Significant New Use Rules on Certain Chemical Substances, 38210-38223 [2013-15032]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Rules and Regulations]
[Pages 38210-38223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15032]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-0279; FRL-9390-6]
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 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 17 
chemical substances which were the subject of premanufacture notices 
(PMNs). Fifteen of these chemical substances are subject to TSCA 
section 5(e) consent orders issued by EPA. This action would require 
persons who intend to manufacture, or process any of these 17 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 that activity before it occurs.

DATES: This final rule is effective August 26, 2013.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2010-0279, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
https://www.epa.gov/dockets.

[[Page 38211]]


FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division, 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, 
process, or use any of the 17 chemical substances contained in this 
final rule. Potentially affected entities may include, but are not 
limited to:
     Manufacturers, 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.  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 17 chemical 
substances which were the subject of PMNs. Fifteen of these chemical 
substances are subject to TSCA section 5(e) consent orders issued by 
EPA. The final SNURs for 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. The final SNURs for the 2 remaining 
substances are not subject to a consent order under TSCA section 5(e). 
In these two cases, EPA has determined in the final SNURs that these 
significant new use activities, ``(i) are different from those 
described in the premanufacture notice for the substance, including any 
amendments, deletions, and additions of activities to the 
premanufacture notice, and (ii) may be accompanied by changes in 
exposure or release levels that are significant in relation to the 
health or environmental concerns identified'' for the PMN substance. 
This action requires persons who intend to manufacture, or process 
these 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 December 28, 2011 (76 
FR 81447) (FRL-9326-2), EPA proposed SNURs for these seventeen chemical 
substances. More information on the specific chemical substances 
subject to this final rule can be found in the Federal Register 
documents proposing the SNURs. The record for the SNURs for these 
seventeen chemical substances was established in the docket under 
docket ID number EPA-HQ-OPPT-2010-0279. That docket includes 
information considered by the Agency in developing the proposed and 
final rules, including comments on those rules.
    EPA received numerous 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 modified 
final rules for these chemical substances as described in Unit V. of 
this document.

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, 
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 chemical substances, 
EPA concluded that for 15 of the 17 chemical substances, 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

[[Page 38212]]

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 orders.
    In the other two cases, where the uses were not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  721.170 were met. For 
additional discussion of the rationale for the SNURs on these 
chemicals, see Units II. and V. of the proposed rule.

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, 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, 
or processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers, 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, 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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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 
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.

V. Response to Comments on Proposed SNURs

    Comment 1: One commenter stated that the practice of EPA 
negotiating consent orders with the PMN submitter first without public 
comment or input has limited the public's ability to use the comment 
process to change requirements for SNURs based on consent orders and 
has contributed to SNURs requiring personal protective equipment rather 
than following the industrial hygiene hierarchy of controls where 
personal protective equipment is the last option selected to control 
exposures.
    EPA Response: EPA issues orders under section 5(e) of TSCA in 
response to PMNs submitted under Section 5(a) of TSCA. EPA can only 
negotiate consent orders with persons who submitted the PMN. Because 
the consent order only restricts the activities of the PMN submitter, 
EPA issues a SNUR to extend the same requirements to all manufacturers, 
and processors. SNURs are issued either using notice and comment 
rulemaking or as direct final rules. Regardless of which procedure is 
used, the public is permitted an opportunity to comment. In accordance 
with the procedural rules for promulgating SNURs based on section 5(e) 
orders (see 40 CFR 721.160(b)), such SNURs are generally based on and 
consistent with the underlying section 5(e) consent order. However, EPA 
may also designate additional activities as significant new uses 
(SNUs). These additional SNUs may be in response to public comment. For 
an example, see the response to Comment 14.
    Comment 2: A commenter objected to the requirement that domestic 
manufacture of certain PMN substances is not permitted. The commenter 
states that if it is unacceptable for Americans to be exposed to these 
substances, then it is unacceptable for other humans to be exposed. 
Conversely, the commenter stated that if these substances can be 
manufactured safely then Americans should also have that opportunity.
    EPA Response: The SNUR does not prevent domestic manufacture from 
occurring, it only requires notification beforehand. Because domestic 
manufacture is not currently anticipated and may never occur, EPA does 
not review potential risks associated with domestic manufacture when a 
PMN is submitted with an indication that the substance will only be 
imported and not domestically manufactured. EPA did not review or 
address potential risks of manufacture outside the United States 
because the statutory authority of TSCA is not applicable to actions 
outside the United States. If and when a person decides to begin 
domestic manufacture of the substance, the SNUN review will then permit 
EPA to assess and address potential risks associated with the SNU 
before they occur.
    Comment 3: For the SNUR for the chemical substance which was the 
subject of PMN P-04-244, one commenter stated that there was no need 
for a production volume limit for the SNUR, based on the limited use of 
the PMN substance as a herbicide intermediate, minimal toxicity 
effects, and the use of personal protective equipment to limit 
exposures. Another commenter, who is subject to the consent order, 
stated that they would petition the Agency to eliminate the testing 
requirement in the consent order. The second commenter recommended that 
EPA finalize the SNUR after the agency takes action on the petition.
    EPA Response: The consent order requires testing at a specific 
production volume limit, which is the basis for the production volume 
limit of manufacture of the PMN substance contained in the SNUR at 
Sec.  721.80(q). After reviewing the petition to modify the consent 
order, EPA decided to retain the testing requirement in the consent 
order, because the petitioner did not submit alternative data that 
addressed the testing requirement in the consent order. EPA retained 
the testing requirement in the consent order at a

[[Page 38213]]

specific production volume limit to address EPA's finding that the 
available information is insufficient to permit a reasoned evaluation 
of the health effects of the PMN substance at larger production 
volumes. Thus, the final rule will contain the same production volume 
limit for manufacture. If the person subject to the consent order 
submits the required testing before exceeding the production volume 
limit, that person is permitted to exceed the production volume limit 
without a significant new use notification. EPA will review the testing 
results and take appropriate action to continue to address any 
potential unreasonable risks. Processors of the PMN substance are not 
subject to the production volume limit.
    Comment 4: EPA should make it clear to PMN submitters of carbon 
nanotubes and other nanomaterials that required test methods will be 
decided on a case-by-case basis and that preference will be given to in 
vitro nanomaterial-specific methods. There are several EPA and National 
Academy of Science testing strategies that support this approach. In 
addition to problems with extrapolating information from animal studies 
to humans for conventional chemicals, nanomaterials possess unique 
physical and toxicological properties that render animal testing even 
more problematic. It is critical to completely and accurately 
characterize nanomaterials and then apply in vitro and in silico 
methods within an integrated test strategy. In the event that 
additional data is requested, EPA should require manufacturers to use 
high-throughput methods that have been specifically designed for 
nanomaterials in order to reduce reliance on animal-based testing.
    EPA Response: EPA identified recommended testing in the preamble of 
the proposed SNUR. Any manufacturers, or processors who intend to 
conduct testing or submit a SNUN are encouraged to contact EPA prior to 
commencing testing to avoid duplicative testing, to identify 
alternative testing, and to discuss protocols and testing strategies 
for any testing to be conducted. EPA recognizes the potential value of 
high-throughput methods, in vitro nanomaterial specific methods, and 
integrated testing strategies for nanomaterials. EPA continues to 
evaluate proposed testing methods for carbon nanotubes and other 
nanomaterials. In assessing this on a case-by-case basis, EPA will 
continue to consider the alternatives identified by the commenter.
    Comment 5: The chemical name for P-10-476 should include the word 
brominated.
    EPA Response: EPA agrees that brominated is part of the chemical 
name and will include the corrected chemical name in the final SNUR.
    Comment 6: All data regarding environmental and health effects of 
nanomaterials, especially adverse effects, should be made publicly 
available. EPA must challenge claims of confidential business 
information (CBI) by manufacturers. EPA could disclose CBI in 
connection with a public proceeding to determine whether a nano product 
causes unreasonable adverse effects on health or the environment, if 
EPA finds such disclosure is necessary in the public interest.
    EPA Response: EPA is committed to ensuring that CBI claims do not 
limit the public availability of environmental and health effects data 
beyond the confidentiality protections provided in TSCA Section 14. EPA 
has well established provisions that provide, as appropriate, a 
mechanism to evaluate CBI claims to ensure such claims are consistent 
with the statute. Regarding the chemical substances that are 
nanomaterials and intended to be subject to the proposed SNUR, each 
consent order and SNUR clearly articulates the basis for EPA's findings 
and describes the data used to assess health and environmental effects 
and risks. Moreover there were no CBI claims for health and safety data 
in the health and safety studies for the substances subject to the 
proposed SNUR.
    Comment 7: The proposed regulations fail to address a number of 
concerns including addressing the public's and worker's right to know 
by not providing for mandatory nano-specific ingredient and warning 
labeling requirements.
    EPA Response: The SNURs and the consent orders which are the basis 
for the SNURs do not require labeling of nano-specific ingredients or 
nano-specific warnings because (1) the basis for the consent orders and 
SNURs is not that they are nanomaterials per se, but rather is based on 
their specific properties and potential risks, and (2) companies that 
manufacture, process, and use chemical substances that are carbon 
nanotubes and fullerenes already clearly identify those chemical 
substances as nanomaterials.
    Comment 8: The requirements for the proposed SNURs for P-09-54-57 
and P-09-142-144 were inconsistent with requirements in the consent 
order. Specifically, the proposed SNURs required Sec.  
721.63(a)(2)(ii), which is full body protective clothing, when the 
consent orders required clothing that covers any other exposed areas of 
the arms, legs, and torso. In addition, for P-09-55, the proposed SNUR 
includes language that respirators must be used ``with an assigned 
protection factor (APF) of at least 50''. The consent order for P-09-55 
does not contain language requiring a respirator with an APF of 50.
    EPA Response: Because the use of clothing that covers any other 
exposed areas of the arms, legs, and torso, as required by the consent 
orders for the PMN substances, is an ongoing use, the proposed SNUR 
requirements have been changed in the final rule to be consistent with 
the ongoing use. In the final rule, EPA has changed the requirements in 
Sec.  721.63 to require clothing that covers any other exposed areas of 
the arms, legs, and torso for these SNURS. Because the consent order 
for P-09-54-57 does not require that the PMN submitter demonstrate that 
the clothing is impervious, the SNUR has been revised accordingly to 
reflect the ongoing use. However, the consent order for P-09-142-144 
does require that the PMN submitter demonstrate that the protective 
clothing is impervious. Therefore, EPA will retain the language in the 
final rules for P-09-142-144 that imperviousness must be demonstrated 
for the clothing. EPA incorrectly included in the proposed rule for P-
09-55 in Sec.  721.63 the language, ``with an assigned protection 
factor (APF) of at least 50''. EPA removed that language for P-09-55 in 
the final rule.
    Comment 9: NIOSH recommends a hierarchical approach to reduce 
worker exposure that relies on respiratory protection only after other 
approaches have been attempted. The proposed rules allow persons who 
would be subject to SNURs for CNT to submit data to EPA in support of a 
New Chemical Exposure Limit (NCEL) under 40 CFR 721.30. The following 
comments pertain primarily to the CNT chemical substances in the 
proposed SNURS. To ensure that the PMN substances that are CNT are 
handled in a safe manner, EPA may want to add a requirement that 
employers submit information about specific workplace exposure controls 
in addition to the supporting evidence of airborne exposure data. EPA 
should also consider providing guidance on methods to measure process 
emissions and worker exposures, and interpretation of those data in 
making risk management decisions. NIOSH has published guidance on 
general approaches as well as specific CNT information. The basis of 
any NCEL should be compatible with current United States government 
risk assessment policies and practices used to set occupational 
exposure limit. NIOSH recommends that EPA use the

[[Page 38214]]

NIOSH REL of 1 ug/m\3\ as an 8 hour-time-weighted average as identified 
in its final CNT bulletin. This would be an interim recommendation for 
controlling workplace exposures, until results of ongoing research can 
elucidate which physical and chemical characteristics of CNT affect 
their toxicity and until improved methods to measure airborne exposures 
are established.
    EPA Response: EPA agrees that a hierarchy of controls should be 
applied and that personal protective equipment is the last resort to 
prevent exposures. See EPA's response to comment 14 describing language 
it will add to the applicable SNURs in this action. EPA's NCELs 
language in consent orders states that preventing exposures is the 
preferred method for protecting workers, see: https://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf. Most PMN and SNUN submissions 
describe engineering controls and other steps that will be taken to 
reduce worker exposures. However, in many cases these measures may not 
sufficiently reduce exposures or may not used by every manufacturer or 
processor. EPA requires personal protective equipment for workers who 
are reasonably likely to be exposed in order to prevent unreasonable 
risks. However, persons subject to the SNURs for carbon nanotubes may 
submit information under 40 CFR 721.30 on any alternative exposure 
controls, including a NCEL, to support a determination that those 
exposure controls are equivalent to the requirements in the SNUR. While 
EPA encourages submission of as much information as possible to support 
that determination, EPA does not require submission of specific 
workplace exposure controls in addition to airborne exposure data. EPA 
can provide information on the approach used to measure releases and 
exposures on a case-by-case basis to support a determination that those 
exposure controls are equivalent to the requirements in the SNUR. Such 
information would take into consideration the fact that new chemical 
substances do not have established methods of detection. When 
establishing a NCEL or other alternative exposure control, EPA will 
consider all available data including United States government policies 
and practices used to set occupational exposure limits. Because of the 
uncertainty surrounding the NIOSH REL of 1 ug/m\3\ (as NIOSH noted in 
its final CNT bulletin the REL is based on the current analytical limit 
of quantification and may not be preventative of all known health 
effects see: https://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf), 
EPA will not adopt the NIOSH REL as a NCEL at this time because EPA 
cannot determine that at the REL the potential exposures may not 
present an unreasonable risk. EPA will consider the final NIOSH REL or 
other alternative exposure controls for CNTs if a submission requesting 
such is made under 40 CFR 721.30. This would allow the submitter to 
send EPA data in support of a proposed exposure level and to 
demonstrate a technique to comply with that level. EPA would then 
evaluate the proposal and data as described in 40 CFR 721.30. See: 
https://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf and 
https://www.epa.gov/oppt/newchems/pubs/ncelresp.pdf, which, 
respectively, are EPA's boilerplate TSCA 5(e) consent order containing 
a NCEL and EPA's Response to Comments on NCELs in TSCA 5(e) Orders. 
These two documents contain additional information on EPA's approach to 
NCELs and developing techniques to comply with those requirements.
    Comment 10: Each CNT SNUR includes a statement that this rule does 
not apply `` . . . to quantities of the PMN substance after they have 
been completely reacted (cured); embedded or incorporated in a polymer 
matrix . . . that is not intended to undergo further processing, except 
for mechanical processing.'' NIOSH agrees with this approach. The 
wording in Sec.  721.10274 of the proposed rule (page 81460) differ 
from that in other sections by stating ``. . . or embedded in a 
permanent solid polymer form with a concentration of the PMN substance 
equal to or below 30 percent. The other sections did not include the 
``30 percent'' requirement. Please clarify the basis for EPA's 
determination for this particular PMN substance.
    EPA Response: Based on confidential information in the PMN, EPA 
determined, that for this PMN substance, P-09-0188, there may not be an 
unreasonable risk if the PMN substance was contained in a polymer form 
with a concentration of the PMN substance equal to or below 30 percent; 
however, EPA is concerned about potential risks above a 30 percent 
concentration. Consequently, the consent order does not apply when the 
concentration of the PMN substance is equal to or below 30 percent in a 
permanent solid polymer form.
    Comment 11: The proposed rules for the carbon nanotube chemical 
substances include statements requiring PMNs to include the projected 
volume of manufacturing and processing of a chemical substance, the 
extent to which a use changes the type or form of exposure of human 
beings or the environment to a chemical substance, the extent to which 
a use increases the magnitude and duration of exposure of human beings 
or the environment to a chemical substance, and the reasonably 
anticipated manner and methods of manufacturing, processing, 
distribution in commerce, and disposal of a chemical substance. A 
change in these factors may not necessarily address potential risk to 
workers.
    EPA Response: These comments pertain to the four factors identified 
in section 5(a)(2) of TSCA that EPA must consider when determining 
significant new uses of a chemical substance. EPA must also consider 
all other relevant factors. These factors are not requirements for 
information that must be included in PMNs or SNUNs. EPA agrees that a 
change in these factors does not necessarily result in a risk to human 
health or the environment. Persons who intend to manufacture, or 
process chemical substances for an activity that is designated as a 
significant new use by this final rule must notify EPA at least 90 days 
before commencing that activity. This required significant new use 
notification would provide EPA with the opportunity to evaluate the 
intended new use and to prohibit or limit any activity associated with 
the new use. EPA would assess the potential risks from those new uses 
and take action to prevent any unreasonable risks to human health or 
the environment from activities described in the SNUN.
    Comment 12: One commenter stated that the proposed SNURs for the 
carbon nanotubes restrict the uses of the PMN substances to those 
specified in the consent order and require certain dermal and 
respiratory personal protective equipment. Submission of a PMN or SNUN 
will allow EPA to review these chemical substances but would not 
address worker safety as the notices would not require reporting of 
information relevant to risk assessment. There are several 
uncertainties associated with risk assessment of nanomaterials 
including a lack of reliable studies, smaller particles may have more 
detrimental and more potent effects, and smaller particles may cause 
different or greater exposures to humans and the environment. Because 
of these uncertainties, risk assessment of nanomaterials will not be 
adequate.
    EPA Response: Despite the uncertainties cited by the commenter, EPA 
believes that its assessment and risk management of nanomaterials, 
although sometimes hampered by a lack of submitted data, is adequate to

[[Page 38215]]

identify and prevent potential unreasonable risks to human health or 
the environment from manufacturing processing, and using nanomaterials 
including risks to workers . EPA has consistently limited exposures to 
and releases of nanomaterials that are new chemical substances to 
prevent unreasonable risks through the use of TSCA section 5(e) orders 
and SNURs.
    Comment 13: The SNURs for the carbon nanotubes should require 
reporting of risk assessment methods and findings, including 
nanoparticle dimension and relevant information. Personal protective 
equipment should be required as the last step in risk management. The 
SNURs should also require some form of engineering and administrative 
controls on top of the required personal protective equipment with 
exhaust ventilation systems designed, tested, and maintained as per the 
recommendations of the American Conference of Governmental Industrial 
Hygienists and requiring ongoing risk monitoring.
    EPA Response: If a manufacturer or processor wants to engage in one 
of the new uses, the submitter of the SNUN must report all test data 
that are in the possession or control of the submitter as well as all 
other data concerning health or environmental effects known or 
reasonably ascertainable by the submitter, as described in 40 CFR 
720.45 and 40 CFR 721.25. Risk assessment methods and findings are not 
specifically required in these regulations to be submitted in a SNUN 
and EPA has not required them for other SNUNs because they are not 
statutorily required to be submitted for section 5 notices under TSCA 
Section 5(d)(1). However, pursuant to TSCA Section 5(d)(1)(B), 
available information relevant to potential hazards and risks must be 
included in a SNUN and could include any relevant risk assessment 
findings that have been developed by the SNUN submitter. For example, 
SNUN submitters should report any available particle size data for 
carbon nanotubes. The SNURs allow for specific engineering and 
administrative controls proposed by a submitter under 40 CFR 721.30, 
once EPA has evaluated those controls. See also the responses to 
comments 9 and 14 for further discussion of engineering and 
administrative controls.
    Comment 14: EPA received a similar set of comments from 26 public 
submissions. Each of these comments generally stated that EPA's 
approach to exclusively requiring personal protective equipment in 
SNURs to prevent worker exposure instead of requiring engineering 
controls is not following the best occupational health and safety 
practices. The commenters suggest approaches that EPA could adopt. 
Several commenters identified the ``hierarchy of controls'' approach 
for industrial hygiene and workplace safety and controls, where 
elimination, substitution, engineering controls, and workplace or 
administrative controls should be used before personal protective 
equipment. Several commenters stated that persons subject to the SNUR 
should follow the OSHA requirements that a hierarchy of controls is 
required before employers use personal protective equipment. Some 
commenters suggest that EPA should specifically incorporate OSHA 
requirements at 40 CFR 1910.134(a)(1) into each SNUR or modify 
requirements in the SNUR at Sec.  721.63 to require a hierarchy of 
controls. Several commenters also suggested that EPA incorporate into 
SNURs applicable to CNT the recommendations in NIOSH Current 
Intelligence Bulletin for CNT. Other commenters noted that a NIOSH 
Progress Toward Safe Nanotechnology publication, a 2006 Rand Report 
summarizing a 2005 workshop, EPA's Nanotechnology White Paper, a NIEHS 
report on training workers, ANSI standards, and a Safe Work of 
Australia information sheet on use of carbon nanotubes either 
specifically recommend a hierarchy of controls or recommend an approach 
using engineering controls to prevent exposures before using personal 
protective equipment.
    EPA Response: EPA agrees that a hierarchy of controls should be 
applied and that personal protective equipment should be the last 
option to prevent exposures. EPA's NCELs language in consent orders 
states that preventing exposures is the preferred method for protecting 
workers. See: https://www.epa.gov/oppt/newchems/pubs/consent-pdf/riskhhncel.pdf. Most PMN and SNUN submissions describe engineering 
controls and other steps that will be taken to reduce worker exposures. 
However, in many cases these measures may not sufficiently reduce 
exposures or it may not be feasible for every manufacturer or processor 
to use engineering controls. EPA requires personal protective equipment 
only for workers who are reasonably likely to be exposed in order to 
prevent unreasonable risks. It should be noted that OSHA regulations 
only recommend but do not require specific engineering controls for 
existing chemical substances even when there are available methods for 
detecting those chemical substances and there are engineering controls 
known to prevent exposures. For new chemical substances, there is often 
no data on detection methods and limited data on which engineering 
controls prevent worker exposures in all situations. In addition, 
because new chemical substances have not previously been in commerce, 
there are no specific applicable exposure limits or protective 
equipment requirements under any other statute. In the case of 
nanomaterials, such as carbon nanotubes, there is currently even more 
uncertainty associated with detection methods and effectiveness of 
certain engineering controls.
    EPA has added language to the SNURs in this final action to require 
engineering controls and administrative controls where feasible but 
will not change its approach at this time for new chemical substances 
regarding requests for alternative control measures as set out in 40 
CFR 721.30, NCELs requirements, or its requirements for personal 
protective equipment. Persons who are subject to a SNUR must follow any 
personal protective equipment requirements where workers are reasonably 
likely to be exposed. Persons subject to SNUR requirements must request 
and demonstrate, as set out in 40 CFR 721.30, how any alternative 
control methods they propose are equivalent to existing SNUR 
requirements.
    Comment 15: EPA also received one comment supporting the SNURs and 
another comment discussing efforts of the tire industry to incorporate 
nanomaterials into their products.
    EPA response: Neither comment contained a substantive comment 
regarding the rule so EPA has no response.

VI. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered 
ongoing rather than new, any person could defeat the SNUR by initiating 
the significant new use before the final rule was issued. Therefore EPA 
has designated the date of publication of the proposed rule as the 
cutoff date for determining whether the new use is ongoing. Consult the 
Federal Register notice of April 24, 1990 (55 FR 17376) (FRL-3658-5) 
for a more detailed discussion of the cutoff date for ongoing uses.
    Any person, who began commercial manufacture, or processing of the 
chemical substances for any of the significant new uses designated in 
the proposed SNUR after the date of publication of the proposed SNUR, 
must

[[Page 38216]]

stop that activity before the effective date of the final rule. Persons 
who ceased those activities will have to first comply with all 
applicable SNUR notification requirements and wait until the notice 
review period, including any extensions, expires, before engaging in 
any activities designated as significant new uses. If a person were to 
meet the conditions of advance compliance under 40 CFR 721.45(h), the 
person would be considered to have met the requirements of the 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.
    In the TSCA section 5(e) consent orders for 15 of the chemical 
substances regulated under this rule, EPA has established restrictions 
in view of the lack of data on the potential health and environmental 
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.
    In cases where EPA issued a TSCA section 5(e) consent order that 
requires or recommends certain testing, Unit IV. of the proposed rule 
lists tests required or recommended in each of the section 5(e) consent 
orders underlying the proposed 5(e) SNURs, and lists tests recommended 
for the substances subject to the proposed non-5(e) SNURs. 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.
    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 https://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, 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-2010-0279.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for several new chemical 
substances that were the subject of PMNs and, in some cases, 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 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.

[[Page 38217]]

    2. The SNUN submitted by any small entity would not cost 
significantly more than $8300.
    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 $8300. 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

    Since this action does not involve any technical standards, NTTAA 
section 12(d) (15 U.S.C. 272 note), does not apply to this action.
    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.

40 CFR Part 721

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

    Dated: June 14, 2013.
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.  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.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
             40 CFR citation                      OMB Control No.
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10265................................  2070-0012
721.10266................................  2070-0012
721.10267................................  2070-0012
721.10268................................  2070-0012
721.10269................................  2070-0012
721.10270................................  2070-0012
721.10271................................  2070-0012
721.10272................................  2070-0012
721.10273................................  2070-0012
721.10274................................  2070-0012
721.10275................................  2070-0012
721.10276................................  2070-0012
721.10277................................  2070-0012
721.10278................................  2070-0012
721.10279................................  2070-0012
721.10280................................  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
2. Add Sec.  721.10265 to subpart E to read as follows:

[[Page 38218]]

Sec.  721.10265  Ethane, 2-bromo-1, 1-difluoro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethane, 2-bromo-
1,1-difluoro-. (PMN P-04-244; CAS No. 359-07-9) 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 after it has been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), (b) 
(concentration set at 0.1 percent), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirator with an assigned 
protection factor (APF) of at least 1000 meets the minimum requirements 
for Sec.  721.63(a)(4): NIOSH-certified supplied-air respirator 
operated in pressure demand or other positive pressure mode and 
equipped with a tight-fitting full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), a manufacturer, 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 0.5 mg/m\3\ 
as an 8-hour time-weighted average. 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.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv)(use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.5 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k)(chemical intermediate for a herbicide) 
and (q).
    (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), (e), (f), (g), (h), and (i) are applicable 
to manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.
0
3. Add Sec.  721.10266 to subpart E to read as follows:


Sec.  721.10266   Multi-walled carbon nanotubes (generic) (P-08-733 and 
P-08-734).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as multi-
walled carbon nanotubes (PMNs P-08-733 and P-08-734) are 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 substances after they have been 
completely reacted (cured); embedded or incorporated into a polymer 
matrix that has been reacted (cured); embedded, encapsulated or 
incorporated by the polymer binder into a permanent solid matrix (does 
not include slurries) that is not intended to undergo further 
processing, except for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., physical containment, exhaust 
control ventilation, or isolation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)--certified 
respirator with an assigned protection factor (APF) of at least 50 
meets the minimum requirements for Sec.  721.63(a)(4): NIOSH-certified 
air-purifying, tight-fitting full-face respirator equipped with N-100, 
P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (k), and (q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
4. Add Sec.  721.10267 to subpart E to read as follows:


Sec.  721.10267  [5,6]Fullerene-C60-Ih.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as [5,6]Fullerene-C60-
Ih (PMN P-09-54; CAS No. 99685-96-8) 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 after it has been completely reacted (cured); 
embedded or incorporated into a polymer matrix that itself has been 
reacted (cured); embedded in a permanent solid polymer form that is not 
intended to undergo further processing except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 filter.

[[Page 38219]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(an intermediate compound for use in 
producing downstream products that will in turn be used in organic 
electronic devices and an additive to improve mechanical properties or 
conductivity; a compound used to improve the mechanical properties of 
rubbers, plastics, and lubricants; or a compound for use as an additive 
to increase the conductivity of materials).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b),(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, 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.  721.10268 to subpart E to read as follows:


Sec.  721.10268  [5,6]Fullerene-C70-D5h(6).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as [5,6]Fullerene-C70-
D5h(6) (PMN P-09-55; CAS No. 115383-22-7) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); embedded in a permanent solid polymer form that 
is not intended to undergo further processing except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63 (a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (an intermediate compound for use in 
producing downstream products that will in turn be used in organic 
electronic devices and an additive to improve mechanical properties or 
conductivity; a compound used to improve the mechanical properties of 
rubbers, plastics, and lubricants; or a compound for use as an additive 
to increase the conductivity of materials).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
6. Add Sec.  721.10269 to subpart E to read as follows:


Sec.  721.10269  [5,6]Fullerene-C84-D2.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as [5,6]Fullerene-C84-
D2 (PMN P-09-56; CAS No. 145809-19-4) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); embedded in a permanent solid polymer form that 
is not intended to undergo further processing except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(an intermediate compound for use in 
producing downstream products that will in turn be used in organic 
electronic devices and an additive to improve mechanical properties or 
conductivity; a compound used to improve the mechanical properties of 
rubbers, plastics, and lubricants; or a compound for use as an additive 
to increase the conductivity of materials).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b),(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.10270 to subpart E to read as follows:


Sec.  721.10270  [5,6]Fullerene-C84-D2d.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as [5,6]Fullerene-C84-
D2d (PMN P-09-57; CAS No. 145809-20-7) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); embedded in a permanent solid polymer form that 
is not intended to undergo further processing except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),

[[Page 38220]]

engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (an intermediate compound for use in 
producing downstream products that will in turn be used in organic 
electronic devices and an additive to improve mechanical properties or 
conductivity; a compound used to improve the mechanical properties of 
rubbers, plastics, and lubricants; or a compound for use as an additive 
to increase the conductivity of materials).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b),(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10271 to subpart E to read as follows:


Sec.  721.10271  3'H-Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic 
acid, 3'-phenyl-, methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3'H-
Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, 
methyl ester, (PMNs P-09-142 and Chemical A in P-09-416, CAS Number 
160848-22-6) 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 
substances after they have been completely reacted (cured); embedded or 
incorporated into a polymer matrix that itself has been reacted 
(cured); or embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(clothing which covers any other exposed 
areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) (use as a compound used in fabrication 
and/or operation of electronic devices that enables or improves the 
conductivity, efficiency, voltage or other characteristics of the 
device, a compound that improves the mechanical properties of 
lubricants and plastics, or use as an acceptor molecule in a polymer 
coating in an encapsulated organic photovoltaic electronic device) and 
(q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
9. Add Sec.  721.10272 to subpart E to read as follows:


Sec.  721.10272  3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-
butanoic acid, 3'-phenyl-,methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as 3'H-
Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, 
methyl ester (PMNs P-09-143 and Chemical B in P-09-416, CAS Number 
609771-63-3) 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 
substances after they have been completely reacted (cured); embedded or 
incorporated into a polymer matrix that itself has been reacted 
(cured); or embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2) (clothing which covers any other 
exposed areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (use as a compound used in fabrication 
and/or operation of electronic devices that enables or improves the 
conductivity, efficiency, voltage or other characteristics of the 
device, a compound that improves the mechanical properties of 
lubricants and plastics, or use as an acceptor molecule in a polymer 
coating in an encapsulated organic photovoltaic electronic device) and 
(q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k)

[[Page 38221]]

are applicable to manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
10. Add Sec.  721.10273 to subpart E to read as follows:


Sec.  721.10273  3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-
butanoic acid, 3'-phenyl-, methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as 3'H-
Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-
,methyl ester (P-09-144 and Chemical C in P-09-416, CAS Number 1051371-
21-1) 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 
substances after they have been completely reacted (cured); embedded or 
incorporated into a polymer matrix that itself has been reacted 
(cured); or embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2) (clothing which covers any other 
exposed areas of the arms, legs, and torso), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator meets the minimum requirements for Sec.  721.63(a)(4): 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 cartridges.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (use as a compound used in fabrication 
and/or operation of electronic devices that enables or improves the 
conductivity, efficiency, voltage or other characteristics of the 
device, a compound that improves the mechanical properties of 
lubricants and plastics, or use as an acceptor molecule in a polymer 
coating in an encapsulated organic photovoltaic electronic device) and 
(q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
11. Add Sec.  721.10274 to subpart E to read as follows:


Sec.  721.10274  Multi-walled carbon nanotubes (generic) (P-09-188).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-09-188) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); or embedded in a permanent solid polymer form 
with a concentration of the PMN substance equal to or below 30 percent 
that is not intended to undergo further processing except for 
mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., physical containment, exhaust control ventilation, or 
isolation) or administrative control measures (e.g., workplace policies 
and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirator meets the 
minimum requirements for Sec.  721.63(a)(4): NIOSH-certified air-
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), (m), (o), and (q).
    (iii) Release to Water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
12. Add Sec.  721.10275 to subpart E to read as follows:


Sec.  721.10275  Multi-walled carbon nanotubes (generic) (P-09-0417).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-09-417) 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 it has been completely reacted (cured); 
embedded or incorporated into a polymer matrix that itself has been 
reacted (cured); embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., physical containment, exhaust 
control ventilation, or isolation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirator with an assigned protection factor (APF) of at

[[Page 38222]]

least 50 meets the minimum requirements for Sec.  721.63(a)(4): NIOSH-
certified air-purifying, tight-fitting full-face respirator equipped 
with N-100, P-100, or R-100 filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (plastics additive to improve 
electrical, thermal and/or mechanical properties), (m), and (o).
    (iii) Release to Water. Requirements as specified in Sec.  
721.90(b)(1), and (c)(1).
    (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), (e), (i) and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.10276 to subpart E to read as follows:


Sec.  721.10276  Multi-walled carbon nanotubes (generic) (P-10-39).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-10-39) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); embedded in a permanent solid polymer, metal, 
glass, or ceramic form that is not intended to undergo further 
processing except for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., physical containment, exhaust control ventilation, or 
isolation) or administrative control measures (e.g., workplace policies 
and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
approved protection factor (APF) of at least 50 meets the minimum 
requirements for Sec.  721.63(a)(4): NIOSH-certified air-purifying, 
tight-fitting full-face respirator equipped with N-100, P-100, or R-100 
filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k), (m), (o), and (p)(120,000 kilograms 
of the aggregate of P-10-39 and P-10-40 the substance described in 
Sec.  721.10277).
    (iii) Release to Water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
14. Add Sec.  721.10277 to subpart E to read as follows:


Sec.  721.10277  Single-walled and multi-walled carbon nanotubes 
(generic) (P-10-40).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as single-
walled and multi-walled carbon nanotubes (PMN P-10-40) 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 after it has been completely 
reacted (cured); embedded or incorporated into a polymer matrix that 
itself has been reacted (cured); embedded in a permanent solid polymer, 
metal, glass, or ceramic form that is not intended to undergo further 
processing except for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., physical containment, exhaust control ventilation, or 
isolation) or administrative control measures (e.g., workplace policies 
and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the minimum 
requirements for Sec.  721.63(a)(4): NIOSH-certified air-purifying, 
tight-fitting full-face respirator equipped with N-100, P-100, or R-100 
filter.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (m), (o), and (p)(120,000 kilograms of 
the aggregate of P-10-40 and P-10-39 the substance described in Sec.  
721.10276).
    (iii) Release to Water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
15. Add Sec.  721.10278 to subpart E to read as follows:


Sec.  721.10278  4,4'-Bipyridinium, 1-(phosphonoalkyl)-1'-substituted-, 
salt with anion (1:2) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 4,4'-
Bipyridinium, 1-(phosphonoalkyl)-1'-substituted-, salt with anion (1:2) 
(PMN P-10-224) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace: Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3)(applicable to gloves only), (a)(4), 
(a)(6), (b)(concentration set at 1.0 percent), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at

[[Page 38223]]

least 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 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).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (j), (s)(1000 kilograms), (v)(1), and 
(v)(2).
    (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), (e), and (i) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.
    The provisions of Sec.  721.1725(b)(1) apply to this section.

0
16. Add Sec.  721.10279 to subpart E to read as follows:


Sec.  721.10279  Multi-walled carbon nanotubes (generic) (P-10-246).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-10-246) 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 after it has been completely reacted 
(cured); embedded or incorporated into a polymer matrix that itself has 
been reacted (cured); embedded in a permanent solid polymer form that 
is not intended to undergo further processing, except for mechanical 
processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4), 
engineering control measures (e.g., physical containment, exhaust 
control ventilation, or isolation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 50 
meet the minimum requirements for Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters; or
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (conductivity additive to resins, 
rubber, and to battery electrodes), and (q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(b)(1), and (c)(1).
    (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), (e), (i), and (k) are applicable to 
manufacturers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
17. Add Sec.  721.10280 to subpart E to read as follows:


Sec.  721.10280  Benzene ethenyl-, polymer with 1,3-butadiene, 
brominated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene ethenyl-, 
polymer with 1,3-butadiene, brominated (PMN P-10-476; CAS No. 1195978-
93-8)) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (manufacture by the method where the 
average number molecular weight is in the range of 1000 to 10,000 
daltons, or where less than 5 percent of the particles are in the 
respirable range of 10 microns or less and the average number molecular 
weight is greater than or equal to 10,000 daltons).
    (ii) [Reserved]
    (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), and (i) are applicable to manufacturers, 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. 2013-15032 Filed 6-25-13; 8:45 am]
BILLING CODE 6560-50-P