further notice and 

comment to amend the table is 

unnecessary. As a result, EPA finds that 

there is ‘‘good cause’’ under section 

553(b)(3)(B) of the Administrative 

Procedure Act (5 U.S.C. 553(b)(3)(B)), to 

amend this table without further notice 

and comment. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to section 605(b) of the RFA, 

5 U.S.C. 601 et seq., I hereby certify that 

promulgation of this SNUR will not 

have a significant economic impact on 

a substantial number of small entities. 

The rationale supporting this 

conclusion is as follows. 

EPA generally finds that proposed 

and final SNURs are not expected to 

have a significant economic impact on 

a substantial number of small entities 

(See, e.g., Ref. 32). Since this SNUR will 

require a person who intends to engage 

in such activity in the future to first 

notify EPA by submitting a SNUN, no 

economic impact will occur unless 

someone files a SNUN to pursue a 

significant new use in the future or 

forgoes profits by avoiding or delaying 

the significant new use. Although some 

small entities may decide to engage in 

such activities in the future, EPA cannot 

presently determine how many, if any, 

there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of SNURs covering 

over 1,000 chemical substances, the 

Agency receives only a handful of 

notices per year. During the six year 

period from 2005–2010, only three 

submitters self-identified as small in 

their SNUN submission (Ref. 5). EPA 

believes the cost of submitting a SNUN 

is relatively small compared to the cost 

of developing and marketing a chemical 

new to a firm and that the requirement 

to submit a SNUN generally does not 

have a significant economic impact. 

A SNUR applies to any person 

(including small or large entities) who 

intends to engage in any activity 

described in the rule as a ‘‘significant 

new use.’’ In the proposed HBCD SNUR 

(Ref. 1), EPA preliminarily determined, 

based in part on the Agency’s market 

research, that HBCD is not 

manufactured or processed for the 

significant new use (i.e., use in 

consumer textiles other than in textiles 

in motor vehicles). EPA received no 

public comment indicating otherwise. 

Therefore, EPA is finalizing its 

determination that use of HBCD in 

consumer textiles (other than in textiles 

in motor vehicles) is not ongoing. Thus 

no small entities presently manufacture 

or import HBCD for the significant new 

use. EPA believes that there will be 

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Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 57301 

minimal impact to processors and 

importers of HBCD as part of textile 

articles from this SNUR. The SNUR 

does not require processors and 

importers of textile articles to conduct 

specific activities to ascertain if they are 

importing or processing a textile article 

containing HBCD. EPA expects 

importers and processors will take 

actions that are commensurate with 

their perceived likelihood of HBCD 

being part of a textile article, and the 

resources they have available. EPA has 

no reason to believe that a firm would 

voluntarily incur substantial costs to 

comply with the SNUR, but rather, EPA 

believes each firm will choose the most 

efficient route to identify whether it is 

importing HBCD in textile articles. 

Therefore, EPA believes that the 

potential economic impact of complying 

with this SNUR is not expected to be 

significant or adversely impact a 

substantial number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reason to 

believe that any State, local, or Tribal 

government will be impacted by this 

rulemaking. As such, EPA has 

determined that this regulatory action 

will not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of 

UMRA (2 U.S.C. 1531–1538). 

E. Executive Order 13132: Federalism 

This action does not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications because it will not have 

any effect (i.e., there will be no increase 

or decrease in authority or jurisdiction) 

on Tribal governments, on the 

relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes. Thus, 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), does not apply to 

this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 (62 FR 19885, April 23, 

1997), because this action is not 

intended to address environmental 

health or safety risks for children. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not expected to 

affect energy supply, distribution, or 

use. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Since this action does not involve any 

technical standards, NTTAA section 

12(d), 15 U.S.C. 272 note, does not 

apply to this action. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898 (59 FR 7629, 

February 16, 1994), because EPA has 

determined that this action will not 

have disproportionately high and 

adverse human health or environmental 

effects on minority or low-income 

populations. This action does not affect 

the level of protection provided to 

human health or the environment. 

K. Congressional Review Act (CRA) 

Pursuant to the CRA, 5 U.S.C. 801 et 

seq., EPA will submit a report 

containing this rule and other required 

information to the U.S. Senate, the U.S. 

House of Representatives, and the 

Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This action is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: September 16, 2015. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, add the following section 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR Citation OMB Control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10281 ............................. 2070–0038 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add new § 721.10281 to subpart E 

to read as follows: 

§ 721.10281 Hexabromocyclododecane 

and 1,2,5,6,9,10-hexabromocyclododecane. 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

as hexabromocyclododecane (CASRN 

25637–99–4) and 1,2,5,6,9,10- 

hexabromocyclododecane (CASRN 

3194–55–6) are subject to reporting 

under this section for the significant 

new use described in paragraph (a)(2) of 

this section. 

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57302 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations 

(2) The significant new use is use in 

consumer textiles, other than for use in 

motor vehicles. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Definitions. The definitions in 

§ 721.3 apply to this section. In 

addition, the following definitions 

apply: 

Consumer textile means any cloth, 

fabric, or other item produced during a 

milling process for textiles (including 

spinning, weaving, knitting, felting, or 

finishing), that is sold or made available 

either as a product or as part of a 

product, to a private individual who 

uses it in or around a permanent or 

temporary household or residence, 

during recreation, or for any personal 

use or enjoyment. Consumer textiles can 

include, but are not limited to, bolts of 

cloth and draperies, as well as textiles 

that are part of upholstered household 

furniture and mattresses. 

Motor vehicle has the meaning found 

at 40 CFR 85.1703. 

(2) Revocation of article exemption. 

The provisions of § 721.45(f) do not 

apply to importers and processors of the 

chemical substances identified in 

paragraph (a)(1) of this section as part of 

a textile. 

[FR Doc. 2015–24178 Filed 9–22–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2011–0079; FRL–9932–51– 

Region 6] 

Approval and Promulgation of 

Implementation Plans; Texas; Revision 

To Control Volatile Organic Compound 

Emissions From Storage Tanks and 

Transport Vessels 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a Texas State 

Implementation Plan (SIP) revision for 

control of volatile organic compound 

(VOC) emissions from degassing of 

storage tanks, transport vessels and 

marine vessels. The revision reformats 

the existing requirement to comply with 

current rule writing standards, adds 

additional control options for owner/

operators to use when complying, 

clarifies the monitoring and testing 

requirements of the rule, and makes 

non-substantive changes to VOC control 

provisions that apply in the BeaumontPort Arthur (BPA) nonattainment area 

(Hardin, Jefferson and Orange Counties), 

four counties in the Dallas-Fort Worth 

(DFW) nonattainment area (Collin, 

Dallas, Denton and Tarrant Counties), El 

Paso County, and the HoustonGalveston-Brazoria (HGB) 

nonattainment area (Brazoria, 

Chambers, Fort Bend, Galveston, Harris, 

Liberty, Montgomery and Waller 

Counties). 

The EPA is also making a ministerial 

correction to the Code of Federal 

Regulations (CFR) to accurately reflect 

approved SIP revisions that pertain to 

Stage II control of VOCs from gasoline 

dispensing facilities in Texas. 

DATES: This final rule is effective on 

October 23, 2015. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R06–OAR–2011–0079. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

or other information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically through http://

www.regulations.gov or in hard copy at 

EPA Region 6, 1445 Ross Avenue, Suite 

700, Dallas, Texas 75202–2733. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Robert M. Todd, (214) 665–2156, 

todd.robert@epa.gov. To inspect the 

hard copy materials, please contact Mr. 

Todd or Mr. Bill Deese (214) 665–7253. 

SUPPLEMENTARY INFORMATION: 

Throughout this document wherever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

the EPA. 

Table of Contents 

I. Background 

II. Response to Comments 

III. Final Action 

IV. Incorporation by Reference 

V. Statutory and Executive Order Reviews 

I. Background 

The background for this action is 

discussed in detail in our May 13, 2015 

direct final rule and proposal (80 FR 

27251 and 80 FR 27275). In the direct 

final rule we approved a SIP submission 

revising the rules for controlling VOC 

emissions from degassing of storage 

tanks, transport vessels and marine 

vessels. The Texas rule revisions were 

adopted by the state on January 26, 2011 

and submitted to us on February 18, 

2011. The revisions submitted by the 

Texas Commission on Environmental 

Quality (TCEQ) apply to Brazoria, 

Chambers, Collin, Dallas, Denton, El 

Paso, Fort Bend, Galveston, Hardin, 

Harris, Jefferson, Liberty, Montgomery, 

Orange, Tarrant and Waller Counties. 

Our May 13, 2015 rule and proposal 

stated that if any relevant adverse 

comments were received by the end of 

the public comment period on June 12, 

2015, the direct final rule would be 

withdrawn and we would respond to 

the comments in a subsequent final 

action. Relevant adverse comments were 

received during the comment period, 

and the direct final rule was withdrawn 

on June 30, 2015 (80 FR 37161). Our 

May 13, 2015 proposal provides the 

basis for this final action. 

Also, on March 17, 2014 we approved 

revisions to the Texas SIP pertaining to 

Stage II control of VOCs from gasoline 

stations (79 FR 14611). Included in the 

approved revisions was removal of 

sections 115.247 and 115.249 from the 

TX SIP. In that document, however, we 

did not update the CFR to show that 30 

TAC 115.247 and 115.249 were removed 

from the SIP. We are using the 

opportunity of this final rule to correct 

this oversight. 

We received comments on our May 

13, 2015 proposal from two 

commenters. Our response to the 

comments are below. 

II. Response to Comments 

Comment: The first commenter stated 

it would be impractical, and possibly 

unreasonable, to require industry to 

comply with the state regulations unless 

the state took the needs of individual 

sources into account and helped them to 

comply. 

Response: The commenter fails to 

specify how and why the submitted 

revisions would be impractical. In 

addition, these revisions merely modify 

and clarify existing rules which have 

been implemented for several years. 

Requirements to control degassing 

emissions, for example, low-leaking 

tank fittings on some control options, 

monitoring control effectiveness and 

reporting compliance from degassing 

operations were first implemented in 

HGB and BPA (62 FR 27964, May 22, 

1997). In DFW and El Paso County, 

these rules were adopted as contingency 

measures under the 1-hour ozone 

standard (62 FR 27964). The Texas 

Commission on Environmental Quality 

has been successfully implementing 

these degassing regulations in Brazoria, 

Chambers, Fort Bend, Galveston, 

Hardin, Harris, Jefferson, Liberty, 

Montgomery, Orange, and Waller 

Counties for several years and we 

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