
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Proposed Rules]
[Pages 57846-57851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20310]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2016-0491; FRL-9951-06]
RIN 2070-AB27


Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for two chemical substances which 
were the subject of premanufacture notices (PMNs). This action would 
require persons who intend to manufacture (defined by statute to 
include import) or process any of the chemical substances for an 
activity that is designated as a significant new use by this proposed 
rule to notify EPA at least 90 days before commencing that activity. 
The required notification initiates EPA's evaluation of the intended 
use within the applicable review period. Manufacture and processing for 
the significant new use is unable to commence until EPA has conducted a 
review of the notice, made an appropriate determination on the notice, 
and taken such actions as are required in association with that 
determination.

DATES: Comments must be received on or before September 23, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0491, 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 
delivery 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: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. 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 (including importers) or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after 
September 23, 2016 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

B. 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

A. What action is the agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for two 
chemical substances which were the subject of PMNs P-14-321 and P-14-
323. These SNURs would require persons who intend to manufacture or 
process any of these chemical substances for an activity that is 
designated as a significant new use to notify EPA at least 90 days 
before commencing that activity.

[[Page 57847]]

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 the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. 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)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury or take such regulatory action as is associated with an 
alternative determination before the manufacture or processing for the 
significant new use can commence. If EPA determines that the 
significant new use is not likely to present an unreasonable risk, EPA 
is required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for two chemical substances in 40 CFR part 721, subpart E. In this 
unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (assigned 
for non-confidential chemical identities).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits (i.e., limits on manufacture volume) 
and other uses designated in this proposed rule, may be claimed as CBI.
PMN Number P-14-321 and P-14-323
    Chemical name: Hydrochlorofluoropropane and 
Hydrochlorofluoropropene (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 12, 2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substances will be as site-
limited, isolated and recycled intermediates. Based on test data on the 
PMN substances, EPA identified concerns for acute toxicity including 
lethality to animals. The Order was issued under TSCA section 
5(a)(3)(B)(ii)(I) based on a finding that the substance may present an 
unreasonable risk of injury to human health. To protect against these 
risks, the consent order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the time trigger specified in the consent order of 
the PMN substances.
    2. Use of impervious gloves and protective clothing where dermal 
exposure is reasonably likely for workers.
    3. Use of respirators with an APF of 1000, in conjunction with a 
minimum set of engineering controls to prevent inhalation exposure for 
workers, or, as an alternative to using respirators, maintain workplace 
airborne concentrations of the PMN substances at or below a specified 
New Chemical Exposure Limit (NCEL) of 130 parts per million (ppm) for 
P-14-321 and 33 parts per billion (ppb) for P-14-323 as an 8-hour time-
weighted average, where inhalation exposure is reasonably likely for 
workers.
    4. Use of engineering controls to limit worker exposure and air 
release of the PMN substances to the environment.
    5. Label containers of the PMN substances and provide Safety Data 
Sheets and worker training.
    6. Manufacture, process and use the PMN substances only in an 
enclosed process.
    7. Use of the PMN substances only as chemical intermediates.
    8. No predictable or purposeful release of the PMN substances from 
manufacturing, processing or use into the waters of the United States 
that result in surface water concentrations exceeding 8 ppb.
    9. Prohibition on the distribution of the PMN substances.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of a 
subacute

[[Page 57848]]

inhalation toxicity: 28-day study (OECD Test Guideline 412) in three 
species: Mouse, rat, and rabbit (6 studies total) and a combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening test (OECD Test Guideline 422) would help 
characterize the human health effects of the PMN substances. The 
submitter has agreed to complete this testing by the production limits 
identified in the consent order.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that regulation was 
warranted under TSCA section 5(e), pending the development of 
information sufficient to make reasoned evaluations of the health or 
environmental effects of the chemical substances. The basis for such 
findings is outlined in Unit IV. Based on these findings, TSCA section 
5(e) consent orders requiring the use of appropriate exposure controls 
were negotiated with the PMN submitters. The SNUR provisions for these 
chemical substances are consistent with the provisions of the TSCA 
section 5(e) consent orders. These SNURs are promulgated pursuant to 
Sec.  [emsp14]721.160 (see Unit VI.).

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
https://www.epa.gov/tsca-inventory.

VI. Applicability of the Proposed Rule to Uses Occurring Before the 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. The identities of the two chemical substances 
subject to this proposed rule have been claimed as confidential and EPA 
has received no post-PMN bona fide submissions (per Sec. Sec.  720.25 
and 721.11). Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates August 15, 2016 (the date of public 
release/web posting of this proposal) as the cutoff date for 
determining whether the new use is ongoing. This designation varies 
slightly from EPA's past practice of designating the date of Federal 
Register publication as the date for making this determination. The 
objective of EPA's approach has been to ensure that a person could not 
defeat a SNUR by initiating a significant new use before the effective 
date of the final rule. In developing this proposal, EPA has recognized 
that, given EPA's practice of now posting proposed rules on its Web 
site a week or more in advance of Federal Register publication, this 
objective could be thwarted even before that publication. Thus, EPA has 
slightly modified its approach in this rulemaking and plans to follow 
this modified approach in future significant new use rulemakings.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of August 
15, 2016 would have to cease any such activity upon the effective date 
of the final rule. To resume their activities, these persons would have 
to first comply with all applicable SNUR notification requirements and 
wait until all TSCA prerequisites for the commencement of manufacture 
or processing have been satisfied. If such a person met the conditions 
of advance compliance under Sec.  721.45(h), the person would be 
considered exempt from the requirements of the SNUR. Consult the 
Federal Register document of April 24, 1990 (55 FR 17376) for a more 
detailed discussion of the cutoff date for ongoing uses.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing new 
information (e.g., generating test data) before submission of a SNUN. 
There is an exception:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule, order, or 
consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a test rule, order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known to or reasonably ascertainable by 
them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the 
Agency has the authority to require appropriate testing. Descriptions 
of tests are provided for informational purposes. EPA strongly 
encourages persons, before performing any testing, to consult with the 
Agency pertaining to protocol selection. To access the OCSPP test 
guidelines referenced in this document electronically, please go to 
http://www.epa.gov/ocspp and select ``Test Guidelines for Pesticides 
and Toxic Substances.''
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN that does not itself include information 
sufficient to permit a reasoned evaluation may increase the likelihood 
that EPA will either respond with a determination that the information 
available to the Agency is insufficient to permit a reasoned evaluation 
of the health and environmental effects of the significant

[[Page 57849]]

new use or, alternatively, that in the absence of sufficient 
information, the manufacture, processing, distribution in commerce, 
use, or disposal of the chemical substance may present an unreasonable 
risk of injury.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs and define the terms of any potentially necessary 
controls if the submitter provides detailed information on:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what information may be useful in 
evaluating a significant new use. Discussions with the Agency prior to 
submission can afford ample time to conduct any tests that might be 
helpful in evaluating risks posed by the substance. According to Sec.  
721.1(c), persons submitting a SNUN must comply with the same 
notification requirements and EPA regulatory procedures as persons 
submitting a PMN, including submission of test data on health and 
environmental effects as described in 40 CFR 720.50. SNUNs must be 
submitted on EPA Form No. 7710-25, generated using e-PMN software, and 
submitted to the Agency in accordance with the procedures set forth in 
40 CFR 720.40 and 721.25. E-PMN software is available electronically at 
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

IX. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the risk assessment documents included in the public docket.
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
this proposed significant new use rule, in Unit II and in the documents 
noted above. EPA recognizes, based on the available information, that 
there is variability and uncertainty in whether any particular 
significant new use would actually present an unreasonable risk. For 
precisely this reason, it is appropriate to secure a future notice and 
review process for these uses, at such time as they are known more 
definitely. The extent to which the various information, procedures, 
measures, methods, protocols, methodologies or models used in EPA's 
decision have been subject to independent verification or peer review 
is adequate to justify their use, collectively, in the record for a 
significant new use rule.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule, during the development of the 
direct final rule. EPA's complete economic analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2016-0491.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for two chemical 
substances that were the subject of PMNs. The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This proposed rule would 
not impose any burden requiring additional OMB approval. If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
average between 30 and 170 hours per response. This burden estimate 
includes the time needed to review instructions, search existing data 
sources, gather and maintain the data needed, and complete, review, and 
submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
proposed rule.
    This proposed rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit IX. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

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 proposed 
rule. As such, EPA has determined that this proposed rule 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.).

[[Page 57850]]

E. Executive Order 13132

    This proposed rule 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, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule 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, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this proposed rule does not address environmental 
health or safety risks disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any 
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would 
not apply to this proposed rule.

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: August 15, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

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

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

0
2. Add Sec.  [emsp14]721.10926 to subpart E to read as follows:


Sec.  [emsp14]721.10926  Hydrochlorofluoropropane and 
Hydrochlorofluoropropene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
hydrochlorofluoropropane and hydrochlorofluoropropene (generic) (PMNs 
P-14-321 and P-14-323) are subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), and 
(c). When determining which persons are reasonably likely to be exposed 
as required for Sec.  [thinsp]721.63(a)(4), 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. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
Assigned Protection Factor (APF) of at least 1000 meet the requirements 
of Sec.  [thinsp]721.63(a)(4):
    (A) Any NIOSH-certified powered air purifying full facepiece 
respirator equipped with appropriate gas/vapor (acid gas, organic 
vapor, or substance specific) cartridges.
    (B) Any NIOSH-certified powered air-purifying respirator equipped 
with a hood or helmet and appropriate gas/vapor (acid gas, organic 
vapor, or substance specific) cartridges with evidence demonstrating 
protection level of 1,000 or greater. (Note: OSHA has assigned APFs of 
1000 for certain types of hoods and helmets with powered air purifying 
respirators (PAPRs) or supplied air respirators (SARs) where the 
manufacturer can demonstrate adequate air flows to maintain positive 
pressure inside the hood or helmet in normal working conditions. 
However, the employer must have evidence provided by the respirator 
manufacturer that the testing of these respirators demonstrates 
performance at a level of protection of 1,000 or greater to receive an 
APF of 1,000. This level of performance can best be demonstrated by 
performing a Workplace Protection Factor (WPF) or Simulated Workplace 
Protection Factor (SWPF) study or equivalent testing. Without testing 
data that demonstrates a level of protection of 1,000 or greater, all 
PAPRs and SARs with helmets/hoods are to be treated as loose-fitting 
facepiece respirators, and receive an APF of 25.)
    (C) Any NIOSH-certified continuous flow supplied-air respirator 
equipped with a full facepiece.
    (D) Any NIOSH-certified continuous flow supplied-air respirator 
equipped with a hood or helmet with evidence demonstrating protection 
level of 1,000 or greater. (See Note under (II), above)
    (E) Any NIOSH-certified pressure-demand or other positive pressure 
mode supplied-air respirator equipped with a full facepiece.
    (1) As an alternative to the respiratory requirements listed here, 
a manufacturer or processor may choose to follow the New Chemical 
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) 
consent order for this substance. The NCEL is 130 parts per million for 
P-14-321 and 33 parts per billion for P-14-323 as an 8-hour time 
weighted average (TWA) verified by actual monitoring data.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(fatal if 
inhaled), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(2)(do not release 
to water).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(a) and (g). It is a significant new use to 
manufacture, process, or use the PMN substances without the engineering 
controls described in the consent order to prevent worker and 
environmental exposures. It is a significant new use to manufacture the 
PMN substances for more than one year.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=8).

[[Page 57851]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are 
applicable to manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2016-20310 Filed 8-23-16; 8:45 am]
 BILLING CODE 6560-50-P


