Response to Public Comments on Proposed Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9, 10
- Hexabromocyclododecane A ugust 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 ena cting the Toxic Substances Control Act ( TSCA ) . The commenter argues furt her 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 tha n 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

. F or polychlorinated biphenyls (the only chemical2

substance specifically addressed in TSCA a s it was originally enacted) , S ection 6(e) of TSCA provides authority for EPA to promulgate rules related to polychlorinated biphenyls in articles, such as electrical transformers.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 regu lation 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 keepin g 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.3

the chemical substance as part of articles) is consistent with legislators ’ observation, in drafting th is 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 environmen tal 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 genera lly exists in non article 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. comme rce. 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 p romulgating 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 to4

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 [incl uding the exemption for importers and processor s 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 pro cessors 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, Sept ember 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 S ection 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 no tes 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 p arts 720 and 721 deal with many similar issues, they are also distinct from each other in important respects. It is significant that i n the 1984 action , whe reby EPA established the article importers’ and article processors’ exempti on for SNURs, it did not simply mirror the 1983 rati ona le for the comparable exemption from PMN5

obligations. For PMNs, EPA noted the difficulties associated with determining the identity and
i nventory status of each chemical substance in imported articles (e.g., automobiles). (48 FR
21726 , May 13, 1983) (FR L 2998

- 5 ). But f or 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 revi se its assumption as warranted in the case of specific substances. EPA had reason to differentiate between the two rationales

. SNUR s 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 t he 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 chemi cal substances, as part of articles or otherwise. B. Development of a Separate Policy Framework for M aking Inapplicable the Exemption f or 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 .” Commenters6

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

. T he 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 t here 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 the7

persons subject to SNUN submission obligations . K nowledge 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 S NURs (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 com pounds 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 exam rples 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 support s the flame retardant release from articles postulate. Like wise, 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 observ ed in biota raised in proximity to articles and living near article recycling sites. Further, o bserved flame retardant levels in biota and in the environment at locations remote from manufacturing sites8

suggest transport of these non

- volatile chemical subs tance s on associated particulate matter from distributed treated articles , which strongly suggest release from a rticles as one potential source (Ref s . 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 (Ref s . 2

- 8).
T he 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 n otes that TSCA section 5(a)(1) establishes a general prohibition on manufacturi ng or processing a chemical substance for a significant new use without prior notice
to EPA

. A n 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

- ca se discretion to make the exemption inapplicable as “warranted for specific substances.” (49 FR 35014, September 5, 1984) (FRL

2541

- 8). EPA does not think that development of a “policy framework” is necessary before reaching the conclusion, with respect t o HBCD , that persons who import or process th is9

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. E xposure 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 thi s information, and other information described in Unit III.E

. of the proposal (77 FR 17 389 to 91 , March 2 6 , 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 arti cle. 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 c omment also suggest s 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 commente r en couraged EPA to develop and articulate publicly a policy framewor k, consider ing the following factors on an article

specific basis, before proceeding to revoke the article exemption with respect to a particular chemical substance:

• Whether t here is, or will be, direct exposure to the chemical substance in the article during the course of the article’s use.

• Whether t here 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 t here is, or will be, a link between import or export of an article and cross

-10

border exposure to the U.S. population.
2. Response

. Given the variety of substances and uses addr essed under SNUR regulations, EPA believe s it is more efficient to address article

- specific issues as they actually arise within each reg ulatory 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 u sed 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 raise d 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 # EPA

HQ

- OPPT

- 2011

- 0489

- 0 036.)
C. A Compelling Basis Standard for Making Inapplicable the Exemption f or Persons who Import
or Process Chemical Substances as Part of Articles
Comment

. Some commenters made the point that revo cation 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 the11

exemption would come to be a “ kind of ‘d e fault’ step” in future SNURs

. One commenter also argues that, where the SNUN submission requirement is to apply to importers and processors of subs tances 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 , whil e 40 CFR 721.45(f) speaks to who is required to notify EPA of the significant new use. I n 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 t he 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 , t o 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 article s. No commenter provided data or other information to undercut the factual basis for either decision.12

Neither TSCA nor the implementing regulations for SNURs establish a separa te “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 revoc ation 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 r ule only makes inapplicable the SNUR general exemption at 40 CFR 721.45(f) for import er s 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, c onduct 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 categ ory). 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 is13

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

. R equiring 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 decisi on to propose a SNUR f or 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 pr ocessing 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 the14

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, c ommercial 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 k now 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 environm ent. 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

u se 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 c onsumer textiles (other than for use in motor vehicles) is planned, EPA anticipates that it would be im portant 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 risk15

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 v ehicles) weighs in favor of determinin g that consumer textile use (other than for use in motor v ehicles) 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 chemic al 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 treatmen t 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 acros s 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 of16

exposure weighs in favor of determining that consumer textile use (other than for use in motor

v ehicles) 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 fact or 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 v ehicles) be expec ted 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 ov erall 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 pictu re weighs in favor of determining that consumer textile use (other than for use in motor v ehicles) 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 v ehicles) 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 to17

consider the 40 CFR 721.45(f) exemption as a su bcomponent 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 suggest s 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 artic le 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.” T his 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 fr om 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 intended18

expansion of use into consumer textiles in the U.S. before it occurs to provide the agency with an opportunity to e valuate the risk. Indeed, one could ask why the significant new use is as narrow as it is. T he 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 vehic les 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

. S ince 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. I f a person decides to begin importing or processing HBCD as part of a consumer textile (other than for use in motor v ehicles) or otherwise, the notice to EPA allows EPA to evaluate the significant new use according to the specific parameters and circumstan ces 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 these19

chemical substances will be used in such articles.” The commenter asserts that b efore 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 commer cial 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 o f public resources. Another comment er 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 provis ion 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 s uggestion 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 situat ions in which EPA is concerned a bout 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 designating20

significant new uses . The purp ose 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 ne w 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 p rocessing of HBCD in textile article s. The proposed HBCD SNUR made the article exemption inapplicable to articles generally; EPA’s final rule makes the exemption inapplicable only for textile articles. F or 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 th at 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 importat ion or processing of chemical substances as part of articles are about to begin ) is impracticabl e . It would likely result in a scenario in which an otherwise significant new use would be allowed to21

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 comm enter’s alternative suggestion: to promulgate a SNUR with out 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 signifi cant new use as part of an article is about to begin, but has not yet begun. In sum, EPA believes the commenter’s suggestion s 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 expla nation of what uses EPA intends to cover, including an explanation of the alternatives if certain situations22

are unclear, will greatly increase the chances that useful information about business practices and common terms of art in an industry will be iden tified.” 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, con stitutes “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 “amp le authority under TSCA, either through regulatory action under section 8 or order authority under section 11 (c).” T he 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

. T he description of the scope of the significant new use in the pr o posed
HBCD SNUR and the A gency’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. Stakeh olders 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

- consumi ng and an unsound use of agency resources. The timelier, less

resource - intensive, and more transparent process is for interested stakeholders, through the23

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

- by

article 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 ma nufacture 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 associ ated 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 dis tinguish 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 definiti on, including those that the commenter claims are “not self

evident 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 conclude d 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 final24

definition of “consumer textile” covers only those textiles that the Agenc y 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 no rmal use of the article.”
3. Response

. T he commenter does not explain why the basis for a SNUR should be limited to those exposure s 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 futur e 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 chem ical 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 i f 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 de fine 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 n ot believe it is prudent to limit the application of the rule based on the26

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 ar ticle 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 am endment 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 min imi s 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 ope rations. One commenter suggests , in particular, that an article importer shou ld 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

Res ponse . 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 kne w 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 chemic al 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 respecting28

the content of the imports. 2 With r espect 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 se ction 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 w ithdraw 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 scre en 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 estab lish 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 th at the chemicals they import or process as part of articles do not trigger SNUN submission requirements (Ref. 11 )

. Based o n 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 Chemical30

Substances as P art 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 neithe r 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 chemica l 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

eco nomic 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 i mportation of HBCD for use in consumer textiles (not including for use in motor v ehicles) is ongoing. However, because this SNUR makes inapplicable the exemption for persons that import or process chemical substances as part of textile article s , companies may take actions to ensure that they comply with the notice requirements if they import any textiles containing HBCD after pro posal of this rule, by such means they deem appropriate. This is not necessarily a new consideration for importers31

given that impo rters 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 t hey 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 chemi cals 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 t he 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 like lihood 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 g lobal 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 Ac t, California’s Proposition 6 5, and the European Union’s regulation on Registration, Evaluation,32

Authorization and Restriction of Chemical s (REACH), which requires customer notification about the presence of certain chemical in articles that a company dist ributes. 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 suc h as the Consumer Product Safety Improvement Act (CPSIA) of 2008, Washington’s Children’s Safe Product Act, and Maine’s Act t o Protect Children’s Health and t he Environment from Toxic Chemicals in Toys a nd 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 article s. Policies and procedures could include supplier agreements, such as Hewlett Packard’s requirement that suppliers meet their General Specifications for the Environm ent (GSE) ( Ref. 11 ) and Walmart’s requirement that suppliers participate in International C ompliance Information Exchange (iCiX) to manage and share compliance information throughout the supply chain ( Ref. 1 2 ). More extensive policies and procedures could even include product testing. Companies may choose to use existing procedures or develop ne w 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 cost s . The conduct of these activities and associated costs are at the disc retion of the company. Table A shows EPA’s estimated a range of costs associated with some of these potential activities for33

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 on ly 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 frequ ency 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 process34

chemical substances as part of articles would be unlikely to lead such persons to i ncur 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 ch ain 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 initia te other activities to determine if consumer textiles (other than for use in motor v ehicles) 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 th e 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 su bstances. 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 rule s 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 to35

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 notificatio n 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 chemic al manufacture compliance with TSCA.” 40 CFR 707.20(b)(1). J. Use of HBCD in textiles for use in motor v ehicles
1. Comment

. One comment addressed availability of substitutes for HBCD in textiles for use in motor v ehicles. 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 alter natives 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 a36

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 subst itution 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 u se in the automotive industry. The reason the SNUR does not apply to textile components of m otor 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 i ndustry 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 ban ned 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 us es 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
A ugust 21, 2015; rather the decision not to include use in motor vehicles was based on the fact37

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 o n 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 vehicl es after 2011, as referenced in the preamble of the proposed rule (77 FR 17389) and the Economic Analysis in the docket. Howev er, the comment clarifies that while automakers are working towards phasing out the use of HBCD, this is dependent on the avai lability 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 cont inue 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

- HQ

OPPT

- 2011

- 0489

- 0035)
3. Response

. EPA monitors developments on HBCD by the EU but does not take
po sitions 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 p ublished a Problem Formulation and Initial Assessment for the Cy clic Alipha tic 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 future38

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 ‘ consu mer 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 mot or vehicles and thus the HBCD SNUR does not apply to vehicles or vehicle equipment. ” (Docket ID# EPA

- HQ

- OPPT

2011

- 0489

- 0036)
4. Response

. EPA disagrees with the commenter that the Agency should clarify that the existing definition of “ consumer product ” i n 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 mot or vehicles is outside of the scope of the rule.
K. S upport 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 in39

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 believ es 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 o n the date the proposal was publish ed 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 ne w 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 EP A 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 advance40

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 workin g with EPA on issues related to HBCD. (Docket ID# EPA

- HQ

- OPPT

- 2011

- 0489

- 0039)
3

. Response

. EPA acknowledges the comment.

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