[Federal Register Volume 80, Number 4 (Wednesday, January 7, 2015)]
[Proposed Rules]
[Pages 845-858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30829]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2014-0760; FRL-9919-23]
RIN 2070-AB27
Proposed Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 13 chemical substances which
were the subject of premanufacture notices (PMNs). This action would
require persons who intend to manufacture (including import) or process
any of the chemical substances for an activity that is designated as a
significant new use by this proposed rule to notify EPA at least 90
days before commencing that activity. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit the activity before it occurs.
DATES: Comments must be received on or before March 9, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0760, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
[[Page 846]]
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division, Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers (including importers) or processors of one
or more subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
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 chemical substances 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 40 CFR 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for 13
chemical substances which were the subject of PMNs P-13-270, P-13-365,
P-13-392, P-13-393, P-13-471, P-13-563, P-13-617, P-13-618, P-13-619,
P-14-60, P-14-267, P-14-268, and P-14-478. These SNURs would require
persons who intend to manufacture or process any of these chemical
substances for an activity that is designated as a significant new use
to notify EPA at least 90 days before commencing that activity. In the
Federal Register publications of February 12, 2014 (79 FR 8273) (FRL-
9903-70), July 8, 2014 (79 FR 38464) (FRL-9911-05), and July 9, 2014
(79 FR 39268) (FRL-9910-01), EPA issued direct final SNURs on ten of
these 13 chemical substances, which are the subject of PMNs P-13-365,
P-13-392, P-13-393, P-13-471, P-13-270, P-13-563, P-13-617, P-13-618,
P-13-619, and P-14-60 in accordance with the procedures at Sec.
721.160(c)(3)(i). EPA received notices of intent to submit adverse
comments on these SNURs. Therefore, as required by Sec.
721.160(c)(3)(ii), EPA removed the direct final SNURs in separate final
rules published in the Federal Register of April 14, 2014 (71 FR 20800)
(FRL-9909-25) and September 4, 2014 (79 FR 52563) (FRL-9915-69), and is
now issuing this proposed rule on these ten chemical substances. The
records for the direct final SNURs on these ten chemical substances
were established as dockets EPA-HQ-OPPT-2013-0739, EPA-HQ-OPPT-2014-
0166, and EPA-HQ-OPPT-2014-0277. Those records include information
considered by the Agency in developing the direct final rule. Adverse
comments received regarding these substances and the direct final rule
are discussed in Unit IV. This proposed rule also includes three SNURs
for the three chemicals which are the subject of PMNs, P-14-267, P-14-
268, and P-14-478 and for which there has not been any previous
rulemaking. The record for the SNURs on these three chemicals was
established as docket EPA-HQ-OPPT-2014-0760. That record includes
information considered by the Agency in developing these three proposed
SNURs.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture 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 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 40 CFR 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 sections 5(b) and 5(d)(1), the exemptions authorized by
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TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations
at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory
action under TSCA section 5(e), 5(f), 6, or 7 to control the activities
for which it has received the SNUN. If EPA does not take action, EPA is
required under TSCA section 5(g) to explain in the Federal Register its
reasons for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute 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.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 13 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
PMN number.
Chemical name.
Chemical Abstracts Service (CAS) Registry number (assigned
for non-confidential chemical identities).
Public comments and EPA's response to comments on the ten
direct final SNURs subject to PMNs, P-13-365, P-13-392, P-13-393, P-13-
471, P-13-270, P-13-563, P-13-617, P-13-618, P-13-619, and P-14-60.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VII. for more
information).
CFR citation assigned in the regulatory text section of
this proposed rule.
The regulatory text section of this proposed rule specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits (i.e., limits on manufacture volume)
and other uses designated in this proposed rule, may be claimed as CBI.
PMN Number P-13-270
Chemical name: Aromatic dibenzoate (generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a catalyst component. Based on
structural activity relationship (SAR) analysis of test data on
analogous esters, EPA predicts chronic toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. Based on uses described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 1 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that should there be
any new use of the substance resulting in releases to surface waters
exceeding 1 ppb significant adverse environmental effects could occur.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
sediment-water chironomid life-cycle toxicity test using spiked water
or spiked sediment (OECD Test Guideline 233); a hydrolysis test (OECD
Test Guideline 111); and a Zahn-Wellens inherent biodegradation test
(OECD Test Guideline 302B) would help characterize the potential for
environmental effects of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media, because of the PMN substance's
low water solubility.
CFR citation: 40 CFR 721.10735.
PMN Number P-13-365
Chemical name: MDI modified polyalkene glycols (generic).
CAS number: Not available.
1. Public comment: One commenter claimed SNUR requirements
associated with P-13-365 for respiratory protection, record-keeping,
and hazard communication are difficult to understand and implement and
they add another layer of complexity for potential customers. Customers
are likely to choose existing adhesive system chemicals with no or
fewer SNUR requirements which may have greater risk potential to avoid
having to comply with the SNUR requirements of P-13-365 and similar new
chemicals.
1. EPA response: The proposed SNUR does not contain significant new
use reporting requirements pertaining to hazard communication. EPA has
issued numerous SNURs with similar recordkeeping and worker protection
requirements that other manufacturers and processors have complied with
and implemented. The comment period for the proposed rule is an
opportunity to provide more detail on specific issues or challenges
posed by the proposed SNUR reporting requirements, as well as potential
suggestions for EPA to better clarify those requirements. Unless EPA
receives specific, quantitative information that demonstrates the
chemical substances subject to these proposed SNURs exhibit a lower
potential for the hazards and risks described in the proposed SNUR or
that they will specifically replace a chemical substance with a higher
potential for hazards and risks, EPA would expect to issue the SNUR as
proposed to provide the Agency with the opportunity to review any new
uses for potential unreasonable risks. As described in the Agency's
ongoing Action Plan for MDI and TDI, diisocyanates are well-known
dermal and inhalation sensitizers in the workplace and have been
documented to cause asthma, lung damage, and in severe cases, fatal
reactions. EPA is concerned about potential health effects that may
result from exposures of consumers or self-employed workers while using
products containing uncured (unreacted) MDI and TDI and its related
polyisocyanates (e.g., spray-applied foam sealants, adhesives, and
coatings) or incidental exposures to the general population while such
products are used in or around buildings including homes or schools.
While workers may already be using protective controls in occupational
settings, due to the nature of the potential risk posed by these
chemicals, EPA believes it is prudent to emphasize its concern
[[Page 848]]
through respiratory protection requirements where there is potential
for inhalation exposure, in addition to proposing significant new uses
such as consumer use and application method. Accordingly, the
regulatory action for new diisocyanates reflects EPA's policy of
consistent treatment of the entire class of potentially hazardous
chemicals, regardless of their statutory status as ``new'' or
``existing'' chemicals. EPA continues to work to lessen the apparent
inequity between regulations of new and existing chemicals.
2. Public comment: The same commenter questioned whether EPA's
basis for adverse human health concerns stem from the residual
diisocyanate monomer or the P-13-365 substance. The P-13-365 substance
is not expected to be volatile under any use.
2. EPA response: The basis for EPA's health concern is for the P-
13-365 substance which includes the presence of any residual
diisocyanate monomer. In addition, EPA finds that there are unreacted
isocyanate groups in the polymer and that there is a significant
percentage of the polymer with molecular weight below 1,000. EPA agrees
that the higher molecular weight components of the P-13-365 substance
are not expected to be volatile. The residual diisocyanate monomer is
expected to be volatile and lower molecular components could be
volatile resulting in a higher potential for exposure.
3. Public comment: The same commenter proposes that instead of
recommending the 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) to characterize the human health effects of the P-13-365
substance, EPA should consider a Differential Scanning Calorimetric or
Thermogravimetric Analysis of the PMN substance to assess vaporization
potential. The 90-day inhalation toxicity test would require delivery
of the PMN substance as a mist or aerosol which the associated SNUR
prohibits. In addition, the results of the test may be heavily
influenced by the residual diisocyanate and not exhibit effects from
the PMN substance itself.
3. EPA response: In the ``Recommended testing'' section, the 90-day
inhalation toxicity and the dermal sensitization tests, are listed as
an appropriate way to characterize potential health effects. EPA will
consider any other testing, data, or information that would be relevant
to assessing potential health effects. The proposed SNUR would require
notification if a method was used that generates a mist or aerosol.
Conducting the 90-day inhalation toxicity test could address the
potential lung effects and respiratory sensitization if a significant
new use notice was submitted to EPA. As stated in the response to
comment 2, EPA is concerned about the health effects of any residual
monomer as well as unreacted isocyanate groups on the polymer.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive component.
Based on test data on analogous diisocyanates, EPA identified concerns
for dermal and respiratory sensitization, and lung and mucous membrane
irritation effects. For the use described in the PMN, EPA does not
expect significant occupational or any consumer inhalation exposure due
to the use of adequate personal protective equipment and because the
substance is not applied using a method that generates a vapor, mist,
or aerosol nor is it used in a consumer product. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator (with eye/face protection, when dermal and/or
ocular exposure is likely) with an APF of at least 10, where there is a
potential for inhalation exposure; any use of the substance in consumer
products; or any use of the substance involving an application method
that generates a vapor, mist, or aerosol, may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10717.
PMN Number P-13-392
Chemical name: Acrylic acid esters polymers, reaction products with
polyisocyanate (generic).
CAS number: Not available.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for wood, plastic, and
automotive paint material. Based on test data on analogous
diisocyanates, EPA identified concerns for dermal and respiratory
sensitization, lung and mucous membrane irritation, and lung effects if
inhaled based on the low molecular weight isocyanates. As described in
the PMN, worker inhalation exposure is not expected and dermal exposure
will be minimal due to the use of adequate personal protective
equipment and consumer exposure is not expected because the substance
will not be used in consumer products. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator (with eye/face protection, when dermal and/or
ocular exposure is likely) with an APF of at least 10, where there is a
potential for inhalation exposure, or any use of the PMN substance in a
consumer product, may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10719.
PMN Number P-13-393
Chemical name: 1,3-Benzenedicarboxylic acid, polymer with 1,4-
benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-
dimethyl-1,3-propanediol,dodecanedioic acid, 1,2-ethanediol,
hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic
isocyanate (generic).
CAS number: Not available.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive.
Based on test data on analogous diisocyanates, the Agency identified
concerns for dermal and respiratory sensitization, lung and mucous
membrane irritation, and lung effects if inhaled based on the low
molecular weight isocyanates. For the use described in the PMN, EPA
does not expect significant occupational or any consumer inhalation
exposure due to the use of adequate personal protective
[[Page 849]]
equipment and because the substance is not applied using a method that
generates a vapor, mist, or aerosol nor is the substance used in a
consumer product. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator (with eye/
face protection, when dermal and/or ocular exposure is likely) with an
APF of at least 10, where there is a potential for inhalation exposure;
any use of the substance in consumer products; or any use of the
substance involving an application method that generates a vapor, mist,
or aerosol, may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10720.
PMN Number P-13-471
Chemical name: Methylene diisocyanate polymer with polypropylene
glycol and diols (generic).
CAS number: Not available.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive.
Based on test data on analogous diisocyanates, EPA identified concerns
for oncogenicity, mutagenicity, respiratory and dermal sensitization,
and lung and mucous membrane irritation. As described in the PMN,
worker inhalation exposure is not expected and dermal exposure will be
minimal due to the use of adequate personal protective equipment, and
consumer exposure is not expected because the substance will not be
used in consumer products. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator (with eye/
face protection, when dermal and/or ocular exposure is likely) with an
APF of at least 10, where there is a potential for inhalation exposure
or the use of the substance in a consumer product, may cause serious
health effects. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600), a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) would help characterize
the human health effects of the PMN substance, and a carcinogenicity
test (OPPTS Test Guideline 870.4200) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10723.
PMN Number P-13-563
Chemical name: Propylene glycol, alpha isocyanate, omega silane
(generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate
for polyurethane polymers. Based on test data on analogous
diisocyanates, EPA identified concerns for oncogenicity, mutagenicity,
respiratory and dermal sensitization and lung and mucous membrane
irritation. For the use described in the PMN, EPA does not expect
significant occupational or any consumer exposure. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator (with eye/face protection, when dermal and/or
ocular exposure is likely) with an APF of at least 10, where there is a
potential for inhalation exposure; any use other than as an
intermediate; or any use of the substance in consumer products, may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C) and
(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600); a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465); and a carcinogenicity
test (OPPTS Test Guideline 870.4200) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10741.
PMN Numbers P-13-617, P-13-618, and P-13-619
Chemical names: (P-13-617) Aromatic dicarboxylic acid polymer with
alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate,
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkylalkanediyl)],hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl-2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (generic), (P-13-618) Alkanedioic acid, polymer with alkyl 2-
alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic); and (P-13-619) Alkanedioic acid,
polymer with alkyl alkylalkenoate, alkanedioic acid, alkanediol,
.alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic
diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid (generic).
CAS numbers: Claimed confidential.
1. Public comment: The commenter (identity confidential) had
concerns about the respirators listed as NIOSH-certified respirators
with an APF of at least 10 meeting the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
The commenter argues these listed respirators have, in fact, APFs
ranging from 25 to 1,000 and not 10 as required.
1. EPA response: The proposed SNUR would require notification if
workers who are reasonably likely to be exposed to the PMN substance by
inhalation did not use a NIOSH certified respirator with an APF of at
least 10. Workers who are exposed may use respirators with an APF
higher than 10. As noted in the response to the comment on P-13-365,
isocyanates are known dermal and respiratory sensitizers and known to
cause other health effects. Thus, EPA requires respirators to provide
protection from all potential exposures. Dermal exposures to
isocyanates can also possibly cause respiratory
[[Page 850]]
exposures. EPA has modified language in the preamble language to
indicate that respirators that provide dermal (face/eyes) protection
are required if dermal and/or ocular exposures are likely.
Consequently, respirators with a higher APF are also indicated because
respirators with an APF of 10 do not provide the desired dermal
protection. The respirators listed were examples of respirators that
meet the requirements of the SNUR. In the proposed regulatory text, EPA
has now also included a respirator that has an APF of 10 and does not
protect against dermal or ocular exposures for scenarios where neither
dermal nor ocular exposures are likely: NIOSH-certified air-purifying
half-mask respirator equipped with appropriate gas/vapor cartridges in
combination with N100, R100, or P100 filters or an appropriate canister
incorporating N100, R100, or P100 filters.
2. Public comment: The same commenter provided data that shows that
diphenylmethane diisocyanate (MDI), ``spills when modeled reached the
[threshold limit value] TLV concentration 3.8 ft at 38 C (after) 10 h
had elapsed (and) the [permissible exposure limit] PEL at 38 C reached
2.2 ft after 10h,'' and that ``MDI diffuses slowly from the spill and
remains close to the surface of the spill.'' The commenter concludes,
``It appears unlikely that respiratory protection would be required to
prevent excessive employee exposure to MDI vapors emitted from the
spill.'' The commenter contends the use of this data as a surrogate for
P-13-617, P-13-618, and P-13-619 is conservative because the average
molecular weight of the individual PMNs is much larger than the 4-4'-
MDI used in this data.
2. EPA response: EPA acknowledges that this could be the type of
data used to determine if a worker is reasonably likely to be exposed
to the PMN substance. However, it does not address every scenario where
workers are reasonably likely to be exposed. EPA is proposing the SNUR
to use the notice and comment process to receive and evaluate more
fully the described data. EPA will then respond to this comment in more
detail in the final rule along with any additional comments on this
topic that are received during the notice and comment process.
Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as an adhesive. Based on
test data on analogous diisocyanates, EPA identified concerns for
dermal and respiratory sensitization. For the use described in the PMN,
EPA does not expect significant occupational or any consumer inhalation
exposure as the substances are not applied using a method that
generates a vapor, mist, or aerosol, nor are they used in a consumer
product. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator (with eye/
face protection, when dermal and/or ocular exposure is likely) with an
APF of at least 10, where there is a potential for inhalation exposure;
any use in consumer products; or any use of the substances involving an
application method that generates a vapor, mist, or aerosol may cause
serious health effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10742 (P-13-617); 40 CFR 721.10743 (P-03-
618) and 40 CFR 721.10744 (P-13-619).
PMN Number P-14-60
Chemical name: 1,1'-methylenebis[isocyanatobenzene], polymer with
polycarboxylic acids in alkane polyols (generic).
CAS number: Claimed confidential.
Public comment: A notice of intent to adversely comment has been
submitted.
EPA response: EPA awaits the adverse comment during the open
comment period for this notice of proposed rule-making.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating component.
Based on test data on analogous diisocyanates, EPA identified concerns
for dermal and respiratory sensitization. As described in the PMN,
worker exposure will be minimal due to the use of adequate personal
protective equipment, and EPA does not expect consumer exposure as the
substance is not used in a consumer product. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator (with eye/face protection, when dermal and/or
ocular exposure is likely) with an APF of at least 10, where there is a
potential for inhalation exposure or any use of the substance in
consumer products may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10762.
PMN Numbers P-14-267 and P-14-268
Chemical name: (P-14-267) Poly(oxy-1,2-ethanediyl), -[ [ (3-
isocyanatomethylphenyl)amino]carbonyl]--methoxy- and (P-14-268)
Carbamic acid, N-(3-isoocyanatomethylphenyl)-, 2-[2-(2-
butoxyethoxy)ethoxy]ethyl ester.
CAS numbers: (P-14-267) 51247-55-3 and (P-14-268) 304855-14-9.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as an intermediate. Based
on test data on analogous isocyanates, EPA identified concerns for
respiratory and dermal sensitization, and lung and mucous membrane
irritation. In addition, the Agency identified concerns for
oncogenicity and mutagenicity based on analog test data. For the use
described in the PMNs, EPA does not expect significant occupational
dermal or inhalation exposure, and does not expect consumer exposure as
the PMNs are not used in consumer products. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substances may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
particulate respirator (with eye/face protection, when dermal and/or
ocular exposure is likely) with an APF of at least 10, where there is a
potential for inhalation exposure; any use in consumer products; or any
use of the substances involving an application method that generates a
vapor, mist, or aerosol may cause serious health effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600), a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465), and a carcinogenicity
test (OPPTS Test Guideline 870.4200) would help characterize the human
health effects of the PMN substance.
[[Page 851]]
CFR citation: 40 CFR 721.10790 (P-14-267) and 40 CFR 721.10791 (P-
14-268).
PMN Number P-14-478
Chemical name: Carbonic acid, dimethyl ester, polymer with 1,4-
diisocyanatobenzene, 1,6-hexanediol and 1,5-pentanediol.
CAS numbers: 1558862-08-0.
Basis for action: The PMN states that the substance will be used to
make thermoplastic polyurethanes. Based on test data on analogous
diisocyanates, EPA identified concerns for lung effects and irritation
to mucous membranes, and for respiratory and dermal sensitization. As
described in the PMN, EPA does not expect significant occupational
dermal or inhalation exposure due to use of adequate personal
protective equipment; and the substance is applied by a method that
does not generate a vapor, mist, or aerosol. Further, consumer
exposures are not expected as the PMN substance is not used in consumer
products. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator (with eye/
face protection, when dermal and/or ocular exposure is likely) with an
APF of at least 10, where there is a potential for inhalation exposure;
any use of the substance involving an application method that generates
a vapor, mist, or aerosol; or any use in consumer products may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR Citation: 40 CFR 721.10792.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
For these 13 PMNs subject to these proposed SNURs, EPA determined
that one or more of the criteria of concern established at 40 CFR
721.170 were met. For additional discussion of the rationale for the
SNURs on these chemical substances, see Units II. and IV. of the
proposed rule.
B. Objectives
EPA is proposing these SNURs for specific chemical substances that
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this proposed rule:
EPA 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 section 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 http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Applicability of the Proposed Rule to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this proposed
rule have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no other person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. The identities for 10 of the 13 chemical
substances subject to this proposed rule have been claimed as
confidential and EPA has received no post-PMN bona fide submissions
(per 40 CFR 720.25 and Sec. 721.11). Based on this, the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this proposed rule are
ongoing.
Therefore, EPA designates January 7, 2015 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of that date would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 (55 FR 17376) for a
more detailed discussion of the cutoff date for ongoing uses.
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 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The OECD test guidelines are
available from the OECD Bookshop at http://www.oecdbookshop.org or
sourceoecd at http://www.sourceoecd.org.
[[Page 852]]
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in 40 CFR 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
40 CFR 720.40 and Sec. 721.25. E-PMN software is available
electronically at http:// www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances which were the subject of PMNs P-13-270, P-13-365, P-13-392,
P-13-393, P-13-471, P-13-563, P-13-617, P-13-618, P-13-619, and P-14-
60, during the development of the direct final rules. EPA's complete
economic analyses associated with these ten PMNs are available in the
docket under docket ID numbers EPA-HQ-OPPT-2013-0739, EPA-HQ-OPPT-2014-
0166, and EPA-HQ-OPPT-2014-0277. EPA has evaluated the potential costs
of establishing SNUN requirements for potential manufacturers and
processors of the chemical substances which were the subject of PMNs P-
14-267, P-14-268, and P-14-478. EPA's complete economic analysis
associated with these three PMNs is available in the docket under
docket ID number EPA-HQ-OPPT-2014-0760.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for 13 chemical substances
that were the subject of PMNs and a TSCA section 5(e) consent order.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to 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.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX.,
and EPA's experience promulgating SNURs (discussed in the
certification), EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of these SNURs would not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
[[Page 853]]
requirements of Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action would not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
List of Subjects
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: December 20, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. 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. 721.10735 to subpart E to read as follows:
Sec. 721.10735 Aromatic dibenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dibenzoate (PMN P-13-270) 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) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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 (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
3. Add Sec. 721.10717 to subpart E to read as follows:
Sec. 721.10717 MDI modified polyalkene glycols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as MDI
modified polyalkene glycols (PMN P-13-365) 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)(4), (a)(6)(ii) and (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), 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.
0
4. Add Sec. 721.10719 to subpart E to read as follows:
Sec. 721.10719 Acrylic acid esters polymers, reaction products with
polyisocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acrylic
acid esters polymers, reaction products with polyisocyanate (PMN P-13-
392) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 NIOSH-certified respirators with an APF
of at least 10 meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister
[[Page 854]]
incorporating N100, R100, or P100 filters (for scenarios where neither
dermal nor ocular exposure is likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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) 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.
0
5. Add Sec. 721.10720 to subpart E to read as follows:
Sec. 721.10720 1,3-Benzenedicarboxylic acid, polymer with 1,4-
benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-
dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol,
hexanedioic acid, 1,6-hexanediol, alkyldiol ester and aromatic
isocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,3-
Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid,
1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-
propanediol,dodecanedioic acid, 1,2-ethanediol, hexanedioic acid, 1,6-
hexanediol, alkyldiol ester and aromatic isocyanate (PMN P-13-393) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), 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.
0
6. Add Sec. 721.10723 to subpart E to read as follows:
Sec. 721.10723 Methylene diisocyanate polymer with polypropylene
glycol and diols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methylene diisocyanate polymer with polypropylene glycol and diols (PMN
P-13-471) 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)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(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 NIOSH-certified respirators
with an APF of at least 10 meet the requirements of Sec. 721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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), 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.
0
7. Add Sec. 721.10741 to subpart E to read as follows:
Sec. 721.10741 Polyalkylene glycol, alpha isocyanate, omega silane
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyalkylene glycol, alpha isocyanate, omega silane (PMN P-13-
[[Page 855]]
563) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (o).
(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), 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.
0
8. Add Sec. 721.10742 to subpart E to read as follows:
Sec. 721.10742 Aromatic dicarboxylic acid polymer with alkanediol,
alkyl alkyl-2-alkenoate, 1,4-dialkyl aromatic dicarboxylate,
alkanedioic acid, alkanedioic acid.alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-
alkenoate, 1,4-dialkyl aromatic dicarboxylate, alkanedioic acid,
alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (PMN P-13-617) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), 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.
0
9. Add Sec. 721.10743 to subpart E to read as follows:
Sec. 721.10743 Alkanedioic acid, polymer with alkyl 2-alkyl-2-
alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymer with alkyl 2-alkyl- 2-alkenoate, alkanedioic
acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-
alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate,
alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (PMN P-13-618) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
[[Page 856]]
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), 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.
0
10. Add Sec. 721.10744 to subpart E to read as follows:
Sec. 721.10744 Alkanedioic acid, polymer with alkyl alkyl-alkenoate,
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl
alkyl-alkeneoate and alkyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymer with alkyl alkylalkenoate, alkanedioic acid,
alkanediol, .alpha.-hydro-.omega.- hydroxypoly[oxy(alkyl- 1,2-
alkanediyl)], aromatic diisocyanate, alkyl alkyl-alkeneoate and alkyl-
alkenoic acid (PMN P-13-619) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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), 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.
0
11. Add Sec. 721.10762 to subpart E to read as follows:
Sec. 721.10762 1,1'-methylenebis[isocyanatobenzene], polymer with
polycarboxylic acids in alkane polyols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,1'-
methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in
alkane polyols (PMN P-14-60) 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)(4), (a)(6)(i) through (a)(6)(iv), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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), 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.
0
12. Add Sec. 721.10790 to subpart E to read as follows:
Sec. 721.10790 Poly(oxy-1,2-ethanediyl), -[ [ (3-
isocyanatomethylphenyl)amino]carbonyl]--methoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), -[ [ (3-isocyanatomethylphenyl)amino]carbonyl]--
[[Page 857]]
methoxy- (PMN P-14-267; CAS No. 51247-55-3) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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) 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.
CFR citation: 40 CFR 721.10790.
0
13. Add Sec. 721.10791 to subpart E to read as follows:
Sec. 721.10791 Carbamic acid, N-(3-isoocyanatomethylphenyl)-, 2-[2-
(2-butoxyethoxy)ethoxy]ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbamic acid, N-
(3-isoocyanatomethylphenyl)-, 2-[2-(2-butoxyethoxy)ethoxy]ethyl ester
(PMN P-14-268; CAS No. 304855-14-9) 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)(4), (a)(6)(ii), (a)(6)(v), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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) 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.
0
14. Add Sec. 721.10792 to subpart E to read as follows:
Sec. 721.10792 Carbonic acid, dimethyl ester, polymer with 1,4-
diisocyanatobenzene, 1,6-hexanediol and 1,5-pentanediol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
dimethyl ester, polymer with 1,4-diisocyanatobenzene, 1,6-hexanediol
and 1,5-pentanediol (PMN P-14-478; CAS No. 1558862-08-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(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)(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 least 10 meet the requirements of Sec.
721.63(a)(4).
(A) NIOSH-certified air-purifying half-mask respirator equipped
with appropriate gas/vapor cartridges in combination with N100, R100,
or P100 filters or an appropriate canister incorporating N100, R100, or
P100 filters (for scenarios where neither dermal nor ocular exposure is
likely).
(B) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters (for
scenarios where dermal and/or ocular exposure is also likely).
(C) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet (for scenarios
where dermal and/or ocular exposure is also likely).
(D) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece (for scenarios where dermal and/or
ocular exposure is also likely).
[[Page 858]]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(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) 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. 2014-30829 Filed 1-6-15; 8:45 am]
BILLING CODE 6560-50-P