Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 845 

visibility FIP in 40 CFR 52.2498. The 

EPA’s Federal visibility new source 

review rules will continue to apply to 

facilities subject to the jurisdiction of 

the Energy Facilities Site Evaluation 

Council; sources subject to the 

jurisdiction of local air authorities; and 

facilities located within Indian 

reservations in Washington (except for 

non-trust land within the exterior 

boundaries of the Puyallup Indian 

Reservation) and any other area where 

the EPA or an Indian tribe has 

demonstrated that a tribe has 

jurisdiction. 

D. The EPA’s Oversight Role 

In approving state new source review 

rules into SIPs, the EPA has a 

responsibility to ensure that all states 

properly implement their SIP-approved 

preconstruction permitting programs. 

The EPA’s approval of Ecology’s PSD 

rules does not divest the EPA of the 

responsibility to continue appropriate 

oversight to ensure that permits issued 

by Ecology are consistent with the 

requirements of the CAA, Federal 

regulations, and the SIP. The EPA’s 

authority to oversee permit program 

implementation is set forth in sections 

113, 167, and 505(b) of the CAA. For 

example, section 167 provides that the 

EPA shall issue administrative orders, 

initiate civil actions, or take whatever 

other action may be necessary to 

prevent the construction or modification 

of a major stationary source that does 

not ‘‘conform to the requirements of’’ 

the PSD program. Similarly, section 

113(a)(5) of the CAA provides for 

administrative orders and civil actions 

whenever the EPA finds that a state ‘‘is 

not acting in compliance with’’ any 

requirement or prohibition of the CAA 

regarding the construction of new 

sources or modification of existing 

sources. Likewise, section 113(a)(1) 

provides for a range of enforcement 

remedies whenever the EPA finds that 

a person is in violation of an applicable 

implementation plan. 

In making judgments as to what 

constitutes compliance with the CAA 

and regulations issued thereunder, the 

EPA looks to (among other sources) its 

prior interpretations regarding those 

statutory and regulatory requirements 

and policies for implementing them. It 

follows that state actions implementing 

the Federal CAA that do not conform to 

the CAA may lead to potential oversight 

action by the EPA. 

V. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this proposed 

action merely approves the state’s law 

as meeting Federal requirements and 

does not impose additional 

requirements beyond those imposed by 

the state’s law. For that reason, this 

proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to the requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

this action does not involve technical 

standards; and 

• does not provide the EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because it will not 

impose substantial direct costs on tribal 

governments or preempt tribal law. As 

discussed above, the SIP is not 

approved to apply in Indian country 

located in the state, except for non-trust 

land within the exterior boundaries of 

the Puyallup Indian Reservation (also 

known as the 1873 Survey Area), or any 

other area where the EPA or an Indian 

tribe has demonstrated that a tribe has 

jurisdiction. Consistent with EPA 

policy, the EPA provided a consultation 

opportunity to the Puyallup Tribe in a 

letter dated February 25, 2014. The EPA 

did not receive a request for 

consultation. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: December 18, 2014. 

Dennis J. McLerran, 

Regional Administrator, Region 10. 

[FR Doc. 2014–30716 Filed 1–6–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2014–0760; FRL–9919–23] 

RIN 2070–AB27 

Proposed Significant New Use Rule on 

Certain Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing significant 

new use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for 13 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). This action would require 

persons who intend to manufacture 

(including import) or process any of the 

chemical substances for an activity that 

is designated as a significant new use by 

this proposed rule to notify EPA at least 

90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or limit 

the activity before it occurs. 

DATES: Comments must be received on 

or before March 9, 2015. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2014–0760, 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. 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
846 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 

• 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: Kenneth 

Moss, Chemical Control Division, Office 

of Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(202) 564–9232; email address: 

moss.kenneth@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. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, process, 

or use the chemical substances 

contained in this proposed rule. 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: 

• Manufacturers (including 

importers) or processors of one or more 

subject chemical substances (NAICS 

codes 325 and 324110), e.g., chemical 

manufacturing and petroleum refineries. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemical substances subject to a final 

SNUR must certify their compliance 

with the 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 final rule 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. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. 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 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. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/

comments.html. 

II. Background 

A. What action is the agency taking? 

EPA is proposing these SNURs under 

TSCA section 5(a)(2) for 13 chemical 

substances which were the subject of 

PMNs P–13–270, P–13–365, P–13–392, 

P–13–393, P–13–471, P–13–563, P–13– 

617, P–13–618, P–13–619, P–14–60, P– 

14–267, P–14–268, and P–14–478. 

These SNURs would require persons 

who intend to manufacture or process 

any of these chemical substances for an 

activity that is designated as a 

significant new use to notify EPA at 

least 90 days before commencing that 

activity. In the Federal Register 

publications of February 12, 2014 (79 

FR 8273) (FRL–9903–70), July 8, 2014 

(79 FR 38464) (FRL–9911–05), and July 

9, 2014 (79 FR 39268) (FRL–9910–01), 

EPA issued direct final SNURs on ten of 

these 13 chemical substances, which are 

the subject of PMNs P–13–365, P–13– 

392, P–13–393, P–13–471, P–13–270, P– 

13–563, P–13–617, P–13–618, P–13– 

619, and P–14–60 in accordance with 

the procedures at § 721.160(c)(3)(i). EPA 

received notices of intent to submit 

adverse comments on these SNURs. 

Therefore, as required by 

§ 721.160(c)(3)(ii), EPA removed the 

direct final SNURs in separate final 

rules published in the Federal Register 

of April 14, 2014 (71 FR 20800) (FRL– 

9909–25) and September 4, 2014 (79 FR 

52563) (FRL–9915–69), and is now 

issuing this proposed rule on these ten 

chemical substances. The records for the 

direct final SNURs on these ten 

chemical substances were established as 

dockets EPA–HQ–OPPT–2013–0739, 

EPA–HQ–OPPT–2014–0166, and EPA– 

HQ–OPPT–2014–0277. Those records 

include information considered by the 

Agency in developing the direct final 

rule. Adverse comments received 

regarding these substances and the 

direct final rule are discussed in Unit 

IV. This proposed rule also includes 

three SNURs for the three chemicals 

which are the subject of PMNs, P–14– 

267, P–14–268, and P–14–478 and for 

which there has not been any previous 

rulemaking. The record for the SNURs 

on these three chemicals was 

established as docket EPA–HQ–OPPT– 

2014–0760. That record includes 

information considered by the Agency 

in developing these three proposed 

SNURs. 

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 the four bulleted TSCA 

section 5(a)(2) factors listed in Unit III. 

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. Persons 

who must report are described in 

§ 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 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. Provisions relating to user 

fees appear at 40 CFR part 700. 

According to 40 CFR 721.1(c), persons 

subject to these SNURs must comply 

with the same notice requirements and 

EPA regulatory procedures as submitters 

of PMNs under TSCA section 5(a)(1)(A). 

In particular, these requirements 

include the information submission 

requirements of TSCA sections 5(b) and 

5(d)(1), the exemptions authorized by 


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TSCA sections 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 for 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. 

III. 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: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• 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 authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the chemical 

substances that are the subject of these 

SNURs, EPA considered relevant 

information about the toxicity of the 

chemical substances, likely human 

exposures and environmental releases 

associated with possible uses, taking 

into consideration the four bulleted 

TSCA section 5(a)(2) factors listed in 

this unit. 

IV. Substances Subject to This Proposed 

Rule 

EPA is proposing significant new use 

and recordkeeping requirements for 13 

chemical substances in 40 CFR part 721, 

subpart E. In this unit, EPA provides the 

following information for each chemical 

substance: 

• PMN number. 

• Chemical name. 

• Chemical Abstracts Service (CAS) 

Registry number (assigned for nonconfidential chemical identities). 

• Public comments and EPA’s 

response to comments on the ten direct 

final SNURs subject to PMNs, P–13– 

365, P–13–392, P–13–393, P–13–471, P– 

13–270, P–13–563, P–13–617, P–13– 

618, P–13–619, and P–14–60. 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VII. for more information). 

• CFR citation assigned in the 

regulatory text section of this proposed 

rule. 

The regulatory text section of this 

proposed rule specifies the activities 

designated as significant new uses. 

Certain new uses, including production 

volume limits (i.e., limits on 

manufacture volume) and other uses 

designated in this proposed rule, may be 

claimed as CBI. 

PMN Number P–13–270 

Chemical name: Aromatic dibenzoate 

(generic). 

CAS number: Claimed confidential. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as a catalyst component. 

Based on structural activity relationship 

(SAR) analysis of test data on analogous 

esters, EPA predicts chronic toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. Based 

on uses described in the PMN, releases 

of the substance are not expected to 

result in surface water concentrations 

that exceed 1 ppb. Therefore, EPA has 

not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

should there be any new use of the 

substance resulting in releases to surface 

waters exceeding 1 ppb significant 

adverse environmental effects could 

occur. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

sediment-water chironomid life-cycle 

toxicity test using spiked water or 

spiked sediment (OECD Test Guideline 

233); a hydrolysis test (OECD Test 

Guideline 111); and a Zahn-Wellens 

inherent biodegradation test (OECD Test 

Guideline 302B) would help 

characterize the potential for 

environmental effects of the PMN 

substance. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substances 

and mixtures (OECD Test Guideline 23) 

be followed to facilitate solubility in the 

test media, because of the PMN 

substance’s low water solubility. 

CFR citation: 40 CFR 721.10735. 

PMN Number P–13–365 

Chemical name: MDI modified 

polyalkene glycols (generic). 

CAS number: Not available. 

1. Public comment: One commenter 

claimed SNUR requirements associated 

with P–13–365 for respiratory 

protection, record-keeping, and hazard 

communication are difficult to 

understand and implement and they 

add another layer of complexity for 

potential customers. Customers are 

likely to choose existing adhesive 

system chemicals with no or fewer 

SNUR requirements which may have 

greater risk potential to avoid having to 

comply with the SNUR requirements of 

P–13–365 and similar new chemicals. 

1. EPA response: The proposed SNUR 

does not contain significant new use 

reporting requirements pertaining to 

hazard communication. EPA has issued 

numerous SNURs with similar 

recordkeeping and worker protection 

requirements that other manufacturers 

and processors have complied with and 

implemented. The comment period for 

the proposed rule is an opportunity to 

provide more detail on specific issues or 

challenges posed by the proposed SNUR 

reporting requirements, as well as 

potential suggestions for EPA to better 

clarify those requirements. Unless EPA 

receives specific, quantitative 

information that demonstrates the 

chemical substances subject to these 

proposed SNURs exhibit a lower 

potential for the hazards and risks 

described in the proposed SNUR or that 

they will specifically replace a chemical 

substance with a higher potential for 

hazards and risks, EPA would expect to 

issue the SNUR as proposed to provide 

the Agency with the opportunity to 

review any new uses for potential 

unreasonable risks. As described in the 

Agency’s ongoing Action Plan for MDI 

and TDI, diisocyanates are well-known 

dermal and inhalation sensitizers in the 

workplace and have been documented 

to cause asthma, lung damage, and in 

severe cases, fatal reactions. EPA is 

concerned about potential health effects 

that may result from exposures of 

consumers or self-employed workers 

while using products containing 

uncured (unreacted) MDI and TDI and 

its related polyisocyanates (e.g., sprayapplied foam sealants, adhesives, and 

coatings) or incidental exposures to the 

general population while such products 

are used in or around buildings 

including homes or schools. While 

workers may already be using protective 

controls in occupational settings, due to 

the nature of the potential risk posed by 

these chemicals, EPA believes it is 

prudent to emphasize its concern 


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through respiratory protection 

requirements where there is potential 

for inhalation exposure, in addition to 

proposing significant new uses such as 

consumer use and application method. 

Accordingly, the regulatory action for 

new diisocyanates reflects EPA’s policy 

of consistent treatment of the entire 

class of potentially hazardous 

chemicals, regardless of their statutory 

status as ‘‘new’’ or ‘‘existing’’ chemicals. 

EPA continues to work to lessen the 

apparent inequity between regulations 

of new and existing chemicals. 

2. Public comment: The same 

commenter questioned whether EPA’s 

basis for adverse human health concerns 

stem from the residual diisocyanate 

monomer or the P–13–365 substance. 

The P–13–365 substance is not expected 

to be volatile under any use. 

2. EPA response: The basis for EPA’s 

health concern is for the P–13–365 

substance which includes the presence 

of any residual diisocyanate monomer. 

In addition, EPA finds that there are 

unreacted isocyanate groups in the 

polymer and that there is a significant 

percentage of the polymer with 

molecular weight below 1,000. EPA 

agrees that the higher molecular weight 

components of the P–13–365 substance 

are not expected to be volatile. The 

residual diisocyanate monomer is 

expected to be volatile and lower 

molecular components could be volatile 

resulting in a higher potential for 

exposure. 

3. Public comment: The same 

commenter proposes that instead of 

recommending the 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) to characterize the human 

health effects of the P–13–365 

substance, EPA should consider a 

Differential Scanning Calorimetric or 

Thermogravimetric Analysis of the PMN 

substance to assess vaporization 

potential. The 90-day inhalation toxicity 

test would require delivery of the PMN 

substance as a mist or aerosol which the 

associated SNUR prohibits. In addition, 

the results of the test may be heavily 

influenced by the residual diisocyanate 

and not exhibit effects from the PMN 

substance itself. 

3. EPA response: In the 

‘‘Recommended testing’’ section, the 90- 

day inhalation toxicity and the dermal 

sensitization tests, are listed as an 

appropriate way to characterize 

potential health effects. EPA will 

consider any other testing, data, or 

information that would be relevant to 

assessing potential health effects. The 

proposed SNUR would require 

notification if a method was used that 

generates a mist or aerosol. Conducting 

the 90-day inhalation toxicity test could 

address the potential lung effects and 

respiratory sensitization if a significant 

new use notice was submitted to EPA. 

As stated in the response to comment 2, 

EPA is concerned about the health 

effects of any residual monomer as well 

as unreacted isocyanate groups on the 

polymer. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an adhesive 

component. Based on test data on 

analogous diisocyanates, EPA identified 

concerns for dermal and respiratory 

sensitization, and lung and mucous 

membrane irritation effects. For the use 

described in the PMN, EPA does not 

expect significant occupational or any 

consumer inhalation exposure due to 

the use of adequate personal protective 

equipment and because the substance is 

not applied using a method that 

generates a vapor, mist, or aerosol nor 

is it used in a consumer product. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

particulate respirator (with eye/face 

protection, when dermal and/or ocular 

exposure is likely) with an APF of at 

least 10, where there is a potential for 

inhalation exposure; any use of the 

substance in consumer products; or any 

use of the substance involving an 

application method that generates a 

vapor, mist, or aerosol, may cause 

serious health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10717. 

PMN Number P–13–392 

Chemical name: Acrylic acid esters 

polymers, reaction products with 

polyisocyanate (generic). 

CAS number: Not available. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be for wood, plastic, and 

automotive paint material. Based on test 

data on analogous diisocyanates, EPA 

identified concerns for dermal and 

respiratory sensitization, lung and 

mucous membrane irritation, and lung 

effects if inhaled based on the low 

molecular weight isocyanates. As 

described in the PMN, worker 

inhalation exposure is not expected and 

dermal exposure will be minimal due to 

the use of adequate personal protective 

equipment and consumer exposure is 

not expected because the substance will 

not be used in consumer products. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

particulate respirator (with eye/face 

protection, when dermal and/or ocular 

exposure is likely) with an APF of at 

least 10, where there is a potential for 

inhalation exposure, or any use of the 

PMN substance in a consumer product, 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10719. 

PMN Number P–13–393 

Chemical name: 1,3- 

Benzenedicarboxylic acid, polymer with 

1,4-benzenedicarboxylic acid, 1,4- 

dimethyl 1,4-benzenedicarboxylate, 2,2- 

dimethyl-1,3- 

propanediol,dodecanedioic acid, 1,2- 

ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (generic). 

CAS number: Not available. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an industrial 

adhesive. Based on test data on 

analogous diisocyanates, the Agency 

identified concerns for dermal and 

respiratory sensitization, lung and 

mucous membrane irritation, and lung 

effects if inhaled based on the low 

molecular weight isocyanates. For the 

use described in the PMN, EPA does not 

expect significant occupational or any 

consumer inhalation exposure due to 

the use of adequate personal protective 


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equipment and because the substance is 

not applied using a method that 

generates a vapor, mist, or aerosol nor 

is the substance used in a consumer 

product. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified particulate respirator 

(with eye/face protection, when dermal 

and/or ocular exposure is likely) with 

an APF of at least 10, where there is a 

potential for inhalation exposure; any 

use of the substance in consumer 

products; or any use of the substance 

involving an application method that 

generates a vapor, mist, or aerosol, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10720. 

PMN Number P–13–471 

Chemical name: Methylene 

diisocyanate polymer with 

polypropylene glycol and diols 

(generic). 

CAS number: Not available. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an industrial 

adhesive. Based on test data on 

analogous diisocyanates, EPA identified 

concerns for oncogenicity, mutagenicity, 

respiratory and dermal sensitization, 

and lung and mucous membrane 

irritation. As described in the PMN, 

worker inhalation exposure is not 

expected and dermal exposure will be 

minimal due to the use of adequate 

personal protective equipment, and 

consumer exposure is not expected 

because the substance will not be used 

in consumer products. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified particulate respirator 

(with eye/face protection, when dermal 

and/or ocular exposure is likely) with 

an APF of at least 10, where there is a 

potential for inhalation exposure or the 

use of the substance in a consumer 

product, may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(1)(i)(C) and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600), a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465) 

would help characterize the human 

health effects of the PMN substance, and 

a carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10723. 

PMN Number P–13–563 

Chemical name: Propylene glycol, 

alpha isocyanate, omega silane 

(generic). 

CAS number: Claimed confidential. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate for polyurethane polymers. 

Based on test data on analogous 

diisocyanates, EPA identified concerns 

for oncogenicity, mutagenicity, 

respiratory and dermal sensitization and 

lung and mucous membrane irritation. 

For the use described in the PMN, EPA 

does not expect significant occupational 

or any consumer exposure. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

without a NIOSH-certified particulate 

respirator (with eye/face protection, 

when dermal and/or ocular exposure is 

likely) with an APF of at least 10, where 

there is a potential for inhalation 

exposure; any use other than as an 

intermediate; or any use of the 

substance in consumer products, may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(1)(i)(C) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600); a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465); 

and a carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10741. 

PMN Numbers P–13–617, P–13–618, and 

P–13–619 

Chemical names: (P–13–617) 

Aromatic dicarboxylic acid polymer 

with alkanediol, alkyl alkyl-2- 

alkenoate,1,4-dialkyl aromatic 

dicarboxylate, alkanedioic acid, 

alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy

(alkylalkanediyl)],hydroxyalkyl 2-alkyl2-alkenoate, aromatic diisocyanate, 

alkyl-2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (generic), (P–13–618) 

Alkanedioic acid, polymer with alkyl 2- 

alkyl-2-alkenoate, alkanedioic acid, 

alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1 2-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, 

aromatic diisocyanate, alkyl 2-alkyl-2- 

alkenoate and 2-alkyl-2-alkenoic acid 

(generic); and (P–13–619) Alkanedioic 

acid, polymer with alkyl alkylalkenoate, 

alkanedioic acid, alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkyl1,2-alkanediyl)], aromatic diisocyanate, 

alkyl alkylalkeneoate and alkyl-alkenoic 

acid (generic). 

CAS numbers: Claimed confidential. 

1. Public comment: The commenter 

(identity confidential) had concerns 

about the respirators listed as NIOSHcertified respirators with an APF of at 

least 10 meeting the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

The commenter argues these listed 

respirators have, in fact, APFs ranging 

from 25 to 1,000 and not 10 as required. 

1. EPA response: The proposed SNUR 

would require notification if workers 

who are reasonably likely to be exposed 

to the PMN substance by inhalation did 

not use a NIOSH certified respirator 

with an APF of at least 10. Workers who 

are exposed may use respirators with an 

APF higher than 10. As noted in the 

response to the comment on P–13–365, 

isocyanates are known dermal and 

respiratory sensitizers and known to 

cause other health effects. Thus, EPA 

requires respirators to provide 

protection from all potential exposures. 

Dermal exposures to isocyanates can 

also possibly cause respiratory 


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exposures. EPA has modified language 

in the preamble language to indicate 

that respirators that provide dermal 

(face/eyes) protection are required if 

dermal and/or ocular exposures are 

likely. Consequently, respirators with a 

higher APF are also indicated because 

respirators with an APF of 10 do not 

provide the desired dermal protection. 

The respirators listed were examples of 

respirators that meet the requirements of 

the SNUR. In the proposed regulatory 

text, EPA has now also included a 

respirator that has an APF of 10 and 

does not protect against dermal or 

ocular exposures for scenarios where 

neither dermal nor ocular exposures are 

likely: NIOSH-certified air-purifying 

half-mask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters. 

2. Public comment: The same 

commenter provided data that shows 

that diphenylmethane diisocyanate 

(MDI), ‘‘spills when modeled reached 

the [threshold limit value] TLV 

concentration 3.8 ft at 38 C (after) 10 h 

had elapsed (and) the [permissible 

exposure limit] PEL at 38 C reached 2.2 

ft after 10h,’’ and that ‘‘MDI diffuses 

slowly from the spill and remains close 

to the surface of the spill.’’ The 

commenter concludes, ‘‘It appears 

unlikely that respiratory protection 

would be required to prevent excessive 

employee exposure to MDI vapors 

emitted from the spill.’’ The commenter 

contends the use of this data as a 

surrogate for P–13–617, P–13–618, and 

P–13–619 is conservative because the 

average molecular weight of the 

individual PMNs is much larger than 

the 4–4′-MDI used in this data. 

2. EPA response: EPA acknowledges 

that this could be the type of data used 

to determine if a worker is reasonably 

likely to be exposed to the PMN 

substance. However, it does not address 

every scenario where workers are 

reasonably likely to be exposed. EPA is 

proposing the SNUR to use the notice 

and comment process to receive and 

evaluate more fully the described data. 

EPA will then respond to this comment 

in more detail in the final rule along 

with any additional comments on this 

topic that are received during the notice 

and comment process. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substances will be as an adhesive. Based 

on test data on analogous diisocyanates, 

EPA identified concerns for dermal and 

respiratory sensitization. For the use 

described in the PMN, EPA does not 

expect significant occupational or any 

consumer inhalation exposure as the 

substances are not applied using a 

method that generates a vapor, mist, or 

aerosol, nor are they used in a consumer 

product. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified particulate respirator 

(with eye/face protection, when dermal 

and/or ocular exposure is likely) with 

an APF of at least 10, where there is a 

potential for inhalation exposure; any 

use in consumer products; or any use of 

the substances involving an application 

method that generates a vapor, mist, or 

aerosol may cause serious health effects. 

Based on this information, the PMN 

substances meet the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10742 (P– 

13–617); 40 CFR 721.10743 (P–03–618) 

and 40 CFR 721.10744 (P–13–619). 

PMN Number P–14–60 

Chemical name: 1,1′- 

methylenebis[isocyanatobenzene], 

polymer with polycarboxylic acids in 

alkane polyols (generic). 

CAS number: Claimed confidential. 

Public comment: A notice of intent to 

adversely comment has been submitted. 

EPA response: EPA awaits the adverse 

comment during the open comment 

period for this notice of proposed rulemaking. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a coating 

component. Based on test data on 

analogous diisocyanates, EPA identified 

concerns for dermal and respiratory 

sensitization. As described in the PMN, 

worker exposure will be minimal due to 

the use of adequate personal protective 

equipment, and EPA does not expect 

consumer exposure as the substance is 

not used in a consumer product. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

particulate respirator (with eye/face 

protection, when dermal and/or ocular 

exposure is likely) with an APF of at 

least 10, where there is a potential for 

inhalation exposure or any use of the 

substance in consumer products may 

cause serious health effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10762. 

PMN Numbers P–14–267 and P–14–268 

Chemical name: (P–14–267) Poly(oxy1,2-ethanediyl), -[ [ (3-

isocyanatomethylphenyl)amino]

carbonyl]—methoxy- and (P–14–268) 

Carbamic acid, N-(3- 

isoocyanatomethylphenyl)-, 2-[2-(2- 

butoxyethoxy)ethoxy]ethyl ester. 

CAS numbers: (P–14–267) 51247–55– 

3 and (P–14–268) 304855–14–9. 

Basis for action: The PMNs state that 

the generic (non-confidential) use of the 

substances will be as an intermediate. 

Based on test data on analogous 

isocyanates, EPA identified concerns for 

respiratory and dermal sensitization, 

and lung and mucous membrane 

irritation. In addition, the Agency 

identified concerns for oncogenicity and 

mutagenicity based on analog test data. 

For the use described in the PMNs, EPA 

does not expect significant occupational 

dermal or inhalation exposure, and does 

not expect consumer exposure as the 

PMNs are not used in consumer 

products. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance without a 

NIOSH-certified particulate respirator 

(with eye/face protection, when dermal 

and/or ocular exposure is likely) with 

an APF of at least 10, where there is a 

potential for inhalation exposure; any 

use in consumer products; or any use of 

the substances involving an application 

method that generates a vapor, mist, or 

aerosol may cause serious health effects. 

Based on this information, the PMN 

substances meet the concern criteria at 

§ 721.170(b)(1)(i)(C) and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600), a 90-day inhalation toxicity 

test (OPPTS Test Guideline 870.3465), 

and a carcinogenicity test (OPPTS Test 

Guideline 870.4200) would help 

characterize the human health effects of 

the PMN substance. 


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CFR citation: 40 CFR 721.10790 (P– 

14–267) and 40 CFR 721.10791 (P–14– 

268). 

PMN Number P–14–478 

Chemical name: Carbonic acid, 

dimethyl ester, polymer with 1,4- 

diisocyanatobenzene, 1,6-hexanediol 

and 1,5-pentanediol. 

CAS numbers: 1558862–08–0. 

Basis for action: The PMN states that 

the substance will be used to make 

thermoplastic polyurethanes. Based on 

test data on analogous diisocyanates, 

EPA identified concerns for lung effects 

and irritation to mucous membranes, 

and for respiratory and dermal 

sensitization. As described in the PMN, 

EPA does not expect significant 

occupational dermal or inhalation 

exposure due to use of adequate 

personal protective equipment; and the 

substance is applied by a method that 

does not generate a vapor, mist, or 

aerosol. Further, consumer exposures 

are not expected as the PMN substance 

is not used in consumer products. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without a NIOSH-certified 

particulate respirator (with eye/face 

protection, when dermal and/or ocular 

exposure is likely) with an APF of at 

least 10, where there is a potential for 

inhalation exposure; any use of the 

substance involving an application 

method that generates a vapor, mist, or 

aerosol; or any use in consumer 

products may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR Citation: 40 CFR 721.10792. 

V. Rationale and Objectives of the 

Proposed Rule 

A. Rationale 

For these 13 PMNs subject to these 

proposed SNURs, EPA determined that 

one or more of the criteria of concern 

established at 40 CFR 721.170 were met. 

For additional discussion of the 

rationale for the SNURs on these 

chemical substances, see Units II. and 

IV. of the proposed rule. 

B. Objectives 

EPA is proposing these SNURs for 

specific chemical substances that have 

undergone premanufacture review 

because the Agency wants to achieve 

the following objectives with regard to 

the significant new uses designated in 

this proposed rule: 

• EPA will receive notice of any 

person’s intent to manufacture or 

process a listed chemical substance for 

the described significant new use before 

that activity begins. 

• EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing a 

listed chemical substance for the 

described significant new use. 

• EPA will be able to regulate 

prospective manufacturers or processors 

of a listed chemical substance before the 

described significant new use of that 

chemical substance occurs, provided 

that regulation is warranted pursuant to 

TSCA section 5(e), 5(f), 6, or 7. 

• EPA will ensure that all 

manufacturers and processors of the 

same chemical substance that is subject 

to a TSCA section 5(e) consent order are 

subject to similar requirements. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Inventory. Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

Internet at http://www.epa.gov/opptintr/ 

existingchemicals/pubs/tscainventory/

index.html. 

VI. Applicability of the Proposed Rule 

to Uses Occurring Before the Effective 

Date of the Final Rule 

To establish a significant ‘‘new’’ use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this proposed rule have 

undergone premanufacture review. In 

cases where EPA has not received a 

notice of commencement (NOC) and the 

chemical substance has not been added 

to the TSCA Inventory, no other person 

may commence such activities without 

first submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this proposed rule are added to the 

TSCA Inventory, EPA recognizes that, 

before the rule is effective, other persons 

might engage in a use that has been 

identified as a significant new use. The 

identities for 10 of the 13 chemical 

substances subject to this proposed rule 

have been claimed as confidential and 

EPA has received no post-PMN bona 

fide submissions (per 40 CFR 720.25 

and § 721.11). Based on this, the Agency 

believes that it is highly unlikely that 

any of the significant new uses 

described in the regulatory text of this 

proposed rule are ongoing. 

Therefore, EPA designates January 7, 

2015 as the cutoff date for determining 

whether the new use is ongoing. Persons 

who begin commercial manufacture or 

processing of the chemical substances 

for a significant new use identified as of 

that date would have to cease any such 

activity upon the effective date of the 

final rule. To resume their activities, 

these persons would have to first 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990 (55 FR 17376) for a more detailed 

discussion of the cutoff date for ongoing 

uses. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

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)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a TSCA section 4 

test rule or a TSCA section 5(b)(4) 

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

Descriptions of tests are provided for 

informational purposes. EPA strongly 

encourages persons, before performing 

any testing, to consult with the Agency 

pertaining to protocol selection. To 

access the OCSPP test guidelines 

referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The OECD 

test guidelines are available from the 

OECD Bookshop at http://

www.oecdbookshop.org or sourceoecd at 

http://www.sourceoecd.org. 


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The recommended tests specified in 

Unit IV. may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data may increase the likelihood that 

EPA will take action under TSCA 

section 5(e), particularly if satisfactory 

test results have not been obtained from 

a prior PMN or SNUN submitter. EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Potential benefits of the chemical 

substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to § 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 720.40 

and § 721.25. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances which were 

the subject of PMNs P–13–270, P–13– 

365, P–13–392, P–13–393, P–13–471, P– 

13–563, P–13–617, P–13–618, P–13– 

619, and P–14–60, during the 

development of the direct final rules. 

EPA’s complete economic analyses 

associated with these ten PMNs are 

available in the docket under docket ID 

numbers EPA–HQ–OPPT–2013–0739, 

EPA–HQ–OPPT–2014–0166, and EPA– 

HQ–OPPT–2014–0277. EPA has 

evaluated the potential costs of 

establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances which were 

the subject of PMNs P–14–267, P–14– 

268, and P–14–478. EPA’s complete 

economic analysis associated with these 

three PMNs is available in the docket 

under docket ID number EPA–HQ– 

OPPT–2014–0760. 

X. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This proposed rule would establish 

SNURs for 13 chemical substances that 

were the subject of PMNs and a TSCA 

section 5(e) consent order. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993). 

B. Paperwork Reduction Act (PRA) 

According to PRA, 44 U.S.C. 3501 et 

seq., 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 PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action would not impose any 

burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

pursuant to RFA section 605(b) (5 U.S.C. 

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this proposed 

rule. 

This proposed rule is within the 

scope of the February 18, 2012 

certification. Based on the Economic 

Analysis discussed in Unit IX., and 

EPA’s experience promulgating SNURs 

(discussed in the certification), EPA 

believes that the following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of these 

SNURs would not have a significant 

economic impact on 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 reasons to 

believe that any State, local, or Tribal 

government would be impacted by this 

proposed rule. As such, EPA has 

determined that this proposed rule 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

of UMRA sections 202, 203, 204, or 205 

(2 U.S.C. 1501 et seq.). 

E. Executive Order 13132 

This action would 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, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This proposed rule would not have 

Tribal implications because it is not 

expected to have substantial direct 

effects on Indian Tribes. This proposed 

rule would not significantly nor 

uniquely affect the communities of 

Indian Tribal governments, nor would it 

involve or impose any requirements that 

affect Indian Tribes. Accordingly, the 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 853 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this proposed rule. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This proposed rule is not subject to 

Executive Order 13211, entitled 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action would 

not involve any technical standards, 

NTTAA section 12(d) (15 U.S.C. 272 

note), would not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

List of Subjects 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 20, 2014. 

Maria J. Doa, 

Director, Chemical Control Division, 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 § 721.10735 to subpart E to 

read as follows: 

§ 721.10735 Aromatic dibenzoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic dibenzoate 

(PMN P–13–270) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Releases to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 3. Add § 721.10717 to subpart E to 

read as follows: 

§ 721.10717 MDI modified polyalkene 

glycols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as MDI modified polyalkene 

glycols (PMN P–13–365) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii) and (a)(6)(v), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 4. Add § 721.10719 to subpart E to 

read as follows: 

§ 721.10719 Acrylic acid esters polymers, 

reaction products with polyisocyanate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylic acid esters 

polymers, reaction products with 

polyisocyanate (PMN P–13–392) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 10 meet the requirements of 

§ 721.63(a)(4): 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
854 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10720 to subpart E to 

read as follows: 

§ 721.10720 1,3-Benzenedicarboxylic acid, 

polymer with 1,4-benzenedicarboxylic acid, 

1,4-dimethyl 1,4-benzenedicarboxylate, 2,2- 

dimethyl-1,3-propanediol, dodecanedioic 

acid, 1,2-ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 1,3-Benzenedicarboxylic 

acid, polymer with 1,4- 

benzenedicarboxylic acid, 1,4-dimethyl 

1,4-benzenedicarboxylate, 2,2-dimethyl1,3-propanediol,dodecanedioic acid, 

1,2-ethanediol, hexanedioic acid, 1,6- 

hexanediol, alkyldiol ester and aromatic 

isocyanate (PMN P–13–393) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in § 721.63 

(a)(4), (a)(6)(ii), (a)(6)(v), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.10723 to subpart E to 

read as follows: 

§ 721.10723 Methylene diisocyanate 

polymer with polypropylene glycol and 

diols (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as methylene diisocyanate 

polymer with polypropylene glycol and 

diols (PMN P–13–471) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(i), (a)(6)(ii), 

(a)(6)(v), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

NIOSH-certified respirators with an APF 

of at least 10 meet the requirements of 

§ 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 7. Add § 721.10741 to subpart E to 

read as follows: 

§ 721.10741 Polyalkylene glycol, alpha 

isocyanate, omega silane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyalkylene glycol, alpha 

isocyanate, omega silane (PMN P–13– 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 855 

563) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 8. Add § 721.10742 to subpart E to 

read as follows: 

§ 721.10742 Aromatic dicarboxylic acid 

polymer with alkanediol, alkyl alkyl-2- 

alkenoate, 1,4-dialkyl aromatic 

dicarboxylate, alkanedioic acid, alkanedioic 

acid.alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, aromatic 

diisocyanate, alkyl 2-alkyl-2-alkenoate and 

2-alkyl-2-alkenoic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic dicarboxylic 

acid polymer with alkanediol, alkyl 

alkyl-2-alkenoate, 1,4-dialkyl aromatic 

dicarboxylate, alkanedioic acid, 

alkanedioic acid. alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2- 

alkenoate, aromatic diisocyanate, alkyl 

2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (PMN P–13–617) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.10743 to subpart E to 

read as follows: 

§ 721.10743 Alkanedioic acid, polymer 

with alkyl 2-alkyl-2-alkenoate, alkanedioic 

acid, alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1 2-alkanediyl)], 

hydroxyalkyl 2-alkyl-2-alkenoate, aromatic 

diisocyanate, alkyl 2-alkyl-2-alkenoate and 

2-alkyl-2-alkenoic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acid, polymer 

with alkyl 2-alkyl- 2-alkenoate, 

alkanedioic acid, alkanediol, .alpha.- 

hydro-.omega.-hydroxypoly[oxy(alkyl-1 

2-alkanediyl)], hydroxyalkyl 2-alkyl-2- 

alkenoate, aromatic diisocyanate, alkyl 

2-alkyl-2-alkenoate and 2-alkyl-2- 

alkenoic acid (PMN P–13–618) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
856 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 721.10744 to subpart E to 

read as follows: 

§ 721.10744 Alkanedioic acid, polymer 

with alkyl alkyl-alkenoate, alkanedioic acid, 

alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl-1,2-alkanediyl)], 

aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acid, polymer 

with alkyl alkylalkenoate, alkanedioic 

acid, alkanediol, .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkyl- 1,2-alkanediyl)], 

aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid 

(PMN P–13–619) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 721.10762 to subpart E to 

read as follows: 

§ 721.10762 1,1′- 

methylenebis[isocyanatobenzene], polymer 

with polycarboxylic acids in alkane polyols 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 1,1′- 

methylenebis[isocyanatobenzene], 

polymer with polycarboxylic acids in 

alkane polyols (PMN P–14–60) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(i) through (a)(6)(iv), 

and (c). When determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

assigned protection factor (APF) of at 

least 10 meet the requirements of 

§ 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (d), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721.10790 to subpart E to 

read as follows: 

§ 721.10790 Poly(oxy-1,2-ethanediyl), -[ [ 

(3- 

isocyanatomethylphenyl)amino]carbonyl]— 

methoxy-. 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified as 

poly(oxy-1,2-ethanediyl), -[ [ (3-isocyan

atomethylphenyl)amino]carbonyl]—


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Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 857 

methoxy- (PMN P–14–267; CAS No. 

51247–55–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d) and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

CFR citation: 40 CFR 721.10790. 

■ 13. Add § 721.10791 to subpart E to 

read as follows: 

§ 721.10791 Carbamic acid, N-(3- 

isoocyanatomethylphenyl)-, 2-[2-(2- 

butoxyethoxy)ethoxy]ethyl ester. 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified as 

carbamic acid, N-(3- 

isoocyanatomethylphenyl)-, 2-[2-(2- 

butoxyethoxy)ethoxy]ethyl ester (PMN 

P–14–268; CAS No. 304855–14–9) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d) and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10792 to subpart E to 

read as follows: 

§ 721.10792 Carbonic acid, dimethyl ester, 

polymer with 1,4-diisocyanatobenzene, 1,6- 

hexanediol and 1,5-pentanediol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

carbonic acid, dimethyl ester, polymer 

with 1,4-diisocyanatobenzene, 1,6- 

hexanediol and 1,5-pentanediol (PMN 

P–14–478; CAS No. 1558862–08–0) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(i), (a)(6)(ii), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4). 

(A) NIOSH-certified air-purifying halfmask respirator equipped with 

appropriate gas/vapor cartridges in 

combination with N100, R100, or P100 

filters or an appropriate canister 

incorporating N100, R100, or P100 

filters (for scenarios where neither 

dermal nor ocular exposure is likely). 

(B) NIOSH-certified power airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters (for scenarios where 

dermal and/or ocular exposure is also 

likely). 

(C) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet 

(for scenarios where dermal and/or 

ocular exposure is also likely). 

(D) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece (for scenarios where 

dermal and/or ocular exposure is also 

likely). 


rljohnson on DSK3VPTVN1PROD with PROPOSALS
858 Federal Register / Vol. 80, No. 4 / Wednesday, January 7, 2015 / Proposed Rules 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o) and (y)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), (d) and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2014–30829 Filed 1–6–15; 8:45 am] 

BILLING CODE 6560–50–P 


rljohnson on DSK3VPTVN1PROD with PROPOSALS