[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