2068 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 

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. 

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: http:// 

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 http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://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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Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 2069 

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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2070 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 

TABLE 1—TOLUENE DIISOCYANATE RELATED COMPOUNDS SUBJECT TO THIS ACTION WITH A PROPOSED SIGNIFICANT

NEW USE OF ‘‘ANY USE IN A CONSUMER PRODUCT’’ 

Chemical name Chemical abstracts index name 

Chemical 

abstracts 

service 

registry 

(CASRN) No. 

Toluene diisocyanate trimer ................................... Benzene, 1,3-diisocyanatomethyl-, trimer ...................................................... 9019–85–6 

Poly(toluene diisocyanate) ..................................... Benzene, 1,3-diisocyanatomethyl-, homopolymer .......................................... 9017–01–0 

Toluene diisocyanate dimer ................................... 1,3-Diazetidine-2,4-dione, 1,3bis(3-isocyanatomethylphenyl)- ....................... 26747–90–0 

Toluene diisocyanate ‘‘cyclic’’ trimer ...................... 1,3,5-Triazine-2,4,6(1H,3H,5H)trione, 1,3,5-tris(3isocyanatomethylphenyl)- 26603–40–7 

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 name Chemical abstracts index name 

Chemical 

abstracts 

service 

registry 

(CASRN) No. 

2,6-Toluene diisocyanate ....................................... Benzene, 1,3-diisocyanato-2-methyl- ............................................................. 91–08–7 

2,4-Toluene diisocyanate ....................................... Benzene, 2,4-diisocyanato-1-methyl- ............................................................. 584–84–9 

Toluene diisocyanate unspecified isomer .............. Benzene, 1,3-diisocyanatomethyl- .................................................................. 26471–62–5 

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 longterm 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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Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 2071 

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 


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2072 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 

(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 


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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 http://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 


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2074 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 

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 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 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. http://

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: http://www.epa.gov/ 

oppt/existingchemicals/pubs/action

plans/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. http://www.ec.gc.ca/eseees/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. http://

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. http://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. http://

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. http://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, 


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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. 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Proposed Rules 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] 

■ 1. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 2. Add § 721.10789 to subpart E to 

read as follows: 

§ 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 name Chemical abstracts index name 

Chemical 

abstracts 

service 

registry 

(CASRN) 

Toluene diisocyanate trimer ................................... Benzene, 1,3-diisocyanatomethyl-, trimer ...................................................... 9019–85–6 

Poly(toluene diisocyanate) ..................................... Benzene, 1,3-diisocyanatomethyl-, homopolymer .......................................... 9017–01–0 

Toluene diisocyanate dimer ................................... 1,3-Diazetidine-2,4-dione, 1,3bis(3-isocyanatomethylphenyl)- ....................... 26747–90–0 

Toluene diisocyanate ‘‘cyclic’’ trimer ...................... 1,3,5-Triazine-2,4,6(1H,3H,5H)trione, 1,3,5-tris(3isocyanatomethylphenyl)- 26603–40–7 

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 name Chemical abstracts index name 

Chemical 

abstracts 

service 

registry No. 

(CASRN) 

2,6-Toluene diisocyanate ....................................... Benzene, 1,3-diisocyanato-2-methyl- ............................................................. 91–08–7 

2,4-Toluene diisocyanate ....................................... Benzene, 2,4-diisocyanato-1-methyl- ............................................................. 584–84–9 

Toluene diisocyanate unspecified isomers ............ Benzene, 1,3-diisocyanatomethyl- .................................................................. 26471–62–5 

(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 

§ 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 15–2, RM–11744; DA 15– 

15] 

Television Broadcasting Services; 

Lansing, Michigan 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Commission has before it 

a petition for rulemaking filed by 

WLAJ–TV LLC, the licensee of station 

WLAJ–TV, channel 51, Lansing, 

Michigan, requesting the substitution of 

channel 25 for channel 51 at Lansing. 

While the Commission instituted a 

freeze on the acceptance of full power 

television rulemaking petitions 

requesting channel substitutions in May 

2011, it subsequently announced that it 

would lift the freeze to accept such 

petitions for rulemaking seeking to 

relocate from channel 51 pursuant to a 

voluntary relocation agreement with 

Lower 700 MHz A Block licensees. 

WLAJ–TV LLC has entered into such a 

voluntary relocation agreement with TMobile USA, Inc. and states that 

operation on channel 25 would 

eliminate potential interference to and 

from wireless operations in the adjacent 

Lower 700 MHZ A Block. 

DATES: Comments must be filed on or 

before January 30, 2015, and reply 

comments on or before February 9, 

2015. 

ADDRESSES: Federal Communications 

Commission, Office of the Secretary, 

445 12th Street SW., Washington, DC 

20554. In addition to filing comments 

with the FCC, interested parties should 

serve counsel for petitioner as follows: 

Christine Reilly, Esq., Pillsbury 

Winthrop Shaw Pittman, LLP, 2300 N 

Street NW., Washington, DC 20037– 

1128. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Bernstein, Joyce.Bernstein@

fcc.gov, Media Bureau, (202) 418–1600. 


rljohnson on DSK3VPTVN1PROD with PROPOSALS