Document ID: EPA-HQ-OPPT-2014-0650-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Uses of Chemical Substances: Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices
Posted Date: 2016-07-28T04:00Z

[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Proposed Rules]
[Pages 49598-49613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: alwood.jim@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by TSCA to include import), process, or use chemical 
substances subject to regulations in 40 CFR part 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
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                                          New chemical    Other chemical
              Regulation                     SNURs            SNURs
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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