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Rin2070-AJ73_EO12866_3-Chemical-SNUR-NPRM_FRdocument_Markup_2012-03-02.docx

As revised to address comments received during the review under EO 12866. 

 BILLING CODE 6560-50-P 

ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Part 721 

[EPA-HQ-OPPT-2010-0573; FRL-8865-2XXXX-X]

RIN 2070–AJ36-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 section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA 

is proposing: to add nine benzidine-based chemical substances to the Significant New 

Use Rule (SNUR) at § 721.1660 on benzidine-based chemical substances; a SNUR for 

Di-n-pentyl 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). 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. In the case of the 

benzidine-based chemical substances, EPA is also proposing to make inapplicable the 

exemption at § 721.45(f) relating to persons that import or process substances as part of 

an article. If finalized this would require persons who intend to import or process all 

listed benzidine-based chemical substances, i.e., the newly proposed nine benzidine-
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based chemical substances as well as the currently listed benzidine-based chemical 

substances, as part of an article 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 [insert date [90] days after date of 

publication in the Federal Register]. 

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-OPPT2010-0573. 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, 
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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 e-mail. The regulations.gov website 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 e-mail 

comment directly to EPA without going through regulations.gov, your e-mail 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 
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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 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 e-mail address: sara.kemme@epa.gov. 

For general information contact: The TSCAHotline, ABVI-Goodwill, 422 South Clinton 

Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCAHotline@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. 
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• 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, process, or import 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 
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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 this proposed rule on or 

after [insert date 30 days after the date of publication in the Federal Register] 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, 
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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 e-mail. 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. 
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 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 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) 
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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, process, or 

import any of the chemicals for a significant new use, consistent with the requirements at 

40 CFR part 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 benzidine-based 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 
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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 significant new use notice (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 
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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 Significant New Use Notice (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 benzidine-based 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 benzidine-based 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 
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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 confidential 

business information (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 CBI for some of the chemicals subject to this 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—Benzidine-Based Chemical Substances 

CAS number C.I. name C.I. number Chemical name 

117-33-9 Not available Not available 1,3-Naphthalenedisulfonic acid, 7-hydroxy8-[2-[4'-[2-(4-hydroxyphenyl)diazenyl][1,1'-

biphenyl]-4-yl]diazenyl]- 
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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. 

26267 

 CAS No. 

CBI (NA) 

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

substituted carbopolycycle azo 

benzenesulfonic acid, sodium 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 azosubstituted carbopolycycloazo 

benzenesulfonic acid, sodium salt. (Generic 

Name) 

Accession No. 

21808 

CAS No. 

 CBI (NA) 

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

hydroxy [[[(substituted phenylamino] 

substituted phenylazo] diphenyl]azo-, 

phenylazo-, disodium salt. ( Generic Name) 

Accession No. 

26701 

CAS No. 

CBI (NA) 

CBI CBI Phenylazoaminohydroxynaphthalenylazobip

henylazo substituted benzene sodium 

sulfonate. 

(Generic Name) 

B. What Action has the Agency Previously Taken on Other Benzidine-Based Chemical 

Substances? 

 In 1996, EPA promulgated a TSCA section 5(a)(2) SNUR for the benzidine-based 

chemical substances listed at § 721.1660 (61 FR 52287, October 7, 1996). 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 
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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 Color 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. 2) within or outside the United States. 

 In addition, four of these benzidine-based chemicals were included in EPA’s 

Benzidine-based Dyes Action Plan. The additional five chemicals were found in the 

confidential TSCA inventory. Designed as a part of a comprehensive approach to 

enhancing EPA’s Chemical Management Program, Action Plans summarize hazard, 
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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. 

1). 

EPA received no public comments (EPA-HQ-OPPT-2010-0570 at 

http://www.regulations.gov) on this Action Plan that would provide any indication of 

ongoing manufacturing, importing, or processing of any of the nine benzidine-based

chemical substances that are proposed for addition to the existing SNUR at § 721.1660.

Finally, a general market review on these chemical substances indicates no current 

manufacture (Ref. 2) within or outside the United States. 

 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. 2). 

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 import of articles containing benzidine-based 

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 
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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 Benzidine-Based 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 benzidine-based 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 the 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 benzidine-based chemical substances to metabolize to the parent benzidine 

molecule, which is a known carcinogen (Refs. 4, 5, and 6). This metabolism occurs in 
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humans by an enzyme-mediated 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 benzidine-based 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 
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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-HQOPPT-2010-0570 at 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 benzidinebased 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? 
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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. EPA received no 

public comments submitted Please note that in response to the public docketa request for 

thiscorrection of the information provided in the 2009 Phthalate Action Plan (EPA-HQOPPT-2010-0342 at http://www.regulations.gov) that would provide any indication of 

ongoing manufacturing, importing or processing of DnPPthat was filed under the 

Agency's Information Quality Guidelines by the American Chemistry Council, EPA 

issued a revised Phthalate Action Plan on [insert date] (Ref. 14). However, subsequent 

internet14b). Copies of the request for correction and EPA’s response to it are available 

at 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 
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for DnPP, excluding 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 
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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 Task 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 is concernednotes 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 
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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 
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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 cycles, and EPA 

found no additional evidence of any importation or manufacturing of the chemical. 
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 Alkanes, C12-13, chloro (CAS No. 71011-12-6) was included in EPA’s ShortChain 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. EPA received no public comments submitted to 

the public docket for this Action Plan (EPA-HQ-OPPT-2010-0334 at 

http://www.regulations.gov) that would provide any indication of ongoing manufacturing, 

importing or processing of Alkanes, C12-13, chloro (CAS No. 71011-12-6) (Ref. 59).

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 short-chain chlorinated paraffins 

(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)? 
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 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. 6059-61). 

 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). 
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 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. 6062-63). 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 
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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. 1) 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 benzidine-based chemical substances within or outside the United States. 

 In addition, as discussed earlier, although some of the currently listed benzidinebased 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. 2) revealed no information indicating import of articles 

containing benzidine-based chemical substances for non-excluded purposes. Supporting 

a conclusion that there is no import of textile articles containing benzidine-based 

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 
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Substances List (RSL) (Ref. 6264). 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 substances, or import for a non-excluded use of articles 

containing any benzidine-based chemical substances, the manufacture (including import) 

or processing of the nine newly 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 benzidine-based chemical substances could significantly 

increase the magnitude and duration of exposure to humans over that which would 

otherwise exist currently. EPA is concerned that such an increase should not occur 

without an opportunity 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 40 CFR § 721.1660, and to make 

inapplicable the article exemption at 40 CFR § 721.45(f) for those chemical substances 

newly proposed in this rulemaking as well as for those already listed at 40 CFR § 

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, 

would be required to submit a SNUN. 
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 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). 
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 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 benzidine-based chemical 

substances was being imported or processed) prior to date of publication of the final rule, 
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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 
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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 benzidine-based 

chemical substances subject to this proposed rule, DnPP and the alkanes, C12-13, chloro 

(CAS No. 71011-12-6), as discussed herein, EPA considered relevant information about 

the toxicity of these substances, likely human exposures and environmental releases 

associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. EPA 

has preliminarily determined 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 
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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, 
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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 
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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 40 

CFR § 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 
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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. 

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 
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RIN 2070-AJ73 Page 37 of 60

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 § 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 one-time 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 
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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 either technical person listed under FOR FURTHER 

INFORMATION CONTACT. The docket is available for review as specified under 

ADDRESSES. 

1. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical Substances 

Derived from Benzidine and Its Congeners, 

http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_0

6232010.noheader.pdf (Accessed January 24, 2011). 

2. 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). 

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. 
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RIN 2070-AJ73 Page 39 of 60

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). 

http://ntp.niehs.nih.gov/?objectid=035E5806-F735-FE81-FF769DFE5509AF0A.

7. Golka, K., Kopps, S., Myslak, Z.W. 2004. Carcinogencitiy of azo colorants: 

influence of solubility and bioavailability. Tox Lett 151:203-210. 

8. EPA.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). 

13. U.S. EPA, 2009. U.S. Environmental Protection Agency. Inventory Update 

Reporting IUR: Non Confidential IUR Production Volume Data 1986-2002. Available at: 
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RIN 2070-AJ73 Page 40 of 60

http://www.epa.gov/oppt/iur/tools/data/2002-vol.html (Updated October 26, 2009). 

1414a. U.S. EPA, 20102009. U.S. Environmental Protection Agency. Phthalates 

Action Plan. 

14 b. U.S. EPA, 2012. U.S. Environmental Protection Agency. Phthalates Action 

Plan (Revised).

http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates.html (Accessed 

January 24, 2011).. 

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 
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RIN 2070-AJ73 Page 41 of 60

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 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: 
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RIN 2070-AJ73 Page 42 of 60

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/bb-phthalate.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: 
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RIN 2070-AJ73 Page 43 of 60

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. Monograph on the Potential Human 

Reproductive and Developmental Effects of Di-Isodecyl Phthalate (DIDP); NIH Pub. No. 

03-4485; U.S. Department of Health and Human Services. Available at: 

http://cerhr.niehs.nih.gov/evals/phthalates/didp/didp.html . 

30. NTP-CERHR, 2006. National Toxicology Program - Center for the 

Evaluation of Risks to Human Reproduction. Monograph on the Potential Human 

Reproductive and Developmental Effects of Di-(2-ethylhexyl) Phthalate (DEHP); NIH 

Pub. No. 06-4476; U.S. Department of Health and Human Services. Available at: 

http://cerhr.niehs.nih.gov/evals/phthalates/dehp/dehp.html . 

31. EC, 2003a. European Commission. European Union Risk Assessment Report: 

1,2-Benzenedicarboxylic Acid, Di-C8-10-Branched Alkyl Esters, C9-Rich And Di-

“Isononyl” Phthalate [DINP], CAS-Nos. 68515-48-0, 28553-12-0. Vol. 35; EUR 

20784EN; Office for Official Publications of the European Communities: Luxembourg. 

Available at: http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/dinpreport046.pdf. 

32. EC, 2003b. European Commission. European Union Risk Assessment Report: 

1,2-Benzenedicarboxylic Acid, Di-C9-11-Branched Alkyl Esters, C10-Rich And Di-

“Isodecyl” Phthalate [DIDP], CAS-Nos 68515-49-1 and 26761-40-0. Vol. 36; EUR 

20785EN; Office for Official Publications of the European Communities: Luxembourg. 

Available at: http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/didpreport041.pdf. 
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33. EC, 2004. European Commission. European Union Risk Assessment Report: 

Dibutyl Phthalate [DBP], CAS-No. 84-74-2. Vol. 29; EUR 19840EN; Office for Official 

Publications of the European Communities: Luxembourg. Available at: 

http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf. 

34. EC, 2008a. European Commission. European Union Risk Assessment Report 

Bis(2-Ethylhexyl) Phthalate (DEHP), CAS-No. 117-81-7. Vol. 80; EUR 23384EN; 

Office for Official Publications of the European Communities: Luxembourg. Available 

at: http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf. 

35. EC, 2008b EC. 2008b. European Commission. European Union Risk 

Assessment Report Benzyl Butyl Phthalate (BBP), CASNo. 85-68-7. Vol. 76; EUR 

22773EN; Luxembourg: Office for Official Publications of the European Communities, 

36. Howdeshell, K.L.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2008a. 

Mechanisms of action of phthalate esters, individually and in combination, to induce 

abnormal reproductive development in male laboratory rats. Environ Res. 108(2):168-76. 

37. Howdeshell K.L., Wilson V.S., Furr J., Lambright C.R., Rider C.V., Blystone 

C.R., Hotchkiss A.K., Gray L.E. Jr. 2008b. A mixture of five phthalate esters inhibits 

fetal testicular testosterone production in the sprague-dawley rat in a cumulative, doseadditive manner. Toxicol Sci. 105(1):153-65. 

38. Liu et al., 2005. Liu, K; Lehmann, KP; Sar, M; et al. (2005) Gene expression 

profiling following in utero exposure to phthalate esters reveals new gene targets in the 

etiology of testicular dysgenesis. Biol Reprod 73(1):180–192. 
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39. Heindel et al., 1989. Heindel, JJ; Gulati, DK; Mounce, RC; et al. (1989) 

Reproductive toxicity of three phthalic acid esters in a continuous breeding protocol. 

Fundam Appl Toxicol 12(3):508–518. 

40. NTP, 1985. NTP (National Toxicology Program). (1985) Di-npentylphthalate: reproduction and fertility assessment in CD-1 mice when administered in 

feed. Research Triangle Park, NC: National Toxicology Program. PB86-118999. 

41. Swan et al, 2005. an, S. H.; Main, K. M.; Stewart, S. L.; Kruse, R. L.; Calafat, 

A. M.; Mao, C. S.; Redmon, J. B.; Ternand, C. L.;Sullivan, S.; Teague. J. L. 2005. Study 

for Future Families Research Team. Decrease in Anogenital Distance among male Infants 

with Prenatal Phthalate Exposure. Environ. Health Perspect. Aug 2005, 113(8), 1056–61. 

42. Huang, P.C.; Kuo, P.L.; Chou, Y.Y.; Lin, S.J.; Lee, C.C. 2009. Association 

between prenatal exposure to phthalates and the health outcome of newborns. Environ. 

Int. 35(1):14–20. 

43. Meeker, J.D.; Calafat, A.M.; Hauser, R. 2007. Di(2-ethylhexyl) phthalate 

metabolites may alter thyroid hormone levels in men. Environ Health Perspect. 

115(7):1029-34. 

44. Qiao, L.; Zheng, L.; Cai, D. 2007. Study on the di-n-butyl phthalate and di-2-

ethylhexyl phthalate level of girl serum related with precocious puberty in Shanghai. Wei 

Sheng Yan Jiu. 36(1): 93-5.

45. Hauser, R.; Williams, P.; Altshul, L.; Calafat, A.M. 2005. Evidence of 

interaction between polychlorinated biphenyls and phthalates in relation to human sperm 

motility. Environ Health Perspect. 113(4):425-30. 

46. Hauser, R.; Meeker, J.D.; Duty, S,; Silva, M.J.; Calafat, A.M. 2006. Altered 
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semen quality in relation to urinary concentrations of phthalate monoester and oxidative 

metabolites. Epidemiology. 17(6):682-91. 

47. Hauser, R.; Meeker, J.D.; Singh, N.P.; Silva, M.J.; Ryan, L.; Duty, S.; Calafat, 

A.M. 2007. DNA damage in human sperm is related to urinary levels of phthalate 

monoester and oxidative metabolites. Hum Reprod. 22(3):688-95. 

48. Duty, S.M.; Calafat, A.M.; Silva, M.J.; Ryan, L.; Hauser, R. 2005. Phthalate 

exposure and reproductive hormones in adult men. Hum Reprod. 20(3):604-10. 

49. Colón, I.; Caro, D,; Bourdony, C.J.; Rosario, O. 2000. Identification of 

phthalate esters in the serum of young Puerto Rican girls with premature breast 

development. Environ Health Perspect. 108(9):895-900. 

50. Latini, G.; De Felice, C.; Presta, G.; Del Vecchio, A.; Paris, I.; Ruggieri, F.; 

Mazzeo, P. 2003. Exposure to Di(2-ethylhexyl)phthalate in humans during pregnancy. 

A preliminary report. Biol Neonate. 83(1):22-4. 

51. Rider, C.V.; Furr, J.; Wilson, V.S.; Gray, L.E. Jr. 2008. A mixture of seven 

antiandrogens induces reproductive malformations in rats. Int J Androl. 31(2):249-62. 

52. Rider, C.V.; Wilson, V.S.; Howdeshell, K.L.; Hotchkiss, A.K.; Furr, J.R.; 

Lambright, C.R.; Gray, LE Jr. 2009. Cumulative effects of in utero administration of 

mixtures of "antiandrogens" on male rat reproductive development. Toxicol Pathol. 

37(1):100-13. 

53. Howdeshell, K.L.; Furr, J.; Lambright, C.R.; Rider, C.V.; Wilson, V.S.; Gray, 

L.E. Jr. 2007. Cumulative effects of dibutyl phthalate and diethylhexyl phthalate on male 

rat reproductive tract development: altered fetal steroid hormones and genes. Toxicol Sci. 

99(1):190-202. 
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54. Gray, L.E. Jr; Wilson, V.S.; Stoker, T.; Lambright, C.; Furr, J.; Noriega, N.; 

Howdeshell, K.; Ankley, G.T.; Guillette, L. 2006. Adverse effects of environmental 

antiandrogens and androgens on reproductive development in mammals. Int J Androl. 

29(1): 96-108. 

55. Hotchkiss, A.K.; Parks-Saldutti. L.G.; Ostby, J.S.; Lambright, C.; Furr, J.; 

Vandenbergh, J.G.; Gray, L.E. Jr. 2004. A mixture of the "antiandrogens" linuron and 

butyl benzyl phthalate alters sexual differentiation of the male rat in a cumulative fashion. 

Biol Reprod. 71(6):1852-61. 

56. Oehlmann et al., 2008. Oehlmann, J.; Schulte-Oehlmann, U.; Werner, K.; 

Jagnytsch, O.; Lutz, I.; Kresten, K.; Wollenberger, L.; Santos, E. .; Paull, G. C.; Van 

Look, K. J. W.; Tyler, C. R. 2008. A Critical Analysis of the Biological Impacts of 

lasticizers on Wildlife. Philos. Trans. R. Soc., B: Biol. Sci. 2008, 364(1526), 2047–2062. 

57. Staples et al., 1997. Staples, C. A.; Adams, W. J.; Parkerton, T. F.; Gorsuch, 

J. W.; Biggingers, G. R.; Reiner, K. H. 1997. Aquatic Toxicity of Eighteen Phthalate 

Esters. Environ. Toxicol. Chem. 1997, 16 (5), 875–891. 

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). 
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60. UNEP. 2009. United Nations Environment Programme. Stockholm 

Convention on 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. 17 October 2011. UNEP/POPS/POPRC.7/19. Available 

at: 

http://chm.pops.int/Convention/POPsReviewCommittee/POPRCMeetings/POPRC7/POP

RC7ReportandDecisions/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. 9 July 2009. UNEP/POPS/POPRC.5/2.]” 

The document cited is available at: 

http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/PO

PR%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 
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Persistent Organic Pollutants (POPs). Persistent Organic Pollutants Review Committee.

Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins. 9 July 2009. 

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

http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/PO

PR 5Documents/tabid/592/language/en-US/Default.aspx. Accessed December 11, 2009..)

61.63. 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. 9 July 2009. UNEP/POPS/POPRC.5/2. 

Available at: 

http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/PO

PR 5Documents/tabid/592/language/en-US/Default.aspx. Accessed December 11, 2009.)

64. 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. 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) has determined 
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that this proposed SNUR this action 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 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 
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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, D.C. 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. The 

rationale supporting this conclusion is as follows. 

Under the RFA, small entities include small businesses, small organizations, and small 

governmental jurisdictions. Small entity is defined in accordance with section 601of 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-for-profit 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 
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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 5 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) (FRL5735-4), 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 
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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.
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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).

 
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List of Subjects in 40 CFR Part 721 

 Environmental protection, Chemicals, Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: _________________ 

__________________________________________ 

Director, Office of Pollution Prevention and Toxics. 

 
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 Therefore, it is proposed that 40 CFR Part 721 be amended as follows: 

[AMENDED] 

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

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

2. In § 721.1660, revise paragraph (a) and (b) to read as follows: 

§721.1660 Benzidine-based Chemical Substances. 

(a) Chemical substances and significant new uses subject to reporting. (1) The 

benzidine-based chemical substances listed in Table 1 and Table 2 of this section are 

subject to reporting under this section for the significant new uses described in paragraph 

(a)(2) of this section. 

Table 1. Benzidine-Based Chemical Substances 

CAS number 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. 

26267 

CAS. No. CBI 

(NA) 

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

substituted carbopolycycle azo benzenesulfonic 

acid, sodium salt. (Generic Name) 

Accession No. 

24921 

CAS No. CBI 

(NA) 

CBI CBI 4-(Substituted naphthalenyl )azo diphenylyl azosubstituted carbopolycycle azo benzenesulfonic 

acid, sodium salt. (Generic Name) 

Accession No. 4-(Substituted phenyl)azo biphenylyl azo-
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26256 

CAS No. CBI 

(NA) 

CBI CBI substituted carbopolycycloazo benzenesulfonic 

acid, sodium salt. (Generic Name) 

Accession No. 

21808 

CAS No. CBI 

(NA) 

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

hydroxy [[[(substituted phenylamino] substituted 

phenylazo] diphenyl]azo-, phenylazo-, disodium 

salt. ( Generic Name) 

Accession No. 

26701 

CAS No. CBI 

(NA) 

CBI CBI Phenylazoaminohydroxynaphthalenylazobiphenyla

zo substituted benzene sodium sulfonate. 

(Generic Name) 

Table 2.—Benzidine-Based Chemical Substances 

CAS number C.I. name C.I. number 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-hydroxy3,6-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-sulfo2-naphthalenyl) azo][1,1’-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt 

2429–83–6 Direct Black 4 C.I. 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-sulfo1-naphthalenyl)azo][1,1’-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt 
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2586–58–5 C.I. Direct 

Brown 1:2 

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

sulfophenyl)azo]phenyl]azo][1,1’-biphenyl]-4-

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

2602–46–2 C.I. Direct Blue 

6 

22610 2,7-Naphthalenedisulfonic acid, 3,3’-[[1,1’-

biphenyl]-4,4’-diylbis(azo)]bis[5-amino-4-

hydroxy-, tetrasodium salt 

2893–80–3 C.I. Direct 

Brown 6 

30140 Benzoic acid, 5-[[4’-[[2,4-dihydroxy-3-[(4-

sulfophenyl) azo]phenyl]azo][1,1’-biphenyl]-4-

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

3530–19–6 C.I. Direct Red 

37 

22240 1,3-Naphthalenedisulfonic acid, 8-[[4’-[(4-

ethoxyphenyl) 

azo][1,1’-biphenyl]-4-yl]azo]-7-hydroxy-,disodium 

salt 

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

[[4-[[(4-methylphenyl) 

sulfonyl]oxy]phenyl]azo][1,1’-biphenyl]-4-yl]azo]-

, disodium salt 

3626–28–6 C.I. Direct Green 

1 

30280 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4’-[(4-hydroxyphenyl)azo][1,1’-

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

3811–71–0 C.I. Direct 

Brown 1 

30045 Benzoic acid, 5-[[4’-[[2,4-diamino-5-[(4-

sulfophenyl) azo]phenyl]azo][1,1’-biphenyl]-4-

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

4335–09–5 C.I. Direct Green 

6 

30295 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-6-[[4’-[(4-hydroxyphenyl)azo][1,1’-

biphenyl]-4-yl] azo]-3-[(4-nitrophenyl)azo]-

,disodium salt 

6358–80–1 C.I. Acid Black 

94 

30336 2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4’-[[4-hydroxy-2-[(2-

methylphenyl)amino]phenyl]azo] [1,1’- biphenyl]-

4-yl]azo]-6-[(4-sulfophenyl) azo]-, trisodium salt 

6360–29–8 C.I. Direct 

Brown 27 

31725 Benzoic acid, 5-[[4’-[[4-[(4-amino-7-sulfo-1-

naphthalenyl)azo]-6-sulfo-1-

naphthalenyl]azo][1,1’-biphenyl]-4-yl] azo]-2-

hydroxy-,trisodium salt 

6360–54–9 C.I. Direct 

Brown 154 

30120 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl] azo][1,1’-biphenyl]-4-

yl]azo]-2- hydroxy-3-methyl-, disodium salt 

8014–91–3 C.I. Direct 

Brown 74 

36300 Benzoic acid, 3,3’-[(3,7-disulfo-1,5-

naphthalenediyl)bis [azo(6-hydroxy-3,1-

phenylene)azo[6(or7)-sulfo-4,1- 

naphthalenediyl]azo[1,1’-biphenyl]-4,4’-

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

16071–86–6 C.I. Direct 

Brown 95 

30145 Cuprate(2-), [5-[[4’-[[2,6-dihydroxy-3-[(2-

hydroxy-5-sulfophenyl)azo]phenyl] azo][1,1’-

biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-
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,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 Color 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. 

3. By adding new § 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: 
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§ 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 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].