18752 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Potato .............. 0.25 12/31/14. 

Rhubarb .......... 10 None. 

Sweet potato, 

roots.

10 None. 

Tomato ............ 5 None. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

3. Revise § 180.276 to read as follows: 

§ 180.276 Formetanate hydrochloride; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide formetanate hydrochloride, 

including its metabolites and 

degradates, in or on the commodities in 

the table in this paragraph. Compliance 

with the tolerance levels specified in 

this paragraph is to be determined by 

measuring only formetanate 

hydrochloride, N,N-dimethyl-N ′-[3- 

[[(methylamino)carbonyl]oxy]phenyl]

methanimidamide hydrochloride, in or 

on the commodity. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Apple ............... 0.50 12/31/13. 

Apple, wet 

pomace.

1.5 12/31/13. 

Grapefruit ........ 1.5 None. 

Lemon ............. 0.60 None. 

Lime ................ 0.03 None. 

Nectarine ......... 0.40 None. 

Orange ............ 1.5 None. 

Peach .............. 0.40 12/31/13. 

Pear ................ 0.50 12/31/13. 

Tangelo ........... 0.03 None. 

Tangerine ........ 0.03 None. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–7445 Filed 3–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2010–0573; FRL–8865–2] 

RIN 2070–AJ73 

Benzidine-Based Chemical 

Substances; Di-n-pentyl phthalate 

(DnPP); and Alkanes, C12–13, Chloro; 

Proposed Significant New Use Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is proposing: 

To add nine benzidine-based chemical 

substances to the Significant New Use 

Rule (SNUR) on benzidine-based 

chemical substances; a SNUR for di-npentyl phthalate (DnPP) (1,2- 

benzenedicarboxylic acid, 1,2-dipentyl 

ester) (CAS No. 131–18–0); and a SNUR 

for alkanes, C12–13, chloro (CAS No. 

71011–12–6). In the case of the 

benzidine-based chemical substances, 

EPA is also proposing to make 

inapplicable the exemption relating to 

persons that import or process 

substances as part of an article. If 

finalized, this rule would require 

persons who intend to manufacture, 

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 that activity. The required 

notification would provide EPA with 

the 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. 

DATES: Comments must be received on 

or before June 26, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2010–0573, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave. NW., 

Washington, DC. Attention: Docket ID 

number EPA–HQ–OPPT–2010–0573. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

• Instructions: Direct your comments 

to docket ID number EPA–HQ–OPPT– 

2010–0573. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

• Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 18753 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Sara 

Kemme, National Program Chemicals 

Division (7404T), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 566–0511; 

email address: sara.kemme@epa.gov. 

For general information contact: The 

TSCA Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA– 

Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

These three different SNURs may 

apply to different entities. 

1. Benzidine-based chemical 

substances. You may be potentially 

affected by this action if you 

manufacture, import, or process, 

including as part of an article, any of the 

benzidine-based 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, importers, 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, importers, or 

processors of the subject chemical 

substances in printing inks. 

These entities may include those 

described by the North American 

Industrial Classification System 

(NAICS) codes 325-chemical 

manufacturing, 313-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. For 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 & 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, import, 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 (defined 

by statute to include importers) of 

SCCPs (NAICS codes 325 and 325998), 

e.g., chemical manufacturing; including 

miscellaneous chemical product and 

preparation manufacturing; and 

processors of SCCPs (NAICS codes 324 

and 324191), e.g., petroleum lubricating 

oil and grease manufacturing. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The NAICS codes have been 

provided to assist you and others in 

determining whether this action might 

apply to certain entities. To determine 

whether you or your business may be 

affected by this action, you should 

carefully examine the applicability 

provisions in § 721.5 for SNUR-related 

obligations and with respect to 

benzidine-based chemical substances, 

the applicability provisions in Unit II.C. 

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. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Persons who import 

any chemical substance governed by a 

final SNUR are subject to the TSCA 

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

certification requirements and the 

corresponding regulations at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Those persons must certify that 

the shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of a proposed or final 

SNUR are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see § 721.20) 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the agency taking? 

EPA is proposing to add nine 

chemical substances (see Table 1. in 

Unit III.A.) to the existing SNUR for 

certain benzidine-based chemical 

substances at § 721.1660. That 

regulation includes as significant new 

uses ‘‘any use other than 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 also 


tkelley on DSK3SPTVN1PROD with PROPOSALS
18754 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 

for Colour Index (C.I.) Direct Red 28 

(Congo Red, CAS No. 573–58–0) as an 

indicator dye.’’ § 721.1660(a)(2). For the 

nine newly-proposed benzidine-based 

chemical substances, EPA is proposing 

to designate any use as a significant new 

use. EPA requests comment on whether 

there are any ongoing uses of these 

chemicals. 

EPA is also proposing to amend the 

SNUR at § 721.1660 to make 

inapplicable the exemption at 

§ 721.45(f) for persons that import or 

process benzidine-based chemical 

substances as part of an article. 

Additionally, EPA is proposing a 

SNUR for DnPP that would designate, as 

a significant new use, any use of the 

substance other than as a chemical 

standard for laboratory use. 

EPA is also proposing a SNUR for 

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

12–6) that would designate any use of 

the substance as a significant new use. 

Because any use of alkanes, C12–13, 

chloro (CAS No. 71011–12–6) would be 

a new use, § 721.5(a)(2) would be 

inapplicable to alkanes, C12–13, chloro 

(CAS No. 71011–12–6). This provision 

addresses manufacturers, importers, and 

processors who are also distributors of 

a chemical substance subject to a SNUR. 

In certain cases, it requires these 

distributors to alert their customers that 

the SNUR exists. This requirement 

serves an important communication 

function when certain uses of a 

chemical, but not others, trigger 

Significant New Use Notice (SNUN) 

requirements. Where there are no 

ongoing, existing uses of a chemical 

substance and EPA determines by rule 

that all future uses trigger SNUNs 

requirement (as with alkanes, C12–13, 

chloro (CAS No. 71011–12–6)), EPA 

believes these alerts are not only 

unnecessary, but unlikely to ever occur. 

These proposed SNURs would require 

persons that manufacture, import, or 

process any of the chemicals for a 

significant new use, consistent with the 

requirements at § 721.25, to notify EPA 

at least 90 days before commencing 

such manufacture, process, or import of 

the chemical substance for a significant 

new use. For the benzidine-based 

chemical substances, the proposed 

elimination of the article exemption at 

§ 721.45(f) would also require persons to 

notify EPA at least 90 days before 

commencing processing or importing as 

part of an article any of the currentlylisted or newly-proposed benzidinebased chemical substances. The 

objectives and rationale for this 

proposed SNUR are explained in Unit 

VI. 

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). These factors include: 

• 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. 

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 SNUN to EPA at 

least 90 days before they manufacture, 

import, or process the chemical 

substance for that use (15 U.S.C. 

2604(a)(1)(B)). The general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

C. Applicability of general provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear 

at 40 CFR part 700. According to 

§ 721.1(c), persons subject to SNURs 

must comply with the same notice 

requirements and EPA regulatory 

procedures as submitters of 

Premanufacture Notices (PMNs) under 

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

these requirements include the 

information submissions requirements 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

on which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

However, § 721.45(f) (which generally 

exempts persons importing or 

processing a substance as part of an 

article) would not apply to benzidinebased chemical substances listed at 40 

CFR 721.1660 and those added by this 

proposed rule. Therefore, a person who 

imports or processes as part of an article 

a benzidine-based chemical substance 

that is covered by this proposed rule 

would not be exempt from submitting a 

SNUN. With respect to articles, it is still 

relevant to the rulemaking whether a 

use was ongoing or not at time of 

proposal. It is not EPA’s intent to 

subject ongoing uses of any chemical 

substances to the requirements of a 

SNUR. Thus, to the extent that 

additional ongoing uses of benzidinebased chemical substances are found in 

the course of rulemaking (whether or 

not they involve importing or 

processing as part of articles), EPA 

would exclude those uses from the final 

SNUR. 

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. 

III. Overview of Benzidine-Based 

Chemical Substances 

A. What additional benzidine-based 

chemical substances are subject to this 

proposed SNUR? 

This proposed rule would add nine 

benzidine-based chemical substances to 

the list of twenty-four chemical 

substances currently regulated under 

§ 721.1660. The nine benzidine-based 

chemical substances covered by this 

proposed SNUR are listed in Table 1. 

The chemicals listed in Table 1 are 

identified by Chemical Abstract Service 

Registry Numbers (CAS number) or if 

the chemical’s CAS number is claimed 

CBI, the chemical is identified by an 

EPA accession number, along with its 

corresponding generic name. The 

accession numbers are EPA assigned 

numbers used to identify chemicals in 

place of confidential CAS numbers. 

Table 1 also indicates the availability of 

the Colour Index (C.I.) name and C.I. 

number, which is either not available or 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 18755 

CBI for some of the chemicals subject to 

this proposed rule. Persons who are 

interested in determining the precise 

identity of the chemical designated by a 

certain accession number and a generic 

name should submit a bonafide request 

to EPA that complies with the 

information requirements stipulated in 

§ 721.11(b). 

TABLE 1—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)- 

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) 

B. What action has the agency 

previously taken on other benzidinebased chemical substances? 

In 1996, EPA promulgated a TSCA 

section 5(a)(2) SNUR for the benzidinebased chemical substances listed at 

§ 721.1660 (61 FR 52287, October 7, 

1996) (FRL–5396–6). That rule 

considered any use of the chemical 

substances except those listed in 

§ 721.1660(a)(2) as a significant new use 

that requires a SNUN to be submitted to 

the Agency prior to manufacture, 

import, or processing of the listed 

chemical substances. Because they were 

identified as ongoing, the SNUR 

excluded as significant new uses the 

following uses: 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; as a reagent for detecting 

blood; and as an analytical standard. In 

addition, for Colour Index (C.I.) Direct 

Red 28 (Congo Red) (CAS No. 573–58– 

0), use as an indicator dye was excluded 

as a significant new use. The SNUR did 

not require a SNUN to be submitted by 

persons that import or process a listed 

substance as part of an article. 

C. What is the production volume of 

newly-proposed and currently-listed 

chemical substances? 

For the newly proposed nine 

benzidine-based chemical substances, 

data reported to EPA for the 2006, 2002, 

and 1998 reporting cycles, as required 

by the TSCA Inventory Update 

Reporting (IUR) rule, indicate no 

evidence of production (including 

import). The IUR regulation requires 

manufacturers and importers of certain 

chemical substances to report site and 

manufacturing information for 

chemicals manufactured (including 

imported) in amounts of 25,000 pounds 

or greater at a single site (prior to 2006, 

reporting was for 10,000 pounds at a 

site). A general market review on these 

chemical substances indicates no 

current manufacture (Ref. 1) within or 

outside the United States. 

In addition, four of these benzidinebased chemicals were included in EPA’s 

Benzidine-based Dyes Action Plan. The 

additional five chemicals were found in 

the confidential TSCA inventory. 

Designed as part of a comprehensive 

approach to enhancing EPA’s Chemical 

Management Program, action plans 

summarize hazard, exposure, and use 

information; outline the potential risks 

that each chemical may pose; and 

identify the specific steps the Agency is 

considering to address those concerns 

(Ref. 2). 

For the benzidine-based chemical 

substances currently listed at 

§ 721.1660, data reported to EPA for the 

2006, 2002, and 1998 reporting cycles, 

as required by the TSCA IUR rule, 

indicate no evidence of domestic 

production (including import) at IUR 

reportable levels. Further, EPA’s general 

market review on the currently listed 

benzidine-based chemical substances 

suggests that the majority of these 

chemical substances are not currently 

being manufactured domestically or 

abroad (Ref. 1). Although some of these 

substances appear to be manufactured 

for allowable uses within the United 

States at a level below current IUR 

reporting thresholds, and some 

substances appear to be manufactured 

outside the United States generally and 

may therefore potentially be imported as 

part of an article, EPA does not have 

information to suggest that the 

substances are being imported, for use 

as part of articles. In fact, the market 

review did not find evidence of any 


tkelley on DSK3SPTVN1PROD with PROPOSALS
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import of articles containing benzidinebased chemical substances. As stated in 

Unit VIII, EPA welcomes comments on 

any aspect of this proposed SNUR. The 

Agency specifically invites comments 

on whether there is ongoing 

manufacture, import, or processing of 

these benzidine-based chemical 

substances, including in articles, other 

than as excepted at § 721.1660(a)(2). 

D. What are the uses of these benzidinebased chemical substances? 

Historically, the benzidine-based 

chemical substances currently listed at 

§ 721.1660 were used as reagents, 

biological stains in laboratories, and in 

food industries. Note that TSCA section 

3(2)(B)(vi) excludes foods, food 

additives, drugs, cosmetics or devices 

(as defined in the Federal Food, Drug, 

and Cosmetic Act) from the statutory 

definition of a ‘‘chemical substance’’ 

when such substances are 

manufactured, processed, or distributed 

in commerce for use as a food, food 

additive, drug, cosmetic, or device. 

Additionally, these previously listed 

bezidine-based substances are believed 

to have been historically used as dyes in 

the textile industry. 

The nine newly-proposed benzidinebased chemical substances are believed 

to have been used in the past in the 

production of textiles, paints, printing 

inks paper, and pharmaceuticals. 

However, based on market information 

and the fact that the 2006 IUR had no 

production reports for any of the 

benzidine-based chemical substances, if 

these chemical substances are used at 

all, they are likely used in small 

volumes, making it difficult to access 

current production and use information. 

E. What are the potential health effects 

of these chemicals? 

The 1980 EPA Preliminary Risk 

Assessment on derivatives of benzidine 

established that the primary hazard 

concern was for the carcinogenic effects 

to humans from exposure to specific 

metabolites of the chemical substances 

(Ref. 3). There is potential for benzidinebased chemical substances to 

metabolize to the parent benzidine 

molecule, which is a known carcinogen 

(Refs. 4, 5, and 6). This metabolism 

occurs in humans by an enzymemediated reaction. These enzymes are 

found in the liver, in gut bacteria, and 

in skin bacteria. The result of this 

enzymatically-aided reduction is the 

release of the carcinogenic aromatic 

amine from the chemical substance. 

Studies have demonstrated that the 

reduction of benzidine-based chemical 

substances occurs in the human body as 

well as on the skin (Ref. 7). Therefore, 

the primary human health concern for 

consumers is exposure to the benzidinebased chemical substances through oral, 

dermal, or inhalation routes. Evidence 

from animal studies suggests that there 

is early life susceptibility to benzidine 

carcinogenesis (Ref. 8). Cancer potency 

for benzidine was substantially 

increased when the dose was given in 

early life as compared to adults (Ref. 8). 

For additional information see 

Benzidine-Based Chemical Substances; 

Significant New Uses of Certain 

Chemical Substances; Final Rule (61 FR 

52287, October 7, 1996). 

F. What are the potential routes and 

sources of exposures to these chemicals? 

There are benzidine related exposure 

concerns as a result of the use of 

benzidine and benzidine-based 

chemical substances. In 1996, EPA 

identified inhalation, skin absorption, 

and ingestion as possible routes of 

exposure in a variety of settings where 

benzidine-based chemical substances 

are either manufactured or used (61 FR 

52287, October 7, 1996). Although EPA 

estimated that the highest exposure 

would be to workers who were involved 

in dye manufacturing, EPA determined 

that it was necessary to apply the SNUR 

to any use of the listed benzidine-based 

chemical substances, with the exception 

of the limited uses mentioned in Unit 

II.A. EPA listed all the benzidine-based 

chemical substances that it was able to 

identify on the TSCA Inventory at that 

time. Since then, EPA has identified the 

nine additional benzidine-based 

chemical substances listed as part of 

Table 1 and has similar concerns about 

potential consumer and worker 

exposure to these substances. 

Dermal exposure can occur from the 

leaching of the chemical substances by 

sweat in contact with the dyed textiles 

(Ref. 7). Dermal exposure is also a 

concern since many of these chemical 

substances can be directly absorbed by 

the skin to some extent. It is well 

established that the enzymatically-aided 

dye reduction to the carcinogenic 

benzidine unit occurs internally in the 

liver and the gut (Refs. 9 and 10). 

Studies have shown that some human 

skin bacteria possess azo-reductases, the 

enzymes necessary to break down the 

benzidine-based chemical substances to 

release the carcinogenic amines, which 

can be more readily absorbed (Ref. 11). 

Consistent with the information on 

dermal absorption that EPA reviewed in 

developing its recent Benzidine-based 

Chemical Substances Action Plan (EPA– 

HQ–OPPT–2010–0570 at http:// 

www.regulations.gov), EPA identified 

the following main routes of consumer 

exposure to benzidine-based chemical 

substances that are of concern: (1) 

Dermal absorption, the primary route 

from wearing dyed clothing or footwear; 

(2) oral ingestion, an additional route for 

babies and young children who suck on 

clothing, blankets, and other non-food 

products which might contain any of 

the benzidine-base chemical substances; 

(3) inhalation exposure, a more 

prevalent route in occupational settings; 

however, it can also occur from the use 

of dyed inks during ‘‘air brushing’’ or 

from off-gassing from the dyed carpets 

to indoor air; and (4) contact with the 

benzidine-based chemical substances 

entering the environment, through the 

whole life cycle of benzidine-based 

chemical substances in textiles (Ref. 12). 

IV. Overview of DnPP 

A. What chemical is included in the 

proposed SNUR? 

This proposed SNUR would apply to 

DnPP (1,2-Benzenedicarboxylic acid, 

1,2-dipentyl ester), CAS No. 131–18–0, 

an ortho-phthalate (or phthalate ester). 

B. What is the production volume of 

DnPP? 

No IUR production volume data were 

reported for DnPP during the 2006, 

2002, 1998, and 1994 reporting cycles 

(Ref. 13). The last reporting of DnPP 

production to the IUR occurred in 1990 

and corresponds to the lowest 

reportable production volume range 

(10,000 to 500,000 pounds) (Ref. 13). 

DnPP was included in EPA’s 

Phthalates Action Plan, which was 

issued on December 30, 2009 (Ref. 14a). 

As stated in Unit III.C., the chemical 

action plans were designed as a part of 

a comprehensive approach to enhancing 

EPA’s Chemical Management Program. 

These action plans summarize available 

hazard, exposure, and use information; 

outline the potential risks that each 

chemical may present; and identify the 

specific steps the Agency is considering 

to address those concerns. Please note 

that in response to a request for 

correction of the information provided 

in the 2009 Phthalate Action Plan that 

was filed under the Agency’s 

Information Quality Guidelines by the 

American Chemistry Council, EPA 

issued a revised Phthalate Action Plan 

on March 14, 2012 (Ref. 14b). Copies of 

the request for correction and EPA’s 

response to it are available at http:// 

www.epa.gov/quality/ 

informationguidelines/iqg-list.html. 

Internet queries performed by EPA 

identified several companies that either 

use or sell DnPP as a chemical standard 

for laboratory use. As a result, EPA is 

proposing a SNUR for DnPP, excluding 


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use of the substance as a chemical 

standard for laboratory use. 

C. What are the uses of DnPP? 

DnPP belongs to a broad category of 

chemicals commonly referred to as 

phthalates. Although a number of 

phthalates are in common use, EPA 

believes the individual phthalate DnPP 

is not in general use in the United 

States, and only has a limited 

application as a chemical standard for 

laboratory use. As a chemical category, 

the major use of phthalates is as 

plasticizers (Refs. 15–23) especially in 

polyvinyl chloride (PVC) products, 

where they are added to impart 

flexibility and other desirable 

properties. Phthalate-containing PVC 

products include a variety of industrial 

and commercial products, as well as 

specialized medical and dental 

applications. The particular phthalate or 

combination of phthalates used in a 

specific product’s formulation depends 

on the properties the phthalates impart, 

as well as their cost. 

D. What are the potential health and 

environmental effects of DnPP? 

1. Human health effects. Exposures of 

some phthalates in animal studies 

resulted in phthalate syndrome effects, 

which consist of changes in the fetal 

development of the reproductive system 

(Refs. 15–22 and 24–35). The phthalates 

that are the most potent at causing 

phthalate syndrome effects are generally 

those with linear ester side chains 

having 4–6 carbons (Ref. 24). DnPP has 

a linear carbon chain length of 5 

carbons. Of the phthalates studied, 

DnPP is the most potent in producing 

testicular toxicity in pubertal animals 

(Ref. 24). 

Developmental oral exposures in rats 

to DnPP showed increased resorptions, 

increased fetal mortality, and decreased 

fetal testicular testosterone production 

(Refs. 36 and 37); and reduced 

anogenital distance in male rat offspring 

(Ref. 38). Effects noted in adult mice 

exposed to DnPP include decreased 

body weight; increased liver weights; 

decreased kidney weights; decreases in 

the weights of the epididymis, cauda 

epididymis, testes, and seminal vesicles; 

complete absence of detectable sperm; 

shorter average estrous cycle length in 

females; and decreased fertility (Refs. 39 

and 40). Gross and microscopic 

evidence of degenerative changes have 

been observed in the testes and 

epididymis (including testicular 

atrophy, interstitial cell hyperplasia, 

degeneration of the seminiferous 

tubules, and accumulation of fluid and 

degenerated cells in the epididymis) of 

rodents (Refs. 39 and 40). There are no 

subchronic or chronic animal studies of 

DnPP exposure through any exposure 

route. 

There are no known human studies of 

exposure to DnPP. However, due to the 

data discussed in this section, the data 

presented and discussed in Phthalates 

and Cumulative Risk Assessment: The 

Tasks Ahead, Committee on the Health 

Risks of Phthalates, National Research 

Council (2008) (Ref. 24) and DnPP’s 

general structure and categorization as a 

phthalate, EPA notes that the human 

health effects of DnPP exposure may be 

similar to that observed for some other 

phthalates. Several human studies have 

reported associations of exposure of 

some other phthalates with adverse 

reproductive outcomes and 

developmental effects similar to those in 

the rat, although no causal link has been 

established (Refs. 24 and 41–50). The 

reproductive developmental effects of 

some phthalates observed in humans 

include shortened anogenital distance 

observed in newborn boys, shortened 

pregnancy, lower sex and thyroid 

hormones, and reduced sperm quality in 

adults; however, some studies failed to 

show these effects (Ref. 42). Since the 

pathway for sexual differentiation in the 

fetus is highly conserved in all 

mammals, the reproductive and 

developmental effects observed in the 

rat studies are potentially relevant to 

humans. 

Studies in animals evaluating the 

cumulative effects of combinations of 

phthalates on testosterone fetal 

mortality, and male and female 

reproductive development later in life 

have demonstrated all mixtures were 

cumulative for all endpoints (Refs. 36– 

37 and 51–55). The reproductive effects 

of DnPP observed in animal studies, the 

reproductive effects of other phthalates 

observed in humans, and the data on the 

cumulative effects of mixtures of 

phthalates, support EPA’s concern for 

potential human health hazards 

following exposure to DnPP. 

2. Environmental effects. EPA does 

not know of any studies of the 

environmental effects of DnPP. Due to 

the general structure of DnPP, its 

behavior in an aquatic environment 

similar to the close analog mono 2- 

ethylhexyl phthalate, its log Kow, and 

water solubility measurements, and its 

categorization as a phthalate, EPA is 

concerned that the environmental 

effects of DnPP may be similar to those 

of other phthalates studied. Other 

phthalates studied have been shown to 

have biological effects in all studied 

animal groups and have been observed 

at environmentally relevant exposures 

in the nanogram/liter to microgram/liter 

range. The combination of the inherent 

toxicity, variable solubility, log of the 

octanol-water coefficient values, and 

bioconcentration factor (BCF) values 

among the studied phthalates elicit both 

acute and chronic toxicity to aquatic 

and terrestrial wildlife by targeting 

thyroid function, liver function, 

reproduction, and other physiological 

mechanisms (Refs. 31–35, 56 and 57). 

E. What are the potential routes and 

sources of exposure to DnPP? 

1. Human exposure. Data from the 

National Health and Nutrition 

Examination Survey (NHANES) 

indicates widespread exposure of the 

general population to various phthalates 

(Ref. 58). Phthalates are used in a wide 

array of plastic products and may be 

released into the environment during 

use and disposal of these products (Ref. 

58). Biomonitoring data from amniotic 

fluid and urine have demonstrated that 

humans are exposed to various 

phthalates in utero, as infants, during 

puberty, and in adult life; and that 

people are exposed to several phthalates 

at once. The urinary metabolites of 

DnPP were not specifically included in 

the 4th National Report on Human 

Exposure to Environmental Chemicals 

(2010), so EPA cannot draw conclusions 

as to the current exposure of the general 

population in the United States to 

DnPP. 

2. Environmental exposure. Due to 

phthalates’ pervasive use and release, as 

well as their propensity for global 

transport, various phthalates may be 

found in most environmental media, 

including ambient air, surface water, 

soil, and sediment (Refs. 25–32 and 34– 

35). Fish and other aquatic organisms, 

as well as terrestrial animals have 

evidenced exposure to a common 

phthalate: di-(2-ethylhexyl) phthalate 

(DEHP) (Refs. 34 and 57). EPA does not 

have available data on environmental 

exposures to DnPP. 

V. Overview of Alkanes, C12–13, Chloro 

(CAS No. 71011–12–6) 

A. What chemical is included in the 

proposed SNUR? 

This proposed SNUR would cover 

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

12–6), one type of short-chain 

chlorinated paraffin (SCCP). This 

consists of C12 and C13 alkanes with 

varying degrees of chlorination. 

B. What is the production volume of 

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

12–6)? 

No production volumes for alkanes, 

C12–13 chloro (CAS No. 71011–12–6) 

were reported to the IUR during the 

2006, 2002, 1998, and 1994 reporting 


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cycles, and EPA found no additional 

evidence of any importation or 

manufacturing of the chemical. 

Alkanes, C12–13, chloro (CAS No. 

71011–12–6) was included in EPA’s 

Short-Chain Chlorinated Paraffins 

(SCCPs) and Other Chlorinated Paraffins 

Action Plan (Ref. 59). As stated in Unit 

III.C., the chemical action plans were 

designed as a part of a comprehensive 

approach to enhancing EPA’s Chemical 

Management Program. These action 

plans summarize available hazard, 

exposure, and use information; outline 

the potential risks that each chemical 

may present; and identify the specific 

steps the Agency is considering to 

address those concerns. 

C. What were the uses of this SCCP? 

Alkanes, C12–13, chloro (CAS No. 

71011–12–6) is an individual chemical 

substance that belongs to a category of 

chemicals referred to as SCCPs. There 

are many different chemical substances 

that are members of the SCCP category. 

Generally these SCCPs have between 10 

and 13 carbon atoms and contain 40— 

70 percent chlorine by weight. Of the 

different SCCPs that are listed on the 

TSCA Inventory, EPA believes the SCCP 

named ‘‘Alkanes, C12–13, chloro (CAS 

No. 71011–12–6)’’ is not in use in the 

United States and EPA has found no 

information that indicates it has ever 

been used. All of the data discussed in 

this section associated with the SCCPs 

general category would pertain to any 

individual member of that category, 

including alkanes, C12–13, chloro (CAS 

No. 71011–12–6). 

D. What are the potential environmental 

effects of alkanes, C12–13, chloro (CAS 

No. 71011–12–6)? 

The primary concern for SCCPs is 

ecotoxicity. There are internationally 

accepted data specifically on the 

ecotoxicity of alkanes, C12–13, chloro 

(CAS No. 71011–12–6) (Ref. 60). 

Alkanes, C12–13, chloro (CAS No. 71011– 

12–6) are highly toxic to aquatic 

invertebrates following acute and 

chronic exposures. In fish, this high 

toxicity is associated with chronic 

exposures, but not for acute exposures. 

For aquatic plants, there is high toxicity 

associated with both acute and chronic 

exposures to SCCPs in general (Ref. 59– 

61). 

Both Health Canada and Environment 

Canada have characterized all 

chlorinated paraffins (short chain 

chlorinated paraffins, medium chain 

chlorinated paraffins, and long chain 

chlorinated paraffins), which include 

the chemical substance covered by this 

proposed rule, as ‘‘toxic’’ under the 

Canadian Environmental Protection Act 

(CEPA) (Ref. 61). Their assessment 

found that these SCCPs have or may 

have an immediate or long term harmful 

effect on the environment or its 

biological diversity; and that they are 

persistent, bioaccumulative, inherently 

toxic and present in the environment 

primarily as a result of human activity 

(Ref. 61). 

E. What are the potential routes and 

sources of exposure to alkanes, C12–13, 

chloro (CAS No. 71011–12–6)? 

The mechanisms or pathways by 

which the 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 has concerns regarding the 

environmental fate and the exposure 

pathways that lead to any SCCP 

presence, including C12 and C13 SCCPs 

(for example, Alkanes, C12–13, Chloro 

(CAS No. 71011–12–6)), in a variety of 

biota, including freshwater aquatic 

species, marine mammals, and avian 

and terrestrial wildlife (Ref. 60). In 

addition, SCCPs, including C12 and C13 

SCCPs, have been detected in samples 

of human breast milk from Canada and 

the United Kingdom, as well as in a 

variety of food items from Japan and 

various regions of Europe (Ref. 62–63). 

SCCPs are routinely found in soil and 

sediment samples. EPA also has 

concerns about the persistence, 

bioaccumulation, and toxicity (PBT) of 

SCCPs (Ref. 60). 

VI. Rationale and Objectives 

A. Rationale 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), EPA’s decision to propose a 

SNUR for a particular chemical use 

need not be based on an extensive 

evaluation of the hazard, exposure, or 

potential risk associated with that use. 

Rather, the Agency’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 summarized in Unit III., 

EPA is concerned about potential 

carcinogenic effects on workers and 

consumers from the manufacture, 

processing, importing, 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. 8). 

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 covered 

by this proposed rule present the same 

concerns (Ref. 2) as those of the 

benzidine-based chemical substances 

currently listed under § 721.1660. 

However, based on a review of IUR data 

and a separate market review, EPA does 

not believe there is any current 

manufacture of these nine benzidinebased chemical substances within or 

outside the United States. 

In addition, as discussed earlier, 

although some of the currently listed 

benzidine-based chemical substances 

may be manufactured or processed 

outside the United States, EPA does not 

have specific information that suggests 

they are entering into the United States 

in imported articles (Ref. 4). In fact, an 

analysis of the benzidine-based 

chemical substances market (Ref. 1) 

revealed no information indicating 

import of articles containing benzidinebased chemical substances for nonexcluded purposes. Supporting a 

conclusion that there is no import of 

textile articles containing benzidinebased chemical substances, the 

American Apparel and Footwear 

Association, the national trade 

association representing apparel, 

footwear, and other sewn products 

companies and their suppliers, which 

compete in the global market, includes 

benzidine on its Restricted Substances 

List (RSL) (Ref. 64). The RSL is a 

compilation of chemicals, regulated or 

banned, that are used by apparel and 

footwear industries. 

Although it appears there is no 

ongoing manufacture of the nine newly 

proposed benzidine-based chemical 


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substances, or import for a nonexcluded use of articles containing any 

benzidine-based chemical substances, 

the manufacture (including import) or 

processing of the nine newly proposed 

benzidine-based chemical substances 

and the import or processing of articles 

containing any benzidine-based 

chemical substances may begin at any 

time, without prior notice to EPA. Thus, 

EPA is concerned that commencement 

of the manufacture, import, or 

processing for any new uses, including 

resumption of past uses, of benzidinebased 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 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. 

Therefore, EPA is proposing a SNUR 

for the nine benzidine-based chemical 

substances by adding them to those 

currently listed at § 721.1660, and to 

make inapplicable the article exemption 

at § 721.45(f) for those chemical 

substances newly proposed in this 

rulemaking as well as for those already 

listed at § 721.1660. If finalized, a 

person who intends to manufacture 

(including import) or process any of the 

benzidine-based chemical substances 

for a non-excluded use, or to import or 

process any listed benzidine-based 

chemical substance for a non-excluded 

use as part of an article, would be 

required to submit a SNUN. 

2. DnPP. As summarized in Unit IV., 

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 

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. Therefore, EPA is 

proposing a SNUR for DnPP that would 

designate, as a significant new use, any 

use of the chemical substance other than 

as a chemical standard for laboratory 

use. If finalized, a person who intends 

to manufacture, import, or process DnPP 

for use other than as a chemical 

standard for laboratory use would be 

required to submit a SNUN. 

3. Alkanes, C12–13, chloro (CAS No. 

71011–12–6). The mechanisms or 

pathways by which the 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, 

processing, and import into the United 

States of alkanes, C12–13, chloro (CAS 

No. 71011–12–6) has ceased. Given EPA 

has no evidence to suggest that there is 

any manufacture, processing, or 

importation 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 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, import 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. Therefore, EPA is proposing 

a SNUR for alkanes, C12–13, chloro (CAS 

No. 71011–12–6) that would designate 

as a significant new use any use of the 

chemical substance. If finalized, a 

person who intends to manufacture, 

import, or process alkanes, C12–13, 

chloro (CAS No. 71011–12–6) for any 

use would be required to submit a 

SNUN. 

EPA is requesting comment on 

whether any of the significant new uses 

identified are currently ongoing. 

However, if EPA determines, based on 

comments on this proposed rule or on 

other information the Agency identifies, 

that any proposed significant new use of 

any of the chemical substances has been 

ongoing (including, in the case of 

benzidine-based chemical substances, 

that an article containing benzidinebased chemical substances was being 

imported or processed) prior to date of 

publication of the final rule, EPA would 

exclude such ongoing uses from the 

final SNUR and consider pursuing other 

regulatory action, as appropriate. 

B. Objectives 

Based on the considerations in Unit 

VI.A.1–3, EPA wants to achieve the 

following objectives with regard to the 

significant new use(s) that are 

designated in this proposed rule: 

1. EPA would receive notice of any 

person’s intent to manufacture or 

process the specified chemicals for the 

described significant new uses before 

that activity begins; 

2. EPA would have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing of 

the specified chemicals for the 

described significant new use; and 

3. EPA would 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. 

VII. 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 would constitute a 

significant new use of the benzidinebased chemical substances subject to 

this proposed rule, DnPP and the 

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

12–6), as discussed herein, EPA 


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considered relevant information about 

the toxicity of these substances, likely 

human exposures and environmental 

releases associated with possible uses, 

and the four factors listed in section 

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

determined that the manufacture, 

import, processing, or import or 

processing as part of an article of any of 

the benzidine-based chemical 

substances subject to this proposed rule, 

except ongoing uses specified in 

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

in this document, is a significant new 

use. EPA has also preliminarily 

determined that the manufacture, 

import, or processing of DnPP for any 

use other than as a chemical standard 

for laboratory use is a significant new 

use, and the manufacture, processing, or 

import of alkanes, C12–13, chloro (CAS 

No. 71011–12–6) for any use is a 

significant new use. 

VIII. Request for Public Comment 

EPA welcomes comments on any 

aspect of this proposed SNUR. 

Information available about 

environmental effects, health effects, 

and exposure would be beneficial. EPA 

is also requesting public comment on 

whether there are any ongoing uses of 

any of these chemicals for the proposed 

significant new uses (including 

processing or import of benzidine-based 

chemical substances in articles) and 

would welcome specific information 

that documents such uses. 

IX. Alternatives 

Before proposing these SNURs, EPA 

considered the following alternative 

regulatory actions: 

A. Promulgate a TSCA Section 8(a) 

Reporting Rule 

Under a TSCA section 8(a) rule, EPA 

could, among other things, generally 

require persons to report information to 

the Agency when they intend to 

manufacture, import, or process a listed 

chemical for a specific use or any use. 

However, for the chemical substances 

subject to this proposed rule, the use of 

TSCA section 8(a) rather than SNUR 

authority would have several 

limitations. First, if EPA were to require 

reporting under TSCA section 8(a) 

instead of TSCA section 5(a), EPA 

would not have the opportunity to 

review human and environmental 

hazards and exposures associated with 

the proposed significant new use and, if 

necessary, take immediate follow-up 

regulatory action under TSCA sections 

5(e) or 5(f) to prohibit or limit the 

activity before it begins. In addition, 

EPA may not receive important 

information from small businesses, 

because such firms generally are exempt 

from TSCA section 8(a) reporting 

requirements. In view of the level of 

health and environmental concerns 

about the chemicals subject to this 

proposed rule if used for the proposed 

significant new uses, EPA believes that 

a TSCA section 8(a) rule for this 

substance would not meet EPA’s 

regulatory objectives. 

B. Regulate Under TSCA Section 6 

EPA may regulate under TSCA 

section 6 if ‘‘the Administrator finds 

that there is a reasonable basis to 

conclude that the manufacture, 

processing, distribution in commerce, 

use or disposal of a chemical substance 

or mixture presents or will present an 

unreasonable risk of injury to health or 

the environment.’’ (TSCA section 6(a)). 

Given that the benzidine-based 

chemical substances subject to this 

proposed rule are no longer being used 

except as provided in the regulatory text 

of this document, DnPP is no longer 

being used except as a chemical 

standard for laboratory use, and alkanes, 

C12–13, chloro (CAS No. 71011–12–6) is 

no longer used in the United States, 

EPA concluded that risk management 

action under TSCA section 6 is not 

necessary at this time. This proposed 

SNUR would allow the Agency to 

address the potential risks associated 

with the proposed significant new uses. 

If EPA learns that these chemicals are in 

use, EPA may reconsider this decision 

and pursue additional regulatory action 

as appropriate. 

X. Applicability of Proposed Rule to 

Uses Occurring Before Effective Date of 

the Final Rule 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376), 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, import, 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. Uses 

arising after the publication of the 

proposed rule are distinguished from 

uses that exist at publication of the 

proposed rule. The former would be 

new uses, the latter ongoing uses. To the 

extent that additional ongoing uses are 

found in the course of rulemaking, EPA 

would exclude those uses from the final 

SNUR. EPA has promulgated provisions 

to allow persons to comply with this 

SNUR before the effective date. If a 

person were to meet the conditions of 

advance compliance under § 721.45(h), 

that person would be considered to have 

met the requirements of the final SNUR 

for those activities. 

XI. 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); 721.25, and 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: 

1. Human exposure and 

environmental releases that may result 

from the significant new uses of the 

chemical substance. 


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2. Potential benefits of the chemical 

substance. 

3. Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

XII. 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 

§ 720.50. SNUNs must be on EPA Form 

No. 7710–25, generated using e-PMN 

software, and submitted to the Agency 

in accordance with the procedures set 

forth in §§ 721.25 and 720.40. E–PMN 

software is available electronically at 

http://www.epa.gov/opptintr/newchems. 

XIII. 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 this proposed 

rule. These economic analyses, which 

are briefly summarized here, are 

available in the docket for this proposed 

rule. 

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 $8,112 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 § 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 

(§ 700.45(b)(1)). In its evaluation of this 

proposed 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 $78.54. 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). 

XIV. References 

As indicated under ADDRESSES, a 

docket has been established for this 

proposed rule under docket ID number 

EPA–HQ–OPPT–2010–0573. The 

following is a listing of the documents 

that have been placed in the docket for 

this proposed rule. The docket includes 

information considered by EPA in 

developing this proposed rule, 

including the documents listed in this 

unit, which are physically located in the 

docket. In addition, interested parties 

should consult documents that are 

referenced in the documents that EPA 

has placed in the docket, regardless of 

whether these referenced documents are 

physically located in the docket. For 

assistance in locating documents that 

are referenced in documents that EPA 

has placed in the docket, but that are 

not physically located in the docket, 

please consult the technical person 

listed under FOR FURTHER INFORMATION

CONTACT. The docket is available for 

review as specified under ADDRESSES. 

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

USEPA/OCSPP/Economics, Exposure, 

and Technology Division. ‘‘Economic 

Analysis to Support the Proposed SNUR 

for Benzidine and Benzidine-based 

Chemical substances’’ (May 24, 2011). 

2. 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%20

Plan_06232010.noheader.pdf (Accessed 

January 24, 2011). 

3. EPA. 1980. Preliminary Risk Assessment: 

Phase I. Benzidine, Its Congeners, and 

their derivative dyes and pigments. 

EPA–560/11–80–019, June 1980. 

4. IARC (1982). Some industrial chemicals 

and dyestuffs. IARC monographs on the 

evaluation of carcinogenic risk of 

chemicals to humans, Suppl. 7, 

International Agency for Research on 

Cancer, Lyon, France. 

5. IARC (1987). Overall evaluation of 

carcinogenicity. IARC monographs on 

the evaluation of carcinogenic risk of 

chemicals to humans, vol. 29, 

International Agency for Research on 

Cancer. 

6. Report on Carcinogens, 11th ed. (2008). 

National Toxicology Program, 

Department of Health and Human 

Services. 

7. Golka, K., Kopps, S., Myslak, Z.W. 2004. 

Carcinogenicity of azo colorants: 

Influence of solubility and 

bioavailability. Tox Lett 151:203–210. 

8. Vesselinovitch, SD; Rao, KV; Mihailovich, 

N. Transplacental and lactational 

carcinogenesis by safrole. Cancer Res 

39(11): 4378–4380 (as cited in EPA. 

2005. Supplemental Guidance for 

Assessing Susceptibility from Early Life 

Exposure to Carcinogens. EPA 630/R–03/ 

003F, March 2005). 

9. Levine, W.G. (1991). Metabolism of azo 

dyes: implication for detoxification and 

activation. Drug Metab. Rev. 23(3&4): 

253–309. 

10. Platzek, T., Lang, C.; Grohmann, G., Giu, 

S.; Baltes, W. (1999). Formation of a 

carcinogenic aromatic amine from an azo 

dye by human skin bacteria in vitro. 

Human & Experimental Toxicology, 18: 

552–559. 

11. Stingley, R., Zou, W., Heinze, T., Chen, 

H. and Cerniglia, C. 2009. Metabolism of 

azo dyes by human skin microbiota. J 

Med Microbiol (2009), DOI: 10.1099/ 

jmm.0.012617–0. 

12. NIOSH, Special Occupational Hazard 

Review for Benzidine-Based Dyes (1980). 

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Protection Agency. Inventory Update 

Reporting IUR: Non Confidential IUR 

Production Volume Data 1986–2002. 

Available at: http://www.epa.gov/oppt/ 

iur/tools/data/2002-vol.html (Updated 

October 26, 2009). 

14a. U.S. EPA, 2009. U.S. Environmental 

Protection Agency. Phthalates Action 

Plan. 

14b. U.S. EPA, 2012. U.S. Environmental 

Protection Agency. Phthalates Action 

Plan (Revised). http://www.epa.gov/ 

oppt/existingchemicals/pubs/ 

actionplans/phthalates.html. 

15. Australian Government, 2008a. Existing 

Chemical Hazard Assessment Report for 

Butylbenzyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

16. Australian Government, 2008b. Existing 

Chemical Hazard Assessment Report for 

Dibutyl Phthalate. Department of Health 

and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

17. Australian Government, 2008c. Existing 

Chemical Hazard Assessment Report for 

Diethylhexyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

18. Australian Government, 2008d. Existing 

Chemical Hazard Assessment Report for 

Diisobutyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

19. Australian Government, 2008e. Existing 

Chemical Hazard Assessment Report for 


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Diisodecyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

20. Australian Government, 2008f. Existing 

Chemical Hazard Assessment Report for 

Diisonoyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

21. Australian Government, 2008g. Existing 

Chemical Hazard Assessment Report for 

Di-n-octyl Phthalate. Department of 

Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

22. Australian Government, 2008h. 

Phthalates Hazard Compendium. A 

Summary of Physicochemical and 

Human Health Hazard Data for 24 

Ortho-Phthalate Chemicals. Department 

of Health and Ageing, National Industrial 

Chemicals Notification and Assessment 

Scheme (NICNAS): Sydney, Australia. 

Available at: http://www.nicnas.gov.au/ 

Publications/CAR/Other/Phthalates.asp 

(accessed Aug 13, 2009). 

23. HSDB, 2009. Hazardous Substance Data 

Bank. U.S. National Library of Medicine 

TOXNET System. http:// 

toxnet.nlm.nih.gov/cgi-bin/sis/ 

htmlgen?HSDB (accessed Aug 13, 2009). 

24. NAS, 2008. National Academy of 

Sciences. Phthalates and Cumulative 

Risk Assessment: The Tasks Ahead. 

25. NTP–CERHR, 2003a. Monograph on the 

Potential Human Reproductive and 

Developmental Effects of Di-n-Butyl 

Phthalate (DBP). U.S. Department of 

Health and Human Services. Available 

at: http://cerhr.niehs.nih.gov/evals/ 

phthalates/dbp/dbp.html. 

26. NTP–CERHR, 2003b. National Toxicology 

Program—Center for the Evaluation of 

Risks to Human Reproduction. 

Monograph on the Potential Human 

Reproductive and Developmental Effects 

of Butyl Benzyl Phthalate (BBP); NIH 

Pub. No. 03–4487; U.S. Department of 

Health and Human Services. Available 

at: http://cerhr.niehs.nih.gov/evals/ 

phthalates/bb-phthalate/bbphthalate.html. 

27. NTP–CERHR, 2003c. National Toxicology 

Program—Center for the Evaluation of 

Risks to Human Reproduction. 

Monograph on the Potential Human 

Reproductive and Developmental Effects 

of Di-n-Octyl Phthalate (DnOP); NIH 

Pub. No. 03–4488; U.S. Department of 

Health and Human Services. Available 

at: http://cerhr.niehs.nih.gov/evals/ 

phthalates/dnop/dnop.html. 

28. NTP–CERHR, 2003d. National Toxicology 

Program—Center for the Evaluation of 

Risks to Human Reproduction. 

Monograph on the Potential Human 

Reproductive and Developmental Effects 

of Diisononyl Phthalate (DINP); U.S. 

Department of Health and Human 

Services. Available at: http:// 

cerhr.niehs.nih.gov/evals/phthalates/ 

dinp/dinp.html. 

29. NTP–CERHR, 2003e. National Toxicology 

Program—Center for the Evaluation of 

Risks to Human Reproduction. 

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of Di-Isodecyl Phthalate (DIDP); NIH 

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Health and Human Services. Available 

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30. NTP–CERHR, 2006. National Toxicology 

Program—Center for the Evaluation of 

Risks to Human Reproduction. 

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of Di-(2-ethylhexyl) Phthalate (DEHP); 

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of Health and Human Services. Available 

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Esters. Environ. Toxicol. Chem. 1997, 

16(5): 875–91. 

58. CDC, 2009. Centers for Disease Control 

and Prevention. Fourth National Report 

on Human Exposure to Environmental 

Chemicals. National Health and 

Nutrition Examination Survey 

(NHANES), Centers for Disease Control 

and Prevention, Atlanta (GA). Available 

at: http://www.cdc.gov/exposurereport/ 

faq.html. 

59. U.S. EPA, 2010. U.S. Environmental 

Protection Agency. Short-Chain 

Chlorinated Paraffins (SCCPs) and Other 

Chlorinated Paraffins Action Plan. 

Available at: http://www.epa.gov/oppt/ 

existingchemicals/pubs/actionplans/ 

sccps.html (Accessed March 7, 2011). 

60. UNEP. 2011. United Nations 

Environment Programme. Stockholm 

Convention on Persistent Organic 

Pollutants (POPs). Persistent Organic 

Pollutants Review Committee. Report of 

the Persistent Organic Pollutants Review 

Committee on the Work of its Seventh 

Meeting. October 17, 2011. UNEP/POPS/ 

POPRC.7/19. Available at: 

http://chm.pops.int/Convention/ 

POPsReviewCommittee/POPRCMeetings/ 

POPRC7/POPRC7ReportandDecisions/ 

tabid/2472/Default.aspx. (accessed 

January 20, 2010). As noted in this 

document ‘‘Consensus has been reached 

on the data considered (in UNEP. 2009. 

United Nations Environment 

Programme. Stockholm Convention on 

Persistent Organic Pollutants (POPs). 

Persistent Organic Pollutants Review 

Committee. Revised Draft Risk Profile: 

Short-Chained Chlorinated Paraffins. 

July 9, 2009. UNEP/POPS/POPRC.5/2.’’ 

The document cited is available at: 

http://chm.pops.int/Convention/ 

POPsReviewCommittee/ 

hrPOPRCMeetings/POPRC5/ 

POPR%205Documents/tabid/592/ 

language/en-US/Default.aspx. Accessed 

December 11, 2009). 

61. Government of Canada. 2008. Order 

Adding Toxic Substances to Schedule 1 

to the Canadian Environmental 

Protection Act, 1999. Canada Gazette. 

September 20, 2008, 142 (38). 

62. Iino F., T. Takasuga, K. Senthilkumar, N. 

Nakamura and J. Nakanish. 2005. Risk 

assessment of short-chain chlorinated 

paraffins in Japan based on the first 

market basket study and species 

sensitivity distributions. Environ. Sci. 

Technol. 39: 859–866 (as cited in UNEP. 

2009. United Nations Environment 

Programme. Stockholm Convention on 

Persistent Organic Pollutants (POPs). 

Persistent Organic Pollutants Review 

Committee. Revised Draft Risk Profile: 

Short-Chained Chlorinated Paraffins. 

July 9, 2009. UNEP/POPS/POPRC.5/2. 

Available at: 

http://chm.pops.int/Convention/ 

POPsReviewCommittee/ 

hrPOPRCMeetings/POPRC5/POPR 

5Documents/tabid/592/language/en-US/ 

Default.aspx. Accessed December 11, 

2009). 

63. Lahaniatis, M.R., Coelhan, M., H. Parlar. 

2000. Clean-up and quantification of 

short and medium chain polychlorinated 

n-alkanes in fish, fish oil, and fish feed. 

Organohalogen Compounds. 47: 276–279 

(as cited in UNEP. 2009. United Nations 

Environment Programme. Stockholm 

Convention on Persistent Organic 

Pollutants (POPs). Persistent Organic 

Pollutants Review Committee. Revised 

Draft Risk Profile: Short-Chained 

Chlorinated Paraffins. July 9, 2009. 

UNEP/POPS/POPRC.5/2. Available at: 

http://chm.pops.int/Convention/ 

POPsReviewCommittee/ 

hrPOPRCMeetings/POPRC5/POPR 

5Documents/tabid/592/language/en-US/ 

Default.aspx. (accessed December 11, 

2009)). 

64. American Apparel and Footwear 

Association (AAFA) Restricted 

Substance List (RSL), September, 2010. 

XV. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

Under Executive Order 12866, 

entitled Regulatory Planning and 

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

the Office of Management and Budget 

(OMB) determined that this proposed 

SNUR is a ‘‘significant regulatory 

action’’ under section 3(f) of the 

Executive Order. Accordingly, EPA 

submitted this action to OMB for review 

under Executive Order 12866 and 

13563, entitled Improving Regulation 

and Regulatory Review (76 FR 3821, 

January 21, 2011). EPA prepared an 

analysis of the potential costs and 

benefits associated with this action, 

which is summarized in Unit XIII. 

Changes made in response to OMB 

recommendations have been 

documented in the docket for this 

rulemaking as required by section 

6(a)(3)(E) of the Executive Order. 

B. Paperwork Activities 

According to the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., an Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under 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. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to the PRA under OMB control 

number 2070–0038 (EPA ICR No. 1188). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average 97 hours per response. This 

burden estimate includes the time 

needed to review instructions, search 


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18764 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 

existing data sources, gather and 

maintain the data needed, and 

complete, review, and submit the 

required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Small Entity Impacts 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that promulgation of this SNUR 

would not have a significant adverse 

economic impact on a substantial 

number of small entities. Under the 

RFA, small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. Small 

entity is defined in accordance with 

section 601 of the RFA as: A small 

business as defined by the Small 

Business Administration’s (SBA) 

regulations at 13 CFR 121.201; a small 

governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and a 

small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. 

For purposes of assessing the impacts 

of this proposed rule on small entities, 

EPA has determined that this proposed 

rule is not expected to impact any small 

not-for-profit organizations or small 

governmental jurisdictions. As such, the 

Agency estimated potential impacts on 

small business. 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.’’ By definition of the word 

‘‘new’’ and based on all information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activity. Since this 

action would require a person who 

intends to engage in such activity in the 

future to first notify EPA by submitting 

a SNUN, no economic impact would 

occur unless someone files a SNUN to 

pursue a significant new use in the 

future or forgoes profits by avoiding or 

delaying the significant new use. 

Although some small entities may 

decide to conduct such activities in the 

future, EPA cannot presently determine 

how many, if any, there may be. 

EPA’s experience to date is that, in 

response to the promulgation of over 

1,000 SNURs, the Agency receives on 

average only five notices per year. Of 

those SNUNs submitted, only one 

appears to be from a small entity in 

response to any SNUR. 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. In a SNUR that 

published as a final rule on August 8, 

1997 (62 FR 42690) (FRL–5735–4), the 

Agency presented its general 

determination that proposed and final 

SNURs are not expected to have a 

significant economic impact on a 

substantial number of small entities, 

which was provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration. 

D. State, Local, and Tribal Governments 

In EPA’s experience with proposing 

and finalizing SNURs since 1980, no 

state, local, or Tribal government has 

initiated the manufacture of a chemical 

for a new use. Furthermore, EPA does 

not have any reason to believe that any 

state, local, or tribal government would 

do so for the chemicals in this 

rulemaking. For that reason, EPA has 

determined that this action does not 

have federalism implications as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), or tribal implications 

as specified in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000). 

In addition, this action does not 

impose any enforceable duty or contain 

any unfunded mandate for State, local, 

or tribal governments under the 

provisions of Title II of the Unfunded 

Mandates Reform Act (UMRA), 2 U.S.C. 

1531–1538. Nor does it otherwise have 

any effect on small governments, or 

estimated impacts on the private sector 

that might exceed $100 million in any 

year. 

Thus, sections 202, 203, 204, or 205 

of UMRA, Executive Order 13132, and 

Executive Order 13175 do not apply to 

this action. 

E. Protection of Children 

This action is not subject to Executive 

Order 13045, entitled Protection of 

Children from Environmental Health 

Risks and Safety Risks (62 FR 19885, 

April 23, 1997), because this action is 

not an economically significant 

regulatory action as defined by 

Executive Order 12866, and it is not 

intended to address environmental 

health or safety risks for children. 

F. Effect on Energy Supply, Distribution, 

or Use 

This action is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and it is not expected to affect 

energy supply, distribution, or use. 

G. Technical Standards 

Since this action does not involve any 

technical standards, section 12(d) of the 

National Technology Transfer and 

Advancement Act (NTTAA), 15 U.S.C. 

272 note, does not apply to this action. 

H. Environmental Justice 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). 

List of Subjects in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: March 20, 2012. 

Wendy C. Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, it is proposed that 40 CFR 

part 721 be amended as follows: 

PART 721—[AMENDED] 

1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

2. 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. 


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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 18765 

TABLE 1—NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS or accession No. C.I. name C.I. number 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) 

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 ..................................... Phenylazoaminohydroxynaphthalenyl azobiphenyl azosubstituted 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 


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18766 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules 

TABLE 2—BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued 

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

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 

(2) The significant new uses are: 

(i) Any use other than use as: 

(A) For the chemicals listed in Table 

2., as 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 and as an 

analytical standard. 

(B) For Colour Index (C.I.) Direct Red 

28 (Congo Red) (CAS No. 573–58–0) 

listed in Table 2., as an indicator dye. 

(ii) For the 9 chemical substances 

listed in Table 1.: Any use. 

(3) Revocation of article exemption. 

The provisions of § 721.45(f) do not 

apply to this section. A person who 

imports or processes the chemical 

substances identified in paragraph (a)(1) 

of this section as part of an article for 

the significant new use described in 

paragraph (a)(2) of this section must 

submit a significant new use notice. 

(b) [Reserved] 

3. 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 as a chemical standard 

for laboratory use. 

(b) [Reserved] 

4. 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. 

(1) Persons who must report. § 721.5 

applies to this section except for 

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

manufacture or import 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. 2012–7208 Filed 3–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2010–0003; Internal 

Agency Docket No. FEMA–B–1114] 

Proposed Flood Elevation 

Determinations 

Correction 

In proposed rule document 2010– 

14558 appearing on pages 34415–34417 

in the issue of June 17, 2010, make the 

following correction: 

§ 67.4 [Corrected] 

On page 34416, in § 67.4, the table 

titled ‘‘Cass County, Texas, and 

Incorporated Areas’’ is corrected to read 

as set forth below: 


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