[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Rules and Regulations]
[Pages 39756-39769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13324]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 720, 721, and 723

[EPA-HQ-OPPT-2014-0650; FRL-5605-02-OCSPP]
RIN 2070-AJ94


Significant New Uses of Chemical Substances; Updates to the 
Hazard Communication Program and Regulatory Framework; Minor Amendments 
to Reporting Requirements for Premanufacture Notices

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is amending the 
regulations governing significant new uses of chemical substances under 
the Toxic Substances Control Act (TSCA) to align with revisions that 
were made to the Occupational Safety and Health Administration (OSHA) 
Hazard Communications Standard (HCS) and changes to the OSHA 
Respiratory Protection Standard and the National Institute for 
Occupational Safety and Health (NIOSH) respirator certification 
requirements for the respiratory protection of workers from exposure to 
chemicals. In addition, EPA is amending the regulations governing 
Significant New Use Rules (SNURs) to address issues that have been 
identified by EPA and raised by stakeholders through public comments. 
EPA is also making a minor change to reporting requirements for 
premanufacture notices (PMNs) and other TSCA notifications. EPA expects 
these changes to have minimal impact on the costs and burdens of 
compliance, while updating the significant new use reporting 
requirements to assist in addressing any potential risks to human 
health and the environment.

DATES: This final rule is effective September 6, 2022.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2014-0650, is available at 
https://www.regulations.gov or in-person at the EPA Docket Center (EPA/
DC). Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Tyler Lloyd, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4016; 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. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by TSCA to include import), process, or use chemical 
substances subject to regulations in 40 CFR part 720, 721, or 723. The 
following list of North American Industry 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:
     Chemical Manufacturers (NAICS code 325).
     Petroleum and Coal Products (NAICS code 324).
     Merchant Wholesalers, Nondurable Goods (NAICS code 424).
    If you have any questions regarding the applicability of this 
action, please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine whether a use of a chemical substance is a ``significant new 
use.'' EPA is required to issue its determination through promulgation 
of a final rule after considering all relevant factors, including those 
listed in TSCA section 5(a)(2). Such rules are called ``significant new 
use rules'' (SNURs). 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 manufacturing or processing a chemical substance for 
that use (15 U.S.C. 2604(a)(1)(B)). TSCA section 5(a)(1)(B) requires 
persons to notify EPA at least 90 days before manufacturing a new 
chemical substance for commercial purposes (under TSCA, manufacture 
includes import). TSCA section 3(11) defines a ``new chemical 
substance'' as any substance that is not on the TSCA Inventory of 
Chemical Substances compiled by EPA under TSCA section 8(b).

C. What action is the Agency taking?

    EPA is finalizing amendments to the general requirements for SNURs 
in 40 CFR part 721, Significant New Uses of Chemical Substances that 
were proposed in 2016 (81 FR 49598, July 16, 2016) (FRL 9944-47) (Ref. 
1). Based on public comments received on proposed changes to 40 CFR 
721.63, EPA will move certain language which was proposed at 40 CFR 
721.63(a)(1) and (4) to new paragraphs at 40 CFR 721.63(a)(7) and 
(a)(8), respectively, to ensure the new provisions only apply to SNURs 
issued after the finalization of this rule (see Unit III.A). With the 
exception of amendments proposed at 40 CFR 721.63(a)(1) and (4), all 
other amendments are being finalized as proposed. Most of the changes 
relate to the standard significant new uses for new chemical SNURs 
identified in 40 CFR 721 subpart B, which EPA cross-references in 
individual SNURs in subpart E. Other changes are procedural changes to 
the general provisions in subpart A that apply to all SNURs. EPA also 
clarified in the preamble of the proposed rule some definitions 
contained in 40 CFR part 721 and is making a minor change to reporting 
requirements for TSCA section 5 notices in 40 CFR parts 720.38, 720.45 
and 723.50.

[[Page 39757]]

D. Why is the Agency taking this action?

    Based on changes that have occurred for respiratory protection 
requirements, codified in NIOSH regulations at 42 CFR part 84 and the 
OSHA standard at 29 CFR 1910.134, EPA is making changes to 40 CFR 
721.63. In addition, based on the updates to 29 CFR 1910.1200, OSHA's 
modified Hazard Communication Standard (HCS) published March 26, 2012 
(77 FR 17574) (Ref. 2), EPA is making changes to 40 CFR 721.72. EPA is 
also amending 40 CFR part 721 subparts A and B and clarifying 
definitions contained in 40 CFR part 721. EPA is making these changes 
and clarifications based on its experience in issuing and administering 
over 2,800 SNURs. Many of the changes are based on public comments 
received by EPA in the course of proposing and issuing SNURs, and 
questions or suggestions from the public regarding current SNUR 
requirements, such as considering a hierarchy of controls before using 
personal protective equipment to control exposures, clarifying the 
meaning of certain uses under 40 CFR 721.80(j), allowing for removal in 
wastewater treatment when computing estimated surface water 
concentrations according to 40 CFR 721.91, and revising the bona fide 
procedure in 40 CFR 721.11 to include coverage of situations where the 
significant new use terms are confidential.

E. What are the estimated incremental impacts of this action?

    There will be a minor increase in the overall compliance burden and 
cost due to the modified requirements in 40 CFR parts 720, 721, and 
723. The modified SNUR requirements will be compatible with the current 
hazard communication requirements under 29 CFR 1910.1200 and the 
respiratory protection requirements at 42 CFR part 84 and 29 CFR 
1910.134. The new paragraphs at 40 CFR 721.63(a)(7) and (8) will only 
apply to SNURs proposed after this final rule and are aligned with 
current industry practice. The modified SNUR requirements at 40 CFR 
721.72 will also allow, but not require, persons subject to a SNUR that 
has been previously issued to use the updated requirements of 40 CFR 
721.72.
    The economic analysis for this final rule (Ref. 3) estimates that 
the amendments for new chemical SNURs and section 5 notices would 
result in a combined total first year burden and cost of 1,585 hours 
and $94,731, respectively. The total steady state increase cost is 
$54,029 per year. On a per unit basis, the rule would impose startup 
costs ranging from $0 to $74.89 per new chemical SNUR, with incremental 
steady states costs ranging from $0 to $137.18.

II. Background

A. What did EPA propose?

    On July 16, 2016 (Ref. 1), EPA proposed amendments to the 
regulations governing significant new uses of chemical substances under 
TSCA to align these regulations with revisions to the OSHA HCS, which 
are cross referenced. EPA further proposed the July 2016 amendments to 
align with changes to the OSHA Respiratory Protection Standard and the 
NIOSH respirator certification requirements for the respiratory 
protection of workers from exposure to chemicals. EPA also proposed 
revising the regulations governing SNURs, based on issues that have 
been identified by EPA and raised by stakeholders through the public 
comment process. Additionally, EPA proposed making a minor change to 
reporting requirements for premanufacture notices (PMNs) and other TSCA 
section 5 notices.

B. How did the Lautenberg Act amend TSCA Section 5?

    Enacted on June 22, 2016, the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act (Lautenberg Act) (Pub. L. 114-182) amended 
several sections of TSCA, including section 5. Among other changes, the 
Lautenberg Act added a new paragraph to TSCA section (5)(a)(3) titled 
``Review and Determination'', which obligates EPA to review and issue a 
determination on each notice received under section 5(a)(1) within the 
applicable review period. As amended by the Lautenberg Act, EPA is also 
now required to issue an order pursuant to TSCA section 5(e)(1) when it 
makes a determination under TSCA section 5(a)(3)(B) that either: (1) 
The information available to EPA is insufficient to permit a reasoned 
evaluation of the health and environmental effects of the chemical 
substance; (2) In the absence of sufficient information, the chemical 
substance may present an unreasonable risk of injury to health or the 
environment, without consideration of costs or other non-risk factors, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by EPA; or (3) The chemical 
substance is or will be produced in substantial quantities and may 
either enter the environment in substantial quantities or result in 
significant or substantial human exposure. While these amendments 
impact EPA's review of significant new use notices (SNUNs), the 
Lautenberg Act did not affect the amendments EPA proposed on July 16, 
2016 (81 FR 4959) (Ref. 1), which EPA is now finalizing.

C. How are the SNUR regulations structured?

    The manner in which the different subparts of 40 CFR part 721 are 
applied to new chemical SNURs and existing chemical SNURs is summarized 
in Table 1. EPA typically utilizes subparts B, C, and D when issuing 
new chemical SNURs for certain chemical substances that have undergone 
PMN review. Other SNURs, including existing chemical SNURs, may be 
issued for chemical substances either not on the TSCA Inventory or for 
those on the TSCA Inventory that typically have not undergone PMN 
review. In issuing existing chemical SNURs, EPA does not use subpart B 
or D but may apply the standard recordkeeping requirements in subpart 
C. The general requirements of subpart A apply to all SNURs unless 
these specific requirements are modified in the significant new use 
requirement section for a specific chemical substance listed in subpart 
E. Finally, Subpart E lists significant new use and recordkeeping 
requirements for new and existing chemical substances.

 Table 1--Subparts Used for New Chemical SNURs and Other Chemical SNURs
------------------------------------------------------------------------
                                          New chemical    Other chemical
         Regulation in 40 CFR                SNURs            SNURs
------------------------------------------------------------------------
Subpart A. General Provisions (Sec.                  X                X
 Sec.   721.1 through 721.47).........
Subpart B. Certain Significant New
 Uses (Sec.  Sec.   721.50 through
 721.91):
    Sec.   721.63. Protection in the                 X
     Workplace........................
    Sec.   721.72. Hazard                            X
     Communication Program............
    Sec.   721.80. Industrial,                       X
     Commercial, and Consumer
     Activities.......................

[[Page 39758]]

 
    Sec.   721.85. Disposal...........               X
    Sec.   721.90. Release to water...               X
    Sec.   721.91. Concentration of                  X
     estimated surface water
     concentrations: Instructions.....
Subpart C. Recordkeeping Requirements                X                X
 (Sec.  Sec.   721.100 through
 721.125).............................
Subpart D. Expedited Process for                     X
 issuing Significant New Use Rules for
 Selected Chemical Substances and
 Limitation or Revocation of Selected
 Significant New Use Rules (Sec.  Sec.
   721.160-721.185)...................
Subpart E. Significant New Uses for                  X                X
 Specific Chemical Substances (Sec.
 Sec.   721.225 through 721.10960) *
 \+\..................................
------------------------------------------------------------------------
* Revised for each published SNUR.
\+\ This figure is current as of May 1, 2022.

    EPA is making substantive changes and clarifications to language in 
Subparts A and B of 40 CFR 721. The changes to Subpart A will affect 
all SNURs. The changes in Subpart B may affect some previously issued 
new chemical SNURs already in subpart E and will affect future new 
chemical SNURs issued using the changed terms in Subpart B. Unit III 
describes each change and how these changes may affect previously 
issued SNURs, as well as SNURs issued after this rule becomes 
effective. Not all of the previously issued new chemical SNURs will be 
affected by the changes in Subpart B. For example, as described in the 
economic analysis for this final rule (Ref. 3) and according to the EPA 
Chemical Data Report (CDR) for Reporting Year 2015, 107 chemicals were 
reported in commerce and subject to new chemical SNURS. Only 18 of the 
107 SNURs contained provisions for worker protection and/or hazard 
communication. In March 2012, OSHA modified its Hazard Communication 
Standard (HCS) to conform to the United Nations' Globally Harmonized 
System of Classification and Labelling of Chemicals (GHS). OSHA's March 
2012 regulatory amendments sought to enhance the effectiveness of the 
HCS by ensuring employees are apprised of the chemical hazards to which 
they may be exposed and reducing incidents of chemical-related 
occupational illnesses and injuries (Ref. 2). The GHS is an 
internationally harmonized system for classifying chemical hazards and 
developing labels and safety data sheets (SDS). The GHS further acts as 
a set of criteria and provisions that regulatory authorities can 
incorporate into existing systems or use to develop new systems.
    The GHS utilizes a building block approach, which allows a 
regulatory authority to implement certain provisions that are 
appropriate for its sphere of regulation. The GHS includes the 
regulatory components, or building blocks, that might be needed for 
classification and the labeling requirements for chemicals in the 
workplace, transport, pesticides, and consumer products. The 2012 
amendments OSHA made to the HCS adopted certain sections of the GHS 
that were appropriate for OSHA's regulatory sector. The building block 
approach also gives regulatory agencies the authority to select which 
classification criteria and provisions to adopt. For example, OSHA 
adopted the classification criteria and provisions for labels and SDSs, 
because the current HCS covers these elements. As described in Unit 
III, EPA is adopting some of the GHS criteria for hazard communication 
pertaining to aquatic toxicity.

D. Did EPA receive public comments on the proposed rule?

    EPA received 18 public comments on the proposed rule. Commenters 
included potentially affected businesses, trade associations, 
environmental and public health advocacy groups, and other Federal 
agencies. In this preamble, EPA has responded to many of the 
significant comments relevant to the proposed rule; however, the more 
comprehensive version of EPA's response to comments related to this 
final action can be found in the Response to Comments document (Ref. 
4). The Response to Comment document summarizes all the comments 
relevant to the proposal and EPA's response to those comments. In the 
Response to Public Comments document, EPA also discusses any changes to 
and clarifications from the proposed rule.

III. Overview of the Final Rule

    This final rule is based on the July 2016 proposal and 
consideration of the public comments received on the proposed rule.
    As a result of changes to OSHA and NIOSH requirements, and other 
issues identified through EPA's experience issuing and administering 
SNURs, EPA is making several changes to the SNUR regulations in 
subparts A and B. The following sections describe the changes and the 
reasons for the changes.

A. Changes to 40 CFR 721.63, Protection in the Workplace

    Based on changes that have occurred in respiratory protection 
requirements since 1989, per the NIOSH regulation at 42 CFR part 84 and 
the OSHA standard at 29 CFR 1910.134, EPA is making changes to 40 CFR 
721.63. In June 1995, NIOSH updated and modernized its regulation for 
testing and certifying non-powered, air-purifying, and particulate-
filter respirators (42 CFR part 84). The 42 CFR part 84 respirators 
have met a higher certification test than older respirators previously 
certified under 30 CFR part 11 and provide increased worker protection 
(Ref. 5). Because the 42 CFR part 84 test criteria simulate worst-case 
respirator use, NIOSH has encouraged discontinuing the use of 
particulate respirators certified under 30 CFR part 11 and switching to 
particulate respirators certified under 42 CFR part 84. However, non-
powered particulate respirators that were approved under 30 CFR part 11 
using the ``old'' labeling were allowed to be manufactured and sold 
until July 10, 1998. Specifically, distributors who purchased 30 CFR 
part 11 particulate filters and respirators prior to July 10, 1998, are 
able to sell them as ``certified'' until inventories of these products 
are depleted. Users who purchased such particulate filters and 
respirators from these distributors will be able to use them until 
their inventories are depleted or until the end of the shelf life or 
service life of these products.
    Additionally, in January 1998, OSHA's revised Respiratory 
Protection Standard (29 CFR 1910.134) replaced the respiratory 
protection standards adopted by OSHA in 1971 (Ref. 6). Subsequently, in 
August 2006, OSHA announced that it modified its Respiratory Protection 
Standard (29 CFR 1910.134) by adding definitions as well as maximum use 
concentration (MUC) and assigned protection factor (APF)

[[Page 39759]]

requirements to 29 CFR 1910.134 (Ref. 7). Due to these changes, the 
respirators currently listed in 40 CFR 721.63 may no longer meet the 
current NIOSH/OSHA criteria for respirator selection and use.
    EPA is updating language pertaining to respiratory protection 
requirements listed in 40 CFR 721.63(a)(4), (a)(5), and (a)(6) to be 
consistent with both OSHA and NIOSH requirements. In 40 CFR 
721.63(a)(4), which requires that respirators be used in accordance 
with 30 CFR part 11, EPA is replacing the reference to 30 CFR part 11 
with a reference to 42 CFR part 84 to incorporate the most updated 
NIOSH regulation for testing and certifying respirators. Most 
manufacturers and processors are already subject to and complying with 
42 CFR part 84. This change will apply to all previously issued SNURs 
that contain significant new use requirements pertaining to respiratory 
protection by clarifying manufacturers and processors subject to 
current SNURs can follow updated respiratory protection requirements 
without triggering a SNUN requirement. The updated language will also 
be included in the issuance of new SNURs as appropriate.
    EPA is also updating NIOSH-certified respirator language in 40 CFR 
721.63(a)(5). At the time of the proposal, EPA had been incorporating 
the updated NIOSH-certified respirator language in newly issued SNURs 
rather than referencing the respirator language currently listed in 40 
CFR 721.63(a)(5). EPA has continued citing the new respirator language 
in SNURs issued since this rule was proposed in July 2016 (81 FR 
49598). The finalized provisions to 40 CFR 721.63(a)(5) will 
standardize the use of the updated NIOSH-certified respirator language 
and allow EPA to cross-reference the language for new chemical SNURs 
rather than on an individual basis.
    EPA has included language that allows any person subject to SNURs 
with older respirator requirements in 40 CFR 721.63(a)(5) already cited 
in subpart E to continue using older-style respirators in order to 
avoid the triggering of a SNUN requirement. These fifteen older 
respirators are listed in 40 CFR 721.63(a)(5)(i) through (xv). EPA also 
includes language in 40 CFR 721.63(a)(5) that would allow any person 
subject to the older respirator requirements in 40 CFR 721.63(a)(5)(i) 
through (xv) to use an equivalent respirator under the newer 
requirements, provided that the APF of the new respirator is equal to 
or greater than the respirator cited in subpart E. EPA has included in 
the public docket a chart comparing the APF of the respirator classes 
in the current regulations with the previous corresponding respirator 
requirements that can be consulted in order to determine availability 
of suitable substitutes (Ref. 8). The amendment to 40 CFR 721.63(a)(6) 
also updates language for the airborne form of a chemical substance 
applicable to the respiratory protection requirements in 40 CFR 
721.63(a)(4). EPA will cite this language when issuing new SNURs.
    EPA is also revising 40 CFR 721.63 to add language that would make 
it a significant new use not to implement a hierarchy of controls to 
protect workers. This revision will require any person subject to an 
applicable SNUR to determine and use appropriate engineering and 
administrative controls before using personal protective equipment 
(PPE) for worker protection, similar to the requirements in OSHA 
standards at 29 CFR 1910.134(a)(1) and guidance in Appendix B to 
subpart I of 29 CFR 1910.
    This change is being made in part due to comments received on 
recently promulgated SNURs. Some of these comments identified the 
industrial hygiene ``hierarchy of controls'' approach for workplace 
health and safety and argued that persons subject to SNURs should 
follow the OSHA standards requiring the use of controls that are higher 
in the hierarchy of controls before requiring employees to use personal 
protective equipment (PPE). In final SNURs published on June 26, 2013 
(78 FR 38210) (FRL-9390-6) (Ref. 9), EPA responded to the comments, 
agreeing that a hierarchy of controls should be applied, and that PPE 
should be the last option in controlling exposures. Where engineering 
and administrative controls are not feasible or are insufficient to 
protect exposed workers, persons who are subject to a SNUR must follow 
any applicable PPE requirements or submit a SNUN to EPA. Since June 26, 
2013, new chemical SNURs containing significant new uses related to 
lack of PPE for workers have included the same language requiring 
consideration and implementation of engineering controls and 
administrative controls where feasible. These requirements to consider 
engineering and administrative controls are based on and consistent 
with the OSHA requirements at 29 CFR 1910.134(a)(1).
    In the July 2016 proposal (81 FR 49598), EPA proposed revising 40 
CFR 721.63(a)(1) and 40 CFR 721.63(a)(4) to add language requiring 
consideration and use of engineering and administrative controls where 
feasible before PPE for worker protection. This change would have 
affected SNURs issued after this rule became effective in addition to 
previously issued SNURs that incorporate references to worker 
protection standards at 40 CFR 721.63(a)(1) and 40 CFR 721.63(a)(4). 
However, based on public comments, EPA has decided to move the language 
that was proposed at 40 CFR 721.63(a)(1) and 40 CFR 721.63(a)(4) to new 
paragraphs 40 CFR 721.63(a)(7) and 40 CFR 721.63(a)(8), respectively. 
These new paragraphs will not affect previously issued SNURs but 
rather, will only be applicable to SNURs issued or amended after this 
rule becomes effective. While EPA is not updating the language 
referenced by many existing SNURs, EPA continues to affirm that a 
hierarchy of controls should be applied, and that PPE should be the 
last option in controlling exposures. Additionally, EPA believes that 
most companies are already following a hierarchy of controls as 
required by OSHA regulations. EPA's response to public comments on the 
hierarchy of control language can be found in the Response to Comment 
document for this rule (Ref. 4).

B. Changes to 40 CFR 721.72, Hazard Communication Program

    Based on the changes to 29 CFR 1910.1200, OSHA's modified HCS, EPA 
is making changes to 40 CFR 721.72. In March 2012, OSHA modified its 
HCS to conform to the United Nations' Globally Harmonized System of 
Classification and Labelling of Chemicals (GHS). OSHA's March 2012 
regulatory amendments sought to enhance the effectiveness of the HCS by 
ensuring that employees are apprised of the chemical hazards to which 
they may be exposed and reducing incidents of chemical-related 
occupational illnesses and injuries (Ref. 2). Modifications to the HCS 
include revised criteria for classification of chemical hazards; 
revised labeling provisions that include requirements for use of 
standardized signal words, pictograms, hazard statements, and 
precautionary statements; a specified format for safety data sheets; 
and related revisions to definitions of terms used in the HCS and 
requirements for employee training on labels and safety data sheets 
(Ref. 2).
    Under EPA's current regulations, when SNURs are issued with a 
citation to 40 CFR 721.72 in subpart E for a chemical substance, it is 
considered a significant new use if the company does not develop a 
written hazard communication program for the substance in the 
workplace. Paragraphs (a) through (h) of 40 CFR 721.72 can be cited in 
subpart E as elements that must

[[Page 39760]]

be included in the hazard communication program. Manufacturers and 
processors subject to a SNUR in subpart E for a chemical substance can 
rely on an existing hazard communication program, such as one 
established under the OSHA HCS or one based on GHS recommendations, to 
comply with this significant new use requirement to the extent the 
hazard communication program contains elements cited for that SNUR from 
40 CFR 721.72 paragraphs (a) through (h).
    EPA is adding new paragraphs (i) and (j) to 40 CFR 721.72 that it 
will use when imposing hazard communication requirements for SNURs 
issued after this rule becomes effective. The new paragraph (i) will 
require that a written hazard communication program be developed and 
implemented for the substance in each workplace in accordance with OSHA 
HCS 29 CFR 1910.1200.
    This approach will maintain consistency in compliance for any 
person subject to TSCA and OSHA regulations for the same activity. By 
cross-referencing the OSHA HCS EPA should minimize duplication of 
requirements and minimize potential confusion that additional 
obligations are being created. In addition, any amendments to the OSHA 
HCS will be automatically encapsulated without EPA having to amend its 
own regulations. This approach is also consistent with the requirement 
for EPA to coordinate with other federal executive departments and 
agencies under TSCA section 9(d) to impose ``the least burdens of 
duplicative requirements on those subject to the chapter and for other 
purposes.''
    The new paragraph (j) describes specific statements and other 
warnings that could be incorporated in SNURs for substances identified 
in subpart E. The specific statements and warnings that could be 
required would be based on EPA's risk assessment of the chemical 
substance and would be consistent with the OSHA HCS and GHS 
recommendations.
    EPA expects that, whenever the statements in paragraphs (g), (h), 
and (j) are required and the determinations for the SNUR are published, 
manufacturers and processors subject to the SNUR will also consider if 
they trigger any other corresponding hazard communication under the 
OSHA HCS requirements or under GHS recommendations. Any hazard and/or 
precautionary statements required by the SNUR will include a minimum 
set of hazard warnings. EPA may also propose individual SNURs or issue 
section 5(e) SNURs under 40 CFR 721.160 using other specific 
statements, signal words, symbols, hazard category, and pictograms as 
hazard communication requirements.
    EPA is updating 40 CFR 721.72 paragraphs (a) through (h) to be 
consistent with both OSHA requirements and GHS recommendations. These 
changes apply to individual SNURs in subpart E issued before the 
effective date of this final rule as described in the next two 
paragraphs. EPA is making changes to 40 CFR 721.72 paragraphs (a), (c), 
and (d) to change using the term ``material safety data sheet'' (MSDS) 
to ``safety data sheet'' (SDS) and allow easily accessible electronic 
versions or other alternatives to maintaining paper copies of the SDS. 
These changes apply to any previously issued SNUR in subpart E that 
cites these paragraphs. EPA is also adding new hazard and precautionary 
statements, listed in 40 CFR 721.72 paragraphs (g) and (h), to make 
this provision consistent with statements under the OSHA HCS 
requirements and the GHS recommendations. While the previously issued 
SNUR precautionary and hazard statements will remain applicable solely 
for previously issued SNURs, EPA has also identified which of the new 
statements can be used as alternatives for the previously issued 
precautionary and hazard statements. Manufacturers and processors 
subject to a previously issued SNUR will have the option to use the 
prior precautionary and hazard statements or use the new alternative 
statements that are consistent with the OSHA HCS requirements or GHS 
recommendations to comply with the SNUR.
    EPA is also including language which allows any person subject to a 
previously issued SNUR containing requirements for 40 CFR 721.72 
paragraphs (a) through (h) to comply with those requirements by 
following the requirements of 40 CFR 721.72 paragraph (i), which will 
be applied to SNURs issued after this final rule, and using any 
statements specified for that substance in the 40 CFR 721.72 paragraphs 
(g) or (h). For example, a person currently subject to a SNUR citing 
the requirement to establish a hazard communication program as 
described in 40 CFR part 721.72 paragraphs (a) through (f) and the 
requirement for using a hazard statement in paragraph (g)(1)(iii), 
central nervous system effects, could comply by taking the following 
steps: That person could establish a hazard communication program 
according to the requirements in paragraph (i) and use the hazard 
statement in paragraph (g)(1)(iii), ``central nervous system effects,'' 
or the alternative hazard statement (g)(1)(xi), ``may cause damage to 
the central nervous system through prolonged or repeated exposure.''
    EPA recommends using a Chemical Abstracts Service (CAS) number to 
identify the chemical substance in an SDS whenever possible. EPA makes 
this recommendation because CAS numbers are widely used by industry to 
provide a unique, unambiguous identifier for chemical substances. Only 
when a CAS number is not available should a different unique numerical 
identifier be used. Because of variations in naming conventions for 
chemical substances, using CAS numbers makes it easier for the 
regulated community to accurately identify and report chemical 
identities. For example, upon importation of a chemical substance, if 
the chemical substance is being identified to assure compliance with 
regulatory requirements, providing the most specific CAS number is the 
most efficient and clear way to ensure this. The changes for SNUR 
hazard communications requirements concerning how to identify chemical 
substances are consistent with OSHA regulations.

C. Clarification of the Use of 40 CFR 721.80, Industrial Commercial and 
Consumer Activities

    EPA is also clarifying the significant new use for new chemical 
SNURs described at 40 CFR 721.80(j), which identifies as a significant 
new use as ``Use other than as described in the premanufacture notice 
referenced in subpart E of this part for the substance.'' EPA is not 
changing the language of 721.80(j). Instead, EPA is clarifying how it 
identifies a significant new use that meet the criteria in 721.80(j) 
for individual SNURs. When EPA issues a SNUR using the designation at 
40 CFR 721.80(j) in subpart E for a chemical substance and that use 
described in the premanufacture notice is claimed as confidential, EPA 
cites 40 CFR 721.80(j). See Unit III.E for a discussion of how 
manufacturers and processors subject to a SNUR with a confidential 
significant new use designation can currently file a bona fide inquiry 
to determine whether a specific use is a significant new use and EPA's 
amendments for future bona fide inquiries. In identifying the 
significant new use in subpart E for certain previously issued SNURs 
where the use described in the premanufacture notice was not claimed 
confidential, EPA cited 40 CFR 721.80(j) and included the PMN use 
described in the premanufacture notice in parentheses. EPA has received 
public comments in response to proposed SNURs and pre-notice inquiries 
for SNUNs stating that

[[Page 39761]]

manufacturers and processors subject to SNURs find it confusing when 
EPA cites 40 CFR 721.80(j) and then identifies the PMN use in 
parentheses. These comments and inquiries have explained that when EPA 
cites the new use this way it appears as though the significant new use 
is the use in the parentheses, where the significant new use is 
actually use other than the use in parentheses.
    To better identify the significant new use, EPA has changed this 
procedure to only cite 40 CFR 721.80(j) when the use described in the 
PMN is confidential. When the use described in the PMN is not 
confidential, EPA intends to identify the significant new use in a new 
chemical SNUR by describing the use, such as in the following example: 
``A significant new use is any use other than as a pesticide 
intermediate.'' (This example was published in the direct final SNUR 
issued on February 12, 2014 (79 FR 8291) (Ref. 10) and is codified in 
subpart E at 40 CFR 721.10718.)

D. Changes to 40 CFR 721.91, Computation of Estimated Surface Water 
Concentrations: Instructions

    When EPA issues a new chemical SNUR citing the significant new uses 
described in 40 CFR 721.90 (a)(4), (b)(4), and (c)(4), the SNUR 
requires significant new use notification if the results of the 
equation for computation of estimated surface water concentrations in 
40 CFR 721.91 exceed the level specified for that SNUR in subpart E. 
The equation estimates surface water concentrations based on the amount 
of a chemical substance released from industrial processes and the 
flows of the water body. The current equation does not take into 
consideration amounts of a chemical substance released to a surface 
water after control technology such as wastewater treatment. As 
proposed, EPA is revising this requirement to allow manufacturers and 
processors to account for reductions in surface water concentrations 
resulting from wastewater treatment. 40 CFR 721.91 contains 
instructions for the computation of estimated surface water 
concentrations according to the equation specified in 40 CFR 721.90 
(a)(4), (b)(4), and (c)(4). EPA is revising the instructions at 40 CFR 
721.91 to allow for a certain percentage of removal of a chemical 
substance from wastewater after undergoing control technology, 
applicable to the requirements at 40 CFR 721.90. EPA has previously 
allowed surface water concentrations to be calculated with a 
consideration of wastewater treatment in certain SNURs by adding 
regulatory text to individual rules. This change to 40 CFR 721.91 will 
make the consideration of control technology part of the calculations 
for the equation specified in 40 CFR 721.90 when cited in subpart E for 
a specific chemical substance. EPA will cite the control technology and 
the percentage removal for SNURs in subpart E, based on EPA's 
assessment of the effectiveness of the control technology for the 
specific chemical substance. The most common form of control technology 
in new chemical SNURs is wastewater treatment. However, EPA will not 
identify a percentage of removal from wastewater for every chemical 
substance subject to a SNUR with the significant new use specified in 
40 CFR 721.90 (a)(4), (b)(4), and (c)(4). Rather, EPA, when 
appropriate, will identify an applicable removal percentage when 
issuing SNURs. The revised provisions will apply only when a removal 
percentage has been identified in the SNUR. This change does not apply 
to existing SNURs where a removal percentage has not been identified.
    Due to questions and comments from manufacturers and processors 
expressing confusion around the meaning of the phrase ``predictable or 
purposeful release'' at 40 CFR 721.90, EPA is making changes to clarify 
the scope of the term. The phrase is used to qualify significant new 
uses pertaining to releases to water in 40 CFR 721.90. As described in 
the April 29, 1987 proposed rule, Proposed General Provisions for New 
Chemicals Follow-up (52 FR 15608) (Ref. 11), the phrase ``predictable 
or purposeful'' does not include releases where emergency conditions 
exist and significant new use notification is not possible. Therefore, 
routine or repeated activity that results in releases to water or non-
routine releases to water that are not due to emergency conditions are 
included in the term ``predictable or purposeful.'' EPA does not intend 
the phrase ``predictable or purposeful release'' to limit the agency's 
strict liability authority under the statute.

E. Changes to 40 CFR 721.11, Applicability Determination When the 
Specific Chemical Identity Is Confidential

    Certain new chemical SNURs have a significant new use designation 
that is based on confidential business information (CBI) contained in 
the PMN and therefore, not disclosed in the published SNUR. Currently, 
for each SNUR containing a significant new use designation considered 
to be CBI, that SNUR cross-references the bona fide procedure in the 
specific SNUR in subpart E for 40 CFR 721.1725. Under the bona fide 
procedures, a manufacturer or processor may request EPA to determine 
whether a specific use would be a significant new use under the rule. 
The manufacturer or processor must show that it has a bona fide intent 
to manufacture or process the chemical substance and must identify the 
specific use for which it intends to manufacture or process the 
chemical substance. If EPA concludes that the person has shown a bona 
fide intent to manufacture or process the chemical substance, EPA will 
tell the person whether the use identified in the bona fide submission 
would be a significant new use under the rule.
    When the chemical identity in a SNUR is CBI, 40 CFR 721.11 provides 
a means by which bona fide submitters can determine whether their 
substance is subject to the SNUR. However, as described in the previous 
paragraph, chemical identity is not the only information contained in a 
SNUR that may be claimed as CBI. EPA is modifying the bona fide 
procedure in 40 CFR 721.11 of subpart A so that it applies to all SNURs 
containing any CBI, including the significant new use. EPA finds it 
would be more efficient to have a bona fide procedure for determining 
confidential significant new uses in subpart A rather than referencing 
40 CFR 721.1725(b)(1) each time EPA issues a SNUR containing a 
significant new use designation containing CBI. In addition, EPA is 
modifying the bona fide procedure that allows EPA to disclose the 
confidential significant new use designations to a manufacturer or 
processor who has established a bona fide intent to manufacture 
(including import) or process a particular chemical substance.

F. Changes for Submission of SDS(s) With PMNs, SNUNs, Low Volume 
Exemptions (LVEs), Low Release and Exposure Exemptions (LoREXs), and 
Test Marketing Exemption (TME) Applications

    EPA is revising requirements in 40 CFR 720.38, 720.45, and 40 CFR 
723.50 to require that any safety data sheet (SDS) already developed, 
even if in draft form, either to comply with OSHA requirements or for 
other purposes, must also be submitted as part of any notification or 
exemption application (PMN, SNUN, LVE, LoREX, or TME) under section 5 
of TSCA. Many submitters already submit available SDSs as part of their 
submission and the information contained in SDSs is often useful for 
EPA's assessments of chemicals. This revision would not require 
submitters to develop an SDS. It only requires a submitter to submit an

[[Page 39762]]

already-developed SDS as part of a notification under TSCA section 5, 
to the extent the SDS is known or reasonably ascertainable by the 
submitter.

G. Fixing Typographical Errors and Other Non-Substantive Changes

    EPA is correcting several typographical errors and more accurately 
applying the terms manufacture, manufacturer, and manufacturing to the 
regulatory text of sections 40 CFR parts 720, 721, and 723.

IV. References

    The following is a list of the documents that are specifically 
referenced in this document. The docket includes these documents, as 
well as other information considered by EPA that are not listed below, 
including documents that are referenced within the documents that are 
included in the docket. For assistance in locating docket items, please 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

1. EPA. Significant New Uses of Chemical Substances; Updates to the 
Hazard Communication Program and Regulatory Framework; Minor 
Amendments to Reporting Requirements for Premanufacture Notices; 
Proposed Rule. Federal Register (81 FR 49598, July 28, 2016) (FRL-
9944-47).
2. OSHA. OSHA Revised Hazard Communication Standard; Final Rule. 
Federal Register (77 FR 17574, March 26, 2012).
3. EPA. Economic Analysis for Final Rule Amendments to Part 721--
Modifications to General and Specific Requirements in the SNUR 
Framework--Significant New Uses of Chemical Substances. May 2022.
4. EPA. Response to Comments on the Proposed Rule Significant New 
Uses of Chemical Substances; Updates to the Hazard Communication 
Program and Regulatory Framework; Minor Amendments to Reporting 
Requirements for Premanufacture Notices. May 2022.
5. NIOSH. Respiratory Protection Devices; Final Rule. Federal 
Register (60 FR 30355, June 8, 1995).
6. OSHA. Respiratory Protection; Final Rule. Federal Register (63 FR 
1152, January 8, 1998).
7. OSHA. Assigned Protection Factors; Final Rule. Federal Register 
(71 FR 50121, August 24, 2006).
8. EPA. Chart comparing assigned protection factors of current 
respirator classes with older respirator requirements.
9. EPA. Significant New Use Rules on Certain Chemical Substances; 
Final Rule. Federal Register (78 FR 32810, June 26, 2013) (FRL-9390-
6).
10. EPA. Significant New Use Rules on Certain Chemical Substances; 
Direct Final Rule. Federal Register (79 FR 8291, February 12, 2014) 
(FRL- 9903-70).
11. EPA. Significant New Uses of Chemical Substances; General 
Provisions for New Chemical Follow-up; Proposed Rule. Federal 
Register (52 FR 15594, April 29, 1987) (FRL-3153-6).

V. 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 action is not a significant regulatory action and was 
therefore not submitted to the Office of Management and Budget (OMB) 
for review under Executive Order 12866 (58 FR 51735, October 4, 1993) 
and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    OMB has approved the information collection activities contained in 
this rule pursuant to the PRA (44 U.S.C. 3501 et seq.) and has assigned 
OMB control number 2070-0012 (EPA ICR No. 574.15). This action does not 
impose any new requirements requiring additional OMB approval under the 
PRA. Estimates presented below reflect minor incremental changes 
associated with the rule as presented in the Economic Analysis (Ref. 
3).
    Respondents/affected entities: Certain manufacturers (including 
importers) and processors (see Unit I.A.).
    Respondent's obligation to respond: Mandatory under TSCA section 5. 
This rule does not change the obligation that is contained in 
individual chemical specific SNURs.
    Estimated number of respondents: 1,226.
    Frequency of response: On occasion, i.e., upon submission of a SNUN 
pursuant to individual chemical specific SNURs.
    Total estimated incremental burden: 1,585 hours (for the first 
year), then 486 hours (per year). Burden is defined at 5 CFR 1320.3(b).
    Total estimated incremental cost: $ 94,731 (for the first year), 
then $ 54,029 (per year). This includes $0 annualized capital or 
operation & maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. In making this determination, EPA concludes that the 
impact of concern for this rule is any significant adverse economic 
impact on small entities and that the Agency is certifying that this 
rule will not have a significant economic impact on a substantial 
number of small entities. The Agency's basis is briefly summarized here 
and is detailed in the Economic Analysis (Ref. 3).
    EPA has observed only a small proportion of SNUNs submitted by 
self-declared small businesses. To the extent that the percentage of 
small firms abiding by a SNUR is similar to the percentage of small 
firms submitting SNUNs, it is unlikely that a substantial number of 
small entities would be affected by this final rule's changes to SNUR 
requirements. Similarly, for TSCA section 5 notices, assuming that a 
similar small proportion of small firms are submitting all notices, it 
is likewise unlikely that substantial number of small entities would be 
affected by this final rule's changes.
    EPA also concludes that the steady state incremental per-firm costs 
of complying with the rule, estimated to range from $23-$109 per firm 
(Ref. 3), are low compared to the cost of developing and marketing a 
chemical.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and will not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local or tribal governments. 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 rulemaking. EPA concludes that this rule is not 
expected to result in expenditures by State, local, and Tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more (when adjusted annually for inflation) in any one year. 
Accordingly, this rule is not subject to the requirements of UMRA 
sections 202, 203, or 205. The Economic Analysis (Ref. 3) for this 
action is summarized in Unit I.E. and is available in the docket.

[[Page 39763]]

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have substantial direct effects on the 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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have substantial direct effects on tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, Executive Order 13175 does not 
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk.

H. 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 it is not 
likely to have a significant adverse effect on the supply, distribution 
or use of energy and has not otherwise been designated as a significant 
energy action by the Administrator of the Office of Information and 
Regulatory Affairs.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards that would require 
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14008: Tackling the Climate Crisis at Home and Abroad

    In accordance with Executive Orders 12898 (59 FR 7629, February 16, 
1994) and 14008 (86 FR 7619, January 27, 2021), EPA finds that this 
action will not result in disproportionately high and adverse human 
health, environmental, climate-related, or other cumulative impacts on 
disadvantaged communities because this action does not establish an 
environmental health or safety standard.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5. U.S.C. 801 et seq., 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 Parts 720, 721, and 723

    Environmental protection, Chemicals, Hazardous materials, 
Recordkeeping, and Reporting Requirements.

    Dated: June 15, 2022.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons set forth in the preamble, 40 CFR 
chapter I is amended as follows:

PART 720--PREMANUFACTURE NOTIFICATION

0
1. The authority citation for part 720 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2613.


Sec.  720.1   [Amended]

0
2. Amend Sec.  720.1 by removing the phrase ``and importers''.

0
3. In Sec.  720.3:
0
a. Revise paragraph (r) introductory text and paragraph (r)(1);
0
b. Revise paragraph (s) introductory text and paragraph (s)(2); and
0
c. Revise paragraph (cc).
    The revisions read as follows:


Sec.  720.3   Definitions.

* * * * *
    (r) Manufacture for commercial purposes means:
    (1) To manufacture with the purpose of obtaining an immediate or 
eventual commercial advantage for the manufacturer, and includes, among 
other things, ``manufacture'' of any amount of a chemical substance or 
mixture:
* * * * *
    (s) Manufacture solely for export means to manufacture for 
commercial purposes a chemical substance solely for export from the 
United States under the following restrictions on activities in the 
United States:
* * * * *
    (2) The manufacturer and any person to whom the substance is 
distributed for purposes of export or processing solely for export (as 
defined in Sec.  721.3 of this chapter), may not use the substance 
except in small quantities solely for research and development in 
accordance with Sec.  720.36.
* * * * *
    (cc) Small quantities solely for research and development (or 
``small quantities solely for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including such research or analysis for the 
development of a product'') means quantities of a chemical substance 
manufactured or processed or proposed to be manufactured or processed 
solely for research and development that are not greater than 
reasonably necessary for such purposes.
* * * * *


Sec.  720.30   [Amended]

0
4. Amend Sec.  720.30 by
0
a. Removing the phrase ``or imported'' wherever it appears; and
0
b. In paragraph (h)(7)(i) removing the word ``intented'' and adding in 
its place ``intended''.


Sec.  720.36   [Amended]

0
5. Amend Sec.  720.36 by removing the phrases ``or imported'', ``or 
importer'', ``or imports'' wherever they appear in the section.

0
6. Amend Sec.  720.38 by:
0
a. Removing the phrase ``or import'' wherever it appears in the 
section; and
0
b. Adding paragraph (b)(7).
    The addition reads as follows:


Sec.  720.38   Exemptions for test marketing.

* * * * *
    (b)(7) Any safety data sheet already developed for the chemical 
substance, including draft safety data sheets.
* * * * *


Sec.  720.40   [Amended]

0
7. Amend Sec.  720.40 by removing the phrases ``or import'' and ``or 
importer'' wherever they appear.

0
8. Amend Sec.  720.45 by:
0
a. In paragraph (e), removing the phrase ``or imported'' wherever it; 
and

[[Page 39764]]

0
b. Adding paragraph (i).
    The addition reads as follows:


Sec.  720.45   Information that must be included in the notice form.

* * * * *
    (i) Any safety data sheet already developed for the new chemical 
substance, including draft safety data sheets.
* * * * *


Sec.  720.57   [Amended]

0
9. In Sec.  720.57 amend paragraph (a) by removing the word 
``chemcial'' and adding in its place ``chemical''.


Sec.  720.78   [Amended]

0
10. Amend Sec.  720.78 by:
0
a. In paragraph (b)(1) introductory text, removing the phrase ``or 
import'';
0
b. In paragraph (b)(1)(iv), removing the word ``manfacturer'' and 
adding in its place ``manufacturer'';
0
c. In paragraph (b)(2), removing the phrase ``or imports'' wherever it 
appears; and
0
d. In paragraph (c) remove the phrase ``or import''.


Sec.  720.85   [Amended]

0
11. Amend Sec.  720.85 by:
0
a. Removing the phrases ``or import'' and ``or importing'' wherever 
they appear;
0
b. In paragraph (b)(1):
0
i. Removing the phrase ``or imported'';
0
ii. Removing the word ``indentity'' and adding in its place 
``identity'';
0
c. In paragraph (b)(2)(i):
0
i. Removing the word ``manfactures'' and adding in its place 
``manufactures'';
0
ii. Removing the phrase ``or imports''; and
0
d. In paragraph (b)(3)(iv)(D) remove the phrase ``on imported''.


Sec.  720.90   [Amended]

0
12. Amend Sec.  720.90 by removing the phrase ``or import'' wherever it 
appears.


Sec.  720.102   [Amended]

0
13. Amend Sec.  720.102 by removing the phrase ``or import'' wherever 
it appears.


Sec.  720.120   [Amended]

0
14. In Sec.  720.120 amend paragraph (b) by:
0
a. Removing the phrase ``or imports''; and
0
b. Removing the word ``requied'' and adding in its place ``required''.

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
15. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).


0
16. Amend part 721 by:
0
a. Removing the acronym ``MSDS'' everywhere it appears and adding in 
its place the acronym ``SDS'';
0
b. Removing the acronym ``MSDSs'' everywhere it appears and adding in 
its place the acronym ``SDSs''; and
0
c. Removing the phrase ``material safety'' everywhere it appears and 
adding in its place the word ``safety''.


Sec.  721.1   [Amended]

0
17. In Sec.  721.1 amend paragraph (a) by removing the phrase 
``manufacturers, importers and processors'' and adding in its place 
``manufacturers and processors''.

0
18. Amend Sec.  721.3 by:
0
a. Revising the definitions of ``Customer,'' ``Employer,'' ``Non-
industrial use,'' and ``Recipient;'' and
0
b. Removing the definition of ``MSDS''; and
0
c. Adding in alphabetical order the definition for ``Safety Data 
Sheet.''
    The revisions and addition read as follows:


Sec.  721.3   Definitions.

* * * * *
    Customer means any person to whom a manufacturer or processor 
distributes any quantity of a chemical substance, or of a mixture 
containing the chemical substance, whether or not a sale is involved.
* * * * *
    Employer means any manufacturer, processor, or user of chemical 
substances or mixtures.
* * * * *
    Non-industrial use means use other than at a facility where 
chemical substances or mixtures are manufactured or processed.
* * * * *
    Recipient means any person who purchases or otherwise obtains a 
chemical substance directly from a person who manufactures or processes 
the substance.
* * * * *
    Safety Data Sheet (SDS) means written or printed material 
concerning a hazardous chemical substance that is prepared as required 
under Sec.  721.72(c).
* * * * *


Sec.  721.5   [Amended]

0
19. Amend Sec.  721.5 by:
0
a. Removing the phrase ``manufacturer, importer, or processor'' 
everywhere it appears, and adding in its place the phrase 
``manufacturer or processor'';
0
b. Removing the phrase ``manufacture, import, or process'' everywhere 
it appears, and adding in its place the phrase ``manufacture or 
process''; and
0
c. In paragraph (d)(1)(iii), removing the word ``recepient's'' and 
adding in its place ``recipient's''.


Sec.  721.11   [Amended]

0
20. Amend Sec.  721.11 by:
0
a. Removing the phrase ``manufacturer, importer, or processor'' 
everywhere it appears, and adding in its place the phrase 
``manufacturer or processor'';
0
b. Removing the phrase ``manufacture, import, or process'' everywhere 
it appears, and adding in its place the phrase ``manufacture or 
process'';
0
c. Revising the section heading and paragraphs (a) and (e) through (g).
    The revisions read as follows:


Sec.  721.11   Applicability determination when the specific chemical 
identity is confidential.

    (a) A person who intends to manufacture or process a chemical 
substance which is subject to a significant new use rule in subpart E 
of this part may ask EPA whether the substance or a proposed use is 
subject to the requirements of this part if that substance is described 
by a generic chemical name or if the significant new use is 
confidential and therefore not described specifically in the rule. EPA 
will answer such an inquiry only if EPA determines that the person has 
a bona fide intent to manufacture or process the chemical substance for 
commercial purposes.
* * * * *
    (e) If the manufacturer or processor has shown a bona fide intent 
to manufacture or process the substance and has provided sufficient 
unambiguous chemical identity information to enable EPA to make a 
conclusive determination as to the identity of the substance, EPA will 
inform the manufacturer or processor whether the chemical substance is 
subject to this part and, if so, which section in subpart E of this 
part applies, and identify any confidential significant new use 
designations.
    (f) A disclosure to a person with a bona fide intent to manufacture 
or process a particular chemical substance that the substance is 
subject to this part or of confidential significant new use 
designations will not be considered public disclosure of confidential 
business information under section 14 of the Act.
    (g) EPA will answer an inquiry on whether a particular chemical 
substance is subject to this part or identify and confidential 
significant new uses within 30 days after receipt of a complete 
submission under paragraph (b) of this section.

[[Page 39765]]

Sec.  721.25   [Amended]

0
21. Amend Sec.  721.25 by:
0
a. In paragraph (a) removing the phrase ``manufacture, import, or 
processing'' and add in its place the phrase ``manufacture or 
processing''.
0
b. In paragraph (d) removing the phrase ``manufacture, import, or 
process'' and add in its place the phrase ``manufacture or process''.


Sec.  721.30   [Amended]

0
22. Amend Sec.  721.30 by:
0
a. Removing the phrase ``manufacture, import, or processing'' 
everywhere it appears and adding in its place the phrase ``manufacture 
or processing'';
0
b. In paragraph (a) remove the phrase ``manufacture, import, or 
process'' and add in its place the phrase ``manufacture or process''.


Sec.  721.35   [Amended]

0
23. Amend Sec.  721.35 by:
0
a. Removing the phrase ``manufactured, imported, or processed'' 
everywhere it appears and adding in its place the phrase ``manufactured 
or processed''; and
0
b. In paragraph (f)(1) removing the phrase ``manufacture, import, or 
processing'' and adding in its place the phrase ``manufacture or 
processing''.


Sec.  721.45   [Amended]

0
24. Amend Sec.  721.45 by removing the phrase ``manufactures, imports, 
or processes'' everywhere it appears and adding in its place the phrase 
``manufactures or processes''.


Sec.  721.47   [Amended]

0
25. Amend Sec.  721.47 by:
0
a. Removing the phrase ``manufactures, imports, or processes'' 
everywhere it appears and adding in its place the phrase ``manufactures 
or processes'';
0
b. Removing the phrase ``manufacturer, importer, or processor'' 
everywhere it appears and add in its place the phrase ``manufacturer or 
processor''; and
0
c. Removing the phrase ``manufacture, import, or process'' everywhere 
it appears and adding in its place the phrase ``manufacture or 
process''.

0
26. Amend Sec.  721.63 by:
0
a. Revising paragraphs (a) introductory text, (a)(4) and (a)(5) 
introductory text;
0
b. Adding paragraphs (a)(5)(xvi) through (a)(5)(li);
0
c. Revising paragraph (a)(6) introductory text;
0
d. Adding paragraphs (a)(6)(vii) through (a)(6)(ix), (a)(7) and (a)(8); 
and
0
e. Revising paragraph (c)(2).
    The revisions and additions read as follows:


Sec.  721.63   Protection in the workplace.

    (a) Whenever a substance is identified in subpart E of this part as 
being subject to this section, any manner or method of manufacturing 
(including importing) or processing associated with any use of the 
substance is considered a significant new use unless a program is 
established whereby:
* * * * *
    (4) Each person who is reasonably likely to be exposed to the 
chemical substance by inhalation in the work area in one or more of the 
forms listed in paragraph (a)(6) of this section and cited in subpart E 
of this part for the chemical substance, is provided with, and is 
required to wear, at a minimum, a NIOSH-approved respirator from one of 
the categories listed in paragraph (a)(5) of this section, and the 
respirator is used in accordance with 29 CFR 1910.134 and 42 CFR part 
84.
    (5) The following NIOSH-certified respirators meet the requirements 
for paragraph (a)(4) of this section:
* * * * *
    (xvi) NIOSH-certified N100 (if oil aerosols absent), R100, or P100 
filtering facepiece respirator. (APF =10).
    (xvii) NIOSH-certified air-purifying half-mask respirator equipped 
with N100 (if oil aerosols absent), R100, or P100 filters. (APF =10).
    (xviii) NIOSH-certified air-purifying half mask respirator equipped 
with appropriate gas/vapor cartridges. (APF =10).
    (xix) 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. (APF =10).
    (xx) NIOSH-certified negative pressure (demand) supplied-air 
respirator equipped with a half-mask. (APF =10).
    (xxi) NIOSH-certified negative pressure (demand) self-contained 
breathing apparatus (SCBA) equipped with a half mask. (APF =10).
    (xxii) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and HEPA filters. (APF =25).
    (xxiii) NIOSH-certified powered air-purifying respirator with a 
hood or helmet equipped with appropriate gas/vapor cartridges. (APF 
=25).
    (xxiv) NIOSH-certified powered air-purifying respirator with a hood 
or helmet and with appropriate gas/vapor cartridges in combination with 
HEPA filters. (APF =25).
    (xxv) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece and HEPA filters. (APF =25).
    (xxvi) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece with appropriate gas/vapor cartridges. 
(APF =25).
    (xxvii) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece with appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF =25).
    (xxviii) NIOSH-certified continuous flow supplied-air respirator 
equipped with a hood or helmet. (APF =25).
    (xxix) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece. (APF =25).
    (xxx) NIOSH-certified air-purifying full facepiece respirator 
equipped with N100, R-100, or P-100 filter(s). (APF =50).
    (xxxi) NIOSH-certified air-purifying full facepiece respirator 
equipped with appropriate gas/vapor cartridges or canisters. (APF =50).
    (xxxii) NIOSH-certified air-purifying full facepiece 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. (APF =50).
    (xxxiii) NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting half mask and HEPA filters. (APF =50).
    (xxxiv) NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting half mask and appropriate gas/vapor cartridges or 
canisters. (APF =50).
    (xxxv) NIOSH-certified powered air-purifying respirator with a 
tight-fitting half mask and appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF =50).
    (xxxvi) NIOSH-certified pressure-demand or other positive pressure 
mode supplied-air respirator equipped with a half-mask. (APF =50).
    (xxxvii) NIOSH-certified negative pressure (demand) supplied-air 
respirator equipped with a full facepiece. (APF =50).
    (xxxviii) NIOSH-certified continuous flow supplied-air respirator 
equipped with a tight-fitting half mask. (APF =50).
    (xxxix) NIOSH-certified negative pressure (demand) self-contained 
breathing apparatus (SCBA) equipped with a hood or helmet or a full 
facepiece. (APF =50).
    (xl) NIOSH-certified powered air purifying full facepiece 
respirator equipped with HEPA filters. (APF =1,000).
    (xli) NIOSH-certified powered air purifying full facepiece 
respirator

[[Page 39766]]

equipped with appropriate gas/vapor cartridges. (APF =1,000).
    (xlii) NIOSH-certified powered air purifying fill facepiece 
respirator equipped with appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF =1,000).
    (xliii) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and N100, R100, or P100 filters with evidence 
demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF =1,000).
    (xliv) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and appropriate gas/vapor cartridges with 
evidence demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF =1,000).
    (xlv) NIOSH-certified powered air-purifying respirator with a 
loose-fitting hood or helmet that is equipped with an appropriate gas/
vapor cartridge in combination with HEPA filters with evidence 
demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF =1,000).
    (xlvi) NIOSH-certified continuous flow supplied-air respirator 
equipped with a full facepiece. (APF =1,000).
    (xlvii) NIOSH-certified continuous flow supplied-air respirator 
equipped with a hood or helmet with evidence demonstrating protection 
level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li). (APF =1,000).
    (xlviii) NIOSH-certified pressure-demand supplied-air respirator 
equipped with a full facepiece. (APF =1,000).
    (xlix) NIOSH-certified pressure-demand or other positive-pressure 
mode (e.g., open/closed circuit) self-contained breathing apparatus 
(SCBA) equipped with a hood or helmet or a full facepiece. (APF 
=10,000).
    (l) If one of the respirators in paragraph (a)(5)(i) through 
(a)(5)(xv) is cited for a substance identified in subpart E an employer 
may substitute a respirator from paragraphs (a)(5)(xvi) through 
(a)(5)(xlix) as long as its assigned protection factor is equal to or 
greater than the respirator cited in subpart E for that substance.
    (li) Without testing data that demonstrates a level of protection 
of 1,000 or greater, all air purifying respirators and supplied air 
respirators with helmets/hoods are to be treated as loose-fitting 
facepiece respirators with an APF of 25.
    (6) When cited in subpart E of this part for a substance, the 
following airborne form(s) of the substance, in combination or alone, 
are referenced by paragraphs (a)(1) and (4) of this section:
* * * * *
    (vii) Particulate or aerosol (solids or liquid droplets suspended 
in a gas, e.g., dust, fume, mist, smoke).
    (viii) Gas/vapor.
    (ix) Combination particulate and gas/vapor (gas and liquid/solid 
physical forms are both present, e.g., particulates and acid gases or 
particulates and organic vapors).
    (7) Where people are reasonably likely to have dermal or eye 
exposure to the chemical substance in the work area, either through 
direct handling of the substance, or through contact with surfaces on 
which the substance may exist, or because the substance becomes 
airborne in the form listed in paragraph (a)(6) of this section, and 
the form is cited in subpart E of this part for the chemical substance, 
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 implemented 
to prevent exposure, where feasible. Where engineering, work practice, 
and administrative controls are not feasible or dermal or eye exposure 
is still reasonably likely, each person who is reasonably likely to be 
exposed to the chemical substance by dermal or eye exposure must be 
provided with, and is required to wear, personal protective equipment 
(PPE) to prevent dermal or eye exposure to the substance. Refer to 29 
CFR 1910.132 and 29 CFR 1910.133 for requirements on selection and use 
of PPE.
    (8) Where each person who is reasonably likely to be exposed to the 
chemical substance by inhalation in the work area in one or more of the 
forms listed in paragraph (a)(6) of this section and cited in subpart E 
of this part for the chemical substance, 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. When engineering, work practice, and 
administrative controls are not feasible or inhalation exposure is 
still reasonably likely, each person who is reasonably likely to be 
exposed to the chemical substance by inhalation in the work area in one 
or more of the forms listed in paragraph (a)(6) of this section and 
cited in subpart E of this part for the chemical substance, must be 
provided with, and is required to wear, a NIOSH- certified respirator 
from one of the categories listed in paragraph (a)(5) of this section. 
Refer to 29 CFR 1910.134 and 42 CFR part 84 for requirements on the 
selection, use, and maintenance of respirators, including establishing 
respiratory protection program, medical determination, and other 
administrative and programmatic requirements for respiratory 
protection.
* * * * *
    (c) * * *
    (2) If, after receiving a statement of assurance from a recipient 
under paragraph (c)(1)(ii) of this section, a manufacturer or processor 
has knowledge that the recipient is engaging in an activity that is not 
consistent with the implementation of the program specified in 
paragraph (a) of this section, that person is considered to have 
knowledge that the person is engaging in a significant new use and is 
required to follow the procedures in Sec.  721.5(d).

0
27. Amend Sec.  721.72 by:
0
a. Revising the introductory text;
0
b. Revising paragraphs (a) introductory text and (a)(1);
0
c. Revising paragraphs (b)(5), (c)(5), (c)(7) and (c)(9);
0
d. Revising paragraphs (g)(1) and (2);
0
e. Revising paragraphs (g)(3)(i) through (g)(3)(ii) and adding 
paragraph (g)(3)(iii);
0
f. Revising paragraphs (g)(4)(i) through (g)(4)(iii) and adding 
paragraph (g)(4)(iv);
0
g. Revising paragraphs (h)(1)(ii), (h)(1)(iii)(A) through 
(h)(1)(iii)(E) and adding paragraphs (h)(1)(iii)(F) through 
(h)(1)(iii)(H);
0
h. Revising paragraphs (h)(1)(iv), (h)(1)(v)(A) through (h)(1)(v)(C) 
and adding paragraph (h)(1)(v)(D);
0
i. Revising paragraphs (h)(2)(ii), (h)(2)(iii) and (h)(2)(iv);
0
j. Revising paragraphs (h)(2)(v)(A) through (h)(2)(v)(C) and adding 
paragraph (h)(2)(v)(D);
0
k. Adding paragraphs (i) and (j).
    The additions and revisions as follows:


Sec.  721.72   Hazard communication program.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of that substance 
is any manner or method of manufacture (including import) or processing 
associated with any use of that substance without establishing a hazard 
communication program as described in this section. Paragraphs (a) 
through (h) of this section apply to SNURs issued July 5, 2022. 
Paragraphs (i) and (j) of his section apply to SNURs issued on or after 
July 5, 2022. Any person subject to the requirements of paragraphs (a) 
through (h) of this section have the option of following the 
requirements of paragraph (i) of this section or using the statements 
specified in paragraphs (g) or (h) of this section.

[[Page 39767]]

    (a) Written hazard communication program. Each employer shall 
develop and implement a written hazard communication program for the 
substance in each workplace. The written program will, at a minimum, 
describe how the requirements of this section for labels, SDSs, and 
other forms of warning material will be satisfied. The employer must 
make the written hazard communication program available, upon request, 
to all employees, contractor employees, and their designated 
representatives. The employer may rely on an existing hazard 
communication program, including an existing program established under 
the Occupational Health and Safety Administration (OSHA) Hazard 
Communication Standard in 29 CFR 1910.1200 of 2012 to comply with this 
paragraph provided that the existing hazard communication program 
satisfies the requirements of this paragraph. The written program shall 
include the following:
    (1) A list of each substance identified in subpart E of this part 
as subject to this section known to be present in the work area. The 
list must be maintained in the work area and must use the identity 
provided on the appropriate SDS for each substance required under 
paragraph (c) of this section. The list may be compiled for the 
workplace or for individual work areas.
* * * * *
    (b) * * *
    (5) If the label or alternative form of warning is to be applied to 
a mixture containing a substance identified in subpart E of this part 
as subject to this section in combination with another substance 
identified in subpart E of this part and/or a substance defined as a 
``hazardous chemical'' under the Occupational Safety and Health 
Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), 
the employer may prescribe on the label, SDS, or alternative form of 
warning, the measures to control worker exposure or environmental 
release which the employer determines provide the greatest degree of 
protection. However, should these control measures differ from the 
applicable measures required under subpart E of this part, the employer 
must seek a determination of equivalency for such alternative control 
measures pursuant to Sec.  721.30 before prescribing them under this 
paragraph (b)(5).
* * * * *
    (c) * * *
    (5) If the employer becomes aware of any significant new 
information regarding the hazards of the substance or ways to protect 
against the hazards, this new information must be added to the SDS 
within 3 months from the time the employer becomes aware of the new 
information. If the substance is not currently being manufactured, 
processed, or used in the employer's workplace, the employer must add 
the new information to the SDS before the substance is reintroduced 
into the workplace.
* * * * *
    (7) The employer must maintain a copy of the SDS in its workplace, 
and must ensure that it is readily accessible during each work shift to 
employees when they are in their work areas. (Easy and immediate 
electronic access and other alternatives to maintaining paper copies of 
the safety data sheets are permitted as long as complete and accurate 
versions of the SDS are available immediately to employees in each 
workplace by such options.)
* * * * *
    (9) The SDS must be in English; however, the information may be 
repeated in other languages.
* * * * *
    (g) * * *
    (1) Human health hazard statements:
    (i) Causes skin irritation.
    (ii) Respiratory complications. (You may also use paragraph 
(g)(1)(x) of this section for this designation.).
    (iii) Central nervous system effects. (You may also use paragraph 
(g)(1)(xi) of this section for this designation but you must include 
this specific effect.)
    (iv) Internal organ effects. (You may also use paragraph (g)(1)(xi) 
of this section for this designation.)
    (v) Birth defects. (You may also use paragraph (g)(1)(xii) of this 
section for this designation but you must include this specific 
effect.)
    (vi) Reproductive effects. (You may also use paragraph (g)(1)(xii) 
of this section for this designation but you must include this specific 
effect.)
    (vii) May cause cancer.
    (viii) Immune system effects. (You may also use paragraph 
(g)(1)(xi) of this section for this designation but you must include 
this specific effect.)
    (ix) Developmental effects. (You may also use paragraph (g)(1)(xii) 
of this section for this designation but you must include this specific 
effect.)
    (x) May cause allergy or asthma symptoms or breathing difficulties 
if inhaled.
    (xi) May cause damage to organs (state all organs identified in 
subpart E of this part for this substance) through prolonged or 
repeated exposure.
    (xii) May damage fertility or the unborn child (state specific 
effect identified in subpart E of this part for this substance).
    (xiii) May cause an allergic skin reaction.
    (xiv) Causes eye irritation.
    (2) Human health hazard precautionary statements:
    (i) Avoid skin contact. (You may also use paragraph (g)(2)(vi) of 
this section for this designation.)
    (ii) Avoid breathing substance. (You may also use paragraph 
(g)(2)(viii) of this section for this designation.)
    (iii) Avoid ingestion.
    (iv) Use respiratory protection. (You may also use paragraph 
(g)(2)(vii) of this section for this designation.)
    (v) Use skin protection. (You may also use paragraph (g)(2)(vi) of 
this section for this designation.)
    (vi) Wear protective gloves/protective clothing/eye protection/face 
protection. (Chemical manufacturer or distributor to specify type of 
equipment, as required.)
    (vii) Wear respiratory protection. (Chemical manufacturer or 
distributor to specify equipment as required.)
    (viii) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical 
manufacturer or distributor to specify applicable conditions.)
    (3) * * *
    (i) Toxic to fish. (You may also use paragraph (g)(3)(iii) of this 
section for this designation.)
    (ii) Toxic to aquatic organisms. (You may also use paragraph 
(g)(3)(iii) of this section for this designation.)
    (iii) Toxic to aquatic life.
    (4) * * *
    (i) Disposal restrictions apply. (You may also use paragraph 
(g)(4)(iv) of this section for this designation.)
    (ii) Spill clean-up restrictions apply. (You may also use paragraph 
(g)(4)(iv) of this section for this designation.)
    (iii) Do not release to water. (You may also use paragraph 
(g)(4)(iv) of this section for this designation.)
    (iv) Dispose of contents/container to . . . (Specify disposal 
requirements in subpart E of this part and whether they apply to 
contents, container or both.)
* * * * *
    (h) * * *
    (ii) Human health hazard statements. (A) Causes skin irritation.
    (B) Respiratory complications. (You may also use paragraph 
(h)(1)(ii)(J) of this section for this designation.)
    (C) Central nervous system effects. (You may also use paragraph 
(h)(1)(ii)(K) of this section for this designation but you must include 
this specific effect.)
    (D) Internal organ effects. (You may also use paragraph 
(h)(1)(ii)(K) of this section for this designation.)

[[Page 39768]]

    (E) Birth defects. (You may also use paragraph (h)(1)(ii)(L) of 
this section for this designation but you must include this specific 
effect.)
    (F) Reproductive effects. (You may also use paragraph (h)(1)(ii)(L) 
of this section for this designation but you must include this specific 
effect.)
    (G) Cancer.
    (H) Immune system effects. (You may also use paragraph 
(h)(1)(ii)(K) of this section for this designation but you must include 
this specific effect.)
    (I) Developmental effects. (You may also use paragraph 
(h)(1)(ii)(L) of this section for this designation but you must include 
this specific effect.)
    (J) May cause allergy or asthma symptoms or breathing difficulties 
if inhaled.
    (K) May cause damage to organs (state all organs identified in 
subpart E of this part for this substance) through prolonged or 
repeated exposure.
    (L) May damage fertility or the unborn child (state specific effect 
identified in subpart E of this part for this substance).
    (M) May cause an allergic skin reaction.
    (N) Causes eye irritation.
    (iii) Human health hazard precautionary statements. (A) Avoid skin 
contact. (You may also use paragraph (h)(1)(iii)(F) of this section for 
this designation.)
    (B) Avoid breathing substance. (You may also use paragraph 
(h)(1)(iii)(H) of this section for this designation.)
    (C) Avoid ingestion.
    (D) Use respiratory protection. (You may also use paragraph 
(h)(1)(iii)(G) of this section for this designation.)
    (E) Use skin protection. (You may also use paragraph (h)(1)(iii)(F) 
of this section for this designation.)
    (F) Wear protective gloves/protective clothing/eye protection/face 
protection. (Chemical manufacturer or distributor to specify type of 
equipment, as required.)
    (G) Wear respiratory protection. (Chemical manufacturer or 
distributor to specify equipment as required.)
    (H) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical 
manufacturer or distributor to specify applicable conditions.)
    (iv) Environmental hazard statements. (A) Toxic to fish. (You may 
also use paragraph (h)(1)(iv)(C) of this section for this designation.)
    (B) Toxic to aquatic organisms. (You may also use paragraph 
(h)(1)(iv)(C) of this section for this designation.)
    (C) Toxic to aquatic life.
    (v) Environmental hazard precautionary statements. Notice to Users:
    (A) Disposal restrictions apply. (You may also use paragraph 
(h)(1)(v)(D) of this section for this designation)
    (B) Spill clean-up restrictions apply. (You may also use paragraph 
(h)(1)(v)(D) of this section for this designation)
    (C) Do not release to water. (You may also use paragraph 
(h)(1)(v)(D) of this section for this designation.)
    (D) Dispose of contents/container to . . . (Specify disposal 
requirements in subpart E of this part and whether they apply to 
contents, container or both.)
* * * * *
    (2) * * *
    (ii) Human health hazard statements. (A) Causes skin irritation.
    (B) Respiratory complications. (You may also use paragraph 
(h)(2)(ii)(J) of this section for this designation.)
    (C) Central nervous system effects. (You may also use paragraph 
(h)(2)(ii)(K) of this section for this designation but you must include 
this specific effect.)
    (D) Internal organ effects. (You may also use paragraph 
(h)(2)(ii)(K) of this section for this designation.)
    (E) Birth defects. (You may also use paragraph (h)(2)(ii)(L) of 
this section for this designation but you must include this specific 
effect.)
    (F) Reproductive effects. (You may also use paragraph (h)(2)(ii)(L) 
of this section for this designation but you must include this specific 
effect.)
    (G) May cause cancer.
    (H) Immune system effects. (You may also use paragraph 
(h)(2)(ii)(K) of this section for this designation but you must include 
this specific effect.)
    (I) Developmental effects. (You may also use paragraph 
(h)(2)(ii)(L) of this section for this designation but you must include 
this specific effect.)
    (J) May cause allergy or asthma symptoms or breathing difficulties 
if inhaled.
    (K) May cause damage to organs (state all organs identified in 
subpart E of this part for this substance.) through prolonged or 
repeated exposure.
    (L) May damage fertility or the unborn child (state specific effect 
identified in subpart E of this part for this substance).
    (M) May cause an allergic skin reaction.
    (N) Causes eye irritation.
    (iii) Human health hazard precautionary statements. (A) Avoid skin 
contact. (You may also use paragraph (h)(2)(iii)(F) of this section for 
this designation.)
    (B) Avoid breathing substance. (You may also use paragraph 
(h)(2)(iii)(H) of this section for this designation.)
    (C) Avoid ingestion.
    (D) Use respiratory protection. (You may also use paragraph 
(h)(2)(iii)(G) of this section for this designation.)
    (E) Use skin protection. (You may also use paragraph (h)(2)(iii)(F) 
of this section for this designation.)
    (F) Wear protective gloves/protective clothing/eye protection/face 
protection. (Chemical manufacturer or distributor to specify type of 
equipment, as required.)
    (G) Wear respiratory protection. (Chemical manufacturer or 
distributor to specify equipment as required.)
    (H) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical 
manufacturer or distributor to specify applicable conditions.)
    (iv) Environmental hazard statements. (A) Toxic to fish. (You may 
also use paragraph (h)(2)(iv)(C) of this section for this designation.)
    (B) Toxic to aquatic organisms. (You may also use paragraph 
(h)(2)(iv)(C) of this section for this designation.)
    (C) Toxic to aquatic life.
    (v) Environmental hazard precautionary statements. Notice to Users:
    (A) Disposal restrictions apply. (You may also use paragraph 
(h)(2)(v)(D) of this section for this designation.)
    (B) Spill clean-up restrictions apply. (You may also use paragraph 
(h)(2)(v)(D) of this section for this designation.)
    (C) Do not release to water. (You may also use paragraph 
(h)(2)(v)(D) of this section for this designation.)
    (D) Dispose of contents/container to . . . (Specify disposal 
requirements in subpart E of this part and whether they apply to 
contents, container or both.)
    (i) Written hazard communication program. Each employer shall 
develop and implement a written hazard communication program for the 
substance in each workplace in accordance with 29 CFR 1910.1200.
    (j) Human health, environmental hazard, exposure, and precautionary 
statements. In addition to the requirements for the hazard 
communication program specified in paragraph (i) of this section, 
whenever referenced in subpart E of this part for a substance, the 
following human health and environmental hazard, exposure, and 
precautionary statements shall appear as specified in paragraph (i) of 
this section.
    (1) Human health hazard statements:
    (i) Causes skin irritation.
    (ii) May cause cancer.
    (iii) Immune system effects.
    (iv) Developmental effects.
    (v) May cause allergy or asthma symptoms or breathing difficulties 
if inhaled.
    (vi) May cause damage to organs (state all organs identified in 
subpart E of this part for this substance) through prolonged or 
repeated exposure.
    (vii) May damage fertility or the unborn child (state specific 
effect identified in subpart E of this part for this substance).

[[Page 39769]]

    (viii) May cause an allergic skin reaction.
    (ix) Causes eye irritation.
    (2) Human health hazard precautionary statements:
    (i) Avoid ingestion.
    (ii) Wear protective gloves/protective clothing/eye protection/face 
protection.
    (Chemical manufacturer or distributor to specify type of equipment, 
as required.)
    (iii) Wear respiratory protection. (Chemical manufacturer or 
distributor to specify equipment as required.)
    (iv) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical 
manufacturer or distributor to specify applicable conditions.)
    (3) Environmental hazard statements: This substance may be:
    (i) Toxic to aquatic life.
    (ii) Very toxic to aquatic life.
    (iii) Harmful to aquatic life.
    (iv) Very toxic to aquatic life with long term effects.
    (v) Toxic to aquatic life with long lasting effects.
    (vi) Harmful to aquatic life with long lasting effects.
    (vii) May cause long lasting harmful effects to aquatic life.
    (4) Environmental hazard precautionary statements: Notice to users:
    (i) Avoid release to the environment (if this is not the intended 
use.)
    (ii) Collect spillage.
    (iii) Dispose of contents/container to . . . (Specify disposal 
requirements in subpart E of this part and whether they apply to 
contents, container or both.)


Sec.  721.80   [Amended]

0
28. Amend Sec.  721.80 by:
0
a. Removing the phrases ``or import'', ``and importation'' and ``or 
importer'' wherever they appear;
0
b. In paragraphs (p), (r), (s), (t) and (u) removing the word 
``manufacture'' and adding in its place the word ``manufacturing''.


Sec.  721.85   [Amended]

0
29. Amend Sec.  721.85 by removing the word ``supercede'' wherever it 
appears and adding in its place ``supersede''.

0
30. Amend Sec.  721.91 by revising the introductory text and adding 
paragraph (a)(7) to read as follows:


Sec.  721.91   Computation of estimated surface water concentrations: 
Instructions.

    These instructions describe the use of the equation specified in 
Sec.  721.90(a)(4), (b)(4), and (c)(4) to compute estimated surface 
water concentrations which will result from release of a substance 
identified in subpart E of this part. The equation shall be computed 
for each site using the stream flow rate appropriate for the site 
according to paragraph (b) of this section, and the highest number of 
kilograms calculated to be released for that site on a given day 
according to paragraph (a) of this section. Two variables shall be 
considered in computing the equation, the number of kilograms released, 
and receiving stream flow.
    (a) * * *
    (7) When a substance is designated in subpart E of this part with a 
specific control technology and a percentage removal of the substance 
from wastewater resulting from use of the specified control technology, 
you may subtract that percentage from the highest expected daily 
release if that control technology is applied.
* * * * *


Sec.  721.100   [Amended]

0
31. In Sec.  721.100, remove the phrase ``manufacturers, importers, and 
processors'' and add in its place ``manufacturers and processors''.

0
32. Amend Sec.  721.125 by revising the introductory text, and 
paragraphs (a), (c) and (j) to read as follows:


Sec.  721.125   Recordkeeping requirements.

    At the time EPA adds a substance to subpart E of this part, EPA 
will specify appropriate recordkeeping requirements which correspond to 
the significant new use designations for the substance selected from 
subpart B of this part. Each manufacturer and processor of the 
substance shall maintain the records for 5 years from the date of their 
creation. In addition to the records specified in Sec.  721.40, the 
records whose maintenance this section requires may include the 
following:
    (a) Records documenting the manufacturing volume of the substance 
and the corresponding dates of manufacture.
* * * * *
    (c) Records documenting the names and addresses (including shipment 
destination address, if different) of all persons outside the site of 
manufacture or processing to whom the manufacturer or processor 
directly sells or transfers the substance, the date of each sale or 
transfer, and the quantity of the substance sold or transferred on such 
date.
* * * * *
    (j) Records documenting compliance with any applicable disposal 
requirements under Sec.  721.85, including the method of disposal, 
location of disposal sites, dates of disposal, and volume of the 
substance disposed. Where the estimated disposal volume is not known to 
or reasonably ascertainable by the manufacturer or processor, that 
person must maintain other records which demonstrate establishment and 
implementation of a program that ensures compliance with any applicable 
disposal requirements.
* * * * *


Sec.  721.160   [Amended]

0
33. Amend Sec.  721.160 by:
0
a. In paragraph (a)(1) removing the phrase ``and import''.
0
b. In paragraph (a)(2) removing the phrase ``or import''.

PART 723--PREMANUFACTURE NOTIFICATION EXEMPTIONS

0
34. The authority citation for part 723 continues to read as follows:

    Authority:  15 U.S.C. 2604.

0
35. Amend Sec.  723. by:
0
a. Revising paragraph (a)(1) introductory text; and
0
b. Revising paragraph (e)(2)(xi)(A); and adding paragraph (e)(2)(xiii).
    The revisions and addition read as follows:


Sec.  723.50   Chemical substances manufactured in quantities of 10,000 
kilograms or less per year, and chemical substances with low 
environmental releases and human exposures

    (a) * * * (1) This section grants an exemption from the 
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic 
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture 
of:
* * * * *
    (e) * * *
    (2) * * *
    (xi) * * *
    (A) The manufacturer intends to manufacture the new chemical 
substance for commercial purposes, other than in small quantities 
solely for research and development, under the terms of this section.
* * * * *
    (xiii) Safety Data Sheet (Sec.  720.45(i)).
* * * * *


Sec.  723.250   [Amended]

0
36. Amend Sec.  723.250 as follows:
0
a. In table 1 to paragraph (e)(3) in the first note removing the phrase 
``composition, complex'' and adding in its place ``composition, 
complex''.
0
b. In paragraph (j)(1), removing the phrase ``or import''.

[FR Doc. 2022-13324 Filed 7-1-22; 8:45 am]
BILLING CODE 6560-50-P