[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Proposed Rules]
[Pages 49598-49613]
[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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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

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

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) *..........
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* 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

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

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

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

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.

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

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:

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''.

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

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

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

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:

    (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''.

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