39756 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

§ 180.660 Pyriofenone; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity 

Parts 

per 

million 

.

* * * * * 

Pepper/eggplant subgroup 8–10B .. 2 

Tomato subgroup 8–10A ................ 0.2 

Tomato subgroup 8–10A1 .............. 0.3 

.

* * * * * 

1This tolerance expires on January 5, 2023. 

* * * * * 

[FR Doc. 2022–14224 Filed 7–1–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 720, 721, and 723 

[EPA–HQ–OPPT–2014–0650; FRL–5605–02– 

OCSPP] 

RIN 2070–AJ94 

Significant New Uses of Chemical 

Substances; Updates to the Hazard 

Communication Program and 

Regulatory Framework; Minor 

Amendments to Reporting 

Requirements for Premanufacture 

Notices 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is amending the 

regulations governing significant new 

uses of chemical substances under the 

Toxic Substances Control Act (TSCA) to 

align with revisions that were made to 

the Occupational Safety and Health 

Administration (OSHA) Hazard 

Communications Standard (HCS) and 

changes to the OSHA Respiratory 

Protection Standard and the National 

Institute for Occupational Safety and 

Health (NIOSH) respirator certification 

requirements for the respiratory 

protection of workers from exposure to 

chemicals. In addition, EPA is 

amending the regulations governing 

Significant New Use Rules (SNURs) to 

address issues that have been identified 

by EPA and raised by stakeholders 

through public comments. EPA is also 

making a minor change to reporting 

requirements for premanufacture 

notices (PMNs) and other TSCA 

notifications. EPA expects these changes 

to have minimal impact on the costs and 

burdens of compliance, while updating 

the significant new use reporting 

requirements to assist in addressing any 

potential risks to human health and the 

environment. 

DATES: This final rule is effective 

September 6, 2022. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2014–0650, is 

available at https://www.regulations.gov 

or in-person at the EPA Docket Center 

(EPA/DC). Due to the public health 

concerns related to COVID–19, the EPA 

Docket Center (EPA/DC) and Reading 

Room is open to visitors by appointment 

only. For the latest status information 

on EPA/DC services and docket access, 

visit https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Tyler Lloyd, New Chemicals Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–4016; email address: 

lloyd.tyler@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

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 crossreferences 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. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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

Regulation in 40 CFR 

New 

chemical 

SNURs 

Other 

chemical 

SNURs 

Subpart A. General Provisions (§§ 721.1 through 721.47) ..................................................................................... X X 

Subpart B. Certain Significant New Uses (§§ 721.50 through 721.91): 

§ 721.63. Protection in the Workplace ............................................................................................................. X 

§ 721.72. Hazard Communication Program ..................................................................................................... X 

§ 721.80. Industrial, Commercial, and Consumer Activities ............................................................................. X 


lotter on DSK11XQN23PROD with RULES1
39758 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

TABLE 1—SUBPARTS USED FOR NEW CHEMICAL SNURS AND OTHER CHEMICAL SNURS—Continued 

Regulation in 40 CFR 

New 

chemical 

SNURs 

Other 

chemical 

SNURs 

§ 721.85. Disposal ............................................................................................................................................ X 

§ 721.90. Release to water ............................................................................................................................... X 

§ 721.91. Concentration of estimated surface water concentrations: Instructions .......................................... X 

Subpart C. Recordkeeping Requirements (§§ 721.100 through 721.125) .............................................................. X X 

Subpart D. Expedited Process for issuing Significant New Use Rules for Selected Chemical Substances and 

Limitation or Revocation of Selected Significant New Use Rules (§§ 721.160–721.185) ................................... X 

Subpart E. Significant New Uses for Specific Chemical Substances (§§ 721.225 through 721.10960) * + ............ X X 

* 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 nonpowered, air-purifying, and particulatefilter 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) 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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 


lotter on DSK11XQN23PROD with RULES1
39760 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

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 prenotice inquiries for SNUNs stating that 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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 Followup (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 


lotter on DSK11XQN23PROD with RULES1
39762 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

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/lawsregulations/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 selfdeclared 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. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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 

■ 1. The authority citation for part 720 

continues to read as follows: 

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

§ 720.1 [Amended] 

■ 2. Amend § 720.1 by removing the 

phrase ‘‘and importers’’. 

■ 3. In § 720.3: 

■ a. Revise paragraph (r) introductory 

text and paragraph (r)(1); 

■ b. Revise paragraph (s) introductory 

text and paragraph (s)(2); and 

■ c. Revise paragraph (cc). 

The revisions read as follows: 

§ 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 § 721.3 of this 

chapter), may not use the substance 

except in small quantities solely for 

research and development in 

accordance with § 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. 

* * * * * 

§ 720.30 [Amended] 

■ 4. Amend § 720.30 by 

■ a. Removing the phrase ‘‘or imported’’ 

wherever it appears; and 

■ b. In paragraph (h)(7)(i) removing the 

word ‘‘intented’’ and adding in its place 

‘‘intended’’. 

§ 720.36 [Amended] 

■ 5. Amend § 720.36 by removing the 

phrases ‘‘or imported’’, ‘‘or importer’’, 

‘‘or imports’’ wherever they appear in 

the section. 

■ 6. Amend § 720.38 by: 

■ a. Removing the phrase ‘‘or import’’ 

wherever it appears in the section; and 

■ b. Adding paragraph (b)(7). 

The addition reads as follows: 

§ 720.38 Exemptions for test marketing. 

* * * * * 

(b)(7) Any safety data sheet already 

developed for the chemical substance, 

including draft safety data sheets. 

* * * * * 

§ 720.40 [Amended] 

■ 7. Amend § 720.40 by removing the 

phrases ‘‘or import’’ and ‘‘or importer’’ 

wherever they appear. 

■ 8. Amend § 720.45 by: 

■ a. In paragraph (e), removing the 

phrase ‘‘or imported’’ wherever it; and 


lotter on DSK11XQN23PROD with RULES1
39764 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

■ b. Adding paragraph (i). 

The addition reads as follows: 

§ 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. 

* * * * * 

§ 720.57 [Amended] 

■ 9. In § 720.57 amend paragraph (a) by 

removing the word ‘‘chemcial’’ and 

adding in its place ‘‘chemical’’. 

§ 720.78 [Amended] 

■ 10. Amend § 720.78 by: 

■ a. In paragraph (b)(1) introductory 

text, removing the phrase ‘‘or import’’; 

■ b. In paragraph (b)(1)(iv), removing 

the word ‘‘manfacturer’’ and adding in 

its place ‘‘manufacturer’’; 

■ c. In paragraph (b)(2), removing the 

phrase ‘‘or imports’’ wherever it 

appears; and 

■ d. In paragraph (c) remove the phrase 

‘‘or import’’. 

§ 720.85 [Amended] 

■ 11. Amend § 720.85 by: 

■ a. Removing the phrases ‘‘or import’’ 

and ‘‘or importing’’ wherever they 

appear; 

■ b. In paragraph (b)(1): 

■ i. Removing the phrase ‘‘or imported’’; 

■ ii. Removing the word ‘‘indentity’’ 

and adding in its place ‘‘identity’’; 

■ c. In paragraph (b)(2)(i): 

■ i. Removing the word ‘‘manfactures’’ 

and adding in its place ‘‘manufactures’’; 

■ ii. Removing the phrase ‘‘or imports’’; 

and 

■ d. In paragraph (b)(3)(iv)(D) remove 

the phrase ‘‘on imported’’. 

§ 720.90 [Amended] 

■ 12. Amend § 720.90 by removing the 

phrase ‘‘or import’’ wherever it appears. 

§ 720.102 [Amended] 

■ 13. Amend § 720.102 by removing the 

phrase ‘‘or import’’ wherever it appears. 

§ 720.120 [Amended] 

■ 14. In § 720.120 amend paragraph (b) 

by: 

■ a. Removing the phrase ‘‘or imports’’; 

and 

■ b. Removing the word ‘‘requied’’ and 

adding in its place ‘‘required’’. 

PART 721—SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 15. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 16. Amend part 721 by: 

■ a. Removing the acronym ‘‘MSDS’’ 

everywhere it appears and adding in its 

place the acronym ‘‘SDS’’; 

■ b. Removing the acronym ‘‘MSDSs’’ 

everywhere it appears and adding in its 

place the acronym ‘‘SDSs’’; and 

■ c. Removing the phrase ‘‘material 

safety’’ everywhere it appears and 

adding in its place the word ‘‘safety’’. 

§ 721.1 [Amended] 

■ 17. In § 721.1 amend paragraph (a) by 

removing the phrase ‘‘manufacturers, 

importers and processors’’ and adding 

in its place ‘‘manufacturers and 

processors’’. 

■ 18. Amend § 721.3 by: 

■ a. Revising the definitions of 

‘‘Customer,’’ ‘‘Employer,’’ ‘‘Nonindustrial use,’’ and ‘‘Recipient;’’ and 

■ b. Removing the definition of 

‘‘MSDS’’; and 

■ c. Adding in alphabetical order the 

definition for ‘‘Safety Data Sheet.’’ 

The revisions and addition read as 

follows: 

§ 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 § 721.72(c). 

* * * * * 

§ 721.5 [Amended] 

■ 19. Amend § 721.5 by: 

■ a. Removing the phrase 

‘‘manufacturer, importer, or processor’’ 

everywhere it appears, and adding in its 

place the phrase ‘‘manufacturer or 

processor’’; 

■ b. Removing the phrase ‘‘manufacture, 

import, or process’’ everywhere it 

appears, and adding in its place the 

phrase ‘‘manufacture or process’’; and 

■ c. In paragraph (d)(1)(iii), removing 

the word ‘‘recepient’s’’ and adding in its 

place ‘‘recipient’s’’. 

§ 721.11 [Amended] 

■ 20. Amend § 721.11 by: 

■ a. Removing the phrase 

‘‘manufacturer, importer, or processor’’ 

everywhere it appears, and adding in its 

place the phrase ‘‘manufacturer or 

processor’’; 

■ b. Removing the phrase ‘‘manufacture, 

import, or process’’ everywhere it 

appears, and adding in its place the 

phrase ‘‘manufacture or process’’; 

■ c. Revising the section heading and 

paragraphs (a) and (e) through (g). 

The revisions read as follows: 

§ 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. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 39765 

§ 721.25 [Amended] 

■ 21. Amend § 721.25 by: 

■ a. In paragraph (a) removing the 

phrase ‘‘manufacture, import, or 

processing’’ and add in its place the 

phrase ‘‘manufacture or processing’’. 

■ b. In paragraph (d) removing the 

phrase ‘‘manufacture, import, or 

process’’ and add in its place the phrase 

‘‘manufacture or process’’. 

§ 721.30 [Amended] 

■ 22. Amend § 721.30 by: 

■ a. Removing the phrase ‘‘manufacture, 

import, or processing’’ everywhere it 

appears and adding in its place the 

phrase ‘‘manufacture or processing’’; 

■ b. In paragraph (a) remove the phrase 

‘‘manufacture, import, or process’’ and 

add in its place the phrase 

‘‘manufacture or process’’. 

§ 721.35 [Amended] 

■ 23. Amend § 721.35 by: 

■ a. Removing the phrase 

‘‘manufactured, imported, or processed’’ 

everywhere it appears and adding in its 

place the phrase ‘‘manufactured or 

processed’’; and 

■ b. In paragraph (f)(1) removing the 

phrase ‘‘manufacture, import, or 

processing’’ and adding in its place the 

phrase ‘‘manufacture or processing’’. 

§ 721.45 [Amended] 

■ 24. Amend § 721.45 by removing the 

phrase ‘‘manufactures, imports, or 

processes’’ everywhere it appears and 

adding in its place the phrase 

‘‘manufactures or processes’’. 

§ 721.47 [Amended] 

■ 25. Amend § 721.47 by: 

■ a. Removing the phrase 

‘‘manufactures, imports, or processes’’ 

everywhere it appears and adding in its 

place the phrase ‘‘manufactures or 

processes’’; 

■ b. Removing the phrase 

‘‘manufacturer, importer, or processor’’ 

everywhere it appears and add in its 

place the phrase ‘‘manufacturer or 

processor’’; and 

■ c. Removing the phrase ‘‘manufacture, 

import, or process’’ everywhere it 

appears and adding in its place the 

phrase ‘‘manufacture or process’’. 

■ 26. Amend § 721.63 by: 

■ a. Revising paragraphs (a) 

introductory text, (a)(4) and (a)(5) 

introductory text; 

■ b. Adding paragraphs (a)(5)(xvi) 

through (a)(5)(li); 

■ c. Revising paragraph (a)(6) 

introductory text; 

■ d. Adding paragraphs (a)(6)(vii) 

through (a)(6)(ix), (a)(7) and (a)(8); and 

■ e. Revising paragraph (c)(2). 

The revisions and additions read as 

follows: 

§ 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 airpurifying respirator equipped with a 

hood or helmet and HEPA filters. (APF 

=25). 

(xxiii) NIOSH-certified powered airpurifying respirator with a hood or 

helmet equipped with appropriate gas/ 

vapor cartridges. (APF =25). 

(xxiv) NIOSH-certified powered airpurifying respirator with a hood or 

helmet and with appropriate gas/vapor 

cartridges in combination with HEPA 

filters. (APF =25). 

(xxv) NIOSH-certified powered airpurifying respirator equipped with a 

loose fitting facepiece and HEPA filters. 

(APF =25). 

(xxvi) NIOSH-certified powered airpurifying respirator equipped with a 

loose fitting facepiece with appropriate 

gas/vapor cartridges. (APF =25). 

(xxvii) NIOSH-certified powered airpurifying 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 airpurifying respirator equipped with a 

tight-fitting half mask and HEPA filters. 

(APF =50). 

(xxxiv) NIOSH-certified powered airpurifying respirator equipped with a 

tight-fitting half mask and appropriate 

gas/vapor cartridges or canisters. (APF 

=50). 

(xxxv) NIOSH-certified powered airpurifying respirator with a tight-fitting 

half mask and appropriate gas/vapor 

cartridges in combination with HEPA 

filters. (APF =50). 

(xxxvi) NIOSH-certified pressuredemand 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 


lotter on DSK11XQN23PROD with RULES1
39766 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

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 airpurifying 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 airpurifying 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 airpurifying 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 pressuredemand supplied-air respirator 

equipped with a full facepiece. (APF 

=1,000). 

(xlix) NIOSH-certified pressuredemand 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 NIOSHcertified 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 

§ 721.5(d). 

■ 27. Amend § 721.72 by: 

■ a. Revising the introductory text; 

■ b. Revising paragraphs (a) 

introductory text and (a)(1); 

■ c. Revising paragraphs (b)(5), (c)(5), 

(c)(7) and (c)(9); 

■ d. Revising paragraphs (g)(1) and (2); 

■ e. Revising paragraphs (g)(3)(i) 

through (g)(3)(ii) and adding paragraph 

(g)(3)(iii); 

■ f. Revising paragraphs (g)(4)(i) through 

(g)(4)(iii) and adding paragraph 

(g)(4)(iv); 

■ 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); 

■ h. Revising paragraphs (h)(1)(iv), 

(h)(1)(v)(A) through (h)(1)(v)(C) and 

adding paragraph (h)(1)(v)(D); 

■ i. Revising paragraphs (h)(2)(ii), 

(h)(2)(iii) and (h)(2)(iv); 

■ j. Revising paragraphs (h)(2)(v)(A) 

through (h)(2)(v)(C) and adding 

paragraph (h)(2)(v)(D); 

■ k. Adding paragraphs (i) and (j). 

The additions and revisions as 

follows: 

§ 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. 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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 § 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.) 


lotter on DSK11XQN23PROD with RULES1
39768 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 

(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). 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Rules and Regulations 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.) 

§ 721.80 [Amended] 

■ 28. Amend § 721.80 by: 

■ a. Removing the phrases ‘‘or import’’, 

‘‘and importation’’ and ‘‘or importer’’ 

wherever they appear; 

■ b. In paragraphs (p), (r), (s), (t) and (u) 

removing the word ‘‘manufacture’’ and 

adding in its place the word 

‘‘manufacturing’’. 

§ 721.85 [Amended] 

■ 29. Amend § 721.85 by removing the 

word ‘‘supercede’’ wherever it appears 

and adding in its place ‘‘supersede’’. 

■ 30. Amend § 721.91 by revising the 

introductory text and adding paragraph 

(a)(7) to read as follows: 

§ 721.91 Computation of estimated surface 

water concentrations: Instructions. 

These instructions describe the use of 

the equation specified in § 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. 

* * * * * 

§ 721.100 [Amended] 

■ 31. In § 721.100, remove the phrase 

‘‘manufacturers, importers, and 

processors’’ and add in its place 

‘‘manufacturers and processors’’. 

■ 32. Amend § 721.125 by revising the 

introductory text, and paragraphs (a), (c) 

and (j) to read as follows: 

§ 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 

§ 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 § 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. 

* * * * * 

§ 721.160 [Amended] 

■ 33. Amend § 721.160 by: 

■ a. In paragraph (a)(1) removing the 

phrase ‘‘and import’’. 

■ b. In paragraph (a)(2) removing the 

phrase ‘‘or import’’. 

PART 723—PREMANUFACTURE 

NOTIFICATION EXEMPTIONS 

■ 34. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 35. Amend § 723. by: 

■ a. Revising paragraph (a)(1) 

introductory text; and 

■ b. Revising paragraph (e)(2)(xi)(A); 

and adding paragraph (e)(2)(xiii). 

The revisions and addition read as 

follows: 

§ 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 (§ 720.45(i)). 

* * * * * 

§ 723.250 [Amended] 

■ 36. Amend § 723.250 as follows: 

■ a. In table 1 to paragraph (e)(3) in the 

first note removing the phrase 

‘‘composition, complex’’ and adding in 

its place ‘‘composition, complex’’. 

■ 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 


lotter on DSK11XQN23PROD with RULES1