Document ID: EPA-HQ-OPPT-2010-1075-0079
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2012-07-23T04:00Z

[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Rules and Regulations]
[Pages 42990-42997]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17895]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-1075; FRL-9354-2]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for the chemical substances rutile, 
tin zinc, calcium-doped (CAS No. 389623-01-2) and rutile, tin zinc, 
sodium-doped (CAS No. 389623-07-8) which were the subject of 
premanufacture notices (PMNs P-06-36 and P-06-37) and a TSCA consent 
order issued by EPA. This action requires persons who intend to 
manufacture, import, or process either of the chemical substances for 
an activity that is designated as a significant new use by this final 
rule to notify EPA at least 90 days before commencing that activity. 
EPA believes that this action is necessary because new uses of the 
chemical substances may be hazardous to human health. The required 
notification would provide EPA with the opportunity to evaluate the 
intended use and, if necessary, to prohibit or limit the activity 
before it occurs.

DATES: This final rule is effective August 22, 2012.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2010-1075. 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., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket 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 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: Jim 
Alwood, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8974; email address: alwood.jim@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. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use either of the chemical substances contained in 
this final rule. Potentially affected entities may include, but are not 
limited to:
     Manufacturers, importers, or processors of the subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    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 North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. 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. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127; 
see also 19 CFR 127.28. Chemical importers must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA. Importers of chemicals subject to a final SNUR 
must certify their compliance with the SNUR requirements. The EPA 
policy in support of import certification appears at 40 CFR part 707, 
subpart B. In addition, any persons who export or intend to export a 
chemical substance that is the subject of this final rule are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) (see Sec.  [emsp14]721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for two chemical 
substances which were the subject of PMNs and a TSCA section 5(e) 
consent order. The two chemical substances are identified as rutile, 
tin zinc, calcium-doped (PMN P-06-36; CAS No. 389623-01-2) and rutile, 
tin zinc, sodium-doped (PMN P-06-37; CAS No. 389623-07-8). The final 
SNURs on these substances are based on and consistent with the 
provisions in the underlying consent order. The final SNURs designate 
as a significant new use manufacture (including import) or processing 
in the absence of the protective measures required in the corresponding 
consent order. This action requires persons who intend to manufacture, 
import, or process either of these two chemical substances for an 
activity that is designated as a significant new use by this final rule 
to notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register issue of October 5, 2011 (76 FR 
61566) (FRL-8880-2), EPA issued direct final SNURs on these two 
chemical substances (see Sec. Sec.  721.10230 and 721.10231). However, 
EPA received notices of intent to submit adverse comments on these 
SNURs. Therefore,

[[Page 42991]]

as required by Sec.  721.160(c)(3)(ii), in the Federal Register issue 
of December 5, 2011 (76 FR 75794) (FRL-9329-5), EPA withdrew the direct 
final SNURs on these two chemical substances and subsequently proposed 
SNURs using notice and comment procedures in the Federal Register issue 
of December 28, 2011 (76 FR 81441) (FRL-9329-4). More information on 
the specific chemical substances subject to this final rule can be 
found in the Federal Register documents announcing the direct final 
SNURs or the proposed SNURs. The record for the SNURs on these two 
chemical substances was established in the docket under docket ID 
number EPA-HQ-OPPT-2010-1075. That docket includes information 
considered by the Agency in developing the direct final rule and this 
final rule including comments on those rules.
    EPA received several comments on the proposed rule. A full 
discussion of EPA's response to these comments is included in Unit V. 
of this document. Based on these comments, EPA is issuing a modified 
final rule on these chemical substances that:
    1. Revises the protection in the workplace and hazard communication 
provisions.
    2. Retains the industrial, commercial, and consumer activities 
provisions.
    In response to the comments, EPA is including in the regulatory 
text the following modifications:
     Revision to the protection in the workplace provision in 
paragraph (a)(2)(i)(1) to reflect a New Chemical Exposure Limit (NCEL) 
of 2.4 mg/m\3\.
     Revision to the hazard communication provision in 
paragraph (a)(2)(ii) to reflect an NCEL of 2.4 mg/m\3\.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use. Persons who 
must report are described in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the final 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 these SNURs 
must comply with the same notice requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA 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 for which it has received the SNUN. If EPA does not take 
action, EPA is required under TSCA section 5(g) to explain in the 
Federal Register its reasons for not taking action.

III. Rationale and Objectives of the Final Rule

A. Rationale

    During review of the PMNs submitted for these two chemical 
substances, EPA concluded that regulation was warranted under TSCA 
section 5(e)(1)(A)(ii)(I), pending the development of information 
sufficient to make reasoned evaluations of the human health effects of 
the chemical substances. Based on these findings, a TSCA section 5(e) 
consent order requiring the use of appropriate exposure controls was 
negotiated with the PMN submitter. The SNUR provisions for these 
chemical substances are consistent with the provisions of the TSCA 
section 5(e) consent order. These final SNURs are issued pursuant to 
Sec.  721.160. See the docket under docket ID number EPA-HQ-OPPT-2010-
1075 for the corresponding consent order. For additional discussion of 
the rationale for the SNURs on these chemicals, see Units II. and V. of 
this document.

B. Objectives

    EPA is issuing these final SNURs for specific chemical substances 
that have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this final rule:
     EPA will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Inventory. Guidance on how 
to determine if a chemical substance is on the TSCA Inventory is 
available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
two chemical substances that are the subject of these SNURs, EPA 
considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, taking into consideration the four 
bulleted TSCA section 5(a)(2) factors listed in this unit.

[[Page 42992]]

V. Response to Comments on Proposed SNURs

    EPA received comments from numerous submitters on the proposed 
rules for rutile, tin zinc, calcium-doped (PMN P-06-36; CAS No. 389623-
01-2) and rutile, tin zinc, sodium-doped (PMN P-06-37; CAS No. 389623-
07-8). A summary and discussion of the comments received and the 
Agency's responses follow.
    Comment 1: In the proposed SNUR, EPA clarified that it considers 
nanomaterials to include substances with a particle size less than 100 
nanometers (nm) where d10 particle size presents the particle size as 
determined by laser light scattering at which 10 percent by weight of 
the substance measured is smaller. The commenter supports this approach 
based on the need for a threshold since solid particulate material will 
contain a distribution of particle sizes. The 10 percent threshold 
strikes a reasonable balance between being adequately protective of 
human health and recognizing practical limitations associated with 
analytical methods available for quantifying materials at or below such 
a threshold. The commenter supports using the weight-based threshold, 
as methods and instrumentation for performing weight-based particle 
size measurements are more widely available than techniques for 
performing measurements based on particle number. There are other 
important elements that should be included in any definition of a 
nanomaterial including recognizing that aggregates and agglomerates are 
not the same as the primary particles of which they are comprised and 
that many agglomerates may not disagglomerate readily in any medium.
    EPA Response: In the proposed rule, EPA did not attempt to clarify 
what it considers to be a definition of a nanomaterial, although 
particle size of less than 100 nm is often used to describe such 
chemical substances. Based on information contained in the PMNs, EPA 
believes that the PMN submitter is not manufacturing or processing the 
PMN substances with a d10 particle size less than 100 nm. EPA also 
believes it is possible that these chemical substances could be 
manufactured or processed with a d10 particle size less than 100 nm. 
EPA proposed a new use in the SNURs for these two PMN substances to 
require notification if those chemical substances were manufactured or 
processed with a d10 particle size less than 100 nm. Upon notification 
of this new use, EPA would review the properties and assess any 
potential risks that were different from the chemical substances as 
reported in the PMNs. While EPA believes that the threshold and method 
used to measure particle size for these PMN substances is appropriate 
and protective of human health, EPA will consider different thresholds 
and methods in other TSCA actions, depending on the chemical substances 
being measured and available scientific knowledge and technology.
    Comment 2: The PMN substances are not nanoscale substances and any 
concerns or regulatory requirements derived from concerns related to 
nanoscale materials are not pertinent to the PMN substances.
    EPA Response: As described in the consent order, the basis for 
EPA's concerns for the PMNs is not whether the substances constitute 
nanoscale materials but rather the fact that they qualify under the new 
chemicals category for respirable, poorly soluble particulates, under 
the subcategory of titanium dioxide (see http://www.epa.gov/oppt/newchems/pubs/chemcat.htm). The category document identifies that there 
is potential for respirability if workers handle material containing 
any particles less than or equal to 10 microns in diameter. Based on 
information in the PMNs, workers are likely to be exposed to particles 
less than or equal to 10 microns in diameter. In addition, based on 
information contained in the PMNs, EPA believes that manufacturers and 
processors could use these chemical substances at particle sizes less 
than 100 nm. Accordingly, EPA has proposed new uses that would enable 
EPA to review any manufacture or processing of the PMN substance 
without the use of appropriate respiratory protective equipment or 
engineering controls, or at particle sizes less than 100 nm. The 
purpose of these notifications (i.e., SNUNs) is to allow EPA to review 
any new properties and assess any potential risks presented by the new 
use.
    Comment 3: EPA's risk assessment stated there is no exposure 
expected to the PMN substances, according to the human health effects 
summary in the consent order. EPA determined that there can be no risk 
warranting regulation under the proposed rule, because of the statement 
that no absorption of the PMNs is expected via any route of exposure if 
the PMN substances are produced via the calcination method. The PMN 
substances can only be manufactured using the calcining process and 
there is no known alternative industrial process for making chemical 
substances such as the PMN substances. Based on review of EPA's risk 
assessment in the 5(e) consent order and the extensive experience of 
the Color Pigment Manufacturers Association (CPMA) members with similar 
products, there is no substantiation of potential risk in the record 
for the proposed rule or the necessity for any regulation of the PMN 
substances.
    EPA Response: The human health effects summary, contained in Unit 
IV. (``EPA's Assessment of the Risk'') of the consent order does not 
address potential exposures to the PMN substances; workplace inhalation 
exposures are addressed in a separate exposure summary of the same Unit 
IV. The health effects summary does state, however, that if the PMN 
substances are calcined then EPA does not expect the PMN substances to 
be absorbed by any route of exposure. In addition, the health effects 
summary identifies concerns for potential lung effects from exposure to 
the PMN substances, according to the chemical category for respirable, 
poorly soluble particulates under the subcategory of titanium dioxide 
(see http://www.epa.gov/oppt/newchems/pubs/chemcat.htm). There is 
concern for the potential lung effects when workers handle material 
containing particles less than or equal to 10 microns in diameter. 
Based on information in the PMNs, workers are likely to be exposed to 
particles less than or equal to 10 microns in diameter. The concern for 
lung effects is not mitigated by calcination; the concern is 
independent of potential for absorption. In fact, because these 
insoluble particles are not absorbed, they remain in the lung longer 
than other particles, causing further inflammation and lung effects. As 
mentioned earlier in this response, the exposure summary in the consent 
order identifies potential inhalation to workers. Based on the 
potential hazard and exposure to workers, EPA concluded that the PMN 
substances may present an unreasonable risk of lung effects to exposed 
workers. The commenter did not provide any specific information 
regarding CPMA's extensive experience with similar products to refute 
EPA's risk finding for the PMN substances.
    Comment 4: EPA should clarify that the PMN substances are not 
salts. It is incorrect for EPA to characterize these chemical 
substances as salts. EPA's health risk analysis based on structural 
analogs does not demonstrate a risk warranting regulation because the 
regulated substances do not exhibit the properties of the constituent 
metals and do not represent an unregulated dust exposure. Titanium 
dioxide is not an analog surrogate for the PMN

[[Page 42993]]

substances. EPA's assessment should evaluate the risk of the finished 
crystal form of the PMN substances.
    EPA Response: EPA is not characterizing the PMN substances as salts 
or as the constituent metals, and the structural analogy in the consent 
order was not based on analogy to salts or constituent metals. EPA's 
structural activity relationship (SAR) analysis was based on the 
category of respirable, poorly soluble particulates that cause lung 
effects as a result of inhaling particles (see http://www.epa.gov/oppt/newchems/pubs/chemcat.htm). Titanium dioxide was chosen as the 
subcategory based on its physical characteristics as a poorly soluble 
particulate, and not any chemically-mediated toxicological properties. 
The risk assessment, as described in the response to comment 3, is 
consistent with the Agency's concerns that potential exposure to 
particles of the finished crystal form of the PMN substances may cause 
an unreasonable risk of lung effects.
    Comment 5: EPA relied on a recommended exposure level (REL) from 
the draft National Institute for Occupational Safety and Health (NIOSH) 
Current Intelligence Bulletin: Occupational Exposure to Titanium 
Dioxide as the source of the proposed NCEL of 1.5 mg/m\3\. Since the 
final NIOSH intelligence bulletin set a higher REL of 2.4 mg/m\3\, EPA 
should revise its risk assessment to incorporate this new information.
    EPA Response: EPA agrees that using the REL of 2.4 mg/m\3\ for 
titanium dioxide, from the final NIOSH bulletin, would be more 
appropriate. This document is located in the docket under docket ID 
number EPA-HQ-OPPT-2010-1075. In fact, paragraph (b)(2) of the NCEL of 
the consent order for the PMN substances contains an automatic sunset 
clause stating that the NCEL in the consent order would automatically 
and immediately be changed to the final REL for titanium dioxide issued 
by NIOSH. Accordingly, EPA will issue the final SNURs with a NCEL of 
2.4 mg/m\3\, based on the final NIOSH REL for titanium dioxide. 
However, because EPA estimates that there are potential exposures 
greater than 2.4 mg/m\3\, EPA continues to find a potential risk of 
concern for the PMN substances.
    Comment 6: These chemical substances are subject to existing 
Occupational Safety and Health Administration (OSHA) Permissible 
Exposure Levels (PELs) for inorganic tin compounds. Given the existing 
applicable OSHA PELs, the proposed SNURs are duplicative and 
unnecessary regulation. The NCELs provisions in the section 5(e) order 
states that the NCEL and respirator requirements are automatically 
nullified if OSHA promulgates a PEL for the same substance. There is a 
separate OSHA standard, applicable to all inert dust particles, of 5 
mg/m\3\. There is no need for EPA to require the development of 
additional and different regulatory monitoring techniques for the PMN 
substances because there are already analytical monitoring techniques 
developed for inorganic tin compounds and inert dust particles.
    EPA Response: While the OSHA PEL for inorganic tin compounds would 
be applicable to the inorganic tin contained in the PMN substances, it 
does not apply to the PMN substances themselves. Based on information 
submitted in the PMNs, EPA considers the substances to be mixed metal 
oxide compounds. Previous comments made the argument that the 
constituent metals are not bioavailable and there should not be concern 
for exposure to bioavailable metals from the PMN substances. EPA agreed 
that it is not characterizing the PMN substances as metals and the 
basis of its risk assessment is not the constituent metals contained in 
the PMN substances. See EPA's response to comment 4. Therefore, the 
OSHA PEL for inorganic tin does not adequately address potential risks 
from the PMN substances. While there is an OSHA inert dust standard of 
5 mg/m\3\, EPA finds there is still a potential risk for lung effects 
from exposures less than 5 mg/m\3\ for the PMN substances. Paragraph 
(b)(2) of the NCEL of the consent order for the PMN substances does 
state, that if OSHA promulgates a PEL specifically applicable to the 
PMN substances then the respirator requirements and NCEL become null 
and void. This paragraph (b)(2) also states that the requirements of 
the consent order are not negated by any pre-existing OSHA PEL, such as 
the PEL for inorganic tin compounds cited by the commenters. Because 
OSHA has not promulgated a PEL specifically applicable to the PMN 
substances, the respirator requirements and NCEL requirements in the 
consent order for the PMN substances remain in effect. Neither the PMN 
submitter nor commenters have supplied any information on whether 
existing monitoring techniques used for inorganic tin compounds would 
be appropriate for use with the PMN substances. EPA has issued the 
consent order and will issue the final SNURs with the NCEL provisions 
to allow for review of any monitoring techniques for the PMN substances 
that would be used to demonstrate compliance with the exposure limits.
    Comment 7: The costs and economic impacts of the rule are 
underestimated significantly. Customers may not use the PMN substances 
because of compliance costs. Manufacturers of the PMN substances will 
incur costs as a result of complying with the SNUR requirements, and 
costs associated with submitting a SNUN, including submitting 
toxicological testing prior to manufacture or import of the PMN 
substances for a significant new use.
    EPA Response: The economic assessment developed by EPA for this 
rule estimates and discusses the potential costs identified by the 
commenter. The commenter did not supply any additional information 
disputing EPA's specific cost estimates or conclusions. Therefore, EPA 
will not change any of its cost estimates or conclusions. Contrary to 
the commenter's assertions, the SNURs do not require testing, and 
submission of a SNUN does not require submission of toxicological 
testing. The preamble to the proposed SNURs did recommend testing that 
could address potential risks EPA has identified for the PMN 
substances, and states that SNUN submitters can submit any other data 
to address potential risks. Anyone submitting a SNUN is strongly 
encouraged to submit information addressing potential risks, but 
specific testing is not required.
    Comment 8: EPA's economic assumptions pursuant to the Regulatory 
Flexibility Act do not reflect the current market. Nearly identical 
structural analogs of the PMN substances already on the TSCA Inventory 
are produced by companies in the United States and abroad. The PMN 
substances are produced abroad and imported in finished articles.
    EPA Response: The commenter did not supply any information on 
present or future significant new uses by small or large entities of 
the substances subject to the SNURs. Therefore, the basis for EPA's 
finding under the Regulatory Flexibility Act, that the promulgation of 
the SNURs will not have a significant adverse economic impact on a 
substantial number of small entities, will remain unchanged in the 
final rule.
    Comment 9: The rule would prevent U.S. manufacturers from 
manufacturing and using the PMN substances in finished products while 
the rule would not prevent the use of the PMN substances outside the 
United States. Foreign manufacturers of finished products containing 
the PMN

[[Page 42994]]

substances will be able to use the PMN substances and import them as 
part of articles exempt from TSCA reporting.
    EPA Response: TSCA primarily addresses risks within the United 
States. The consent order and the SNURs do not prevent United States 
manufacturers from manufacturing and using the PMN substances in 
finished products. In fact, the consent order negotiated with the PMN 
submitter allows manufacture, subject to certain restrictions. Those 
restrictions are reflected in the SNURs. The SNURs exempt all 
manufacturers and processors from significant new use reporting once 
the PMN substances have been incorporated into a polymer, glass, 
dispersion, cementitious matrix, or a similar incorporation. This 
includes articles imported into the United States. For these uses, no 
significant exposures are expected. The consent order and the SNURs 
would only be applicable in the United States to manufacturers or 
processors of the PMN substances in particulate form. EPA issued the 
consent order and is issuing the SNURs to address potential worker 
exposures associated with manufacture and processing of the PMN 
substances that could result in a risk of lung effects.
    Comment 10: There are economic and environmental benefits 
identified in the PMN submissions for these chemical substances. 
Specifically, the PMN substances are intended to replace pigments 
containing heavy metals such as lead and cadmium, which are associated 
with risks to human health and the environment.
    EPA Response: While EPA agrees that it would be beneficial to 
replace pigments that contain lead and cadmium, EPA found that the 
potential unreasonable risks associated with the PMN substances 
warranted issuing a consent order and SNUR.

VI. Applicability of 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 TSCA section 5(a)(1)(B) 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 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 significant new use before the rule became 
effective, and then argue that the use was ongoing before the effective 
date of the final rule.
    Any person who began commercial manufacture, import, or processing 
of the specific chemical substances for any of the significant new uses 
designated in the proposed rule after the date of publication of the 
proposed rule must stop that activity before the effective date of this 
final rule. Persons who ceased those activities will have to meet all 
applicable SNUR notice requirements and wait until the notice review 
period, including any extensions, before engaging in any activities 
designated as significant new uses.
    EPA has promulgated provisions to allow persons to comply with 
these SNURs before the effective date. If a person were to meet the 
conditions of advance compliance under Sec.  [emsp14]721.45(h), the 
person would be considered to have met the requirements of this final 
SNUR for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (see Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection and test reporting.
    EPA has determined that a 90-day inhalation toxicity test (OPPTS 
Test Guideline 870.3465) in rats would help characterize the human 
health effects of the PMN substances. To access this guideline, please 
to go http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.'' This test may not be the only means of addressing the 
potential risks of the chemical substances. However, submitting a SNUN 
without any test data may increase the likelihood that EPA will take 
action under TSCA section 5(e), particularly if satisfactory test 
results have not been obtained from a prior PMN or SNUN submitter. EPA 
recommends that potential SNUN submitters contact EPA early enough so 
that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to Sec.  [emsp14]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 submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in Sec. Sec.  721.25 and 720.40. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances during the development of the direct final 
rule. EPA's complete economic analysis is available in the docket under 
docket ID number EPA-HQ-OPPT-2010-1075.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for two new chemical substances 
that were the subject of PMNs and a TSCA section 5(e) consent order. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

    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 PRA, unless it has been approved by OMB

[[Page 42995]]

and displays a currently valid OMB control number. The OMB control 
numbers for EPA's regulations in title 40 of the CFR, after appearing 
in the Federal Register, are listed in 40 CFR part 9, and included on 
the related collection instrument or form, if applicable. EPA is 
amending the table in 40 CFR part 9 to list the OMB approval number for 
the information collection requirements contained in this final rule. 
This listing of the OMB control numbers and their subsequent 
codification in the CFR satisfies the display requirements of PRA and 
OMB's implementing regulations at 5 CFR part 1320. This Information 
Collection Request (ICR) was previously subject to public notice and 
comment prior to OMB approval, and given the technical nature of the 
table, EPA finds that further notice and comment to amend it is 
unnecessary. As a result, EPA finds that there is ``good cause'' under 
section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 
553(b)(3)(B), to amend this table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action 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 between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    On February 18, 2012, EPA certified pursuant to section 605(b) of 
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that 
promulgation of a SNUR does not have a significant economic impact on a 
substantial number of small entities where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUN submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the economic analysis discussed in Unit IX. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300. Therefore, the promulgation of the SNUR 
would not have a significant economic impact on a substantial number of 
small entities.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this final rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments, nor does it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175, entitled Consultation and Coordination With 
Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply 
to this final rule.

G. Executive Order 13045

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

H. Executive Order 13211

    This 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 expected to affect energy supply, distribution, or use and 
because this action is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

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

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

[[Page 42996]]

40 CFR Part 721

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

    Dated: July 16, 2012.

Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. The table in Sec.  [emsp14]9.1 is amended by adding the following 
sections in numerical order under the undesignated center heading 
``Significant New Uses of Chemical Substances'' to read as follows:

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
              40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10230.................................  2070-0012
721.10231.................................  2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

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

0
4. Add Sec.  721.10230 to subpart E to read as follows:

Sec.  721.10230  Rutile, tin zinc, calcium doped.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as rutile, tin zinc, 
calcium-doped (PMN P-06-36; CAS No. 389623-01-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this rule do not 
apply to quantities of the PMN substance that have been incorporated 
into a polymer, glass, dispersion, cementitious matrix, or a similar 
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(i), (b) (concentration set at 1.0 percent), and 
(c). The following National Institute for Occupational Safety and 
Health (NIOSH)-certified respirators with an assigned protection factor 
(APF) of 10 meet the minimum requirements for Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose- fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting face-piece (either half-face or full-face) and HEPA 
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting face-piece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose 
to follow the new chemical exposure limit (NCEL) provisions listed in 
the TSCA section 5(e) consent order for this substance. The NCEL is 2.4 
mg/m\3\ as an 8-hour time-weighted-average for this substance (PMN P-
06-36; CAS No. 389623-01-2) and the substance referred to in 40 CFR 
721.10231 (PMN P-06-37; CAS No. 389623-07-8) combined. Persons who wish 
to pursue NCELs as an alternative to the Sec.  721.63 respirator 
requirements may request to do so under Sec.  721.30. Persons whose 
Sec.  721.30 requests to use the NCELs approach are approved by EPA 
will receive NCELs provisions comparable to those contained in the 
corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 2.4 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the substance with a 
particle size less than 100 nanometers, where d10 particle size 
presents the particle size, as determined by laser light scattering, at 
which 10 percent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10231 to subpart E to read as follows:

Sec.  721.10231  Rutile, tin zinc, sodium-doped.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as rutile, tin zinc, 
sodium-doped (PMN P-06-37; CAS No. 389623-07-8) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this rule do not apply to 
quantities of the PMN substance that have been incorporated into a 
polymer, glass, dispersion, cementitious matrix, or a similar 
incorporation.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(i), (b) (concentration set at 1.0 percent), and 
(c). The following National Institute for Occupational Safety and 
Health (NIOSH)-certified respirators with an assigned protection factor 
(APF) of 10 meet the minimum requirements for Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a

[[Page 42997]]

tight-fitting face-piece (either half-face or full-face) and HEPA 
filters; or
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting face-piece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose 
to follow the new chemical exposure limit (NCEL) provisions listed in 
the TSCA section 5(e) consent order for this substance. The NCEL is 2.4 
mg/m\3\ as an 8-hour time-weighted-average for this substance (PMN P-
06-37; CAS No. 389623-07-8) and the substance referred to in 40 CFR 
721.10230 (PMN P-06-36; CAS No. 389623-01-2) combined. Persons who wish 
to pursue NCELs as an alternative to the Sec.  721.63 respirator 
requirements may request to do so under Sec.  721.30. Persons whose 
Sec.  721.30 requests to use the NCELs approach are approved by EPA 
will receive NCELs provisions comparable to those contained in the 
corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 2.4 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the substance with a 
particle size less than 100 nanometers, where d10 particle size 
presents the particle size, as determined by laser light scattering, at 
which 10 percent by weight of the substance measured is smaller).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2012-17895 Filed 7-20-12; 8:45 am]
BILLING CODE 6560-50-P