[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Rules and Regulations]
[Pages 36833-36839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15895]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0941; FRL-9995-09]
RIN 2070-AB27
Modification of Significant New Uses for Oxazolidine, 3,3'-
Methylenebis[5-methyl-,
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is amending a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for
oxazolidine, 3,3'-methylenebis[5-methyl-, which was the subject of
premanufacture notice (PMN) P-03-325 and significant new use notice
(SNUN) S-17-4. The chemical substance is also subject to an Order
issued by EPA pursuant to TSCA section 5(e). This action amends the
SNUR to the uses allowable without further SNUN reporting requirement
to include use as an anti-corrosive agent in oilfield operations and
hydraulic fluids and makes the lack of certain worker protections a
significant new use. The SNUR requires persons who intend to
manufacture (defined by statute to include import) or process this
chemical substance for an activity that is designated as a significant
new use by this rule to notify EPA at least 90 days before commencing
that activity. The required notification initiates EPA's evaluation of
the use, under the conditions of use for the chemical substance, within
the applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required with that determination.
DATES: This final rule is effective September 30, 2019.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2011-0941, is available at
http://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
http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 36834]]
I. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substance identified as oxazolidine, 3,3'-
methylenebis[5-methyl- (PMN P-03-325 and SNUN S-17-4. 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, but are not limited to: Manufacturers
(including importers) or processors of the subject chemical substance
(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,
and 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 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 the chemical
substance that is the subject of a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see 40 CFR 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 amendments to the SNUR for the chemical substance
in 40 CFR 721.10461. Previously, in the Federal Register of February 8,
2018 (83 FR 5599) (FRL-9973-02), EPA proposed an amendment to the SNUR
for the chemical substance in 40 CFR 721.10461. EPA received public
comments for that proposed amendment, including that additional
information should be added to the public docket and stakeholders
should be allowed additional time to comment on the proposed amendment.
EPA added additional information to the public docket that it
considered in developing the proposed amendment. In the Federal
Register of July 23, 2018 (83 FR 34819) (FRL-9979-23), EPA published
notification that additional data was available in the docket and
provided an additional 30-day comment period for the proposed
amendment. EPA received one additional comment to the proposed
amendment. EPA will address public comments to the proposed SNUR
amendment in this Unit. Because EPA did not receive any comments that
led to changes to the proposed SNUR amendment, EPA is issuing the final
SNUR amendment as proposed. The record for the SNUR was established in
the docket under docket ID number EPA-HQ-OPPT-2011-0941. That docket
includes information considered by the Agency in developing the
proposed and final rules.
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). EPA
may respond to SNUNs by, among other things, issuing or modifying a
TSCA section 5(e) Order and/or amending the SNUR promulgated under TSCA
section 5(a)(2). Amendment of the SNUR will often be necessary to allow
persons other than the SNUN submitter to engage in the newly authorized
use(s), because even after a person submits a SNUN and the review
period expires, other persons still must submit a SNUN before engaging
in the significant new use. Procedures and criteria for modifying or
revoking SNUR requirements appear at Sec. 721.185.
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 must
either determine that the significant new use, under the conditions of
use for the chemical, is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination before the manufacture or processing for the
significant new use can commence. If EPA determines that the
significant new use, under the conditions of use for the chemical, is
not likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
Response to Comments
Comment 1: The commenter stated that EPA has failed to consider all
reasonably available information and to consider relevant aspects of
the problem when proposing the SNUR amendment. The commenter
specifically noted that EPA failed to consider the data submitted under
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and EPA
Office of Pesticide Programs (OPP) reviews of the same chemical
substance, including FIFRA restrictions for its pesticide use and its
microbiocidal properties.
Response: EPA did consider all reasonably available information
when reviewing the SNUN and proposing the SNUR amendment, including the
available data from the OPP review of the chemical substance. As noted
in the SNUN risk assessment, OPP assessed inhalation risk using an
inhalation NOAEC of 0.12 mg/m\3\ (0.015 mg/kg-bw) from a study that
reported nasal and respiratory effects in workers occupationally
exposed to formaldehyde via inhalation. EPA used the same effect level
to assess the SNUN. When assessing worker exposure levels from use of
the SNUN substance, EPA made the same assumptions as the OPP review,
concerning inhalation exposure from the closed system that is used to
produce, load, sample or dispense the SNUN substance from containers.
For the SNUN review, EPA quantified the worker exposure to the SNUN
substance during use and concluded no unreasonable risk from inhalation
exposures to the SNUN substance including the same level of potential
exposure to formaldehyde. The SNUN submitter did not notify EPA that
they intended to exceed the water release limits in the SNUR of 40 ppb
in saltwater and 100 ppb in freshwater. As described in the assessments
for the original PMN P-03-325 and SNUN S-17-4, EPA concludes that there
are no unreasonable risks if surface water concentrations do not exceed
these levels. The SNUR continues to require notification before
exceeding these
[[Page 36835]]
limits. Regarding FIFRA restrictions for pesticide use of the SNUN
substance, EPA used all the available data to assess hazards and risks.
When determining the requirements for the Order and SNUR under TSCA,
EPA based those decisions on exposures and risks for TSCA uses. FIFRA
restrictions are based on exposures and risks for FIFRA uses, which
includes use as a microbiocide.
Comment 2: A commenter stated that EPA should enhance the SNUR's
incorporation of the industrial hygiene hierarchy of controls, under
which engineering, work practice, and administrative controls are to be
the primary means used to reduce employee exposure to occupational
hazards. Because the SNUR would require that the hierarchy of controls
``be considered and implemented to prevent exposure, where feasible'',
EPA should clarify that its references to ``feasible'' have the same
meaning as does that term under the Occupational Safety and Health Act.
The commenter also asserted that use of the term ``where feasible''
allows a manufacturer or processor to decide on their own that use of
the chemical without engineering or administrative controls would not
constitute a significant new use requiring filing of a SNUN, in which
case EPA would not have the opportunity to review such use and that
associated claim of infeasibility. The commenter observed that the
Supreme Court has defined this ability in the context of worker
protection and urges EPA to confirm in its final rule that the
requirement to consider and implement the hierarchy of controls where
``feasible'' applies wherever it is ``capable of being done,''
regardless of cost.
Response: EPA's approach to the hierarchy of controls is the same
for this SNUR as all other Orders and SNURs since June 2013 (see 78 FR
38210, June 26, 2013). EPA developed an approach that incorporates OSHA
requirements that the hierarchy of controls should be considered before
using personal protective equipment for workers. EPA retained worker
personal protection equipment requirements to prevent unreasonable
risks for those situations where engineering and other controls have
yet to be validated or proven effective in reducing exposures
sufficiently or would not prevent exposures. In this regard, EPA's
approach is that the TSCA requirement is the same as the OSHA
requirement. Feasibility is a commonly used term that is not the same
as discretion. It is a concept, like other concepts in the rule, that
requires an objective analysis. That the Supreme Court has defined a
specific term provides no legal or policy rationale for EPA including
its own definition.
Comment 3: A commenter stated that personal protective clothing,
testing and use requirements in the SNUR are not as protective as those
in the Consent Order. The commenter specifically noted that the Order
requires permeation testing to be conducted according to the American
Society for Testing and Materials (ASTM) F739 ``Standard Test Method
for Permeation of Liquids and Gases through Protective Clothing
Materials under Conditions of Continuous Contact'' and that this
language should be included in the SNUR.
Response: The comment references language in the Order requiring
this ASTM method. The commenter also notes that, as an alternative, the
Order and SNUR allow evaluation of manufacturers' specifications to
demonstrate imperviousness. The Order unfortunately contains incorrect
language that the ASTM method is the only test method a company can
conduct to demonstrate imperviousness of dermal protective equipment.
In most Orders issued by the Agency, there is no requirement for a
specific method and this ASTM method is cited as one example of a test
acceptable to EPA. EPA will consult with the SNUN submitter and
determine if the Order should be amended.
Comment 4: A commenter stated that respirators need to be required
for processing and other downstream uses as well as in manufacturing
settings.
Response: The Order and the SNUR require respiratory protection
during manufacture but require fully enclosed equipment to be used
during unloading, processing, and use. Because of this enclosed
equipment requirement, there is only limited inhalation exposure during
unloading, processing and use that does not present an unreasonable
risk (see the response to Comment 1). Therefore, respiratory protection
is not required during unloading, processing, and use.
Comment 5: The commenter noted numerous areas where it appears that
EPA did not properly document the basis for its worker exposure
estimates including the number of sites, number of workers, and dermal
and inhalation exposure to workers. Because of this the commenter
stated the public has no ability to know whether these numbers reflect
real-world worker exposures and cannot judge whether the proposed
amendments to the SNUR are sufficient. The commenter added that EPA
appears to have been working with entirely insufficient information
from the SNUN submitter bearing on worker exposure to the SNUN
substance and it appears the Agency has relied on models, uncited or
insufficiently cited sources, or in some cases what seem to be complete
guesses. The commenter assumed that the Organization for Economic Co-
operation and Development (OECD) Emission Scenario Document on
Chemicals Used in Oil Well Production was used to make numerous
exposure estimates. The commenter noted that the OECD document
referenced the 2002 U.S. Census for arriving at an estimate of 8
workers per site. The commenter stated this means that this estimate
value is 16 years old and given the explosion in domestic oil
production and hydraulic fracturing activities since 2002, there is no
reason to believe that value reflects current occupational exposures in
this sector. EPA needs to account for this factor and adjust its
estimates accordingly.
Response: The SNUN contained available information from the SNUN
submitter regarding how the chemical is used. EPA properly documented
the basis for its worker exposure estimates in the EPA Engineering
Report for the use of the SNUN substance. The engineering report gives
the basis for each exposure estimate made in the report, including when
no information is available from the submitter. In many cases,
including this one, this means EPA estimates reasonable worst-case
exposures based on models and professional judgment. When using these
tools EPA can only state that in most cases they are reasonable worst-
case estimates. The commenter is correct that one of the generic
scenarios used for the SNUN was the OECD Emission Scenario Document on
Chemicals Used in Oil Well Production. The OECD document contains the
2002 data cited by the commenter. The OECD document was finalized in
2012 using the best available information. EPA also used the PMN
submission P-03-325 as the best source of identifying the number of use
sites for the SNUN. EPA's general approach to estimating exposure with
limited data is available at https://www.epa.gov/tsca-screening-tools/using-predictive-methods-assess-exposure-and-fate-under-tsca#fate. EPA
uses all available information to make reasonable worst-case estimates.
When newer information is available, EPA would adjust its estimates
accordingly. Growth in an industry is not the only factor to affect
worst-case estimates of number of sites, number of workers per site,
and dermal and inhalation exposure to workers.
Comment 6: A commenter stated that EPA must codify its exposure
assumptions as notification triggers in
[[Page 36836]]
the amended SNUR. The commenter noted that given that EPA has chosen to
rely on a number of exposure assumptions in its review of the SNUN that
serve as the basis for its proposed amendments to the SNUR and
presuming these assumptions can be adequately justified and documented,
the Agency must incorporate these assumptions as notification triggers
in the amended SNUR itself in order to make those assumptions
enforceable.
Response: Codifying EPA's exposure assumptions as notification
requirements for SNURs would not add meaningful protective measures
beyond those significant new uses now included in the SNUR, which were
proposed after a consideration of all relevant factors, including those
listed in Unit IV. The significant new uses identified in the SNUR
(based on requirements in the Order) already consider potential
exposures and address those activities that could lead to changes in
exposures and therefore potential risks.
Comment 7: One commenter noted that EPA should exercise its
authority to require submission of records required to be kept under
the amended SNUR. Given the critical role that the exposure assumptions
EPA has made in determining the level of risk that will be allowed
under the SNUR without triggering notification, it is essential that
EPA determine what the actual conditions are. It should use its
existing authorities to require submission of records from companies
using the SNUN substance for the uses to be allowed under the amended
SNUR, and from the company under the Order.
Response: EPA already requires records to be retained by the
company demonstrating compliance with the SNUR, identifying how much of
the chemical substance it manufactures or processes, and how much and
where it distributes the chemical substance. These records are
available for EPA to review when a company is inspected. Requiring
companies manufacturing and processing the substance to submit records
to EPA would be an additional administrative burden for both EPA and
the companies, without any increase in enforcement capability or
compliance with the rule. Therefore, EPA is not requiring submission of
records required to be retained under the rule.
Comment 8: A commenter stated that EPA needs to explain and justify
why a NIOSH-certified respirator with an assigned protection factor
(APF) of at least a 1,000 is sufficient to ensure protection against
exposure via inhalation.
Response: Based on data supplied by the S-17-4 SNUN submitter and
reviewed by EPA regarding formaldehyde exposure to workers when
manufacturing the S-17-4 SNUN substance outside the United States, a
respirator with an APF of 1000 would limit exposure with an adequate
margin of safety based on the NOAEC of 0.12 mg/m\3\ level.
Comment 9: A commenter stated that key health and safety studies
are missing from the docket, preventing the public from understanding
and independently assessing the consequences of the Agency's proposed
amendments to the SNUR. The missing information includes: (1) An acute
inhalation study conducted according to OECD guideline 436, and 2)
monitoring studies of formaldehyde release in specific industrial
settings.
Response: EPA added these additional health and safety information
studies to the docket. EPA also added additional information to the
docket as described in the response to Comment 13.
Comment 10: One commenter asserted that EPA has impermissibly
redacted portions of the health and safety studies provided in
violation of TSCA section 14. Without this information, it is difficult
to adequately or sufficiently characterize potential risks to workers.
The commenter also stated that for all of the documents in the docket,
EPA should immediately review the redactions and disclose the
information that does not qualify for confidentiality under TSCA
section 14. Health and safety information never qualifies for
confidentiality unless it meets one of the two narrow exceptions of
TSCA section 14(b)(2). With respect to all other information,
information only qualifies for nondisclosure if it meets all of the
substantive and procedural requirements of TSCA section 14.
Response: The SNUN submitter redacted any confidential business
information for submissions contained in the SNUN. All health and
safety studies and information relevant to EPA's risk assessment have
been disclosed. For example, all toxicity study results which includes
the level of toxicity used to assess the SNUN substance is available in
the docket. For the monitoring studies of formaldehyde during
manufacture, the average ambient concentration of formaldehyde in air
of 0.068 mg/m\3\ and the maximum concentration of 0.094 mg/m\3\ is
available in the docket. The information in the public docket
identifies the inhalation NOAEC of 0.12 mg/m\3\ (0.015 mg/kg-bw) used
for risk assessment and the potential inhalation exposures during
manufacture (0.068 mg/m\3\ of formaldehyde) and use (0.052 mg/m\3\ of
the PMN substance). It is this information that is the basis for EPA's
conclusion. Thus, the information in the public docket allows
stakeholders to understand and comment on the basis for EPA's risk
assessment.
Comment 11: A commenter stated that the precautionary statements
EPA has required under the Consent Order, and that would be
incorporated in the amended SNUR, are inadequate and should be
rectified by the Agency. Specifically, EPA should add ``severe skin and
eye irritant'' and ``cancer'' as EPA has identified these as known
health hazards of the SNUN substance.
Response: EPA expects there is compliance with federal and state
laws, such as worker protection standards, unless case-specific facts
indicate otherwise, and therefore existing OSHA regulations for worker
protection and hazard communication will result in use of appropriate
PPE consistent with the applicable SDSs in a manner adequate to protect
workers. In this case, warnings for severe skin and eye burns are
already contained in the submitter's SDS for the SNUN substance.
Additionally, given the severely irritating and corrosive nature of the
chemical, EPA expects limited exposures. Because of the limited
exposure, EPA determined that the hazard warnings for ``severe skin and
eye irritant'' and ``cancer'' were not necessary to include in the
Consent Order. For the same reasons, EPA is not incorporating the
warnings in this final SNUR.
Comment 12: A commenter stated that EPA has not taken into account
other sources of formaldehyde exposures to workers using the SNUN
substance. EPA's exclusion from consideration of these other sources of
formaldehyde means that the Agency has likely significantly
underestimated the risks associated with SNUN substance. EPA needs to
explain whether and if so, how, it took these additional potential
exposures into account in establishing conditions to limit exposure
included in the proposed amended SNUR.
Response: As described in the response to Comment 1, EPA estimated
inhalation exposures to the SNUN substance during use, which would
result in potential exposure to formaldehyde during use. The Order and
SNUR contain provisions to prevent risks from these potential
exposures. Based on the use limitation in the SNUR as a metal working
fluid and the submission of a SNUN for use as an anti-corrosive agent
in oilfield operations and hydraulic fluids, EPA
[[Page 36837]]
did not identify and does not expect any other sources of exposures to
the SNUN substance during its use. The other sources of formaldehyde
cited by the commenter do not identify the specific sources of the
formaldehyde and also identify several other hazardous chemicals
contained in the air at oil and gas production sites. Assessment and
findings of risks from a new chemical substance under TSCA do not
include sources of chemical exposure unrelated to the new chemical
substance.
Comment 13: A commenter stated that EPA has failed to complete the
docket with critical health and safety information. EPA has provided an
inadequate amount of time for the public to comment based on a full
record.
Response: In response to comments received on the initial proposed
SNUR modification in the Federal Register of February 8, 2018 (83 FR
5598) (FRL-9973-02), EPA posted additional risk assessment documents
and health and safety studies to the docket that were used in the risk
assessment of the SNUN substance. EPA included the FIFRA documents that
were used in the risk assessment of the SNUN substance but did not
repost the entire FIFRA docket as it is publicly available (see Docket
ID EPA-HQ-OPP-2009-0997). In the Federal Register of July 23, 2018 (83
FR 34819) (FRL-9979-23), EPA published notification that additional
data was available in the docket and that there would be an additional
30-day comment period for the proposed amendment.
Comment 14: One commenter supplied a public SDS for a product
containing the chemical substance as evidence that the chemical
substance was used for a significant new use before submission of a
SNUN. The commenter noted that EPA should have been able to find and
use this information in its review.
Response: Because this is evidence that someone may have engaged in
a significant new use before submission of a SNUN, EPA has referred
this information to its Office of Enforcement and Compliance Assurance
for investigation. The information contained in that document, however,
does not contribute pertinent information that would affect EPA's
assessment or findings for the Order and SNUR. The SDS only contains
information on basic chemical properties, hazard warnings, and handling
procedures. This information was already available to EPA from the PMN
and SNUN submissions. The SDS does not contain the detailed toxicity
and exposure data submitted with the PMN and SNUN submissions that EPA
used in the SNUN risk assessment.
III. Rationale and Objectives for the Final Rule
A. Rationale
During review of the SNUN submitted for this chemical substance,
EPA concluded that regulation was warranted under TSCA section
5(e)(1)(A)(ii)(I), pending the development of information sufficient to
make reasoned evaluations of the human health effects of the chemical
substance. Based on these findings, a TSCA section 5(e) Order requiring
the use of appropriate exposure controls was negotiated with the SNUN
submitters. EPA is amending the SNUR provisions for this chemical
substance to be consistent with the provisions of the TSCA section 5(e)
Orders. See the docket under docket ID number EPA-HQ-OPPT-2011-0491 for
the corresponding Orders. For additional discussion of the rationale
for the SNUR on this chemical, see Units II. and V. of the proposed
rule.
B. Objectives
EPA is issuing this final SNUR for a chemical substance that has
undergone premanufacture and significant new use notice review because
the Agency wants to achieve the following objectives with regard to the
significant new uses designated in this final rule:
EPA will receive notice of any person's intent to
manufacture, import, or process the chemical substance for the
described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing the chemical substance for the described
significant new use.
EPA will be able to regulate prospective manufacturers,
importers, or processors of the chemical substance before the described
significant new use of the chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) Order are subject to similar requirements.
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.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this SNUR, EPA considered
relevant information about the toxicity of the chemical substance,
likely human exposures and environmental releases associated with
possible uses, taking into consideration the four TSCA section 5(a)(2)
factors listed in this unit.
V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. EPA solicited comments in the proposed rule on whether
any of the uses proposed as significant new uses were ongoing. EPA
designated February 8, 2018 as the cutoff date for determining whether
the new use is ongoing. EPA has decided that the intent of TSCA section
5(a)(1)(B) is best served by designating a use as a significant new use
as of the date of public release of the proposed SNUR rather than as of
the effective date of the final rule. If uses begun after public
release were considered ongoing rather than new, it would be difficult
for EPA to establish SNUR notice requirements, because a person could
defeat the SNUR by initiating the proposed significant new use before
the rule became effective, and then argue that the use was ongoing as
of the effective date of the final rule. EPA received no comments that
any of the uses were ongoing. Thus, any persons who begin commercial
manufacture or processing activities with the chemical substance that
are not currently a significant new use under the current rule but
which would be regulated as a ``significant new use'' if the proposed
rule is finalized, must cease any such activity as of the effective
date of the rule if and when finalized. Before resuming their
activities, these persons would have to first comply with all
applicable SNUR notice requirements and receive an affirmative
determination on the notice from EPA.
[[Page 36838]]
VI. 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) Order for the chemical substance 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
substance. These restrictions will not be removed until EPA determines
that the unrestricted use is not likely to present an unreasonable risk
of injury.
Unit IV. of the proposed rule lists information identified in the
section 5(e) Order underlying the proposed SNUR modification.
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 substance.
VII. SNUN Submissions
According to 40 CFR 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/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances during the development of the proposed rule.
EPA's complete Economic Analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2011-0941.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This final rule modifies a SNUR for a chemical substance that was
subject of a PMN, SNUNs, and a TSCA section 5(e) Order. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with new
chemical SNURs have already been approved under OMB control number
2070-0012 (EPA ICR No. 0574). 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.
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 the 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, as applicable.
D. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., the Agency
hereby certifies that promulgation of this SNUR does not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, and 14 in FY2017,
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
[[Page 36839]]
E. 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 will be impacted by this final rule.
As such, the requirements of UMRA sections 202, 203, 204, and 205, 2
U.S.C. 1531-1538, do not apply to this action.
F. Executive Order 13132: Federalism
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 (64 FR 43255,
August 10, 1999).
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
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 (65 FR 67249, November 9, 2000), do not apply
to this final rule.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action does not address environmental
health or safety risks, and EPA interprets Executive Order 13045 as
applying only to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards and is
therefore not subject to considerations under section 12(d) of NTTAA,
15 U.S.C. 272 note.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does not affect the level of protection provided to human
health or the environment.
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801-808, and EPA will
submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 8, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR chapter I is 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. Amend Sec. 721.10461 by revising paragraphs (a) and (b)(1) to read
as follows:
Sec. 721.10461 Oxazolidine, 3,3'-methylenebis[5-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxazolidine, 3,3'-
methylenebis[5-methyl- (PMN P-03-325 and SNUN S-17-4; CAS No. 66204-44-
2) 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), (a)(4) (use of the respirator only
applies to inhalation exposures to the substance when manufactured in
the United States), when determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(1) and (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, (a)(5)
(respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 1,000),
(a)(6)(v) and (vi), (b) (concentration set at 0.1 percent), and (c). It
is a significant new use for the substance to be unloaded, processed
and used other than with fully enclosed equipment.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b) (concentration set at 0.1 percent), (c), (d), (f),
(g)(1)(allergic or sensitization response), (g)(1)(ii), (iii), (v),
(vi), and (ix), (g)(2)(i), (ii), (iii), (v), and (iv), (g)(3)(i) and
(ii), (g)(4) (do not release to water such that concentrations exceed
40 or 100 ppb in saltwater or freshwater, respectively), and (g)(5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is use other than
as a metalworking fluid and an anti-corrosive agent in oilfield
operations and hydraulic fluids.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 40 (saltwater) and N = 100
(freshwater)).
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
* * * * *
[FR Doc. 2019-15895 Filed 7-29-19; 8:45 am]
BILLING CODE 6560-50-P