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[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Rules and Regulations]
[Pages 57293-57302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24178]

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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.

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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).

[[Page 57294]]

     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 E-payment 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

[[Page 57295]]

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).
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    \1\ As 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 
final rule in the Federal Register issue of August 16, 2011 (76 FR 
50816).
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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 treatment-related 
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

[[Page 57296]]

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

[[Page 57297]]

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 e-PMN 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

[[Page 57298]]

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 Sec.  721.45(f).'' 77 FR 17386, 17391, March 26, 2012. 
(Ref. 1) Accordingly, the proposed regulatory text stated that ``[t]he 
provisions of Sec.  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

[[Page 57299]]

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. Hexabromocyclododecane-induced 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.

[[Page 57300]]

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

[[Page 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]

0
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.

0
2. In Sec.  [emsp14]9.1, add the following section in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR Citation                            No.
------------------------------------------------------------------------
 >
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10281...............................................       2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add new Sec.  721.10281 to subpart E to read as follows:

Sec.  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.

[[Page 57302]]

    (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 Sec.  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 Sec.  
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
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