[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]
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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.
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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
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New chemical Other chemical
Regulation in 40 CFR SNURs SNURs
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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) *
\+\..................................
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* 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