81_FR_49743 81 FR 49598 - Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices

81 FR 49598 - Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 145 (July 28, 2016)

Page Range49598-49613
FR Document2016-15005

EPA is proposing changes to the existing regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align these regulations with revisions to the Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS), which are proposed to be cross referenced, and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA is also proposing changes to the significant new uses of chemical substances regulations based on issues that have been identified by EPA and issues raised by public commenters for Significant New Use Rules (SNURs) previously proposed and issued under these regulations. Additionally, EPA is proposing a minor change to reporting requirements for premanufacture notices (PMNs) and other TSCA section 5 notices. EPA expects these changes to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment.

Federal Register, Volume 81 Issue 145 (Thursday, July 28, 2016)
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Proposed Rules]
[Pages 49598-49613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15005]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 720, 721, and 723

[EPA-HQ-OPPT-2014-0650; FRL-9944-47]
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: Proposed rule.

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SUMMARY: EPA is proposing changes to the existing regulations governing 
significant new uses of chemical substances under the Toxic Substances 
Control Act (TSCA) to align these regulations with revisions to the 
Occupational Safety and Health Administration's (OSHA) Hazard 
Communications Standard (HCS), which are proposed to be cross 
referenced, and with changes to the OSHA Respiratory Protection 
Standard and the National Institute for Occupational Safety and Health 
(NIOSH) respirator certification requirements pertaining to respiratory 
protection of workers from exposure to chemicals. EPA is also proposing 
changes to the significant new uses of chemical substances regulations 
based on issues that have been identified by EPA and issues raised by 
public commenters for Significant New Use Rules (SNURs) previously 
proposed and issued under these regulations. Additionally, EPA is 
proposing a minor change to reporting requirements for premanufacture 
notices (PMNs) and other TSCA section 5 notices. EPA expects these 
changes to have minimal impacts on the costs and burdens of complying, 
while updating the significant new use reporting requirements to assist 
in addressing any potential effects to human health and the 
environment.

DATES: Comments must be received on or before September 26, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2014-0650, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
deliver or delivery of boxed information, please follow the 
instructions at: http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8974; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by TSCA to include import), process, or use chemical 
substances subject to regulations in 40 CFR part 721. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this document applies to them. Potentially 
affected entities may include:
     Manufacturers or processors of chemical substances (NAICS 
codes 325 and 324), e.g., chemical manufacturing, and petroleum and 
coals manufacturing.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). 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 they manufacture or 
process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). 
Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 90 
days before manufacturing a new chemical substance for commercial 
purposes (under TSCA manufacture includes import). Section 3(9) of TSCA 
defines a ``new chemical substance'' as any substance that is not on 
the TSCA Inventory of Chemical Substances compiled by EPA under section 
8(b) of TSCA.

C. What action is the Agency taking?

    EPA is proposing changes to general requirements for SNURs in 40 
CFR part 721, Significant New Uses of Chemical Substances. Most of the 
proposed changes are changes to the standard significant new uses for 
new chemical SNURs identified in subpart B which apply to chemical 
substances when they are cited in subpart E. Other proposed changes are 
procedural changes to the general provisions in subpart A that apply to 
all SNURs. EPA is also clarifying in the preamble of this proposed rule 
some definitions contained in 40 CFR part 721 and proposing a minor 
change to reporting requirements for TSCA section 5 notices

[[Page 49599]]

in 40 CFR parts 720.38, 720.45 and 723.50.

D. Why is the Agency taking this action?

    Based on changes that have occurred for respiratory protection 
requirements since 1989, as codified in NIOSH regulations at 42 CFR 
part 84 and the OSHA standard at 29 CFR 1910.134, EPA is proposing 
changes to 40 CFR 721.63. In addition, based on the changes to 29 CFR 
1910.1200, OSHA's modified Hazard Communication Standard (HCS) 
published March 26, 2012 (77 FR 17574) (Ref. 1), EPA is proposing 
changes to 40 CFR 721.72. EPA is also proposing other changes to 40 CFR 
part 721 subparts A and B and clarifying definitions contained in 40 
CFR part 721. EPA is proposing these changes and making the 
clarifications based on its experience in issuing and administering 
over 2,800 SNURs. Many of the proposed changes are based on public 
comments received by EPA when proposing and issuing SNURs, and 
questions from the public regarding current SNUR requirements such as: 
Considering a hierarchy of controls before using personal protective 
equipment to control exposures; clarifying what use other than as 
described in the premanufacture notice referenced in subpart E of this 
part for the substance means 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 very minor increase in the overall compliance 
burden and cost because of 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 modified SNUR requirements will also allow 
persons subject to a SNUR that has been previously issued to use the 
updated requirements of 40 CFR 721.63 and 721.72 without additional 
rulemaking.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    On July 27, 1989 (54 FR 31298; FRL-3504-6) (Ref. 2), EPA published 
a final rule, titled ``Significant New Use Rules; General Provisions 
for New Chemicals Follow-up'' that put into place an expedited process 
for issuing SNURs for certain new chemical substances. The process 
applies to new chemical substances for which EPA has issued TSCA 
section 5(e) consent orders and other new chemical substances for which 
no TSCA section 5(e) consent orders have been issued, but that may 
present risks to human health or the environment if exposures or 
releases are significantly different from those described in the PMN. 
EPA has issued over 2,800 new chemical SNURs using these standard 
significant new uses. The standard designations in the sections titled 
``Protection in the workplace'' (40 CFR 721.63) and ``Hazard 
communication program'' (40 CFR 721.72) were modeled on OSHA and NIOSH 
regulations that were in force at the time the rule was issued in 1989.
    The July 27, 1989 final rule established subparts B, C, and D and 
amended subpart A of 40 CFR part 721. Subpart A contains definitions 
and general provisions that apply to all SNURs. In subpart B of 40 CFR 
part 721, EPA identified certain standard significant new uses that EPA 
regularly cites in new chemical SNURs. For example, EPA may consider 
use of a specific chemical substance to be a ``significant new use'' if 
the use does not meet requirements for protection in the workplace as 
described in 40 CFR 721.63(a)(1). EPA applies these standard 
significant new uses as appropriate when promulgating SNURs for a 
specific chemical substance. As explained in 40 CFR 721.50, these 
standard significant new use designations apply only when they are 
referenced as applying to a chemical substance listed in 40 CFR part 
721 subpart E. Subpart C describes recordkeeping requirements for 
SNURs. As described in 40 CFR 721.100, these standard recordkeeping 
requirements apply only when they are referenced as applying to a 
chemical substance listed in 40 CFR part 721 subpart E. Subpart D 
describes an expedited process for issuing significant new use rules 
for new chemical substances and the process for the modification or 
revocation of significant new use requirements for new chemical 
substances. Subpart E lists significant new use and recordkeeping 
requirements for specific chemical substances.
    On March 29, 1995 (60 FR 16311; FRL-4291-9) (Ref. 3), EPA published 
an amended rule titled, ``Amendment for Expedited Process to Issue 
Significant New Use Rules for Selected New Chemical Substances.'' The 
rule amendment authorized EPA to use ``significant new use'' 
designations using expedited rulemaking procedures to promulgate SNURs 
for certain new chemical substances not subject to TSCA section 5(e) 
orders (referred to as non-section 5(e) SNURs). The amendment 
authorized EPA to include other designations, such as protection in the 
workplace and hazard communication, in non-section 5(e) SNURs 
promulgated via expedited rulemaking procedures.
    As explained in the March 29, 1995 final rule, a TSCA section 5(e) 
consent order applies only to the original PMN submitter who signs the 
consent order, while a SNUR applies to all other manufacturers and 
processors of the chemical substance. The reporting requirements of a 
non-section 5(e) SNUR apply to all manufacturers and processors of a 
chemical substance including the PMN submitter. The changes to subpart 
B in this proposed rule would make it possible for EPA to issue non-
section 5(e) SNURs as direct final rules with the updated standard SNUR 
designations.
    How the different subparts of 40 CFR part 721 are used for new 
chemical SNURs and existing chemical SNURs are summarized in Table 1. 
New chemical SNURs are issued for certain chemical substances that have 
undergone PMN review. EPA typically utilizes subparts B, C, and D when 
issuing new chemical SNURs. 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. EPA does not

[[Page 49600]]

use subpart B or D for existing chemical SNURs but has applied the 
standard recordkeeping requirements in subpart C. The general 
requirements of subpart A apply to all SNURs unless they are modified 
in the significant new use requirements for a specific chemical 
substance in subpart E. Subpart E lists significant new use and 
recordkeeping for new and existing chemical substances.

 Table 1--Subparts Used for New Chemical SNURs and Other Chemical SNURs
------------------------------------------------------------------------
                                          New chemical    Other chemical
              Regulation                     SNURs            SNURs
------------------------------------------------------------------------
Subpart A. General Provisions (Sec.                  X                X
 Sec.   721.1-721.47).................
Subpart B. Certain Significant New
 Uses (Sec.  Sec.   721.50-721.91):
     Sec.   721.63. Protection               X
     in the Workplace.................
     Sec.   721.72. Hazard                   X
     Communication Program............
     Sec.   721.80.                          X
     Industrial, Commercial, and
     Consumer Activities..............
     Sec.   721.85. Disposal..               X
     Sec.   721.90. Release to               X
     water............................
     Sec.   721.91.                          X
     Concentration of estimated
     surface water concentrations:
     Instructions.....................
Subpart C. Recordkeeping Requirements                X                X
 (Sec.  Sec.   721.100-721.125).......
Subpart D. Expedited Process for                     X
 issuing Significant New Use Rules for
 Selected Chemical Substances and
 Limitation or Revocation of Selected
 Significant New Use Rules (Sec.  Sec.
   721.160-721.185)...................
Subpart E. Significant New Uses for                  X                X
 Specific Chemical Substances (Sec.
 Sec.   721.225-721.10829) *..........
------------------------------------------------------------------------
* revised for each published SNUR.

    EPA is proposing substantive changes or clarifying language in 
subparts A and B. The proposed changes in subpart A would affect all 
SNURs. The proposed changes in Subpart B may affect some previously 
issued new chemical SNURs already in subpart E and would affect future 
new chemical SNURs that would be issued using the changed terms in 
Subpart B. Unit III describes each proposed change and how the changes 
affect previously issued SNURs and SNURs that would be issued after the 
proposed rule becomes final. Not all of the more than 2,800 previously 
issued new chemical SNURs will be affected by the changes in Subpart B. 
For example, as described in the economic analysis for this proposed 
rule (Ref.13), per the EPA Chemical Data Report for Reporting Year 
2011, 195 chemicals were reported in commerce and subject to new 
chemical SNURS. Only 60 of the 195 chemicals contained provisions for 
worker protection and/or hazard communication. This rule does not 
propose any changes to subparts C, D, or E.
    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) to enhance the 
effectiveness of the HCS by ensuring that employees are apprised of the 
chemical hazards to which they may be exposed, and by reducing the 
incidence of chemical-related occupational illnesses and injuries. 
(Ref. 1) The GHS is an internationally harmonized system for 
classifying chemical hazards and developing labels and safety data 
sheets. It is a set of criteria and provisions that regulatory 
authorities can incorporate into existing systems, or use to develop 
new systems.
    The GHS allows a regulatory authority to choose the provisions that 
are appropriate to its sphere of regulation. This is referred to as the 
``building block approach.'' The GHS includes all of the regulatory 
components, or building blocks, that might be needed for classification 
and 22 labeling requirements for chemicals in the workplace, transport, 
pesticides, and consumer products. The modified HCS adopted those 
sections of the GHS that are appropriate to OSHA's regulatory sector. 
For example, while the GHS includes criteria on classifying chemicals 
for aquatic toxicity, these provisions were not adopted for the HCS 
because OSHA does not have the regulatory authority to address 
environmental concerns. The building block approach also gives 
regulatory agencies the authority to select which classification 
criteria and provisions to adopt. 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 also proposing 
to adopt some of the GHS criteria for hazard communication pertaining 
to aquatic toxicity.

III. Summary of 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 proposing several changes to the SNUR regulations in 
subparts A and B. EPA will describe each proposed change and the reason 
for proposing the change.

1. Proposed 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 proposing changes to 40 
CFR 721.63. In June 1995, NIOSH updated and modernized its Federal 
regulation for testing and certifying non-powered, air-purifying, and 
particulate-filter respirators (42 CFR part 84). The 42 CFR part 84 
respirators have passed a more demanding certification test than older 
respirators (e.g., dust and mist [DM], dust, fume and mist [DFM], spray 
paint, pesticide) previously certified under 30 CFR part 11, and 
provide increased worker protection (Ref. 4). 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 for these 
products.
    Additionally, in January 1998, OSHA's revised Respiratory 
Protection

[[Page 49601]]

Standard (29 CFR 1910.134) replaced the respiratory protection 
standards adopted by OSHA in 1971 (Ref. 5). 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) requirements 
to 29 CFR 1910.134 (Ref. 6). 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 proposing to update language pertaining to respiratory 
protection requirements that is 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 proposing to replace the 
reference to 30 CFR part 11 with a reference to 42 CFR part 84 to cite 
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 would apply to all 
previously issued SNURs that contain significant new use requirements 
pertaining to respiratory protection in that it will make clear that 
manufacturers and processors subject to current SNURs can follow 
updated respiratory protection requirements without triggering a SNUN 
requirement; and the updated language would be cited when issuing new 
SNURs as appropriate. EPA is proposing updated NIOSH-certified 
respirator language in 40 CFR 721.63(a)(5). EPA is currently citing the 
new respirator language in SNURs and has not been referencing the 
respirators currently listed in 40 CFR 721.63(a)(5). EPA intends to 
continue citing the new respirator language when issuing new SNURs 
during the pendency of this rulemaking. The proposed updates to 40 CFR 
721.63(a)(5) would standardize the use of the new respirator language 
by allowing EPA to cross-reference the respirator language for new 
chemical SNURs rather than impose the respirator language on a case-by-
case basis.
    EPA is proposing language that would allow persons subject to SNURs 
with older respirator requirements in 40 CFR 721.63(a)(5) already cited 
in subpart E to avoid triggering a SNUN requirement by continuing to 
use those respirators, if they are available. These are the 15 listed 
respirators in 40 CFR 721.63(a)(5)(i) through (xv). EPA is also 
proposing language in 40 CFR 721.63(a)(5) that would allow persons 
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 corresponding older respirator 
requirements that can be consulted in order to determine availability 
of suitable substitutes (Ref. 7). The proposed language in 40 CFR 
721.63(a)(6) also updates language for the airborne form of a chemical 
substance that would apply to the respiratory protection requirements 
in 40 CFR 721.63(a)(4). EPA would cite this language when issuing new 
SNURs.
    Any personal protection equipment requirements would be a minimum 
set of requirements so that users are encouraged to modernize (upgrade 
to next generation) protective equipment to include such features as an 
electronic chip to identify when personnel use and discontinue use of a 
respirator. The electronic chip also could monitor the condition and 
maintenance of the respirator. EPA is specifically requesting comments 
on the use of next generation respirators.
    EPA is also proposing a revision to 40 CFR 721.63 that would make 
it a significant new use not to implement a hierarchy of controls to 
protect workers. This revision would require persons subject to 
applicable SNURs 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 proposed partly due to comments received on 
recently promulgated SNURs. In response to the proposed SNURs published 
in the Federal Register of December 28, 2011 (76 FR 81447) (FRL-9326-2) 
(Ref. 8), EPA received comments from 26 public submissions. Each of 
these comments generally stated that EPA's approach of exclusively 
identifying the absence of adequate personal protective equipment as a 
significant new use instead of engineering and administrative controls 
is not following the best occupational health and safety practices. The 
commenters suggested approaches that EPA could adopt. Several 
commenters identified the industrial hygiene ``hierarchy of controls'' 
approach for workplace health and safety, where elimination, 
substitution, engineering controls, and workplace or administrative 
controls should be implemented before use of personal protective 
equipment for worker protection. Several commenters stated that persons 
subject to SNURs should follow the OSHA requirements to use controls 
that are higher in the hierarchy of controls before requiring employees 
to use personal protective equipment. Some commenters suggested that 
EPA should specifically incorporate the OSHA requirements at 29 CFR 
1910.134(a)(1) into each SNUR or modify standard requirements for SNURs 
at 40 CFR 721.63 to require a hierarchy of controls. Other commenters 
noted several publications or standards that either specifically 
recommend a hierarchy of controls or recommend an approach using 
engineering controls to prevent exposures before using personal 
protective equipment.
    In the final SNURs published on June 26, 2013 (78 FR 32810) (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 to control exposures. EPA noted that its New Chemicals Exposure 
Limits language in TSCA section 5(e) consent orders already states that 
attempting to prevent exposures through higher controls in the 
hierarchy than PPE is EPA's preferred method for protecting workers. 
See: http://www.epa.gov/sites/production/files/2015-06/documents/draft_ncel_insert_042115.pdf (Ref. 10). EPA added language to the final 
SNURs issued June 26, 2013, that contained significant new uses 
pertaining to PPE for workers to require persons subject to the SNURs 
to consider and implement engineering controls and administrative 
controls where feasible. 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 PPE requirements or 
submit a SNUN to EPA.
    All new chemical SNURs published since June 26, 2013 have included 
the same language to consider and implement engineering controls and 
administrative controls where feasible when the SNURs contained 
significant new uses pertaining to the lack of PPE for workers. These 
requirements to consider engineering and administrative controls are 
based on and consistent with the OSHA requirements at 29 CFR 
1910.134(a)(1). EPA is proposing to revise 40 CFR 721.63(a)(1) and 40 
CFR 721.63(a)(4) to add language which requires consideration and use 
of engineering and administrative controls where feasible before PPE 
for worker protection. This proposed change would

[[Page 49602]]

affect SNURs issued after this proposed rule becomes a final effective 
rule and would affect previously issued SNURs that incorporate worker 
protection referencing the existing 40 CFR 721.63(a)(1) and 40 CFR 
721.63(a)(4) regulations. EPA believes most companies are already 
following a hierarchy of controls due to OSHA regulations. EPA is 
specifically seeking comments on this proposal to incorporate a 
hierarchy of controls for significant new use rules.

2. Proposed Changes to 40 CFR 721.72, Hazard Communication Program

    Based on the changes to 29 CFR 1910.1200, OSHA's modified HCS, EPA 
is proposing 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) to enhance the 
effectiveness of the HCS by ensuring that employees are apprised of the 
chemical hazards to which they may be exposed, and by reducing the 
incidence of chemical-related occupational illnesses and injuries. 
(Ref. 1) 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.
    Under the current rules, when SNURs are issued citing section 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 the 
elements that must 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 proposing to add new paragraphs (i) and (j) that EPA would 
use when issuing hazard communication requirements for SNURs issued 
after this rulemaking has been finalized. The new paragraph (i) would 
require that a written hazard communication program be developed and 
implemented for the substance in each workplace in accordance with 29 
CFR 1910.1200, the OSHA HCS.
    The proposed approach would maintain consistency in compliance for 
persons subject to TSCA and OSHA regulations for the same activity. 
Because the OSHA HCS is detailed and complex, by cross-referencing it 
EPA would avoid any errors in duplication as well as avoid the 
unintentional creation of additional obligations. In addition, any 
amendments to the OSHA HCS would apply at the same time for the 
purposes of complying with the SNUR. This approach would also be 
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 required for 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 requirements 
under the OSHA HCS or recommendations under GHS recommendations. Any 
hazard and precautionary statements required by the SNUR would be 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 proposing to update 40 CFR 721.72 paragraphs (a) through (h) 
to be consistent with both OSHA requirements and GHS recommendations. 
When the rulemaking is finalized, these changes would apply to 
individual SNURs in subpart E issued before the effective date of the 
final rule as described in the next two paragraphs. EPA is proposing 
changes to 40 CFR 721.72 paragraphs (a), (c), and (d) to change using 
the word material safety data sheet (MSDS) to safety data sheet (SDS) 
and to allow easily accessible electronic versions and other 
alternatives to maintaining paper copies of the SDS. These changes 
would apply to any previously issued SNUR in subpart E that cites these 
paragraphs. EPA is also proposing changes pertaining to hazard and 
precautionary statements that are listed in 40 CFR 721.72 paragraphs 
(g) and (h) to be consistent with statements required under the OSHA 
HCS and recommended by the GHS. The proposed changes would add new 
precautionary and hazard statements that are consistent with the OSHA 
HCS and GHS recommendations. While the previously issued SNUR 
precautionary and hazard statements will be retained solely for 
previously issued SNURs, EPA is proposing to identify which of the 
proposed new statements can be used as alternatives. EPA is proposing 
that manufacturers and processors subject to a previously issued SNUR 
will have the option to use the prior older precautionary and hazard 
statements or use the new alternative statements that are consistent 
with the OSHA HCS or GHS recommendations to comply with the SNUR.
    EPA is also proposing language allowing any person subject to a 
previously issued SNUR for a substance identified in subpart E 
containing requirements for 40 CFR 721.72 paragraphs (a) through (h) to 
comply with those requirements by following the requirements of the 
proposed 40 CFR 721.72 paragraph (i), which is being proposed for use 
in future SNURs, and using any statements specified for that substance 
in the proposed 40 CFR 721.72 paragraphs (g) or (h). For example, a 
person currently subject to a SNUR citing the requirements to establish 
a hazard communication program as described in 40 CFR part 721.72 
paragraphs (a) through (f) and the requirement for 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 the proposed 
paragraph (i) and use the hazard statement in paragraph (g)(1)(iii), 
``central nervous system effects,'' or the proposed 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 whenever available. EPA makes this 
recommendation because CAS numbers are widely used by industry 
including in SDSs to provide a unique identifier for chemical 
substances and provide an

[[Page 49603]]

unambiguous way to identify a chemical substance, unlike the variety of 
possible systematic, generic, or proprietary names that may be 
available for the same chemical substance. 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 proposed changes for SNUR hazard communications 
requirements concerning how to identify chemical substances would be 
consistent with OSHA regulations.

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

    EPA is also clarifying its use of the significant new use for new 
chemical SNURs described at 40 CFR 721.80(j), which identifies as a 
significant new use, ``Use other than as described in the 
premanufacture notice referenced in subpart E of this part for the 
substance.'' EPA is not proposing to change the language of 721.80(j). 
Instead, EPA is clarifying how it identifies as a significant new use, 
``Use other than as described in the premanufacture notice referenced 
in subpart E of this part for the substance'' 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.5 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 proposal for future 
bona fide inquiries. In identifying the significant new use in subpart 
E for certain previously issued SNURs where the use described in the 
premanufacture notice was not claimed confidential, EPA cited 40 CFR 
721.80(j) and included the PMN use described in the premanufacture 
notice in parentheses. EPA has received public comments in response to 
proposed SNURs and pre-notice inquiries for SNUNs that 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 stated 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 given 40 CFR 721.80(j).
    To more clearly 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. 11) and is codified in 
subpart E at 40 CFR 721.10718.)

4. Proposed 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. EPA is 
proposing to revise 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 proposing to revise 40 CFR 721.91 to 
allow for a certain percentage of removal of a chemical substance from 
wastewater when undergoing control technology, when using the equation 
to calculate surface water concentrations to meet requirements in 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. Based on past 
experience with new chemical SNURs, EPA expects that the control 
technology will usually be 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). EPA would identify an 
applicable removal percentage when issuing new SNURs. It does not apply 
to existing SNURs where a removal percentage has not been identified.
    Because of numerous questions from manufacturers and processors 
about the phrase ``predictable or purposeful release'' in 40 CFR 
721.90, EPA is clarifying the meaning of that phrase. The phrase is 
used to qualify significant new uses pertaining to releases to water in 
40 CFR 721.90. As described in the proposed rule of April 29, 1987, 
Proposed General Provisions for New Chemicals Follow-up (52 FR 15608) 
(Ref. 12), the phrase predictable or purposeful does not include 
releases where true 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 would be included in the term 
predictable or purposeful. EPA did not intend the phrase ``predictable 
or purposeful release'' to limit the agency's strict liability 
authority under the statute.

5. Proposed Changes to 40 CFR 721.11, Determining Whether a Chemical 
Substance or a Specific Use Is Subject to This Part When the Chemical 
Substance Identity or Significant New Use Is Confidential

    Some new chemical SNURs have a significant new use designation 
which is a production volume limit or use other than described in the 
PMN that is based on CBI contained in the PMN and which is therefore 
not disclosed in the published SNUR. Currently, for each SNUR that 
contains a significant new use designation that is CBI, that SNUR 
cross-references the bona fide procedure in the specific SNUR in 
subpart E for 40 CFR 721.1725. That specific SNUR contains a 
significant new use designation that includes CBI (and is

[[Page 49604]]

therefore not disclosed in the published SNUR) and describes the bona 
fide procedure that must be followed to allow a person to determine 
whether a specific use is a significant new use.
    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 proposing to modify the bona 
fide procedure in 40 CFR 721.11 of subpart A of 40 CFR part 721 so that 
it applies to all SNURs that contain any confidential information in 
the SNUR, including the significant new use. EPA believes 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 
confidential significant new use designation. In addition, EPA is 
proposing to modify 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.

6. Proposed 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 proposing to revise requirements in 40 CFR 720.38, 720.45, 
and 40 CFR 723.50 to require that any SDS already developed to either 
comply with OSHA requirements or already developed by a notice 
submitter for other purposes must also be submitted as part of the 
notification (PMN, SNUN, LVE, LoREX, or TME application) 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 proposed revision would not 
require submitters to develop an SDS. It would only require a submitter 
to submit an SDS that has already been developed to the extent it is 
known or reasonably ascertainable by the submitter.

7. Fixing Typographical Errors and Other Non-Substantive Changes

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

IV. Economic Analysis

    EPA evaluated the potential costs of implementing these proposed 
changes to section 5 SNUR requirements for potential manufacturers 
(including importers) and processors of the chemical substances. The 
proposed changes result in minimal increases in burden associated with 
issuing future SNURs and administration and compliance with previously 
issued SNURs. For new chemical SNURs, the incremental increase is 
estimated at 364 hours of burden with an associated $20,387 in the 
steady state; for section 5 notices, the incremental increase is 
estimated at 247 hours of burden with an associated cost of $17,843 in 
the steady state. The Agency's complete Economic Analysis is available 
in the docket under docket ID number EPA-HQ-OPPT-2014-0650 (Ref. 13).

V. References

    The following is a listing of the documents that are specifically 
referenced in this action. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. 2012. OSHA. OSHA Revised Hazard Communication Standard; Final 
Rule. Federal Register (77 FR 17574, March 26, 2012).
2. 1989. EPA. Significant New Use Rules; General Provisions for New 
Chemicals Follow-up; Final Rule. Federal Register (54 FR 31298, July 
27, 1989) (FRL-3504-6).
3. 1995. EPA. Amendment for Expedited Process to Issue Significant 
New Use Rules for Selected New Chemical Substances; Final Rule. 
Federal Register March 29, 1995 (60 FR 16311, March 29, 1995) (FRL-
4291-9).
4. 1995. NIOSH. Respiratory Protection Devices; Final Rule. Federal 
Register (60 FR 30355, June 8, 1995).
5. 1998. OSHA. Respiratory Protection; Final Rule. Federal Register 
(63 FR 1152, January 8, 1998).
6. 2006. OSHA. Assigned Protection Factors; Final Rule. Federal 
Register (71 FR 50121, August 24, 2006).
7. 2015. EPA. Chart comparing assigned protection factors of current 
respirator classes with older respirator requirements.
8. 2011. EPA. Proposed Significant New Use Rules on Certain Chemical 
Substances; Proposed Rule. Federal Register (76 FR 81447, December 
28, 2011) (FRL-9326-2).
9. 2013. EPA. Significant New Use Rules on Certain Chemical 
Substances; Final Rule. Federal Register (78 FR 32810, June 26, 
2014) (FRL-9390-6).
10. 2015. EPA. Boilerplate consent order containing new chemicals 
exposure limits. http://www.epa.gov/sites/production/files/2015-06/documents/draft_ncel_042115.pdf.
11. 2014. EPA. Significant New Use Rules on Certain Chemical 
Substances; Direct Final Rule. Federal Register (79 FR 8291, 
February 12, 2014) (FRL-9903-70).
12. 1987. EPA. Significant New Uses of Chemical Substances; General 
Provisions for New Chemical Follow-up; Proposed Rule. Federal 
Register April 29, 1987 (52 FR 15594, April 29, 1987) (FRL-3153-6).
13. 2016. EPA. Economic Analysis for Proposed Rule Amendments to 
Part 721--Modifications to General and Specific Requirements in the 
SNUR Framework--Significant New Uses of Chemical Substances. (RIN 
2070-AB27). March 2016.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) has determined that this 
proposed rule is not a ``significant regulatory action,'' under section 
3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). 
Accordingly, this action was not submitted to OMB for review under 
Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    An agency may not conduct or sponsor, and a person is not required 
to respond to an information collection request subject to the PRA (44 
U.S.C. 3501 et seq.), unless it displays a currently valid OMB control 
number. The information collection requirements related to this action 
have already been approved by OMB pursuant to PRA under OMB control 
number 2070-0012 (EPA ICR No. 574.15). This action would not impose any 
burden requiring additional OMB approval. Estimates presented below 
reflect incremental changes associated with the rule.
    Respondents/affected entities: Certain manufacturers (including 
importers) and processors.

[[Page 49605]]



------------------------------------------------------------------------
                                             Number of       Number of
               Description                  respondents      responses
------------------------------------------------------------------------
Section 5 Notices.......................             988             988
New Chemical SNURs (newly issued and                 221             334
 previously issued).....................
                                         -------------------------------
    Rule Total..........................           1,209           1,322
------------------------------------------------------------------------

    Respondent's obligation to respond: Mandatory.
    Frequency of Response: Incidental, upon submission of notice or 
implementing/updating New Chemical SNURs.
    Total estimated incremental burden (hours per year): Burden is 
defined at 5 CFR part 178.

------------------------------------------------------------------------
               Description                  First year     Steady state
------------------------------------------------------------------------
Section 5 Notices.......................             415             247
New Chemical SNURs (newly issued and                 661             364
 previously issued).....................
                                         -------------------------------
    Rule Total..........................           1,073             611
------------------------------------------------------------------------

    Total estimated incremental cost (2014$ annual):

------------------------------------------------------------------------
               Description                  First year     Steady state
------------------------------------------------------------------------
Section 5 Notices.......................         $30,420         $17,843
New Chemical SNURs (newly issued and             $42,618         $20,386
 previously issued).....................
                                         -------------------------------
    Rule Total..........................         $73,038         $38,229
------------------------------------------------------------------------

    In your comments on this proposed rule, EPA is also interested in 
any comments about the accuracy of the burden estimate, and any 
suggested methods for minimizing respondent burden, including revisions 
to the automated collection techniques being used for submissions to 
EPA under TSCA, which are now required to use the Agency's Central Data 
Exchange (CDX) portal at http://cdx.epa.gov/epa_home.asp.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), I hereby certify that this action would not 
have a significant adverse economic impact on a substantial number of 
small entities. The Agency's basis is briefly summarized here and is 
detailed in the economic analysis in the public docket for this 
proposed rule (Ref. 13).
    Under the RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this proposed rule on small entities, small 
entity is defined as: (1) A small business, as defined by the Small 
Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a 
small governmental jurisdiction that is a government of a city, county, 
town, school district or special district with a population of less 
than 50,000; and (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field. Since the regulated community is not expected to 
include small governmental jurisdictions or small not-for-profit 
organizations, the analysis focuses on small businesses.
    EPA has observed only a very small proportion of SNUNs submitted by 
self-declared small businesses. To the extent that the percentage of 
small firms abiding by a SNUR is similar to the percentage of small 
firms submitting SNUNs, it is unlikely that a substantial number of 
small entities would be affected by this proposed rule's changes to 
SNUR requirements. Similarly, for 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 proposed rule's changes.
    EPA also believes the incremental per-response costs for complying 
with the proposed rule at $61 per SNUR chemicalfirm and $18 per 
notice are low compared to the cost of developing and marketing a 
chemical new to the firm. Given the relatively low prevalence of small 
businesses in the new chemicals universe, and the extremely small 
incremental burden, the proposed rule is thus very unlikely to have a 
significant adverse economic impact on a substantial number of small 
entities (SISNOSE). Therefore EPA presumes a ``no SISNOSE'' finding. 
EPA continues to be interested in the potential impacts of this 
proposed rule on small entities and welcomes comments on issues related 
to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, EPA has determined that this action would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action would not have a substantial direct effect on States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government, as specified in

[[Page 49606]]

Executive Order 13132 (64 FR 43255, August 10, 1999).

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

    This action would not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), 
do not apply to this proposed rule.

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

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

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 energy supply, 
distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d) (15 U.S.C. 272 note) does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because EPA has determined that this action 
will not have disproportionately high and adverse human health or 
environmental effects on minority or low-income populations.

List of Subjects in 40 CFR Parts 720, 721, and 723

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

    Dated: June 9, 2016.
Wendy Cleland-Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 720--[AMENDED]

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

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


Sec.  720.1  [Amended]

0
2. In Sec.  720.1, remove the phrase ``and importers''.
0
3. Amend Sec.  720.3 by:
0
a. Revising paragraph (r) introductory text.
0
b. Revising paragraph (r)(1).
0
c. Revising paragraph (s) introductory text.
0
d. Revising paragraph (s)(2).
0
e. Revising paragraph (cc).
    The revisions reads as follows:


Sec.  720.3  Definitions.

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


Sec.  720.25  [Amended]

0
4. In Sec.  720.25 removing the phrase ``or import'' wherever it 
appears in the section.


Sec.  720.30  [Amended]

0
5. Amend Sec.  720.30 by:
0
a. Removing the phrase ``or imported'' wherever it appears in the 
section.
0
b. Removing in paragraph (h)(7) the word ``intented'' and add in its 
place ``intended''.


Sec.  720.36  [Amended]

0
6. In Sec.  720.36 removing the phrases ``or imported'', ``or 
importer'', ``or imports'' wherever they appear in the section.
0
7. Amend Sec.  720.38 by:
0
a. Removing the phrase ``or import'' wherever it appears in the 
section.
0
b. Adding paragraph (b)(6) to read as follows:


Sec.  720.38  Exemptions for test marketing.

* * * * *
    (b)(6) Any safety data sheet already developed for the chemical 
substance.
* * * * *


Sec.  720.40  [Amended]

0
8. In Sec.  720.40, removing the phrases ``or import'' and ``or 
importer'' wherever they appear in the section.
0
9. Amend Sec.  720.45 by:
0
a. Removing in paragraph (e), the phrase ``or imported'' wherever it 
appears in the paragraph.
0
b. Adding paragraph (i) to read as follows:


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

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


Sec.  720.57  [Amended]

0
10. Removing in Sec.  720.57 paragraph (a), the word ``chemcial'' and 
add in its place ``chemical''.


Sec.  720.75  [Amended]

0
11. In Sec.  720.75 paragraph (e)(2), remove the phrase ``or 
importer''.
0
12. Amend Sec.  720.78 by:
0
a. Removing in paragraph (b)(1), the phrase ``or import''.
0
b. Removing in paragraph (b)(1)(iv), the word ``manfacturer'' and add 
in its place ``manufacturer''.
0
c. Removing in paragraph (b)(2), the phrase ``or imports'' wherever it 
appears in the paragraph.
0
d. Removing in paragraph (c) the phrase ``or import''.


Sec.  720.85  [Amended]

0
13. Amend Sec.  720.85 by:

[[Page 49607]]

0
a. Removing the phrase ``or import'' wherever it appears in the 
section.
0
b. Removing the phrase ``or importing'' wherever it appears in the 
section.
0
c. Removing in paragraph (b)(1) the phrase ``or imported''.
0
d. Removing in paragraph (b)(1) the word ``indentity'' and add in its 
place ``identity''.
0
e. Removing in paragraph (b)(2)(i) the word ``manfactures'' and add in 
its place ``manufactures''.
0
f. Removing in paragraph (b)(2)(i) the phrase ``or imports''.
0
g. Removing in paragraph (b)(3)(iv)(D) the phrase ``on imported''.


Sec.  720.90  [Amended]

0
14. Removing throughout Sec.  720.90 the phrase ``or import'' wherever 
it appears in the section.
0
15. Removing throughout subpart F the phrase ``or import'' wherever it 
appears in the subpart.


Sec.  720.120  [Amended]

0
16. Amend Sec.  720.120 by:
0
a. Removing in paragraph (b) the phrase ``or imports''.
0
b. Removing in paragraph (b) the word ``requied'' and add in its place 
``required''.

PART 721--[AMENDED]

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

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

0
18. Removing in part 721, the acronym ``MSDS'' and add in its place the 
acronym ``SDS'' everywhere it appears.
0
19. Removing in part 721, the acronym ``MSDSs'' and add in its place 
the acronym ``SDSs'' everywhere it appears.
0
20. Removing in part 721, the phrase ``material safety'' and add in its 
place the word ``safety'' everywhere it appears.


Sec.  721.1  [Amended]

0
21. Removing in Sec.  721.1(a) the phrase ``manufacturers, importers 
and processors'' and add in its place ``manufacturers and processors''.
0
22. Amend Sec.  721.3 by:
0
a. Adding in alphabetical order the definition for ``Safety Data 
Sheet''
0
b. Revising the definition for ``Customer''.
0
c. Revising the definition of ``Employer''.
0
d. Removing the definition of ``MSDS''.
0
e. Revising the definition of ``Non-industrial use''.
0
f. Revising the definition of ``Recipient''.
    The revisions read as follows:
    Customer means any person to whom a manufacturer or processor 
distributes any quantity of a chemical substance, or of a mixture 
containing the chemical substance, whether or not a sale is involved.
    Employer means any manufacturer, processor, or user of chemical 
substances or mixtures.
    Non-industrial use means use other than at a facility where 
chemical substances or mixtures are manufactured or processed.
    Recipient means any person who purchases or otherwise obtains a 
chemical substance directly from a person who manufactures or processes 
the substance.
    Safety Data Sheet (SDS) means written or printed material 
concerning a hazardous chemical substance that is prepared as required 
under Sec.  721.72(c).


Sec.  721.5  [Amended]

0
23. Amend Sec.  721.5 by:
0
a. Removing the phrase ``manufacturer, importer, or processor'' and add 
in its place the phrase ``manufacturer or processor'' everywhere it 
appears.
0
b. Removing the phrase ``manufacture, import, or process'' and add in 
its place the phrase ``manufacture or process'' everywhere it appears.
0
c. Removing in paragraph (d)(1)(iii), the word ``recepient's'' and add 
in its place ``recipient's''.
0
24. Amend Sec.  721.11 by:
0
a. Removinig the phrase ``manufacturer, importer, or processor'' and 
add in its place the phrase ``manufacturer or processor'' everywhere it 
appears.
0
b. Removing the phrase ``manufacture, import, or process'' and add in 
its place the phrase ``manufacture or process'' everywhere it appears.
0
c. Revising the section heading, and paragraphs (a), (e), (f), and (g).
    The revisions reads as follows:


Sec.  721.11  Determining whether a chemical substance or a specific 
use is subject to this part when the chemical substance identity or 
significant new use 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.


Sec.  721.25  [Amended]

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


Sec.  721.30  [Amended]

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


Sec.  721.35  [Amended]

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

[[Page 49608]]

0
28. Throughout Sec.  721.45 remove the phrase ``manufactures, imports, 
or processes'' and add in its place the phrase ``manufactures or 
processes'' everywhere it appears.


Sec.  721.47  [Amended]

0
29. Revise Sec.  721.47 by:
0
a. Removing the phrase ``manufactures, imports, or processes'' and add 
in its place the phrase ``manufactures or processes'' everywhere it 
appears.
0
b. Removing the phrase ``manufacturer, importer, or processor'' and add 
in its place the phrase ``manufacturer or processor'' everywhere it 
appears.
0
c. Removing the phrase ``manufacture, import, or process'' and add in 
its place the phrase ``manufacture or process'' everywhere it appears.
0
30. Amend Sec.  721.63 by:
0
a. Revising paragraph (a) introductory text, paragraph (a)(1), (4), and 
(5)
0
b. Adding new paragraphs (a)(5)(xvi) through (a)(5)(li).
0
c. Revising paragraph (a)(6).
0
d. Adding new paragraphs (a)(6)(vii) through (a)(6)(ix).
0
e. Removing in paragraph (c)(2) the phrase ``manufacturer, importer, or 
processor'' and add in its place the phrase ``manufacturer or 
processor''.
    The revisions and additions read as follows:


Sec.  721.63  Protection in the workplace

    (a) Whenever a substance is identified in subpart E of this part as 
being subject to this section, any manner or method of manufacturing 
(including importing) or processing associated with any use of the 
substance is considered a significant new use unless a program is 
established whereby:
    (1) 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 considered 
and 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.
* * * * *
    (4) Where each person who is reasonably likely to be exposed to the 
chemical substance by inhalation in the work area in one or more of the 
forms listed in paragraph (a)(6) of this section and cited in subpart E 
of this part for the chemical substance, engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. When engineering, work practice, and 
administrative controls are not feasible or inhalation exposure is 
still reasonably likely, each person who is reasonably likely to be 
exposed to the chemical substance by inhalation in the work area in one 
or more of the forms listed in paragraph (a)(6) of this section and 
cited in subpart E of this part for the chemical substance, must be 
provided with, and is required to wear, a NIOSH- certified respirator 
from one of the categories listed in paragraph (a)(5) of this section. 
Refer to 29 CFR 1910.134 and 42 CFR part 84 for requirements on the 
selection, use, and maintenance of respirators, including establishing 
respiratory protection program, medical determination, and other 
administrative and programmatic requirements for respiratory 
protection.
    (5) The following NIOSH-certified respirators meet the requirements 
for paragraph (a)(4) of this section:
* * * * *
    (xvi) NIOSH-certified N100 (if oil aerosols absent), R100, or P100 
filtering facepiece respirator. (APF = 10)
    (xvii) NIOSH-certified air-purifying half-mask respirator equipped 
with N100 (if oil aerosols absent), R100, or P100 filters. (APF = 10)
    (xviii) NIOSH-certified air-purifying half mask respirator equipped 
with appropriate gas/vapor cartridges. (APF = 10)
    (xix) NIOSH-certified air-purifying half-mask respirator equipped 
with appropriate gas/vapor cartridges in combination with N100, R100, 
or P100 filters or an appropriate canister incorporating N100, R100, or 
P100 filters. (APF = 10)
    (xx) NIOSH-certified negative pressure (demand) supplied-air 
respirator equipped with a half-mask. (APF = 10)
    (xxi) NIOSH-certified negative pressure (demand) self-contained 
breathing apparatus (SCBA) equipped with a half mask. (APF = 10)
    (xxii) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and HEPA filters. (APF = 25)
    (xxiii) NIOSH-certified powered air-purifying respirator with a 
hood or helmet equipped with appropriate gas/vapor cartridges. (APF = 
25)
    (xxiv) NIOSH-certified powered air-purifying respirator with a hood 
or helmet and with appropriate gas/vapor cartridges in combination with 
HEPA filters. (APF = 25)
    (xxv) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece and HEPA filters. (APF = 25)
    (xxvi) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece with appropriate gas/vapor cartridges. 
(APF = 25)
    (xxvii) NIOSH-certified powered air-purifying respirator equipped 
with a loose fitting facepiece with appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF = 25)
    (xxviii) NIOSH-certified continuous flow supplied-air respirator 
equipped with a hood or helmet. (APF = 25)
    (xxix) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece. (APF = 25)
    (xxx) NIOSH-certified air-purifying full facepiece respirator 
equipped with N100, R-100, or P-100 filter(s). (APF = 50)
    (xxxi) NIOSH-certified air-purifying full facepiece respirator 
equipped with appropriate gas/vapor cartridges or canisters. (APF = 50)
    (xxxii) NIOSH-certified air-purifying full facepiece respirator 
equipped with appropriate gas/vapor cartridges in combination with 
N100, R100, or P100 filters or an appropriate canister incorporating 
N100, R100, or P100 filters. (APF = 50)
    (xxxiii) NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting half mask and HEPA filters. (APF = 50)
    (xxxiv) NIOSH-certified powered air-purifying respirator equipped 
with a tight-fitting half mask and appropriate gas/vapor cartridges or 
canisters. (APF = 50)
    (xxxv) NIOSH-certified powered air-purifying respirator with a 
tight-fitting half mask and appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF = 50)
    (xxxvi) NIOSH-certified pressure-demand or other positive pressure 
mode

[[Page 49609]]

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 equipped with appropriate gas/vapor cartridges. (APF = 
1,000)
    (xlii) NIOSH-certified powered air purifying fill facepiece 
respirator equipped with appropriate gas/vapor cartridges in 
combination with HEPA filters. (APF = 1,000)
    (xliii) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and N100, R100, or P100 filters with evidence 
demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF = 1,000)
    (xliv) NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and appropriate gas/vapor cartridges with 
evidence demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF = 1,000)
    (xlv) NIOSH-certified powered air-purifying respirator with a 
loose-fitting hood or helmet that is equipped with an appropriate gas/
vapor cartridge in combination with HEPA filters with evidence 
demonstrating protection level of 1,000 or greater. See 40 CFR 
721.63(a)(5)(li). (APF = 1,000)
    (xlvi) NIOSH-certified continuous flow supplied-air respirator 
equipped with a full facepiece. (APF = 1,000)
    (xlvii) NIOSH-certified continuous flow supplied-air respirator 
equipped with a hood or helmet with evidence demonstrating protection 
level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li). (APF = 1,000)
    (xlviii) NIOSH-certified pressure-demand supplied-air respirator 
equipped with a full facepiece. (APF = 1,000)
    (xlix) NIOSH-certified pressure-demand or other positive-pressure 
mode (e.g., open/closed circuit) self-contained breathing apparatus 
(SCBA) equipped with a hood or helmet or a full facepiece. (APF = 
10,000)
    (l) If one of the respirators in paragraph (a)(5)(i) through 
(a)(5)(xv) is cited for a substance identified in subpart E an employer 
may substitute a respirator from paragraphs (a)(5)(xvi) through 
(a)(5)(xlix) as long as its assigned protection factor is equal to or 
greater than the respirator cited in subpart E for that substance.
    (li) Without testing data that demonstrates a level of protection 
of 1,000 or greater, all air purifying respirators and supplied air 
respirators with helmets/hoods are to be treated as loose-fitting 
facepiece respirators with an APF of 25.
    (6) When cited in subpart E of this part for a substance, the 
following airborne form(s) of the substance, in combination or alone, 
are referenced by paragraphs (a)(1) and (4) of this section:
* * * * *
    (vii) Particulate or aerosol (solids or liquid droplets suspended 
in a gas; e.g., dust, fume, mist, smoke).
    (viii) Gas/vapor.
    (ix) Combination particulate and gas/vapor (gas and liquid/solid 
physical forms are both present, e.g., particulates and acid gases or 
particulates and organic vapors).
* * * * *
    (c) * * *
    (2) If, after receiving a statement of assurance from a recipient 
under paragraph (c)(1)(ii) of this section, a manufacturer or processor 
has knowledge that the recipient is engaging in an activity that is not 
consistent with the implementation of the program specified in 
paragraph (a) of this section, that person is considered to have 
knowledge that the person is engaging in a significant new use and is 
required to follow the procedures in Sec.  721.5(d).
* * * * *
0
31. Amend Sec.  721.72 by:
0
a. Revising the introductory text paragraph.
0
b. Revising paragraph (a) and (1).
0
c. Revising paragraph (b)(5).
0
d. Revising paragraph (c)(5), (7) and (9).
0
e. Revising paragraph (g)(1) introductory text and paragraphs (g)(1)(i) 
through (g)(1)(ix).
0
f. Adding paragraphs (g)(1)(x) through (g)(1)(xiv).
0
g. Revising paragraph (g)(2) introductory text and paragraphs (g)(2)(i) 
through (g)(2)(v).
0
h. Adding paragraphs (g)(2)(vi) through (g)(2)(viii).
0
i. Revising paragraphs (g)(3)(i) through (g)(3)(ii).
0
j. Adding paragraph (g)(3)(iii).
0
k. Revising paragraphs (g)(4)(i) through (g)(4)(iii).
0
l. Adding paragraph (g)(4)(iv).
0
m. Revising paragraph (h)(1)(ii) introductory text and paragraphs 
(h)(1)(ii)(A) through (h)(1)(ii)(I).
0
n. Adding paragraphs (h)(1)(ii)(J) through (h)(1)(ii)(N).
0
o. Revising paragraphs (h)(1)(iii)(A) through (h)(1)(iii)(E).
0
p. Adding paragraphs (h)(1)(iii)(F) through (h)(1)(iii)(H).
0
q. Revising paragraph (h)(1)(iv) introductory text and paragraphs 
(h)(1)(iv)(A) through (h)(1)(iv)(B).
0
r. Adding paragraph (h)(1)(iv)(C).
0
s. Revising paragraphs (h)(1)(v)(A) through (h)(1)(v)(C).
0
t. Adding paragraph (h)(1)(v)(D).
0
u. Revising paragraph (h)(2)(ii) introductory text and paragraphs 
(h)(2)(ii)(A) through (h)(2)(ii)(I).
0
v. Adding paragraphs (h)(2)(ii)(J) through (h)(2)(ii)(N).
0
w. Revising paragraph (h)(2)(iii) introductory text and paragraphs 
(h)(2)(iii)(A) through (h)(2)(iii)(E).
0
x. Adding paragraphs (h)(2)(iii)(F) through (h)(2)(iii)(H)
0
y. Revising paragraph (h)(2)(iv) introductory text and paragraphs 
(h)(2)(iv)(A) and (h)(2)(iv)(B).
0
z. Adding paragraph (h)(2)(iv)(C).
0
aa. Revising paragraphs (h)(2)(v)(A) through (h)(2)(v)(C).
0
bb. Adding paragraph (h)(2)(v)(D).
0
cc. Adding paragraphs (i) and (j).
    The revisions and additions read as follows:


Sec.  721.72  Hazard communication program.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of that substance 
is any manner or method of manufacture (including import) or processing 
associated with any use of that substance without establishing a hazard 
communication program as described in this section. Paragraphs (a) 
through (h) apply to SNURs issued before September 26, 2016. Paragraphs 
(i) and (j) apply to SNURs issued on or after September 26, 2016. Any 
person subject to the requirements of paragraphs (a) through (h) have 
the option of following the requirements of paragraph (i) or using the 
statements specified in paragraphs (g) or (h).
    (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

[[Page 49610]]

their designated representatives. The employer may rely on an existing 
hazard communication program, including an existing program established 
under the Occupational Health and Safety Administration (OSHA) Hazard 
Communication Standard in 29 CFR 1910.1200 of 2012 to comply with this 
paragraph provided that the existing hazard communication program 
satisfies the requirements of this paragraph. The written program shall 
include the following:
    (1) A list of each substance identified in subpart E of this part 
as subject to this section known to be present in the work area. The 
list must be maintained in the work area and must use the identity 
provided on the appropriate SDS for each substance required under 
paragraph (c) of this section. The list may be compiled for the 
workplace or for individual work areas.
* * * * *
    (b) * * *
    (5) If the label or alternative form of warning is to be applied to 
a mixture containing a substance identified in subpart E of this part 
as subject to this section in combination with another substance 
identified in subpart E of this part and/or a substance defined as a 
``hazardous chemical'' under the Occupational Safety and Health 
Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), 
the employer may prescribe on the label, SDS, or alternative form of 
warning, the measures to control worker exposure or environmental 
release which the employer determines provide the greatest degree of 
protection. However, should these control measures differ from the 
applicable measures required under subpart E of this part, the employer 
must seek a determination of equivalency for such alternative control 
measures pursuant to Sec.  721.30 before prescribing them under this 
paragraph (b)(5).
* * * * *
    (c) * * *
    (5) If the employer becomes aware of any significant new 
information regarding the hazards of the substance or ways to protect 
against the hazards, this new information must be added to the SDS 
within 3 months from the time the employer becomes aware of the new 
information. If the substance is not currently being manufactured, 
processed, or used in the employer's workplace, the employer must add 
the new information to the SDS before the substance is reintroduced 
into the workplace.
* * * * *
    (7) The employer must maintain a copy of the SDS in its workplace, 
and must ensure that it is readily accessible during each work shift to 
employees when they are in their work areas. (Easy and immediate 
electronic access and other alternatives to maintaining paper copies of 
the safety data sheets are permitted as long as complete and accurate 
versions of the SDS are available immediately to employees in each 
workplace by such options.)
* * * * *
    (9) The SDS must be in English; however, the information may be 
repeated in other languages.
* * * * *
    (g) * * *
    (1) Human health hazard statements:
    (i) Causes skin irritation.
    (ii) Respiratory complications. (You may also use paragraph 
(g)(1)(x) of this section for this designation.).
    (iii) Central nervous system effects. (You may also use paragraph 
(g)(1)(xi) of this section for this designation but you must include 
this specific effect.)
    (iv) Internal organ effects. (You may also use paragraph (g)(1)(xi) 
of this section for this designation.)
    (v) Birth defects. (You may also use paragraph (g)(1)(xii) of this 
section for this designation but you must include this specific 
effect.)
    (vi) Reproductive effects. (You may also use paragraph (g)(1)(xii) 
of this section for this designation but you must include this specific 
effect.)
    (vii) May cause cancer.
    (viii) Immune system effects. (You may also use paragraph 
(g)(1)(xi) of this section for this designation but you must include 
this specific effect.)
    (ix) Developmental effects. (You may also use paragraph (g)(1)(xii) 
of this section for this designation but you must include this specific 
effect.)
    (x) May cause allergy or asthma symptoms or breathing difficulties 
if inhaled.
    (xi) May cause damage to organs <. . .> through prolonged or 
repeated exposure.
    <. . .> (State all organs identified in subpart E of this part for 
this substance.).
    (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)(1) * * *
    (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.)
    (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

[[Page 49611]]

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 <. . .> through prolonged or 
repeated exposure.
    <. . .> (state all organs identified in subpart E of this part for 
this substance.)
    (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 <. . .> through prolonged or 
repeated exposure.<. . .> (state all organs identified in subpart E for 
this substance.)
    (L) May damage fertility or the unborn child <. . .>.<. . .> (state 
specific effect identified in subpart E 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), 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 <. . .>through prolonged or 
repeated exposure.<. . .> (state all organs identified in subpart E for 
this substance.)
    (vii) May damage fertility or the unborn child<. . .>.< . . . 
>(state specific effect identified in subpart E for this substance.)
    (viii) May cause an allergic skin reaction.
    (ix) Causes eye irritation.
    (2) Human health hazard precautionary statements:

[[Page 49612]]

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


Sec.  721.80  [Amended]

0
32. Amend Sec.  721.80 by:
0
a. Removing the phrase ``or import'' wherever it appears in the 
section.
0
b. Removing the phrase ``and importation'' wherever it appears in the 
section.
0
c. Removing the phrase ``or importer'' wherever it appears in the 
section.
0
d. Removing the word ``manufacture'' wherever it appears and add in its 
place the word ``manufacturing''.


Sec.  721.85  [Amended]

0
33. In Sec.  721.85, remove the word ``supercede'' wherever it appears 
and add in its place the word ``supersede''.
0
34. Amend Sec.  [emsp14]721.91 by:
0
a. Revising the introductory paragraph, and
0
b. Adding paragraph (a)(7).
    The revision reads as follows:


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

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


Sec.  721.100  [Amended]

0
35. In Sec.  721.100, remove the phrase ``manufacturers, importers, and 
processors'' and add in its place ``manufacturers and processors''.
0
36. Amend Sec.  721.125 by revising the introductory paragraph, 
paragraph (a), (c), and (j) to read as follows:


Sec.  721.125  Recordkeeping requirements.

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


Sec.  721.160  [Amended]

0
37. Amend Sec.  721.160 by:
0
a. Removing in paragraph (a)(1) the phrase ``and import''.
0
b. Removing in paragraph (a)(2) the phrase ``or import''.

PART 723--[AMENDED]

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

    Authority:  15 U.S.C. 2604.

0
39. Amend Sec.  [emsp14]723.50 by:
0
a. Revising paragraph (a)(1) introductory text.
0
b. Revising paragraph (e)(2)(xi)(A).
0
c. Adding paragraph (e)(2)(xiii).
    The revisions read as follows:


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

    (a) * * *
    (1) This section grants an exemption from the premanufacture notice 
requirements of section 5(a)(1)(A) of the Toxic Substances Control Act 
(15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
     * * *
    (e) * * *
    (2) * * *
    (xi) * * *
    (A) The manufacturer intends to manufacture the new chemical 
substance for commercial purposes, other than in small quantities 
solely for research and development, under the terms of this section.
     * * *
    (xiii) Safety Data Sheet (Sec.  [emsp14]720.45(i)).
* * * * *


Sec.  723.175  [Amended]

0
40. Amend Sec.  723.175 by:
0
a. Removing in paragraph (f)(2)(iii), the word ``imprevious'' and add 
in its place ``impervious''.
0
b. Removing in paragraph (g), the word ``chemcial'' and add in its 
place ``chemical''.
0
c. Removing in paragraph (h)(2), the phrase ``chemcial subtance'' and 
add in its place ``chemical substance''.
0
d. Removing in paragraph (i)(1)(ii)(A), the word ``disagram'' and add 
in its place ``diagram''.
0
e. Removing in paragraph (i)(1)(ii)(C), the word ``indentify'' and add 
in its place ``identify''.

[[Page 49613]]

0
f. Removing in paragraph (i)(1)(iii), the word ``chemcial'' and add in 
its place ``chemical''.


Sec.  723.250  [Amended]

0
41. Amend Sec.  723.250 by:
0
a. Removing in paragraph (e)(3) the phrase ``composition, complex'' and 
add in its place ``composition, complex''.
0
b. Removing in paragraph (j)(1), the phrase ``or import''.

[FR Doc. 2016-15005 Filed 7-27-16; 8:45 am]
 BILLING CODE 6560-50-P



                                               49598                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               be inconsistent with the Clean Air Act;                  (NIOSH) respirator certification                      I. Executive Summary
                                               and                                                      requirements pertaining to respiratory
                                                                                                                                                              A. Does this action apply to me?
                                                  • does not provide the EPA with the                   protection of workers from exposure to
                                               discretionary authority to address, as                   chemicals. EPA is also proposing                         You may be potentially affected by
                                               appropriate, disproportionate human                      changes to the significant new uses of                this action if you manufacture (defined
                                               health or environmental effects, using                   chemical substances regulations based                 by TSCA to include import), process, or
                                               practicable and legally permissible                      on issues that have been identified by                use chemical substances subject to
                                               methods, under Executive Order 12898                     EPA and issues raised by public                       regulations in 40 CFR part 721. The
                                               (59 FR 7629, February 16, 1994).                         commenters for Significant New Use                    following list of North American
                                                  The SIP is not approved to apply on                   Rules (SNURs) previously proposed and                 Industrial Classification System
                                               any Indian reservation land or in any                    issued under these regulations.                       (NAICS) codes is not intended to be
                                               other area where the EPA or an Indian                    Additionally, EPA is proposing a minor                exhaustive, but rather provides a guide
                                               tribe has demonstrated that a tribe has                  change to reporting requirements for                  to help readers determine whether this
                                               jurisdiction. In those areas of Indian                   premanufacture notices (PMNs) and                     document applies to them. Potentially
                                               country, the rule does not have tribal                   other TSCA section 5 notices. EPA                     affected entities may include:
                                               implications and will not impose                         expects these changes to have minimal                    • Manufacturers or processors of
                                               substantial direct costs on tribal                       impacts on the costs and burdens of                   chemical substances (NAICS codes 325
                                               governments or preempt tribal law as                     complying, while updating the                         and 324), e.g., chemical manufacturing,
                                               specified by Executive Order 13175 (65                   significant new use reporting                         and petroleum and coals manufacturing.
                                               FR 67249, November 9, 2000).                             requirements to assist in addressing any
                                                                                                        potential effects to human health and                 B. What is the Agency’s authority for
                                               List of Subjects in 40 CFR Part 52                                                                             taking this action?
                                                                                                        the environment.
                                                 Environmental protection, Air                          DATES: Comments must be received on                      Section 5(a)(2) of TSCA (15 U.S.C.
                                               pollution control, Incorporation by                      or before September 26, 2016.                         2604(a)(2)) authorizes EPA to determine
                                               reference, Nitrogen dioxide, Ozone,                                                                            that a use of a chemical substance is a
                                                                                                        ADDRESSES: Submit your comments,
                                               Particulate matter, Reporting and                                                                              ‘‘significant new use.’’ EPA must make
                                               recordkeeping requirements, Sulfur                       identified by docket identification (ID)
                                                                                                        number EPA–HQ–OPPT–2014–0650, by                      this determination by rule after
                                               oxides, Volatile organic compounds.                                                                            considering all relevant factors,
                                                                                                        one of the following methods:
                                                Dated: July 18, 2016.                                      • Federal eRulemaking Portal: http://              including those listed in TSCA section
                                               Michelle L. Pirzadeh,                                    www.regulations.gov. Follow the online                5(a)(2). Such rules are called
                                               Acting Regional Administrator, Region 10.                instructions for submitting comments.                 ‘‘significant new use rules’’ (SNURs).
                                               [FR Doc. 2016–17714 Filed 7–27–16; 8:45 am]              Do not submit electronically any                      Once EPA determines that a use of a
                                               BILLING CODE 6560–50–P                                   information you consider to be                        chemical substance is a significant new
                                                                                                        Confidential Business Information (CBI)               use, TSCA section 5(a)(1)(B) requires
                                                                                                        or other information whose disclosure is              persons to submit a significant new use
                                               ENVIRONMENTAL PROTECTION                                 restricted by statute.                                notice (SNUN) to EPA at least 90 days
                                               AGENCY                                                      • Mail: Document Control Office                    before they manufacture or process the
                                                                                                        (7407M), Office of Pollution Prevention               chemical substance for that use (15
                                               40 CFR Parts 720, 721, and 723                           and Toxics (OPPT), Environmental                      U.S.C. 2604(a)(1)(B)). Section 5(a)(1)(A)
                                               [EPA–HQ–OPPT–2014–0650; FRL–9944–47]                     Protection Agency, 1200 Pennsylvania                  of TSCA requires persons to notify EPA
                                                                                                        Ave. NW., Washington, DC 20460–0001.                  at least 90 days before manufacturing a
                                               RIN 2070–AJ94
                                                                                                           • Hand Delivery: To make special                   new chemical substance for commercial
                                                                                                        arrangements for hand deliver or                      purposes (under TSCA manufacture
                                               Significant New Uses of Chemical                                                                               includes import). Section 3(9) of TSCA
                                               Substances; Updates to the Hazard                        delivery of boxed information, please
                                                                                                        follow the instructions at: http://                   defines a ‘‘new chemical substance’’ as
                                               Communication Program and                                                                                      any substance that is not on the TSCA
                                               Regulatory Framework; Minor                              www.epa.gov/dockets/contacts.html.
                                                                                                        Additional instructions on commenting                 Inventory of Chemical Substances
                                               Amendments to Reporting                                                                                        compiled by EPA under section 8(b) of
                                               Requirements for Premanufacture                          or visiting the docket, along with more
                                                                                                        information about dockets generally, is               TSCA.
                                               Notices
                                                                                                        available at http://www.epa.gov/                      C. What action is the Agency taking?
                                               AGENCY:  Environmental Protection                        dockets.
                                               Agency (EPA).                                                                                                    EPA is proposing changes to general
                                                                                                        FOR FURTHER INFORMATION CONTACT:              For     requirements for SNURs in 40 CFR part
                                               ACTION: Proposed rule.                                   technical information contact: Jim                    721, Significant New Uses of Chemical
                                               SUMMARY:   EPA is proposing changes to                   Alwood, Chemical Control Division,                    Substances. Most of the proposed
                                               the existing regulations governing                       Office of Pollution Prevention and                    changes are changes to the standard
                                               significant new uses of chemical                         Toxics, Environmental Protection                      significant new uses for new chemical
                                               substances under the Toxic Substances                    Agency, 1200 Pennsylvania Ave. NW.,                   SNURs identified in subpart B which
                                               Control Act (TSCA) to align these                        Washington, DC 20460–0001; telephone                  apply to chemical substances when they
                                               regulations with revisions to the                        number: (202) 564–8974; email address:                are cited in subpart E. Other proposed
                                               Occupational Safety and Health                           alwood.jim@epa.gov.                                   changes are procedural changes to the
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                                               Administration’s (OSHA) Hazard                             For general information contact: The                general provisions in subpart A that
                                               Communications Standard (HCS),                           TSCA-Hotline, ABVI-Goodwill, 422                      apply to all SNURs. EPA is also
                                               which are proposed to be cross                           South Clinton Ave., Rochester, NY                     clarifying in the preamble of this
                                               referenced, and with changes to the                      14620; telephone number: (202) 554–                   proposed rule some definitions
                                               OSHA Respiratory Protection Standard                     1404; email address: TSCA-Hotline@                    contained in 40 CFR part 721 and
                                               and the National Institute for                           epa.gov.                                              proposing a minor change to reporting
                                               Occupational Safety and Health                           SUPPLEMENTARY INFORMATION:                            requirements for TSCA section 5 notices


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                         49599

                                               in 40 CFR parts 720.38, 720.45 and                       information in a disk or CD–ROM that                  referenced as applying to a chemical
                                               723.50.                                                  you mail to EPA, mark the outside of the              substance listed in 40 CFR part 721
                                                                                                        disk or CD–ROM as CBI and then                        subpart E. Subpart C describes
                                               D. Why is the Agency taking this action?
                                                                                                        identify electronically within the disk or            recordkeeping requirements for SNURs.
                                                  Based on changes that have occurred                   CD–ROM the specific information that                  As described in 40 CFR 721.100, these
                                               for respiratory protection requirements                  is claimed as CBI. In addition to one                 standard recordkeeping requirements
                                               since 1989, as codified in NIOSH                         complete version of the comment that                  apply only when they are referenced as
                                               regulations at 42 CFR part 84 and the                    includes information claimed as CBI, a                applying to a chemical substance listed
                                               OSHA standard at 29 CFR 1910.134,                        copy of the comment that does not                     in 40 CFR part 721 subpart E. Subpart
                                               EPA is proposing changes to 40 CFR                       contain the information claimed as CBI                D describes an expedited process for
                                               721.63. In addition, based on the                        must be submitted for inclusion in the                issuing significant new use rules for
                                               changes to 29 CFR 1910.1200, OSHA’s                      public docket. Information so marked                  new chemical substances and the
                                               modified Hazard Communication                            will not be disclosed except in                       process for the modification or
                                               Standard (HCS) published March 26,                       accordance with procedures set forth in               revocation of significant new use
                                               2012 (77 FR 17574) (Ref. 1), EPA is                      40 CFR part 2.                                        requirements for new chemical
                                               proposing changes to 40 CFR 721.72.                         2. Tips for preparing your comments.               substances. Subpart E lists significant
                                               EPA is also proposing other changes to                   When preparing and submitting your                    new use and recordkeeping
                                               40 CFR part 721 subparts A and B and                     comments, see the commenting tips at                  requirements for specific chemical
                                               clarifying definitions contained in 40                   http://www.epa.gov/dockets/                           substances.
                                               CFR part 721. EPA is proposing these                     comments.html.                                           On March 29, 1995 (60 FR 16311;
                                               changes and making the clarifications                                                                          FRL–4291–9) (Ref. 3), EPA published an
                                               based on its experience in issuing and                   II. Background
                                                                                                                                                              amended rule titled, ‘‘Amendment for
                                               administering over 2,800 SNURs. Many                        On July 27, 1989 (54 FR 31298; FRL–                Expedited Process to Issue Significant
                                               of the proposed changes are based on                     3504–6) (Ref. 2), EPA published a final               New Use Rules for Selected New
                                               public comments received by EPA when                     rule, titled ‘‘Significant New Use Rules;             Chemical Substances.’’ The rule
                                               proposing and issuing SNURs, and                         General Provisions for New Chemicals                  amendment authorized EPA to use
                                               questions from the public regarding                      Follow-up’’ that put into place an                    ‘‘significant new use’’ designations
                                               current SNUR requirements such as:                       expedited process for issuing SNURs for               using expedited rulemaking procedures
                                               Considering a hierarchy of controls                      certain new chemical substances. The                  to promulgate SNURs for certain new
                                               before using personal protective                         process applies to new chemical                       chemical substances not subject to
                                               equipment to control exposures;                          substances for which EPA has issued                   TSCA section 5(e) orders (referred to as
                                               clarifying what use other than as                        TSCA section 5(e) consent orders and                  non-section 5(e) SNURs). The
                                               described in the premanufacture notice                   other new chemical substances for                     amendment authorized EPA to include
                                               referenced in subpart E of this part for                 which no TSCA section 5(e) consent                    other designations, such as protection in
                                               the substance means under 40 CFR                         orders have been issued, but that may                 the workplace and hazard
                                               721.80(j); allowing for removal in                       present risks to human health or the                  communication, in non-section 5(e)
                                               wastewater treatment when computing                      environment if exposures or releases are              SNURs promulgated via expedited
                                               estimated surface water concentrations                   significantly different from those                    rulemaking procedures.
                                               according to 40 CFR 721.91; and                          described in the PMN. EPA has issued                     As explained in the March 29, 1995
                                               revising the bona fide procedure in 40                   over 2,800 new chemical SNURs using                   final rule, a TSCA section 5(e) consent
                                               CFR 721.11 to include coverage of                        these standard significant new uses. The              order applies only to the original PMN
                                               situations where the significant new use                 standard designations in the sections                 submitter who signs the consent order,
                                               terms are confidential.                                  titled ‘‘Protection in the workplace’’ (40            while a SNUR applies to all other
                                                                                                        CFR 721.63) and ‘‘Hazard                              manufacturers and processors of the
                                               E. What are the estimated incremental                    communication program’’ (40 CFR                       chemical substance. The reporting
                                               impacts of this action?                                  721.72) were modeled on OSHA and                      requirements of a non-section 5(e)
                                                 There will be a very minor increase in                 NIOSH regulations that were in force at               SNUR apply to all manufacturers and
                                               the overall compliance burden and cost                   the time the rule was issued in 1989.                 processors of a chemical substance
                                               because of the modified requirements in                     The July 27, 1989 final rule                       including the PMN submitter. The
                                               40 CFR parts 720, 721, and 723. The                      established subparts B, C, and D and                  changes to subpart B in this proposed
                                               modified SNUR requirements will be                       amended subpart A of 40 CFR part 721.                 rule would make it possible for EPA to
                                               compatible with the current hazard                       Subpart A contains definitions and                    issue non-section 5(e) SNURs as direct
                                               communication requirements under 29                      general provisions that apply to all                  final rules with the updated standard
                                               CFR 1910.1200 and the respiratory                        SNURs. In subpart B of 40 CFR part 721,               SNUR designations.
                                               protection requirements at 42 CFR part                   EPA identified certain standard                          How the different subparts of 40 CFR
                                               84 and 29 CFR 1910.134. The modified                     significant new uses that EPA regularly               part 721 are used for new chemical
                                               SNUR requirements will also allow                        cites in new chemical SNURs. For                      SNURs and existing chemical SNURs
                                               persons subject to a SNUR that has been                  example, EPA may consider use of a                    are summarized in Table 1. New
                                               previously issued to use the updated                     specific chemical substance to be a                   chemical SNURs are issued for certain
                                               requirements of 40 CFR 721.63 and                        ‘‘significant new use’’ if the use does not           chemical substances that have
                                               721.72 without additional rulemaking.                    meet requirements for protection in the               undergone PMN review. EPA typically
                                                                                                        workplace as described in 40 CFR                      utilizes subparts B, C, and D when
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                                               F. What should I consider as I prepare                   721.63(a)(1). EPA applies these standard              issuing new chemical SNURs. Other
                                               my comments for EPA?                                     significant new uses as appropriate                   SNURs including existing chemical
                                                 1. Submitting CBI. Do not submit this                  when promulgating SNURs for a                         SNURs may be issued for chemical
                                               information to EPA through                               specific chemical substance. As                       substances either not on the TSCA
                                               regulations.gov or email. Clearly mark                   explained in 40 CFR 721.50, these                     Inventory or for those on the TSCA
                                               the part or all of the information that                  standard significant new use                          Inventory that typically have not
                                               you claim to be CBI. For CBI                             designations apply only when they are                 undergone PMN review. EPA does not


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                                               49600                           Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               use subpart B or D for existing chemical                                A apply to all SNURs unless they are                                    significant new use and recordkeeping
                                               SNURs but has applied the standard                                      modified in the significant new use                                     for new and existing chemical
                                               recordkeeping requirements in subpart                                   requirements for a specific chemical                                    substances.
                                               C. The general requirements of subpart                                  substance in subpart E. Subpart E lists

                                                                           TABLE 1—SUBPARTS USED FOR NEW CHEMICAL SNURS AND OTHER CHEMICAL SNURS
                                                                                                                                                                                                                                     Other
                                                                                                                                                                                                                    New chemical
                                                                                                                        Regulation                                                                                                 chemical
                                                                                                                                                                                                                      SNURs         SNURs

                                               Subpart A. General Provisions (§§ 721.1–721.47) ..................................................................................................                        X            X
                                               Subpart B. Certain Significant New Uses (§§ 721.50–721.91):
                                                   • § 721.63. Protection in the Workplace ..........................................................................................................                    X
                                                   • § 721.72. Hazard Communication Program ..................................................................................................                           X
                                                   • § 721.80. Industrial, Commercial, and Consumer Activities .........................................................................                                 X
                                                   • § 721.85. Disposal .........................................................................................................................................        X
                                                   • § 721.90. Release to water ...........................................................................................................................              X
                                                   • § 721.91. Concentration of estimated surface water concentrations: Instructions .......................................                                             X
                                               Subpart C. Recordkeeping Requirements (§§ 721.100–721.125) ..........................................................................                                     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 (§§ 721.225–721.10829) * ...........................                                                     X            X
                                                  * revised for each published SNUR.


                                                  EPA is proposing substantive changes                                 regulatory authorities can incorporate                                  1. Proposed Changes to 40 CFR 721.63,
                                               or clarifying language in subparts A and                                into existing systems, or use to develop                                Protection in the Workplace
                                               B. The proposed changes in subpart A                                    new systems.                                                               Based on changes that have occurred
                                               would affect all SNURs. The proposed                                      The GHS allows a regulatory authority                                 in respiratory protection requirements
                                               changes in Subpart B may affect some                                    to choose the provisions that are                                       since 1989, per the NIOSH regulation at
                                               previously issued new chemical SNURs                                    appropriate to its sphere of regulation.                                42 CFR part 84 and the OSHA standard
                                               already in subpart E and would affect                                   This is referred to as the ‘‘building block                             at 29 CFR 1910.134, EPA is proposing
                                               future new chemical SNURs that would                                    approach.’’ The GHS includes all of the                                 changes to 40 CFR 721.63. In June 1995,
                                               be issued using the changed terms in                                    regulatory components, or building                                      NIOSH updated and modernized its
                                               Subpart B. Unit III describes each                                      blocks, that might be needed for                                        Federal regulation for testing and
                                               proposed change and how the changes                                     classification and 22 labeling                                          certifying non-powered, air-purifying,
                                               affect previously issued SNURs and                                      requirements for chemicals in the                                       and particulate-filter respirators (42 CFR
                                               SNURs that would be issued after the                                    workplace, transport, pesticides, and                                   part 84). The 42 CFR part 84 respirators
                                               proposed rule becomes final. Not all of                                 consumer products. The modified HCS                                     have passed a more demanding
                                               the more than 2,800 previously issued                                   adopted those sections of the GHS that                                  certification test than older respirators
                                               new chemical SNURs will be affected by                                  are appropriate to OSHA’s regulatory                                    (e.g., dust and mist [DM], dust, fume
                                               the changes in Subpart B. For example,                                  sector. For example, while the GHS                                      and mist [DFM], spray paint, pesticide)
                                               as described in the economic analysis                                   includes criteria on classifying                                        previously certified under 30 CFR part
                                               for this proposed rule (Ref.13), per the                                chemicals for aquatic toxicity, these                                   11, and provide increased worker
                                               EPA Chemical Data Report for Reporting                                  provisions were not adopted for the                                     protection (Ref. 4). Because the 42 CFR
                                               Year 2011, 195 chemicals were reported                                  HCS because OSHA does not have the                                      part 84 test criteria simulate worst-case
                                               in commerce and subject to new                                          regulatory authority to address                                         respirator use, NIOSH has encouraged
                                               chemical SNURS. Only 60 of the 195                                      environmental concerns. The building                                    discontinuing the use of particulate
                                               chemicals contained provisions for                                      block approach also gives regulatory                                    respirators certified under 30 CFR part
                                               worker protection and/or hazard                                         agencies the authority to select which                                  11 and switching to particulate
                                               communication. This rule does not                                       classification criteria and provisions to                               respirators certified under 42 CFR part
                                               propose any changes to subparts C, D,                                   adopt. OSHA adopted the classification                                  84. However, non-powered particulate
                                               or E.                                                                   criteria and provisions for labels and                                  respirators that were approved under 30
                                                  In March, 2012, OSHA modified its                                    SDSs, because the current HCS covers                                    CFR part 11 using the ‘‘old’’ labeling
                                               Hazard Communication Standard (HCS)                                     these elements. As described in Unit III,                               were allowed to be manufactured and
                                               to conform to the United Nations’                                       EPA is also proposing to adopt some of                                  sold until July 10, 1998. Specifically,
                                               Globally Harmonized System of                                           the GHS criteria for hazard                                             distributors who purchased 30 CFR part
                                               Classification and Labelling of                                         communication pertaining to aquatic                                     11 particulate filters and respirators
                                               Chemicals (GHS) to enhance the                                          toxicity.                                                               prior to July 10, 1998, are able to sell
                                               effectiveness of the HCS by ensuring                                                                                                            them as ‘‘certified’’ until inventories of
                                                                                                                       III. Summary of Proposed Rule
                                               that employees are apprised of the                                                                                                              these products are depleted. Users who
                                               chemical hazards to which they may be                                      As a result of changes to OSHA and                                   purchased such particulate filters and
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                                               exposed, and by reducing the incidence                                  NIOSH requirements, and other issues                                    respirators from these distributors will
                                               of chemical-related occupational                                        identified through EPA’s experience                                     be able to use them until their
                                               illnesses and injuries. (Ref. 1) The GHS                                issuing and administering SNURs, EPA                                    inventories are depleted or until the end
                                               is an internationally harmonized system                                 is proposing several changes to the                                     of the shelf life or service life for these
                                               for classifying chemical hazards and                                    SNUR regulations in subparts A and B.                                   products.
                                               developing labels and safety data sheets.                               EPA will describe each proposed change                                     Additionally, in January 1998,
                                               It is a set of criteria and provisions that                             and the reason for proposing the change.                                OSHA’s revised Respiratory Protection


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                         49601

                                               Standard (29 CFR 1910.134) replaced                      subject to the older respirator                       controls, and workplace or
                                               the respiratory protection standards                     requirements in 40 CFR 721.63(a)(5)(i)                administrative controls should be
                                               adopted by OSHA in 1971 (Ref. 5).                        through (xv) to use an equivalent                     implemented before use of personal
                                               Subsequently, in August 2006, OSHA                       respirator under the newer requirements               protective equipment for worker
                                               announced that it modified its                           provided that the APF of the new                      protection. Several commenters stated
                                               Respiratory Protection Standard (29 CFR                  respirator is equal to or greater than the            that persons subject to SNURs should
                                               1910.134) by adding definitions as well                  respirator cited in subpart E. EPA has                follow the OSHA requirements to use
                                               as maximum use concentration (MUC)                       included in the public docket a chart                 controls that are higher in the hierarchy
                                               and assigned protection factor (APF)                     comparing the APF of the respirator                   of controls before requiring employees
                                               requirements to 29 CFR 1910.134 (Ref.                    classes in the current regulations with               to use personal protective equipment.
                                               6). Due to these changes, the respirators                the corresponding older respirator                    Some commenters suggested that EPA
                                               currently listed in 40 CFR 721.63 may                    requirements that can be consulted in                 should specifically incorporate the
                                               no longer meet the current NIOSH/                        order to determine availability of                    OSHA requirements at 29 CFR
                                               OSHA criteria for respirator selection                   suitable substitutes (Ref. 7). The                    1910.134(a)(1) into each SNUR or
                                               and use.                                                 proposed language in 40 CFR                           modify standard requirements for
                                                  EPA is proposing to update language                   721.63(a)(6) also updates language for                SNURs at 40 CFR 721.63 to require a
                                               pertaining to respiratory protection                     the airborne form of a chemical                       hierarchy of controls. Other commenters
                                               requirements that is listed in 40 CFR                    substance that would apply to the                     noted several publications or standards
                                               721.63(a)(4), (a)(5), and (a)(6) to be                   respiratory protection requirements in                that either specifically recommend a
                                               consistent with both OSHA and NIOSH                      40 CFR 721.63(a)(4). EPA would cite                   hierarchy of controls or recommend an
                                               requirements. In 40 CFR 721.63(a)(4)                     this language when issuing new SNURs.                 approach using engineering controls to
                                               which requires that respirators be used                     Any personal protection equipment                  prevent exposures before using personal
                                               in accordance with 30 CFR part 11, EPA                   requirements would be a minimum set                   protective equipment.
                                               is proposing to replace the reference to                 of requirements so that users are                        In the final SNURs published on June
                                               30 CFR part 11 with a reference to 42                    encouraged to modernize (upgrade to                   26, 2013 (78 FR 32810) (FRL–9390–6)
                                               CFR part 84 to cite the most updated                     next generation) protective equipment                 (Ref. 9), EPA responded to the
                                               NIOSH regulation for testing and                         to include such features as an electronic             comments, agreeing that a hierarchy of
                                               certifying respirators. Most                             chip to identify when personnel use and               controls should be applied and that PPE
                                               manufacturers and processors are                         discontinue use of a respirator. The                  should be the last option to control
                                               already subject to and complying with                    electronic chip also could monitor the                exposures. EPA noted that its New
                                               42 CFR part 84. This change would                        condition and maintenance of the                      Chemicals Exposure Limits language in
                                               apply to all previously issued SNURs                     respirator. EPA is specifically requesting            TSCA section 5(e) consent orders
                                               that contain significant new use                         comments on the use of next generation                already states that attempting to prevent
                                               requirements pertaining to respiratory                   respirators.                                          exposures through higher controls in the
                                               protection in that it will make clear that                  EPA is also proposing a revision to 40             hierarchy than PPE is EPA’s preferred
                                               manufacturers and processors subject to                  CFR 721.63 that would make it a                       method for protecting workers. See:
                                               current SNURs can follow updated                         significant new use not to implement a                http://www.epa.gov/sites/production/
                                               respiratory protection requirements                      hierarchy of controls to protect workers.             files/2015-06/documents/draft_ncel_
                                               without triggering a SNUN requirement;                   This revision would require persons                   insert_042115.pdf (Ref. 10). EPA added
                                               and the updated language would be                        subject to applicable SNURs to                        language to the final SNURs issued June
                                               cited when issuing new SNURs as                          determine and use appropriate                         26, 2013, that contained significant new
                                               appropriate. EPA is proposing updated                    engineering and administrative controls               uses pertaining to PPE for workers to
                                               NIOSH-certified respirator language in                   before using personal protective                      require persons subject to the SNURs to
                                               40 CFR 721.63(a)(5). EPA is currently                    equipment (PPE) for worker protection,                consider and implement engineering
                                               citing the new respirator language in                    similar to the requirements in OSHA                   controls and administrative controls
                                               SNURs and has not been referencing the                   standards at 29 CFR 1910.134(a)(1) and                where feasible. Where engineering and
                                               respirators currently listed in 40 CFR                   guidance in Appendix B to subpart I of                administrative controls are not feasible
                                               721.63(a)(5). EPA intends to continue                    29 CFR 1910.                                          or are insufficient to protect exposed
                                               citing the new respirator language when                     This change is being proposed partly               workers, persons who are subject to a
                                               issuing new SNURs during the                             due to comments received on recently                  SNUR must follow any PPE
                                               pendency of this rulemaking. The                         promulgated SNURs. In response to the                 requirements or submit a SNUN to EPA.
                                               proposed updates to 40 CFR 721.63(a)(5)                  proposed SNURs published in the                          All new chemical SNURs published
                                               would standardize the use of the new                     Federal Register of December 28, 2011                 since June 26, 2013 have included the
                                               respirator language by allowing EPA to                   (76 FR 81447) (FRL–9326–2) (Ref. 8),                  same language to consider and
                                               cross-reference the respirator language                  EPA received comments from 26 public                  implement engineering controls and
                                               for new chemical SNURs rather than                       submissions. Each of these comments                   administrative controls where feasible
                                               impose the respirator language on a                      generally stated that EPA’s approach of               when the SNURs contained significant
                                               case-by-case basis.                                      exclusively identifying the absence of                new uses pertaining to the lack of PPE
                                                  EPA is proposing language that would                  adequate personal protective equipment                for workers. These requirements to
                                               allow persons subject to SNURs with                      as a significant new use instead of                   consider engineering and administrative
                                               older respirator requirements in 40 CFR                  engineering and administrative controls               controls are based on and consistent
                                               721.63(a)(5) already cited in subpart E to               is not following the best occupational                with the OSHA requirements at 29 CFR
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                                               avoid triggering a SNUN requirement by                   health and safety practices. The                      1910.134(a)(1). EPA is proposing to
                                               continuing to use those respirators, if                  commenters suggested approaches that                  revise 40 CFR 721.63(a)(1) and 40 CFR
                                               they are available. These are the 15                     EPA could adopt. Several commenters                   721.63(a)(4) to add language which
                                               listed respirators in 40 CFR                             identified the industrial hygiene                     requires consideration and use of
                                               721.63(a)(5)(i) through (xv). EPA is also                ‘‘hierarchy of controls’’ approach for                engineering and administrative controls
                                               proposing language in 40 CFR                             workplace health and safety, where                    where feasible before PPE for worker
                                               721.63(a)(5) that would allow persons                    elimination, substitution, engineering                protection. This proposed change would


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                                               49602                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               affect SNURs issued after this proposed                  require that a written hazard                         other alternatives to maintaining paper
                                               rule becomes a final effective rule and                  communication program be developed                    copies of the SDS. These changes would
                                               would affect previously issued SNURs                     and implemented for the substance in                  apply to any previously issued SNUR in
                                               that incorporate worker protection                       each workplace in accordance with 29                  subpart E that cites these paragraphs.
                                               referencing the existing 40 CFR                          CFR 1910.1200, the OSHA HCS.                          EPA is also proposing changes
                                               721.63(a)(1) and 40 CFR 721.63(a)(4)                        The proposed approach would                        pertaining to hazard and precautionary
                                               regulations. EPA believes most                           maintain consistency in compliance for                statements that are listed in 40 CFR
                                               companies are already following a                        persons subject to TSCA and OSHA                      721.72 paragraphs (g) and (h) to be
                                               hierarchy of controls due to OSHA                        regulations for the same activity.                    consistent with statements required
                                               regulations. EPA is specifically seeking                 Because the OSHA HCS is detailed and                  under the OSHA HCS and
                                               comments on this proposal to                             complex, by cross-referencing it EPA                  recommended by the GHS. The
                                               incorporate a hierarchy of controls for                  would avoid any errors in duplication                 proposed changes would add new
                                               significant new use rules.                               as well as avoid the unintentional                    precautionary and hazard statements
                                                                                                        creation of additional obligations. In                that are consistent with the OSHA HCS
                                               2. Proposed Changes to 40 CFR 721.72,                    addition, any amendments to the OSHA                  and GHS recommendations. While the
                                               Hazard Communication Program                             HCS would apply at the same time for                  previously issued SNUR precautionary
                                                  Based on the changes to 29 CFR                        the purposes of complying with the                    and hazard statements will be retained
                                               1910.1200, OSHA’s modified HCS, EPA                      SNUR. This approach would also be                     solely for previously issued SNURs,
                                               is proposing changes to 40 CFR 721.72.                   consistent with the requirement for EPA               EPA is proposing to identify which of
                                               In March, 2012, OSHA modified its HCS                    to coordinate with other federal                      the proposed new statements can be
                                               to conform to the United Nations’                        executive departments and agencies                    used as alternatives. EPA is proposing
                                               Globally Harmonized System of                            under TSCA section 9(d) to impose ‘‘the               that manufacturers and processors
                                               Classification and Labelling of                          least burdens of duplicative                          subject to a previously issued SNUR
                                               Chemicals (GHS) to enhance the                           requirements on those subject to the                  will have the option to use the prior
                                               effectiveness of the HCS by ensuring                     chapter and for other purposes.’’                     older precautionary and hazard
                                               that employees are apprised of the                          The new paragraph (j) describes                    statements or use the new alternative
                                               chemical hazards to which they may be                    specific statements and other warnings                statements that are consistent with the
                                               exposed, and by reducing the incidence                   that could be required for SNURs for                  OSHA HCS or GHS recommendations to
                                               of chemical-related occupational                         substances identified in subpart E. The               comply with the SNUR.
                                               illnesses and injuries. (Ref. 1)                         specific statements and warnings that                    EPA is also proposing language
                                               Modifications to the HCS include                         could be required would be based on                   allowing any person subject to a
                                               revised criteria for classification of                   EPA’s risk assessment of the chemical                 previously issued SNUR for a substance
                                               chemical hazards; revised labeling                       substance and would be consistent with                identified in subpart E containing
                                               provisions that include requirements for                 the OSHA HCS and GHS                                  requirements for 40 CFR 721.72
                                               use of standardized signal words,                        recommendations.                                      paragraphs (a) through (h) to comply
                                               pictograms, hazard statements, and                          EPA expects that, whenever the                     with those requirements by following
                                               precautionary statements; a specified                    statements in paragraphs (g), (h), and (j)            the requirements of the proposed 40
                                               format for safety data sheets; and related               are required and the determinations for               CFR 721.72 paragraph (i), which is
                                               revisions to definitions of terms used in                the SNUR are published, manufacturers                 being proposed for use in future SNURs,
                                               the HCS and requirements for employee                    and processors subject to the SNUR will               and using any statements specified for
                                               training on labels and safety data sheets.               also consider if they trigger any other               that substance in the proposed 40 CFR
                                                  Under the current rules, when SNURs                   corresponding hazard communication                    721.72 paragraphs (g) or (h). For
                                               are issued citing section 40 CFR 721.72                  requirements under the OSHA HCS or                    example, a person currently subject to a
                                               in subpart E for a chemical substance,                   recommendations under GHS                             SNUR citing the requirements to
                                               it is considered a significant new use if                recommendations. Any hazard and                       establish a hazard communication
                                               the company does not develop a written                   precautionary statements required by                  program as described in 40 CFR part
                                               hazard communication program for the                     the SNUR would be a minimum set of                    721.72 paragraphs (a) through (f) and
                                               substance in the workplace. Paragraphs                   hazard warnings. EPA may also propose                 the requirement for a hazard statement
                                               (a) through (h) of 40 CFR 721.72 can be                  individual SNURs or issue section 5(e)                in paragraph (g)(1)(iii), central nervous
                                               cited in subpart E as the elements that                  SNURs under 40 CFR 721.160 using                      system effects, could comply by taking
                                               must be included in the hazard                           other specific statements, signal words,              the following steps: That person could
                                               communication program. Manufacturers                     symbols, hazard category, and                         establish a hazard communication
                                               and processors subject to a SNUR in                      pictograms as hazard communication                    program according to the requirements
                                               subpart E for a chemical substance can                   requirements.                                         in the proposed paragraph (i) and use
                                               rely on an existing hazard                                  EPA is proposing to update 40 CFR                  the hazard statement in paragraph
                                               communication program, such as one                       721.72 paragraphs (a) through (h) to be               (g)(1)(iii), ‘‘central nervous system
                                               established under the OSHA HCS or one                    consistent with both OSHA                             effects,’’ or the proposed alternative
                                               based on GHS recommendations to                          requirements and GHS                                  hazard statement (g)(1)(xi), ‘‘may cause
                                               comply with this significant new use                     recommendations. When the                             damage to the central nervous system
                                               requirement to the extent the hazard                     rulemaking is finalized, these changes                through prolonged or repeated
                                               communication program contains                           would apply to individual SNURs in                    exposure.’’
                                               elements cited for that SNUR from 40                     subpart E issued before the effective                    EPA recommends using a Chemical
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                                               CFR 721.72 paragraphs (a) through (h).                   date of the final rule as described in the            Abstracts Service (CAS) number to
                                                  EPA is proposing to add new                           next two paragraphs. EPA is proposing                 identify the chemical substance
                                               paragraphs (i) and (j) that EPA would                    changes to 40 CFR 721.72 paragraphs                   whenever available. EPA makes this
                                               use when issuing hazard                                  (a), (c), and (d) to change using the word            recommendation because CAS numbers
                                               communication requirements for SNURs                     material safety data sheet (MSDS) to                  are widely used by industry including
                                               issued after this rulemaking has been                    safety data sheet (SDS) and to allow                  in SDSs to provide a unique identifier
                                               finalized. The new paragraph (i) would                   easily accessible electronic versions and             for chemical substances and provide an


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                          49603

                                               unambiguous way to identify a chemical                   use in parentheses. These comments                    consideration of control technology part
                                               substance, unlike the variety of possible                and inquiries have stated that when                   of the calculations for the equation
                                               systematic, generic, or proprietary                      EPA cites the new use this way it                     specified in 40 CFR 721.90 when cited
                                               names that may be available for the                      appears as though the significant new                 in subpart E for a specific chemical
                                               same chemical substance. Only when a                     use is the use in the parentheses, where              substance. EPA will cite the control
                                               CAS number is not available should a                     the significant new use is actually use               technology and the percentage removal
                                               different unique numerical identifier be                 other than the use in parentheses given               for SNURs in subpart E, based on EPA’s
                                               used. Because of variations in naming                    40 CFR 721.80(j).                                     assessment of the effectiveness of the
                                               conventions for chemical substances,                        To more clearly identify the                       control technology for the specific
                                               using CAS numbers makes it easier for                    significant new use, EPA has changed                  chemical substance. Based on past
                                               the regulated community to accurately                    this procedure to only cite 40 CFR                    experience with new chemical SNURs,
                                               identify and report chemical identities.                 721.80(j) when the use described in the               EPA expects that the control technology
                                               For example, upon importation of a                       PMN is confidential. When the use                     will usually be wastewater treatment.
                                               chemical substance, if the chemical                      described in the PMN is not                           However, EPA will not identify a
                                               substance is being identified to assure                  confidential, EPA intends to identify the             percentage of removal from wastewater
                                               compliance with regulatory                               significant new use in a new chemical                 for every chemical substance subject to
                                               requirements, providing the most                         SNUR by describing the use, such as in                a SNUR with the significant new use
                                               specific CAS number is the most                          the following example: ‘‘A significant                specified in 40 CFR 721.90 (a)(4), (b)(4),
                                               efficient and clear way to ensure this.                  new use is any use other than as a                    and (c)(4). EPA would identify an
                                               The proposed changes for SNUR hazard                     pesticide intermediate.’’ (This example               applicable removal percentage when
                                               communications requirements                              was published in the direct final SNUR                issuing new SNURs. It does not apply to
                                               concerning how to identify chemical                      issued on February 12, 2014 (79 FR                    existing SNURs where a removal
                                               substances would be consistent with                      8291) (Ref. 11) and is codified in                    percentage has not been identified.
                                               OSHA regulations.                                        subpart E at 40 CFR 721.10718.)                          Because of numerous questions from
                                                                                                                                                              manufacturers and processors about the
                                               3. Clarification of the Use of 40 CFR                    4. Proposed Changes to 40 CFR 721.91,
                                                                                                                                                              phrase ‘‘predictable or purposeful
                                               721.80, Industrial Commercial and                        Computation of Estimated Surface
                                                                                                                                                              release’’ in 40 CFR 721.90, EPA is
                                               Consumer Activities                                      Water Concentrations: Instructions
                                                                                                                                                              clarifying the meaning of that phrase.
                                                  EPA is also clarifying its use of the                    When EPA issues a new chemical                     The phrase is used to qualify significant
                                               significant new use for new chemical                     SNUR citing the significant new uses                  new uses pertaining to releases to water
                                               SNURs described at 40 CFR 721.80(j),                     described in 40 CFR 721.90 (a)(4), (b)(4),            in 40 CFR 721.90. As described in the
                                               which identifies as a significant new                    and (c)(4), the SNUR requires significant             proposed rule of April 29, 1987,
                                               use, ‘‘Use other than as described in the                new use notification if the results of the            Proposed General Provisions for New
                                               premanufacture notice referenced in                      equation for computation of estimated                 Chemicals Follow-up (52 FR 15608)
                                               subpart E of this part for the substance.’’              surface water concentrations in 40 CFR                (Ref. 12), the phrase predictable or
                                               EPA is not proposing to change the                       721.91 exceed the level specified for                 purposeful does not include releases
                                               language of 721.80(j). Instead, EPA is                   that SNUR in subpart E. The equation                  where true emergency conditions exist
                                               clarifying how it identifies as a                        estimates surface water concentrations                and significant new use notification is
                                               significant new use, ‘‘Use other than as                 based on the amount of a chemical                     not possible. Therefore, routine or
                                               described in the premanufacture notice                   substance released from industrial                    repeated activity that results in releases
                                               referenced in subpart E of this part for                 processes and the flows of the water                  to water or non-routine releases to water
                                               the substance’’ for individual SNURs.                    body. The current equation does not                   that are not due to emergency
                                               When EPA issues a SNUR using the                         take into consideration amounts of a                  conditions would be included in the
                                               designation at 40 CFR 721.80(j) in                       chemical substance released to a surface              term predictable or purposeful. EPA did
                                               subpart E for a chemical substance and                   water after control technology such as                not intend the phrase ‘‘predictable or
                                               that use described in the                                wastewater treatment. EPA is proposing                purposeful release’’ to limit the agency’s
                                               premanufacture notice is claimed as                      to revise this requirement to allow                   strict liability authority under the
                                               confidential, EPA cites 40 CFR 721.80(j).                manufacturers and processors to                       statute.
                                               See Unit III.5 for a discussion of how                   account for reductions in surface water
                                               manufacturers and processors subject to                  concentrations resulting from                         5. Proposed Changes to 40 CFR 721.11,
                                               a SNUR with a confidential significant                   wastewater treatment. 40 CFR 721.91                   Determining Whether a Chemical
                                               new use designation can currently file a                 contains instructions for the                         Substance or a Specific Use Is Subject
                                               bona fide inquiry to determine whether                   computation of estimated surface water                to This Part When the Chemical
                                               a specific use is a significant new use                  concentrations according to the                       Substance Identity or Significant New
                                               and EPA’s proposal for future bona fide                  equation specified in 40 CFR 721.90                   Use Is Confidential
                                               inquiries. In identifying the significant                (a)(4), (b)(4), and (c)(4). EPA is                       Some new chemical SNURs have a
                                               new use in subpart E for certain                         proposing to revise 40 CFR 721.91 to                  significant new use designation which
                                               previously issued SNURs where the use                    allow for a certain percentage of                     is a production volume limit or use
                                               described in the premanufacture notice                   removal of a chemical substance from                  other than described in the PMN that is
                                               was not claimed confidential, EPA cited                  wastewater when undergoing control                    based on CBI contained in the PMN and
                                               40 CFR 721.80(j) and included the PMN                    technology, when using the equation to                which is therefore not disclosed in the
                                               use described in the premanufacture                      calculate surface water concentrations                published SNUR. Currently, for each
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                                               notice in parentheses. EPA has received                  to meet requirements in 40 CFR 721.90.                SNUR that contains a significant new
                                               public comments in response to                           EPA has previously allowed surface                    use designation that is CBI, that SNUR
                                               proposed SNURs and pre-notice                            water concentrations to be calculated                 cross-references the bona fide procedure
                                               inquiries for SNUNs that manufacturers                   with a consideration of wastewater                    in the specific SNUR in subpart E for 40
                                               and processors subject to SNURs find it                  treatment in certain SNURs by adding                  CFR 721.1725. That specific SNUR
                                               confusing when EPA cites 40 CFR                          regulatory text to individual rules. This             contains a significant new use
                                               721.80(j) and then identifies the PMN                    change to 40 CFR 721.91 will make the                 designation that includes CBI (and is


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                                               49604                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               therefore not disclosed in the published                 accurately use the terms manufacture,                 8. 2011. EPA. Proposed Significant New Use
                                               SNUR) and describes the bona fide                        manufacturer, and manufacturing in the                     Rules on Certain Chemical Substances;
                                               procedure that must be followed to                       regulatory text of sections 40 CFR parts                   Proposed Rule. Federal Register (76 FR
                                               allow a person to determine whether a                    720, 721, and 723.                                         81447, December 28, 2011) (FRL–9326–
                                               specific use is a significant new use.                                                                              2).
                                                  When the chemical identity in a                       IV. Economic Analysis                                 9. 2013. EPA. Significant New Use Rules on
                                               SNUR is CBI, 40 CFR 721.11 provides a                      EPA evaluated the potential costs of                     Certain Chemical Substances; Final Rule.
                                               means by which bona fide submitters                      implementing these proposed changes                        Federal Register (78 FR 32810, June 26,
                                               can determine whether their substance                    to section 5 SNUR requirements for                         2014) (FRL–9390–6).
                                               is subject to the SNUR. However, as                      potential manufacturers (including                    10. 2015. EPA. Boilerplate consent order
                                               described in the previous paragraph,                     importers) and processors of the                           containing new chemicals exposure
                                               chemical identity is not the only                        chemical substances. The proposed                          limits. http://www.epa.gov/sites/
                                               information contained in a SNUR that                     changes result in minimal increases in                     production/files/2015-06/documents/
                                                                                                                                                                   draft_ncel_042115.pdf.
                                               may be claimed as CBI. EPA is                            burden associated with issuing future
                                                                                                                                                              11. 2014. EPA. Significant New Use Rules on
                                               proposing to modify the bona fide                        SNURs and administration and
                                                                                                                                                                   Certain Chemical Substances; Direct
                                               procedure in 40 CFR 721.11 of subpart                    compliance with previously issued                          Final Rule. Federal Register (79 FR 8291,
                                               A of 40 CFR part 721 so that it applies                  SNURs. For new chemical SNURs, the                         February 12, 2014) (FRL–9903–70).
                                               to all SNURs that contain any                            incremental increase is estimated at 364              12. 1987. EPA. Significant New Uses of
                                               confidential information in the SNUR,                    hours of burden with an associated                         Chemical Substances; General Provisions
                                               including the significant new use. EPA                   $20,387 in the steady state; for section                   for New Chemical Follow-up; Proposed
                                               believes it would be more efficient to                   5 notices, the incremental increase is                     Rule. Federal Register April 29, 1987 (52
                                               have a bona fide procedure for                           estimated at 247 hours of burden with                      FR 15594, April 29, 1987) (FRL–3153–6).
                                               determining confidential significant                     an associated cost of $17,843 in the                  13. 2016. EPA. Economic Analysis for
                                               new uses in subpart A rather than                        steady state. The Agency’s complete                        Proposed Rule Amendments to Part
                                               referencing 40 CFR 721.1725(b)(1) each                   Economic Analysis is available in the                      721—Modifications to General and
                                               time EPA issues a SNUR containing a                      docket under docket ID number EPA–                         Specific Requirements in the SNUR
                                               confidential significant new use                         HQ–OPPT–2014–0650 (Ref. 13).                               Framework—Significant New Uses of
                                               designation. In addition, EPA is                                                                                    Chemical Substances. (RIN 2070–AB27).
                                               proposing to modify the bona fide                        V. References                                              March 2016.
                                               procedure that allows EPA to disclose                      The following is a listing of the
                                                                                                                                                              VI. Statutory and Executive Order
                                               the confidential significant new use                     documents that are specifically
                                                                                                                                                              Reviews
                                               designations to a manufacturer or                        referenced in this action. The docket
                                               processor who has established a bona                     includes these documents and other                    A. Executive Order 12866: Regulatory
                                               fide intent to manufacture (including                    information considered by EPA,                        Planning and Review and Executive
                                               import) or process a particular chemical                 including documents that are referenced               Order 13563: Improving Regulation and
                                               substance.                                               within the documents that are included                Regulatory Review
                                               6. Proposed Changes for Submission of                    in the docket, even if the referenced
                                                                                                        document is not physically located in                   The Office of Management and Budget
                                               SDS(s) With PMNs, SNUNs, Low                                                                                   (OMB) has determined that this
                                               Volume Exemptions (LVEs), Low                            the docket. For assistance in locating
                                                                                                        these other documents, please consult                 proposed rule is not a ‘‘significant
                                               Release and Exposure Exemptions                                                                                regulatory action,’’ under section 3(f) of
                                               (LoREXs), and Test Marketing                             the technical person listed under FOR
                                                                                                        FURTHER INFORMATION CONTACT.                          Executive Order 12866 (58 FR 51735,
                                               Exemption (TME) Applications                                                                                   October 4, 1993). Accordingly, this
                                                                                                        1. 2012. OSHA. OSHA Revised Hazard
                                                  EPA is proposing to revise                                                                                  action was not submitted to OMB for
                                                                                                             Communication Standard; Final Rule.
                                               requirements in 40 CFR 720.38, 720.45,                        Federal Register (77 FR 17574, March             review under Executive Order 12866
                                               and 40 CFR 723.50 to require that any                         26, 2012).                                       and 13563 (76 FR 3821, January 21,
                                               SDS already developed to either comply                   2. 1989. EPA. Significant New Use Rules;              2011).
                                               with OSHA requirements or already                             General Provisions for New Chemicals
                                               developed by a notice submitter for                           Follow-up; Final Rule. Federal Register          B. Paperwork Reduction Act (PRA)
                                               other purposes must also be submitted                         (54 FR 31298, July 27, 1989) (FRL–3504–
                                                                                                             6).                                                An agency may not conduct or
                                               as part of the notification (PMN, SNUN,                                                                        sponsor, and a person is not required to
                                               LVE, LoREX, or TME application) under                    3. 1995. EPA. Amendment for Expedited
                                                                                                             Process to Issue Significant New Use             respond to an information collection
                                               section 5 of TSCA. Many submitters                                                                             request subject to the PRA (44 U.S.C.
                                                                                                             Rules for Selected New Chemical
                                               already submit available SDSs as part of                      Substances; Final Rule. Federal Register         3501 et seq.), unless it displays a
                                               their submission and the information                          March 29, 1995 (60 FR 16311, March 29,           currently valid OMB control number.
                                               contained in SDSs is often useful for                         1995) (FRL–4291–9).                              The information collection requirements
                                               EPA’s assessments of chemicals. This                     4. 1995. NIOSH. Respiratory Protection
                                                                                                                                                              related to this action have already been
                                               proposed revision would not require                           Devices; Final Rule. Federal Register (60
                                                                                                             FR 30355, June 8, 1995).                         approved by OMB pursuant to PRA
                                               submitters to develop an SDS. It would
                                                                                                        5. 1998. OSHA. Respiratory Protection; Final          under OMB control number 2070–0012
                                               only require a submitter to submit an
                                                                                                             Rule. Federal Register (63 FR 1152,              (EPA ICR No. 574.15). This action
                                               SDS that has already been developed to
                                                                                                             January 8, 1998).                                would not impose any burden requiring
                                               the extent it is known or reasonably
Lhorne on DSK30JT082PROD with PROPOSALS




                                                                                                        6. 2006. OSHA. Assigned Protection Factors;           additional OMB approval. Estimates
                                               ascertainable by the submitter.                               Final Rule. Federal Register (71 FR              presented below reflect incremental
                                               7. Fixing Typographical Errors and                            50121, August 24, 2006).                         changes associated with the rule.
                                               Other Non-Substantive Changes                            7. 2015. EPA. Chart comparing assigned
                                                                                                             protection factors of current respirator           Respondents/affected entities: Certain
                                                  EPA is proposing to correct several                        classes with older respirator                    manufacturers (including importers)
                                               typographical errors and more                                 requirements.                                    and processors.




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                                                                                Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                                                                   49605

                                                                                                                                                                                                                             Number of      Number of
                                                                                                                          Description                                                                                       respondents     responses

                                               Section 5 Notices .....................................................................................................................................................                988            988
                                               New Chemical SNURs (newly issued and previously issued) ................................................................................                                               221            334

                                                     Rule Total .........................................................................................................................................................           1,209          1,322



                                                 Respondent’s obligation to respond:                                      implementing/updating New Chemical                                            Total estimated incremental burden
                                               Mandatory.                                                                 SNURs.                                                                      (hours per year): Burden is defined at 5
                                                 Frequency of Response: Incidental,                                                                                                                   CFR part 178.
                                               upon submission of notice or

                                                                                                                          Description                                                                                        First year     Steady state

                                               Section 5 Notices .....................................................................................................................................................                415            247
                                               New Chemical SNURs (newly issued and previously issued) ................................................................................                                               661            364

                                                     Rule Total .........................................................................................................................................................           1,073            611



                                                 Total estimated incremental cost
                                               (2014$ annual):

                                                                                                                          Description                                                                                        First year     Steady state

                                               Section 5 Notices .....................................................................................................................................................           $30,420         $17,843
                                               New Chemical SNURs (newly issued and previously issued) ................................................................................                                          $42,618         $20,386

                                                     Rule Total .........................................................................................................................................................        $73,038         $38,229



                                                 In your comments on this proposed                                        a small organization that is any not-for-                                   have a significant adverse economic
                                               rule, EPA is also interested in any                                        profit enterprise which is independently                                    impact on a substantial number of small
                                               comments about the accuracy of the                                         owned and operated and is not                                               entities (SISNOSE). Therefore EPA
                                               burden estimate, and any suggested                                         dominant in its field. Since the                                            presumes a ‘‘no SISNOSE’’ finding. EPA
                                               methods for minimizing respondent                                          regulated community is not expected to                                      continues to be interested in the
                                               burden, including revisions to the                                         include small governmental                                                  potential impacts of this proposed rule
                                               automated collection techniques being                                      jurisdictions or small not-for-profit                                       on small entities and welcomes
                                               used for submissions to EPA under                                          organizations, the analysis focuses on                                      comments on issues related to such
                                               TSCA, which are now required to use                                        small businesses.                                                           impacts.
                                               the Agency’s Central Data Exchange                                            EPA has observed only a very small
                                               (CDX) portal at http://cdx.epa.gov/epa_                                                                                                                D. Unfunded Mandates Reform Act
                                                                                                                          proportion of SNUNs submitted by self-                                      (UMRA)
                                               home.asp.                                                                  declared small businesses. To the extent
                                               C. Regulatory Flexibility Act (RFA)                                        that the percentage of small firms                                            Based on EPA’s experience with
                                                                                                                          abiding by a SNUR is similar to the                                         proposing and finalizing SNURs, State,
                                                 Pursuant to section 605(b) of the
                                                                                                                          percentage of small firms submitting                                        local, and Tribal governments have not
                                               Regulatory Flexibility Act (RFA) (5
                                               U.S.C. 601 et seq.), I hereby certify that                                 SNUNs, it is unlikely that a substantial                                    been impacted by these rulemakings,
                                               this action would not have a significant                                   number of small entities would be                                           and EPA does not have any reasons to
                                               adverse economic impact on a                                               affected by this proposed rule’s changes                                    believe that any State, local, or Tribal
                                               substantial number of small entities.                                      to SNUR requirements. Similarly, for                                        government would be impacted by this
                                               The Agency’s basis is briefly                                              section 5 notices, assuming that a                                          rulemaking. As such, EPA has
                                               summarized here and is detailed in the                                     similar small proportion of small firms                                     determined that this action would not
                                               economic analysis in the public docket                                     are submitting all notices, it is likewise                                  impose any enforceable duty, contain
                                               for this proposed rule (Ref. 13).                                          unlikely that substantial number of                                         any unfunded mandate, or otherwise
                                                 Under the RFA, small entities include                                    small entities would be affected by this                                    have any effect on small governments
                                               small businesses, small organizations,                                     proposed rule’s changes.                                                    subject to the requirements of UMRA
                                               and small governmental jurisdictions.                                         EPA also believes the incremental                                        sections 202, 203, 204, or 205 (2 U.S.C.
                                               For purposes of assessing the impacts of                                   per-response costs for complying with                                       1501 et seq.).
                                               this proposed rule on small entities,                                      the proposed rule at $61 per SNUR                                           E. Executive Order 13132: Federalism
                                               small entity is defined as: (1) A small                                    chemical•firm and $18 per notice are
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                                               business, as defined by the Small                                          low compared to the cost of developing                                        This action would not have a
                                               Business Administration’s (SBA)                                            and marketing a chemical new to the                                         substantial direct effect on States, on the
                                               regulations at 13 CFR 121.201; (2) a                                       firm. Given the relatively low                                              relationship between the national
                                               small governmental jurisdiction that is a                                  prevalence of small businesses in the                                       government and the States, or on the
                                               government of a city, county, town,                                        new chemicals universe, and the                                             distribution of power and
                                               school district or special district with a                                 extremely small incremental burden, the                                     responsibilities among the various
                                               population of less than 50,000; and (3)                                    proposed rule is thus very unlikely to                                      levels of government, as specified in


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                                               49606                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               Executive Order 13132 (64 FR 43255,                        Dated: June 9, 2016.                                 § 720.25    [Amended]
                                               August 10, 1999).                                        Wendy Cleland-Hamnett,                                 ■ 4. In § 720.25 removing the phrase ‘‘or
                                                                                                        Director, Office of Pollution Prevention and           import’’ wherever it appears in the
                                               F. Executive Order 13175: Consultation                   Toxics.                                                section.
                                               and Coordination With Indian Tribal
                                               Governments                                                Therefore, it is proposed that 40 CFR                § 720.30    [Amended]
                                                                                                        chapter I be amended as follows:
                                                 This action would not have Tribal                                                                             ■  5. Amend § 720.30 by:
                                               implications because it is not expected                  PART 720—[AMENDED]                                     ■  a. Removing the phrase ‘‘or imported’’
                                               to have substantial direct effects on                                                                           wherever it appears in the section.
                                               Indian Tribes. This proposed rule would                  ■ 1. The authority citation for part 720               ■ b. Removing in paragraph (h)(7) the
                                               not significantly nor uniquely affect the                continues to read as follows:                          word ‘‘intented’’ and add in its place
                                               communities of Indian Tribal                                                                                    ‘‘intended’’.
                                                                                                             Authority: 15 U.S.C. 2604, 2607, and 2613.
                                               governments, nor would it involve or                                                                            § 720.36    [Amended]
                                               impose any requirements that affect                      § 720.1    [Amended]
                                                                                                        ■ 2. In § 720.1, remove the phrase ‘‘and               ■  6. In § 720.36 removing the phrases
                                               Indian Tribes. Accordingly, the                                                                                 ‘‘or imported’’, ‘‘or importer’’, ‘‘or
                                               requirements of Executive Order 13175                    importers’’.
                                                                                                        ■ 3. Amend § 720.3 by:                                 imports’’ wherever they appear in the
                                               (65 FR 67249, November 9, 2000), do                                                                             section.
                                               not apply to this proposed rule.                         ■ a. Revising paragraph (r) introductory
                                                                                                        text.                                                  ■ 7. Amend § 720.38 by:
                                               G. Executive Order 13045: Protection of                  ■ b. Revising paragraph (r)(1).                        ■ a. Removing the phrase ‘‘or import’’
                                               Children From Environmental Health                       ■ c. Revising paragraph (s) introductory               wherever it appears in the section.
                                               Risks and Safety Risks                                   text.                                                  ■ b. Adding paragraph (b)(6) to read as
                                                                                                        ■ d. Revising paragraph (s)(2).                        follows:
                                                 This action is not subject to Executive
                                                                                                        ■ e. Revising paragraph (cc).
                                               Order 13045 (62 FR 19885, April 23,                        The revisions reads as follows:
                                                                                                                                                               § 720.38    Exemptions for test marketing.
                                               1997), because this is not an                                                                                   *     *    *     *    *
                                               economically significant regulatory                      § 720.3    Definitions.                                  (b)(6) Any safety data sheet already
                                               action as defined by Executive Order                     *     *     *     *    *                               developed for the chemical substance.
                                               12866, and this action does not address                    (r) Manufacture for commercial                       *     *    *     *    *
                                               environmental health or safety risks                     purposes means:
                                               disproportionately affecting children.                     (1) To manufacture with the purpose                  § 720.40    [Amended]
                                                                                                        of obtaining an immediate or eventual                  ■  8. In § 720.40, removing the phrases
                                               H. Executive Order 13211: Actions
                                                                                                        commercial advantage for the                           ‘‘or import’’ and ‘‘or importer’’ wherever
                                               Concerning Regulations That
                                                                                                        manufacturer, and includes, among                      they appear in the section.
                                               Significantly Affect Energy Supply,
                                                                                                        other things, ‘‘manufacture’’ of any                   ■ 9. Amend § 720.45 by:
                                               Distribution, or Use                                                                                            ■ a. Removing in paragraph (e), the
                                                                                                        amount of a chemical substance or
                                                 This action is not a ‘‘significant                     mixture:                                               phrase ‘‘or imported’’ wherever it
                                               energy Action’’ as defined in Executive                  *     *     *     *    *                               appears in the paragraph.
                                               Order 13211 (66 FR 28355, May 22,                          (s) Manufacture solely for export                    ■ b. Adding paragraph (i) to read as
                                               2001), because it is not likely to have a                means to manufacture for commercial                    follows:
                                               significant adverse effect on energy                     purposes a chemical substance solely                   § 720.45 Information that must be included
                                               supply, distribution, or use.                            for export from the United States under                in the notice form.
                                               I. National Technology Transfer and                      the following restrictions on activities in            *     *    *     *     *
                                               Advancement Act (NTTAA)                                  the United States:                                       (i) Any safety data sheet already
                                                                                                        *     *     *     *    *                               developed for the new chemical
                                                 Since this action does not involve any
                                                                                                          (2) The manufacturer and any person                  substance.
                                               technical standards, NTTAA section
                                                                                                        to whom the substance is distributed for               *     *    *     *     *
                                               12(d) (15 U.S.C. 272 note) does not
                                                                                                        purposes of export or processing solely
                                               apply to this action.
                                                                                                        for export (as defined in § 721.3 of this              § 720.57    [Amended]
                                               J. Executive Order 12898: Federal                        chapter), may not use the substance                    ■ 10. Removing in § 720.57 paragraph
                                               Actions To Address Environmental                         except in small quantities solely for                  (a), the word ‘‘chemcial’’ and add in its
                                               Justice in Minority Populations and                      research and development in                            place ‘‘chemical’’.
                                               Low-Income Populations                                   accordance with § 720.36.
                                                                                                                                                               § 720.75    [Amended]
                                                  This action does not entail special                   *     *     *     *    *
                                                                                                          (cc) Small quantities solely for                     ■ 11. In § 720.75 paragraph (e)(2),
                                               considerations of environmental justice
                                                                                                        research and development (or ‘‘small                   remove the phrase ‘‘or importer’’.
                                               related issues as delineated by                                                                                 ■ 12. Amend § 720.78 by:
                                               Executive Order 12898 (59 FR 7629,                       quantities solely for purposes of
                                                                                                        scientific experimentation or analysis or              ■ a. Removing in paragraph (b)(1), the
                                               February 16, 1994), because EPA has                                                                             phrase ‘‘or import’’.
                                               determined that this action will not                     chemical research on, or analysis of,
                                                                                                                                                               ■ b. Removing in paragraph (b)(1)(iv),
                                               have disproportionately high and                         such substance or another substance,
                                                                                                        including such research or analysis for                the word ‘‘manfacturer’’ and add in its
                                               adverse human health or environmental                                                                           place ‘‘manufacturer’’.
                                                                                                        the development of a product’’) means
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                                               effects on minority or low-income                                                                               ■ c. Removing in paragraph (b)(2), the
                                               populations.                                             quantities of a chemical substance
                                                                                                                                                               phrase ‘‘or imports’’ wherever it appears
                                                                                                        manufactured or processed or proposed
                                               List of Subjects in 40 CFR Parts 720,                                                                           in the paragraph.
                                                                                                        to be manufactured or processed solely
                                                                                                                                                               ■ d. Removing in paragraph (c) the
                                               721, and 723                                             for research and development that are
                                                                                                                                                               phrase ‘‘or import’’.
                                                 Environmental protection, Chemicals,                   not greater than reasonably necessary
                                               Hazardous materials, Recordkeeping,                      for such purposes.                                     § 720.85    [Amended]
                                               and Reporting requirements.                              *     *     *     *    *                               ■   13. Amend § 720.85 by:


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                          49607

                                               ■  a. Removing the phrase ‘‘or import’’                  ■  f. Revising the definition of                      described specifically in the rule. EPA
                                               wherever it appears in the section.                      ‘‘Recipient’’.                                        will answer such an inquiry only if EPA
                                               ■ b. Removing the phrase ‘‘or                               The revisions read as follows:                     determines that the person has a bona
                                               importing’’ wherever it appears in the                      Customer means any person to whom                  fide intent to manufacture or process the
                                               section.                                                 a manufacturer or processor distributes               chemical substance for commercial
                                               ■ c. Removing in paragraph (b)(1) the                    any quantity of a chemical substance, or              purposes.
                                               phrase ‘‘or imported’’.                                  of a mixture containing the chemical                  *      *      *    *     *
                                               ■ d. Removing in paragraph (b)(1) the                    substance, whether or not a sale is                      (e) If the manufacturer or processor
                                               word ‘‘indentity’’ and add in its place                  involved.                                             has shown a bona fide intent to
                                               ‘‘identity’’.                                               Employer means any manufacturer,                   manufacture or process the substance
                                               ■ e. Removing in paragraph (b)(2)(i) the                 processor, or user of chemical                        and has provided sufficient
                                               word ‘‘manfactures’’ and add in its                      substances or mixtures.                               unambiguous chemical identity
                                               place ‘‘manufactures’’.                                     Non-industrial use means use other                 information to enable EPA to make a
                                               ■ f. Removing in paragraph (b)(2)(i) the                 than at a facility where chemical                     conclusive determination as to the
                                               phrase ‘‘or imports’’.                                   substances or mixtures are                            identity of the substance, EPA will
                                               ■ g. Removing in paragraph (b)(3)(iv)(D)                 manufactured or processed.                            inform the manufacturer or processor
                                               the phrase ‘‘on imported’’.                                 Recipient means any person who                     whether the chemical substance is
                                                                                                        purchases or otherwise obtains a                      subject to this part and, if so, which
                                               § 720.90    [Amended]                                                                                          section in subpart E of this part applies,
                                                                                                        chemical substance directly from a
                                               ■ 14. Removing throughout § 720.90 the                   person who manufactures or processes                  and identify any confidential significant
                                               phrase ‘‘or import’’ wherever it appears                 the substance.                                        new use designations.
                                               in the section.                                             Safety Data Sheet (SDS) means                         (f) A disclosure to a person with a
                                               ■ 15. Removing throughout subpart F                      written or printed material concerning a              bona fide intent to manufacture or
                                               the phrase ‘‘or import’’ wherever it                     hazardous chemical substance that is                  process a particular chemical substance
                                               appears in the subpart.                                  prepared as required under § 721.72(c).               that the substance is subject to this part
                                                                                                                                                              or of confidential significant new use
                                               § 720.120   [Amended]                                    § 721.5   [Amended]                                   designations will not be considered
                                               ■  16. Amend § 720.120 by:                               ■ 23. Amend § 721.5 by:                               public disclosure of confidential
                                               ■  a. Removing in paragraph (b) the                      ■ a. Removing the phrase                              business information under section 14
                                               phrase ‘‘or imports’’.                                   ‘‘manufacturer, importer, or processor’’              of the Act.
                                               ■ b. Removing in paragraph (b) the word                  and add in its place the phrase                          (g) EPA will answer an inquiry on
                                               ‘‘requied’’ and add in its place                         ‘‘manufacturer or processor’’                         whether a particular chemical substance
                                               ‘‘required’’.                                            everywhere it appears.                                is subject to this part or identify and
                                                                                                        ■ b. Removing the phrase ‘‘manufacture,               confidential significant new uses within
                                               PART 721—[AMENDED]                                                                                             30 days after receipt of a complete
                                                                                                        import, or process’’ and add in its place
                                               ■ 17. The authority citation for part 721                the phrase ‘‘manufacture or process’’                 submission under paragraph (b) of this
                                               continues to read as follows:                            everywhere it appears.                                section.
                                                                                                        ■ c. Removing in paragraph (d)(1)(iii),
                                                 Authority: 15 U.S.C. 2604, 2607, and                                                                         § 721.25    [Amended]
                                               2625(c).                                                 the word ‘‘recepient’s’’ and add in its
                                                                                                                                                              ■ 25. Amend § 721.25 by:
                                                                                                        place ‘‘recipient’s’’.                                ■ a. Removing in paragraph (a) the
                                               ■ 18. Removing in part 721, the                          ■ 24. Amend § 721.11 by:
                                               acronym ‘‘MSDS’’ and add in its place                                                                          phrase ‘‘manufacture, import, or
                                                                                                        ■ a. Removinig the phrase
                                               the acronym ‘‘SDS’’ everywhere it                                                                              processing’’ and add in its place the
                                                                                                        ‘‘manufacturer, importer, or processor’’              phrase ‘‘manufacture or processing’’.
                                               appears.                                                 and add in its place the phrase
                                               ■ 19. Removing in part 721, the                                                                                ■ b. Removing in paragraph (d) the
                                                                                                        ‘‘manufacturer or processor’’                         phrase ‘‘manufacture, import, or
                                               acronym ‘‘MSDSs’’ and add in its place                   everywhere it appears.
                                               the acronym ‘‘SDSs’’ everywhere it                                                                             process’’ and add in its place the phrase
                                                                                                        ■ b. Removing the phrase ‘‘manufacture,               ‘‘manufacture or process’’.
                                               appears.                                                 import, or process’’ and add in its place
                                               ■ 20. Removing in part 721, the phrase                   the phrase ‘‘manufacture or process’’                 § 721.30    [Amended]
                                               ‘‘material safety’’ and add in its place                 everywhere it appears.                                ■ 26. Amend § 721.30 by:
                                               the word ‘‘safety’’ everywhere it                        ■ c. Revising the section heading, and                ■ a. Removing the phrase ‘‘manufacture,
                                               appears.                                                 paragraphs (a), (e), (f), and (g).                    import, or processing’’ and add in its
                                               § 721.1    [Amended]                                       The revisions reads as follows:                     place the phrase ‘‘manufacture or
                                                                                                                                                              processing’’ everywhere it appears.
                                               ■  21. Removing in § 721.1(a) the phrase                 § 721.11 Determining whether a chemical               ■ b. Removing in paragraph (a) the
                                               ‘‘manufacturers, importers and                           substance or a specific use is subject to             phrase ‘‘manufacture, import, or
                                               processors’’ and add in its place                        this part when the chemical substance
                                                                                                                                                              process’’ and add in its place the phrase
                                               ‘‘manufacturers and processors’’.                        identity or significant new use is
                                                                                                        confidential.                                         ‘‘manufacture or process’’.
                                               ■ 22. Amend § 721.3 by:
                                               ■ a. Adding in alphabetical order the                      (a) A person who intends to                         § 721.35    [Amended]
                                               definition for ‘‘Safety Data Sheet’’                     manufacture or process a chemical                     ■ 27. Amend § 721.35 by:
                                               ■ b. Revising the definition for                         substance which is subject to a                         a. Remove the phrase ‘‘manufactured,
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                                                                                                                                                              ■
                                               ‘‘Customer’’.                                            significant new use rule in subpart E of              imported, or processed’’ and add in its
                                               ■ c. Revising the definition of                          this part may ask EPA whether the                     place the phrase ‘‘manufactured or
                                               ‘‘Employer’’.                                            substance or a proposed use is subject                processed’’ everywhere it appears.
                                               ■ d. Removing the definition of                          to the requirements of this part if that              ■ b. Removing in paragraph (f)(1) the
                                               ‘‘MSDS’’.                                                substance is described by a generic                   phrase ‘‘manufacture, import, or
                                               ■ e. Revising the definition of ‘‘Non-                   chemical name or if the significant new               processing’’ and add in its place the
                                               industrial use’’.                                        use is confidential and therefore not                 phrase ‘‘manufacture or processing’’.


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                                               49608                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                               ■ 28. Throughout § 721.45 remove the                     chemical substance by dermal or eye                   respirator equipped with a half-mask.
                                               phrase ‘‘manufactures, imports, or                       exposure must be provided with, and is                (APF = 10)
                                               processes’’ and add in its place the                     required to wear, personal protective                    (xxi) NIOSH-certified negative
                                               phrase ‘‘manufactures or processes’’                     equipment (PPE) to prevent dermal or                  pressure (demand) self-contained
                                               everywhere it appears.                                   eye exposure to the substance. Refer to               breathing apparatus (SCBA) equipped
                                                                                                        29 CFR 1910.132 and 29 CFR 1910.133                   with a half mask. (APF = 10)
                                               § 721.47   [Amended]                                     for requirements on selection and use of                 (xxii) NIOSH-certified powered air-
                                               ■ 29. Revise § 721.47 by:                                PPE.                                                  purifying respirator equipped with a
                                               ■ a. Removing the phrase                                                                                       hood or helmet and HEPA filters. (APF
                                                                                                        *      *     *    *     *
                                               ‘‘manufactures, imports, or processes’’                     (4) Where each person who is                       = 25)
                                               and add in its place the phrase                          reasonably likely to be exposed to the                   (xxiii) NIOSH-certified powered air-
                                               ‘‘manufactures or processes’’                            chemical substance by inhalation in the               purifying respirator with a hood or
                                               everywhere it appears.                                   work area in one or more of the forms                 helmet equipped with appropriate gas/
                                               ■ b. Removing the phrase                                                                                       vapor cartridges. (APF = 25)
                                                                                                        listed in paragraph (a)(6) of this section
                                               ‘‘manufacturer, importer, or processor’’                                                                          (xxiv) NIOSH-certified powered air-
                                                                                                        and cited in subpart E of this part for the
                                               and add in its place the phrase                                                                                purifying respirator with a hood or
                                                                                                        chemical substance, engineering control
                                               ‘‘manufacturer or processor’’                                                                                  helmet and with appropriate gas/vapor
                                                                                                        measures (e.g., enclosure or
                                               everywhere it appears.                                                                                         cartridges in combination with HEPA
                                                                                                        confinement of the operation, general
                                               ■ c. Removing the phrase ‘‘manufacture,                                                                        filters. (APF = 25)
                                                                                                        and local ventilation) or administrative
                                               import, or process’’ and add in its place                                                                         (xxv) NIOSH-certified powered air-
                                                                                                        control measures (e.g., workplace
                                               the phrase ‘‘manufacture or process’’                                                                          purifying respirator equipped with a
                                                                                                        policies and procedures) shall be
                                               everywhere it appears.                                                                                         loose fitting facepiece and HEPA filters.
                                                                                                        considered and implemented to prevent
                                               ■ 30. Amend § 721.63 by:                                                                                       (APF = 25)
                                               ■ a. Revising paragraph (a) introductory
                                                                                                        exposure, where feasible. When
                                                                                                                                                                 (xxvi) NIOSH-certified powered air-
                                               text, paragraph (a)(1), (4), and (5)                     engineering, work practice, and
                                                                                                                                                              purifying respirator equipped with a
                                               ■ b. Adding new paragraphs (a)(5)(xvi)
                                                                                                        administrative controls are not feasible
                                                                                                                                                              loose fitting facepiece with appropriate
                                               through (a)(5)(li).                                      or inhalation exposure is still
                                                                                                                                                              gas/vapor cartridges. (APF = 25)
                                               ■ c. Revising paragraph (a)(6).
                                                                                                        reasonably likely, each person who is
                                                                                                                                                                 (xxvii) NIOSH-certified powered air-
                                               ■ d. Adding new paragraphs (a)(6)(vii)
                                                                                                        reasonably likely to be exposed to the
                                                                                                                                                              purifying respirator equipped with a
                                               through (a)(6)(ix).                                      chemical substance by inhalation in the
                                                                                                                                                              loose fitting facepiece with appropriate
                                               ■ e. Removing in paragraph (c)(2) the                    work area in one or more of the forms
                                                                                                                                                              gas/vapor cartridges in combination
                                               phrase ‘‘manufacturer, importer, or                      listed in paragraph (a)(6) of this section
                                                                                                                                                              with HEPA filters. (APF = 25)
                                               processor’’ and add in its place the                     and cited in subpart E of this part for the              (xxviii) NIOSH-certified continuous
                                               phrase ‘‘manufacturer or processor’’.                    chemical substance, must be provided                  flow supplied-air respirator equipped
                                                 The revisions and additions read as                    with, and is required to wear, a NIOSH-               with a hood or helmet. (APF = 25)
                                               follows:                                                 certified respirator from one of the                     (xxix) NIOSH-certified continuous
                                                                                                        categories listed in paragraph (a)(5) of              flow supplied-air respirator equipped
                                               § 721.63   Protection in the workplace                   this section. Refer to 29 CFR 1910.134                with a loose fitting facepiece. (APF = 25)
                                                  (a) Whenever a substance is identified                and 42 CFR part 84 for requirements on                   (xxx) NIOSH-certified air-purifying
                                               in subpart E of this part as being subject               the selection, use, and maintenance of                full facepiece respirator equipped with
                                               to this section, any manner or method                    respirators, including establishing                   N100, R–100, or P–100 filter(s). (APF =
                                               of manufacturing (including importing)                   respiratory protection program, medical               50)
                                               or processing associated with any use of                 determination, and other administrative                  (xxxi) NIOSH-certified air-purifying
                                               the substance is considered a significant                and programmatic requirements for                     full facepiece respirator equipped with
                                               new use unless a program is established                  respiratory protection.                               appropriate gas/vapor cartridges or
                                               whereby:                                                    (5) The following NIOSH-certified                  canisters. (APF = 50)
                                                  (1) Where people are reasonably likely                respirators meet the requirements for                    (xxxii) NIOSH-certified air-purifying
                                               to have dermal or eye exposure to the                    paragraph (a)(4) of this section:                     full facepiece respirator equipped with
                                               chemical substance in the work area,                     *      *     *    *     *                             appropriate gas/vapor cartridges in
                                               either through direct handling of the                       (xvi) NIOSH-certified N100 (if oil                 combination with N100, R100, or P100
                                               substance, or through contact with                       aerosols absent), R100, or P100 filtering             filters or an appropriate canister
                                               surfaces on which the substance may                      facepiece respirator. (APF = 10)                      incorporating N100, R100, or P100
                                               exist, or because the substance becomes                     (xvii) NIOSH-certified air-purifying               filters. (APF = 50)
                                               airborne in the form listed in paragraph                 half-mask respirator equipped with                       (xxxiii) NIOSH-certified powered air-
                                               (a)(6) of this section, and the form is                  N100 (if oil aerosols absent), R100, or               purifying respirator equipped with a
                                               cited in subpart E of this part for the                  P100 filters. (APF = 10)                              tight-fitting half mask and HEPA filters.
                                               chemical substance, engineering control                     (xviii) NIOSH-certified air-purifying              (APF = 50)
                                               measures (e.g., enclosure or                             half mask respirator equipped with                       (xxxiv) NIOSH-certified powered air-
                                               confinement of the operation, general                    appropriate gas/vapor cartridges. (APF =              purifying respirator equipped with a
                                               and local ventilation) or administrative                 10)                                                   tight-fitting half mask and appropriate
                                               control measures (e.g., workplace                           (xix) NIOSH-certified air-purifying                gas/vapor cartridges or canisters. (APF =
                                               policies and procedures) shall be                        half-mask respirator equipped with                    50)
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                                               considered and implemented to prevent                    appropriate gas/vapor cartridges in                      (xxxv) NIOSH-certified powered air-
                                               exposure, where feasible. Where                          combination with N100, R100, or P100                  purifying respirator with a tight-fitting
                                               engineering, work practice, and                          filters or an appropriate canister                    half mask and appropriate gas/vapor
                                               administrative controls are not feasible                 incorporating N100, R100, or P100                     cartridges in combination with HEPA
                                               or dermal or eye exposure is still                       filters. (APF = 10)                                   filters. (APF = 50)
                                               reasonably likely, each person who is                       (xx) NIOSH-certified negative                         (xxxvi) NIOSH-certified pressure-
                                               reasonably likely to be exposed to the                   pressure (demand) supplied-air                        demand or other positive pressure mode


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                           49609

                                               supplied-air respirator equipped with a                  cited for a substance identified in                   ■ m. Revising paragraph (h)(1)(ii)
                                               half-mask. (APF = 50)                                    subpart E an employer may substitute a                introductory text and paragraphs
                                                  (xxxvii) NIOSH-certified negative                     respirator from paragraphs (a)(5)(xvi)                (h)(1)(ii)(A) through (h)(1)(ii)(I).
                                               pressure (demand) supplied-air                           through (a)(5)(xlix) as long as its                   ■ n. Adding paragraphs (h)(1)(ii)(J)
                                               respirator equipped with a full                          assigned protection factor is equal to or             through (h)(1)(ii)(N).
                                               facepiece. (APF = 50)                                    greater than the respirator cited in                  ■ o. Revising paragraphs (h)(1)(iii)(A)
                                                  (xxxviii) NIOSH-certified continuous                  subpart E for that substance.                         through (h)(1)(iii)(E).
                                               flow supplied-air respirator equipped                       (li) Without testing data that                     ■ p. Adding paragraphs (h)(1)(iii)(F)
                                               with a tight-fitting half mask. (APF = 50)               demonstrates a level of protection of                 through (h)(1)(iii)(H).
                                                  (xxxix) NIOSH-certified negative                      1,000 or greater, all air purifying                   ■ q. Revising paragraph (h)(1)(iv)
                                               pressure (demand) self-contained                         respirators and supplied air respirators              introductory text and paragraphs
                                               breathing apparatus (SCBA) equipped                      with helmets/hoods are to be treated as               (h)(1)(iv)(A) through (h)(1)(iv)(B).
                                               with a hood or helmet or a full                          loose-fitting facepiece respirators with              ■ r. Adding paragraph (h)(1)(iv)(C).
                                               facepiece. (APF = 50)                                    an APF of 25.                                         ■ s. Revising paragraphs (h)(1)(v)(A)
                                                  (xl) NIOSH-certified powered air                         (6) When cited in subpart E of this                through (h)(1)(v)(C).
                                               purifying full facepiece respirator                      part for a substance, the following                   ■ t. Adding paragraph (h)(1)(v)(D).
                                               equipped with HEPA filters. (APF =                       airborne form(s) of the substance, in                 ■ u. Revising paragraph (h)(2)(ii)
                                               1,000)                                                   combination or alone, are referenced by               introductory text and paragraphs
                                                  (xli) NIOSH-certified powered air                     paragraphs (a)(1) and (4) of this section:            (h)(2)(ii)(A) through (h)(2)(ii)(I).
                                               purifying full facepiece respirator                                                                            ■ v. Adding paragraphs (h)(2)(ii)(J)
                                                                                                        *       *     *     *     *
                                               equipped with appropriate gas/vapor                         (vii) Particulate or aerosol (solids or            through (h)(2)(ii)(N).
                                               cartridges. (APF = 1,000)                                                                                      ■ w. Revising paragraph (h)(2)(iii)
                                                                                                        liquid droplets suspended in a gas; e.g.,
                                                  (xlii) NIOSH-certified powered air                                                                          introductory text and paragraphs
                                                                                                        dust, fume, mist, smoke).
                                               purifying fill facepiece respirator                                                                            (h)(2)(iii)(A) through (h)(2)(iii)(E).
                                                                                                           (viii) Gas/vapor.
                                               equipped with appropriate gas/vapor                                                                            ■ x. Adding paragraphs (h)(2)(iii)(F)
                                                                                                           (ix) Combination particulate and gas/
                                               cartridges in combination with HEPA                                                                            through (h)(2)(iii)(H)
                                                                                                        vapor (gas and liquid/solid physical
                                               filters. (APF = 1,000)                                                                                         ■ y. Revising paragraph (h)(2)(iv)
                                                                                                        forms are both present, e.g., particulates
                                                  (xliii) NIOSH-certified powered air-                                                                        introductory text and paragraphs
                                                                                                        and acid gases or particulates and
                                               purifying respirator equipped with a                                                                           (h)(2)(iv)(A) and (h)(2)(iv)(B).
                                                                                                        organic vapors).
                                               hood or helmet and N100, R100, or P100                                                                         ■ z. Adding paragraph (h)(2)(iv)(C).
                                               filters with evidence demonstrating                      *       *     *     *     *                           ■ aa. Revising paragraphs (h)(2)(v)(A)
                                               protection level of 1,000 or greater. See                   (c) * * *                                          through (h)(2)(v)(C).
                                               40 CFR 721.63(a)(5)(li). (APF = 1,000)                      (2) If, after receiving a statement of             ■ bb. Adding paragraph (h)(2)(v)(D).
                                                  (xliv) NIOSH-certified powered air-                   assurance from a recipient under                      ■ cc. Adding paragraphs (i) and (j).
                                               purifying respirator equipped with a                     paragraph (c)(1)(ii) of this section, a                 The revisions and additions read as
                                               hood or helmet and appropriate gas/                      manufacturer or processor has                         follows:
                                               vapor cartridges with evidence                           knowledge that the recipient is engaging
                                                                                                        in an activity that is not consistent with            § 721.72    Hazard communication program.
                                               demonstrating protection level of 1,000
                                               or greater. See 40 CFR 721.63(a)(5)(li).                 the implementation of the program                        Whenever a substance is identified in
                                               (APF = 1,000)                                            specified in paragraph (a) of this                    subpart E of this part as being subject to
                                                  (xlv) NIOSH-certified powered air-                    section, that person is considered to                 this section, a significant new use of
                                               purifying respirator with a loose-fitting                have knowledge that the person is                     that substance is any manner or method
                                               hood or helmet that is equipped with an                  engaging in a significant new use and is              of manufacture (including import) or
                                               appropriate gas/vapor cartridge in                       required to follow the procedures in                  processing associated with any use of
                                               combination with HEPA filters with                       § 721.5(d).                                           that substance without establishing a
                                               evidence demonstrating protection level                  *       *     *     *     *                           hazard communication program as
                                               of 1,000 or greater. See 40 CFR                          ■ 31. Amend § 721.72 by:                              described in this section. Paragraphs (a)
                                               721.63(a)(5)(li). (APF = 1,000)                          ■ a. Revising the introductory text                   through (h) apply to SNURs issued
                                                  (xlvi) NIOSH-certified continuous                     paragraph.                                            before September 26, 2016. Paragraphs
                                               flow supplied-air respirator equipped                    ■ b. Revising paragraph (a) and (1).                  (i) and (j) apply to SNURs issued on or
                                               with a full facepiece. (APF = 1,000)                     ■ c. Revising paragraph (b)(5).                       after September 26, 2016. Any person
                                                  (xlvii) NIOSH-certified continuous                    ■ d. Revising paragraph (c)(5), (7) and               subject to the requirements of
                                               flow supplied-air respirator equipped                    (9).                                                  paragraphs (a) through (h) have the
                                               with a hood or helmet with evidence                      ■ e. Revising paragraph (g)(1)                        option of following the requirements of
                                               demonstrating protection level of 1,000                  introductory text and paragraphs                      paragraph (i) or using the statements
                                               or greater. See 40 CFR 721.63(a)(5)(li).                 (g)(1)(i) through (g)(1)(ix).                         specified in paragraphs (g) or (h).
                                               (APF = 1,000)                                            ■ f. Adding paragraphs (g)(1)(x) through                 (a) Written hazard communication
                                                  (xlviii) NIOSH-certified pressure-                    (g)(1)(xiv).                                          program. Each employer shall develop
                                               demand supplied-air respirator                           ■ g. Revising paragraph (g)(2)                        and implement a written hazard
                                               equipped with a full facepiece. (APF =                   introductory text and paragraphs                      communication program for the
                                               1,000)                                                   (g)(2)(i) through (g)(2)(v).                          substance in each workplace. The
                                                  (xlix) NIOSH-certified pressure-                      ■ h. Adding paragraphs (g)(2)(vi)                     written program will, at a minimum,
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                                               demand or other positive-pressure mode                   through (g)(2)(viii).                                 describe how the requirements of this
                                               (e.g., open/closed circuit) self-contained               ■ i. Revising paragraphs (g)(3)(i) through            section for labels, SDSs, and other forms
                                               breathing apparatus (SCBA) equipped                      (g)(3)(ii).                                           of warning material will be satisfied.
                                               with a hood or helmet or a full                          ■ j. Adding paragraph (g)(3)(iii).                    The employer must make the written
                                               facepiece. (APF = 10,000)                                ■ k. Revising paragraphs (g)(4)(i)                    hazard communication program
                                                  (l) If one of the respirators in                      through (g)(4)(iii).                                  available, upon request, to all
                                               paragraph (a)(5)(i) through (a)(5)(xv) is                ■ l. Adding paragraph (g)(4)(iv).                     employees, contractor employees, and


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                                               49610                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

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


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                           49611

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


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                                               49612                    Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules

                                                  (i) Avoid ingestion.                                  for the site according to paragraph (b) of            ascertainable by the manufacturer or
                                                  (ii) Wear protective gloves/protective                this section, and the highest number of               processor, that person must maintain
                                               clothing/eye protection/face protection.                 kilograms calculated to be released for               other records which demonstrate
                                               (Chemical manufacturer or distributor to                 that site on a given day according to                 establishment and implementation of a
                                               specify type of equipment, as required.)                 paragraph (a) of this section. Two                    program that ensures compliance with
                                                  (iii) Wear respiratory protection.                    variables shall be considered in                      any applicable disposal requirements.
                                                  (Chemical manufacturer or distributor                 computing the equation, the number of                 *     *    *     *    *
                                               to specify equipment as required.)                       kilograms released, and receiving stream
                                                  (iv) Avoid breathing dust/fume/gas/                   flow.                                                 § 721.160    [Amended]
                                               mist/vapors/spray.                                          (a) * * *                                          ■ 37. Amend § 721.160 by:
                                                  (Chemical manufacturer or distributor                    (7) When a substance is designated in              ■ a. Removing in paragraph (a)(1) the
                                               to specify applicable conditions.)                       subpart E of this part with a specific                phrase ‘‘and import’’.
                                                  (3) Environmental hazard statements:                  control technology and a percentage                   ■ b. Removing in paragraph (a)(2) the
                                               This substance may be:                                   removal of the substance from                         phrase ‘‘or import’’.
                                                  (i) Toxic to aquatic life.                            wastewater resulting from use of the
                                                  (ii) Very toxic to aquatic life.                      specified control technology, you may                 PART 723—[AMENDED]
                                                  (iii) Harmful to aquatic life.                        subtract that percentage from the                     ■ 38. The authority citation for part 723
                                                  (iv) Very toxic to aquatic life with                  highest expected daily release if that                continues to read as follows:
                                               long term effects.                                       control technology is applied.
                                                  (v) Toxic to aquatic life with long                                                                             Authority: 15 U.S.C. 2604.
                                                                                                        *      *     *    *     *
                                               lasting effects.                                                                                               ■ 39. Amend § 723.50 by:
                                                  (vi) Harmful to aquatic life with long                § 721.100    [Amended]                                ■ a. Revising paragraph (a)(1)
                                               lasting effects.                                         ■ 35. In § 721.100, remove the phrase                 introductory text.
                                                  (vii) May cause long lasting harmful                  ‘‘manufacturers, importers, and                       ■ b. Revising paragraph (e)(2)(xi)(A).
                                               effects to aquatic life.                                 processors’’ and add in its place                     ■ c. Adding paragraph (e)(2)(xiii).
                                                  (4) Environmental hazard                              ‘‘manufacturers and processors’’.                       The revisions read as follows:
                                               precautionary statements: Notice to                      ■ 36. Amend § 721.125 by revising the
                                               users:                                                                                                         § 723.50 Chemical substances
                                                                                                        introductory paragraph, paragraph (a),
                                                                                                                                                              manufactured in quantities of 10,000
                                                  (i) Avoid release to the environment                  (c), and (j) to read as follows:                      kilograms or less per year, and chemical
                                               (if this is not the intended use.)                                                                             substances with low environmental
                                                  (ii) Collect spillage.                                § 721.125    Recordkeeping requirements.
                                                                                                                                                              releases and human exposures
                                                  (iii) Dispose of contents/container to                   At the time EPA adds a substance to
                                                                                                                                                                 (a) * * *
                                               . . . (Specify disposal requirements in                  subpart E of this part, EPA will specify
                                                                                                                                                                 (1) This section grants an exemption
                                               subpart E of this part and whether they                  appropriate recordkeeping requirements
                                                                                                                                                              from the premanufacture notice
                                               apply to contents, container or both.)                   which correspond to the significant new
                                                                                                                                                              requirements of section 5(a)(1)(A) of the
                                                                                                        use designations for the substance
                                               § 721.80   [Amended]                                                                                           Toxic Substances Control Act (15 U.S.C.
                                                                                                        selected from subpart B of this part.
                                               ■ 32. Amend § 721.80 by:                                                                                       2604(a)(1)(A)) for the manufacture of:
                                                                                                        Each manufacturer and processor of the
                                               ■ a. Removing the phrase ‘‘or import’’                                                                            * * *
                                                                                                        substance shall maintain the records for
                                               wherever it appears in the section.                                                                               (e) * * *
                                                                                                        5 years from the date of their creation.
                                               ■ b. Removing the phrase ‘‘and
                                                                                                                                                                 (2) * * *
                                                                                                        In addition to the records specified in
                                               importation’’ wherever it appears in the                                                                          (xi) * * *
                                                                                                        § 721.40, the records whose
                                               section.                                                                                                          (A) The manufacturer intends to
                                                                                                        maintenance this section requires may
                                               ■ c. Removing the phrase ‘‘or importer’’
                                                                                                                                                              manufacture the new chemical
                                                                                                        include the following:
                                               wherever it appears in the section.                                                                            substance for commercial purposes,
                                                                                                           (a) Records documenting the
                                               ■ d. Removing the word ‘‘manufacture’’
                                                                                                                                                              other than in small quantities solely for
                                                                                                        manufacturing volume of the substance
                                               wherever it appears and add in its place                                                                       research and development, under the
                                                                                                        and the corresponding dates of
                                               the word ‘‘manufacturing’’.                                                                                    terms of this section.
                                                                                                        manufacture.
                                                                                                                                                                 * * *
                                               § 721.85   [Amended]                                     *      *    *     *     *                                (xiii) Safety Data Sheet (§ 720.45(i)).
                                                                                                           (c) Records documenting the names
                                               ■  33. In § 721.85, remove the word                                                                            *      *     *     *    *
                                                                                                        and addresses (including shipment
                                               ‘‘supercede’’ wherever it appears and
                                                                                                        destination address, if different) of all             § 723.175    [Amended]
                                               add in its place the word ‘‘supersede’’.
                                                                                                        persons outside the site of manufacture               ■  40. Amend § 723.175 by:
                                               ■ 34. Amend § 721.91 by:
                                                                                                        or processing to whom the manufacturer                ■  a. Removing in paragraph (f)(2)(iii),
                                               ■ a. Revising the introductory
                                                                                                        or processor directly sells or transfers              the word ‘‘imprevious’’ and add in its
                                               paragraph, and
                                                                                                        the substance, the date of each sale or               place ‘‘impervious’’.
                                               ■ b. Adding paragraph (a)(7).
                                                                                                        transfer, and the quantity of the                     ■ b. Removing in paragraph (g), the
                                                  The revision reads as follows:
                                                                                                        substance sold or transferred on such                 word ‘‘chemcial’’ and add in its place
                                               § 721.91 Computation of estimated surface                date.                                                 ‘‘chemical’’.
                                               water concentrations: Instructions.                      *      *    *     *     *                             ■ c. Removing in paragraph (h)(2), the
                                                 These instructions describe the use of                    (j) Records documenting compliance                 phrase ‘‘chemcial subtance’’ and add in
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                                               the equation specified in § 721.90(a)(4),                with any applicable disposal                          its place ‘‘chemical substance’’.
                                               (b)(4), and (c)(4) to compute estimated                  requirements under § 721.85, including                ■ d. Removing in paragraph (i)(1)(ii)(A),
                                               surface water concentrations which will                  the method of disposal, location of                   the word ‘‘disagram’’ and add in its
                                               result from release of a substance                       disposal sites, dates of disposal, and                place ‘‘diagram’’.
                                               identified in subpart E of this part. The                volume of the substance disposed.                     ■ e. Removing in paragraph (i)(1)(ii)(C),
                                               equation shall be computed for each site                 Where the estimated disposal volume is                the word ‘‘indentify’’ and add in its
                                               using the stream flow rate appropriate                   not known to or reasonably                            place ‘‘identify’’.


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                                                                        Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Proposed Rules                                                    49613

                                               ■  f. Removing in paragraph (i)(1)(iii), the             information: The originating and                          would make all TIH waybills available
                                               word ‘‘chemcial’’ and add in its place                   terminating freight stations, the                         to the complainant for the most current
                                               ‘‘chemical’’.                                            railroads participating in the movement,                  period. (Id. at 8.) Second, the AAR
                                                                                                        the points of all railroad interchanges,                  suggests that the Board could assess TIH
                                               § 723.250   [Amended]                                    the number of cars, the car initial and                   traffic by obtaining data from the
                                               ■ 41. Amend § 723.250 by:                                number, the movement weight in                            Transportation Security Administration,
                                               ■ a. Removing in paragraph (e)(3) the                    hundredweight, the commodity, and the                     which collects some of the data that
                                               phrase ‘‘composition, complex’’ and add                  freight revenue. Currently, railroads that                would be found in the Waybill Sample.
                                               in its place ‘‘composition, complex’’.                   are required to file Waybill Sample
                                               ■ b. Removing in paragraph (j)(1), the
                                                                                                                                                                  (Id.) Lastly, the AAR suggests that, if the
                                                                                                        information may report a random                           Board were to collect 100% of TIH
                                               phrase ‘‘or import’’.                                    sample of as little as 1% (using the
                                                                                                                                                                  waybill data, then the Board should
                                               [FR Doc. 2016–15005 Filed 7–27–16; 8:45 am]              manual system) or 2.5% (using the
                                                                                                                                                                  restrict access to the data and house the
                                               BILLING CODE 6560–50–P                                   computerized system) of carloads on a
                                                                                                        waybill. See 49 CFR 1244.4(b) and (c).1                   data in a secure separate file. (Id. at 10–
                                                                                                           In the NPR, the Board suggested that                   14.)
                                               SURFACE TRANSPORTATION BOARD                             the expanded information gathered from                       The Board appreciates and
                                                                                                        the proposed rule would permit the                        understands the AAR’s concerns about
                                               49 CFR Part 1244                                         Board to assess TIH traffic within the                    security as it relates to TIH traffic.
                                                                                                        United States more accurately. The NPR                    Without commenting on the AAR’s
                                               [Docket No. EP 385 (Sub-No. 7)]                          also stated that the information would                    suggested alternatives, we will
                                               Waybill Data Reporting for Toxic                         be beneficial in Three-Benchmark rail                     discontinue this proceeding. Taking into
                                                                                                        rate cases involving TIH traffic, giving                  consideration the security concerns
                                               Inhalation Hazards; Withdrawal
                                                                                                        parties a larger number of movements                      raised and the lack of broader comment
                                               AGENCY:    Surface Transportation Board.                 from which to develop comparison                          on the NPR, we will not move forward
                                               ACTION:   Proposed rule, withdrawal.                     groups. The additional information                        with the proposed rule and will
                                                                                                        would also assist the Board in                            discontinue this docket in the interest of
                                               SUMMARY:    The Surface Transportation                   quantifying the magnitude of TIH traffic,                 administrative finality. However, the
                                               Board is withdrawing the proposed                        and would help the Board more
                                                                                                                                                                  Board will consider ways to address this
                                               rules and discontinuing the EP 385                       accurately measure the associated costs
                                                                                                                                                                  issue as part of future proceedings.
                                               (Sub-No. 7) rulemaking proceeding                        of handling such traffic.
                                               which proposed to expand the Waybill                        On March 4, 2010, the Association of                     Decided: July 21, 2016.
                                               Sample collection with respect to traffic                American Railroads (AAR) filed the
                                               movements designated as a Toxic                          single comment received in response to                      By the Board, Chairman Elliott, Vice
                                               Inhalation Hazard.                                       the NPR. The AAR agrees that expanded                     Chairman Miller, and Commissioner
                                                                                                        TIH waybill data for use in Three-                        Begeman. Commissioner Begeman
                                               DATES: The proposed rule published on
                                                                                                        Benchmark rate cases would be useful;                     commented with a separate expression.
                                               February 2, 2010 (75 FR 5261) is
                                               withdrawn and the rulemaking                             but, it expressed several security-related                   COMMISSIONER BEGEMAN,
                                               proceeding is discontinued on July 28,                   concerns regarding the potential use of                   commenting:
                                               2016.                                                    TIH-related data the Board proposed to
                                                                                                        collect. (AAR Comments 2, 7.) 2 The                          This proceeding was initiated in
                                               FOR FURTHER INFORMATION CONTACT:                                                                                   January 2010, well before a majority of
                                                                                                        AAR submits that, in light of the
                                               Allison Davis at (202) 245–0378.                         sensitive nature of detailed TIH waybill                  the current members began serving here.
                                               Assistance for the hearing impaired is                   data, the Board should not collect and                    The only real action that has occurred
                                               available through the Federal                            maintain this data and subject it to                      on this matter that I am aware of was
                                               Information Relay Service (FIRS) at 1–                   potential inadvertent disclosure                          when the Association of American
                                               800–877–8339.                                            unnecessarily. (Id. at 8.) The AAR                        Railroads filed its comments in March
                                               SUPPLEMENTARY INFORMATION: On                            suggests several alternatives to the                      2010. Since that time, the Board could
                                               January 28, 2010, in the above titled                    Board’s proposal. First, the AAR                          have worked to meaningfully address
                                               docket, the Board issued a Notice of                     suggests disclosure on a case-by-case                     AAR’s concerns and ultimately improve
                                               Proposed Rulemaking (NPR) seeking                        basis, where the defendant carrier in a                   the proposal. Yet no such effort
                                               public comment on a proposal to                          Three-Benchmark rate proceeding                           occurred. Therefore, the best course of
                                               expand information that certain                                                                                    action for this proceeding—one that has
                                               railroads are required to submit to the                     1 Under 49 CFR 1244.2, a railroad is required to
                                                                                                                                                                  been effectively dormant for over six
                                               Board for purposes of the carload                        file Waybill Sample information for all line-haul
                                                                                                                                                                  years—is for it to be discontinued,
                                               Waybill Sample (75 FR 5261, February                     revenue waybills terminated on its lines if it
                                                                                                        terminated at least 4,500 revenue carloads in any         regardless of the proposal’s potential
                                               2, 2010). Specifically, the proposal                     of the three preceding years, or it terminated at least   merits.
                                               would require railroads to submit                        5% of the revenue carloads terminating in any state
                                               information about all traffic movements                  in any of the three preceding years. The Board               This proceeding is just one example
                                                                                                        recognizes that some of the submitted information         of why I believe Congress has directed
                                               designated as a Toxic Inhalation Hazard                  is commercially sensitive, and thus the Board’s
                                               (TIH).                                                   regulations place limitations on releasing Waybill
                                                                                                                                                                  the Board to issue quarterly reporting on
                                                  As explained below, this proceeding                   Sample data. See 49 CFR 1244.9.                           all of its outstanding rulemaking
                                               will be discontinued.                                       2 Federal agencies view TIH movements as a             proposals. We simply must do more to
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                                                  The Waybill Sample is the Board’s                     potential target for terrorist activity and consider      improve the timeliness of all Board
                                                                                                        detailed information pertaining to TIH movements
                                               primary source of information about                      as sensitive security information (SSI). See, e.g.,       actions.
                                               freight rail shipments terminating in the                Federal R.R. Admin. Order, Designation of Sensitive
                                                                                                        Security Information under 49 U.S.C. 40119(b), SSI        Kenyatta Clay,
                                               United States. A waybill is a document
                                                                                                        Order 2011–06–FRA–01 (July 29, 2011), http://             Clearance Clerk.
                                               describing the characteristics of an                     www.stb.dot.gov/stb/industry/Rate_Cases.htm
                                               individual rail shipment, and includes                                                                             [FR Doc. 2016–17883 Filed 7–27–16; 8:45 am]
                                                                                                        (follow ‘‘Federal Railroad Administration, July 29,
                                               (among other things) the following                       2011’’ hyperlink).                                        BILLING CODE 4915–01–P




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Document Created: 2016-07-28 01:47:29
Document Modified: 2016-07-28 01:47:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before September 26, 2016.
ContactFor technical information contact: Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; email
FR Citation81 FR 49598 
RIN Number2070-AJ94
CFR Citation40 CFR 720
40 CFR 721
40 CFR 723
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Materials; Recordkeeping and Reporting Requirements

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