Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77891 

As used in this exclusion, ‘‘anti-personnel landmine’’ means any mine placed under, on, or near the ground or other surface area, or delivered 

by artillery, rocket, mortar, or similar means or dropped from an aircraft and which is designed to be detonated or exploded by the presence, 

proximity, or contact of a person; any device or material which is designed, constructed, or adapted to kill or injure and which functions unexpectedly when a person disturbs or approaches an apparently harmless object or performs an apparently safe act; any manually-emplaced munition 

or device designed to kill, injure, or damage and which is actuated by remote control or automatically after a lapse of time. 

Note 16: The radar systems described are controlled in USML Category XI(a)(3)(i) through (v). As used in this entry, the term ‘‘systems’’ includes equipment, devices, software, assemblies, modules, components, practices, processes, methods, approaches, schema, frameworks, and 

models. 

Note 17: This exclusion does not apply to the export of defense articles previously notified to Congress pursuant to § 123.15 or § 124.11 of 

this subchapter. For use of the Australian and UK exemptions for congressional notification, see § 126.16(o) and § 126.17(o). 

Rose E. Gottemoeller, 

Under Secretary, Arms Control and 

International Security, Department of State. 

[FR Doc. 2014–30232 Filed 12–24–14; 8:45 am] 

BILLING CODE 4710–25–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2010–0573; FRL–9915–60] 

RIN 2070–AJ73 

Benzidine-Based Chemical 

Substances; Di-n-pentyl Phthalate 

(DnPP); and Alkanes, C12-13, Chloro; 

Significant New Use Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is 

promulgating a significant new use rule 

(SNUR) to add nine benzidine-based 

chemical substances to the existing 

SNUR on benzidine-based chemical 

substances. With respect to both the 

newly-added benzidine-based chemical 

substances and the previously-listed 

benzidine-based chemical substances, 

this rule makes inapplicable the 

exemption relating to persons that 

import or process substances as part of 

an article. EPA is also promulgating a 

SNUR for di-n-pentyl phthalate (DnPP) 

and a SNUR for alkanes, C12-13, chloro. 

These actions require persons who 

intend to manufacture (defined by 

statute to include import) or process 

these chemical substances for an 

activity that is designated as a 

significant new use to notify EPA at 

least 90 days before commencing such 

manufacture or processing. The required 

notifications will provide EPA with the 

opportunity to evaluate activities 

associated with a significant new use 

and, if necessary based on the 

information available at that time, an 

opportunity to protect against potential 

unreasonable risks, if any, from that 

activity before it occurs. EPA is also 

making a technical amendment to the 

codified list of control numbers for 

approved information collection 

activities so that it includes the control 

number assigned by the Office of 

Management and Budget (OMB) to the 

information collection activities 

contained in this rule. 

DATES: This final rule is effective 

February 27, 2015. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0573, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), EPA 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT:

For technical information contact: 

Sara Kemme, National Program 

Chemicals Division (7404T), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(202) 566–0511; email address: 

kemme.sara@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

These three different SNURs may 

apply to different entities. The North 

American Industrial Classification 

System (NAICS) codes have been 

provided to assist you and others in 

determining whether this action might 

apply to certain entities. 

1. Benzidine-based chemical 

substances. You may be potentially 

affected by this action if you 

manufacture (defined by statute to 

include import), or process, including as 

part of an article, any of the benzidinebased chemical substances listed in 

Tables 1 and 2 of the regulatory text in 

this document. Potentially affected 

entities may include, but are not limited 

to: 

• Manufacturers or processors of one 

or more of the subject chemical 

substances. 

• Entities which plan to use the listed 

chemical substances in conjunction 

with apparel and other finished 

products made from fabrics, leather, and 

similar materials. 

• Entities which plan to use the listed 

chemical substances in conjunction 

with paper and allied products. 

• Manufacturers or processors of the 

subject chemical substances in printing 

inks. These entities may include those 

described by the NAICS codes 325— 

chemical manufacturing, 31—textile 

manufacturers, 316—leather and allied 

products manufacturers, 322—paper 

manufacturers, 4243 apparel, piece 

goods, and notions wholesalers, or 

443—clothing and accessories stores. 

2. DnPP. You may be potentially 

affected by this action if you 

manufacture (defined by statute to 

include import), or process DnPP. 

Potentially affected entities may 

include, but are not limited to: Chemical 

industry—plastic material and resins 

(NAICS code 325211). 

3. Alkanes, C12-13, chloro (CAS No. 

71011–12–6). You may be potentially 

affected by this action if you 

manufacture or process the following 

short-chained chlorinated paraffin 

(SCCP): Alkanes, C12-13, chloro (CAS No. 

71011–12–6). Potentially affected 

entities may include, but are not limited 

to: Manufacturers of SCCPs (NAICS 

codes 325 and 325998), chemical 

manufacturing; including miscellaneous 

chemical product and preparation 

manufacturing; and processors of SCCPs 

(NAICS codes 324 and 324191), 

petroleum lubricating oil and grease 

manufacturing. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Persons who import 

any chemical substance governed by a 

final SNUR are subject to the TSCA 

section 13 (15 U.S.C. 2612) import 

mstockstill on DSK4VPTVN1PROD with RULES

77892 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

certification requirements and the 

corresponding regulations at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Those persons must certify that 

the shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of a proposed or final 

SNUR 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. 

To determine whether you or your 

business may be affected by this action, 

you should carefully examine the 

applicability provisions in 40 CFR 721.5 

for SNUR-related obligations and with 

respect to benzidine-based chemical 

substances, the applicability provisions 

in Unit V. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. What Is the Agency’s Authority for 

Taking this Action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture or 

process the chemical substance for that 

use (15 U.S.C. 2604(a)(1)(B)). As 

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

C. What action is the agency taking? 

In a Federal Register proposed rule 

published on March 28, 2012 (77 FR 

18752) (FRL–8865–2), EPA proposed 

three chemical specific SNURs being 

addressed in this final rule (Ref. 1). 

EPA’s response to public comments 

received on the proposed rule appears 

in Unit X. Please consult the March 28, 

2012 Federal Register proposed rule 

(Ref. 1) for further background 

information for this final rule. 

These final SNURs will require 

persons to notify EPA at least 90 days 

before commencing the manufacture 

(including import) or processing of: 

• The nine benzidine-based chemical 

substances identified in Table A of Unit 

II., which are being added to 40 CFR 

721.1660 with a designation of any use 

as a significant new use; 

• DnPP with a designation of any use 

other than as a chemical standard for 

analytical experiments as a significant 

new use; and 

• Alkanes, C12–13, chloro (CAS No. 

71011–12–6) with a designation of any 

use as a significant new use. 

In addition, this final rule amends the 

SNUR at 40 CFR 721.1660 to make 

inapplicable the exemption at 40 CFR 

721.45(f) for persons that import or 

process benzidine-based chemical 

substances as part of an article. For the 

benzidine-based chemical substances, 

the elimination of the article exemption 

at 40 CFR 721.45(f) will require persons 

to notify EPA at least 90 days before 

commencing processing or importing as 

part of an article any of the newly-added 

benzidine-based chemical substances, as 

well as those already covered (61 FR 

52287, October 7, 1996 (FRL–5396–6), 

codified at 40 CFR 721.1660) (Ref. 2). 

D. Why is the agency taking this action? 

These SNURs are necessary to ensure 

that EPA receives timely advance notice 

of any future manufacturing and 

processing of these chemical substances 

for new uses that may produce changes 

in human and environmental exposures. 

The rationale and objectives for this 

SNUR are explained in Unit III. 

E. What are the estimated incremental 

impacts of this action? 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of the 

chemical substances included in this 

final rule. This analysis, which is 

available in the docket, is discussed in 

Unit IX., and is briefly summarized 

here. In the event that a SNUN is 

submitted, costs are estimated to be less 

than $8,700 per SNUN submission for 

large business submitters and $6,300 for 

small business submitters. These 

estimates include the cost to prepare 

and submit the SNUN and the payment 

of a user fee. In addition, for persons 

exporting a substance that is the subject 

of a SNUR, a one-time notice must be 

provided for the first export or intended 

export to a particular country, which is 

estimated to cost less than $100 on 

average per notification. The rule may 

also affect firms that import or process 

articles that may contain benzidinebased chemicals, because, while not 

required by the SNUR, these parties may 

take additional steps to determine 

whether benzidine-based chemicals are 

part of the articles that they are 

considering to import or process. Since 

EPA is unable to predict whether 

anyone might engage in future activities 

that would require reporting, potential 

total costs were not estimated. 

II. Overview of the Chemical 

Substances Subject to This Rule 

The SNURs in this final rule involve 

certain benzidine-based chemical 

substances in the existing SNUR at 40 

CFR 721.1660 (Ref. 1), the nine 

benzidine-based chemical substances 

listed in Table A of this unit, DnPP 

(CAS No. 131–18–0), and alkanes, C12- 

13, chloro (CAS No. 71011–12–6). 

TABLE A—NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS or accession No. C.I. name C.I. No. Chemical name 

117–33–9 ........................ Not available .................. Not available .................. 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4’-[2-(4- 

hydroxyphenyl)diazenyl][1,1’- biphenyl]-4-yl]diazenyl]-. 

65150–87–0 .................... Not available .................. Not available .................. 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[2-[4’-[2-(2-hydroxy-1-naphthalenyl)diazenyl][1,1’-biphenyl]-4-yl]diazenyl]-, 

lithium salt (1:3). 

68214–82–4 .................... Direct Navy BH .............. Not available .................. 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4’-[2-(7-amino-1- 

hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1’-biphenyl]-4- 

yl]diazenyl]-4-hydroxy-, sodium salt (1:2). 

72379–45–4 .................... Not available .................. Not available .................. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[4’-[2- 

[2-hydroxy-4-[(2- methylphenyl)amino] phenyl]diazenyl][1,1’- 

biphenyl]-4-yl]diazenyl]-6-(2- phenyldiazenyl)-. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77893 

TABLE A—NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued 

CAS or accession No. C.I. name C.I. No. Chemical name 

Accession No. 21808 .....

CAS No. CBI (NA) 

CBI ................................. CBI ................................. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, 

phenylazo-, disodium salt. (generic name). 

Accession No. 24921 .....

CAS No. CBI (NA) 

CBI ................................. CBI ................................. 4-(Substituted naphthalenyl)azo diphenylyl 

azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name). 

Accession No. 26256 .....

CAS No. CBI (NA) 

CBI ................................. CBI ................................. 4-(Substituted phenyl)azo biphenylyl azo-substituted 

carbopolycycloazo benzenesulfonic acid, sodium salt. (generic name) 

Accession No. 26267 .....

CAS No. CBI (NA) 

CBI ................................. CBI ................................. 4-(Substituted phenyl)azo biphenylyl azo-substituted 

carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name). 

Accession No. 26701 .....

CAS No. CBI (NA) 

CBI ................................. CBI ................................. Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted benzene sodium sulfonate. (generic name). 

CAS = Chemical Abstracts Services. CBI = Confidential Business Information. CBI (NA) = Confidential Business Information (Not Available). 

C.I. = Chemical Index. 

III. Rationale and Objectives 

A. Rationale 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), EPA’s decision to issue a SNUR 

for a particular chemical use need not 

be based on an extensive evaluation of 

the hazard, exposure, or potential risk 

associated with that use. Rather, the 

Agency’s action is based on EPA’s 

determination that if the use begins or 

resumes, it may present a risk that EPA 

should evaluate under TSCA before the 

manufacturing or processing for that use 

begins. Since the new use does not 

currently exist, deferring a detailed 

consideration of potential risks or 

hazards related to that use is an effective 

use of resources. If a person decides to 

begin manufacturing or processing the 

chemical for the use, the notice to EPA 

allows EPA to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use. 

1. Benzidine-based chemical 

substances. As described in the 

proposal (Ref. 1), EPA is concerned 

about potential carcinogenic effects on 

workers and consumers from the 

manufacture, processing, or use of these 

substances. Consumers exposed via 

dermal exposure to consumer products 

containing the benzidine-based 

chemical substances are a particular 

concern because enzymes present in the 

human body and in bacteria on the skin 

aid in the reduction of these chemical 

substances to the benzidine unit, an 

established human carcinogen (Ref. 3). 

The main consumer products that could 

result in dermal exposure if containing 

these chemical substances include 

textiles and leather products because 

they are in prolonged contact with 

human skin. 

During the review of information on 

benzidine-based chemical substances, 

EPA determined that the newly 

identified chemical substances that are 

being added to 40 CFR 721.1660 by this 

final rule present the same concerns 

(Ref. 4) as those of the benzidine-based 

chemical substances already listed in 

the rule ((Ref. 2)), codified at 40 CFR 

721.1660). EPA does not believe there is 

any current use of these nine benzidinebased chemical substances within or 

outside the United States. This 

conclusion is based on a review of 

EPA’s own Inventory Update Reporting 

(IUR) data, and more recent Chemical 

Data Reporting (CDR) data as well as 

other sources including the Colour 

Index International, published by the 

Society of Dyers and Colourists and 

American Association of Textile 

Chemists and Colorists; IHS Chemical 

Economics Handbook, Dyes; and ICIS 

Directory of World Chemical Producers. 

In addition, as discussed earlier, 

although some of the benzidine-based 

chemical substances subject to the 1996 

SNUR may be manufactured or 

processed outside the United States, an 

analysis of the benzidine-based 

chemical substances market (Ref. 4) 

revealed no information indicating 

import of articles containing benzidinebased chemical substances for nonexcluded purposes. 

Although it appears there is no 

ongoing domestic manufacture of the 

nine newly added benzidine-based 

chemical substances, or import for a 

non-excluded use of articles containing 

any benzidine-based chemical 

substances, the manufacture (including 

import) or processing of the nine newly 

added benzidine-based chemical 

substances and the import or processing 

of articles containing any benzidinebased chemical substances may begin at 

any time, without prior notice to EPA. 

Thus, EPA is concerned that 

commencement of the manufacture 

(including import) or processing for any 

new uses, including resumption of past 

uses, of benzidine-based chemical 

substances could significantly increase 

the magnitude and duration of exposure 

to humans over that which would 

otherwise exist currently. EPA is 

concerned that such an increase should 

not occur without an opportunity for the 

Agency to evaluate activities associated 

with a significant new use and an 

opportunity to protect against potential 

unreasonable risks, if any, from 

exposure to the chemical substance. 

Accordingly, EPA is finalizing a 

SNUR for the nine benzidine-based 

chemical substances by adding them to 

those currently listed at 40 CFR 

721.1660, and making inapplicable the 

article exemption at 40 CFR 721.45(f) for 

those chemical substances newly added 

in this rulemaking as well as for those 

already listed at 40 CFR 721.1660. This 

final rule will require persons who 

intend to manufacture (including 

import) or process any of the benzidinebased chemical substances for a nonexcluded use, including importing or 

processing any listed benzidine-based 

chemical substance for a non-excluded 

use as part of an article, to submit a 

SNUN. 

2. DnPP. As described in the proposal 

(Ref. 1), EPA has concerns regarding 

potential adverse human health and 

environmental effects that may be 

caused by DnPP. EPA has direct 

information from animal studies that 

DnPP specifically can elicit 

developmental/reproductive effects that 

are relevant to human health and also 

indicate potential effects in wildlife. 

EPA also is concerned that due to its 

general structure and categorization as a 

phthalate that DnPP may elicit adverse 

environmental effects similar to those 

mstockstill on DSK4VPTVN1PROD with RULES

77894 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

described for other phthalates. EPA is 

concerned that any manufacturing 

(including import) or processing of 

DnPP, beyond that for its limited 

ongoing use as a chemical standard for 

laboratory use, could significantly 

increase the magnitude and duration of 

exposure to humans over that which 

would otherwise exist currently. EPA is 

concerned that such an increase should 

not occur without an opportunity to 

evaluate activities associated with a 

significant new use and an opportunity 

to protect against potential unreasonable 

risks, if any, from exposure to the 

chemical substance. Accordingly, EPA 

is finalizing a SNUR for DnPP that 

would designate, as a significant new 

use, any use of the chemical substance 

other than use as a chemical standard 

for analytical experiments. A person 

who intends to manufacture or process 

DnPP for use other than use as a 

chemical standard for analytical 

experiments would be required to 

submit a SNUN. 

3. Alkanes, C12-13, chloro (CAS No. 

71011–12–6). As described in the 

proposal (Ref. 1), EPA has a primary 

concern regarding adverse 

environmental effects that may be 

caused by alkanes, C12-13, chloro (CAS 

No. 71011–12–6), one type of SCCP. For 

example, alkanes, C12-13, chloro, have 

been shown to be highly toxic to aquatic 

invertebrates following acute and 

chronic exposures and to fish following 

chronic exposures. EPA also has 

concerns about the persistence and 

bioaccumulation potential of SCCPs, 

including alkanes, C12-13, chloro, since 

these substances have been measured in 

a variety of biota (i.e., freshwater aquatic 

species, marine mammals, and avian 

and terrestrial wildlife) and have also 

been measured in human breast milk 

from Canada and the United Kingdom. 

The mechanisms or pathways by which 

SCCPs, including alkanes, C12-13, 

chloro (CAS No. 71011–12–6), move 

into and through the environment and 

humans are not fully understood, but 

are likely to include releases from 

manufacturing of the chemicals, 

manufacturing of products like plastics 

or textiles, aging and wear of products 

like sofas and electronics, and releases 

at the end of product life (e.g., disposal, 

recycling). 

EPA believes that all manufacture and 

processing into the United States of 

alkanes, C12-13, chloro (CAS No. 

71011–12–6) has ceased. Given that EPA 

has no evidence to suggest that there is 

any manufacture or processing of this 

chemical substance in the United States, 

and taking into consideration the 

negative commercial and regulatory 

environment associated with this 

chemical internationally (including the 

European Union (EU) and Canadian ban 

on marketing) and use of the alkanes, 

C12-13, chloro (CAS No. 71011–12–6) 

domestically, EPA does not expect to 

find such activity. However, EPA is 

concerned that commencement of the 

manufacture or processing for any new 

uses, including resumption of past uses, 

could significantly increase the 

magnitude and duration of exposure to 

humans over that which would 

otherwise exist. EPA is concerned that 

such an increase should not occur 

without an opportunity to evaluate 

activities associated with a significant 

new use and an opportunity to protect 

against potential unreasonable risks, if 

any, from exposure to the chemical 

substance. Accordingly, EPA is 

finalizing a SNUR for alkanes, C12-13, 

chloro (CAS No. 71011–12–6) that 

designates as a significant new use any 

use of the chemical substance. This 

SNUR requires a person who intends to 

manufacture or process alkanes, C12-13, 

chloro (CAS No. 71011–12–6) for any 

use to submit a SNUN. 

B. Objectives 

Based on the considerations described 

in the proposal (Ref. 1) and in the 

response to public comments, EPA 

expects to achieve the following 

objectives with regard to the significant 

new uses that are designated in this 

final rule: 

1. EPA will receive notice of any 

person’s intent to manufacture or 

process the specified chemicals for the 

described significant new uses before 

that activity begins; 

2. EPA will have an opportunity to 

review and evaluate data submitted in 

the SNUN before the notice submitter 

begins manufacturing or processing of 

the specified chemicals for the 

described significant new use; 

3. EPA will be able to regulate 

prospective uses of the specified 

chemicals before the described 

significant new uses occur, provided 

that regulation is warranted pursuant to 

TSCA sections 5(e), 5(f), 6 or 7; and 

4. EPA would receive a notice alerting 

the Agency to a reversal of an industry 

trend toward deselecting for a chemical. 

IV. Significant New Use Determination 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors including: 

• 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 authorizes EPA to consider any 

other relevant factors. 

To determine what constitutes a 

significant new use of the benzidinebased chemical substances, DnPP, and 

alkanes, C12-13, chloro (CAS No. 

71011–12–6) subject to this rule, EPA 

considered relevant information about 

the toxicity of these substances, likely 

human exposures and environmental 

releases associated with possible uses, 

and the four factors listed in section 

5(a)(2) of TSCA. EPA has determined 

that the manufacture or processing, of 

any of the benzidine-based chemical 

substances subject to the 1996 SNUR or 

being newly added to 40 CFR 721.1660 

by this final rule, except for ongoing 

uses specified in 40 CFR 

721.1660(a)(2)(i) of the regulatory text in 

this document, is a significant new use. 

EPA has also determined that the 

manufacture or processing of DnPP for 

any use other than use as a chemical 

standard for analytical experiments is a 

significant new use, and the 

manufacture or processing of alkanes, 

C12-13, chloro (CAS No. 71011–12–6) 

for any use is a significant new use. 

V. Applicability of the General 

Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear 

at 40 CFR part 700. According to 40 CFR 

721.1(c), persons subject to SNURs must 

comply with the same notice 

requirements and EPA regulatory 

procedures as submitters of 

Premanufacture Notices (PMNs) under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submissions requirements 

of TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6 or 7 to control the activities 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77895 

on which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

However, 40 CFR 721.45(f) (which 

generally exempts persons importing or 

processing a substance as part of an 

article) will not apply to the benzidinebased chemical substances listed at 40 

CFR 721.1660 and those added by this 

final rule. Therefore, a person who 

imports or processes as part of an article 

a benzidine-based chemical substance 

that is covered by this rule would not 

be exempt from submitting a SNUN. 

Persons who export or intend to 

export a chemical substance identified 

in a proposed or final SNUR are subject 

to the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. Persons 

who import a chemical substance 

identified in a final SNUR are subject to 

the TSCA section 13 import certification 

requirements, codified at 19 CFR 12.118 

through 12.127; see also 19 CFR 127.28. 

Those persons must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. 

VI. Applicability of the Final Rule to 

Uses Occurring Before the Effective 

Date of the Final Rule 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376) (FRL– 

3658–5) (Ref. 5), EPA has decided that 

the intent of section 5(a)(1)(B) of TSCA 

is best served by designating a use as a 

significant new use as of the date of 

publication of the proposed rule rather 

than as of the effective date of the final 

rule. If uses begun after publication of 

the proposed rule were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements, because a person 

could defeat the SNUR by initiating the 

proposed significant new use before the 

rule became final, and then argue that 

the use was ongoing as of the effective 

date of the final rule. Thus, persons who 

begin the commercial manufacture or 

processing of a covered substance as a 

significant new use have to cease any 

such activity as of the effective date of 

the rule if and when finalized. To 

resume their activities, these persons 

would have to comply with all 

applicable SNUR notice requirements 

and wait until the notice review period, 

including all extensions, expires. If a 

person were to meet the conditions of 

advance compliance under 40 CFR 

721.45(h), that person would be 

considered to have met the 

requirements of the final SNUR for 

those activities. 

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. There are two exceptions: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)) and 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a section 4 test rule 

or a section 5(b)(4) listing covering the 

chemical substance, persons are 

required only to submit test data in their 

possession or control and to describe 

any other data known to or reasonably 

ascertainable by them (15 U.S.C. 

2604(d); 40 CFR 721.25, and 40 CFR 

720.50). However, as a general matter, 

EPA recommends that SNUN submitters 

include data that would permit a 

reasoned evaluation of risks posed by 

the chemical substance during its 

manufacture, import, processing, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN. 

As part of this optional pre-notice 

consultation, EPA would discuss 

specific data it believes may be useful 

in evaluating a significant new use. 

SNUNs submitted for significant new 

uses without any test data may increase 

the likelihood that EPA would take 

action under TSCA section 5(e) to 

prohibit or limit activities associated 

with this chemical. SNUN submitters 

should be aware that EPA will be better 

able to evaluate SNUNs that provide 

detailed information on: 

• Human exposure and 

environmental releases that may result 

from the significant new uses of the 

chemical substance. 

• Potential benefits of the chemical 

substance. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with 

the same notice requirements and EPA 

regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be on EPA 

Form No. 7710–25, generated using ePMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in 40 CFR 721.25 

and 720.40. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

IX. Economic Analysis 

A. SNUNs 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of these 

chemicals and for articles containing 

any of the benzidine-based chemical 

substances included in the 1996 SNUR 

and those newly added by this final rule 

when imported or processed as part of 

an article. These economic analyses, 

which are briefly summarized here, are 

available in the docket for this rule. EPA 

added additional information to the 

economic analysis for the benzidinebased chemical substances in response 

to public comments. 

The costs of submission of a SNUN 

would be incurred when a company 

decides to pursue a significant new use 

of one of these chemicals. In the event 

that a SNUN is submitted, costs are 

estimated at approximately $8,600 per 

SNUN submission, and include the cost 

for preparing and submitting the SNUN, 

recordkeeping, and the payment of a 

user fee. Businesses that submit a SNUN 

are either subject to a $2,500 user fee 

required by 40 CFR 700.45(b)(2)(iii), or, 

if they are a small business with annual 

sales of less than $40 million when 

combined with those of the parent 

company (if any), a reduced user fee of 

$100 (40 CFR 700.45(b)(1)). In its 

evaluation of this final rule, EPA also 

considered the potential costs a 

company might incur by avoiding or 

delaying the significant new use in the 

future, but these costs have not been 

quantified. 

B. Export Notification 

EPA regulations under TSCA section 

12(b) (15 U.S.C. 2611(b)) at 40 CFR part 

707, subpart D require that, for 

chemicals subject to a proposed or final 

SNUR, a company notify EPA of the first 

export or intended export to a particular 

country of an affected chemical 

substance. EPA estimated that the onetime cost of preparing and submitting an 

export notification to be $84. The total 

costs of export notification would vary 

per chemical, depending on the number 

of required notifications (i.e., number of 

countries to which the chemical is 

exported). 

mstockstill on DSK4VPTVN1PROD with RULES

77896 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

1 It should be noted that there is no general SNUN 

exemption for uses of a chemical substances 

involving articles and EPA routinely defines 

significant new uses to include use in articles. The 

exemption at 40 CFR 721.45(f) relates to a different 

question: whether the SNUR applies to persons who 

process or import a chemical substance by 

processing or importing the substance as part of an 

article. 

C. Import or Processing Benzidine-Based 

Chemical Substances as Part of an 

Article 

In the case of the benzidine-based 

chemical substances, this rule makes 

inapplicable the exemption relating to 

persons that import or process 

substances as part of an article. In the 

proposed rule EPA preliminarily 

determined, based on the Agency’s 

market research, that there was no 

ongoing manufacturing (including 

import) or processing of these chemical 

substances for significant new uses as 

part of articles or otherwise. For the 

nine newly-added benzidine-based 

chemical substances, EPA found no 

evidence of manufacture either 

domestically or abroad, and thus also no 

evidence of importation or processing of 

these chemical substances as part of 

articles (Ref. 1). For the majority of the 

24 previously listed benzidine-based 

chemical substances, EPA found no 

evidence of manufacture, either 

domestically or abroad. While EPA 

found that some of the previously listed 

benzidine-based chemical substances 

were being manufactured domestically 

for discrete uses that are not subject to 

this SNUR, EPA found no evidence that 

these chemical substances were being 

imported or processed as part of articles 

(Ref. 1). EPA received no public 

comments indicating otherwise. Based 

on the global trend away from using 

these chemical substances, the fact that 

they are regulated in numerous 

jurisdictions, and the absence of public 

comments indicating their ongoing use 

for significant new uses, EPA is 

finalizing its determination that these 

benzidine-based chemical substances 

are not being manufactured (including 

import) or processed for a significant 

new use as part of articles or otherwise. 

However, the rule may affect firms 

that plan to import or process types of 

articles that benzidine-based chemicals 

are potentially a part of. Some firms 

have an understanding of the contents 

of the articles they import or process. 

However, EPA acknowledges that 

importers and processors of articles may 

have varying levels of knowledge about 

the chemical content of the articles that 

they import or process. These parties 

may need to become familiar with the 

requirements of the rule. And, while not 

required by the SNUR, these parties may 

take additional steps to determine 

whether benzidine-based chemicals are 

part of the articles that they are 

considering to import or process. This 

determination may involve activities 

such as gathering information from 

suppliers along the supply chain, and/ 

or testing samples of the article itself. 

Costs vary across the activities chosen 

and the extent of familiarity a firm has 

regarding the articles it imports or 

processes. Cost ranges are presented in 

the ‘‘Economic Analysis of the Final 

Significant New Use Rule for Nine 

Benzidine Based Chemical Substances’’ 

(Ref. 4). Given existing regulatory 

limitations on certain benzidine-based 

substances both internationally and 

within the U.S., industry-wide 

processes, resources that support 

companies in understanding and 

managing their supply chains, and 

evidence showing minimal worldwide 

availability of the dyes regulated under 

the SNUR, EPA believes that article 

importers that choose to investigate 

their products would incur costs at the 

lower end of the ranges presented in the 

Economic Analysis as a result of this 

rule. For those companies choosing to 

undertake actions to assess the 

composition of the articles they import 

or process, EPA expects that in all 

likelihood, these importers and 

processors would take actions that are 

commensurate with the company’s 

perceived likelihood that a chemical 

substance might be a part of an article 

they intend to import into the United 

States and the resources it has available. 

X. Response to Public Comment 

The Agency reviewed and considered 

all comments received related to the 

proposed rule. Copies of all non-CBI 

comments are available in the docket for 

this action. A discussion of the major 

comments germane to the rulemaking 

and the Agency’s responses follow 

A. Legal Authority To Make 

Inapplicable the Exemption for Persons 

Who Import or Process Chemical 

Substances as Part of Articles 

One commenter suggests that if 

chemical substances are not exempted 

from the SNUR at the point they are 

incorporated into articles, then EPA 

should consider whether it is 

inappropriately regulating ‘‘articles 

under the chemical management 

authorities of TSCA,’’ (emphasis 

original) inconsistent with 

Congressional intent in enacting TSCA. 

The commenter argues further that the 

regulation of articles is not the primary 

purpose of TSCA and that such 

regulation should be addressed by other 

agencies operating under other statutes 

such as the Occupational Safety and 

Health Act of 1970 and the Consumer 

Product Safety Act of 1972. Another 

comment raises similar issues. 

EPA responded that the SNUR for 

benzidine-based chemical substances 

does not regulate articles per se, but 

rather persons who manufacture or 

process these chemical substances, 

including when the chemical substances 

are present as part of articles. TSCA 

clearly contemplates such regulation, as 

certain articles are expressly removed 

from TSCA jurisdiction at TSCA section 

3(2). Indeed, EPA has a long history of 

regulating chemical substances as part 

of articles under TSCA. For 

polychlorinated biphenyls (the only 

chemical substance specifically 

addressed in TSCA as it was originally 

enacted), section 6(e) of TSCA provides 

authority for EPA to promulgate rules 

related to polychlorinated biphenyls in 

articles, such as electrical transformers. 

Other examples include the regulation 

of asbestos (40 CFR 763.160) and 

regulation of manufacturers of consumer 

products intended for use by children 

who also manufacture (including 

import) lead (40 CFR 716.21(a)(8)). 

TSCA section 5 provides EPA with 

authority to regulate chemical 

substances, including chemical 

substances that are part of articles.1

Under this section, EPA has previously 

regulated persons that import or process 

chemical substances as part of articles, 

including articles containing erionite 

fiber (40 CFR 721.2800) and mercury (40 

CFR 721.10068). This is in keeping with 

the statutory language authorizing the 

Administrator to designate a ‘‘use of a 

chemical substance as a significant new 

use’’ and to require SNUN submissions 

from persons that intend to manufacture 

or process a chemical for a designated 

significant new use. The commenter is 

incorrect in suggesting that regulation to 

address chemical substances in articles 

is beyond the originally intended 

functions of TSCA. When TSCA was 

being drafted, legislators characterized it 

as ‘‘a mechanism to protect against 

dangerous chemical materials contained 

in consumer and industrial products’’; 

by way of example, the drafters cited 

‘‘the presence of mercury in such 

consumer products as paint, home 

thermometers, sponges, and a variety of 

other products.’’ S. Rep. No. 94–698, 

94th Cong., 2d Sess., 5–6 (1976). 

Furthermore, this application of the 

regulations (to persons who 

manufacture or process the chemical 

substance as part of articles) is 

consistent with legislators’ observation, 

in drafting this section, that: 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77897 

[T]he most desirable time to determine the 

health and environmental effects of a 

substance, and to take action to protect 

against any potential adverse effects, occurs 

before commercial production begins. Not 

only is human and environmental harm 

avoided or alleviated, but the cost of any 

regulatory action in terms of loss of jobs and 

capital investment is minimized. 

H.R. Rep. 94–1679, 94th Cong., 2d Sess., 

65 (1976). 

When a chemical substance is 

domestically produced, the substance 

generally exists in non-article form at 

the earliest point of commercial 

production in the United States. When 

a chemical substance is imported, 

however, it may in many instances 

already be part of an article, even at the 

earliest point that it enters U.S. 

commerce. By this action, EPA makes 

importers of specific chemical 

substances subject to the same SNUN 

requirements as domestic manufacturers 

of the same substance, irrespective of 

whether such import is as part of an 

article. This action is consistent with 

the plain text of TSCA 5(a)(1)(B) 

(generally, ‘‘no person may . . . 

manufacture or process’’ for a 

significant new use without proper 

notice) and with one of the intended 

goals of TSCA: to hold importers to ‘‘the 

same responsibilities and obligations as 

domestic manufacturers,’’ H.R. Rep. No. 

94–1341, 94th Cong. 2d. Sess., 12–13 

(1976). This action is also consistent 

with EPA’s identified concerns 

regarding benzidine-based chemical 

substances when they are present as 

part of an article (See Ref. 1, pg. 18756). 

Moreover, when originally 

promulgating the presumptive SNUN 

submission exemption for persons who 

import or process chemical substances 

as part of articles (40 CFR 721.45(f)), 

EPA did so based on a belief that people 

and the environment would generally 

not be exposed to chemical substances 

in articles. To address those cases where 

the assumption may not be valid, EPA 

specifically noted that, ‘‘EPA may 

decide to eliminate one or all of 

these . . . exemptions [including the 

exemption for importers and processors 

of chemicals as part of articles] if EPA 

decides that review under a SNUR is 

warranted for specific substances . . . 

in articles.’’ (Ref. 6). Thus, while EPA 

clearly has statutory authority to subject 

importers and processors of chemical 

substances in articles to SNUN 

requirements, they are presumptively 

excluded by rule at 40 CFR 721.45(f), 

based on an assumption that people and 

the environment will generally not be 

exposed to substances in articles. (Ref. 

6). To the extent that potential exposure 

to a chemical substance as part of an 

article contributes to the EPA’s 

determination pursuant to the factors in 

section 5(a)(2) of TSCA that the new use 

is significant (i.e., EPA has reason to 

anticipate that use as part of an article 

would raise important questions, related 

to potential exposure, that EPA should 

have an opportunity to review before 

such use could resume or occur), it is 

appropriate to make the exemption 

inapplicable. 

EPA notes that one of the commenters 

appears to have conflated the Federal 

Register notice establishing the article 

importers’ and article processors’ 

exemption from PMN requirements (Ref. 

7), discussing 40 CFR 720.22(b)) with 

another Federal Register notice 

establishing the comparable exemptions 

from SNUR requirements (Ref. 6), 

discussing 40 CFR 721.45(f)). While 

EPA recognizes that parts 720 and 721 

deal with many similar issues, they are 

also distinct from each other in 

important respects. It is significant that 

in the 1984 action, whereby EPA 

established the article importers’ and 

article processors’ exemption for 

SNURs, it did not simply mirror the 

1983 rationale for the comparable 

exemption from PMN obligations. For 

PMNs, EPA noted the difficulties 

associated with determining the identity 

and Inventory status of each chemical 

substance in imported articles (e.g., 

automobiles) (Ref. 7). But for SNURs, 

EPA placed special emphasis on its 

assumption that import of the substance 

as part of an article would not affect 

human or environmental exposure to 

the substance, while taking particular 

care to reserve ongoing discretion to 

revise its assumption as warranted in 

the case of specific substances. EPA had 

reason to differentiate between the two 

rationales. SNURs are for specified 

chemical substances for which EPA has 

identified exposure-based concerns for 

the defined significant new use (per the 

TSCA section 5(a)(2) factors). By 

contrast, PMNs are required for all new 

chemicals (i.e., those not on the TSCA 

inventory), not a specified set of 

chemicals. 

Finally, there is no basis for the 

commenter’s suggestion that EPA 

should decline to review significant 

new uses, in deference to the 

Occupational Safety and Health 

Administration (OSHA) or the 

Consumer Product Safety Commission 

(CPSC), simply because a significant 

new use notice would be submitted by 

a person who imports or processes the 

chemical substance as part of an article. 

Neither the Occupational Safety and 

Health Act of 1970 nor the Consumer 

Product Safety Act of 1972 contains a 

comparable mechanism to ensure 

advance notice and opportunity to 

review significant new uses of chemical 

substances, as part of articles or 

otherwise. 

B. Development of a Separate Policy 

Framework for Making Inapplicable the 

Exemption for Persons Who Import or 

Process Chemical Substances as Part of 

Articles 

1. Comment. Some commenters 

suggest that before finalizing a 

rulemaking to make the ‘‘articles 

exemption’’ inapplicable to the 

benzidine-based chemical substances, 

the EPA should complete a separate 

public comment process to develop a 

general ‘‘policy framework for the 

issuance of article SNURs.’’ 

Commenters suggest that this policy 

framework should include science 

based criteria, feasibility criteria, costs, 

and other factors. 

One comment suggests that, in 

formulating the ‘‘policy framework’’ or 

criteria for making the exemption for 

importers and processors of chemical 

substances as part of articles 

inapplicable, EPA should address the 

following questions: 

• Can the risk posed by the chemical 

of concern be addressed through the 

standard regulation? 

• Why is the standard approach for 

SNURs that exempts articles not 

sufficient? 

• What conditions make direct 

regulation of articles necessary? 

• What gaps in health and 

environmental protection are likely to 

occur if a SNUR only regulates 

chemicals and mixtures? 

Response. The comments conflate two 

separate issues: The determination of a 

significant new use under TSCA section 

5(a)(2), and the decision to make the 

regulatory exemption at 40 CFR 

721.45(f) inapplicable. (40 CFR 721.45(f) 

provides that persons who import or 

process a chemical substance as part of 

an article are not subject to the 

notification requirements at 40 CFR 

721.25; this exemption is referred to as 

the ‘‘articles exemption’’ by some 

commenters). EPA first makes a 

determination on whether a use of a 

chemical substance is a significant new 

use considering the factors listed in 

TSCA section 5(a)(2). Once that 

determination is made, EPA separately 

determines whether it would be 

appropriate to revoke the regulatory 

exemption at 40 CFR 721.45(f) for 

persons who import or process a 

chemical substance as part of an article. 

EPA notes that there may be a variety 

of cases in which it may be appropriate 

for EPA to include persons who import 

or process the chemical substance as 

mstockstill on DSK4VPTVN1PROD with RULES

77898 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

part of an article among the persons 

subject to SNUN submission 

obligations. Knowledge regarding 

chemical exposures from articles has 

evolved since the Agency established 

the exemption at 40 CFR 721.45(f) in 

1984, and there has been a steady 

increase in international trade of 

chemicals in articles. Accumulated data 

illustrate that SNURs (and section 5(e) 

consent orders) that include the 

exemption for persons who import or 

process a chemical substance as part of 

an article are sometimes insufficient to 

appropriately flag significant new 

exposures from downstream uses. For 

example, there have been instances in 

which a section 5(e) consent order for a 

new chemical substance was issued, 

prohibiting the release of the chemical 

substance to water, and yet the chemical 

substance at issue was later found in the 

environment and biota. The presence of 

the chemical substance in the 

environment and in biota then appears 

to be associated with the use of the 

substance in articles (Ref. 8). There are 

also documented exposures (and 

resulting toxicity) of children to lead 

and cadmium and their compounds 

from a variety of articles, such as toys 

(Ref. 9), and exposures to other heavy 

metals from articles, as measured in 

indoor air and house dust samples, 

which are direct routes of exposure 

accounting for children’s levels and 

toxicity (Ref. 10). Other welldocumented examples are the presence 

of brominated flame retardants (e.g., 

polybrominated diphenyl ethers and 

brominated phthalates and benzoates) in 

samplings of articles, indoor air, people, 

and house dust. The low exchange rate 

of indoor air and house dust to sources 

outside the home support the flame 

retardant release from articles postulate. 

Likewise, other semi-sealed 

environments, such as automobiles, 

have demonstrated migration of flame 

retardants from treated articles to 

interior surfaces and indoor air, as no 

other source was possible. In addition, 

high flame retardant levels have been 

observed in biota raised in proximity to 

articles and living near article recyling 

sites. Further, observed flame retardant 

levels in biota and in the environment 

at locations remote from manufacturing 

sites suggest transport of these nonvolatile chemical substances on 

associated particulate matter from 

distributed treated articles, which 

strongly suggest release from articles as 

one potential source (Ref. 11–15). 

The information discussed in this 

unit—the well-documented exposures 

(and resulting toxicity) of children to 

lead, cadmium, and other metals from a 

variety of articles; the data on other 

chemicals used in articles; and the 

presence in the environment and biota 

of certain brominated flame retardants 

(e.g., polybrominated diphenyl ethers 

and brominated phthalates and 

benzoates)—all illustrate that there can 

be exposure to the chemicals associated 

with their presence in articles (Refs. 9– 

15). 

The scope of the suggested criteria 

(which the commenters suggest EPA 

should now develop to govern its 

exercise of its authority to make the 

exemption at 40 CFR 721.45(f) 

inapplicable) is incommensurate with 

the level of analysis supporting the 

original development of the exemption. 

EPA notes that TSCA section 5(a)(1) 

establishes a general prohibition on 

manufacturing or processing a chemical 

substance for a significant new use 

without prior notice to EPA. 40 CFR 

721.45(f) establishes an exemption from 

this prohibition, but it is based on a 

fairly minimal rationale: ‘‘EPA believes 

people and the environment will 

generally not be exposed to substances 

in articles.’’ (Ref. 6). EPA 

counterbalanced its reliance on this 

generalized assumption (about all 

chemicals that exist as part of articles) 

with a broad reservation of case-by-case 

discretion to make the exemption 

inapplicable as ‘‘warranted for specific 

substances.’’ (Ref. 6). 

EPA does not think that development 

of a ‘‘policy framework’’ is necessary 

before reaching the conclusion, with 

respect to benzidine-based chemical 

substances, that persons who import or 

process these substances as part of 

articles should be subject to the 

notification provisions of 40 CFR 

721.25. Dermal exposure can occur from 

the leaching of the benzidine-based 

chemical substances by sweat in contact 

with the dyed textiles (Ref. 1)). In 

addition, data indicate that exposure to 

other chemicals in materials such as 

textiles and foam can result from the 

dust that is generated from abrasion 

and/or degradation of the materials (Ref. 

16). EPA notes that the commenter did 

not offer data to undercut the 

conclusion that such exposure can 

occur. Because of this information, and 

other information described in Unit 

III.E. of the (Ref. 1), EPA does not 

assume that new types or forms of 

exposure associated with new use of 

benzidine-based chemical substances 

would be insignificant merely because 

the chemical substance is imported or 

processed as part of an article. Thus, 

EPA does not believe the default 

assumption used to support 40 CFR 

721.45(f) (that people and the 

environment will generally not be 

exposed to substances in articles) holds 

with respect to benzidine-based 

chemical substances. 

2. Comment. Comments also suggest 

that EPA analyze the ‘‘variety of 

products’’ that could be construed as 

articles, the ‘‘practical questions that 

will arise’’ if the import and processing 

of such products were not exempt from 

SNURs, and the ‘‘unique channels of 

trade,’’ through which different varieties 

of products move. Commenters 

encouraged EPA to develop and 

articulate publicly a policy framework, 

considering the following factors on an 

article-specific basis, before proceeding 

to revoke the article exemption with 

respect to a particular chemical 

substance: 

• Whether there is, or will be, direct 

exposure to the chemical substance in 

the article during the course of the 

article’s use. 

• Whether there is, or will be, a 

release of the regulated substance, or a 

metabolite or breakdown product from 

the substance, during subsequent 

processing, distribution, use or disposal 

of the article. 

• Whether there is, or will be, a link 

between import or export of an article 

and cross-border exposure to the U.S. 

population. 

Response. Given the variety of 

substances and uses addressed under 

SNUR regulations, EPA believes it is 

more efficient to address article-specific 

issues as they actually arise within each 

regulatory action than to develop, as 

suggested by the commenter, an 

anticipatory ‘‘policy framework’’ 

document. 

The importers and processors of 

chemical substances present in articles 

are generally in the best position to 

know which chemical substances are 

used in which types of articles. When 

EPA identifies a particular chemical 

substance in a SNUR, such stakeholders 

have an opportunity to identify, in their 

public comments, any article-specific 

issues that concern them. Furthermore, 

these issues are likely to be more 

accurately identified and more 

appropriately addressed in connection 

with the development of a SNUR for 

particular chemical substances than 

they would be if they were reviewed 

generically. In this case, commenters 

did not raise any issues specific to 

certain articles. 

C. A Compelling Basis Standard for 

Making Inapplicable the Exemption for 

Persons Who Import or Process 

Chemical Substances as Part of Articles 

1. Comment. Some commenters made 

the point that revocation of the 

exemption at 40 CFR 721.45(f) should 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77899 

not be a presumed component of all 

SNURs. This was part of a broader 

comment that EPA should not make this 

exemption inapplicable unless there 

was a ‘‘compelling basis’’ to do so. One 

commenter was concerned that if EPA 

proceeds on a case-by-case basis, 

following reasoning that ‘‘could be 

applied to many chemicals,’’ then 

elimination of the exemption would 

come to be a ‘‘kind of ‘default’ step’’ in 

future SNURs. One commenter also 

argues that, where the SNUN 

submission requirement is to apply to 

importers and processors of substances 

as part of articles, the TSCA section 

5(a)(2) criteria require EPA to undertake 

a compelling analysis of how the use 

and distribution of the ‘‘specific articles 

or article categories,’’ would ‘‘contribute 

to potential exposures of concern.’’ 

Response. As an initial matter, the 

comments conflate two separate issues: 

The determination of a significant new 

use under TSCA section 5(a)(2), and the 

decision to make the regulatory 

exemption at 40 CFR 721.45(f) 

inapplicable. The TSCA section 5(a)(2) 

factors do not impose a ‘‘compelling 

analysis’’ requirement on the 

elimination of the 40 CFR 721.45(f) 

exemption because (among other 

reasons) these two actions concern two 

discrete issues. The section 5(a)(2) 

factors speak to the significant new use 

itself. 40 CFR 721.45(f) speaks to who is 

required to notify EPA of the significant 

new use. 

In this case, EPA identified its 

reasons, under the TSCA section 5(a)(2) 

factor analysis, to anticipate that the 

new use would pose important new 

questions related to the substances’ 

potential to threaten health or the 

environment (Ref. 1, pg. 18756), and 

that EPA should have an opportunity to 

consider those questions before such 

use could occur. (In essence, a SNUR 

puts a particular set of uses on the same 

footing as a new chemical, which is 

subject to automatic review under TSCA 

section 5(a)(1) unless EPA specifically 

excludes it from such review.) EPA also 

identified a basis, specific to benzidinebased chemical substances, to question 

the assumption that people and the 

environment will generally not be 

exposed to the chemical substances in 

articles. Therefore, EPA is also making 

inapplicable the exemption at 40 CFR 

721.45(f) for persons who import or 

process a chemical substance as part of 

an article. No commenter provided data 

or other information to undercut the 

factual basis for either decision. 

Neither TSCA nor the implementing 

regulations for SNURs establish a 

separate ‘‘compelling basis’’ standard, 

either with respect to the determination 

of a significant new use or with respect 

to the decision to make the exemption 

at 40 CFR 721.45(f) inapplicable. Nor 

have commenters identified a 

persuasive basis for EPA to adopt such 

a standard under either scenario. 

EPA’s specific action with respect to 

benzidine-based chemical substances is 

not, as commenters suggest, tantamount 

to the presumptive revocation of the 

SNUN submission exemption for 

importers and processors of chemical 

substances as part of articles in all 

future instances. EPA has not proposed 

to globally modify or eliminate the 

SNUR exemption for persons who 

import or process chemical substances 

as part of articles. EPA need not 

presently address the merits of an action 

it is not presently taking, and did not 

previously propose to take. 

TSCA sections 5(a)(2)(B) and (C) 

require EPA to consider the extent to 

which a new use ‘‘changes the type or 

form of exposure’’ or ‘‘increases the 

magnitude and duration of exposure’’ 

before making a determination that a 

particular use is a ‘‘significant new 

use.’’ EPA disagrees that it must 

therefore, as one commenter suggests, 

conduct a multiplicity of separate 

significant new use analyses whenever 

the use under consideration involves an 

article (i.e., one for each specific article 

or article category, comparing the 

relative significance of each particular 

article or article category). In particular, 

the commenter’s interpretation of TSCA 

section 5(a)(2) misconstrues the baseline 

against which the ‘‘newness’’ and the 

‘‘significance’’ of a significant new use 

are evaluated. As EPA has long 

maintained, the single analytical 

baseline is the set of uses that were 

ongoing ‘‘as of the date of publication’’ 

of the SNUR proposal. (See e.g., Ref. 1). 

Furthermore, the particular analytical 

standards the commenter suggests are 

not commensurate with the 

establishment of a one-time notice 

requirement intended to give EPA an 

opportunity to later evaluate the need 

for testing or other regulatory action 

under TSCA. Requiring upfront answers 

to the very questions EPA would 

evaluate after receiving a significant 

new use notice, as a pre-condition of 

requiring the notices, would undermine 

the statutory authorization to issue 

SNURs in the first place. EPA’s decision 

to propose a SNUR for a particular 

chemical use and to make the 

exemption at 40 CFR 721.45(f) 

inapplicable to that SNUR need not be 

based on an extensive evaluation of the 

hazard, exposure, or potential risk 

associated with that use. Rather, the 

Agency is acting because it has reason 

to anticipate that such use would raise 

important new questions related to the 

substance’s potential to threaten health 

or the environment, and that EPA 

should have an opportunity to consider 

those questions before such use could 

occur. Since the use designated as a 

significant new use does not currently 

exist, deferring a detailed consideration 

of potential risks or hazards related to 

that use is an effective use of resources. 

If a person decides to begin 

manufacturing or processing the 

chemical for the significant new use, in 

articles or otherwise, the notice to EPA 

allows EPA to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use. 

Even if it were appropriate to construe 

the decision to make the 40 CFR 

721.45(f) exemption inapplicable as a 

subcomponent of the significant new 

use determination under section 5(a)(2) 

(rather than as a subsequent 

determination), EPA adequately 

considered the section 5(a)(2) factors. 

The first factor is the ‘‘projected 

volume of manufacturing and 

processing of a chemical substance’’ 

(TSCA section 5(a)(2)(A)). EPA projects 

that these substances will not be 

manufactured or processed at any 

volume for the new uses in question and 

notes that for the newly proposed nine 

benzidine-based chemical substances, 

data reported to EPA for the 2012, 2006, 

2002, and 1998 reporting cycles, as 

required by the TSCA IUR rule, indicate 

no evidence of manufacture (including 

import) (Refs. 1 and 17). Any increase 

in the projected volume of 

manufacturing (including import) or 

processing of these substances, beyond 

the very limited uses currently ongoing, 

would reflect a significant departure 

from prior trends. Given that these 

chemical substances are anticipated to 

metabolize to the parent benzidine 

molecule, which is a known human 

carcinogen, EPA anticipates that 

information presented in the SNUN on 

the quantities manufactured (including 

imported) and processed of benzidine 

based chemical substances would be 

important to EPA’s overall evaluation of 

whether the new use may present an 

unreasonable risk to human health or 

the environment. The necessary 

increase in volume of this substance 

from any new use weighs in favor of 

determining that the new use is a 

significant new use. 

The second factor is ‘‘the extent to 

which a use changes the type or form of 

exposure of human beings or the 

environment to a chemical substance’’ 

(TSCA section 5(a)(2)(B)). For the newly 

added benzidine-based chemical 

substances, a general market review on 

mstockstill on DSK4VPTVN1PROD with RULES

77900 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

these chemical substances indicates no 

current manufacture within or outside 

the United States. Although some of the 

chemical substances subject to the 1996 

SNUR may still have certain limited 

ongoing uses (e.g., as a test reagent, lab 

standard, or microscopy stain), such 

uses are expected to be confined to 

limited laboratory or technical 

applications that are not expected to 

represent an appreciable amount of 

overall exposure. Furthermore, EPA did 

not find evidence of actual ongoing 

importation or domestic production for 

these uses. No comments provided 

evidence of ongoing manufacture 

(including import) or processing of 

these chemical substances as part of 

articles or otherwise. Thus, EPA 

believes that there is no, or almost no, 

current exposure to these chemical 

substances in the United States. 

Should a significant new use be 

planned, EPA anticipates that the new 

use would raise important new 

questions such as the following: 

• To what extent would the use be 

expected to involve dermal contact with 

the substance? 

• Would the substance be used in a 

setting where oral exposure is likely 

(e.g., would young children be able to 

mouth the article)? 

• How would potential occupational 

exposures and releases to the 

environment over the substance’s 

lifecycle be expected to be managed? 

Given that these chemical substances 

are anticipated to metabolize to the 

parent benzidine molecule, which is a 

known human carcinogen, EPA 

anticipates that the answers to such 

questions would be important to EPA’s 

evaluation of whether the new use may 

present an unreasonable risk to human 

health or the environment. The 

potential for a new use to change the 

type or form of exposure weighs in favor 

of determining that the new use is a 

significant new use. 

The third factor is ‘‘the extent to 

which a use increases the magnitude 

and duration of exposure of human 

beings or the environment to a chemical 

substance’’ (TSCA section 5(a)(2)(C)). 

Should one of the designated significant 

new uses be planned, EPA anticipates 

that the planned new use would raise 

important new questions relating to the 

concentration in which the substance 

would be used, the potential for 

repeated exposure, and the potential for 

continuous exposure. Given these 

chemical substances are anticipated to 

metabolize to the parent benzidine 

molecule, which is a known human 

carcinogen, EPA anticipates that the 

answers to these questions would be 

important to EPA’s overall evaluation of 

whether the new use may present an 

unreasonable risk to human health or 

the environment. EPA also notes that 

dermal exposure can occur from the 

leaching of the chemical substances by 

sweat in contact with the dyed textiles 

(Ref. 1). Because of this information, 

and the information described in Unit 

III.E. of the proposal (Ref. 1), EPA does 

not assume that new types or forms of 

exposure associated with new use of 

these substances would be insignificant 

merely because they relate to new use 

in an article or because the pertinent 

manufacturing or processing of the 

substance occurred as part of an article. 

The potential for activities related to a 

new use to increase the magnitude and 

duration of exposure weighs in favor of 

determining that any non-ongoing use is 

a significant new use. 

The fourth factor is ‘‘the reasonably 

anticipated manner and methods of 

manufacturing, processing, distribution 

in commerce, and disposal of a 

chemical substance’’ (TSCA section 

5(a)(2)(D)). EPA anticipates that any 

new use, beyond the very limited uses 

currently ongoing, would raise 

important new questions such as the 

following: 

• To what extent can the anticipated 

manufacturing, processing, distribution 

in commerce, and disposal of the 

chemical substance be expected to 

result in worker exposure, user 

exposure, or release of the chemical 

substance to the environment? 

• What potential controls are 

available to limit such releases? 

Given these chemical substances are 

anticipated to metabolize to the parent 

benzidine molecule, which is a known 

human carcinogen, EPA anticipates that 

the answers to these questions would be 

important to EPA’s overall evaluation of 

whether the new use ‘‘may present an 

unreasonable risk to human health or 

the environment.’’ The potential for 

manufacturing, processing, distribution 

in commerce or disposal of these 

benzidine-based chemical substances to 

change the overall exposure picture 

weighs in favor of determining that 

consumer textile use is a significant new 

use. 

After considering each of the four 

TSCA 5(a)(2) factors, EPA has 

concluded that the factors taken 

together weigh in favor of determining 

that manufacture or processing of these 

benzidine-based chemical substances 

for any non-ongoing use would be a 

significant new use such that the 

Agency should have an opportunity to 

analyze the new use before such use 

(and potential exposures) occurs. This 

determination would still hold even if 

one were to consider the 40 CFR 

721.45(f) exemption as a subcomponent 

of the significant new use determination 

under section 5(a)(2). 

D. Narrowing the Scope of SNURs 

Where the Exemption for Importers and 

Processors of Chemical Substances as 

Part of Articles Is Made Inapplicable 

Some comments suggest that 

significant new uses should not be 

‘‘open-ended’’ but instead must be 

targeted to specific articles, particularly 

in cases where the exemption at 40 CFR 

721.45(f) is made inapplicable. The 

concern expressed is that if the SNUN 

applies to ‘‘any use of a substance, then 

regulated parties and the EPA would be 

obligated to proceed through the SNUR 

process for an article that would have 

little relevance to the perceived hazard 

that drove the original SNUR.’’ The 

commenter further writes that ‘‘openended article SNUR’s can trigger 

reviews for articles that may have no 

relationship to the hazard or exposure 

concerns that motivated EPA’s decision 

to initiate the rule.’’ 

EPA’s concern with these benzidinebased dyes is not limited to certain 

exposure pathways to specific articles. 

EPA’s concern is specific to the 

benzidine-based dyes and thus to the 

range of exposures that could occur for 

these chemical substances. The 

preamble of the proposed rule notes 

multiple potential routes and sources of 

exposure including inhalation, skin 

absorption via dyed textiles, and 

ingestion. (Ref. 1). Furthermore, SNURs 

need not be narrowly focused on the 

mitigation of currently foreseeable 

exposure scenarios—it is proper that 

they will also ensure EPA has timely 

notice of future (and currently 

unforeseeable) exposure scenarios. An 

additional requirement to make targeted 

predictions of the particular uses that 

‘‘may be proposed in the future’’ would 

undermine this intended function of the 

SNUR. 

More generally, an exhaustive list of 

all applications that could possibly fall 

within the ambit of a significant new 

use definition is not a prerequisite for 

issuing a SNUR. Since the significant 

new use does not currently exist, 

deferring a detailed consideration of 

potential risks related to the importation 

or processing of these chemical 

substances (including as part of articles) 

is an effective use of resources. If a 

person decides to begin importing or 

processing the chemical, as part of an 

article or otherwise, the notice to EPA 

allows EPA to evaluate the significant 

new use according to the specific 

parameters and circumstances 

surrounding that intended use. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77901 

E. EPA Should Have a Reasonable Basis 

To Conclude That Identified Articles 

Would Be Distributed in the United 

States 

One comment states that ‘‘EPA 

presents an exposure-based rationale for 

why certain articles could be a concern, 

but indicates that there is no current 

expectation that these chemical 

substances will be used in such 

articles.’’ The commenter believes that 

before issuing an article SNUR, EPA 

should have a reasonable basis to 

conclude that identified articles of 

concern would be distributed in the 

United States. The commenter contends 

that EPA should identify an article 

containing such a chemical that is 

currently in global commerce and 

explain why it is likely to be distributed 

in the United States. The commenter 

believes that it might also be possible to 

identify an article at the research and 

development stage that is likely to 

proceed to commercial development. 

Without such findings, however, the 

commenter is concerned that EPA 

would be issuing an article SNUR for a 

situation that presents no current or 

likely future threats to health or the 

environment, and thus that the rule 

would be a waste of public resources. 

Another comment raises similar issues, 

arguing that EPA should provide even 

more specific information on how the 

significant new uses contribute to risk. 

Alternatively, the first commenter 

suggests that EPA include a specific 

provision suspending enforcement of 

the SNUR until a determination is made 

that there is a reasonable basis to believe 

that an article containing the specific 

chemical had been, or would be, 

distributed in the United States. 

EPA disagrees with the suggestion to 

limit the application of SNUN 

submission requirements for importers 

and processors of the chemical 

substances as part of articles to 

situations where importation or 

processing as part of an article is known 

to be imminent. SNURs address 

situations in which EPA is concerned 

about the potential for use to commence 

without prior opportunity for review 

and risk management action where 

appropriate. For purposes of SNURs, 

EPA cannot be expected to predict 

specific situations where new uses may 

be imminent, or how those specific uses 

may contribute to risk, before 

designating significant new uses. The 

purpose of a SNUR is to obtain such 

information so that EPA can evaluate 

risks associated with, and take risk 

management action where appropriate 

regarding, any notified activities. These 

rules serve the important function of 

alerting EPA when a significant new use 

is intended. Without them, EPA would 

have no expectation of timely 

identification of new uses of these 

chemicals. Notice relating to the import 

or processing of articles is particularly 

important in this case, as the proposal 

specifically identified a concern related 

to the potential for dermal exposure via 

dyed articles (i.e., from the leaching of 

the benzidine-based chemical 

substances by sweat in contact dyed 

articles, such as textiles). (Ref. 1). 

It would not be an efficient use of 

government resources for EPA to 

continually monitor global commerce to 

try to predict which chemicals are about 

to be imported as part of articles (but 

have not yet been imported) into the 

United States. Persons who wish to 

manufacture (including import) or 

process these chemical substances for a 

significant new use, as part of an article 

or otherwise, are in a better position 

than EPA to evaluate when they are 

about to initiate a particular significant 

new use. 

Given that SNURs cannot be issued 

for ongoing uses, the commenter’s 

suggestion (that EPA must itself make 

an upfront demonstration that a 

particular new use is about to begin, to 

secure the opportunity to be notified of 

when significant new uses involving 

importation or processing of chemical 

substances as part of articles are about 

to begin) is impracticable. It would 

likely result in a scenario in which an 

otherwise significant new use would be 

allowed to commence prior to the 

issuance of a SNUR proposal, thereby 

placing that use outside of EPA’s SNUR 

authority. Furthermore, EPA has already 

considered and rejected (in 2006, 

following public comment on a 2004 

proposal) the position that it must defer 

revocation of the 40 CFR 721.45(f) 

exemption for a SNUR until it appears 

likely ‘‘that these chemical substances 

will be imported as part of 

articles.’’(Ref. 18). EPA concluded in 

2006, after a re-evaluation of the issue 

prompted by public comments, that ‘‘if 

the subject substances when imported 

as a part of articles are not subject to the 

SNUR, EPA could miss the opportunity 

to obtain notifications that would 

provide information of potential 

regulatory and assessment value.’’ (Ref. 

19)(ultimately declining to make the 

exemption inapplicable, based on a 

separate concern that the use with 

respect to articles appeared to be 

already ongoing). 

Finally, for essentially the same 

reasons as set forth in this unit, EPA 

believes it would be inappropriate to 

follow one commenter’s alternative 

suggestion: To promulgate a SNUR 

without the exemption for importers 

and processors of chemical substances 

as part of articles, while somehow 

‘‘suspending enforcement’’ until the 

precise moment that manufacture or 

processing for a significant new use as 

part of an article is about to begin, but 

has not yet begun. 

In sum, EPA believes commenter’s 

suggestions would turn the regulatory 

process on its head. EPA would likely 

need to already have a SNUR in place 

in order to obtain the kind of timely 

information about significant new use 

that the commenter asserts should be 

prerequisite to issuing the SNUR in the 

first place. 

F. Intended Coverage of the BenzidineBased Chemical Substances SNUR 

1. Comment. One commenter writes 

that ‘‘A proposed rule offering a clear 

explanation of what uses EPA intends to 

cover, including an explanation of the 

alternatives if certain situations are 

unclear, will greatly increase the 

chances that useful information about 

business practices and common terms of 

art in an industry will be identified.’’ 

EPA should define the scope of the uses 

to be regulated as clearly and precisely 

as possible. 

The commenter also contended that 

soliciting public comment on the 

appropriate scope of new uses to be 

regulated, for a specific chemical 

substance, constitutes ‘‘an abdication of 

the role that EPA should be 

undertaking.’’ The commenter suggests 

that before soliciting public comments, 

EPA should have first pursued an 

informal coordination with downstream 

industries and (as necessary) an exercise 

of its ‘‘ample authority under TSCA, 

either through regulatory action under 

section 8 or order authority under 

section 11(c).’’ Finally, the commenter 

suggests that to the extent the proposed 

significant new uses admit ambiguity or 

potential need for adjustment in 

response to public comment, that is 

evidence that EPA ‘‘should have learned 

more about the uses’’ before issuing the 

proposal and is improperly seeking ‘‘to 

shift the responsibility to stakeholders.’’ 

Response. The description of the 

scope of the significant new uses in the 

benzidine-based chemical substances 

proposed SNUR and the Agency’s basis 

for the proposal were explicit. The 

SNUR proposal fairly apprised 

stakeholders as to the chemical at issue 

and the particular concerns driving the 

proposed action. It further indicated 

that based on information available to 

EPA, the significant new uses identified 

are not currently on-going. Stakeholders 

had an opportunity to oppose any of 

these preliminary findings by supplying 

mstockstill on DSK4VPTVN1PROD with RULES

77902 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

countervailing information thorough the 

rulemaking process itself. Grafting 

additional pre-proposal steps onto the 

SNUR rulemaking process would be 

unnecessarily time-consuming and an 

unsound use of agency resources. The 

timelier, less resource-intensive, and 

more transparent process is for 

interested stakeholders, through the 

public comment process itself, to simply 

provide any pertinent countervailing 

information they wish to add to the 

initial collection of information EPA 

presented in the proposal. 

As noted earlier, TSCA section 5(a)(2) 

does not compel nor contemplate an 

article by article analysis to identify 

every conceivable significant new use of 

a chemical substance. EPA evaluates 

whether a new use is ‘‘significant’’ 

consistent with the evidence of 

Congressional intent underlying the 

enactment of TSCA. See H.R. Rep. No. 

94–1341 at 24 (1976) (‘‘[B]ecause of the 

nature of a substance, it is possible that 

any new use of it will be significant. 

Thus, a potentially dangerous substance 

which is manufactured for a particular 

use may, if manufactured for a different 

use present additional health or 

environmental problems and 

consequently there should be notice of 

the intent to manufacture it for such 

different use.’’ H.R. Rep. No 94–1679 at 

66 (1976) (‘‘[T]he conferees intend that 

any potential threats to health or the 

environment from the manufacture, 

processing, distribution in commerce, or 

disposal of a substance associated with 

a new use be considered by the 

Administrator when determining the 

significance of a new use.’’) Finally, a 

broad construction of the significant 

new use is particularly appropriate 

where (as in the case of benzidine-based 

dyes) any increase in the projected 

volume of manufacturing (including 

import) or processing of these 

substances, beyond the very limited 

uses currently ongoing, would reflect a 

significant departure from prior trends. 

2. Comment. ‘‘It does not make sense 

to issue article SNUR’s [sic] for full size 

machines or structures. An article SNUR 

should focus on the specific 

components of more complex machines 

or structures that involve the chemical 

of concern.’’ 

Response. The commenter neither 

explains what the commenter means by 

‘‘full size,’’ nor offers any specific 

evidence to support their general view 

that new uses of chemical substances in 

‘‘full size machines or structures,’’ are 

any less likely to be significant than 

new uses of chemical substances in 

‘‘specific components.’’ Nor does the 

commenter indicate why persons who 

import or process chemical substances 

as part of articles would be more likely 

to be importing or processing the 

chemical substances for use in ‘‘full 

size’’ articles. Attempting to define and 

distinguish between ‘‘full size’’ article 

uses and other uses, and correlating 

such distinctions to whether persons are 

importing or processing these chemical 

substances as part of articles, would 

delay the rulemaking and increase its 

complexity, in a manner that does not 

seem warranted on the basis of the 

limited information supplied in the 

comment. 

3. Comment. ‘‘Chemicals used in 

articles may sometimes be incorporated 

into ’internal’ mechanisms of the article 

that are unlikely to come into contact 

with people or be released into the 

environment during normal use of the 

article.’’ 

Response. The commenter does not 

explain why the basis for a SNUR 

should be limited to those exposures 

that occur concurrent with the article 

fulfilling its intended function, when 

TSCA section 5(a)(2)(D) contemplates 

that EPA will consider the value of 

ensuring it has a future opportunity to 

review the whole life-cycle impact (e.g., 

‘‘manufacturing, processing, 

distribution in commerce, and 

disposal’’) of a significant new use of a 

chemical substance. The exposure to the 

chemical substance, including when it 

is in an article, may be larger during 

disposal or recycling than during the 

‘‘normal use’’ of the chemical. Further, 

chemical substances that are ‘internal’ 

to an article may still result in exposure 

if the chemical substance has certain 

physical- chemical properties (e.g., a 

relatively volatile chemical used as a 

plasticizer in interior automobile parts) 

or due to abrasion of the article (e.g., a 

dye incorporated into furniture 

covering.) 

Nor does the commenter indicate why 

persons who import or process chemical 

substances as part of articles would be 

more likely than any other 

manufacturers or processors to be 

manufacturing or processing for use in 

the internal mechanisms of articles. 

Attempting to define and meaningfully 

distinguish between ‘‘internal’’ article 

uses and other uses, and correlating 

such distinctions to whether 

manufacturing or processing of the 

substance occurs as part of an article, 

would delay the rulemaking and 

increase its complexity, in a manner 

that does not seem warranted on the 

basis of the limited information 

supplied in the comment. 

4. Comment. ‘‘EPA should clarify 

whether the SNUR applies to articles 

containing the chemical of concern in a 

solid, liquid, particle or gaseous form.’’ 

Response. This SNUR applies to the 

chemical substances regardless of form. 

To the extent the commenter seeks to 

continue some aspect of the exemption 

at 40 CFR 721.45(f), depending on the 

form of the chemical substance in the 

article that is being imported or 

processed, the commenter has not 

offered any specific support for that 

proposition, either generally or in any 

particular case. In the SNUR at issue, 

EPA does not believe it is prudent to 

limit the application of the rule based 

on the form (solid, liquid, or gaseous) of 

the chemical substances at issue. 

Chemicals that may have been used in 

one form during the manufacture of the 

article may be released from the article 

in a different physical form. Also, fluids 

and particles are not covered under the 

applicable definition of article at 40 CFR 

704.3. EPA received no comments 

suggesting that use of these chemicals in 

one form or another may not be 

significant based on the TSCA section 

5(a)(2) factors. Moreover, information 

relevant to a specific form of a chemical 

substance can be submitted in a SNUN 

and may be considered by EPA in 

review of that SNUN in determining 

whether follow-up action is warranted, 

and may support EPA’s amendment of 

the SNUR to limit its scope. 

5. Comment. ‘‘[A] chemical may be 

present at a very low concentration that 

is unlikely to be associated with a risk 

warranting EPA risk management 

action. . . . EPA should consider 

whether it can establish a de minimus 

exclusion [from the SNUR].’’ 

Response. EPA notes that the SNUR 

already contains a general exemption for 

unintentionally present impurities at 40 

CFR 721.45(d). To the extent chemical 

substances are intentionally added to 

articles at very low concentrations, the 

question of whether the substance 

warrants risk management action is one 

that EPA can address upon receipt of 

the SNUN, not an analytical prerequisite 

to deciding whether it should receive 

the SNUN in the first place. 

G. Screening for Benzidine-Based 

Chemical Substances 

Some commenters faulted the 

proposal for not identifying precise 

screening operations to be taken in 

response to the SNUR, and for not 

conducting additional analyses of the 

cost and feasibility of such screening 

operations. One commenter suggests, in 

particular, that an article importer 

should be deemed in compliance with 

the SNUR if the chemical is present 

below an established de minimis level 

(based on mass or concentration), or if 

it simply does not know the article’s 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77903 

2The limiting clause in the definition of 

‘‘principal importer’’ at 40 CFR 721.3—‘‘knowing 

that a chemical substance will be imported’’—is a 

limit based on the person’s knowledge that he or 

she is engaged in an import transaction, not a limit 

based on the person’s knowledge of a particular 

chemical’s identity and regulatory status. (48 FR 

21727, May 13, 1983) (FRL 2998–5). 

content after conducting a reasonable 

inquiry for such information. 

With respect to processors, given the 

requirements of 40 CFR 721.5(a)(2), a 

processor of the chemical substance 

should have received notification that 

the chemical substance is the subject of 

a SNUR. A processor is not required to 

submit a SNUN for its unknowing 

processing of a chemical substance 

subject to a SNUR if (upon obtaining 

knowledge) the processor can document 

that when the past processing occurred, 

the processor neither knew the chemical 

identity of the substance it was 

processing nor knew that substance was 

subject to a SNUR. See 40 CFR 721.5(c). 

EPA would generally expect that 

processors would only fail to be aware 

of the presence of a chemical subject to 

a SNUR if the manufacturer (including 

importer) or upstream processor of the 

chemical substances failed to meet their 

obligations under 40 CFR 721.5(a)(2). 

With respect to importers, EPA 

disagrees that it would be appropriate or 

necessary for the SNUR itself to define 

screening procedures to be employed for 

compliance purposes. The Agency did 

not propose to require a particular 

screening procedure and, for the 

following reasons, it does not agree that 

particular screening procedures should 

be specified and incorporated into the 

final rule. 

First, EPA believes that adding these 

sort of screening-effort exemptions, 

specifically for importers of chemical 

substances as part of articles, would be 

especially difficult to reconcile with the 

general statutory prohibition (under 

TSCA section 5(a)(1)) on manufacturing 

or processing a chemical substance for 

a significant new use without prior 

notice to EPA. The issue under the 

statute is whether or not an importer 

actually imports a substance. This is a 

separate question from the importers’ 

level of knowledge or level of effort to 

obtain knowledge respecting the content 

of the imports.2 With respect to SNURs, 

EPA notes that its direct rulemaking 

authority is to identify significant new 

uses under section 5(a)(2). The Agency 

has been appropriately cautious in 

exercising its implicit rulemaking 

authority to limit the applicability of 

section 5(a)(1). EPA recognizes that it 

did previously exercise such implicit 

rulemaking authority when establishing 

40 CFR 721.45(f). However, as noted in 

this unit, the exemption at 40 CFR 

721.45(f) was established along with a 

broad reservation of authority to 

withdraw the exemption where, as here, 

it is inaccurate to assume that there 

would not be exposure to the substance 

simply because it is present as part of 

an article. And a screening-effort 

exemption is especially difficult to 

reconcile with the statute in the case of 

importers. With importers, unlike with 

processors, there are no upstream 

entities with a duty under TSCA to 

notify importers of the presence of a 

chemical substance subject to a SNUR. 

Second, establishing a safe-harbor for 

importers based on lack of knowledge 

would create incentives for foreign 

suppliers to deliberately withhold 

information from importers. This could 

greatly reduce the efficacy of this SNUR. 

Currently, when an importer wishes to 

import a substance it knows would be 

subject to notification requirements, but 

for which the chemical identity is 

claimed as CBI by a foreign 

manufacturer, EPA’s longstanding 

practice when reviewing PMNs and 

SNUNs is to accept the relevant 

information on chemical identity 

directly from the foreign manufacturer. 

See, (Ref. 7)(‘‘[t]he principal importer 

need not know the specific chemical 

identity of the imported substance’’ and 

‘‘may have its foreign manufacturer or 

supplier, or some other person, report 

the chemical identity to EPA.’’) Offering 

an outright regulatory exemption to an 

importer simply because it is ignorant of 

the existence of a SNUR-regulated 

substance in the imported article (after 

conducting a prescribed inquiry) would 

allow foreign suppliers to short-circuit 

this process simply by refusing to 

divulge to the importer whether the 

import contains a chemical substance 

subject to SNUR. 

Third, to the extent the chemical 

substance subject to the SNUR is only 

‘‘unintentionally present’’ at the point of 

foreign manufacture, it is already 

exempt from reporting by the importer 

as an imported impurity. See 40 CFR 

721.3 (chapeau), 40 CFR 720.3(m), and 

40 CFR 721.45(d). Thus, importers are 

not required to submit a SNUN for a 

substance based simply on that 

substance’s presence as an impurity 

(i.e., a chemical substances 

unintentionally present with another 

chemical substance). 

Fourth, whether and how it may 

appropriate for importers to screen for 

benzidine-based chemical substances 

will depend on many factors, including 

their current state of knowledge about 

the articles that they import and the 

potential risk of unknowingly importing 

articles that contain these chemical 

substances. The relevant factors are 

largely impossible for EPA to establish 

at this time, given that there is currently 

no on-going import of these substances 

for the designated significant new uses. 

Finally, EPA did conduct additional 

analysis of potential screening burden to 

explore commenters’ concerns. As 

described in Unit X.H., EPA 

acknowledges the costs of the various 

activities that certain entities may 

choose to undertake, in response to this 

rule, to ensure that the chemicals they 

import or process as part of articles do 

not trigger SNUN submission 

requirements (Ref. 20). Based on EPA’s 

economic analysis and the responses to 

the proposed rule, EPA does not believe 

that these costs will be significant for 

any individual entity. 

H. Costs Associated With Making the 

Exemption for Persons That Import or 

Process Chemical Substances as Part of 

Articles Inapplicable 

Some comments note that the 

economic analysis, which focuses on 

the cost of filing a SNUN, does not 

include any analysis of the costs that 

might be associated with screening 

articles to determine whether these 

SNURs would apply. One comment also 

notes that ‘‘the preambles to the 

proposed rules do not discuss what, if 

any obligations companies have to 

screen articles for the chemicals 

included in the SNUR’s.’’ 

With respect to processors: existing 

SNUR regulations already provide that 

the unknowing processing of a chemical 

substance does not itself trigger SNUN 

requirements if the processor can (upon 

obtaining knowledge) document that 

when the past processing occurred, the 

processor neither knew the chemical 

identity of the substance it was 

processing nor knew that substance was 

subject to a SNUR. See 40 CFR 721.5(c). 

With respect to importers: Based on 

an assessment of current market activity 

in the economic analysis, EPA believes 

that the chemicals subject to the final 

SNUR are not currently being imported 

into the United States for the identified 

significant new uses in articles. EPA 

received no public comments on the 

proposed SNUR that indicate that 

importation of these benzidine-based 

chemical substances for the finalized 

significant new uses, in articles or 

otherwise, is ongoing. However, because 

this SNUR makes inapplicable the 

exemption for persons that import or 

process chemical substances as part of 

articles, companies may take actions to 

ensure that they do not import any 

articles containing the subject chemical 

substances after promulgation of this 

rule, by such means they deem 

mstockstill on DSK4VPTVN1PROD with RULES

77904 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

appropriate. This is not necessarily a 

new consideration for importers given 

that importers of mixtures have needed 

to be aware of chemical substances 

subject to a SNUR that may be a 

component of imported mixtures. 

Whether and how companies respond 

will depend on many factors, including 

their current state of knowledge about 

articles that they import and their own 

assessments of the potential risk of 

unknowingly importing articles that 

contain these chemicals. As noted in 

this unit, EPA did conduct additional 

analysis of burdens that may be 

associated with activities entities may 

undertake to ensure the chemicals they 

import or process as part of articles do 

not trigger SNUN submission 

requirements (Ref. 20). 

In any event, EPA did not propose to 

mandate any particular level of 

screening of imported or processed 

articles. The preamble to the proposed 

SNUR did not discuss the precise steps 

that an importer or processor must take 

in this regard because there is no precise 

level of screening by which the 

manufacturer or processor could be 

separately liable under the rule (if not 

performed) or by which a manufacturer 

or processor could obtain ‘‘safe harbor’’ 

from what would otherwise be a 

violation of the rule. While EPA might 

potentially take screening practices into 

consideration when evaluating a 

particular instance in which the SNUR 

was nevertheless violated, that would be 

as a matter of enforcement policy, not as 

a provision of the rule itself. 

EPA has included estimates for some 

activities that importers may undertake 

(e.g., supplier inquiries) in order to 

evaluate the likelihood of chemicals 

being imported as part of articles. These 

costs will vary for individual companies 

and their experience with suppliers. 

Awareness of article components and 

constituents is becoming more 

commonplace as companies frequently 

operate on a global scale and are subject 

to numerous regulatory requirements 

around the world that affect product 

stewardship responsibilities. Existing 

requirements that may compel a 

company to investigate an article’s 

components include the Consumer 

Product Safety Act, California’s 

Proposition 65, and the EU’s regulation 

on Registration, Evaluation, 

Authorization and Restriction of 

Chemical (REACH), which requires 

customer notification about the 

presence of certain chemical in articles 

that a company distributes. U.S. 

importing companies may already be 

familiar with the process of determining 

whether the articles they import contain 

restricted chemical substances, if they 

are subject to the requirements cited 

above or various U.S. regulations, such 

as the Product Safety Improvement Act 

(CPSIA) of 2008, Washington’s 

Children’s Safe Product Act, and 

Maine’s Act to Protect Children’s Health 

and the Environment from Toxic 

Chemicals in Toys and Children’s 

Products (Ref. 20). 

Given the existing regulatory 

limitations on certain chemicals both 

internationally and within the United 

States, regulated industries have begun 

to develop industry-wide processes and 

other resources to obtain information on 

chemical substances in articles. Policies 

and procedures could include supplier 

agreements, such as Hewlett Packard’s 

requirement that suppliers meet their 

General Specifications for the 

Environment (GSE) (Ref. 21) and 

Walmart’s requirement that suppliers 

participate in International Compliance 

Information Exchange (iCiX) to manage 

and share compliance information 

throughout the supply chain (Ref. 22). 

More extensive policies and procedures 

could even include product testing. 

Companies may choose to use existing 

procedures or develop new ones that 

could range from document review, to 

supplier agreements, to product testing. 

Additional analysis conducted by 

EPA on activities that companies may 

choose to undertake to ensure that the 

chemicals they import or process as part 

of articles do not trigger requirements of 

the SNUR shows a wide range of 

potential activities and associated costs. 

The conduct of these activities and 

associated costs are at the discretion of 

the company. Table B of this unit shows 

EPA’s estimated range of costs 

associated with some of these potential 

activities for importers of articles. 

TABLE B—RANGE OF COSTS ASSOCIATED WITH AN IMPORTER’S IDENTIFICATION OF CHEMICALS SUBJECT TO SNURS IN

ARTICLES

Activity Cost US 

($) Notes 

Per Rule Costs 

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

2. Identify the type of imported articles that potentially contain the restricted 

substances.

$130 to $1,550 ................... Actual costs may vary based on number of articles imported and the complexity of 

the article itself (number of components). 

3. Identify all suppliers involved.$950 ................................... Actual costs may vary depending on the number of articles imported, number of 

suppliers, and frequency of supplier changes. 

6. Recordkeeping ................. $10 ..................................... Cost typically already included in SNUR Economic Analyses. 

Article-Related Costs 

4. Collect data from suppliers.$5 to $515 per article reviewed. $0 if no data collected Actual costs only apply to those companies that choose to collect data from suppliers. They will vary depending on the specific data collection method chosen. 

Total costs depend on considerations including the number of articles imported, 

number of suppliers, and frequency of supplier changes. 

5. Chemical testing .............. $130 per article tested. $0 

if no testing. 

Actual costs only apply to those companies that choose to collect data from suppliers. Total costs per company will depend on considerations including the number of articles tested, which may be affected by the number of suppliers and risk 

associated with each, and frequency of supplier changes. 

Should processors of articles need to 

demonstrate compliance with a SNUR, 

it is expected that they could use the 

shipping or labeling documents 

received with the article in the ordinary 

course of business. As these documents 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77905 

would be received and stored anyway, 

as per standard business practices, the 

elimination of the exemption in the 

SNUR for persons that import or process 

chemical substances as part of articles 

would be unlikely to lead such persons 

to incur significant additional costs. To 

the extent that processors choose to 

undertake more steps to identify 

regulated chemicals as part of articles, 

the costs of these activities would be 

similar to those in Table B of this unit 

for importers of similar size, supply 

chain complexity, and level of 

compliance with other chemical 

regulations. 

There are a number of regulations, 

including California’s Proposition 65 

and the EU’s REACH that currently 

restrict or otherwise affect the use of 

certain benzidine-based substances, 

particularly in their use as dyes in 

textiles and leather. California’s 

Proposition 65 Chemical List includes 

benzidine-based dyes as a potential 

carcinogen and requires that firms 

provide a clear and reasonable warning 

before knowingly and intentionally 

exposing anyone to a listed chemical. 

This warning may include the labeling 

of consumer products (Refs. 23–24). 

The EU has banned, in textile and 

leather articles which may come into 

direct and prolonged contact with 

humans, the use of azo dyes which can 

break down to release any of 22 listed 

carcinogenic aromatic amines 

(including benzidine and its congeners) 

in amounts above 30 ppm (Ref. 25). The 

European Commission’s Directorate 

General for Health and Consumers 

maintains the RAPEX database that 

member countries can use to report 

dangerous products and the measures 

they have taken to prevent or restrict 

those products. Despite the EU ban, 

small numbers of products containing 

such azo dyes have recently been listed 

on RAPEX. The products are typically 

voluntarily withdrawn from the market 

and/or destroyed by the importer or 

have been placed under an order by the 

authorities to cease sales (Refs. 26, 27). 

Therefore, azo dyes in imported articles 

still remain a potential issue in the EU. 

Other countries have also banned the 

manufacture and use of the azo dyes in 

textiles. Currently the manufacture of 

azo dyes is banned in South Korea and 

Japan (Ref. 27). Use of these chemicals 

is banned by Egypt, India, China, South 

Korea, Taiwan and Vietnam (Ref. 28), 

and Indonesia has banned the use of the 

dyes in children’s and baby’s clothing 

(Ref. 29). In 2012, the Japanese textiles 

and leather industry announced 

voluntary restrictions of the chemicals 

(Refs. 29, 30). Canada has also expressed 

concern about the potential release of 

benzidine or its congeners from azo 

dyes and is evaluating potential 

approaches for addressing azo dyes (Ref. 

30). Organizations, such as the 

American Apparel & Footwear 

Association (AAFA), have developed a 

comprehensive Restricted Substances 

List (RSL) as a reference for companies 

and have developed a toolkit to help 

apparel and footwear companies to 

better manage chemicals throughout the 

supply chain. Given the current level of 

international and domestic regulation 

and attention to benzidine-related 

chemicals, EPA believes that importers 

and processors of articles may already 

have undertaken a number of activities 

to manage chemicals within their 

supply chains and generally to deselect 

for these chemicals. Therefore, EPA 

expects that companies that could 

potentially commence importing or 

processing benzidine-based chemicals 

as part of articles may already have 

some knowledge of the chemicals 

within their supply chain and would 

undertake few of the activities listed in 

Table B and would fall toward the lower 

end of the cost range for any activities 

undertaken. More detailed information 

is included in EPA’s economic analysis. 

EPA does not believe that the subject 

chemicals are entering the United States 

in imported articles for the significant 

new uses defined by the final 

regulation. However, companies may 

screen or initiate other activities to 

determine if articles they import in the 

future contain chemicals included in 

this SNUR. EPA notes that no 

commenters provided data that could be 

used to estimate what, if any, costs 

might be associated with continued 

assurance that imported articles are free 

from the chemical substances subject to 

this SNUR. The number of companies 

that may take such actions is not 

known, nor is the level of action that 

may be taken by a particular company. 

Based on EPA’s economic analysis and 

the responses to the proposed rule, EPA 

does not believe that these costs will be 

significant for any individual entity. 

I. Import and Export Regulations for 

Chemical Substances as Part of Articles 

One comment noted that EPA is not 

proposing to change the way in which 

TSCA’s export and import rules 

(pursuant to TSCA sections 12(b) and 

13, respectively) apply to articles 

containing these chemical substances. 

The comment indicates that (under the 

status quo of the import rules) the U.S. 

Customs and Border Protection (CBP) 

will not be screening articles for the 

chemical substances in the proposed 

SNURs. 

EPA agrees that the TSCA import 

rules are important TSCA compliance 

mechanisms and that 19 CFR 12.119 

allows EPA to establish section 13 

import certification requirements for 

chemicals in articles. However, 

declining to subject importers to one 

notice requirement (section 13 import 

certification) does not render another 

notice requirement (section 5 SNUN 

submission) unenforceable. 

In this case, EPA did not propose to 

require section 13 import certification or 

section 12 export notification for the 

subject chemical substances when part 

of articles. This is consistent with EPA’s 

past practice of making the exemption at 

40 CFR 721.45(f) inapplicable without 

also requiring import certification or 

export notification for these chemical 

substances as part of articles (40 CFR 

721.2800; 40 CFR 721.10068). However, 

the Agency continues to study this issue 

and has not ruled out a later proposal 

to require import certification and/or 

export notification for these chemical 

substances as part of articles. 

With or without an import 

certification requirement, it is the 

importer that is ‘‘responsible for 

insuring that chemical importation 

complies with TSCA just as domestic 

manufacturers are responsible for 

insuring that chemical manufacture 

compliance with TSCA.’’ 40 CFR 

707.20(b)(1). 

J. Distinguishing Between Chemicals in 

Non-Article Form and Other Products 

One comment contends that the rule, 

as proposed, ‘‘would not allow [EPA] to 

distinguish between a chemical being 

brought into the United States in its raw 

form and a chemical being brought in on 

a shift as a dye or finish.’’ The comment 

goes on to state that treating them the 

same way is unrealistic and 

scientifically unsound. 

EPA disagrees with the comment and 

notes that it was not proposing to 

eliminate all distinctions, in all 

regulatory provisions under TSCA, 

between import of a chemical substance 

in non-article form, and import of a 

chemical substance as part of an article. 

The rule simply removes one particular 

distinction between persons who import 

or process a chemical substance in nonarticle form and persons who import or 

process a chemical substance as part of 

an article. Thus, while the raw chemical 

manufacturer and the article importer 

may both be required to submit a SNUN, 

EPA would be able distinguish between 

the two scenarios, as appropriate, in its 

review of the SNUN. The SNUN review 

process will allow case-by-case analysis 

of each circumstance. 

mstockstill on DSK4VPTVN1PROD with RULES

77906 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

With respect to the commenter’s 

comparison of the volume at which 

these chemical substances are currently 

manufactured in non-article form and 

the volume at which these chemical 

substances are currently manufactured 

in article form (i.e., via import of a 

chemical substance as part of an article), 

EPA’s conclusion, with respect to the 

significant new uses, is that the two 

volumes are currently the same. This is 

because EPA has concluded that there is 

no current manufacture of these 

chemical substances for the significant 

new uses, either through domestic 

manufacture of the substances in nonarticle form, or through import of 

articles containing the substances. Thus, 

both production volumes are currently 

zero. 

K. Provisions for Processors 

In a comment submitted after the 

closing of the public comment period, 

one commenter questions the utility of 

a provision for processors at 40 CFR 

721.5(c), as applied to notice 

requirements under this rule. The 

commenter states that 40 CFR 721.5(c) 

would not protect companies unless 

they could document lack of knowledge 

that a SNUR applies. The commenter 

believes that this requirement is 

therefore impossible to meet, explaining 

that it is impossible to document what 

one does not know. 

EPA will respond to this comment, 

although it was submitted after the 

closing of the public comment period 

for this action, because it relates closely 

to the timely submitted comments. EPA 

disagrees that applying 40 CFR 721.5(c) 

is impossible or impracticable. The 

provisions at 40 CFR 721.5(c) provide 

that the unknowing processing of a 

chemical substance does not itself 

trigger SNUN submission requirements, 

subject to meeting certain 

documentation requirements. Upon 

obtaining knowledge that it previously 

engaged in activities covered by the 

SNUR, a processor can at that time 

assemble evidence relating to the period 

when the past processing occurred. 

Specifically, this would be evidence 

bearing on whether the processor 

previously knew the chemical identity 

of the substance it was processing or 

previously knew that that substance was 

subject to a SNUR. Evidence to establish 

a prior lack of knowledge could include 

items such as a purchase order and, 

where applicable, a material safety data 

sheet (MSDS) that indicates neither the 

relevant chemical identity nor the 

presence of a chemical subject to a 

SNUR. Another type of evidence would 

be the affidavit of a person in a position 

of appropriate authority swearing to the 

prior lack of knowledge. EPA would 

generally consider the wording on a 

purchase order and, where applicable, 

an MSDS, along with an affidavit as 

described above, in determining 

whether there is sufficiently clear 

documentation for purposes of 40 CFR 

721.5(c). However, if there was also 

contrary documentary evidence, 

indicative of the prior possession of 

knowledge (e.g., receipt of a notice 

given to the processor pursuant to 40 

CFR 721.5(a)(1)(i)) then the overall 

documentary evidence would not allow 

the processor to take advantage of the 

provisions of 40 CFR 721.5(c). 

L. Potential Ongoing Use of DnPP 

One commenter identified a potential 

ongoing use of DnPP in grease in 

automotive switches. The commenter 

requested that EPA exclude the 

identified use from the SNUR. 

After investigation, EPA has 

determined that there is no ongoing use 

of DnPP in grease in automotive 

switches. 

The commenter states that ‘‘[b]ased on 

current use information . . . [the 

commenter] believes that DnPP is being 

used in grease in some automotive 

switches.’’ The proposal stated that EPA 

‘‘welcome[d] specific information that 

documents [ongoing] use.’’ Yet the 

commenter does not provide any 

current use information to substantiate 

this belief. When raising a potential 

ongoing use, it is generally preferable to 

include information substantiating that 

use, especially where the entity raising 

that use is not an actual manufacturer 

(including importer) or processor of that 

chemical substance for that use and thus 

would not be anticipated to have direct 

knowledge of that use. 

In order to determine whether there is 

an ongoing use of DnPP in grease in 

automotive switches, EPA performed 

targeted searches of sources including 

IHS Chemical Economics Handbook, 

MSDS search tools such as Seton’s 

MSDS Hazard Communication Library 

and patent searches and was unable to 

substantiate this use as an ongoing use 

of DnPP. EPA reviewed several grease 

MSDS, and no grease MSDS listed any 

phthalate in its composition. EPA’s DfE 

alternatives analysis also has not 

identified use in grease in automotive 

switches as an ongoing use of DnPP. 

EPA also conducted patent searches 

for grease in automotive switches, and 

dampening greases in general. A patent 

search found mentions of the term 

phthalates with electronic components, 

but not DnPP specifically for automotive 

switches. However, one patent gave a 

very broad alkyl range that release of 

phthalates C4 and C8 were observed 

during the vacuum burn pretreatment of 

electronic components [disc drives]. 

This process is routine treatment to 

remove volatiles from electronic 

components, including electronic 

switches (Vacuum baking process USP 

6,051,169 and Electric switches USP 

3,694,601). EPA does not believe the 

existence of this information is 

indicative of current use of DnPP in 

grease in automotive switches because, 

patents do not necessarily indicate 

current use. As noted in the proposed 

rule (Ref. 1), no IUR production volume 

data were reported for DnPP during the 

2006, 2002, 1998 and 1994 reporting 

cycles. In addition, no production 

volume data were reported for the 2012 

CDR (Ref. 17) 

Accordingly, EPA is declining to 

exclude use ‘‘in grease in automotive 

switches’’ from the significant new uses 

of DnPP. 

M. Reliance on Inventory Update Rule 

(IUR) Data in Assessing Ongoing Use of 

DnPP 

One commenter suggests that EPA 

relied solely on the IUR data for 

determining ongoing uses of DnPP, and 

that such reliance may be misleading or 

incomplete. The commenter notes that 

ongoing uses below the IUR reporting 

threshold of 10,000 lbs would not be 

reported to EPA through the IUR 

process. 

EPA uses IUR data to identify ongoing 

uses of chemical substances. However, 

this is not the sole source of information 

relied upon to support the SNUR. EPA 

first identified a SNUR as a regulatory 

alternative for DnPP in the Phthalates 

Action Plan because EPA found that the 

most recent IUR data contained no 

reports of DnPP being produced in or 

imported into the United States. In 

proposing the SNUR, EPA prepared the 

‘‘Economic Analysis of the Proposed 

Significant New Use Rule for Di-npentyl Phthalate (DnPP)’’ (Ref. 31) and 

conducted internet queries in order to 

ascertain whether there were any 

ongoing uses of DnPP at levels below 

the IUR reporting threshold. During the 

course of this research EPA identified 

several companies which either use or 

sell DnPP as a chemical standard for use 

in phthalates testing. Accordingly, the 

significant new uses of DnPP does not 

include use of DnPP as a chemical 

standard for analytical experiments as a 

significant new use. 

N. Design for the Environment (DfE) 

Assessment for Phthalates 

One commenter noted that EPA has 

undertaken a DfE project focused on 

phthalates, including but not limited to, 

DnPP. The commenter believes that the 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77907 

DfE phthalates alternative assessment 

will provide valuable information about 

potential alternatives to industries using 

phthalates. The commenter 

recommends that EPA refrain from 

further action on any phthalate until the 

DfE project is finalized. 

EPA disagrees that finalization of the 

DnPP SNUR should be delayed until the 

DfE project is complete. (To the extent 

the comment is discussing the timing of 

other potential EPA actions to address 

phthalates, it is outside the scope of this 

proposal.) 

The comment states that the final DfE 

report would identify alternatives, their 

viability as substitutes, and EPA’s 

comparative hazard information. EPA 

disagrees that this report is likely to 

provide information relevant to this 

SNUR. When defining the ‘‘significant 

new use,’’ EPA is limited to uses of the 

chemical substance that are not ongoing. 

The DfE report is not expected to 

identify alternatives for chemical 

substances that are generally no longer 

in use. It is already clear that there are 

many alternatives to DnPP use, because 

there are almost no ongoing uses of 

DnPP. Furthermore, the DfE report is 

not expected to suggest DnPP itself as an 

alternative to another phthalate because 

of its toxicity relative to other 

phthalates. Even if the DfE report were 

to identify a significant new use of 

DnPP as an alternative to some other 

chemical substance, then EPA would 

have the opportunity to consider that 

information at such time as it received 

the significant new use notice for DnPP. 

EPA notes that it is a regular practice 

to finalize SNURs for chemical 

substances that have not undergone a 

DfE assessment. Given that the DfE 

report is unlikely to provide additional 

information relevant to EPA’s 

significant new use determination for 

DnPP, that newly available information 

respecting any particular use of DnPP 

could be included in the significant new 

use notice itself, and that further delay 

would increase regulatory uncertainty, 

EPA disagrees that it would be 

appropriate to delay issuance of the 

SNUR on DnPP pending the release of 

the DfE report. 

XI. References 

The following is a listing of the 

documents that are specifically 

referenced in this action. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are in the 

docket, even if the referenced document 

is not physically located in the docket. 

For assistance in locating these other 

documents, please consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

1. U.S. EPA. Proposed Rule; Benzidine-Based 

Chemical Substances; Di-n-pentyl 

phthalate (DnPP); and Alkanes, C12–13, 

Chloro; Significant New Use Rules. 77 

FR 18752, March 28, 2012 (FRL–8865–2). 

2. U.S. EPA. Benzidine-Based Chemical 

Substances; Significant New Uses of 

Certain Chemical Substances, 61 FR 

52287, October 7, 1996 (FRL–5396–6). 

3. U.S. EPA, 2010. U.S. Environmental 

Protection Agency. Chemical Substances 

Derived from Benzidine and Its 

Congeners, http://www.epa.gov/oppt/

existingchemicals/pubs/actionplans/

DCB%20Action%20Plan_

06232010.noheader.pdf (Accessed 

January 24, 2011). 

4. U.S. EPA. Economics and Policy Branch, 

USEPA/OCSPP/Economics, Exposure, 

and Technology Division. ‘‘Economic 

Analysis to Support the Final SNUR for 

Benzidine and Benzidine-based 

Chemical substances.’’ 

5. U.S. EPA. Significant New Uses of Certain 

Chemical Substances, 55 FR 17376, April 

24, 1990 (FRL–3658–5). 

6. U.S. EPA. Significant New Uses of 

Chemical Substances; Certain Chemicals. 

49 FR 35014, September 5, 1984 (FRL– 

2541–8). 

7. U.S. EPA. Premanufacture Notification; 

Premanufacture Notice Requirements 

and Review Procedures. 48 FR 21722, 

May 13, 1983 (FRL 2998–5). 

8. Testimony of James J. Jones, Acting 

Assistant Administrator Office of 

Chemical Safety and Pollution 

Prevention, U.S. Environmental 

Protection Agency before the Committee 

on Environment and Public Works and 

the Subcommittee on Superfund, Toxic 

and Environmental Health United States 

Senate, July 24, 2012, available at http:// 

www.epa.gov/ocir/hearings/pdf/2012_

jjones_testimony1.pdf. 

9. CPSC, 2011. Staff Briefing Package. 

Petition HP 10–2. Requesting Restriction 

of Cadmium in Toy Jewelry (Consumer 

Product Safety Commission (February 9, 

2011). Staff Report, Cadmium in 

Children’s Metal Jewelry. Toxicity 

Review of Cadmium. TAB B pp19–39 

http://www.cpsc.gov/PageFiles/96192/

cadmiumtoy.pdf (October 14, 2010). 

10. Danish Environmental Protection Agency, 

Survey of Chemical Substances in 

Consumer Products Survey No. 25 2003, 

Mapping the Liberation of Organic Tin 

Compounds in Mattress Pads, To 

Mattresses, and Baby/Junior Duvets. 

11. Stapleton, et al., 2008, Alternate and New 

Brominated Flame Retardants Detected 

in U.S. House Dust, Environ. Sci. 

Technol. 

12. CPSC Staff Preliminary Risk Assessment 

of Flame Retardant [FR] Chemicals in 

Upholstered Furniture Foam, December 

21, 2006. 

13. Muller, et al., 2011, Car Indoor Air 

Pollution—Analysis of Potential Sources, 

Journal of Occupations Medicine and 

Toxicology 2011, 6:33. 

14. Wu, et al., 2009, Residues of 

Polybrominated Diphenyl Ethers in 

Frogs (Rana limnocharis) from a 

Contaminated Site, South China: Tissue 

Distribution, Biomagnification, and 

Maternal Transfer, Environ. Sci. Technol. 

2009, 42: 5212–5217. 

15. Gaylor, et al. 2012, House Crickets Can 

Accumulate Polybrominated Diphenyl 

Ethers (PBDEs) Directly from 

Polyurethane Foam Common in 

Consumer Products, Chemosphere, 2012, 

86: 500–505. 

16. Covaci, et al. 2006, 

Hexabromocyclododecanes (HBCDs) in 

the Environment and Humans: A 

Review. Environ. Sci. Technol. 2006, 40: 

3679–3688. 

17. U.S. EPA, Chemical Data Access Tool 

(CDAT), http://java.epa.gov/oppt_

chemical_search/. 

18. U.S. EPA, Certain Polybrominated 

Diphenylethers; Proposed Significant 

New Use Rule. 69 FR 70409, December 

6, 2004 (FRL 7633–1). 

19. U.S. EPA, Certain Polybrominated 

Diphenylethers; Significant New Use 

Rule.71 FR 34018, June 13, 2006 (FRL 

7743–2). 

20. U.S. EPA, Understanding the Costs 

Associated with Eliminating Exemptions 

for Articles in SNURs, May 1, 2013. 

21. Hewlett-Packard Development Company, 

LP. (2010). ‘‘International Material Data 

System.’’ Retrieved from http://

www.mdsystem.com/. 

22. Wal-Mart. (2012). Become a Supplier: 

Requirements. Retrieved from http://

www.walmartstores.com/Suppliers/

248.aspx. 

23. CAEPA, 2013a. State of California 

Environmental Protection Agency. 

Chemicals Known to the State to Cause 

Cancer or Reproductive Toxicity. Office 

of Environmental Health Hazard 

Assessment, 04 February 2013. http://

oehha.ca.gov/prop65/prop65_list/files/

P65list020813.pdf. 

24. CAEPA, 2013b. State of California 

Environmental Protection Agency. 

Proposition 65 in Plain Language! 

Febuary 2013. http://oehha.ca.gov/

prop65/background/p65plain.html. 

25. European Commission. 2009. 

Commission Regulation EC No. 552/2009 

Commission Regulation (EC) No 552/

2009 of 22 June 2009 amending 

Regulation (EC) No 1907/2006 of the 

European Parliament and of the Council 

on REACH as regards Annex XVII. 

26. European Commission. 2010. RAPEX— 

Latest Notifications. Directorate General 

for Health and Consumers. http://

ec.europa.eu/consumers/dynex/rapex/

rapex_achives_en.cfm. 

27. IARC, 2012. International Agency for the 

Research on Cancer. IARC Monographs 

on the Evaluation of Carcinogenic Risks 

to Humans—Benzidine.Volume 100F: 

53–63. 

28. Textination, 2012. Textination ‘‘Textile 

and Apparel Weekly June, 8 2012’’. 

http://textination.de/en/tiw/2012/

TIW08062012.pdf. 

29. Intertek, 2013. Intertek, ‘‘Requirements of 

Azo dyes and Formaldehyde content in 

fabric for babies and children clothing in 

Indonesia’’ Jan 4, 2013. 

mstockstill on DSK4VPTVN1PROD with RULES

77908 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

30. HKTDC, 2012. HKTDC Research ‘‘Japan 

Industry Stipulates Voluntary AZO Dyes 

Standard for Textile and Leather 

Products’’ May 22, 2012. 

31. Environment Canada. 2009. Strategic 

options for the management of toxic 

substances benzidine and 3,3- 

dichlorobenzidine. Available at: http://

www.ec.gc.ca/toxics/docs/sor/bdine/EN/

sum.cfm (Accessed 10 September, 2009). 

32. U.S. EPA. Economics and Policy Branch, 

USEPA/OCSPP/Economics, Exposure, 

and Technology Division. ‘‘Economic 

Analysis of the Final Significant New 

Use Rule for Di-n-pentyl phthalate 

(DnPP).’’ 

33. U.S. EPA. Economics and Policy Branch, 

USEPA/OCSPP/Economics, Exposure, 

and Technology Division. ‘‘Economic 

Analysis of the Final Significant New 

Use Rule for Alkanes, C12-13, chloro (CAS 

RN: 71011–12–6).’’ 

34. U.S. EPA. Modification of Significant 

New Use Rules for Certain Substances, 

62 FR 42690, August 8, 1997 (FRL–5735– 

4). 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This final rule has been designated by 

OMB as a ‘‘significant regulatory action’’ 

under section 3(f) of Executive Order 

12866 (58 FR 51735, October 4, 1993). 

Accordingly, EPA submitted this action 

to OMB for review under Executive 

Order 12866 and 13563 (76 FR 3821, 

January 21, 2011), and any changes 

made in response to OMB 

recommendations are documented in 

the docket. 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

information collection burden under the 

PRA, 44 U.S.C. 3501 et seq. Burden is 

defined in 5 CFR 1320.3(b). The 

information collection activities 

associated with existing chemical 

SNURs are already approved by OMB 

under OMB control number 2070–0038 

(EPA ICR No. 1188); and the 

information collection activities 

associated with export notifications are 

already approved by OMB under OMB 

control number 2070–0030 (EPA ICR 

No. 0795). If an entity were to submit a 

SNUN to the agency, the annual burden 

is estimated to be less than 100 hours 

per response, and the estimated burden 

for an export notifications is less than 

1.5 hours per notification. In both cases, 

burden is estimated to be reduced for 

submitters who have already registered 

to use the electronic submission system. 

Additional burden, estimated to be less 

than 10 hours, could be incurred where 

additional record keeping requirements 

are specified under 40 CFR 721.125(a), 

(b), and (c). 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in Title 

40 of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9 and included on the related 

collection instrument, or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list this SNUR. This 

listing of the OMB control numbers and 

their subsequent codification in the CFR 

satisfies the display requirements of the 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. Since 

the existing OMB approval was 

previously subject to public notice and 

comment before OMB approval, and 

given the technical nature of the table, 

EPA finds that further notice and 

comment to amend the table is 

unnecessary. As a result, EPA finds that 

there is ‘‘good cause’’ under section 

553(b)(3)(B) of the Administrative 

Procedure Act, 5 U.S.C. 553(b)(3)(B), to 

amend this table without further notice 

and comment. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to section 605(b) of the RFA, 

5 U.S.C. 601 et seq., I hereby certify that 

promulgation of this SNUR will not 

have a significant economic impact on 

a substantial number of small entities. 

The rationale supporting this 

conclusion is as follows. 

EPA generally finds that proposed 

and final SNURs are not expected to 

have a significant economic impact on 

a substantial number of small entities 

(See, e.g., Ref. 34). Since these SNURs 

will require a person who intends to 

engage in such activity in the future to 

first notify EPA by submitting a SNUN, 

no economic impact will occur unless 

someone files a SNUN to pursue a 

significant new use in the future or 

forgoes profits by avoiding or delaying 

the significant new use. Although some 

small entities may decide to engage in 

such activities in the future, EPA cannot 

presently determine how many, if any, 

there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of SNURs covering 

over 1,000 chemical substances, the 

Agency receives only a handful of 

notices per year. During the six year 

period from 2005–2011, only three 

submitters self-identified as small in 

their SNUN submission (Refs. 5, 32, 33). 

EPA believes the cost of submitting a 

SNUN is relatively small compared to 

the cost of developing and marketing a 

chemical new to a firm and that the 

requirement to submit a SNUN 

generally does not have a significant 

economic impact. 

A SNUR applies to any person 

(including small or large entities) who 

intends to engage in any activity 

described in the rule as a ‘‘significant 

new use.’’ In the proposed SNUR EPA 

preliminarily determined, based in part, 

on the Agency’s market research, that 

these chemical substances are not being 

manufactured (including imported) or 

processed for a significant new use. In 

the case of the benzidine-based dyes, 

this preliminary determination also 

included importation and processing of 

these chemical substances as part of 

articles (Ref. 1). EPA received no public 

comment indicating any ongoing 

importation of the benzidine-based 

chemical substances as part of articles 

or otherwise. Therefore, EPA is 

finalizing its determination that these 

uses, including the importation and 

processing of benzidine-based dyes as 

part of articles, are new and not 

ongoing. Thus no small entities 

presently engage in a significant new 

use. 

Therefore, EPA believes that the 

potential economic impact of complying 

with this SNUR is not expected to be 

significant or adversely impact a 

substantial number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reason to 

believe that any State, local, or Tribal 

government would be impacted by this 

rulemaking. As such, EPA has 

determined that this regulatory action 

would not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise have any effect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of 

UMRA, 2 U.S.C. 1531–1538. 

E. Executive Order 13132: Federalism 

This action does not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77909 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications because it will not have 

any effect (i.e., there will be no increase 

or decrease in authority or jurisdiction) 

on Tribal governments, on the 

relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes. Thus, 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), does not apply to 

this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 (62 FR 19885, April 23, 

1997), because this action is not 

intended to address environmental 

health or safety risks for children. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not expected to 

affect energy supply, distribution, or 

use. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Since this action does not involve any 

technical standards, section 12(d) of 

NTTAA, 15 U.S.C. 272 note, does not 

apply to this action. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898 (59 FR 7629, 

February 16, 1994), because EPA has 

determined that this action will not 

have disproportionately high and 

adverse human health or environmental 

effects on minority or low-income 

populations. This action does not affect 

the level of protection provided to 

human health or the environment. 

K. Congressional Review Act (CRA) 

Pursuant to the CRA, 5 U.S.C. 801 et 

seq., EPA will submit a report 

containing this rule and other required 

information to the U.S. Senate, the U.S. 

House of Representatives, and the 

Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This action is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 16, 2014. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB Control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10226 ......................... 2070–0038 

721.10227 ......................... 2070–0038 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Revise § 721.1660 to read as 

follows: 

§ 721.1660 Benzidine-based chemical 

substances. 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The benzidine-based chemical 

substances listed in Table 1 and Table 

2 of this section are subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS or accession No. C.I. name C.I. No. Chemical name 

117–33–9 ..................... Not available .............. Not available .............. 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4’-[2-(4- 

hydroxyphenyl)diazenyl][1,1’-biphenyl]-4-yl]diazenyl]- 

65150–87–0 ................. Not available .............. Not available .............. 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[2-[4’-[2-(2-hydroxy-1- 

naphthalenyl)diazenyl][1,1’- biphenyl]-4-yl]diazenyl]-, lithium salt 

(1:3) 

68214–82–4 ................. Direct Navy BH .......... 22590 ......................... 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4’-[2-(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1’-biphenyl]-4- 

yl]diazenyl]-4-hydroxy-, sodium salt (1:2) 

72379–45–4 ................. Not available .............. Not available .............. 2,7-Naphthalenedisulfonic acid, 4-amino-5- 

hydroxy-3-[2-[4’-[2-[2-hydroxy-4-[(2- 

methylphenyl)amino]phenyl]diazenyl][1,1’- biphenyl]-4-yl]diazenyl]- 

6-(2-phenyldiazenyl)- 

Accession No. 21808 ..

CAS No. CBI (NA) 

CBI ............................. CBI ............................. 2,7-Naphthalenedisulfonic acid, 4-amino-5- 

hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. (generic name) 

mstockstill on DSK4VPTVN1PROD with RULES

77910 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 

TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued 

CAS or accession No. C.I. name C.I. No. Chemical name 

Accession No. 24921 ..

CAS No. 

CBI ............................. CBI ............................. 4-(Substituted naphthalenyl )azo diphenylyl azo-substituted 

carbopolycycle azo benzenesulfonic acid, sodium salt. (generic 

name) 

Accession No. 26256 ..

CAS No. CBI (NA) 

CBI ............................. CBI ............................. 4-(Substituted phenyl)azo biphenylyl azosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. 

(generic name) 

Accession No. 26267 ..

CAS No. CBI (NA) 

CBI ............................. CBI ............................. 4-(Substituted phenyl)azo biphenylyl azo - 

substituted carbopolycycle azo benzenesulfonic acid, sodium salt. 

(generic name) 

Accession No. 26701 ..

CAS No. CBI (NA) 

CBI ............................. CBI ............................. Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted 

benzene sodium sulfonate. (generic name). 

TABLE 2—BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS No. C.I. name C.I. No. Chemical name 

92–87–5 .................. Benzidine .............. Not available ......... [1,1′-Biphenyl]-4,4′-diamine. 

531–85–1 ................ Benzidine · 2HCl ... Not available ......... [1,1′-Biphenyl]-4,4′-diamine, dihydrochloride. 

573–58–0 ................ C.I. Direct Red 28 22120 .................... 1- Naphthalenesulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[4-amino-, 

disodium salt. 

1937–37–7 .............. C.I. Direct Black 38 30235 .................... 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diaminophenyl) azo][1,1′- 

biphenyl]-4- yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt. 

2302–97–8 .............. C.I. Direct Red 44 22500 .................... 1-Naphthalenesulfonic acid, 8,8′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[7-hydroxy-, disodium salt. 

2429–73–4 .............. C.I. Direct Blue 2 .. 22590 .................... 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4′-[(7-amino-1-hydroxy-3-sulfo-2- 

naphthalenyl)azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt. 

2429–79–0 .............. C.I. Direct Orange 

8.

22130 .................... Benzoic acid, 5-[[4′-[(1-amino-4-sulfo-2-naphthalenyl) azo][1,1′-biphenyl]-4- 

yl]azo]-2- hydroxy-, disodium salt. 

2429–81–4 .............. C.I. Direct Brown 

31.

35660 .................... Benzoic acid, 5-[[4′-[[2,6-diamino-3-[[8-hydroxy-3,6-disulfo-7-[(4-sulfo-1- 

naphthalenyl)azo]-2- naphthalenyl]azo]-5-methylphenyl]azo][1,1′- biphenyl]- 

4-yl]azo]-2-hydroxy-, tetrasodium salt. 

2429–82–5 .............. C.I. Direct Brown 2 22311 .................... Benzoic acid, 5-[[4′-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl) azo][1,1′- 

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt. 

2429–83–6 .............. Direct Black 4 ....... 30245 .................... 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diamino-5- 

methylphenyl)azo][1,1′-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)-, disodium salt. 

2429–84–7 .............. C.I. Direct Red 1 ... 22310 .................... Benzoic acid, 5-[[4′-[(2-amino-8-hydroxy-6-sulfo-1-naphthalenyl)azo][1,1′- 

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt. 

2586–58–5 .............. C.I. Direct Brown 

1:2.

30110 .................... Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4- 

sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4- yl]azo]-2-hydroxy-, disodium 

salt. 

2602–46–2 .............. C.I. Direct Blue 6 .. 22610 .................... 2,7-Naphthalenedisulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5- 

amino-4-hydroxy-, tetrasodium salt. 

2893–80–3 .............. C.I. Direct Brown 6 30140 .................... Benzoic acid, 5-[[4′-[[2,4-dihydroxy-3-[(4-sulfophenyl) azo]phenyl]azo][1,1′- 

biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt. 

3530–19–6 .............. C.I. Direct Red 37 22240 .................... 1,3-Naphthalenedisulfonic acid, 8-[[4′-[(4-ethoxyphenyl)azo][1,1′-biphenyl]-4- 

yl]azo]-7-hydroxy-, disodium salt 

3567–65–5 .............. C.I. Acid Red 85 ... 22245 .................... 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4′-[[4-[[(4- 

methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-, disodium 

salt. 

3626–28–6 .............. C.I. Direct Green 1 30280 .................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4′-[(4- 

hydroxyphenyl)azo][1,1′- biphenyl]-4- yl]azo]-6-(phenylazo)-, disodium salt. 

3811–71–0 .............. C.I. Direct Brown 1 30045 .................... Benzoic acid, 5-[[4′-[[2,4-diamino-5-[(4-sulfophenyl) azo]phenyl]azo][1,1′ 

biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt. 

4335–09–5 .............. C.I. Direct Green 6 30295 .................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4′-[(4- 

hydroxyphenyl)azo][1,1′-biphenyl]-4- yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt. 

6358–80–1 .............. C.I. Acid Black 94 30336 .................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4′-[[4-hydroxy-2-[(2- 

methylphenyl)amino]phenyl]azo] [1,1′- biphenyl]-4-yl]azo]-6-[(4-sulfophenyl) 

azo]-, trisodium salt. 

6360–29–8 .............. C.I. Direct Brown 

27.

31725 .................... Benzoic acid, 5-[[4′-[[4-[(4-amino-7-sulfo-1-naphthalenyl)azo]-6-sulfo-1- 

naphthalenyl]azo][1,1′-biphenyl]-4-yl] azo]-2- hydroxy-, trisodium salt. 

6360–54–9 .............. C.I. Direct Brown 

154.

30120 .................... Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4-sulfophenyl)azo]phenyl] 

azo][1,1′-biphenyl]-4-yl]azo]-2- hydroxy-3-methyl-, disodium salt. 

8014–91–3 .............. C.I. Direct Brown 

74.

36300 .................... Benzoic acid, 3,3′-[(3,7-disulfo-1,5-naphthalenediyl)bis [azo(6-hydroxy-3,1- 

phenylene)azo[6(or7)-sulfo-4,1-naphthalenediyl]azo[1,1′-biphenyl]-4,4′- 

diylazo]]bis[6-hydroxy-, hexasodium salt. 

16071–86–6 ............ C.I. Direct Brown 

95.

30145 .................... Cuprate(2-), [5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl] 

azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77911 

(2) The significant new uses are: 

(i) For each of the chemical 

substances listed in Table 2 of this 

section, any use other than use as a 

reagent to test for hydrogen peroxide in 

milk; a reagent to test for hydrogen 

sulfate, hydrogen cyanide, and nicotine; 

a stain in microscopy; a reagent for 

detecting blood; an analytical standard; 

and, additionally for Colour Index (C.I.) 

Direct Red 28 (Congo Red) (CAS No. 

573–58–0), an indicator dye. 

(ii) For the chemical substances listed 

in Table 1 of this section: Any use. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Revocation of certain notification 

exemptions. The provisions of 

§ 721.45(f) do not apply to this section. 

A person who imports or processes a 

chemical substance identified in 

paragraph (a)(1) of this section as part of 

an article for a significant new use 

described in paragraph (a)(2) of this 

section is not exempt from submitting a 

significant new use notice. 

(2) [Reserved] 

■ 5. Add § 721.10226 to subpart E to 

read as follows: 

§ 721.10226 Di-n-pentyl phthalate (DnPP). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

di-n-pentyl phthalate (DnPP) (1,2- 

benzenedicarboxylic acid, 1,2-dipentyl 

ester) (CAS No. 131–18–0) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new use is: Any 

use other than use as a chemical 

standard for analytical experiments. 

(b) [Reserved] 

■ 6. Add § 721.10227 to subpart E to 

read as follows: 

§ 721.10227 Alkanes, C12-13, chloro (CAS 

No. 71011–12–6). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C12-13, chloro (CAS No. 71011– 

12–6) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new use is: Any 

use. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Persons who must report. Section 

721.5 applies to this section except for 

§ 721.5(a)(2). A person who intends to 

manufacture for commercial purposes a 

substance identified in paragraph (a)(1) 

of this section and intends to distribute 

the substance in commerce must submit 

a significant new use notice. 

(2) [Reserved] 

[FR Doc. 2014–29887 Filed 12–24–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2014–0409; FRL–9920–68– 

Region–3] 

Approval and Promulgation of Air 

Quality Implementation Plan; 

Pennsylvania; Determination of 

Attainment for the 2008 Lead National 

Ambient Air Quality Standard for the 

Lyons Nonattainment Area 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

determine that the Lyons, Pennsylvania 

nonattainment area (hereafter referred to 

as the ‘‘Lyons Area’’ or ‘‘Area’’) has 

attained the 2008 lead (Pb) national 

ambient air quality standard (NAAQS). 

On March 31, 2014, the Commonwealth 

of Pennsylvania, through the 

Pennsylvania Department of 

Environmental Protection, submitted a 

request to EPA to make a determination 

that the Lyons Area has attained the 

2008 Pb NAAQS. This determination of 

attainment is based upon certified, 

quality-assured, and quality-controlled 

ambient air monitoring data from 2011– 

2013 which shows that the Area has 

monitored attainment for the 2008 Pb 

NAAQS. Additionally, as a result of this 

determination, EPA is taking final 

action to suspend the requirements for 

the Area to submit an attainment 

demonstration, together with reasonably 

available control measures (RACM), a 

reasonable further progress (RFP) plan, 

and contingency measures for failure to 

meet RFP or attainment deadlines for so 

long as the Area continues to attain the 

2008 Pb NAAQS. This determination 

does not constitute a redesignation to 

attainment. The Lyons Area will remain 

designated nonattainment for the 2008 

Pb NAAQS until such time as EPA 

determines that the Lyons Area meets 

the Clean Air Act (CAA) requirements 

for redesignation to attainment, 

including an approved maintenance 

plan. These actions are being taken 

under the Clean Air Act (CAA). 

DATES: This final rule is effective on 

January 28, 2015. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R03–OAR–2014–0409. All 

documents in the docket are listed in 

the www.regulations.gov. Although 

listed in the electronic docket, some 

information is not publicly available, 

i.e., confidential business information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy for 

public inspection during normal 

business hours at the Air Protection 

Division, U.S. Environmental Protection 

Agency, Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Schmitt, (215) 814–5787, or by 

email at schmitt.ellen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 7, 2014 (79 FR 46211), 

EPA published a notice of proposed 

rulemaking (NPR) for the 

Commonwealth of Pennsylvania. In the 

August 7, 2014 NPR, EPA proposed to 

make a clean data determination, 

finding that the Lyons Area has attained 

the 2008 Pb NAAQS, based on certified, 

quality-assured, and quality-controlled 

ambient air monitoring data from 2011– 

2013. The Lyons Area is located in 

Berks County, Pennsylvania and 

bounded by Kutztown Borough, Lyons 

Borough, Maxatawny Township, and 

Richmond Township. See 40 CFR 

81.339. 

II. Summary of Rulemaking Action 

EPA is taking final action to 

determine that the Lyons Area has 

attaining data for the 2008 Pb NAAQS. 

This determination of attainment is 

based upon certified, quality-assured, 

and quality-controlled air monitoring 

data that shows the Area has monitored 

attainment of the 2008 Pb NAAQS based 

on 2011–2013 data. 

Other specific requirements of the 

determination of attainment and the 

rationale for EPA’s action are explained 

in the NPR published on August 7, 2014 

(79 FR 46211) as well as in the 

Technical Support Document (TSD) that 

accompanied the NPR, and will not be 

restated here. The TSD is available in 

the docket for this rulemaking action at 

www.regulations.gov. 

III. Effect of This Action 

This final action suspends the 

requirements for the Lyons Area to 

mstockstill on DSK4VPTVN1PROD with RULES