Federal Register, Volume 77 Issue 60 (Wednesday, March 28, 2012)

[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Proposed Rules]
[Pages 18752-18766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7208]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2010-0573; FRL-8865-2]
RIN 2070-AJ73

Benzidine-Based Chemical Substances; Di-n-pentyl phthalate
(DnPP); and Alkanes, C[ihel1][ihel2]-[ihel1][ihel3], Chloro; Proposed
Significant New Use Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing: To add nine benzidine-based chemical substances to the
Significant New Use Rule (SNUR) on benzidine-based chemical substances;
a SNUR for di-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). In the case of the
benzidine-based chemical substances, EPA is also proposing to make
inapplicable the exemption relating to persons that import or process
substances as part of an article. If finalized, this rule would require
persons who intend to manufacture, import, or process these chemical
substances for an activity that is designated as a significant new use
to notify EPA at least 90 days before commencing that activity. The
required notification would provide EPA with the opportunity to
evaluate activities associated with a significant new use and an
opportunity to protect against potential unreasonable risks, if any,
from exposure to the chemical substance.

DATES: Comments must be received on or before June 26, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-0573, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2010-0573. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number
EPA-HQ-OPPT-2010-0573. EPA's policy is that all comments received will
be included in the docket without change and may be made available on-
line at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the
docket index available at http://www.regulations.gov. Although listed
in the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required

[[Page 18753]]

to show photographic identification, pass through a metal detector, and
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Sara Kemme, National Program Chemicals Division (7404T), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (202) 566-0511; email address:
sara.kemme@epa.gov.
For general information contact: The TSCA Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

These three different SNURs may apply to different entities.
1. Benzidine-based chemical substances. You may be potentially
affected by this action if you manufacture, import, or process,
including as part of an article, any of the benzidine-based chemical
substances listed in Tables 1. and 2. of the regulatory text in this
document. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of one or more of
the subject chemical substances.
Entities which plan to use the listed chemical substances
in conjunction with apparel and other finished products made from
fabrics, leather, and similar materials.
Entities which plan to use the listed chemical substances
in conjunction with paper and allied products.
Manufacturers, importers, or processors of the subject
chemical substances in printing inks.
These entities may include those described by the North American
Industrial Classification System (NAICS) codes 325-chemical
manufacturing, 313-textile manufacturers, 316-leather and allied
products manufacturers, 322-paper manufacturers, 4243-apparel, piece
goods, and notions wholesalers, or 443-clothing and accessories stores.
2. DnPP. For DnPP, you may be potentially affected by this action
if you manufacture (defined by statute to include import), or process
DnPP. Potentially affected entities may include, but are not limited
to: Chemical industry--plastic material & resins (NAICS code 325211).
3. Alkanes, C12 13, chloro (CAS No. 71011-12-6). You may be
potentially affected by this action if you manufacture, import, or
process the following short-chained chlorinated paraffin (SCCP):
Alkanes, C12-13, chloro (CAS No. 71011-12-6). Potentially
affected entities may include, but are not limited to: Manufacturers
(defined by statute to include importers) of SCCPs (NAICS codes 325 and
325998), e.g., chemical manufacturing; including miscellaneous chemical
product and preparation manufacturing; and processors of SCCPs (NAICS
codes 324 and 324191), e.g., petroleum lubricating oil and grease
manufacturing.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The NAICS codes have been provided to assist you and others
in determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in Sec.
721.5 for SNUR-related obligations and with respect to benzidine-based
chemical substances, the applicability provisions in Unit II.C. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. 721.20) and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

EPA is proposing to add nine chemical substances (see Table 1. in
Unit III.A.) to the existing SNUR for certain benzidine-based chemical
substances at Sec. 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

[[Page 18754]]

for Colour Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as
an indicator dye.'' Sec. 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 Sec. 721.1660 to make
inapplicable the exemption at Sec. 721.45(f) for persons that import
or process benzidine-based chemical substances as part of an article.
Additionally, EPA is proposing a SNUR for DnPP that would
designate, as a significant new use, any use of the substance other
than as a chemical standard for laboratory use.
EPA is also proposing a SNUR for alkanes, C12-13, chloro
(CAS No. 71011-12-6) that would designate any use of the substance as a
significant new use. Because any use of alkanes, C12-13,
chloro (CAS No. 71011-12-6) would be a new use, Sec. 721.5(a)(2) would
be inapplicable to alkanes, C12-13, chloro (CAS No. 71011-
12-6). This provision addresses manufacturers, importers, and
processors who are also distributors of a chemical substance subject to
a SNUR. In certain cases, it requires these distributors to alert their
customers that the SNUR exists. This requirement serves an important
communication function when certain uses of a chemical, but not others,
trigger Significant New Use Notice (SNUN) requirements. Where there are
no ongoing, existing uses of a chemical substance and EPA determines by
rule that all future uses trigger SNUNs requirement (as with alkanes,
C12-13, chloro (CAS No. 71011-12-6)), EPA believes these
alerts are not only unnecessary, but unlikely to ever occur.
These proposed SNURs would require persons that manufacture,
import, or process any of the chemicals for a significant new use,
consistent with the requirements at Sec. 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 Sec. 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 currently-listed 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 determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). These
factors include:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
Once EPA determines that a use of a chemical substance is a
significant new use, TSCA section 5(a)(1)(B) requires persons to submit
a SNUN to EPA at least 90 days before they manufacture, import, or
process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).
The general SNUR provisions are found at 40 CFR part 721, subpart A.

C. Applicability of general provisions

General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule.
Provisions relating to user fees appear at 40 CFR part 700.
According to Sec. 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
However, Sec. 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 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 Sec. 721.1660. The nine benzidine-based chemical
substances covered by this proposed SNUR are listed in Table 1. The
chemicals listed in Table 1 are identified by Chemical Abstract Service
Registry Numbers (CAS number) or if the chemical's CAS number is
claimed CBI, the chemical is identified by an EPA accession number,
along with its corresponding generic name. The accession numbers are
EPA assigned numbers used to identify chemicals in place of
confidential CAS numbers. Table 1 also indicates the availability of
the Colour Index (C.I.) name and C.I. number, which is either not
available or

[[Page 18755]]

CBI for some of the chemicals subject to this proposed rule. Persons
who are interested in determining the precise identity of the chemical
designated by a certain accession number and a generic name should
submit a bonafide request to EPA that complies with the information
requirements stipulated in Sec. 721.11(b).

Table 1--Newly Added Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
CAS or Accession No. C.I. name C.I. No. Chemical name
----------------------------------------------------------------------------------------------------------------
117-33-9........................... Not available......... Not available......... 1,3-Naphthalenedi sulfonic
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-Naphthalenetri
sulfonic 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-Naphthalenedi sulfonic
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-Naphthalenedi sulfonic
acid, 4-amino-5-hydroxy-3-
[2-[4'-[2-[2-hydroxy-4-[(2-
methylphenyl)amino]
phenyl]diazenyl][1,1'-
biphenyl]-4-yl]diazenyl]-6-
(2-phenyldiazenyl)-
Accession No. 21808 CAS No. CBI CBI................... CBI................... 2,7-Naphthalenedi sulfonic
(NA). acid, 4-amino-5-hydroxy
[[[(substituted
phenylamino)] substituted
phenylazo] diphenyl]azo-,
phenylazo-, disodium salt.
(generic name)
Accession No. 24921 CAS No. CBI CBI................... CBI................... 4-(Substituted
(NA). naphthalenyl)azo
diphenylyl azo-substituted
carbopolycycle azo benzene
sulfonic acid, sodium
salt. (generic name)
Accession No. 26256 CAS No. CBI CBI................... CBI................... 4-(Substituted phenyl)azo
(NA). biphenylyl azo-substituted
carbopolycycloazo benzene
sulfonic acid, sodium
salt. (generic name)
Accession No. 26267 CAS No. CBI CBI................... CBI................... 4-(Substituted phenyl)azo
(NA). biphenylyl azo--
substituted carbo
polycycle azo benzene
sulfonic acid, sodium
salt. (generic name)
Accession No. 26701 CAS No. CBI CBI................... CBI................... Phenylazoamino
(NA). hydroxynaphthalenylazobiph
enylazo 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 Sec. 721.1660 (61 FR
52287, October 7, 1996) (FRL-5396-6). That rule considered any use of
the chemical substances except those listed in Sec. 721.1660(a)(2) as
a significant new use that requires a SNUN to be submitted to the
Agency prior to manufacture, import, or processing of the listed
chemical substances. Because they were identified as ongoing, the SNUR
excluded as significant new uses the following uses: As a reagent to
test for hydrogen peroxide in milk; a reagent to test for hydrogen
sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; as a
reagent for detecting blood; and as an analytical standard. In
addition, for Colour Index (C.I.) Direct Red 28 (Congo Red) (CAS No.
573-58-0), use as an indicator dye was excluded as a significant new
use. The SNUR did not require a SNUN to be submitted by persons that
import or process a listed substance as part of an article.

C. What is the production volume of newly-proposed and currently-listed
chemical substances?

For the newly proposed nine benzidine-based chemical substances,
data reported to EPA for the 2006, 2002, and 1998 reporting cycles, as
required by the TSCA Inventory Update Reporting (IUR) rule, indicate no
evidence of production (including import). The IUR regulation requires
manufacturers and importers of certain chemical substances to report
site and manufacturing information for chemicals manufactured
(including imported) in amounts of 25,000 pounds or greater at a single
site (prior to 2006, reporting was for 10,000 pounds at a site). A
general market review on these chemical substances indicates no current
manufacture (Ref. 1) within or outside the United States.
In addition, four of these 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
part of a comprehensive approach to enhancing EPA's Chemical Management
Program, action plans summarize hazard, exposure, and use information;
outline the potential risks that each chemical may pose; and identify
the specific steps the Agency is considering to address those concerns
(Ref. 2).
For the benzidine-based chemical substances currently listed at
Sec. 721.1660, data reported to EPA for the 2006, 2002, and 1998
reporting cycles, as required by the TSCA IUR rule, indicate no
evidence of domestic production (including import) at IUR reportable
levels. Further, EPA's general market review on the currently listed
benzidine-based chemical substances suggests that the majority of these
chemical substances are not currently being manufactured domestically
or abroad (Ref. 1). Although some of these substances appear to be
manufactured for allowable uses within the United States at a level
below current IUR reporting thresholds, and some substances appear to
be manufactured outside the United States generally and may therefore
potentially be imported as part of an article, EPA does not have
information to suggest that the substances are being imported, for use
as part of articles. In fact, the market review did not find evidence
of any

[[Page 18756]]

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 ongoing manufacture, import, or processing of these benzidine-
based chemical substances, including in articles, other than as
excepted at Sec. 721.1660(a)(2).

D. What are the uses of these benzidine-based chemical substances?

Historically, the benzidine-based chemical substances currently
listed at Sec. 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 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 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 exposure to these
substances.
Dermal exposure can occur from the leaching of the chemical
substances by sweat in contact with the dyed textiles (Ref. 7). Dermal
exposure is also a concern since many of these chemical substances can
be directly absorbed by the skin to some extent. It is well established
that the enzymatically-aided dye reduction to the carcinogenic
benzidine unit occurs internally in the liver and the gut (Refs. 9 and
10). Studies have shown that some human skin bacteria possess azo-
reductases, the enzymes necessary to break down the benzidine-based
chemical substances to release the carcinogenic amines, which can be
more readily absorbed (Ref. 11).
Consistent with the information on dermal absorption that EPA
reviewed in developing its recent Benzidine-based Chemical Substances
Action Plan (EPA-HQ-OPPT-2010-0570 at http://www.regulations.gov), EPA
identified the following main routes of consumer exposure to benzidine-
based chemical substances that are of concern: (1) Dermal absorption,
the primary route from wearing dyed clothing or footwear; (2) oral
ingestion, an additional route for babies and young children who suck
on clothing, blankets, and other non-food products which might contain
any of the benzidine-base chemical substances; (3) inhalation exposure,
a more prevalent route in occupational settings; however, it can also
occur from the use of dyed inks during ``air brushing'' or from off-
gassing from the dyed carpets to indoor air; and (4) contact with the
benzidine-based chemical substances entering the environment, through
the whole life cycle of benzidine-based chemical substances in textiles
(Ref. 12).

IV. Overview of DnPP

A. What chemical is included in the proposed SNUR?

This proposed SNUR would apply to DnPP (1,2-Benzenedicarboxylic
acid, 1,2-dipentyl ester), CAS No. 131-18-0, an ortho-phthalate (or
phthalate ester).

B. What is the production volume of DnPP?

No IUR production volume data were reported for DnPP during the
2006, 2002, 1998, and 1994 reporting cycles (Ref. 13). The last
reporting of DnPP production to the IUR occurred in 1990 and
corresponds to the lowest reportable production volume range (10,000 to
500,000 pounds) (Ref. 13).
DnPP was included in EPA's Phthalates Action Plan, which was issued
on December 30, 2009 (Ref. 14a). As stated in Unit III.C., the chemical
action plans were designed as a part of a comprehensive approach to
enhancing EPA's Chemical Management Program. These action plans
summarize available hazard, exposure, and use information; outline the
potential risks that each chemical may present; and identify the
specific steps the Agency is considering to address those concerns.
Please note that in response to a request for correction of the
information provided in the 2009 Phthalate Action Plan that was filed
under the Agency's Information Quality Guidelines by the American
Chemistry Council, EPA issued a revised Phthalate Action Plan on March
14, 2012 (Ref. 14b). Copies of the request for correction and EPA's
response to it are available at http://www.epa.gov/quality/informationguidelines/iqg-list.html. Internet queries performed by EPA
identified several companies that either use or sell DnPP as a chemical
standard for laboratory use. As a result, EPA is proposing a SNUR for
DnPP, excluding

[[Page 18757]]

use of the substance as a chemical standard for laboratory use.

C. What are the uses of DnPP?

DnPP belongs to a broad category of chemicals commonly referred to
as phthalates. Although a number of phthalates are in common use, EPA
believes the individual phthalate DnPP is not in general use in the
United States, and only has a limited application as a chemical
standard for laboratory use. As a chemical category, the major use of
phthalates is as plasticizers (Refs. 15-23) especially in polyvinyl
chloride (PVC) products, where they are added to impart flexibility and
other desirable properties. Phthalate-containing PVC products include a
variety of industrial and commercial products, as well as specialized
medical and dental applications. The particular phthalate or
combination of phthalates used in a specific product's formulation
depends on the properties the phthalates impart, as well as their cost.

D. What are the potential health and environmental effects of DnPP?

1. Human health effects. Exposures of some phthalates in animal
studies resulted in phthalate syndrome effects, which consist of
changes in the fetal development of the reproductive system (Refs. 15-
22 and 24-35). The phthalates that are the most potent at causing
phthalate syndrome effects are generally those with linear ester side
chains having 4-6 carbons (Ref. 24). DnPP has a linear carbon chain
length of 5 carbons. Of the phthalates studied, DnPP is the most potent
in producing testicular toxicity in pubertal animals (Ref. 24).
Developmental oral exposures in rats to DnPP showed increased
resorptions, increased fetal mortality, and decreased fetal testicular
testosterone production (Refs. 36 and 37); and reduced anogenital
distance in male rat offspring (Ref. 38). Effects noted in adult mice
exposed to DnPP include decreased body weight; increased liver weights;
decreased kidney weights; decreases in the weights of the epididymis,
cauda epididymis, testes, and seminal vesicles; complete absence of
detectable sperm; shorter average estrous cycle length in females; and
decreased fertility (Refs. 39 and 40). Gross and microscopic evidence
of degenerative changes have been observed in the testes and epididymis
(including testicular atrophy, interstitial cell hyperplasia,
degeneration of the seminiferous tubules, and accumulation of fluid and
degenerated cells in the epididymis) of rodents (Refs. 39 and 40).
There are no subchronic or chronic animal studies of DnPP exposure
through any exposure route.
There are no known human studies of exposure to DnPP. However, due
to the data discussed in this section, the data presented and discussed
in Phthalates and Cumulative Risk Assessment: The Tasks Ahead,
Committee on the Health Risks of Phthalates, National Research Council
(2008) (Ref. 24) and DnPP's general structure and categorization as a
phthalate, EPA notes that the human health effects of DnPP exposure may
be similar to that observed for some other phthalates. Several human
studies have reported associations of exposure of some other phthalates
with adverse reproductive outcomes and developmental effects similar to
those in the rat, although no causal link has been established (Refs.
24 and 41-50). The reproductive developmental effects of some
phthalates observed in humans include shortened anogenital distance
observed in newborn boys, shortened pregnancy, lower sex and thyroid
hormones, and reduced sperm quality in adults; however, some studies
failed to show these effects (Ref. 42). Since the pathway for sexual
differentiation in the fetus is highly conserved in all mammals, the
reproductive and developmental effects observed in the rat studies are
potentially relevant to humans.
Studies in animals evaluating the cumulative effects of
combinations of phthalates on testosterone fetal mortality, and male
and female reproductive development later in life have demonstrated all
mixtures were cumulative for all endpoints (Refs. 36-37 and 51-55). The
reproductive effects of DnPP observed in animal studies, the
reproductive effects of other phthalates observed in humans, and the
data on the cumulative effects of mixtures of phthalates, support EPA's
concern for potential human health hazards following exposure to DnPP.
2. Environmental effects. EPA does not know of any studies of the
environmental effects of DnPP. Due to the general structure of DnPP,
its behavior in an aquatic environment similar to the close analog mono
2-ethylhexyl phthalate, its log Kow, and water solubility
measurements, and its categorization as a phthalate, EPA is concerned
that the environmental effects of DnPP may be similar to those of other
phthalates studied. Other phthalates studied have been shown to have
biological effects in all studied animal groups and have been observed
at environmentally relevant exposures in the nanogram/liter to
microgram/liter range. The combination of the inherent toxicity,
variable solubility, log of the octanol-water coefficient values, and
bioconcentration factor (BCF) values among the studied phthalates
elicit both acute and chronic toxicity to aquatic and terrestrial
wildlife by targeting thyroid function, liver function, reproduction,
and other physiological mechanisms (Refs. 31-35, 56 and 57).

E. What are the potential routes and sources of exposure to DnPP?

1. Human exposure. Data from the National Health and Nutrition
Examination Survey (NHANES) indicates widespread exposure of the
general population to various phthalates (Ref. 58). Phthalates are used
in a wide array of plastic products and may be released into the
environment during use and disposal of these products (Ref. 58).
Biomonitoring data from amniotic fluid and urine have demonstrated that
humans are exposed to various phthalates in utero, as infants, during
puberty, and in adult life; and that people are exposed to several
phthalates at once. The urinary metabolites of DnPP were not
specifically included in the 4th National Report on Human Exposure to
Environmental Chemicals (2010), so EPA cannot draw conclusions as to
the current exposure of the general population in the United States to
DnPP.
2. Environmental exposure. Due to phthalates' pervasive use and
release, as well as their propensity for global transport, various
phthalates may be found in most environmental media, including ambient
air, surface water, soil, and sediment (Refs. 25-32 and 34-35). Fish
and other aquatic organisms, as well as terrestrial animals have
evidenced exposure to a common phthalate: di-(2-ethylhexyl) phthalate
(DEHP) (Refs. 34 and 57). EPA does not have available data on
environmental exposures to DnPP.

V. Overview of Alkanes, C12-13, Chloro (CAS No. 71011-12-6)

A. What chemical is included in the proposed SNUR?

This proposed SNUR would cover alkanes, C12-13, chloro
(CAS No. 71011-12-6), one type of short-chain chlorinated paraffin
(SCCP). This consists of C12 and C13 alkanes with
varying degrees of chlorination.

B. What is the production volume of alkanes, C12 13, chloro (CAS No.
71011-12-6)?

No production volumes for alkanes, C12-13 chloro (CAS
No. 71011-12-6) were reported to the IUR during the 2006, 2002, 1998,
and 1994 reporting

[[Page 18758]]

cycles, and EPA found no additional evidence of any importation or
manufacturing of the chemical.
Alkanes, C12-13, chloro (CAS No. 71011-12-6) was
included in EPA's Short-Chain Chlorinated Paraffins (SCCPs) and Other
Chlorinated Paraffins Action Plan (Ref. 59). As stated in Unit III.C.,
the chemical action plans were designed as a part of a comprehensive
approach to enhancing EPA's Chemical Management Program. These action
plans summarize available hazard, exposure, and use information;
outline the potential risks that each chemical may present; and
identify the specific steps the Agency is considering to address those
concerns.

C. What were the uses of this SCCP?

Alkanes, C12-13, chloro (CAS No. 71011-12-6) is an
individual chemical substance that belongs to a category of chemicals
referred to as SCCPs. There are many different chemical substances that
are members of the SCCP category. Generally these SCCPs have between 10
and 13 carbon atoms and contain 40--70 percent chlorine by weight. Of
the different SCCPs that are listed on the TSCA Inventory, EPA believes
the SCCP named ``Alkanes, C12-13, chloro (CAS No. 71011-12-
6)'' is not in use in the United States and EPA has found no
information that indicates it has ever been used. All of the data
discussed in this section associated with the SCCPs general category
would pertain to any individual member of that category, including
alkanes, C12-13, chloro (CAS No. 71011-12-6).

D. What are the potential environmental effects of alkanes, C12 13,
chloro (CAS No. 71011-12-6)?

The primary concern for SCCPs is ecotoxicity. There are
internationally accepted data specifically on the ecotoxicity of
alkanes, C12-13, chloro (CAS No. 71011-12-6) (Ref. 60).
Alkanes, C12-13, chloro (CAS No. 71011-12-6) are highly
toxic to aquatic invertebrates following acute and chronic exposures.
In fish, this high toxicity is associated with chronic exposures, but
not for acute exposures. For aquatic plants, there is high toxicity
associated with both acute and chronic exposures to SCCPs in general
(Ref. 59-61).
Both Health Canada and Environment Canada have characterized all
chlorinated paraffins (short chain chlorinated paraffins, medium chain
chlorinated paraffins, and long chain chlorinated paraffins), which
include the chemical substance covered by this proposed rule, as
``toxic'' under the Canadian Environmental Protection Act (CEPA) (Ref.
61). Their assessment found that these SCCPs have or may have an
immediate or long term harmful effect on the environment or its
biological diversity; and that they are persistent, bioaccumulative,
inherently toxic and present in the environment primarily as a result
of human activity (Ref. 61).

E. What are the potential routes and sources of exposure to alkanes,
C12 13, chloro (CAS No. 71011-12-6)?

The mechanisms or pathways by which the SCCPs, including alkanes,
C12-13, chloro (CAS No. 71011-12-6), move into and through
the environment and humans are not fully understood, but are likely to
include releases from manufacturing of the chemicals, manufacturing of
products like plastics or textiles, aging and wear of products like
sofas and electronics, and releases at the end of product life (e.g.,
disposal, recycling).
EPA has concerns regarding the environmental fate and the exposure
pathways that lead to any SCCP presence, including C12 and C13 SCCPs
(for example, Alkanes, C12-13, Chloro (CAS No. 71011-12-6)),
in a variety of biota, including freshwater aquatic species, marine
mammals, and avian and terrestrial wildlife (Ref. 60). In addition,
SCCPs, including C12 and C13 SCCPs, have been detected in samples of
human breast milk from Canada and the United Kingdom, as well as in a
variety of food items from Japan and various regions of Europe (Ref.
62-63). SCCPs are routinely found in soil and sediment samples. EPA
also has concerns about the persistence, bioaccumulation, and toxicity
(PBT) of SCCPs (Ref. 60).

VI. Rationale and Objectives

A. Rationale

Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows EPA to
evaluate the use according to the specific parameters and circumstances
surrounding that intended use.
1. Benzidine-based chemical substances. As summarized in Unit III.,
EPA is concerned about potential carcinogenic effects on workers and
consumers from the manufacture, processing, importing, or use of these
substances. Consumers exposed via dermal exposure to consumer products
containing the benzidine-based chemical substances are a particular
concern because enzymes present in the human body and in bacteria on
the skin aid in the reduction of these chemical substances to the
benzidine unit, an established human carcinogen (Ref. 8). The main
consumer products that could result in dermal exposure if containing
these chemical substances include textiles and leather products because
they are in prolonged contact with human skin.
During the review of information on benzidine-based chemical
substances, EPA determined that the newly identified chemical
substances covered by this proposed rule present the same concerns
(Ref. 2) as those of the benzidine-based chemical substances currently
listed under Sec. 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 benzidine-based chemical substances may be manufactured or
processed outside the United States, EPA does not have specific
information that suggests they are entering into the United States in
imported articles (Ref. 4). In fact, an analysis of the benzidine-based
chemical substances market (Ref. 1) revealed no information indicating
import of articles containing 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 Substances List (RSL) (Ref. 64).
The RSL is a compilation of chemicals, regulated or banned, that are
used by apparel and footwear industries.
Although it appears there is no ongoing manufacture of the nine
newly proposed benzidine-based chemical

[[Page 18759]]

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 Sec.
721.1660, and to make inapplicable the article exemption at Sec.
721.45(f) for those chemical substances newly proposed in this
rulemaking as well as for those already listed at Sec. 721.1660. If
finalized, a person who intends to manufacture (including import) or
process any of the benzidine-based chemical substances for a non-
excluded use, or to import or process any listed benzidine-based
chemical substance for a non-excluded use as part of an article, would
be required to submit a SNUN.
2. DnPP. As summarized in Unit IV., EPA has concerns regarding
potential adverse human health and environmental effects that may be
caused by DnPP. EPA has direct information from animal studies that
DnPP specifically can elicit developmental/reproductive effects that
are relevant to human health and also indicate potential effects in
wildlife. EPA also is concerned that due to its general structure and
categorization as a phthalate that DnPP may elicit adverse
environmental effects similar to those described for other phthalates.
EPA is concerned that any manufacturing (including import) or
processing of DnPP, beyond that for its limited ongoing use as a
chemical standard for laboratory use, could significantly increase the
magnitude and duration of exposure to humans over that which would
otherwise exist currently. EPA is concerned that such an increase
should not occur without an opportunity to evaluate activities
associated with a significant new use and an opportunity to protect
against potential unreasonable risks, if any, from exposure to the
chemical substance. Therefore, EPA is proposing a SNUR for DnPP that
would designate, as a significant new use, any use of the chemical
substance other than as a chemical standard for laboratory use. If
finalized, a person who intends to manufacture, import, or process DnPP
for use other than as a chemical standard for laboratory use would be
required to submit a SNUN.
3. Alkanes, C12 13, chloro (CAS No. 71011-12-6). The mechanisms or
pathways by which the SCCPs, including alkanes, C12-13,
chloro (CAS No. 71011-12-6), move into and through the environment and
humans are not fully understood, but are likely to include releases
from manufacturing of the chemicals, manufacturing of products like
plastics or textiles, aging and wear of products like sofas and
electronics, and releases at the end of product life (e.g., disposal,
recycling).
EPA believes that all manufacture, processing, and import into the
United States of alkanes, C12-13, chloro (CAS No. 71011-12-
6) has ceased. Given EPA has no evidence to suggest that there is any
manufacture, processing, or importation of this chemical substance in
the United States, and taking into consideration the negative
commercial and regulatory environment associated with this chemical
internationally (including the EU and Canadian ban on marketing) and
use of the alkanes, C12-13, chloro (CAS No. 71011-12-6)
domestically, EPA does not expect to find such activity. However, EPA
is concerned that commencement of the manufacture, import or processing
for any new uses, including resumption of past uses, could
significantly increase the magnitude and duration of exposure to humans
over that which would otherwise exist. EPA is concerned that such an
increase should not occur without an opportunity to evaluate activities
associated with a significant new use and an opportunity to protect
against potential unreasonable risks, if any, from exposure to the
chemical substance. Therefore, EPA is proposing a SNUR for alkanes,
C12-13, chloro (CAS No. 71011-12-6) that would designate as
a significant new use any use of the chemical substance. If finalized,
a person who intends to manufacture, import, or process alkanes,
C12-13, chloro (CAS No. 71011-12-6) for any use would be
required to submit a SNUN.
EPA is requesting comment on whether any of the significant new
uses identified are currently ongoing. However, if EPA determines,
based on comments on this proposed rule or on other information the
Agency identifies, that any proposed significant new use of any of the
chemical substances has been ongoing (including, in the case of
benzidine-based chemical substances, that an article containing
benzidine-based chemical substances was being imported or processed)
prior to date of publication of the final rule, EPA would exclude such
ongoing uses from the final SNUR and consider pursuing other regulatory
action, as appropriate.

B. Objectives

Based on the considerations in Unit VI.A.1-3, EPA wants to achieve
the following objectives with regard to the significant new use(s) that
are designated in this proposed rule:
1. EPA would receive notice of any person's intent to manufacture
or process the specified chemicals for the described significant new
uses before that activity begins;
2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing of the specified chemicals for the described significant new
use; and
3. EPA would be able to regulate prospective uses of the specified
chemicals before the described significant new uses occur, provided
that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or
7.

VII. Significant New Use Determination

Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use of the
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

[[Page 18760]]

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 Sec. 721.1660(a)(2)(i) of the
regulatory text in this document, is a significant new use. EPA has
also preliminarily determined that the manufacture, import, or
processing of DnPP for any use other than as a chemical standard for
laboratory use is a significant new use, and the manufacture,
processing, or import of alkanes, C12-13, chloro (CAS No.
71011-12-6) for any use is a significant new use.

VIII. Request for Public Comment

EPA welcomes comments on any aspect of this proposed SNUR.
Information available about environmental effects, health effects, and
exposure would be beneficial. EPA is also requesting public comment on
whether there are any ongoing uses of any of these chemicals for the
proposed significant new uses (including processing or import of
benzidine-based chemical substances in articles) and would welcome
specific information that documents such uses.

IX. Alternatives

Before proposing these SNURs, EPA considered the following
alternative regulatory actions:

A. Promulgate a TSCA Section 8(a) Reporting Rule

Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture, import, or process a listed chemical for a
specific use or any use. However, for the chemical substances subject
to this proposed rule, the use of TSCA section 8(a) rather than SNUR
authority would have several limitations. First, if EPA were to require
reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA
would not have the opportunity to review human and environmental
hazards and exposures associated with the proposed significant new use
and, if necessary, take immediate follow-up regulatory action under
TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it
begins. In addition, EPA may not receive important information from
small businesses, because such firms generally are exempt from TSCA
section 8(a) reporting requirements. In view of the level of health and
environmental concerns about the chemicals subject to this proposed
rule if used for the proposed significant new uses, EPA believes that a
TSCA section 8(a) rule for this substance would not meet EPA's
regulatory objectives.

B. Regulate Under TSCA Section 6

EPA may regulate under TSCA section 6 if ``the Administrator finds
that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use or disposal of a chemical
substance or mixture presents or will present an unreasonable risk of
injury to health or the environment.'' (TSCA section 6(a)). Given that
the benzidine-based chemical substances subject to this proposed rule
are no longer being used except as provided in the regulatory text of
this document, DnPP is no longer being used except as a chemical
standard for laboratory use, and alkanes, C12-13, chloro
(CAS No. 71011-12-6) is no longer used in the United States, EPA
concluded that risk management action under TSCA section 6 is not
necessary at this time. This proposed SNUR would allow the Agency to
address the potential risks associated with the proposed significant
new uses. If EPA learns that these chemicals are in use, EPA may
reconsider this decision and pursue additional regulatory action as
appropriate.

X. Applicability of Proposed Rule to Uses Occurring Before Effective
Date of the Final Rule

As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
begin the commercial manufacture, import, or processing of a covered
substance as a significant new use have to cease any such activity as
of the effective date of the rule if and when finalized. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. Uses arising after the
publication of the proposed rule are distinguished from uses that exist
at publication of the proposed rule. The former would be new uses, the
latter ongoing uses. To the extent that additional ongoing uses are
found in the course of rulemaking, EPA would exclude those uses from
the final SNUR. EPA has promulgated provisions to allow persons to
comply with this SNUR before the effective date. If a person were to
meet the conditions of advance compliance under Sec. 721.45(h), that
person would be considered to have met the requirements of the final
SNUR for those activities.

XI. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions: (1) Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)) and (2) development of test data
may be necessary where the chemical substance has been listed under
TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a
section 4 test rule or a section 5(b)(4) listing covering the chemical
substance, persons are required only to submit test data in their
possession or control and to describe any other data known to or
reasonably ascertainable by them (15 U.S.C. 2604(d); 721.25, and
720.50). However, as a general matter, EPA recommends that SNUN
submitters include data that would permit a reasoned evaluation of
risks posed by the chemical substance during its manufacture, import,
processing, use, distribution in commerce, or disposal. EPA encourages
persons to consult with the Agency before submitting a SNUN. As part of
this optional pre-notice consultation, EPA would discuss specific data
it believes may be useful in evaluating a significant new use. SNUNs
submitted for significant new uses without any test data may increase
the likelihood that EPA would take action under TSCA section 5(e) to
prohibit or limit activities associated with this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.

[[Page 18761]]

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 Sec. 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 Sec. Sec.
721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

XIII. Economic Analysis

A. SNUNs

EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
these chemicals and for articles containing any of the benzidine-based
chemical substances included in this proposed rule. These economic
analyses, which are briefly summarized here, are available in the
docket for this proposed rule.
The costs of submission of a SNUN would be incurred when a company
decides to pursue a significant new use of one of these chemicals. In
the event that a SNUN is submitted, costs are estimated at
approximately $8,112 per SNUN submission, and include the cost for
preparing and submitting the SNUN, recordkeeping, and the payment of a
user fee. Businesses that submit a SNUN are either subject to a $2,500
user fee required by Sec. 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 (Sec.
700.45(b)(1)). In its evaluation of this proposed rule, EPA also
considered the potential costs a company might incur by avoiding or
delaying the significant new use in the future, but these costs have
not been quantified.

B. Export Notification

EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at 40
CFR part 707, subpart D require that, for chemicals subject to a
proposed or final SNUR, a company notify EPA of the first export or
intended export to a particular country of an affected chemical
substance. EPA estimated that the 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 rule under docket ID number EPA-HQ-OPPT-2010-0573. The
following is a listing of the documents that have been placed in the
docket for this proposed rule. The docket includes information
considered by EPA in developing this proposed rule, including the
documents listed in this unit, which are physically located in the
docket. In addition, interested parties should consult documents that
are referenced in the documents that EPA has placed in the docket,
regardless of whether these referenced documents are physically located
in the docket. For assistance in locating documents that are referenced
in documents that EPA has placed in the docket, but that are not
physically located in the docket, please consult the technical person
listed under FOR FURTHER INFORMATION CONTACT. The docket is available
for review as specified under ADDRESSES.

1. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics,
Exposure, and Technology Division. ``Economic Analysis to Support
the Proposed SNUR for Benzidine and Benzidine-based Chemical
substances'' (May 24, 2011).
2. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical
Substances Derived from Benzidine and Its Congeners, http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_06232010.noheader.pdf (Accessed January 24,
2011).
3. EPA. 1980. Preliminary Risk Assessment: Phase I. Benzidine, Its
Congeners, and their derivative dyes and pigments. EPA-560/11-80-
019, June 1980.
4. IARC (1982). Some industrial chemicals and dyestuffs. IARC
monographs on the evaluation of carcinogenic risk of chemicals to
humans, Suppl. 7, International Agency for Research on Cancer, Lyon,
France.
5. IARC (1987). Overall evaluation of carcinogenicity. IARC
monographs on the evaluation of carcinogenic risk of chemicals to
humans, vol. 29, International Agency for Research on Cancer.
6. Report on Carcinogens, 11th ed. (2008). National Toxicology
Program, Department of Health and Human Services.
7. Golka, K., Kopps, S., Myslak, Z.W. 2004. Carcinogenicity of azo
colorants: Influence of solubility and bioavailability. Tox Lett
151:203-210.
8. Vesselinovitch, SD; Rao, KV; Mihailovich, N. Transplacental and
lactational carcinogenesis by safrole. Cancer Res 39(11): 4378-4380
(as cited in EPA. 2005. Supplemental Guidance for Assessing
Susceptibility from Early Life Exposure to Carcinogens. EPA 630/R-
03/003F, March 2005).
9. Levine, W.G. (1991). Metabolism of azo dyes: implication for
detoxification and activation. Drug Metab. Rev. 23(3&4): 253-309.
10. Platzek, T., Lang, C.; Grohmann, G., Giu, S.; Baltes, W. (1999).
Formation of a carcinogenic aromatic amine from an azo dye by human
skin bacteria in vitro. Human & Experimental Toxicology, 18: 552-
559.
11. Stingley, R., Zou, W., Heinze, T., Chen, H. and Cerniglia, C.
2009. Metabolism of azo dyes by human skin microbiota. J Med
Microbiol (2009), DOI: 10.1099/jmm.0.012617-0.
12. NIOSH, Special Occupational Hazard Review for Benzidine-Based
Dyes (1980).
13. U.S. EPA, 2009. U.S. Environmental Protection Agency. Inventory
Update Reporting IUR: Non Confidential IUR Production Volume Data
1986-2002. Available at: http://www.epa.gov/oppt/iur/tools/data/2002-vol.html (Updated October 26, 2009).
14a. U.S. EPA, 2009. U.S. Environmental Protection Agency.
Phthalates Action Plan.
14b. U.S. EPA, 2012. U.S. Environmental Protection Agency.
Phthalates Action Plan (Revised). http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates.html.
15. Australian Government, 2008a. Existing Chemical Hazard
Assessment Report for Butylbenzyl Phthalate. Department of Health
and Ageing, National Industrial Chemicals Notification and
Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
16. Australian Government, 2008b. Existing Chemical Hazard
Assessment Report for Dibutyl Phthalate. Department of Health and
Ageing, National Industrial Chemicals Notification and Assessment
Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
17. Australian Government, 2008c. Existing Chemical Hazard
Assessment Report for Diethylhexyl Phthalate. Department of Health
and Ageing, National Industrial Chemicals Notification and
Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
18. Australian Government, 2008d. Existing Chemical Hazard
Assessment Report for Diisobutyl Phthalate. Department of Health and
Ageing, National Industrial Chemicals Notification and Assessment
Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
19. Australian Government, 2008e. Existing Chemical Hazard
Assessment Report for

[[Page 18762]]

Diisodecyl Phthalate. Department of Health and Ageing, National
Industrial Chemicals Notification and Assessment Scheme (NICNAS):
Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009).
20. Australian Government, 2008f. Existing Chemical Hazard
Assessment Report for Diisonoyl Phthalate. Department of Health and
Ageing, National Industrial Chemicals Notification and Assessment
Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
21. Australian Government, 2008g. Existing Chemical Hazard
Assessment Report for Di-n-octyl Phthalate. Department of Health and
Ageing, National Industrial Chemicals Notification and Assessment
Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed
Aug 13, 2009).
22. Australian Government, 2008h. Phthalates Hazard Compendium. A
Summary of Physicochemical and Human Health Hazard Data for 24
Ortho-Phthalate Chemicals. Department of Health and Ageing, National
Industrial Chemicals Notification and Assessment Scheme (NICNAS):
Sydney, Australia. Available at: http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009).
23. HSDB, 2009. Hazardous Substance Data Bank. U.S. National Library
of Medicine TOXNET System. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB (accessed Aug 13, 2009).
24. NAS, 2008. National Academy of Sciences. Phthalates and
Cumulative Risk Assessment: The Tasks Ahead.
25. NTP-CERHR, 2003a. Monograph on the Potential Human Reproductive
and Developmental Effects of Di-n-Butyl Phthalate (DBP). U.S.
Department of Health and Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dbp/dbp.html.
26. NTP-CERHR, 2003b. National Toxicology Program--Center for the
Evaluation of Risks to Human Reproduction. Monograph on the
Potential Human Reproductive and Developmental Effects of Butyl
Benzyl Phthalate (BBP); NIH Pub. No. 03-4487; U.S. Department of
Health and Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/bb-phthalate/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: 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://publications.jrc.ec.europa.eu/repository/bitstream/111111111/5395/1/EUR%2020784%20EN.pdf. (accessed March 5, 2012).
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://publications.jrc.ec.europa.eu/repository/bitstream/111111111/5459/1/EUR%2020785%20EN.pdf. (accessed March 5, 2012).
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://publications.jrc.ec.europa.eu/repository/bitstream/111111111/5681/1/EUR%2019840%20EN.pdf. (accessed March 5, 2012).
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://publications.jrc.ec.europa.eu/repository/bitstream/111111111/5648/1/dehpreport042.pdf. (accessed March 5, 2012).
35. EC, 2008b EC. 2008b. European Commission. European Union Risk
Assessment Report Benzyl Butyl Phthalate (BBP), CAS No. 85-68-7.
Vol. 76; EUR 22773EN; Luxembourg: Office for Official Publications
of the European Communities. Available at: http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/10948/1/benzylbutylphthalatereport318.pdf. (accessed March 5, 2012).
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, dose-additive
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.
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-n-
pentylphthalate: 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. Swan, 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 semen quality in relation to urinary

[[Page 18763]]

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. Col[oacute]n, 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.
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): 875-91.
58. CDC, 2009. Centers for Disease Control and Prevention. Fourth
National Report on Human Exposure to Environmental Chemicals.
National Health and Nutrition Examination Survey (NHANES), Centers
for Disease Control and Prevention, Atlanta (GA). Available at:
http://www.cdc.gov/exposurereport/faq.html.
59. U.S. EPA, 2010. U.S. Environmental Protection Agency. Short-
Chain Chlorinated Paraffins (SCCPs) and Other Chlorinated Paraffins
Action Plan. Available at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/sccps.html (Accessed March 7,
2011).
60. UNEP. 2011. United Nations Environment Programme. Stockholm
Convention on Persistent Organic Pollutants (POPs). Persistent
Organic Pollutants Review Committee. Report of the Persistent
Organic Pollutants Review Committee on the Work of its Seventh
Meeting. October 17, 2011. UNEP/POPS/POPRC.7/19. Available at:
http://chm.pops.int/Convention/POPsReviewCommittee/POPRCMeetings/POPRC7/POPRC7ReportandDecisions/tabid/2472/Default.aspx. (accessed
January 20, 2010). As noted in this document ``Consensus has been
reached on the data considered (in UNEP. 2009. United Nations
Environment Programme. Stockholm Convention on Persistent Organic
Pollutants (POPs). Persistent Organic Pollutants Review Committee.
Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins.
July 9, 2009. UNEP/POPS/POPRC.5/2.'' The document cited is available
at: http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/POPR%205Documents/tabid/592/language/en-US/
Default.aspx. Accessed December 11, 2009).
61. Government of Canada. 2008. Order Adding Toxic Substances to
Schedule 1 to the Canadian Environmental Protection Act, 1999.
Canada Gazette. September 20, 2008, 142 (38).
62. Iino F., T. Takasuga, K. Senthilkumar, N. Nakamura and J.
Nakanish. 2005. Risk assessment of short-chain chlorinated paraffins
in Japan based on the first market basket study and species
sensitivity distributions. Environ. Sci. Technol. 39: 859-866 (as
cited in UNEP. 2009. United Nations Environment Programme. Stockholm
Convention on Persistent Organic Pollutants (POPs). Persistent
Organic Pollutants Review Committee. Revised Draft Risk Profile:
Short-Chained Chlorinated Paraffins. July 9, 2009. UNEP/POPS/
POPRC.5/2. Available at: http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/POPR 5Documents/tabid/
592/language/en-US/Default.aspx. Accessed December 11, 2009).
63. Lahaniatis, M.R., Coelhan, M., H. Parlar. 2000. Clean-up and
quantification of short and medium chain polychlorinated n-alkanes
in fish, fish oil, and fish feed. Organohalogen Compounds. 47: 276-
279 (as cited in UNEP. 2009. United Nations Environment Programme.
Stockholm Convention on Persistent Organic Pollutants (POPs).
Persistent Organic Pollutants Review Committee. Revised Draft Risk
Profile: Short-Chained Chlorinated Paraffins. July 9, 2009. UNEP/
POPS/POPRC.5/2. Available at: http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/POPR 5Documents/tabid/
592/language/en-US/Default.aspx. (accessed December 11, 2009)).
64. American Apparel and Footwear Association (AAFA) Restricted
Substance List (RSL), September, 2010.

XV. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) determined that this proposed SNUR is a ``significant
regulatory action'' under section 3(f) of the Executive Order.
Accordingly, EPA submitted this action to OMB for review under
Executive Order 12866 and 13563, entitled Improving Regulation and
Regulatory Review (76 FR 3821, January 21, 2011). EPA prepared an
analysis of the potential costs and benefits associated with this
action, which is summarized in Unit XIII.
Changes made in response to OMB recommendations have been
documented in the docket for this rulemaking as required by section
6(a)(3)(E) of the Executive Order.

B. Paperwork Activities

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in Title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9 and included on the related
collection instrument, or form, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0038 (EPA ICR No. 1188). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average 97 hours
per response. This burden estimate includes the time needed to review
instructions, search

[[Page 18764]]

existing data sources, gather and maintain the data needed, and
complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Small Entity Impacts

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of
this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. Under the RFA, small entities
include small businesses, small organizations, and small governmental
jurisdictions. Small entity is defined in accordance with section 601
of the RFA as: A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201; a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and a small organization that is any not-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 new use.'' By definition of
the word ``new'' and based on all information currently available to
EPA, it appears that no small or large entities presently engage in
such activity. Since this action would require a person who intends to
engage in such activity in the future to first notify EPA by submitting
a SNUN, no economic impact would occur unless someone files a SNUN to
pursue a significant new use in the future or forgoes profits by
avoiding or delaying the significant new use. Although some small
entities may decide to conduct such activities in the future, EPA
cannot presently determine how many, if any, there may be.
EPA's experience to date is that, in response to the promulgation
of over 1,000 SNURs, the Agency receives on average only five notices
per year. Of those SNUNs submitted, only one appears to be from a small
entity in response to any SNUR. Therefore, EPA believes that the
potential economic impact of complying with this SNUR is not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published as a final rule on August 8, 1997
(62 FR 42690) (FRL-5735-4), the Agency presented its general
determination that proposed and final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

D. State, Local, and Tribal Governments

In EPA's experience with proposing and finalizing SNURs since 1980,
no state, local, or Tribal government has initiated the manufacture of
a chemical for a new use. Furthermore, EPA does not have any reason to
believe that any state, local, or tribal government would do so for the
chemicals in this rulemaking. For that reason, EPA has determined that
this action does not have federalism implications as specified in
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), or tribal implications as specified in Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 9, 2000).
In addition, this action does not impose any enforceable duty or
contain any unfunded mandate for State, local, or tribal governments
under the provisions of Title II of the Unfunded Mandates Reform Act
(UMRA), 2 U.S.C. 1531-1538. Nor does it otherwise have any effect on
small governments, or estimated impacts on the private sector that
might exceed $100 million in any year.
Thus, sections 202, 203, 204, or 205 of UMRA, Executive Order
13132, and Executive Order 13175 do not apply to this action.

E. Protection of Children

This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this action is not an
economically significant regulatory action as defined by Executive
Order 12866, and it is not intended to address environmental health or
safety risks for children.

F. Effect on Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not an economically significant regulatory action as defined by
Executive Order 12866, and it is not expected to affect energy supply,
distribution, or use.

G. Technical Standards

Since this action does not involve any technical standards, section
12(d) of the National Technology Transfer and Advancement Act (NTTAA),
15 U.S.C. 272 note, does not apply to this action.

H. Environmental Justice

This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

Dated: March 20, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

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

PART 721--[AMENDED]

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

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

2. Revise Sec. 721.1660 to read as follows:

Sec. 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.

[[Page 18765]]

Table 1--Newly Added Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
CAS or accession No. C.I. name C.I. number Chemical name
----------------------------------------------------------------------------------------------------------------
117-33-9........................... Not available......... Not available......... 1,3-Naphthalenedisulfonic
acid, 7-hydroxy-8-[2-[4'-
[2-(4-
hydroxyphenyl)diazenyl][1,
1'-biphenyl]-4-
yl]diazenyl]-
65150-87-0......................... Not available......... Not available......... 1,3,6-
Naphthalenetrisulfonic
acid, 8-hydroxy-7-[2-[4'-
[2-(2-hydroxy-1-
naphthalenyl)diazenyl][1,1
'-biphenyl]-4-yl]diazenyl]-
, lithium salt (1:3)
68214-82-4......................... Direct Navy BH........ 22590................. 2,7-Naphthalenedisulfonic
acid, 5-amino-3-[2-[4'-[2-
(7-amino-1-hydroxy-3-sulfo-
2-
naphthalenyl)diazenyl][1,1
'-biphenyl]-4-yl]diazenyl]-
4-hydroxy-, sodium salt
(1:2)
72379-45-4......................... Not available......... Not available......... 2,7-Naphthalenedisulfonic
acid, 4-amino-5-hydroxy-3-
[2-[4'-[2-[2-hydroxy-4-[(2-
methylphenyl)amino]
phenyl]diazenyl][1,1'-
biphenyl]-4-yl]diazenyl]-6-
(2-phenyldiazenyl)-
Accession No. 21808 CAS No. CBI CBI................... CBI................... 2,7-Naphthalenedisulfonic
(NA). acid, 4-amino-5-hydroxy
[[[(substituted
phenylamino)] substituted
phenylazo] diphenyl]azo-,
phenylazo-, disodium salt.
(generic name)
Accession No. 24921 CAS No. CBI CBI................... CBI................... 4-(Substituted naphthalenyl
(NA). )azo diphenylyl azo-
substituted carbopolycycle
azo benzenesulfonic acid,
sodium salt. (generic
name)
Accession No. 26256 CAS No. CBI CBI................... CBI................... 4-(Substituted phenyl) azo
(NA). biphenylyl azo-substituted
carbopolycycloazo
benzenesulfonic acid,
sodium salt. (generic
name)
Accession No. 26267 CAS No. CBI CBI................... CBI................... 4-(Substituted phenyl)azo
(NA). biphenylyl azo-substituted
carbopolycycle azo
benzenesulfonic acid,
sodium salt. (generic
name)
Accession No. 26701 CAS No. CBI CBI................... CBI................... Phenylazoaminohydroxynaphth
(NA). alenyl azobiphenyl azo-
substituted benzene sodium
sulfonate. (generic name)
----------------------------------------------------------------------------------------------------------------

Table 2--Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
CAS No. C.I. name C.I. No. Chemical name
----------------------------------------------------------------------------------------------------------------
92-87-5............................ Benzidine............. Not available......... [1,1'-Biphenyl]-4,4'-
diamine
531-85-1........................... Benzidine [middot] Not available......... [1,1'-Biphenyl]-4,4'-
2HCl. diamine, dihydrochloride
573-58-0........................... C.I. Direct Red 28.... 22120................. 1-Naphthalenesulfonic acid,
3,3'-[[1,1'-biphenyl]-4,4'-
diylbis(azo)]bis[4-amino-,
disodium salt
1937-37-7.......................... C.I. Direct Black 38.. 30235................. 2,7-Naphthalenedisulfonic
acid, 4-amino-3-[[4'-[(2,4-
diaminophenyl) azo][1,1'-
biphenyl]-4-yl]azo]-5-
hydroxy-6-(phenylazo)-,
disodium salt
2302-97-8.......................... C.I. Direct Red 44.... 22500................. 1-Naphthalenesulfonic acid,
8,8'-[[1,1'-biphenyl]-4,4'-
diylbis(azo)]bis[7-hydroxy-
,disodium salt
2429-73-4.......................... C.I. Direct Blue 2.... 22590................. 2,7-Naphthalenedisulfonic
acid, 5-amino-3-[[4'-[(7-
amino-1-hydroxy-3-sulfo-2-
naphthalenyl)azo][1,1'-
biphenyl]-4-yl]azo]-4-
hydroxy-, trisodium salt
2429-79-0.......................... C.I. Direct Orange 8.. 22130................. Benzoic acid, 5-[[4'-[(1-
amino-4-sulfo-2-
naphthalenyl) azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-,disodium salt
2429-81-4.......................... C.I. Direct Brown 31.. 35660................. Benzoic acid, 5-[[4'-[[2,6-
diamino-3-[[8-hydroxy-3,6-
disulfo-7-[(4-sulfo-1-
naphthalenyl)azo]-2-
naphthalenyl]azo]-5-
methylphenyl]azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-, tetrasodium salt
2429-82-5.......................... C.I. Direct Brown 2... 22311................. Benzoic acid, 5-[[4'-[(7-
amino-1-hydroxy-3-sulfo-2-
naphthalenyl) azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-, disodium salt
2429-83-6.......................... Direct Black 4........ 30245................. 2,7-Naphthalenedisulfonic
acid, 4-amino-3-[[4'-[(2,4-
diamino-5-
methylphenyl)azo][1,1'-
biphenyl]-4-yl]azo]-5-
hydroxy-6-(phenylazo)-,
disodium salt
2429-84-7.......................... C.I. Direct Red 1..... 22310................. Benzoic acid, 5-[[4'-[(2-
amino-8-hydroxy-6-sulfo-1-
naphthalenyl)azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-, disodium salt
2586-58-5.......................... C.I. Direct Brown 1:2. 30110................. Benzoic acid, 5-[[4'-[[2,6-
diamino-3-methyl-5-[(4-
sulfophenyl)azo]phenyl]azo
][1,1'-biphenyl]-4-yl]azo]-
2-hydroxy-, disodium salt
2602-46-2.......................... C.I. Direct Blue 6.... 22610................. 2,7-Naphthalenedisulfonic
acid, 3,3'-[[1,1'-
biphenyl]-4,4'-
diylbis(azo)]bis[5-amino-4-
hydroxy-, tetrasodium salt
2893-80-3.......................... C.I. Direct Brown 6... 30140................. Benzoic acid, 5-[[4'-[[2,4-
dihydroxy-3-[(4-
sulfophenyl)
azo]phenyl]azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-, disodium salt

[[Page 18766]]

3530-19-6.......................... C.I. Direct Red 37.... 22240................. 1,3-Naphthalenedisulfonic
acid, 8-[[4'-[(4-
ethoxyphenyl) azo][1,1'-
biphenyl]-4-yl]azo]-7-
hydroxy-,disodium salt
3567-65-5.......................... C.I. Acid Red 85...... 22245................. 1,3-Naphthalenedisulfonic
acid, 7-hydroxy-8-[[4'-[[4-
[[(4-methylphenyl)
sulfonyl]oxy]phenyl]azo][1
,1'-biphenyl]-4-yl]azo]-,
disodium salt
3626-28-6.......................... C.I. Direct Green 1... 30280................. 2,7-Naphthalenedisulfonic
acid, 4-amino-5-hydroxy-3-
[[4'-[(4-
hydroxyphenyl)azo][1,1'-
biphenyl]-4- yl]azo]-6-
(phenylazo)-, disodium
salt
3811-71-0.......................... C.I. Direct Brown 1... 30045................. Benzoic acid, 5-[[4'-[[2,4-
diamino-5-[(4-sulfophenyl)
azo]phenyl]azo][1,1'-
biphenyl]-4-yl]azo]-2-
hydroxy-, disodium salt
4335-09-5.......................... C.I. Direct Green 6... 30295................. 2,7-Naphthalenedisulfonic
acid, 4-amino-5-hydroxy-6-
[[4'-[(4-
hydroxyphenyl)azo][1,1'-
biphenyl]-4-yl] azo]-3-[(4-
nitrophenyl)azo]-,
disodium salt
6358-80-1.......................... C.I. Acid Black 94.... 30336................. 2,7-Naphthalenedisulfonic
acid, 4-amino-5-hydroxy-3-
[[4'-[[4-hydroxy-2-[(2-
methylphenyl)amino]phenyl]
azo] [1,1'- biphenyl]-4-
yl]azo]-6-[(4-sulfophenyl)
azo]-, trisodium salt
6360-29-8.......................... C.I. Direct Brown 27.. 31725................. Benzoic acid, 5-[[4'-[[4-
[(4-amino-7-sulfo-1-
naphthalenyl)azo]-6-sulfo-
1-naphthalenyl]azo][1,1'-
biphenyl]-4-yl] azo]-2-
hydroxy-, trisodium salt
6360-54-9.......................... C.I. Direct Brown 154. 30120................. Benzoic acid, 5-[[4'-[[2,6-
diamino-3-methyl-5-[(4-
sulfophenyl)azo]phenyl]
azo][1,1'-biphenyl]-4-
yl]azo]-2- hydroxy-3-
methyl-, disodium salt
8014-91-3.......................... C.I. Direct Brown 74.. 36300................. Benzoic acid, 3,3'-[(3,7-
disulfo-1,5-
naphthalenediyl)bis [azo(6-
hydroxy-3,1-
phenylene)azo[6(or7)-sulfo-
4,1-
naphthalenediyl]azo[1,1'-
biphenyl]-4,4'-
diylazo]]bis[6-hydroxy-,
hexasodium salt
16071-86-6......................... C.I. Direct Brown 95.. 30145................. Cuprate(2-), [5-[[4'-[[2,6-
dihydroxy-3-[(2-hydroxy-5-
sulfophenyl)azo]phenyl]
azo][1,1'-biphenyl]-4-
yl]azo]-2-
hydroxybenzoato(4-)]-,
disodium salt
----------------------------------------------------------------------------------------------------------------

(2) The significant new uses are:
(i) Any use other than use as:
(A) For the chemicals listed in Table 2., as reagent to test for
hydrogen peroxide in milk; a reagent to test for hydrogen sulfate,
hydrogen cyanide, and nicotine; a stain in microscopy; a reagent for
detecting blood and as an analytical standard.
(B) For Colour Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-
58-0) listed in Table 2., as an indicator dye.
(ii) For the 9 chemical substances listed in Table 1.: Any use.
(3) Revocation of article exemption. The provisions of Sec.
721.45(f) do not apply to this section. A person who imports or
processes the chemical substances identified in paragraph (a)(1) of
this section as part of an article for the significant new use
described in paragraph (a)(2) of this section must submit a significant
new use notice.
(b) [Reserved]
3. Add Sec. 721.10226 to subpart E to read as follows:

Sec. 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 Sec. 721.10227 to subpart E to read as follows:

Sec. 721.10227 Alkanes, C12-13, chloro (CAS No. 71011-12-6).

(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C12-13, chloro (CAS No. 71011-12-6) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new use is: Any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Persons who must report. Sec. 721.5 applies to this section
except for Sec. 721.5(a)(2). A person who intends to manufacture or
import for commercial purposes a substance identified in paragraph
(a)(1) of this section and intends to distribute the substance in
commerce must submit a significant new use notice.
(2) [Reserved]

[FR Doc. 2012-7208 Filed 3-27-12; 8:45 am]
BILLING CODE 6560-50-P