[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]


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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.

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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: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

[[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


