80_FR_57477 80 FR 57293 - Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10-Hexabromocyclododecane

80 FR 57293 - Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10-Hexabromocyclododecane

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 184 (September 23, 2015)

Page Range57293-57302
FR Document2015-24178

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.

Federal Register, Volume 80 Issue 184 (Wednesday, September 23, 2015)
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Rules and Regulations]
[Pages 57293-57302]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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.thefederalregister.org/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



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

                                                   (3) A battery failure sensing and                    condition, the criticality of a function              and Toxics Docket (OPPT Docket), EPA
                                                warning system with a means for                         will include the mitigating factors. The              Docket Center (EPA/DC), West William
                                                automatically disconnecting the battery                 failure conditions must address the loss              Jefferson Clinton Bldg., Rm. 3334, 1301
                                                from its charging source in the event of                of function and improper operations.                  Constitution Ave. NW., Washington,
                                                battery failure.                                          Issued in Kansas City, Missouri, on                 DC. The Public Reading Room is open
                                                   h. Any Li-ion battery installation                   September 14, 2015.                                   from 8:30 a.m. to 4:30 p.m., Monday
                                                whose function is required for safe                     Mel Johnson,                                          through Friday, excluding legal
                                                operation of the airplane, must                                                                               holidays. The telephone number for the
                                                                                                        Acting Manager, Small Airplane Directorate,
                                                incorporate a monitoring and warning                                                                          Public Reading Room is (202) 566–1744,
                                                                                                        Aircraft Certification Service.
                                                feature that will provide an indication                                                                       and the telephone number for the OPPT
                                                                                                        [FR Doc. 2015–24164 Filed 9–22–15; 8:45 am]
                                                to the appropriate flightcrew members                                                                         Docket is (202) 566–0280. Please review
                                                                                                        BILLING CODE 4910–13–P
                                                whenever the capacity and State of                                                                            the visitor instructions and additional
                                                Charge (SOC) of the batteries have fallen                                                                     information about the docket available
                                                below levels considered acceptable for                                                                        at http://www.epa.gov/dockets.
                                                dispatch of the airplane.                               ENVIRONMENTAL PROTECTION
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT: For
                                                   i. The Instructions for Continued                    AGENCY
                                                                                                                                                              technical information contact: Sue
                                                Airworthiness (ICA) must contain                                                                              Slotnick, National Program Chemicals
                                                recommended manufacturers                               40 CFR Parts 9 and 721
                                                                                                                                                              Division (7404T), Office of Pollution
                                                maintenance and inspection                              [EPA–HQ–OPPT–2011–0489; FRL 9927–44]                  Prevention and Toxics, Environmental
                                                requirements to ensure that batteries,                                                                        Protection Agency, 1200 Pennsylvania
                                                                                                        RIN 2070–AJ88
                                                including single cells, meet a safety                                                                         Ave. NW., Washington, DC 20460–0001;
                                                function level essential to the aircraft’s              Significant New Use Rule for                          telephone number: (202) 566–1973;
                                                continued airworthiness.                                Hexabromocyclododecane and                            email address: slotnick.sue@epa.gov.
                                                   (1) The ICA must contain operating                   1,2,5,6,9,10-Hexabromocyclododecane                      For general information contact: The
                                                instructions and equipment limitations                                                                        TSCA-Hotline, ABVI-Goodwill, 422
                                                in an installation maintenance manual.                  AGENCY:  Environmental Protection                     South Clinton Ave., Rochester, NY
                                                   (2) The ICA must contain installation                Agency (EPA).                                         14620; telephone number: (202) 554–
                                                procedures and limitations in a                         ACTION: Final rule.                                   1404; email address: TSCA-Hotline@
                                                maintenance manual, sufficient to                                                                             epa.gov.
                                                ensure that cells or batteries, when                    SUMMARY:    EPA is promulgating a
                                                installed according to the installation                 significant new use rule (SNUR) under                 SUPPLEMENTARY INFORMATION:
                                                procedures, still meet safety functional                the Toxic Substances Control Act                      I. Executive Summary
                                                levels essential to the aircraft’s                      (TSCA) for two chemical substances
                                                continued airworthiness. The                            collectively referred to as ‘‘HBCD.’’ This            A. Does this action apply to me?
                                                limitations must identify any unique                    action requires persons who intend to                   You may be potentially affected by
                                                aspects of the installation.                            manufacture (including import) or                     this action if you manufacture (defined
                                                   (3) The ICA must contain corrective                  process hexabromocyclododecane or                     by statute to include import) or process
                                                maintenance procedures to check                         1,2,5,6,9,10-hexabromocyclododecane                   hexabromocyclododecane (Chemical
                                                battery capacity at manufacturers                       (HBCD) for use in consumer textiles                   Abstracts Service Registry Number
                                                recommended inspection intervals.                       (other than for use in motor vehicles) to             (CASRN) 25637-99-4) or 1,2,5,6,9,10-
                                                   (4) The ICA must contain scheduled                   notify EPA at least 90 days before                    hexabromocyclododecane (CASRN
                                                servicing information to replace                        commencing that activity. The required                3194-55-6) for use in consumer textiles
                                                batteries at manufacturers                              notification will provide EPA with the                other than for use in motor vehicles.
                                                recommended replacement time.                           opportunity to evaluate the intended                  Throughout this final rule preamble, the
                                                   (5) The ICA must contain                             use and, if appropriate, to prohibit or               term ‘‘HBCD’’ represents both chemical
                                                maintenance and inspection                              limit that activity before it occurs. In              substances, unless a specific CASRN is
                                                requirements to check visually for                      this SNUR, the exemption for persons                  also noted. The North American
                                                battery and/or charger degradation.                     importing or processing a chemical                    Industrial Classification System
                                                   j. Batteries in a rotating stock (spares)            substance as part of an article does not              (NAICS) codes that are identified in this
                                                that have experienced degraded charge                   apply to importers and processors of                  unit are not intended to be exhaustive,
                                                retention capability or other damage due                HBCD as part of a textile article (e.g., as           but rather provide a guide to help
                                                to prolonged storage must be                            part of a bolt of cloth or part of an                 readers determine whether this rule
                                                functionally checked at manufacturers                   upholstered chair). EPA is also making                applies to them. Potentially affected
                                                recommended inspection intervals.                       a technical amendment to the codified                 entities may include:
                                                   k. The System Safety Assessment                      list of control numbers for approved                    • Chemical Manufacturing (NAICS
                                                (SSA) process should address the                        information collection activities so that             code 325).
                                                software and complex hardware levels                    it includes the control number assigned                 • Painting and Wall Covering
                                                for the sensing, monitoring, and                        by the Office of Management and                       Contractors (NAICS code 238320).
                                                warning systems if these systems                        Budget (OMB) to the information                         • Textile and Fabric Finishing (except
                                                contain complex devices. The                            collection activities contained in this               Broadwoven Fabric) Mills (NAICS code
                                                functional hazard assessment (FHA) for                  rule.                                                 313312).
                                                the system is required based on the                                                                             • Curtain and Drapery Mills (NAICS
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                                                intended functions described. The                       DATES:  This final rule is effective                  code 314121).
                                                criticality of the specific functions will              November 23, 2015.                                      • Other Household Textile Product
                                                be determined by the safety assessment                  ADDRESSES: The docket for this action,                Mills (NAICS code 314129).
                                                process for compliance with § 23.1309.                  identified by docket identification (ID)                • All Other Miscellaneous Textile
                                                Advisory Circular 23–1309–1C contains                   number EPA–HQ–OPPT–2011–0489, is                      Product Mills (NAICS code 314999).
                                                acceptable means for accomplishing this                 available at http://www.regulations.gov                 • Upholstered Household Furniture
                                                requirement. For determining the failure                or at the Office of Pollution Prevention              Manufacturing (NAICS code 337121).


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

                                                  • Household Furniture (except Wood                    mattresses. The general provisions for                SNUN submission for small business
                                                and Metal) Manufacturing (NAICS code                    SNURs include an exemption for                        submitters. These estimates include the
                                                337125).                                                persons who import or process chemical                cost to prepare and submit the SNUN
                                                  • Mattress Manufacturing (NAICS                       substances as part of an article (40 CFR              and the payment of a user fee. Persons
                                                code 337910).                                           721.45(f)). However, for this SNUR, EPA               that must submit a SNUN under this
                                                  • Blind and Shade Manufacturing                       is making the exemption at 40 CFR                     SNUR who are first-time submitters of
                                                (NAICS code 337920).                                    721.45(f) inapplicable for importers or               any TSCA section 5 notice must register
                                                  • Furniture Merchant Wholesalers                      processors of HBCD as part of a textile               their company and key users with the
                                                (NAICS code 423210).                                    article. Accordingly, importers and                   Central Data Exchange reporting tool,
                                                  • Home Furnishing Merchant                            processors of HBCD as part of a textile               deliver a CD electronic signature to
                                                Wholesalers (NAICS code 423220).                        article (whether or not it is a consumer              EPA, and establish and use a Pay.gov E-
                                                  • Reupholstery and Furniture Repair                   textile) are subject to this SNUR. The                payment account before they may
                                                (NAICS code 811420).                                    term ‘‘textile article’’ is intended to be            submit a SNUN, for a cost of $200 per
                                                  If you have any questions regarding                   read in conjunction with the definition               firm. However, these activities are only
                                                the applicability of this action to a                   of ‘‘consumer textile’’ and includes bolts            required of first-time submitters of
                                                particular entity, consult the technical                of cloth and draperies, as well as textiles           section 5 notices. The rule may also
                                                person listed under FOR FURTHER                         that are part of upholstered household                affect firms that import or process
                                                INFORMATION CONTACT.                                    furniture and mattresses. EPA proposed                articles that may contain HBCD,
                                                  This action may affect importers and                  the rule on March 26, 2012 (Ref. 1) and               because, while not required by the
                                                exporters of HBCD through pre-existing                  received seven public comments. The                   SNUR, these parties may take additional
                                                import certification and export                         comments and EPA’s responses to them                  steps to determine whether HBCD is
                                                notification rules under TSCA,                          (Ref. 2) are in the public docket for this            part of the articles that they are
                                                regardless of the use of the HBCD.                      rule (EPA–HQ–OPPT–2011–0489) and                      considering to import or process. Since
                                                B. What is the Agency’s authority for                   are also summarized below in Unit X.                  EPA is unable to predict whether
                                                taking this action?                                        The Agency is promulgating the                     anyone might engage in future activities
                                                                                                        SNUR as proposed with two exceptions.                 that would require reporting, potential
                                                   Section 5(a)(2) of TSCA (15 U.S.C.                   The first exception is the scope of the
                                                2604(a)(2)) authorizes EPA to determine                                                                       total costs were not estimated. In
                                                                                                        exemption for persons who import or                   addition, for persons exporting a
                                                that a use of a chemical substance is a                 process HBCD as part of an article. EPA
                                                ‘‘significant new use.’’ EPA must make                                                                        substance that is the subject of a SNUR,
                                                                                                        had proposed to make the exemption at                 a one-time notice must be provided for
                                                this determination by rule after                        40 CFR 721.45(f) completely
                                                considering all relevant factors                                                                              the first export or intended export to a
                                                                                                        inapplicable in the HBCD SNUR, which                  particular country, which is estimated
                                                including those listed in TSCA section                  would have meant that importers and
                                                5(a)(2). Once EPA determines that a use                                                                       to cost less than $80 on average per
                                                                                                        processors of HBCD as part of any                     notification.
                                                of a chemical substance is a significant                article would be subject to the rule. As
                                                new use, TSCA section 5(a)(1)(B)                        stated above in this section, the final               II. Overview of the Chemical
                                                requires persons to submit a significant                rule makes the exemption inapplicable                 Substances Subject to This Rule
                                                new use notice (SNUN) to EPA at least                   only to importers and processors of
                                                90 days before they manufacture or                                                                            A. What chemicals are included in the
                                                                                                        HBCD as part of textile articles. The                 SNUR?
                                                process the chemical substance for that                 second change from the proposed rule is
                                                use (15 U.S.C. 2604(a)(1)(B)). As                       EPA’s clarification to the proposed                     This SNUR applies to two chemical
                                                described in Unit V., the general SNUR                  definition of ‘‘consumer textile.’’ For               substances: Hexabromocyclododecane
                                                provisions are found at 40 CFR part 721,                further explanation of both changes, see              (CASRN 25637-99-4) and 1,2,5,6,9,10-
                                                subpart A.                                              Unit X.                                               hexabromocyclododecane (CASRN
                                                C. What action is the Agency taking?                    D. Why is the Agency taking this action?              3194-55-6). Hexabromocyclododecane is
                                                                                                                                                              manufactured by adding bromine to
                                                   This final rule designates use of                      This SNUR is necessary to ensure that               technical grade 1,5,9-cyclododecatriene
                                                HBCD in consumer textiles (other than                   EPA receives timely advance notice of                 to make a chemical substance where the
                                                for use in motor vehicles) as a                         any future manufacturing and                          positions of the six bromine atoms are
                                                significant new use. EPA has concluded                  processing of HBCD for new uses that                  not specified on the cyclododecane ring,
                                                that the only current use of HBCD for                   may produce changes in human and                      corresponding to CASRN 25637-99-4.
                                                consumer textiles is in motor vehicles.                 environmental exposures. The rationale                The specific 1,2,5,6,9,10-
                                                That use and other current uses of                      and objectives for this SNUR are                      hexabromocyclododecane isomer
                                                HBCD (e.g., in non-consumer textiles                    explained in Unit III.                                (CASRN 3194-55-6) is the major
                                                and in building insulation) are not                                                                           component of CASRN 25637-99-4.
                                                covered by this rule, not because EPA                   E. What are the estimated incremental
                                                has determined that these uses are not                  impacts of this action?                               B. What is the production volume of
                                                ‘‘significant,’’ but because they are                      EPA has evaluated the potential costs              HBCD?
                                                ongoing and thus not ‘‘new uses.’’                      of establishing SNUR reporting
                                                   This action requires persons who                     requirements for potential                              The most recent production volume
                                                intend to manufacture or process HBCD                   manufacturers and processors of the                   submitted to EPA for Chemical Data
                                                as part of consumer textiles (other than                chemical substances included in this                  Reporting was in 2012 and was claimed
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                                                for use in motor vehicles) to notify EPA                final rule. This analysis, which is                   as Confidential Business Information
                                                at least 90 days before commencing that                 available in the docket, is discussed in              (CBI). Earlier Inventory Update Rule
                                                activity. The definition of ‘‘consumer                  Unit IX., and is briefly summarized                   (IUR) 1 submissions to EPA reported
                                                textile’’ in this rule can include the                  here. In the event that a SNUN is                       1 As of August 16, 2011, the Inventory Update
                                                following examples: bolts of cloth and                  submitted, costs are estimated to be less             Rule (IUR) was renamed ‘‘Chemical Data Reporting
                                                draperies, as well as textiles that are                 than $8,600 per SNUN submission for                   rule (CDR).’’ See the TSCA Inventory Update
                                                part of household furniture and                         large business submitters and $6,200 per              Reporting Modifications; Chemical Data Reporting



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

                                                annual U.S. import/production volumes                     vehicles, there is concern about whether              genes (mRNA) associated with liver and
                                                of 10–50 million pounds (lbs.) in 2002                    viable substitutes will be available.                 thyroid function (Ref. 21). Thinner egg
                                                and 2006 for CASRN 3194-55-6 (Ref. 3).                    Thus, after considering the available                 shells were measured in American
                                                IUR submissions to EPA reported                           information, EPA concludes that HBCD                  kestrels exposed to a combination of
                                                annual U.S. import/production volumes                     is not used in consumer textiles other                polybrominated diphenyl ethers and
                                                of 10,000 to 500,000 lbs. in 2002 for                     than for use in motor vehicles.                       HBCD (Ref. 22).
                                                CASRN 25637-99-4; no import/
                                                                                                          D. What are the potential health and                  E. What are the potential sources and
                                                production was reported in 2006 (Ref.
                                                                                                          environmental effects of HBCD?                        routes of exposure to HBCD?
                                                4).
                                                                                                             This section summarizes results of                    There is potential for HBCD to be
                                                C. What are the uses of HBCD?                             laboratory testing of 1,2,5,6,9,10-                   released at any point in the lifecycle of
                                                   The major use of HBCD is in                            hexabromocyclododecane (CASRN                         consumer textiles treated with HBCD.
                                                polystyrene foam insulation boards used                   3194-55-6). The results are also valid for            There is potential for release when the
                                                in construction. In the IUR data from                     unspecified hexabromocyclododecane                    HBCD is being formulated into the
                                                2006, one manufacturer/importer of                        (CASRN 25637-99-4) and therefore                      textile coating, as well as when it is
                                                HBCD (CASRN 3194-55-6) reported the                       relevant to both chemical substances in               applied to the textile material. In
                                                use of the chemical substance under the                   this rule.                                            addition, because HBCD is not
                                                NAICS code for textile and fabric                            1. Human health effects. Animal                    chemically bound to its substrate (the
                                                finishing mills. This use constituted less                studies give an indication of potential               protected textile material), HBCD can be
                                                than 1 percent of the total production                    human health effects of HBCD. Repeated                released during the service life of the
                                                volume of the chemical substance. The                     exposure of HBCD to rats showed                       textile material containing it, including
                                                reporting does not distinguish between                    disturbances in thyroid hormone system                release into water used to wash the
                                                commercial and consumer use (Ref. 4).                     and effects on the thyroid in males and               treated textiles or into the air via dust
                                                However, as explained below, and in                       females (Ref. 10). A 2-generation                     particulates. Workers and the general
                                                greater detail in the Economic Analysis                   reproductive toxicity study in rats                   population can be exposed to HBCD
                                                for this rule, EPA concluded that HBCD                    exposed to HBCD showed a treatment-                   through direct contact as it migrates
                                                is not used in consumer textiles (as                      related reproductive effect (a significant            across land, in air, and in water by
                                                defined by this regulation) other than                    decrease in the number of primordial                  diffusion or environmental transport.
                                                for use in motor vehicles (Ref. 5).                       follicles in the F1 females) (Ref. 11).               Other opportunities for release can
                                                   Information available to EPA                           Although this decrease in ovarian                     occur at the end of the lifecycle of
                                                indicates that the use of HBCD in                         follicles did not affect any reproductive             HBCD-treated textiles when they are
                                                textiles is as a coating to function as a                 parameters in this study, this effect is              transported and incinerated or
                                                flame retardant. EPA conducted                            suggestive of potential reproductive                  landfilled (Ref. 23). Evidence strongly
                                                research to determine whether HBCD                        toxicity. Developmental effects were                  suggests there is potential for exposure
                                                was used in textile applications for end                  observed, including delays in eye                     to the general population from HBCD in
                                                products sold to consumers. In 2010, an                   opening in the second (F2) generation                 the environment and also from products
                                                HBCD expert with the Consumer                             and transient changes in learning and                 and dust in the home and workplace.
                                                Product Safety Commission (CPSC)                          memory in F1 males, but exposure did                  HBCD is found worldwide in the
                                                expressed to EPA his understanding that                   not cause any changes in spontaneous                  environment and wildlife (Note: Only
                                                HBCD is used only in non-consumer                         behavior. In addition, there was high                 the specific 1,2,5,6,9,10-
                                                textiles such as firefighters’ suits (Ref.                and dose-dependent pup mortality                      hexabromocyclododecane isomer
                                                6). In 2011, EPA requested information                    during lactation (Ref. 11).                           (CASRN 3194–55–6) or the alpha, beta,
                                                from current and former manufacturers                        2. Environmental effects. Laboratory               and gamma isomers are monitored in
                                                of HBCD. The responses indicate that                      studies have shown that HBCD is                       biota and the environment, not the
                                                only one manufacturer sells HBCD for                      capable of producing adverse effects in               unspecified hexabromocyclododecane
                                                textile uses. The company does not                        a variety of organisms including algae,               (CASRN 25637–99–4)). Human
                                                know whether the end use of any of                        fish, invertebrates, and soil-dwelling                exposure is evidenced from its presence
                                                those textiles is a consumer article (Ref.                organisms at environmentally relevant                 in breast milk, adipose tissue, and blood
                                                7). Additionally, a representative of                     concentrations. HBCD is toxic to algae                (Ref. 24). The chemical substances
                                                Herman Miller, a company which                            and acutely toxic to fish embryos (Ref.               bioaccumulate and biomagnify in food
                                                manufactures commercial and consumer                      12), (Ref. 13). A number of sub-lethal                chains. The frequent detection of HBCD
                                                furniture, told EPA that HBCD is not in                   effects (e.g., altered thyroid status,                over a large geographic area, with
                                                its products (Ref. 8).                                    protein metabolism, oxidative stress,                 increasing exposure in remote locations
                                                   EPA also received information from a                   reproductive activity), have also been                such as the Arctic, where no
                                                group of textile formulators that the end                 observed in fish (Ref. 14), (Ref. 15), (Ref.          demonstrable local sources exist that
                                                uses of HBCD-containing textiles are for                  16), and (Ref. 17). One study reported a              can account for these exposures, suggest
                                                military, institutional, and aviation uses                reduced number and size of daphnid                    that HBCD is persistent and undergoes
                                                only (Ref. 9). EPA found that a small                     offspring in first and second generations             long-range transport (Ref. 25).
                                                amount of HBCD is used in motor                           (Ref. 18). Thyroid hormone-dependent                     To the extent HBCD is present in
                                                vehicles sold in the United States,                       developmental effects were observed in                household applications (e.g., building
                                                including in floor mats, headliners, and                  tadpoles (Xenopus laevis) exposed to                  foam, furniture upholstery, carpeting),
                                                possibly other interior fabrics. EPA                      HBCD (Ref. 19). HBCD has been                         children could be exposed, especially
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                                                received a public comment stating that                    reported to reduce egg production and                 given children’s increased exposure to
                                                although automakers are working                           lower biomass in soil dwelling                        dust and the hand-to-mouth ingestion
                                                towards ultimately phasing out the use                    organisms (Lumbriculus variegatus)                    pathway. In vitro experiments
                                                of HBCD in consumer textiles in motor                     (Ref. 20). HBCD administered to chicken               conducted to demonstrate leaching of
                                                                                                          (Gallus domesticus) embryonic                         HBCD from textiles showed that the
                                                final rule in the Federal Register issue of August        hepatocytes in vitro resulted in                      presence of simulated biological fluids
                                                16, 2011 (76 FR 50816).                                   significant alterations in expression of              (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                   B. Objectives                                         not persistent and bioaccumulative with
                                                samples (Ref. 26). HBCD exposure                          Based on the considerations described               the potential for long range transport.
                                                values for children have been estimated                 in the proposal (Ref. 1), and in the                  The fourth factor is ‘‘the reasonably
                                                from mouthing of textiles and from                      response to public comments, EPA                      anticipated manner and methods of
                                                ingestion of dust (Ref. 27).                            expects to achieve the following                      manufacturing, processing, distribution
                                                                                                        objectives with regard to the significant             in commerce, and disposal of a
                                                   HBCD has been measured in air and
                                                                                                        new use that is designated in this final              chemical substance’’ (TSCA section
                                                sediment in Scandinavian countries,
                                                                                                        rule:                                                 5(a)(2)(D)). Should a significant new use
                                                North America and Asia (Ref. 24), (Ref.
                                                                                                          1. EPA will receive notification of any             be planned, EPA anticipates that the
                                                28). HBCD has also been measured in                                                                           new use would raise important
                                                marine and Arctic mammals, freshwater                   person’s intent to manufacture or
                                                                                                        process HBCD for the described                        questions such as what the impacts
                                                and marine fish, aquatic invertebrates,                                                                       would be on consumer exposure,
                                                birds and bird eggs, and one plant                      significant new use before that activity
                                                                                                        begins;                                               worker exposure, user exposure, or
                                                species (Ref. 24), (Ref. 28), and (Ref. 29).                                                                  release of the substance to the
                                                                                                          2. EPA will have an opportunity to
                                                   For more information on HBCD                         review and evaluate data submitted in a               environment, and what potential
                                                concerning its physical-chemical                        SNUN before the notice submitter                      controls are available to limit such
                                                properties, fate, releases, and human                   begins manufacturing or processing                    exposures and releases (see Unit II. E.).
                                                and environmental exposure, see EPA’s                   HBCD for the described significant new                   In addition to considering the four
                                                HBCD Problem Formulation and Initial                    use; and                                              factors in section 5(a)(2) of TSCA, EPA
                                                Assessment dated August 2015 (Ref. 30).                   3. EPA will be able to regulate the                 considered relevant information about
                                                                                                        prospective manufacturing or                          the toxicity of HBCD, and likely human
                                                III. Rationale and Objectives                                                                                 exposures and environmental releases
                                                                                                        processing of HBCD before the
                                                A. Rationale                                            described significant new use of the                  associated with possible uses (see Unit
                                                                                                        chemical substance(s) occurs, provided                II.D. and II.E.). EPA has concluded that
                                                   Consistent with EPA’s past practice                  that regulation is warranted pursuant to              the factors taken together weigh in favor
                                                for issuing SNURs under TSCA section                    TSCA sections 5(e), 5(f), 6, or 7.                    of determining that manufacture or
                                                5(a)(2), EPA’s decision to issue a SNUR                                                                       processing of HBCD for any consumer
                                                for a particular chemical use need not                  IV. Significant New Use Determination                 textile use (other than for use in motor
                                                be based on an extensive evaluation of                    As required by section 5(a)(2) of                   vehicles) would be a significant new use
                                                the hazard, exposure, or potential risk                 TSCA, EPA considered the four specific                such that the Agency should have an
                                                associated with that use. Rather, the                   factors contained in that section along               opportunity to analyze the new use
                                                Agency’s action is based on EPA’s                       with other relevant factors in making its             before such use (and potential
                                                determination that, if the use begins or                determination of the significant new use              exposures) occurs. Further explanation
                                                resumes, it may present a risk that EPA                 of HBCD for this rule. The first factor is            of EPA’s consideration of those factors
                                                should evaluate under TSCA before the                   the ‘‘projected volume of manufacturing               is contained in the Response to
                                                manufacturing or processing for that use                and processing of a chemical substance’’              Comments document (Ref. 2) in the
                                                begins. Since the new use does not                      (TSCA section 5(a)(2)(A)). The potential              docket for this rule (EPA–HQ–OPPT–
                                                currently exist, deferring a detailed                   increase in volume of this persistent,                2011–0489).
                                                consideration of potential risks or                     bioaccumulative and toxic chemical                    V. Applicability of General Provisions
                                                hazards related to that use is an effective             from consumer textile use weighs in
                                                use of resources. If a person decides to                favor of determining that consumer                       General provisions for SNURs appear
                                                begin manufacturing or processing the                   textile use (other than for use in motor              under 40 CFR part 721, subpart A.
                                                chemical for the use, the notice to EPA                 vehicles) is a significant new use. The               These provisions describe persons
                                                allows EPA to evaluate the use                          second factor is ‘‘the extent to which a              subject to the rule, recordkeeping
                                                according to the specific parameters and                use changes the type or form of                       requirements, and exemptions to
                                                circumstances surrounding that                          exposure of human beings or the                       reporting requirements.
                                                intended use.                                           environment to a chemical substance’’                    Provisions relating to user fees appear
                                                                                                        (TSCA section 5(a)(2)(B)). Human                      at 40 CFR part 700, subpart C.
                                                   As summarized in Units II.D., and                    exposure to consumer textile use may                  Additional provisions governing SNUN
                                                II.E., EPA has concerns regarding the                   differ from exposure to commercial                    submissions appear in 40 CFR part 720,
                                                potential exposure to and human health                  textiles and other current uses. The                  which are the notice requirements and
                                                and environmental effects of HBCD.                      third factor is ‘‘the extent to which a use           EPA regulatory procedures that
                                                EPA believes that, in the future, HBCD                  increases the magnitude and duration of               submitters of Premanufacture Notices
                                                could be manufactured or processed for                  exposure of human beings or the                       (PMNs) under TSCA section 5(a)(1)(A)
                                                consumer textile uses (in addition to the               environment to a chemical substance’’                 must follow (see 40 CFR 721.1(c)).
                                                current textiles in motor vehicles).                    (TSCA section 5(a)(2)(C)). Because                    SNUR requirements also include the
                                                Accordingly, EPA wants the                              HBCD is a persistent, bioaccumulative,                information submission requirements of
                                                opportunity to evaluate and control,                    and toxic chemical that has potential for             TSCA sections 5(b) and 5(d)(1), and
                                                where appropriate, activities associated                long range transport (Ref. 1), even a                 companies may wish to consider
                                                with consumer textile use, if such                      small increase in the amount that is                  whether they are eligible for the
                                                manufacturing or processing were to                     manufactured and processed, and thus                  exemptions authorized by TSCA
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                                                commence in the future. The required                    subsequently used, would have a larger                sections 5(h)(1), (h)(2), (h)(3), and (h)(5).
                                                notification provided by a SNUN will                    impact on potential exposures in terms                Once EPA receives a SNUN, EPA may
                                                provide EPA with the opportunity to                     of the number of people exposed and/                  take regulatory action under TSCA
                                                evaluate activities associated with the                 or the amount of exposure. The                        sections 5(e), 5(f), 6 or 7 to control the
                                                significant new use and an opportunity                  potential for exposure would last for                 activities on which it has received the
                                                to protect against potential unreasonable               longer periods of time over a significant             SNUN. If EPA does not take action, EPA
                                                risks, if any, from exposure to HBCD.                   area as compared to a chemical that is                is required under TSCA section 5(g) to


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                                                             Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations                                         57297

                                                explain in a Federal Register notice its                requirements and wait until the                       the same notice requirements and EPA
                                                reasons for not taking action.                          notification review period, including all             regulatory procedures as persons
                                                   Exemptions from SNUR requirements                    extensions, expires. EPA has                          submitting a PMN, including
                                                are found at 40 CFR 721.45. For this                    promulgated provisions (40 CFR                        submission of test data on health and
                                                SNUR, 40 CFR 721.45(f), which exempts                   721.45(h)) to allow persons to comply                 environmental effects as described in 40
                                                persons who import or process a                         with this SNUR before the effective                   CFR 720.50. SNUNs must be on EPA
                                                chemical substance as part of an article,               date. If a person meets the conditions of             Form No. 7710–25, generated using e-
                                                does not apply to importers and                         advance compliance under 40 CFR                       PMN software, and submitted to the
                                                processors of HBCD as part of a textile,                721.45(h), that person is considered to               Agency in accordance with the
                                                regardless of whether the textile is a                  have met the requirements of the final                procedures set forth in 40 CFR 721.25
                                                consumer textile, as further explained in               SNUR for those activities.                            and 720.40. E–PMN software is
                                                Unit X.                                                                                                       available electronically at http://
                                                   Persons who export or intend to                      VII. Test Data and Other Information
                                                                                                                                                              www.epa.gov/opptintr/newchems. For
                                                export a chemical substance identified                    EPA recognizes that TSCA section 5                  first-time submitters of a TSCA section
                                                in a proposed or final SNUR are subject                 does not require developing any                       5 notice, see requirements at Unit I. E.
                                                to the export notification provisions of                particular test data before submission of
                                                TSCA section 12(b). The regulations that                a SNUN. There are two exceptions: (1)                 IX. Economic Analysis
                                                interpret TSCA section 12(b) appear at                  Development of test data is required                    EPA has evaluated the potential costs
                                                40 CFR part 707, subpart D. Persons                     where the chemical substance subject to               of establishing SNUR reporting
                                                who import a chemical substance                         the SNUR is also subject to a test rule               requirements for potential
                                                identified in a final SNUR are subject to               under TSCA section 4 (see TSCA                        manufacturers and processors of HBCD
                                                the TSCA section 13 import certification                section 5(b)(1)); and (2) development of              in consumer textiles. The evaluation is
                                                requirements, codified at 19 CFR 12.118                 test data may be necessary where the                  in the ‘‘Economic Analysis of the Final
                                                through 12.127 (see also 19 CFR 127.28).                chemical substance has been listed                    Significant New Use Rule for
                                                Those persons must certify that the                     under TSCA section 5(b)(4) (see TSCA                  Hexabromocyclododecane (HBCD)’’
                                                shipment of the chemical substance                      section 5(b)(2)). In the absence of a                 (Ref. 5). It is briefly summarized here
                                                complies with all applicable rules and                  TSCA section 4 test rule or a TSCA                    and is available in the docket for this
                                                orders under TSCA, including any                        section 5(b)(4) listing covering the                  rule (EPA–HQ–OPPT–2011–0489). EPA
                                                SNUR requirements. The EPA policy in                    chemical substance, persons are                       added additional information to the
                                                support of import certification appears                 required only to submit test data in their            economic analysis for HBCD in response
                                                at 40 CFR part 707, subpart B (see 40                   possession or control and to describe                 to public comments.
                                                CFR 721.20). The TSCA section 13                        any other data known to or reasonably                 A. SNUN Submission
                                                import certification requirement applies                ascertainable by them (15 U.S.C.
                                                to articles containing a chemical                       2604(d); 40 CFR 720.50 and 40 CFR                        The costs of submitting a SNUN
                                                substance or mixture if so required by                  721.25). However, as a general matter,                would be incurred when a company
                                                the Administrator by a specific rule                    EPA recommends that SNUN submitters                   decides to pursue a significant new use
                                                under TSCA. At this time EPA is not                     include data that would permit a                      of one of these chemicals. In the event
                                                requiring import certification for these                reasoned evaluation of risks posed by                 that a SNUN is submitted, costs are
                                                chemical substances as part of articles.                the chemical substance during its                     estimated at approximately $8,600 per
                                                                                                        manufacture, processing, use,                         SNUN submission for large businesses
                                                VI. Applicability of the Final Rule to                                                                        and $6,200 per SNUN submission for
                                                Uses Occurring Before the Effective                     distribution in commerce, or disposal.
                                                                                                        EPA encourages persons to consult with                small businesses, and include the cost
                                                Date of the Final Rule
                                                                                                        the Agency before submitting a SNUN.                  to prepare and submit the SNUN and
                                                   As discussed in the Federal Register                 As part of this optional pre-notice                   the payment of a user fee. Businesses
                                                of April 24, 1990 (55 FR 17376) (Ref.                   consultation, EPA would discuss                       that submit a SNUN are either subject to
                                                31), EPA has decided that the intent of                 specific data it believes may be useful               a $2,500 user fee required by 40 CFR
                                                TSCA section 5(a)(1)(B) is best served by               in evaluating a significant new use.                  700.45(b)(2)(iii), or, if they are a small
                                                designating a use as a significant new                  SNUNs submitted for significant new                   business with annual sales of less than
                                                use as of the date of publication of the                uses without any test data may increase               $40 million when combined with those
                                                proposed rule rather than as of the                     the likelihood that EPA would take                    of the parent company (if any), a
                                                effective date of the final rule. If uses               action under TSCA section 5(e) to                     reduced user fee of $100 (40 CFR
                                                begun after publication of the proposed                 prohibit or limit activities associated               700.45(b)(1)). In its evaluation of this
                                                rule were considered ongoing rather                     with this chemical. SNUN submitters                   final rule, EPA also considered the
                                                than new, it would be difficult for EPA                 should be aware that EPA will be better               potential costs a company might incur
                                                to establish SNUR notification                          able to evaluate SNUNs that provide                   by avoiding or delaying the significant
                                                requirements, because a person could                    detailed information on:                              new use in the future, but these costs
                                                defeat the SNUR by initiating the                         1. Human exposure and                               have not been quantified.
                                                proposed significant new use before the                 environmental releases that may result
                                                rule became final, and then argue that                                                                        B. Import or Processing HBCD as Part of
                                                                                                        from the significant new use of the                   a Textile
                                                the use was ongoing as of the effective                 chemical substance.
                                                date of the final rule. Thus, persons who                 2. Potential benefits of the chemical                  Persons who import or process HBCD,
                                                began commercial manufacture or                         substance.                                            including as part of a textile article, are
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                                                processing of HBCD for a significant                      3. Information on risks posed by the                covered by this rule. As explained in
                                                new use after the publication of the                    chemical substance compared to risks                  Unit X., EPA is making the exemption
                                                proposed rule must cease any such                       posed by potential substitutes.                       at 40 CFR 721.45(f) inapplicable for
                                                activity before the effective date of the                                                                     importers or processors of HBCD as part
                                                final rule. To resume their activities,                 VIII. SNUN Submissions                                of a textile article. Accordingly,
                                                these persons must comply with all                        According to 40 CFR 721.1(c), persons               importers and processors of HBCD as
                                                applicable SNUR notification                            submitting a SNUN must comply with                    part of textile articles including


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                                                57298        Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations

                                                consumer and non-consumer textile                       and EPA’s complete response (Ref. 2)                  of textiles, so by requiring importers and
                                                articles, are subject to this SNUR. This                are available in the docket for this final            processors of all textiles containing
                                                provision is explained in Unit X.                       rule (EPA–HQ–OPPT–2011–0489). EPA                     HBCD to meet the notification
                                                   Some firms have an understanding of                  made two changes to the regulatory text               requirements at 40 CFR 721.5, EPA is
                                                the contents of the articles they import                as a result of issues raised in public                ensuring that the regulatory
                                                or process. However, EPA acknowledges                   comments; these changes are explained                 mechanisms designed to prevent
                                                that importers and processors of articles               below in Section A of this unit. A                    significant new uses without notice to
                                                may have varying levels of knowledge                    summary of the remaining issues is in                 the Agency will apply to import and
                                                about the chemical content of the                       Section B of this unit, and the full                  processing of HBCD-containing articles
                                                articles that they import or process.                   discussion of these comments is in the                that have the potential to be used as
                                                These parties may take steps to become                  docket.                                               consumer textiles.
                                                familiar with the requirements of the                                                                            Thus, EPA is making the exemption at
                                                rule. And, while not required by the                    A. Changes to Regulatory Text as a                    40 CFR 721.45(f) inapplicable for
                                                SNUR, these parties may take additional                 Result of Public Comments                             importers and processors of HBCD as
                                                steps to determine whether HBCD is                         Article exemption. Two commenters                  part of a textile article, rather than as
                                                part of the articles that they are                      indicated that there was some concern                 part of all articles. Accordingly,
                                                considering importing or processing.                    regarding the breadth of the lifting of the           importers and processors of HBCD as
                                                This determination may involve                          exemption for persons who import or                   part of textile articles, regardless of
                                                activities such as gathering information                process chemical substances as part of                whether those textiles are consumer
                                                from suppliers along the supply chain,                  an article. EPA had proposed to make                  textiles, are subject to this final SNUR.
                                                and/or testing samples of the article                   the exemption at 40 CFR 721.45(f)                     The term ‘‘textile’’ is intended to be read
                                                itself. Costs vary across the activities                inapplicable to this rule.                            in conjunction with the definition of
                                                chosen. Cost ranges are presented in the                   The proposal preamble stated that                  ‘‘consumer textile’’ and includes, but is
                                                ‘‘Economic Analysis of the Final                        ‘‘EPA is concerned that exempting                     not limited to, bolts of cloth and
                                                Significant New Use Rule for                            HBCD as part of articles would render                 draperies, as well as textiles that are
                                                Hexabromocyclododecane (HBCD)’’                         the SNUR less effective because of the                part of upholstered household furniture
                                                (Ref. 5). Given existing regulatory                     possibility that consumer textile articles            and mattresses. The definition of
                                                limitations on HBCD internationally,                    containing HBCD, the primary concern                  ‘‘consumer textile’’ for this rule is in the
                                                industry-wide processes, and resources                  of EPA associated with this proposed                  regulatory text at 40 CFR 721.10281.
                                                that support companies in                               rule, could be imported or processed for              The Agency’s decision to lift the
                                                understanding and managing their                        uses subject to this proposed SNUR                    exemption for importers and processors
                                                supply chains, EPA believes that article                without the submission of a SNUN. This                of HBCD as part of textile articles rather
                                                importers who choose to investigate                     proposed rule would not include the                   than for importers and processors of all
                                                their products would incur costs at the                 exemption at § 721.45(f).’’ 77 FR 17386,              HBCD-containing articles is specific to
                                                lower end of the ranges presented in the                17391, March 26, 2012. (Ref. 1)                       this SNUR and based on the particular
                                                Economic Analysis as a result of this                   Accordingly, the proposed regulatory                  significant new use in this SNUR.
                                                rule. For those companies choosing to                   text stated that ‘‘[t]he provisions of                   Definition of consumer textile. One of
                                                undertake actions to assess the                         § 721.45(f) do not apply to this section.             the seven commenters stated that the
                                                composition of the articles they import                 A person who imports or processes the                 definition of ‘‘consumer textile’’ in the
                                                or process, EPA expects that importers                  chemical substances identified in                     proposed SNUR is ‘‘rather nuanced . . .
                                                and processors would take actions that                  paragraph (a)(1) of this section as part of           [and] contains several terms that are not
                                                are commensurate with the company’s                     an article for the significant new use                self-evident on their face.’’ The
                                                perceived likelihood that a chemical                    described in paragraph (a)(2) of this                 proposed definition at 77 FR 17386,
                                                substance might be a part of an article,                section must submit a significant new                 17394, March 26, 2012 was: ‘‘Consumer
                                                and the resources it has available.                     use notice (SNUN).’’                                  textile means any cloth, fabric, or other
                                                Example activities and their costs are                     Although the Agency has the                        item produced during the milling
                                                provided in the accompanying                            authority to lift the exemption for                   process (including spinning, weaving,
                                                Economic Analysis of this rule.                         importers and processors of HBCD as                   knitting, felting, or finishing), consisting
                                                                                                        part of all articles, such a broad                    in whole or as part of a product that is
                                                C. Export Notification                                  application is not necessary or desirable             sold to or made available to a private
                                                  EPA regulations under TSCA section                    for this rule. This is because there are              individual who uses the product in or
                                                12(b) (15 U.S.C. 2611(b)) at 40 CFR part                ongoing uses of HBCD as part of articles              around a permanent or temporary
                                                707, subpart D require that, for                        that are unlikely to be diverted to the               household or residence, during
                                                chemicals subject to a proposed or final                significant new use.                                  recreation, or for any personal use or
                                                SNUR, a company must notify EPA of                         EPA considered a narrow approach                   enjoyment. Consumer textiles include
                                                the first export or intended export to a                that would have made the exemption                    but are not limited to draperies and
                                                particular country of an affected                       inapplicable to importers and                         textiles that are part of upholstered
                                                chemical substance. EPA estimated the                   processors of HBCD as part of consumer                household furniture and mattresses’’
                                                one-time cost of preparing and                          textiles only, not all textiles. EPA is               (Ref. 1). The proposal defined
                                                submitting an export notification to be                 concerned that if the inapplicability of              ‘‘consumer textile’’ to distinguish
                                                $80. The total costs of export                          the exemption was limited to consumer                 consumer textiles from other textiles
                                                notification would vary per chemical,                   textiles, undifferentiated textiles (e.g.,            (e.g., commercial, industrial,
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                                                depending on the number of required                     the type of textiles that could be for a              institutional, military). While this rule
                                                notifications (i.e., number of countries                consumer use or a non-consumer use),                  does not use the term ‘‘consumer
                                                to which the chemical is exported).                     could be imported or processed and                    product’’ as defined in 40 CFR 721.3,
                                                                                                        distributed in commerce for consumer                  some of the terms and phrases used in
                                                X. Response to Public Comments                          use without notification to the Agency.               the consumer textile definition,
                                                  EPA received seven public comments                    The category ‘‘consumer textiles’’ is                 including those that the commenter
                                                on the proposed SNUR. The comments                      fully subsumed by the broader category                claims are ‘‘not self-evident on their


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                                                             Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Rules and Regulations                                           57299

                                                face,’’ are the same as those in the                    product as defined by 40 CFR 721.3.                   5. EPA Environmental Economics and
                                                consumer product definition.                            EPA’s response is that the HBCD SNUR                       Technology Division (EETD), Economic
                                                   However, in the course of considering                does not rely on the definition of                         and Policy Analysis Branch (EPAB).
                                                the comments, EPA revisited the                         consumer product as defined by 40 CFR                      Economic Analysis of the Final
                                                                                                                                                                   Significant New Use Rule for
                                                definition of consumer textile, and                     721.3. Instead, the rule specifically                      Hexabromocyclododecane (HBCD),
                                                concluded it could be clarified in                      defines ‘‘consumer textile’’ and the                       Washington, DC. 2015.
                                                certain respects. In this final rule, EPA               definition would ordinarily encompass                 6. Consumer Product Safety Commission.
                                                is making minor changes to clarify the                  textiles used in motor vehicles. Another                   Personal communication with Dr.
                                                definition, as explained below. The                     commenter said the proposed exclusion                      Michael Babich, Chemist, United States
                                                changes do not impact the scope of the                  for consumer textiles in motor vehicles                    Consumer Product Safety Commission
                                                SNUR, as the final definition of                        is appropriate but that the proposed                       (CPSC). March 16, 2010.
                                                ‘‘consumer textile’’ covers only those                  SNUR appears to be a signal that EPA                  7. ACC. Personal communication with
                                                textiles that the Agency intended to                                                                               Jackson Morrill, Director of Chemical
                                                                                                        would like HBCD to be phased out of
                                                                                                                                                                   Products of the American Chemistry
                                                cover in the proposal. The final                        use in textiles in vehicles. The                           Council (ACC). February 16, 2011.
                                                definition is: ‘‘Consumer textile means                 commenter is concerned that the                       8. Herman Miller. Personal communication
                                                any cloth, fabric, or other item produced               phasing out of HBCD would leave the                        with Gabe Wing of Herman Miller, Inc.
                                                during a milling process for textiles                   automotive industry without a                              March 30, 2011.
                                                (including spinning, weaving, knitting,                 substitute. EPA’s response is that the                9. Eagle Performance Products. Personal
                                                felting, or finishing), that is sold or                 exclusion from this SNUR for                               communication with John Friddle,
                                                made available either as a product or as                manufacture and import of HBCD as                          President of Eagle Performance Products.
                                                part of a product, to a private individual              part of textiles in motor vehicles is not                  March 3, 2011.
                                                who uses it in or around a permanent                    a signal that EPA would like this use of              10. Chengelis. An oral (gavage) 90 day
                                                                                                                                                                   toxicity study of HBCD in rats. Study No.
                                                or temporary household or residence,                    HBCD to be phased out. Use of HBCD                         WIL–186012. WIL Research Laboratories,
                                                during recreation, or for any personal                  in textiles in motor vehicles is                           Inc. Ashland, Ohio, USA. 2001.
                                                use or enjoyment. Consumer textiles can                 unaffected by this SNUR because the                   11. Ema, M., et al. Two-generation
                                                include, but are not limited to, bolts of               use is ongoing. EPA continues to                           reproductive toxicity study of the flame
                                                cloth and draperies, as well as textiles                evaluate ongoing uses of HBCD as part                      retardant hexabromocyclododecane in
                                                that are part of upholstered household                  of its TSCA Work Plan chemical                             rats. Reproductive Toxicology. April
                                                furniture and mattresses.’’ Because there               assessments (see http://www.epa.gov/                       2008. 25(3), pp. 335–351.
                                                are milling processes that do not relate                oppt/existingchemicals/pubs/                          12. Desjardins, et al.
                                                to textiles, the final definition clarifies             riskassess.html). The remaining three                      Hexabromocyclododecane (HBCD): A 72-
                                                that only items produced during milling                 commenters supported the proposed                          hour toxicity test with the marine diatom
                                                                                                                                                                   (Skeletonema costatum). Final Report.
                                                processes for textiles are covered. The                 SNUR.                                                      Wildlife International, Ltd. Easton,
                                                final definition also clarifies that the                                                                           Maryland, USA. 2004. p. 66.
                                                textile itself can be a consumer textile                XI. References
                                                                                                                                                              13. Deng, et al. Hexabromocyclododecane-
                                                and that the textile need not be part of                  The following is a listing of the                        induced developmental toxicity and
                                                a larger product like a mattress. This                  documents that are specifically                            apoptosis in zebrafish embryos. Aquatic
                                                clarification is made in two places: By                 referenced in this action. The docket                      Toxicology. June 2009. 93(1), pp. 29–36.
                                                changing ‘‘consisting in whole or as part               includes these documents and other                    14. Palace, et al. Biotransformation enzymes
                                                of a product’’ to ‘‘as a product or as part             information considered by EPA in                           and thyroid axis disruption in juvenile
                                                of a product’’ and by adding ‘‘bolts of                 developing this rule, including                            rainbow trout (Oncorhynchus mykiss)
                                                cloth’’ as an example of a type of textile.             documents that are referenced within                       exposed to hexabromocyclododecane
                                                                                                        the documents that are in the docket,                      diastereoisomers. Environmental Science
                                                B. Summary of Response to Remaining                     even if the referenced document is not                     and Technology. February 2008. 42(6),
                                                Public Comments                                                                                                    pp. 1967–1972.
                                                                                                        physically located in the docket. For                 15. Kling, et al. Proteomic studies in
                                                   Some commenters questioned                           assistance in locating these other                         zebrafish liver cells exposed to the
                                                whether EPA has the legal authority to                  documents, please consult the technical                    brominated flame retardants HBCD and
                                                regulate articles under TSCA. EPA’s                     person listed under FOR FURTHER                            TBBPA. Ecotoxicology and
                                                response is that TSCA section 5                         INFORMATION CONTACT.                                       Environmental Safety. November 2009.
                                                provides EPA with authority to regulate                 1. EPA. Significant New Use Rule for
                                                                                                                                                                   72, pp. 985–1993.
                                                chemical substances, including                                                                                16. Zhang, et al. Induction of hepatic
                                                                                                            Hexabromocyclododecane and
                                                chemical substances that are part of                        1,2,5,6,9,10-Hexabromocyclododecane:                   enzymes and oxidative stress in Chinese
                                                articles. Commenters also stated that                       Proposed Rule. Federal Register (77 FR                 rare minnow (Gobiocypris rarus)
                                                EPA should establish a policy                               17386, March 26, 2012) (FRL–9341–6).                   exposed to waterborne
                                                                                                            Available at http://www.gpo.gov/fdsys/                 hexabromocyclododecane (HBCD).
                                                framework by rule for the issuance of                                                                              Aquatic Toxicology. January 2008. 86(1),
                                                article SNURs. EPA’s response is that                       browse/
                                                                                                            collection.action?collectionCode=FR.                   pp. 4–11.
                                                development of a ‘‘policy framework’’ is                                                                      17. Ronisz, et al. Sublethal effects of the
                                                                                                        2. EPA. Response to Public Comments on
                                                not necessary before reaching the                           Proposed Significant New Use Rule for                  flame retardants
                                                conclusion, with respect to HBCD, that                      Hexabromocyclododecane and                             hexabromocyclododecane (HBCDD), and
                                                persons who import or process this                          1,2,5,6,9,10-Hexabromocyclododecane,                   tetrabromobisphenol A (TBBPA), on
                                                substance as part of consumer textiles                      April 24, 2015.                                        hepatic enzymes and other biomarkers in
                                                (other than for use in motor vehicles)                  3. EPA. 2012 Chemical Data Reporting (CDR).                juvenile rainbow trout and feral eelpout.
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                                                should be subject to the notification                       Chemical Data Access Tool (CDAT).                      Aquatic Toxicology. August 2004. 69(3),
                                                                                                            Available at: http://java.epa.gov/oppt_                pp. 229–245.
                                                provisions of 40 CFR 721.25.                                                                                  18. Drottar, Hexabromocyclododecane
                                                   One commenter objected to the                            chemical_search/. Accessed May 21,
                                                                                                            2013. Last updated April 4, 2013.                      (HBCD): A flow-through life-cycle
                                                wording of the significant new use                      4. EPA. Inventory Update Reporting (IUR):                  toxicity test with the cladoceran
                                                (‘‘consumer textiles, other than for use                    Non-Confidential 2006 TSCA Inventory                   (Daphnia magna). Final Report. 439A–
                                                in motor vehicles’’) because it implies                     Update Rule (IUR) Records. Available at:               108, Wildlife International, Ltd. Easton,
                                                that a motor vehicle is a consumer                          http://cfpub.epa.gov/iursearch.                        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               31. EPA. Significant New Uses of Certain              given the technical nature of the table,
                                                     hormone-mediated Xenopus laevis                         Chemical Substances, Final Rule.                 EPA finds that further notice and
                                                     tadpole tail tip regression by                          Federal Register (55 FR 17376, April 24,         comment to amend the table is
                                                     hexabromocyclododecane (HBCD) and                       1990) (FRL–3658–5).
                                                                                                                                                              unnecessary. As a result, EPA finds that
                                                     2,2′,3,3′,4,4′,5,5′, 6-nona brominated             32. EPA. Modification of Significant New Use
                                                     diphenyl ether (BDE206). Chemosphere.                   Rules for Certain Substances, Final Rule.        there is ‘‘good cause’’ under section
                                                     December 2006. 65(10), pp. 1904–1908.                   Federal Register (62 FR 42690, August 8,         553(b)(3)(B) of the Administrative
                                                20. Oetken, et al. Validation of the                         1997) (FRL–5735–4).                              Procedure Act (5 U.S.C. 553(b)(3)(B)), to
                                                     preliminary EU-concept of assessing the                                                                  amend this table without further notice
                                                     impact of chemicals to organisms in                XII. Statutory and Executive Order                    and comment.
                                                     sediment by using selected substances.             Reviews
                                                     UBA–FB 299 67 411, Institute of                                                                          C. Regulatory Flexibility Act (RFA)
                                                     Hydrobiology, Dresden University of                A. Executive Order 12866: Regulatory
                                                                                                        Planning and Review and Executive                        Pursuant to section 605(b) of the RFA,
                                                     Technology, Dresden, Germany. 2001.                                                                      5 U.S.C. 601 et seq., I hereby certify that
                                                     pp. 97.                                            Order 13563: Improving Regulation and
                                                21. Crump, et al. Effects of                            Regulatory Review                                     promulgation of this SNUR will not
                                                     hexabromocyclododecane and                                                                               have a significant economic impact on
                                                     polybrominated diphenyl ethers on                     This final rule is not a ‘‘significant             a substantial number of small entities.
                                                     mRNA expression in chicken (Gallus                 regulatory action’’ under the terms of                The rationale supporting this
                                                     domesticus) hepatocytes. Toxicological             Executive Order 12866 (58 FR 51735,                   conclusion is as follows.
                                                     Sciences. December 2008. 106(2), pp.               October 4, 1993) and is therefore not                    EPA generally finds that proposed
                                                     479–487.                                           subject to review under Executive                     and final SNURs are not expected to
                                                22. Fernie, et al. Environmentally relevant             Orders 12866 and 13563, entitled                      have a significant economic impact on
                                                     concentrations of DE–71 and HBCD alter             ‘‘Improving Regulation and Regulatory                 a substantial number of small entities
                                                     eggshell thickness and reproductive
                                                     success of American kestrels.
                                                                                                        Review’’ (76 FR 3821, January 21, 2011).              (See, e.g., Ref. 32). Since this SNUR will
                                                     Environmental Science and Technology.              B. Paperwork Reduction Act (PRA)                      require a person who intends to engage
                                                     March 2009. 43(6), pp. 2124–30.                                                                          in such activity in the future to first
                                                23. Posner. Survey and technical assessment                This action does not impose any new                notify EPA by submitting a SNUN, no
                                                     of alternatives to TBBPA and HBCDD.                information collection burden under the               economic impact will occur unless
                                                     Kemi (Kemikalieinspektionen) (Swedish              PRA, 44 U.S.C. 3501 et seq. Burden is                 someone files a SNUN to pursue a
                                                     Chemicals Agency, Sweden).                         defined in 5 CFR 1320.3(b). The                       significant new use in the future or
                                                     Sundbyberg, Sweden. January, 2006.                 information collection activities                     forgoes profits by avoiding or delaying
                                                24. Covaci, et al. Hexabromocyclododecanes              associated with existing chemical
                                                     (HBCDs) in the Environment and                                                                           the significant new use. Although some
                                                     Humans: A Review. Environmental
                                                                                                        SNURs are already approved by OMB                     small entities may decide to engage in
                                                     Science and Technology. May 2006.                  under OMB control number 2070–0038                    such activities in the future, EPA cannot
                                                     40(12), pp. 3679–3688.                             (EPA ICR No. 1188), and the                           presently determine how many, if any,
                                                25. UNEP. Stockholm Convention on                       information collection activities                     there may be. However, EPA’s
                                                     Persistent Organic Pollutants. Persistent          associated with export notifications are              experience to date is that, in response to
                                                     Organic Pollutants Review Committee,               already approved by OMB under OMB                     the promulgation of SNURs covering
                                                     Third meeting, Geneva. pp. 19–23,                  control number 2070–0030 (EPA ICR                     over 1,000 chemical substances, the
                                                     November 2007, Item 7 of the                       No. 0795). If an entity were to submit a              Agency receives only a handful of
                                                     provisional agenda, Presentation on
                                                     environmental transport and modeling.
                                                                                                        SNUN to the Agency, the annual burden                 notices per year. During the six year
                                                     The OECD screening tool for overall                is estimated to be less than 100 hours                period from 2005–2010, only three
                                                     persistence and long-range transport               per response, and the estimated burden                submitters self-identified as small in
                                                     potential. UNEP/POPS/POPRC.3/INF/7.                for an export notification is less than 1.5           their SNUN submission (Ref. 5). EPA
                                                26. Ghanem, R. Kinetics of Thermal and                  hours per notification. In both cases,                believes the cost of submitting a SNUN
                                                     Photolytic Segregation of                          burden is estimated to be reduced for                 is relatively small compared to the cost
                                                     Hexabromocyclododecane in Backcoated               submitters who have already registered                of developing and marketing a chemical
                                                     Textile Samples. Jordan Journal of                 to use the electronic submission system.              new to a firm and that the requirement
                                                     Chemistry. April 2009. 4(2), pp. 171–181.             An agency may not conduct or
                                                27. European Commission (EC). Risk
                                                                                                                                                              to submit a SNUN generally does not
                                                     Assessment: Hexabromocyclododecane
                                                                                                        sponsor, and a person is not required to              have a significant economic impact.
                                                     CAS-No.: 25637–99–4 EINECS-No.: 247–               respond to, a collection of information                  A SNUR applies to any person
                                                     148–4, Final Report. Office for Official           that requires OMB approval under the                  (including small or large entities) who
                                                     Publications of the European                       PRA, unless it has been approved by                   intends to engage in any activity
                                                     Communities: Luxembourg. May 2008.                 OMB and displays a currently valid                    described in the rule as a ‘‘significant
                                                28. Arnot, et al. An evaluation of                      OMB control number. The OMB control                   new use.’’ In the proposed HBCD SNUR
                                                     hexabromocyclododecane (HBCD) for                  numbers for EPA’s regulations in Title                (Ref. 1), EPA preliminarily determined,
                                                     Persistent Organic Pollutant (POP)                 40 of the CFR, after appearing in the                 based in part on the Agency’s market
                                                     properties and the potential for adverse
                                                     effects in the environment. Submitted to
                                                                                                        Federal Register, are listed in 40 CFR                research, that HBCD is not
                                                     European Brominated Flame Retardant                part 9 and included on the related                    manufactured or processed for the
                                                     Industry Panel (EBFRIP). May 2009.                 collection instrument, or form, if                    significant new use (i.e., use in
                                                29. UNEP. Stockholm Convention on                       applicable. EPA is amending the table in              consumer textiles other than in textiles
                                                     Persistent Organic Pollutants. Summary             40 CFR part 9 to list this SNUR. This                 in motor vehicles). EPA received no
                                                     of the proposal for the listing of                 listing of the OMB control numbers and                public comment indicating otherwise.
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                                                     hexabromocyclododecane (HBCDD) in                  their subsequent codification in the CFR              Therefore, EPA is finalizing its
                                                     Annex A to the Convention. July 2009.              satisfies the display requirements of the             determination that use of HBCD in
                                                30. EPA. TSCA Work Plan Chemical Problem
                                                     Formulation and Initial Assessment,
                                                                                                        PRA and OMB’s implementing                            consumer textiles (other than in textiles
                                                     Cyclic Aliphatic Bromides Cluster,                 regulations at 5 CFR part 1320. Since                 in motor vehicles) is not ongoing. Thus
                                                     Flame Retardants. August 2015.                     the existing OMB approval was                         no small entities presently manufacture
                                                     Available at http://www.epa.gov/oppt/              previously subject to public notice and               or import HBCD for the significant new
                                                     existingchemicals/pubs/riskassess.html.            comment before OMB approval, and                      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                        November 9, 2000), does not apply to                    Dated: September 16, 2015.
                                                importers of HBCD as part of textile                    this action.                                          Wendy C. Hamnett,
                                                articles from this SNUR. The SNUR                                                                             Director, Office of Pollution Prevention and
                                                                                                        G. Executive Order 13045: Protection of
                                                does not require processors and                                                                               Toxics.
                                                                                                        Children From Environmental Health
                                                importers of textile articles to conduct
                                                                                                        Risks and Safety Risks                                  Therefore, 40 CFR parts 9 and 721 are
                                                specific activities to ascertain if they are
                                                                                                                                                              amended as follows:
                                                importing or processing a textile article                 This action is not subject to Executive
                                                containing HBCD. EPA expects                            Order 13045 (62 FR 19885, April 23,                   PART 9—[AMENDED]
                                                importers and processors will take                      1997), because this action is not
                                                actions that are commensurate with                      intended to address environmental                     ■ 1. The authority citation for part 9
                                                their perceived likelihood of HBCD                      health or safety risks for children.                  continues to read as follows:
                                                being part of a textile article, and the                                                                         Authority: 7 U.S.C. 135 et seq., 136–136y;
                                                resources they have available. EPA has                  H. Executive Order 13211: Actions
                                                                                                        Concerning Regulations That                           15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
                                                no reason to believe that a firm would                                                                        21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
                                                voluntarily incur substantial costs to                  Significantly Affect Energy Supply,
                                                                                                                                                              U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
                                                comply with the SNUR, but rather, EPA                   Distribution, or Use                                  1321, 1326, 1330, 1342, 1344, 1345 (d) and
                                                believes each firm will choose the most                    This action is not subject to Executive            (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
                                                efficient route to identify whether it is               Order 13211 (66 FR 28355, May 22,                     1971–1975 Comp. p. 973; 42 U.S.C. 241,
                                                importing HBCD in textile articles.                                                                           242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
                                                                                                        2001), because it is not expected to                  300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
                                                   Therefore, EPA believes that the                     affect energy supply, distribution, or                300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
                                                potential economic impact of complying                  use.                                                  6901–6992k, 7401–7671q, 7542, 9601–9657,
                                                with this SNUR is not expected to be                                                                          11023, 11048.
                                                significant or adversely impact a                       I. National Technology Transfer and
                                                substantial number of small entities.                   Advancement Act (NTTAA)                               ■  2. In § 9.1, add the following section
                                                                                                                                                              in numerical order under the
                                                D. Unfunded Mandates Reform Act                           Since this action does not involve any
                                                                                                                                                              undesignated center heading
                                                (UMRA)                                                  technical standards, NTTAA section
                                                                                                                                                              ‘‘Significant New Uses of Chemical
                                                                                                        12(d), 15 U.S.C. 272 note, does not
                                                  Based on EPA’s experience with                                                                              Substances’’ to read as follows:
                                                                                                        apply to this action.
                                                proposing and finalizing SNURs, State,                                                                        § 9.1 OMB approvals under the Paperwork
                                                local, and Tribal governments have not                  J. Executive Order 12898: Federal
                                                                                                                                                              Reduction Act.
                                                been impacted by these rulemakings,                     Actions To Address Environmental
                                                                                                        Justice in Minority Populations and                   *        *      *        *        *
                                                and EPA does not have any reason to
                                                believe that any State, local, or Tribal                Low-Income Populations
                                                                                                                                                                                                        OMB Control
                                                government will be impacted by this                                                                                    40 CFR Citation
                                                                                                           This action does not entail special                                                             No.
                                                rulemaking. As such, EPA has                            considerations of environmental justice
                                                determined that this regulatory action                  related issues as delineated by
                                                will not impose any enforceable duty,                                                                             *           *       *        *       *
                                                                                                        Executive Order 12898 (59 FR 7629,                            Significant New Uses of Chemical
                                                contain any unfunded mandate, or                        February 16, 1994), because EPA has                                       Substances
                                                otherwise have any effect on small                      determined that this action will not
                                                governments subject to the requirements                 have disproportionately high and
                                                of sections 202, 203, 204, or 205 of                    adverse human health or environmental                    *         *              *             *         *
                                                UMRA (2 U.S.C. 1531–1538).                              effects on minority or low-income                     721.10281 .............................       2070–0038
                                                E. Executive Order 13132: Federalism                    populations. This action does not affect
                                                                                                                                                                  *            *            *           *        *
                                                                                                        the level of protection provided to
                                                  This action does not have a                           human health or the environment.
                                                substantial direct effect on States, on the                                                                   *        *      *        *        *
                                                relationship between the national                       K. Congressional Review Act (CRA)
                                                                                                                                                              PART 721—[AMENDED]
                                                government and the States, or on the                       Pursuant to the CRA, 5 U.S.C. 801 et
                                                distribution of power and                               seq., EPA will submit a report                        ■ 3. The authority citation for part 721
                                                responsibilities among the various                      containing this rule and other required               continues to read as follows:
                                                levels of government, as specified in                   information to the U.S. Senate, the U.S.
                                                Executive Order 13132 (64 FR 43255,                                                                             Authority: 15 U.S.C. 2604, 2607, and
                                                                                                        House of Representatives, and the                     2625(c).
                                                August 10, 1999).                                       Comptroller General of the United
                                                F. Executive Order 13175: Consultation                  States prior to publication of the rule in            ■ 4. Add new § 721.10281 to subpart E
                                                and Coordination With Indian Tribal                     the Federal Register. This action is not              to read as follows:
                                                Governments                                             a ‘‘major rule’’ as defined by 5 U.S.C.
                                                                                                                                                              § 721.10281 Hexabromocyclododecane
                                                                                                        804(2).                                               and 1,2,5,6,9,10-hexabromocyclododecane.
                                                  This action does not have Tribal
                                                implications because it will not have                   List of Subjects                                        (a) Chemical substances and
                                                any effect (i.e., there will be no increase             40 CFR Part 9                                         significant new uses subject to reporting.
                                                or decrease in authority or jurisdiction)                                                                     (1) The chemical substances identified
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                                                on Tribal governments, on the                             Environmental protection, Reporting                 as hexabromocyclododecane (CASRN
                                                relationship between the Federal                        and recordkeeping requirements.                       25637–99–4) and 1,2,5,6,9,10-
                                                government and the Indian tribes, or on                 40 CFR Part 721                                       hexabromocyclododecane (CASRN
                                                the distribution of power and                                                                                 3194–55–6) are subject to reporting
                                                responsibilities between the Federal                      Environmental protection, Chemicals,                under this section for the significant
                                                government and Indian tribes. Thus,                     Hazardous substances, Reporting and                   new use described in paragraph (a)(2) of
                                                Executive Order 13175 (65 FR 67249,                     recordkeeping requirements.                           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                provisions that apply in the Beaumont-                2011. The revisions submitted by the
                                                consumer textiles, other than for use in                Port Arthur (BPA) nonattainment area                  Texas Commission on Environmental
                                                motor vehicles.                                         (Hardin, Jefferson and Orange Counties),              Quality (TCEQ) apply to Brazoria,
                                                   (b) Specific requirements. The                       four counties in the Dallas-Fort Worth                Chambers, Collin, Dallas, Denton, El
                                                provisions of subpart A of this part                    (DFW) nonattainment area (Collin,                     Paso, Fort Bend, Galveston, Hardin,
                                                apply to this section except as modified                Dallas, Denton and Tarrant Counties), El              Harris, Jefferson, Liberty, Montgomery,
                                                by this paragraph.                                      Paso County, and the Houston-                         Orange, Tarrant and Waller Counties.
                                                   (1) Definitions. The definitions in                  Galveston-Brazoria (HGB)                                 Our May 13, 2015 rule and proposal
                                                § 721.3 apply to this section. In                       nonattainment area (Brazoria,                         stated that if any relevant adverse
                                                addition, the following definitions                     Chambers, Fort Bend, Galveston, Harris,               comments were received by the end of
                                                apply:                                                  Liberty, Montgomery and Waller                        the public comment period on June 12,
                                                   Consumer textile means any cloth,                    Counties).                                            2015, the direct final rule would be
                                                fabric, or other item produced during a                    The EPA is also making a ministerial               withdrawn and we would respond to
                                                milling process for textiles (including                 correction to the Code of Federal                     the comments in a subsequent final
                                                spinning, weaving, knitting, felting, or                Regulations (CFR) to accurately reflect               action. Relevant adverse comments were
                                                finishing), that is sold or made available              approved SIP revisions that pertain to                received during the comment period,
                                                either as a product or as part of a                     Stage II control of VOCs from gasoline                and the direct final rule was withdrawn
                                                product, to a private individual who                    dispensing facilities in Texas.                       on June 30, 2015 (80 FR 37161). Our
                                                uses it in or around a permanent or                                                                           May 13, 2015 proposal provides the
                                                                                                        DATES: This final rule is effective on
                                                temporary household or residence,                                                                             basis for this final action.
                                                                                                        October 23, 2015.
                                                during recreation, or for any personal                                                                           Also, on March 17, 2014 we approved
                                                                                                        ADDRESSES: The EPA has established a                  revisions to the Texas SIP pertaining to
                                                use or enjoyment. Consumer textiles can
                                                include, but are not limited to, bolts of               docket for this action under Docket ID                Stage II control of VOCs from gasoline
                                                cloth and draperies, as well as textiles                No. EPA–R06–OAR–2011–0079. All                        stations (79 FR 14611). Included in the
                                                that are part of upholstered household                  documents in the docket are listed on                 approved revisions was removal of
                                                furniture and mattresses.                               the http://www.regulations.gov Web                    sections 115.247 and 115.249 from the
                                                   Motor vehicle has the meaning found                  site. Although listed in the index, some              TX SIP. In that document, however, we
                                                at 40 CFR 85.1703.                                      information is not publicly available,                did not update the CFR to show that 30
                                                   (2) Revocation of article exemption.                 e.g., Confidential Business Information               TAC 115.247 and 115.249 were removed
                                                The provisions of § 721.45(f) do not                    or other information whose disclosure is              from the SIP. We are using the
                                                apply to importers and processors of the                restricted by statute. Certain other                  opportunity of this final rule to correct
                                                chemical substances identified in                       material, such as copyrighted material,               this oversight.
                                                paragraph (a)(1) of this section as part of             is not placed on the Internet and will be                We received comments on our May
                                                a textile.                                              publicly available only in hard copy                  13, 2015 proposal from two
                                                                                                        form. Publicly available docket                       commenters. Our response to the
                                                [FR Doc. 2015–24178 Filed 9–22–15; 8:45 am]
                                                                                                        materials are available either                        comments are below.
                                                BILLING CODE 6560–50–P
                                                                                                        electronically through http://
                                                                                                        www.regulations.gov or in hard copy at                II. Response to Comments
                                                                                                        EPA Region 6, 1445 Ross Avenue, Suite                    Comment: The first commenter stated
                                                ENVIRONMENTAL PROTECTION                                                                                      it would be impractical, and possibly
                                                                                                        700, Dallas, Texas 75202–2733.
                                                AGENCY                                                                                                        unreasonable, to require industry to
                                                                                                        FOR FURTHER INFORMATION CONTACT: Mr.
                                                40 CFR Part 52                                          Robert M. Todd, (214) 665–2156,                       comply with the state regulations unless
                                                                                                        todd.robert@epa.gov. To inspect the                   the state took the needs of individual
                                                [EPA–R06–OAR–2011–0079; FRL–9932–51–                                                                          sources into account and helped them to
                                                Region 6]
                                                                                                        hard copy materials, please contact Mr.
                                                                                                        Todd or Mr. Bill Deese (214) 665–7253.                comply.
                                                                                                                                                                 Response: The commenter fails to
                                                Approval and Promulgation of                            SUPPLEMENTARY INFORMATION:
                                                                                                                                                              specify how and why the submitted
                                                Implementation Plans; Texas; Revision                   Throughout this document wherever                     revisions would be impractical. In
                                                To Control Volatile Organic Compound                    ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean           addition, these revisions merely modify
                                                Emissions From Storage Tanks and                        the EPA.                                              and clarify existing rules which have
                                                Transport Vessels                                                                                             been implemented for several years.
                                                                                                        Table of Contents
                                                AGENCY:  Environmental Protection                                                                             Requirements to control degassing
                                                                                                        I. Background
                                                Agency (EPA).                                           II. Response to Comments
                                                                                                                                                              emissions, for example, low-leaking
                                                ACTION: Final rule.                                     III. Final Action                                     tank fittings on some control options,
                                                                                                        IV. Incorporation by Reference                        monitoring control effectiveness and
                                                SUMMARY:    The Environmental Protection                V. Statutory and Executive Order Reviews              reporting compliance from degassing
                                                Agency (EPA) is approving a Texas State                                                                       operations were first implemented in
                                                Implementation Plan (SIP) revision for                  I. Background                                         HGB and BPA (62 FR 27964, May 22,
                                                control of volatile organic compound                       The background for this action is                  1997). In DFW and El Paso County,
                                                (VOC) emissions from degassing of                       discussed in detail in our May 13, 2015               these rules were adopted as contingency
                                                storage tanks, transport vessels and                    direct final rule and proposal (80 FR                 measures under the 1-hour ozone
                                                marine vessels. The revision reformats                  27251 and 80 FR 27275). In the direct                 standard (62 FR 27964). The Texas
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                                                the existing requirement to comply with                 final rule we approved a SIP submission               Commission on Environmental Quality
                                                current rule writing standards, adds                    revising the rules for controlling VOC                has been successfully implementing
                                                additional control options for owner/                   emissions from degassing of storage                   these degassing regulations in Brazoria,
                                                operators to use when complying,                        tanks, transport vessels and marine                   Chambers, Fort Bend, Galveston,
                                                clarifies the monitoring and testing                    vessels. The Texas rule revisions were                Hardin, Harris, Jefferson, Liberty,
                                                requirements of the rule, and makes                     adopted by the state on January 26, 2011              Montgomery, Orange, and Waller
                                                non-substantive changes to VOC control                  and submitted to us on February 18,                   Counties for several years and we


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Document Created: 2015-12-15 09:44:30
Document Modified: 2015-12-15 09:44:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective November 23, 2015.
ContactFor 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:
FR Citation80 FR 57293 
RIN Number2070-AJ88
CFR Citation40 CFR 721
40 CFR 9

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