[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81441-81447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33255]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2010-1075; FRL-9329-4]
RIN 2070-AB27
Proposed Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under
section 5(a)(2) of 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
TSCA section 5(e) consent orders issued by EPA. The proposed SNURs on
these substances, which are based on and consistent with the provisions
of the underlying consent orders, would designate as a significant new
use the absence of the protective measures required in the consent
orders. This action would require 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 proposed rule to
notify EPA at least 90 days before commencing that activity. 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: Comments must be received on or before January 27, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID)
[[Page 81442]]
number EPA-HQ-OPPT-2010-1075, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-1075. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-1075. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required 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:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
Manufacturers, importers, or processors of one or more
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 a proposed or final SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec. [emsp14]721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should i consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
[[Page 81443]]
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing significant new use rules (SNURs) under section
5(a)(2) of TSCA for two chemical substances which were the subject of
PMNs and TSCA section 5(e) consent orders. 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 proposed SNUR on these substances are based on and
consistent with the provisions in the underlying consent orders. The
proposed SNURs designate as a significant new use the absence of the
protective measures required in the corresponding consent orders. These
SNURs would require persons who intend to manufacture, import, or
process either of these chemical substances for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
In the Federal Register of October 5, 2011 (76 FR 61566) (FRL-8880-
2), EPA issued direct final SNURs on these two chemical substances in
accordance with the procedures at Sec. 721.160(c)(3)(i). EPA received
notice of intent to submit adverse comments on these SNURs. Therefore,
as required by Sec. 721.160(c)(3)(ii), in the Federal Register of
December 5, 2011 (76 FR 75794) (FRL-9329-5), EPA withdrew the direct
final SNURs and is now issuing this proposed rule on the two chemical
substances. The record for the direct final SNURs on these substances
was established as docket EPA-HQ-OPPT-2010-1075. That record includes
information considered by the Agency in developing the direct final
rule and the notice of intent to submit adverse comments.
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 the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. 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. [emsp14]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 rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. [emsp14]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. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
two chemical substances that are the subject of these proposed 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.
IV. Substances Subject to This Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for two chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
PMN number.
Chemical name.
Chemical Abstracts Service (CAS) number.
Basis for the TSCA section 5(e) consent order.
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
CFR citation assigned in the regulatory text section of
this proposed rule.
This proposed rule concerns two PMN substances that are subject to
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I).
Those consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec. 721.160, and are based on and consistent with the provisions in
the underlying consent orders. The 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
PMN Numbers P-06-36 and P-06-37
Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-
06-37) Rutile, tin zinc, sodium-doped.
CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.
Effective date of TSCA section 5(e) consent order: February 17,
2009.
Basis for TSCA section 5(e) consent order: The PMN states that the
substances will be used as colorants for
[[Page 81444]]
polymers and industrial coatings. The order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that
the substances may present an unreasonable risk of injury to human
health. To protect against these risks, the consent order requires: Use
of personal respiratory equipment, including a National Institute for
Occupational Safety and Health (NIOSH)-certified respirator with an
Assigned Protection Factor (APF) of at least 10, or compliance with a
New Chemical Exposure Limit (NCEL) of 1.5 mg/m\3\ as an 8-hour time
weighted average; establishment of a hazard communication program; and
restricts the company from manufacturing the PMN substances with a d10
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; and
corresponding recordkeeping. The SNUR designates as a ``significant new
use'' the absence of these protective measures.
Toxicity concern: Based on structural activity relationship
analysis derived from test data on structurally similar respirable,
poorly soluble particulates, the PMN substances may cause lung overload
and fibrosis in workers exposed to the PMN substances by the inhalation
route.
Recommended testing: EPA has determined that the following test
would help characterize the human health effects of the PMN substances:
A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in
rats. The testing should include a 60-day recovery period to assess the
progression or regression of any lesions; and include special attention
to histopathology (inflammation and cell proliferation) of the lung
tissues and to various parameters of the bronchoalveolar lavage fluid
(BALF), e.g., marker enzyme activities, total protein content, total
cell count, cell differential, and cell viability. The order does not
require submission of the aforementioned information at any specified
time or production volume. However, the order's restrictions on
manufacturing, import, processing, distribution in commerce, use, and
disposal of the PMN substances will remain in effect until the order is
modified or revoked by EPA based on submission of that or other
relevant information.
CFR citations: 40 CFR 721.10230 (P-06-36) and 40 CFR 721.10231 (P-
06-37).
V. Rationale and Objectives of the Proposed 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), pending the development of information sufficient to make
reasoned evaluations of the human health effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The proposed SNUR provisions for these chemical substances
are consistent with the provisions of the TSCA section 5(e) consent
orders. These proposed SNURs are issued pursuant to Sec. 721.160.
B. Objectives
EPA is proposing these 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 proposed rule:
EPA would 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 would 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 would 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 would 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.
VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this proposed
rule have undergone premanufacture review and are subject to TSCA
section 5(e) consent orders. The PMN submitters are prohibited by these
TSCA section 5(e) consent orders from undertaking activities which EPA
is proposing as significant new uses. EPA solicits comments on whether
any of the uses proposed as significant new uses are ongoing.
As discussed in the Federal Register issue 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
final, and then argue that the use was ongoing before the effective
date of the final rule. Thus, persons who begin commercial manufacture,
import, or processing activities with the chemical substances regulated
through this proposed SNUR must cease any such activity before the
effective date of the rule, if and when finalized. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
proposed SNUR before the effective date. If a person meets the
conditions of advance compliance under Sec. 721.45(h), the person is
considered exempt from the requirements of the SNUR.
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)
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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. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. describes those tests. 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. To access the harmonized test
guidelines referenced in this document electronically, please go to
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
In the TSCA section 5(e) consent orders for the two chemical
substances regulated under this proposed rule, EPA has established
restrictions in view of the lack of data on the potential human health
risks that may be posed by the significant new uses or increased
exposure to the chemical substances. These restrictions will not be
removed until EPA determines that the unrestricted use will not present
an unreasonable risk of injury or result in significant or substantial
exposure or environmental release. This determination is usually made
based on the results of the required or recommended toxicity tests.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
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. 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 proposed rule would establish SNURs for two chemical
substances that were the subject of PMNs and TSCA section 5(e) consent
orders. 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 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 would amend the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed 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 would 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
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The requirement to submit a SNUN
applies to any person (including small or large entities) who intends
to engage in any activity described in the final rule as a
``significant new use.'' Because these uses are ``new,'' based on all
information currently available to EPA, it appears that no small or
large entities presently engage in such activities. A SNUR requires
that any person who intends to engage in such activity in the future
must first notify EPA by submitting a SNUN. Although some small
entities may decide to pursue a significant new use in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemicals substances, the Agency receives
only a handful of
[[Page 81446]]
SNUNs per year. For example, the number of SNUNs was four in Federal
fiscal year (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY
2008, and seven in FY 2009. During this 5-year period, three small
entities submitted a SNUN. In addition, the estimated reporting cost
for submission of a SNUN (see Unit VIII.) is minimal regardless of the
size of the firm. Therefore, EPA believes that the potential economic
impacts of complying with those SNURs are not expected to be
significant or adversely impact a substantial number of small entities.
In a SNUR that published in the Federal Register issue of June 2, 1997
(62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. 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 would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any affect 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 would 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would 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 proposed 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 proposed rule 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).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 16, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Add Sec. [emsp14]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)(5), (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)(5):
(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 facepiece (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 facepiece (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 these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances 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
[[Page 81447]]
(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 1.5 mg/m\3\), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture of the substances 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.
3. Add Sec. [emsp14]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)(5), (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)(5):
(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 facepiece (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 facepiece (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 these substances. The NCEL is
1.5 mg/m\3\ as an 8-hour time-weighted-average for both chemical
substances 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 1.5 mg/m\3\), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture of the substances 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. 2011-33255 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P