Response to Public Comments on Proposed Significant New Use Rule

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

August 17, 2015

Note: Sections A through I pertain to public comments about regulation of chemicals as part of 

articles. Sections J through L pertain to all other public comments on the 

Hexabromocyclododecane (HBCD) Significant New Use Rule (SNUR).

A. Legal Authority to Make Inapplicable the Exemption for Persons who Import or Process

Chemical Substances as Part of Articles. 

Comment. One commenter suggests that if chemical substances are not exempted from 

the SNUR at the point they are incorporated into articles, then EPA should consider whether it is

inappropriately regulating “articles under the chemical management authorities of TSCA,” 

(emphasis original) inconsistent with Congressional intent in enacting the Toxic Substances 

Control Act (TSCA). The commenter argues further that the regulation of articles is not the 

primary purpose of TSCA and that such regulation should be addressed by other agencies 

operating under other statutes such as the Occupational Safety and Health Act of 1970 and the 

Consumer Product Safety Act of 1972. 

Response. The SNUR for HBCD does not regulate articles per se, but rather persons who 

manufacture or process HBCD for use in consumer textiles other than for use in motor vehicles. 

TSCA clearly contemplates such regulation, as certain articles are expressly removed from 

TSCA jurisdiction at TSCA section 3(2). Indeed, EPA has a long history of regulating chemical 

substances as part of articles under TSCA. For polychlorinated biphenyls (the only chemical
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substance specifically addressed in TSCA as it was originally enacted), Section 6(e) of TSCA 

provides authority for EPA to promulgate rules related to polychlorinated biphenyls in articles, 

such as electrical transformers. Other examples include the regulation of asbestos (40 CFR 

763.160) and regulation of manufacturers of consumer products intended for use by children who 

also manufacture (including import) lead (40 CFR 716.21(a)(8)). 

TSCA section 5 provides EPA with authority to regulate chemical substances, including 

chemical substances that are part of articles.1 Under this section, EPA has previously regulated 

persons that import or process chemical substances as part of articles, including articles 

containing erionite fiber (40 CFR 721.2800) and mercury (40 CFR 721.10068). This is in 

keeping with the statutory language authorizing the Administrator to designate a “use of a 

chemical substance as a significant new use” and to require significant new use notice (SNUN)

submissions from persons that intend to manufacture or process a chemical for a designated 

significant new use.

The commenter is incorrect in suggesting that regulation to address chemical substances 

in articles is beyond the originally intended functions of TSCA. When TSCA was being drafted, 

legislators characterized it as “a mechanism to protect against dangerous chemical materials 

contained in consumer and industrial products;” by way of example, the drafters cited “the 

presence of mercury in such consumer products as paint, home thermometers, sponges, and a 

variety of other products.” S. Rep. No. 94-698, 94th Cong., 2d Sess., 5-6 (1976).

Furthermore, this application of the regulations (to persons who manufacture or process

 1 It should be noted that there is no general SNUN exemption for uses of a chemical substances involving articles 

and EPA routinely defines significant new uses to include use in articles. The exemption at 40 CFR 721.45(f) relates 

to a different question: whether the SNUR applies to persons who process or import a chemical substance by 

processing or importing the substance as part of an article.
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the chemical substance as part of articles) is consistent with legislators’ observation, in drafting 

this section, that: 

[T]he most desirable time to determine the health and environmental effects of a 

substance, and to take action to protect against any potential adverse effects, occurs 

before commercial production begins. Not only is human and environmental harm 

avoided or alleviated, but the cost of any regulatory action in terms of loss of jobs 

and capital investment is minimized. H.R. Rep. 94-1679, 94th Cong., 2d Sess., 65 

(1976).

When a chemical substance is domestically produced, the substance generally exists in nonarticle form at the earliest point of commercial production in the United States. When a chemical 

substance is imported, however, it may in many instances already be part of an article, even at 

the earliest point that it enters U.S. commerce. By this action, EPA makes importers of specific 

chemical substances subject to the same SNUN requirements as domestic manufacturers of the 

same substance, irrespective of whether such import is as part of an article. This action is 

consistent with the plain text of TSCA section 5(a)(1)(B) (generally, “no person may . . . 

manufacture or process” for a significant new use without proper notice) and with one of the 

intended goals of TSCA: to hold importers to “the same responsibilities and obligations as 

domestic manufacturers,” H.R. Rep. No. 94-1341, 94th Cong. 2d. Sess., 12-13 (1976). This 

action is also consistent with EPA’s identified concerns regarding HBCD as part of consumer 

textiles (See 77 FR 17386, 17389 to 91, March 26, 2012) (FRL 9341-6).

Moreover, when originally promulgating the presumptive SNUN submission exemption 

for persons who import or process chemical substances as part of articles (40 CFR 721.45(f)), 

EPA did so based on a belief that people and the environment would generally not be exposed to 
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chemical substances in articles. To address those cases where the assumption may not be valid, 

EPA specifically noted that, “EPA may decide to eliminate one or all of these . . . exemptions 

[including the exemption for importers and processors of chemicals as part of articles] if EPA 

decides that review under a SNUR is warranted for specific substances . . . in articles.” (49 FR 

35014, September 5, 1984) (FRL-2541-8). Thus, while EPA clearly has statutory authority to 

subject importers and processors of chemical substances in articles to SNUN requirements, they 

are presumptively excluded by rule at 40 CFR 721.45(f), based on an assumption that people and 

the environment will generally not be exposed to substances in articles. (49 FR 35014, 

September 5, 1984) (FRL-2541-8). To the extent that potential exposure to a chemical substance 

as part of an article contributes to the EPA’s determination pursuant to the factors in Section 

5(a)(2) of TSCA that the new use is significant (i.e., EPA has reason to anticipate that use as part 

of an article would raise important questions, related to potential exposure, that EPA should have 

an opportunity to review before such use could resume or occur), it is appropriate to make the 

exemption inapplicable.

EPA notes that one of the commenters appears to have conflated the Federal Register 

notice establishing the article importers’ and article processors’ exemption from premanufacture 

notice (PMN) requirements ((48 FR 21726, May 13, 1983) (FRL 2998-5), discussing 40 CFR 

720.22(b)) with another Federal Register notice establishing the comparable exemptions from 

SNUR requirements ((49 FR 35014, September 5, 1984) (FRL-2541-8), discussing 40 CFR 

721.45(f)). While EPA recognizes that 40 CFR parts 720 and 721 deal with many similar issues, 

they are also distinct from each other in important respects. It is significant that in the 1984 

action, whereby EPA established the article importers’ and article processors’ exemption for 

SNURs, it did not simply mirror the 1983 rationale for the comparable exemption from PMN 
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obligations. For PMNs, EPA noted the difficulties associated with determining the identity and 

inventory status of each chemical substance in imported articles (e.g., automobiles). (48 FR 

21726, May 13, 1983) (FRL 2998-5). But for SNURs, EPA placed special emphasis on its 

assumption that import of the substance as part of an article would not affect human or 

environmental exposure to the substance, while taking particular care to reserve ongoing 

discretion to revise its assumption as warranted in the case of specific substances. EPA had 

reason to differentiate between the two rationales. SNURs are for specified chemical substances 

for which EPA has identified exposure-based concerns for the defined significant new use (per 

the TSCA section 5(a)(2) factors). By contrast, PMNs are required for all new chemicals (i.e., 

those not on the TSCA inventory), not a specified set of chemicals. 

Finally, there is no basis for the commenter’s suggestion that EPA should decline to 

review significant new uses, in deference to the Occupational Safety and Health Administration 

(OSHA) or the Consumer Product Safety Commission (CPSC), simply because a significant new 

use notice would be submitted by a person who imports or processes the chemical substance as 

part of an article. Neither the Occupational Safety and Health Act of 1970 nor the Consumer 

Product Safety Act of 1972 contains a comparable mechanism to ensure advance notice and 

opportunity to review significant new uses of chemical substances, as part of articles or 

otherwise. 

B. Development of a Separate Policy Framework for Making Inapplicable the Exemption for 

Persons who Import or Process Chemical Substances as Part of Articles 

1. Comment. Some commenters suggest that before finalizing a rulemaking to make the 

“articles exemption” inapplicable to HBCD, EPA should complete a separate public comment 

process to develop a general “policy framework for the issuance of article SNURs.” Commenters 
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suggest that this policy framework should include science-based criteria, feasibility criteria, 

costs, and other factors. 

One comment suggests that, in formulating the “policy framework” or criteria for making 

the exemption for importers and processors of chemical substances as part of articles

inapplicable, EPA should address the following questions: 

• Can the risk posed by the chemical of concern be addressed through the standard 

regulation?

• Why is the standard approach for SNURs that exempts articles not sufficient? 

• What conditions make direct regulation of articles necessary?

• What gaps in health and environmental protection are likely to occur if a SNUR only 

regulates chemicals and mixtures?

1. Response. The comments conflate two separate issues: the determination of a 

significant new use under TSCA section 5(a)(2), and the decision to make the regulatory 

exemption at 40 CFR 721.45(f) inapplicable. (40 CFR 721.45(f) provides that persons who 

import or process a chemical substance as part of an article are not subject to the notification 

requirements at 40 CFR 721.25; this exemption is referred to as the “articles exemption” by 

some commenters.) EPA first makes a determination on whether a use of a chemical substance is 

a significant new use considering the factors listed in TSCA section 5(a)(2). Once that 

determination is made, EPA separately determines whether it would be appropriate to revoke the 

regulatory exemption at 40 CFR 721.45(f) for persons who import or process a chemical 

substance as part of an article. 

EPA notes that there may be a variety of cases in which it may be appropriate for EPA to 

include persons who import or process the chemical substance as part of an article among the 
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persons subject to SNUN submission obligations. Knowledge regarding chemical exposures 

from articles has evolved since the agency established the exemption at 40 CFR 721.45(f) in 

1984, and there has been a steady increase in international trade of chemicals in articles. 

Accumulated data illustrate that SNURs (and TSCA section 5(e) consent orders) that include the 

exemption for persons who import or process a chemical substance as part of an article are 

sometimes insufficient to appropriately flag significant new exposures from downstream uses. 

For example, there have been instances in which a TSCA section 5(e) consent order for a new 

chemical substance was issued, prohibiting the release of the chemical substance to water, and 

yet the chemical substance at issue was later found in the environment and biota. The presence of 

the chemical substance in the environment and in biota appears to be associated with the use of 

the substance in articles (Ref. 1). There are also documented exposures (and resulting toxicity) of 

children to lead and cadmium and their compounds from a variety of articles, such as toys (Ref. 

2), and exposures to other heavy metals from articles, as measured in indoor air and house dust 

samples, which are direct routes of exposure accounting for children’s levels and toxicity (Ref. 

3). Other well-documented examrples are the presence of HBCD and other brominated flame 

retardants (e.g., polybrominated diphenyl ethers and brominated phthalates and benzoates) in 

samplings of articles, indoor air, people, and house dust. The low exchange rate of indoor air and 

house dust to sources outside the home supports the flame retardant release from articles 

postulate. Likewise, other semi-sealed environments, such as automobiles, have demonstrated 

migration of flame retardants from treated articles to interior surfaces and indoor air, as no other 

source was possible. In addition, high flame retardant levels have been observed in biota raised 

in proximity to articles and living near article recycling sites. Further, observed flame retardant 

levels in biota and in the environment at locations remote from manufacturing sites 
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suggest transport of these non-volatile chemical substances on associated particulate matter from 

distributed treated articles, which strongly suggest release from articles as one potential source 

(Refs. 4-8). 

The information discussed above – the well-documented exposures (and resulting 

toxicity) of children to lead, cadmium, and other metals from a variety of articles; the data on 

other chemicals used in articles; and the presence in the environment and biota of certain 

brominated flame retardants (e.g., polybrominated diphenyl ethers and brominated phthalates 

and benzoates) – all illustrate that there can be exposure to the chemicals associated with their 

presence in articles (Refs. 2-8). 

The scope of the suggested criteria (which the commenters suggest EPA should now 

develop to govern its exercise of its authority to make the exemption at 40 CFR 721.45(f)

inapplicable) is incommensurate with the level of analysis supporting the original development 

of the exemption. EPA notes that TSCA section 5(a)(1) establishes a general prohibition on 

manufacturing or processing a chemical substance for a significant new use without prior notice 

to EPA. An exemption from this prohibition is established at 40 CFR 721.45(f), but it is based on 

a fairly minimal rationale: “EPA believes people and the environment will generally not be 

exposed to substances in articles.” (49 FR 35014, September 5, 1984) (FRL-2541-8). EPA 

counterbalanced its reliance on this generalized assumption (about all chemicals that exist as part 

of articles) with a broad reservation of case-by-case discretion to make the exemption 

inapplicable as “warranted for specific substances.” (49 FR 35014, September 5, 1984) (FRL2541-8). 

EPA does not think that development of a “policy framework” is necessary before 

reaching the conclusion, with respect to HBCD, that persons who import or process this 
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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. Exposure to chemicals in materials such as textiles 

and foam can result from the dust that is generated from abrasion of the materials (Ref. 9). EPA 

notes that the commenter did not offer data to undercut the conclusion that such exposure can 

occur. Because of this information, and other information described in Unit III.E. of the proposal 

(77 FR 17389 to 91, March 26, 2012) (FRL 9341-6), EPA does not assume that new types or 

forms of exposure associated with a new use of HBCD would be insignificant merely because 

the chemical substance is imported or processed as part of an article. Thus, EPA does not believe 

the default assumption used to support 40 CFR 721.45(f) (that people and the environment will 

generally not be exposed to substances in articles) holds with respect to HBCD.

2. Comment. One comment also suggests that EPA analyze the “variety of products” that 

could be construed as articles, the “practical questions that will arise” if the import and 

processing of such products were not exempt from SNURs, and the “unique channels of trade,” 

through which different varieties of products move. The commenter encouraged EPA to develop 

and articulate publicly a policy framework, considering the following factors on an articlespecific basis, before proceeding to revoke the article exemption with respect to a particular 

chemical substance: 

• Whether there is, or will be, direct exposure to the chemical substance in the article 

during the course of the article’s use. 

• Whether there is, or will be, a release of the regulated substance, or a metabolite or 

breakdown product from the substance, during subsequent processing, distribution, use or 

disposal of the article. 

• Whether there is, or will be, a link between import or export of an article and cross-
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border exposure to the U.S. population. 

2. Response. Given the variety of substances and uses addressed under SNUR 

regulations, EPA believes it is more efficient to address article-specific issues as they actually 

arise within each regulatory action than to develop, as suggested by the commenter, an 

anticipatory “policy framework” document. 

The importers and processors of chemical substances present in articles are generally in 

the best position to know which chemical substances are used in which types of articles. When 

EPA identifies a particular chemical substance in a SNUR, such stakeholders have an 

opportunity to identify, in their public comments, any article-specific issues that concern them. 

Furthermore, these issues are likely to be more accurately identified and more appropriately 

addressed in connection with the development of a SNUR for particular chemical substances 

than they would be if they were reviewed generically. In this case, two commenters raised issues 

specific to articles about the exclusion of motor vehicles from the rule, but these comments did 

not raise exposure issues related to articles. These comments are addressed as part of this 

rulemaking. (See responses below to Docket ID # EPA-HQ-OPPT-2011-0489-0035 and # EPAHQ-OPPT-2011-0489-0036.)

C. A Compelling Basis Standard for Making Inapplicable the Exemption for Persons who Import 

or Process Chemical Substances as Part of Articles

Comment. Some commenters made the point that revocation of the exemption at 40 CFR 

721.45(f) should not be a presumed component of all SNURs. This was part of a broader 

comment that EPA should not make this exemption inapplicable unless there was a “compelling 

basis” to do so. One commenter was concerned that if EPA proceeds on a case-by-case basis, 

following reasoning that “could be applied to many chemicals,” then elimination of the 
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exemption would come to be a “kind of ‘default’ step” in future SNURs. One commenter also 

argues that, where the SNUN submission requirement is to apply to importers and processors of 

substances as part of articles, the TSCA section 5(a)(2) criteria require EPA to undertake a 

compelling analysis of how the use and distribution of the “specific articles or article categories,” 

would “contribute to potential exposures of concern.”

Response. As an initial matter, the comments conflate two separate issues: the 

determination of a significant new use under TSCA section 5(a)(2), and the decision to make the 

regulatory exemption at 40 CFR 721.45(f) inapplicable. The TSCA section 5(a)(2) factors do not 

impose a “compelling analysis” requirement on the elimination of the 40 CFR 721.45(f) 

exemption because (among other reasons) these two actions concern two discrete issues. The 

TSCA section 5(a)(2) factors speak to the significant new use itself, while 40 CFR 721.45(f) 

speaks to who is required to notify EPA of the significant new use.

In this case, EPA identified its reasons, under the TSCA section 5(a)(2) factor analysis, to 

anticipate that the new use would pose important new questions related to the substances’ 

potential to threaten health or the environment (77 FR 13786, 17389 to 91, March 26, 2012) 

(FRL 9341-6) and that EPA should have an opportunity to consider those questions before such 

use could occur. (In essence, a SNUR puts a particular set of uses on the same footing as a new 

chemical, which is subject to automatic review under TSCA section 5(a)(1) unless EPA 

specifically excludes it from such review.) EPA also identified a basis, specific to HBCD, to 

question the assumption that people and the environment will generally not be exposed to the 

chemical substance in articles. Therefore, EPA is also making inapplicable the exemption at 40 

CFR 721.45(f) for persons who import or process HBCD as part of textile articles. No 

commenter provided data or other information to undercut the factual basis for either decision.
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Neither TSCA nor the implementing regulations for SNURs establish a separate 

“compelling basis” standard, either with respect to the determination of a significant new use or 

with respect to the decision to make the exemption at 40 CFR 721.45(f) inapplicable. Nor have 

commenters identified a persuasive basis for EPA to adopt such a standard under either scenario. 

EPA’s specific action with respect to HBCD is not, as commenters suggest, tantamount 

to the presumptive revocation of the SNUN submission exemption for importers and processors 

of chemical substances as part of articles in all future instances. EPA has not proposed to 

globally modify or eliminate the SNUR exemption for persons who import or process chemical 

substances as part of articles. EPA need not presently address the merits of an action it is not 

presently taking, and did not previously propose to take. To be clear, this rule only makes 

inapplicable the SNUR general exemption at 40 CFR 721.45(f) for importers and processors of 

HBCD as part of textile articles, not any article that could contain HBCD. 

TSCA sections 5(a)(2)(B) and (C) require EPA to consider the extent to which a new use 

“changes the type or form of exposure” or “increases the magnitude and duration of exposure” 

before making a determination that a particular use is a “significant new use.” EPA disagrees 

that it must therefore, as one commenter suggests, conduct a multiplicity of separate significant 

new use analyses whenever the use under consideration involves an article (i.e., one for each 

specific article or article category, comparing the relative significance of the particular article or 

article category). In particular, the commenter’s interpretation of TSCA section 5(a)(2) 

misconstrues the baseline against which the “newness” and the “significance” of a significant 

new use are evaluated. As EPA has long maintained, the analytical baseline includes uses that 

were ongoing “as of the date of publication” of the SNUR proposal. (See e.g., 77 FR 17386, 

17391, March 26, 2012 (FRL 9341-6)). Note, however that for this particular SNUR, there is 
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only one type of article covered (consumer textiles).

Furthermore, the particular analytical standards the commenter suggests are not 

commensurate with the establishment of a one-time notice requirement intended to give EPA an 

opportunity to later evaluate the need for testing or other regulatory action under TSCA. 

Requiring upfront answers to the very questions EPA would evaluate after receiving a significant 

new use notice, as a pre-condition of requiring the notices, would undermine the statutory 

authorization to issue SNURs in the first place. EPA’s decision to propose a SNUR for a 

particular chemical use and to make the exemption at 40 CFR 721.45(f) inapplicable to that 

SNUR need not be based on an extensive evaluation of the hazard, exposure, or potential risk 

associated with that use. Rather, the Agency is acting because it has reason to anticipate that such 

use would raise important new questions related to the substance’s potential to threaten health or 

the environment, and that EPA should have an opportunity to consider those questions before 

such use could occur. Since the use designated as a significant 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 

significant new use, in articles or otherwise, the notice to EPA allows EPA to evaluate the use 

according to the specific parameters and circumstances surrounding that intended use. While the 

Agency is aware of some parameters surrounding the intended use (e.g., to be made available to 

private individuals), other parameters would be unknown (e.g., how the HBCD would be 

incorporated into the consumer textile). 

Even if it were appropriate to construe the decision to make the 40 CFR 721.45(f) 

exemption inapplicable as a subcomponent of the significant new use determination under TSCA 

section 5(a)(2) (rather than as a subsequent determination), EPA adequately considered the 
14

TSCA section 5(a)(2) factors. 

The first factor is the “projected volume of manufacturing and processing of a chemical 

substance” (TSCA section 5(a)(2)(A)). Currently, most of the HBCD used in the U.S. is in foam 

insulation boards, with a very small amount used in electronic products, commercial textiles, and 

textiles in motor vehicles. Because HBCD is a persistent, bioaccumulative, and toxic chemical 

(PBT), even a small increase in the amount that is manufactured and processed, and thus 

subsequently used, would be important for EPA to know prior to a new use occurring. If EPA 

learned that a manufacturer, importer or processor intended to use HBCD in consumer textiles 

(other than for use in motor vehicles), the Agency would want to know the increase in volume of 

HBCD over time that could be expected from this use. EPA anticipates that knowing the 

expected increase in volume of HBCD due to the new use would be important to the Agency’s

overall evaluation of whether the new use may present an unreasonable risk to human health or 

the environment. The potential increase in volume of this PBT 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)). While 

HBCD is used in commercial textiles, it is not currently used in consumer textiles (other than for 

use in motor vehicles). Human exposure to consumer textile use may differ from exposure to 

commercial textiles and other current uses. If use of HBCD in consumer textiles (other than for 

use in motor vehicles) is planned, EPA anticipates that it would be important to identify the 

expected final uses to which the general population could be exposed. This information would be 

important to EPA’s overall evaluation of whether the new use may present an unreasonable risk 
15

to human health or the environment. The potential for a change in the type or form of exposure 

from consumer textile use (other than for use in motor vehicles) weighs in favor of determining 

that consumer textile use (other than for use in motor vehicles) is a significant new use.

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 (77 FR 17386, 17390, March 26, 2012), 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 and 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 particles of HBCD used to treat textiles for flame retardancy are small 

enough to become lodged in the deep lung if those particles separate from the textile and are 

subsequently inhaled. (Ref. 10) Furthermore, EPA notes that because HBCD is not chemically 

bound to textile substrates, there is potential for HBCD to be released from textiles at any point 

in the product lifecycle associated with the textile treatment use. This potential exists from initial 

manufacture, during formulation into the material that is commonly used in textile back coatings, 

as well as when it is being combined with the textile material to which it is added. 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. (77 FR 17386, 17389 to 90, March 26, 2012)

Thus, the potential for use in consumer textiles to increase the magnitude and duration of 
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exposure weighs in favor of determining that consumer textile use (other than for use in motor 

vehicles) is a significant new use. This potential would be important to EPA’s overall evaluation 

of whether the new use may present an unreasonable risk to human health or the environment.

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 the following: 

• To what extent can the anticipated manufacturing, processing, distribution in commerce, 

and disposal of HBCD for use in or as part of consumer textiles (other than for use in 

motor vehicles) be expected to result in worker exposure, user exposure, or release of the 

substance to the environment? 

• What potential controls are available to limit such exposures and releases?

EPA anticipates that the answers to these questions would be important to EPA’s overall 

evaluation of whether the new use may present an unreasonable risk to human health or the 

environment. The potential for manufacturing, processing, distribution in commerce or disposal 

of HBCD in consumer textiles to change the overall exposure picture weighs in favor of 

determining that consumer textile use (other than for use in motor vehicles) is a significant new 

use.

After considering each of the four TSCA section 5(a)(2) factors, 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. This determination would still hold even if one were to 
17

consider the 40 CFR 721.45(f) exemption as a subcomponent of the significant new use 

determination under TSCA section 5(a)(2).

D. Narrowing the Scope of SNURs where the Exemption for Importers and Processors of 

Chemical Substances as Part of Articles is Made Inapplicable 

Comment. One comment suggests that significant new uses should not be “open-ended” 

but instead must be targeted to specific articles, particularly in cases where the exemption at 40 

CFR 721.45(f) is made inapplicable. The concern expressed is that if the SNUN applies to “any 

use of a substance, then regulated parties and the EPA would be obligated to proceed through the 

SNUR process for an article that would have little relevance to the perceived hazard that drove 

the original SNUR.” The commenter further writes that “open-ended article SNUR’s (sic) can 

trigger reviews for articles that may have no relationship to the hazard or exposure concerns that 

motivated EPA’s decision to initiate the rule.” This commenter characterizes consumer textiles 

as a “broad category,” and the HBCD SNUR as “open-ended.” Another commenter described 

EPA’s SNUR proposal on HBCD as “appropriately focused in a narrow application – use in 

consumer textiles . . .”

Response. EPA determined the scope of the HBCD SNUR based on concern for 

potential exposure. HBCD is used in residential furniture, mattresses, and draperies in other 

developed countries, and it is used in commercial textiles in the U.S., so its use in consumer 

textiles is feasible. HBCD is used as a coating on textiles and can become separated from the 

fabric and attach to particles of dust which children can ingest. This potential for exposure is not 

limited to particular types of consumer textiles and there is no reason to narrow the category. 

Due to the potential for adverse health effects from exposure to HBCD, particularly in children 

(see Unit III. in the proposed rule preamble), it is prudent for EPA to learn about any intended 
18

expansion of use into consumer textiles in the U.S. before it occurs to provide the agency with an 

opportunity to evaluate the risk. Indeed, one could ask why the significant new use is as narrow 

as it is. The reason the SNUR does not apply to textiles in motor vehicles is not because there is 

no potential for exposure to HBCD but because use in textiles in motor vehicles is ongoing and 

therefore is not a “new” use. (HBCD is also currently used in foam insulation board and 

electrical applications.) 

Although the HBCD SNUR is focused on a limited category of use, a SNUR need not be 

narrowly focused on the mitigation of currently foreseeable exposure scenarios—it is proper that 

the SNUR will also ensure EPA has timely notice of future (and currently unforeseeable) 

exposure scenarios. An additional requirement to make targeted predictions of the particular uses 

that “may be proposed in the future” would undermine this intended function of the SNUR. 

More generally, an exhaustive list of all applications that could possibly fall within the ambit of a 

significant new use definition is not a prerequisite for issuing a SNUR. Since the significant new 

use does not currently exist, deferring a detailed consideration of potential risks related to the 

importation or processing of the chemical substance, including as part of articles for that use, is 

an effective use of resources. If a person decides to begin importing or processing HBCD as part 

of a consumer textile (other than for use in motor vehicles) or otherwise, the notice to EPA 

allows EPA to evaluate the significant new use according to the specific parameters and 

circumstances surrounding that intended use.

E. EPA Should Have a Reasonable Basis to Conclude that Identified Articles Would be 

Distributed in the United States

Comment. One comment states that “EPA presents an exposure-based rationale for why 

certain articles could be a concern, but indicates that there is no current expectation that these 
19

chemical substances will be used in such articles.” The commenter asserts that before issuing an 

article SNUR, EPA should have a reasonable basis to conclude that identified articles of concern 

would be distributed in the United States. For the HBCD SNUR, EPA should analyze 

performance and market data of consumer and non-consumer textiles. The commenter contends 

that EPA should identify an article containing such a chemical that is currently in global 

commerce and explain why it is likely to be distributed in the United States. The commenter 

suggests that it might also be possible to identify an article at the research and development stage 

that is likely to proceed to commercial development. Without such findings, however, the 

commenter is concerned that EPA would be issuing an article SNUR for a situation that presents 

no current or likely future threats to health or the environment, and thus that the rule would be a

waste of public resources. Another commenter raises similar issues, arguing that EPA should 

provide even more specific information on how the significant new uses contribute to risk. 

Alternatively, the first commenter suggests that EPA include a specific provision 

suspending enforcement of the SNUR until a determination is made that there is a reasonable 

basis to believe that an article containing the specific chemical had been, or would be, distributed 

in the United States. 

Response. EPA disagrees with the suggestion to limit the application of SNUN 

submission requirements for importers and processors of the chemical substances as part of 

articles to situations where importation or processing as part of an article is known to be 

imminent. SNURs address situations in which EPA is concerned about the potential for use to 

commence without prior opportunity for review and risk management action where appropriate. 

For purposes of SNURs, EPA cannot be expected to predict specific situations where new uses 

may be imminent, or how those specific uses may contribute to risk, before designating 
20

significant new uses. The purpose of a SNUR is to obtain such information so that EPA can 

evaluate risks associated with, and take risk management action where appropriate regarding,

any notified activities. These rules serve the important function of alerting EPA when a 

significant new use is intended. Without them, EPA would have no expectation of timely 

identification of new uses of these chemicals. Notice relating to the import or processing of 

articles is particularly important in this case, as the proposal specifically identified a concern 

related to exposure to HBCD in consumer textiles. (77 FR 17386, 17389 to 91, March 26, 2012) 

(FRL 9341-6). Because the importation or processing of textiles is likely to be undifferentiated, 

the final rule removes the exemption for importing or processing of HBCD in textile articles. The 

proposed HBCD SNUR made the article exemption inapplicable to articles generally; EPA’s 

final rule makes the exemption inapplicable only for textile articles. For a discussion of this 

modification, see the HBCD SNUR preamble, Unit X. “Response to Public Comments.”

It would not be an efficient use of government resources for EPA to continually monitor 

global commerce to try to predict which chemicals are about to be imported as part of articles 

(but have not yet been imported) into the United States. Persons who wish to manufacture 

(including import) or process these chemical substances for a significant new use, as part of an 

article or otherwise, are in a better position than EPA to evaluate when they are about to initiate a 

particular significant new use. 

Given that SNURs cannot be issued for ongoing uses, the commenter’s suggestion (that 

EPA must itself make an upfront demonstration that a particular new use is about to begin, to 

secure the opportunity to be notified of when significant new uses involving importation or 

processing of chemical substances as part of articles are about to begin) is impracticable. It

would likely result in a scenario in which an otherwise significant new use would be allowed to 
21

commence prior to the issuance of a SNUR proposal, thereby placing that use outside of EPA’s 

SNUR authority. Furthermore, EPA has already considered and rejected (in 2006, following 

public comment on a 2004 proposal) the position that it must defer revocation of the 40 CFR 

721.45(f) exemption for a SNUR until it appears likely “that these chemical substances will be 

imported as part of articles.” (69 FR 70409, December 6, 2004) (FRL 7633-1). EPA concluded 

in 2006, after a re-evaluation of the issue prompted by public comments, that “if the subject 

substances when imported as a part of articles are not subject to the SNUR, EPA could miss the 

opportunity to obtain notifications that would provide information of potential regulatory and 

assessment value.” (71 FR 34018, June 13, 2006) (FRL 7743-2) (ultimately declining to make 

the exemption inapplicable, based on a separate concern that the use with respect to articles 

appeared to be already ongoing). 

Finally, for essentially the same reasons as set forth above, EPA believes it would be 

inappropriate to follow one commenter’s alternative suggestion: to promulgate a SNUR without 

the exemption for importers and processors of chemical substances as part of articles, while 

somehow “suspending enforcement” until the precise moment that manufacture or processing for 

a significant new use as part of an article is about to begin, but has not yet begun.

In sum, EPA believes the commenter’s suggestions would turn the regulatory process on 

its head. EPA would likely need to already have a SNUR in place in order to obtain the kind of 

timely information about significant new use that the commenter asserts should be prerequisite to 

issuing the SNUR in the first place.

F. Intended Coverage of the HBCD SNUR 

1. Comment. One commenter writes that “A proposed rule offering a clear explanation of 

what uses EPA intends to cover, including an explanation of the alternatives if certain situations 
22

are unclear, will greatly increase the chances that useful information about business practices and 

common terms of art in an industry will be identified.” EPA should define the scope of the uses 

to be regulated as clearly and precisely as possible.

The commenter also contended that soliciting public comment on the appropriate scope 

of new uses to be regulated, for a specific chemical substance, constitutes “an abdication of the 

role that EPA should be undertaking.” The commenter suggests that before soliciting public 

comments, EPA should have first pursued an informal coordination with downstream industries 

and (as necessary) an exercise of its “ample authority under TSCA, either through regulatory 

action under section 8 or order authority under section 11 (c).” The commenter suggests that to 

the extent the proposed significant new uses admit ambiguity or potential need for adjustment in 

response to public comment, that is evidence that EPA “should have learned more about the 

uses” before issuing the proposal and is improperly seeking “to shift the responsibility to 

stakeholders.” Finally, the commenter argues that the definition of “consumer textile” is nuanced 

and uses terms that are “not self-evident on their face.”

1. Response. The description of the scope of the significant new use in the proposed 

HBCD SNUR and the Agency’s basis for the proposal were explicit. The SNUR proposal fairly 

apprised stakeholders as to the chemical at issue and the particular concerns driving the proposed 

action. It further indicated that based on information available to EPA, the significant new use

identified is not currently on-going. Stakeholders had an opportunity to oppose any of these 

preliminary findings by supplying countervailing information through the rulemaking process 

itself. Grafting additional pre-proposal steps onto the SNUR rulemaking process would be 

unnecessarily time-consuming and an unsound use of agency resources. The timelier, less 

resource-intensive, and more transparent process is for interested stakeholders, through the 
23

public comment process itself, to simply provide any pertinent countervailing information they 

wish to add to the initial collection of information EPA presented in the proposal.

As noted earlier, TSCA section 5(a)(2) does not compel nor contemplate an article-byarticle analysis to identify every conceivable significant new use of a chemical substance. EPA 

evaluates whether a new use is “significant” consistent with the evidence of Congressional intent 

underlying the enactment of TSCA. See H.R. Rep. No. 94-1341 at 24 (1976) (“[B]ecause of the 

nature of a substance, it is possible that any new use of it will be significant. Thus, a potentially 

dangerous substance which is manufactured for a particular use may, if manufactured for a 

different use present additional health or environmental problems and consequently there should 

be notice of the intent to manufacture it for such different use.”) See also H.R. Rep. No 94-1679 

at 66 (1976) (“[T]he conferees intend that any potential threats to health or the environment from 

the manufacture, processing, distribution in commerce, or disposal of a substance associated with 

a new use be considered by the Administrator when determining the significance of a new 

use.”) 

Regarding the commenter’s problem with the definition of “consumer textile” in the 

proposed HBCD SNUR, 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 selfevident on their 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. The changes do not impact the scope of the SNUR, as the final 
24

definition of “consumer textile” covers only those textiles that the Agency intended to cover in 

the proposal. EPA’s complete response to this comment issue is contained in Unit X. of the 

preamble to this rule.

2. Comment. “It does not make sense to issue article SNUR’s (sic) for full size machines 

or structures. An article SNUR should focus on the specific components of more complex 

machines or structures that involve the chemical of concern.”

2. Response. The commenter neither explains what the commenter means by “full size,” 

nor offers any specific evidence to support their general view that new uses of chemical 

substances in “full size machines or structures” are any less likely to be significant than new uses 

of chemical substances in “specific components.” Nor does the commenter indicate why persons 

who import or process chemical substances as part of articles would be more likely to be 

importing or processing the chemical substances for use in “full size” articles. Attempting to 

define and distinguish between “full size” article uses and other uses, and correlating such 

distinctions to whether persons are importing or processing these chemical substances as part of 

articles, would delay the rulemaking and increase its complexity, in a manner that does not seem 

warranted on the basis of the limited information supplied in the comment.

3. Comment. “Chemicals used in articles may sometimes be incorporated into ‘internal’

mechanisms of the article that are unlikely to come into contact with people or be released into 

the environment during normal use of the article.”

3. Response. The commenter does not explain why the basis for a SNUR should be 

limited to those exposures that occur concurrent with the article fulfilling its intended function, 

when TSCA section 5(a)(2)(D) contemplates that EPA will consider the value of ensuring it has 

a future opportunity to review the whole life-cycle impact (e.g., “manufacturing, processing, 
25

distribution in commerce, and disposal”) of a significant new use of a chemical substance. The 

exposure to the chemical substance, including when it is in an article, may be larger during 

disposal or recycling than during the “normal use” of the chemical. Further, chemical substances 

that are part of the “internal” mechanism of an article may still result in exposure if the chemical 

substance has certain physical- chemical properties (e.g., a relatively volatile chemical used as a 

plasticizer in interior automobile parts) or due to abrasion of the article (e.g., a dye incorporated 

into furniture covering.)

Nor does the commenter indicate why persons who import or process chemical 

substances as part of articles would be more likely than any other manufacturers or processors to 

be manufacturing or processing for use in the internal mechanisms of articles. Attempting to 

define and meaningfully distinguish between “internal” article uses and other uses, and 

correlating such distinctions to whether manufacturing or processing of the substance occurs as 

part of an article, would delay the rulemaking and increase its complexity, in a manner that does 

not seem warranted on the basis of the limited information supplied in the comment. 

In any event, it may not be likely that textiles would be incorporated into the internal 

mechanisms of articles.

4. Comment. “EPA should clarify whether the SNUR applies to articles containing the 

chemical of concern in a solid, liquid, particle or gaseous form.”

4. Response. This SNUR applies to HBCD regardless of form. To the extent the 

commenter seeks to continue some aspect of the exemption at 40 CFR 721.45(f), depending on 

the form of the HBCD in the article that is being imported or processed, the commenter has not 

offered any specific support for that proposition, either generally or in any particular case. In the 

SNUR at issue, EPA does not believe it is prudent to limit the application of the rule based on the 
26

form (solid, liquid, or gaseous) of the chemical substances at issue. Chemicals that may have 

been used in one form during the manufacture of the article may be released from the article in a 

different physical form. Also, fluids and particles are not covered under the applicable definition 

of article at 40 CFR 704.3. EPA received no comments suggesting that use of HBCD in one form 

or another may not be significant based on the TSCA section 5(a)(2) factors. Moreover, 

information relevant to a specific form of a chemical substance can be submitted in a SNUN and 

may be considered by EPA in review of that SNUN in determining whether follow-up action is 

warranted, and may support EPA’s amendment of the SNUR to limit its scope. 

5. Comment. “[A] chemical may be present at a very low concentration that is unlikely to 

be associated with a risk warranting EPA risk management action. . . . EPA should consider 

whether it can establish a de minimis exclusion [from the SNUR].”

5. Response. EPA notes that the SNUR already contains a general exemption for 

unintentionally present impurities at 40 CFR 721.45(d). To the extent chemical substances are 

intentionally added to articles at very low concentrations, the question of whether the substance

warrants risk management action is one that EPA can address upon receipt of the SNUN, not an 

analytical prerequisite to deciding whether it should receive the SNUN in the first place.

G. Screening for HBCD

Comment. Some commenters faulted the proposal for not identifying precise screening 

operations to be taken in response to the SNUR, and for not conducting additional analyses of 

the cost and feasibility of such screening operations. One commenter suggests, in particular, that 

an article importer should be deemed in compliance with the SNUR if the chemical is present 

below an established de minimis level (based on mass or concentration), or if it simply does not 

know the article’s content after conducting a reasonable inquiry for such information.
27

Response. With respect to processors, given the requirements of 40 CFR 721.5(a)(2), a 

processor of the chemical substance should have received notification that the chemical 

substance is the subject of a SNUR. A processor is not required to submit a SNUN for its 

unknowing processing of a chemical substance subject to a SNUR if (upon obtaining knowledge) 

the processor can document that when the past processing occurred, the processor neither knew 

the chemical identity of the substance it was processing nor knew that substance was subject to a 

SNUR. See 40 CFR 721.5(c). EPA would generally expect that processors would only fail to be 

aware of the presence of a chemical subject to a SNUR if the manufacturer (including importer) 

or upstream processor of the chemical substance failed to meet their obligations under 40 CFR 

721.5(a)(2). 

With respect to importers, EPA disagrees that it would be appropriate or necessary for the 

SNUR itself to define screening procedures to be employed for compliance purposes. The 

Agency did not propose to require a particular screening procedure and, for the following 

reasons, it does not agree that particular screening procedures should be specified and 

incorporated into the final rule. Regardless, the only types of articles for which an importer 

would need to screen are textiles, not every possible article. 

First, EPA believes that adding these sort of screening-effort exemptions, specifically for 

importers of chemical substances as part of articles, would be especially difficult to reconcile 

with the general statutory prohibition (under TSCA section 5(a)(1)) on manufacturing or 

processing a chemical substance for a significant new use without prior notice to EPA. The issue 

under the statute is whether or not an importer actually imports a substance. This is a separate 

question from the importers’ level of knowledge or level of effort to obtain knowledge respecting 
28

the content of the imports.2 With respect to SNURs, EPA notes that its direct rulemaking 

authority is to identify significant new uses under TSCA section 5(a)(2). The Agency has been 

appropriately cautious in exercising its implicit rulemaking authority to limit the applicability of 

TSCA section 5(a)(1). EPA recognizes that it did previously exercise such implicit rulemaking 

authority when establishing 40 CFR 721.45(f). However, as noted above, the exemption at 40 

CFR 721.45(f) was established along with a broad reservation of authority to withdraw the 

exemption where, as here, it is inaccurate to assume that there would not be exposure to the 

substance simply because it is present as part of an article. And a screening-effort exemption is 

especially difficult to reconcile with the statute in the case of importers. With importers, unlike 

with processors, there are no upstream entities with a duty under TSCA to notify importers of the 

presence of a chemical substance subject to a SNUR. 

Second, establishing a safe-harbor for importers based on lack of knowledge would 

create incentives for foreign suppliers to deliberately withhold information from importers. This 

could greatly reduce the efficacy of this SNUR. Currently, when an importer wishes to import a 

substance it knows would be subject to notification requirements, but for which the chemical 

identity is claimed as confidential business information by a foreign manufacturer, EPA’s 

longstanding practice when reviewing PMNs and SNUNs is to accept the relevant information 

on chemical identity directly from the foreign manufacturer. See 48 FR 21726, May 13, 1983 

(FRL 2998-5) (“[t]he principal importer need not know the specific chemical identity of the 

imported substance” and “may have its foreign manufacturer or supplier, or some other person, 

 2 The limiting clause in the definition of “principal importer” at 40 CFR 721.3—“knowing that a chemical substance 

will be imported”—is a limit based on the person’s knowledge that he or she is engaged in an import transaction, not 

a limit based on the person’s knowledge of a particular chemical’s identity and regulatory status. (48 FR 21727, 

May 13, 1983) (FRL 2998-5).
29

report the chemical identity to EPA.”) Offering an outright regulatory exemption to an importer 

simply because it is ignorant of the existence of a SNUR-regulated substance in the imported 

article (after conducting a prescribed inquiry) would allow foreign suppliers to short-circuit this 

process simply by refusing to divulge to the importer whether the import contains a chemical 

substance subject to SNUR.

Third, to the extent the chemical substance subject to the SNUR is only “unintentionally 

present” at the point of foreign manufacture, it is already exempt from reporting by the importer 

as an imported impurity. See 40 CFR 721.3 (chapeau), 40 CFR 720.3(m), and 40 CFR 721.45(d). 

Thus, importers are not required to submit a SNUN for a substance based simply on that 

substance’s presence as an impurity (i.e., a chemical substance unintentionally present with 

another chemical substance).

Fourth, whether and how it may be appropriate for importers to screen for HBCD will 

depend on many factors, including their current state of knowledge about the articles that they 

import and the potential risk of unknowingly importing articles that contain HBCD. The relevant 

factors are largely impossible for EPA to establish at this time, given that there is currently no 

on-going import of HBCD for the designated significant new use. 

Finally, EPA did conduct additional analysis of potential screening burden to explore 

commenters’ concerns. As described below, EPA acknowledges the costs of the various

activities that certain entities may choose to undertake, in response to this rule, to ensure that the

chemicals they import or process as part of articles do not trigger SNUN submission 

requirements (Ref. 11). Based on EPA’s economic analysis and the responses to the proposed 

rule, EPA does not believe that these costs will be significant for any individual entity.

H. Costs Associated with Making the Exemption for Persons that Import or Process Chemical 
30

Substances as Part of Articles Inapplicable 

Comment. Some comments note that the economic analysis, which focuses on the cost of 

filing a SNUN, does not include any analysis of the costs that might be associated with screening 

articles to determine whether these SNURs would apply. One comment also notes that “the 

preambles to the proposed rules do not discuss what, if any obligations companies have to screen 

articles for the chemicals included in the SNUR’s (sic).”

Response. With respect to processors, existing SNUR regulations already provide that 

the unknowing processing of a chemical substance does not itself trigger SNUN requirements if 

the processor can (upon obtaining knowledge) document that when the past processing occurred, 

the processor neither knew the chemical identity of the substance it was processing nor knew that 

substance was subject to a SNUR. See 40 CFR 721.5(c). However, as noted above, EPA would 

generally expect that processors would only fail to be aware of the presence of a chemical 

subject to a SNUR if the manufacturer (including importer) or upstream processor of the 

chemical substance failed to meet their obligations under 40 CFR 721.5(a)(2).

With respect to importers, based on an assessment of current market activity in the 

economic analysis, EPA believes that the chemicals subject to the final SNUR are not currently 

being imported into the United States for the identified significant new uses in articles. EPA 

received no public comments on the proposed SNUR that indicate that importation of HBCD for 

use in consumer textiles (not including for use in motor vehicles) is ongoing. However, because 

this SNUR makes inapplicable the exemption for persons that import or process chemical 

substances as part of textile articles, companies may take actions to ensure that they comply with 

the notice requirements if they import any textiles containing HBCD after proposal of this rule, 

by such means they deem appropriate. This is not necessarily a new consideration for importers 
31

given that importers of mixtures have needed to be aware of chemical substances subject to a 

SNUR that may be a component of imported mixtures. Whether and how companies respond 

will depend on many factors, including their current state of knowledge about articles that they 

import and their own assessments of the potential risk of unknowingly importing textiles that 

contain HBCD. As noted above, EPA did conduct additional analysis of burdens that may be 

associated with activities entities may undertake to ensure the chemicals they import or process 

as part of articles do not trigger SNUN submission requirements (Ref. 11). See Table A below.

In any event, EPA did not propose to mandate any particular level of screening of 

imported or processed articles. The preamble to the proposed SNUR did not discuss the precise 

steps that an importer or processor must take in this regard because there is no precise level of 

screening by which the manufacturer or processor could be separately liable under the rule (if not 

performed) or by which a manufacturer or processor could obtain “safe harbor” from what would 

otherwise be a violation of the rule. While EPA might potentially take screening practices into 

consideration when evaluating a particular instance in which the SNUR was nevertheless 

violated, that would be as a matter of enforcement policy, not as a provision of the rule itself.

EPA has included estimates for some activities that importers may undertake (e.g., 

supplier inquiries) in order to evaluate the likelihood of chemicals being imported as part of 

articles. These costs will vary for individual companies and their experience with suppliers. 

Awareness of article components and constituents is becoming more commonplace as companies 

frequently operate on a global scale and are subject to numerous regulatory requirements around 

the world that affect product stewardship responsibilities. Existing requirements that may compel 

a company to investigate an article’s components include the Consumer Product Safety Act, 

California’s Proposition 65, and the European Union’s regulation on Registration, Evaluation, 
32

Authorization and Restriction of Chemicals (REACH), which requires customer notification 

about the presence of certain chemical in articles that a company distributes. U.S. importing 

companies may already be familiar with the process of determining whether the articles they 

import contain restricted chemical substances, if they are subject to the requirements cited above 

or various U.S. federal or state laws such as the Consumer Product Safety Improvement Act 

(CPSIA) of 2008, Washington’s Children’s Safe Product Act, and Maine’s Act to Protect 

Children’s Health and the Environment from Toxic Chemicals in Toys and Children’s Products 

(Ref. 11).

Given the existing regulatory limitations on certain chemicals both internationally and 

within the United States, regulated industries have begun to develop industry-wide processes and 

other resources to obtain information on chemical substances in articles. Policies and procedures 

could include supplier agreements, such as Hewlett Packard’s requirement that suppliers meet 

their General Specifications for the Environment (GSE) (Ref. 11) and Walmart’s requirement 

that suppliers participate in International Compliance Information Exchange (iCiX) to manage 

and share compliance information throughout the supply chain (Ref. 12). More extensive policies 

and procedures could even include product testing. Companies may choose to use existing 

procedures or develop new ones that could range from document review, to supplier agreements, 

to product testing.

Additional analysis conducted by EPA on activities that companies may choose to 

undertake to ensure that the chemicals they import or process as part of articles do not trigger 

requirements of the SNUR shows a wide range of potential activities and associated costs. The 

conduct of these activities and associated costs are at the discretion of the company. Table A

shows EPA’s estimated a range of costs associated with some of these potential activities for 
33

importers of articles.

Table A: Range of Costs Associated with an Importer’s Identification of Chemicals Subject 

to SNURs in Articles

Activity Cost US$) Notes

Per Rule Costs

1. Rule familiarization $55 Cost typically already included in SNUR 

Economic Analyses

2. Identify the type of imported 

articles that potentially contain 

the restricted substances

$130 to 

$1,550 

Actual costs may vary based on number of 

articles imported and the complexity of the 

article itself (number of components)

3. Identify all suppliers involved

$950

Actual costs may vary depending on the number 

of articles imported, number of suppliers, and 

frequency of supplier changes

6. Recordkeeping $10 Cost typically already included in SNUR

Economic Analyses

Article-Related Costs

4. Collect data from suppliers $5 to 

$515 per 

article 

reviewe

d. $0 if 

no data 

collecte

d.

Actual costs only apply to those companies that 

choose to collect data from suppliers. They will 

vary depending on the specific data collection 

method chosen. Total costs depend on 

considerations including the number of articles 

imported, number of suppliers, and frequency of 

supplier changes.

5. Chemical testing

$130 per 

article 

tested. 

$0 if no 

testing. 

Actual costs only apply to those companies that 

choose to collect data from suppliers. Total 

costs per company will depend on 

considerations including the number of articles 

tested, which may be affected by the number of 

suppliers and risk associated with each, and 

frequency of supplier changes.

Should processors of articles need to demonstrate compliance with a SNUR, it is expected that 

they could use the shipping or labeling documents received with the article in the ordinary course 

of business. As these documents would be received and stored anyway, as per standard business 

practices, the elimination of the exemption in the SNUR for persons that import or process 
34

chemical substances as part of articles would be unlikely to lead such persons to incur significant 

additional costs. To the extent that processors choose to undertake more steps to identify 

regulated chemicals as part of articles, the costs of these activities would be similar to those in 

Table A for importers of similar size, supply chain complexity, and level of compliance with 

other chemical regulations.

EPA does not believe that HBCD is entering the United States in imported articles for the 

significant new use defined by the final regulation. However, companies may screen or initiate 

other activities to determine if consumer textiles (other than for use in motor vehicles) that they 

import in the future contain HBCD. EPA notes that no commenters provided data that could be 

used to estimate what, if any, costs might be associated with continued assurance that imported 

textiles are free of HBCD. The number of companies that may take such actions is not known, 

nor is the level of action that may be taken by a particular company. Based on EPA’s economic 

analysis and the responses to the proposed rule, EPA does not believe that these costs will be 

significant for any individual entity. 

I. Import and Export Regulations for Chemical Substances as Part of Articles

Comment. One comment noted that EPA is not proposing to change the way in which 

TSCA’s export and import rules (pursuant to TSCA sections 12(b) and 13, respectively) apply to 

articles containing these chemical substances. The comment indicates that (under the status quo 

of the import rules) the U.S. Customs and Border Protection (CBP) will not be screening articles 

for the chemical substances in the proposed SNURs.

Response. EPA agrees that the TSCA import rules are important TSCA compliance 

mechanisms and that 19 CFR 12.119 allows EPA to establish TSCA section 13 import 

certification requirements for chemicals in articles. However, declining to subject importers to 
35

one notice requirement (TSCA section 13 import certification) does not render another notice 

requirement (TSCA section 5 SNUN submission) unenforceable. 

In this case, EPA did not propose to require TSCA section 13 import certification or 

TSCA section 12 export notification for the subject chemical substances when part of articles. 

This is consistent with EPA’s past practice of making the exemption at 40 CFR 721.45(f) 

inapplicable without also requiring import certification or export notification for these chemical 

substances as part of articles (40 CFR 721.2800; 40 CFR 721.10068). However, the Agency 

continues to study this issue and has not ruled out a later proposal to require import certification 

and/or export notification for these chemical substances as part of articles. 

With or without an import certification requirement, it is the importer that is “responsible 

for insuring that chemical importation complies with TSCA just as domestic manufacturers are 

responsible for insuring that chemical manufacture compliance with TSCA.” 40 CFR 

707.20(b)(1).

J. Use of HBCD in textiles for use in motor vehicles

1. Comment. One comment addressed availability of substitutes for HBCD in textiles for 

use in motor vehicles. The commenter supports use of safe chemicals and products in the 

automotive industry and is “working to phase out HBCD uses as soon as viable substitutes are 

available.” EPA’s exclusion of motor vehicles from the proposed SNUR is “appropriate” and the 

commenter “appreciates EPA’s recognition of the ongoing and essential uses of HBCD in the 

automotive sector.” However, the commenter is concerned about whether there will be 

substitutes for these uses: “EPA noted . . . that DecaBDE is one of the alternatives to HBCD. 

Given EPA’s past and recent actions related to decaBDE, it is not a viable alternative at this 

time.” The commenter also states: “While EPA’s proposed SNUR would appear to signal a 
36

desire for the automotive sector to begin substitution for HBCD, EPA itself is unsure of what 

substitutes it would find acceptable.” The commenter recommends that EPA wait for the 

completion of the DfE assessment of alternatives to decaBDE and then “engage the automotive 

sector in discussions about possible substitution in textiles.” (Docket ID# EPA-HQ-OPPT-2011-

0489-0035)

1. Response. EPA appreciates the interest on the part of the commenter to find safer 

chemicals for use in the automotive industry. The reason the SNUR does not apply to textile 

components of motor vehicles is because those are ongoing uses. The commenter is mistaken in 

saying that EPA recognizes that use of HBCD in the automotive sector is “essential,” as EPA has 

not made that conclusion. Nor is the SNUR intended as a signal to the automotive industry to 

begin substitution for HBCD, as the commenter surmises. Thus, the commenter’s suggestion that 

EPA engage the automotive sector in a discussion about substitutes for HBCD is not germane to 

this SNUR rulemaking. Nevertheless, EPA welcomes information from the Association of 

Global Automakers on alternative flame retardants in textiles.

2. Comment. The commenter states that EPA’s exemption for motor vehicles in the 

HBCD SNUR “appears to be predicated on the assumption that HBCD will be banned for all 

uses in the EU after August 21, 2015 and that the U.S. automotive sector will immediately 

discontinue all use of HBCD.” The commenter states that “EPA provides no explanation for the 

basis of the statement that ‘the automotive industry plans to phase out these uses in 2015.’”

(Docket ID# EPA-HQ-OPPT-2011-0489-0035)

2. Response. EPA did not base the decision not to include use in motor vehicles from the 

HBCD SNUR on the assumption that the chemical might be banned for all uses in the EU after 

August 21, 2015; rather the decision not to include use in motor vehicles was based on the fact 
37

that HBCD use in motor vehicle textiles is ongoing in the market. The statement in the preamble 

that the industry plans to phase out HBCD use by 2015 was based on indications from some 

companies that they plan to stop using HBCD by 2015 in order to meet the deadline set by the 

EU’s REACH directive. In addition, the Ford Motor Company included HBCD-treated fabrics 

on a list of parts that were “prohibited” in vehicles after 2011, as referenced in the preamble of 

the proposed rule (77 FR 17389) and the Economic Analysis in the docket. However, the 

comment clarifies that while automakers are working towards phasing out the use of HBCD, this 

is dependent on the availability of viable substitutes. EPA is adding this information to the 

preamble of the final rule to reflect this clarification.

3. Comment. The commenter asked questions about future EPA actions on HBCD: 1) 

whether EPA will support an EU decision to continue allowing HBCD use on textiles; 2) what 

are EPA's plans for additional actions on HBCD; and 3) whether EPA will consult stakeholders 

before taking regulatory actions on HBCD in the automotive sector. (Docket ID# EPA-HQOPPT-2011-0489-0035)

3. Response. EPA monitors developments on HBCD by the EU but does not take 

positions on those developments. Regarding EPA’s plans for additional actions on HBCD, EPA's 

2010 Action Plan for HBCD, which is referenced in the preamble, said EPA will consider 

regulating the manufacturing, processing, distribution in commerce, and use of HBCD under 

TSCA section 6(a) (See 77 FR 17390). In August 2015, EPA published a Problem Formulation 

and Initial Assessment for the Cyclic Aliphatic Bromides Cluster of Flame Retardants, including

HBCD (See www.epa.gov/oppt/existingchemicals/pubs/riskassess.html) (Ref. 13). EPA has not 

decided on specific steps (such as consultation with stakeholders) it will take before any future 
38

regulatory action on HBCD, however any future rulemaking would provide for public notice and 

comment.

4. Comment. Another commenter appreciates the exemption for use in motor vehicles 

but “objects to the proposed SNUR to the extent that it assumes that, but for that exemption, the 

term ‘consumer textiles’ would include textiles for motor vehicles and motor vehicle 

equipment.” The comment points to four federal statutes in which motor vehicles or automobiles 

are distinguished from consumer products. The “leading definition of consumer product” is in 

the Consumer Product Safety Act, according to the comment, which “specifically excludes motor 

vehicles and motor vehicle equipment.” The commenter recommends that EPA “clarify that the 

SNUR definition of 'consumer product' [40 CFR 721.3] excludes motor vehicles and thus the 

HBCD SNUR does not apply to vehicles or vehicle equipment.” (Docket ID# EPA-HQ-OPPT2011-0489-0036)

4. Response. EPA disagrees with the commenter that the Agency should clarify that the 

existing definition of “consumer product” in the SNUR regulations (40 CFR 721.3) excludes 

motor vehicles. This SNUR does not cover the use of HBCD in motor vehicles because use of 

HBCD in textiles in motor vehicles is ongoing. In addition, EPA did not propose to revise the 

existing definition of “consumer product” in the proposed HBCD SNUR. As such, clarifying the 

definition of “consumer product” as it relates to motor vehicles is outside of the scope of the rule. 

K. Support for HBCD SNUR

1. Comment. One commenter supported the proposed rule because the commenter 

expects it will help make homes safer from fire by increasing the use of HBCD. (Docket ID# 

EPA-HQ-OPPT-2011-0489-0034)

1. Response. The SNUR is not expected to increase the amount of HBCD used in 
39

residences. It requires a manufacturer or processor that intends to use HBCD in consumer 

textiles to notify EPA 90 days before beginning that use. The purpose of the rule is to provide 

EPA with an opportunity to evaluate potential risks to human health and the environment from 

that use.

2. Comment. Another commenter supported EPA’s proposal to consider any importation 

of an article, or manufacture or processing of a consumer textile containing HBCD, as new after 

the effective date of the regulation, subject to notification under the applicable Significant New 

Use provisions. (Docket ID# EPA-HQ-OPPT-2011-0489-0038)

2. Response. To the extent the commenter believes the date used in determining whether 

a use is new is the date of finalization of the rule, this is incorrect. As with other SNURs, EPA’s 

determination of what uses are on-going was based on the uses that were current on the date the 

proposal was published on March 26, 2012. While the obligation to notify EPA before 

manufacturing or processing HBCD for consumer textile use does not begin until the effective 

date of the final rule, EPA considers any use that begins after the proposal to be a significant new 

use. As discussed in the Federal Register of April 24, 1990 (55 FR 17376), 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, if persons begin the activity 

after the proposal date and EPA finalizes the proposal, the persons would be required to cease 

the activity before the effective date of the final rule. To resume their activities, these persons 

would have to comply with all applicable SNUR notice requirements and wait until the notice

review period expires. EPA has promulgated provisions at 40 CFR 721.45(h) for advance 
40

compliance (submitting a SNUN before the effective date of the SNUR). 77 FR 17391 (March 

26, 2012)

3. Comment. One commenter wrote to say it intends to continue working with EPA on 

issues related to HBCD. (Docket ID# EPA-HQ-OPPT-2011-0489-0039)

3. Response. EPA acknowledges the comment.

References

1. Davis et al., 2012. Measurement of Flame Retardants and Triclosan in Municipal Sewage 

Sludge and Biosolids. Environment International, 40, 1-7.

2. Dodson et al, 2012. After the PBDE Phase-Out: A Broad Suite of Flame Retardants in

Repeat House Dust Samples from California. Environmental Science and Technology, 

46(24), 13056-13066.

3. Sagerup et al., 2010. New Brominated Flame Retardants in Arctic Biota. Klima-Og 

Forurensnings-Direktoratet, (Statlig program for forurensningsovervåking).

4. Stapleton et al., 2011. Identification of Flame Retardants in Polyurethane Foam Collected 

from Baby Products. Environmental Science and Technology, 45(12), 5323-5331.

5. CPSC, 2011. Staff Briefing Package. Petition HP 10-2. Requesting Restriction of 

Cadmium in Toy Jewelry (Consumer Product Safety Commission (February 9, 2011). 

Staff Report, Cadmium in Children’s Metal Jewelry. Toxicity Review of Cadmium. TAB 

B pp19-39 http://www.cpsc.gov/PageFiles/96192/cadmiumtoy.pdf (October 14, 2010).

6. Danish Environmental Protection Agency, Survey of Chemical Substances in Consumer 

Products Survey No. 25 2003, Mapping the Liberation of Organic Tin Compounds in 

Mattress Pads, To Mattresses, and Baby/Junior Duvets.
41

7. Stapleton, et al., 2008. Alternate and New Brominated Flame Retardants Detected in U.S. 

House Dust. Environ. Sci. Technology, 42 (18), pp 6910–6916.

8. CPSC Staff Preliminary Risk Assessment of Flame Retardant [FR] Chemicals in 

Upholstered Furniture Foam, December 21, 2006.

9. Muller, et al., 2011. Car Indoor Air Pollution- Analysis of Potential Sources. Journal of 

Occupations Medicine and Toxicology. 6:33.

10. Wu, et al., 2009. Residues of Polybrominated Diphenyl Ethers in Frogs (Rana 

limnocharis) from a Contaminated Site, South China: Tissue Distribution, 

Biomagnification, and Maternal Transfer, Environ. Sci. Technology, 42: 5212-5217. 

11. Gaylor, et al. 2012. House Crickets Can Accumulate Polybrominated Diphenyl Ethers 

(PBDEs) Directly from Polyurethane Foam Common in Consumer Products.

Chemosphere, 86: 500-505. 

12. Covaci, et al. 2006. Hexabromocyclododecanes (HBCDs) in the Environment and 

Humans: A Review. Environ. Sci. Technology, 40: 3679-3688. 

13. U.S. 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

14. U.S. EPA, Understanding the Costs Associated with Eliminating Exemptions for Articles 

in SNURs, May 1, 2013.

15. Wal-Mart. (2012). Become a Supplier: Requirements. Retrieved from 

http://www.walmartstores.com/Suppliers/248.aspx.