Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule, 2068-2077 [2015-00474]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Proposed Rules]
[Pages 2068-2077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00474]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0976; FRL-9915-62]
RIN 2070-AJ91


Toluene Diisocyanates (TDI) and Related Compounds; Significant 
New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing 
a significant new use rule (SNUR) for 2,4-toluene diisocyanate, 2,6-
toluene diisocyanate, toluene diisocyanate unspecified isomers (these 
three chemical substances are hereafter referred to as toluene 
diisocyanates or TDI) and related compounds as identified in this 
proposed rule. The proposed significant new use is any use in a 
consumer product, with a proposed exception for use of certain chemical 
substances in coatings, elastomers, adhesives, binders, and sealants 
that results in less than or equal to 0.1 percent by weight of TDI in a 
consumer product. In addition, EPA is also proposing that the general 
SNUR article exemption for persons who import or process these chemical 
substances as part of an article would not apply. Persons subject to 
the SNUR would be required to notify EPA at least 90 days before 
commencing any manufacturing or processing. The required notification 
would provide EPA with the opportunity to evaluate the intended use 
and, if necessary based on the information available at that time, an 
opportunity to protect against potential unreasonable risks, if any, 
from that activity before it occurs.

DATES: Comments must be received on or before March 16, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0976, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Katherine Sleasman, Chemical 
Control Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: 202-564-7716; email 
address: sleasman.katherine@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or distribute in commerce chemical substances and mixtures. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Chemical and Allied Products Manufacturers (NAICS code 
32411).
     Petroleum Refining (NAICS code 325 and 32411).
     Paints, coatings and adhesives manufacturing (NAICS code 
3255).
     Urethane and other foam product manufacturing (NAICS code 
326150).
     Transportation polyurethane foam products (NAICS code 
32615011).
     Building and construction polyurethane foam products 
(NAICS code 32615031).
     Products made of foam other than polystyrene or 
polyurethane (NAICS code 32615091).
     All other miscellaneous polyurethane foam products (NAICS 
code 32615061).
     Consumer and institutional polyurethane foam products 
(NAICS code 32615051).
     Packing polyurethane foam products (NAICS code 32615021).
     Elastomers (NAICS code 326199).
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Those persons must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA, including any SNUR requirements. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B. In addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after 
February 17, 2015 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture 
or process the chemical substance for that use (15 U.S.C. 
2604(a)(1)(B)). As described in Unit V., the general SNUR provisions 
are found at 40 CFR part 721, subpart A.

C. What action is the agency taking?

    EPA is proposing a SNUR for 2,4-toluene diisocyanate, 2,6-toluene 
diisocyanate, toluene diisocyanate unspecified isomers (these three 
chemical substances are hereafter referred to as toluene diisocyanates 
or TDI) and related compounds. The proposed significant new use is: Any 
use in a consumer product of any chemical substance listed in Table 1 
of Unit II.A.; and any use in a consumer product of any chemical listed 
in Table 2 of Unit II.A. (except for use in coatings, elastomers, 
adhesives, binders, and sealants that results in less than or

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equal to 0.1 percent by weight of TDI in a consumer product).
    This proposed significant new use rule would apply to the uses EPA 
has identified in this unit that EPA believes are not ongoing at the 
time of this proposed rule. EPA is requesting public comment on this 
proposal, and specifically on the Agency's understanding of ongoing 
uses for the chemicals identified in Table 1 of Unit II.A and Table 2 
of Unit II.A. in consumer products. EPA is particularly interested in 
whether there are any ongoing uses of these chemicals in consumer 
products of which the Agency is currently unaware and would welcome 
specific documentation of any such ongoing uses. A consumer product is 
defined at 40 CFR 721.3 as: A chemical substance that is directly, or 
as part of a mixture, sold or made available to consumers for their use 
in or around a permanent or temporary household or residence, in or 
around a school, or in recreational settings.
    This proposed SNUR would require persons that manufacture 
(including import) or process any of the chemicals for a significant 
new use, consistent with the requirements at 40 CFR 721.25, to notify 
EPA at least 90 days before commencing such manufacture or process of 
the chemical substance for a significant new use. For this proposed 
rule, EPA is proposing that the general SNUR article exemption at 40 
CFR 721.45(f) for persons who import or process chemical substances as 
part of an article would not apply. The article exemption at 40 CFR 
721.45(f) is based on an assumption that people and the environment 
will generally not be exposed to chemical substances in articles (see 
September 5, 1984; 49 FR 35014; FRL-2541-8) (Ref. 1). However, TDI and 
related compounds are volatile and as such could migrate out of 
articles that contain them. For instance, studies of TDI in 
polyurethane products reported that after the reaction between an 
isocyanate and an alcohol to form polyurethane products, residual 
levels of isocyanates were detected on the surface of the products, 
(e.g. flexible foams), which if used could lead to exposure (Refs. 2 
and 3). Because TDI and related compounds are known to be volatile 
chemical substances, have been reported to migrate from products, are 
sensitizers, and would be expected to present a higher potential for 
exposure if the TDI in the article were a consumer product, EPA would 
like the opportunity to evaluate such potential uses in consumer 
products for any associated risks or hazards that might exist before 
those uses would begin.

D. Why is the agency taking this action?

    These SNURs are necessary to ensure that EPA receives timely 
advance notice of any future manufacturing and processing of TDI and 
related compounds for new uses that may produce changes in human and 
environmental exposures. The rationale and objectives for this SNUR are 
explained in Unit III.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substances included in this proposed rule. This analysis, 
which is available in the docket, is discussed in Unit IX., and is 
briefly summarized here. In the event that a SNUN is submitted, costs 
are estimated to be less than $8,589 per SNUN submission for large 
business submitters and $6,189 for small business submitters. These 
estimates include the cost to prepare and submit the SNUN and the 
payment of a user fee. The proposed SNUR would require first-time 
submitters of any TSCA section 5 notice to register their company and 
key users with the CDX reporting tool, deliver a CDX electronic 
signature to EPA, and establish and use a Pay.gov E-payment account 
before they may submit a SNUN, for a cost of $200 per firm. However, 
these activities are only required of first-time submitters of section 
5 notices. In addition, for persons exporting a substance that is the 
subject of a SNUR, a one-time notice must be provided for the first 
export or intended export to a particular country, which is estimated 
to be $84.22 per notification. The rule may also affect firms that plan 
to import or process articles that contain TDI and related compounds, 
because, while not required by the SNUR, these parties may take 
additional steps to determine whether TDI and related compounds are 
part of the articles that they are considering to import or process. 
Since EPA is unable to predict whether anyone might engage in future 
activities that would require reporting, potential total costs were not 
estimated.

II. Chemical Substances Subject to This Proposed Rule

A. What chemicals are included in the proposed SNUR?

    This proposed SNUR would apply to TDI and its related compounds 
listed in Table 1 of this unit and Table 2 of this unit in consumer 
products. Diisocyanates contain free isocyanate functional groups 
(=N=C=O). Diisocyanates are combined with other compounds that contain 
free hydroxyl functional groups (i.e., =OH), typically called 
``polyols.'' These two-part components react and begin to form 
polyurethane polymers. This chemical reaction is completed when all of 
the isocyanate functional groups are bound within the polymer network. 
This process is commonly referred to as ``curing.'' Products that 
contain free isocyanate functional groups are intended to react further 
and undergo ``curing'' in the process of use. The chemical substances 
subject to this proposed SNUR contain free isocyanate functional groups 
and are by definition uncured. Prior to complete curing, consumers and 
bystanders can potentially be exposed to isocyanates through both 
dermal and respiratory routes. Exposures to uncured isocyanates could 
lead to sensitization.
    To ascertain if TDI and related compounds are used in consumer 
products, EPA reviewed published literature, the most recent data from 
EPA's Chemical Data Reporting program (CDR), and communicated directly 
with manufacturers and processors. Reporting under the CDR indicated no 
consumer uses of TDI or related compounds. However, during 
conversations between EPA personnel and manufacturers and processors, 
it was revealed that in some cases consumer products may still contain 
residual TDI of no more than 0.1 percent by weight, as noted in Table 2 
of this unit (Ref. 4). This was also confirmed by review of published 
literature and SDS for consumer adhesives and sealants available in 
retail outlets. It is EPA's understanding that any TDI present in a 
coating, adhesive, elastomer, binder or sealant consumer product is at 
levels of no more than 0.1 percent by weight and would typically be 
considered residual diisocyanate remaining from the manufacture of a 
polyurethane polymer, a concentration which is above the detection 
level (Ref. 5). EPA believes that other consumer products do not 
contain TDI or related compounds at any level.

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 Table 1--Toluene Diisocyanate Related Compounds Subject to This Action
With a Proposed Significant New Use of ``Any Use in a Consumer Product''
------------------------------------------------------------------------
                                                             Chemical
                                                             abstracts
           Chemical name             Chemical abstracts       service
                                         index name          registry
                                                            (CASRN) No.
------------------------------------------------------------------------
Toluene diisocyanate trimer.......  Benzene, 1,3-              9019-85-6
                                     diisocyanatomethyl-
                                     , trimer.
Poly(toluene diisocyanate)........  Benzene, 1,3-              9017-01-0
                                     diisocyanatomethyl-
                                     , homopolymer.
Toluene diisocyanate dimer........  1,3-Diazetidine-2,4-      26747-90-0
                                     dione, 1,3bis(3-
                                     isocyanatomethylphe
                                     nyl)-.
Toluene diisocyanate ``cyclic''     1,3,5-Triazine-           26603-40-7
 trimer.                             2,4,6(1H,3H,5H)trio
                                     ne, 1,3,5-
                                     tris(3isocyanatomet
                                     hylphenyl)-.
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  Table 2--Toluene Diisocyanates Subject to This Action With a Proposed
  Significant Use of ``Any Use in a Consumer Product (Except for use in
 Coatings, Adhesives, Elastomers, Binders, and Sealants at Less Than or
              Equal to 0.1 Percent in a Consumer Product)''
------------------------------------------------------------------------
                                                             Chemical
                                                             abstracts
           Chemical name             Chemical abstracts       service
                                         index name          registry
                                                            (CASRN) No.
------------------------------------------------------------------------
2,6-Toluene diisocyanate..........  Benzene, 1,3-                91-08-7
                                     diisocyanato-2-
                                     methyl-.
2,4-Toluene diisocyanate..........  Benzene, 2,4-               584-84-9
                                     diisocyanato-1-
                                     methyl-.
Toluene diisocyanate unspecified    Benzene, 1,3-             26471-62-5
 isomer.                             diisocyanatomethyl-.
------------------------------------------------------------------------

B. What are the production volumes and uses of TDI and related 
compounds?

    TDI and the related compounds are generally high production volume 
chemicals, predominantly used in the production of polyurethanes. There 
are many types of polyurethane products in the marketplace, with foams 
representing the largest sector of the polyurethane industry. Flexible 
foam is primarily used for cushioning, while rigid foam is used mainly 
for insulation (Ref. 6). Approximately 90 percent of TDI, typically a 
mixture of toluene diisocyanate isomers, is used in the production of 
flexible foams, which are designed to be fully cured in a final 
product. Non-foam polyurethane use sectors of TDI include coatings, 
adhesives, elastomers, binders, and sealants. These products may be 
sold and used, most often in a mixture of formulated product, in an 
uncured form. Because of its hazards, some industry representatives 
assert that TDI is used in products intended for industrial use only 
(Ref. 7). In contrast, EPA believes coatings, adhesives, elastomers, 
binders, and sealants used by general consumers contain residual TDI of 
no more than 0.1 percent by weight. Due to the projected growth of the 
market for such use in consumer products as discussed further in Unit 
II.D., EPA is concerned that consumer products in the future might 
contain amounts of TDI above these levels. Therefore, EPA is proposing 
this action to provide the Agency with an opportunity to evaluate such 
potential uses in consumer products for any associated risks or hazards 
that might exist before those uses would begin.

C. What are the potential health effects of TDI and related compounds?

    In acute, subacute, and chronic animal exposure studies for TDI, 
the respiratory tract was the target organ, with nasal irritation 
evident at concentrations above 0.1 ppm and effects becoming more 
severe with increasing concentration (Ref. 8). TDI is uniformly 
distributed throughout the body, following inhalation exposure (Refs. 8 
and 9). TDI causes skin, eye, and lung irritation, progressive 
impairment of lung function with long-term inhalation exposure and is a 
respiratory sensitizer via both the dermal and inhalation routes of 
exposure in animals (Ref. 8).
    Most data on human health hazards resulting from diisocyanate 
exposures are from occupational populations rather than exposures to 
consumer products. As discussed in the Toluene Diisocyanate and Related 
Compounds Action Plan (Ref. 10), diisocyanates, including TDI and 
related compounds, are well-known dermal, eye, and inhalation irritants 
and sensitizers based on worker data. They have been documented in the 
workplace to cause asthma and respiratory problems, such as 
hypersensitivity pneumonitis, an inflammation of the lungs. In severe 
cases, there have been reported fatal reactions.
    Isocyanate exposure has been identified as the leading attributable 
cause of work-related asthma, and prevalence in the exposed workforce 
has been estimated at 1-20 percent (Refs. 11 and 12). Once a worker is 
sensitized to diisocyanates, subsequent exposures can trigger severe 
asthma attacks. Spray application and heated processes are associated 
with higher incidences of asthma than other application methods because 
they can generate airborne isocyanate vapors and mists, which lead to 
worker exposure via the respiratory and dermal routes. Most workers who 
develop diisocyanate asthma have experienced long periods of exposure 
(months or longer); however, the minimum exposure to isocyanates that 
can elicit sensitization responses or asthma is unknown. In addition, 
immune response and subsequent disease in humans can vary significantly 
between individuals (Ref. 6). Fatalities linked to diisocyanate 
exposures in sensitized persons have been reported (Refs. 13 and 14).
    The International Agency for Research on Cancer (IARC) classified 
toluene diisocyanates as ``possibly carcinogenic to humans'' 
(Carcinogenicity Group 2B), based on inadequate evidence for the 
carcinogenicity of TDI in humans and sufficient evidence for the 
carcinogenicity of TDI in experimental animals (Ref. 15). TDI has also 
been classified by the European Commission (EC) as Category 3 for 
carcinogenicity (``causes concerns for humans owing to possible 
carcinogenic effects'') (Ref. 16) and by the United States National 
Toxicology Program (NTP) as ``reasonably anticipated to be a human 
carcinogen'' (Ref. 17). National

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Institutes for Occupational Safety and Health (NIOSH) considers TDI to 
be an occupational carcinogen and recommends exposure reduction to the 
lowest feasible levels (Ref 18).
    There are very few reports available regarding non-occupational 
health effects from exposures to TDI products. However, there are case 
reports suggesting that paraoccupational (brought outside of the 
workplace) asthma may have resulted from incidental exposure to TDI, 
one of which involved incidental exposure to varnishing products (Ref. 
19). A specific, potential concern for consumer products is exposures 
to children. Children exposed to the same levels of TDI vapor as adults 
may receive a larger dose because they have greater lung surface area 
to body weight ratios and increased respiratory minute volumes to 
weight ratios. TDI vapor is heavier than air and may layer close to the 
floor; therefore, children who crawl, roll, or sit on surfaces treated 
with chemicals (i.e. carpets and floors) and play with objects such as 
toys where residues may settle could potentially receive higher doses 
of inhaled toxicants than adults present in the same room (Ref. 20).

D. What are the potential route and sources of exposure to TDI and 
related compounds?

    There is available information on worker exposures to industrial 
products containing TDI, such as coatings, adhesives, and sealants. 
Exposures resulting from the use of these industrial products may 
indicate potential but lower level exposures that may result for users 
conducting similar activities with consumer products containing 
residual TDI. There is a potential for worker exposure to TDI in all 
industrial and commercial settings where TDI is present (Ref. 7). 
Because of the high volatility of TDI, exposure can occur in all phases 
of its use, even in the final product (Ref.17), and it is unknown to 
what extent factors such as application techniques, product 
composition, and environmental conditions influence the availability of 
TDI in products. One activity where overexposures have been documented 
is floor finishing in both personal and area samples in one NIOSH 
evaluation (Ref. 21). Exposure data for professional workers may 
provide an indication of possible exposures if consumer products and 
articles were to contain residual TDI.
    As previously discussed, TDI is used in coatings, adhesives, 
sealants, and other polyurethane products. TDI is used in the 
manufacturing process of the polymer and as a result, a small 
percentage of TDI may be present in consumer products, including 
articles. Further, researchers looking at workplace exposures to 
diisocyanates have noted an increase in the number of isocyanate-
containing products used by consumers (Ref. 6). In addition, consumer 
use of adhesives and sealants is a potential growth sector as seen in 
the increasing numbers of ``Do It Yourself'' (DIY), energy-conscious 
homeowners doing more of their own home renovation and repair work, as 
well as from craftsmen and consumers generally continuing to use 
adhesives (Ref. 22). Most consumers would be unaware of the potential 
hazards of consumer products, including articles, containing TDI or 
other diisocyanates. Consequently, insufficient and inadequate hazard 
communication may lead to incorrect use and increased consumer and 
bystander exposures, particularly for sensitive groups, such as 
children. For example, exposures to bystanders and building occupants 
(including children) to TDI in industrial products have been reported 
in the literature, including emissions of TDI from concrete patio 
sealants (Refs. 23 and 24) and detection of TDI in building air samples 
following use of urethanes containing TDI to coat wood floors (Ref. 
25). It is possible that lower level exposures could occur when 
conducting comparable activities using similar types of consumer 
products containing residual TDI. Even if consumers are aware of such 
potential hazards, they may not take appropriate precautions or 
research the appropriate resources in which these precautions are 
addressed. Of particular concern is the fact that children may have a 
greater potential for exposure if they use or are bystanders to the use 
of consumer products containing even residual amounts of TDI, because 
they may not have fully developed judgment for following labeling 
instructions and safety precautions and may not cease activity even 
when they are experiencing symptoms of exposure.

III. Rationale and Objectives

A. Rationale

    Diisocyanates are potent dermal and lung sensitizers and an 
attributable cause of work-related asthma worldwide (Ref. 26). In the 
past, consumer exposures have not been a focus of concern with respect 
to diisocyanates, because it had been assumed that consumers were 
generally exposed to products containing only completely cured 
polyurethanes, which have been generally considered to have low 
toxicity (Ref. 2). However, an increase in consumer use of polyurethane 
products that may further react and undergo ``curing'' could occur if 
consumer products, such as coatings, elastomers, adhesives, and 
sealants contained TDI in amounts greater than residual amounts. In 
such instances, TDI and related compounds that are not completely 
reacted upon their application can provide potential exposures both to 
the consumer as the direct user or to bystanders when products are used 
by others (Refs. 2 and 3). In sensitized individuals, exposure to even 
small amounts of diisocyanates may cause allergic respiratory reactions 
like asthma and severe breathing difficulties (Ref. 6). EPA believes 
that the use of any of these chemical substances in consumer products 
above current levels could significantly increase human exposure, and 
that such increase should not occur without an opportunity for EPA 
review and control as appropriate. As discussed in Unit II., regarding 
the chemicals listed in Table 2 of Unit II.A., based on Safety Data 
Sheets (SDS) information that coating-, adhesive-, elastomer-, binder-, 
or sealant-consumer products may contain residual TDI of no more than 
0.1 percent by weight, EPA believes that these consumer products do not 
contain residual TDI of more than 0.1 percent by weight. EPA believes 
that other consumer products do not contain TDI or related compounds at 
any level.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
the Agency action is based on EPA's determination that if the use 
begins or resumes, it may present a risk that EPA should evaluate under 
TSCA before the manufacturing or processing for that use begins. Since 
the new use does not currently exist, deferring a detailed 
consideration of potential risks or hazards related to that use is an 
effective use of resources. If a person decides to begin manufacturing 
or processing the chemical for the use, the notice to EPA allows EPA to 
evaluate the use according to the specific parameters and circumstances 
surrounding that intended use.

B. Objectives

    Based on the considerations in Unit III.A., EPA wants to achieve 
the following objectives with regard to the significant new use(s) that 
are designated in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture 
or process TDI or its related compounds

[[Page 2072]]

(see Table 1 of Unit II.A. and Table 2 of Unit II.A.) for the described 
significant new use before that activity begins.
    2. EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing TDI or its related compounds (see Table 1 of Unit II.A. and 
Table 2 of Unit II.A.) for the described significant new use.
    3. EPA would be able to regulate prospective manufacturers or 
processors of TDI or its related compounds (see Table 1 of Unit II.A. 
and Table 2 of Unit II.A.) before the described significant new use of 
the chemical substance occurs, provided that regulation is warranted 
pursuant to TSCA sections 5(e), 5(f), 6 or 7.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
    1. The projected volume of manufacturing and processing of a 
chemical substance.
    2. The extent to which a use changes the type or form of exposure 
of human beings or the environment to a chemical substance.
    3. The extent to which a use increases the magnitude and duration 
of exposure of human beings or the environment to a chemical substance.
    4. The reasonably anticipated manner and methods of manufacturing, 
processing, distribution in commerce, and disposal of a chemical 
substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of TDI or 
its related compounds subject to this proposed rule, as discussed in 
this unit, EPA considered relevant information about the toxicity of 
these substances, likely human exposures and environmental releases 
associated with possible uses, and the four factors listed in section 
5(a)(2) of TSCA. EPA has preliminarily determined as the significant 
new uses: Any use in a consumer product for any chemical listed in 
Table 1 of Unit II.A.; and any use in a consumer product for any 
chemical listed in Table 2 of Unit II.A. (except for use in coatings, 
elastomers, adhesives, binders, and sealants that results in less than 
or equal to 0.1 percent by weight of TDI in a consumer product).
    The article exemption at 40 CFR 721.45(f) is based on an assumption 
that people and the environment will generally not be exposed to 
chemical substances in articles (see September 5, 1984; 49 FR 35014,) 
(Ref. 1). However, TDI and related compounds are volatile and as such 
could migrate out of articles that contain them. For instance, studies 
of TDI in polyurethane products reported that after the reaction 
between an isocyanate and an alcohol to form polyurethane products, 
residual levels of isocyanates were detected on the surface of the 
products, which if used could lead to exposure (Refs. 2 and 3). Because 
TDI and related compounds are known to be volatile chemical substances, 
have been reported to migrate from products, are sensitizers, and would 
be expected to present a higher potential for exposure if the TDI in 
the article were a consumer product, EPA would like the opportunity to 
evaluate such potential uses in consumer products for any associated 
risks or hazards that might exist before those uses would begin.
    EPA believes any new use of TDI and related compounds as part of 
articles would increase the duration and magnitude of human exposure to 
the substance. Based on these considerations, EPA has preliminarily 
determined that importing or processing substances in Table 1 of Unit 
II.A. and Table 2 of Unit II.A. as part of articles warrants making 
inapplicable the article exemption at 40 CFR 721.45(f) for the 
significant new uses identified in the tables in Unit II.A.

V. Importers and Processors of These Chemical Substances as Part of 
Articles

    Once the determination of a significant new use under TSCA section 
5(a)(2) has been made, EPA may separately determine whether it would be 
appropriate to make the regulatory exemption for some or all persons 
who import or process a chemical substance as part of an article (40 
CFR 721.45(f)) inapplicable to a SNUR. In this case, EPA believes that 
the assumption underpinning this exemption, that people and the 
environment will generally not be exposed to chemical substances as 
part of articles, does not hold true. See Unit IV. for a discussion of 
why EPA believes this assumption is incorrect. Thus EPA is proposing to 
make this exemption inapplicable to importers or processors of the TDI 
and related compounds as part of an article for the identified 
significant new uses. EPA is requesting comment on the potential for 
exposure to these chemical substances via these articles and for 
comments on the ongoing uses of the TDI and related compounds as part 
of an article.

VI. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. However, for this action, EPA is proposing that 40 CFR 721.45(f) 
(which generally exempts persons importing or processing a substance as 
part of an article) will not apply and a person who imports or 
processes a chemical substance as part of an article would not be 
exempt from submitting a SNUN.
    Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same notice requirements and EPA regulatory procedures as 
submitters of Premanufacture Notices (PMNs) under TSCA section 
5(a)(1)(A). In particular, these requirements include the information 
submissions requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 
or 7 to control the activities on which it has received the SNUN. If 
EPA does not take action, EPA is required under TSCA section 5(g) to 
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In 
accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 
export notification for articles. Persons who import a chemical 
substance identified in a final SNUR are subject to the TSCA section 13 
import certification requirements, codified at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Those persons must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA, including any SNUR requirements. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B. The TSCA section 13 import certification requirement applies to 
articles containing a chemical substance or mixture if so required by 
the Administrator by a specific rule under TSCA. At this time EPA is 
not proposing to require import certification

[[Page 2073]]

for these chemical substances as part of articles.

VII. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376; FRL-3658-5) (Ref. 27), EPA has decided that the intent of 
section 5(a)(1)(B) of TSCA is best served by designating a use as a 
significant new use as of the date of publication of the proposed rule 
rather than as of the effective date of the final rule. If uses begun 
after publication of the proposed rule were considered ongoing rather 
than new, it would be difficult for EPA to establish SNUR notice 
requirements, because a person could defeat the SNUR by initiating the 
proposed significant new use before the rule became final, and then 
argue that the use was ongoing as of the effective date of the final 
rule. Thus, persons who begin commercial manufacture or processing of 
the chemical substance(s) that would be regulated through this proposed 
rule, if finalized, would have to cease any such activity before the 
effective date of the rule if and when finalized. To resume their 
activities, these persons would have to comply with all applicable SNUR 
notice requirements and wait until the notice review period, including 
all extensions, expires. Uses arising after the publication of the 
proposed rule are distinguished from uses that exist at publication of 
the proposed rule. The former would be new uses, the latter ongoing 
uses, except that uses that are ongoing as of the publication of the 
proposed rule would not be considered ongoing uses if they have ceased 
by the date of issuance of a final rule. To the extent that additional 
ongoing uses are found in the course of rulemaking, EPA would exclude 
those specific chemical substances for those specific uses from the 
final SNUR. EPA has promulgated provisions to allow persons to comply 
with the final SNUR before the effective date. If a person were to meet 
the conditions of advance compliance under 40 CFR 721.45(h), that 
person would be considered to have met the requirements of the final 
SNUR for those activities.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require 
developing any particular test data before submission of a SNUN. There 
are two exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)); and
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a section 4 test rule or a section 5(b)(4) 
listing covering the chemical substance, persons are required to submit 
only test data in their possession or control and to describe any other 
data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 
40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA 
recommends that SNUN submitters include data that would permit a 
reasoned evaluation of risks posed by the chemical substance during its 
manufacture, processing, use, distribution in commerce, or disposal. 
EPA encourages persons to consult with the agency before submitting a 
SNUN. As part of this optional pre-notice consultation, EPA would 
discuss specific data it believes may be useful in evaluating a 
significant new use. SNUNs submitted for significant new uses without 
any test data may increase the likelihood that EPA will take action 
under TSCA section 5(e) to prohibit or limit activities associated with 
this chemical.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on:
     Human exposure and environmental releases that may result 
from the significant new uses of the chemical substance,
     Potential benefits of the chemical substance, and
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
significant new use. Discussions with the Agency prior to submission 
can afford ample time to conduct any tests that might be helpful in 
evaluating risks posed by the substance. According to 40 CFR 721.1(c), 
persons submitting a SNUN must comply with the same notice requirements 
and EPA regulatory procedures as persons submitting a PMN, including 
submission of test data on health and environmental effects as 
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 
7710-25, generated using e-PMN software, and submitted to the Agency in 
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 
720.40. E-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.

X. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substances included in this proposed rule, including as 
part of articles (Ref. 28). In the event that a SNUN is submitted, 
costs are estimated at approximately $8,589 per SNUN submission for 
large business submitters and $6,189 for small business submitters. 
These estimates include the cost to prepare and submit the SNUN, and 
the payment of a user fee. Businesses that submit a SNUN would be 
subject to either a $2,500 user fee required by 40 CFR 
700.45(b)(2)(iii), or, if they are a small business with annual sales 
of less than $40 million when combined with those of the parent company 
(if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). EPA's 
complete economic analysis is available in the public docket for this 
proposed rule (Ref. 28).

B. Export Notification

    Under section 12(b) of TSCA and the implementing regulations at 40 
CFR part 707, subpart D, exporters must notify EPA if they export or 
intend to export a chemical substance or mixture for which, among other 
things, a rule has been proposed or promulgated under TSCA section 5. 
For persons exporting a substance that is the subject of a SNUR, a one-
time notice must be provided for the first export or intended export to 
a particular country. The total costs of export notification will vary 
by chemical, depending on the number of required notifications (i.e., 
the number of countries to which the chemical is exported). While EPA 
is unable to make any estimate of the likely number of export 
notifications for the chemical covered in this proposed SNUR, as stated 
in the accompanying EA of this proposed SNUR, the estimated cost of the 
export notification requirement on a per unit basis is $84.22.

 C. Import or Processing Chemical Substances as Part of an Article

    In proposing to make inapplicable the exemption relating to persons 
that import or process certain chemical substances as part of an 
article, this action may affect firms that plan to import or process 
types of articles that may contain the subject chemical substance. Some 
firms have an understanding of the contents of the

[[Page 2074]]

articles they import or process. However, EPA acknowledges that 
importers and processors of articles may have varying levels of 
knowledge about the chemical content of the articles that they import 
or process. These parties may need to become familiar with the 
requirements of the rule. And, while not required by the SNUR, these 
parties may take additional steps to determine whether the subject 
chemical substances are part of the articles that they are considering 
to import or process. This determination may involve activities such as 
gathering information from suppliers along the supply chain, and/or 
testing samples of the article itself. Costs vary across the activities 
chosen and the extent of familiarity a firm has regarding the articles 
it imports or processes. Cost ranges are presented in the 
``Understanding the Costs Associated with Eliminating Exemptions for 
Articles in SNURs'' (Ref. 29). Based on available information, EPA 
believes that article importers that choose to investigate their 
products would incur costs at the lower end of the ranges presented in 
the Economic Analysis. For those companies choosing to undertake 
actions to assess the composition of the articles they import or 
process, EPA expects that importers would take actions that are 
commensurate with the company's perceived likelihood that a chemical 
substance might be a part of an article, and the resources it has 
available. Example activities and their costs are provided in the 
accompanying Economic Analysis of this rule (Ref. 28).

XI. Alternatives

    Before proposing this SNUR, EPA considered the following 
alternative regulatory action:

A. Promulgate a TSCA Section 8(a) Reporting Rule

    Under a TSCA section 8(a) rule, EPA could, among other things, 
generally require persons to report information to the agency when they 
intend to manufacture or process a listed chemical for a specific use 
or any use. However, for TDI, the use of TSCA section 8(a) rather than 
SNUR authority would have several limitations. First, if EPA were to 
require reporting under TSCA section 8(a) instead of TSCA section 5(a), 
EPA would not have the opportunity to review human and environmental 
hazards and exposures associated with the proposed significant new use 
and, if necessary, take immediate follow-up regulatory action under 
TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it 
begins. In addition, EPA may not receive important information from 
small businesses, because such firms generally are exempt from TSCA 
section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 
8(a)(1)(B)). In view of the level of health concerns about TDI if used 
for the proposed significant new use, EPA believes that a TSCA section 
8(a) rule for this substance would not meet EPA's regulatory 
objectives.

B. Allow the Exemption for Persons Who Import or Process TDI and 
Related Compounds as Part of Articles That Would Be Subject to the 
Proposed SNUR

    Under the SNUR exemption provision at 40 CFR 721.45(f), a person 
who imports or processes a chemical substance covered by a SNUR 
identified in 40 CFR part 721, subpart E, as part of an article is not 
generally subject to the notification requirements of 40 CFR 721.25 for 
that chemical substance. However, EPA is concerned that exempting TDI 
and related compounds as part of articles would render the SNUR less 
effective because of the possibility that articles could be imported or 
processed for uses subject to this proposed SNUR without the submission 
of a SNUN. This proposed rule would not include the exemption at 40 CFR 
721.45(f).

XII. Request for Comment

A. Do you have comments or information about ongoing uses?

    EPA welcomes comment on all aspects of this proposed rule. EPA 
based its understanding of the use profile of these chemicals on the 
published literature, the 2012 CDR submissions, market research, 
discussions with manufacturers, and product SDSs. To confirm EPA's 
understanding, the Agency is requesting public comment on the EPA's 
understanding that coating, adhesive, elastomer, binder, or sealant 
consumer products do not contain residual TDI of more than 0.1 percent 
by weight, as noted in Table 2 of Unit II.A. EPA believes that other 
consumer products do not contain TDI or related compounds at any level. 
In providing comments on the concentration of TDI and related compounds 
in the consumer product, it would be helpful if you provide sufficient 
information for EPA to substantiate any assertions of use and 
concentrations.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. It is EPA's policy to include all comments 
received in the public docket without change or further notice to the 
commenter and to make the comments available on-line at 
www.regulations.gov, including any personal information provided, 
unless a comment includes information claimed to be CBI or other 
information whose disclosure is restricted by statute. Do not submit 
this information to EPA through regulations.gov or email. Clearly mark 
the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD ROM that you mail to EPA, mark the outside 
of the disk or CD ROM that you mail to EPA as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is claimed as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2, subpart B.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The agency may ask you to respond to 
specific questions or organize comments by referencing a CFR part or 
section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

XIII. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are in the docket, even if the 
referenced document is not physically located in the docket. For 
assistance in locating these other

[[Page 2075]]

documents, please consult technical person listed under FOR FURTHER 
INFORMATION CONTACT.

1. U.S. EPA. Significant New Uses of Chemical Substances; Certain 
Chemicals. 49 FR 35014, September 5, 1984 (FRL-2541-8).
2. Krone, C., and Klinger, T. (2005). Isocyanates, polyurethane and 
childhood asthma. Pediatric Allergy and Immunology 16, 378-379.
3. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., 
Streicher, R. P., Cullen, M. R., Liu, Y., and Redlich, C. A. (2007). 
Skin Exposure to Isocyanates: Reasons for Concern. Environmental 
Health Perspectives 115.
4. BASF Corporation. (2011). Project Summary Report Requested 
Industrial Hygiene personal and Area Monitoring for Identified 
Airborne Chemical Hazards of MDI and/or TDI Associated with 
Isocyanate-Containing Product Use Scenarios for Identified 
Construction Sealants and/or Basecoat Products (Sanitized Version). 
JKInc. Report #: 111-11, 1-6.
5. Vangronsveld, E, Berckmans, S., and Spence, M. (2013). Comparison 
of Solvent/Derivatization Agent Systems for Determination of 
Extractable Toluene Diisocyanate from Flexible Polyurethane Foam. 
Annals of Occupational Hygiene 57(5), 640-649.
6. Redlich, C. A., Bello, D., and Wisnewski, A. (2006). Isocyanate 
exposures and health effects. In Environmental and Occupational 
Medicine (W. Rom, and S. Markowitz, Eds.), pp. 502-516. Lippincott 
Williams & Wilkins Philadelphia, PA.
7. DOW (2009). Product Safety Assessment DOW Modified Toluene 
Diisocyanate (TDI) Products. July 16 2010. https://www.dow.com/PublishedLiterature/dh_034d/0901b8038034d515.pdf?filepath=pructsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc.
8. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 
Occupational and Environmental Hygiene 17, 846-855.
9. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. 
(2005). Absorption, distribution, metabolism and excretion of an 
inhalation does of 14C 4,4' methylenediphenyl diisocyanate in the 
male rat. Xenobiotica 35, 273-292.
10. EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds 
Action Plan. Available online at: https://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf.
11. Ott, M.G., Diller, W.F., and Jolly, A.T. (2003). Respiratory 
effects of toluene diisocyanates in the workplace; a discussion of 
exposure-response relationships. Critical Review Toxicology 33, 1-
59.
12. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M. 
H., Eisen, E. A. Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, 
M. R., and Redlich, C. A. (2004). Polyisocyanates in occupational 
environments: a critical review of exposure limits and metrics. 
American Journal Industrial Medicine 46, 480-491.
13. NIOSH (1996). National Institute for Occupational Safety and 
Health. Preventing asthma and death from diisocyanate exposure: 
NIOSH Alert. (DHHS, Ed.).
14. American Chemistry Council (ACC) (2005). TSCA Section 8(e) 
Notice of Substantial Risk 8EHQ-0905-16225 Fatalities linked to 
diisocyanates. EPA.
15. IARC. (1999).Toluene Diisocyanates. WHO. p. 865-879.
16. Environment Canada. (2008). Screening Assessment for the 
Challenge: Toluene Diisocyanate. https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=69A64ACA.
17. NTP (2011). National Toxicology Program. Report on Carcinogens, 
Twelfth Edition; U.S. Department of Health and Human Services, 
Public Health Service. Substance Profile, Toluene Diisocyanates. 
https://ntp.niesh.nih.gov?objectid=03C9AF75-E1BF-FF40-
DBA9EC0928DF8B15.
18. NIOSH (2005). National Institute of Occupational Safety and 
Health. NIOSH Pocket Guide to Chemical Hazards July 16, 2010. https://www.cdc.gov/NIOSH/npg/npgdcas.html.
19. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). 
Two cases of paraoccupational asthma due to toluene diisocyanate 
(TDI). Occupational and Environmental Medicine 57, 837-839.
20. Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies 
in Environmental Medicine: Pediatric Environmental Health. ATSDR 
Publication No. ATSDR-HE-CD-2002-0002.
21. NIOSH (2004). National Institute for Occupational Safety and 
Health. A Summary of Health Hazard Evaluations: Issues Related to 
Occupational Exposure to Isocyanates 1989-2002. (D. o. H. a. H. 
Services, Ed.), pp. 1-42, Cincinnati, OH.
22. Pianoforte, K. (2009). Adhesives and sealants market update, 
November 1, 2009. In Coatings World.
23. Kelly, T. J., Myers, J. D., and Holdren, M. W. (1999). Testing 
of Household Products and Materials for Emission of Toluene 
Diisocyanate. Indoor Air 9, 117-124.
24. Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J. 
(2002). Diisocyanate emission from a paint product: a preliminary 
analysis. Applied Occupational Environmental Hygiene 17, 491-494.
25. NYC-DOHMH (2010). New York City Department of Health and Mental 
Hygiene. Moisture Cure Urethanes (MCU). July 16, 2010. https://www.nyc.gov/html/doh/html/epi/mcufact.shtml.
26. NIOSH (2006). National Institute for Occupational Safety and 
Health. Preventing Asthma and Death from MDI Exposure During Spray-
on Truck Bed Liner and Related Applications: NIOSH Alert. https://www.cdc.gov/niosh/docs/2006-149/default.html.
27. U.S. EPA. Significant New Uses of Certain Chemical Substances. 
55 FR 173776, April 24, 1990 (FRL-3658-5).
28. EPA. Economic Analysis of the Significant New Use Rule for 
Toluene Diisocyanate (TDI) and Related Compounds. April 2, 2014.
29. EPA, Understanding the Costs Associated with Eliminating 
Exemptions for Articles in SNURs. May 1, 2013.
30. U.S. EPA. Modifications of Significant New Use Rules for Certain 
Substances. 62 FR 42690, August 8, 1997 (FRL-5735-4).

XIV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This proposed SNUR has been designated by the Office of Management 
and Budget (OMB) as a ``significant regulatory action'' under section 
3(f) of Executive Order (58 FR 51735, October 4, 1993). Accordingly, 
EPA submitted this action to OMB for review under Executive Orders 
12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in 
response to OMB recommendations are documented in the docket.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with 
existing chemical SNURs are already approved by OMB under OMB control 
number 2070-0038 (EPA ICR No. 1188); and the information collection 
activities associated with export notifications are already approved by 
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
be less than 100 hours per response, and the estimated burden for an 
export notifications is less than 1.5 hours per notification. In both 
cases, burden is estimated to be reduced for submitters who have 
already registered to use the electronic submission system. Additional 
burden, estimated to be less than 10 hours, could be incurred where 
additional record keeping requirements are specified under 40 CFR 
721.125(a), (b), and (c).
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in Title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR,

[[Page 2076]]

part 9, and included on the related collection instrument, or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list this 
SNUR. This listing of the OMB control numbers and their subsequent 
codification in the CFR satisfies the display requirements of the PRA 
and OMB's implementing regulations at 5 CFR part 1320. Since the 
existing OMB approval was previously subject to public notice and 
comment before OMB approval, and given the technical nature of the 
table, EPA finds that further notice and comment to amend the table is 
unnecessary. As a result, EPA finds that there is ``good cause'' under 
section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) to amend this table without further notice and comment.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
hereby certify that promulgation of this proposed SNUR would not have a 
significant economic impact on a substantial number of small entities. 
The rationale supporting this conclusion is as follows.
    EPA generally finds that proposed and final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities (See, e.g., Ref. 30). Since these proposed SNURs would require 
a person who intends to engage in such activity in the future to first 
notify EPA by submitting a SNUN, no economic impact would occur unless 
someone files a SNUN to pursue a significant new use in the future or 
forgoes profits by avoiding or delaying the significant new use. 
Although some small entities may decide to engage in such activities in 
the future, EPA cannot presently determine how many, if any, there may 
be. However, EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemical substances, the 
Agency receives only a handful of notices per year. During the six year 
period from 2005-2011, only three submitters self-identified as small 
in their SNUN submission (Ref. 28). EPA believes the cost of submitting 
a SNUN is relatively small compared to the cost of developing and 
marketing a chemical new to a firm and that the requirement to submit a 
SNUN generally does not have a significant economic impact.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the rule as a 
``significant new use.'' EPA has preliminarily determined, based in 
part, on the Agency's market research, that these chemical substances 
are not being manufactured (including imported) or processed for a 
significant new use. This preliminary determination also includes 
importation and processing of these chemical substances as part of 
articles for the significant new use (Unit IV.). Therefore, based on 
current knowledge, EPA has preliminarily determined that these uses, 
including the importation of these chemical substances as part of 
articles, are not ongoing, and that no small entities presently 
manufacture for the significant new uses addressed in this proposed 
rule. EPA will consider information received during the comment period 
that might indicate that this preliminary determination is incorrect.
    EPA believes that there will be minimal impact to processors and 
importers of these chemical substances as part of articles from this 
proposed SNUR. The SNUR does not require processors and importers of 
articles to conduct specific activities to ascertain if they are 
importing or processing an article that uses a chemical subject to the 
proposed rule. EPA expects importers would take actions that are 
commensurate with their perceived likelihood of a chemical substance 
subject to the SNUR being part of an article, and the resources it has 
available. EPA has no reason to believe that a firm would voluntarily 
incur substantial costs to comply with the SNUR, but rather EPA 
believes each firm will choose the most efficient route to identify 
whether it is importing the subject chemical substances in articles.
    Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR is not expected to be significant or 
adversely impact a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reason to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, the requirements of sections 202, 203, 204, or 205 
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This proposed rule does not have Tribal implications because it is 
not expected to have any effect (i.e., there will be no increase or 
decrease in authority or jurisdiction) on Tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, 
November 9, 2000), does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this action is not intended to address 
environmental health or safety risks for children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001), because this action is not expected to affect 
energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, section 
12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this section.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This proposed rule does not invoke special consideration of 
environmental justice related issues as delineated by Executive Order 
12898 (59 FR 7629, February 16, 1994), because EPA has determined that 
this action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations. 
This action does not affect the level of protection provided to human 
health or the environment.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


[[Page 2077]]


    Dated: January 7, 2015.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

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

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

0
2. Add Sec.  721.10789 to subpart E to read as follows:


Sec.  721.10789  Toluene diisocyanates and related compounds.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 and Table 2 of 
this paragraph are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.

     Table 1--Toluene Diisocyanates and Related Compounds Subject To
               Reporting for Any Use in a Consumer Product
------------------------------------------------------------------------
                                                             Chemical
                                                             abstracts
           Chemical name             Chemical abstracts       service
                                         index name          registry
                                                              (CASRN)
------------------------------------------------------------------------
Toluene diisocyanate trimer.......  Benzene, 1,3-              9019-85-6
                                     diisocyanatomethyl-
                                     , trimer.
Poly(toluene diisocyanate)........  Benzene, 1,3-              9017-01-0
                                     diisocyanatomethyl-
                                     , homopolymer.
Toluene diisocyanate dimer........  1,3-Diazetidine-2,4-      26747-90-0
                                     dione, 1,3bis(3-
                                     isocyanatomethylphe
                                     nyl)-.
Toluene diisocyanate ``cyclic''     1,3,5-Triazine-           26603-40-7
 trimer.                             2,4,6(1H,3H,5H)trio
                                     ne, 1,3,5-
                                     tris(3isocyanatomet
                                     hylphenyl)-.
------------------------------------------------------------------------


     Table 2--Toluene Diisocyanates and Related Compounds Subject To
               Reporting for Any Use in a Consumer Product
    [Except for use in coatings, adhesives, elastomers, binders, and
  sealants at less than or equal to 0.1 percent in a consumer product]
------------------------------------------------------------------------
                                                             Chemical
                                                             abstracts
           Chemical name             Chemical abstracts       service
                                         index name        registry No.
                                                              (CASRN)
------------------------------------------------------------------------
2,6-Toluene diisocyanate..........  Benzene, 1,3-                91-08-7
                                     diisocyanato-2-
                                     methyl-.
2,4-Toluene diisocyanate..........  Benzene, 2,4-               584-84-9
                                     diisocyanato-1-
                                     methyl-.
Toluene diisocyanate unspecified    Benzene, 1,3-             26471-62-5
 isomers.                            diisocyanatomethyl-.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) For the chemical substances listed in Table 1 of paragraph 
(a)(1), any use of the chemical substance in consumer products.
    (ii) For the chemical substances listed in Table 2 of paragraph 
(a)(1), any use of the chemical substance in a consumer product (except 
for use in coatings, adhesives, elastomers, binders, and sealants, that 
results in less than or equal to 0.1 percent by weight of such chemical 
substance in the consumer product).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b):
    (1) Revocation of certain notification exemptions. The provisions 
of Sec.  721.45(f) do not apply to this section. A person who imports 
or processes a chemical substance identified in paragraph (a)(1) of 
this section as part of an article for a significant new use described 
in paragraph (a)(2) of this section is not thereby exempt from 
submitting a significant new use notice.
    (2) [Reserved]

[FR Doc. 2015-00474 Filed 1-14-15; 8:45 am]
BILLING CODE 6560-50-P