[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Proposed Rules]
[Pages 60584-60591]
[FR Doc No: 2015-24849]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2015-0626; FRL-9934-71]

Mercury; TSCA Section 21 Petition; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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

SUMMARY: This document provides the reasons for EPA's denial of a
petition it received under Section 21 of the Toxic Substances Control
Act (TSCA). The TSCA section 21 petition was received from the Natural
Resources Defense Council (NRDC) and the Northeast Waste Management
Officials' Association (NEWMOA) on June 24, 2015. The petitioners
requested EPA to ``promulgate a TSCA section 8(a) rule that requires
persons who manufacture, process, or import into the United States
mercury, mercury compounds, or mercury-added products to keep records
of and submit information to EPA concerning such manufacture,
processing, or importation of mercury.'' After careful consideration,
EPA denied the TSCA section 21 petition for the reasons discussed in
this document.

DATES: EPA's response to this TSCA section 21 petition was signed
September 21, 2015.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Thomas Groeneveld, National Program Chemicals Division (7404M), 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. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who manufacture, process, or
distribute in commerce mercury, mercury compounds, or mercury-added
products. Since other entities may also be interested, the Agency has
not attempted to describe all the specific entities that may be
affected by this action.

B. How can I access information about this petition?

    The docket for this TSCA section 21 petition, identified by docket
identification (ID) number EPA-HQ-OPPT-2015-0626, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA
to initiate a rulemaking proceeding for the issuance, amendment, or
repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA
section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth the
facts that are claimed to establish the necessity for the action
requested. EPA is required to grant or deny the petition within 90 days
of its filing. If EPA grants the petition, the Agency must promptly
commence an appropriate proceeding. If EPA denies the petition, the
Agency must publish its reasons for the denial in the Federal Register.
A petitioner may commence a civil action in a U.S. District Court to
compel initiation of the requested rulemaking proceeding within 60 days
of either a denial or the expiration of the 90-day period.

B. What criteria apply to a decision on a TSCA section 21 petition?

    Section 21(b)(1) of TSCA requires that the petition ``set forth the
facts which it is claimed establish that it is necessary'' to issue the
rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21
implicitly incorporates the statutory standards that apply to the
requested actions. In addition, TSCA section 21 establishes standards a
court must use to decide whether to order EPA to initiate rulemaking in
the event of a lawsuit filed by the petitioner after denial of a TSCA
section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has
relied on the standards in TSCA section 21 and in the provisions under
which actions have been requested to evaluate this TSCA section 21
petition.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On June 24, 2015, NRDC and NEWMOA petitioned EPA to ``promulgate a
TSCA section 8(a) rule that requires persons who manufacture, process,
or import into the United States mercury, mercury compounds, or
mercury-added products to keep records of and submit information to EPA
concerning such manufacture, processing, or importation of mercury''
(Ref. 1). In describing the framework for the envisioned rule, the
petitioners offer definitions for various terms and modifications to
exemptions to TSCA section 8(a) information-gathering rules (see 40 CFR
704.5); describe persons who would be required to report in the
envisioned information collecting and reporting apparatus; explain why
existing quantity- and sales-based reporting thresholds should or
should not apply to the persons who must report; establish the minimal
amounts of information EPA should request via sets of example questions
applicable to mercury, mercury compounds, mixtures containing mercury,
and mercury-added products; and set forth their preferred frequency and
format for reporting, as well as certification and recordkeeping
requirements (Ref. 1).

B. What support do the petitioners offer?

    The petitioners state that a ``lack of comprehensive data on
mercury production and use in the United States has been acknowledged
by virtually all of the federal and state agencies involved in tracking
or regulating the chemical in commerce'' (Ref. 1). The petitioners
state that there is ``no mechanism in place to obtain such data,''
which is underscored by describing data gaps in the Interstate Mercury
Education Reduction Clearinghouse (IMERC) and discussing the
limitations of Agency resources, including the September 2014 ``EPA
Strategy to Address Mercury-Containing

Products'' (EPA Strategy or Strategy) (Ref. 2), the Toxics Release
Inventory (TRI) program (Ref. 3), and the Chemical Data Reporting (CDR)
Rule (Ref. 4). Collecting comprehensive data is necessary, the
petitioners say, to ``prevent unreasonable risks of injury to human
health and the environment created by the ongoing manufacture,
processing, and importation of mercury and mercury compounds'' (Ref.
1). As such, the petitioners argue that a TSCA section 8(a) rule is
``warranted'' because available data are inadequate to determine
whether mercury used in products and processes, in fact, creates
unreasonable risk and, if so, the appropriate means to reduce such risk
(Ref. 1). The petitioners also point to the obligations of the Minamata
Convention on Mercury (Minamata Convention), which the United States
signed and joined on November 6, 2013, that they believe will go
unfulfilled without the collection of comprehensive data. In addition,
the petitioners argue that ``incomplete and non-comprehensive data
hampers EPA's ability to effectively assess risks from exposure to
mercury'' and, therefore, the TSCA section 8(a) rule envisioned ``would
result in substantial benefits'' (Ref. 1). Based on these assertions,
as well as a discussion of the toxicity, exposure pathways, and risks
associated with mercury used in products and processes, the petitioners
state that ``there is a reasonable--indeed, an ample--basis to conclude
that a section 8(a) reporting rule for mercury is necessary to protect
health and the environment against an unreasonable risk of injury to
health and the environment from ongoing domestic uses of mercury in
products and processes'' (Ref. 1).

IV. Disposition of TSCA Section 21 Petition

A. What is EPA's response?

    After careful consideration, EPA denied the petition. EPA found
that the continued implementation of its published EPA Strategy (Ref.
2) is sufficient to carry out TSCA, as well as preferable for achieving
the goal it shares with the petitioners: To acquire the information
needed to allow EPA to better understand continuing uses of mercury, to
further reduce such uses, and to prevent potential exposure and risk to
human health and the environment linked to releases of mercury into the
environment. A copy of the Agency's response, which consists of a
letter to the petitioners, is available in the docket for this TSCA
section 21 petition.

B. What is EPA's reason for this response?

    EPA agrees with many aspects of the petition. The Agency agrees
that mercury poses potential risks to human health and the environment
and that there is value in gathering additional information to better
understand continuing uses of mercury, to further reduce such uses, and
to prevent potential risks to human health and the environment from
mercury exposure. However, EPA believes that continued implementation
of its EPA Strategy is a faster, more efficient pathway towards
achieving our shared goals and is confident that the actions
contemplated under the Strategy are both sufficient to carry out TSCA
and preferable to the requested rulemaking.
    1. Background on TSCA section 8. TSCA section 8(a) (15 U.S.C.
2607(a)) authorizes EPA to promulgate rules under which manufacturers
(including importers) and processors of chemical substances must
maintain records and submit such information as the EPA Administrator
may reasonably require. TSCA section 8(a) also authorizes EPA to
promulgate rules under which manufacturers and processors of mixtures
must maintain records and submit information to the extent the EPA
Administrator determines the maintenance of records or submission of
reports, or both, is necessary for the effective enforcement of TSCA.
TSCA section 8(a) generally excludes small manufacturers and processors
of chemical substances or mixtures from the reporting requirements (see
15 U.S.C. 2507(a)). However, EPA is authorized by TSCA section
8(a)(3)(A)(ii) to require TSCA section 8(a) reporting from small
manufacturers and processors with respect to any chemical substance or
mixture that is the subject of a rule proposed or promulgated under
TSCA section 4, 5(b)(4), or 6, or that is the subject of an order in
effect under TSCA section 5(e), or that is the subject of relief
granted pursuant to a civil action under TSCA section 5 or 7. TSCA
section 8(a) also provides that, to the extent feasible, the EPA
Administrator must not require reporting under TSCA section 8(a)(1)
that is unnecessary or duplicative. If the Agency denies a petition
submitted under TSCA section 21, judicial review for TSCA section 8(a)
requires the petitioner to show by a ``preponderance of the evidence
that . . . there is a reasonable basis to conclude that the issuance of
such a rule or order is necessary to protect health or the environment
against an unreasonable risk of injury'' (15 U.S.C. 2620(b)(4)(B)(ii)).
    2. State of domestic mercury marketplace. The United States has
seen a strong downward trend of more than 97 percent in the domestic
use of mercury in products over the past three decades. In 1980, the
United States used more than 1,800 metric tons of mercury annually; in
2010, the continued annual use of mercury in manufactured or imported
products was approximately 52 metric tons. Likewise, the use of mercury
in industrial processes, such as chlor-alkali manufacturing, has also
fallen dramatically from 358 metric tons in 1980 to an estimated 38
metric tons in 2001. This shifting landscape can be attributed to a
number of factors, including market trends leading to the voluntary
reduction of use of mercury in products and processes; federal,
regional, state, and local programs that encourage the use of effective
and economically feasible non[hyphen]mercury substitutes; state laws or
regulations that prohibit or reduce the use of mercury in products; and
Congressional actions that banned the sale of a range of mercury
batteries and prohibited the export of mercury (e.g., the Mercury-
Containing and Rechargeable Battery Management Act of 1996 (Pub. L.
104-142) and the Mercury Export Ban Act of 2008 (MEBA) (Pub. L. 110-
114)). The United States also negotiated and joined the Minamata
Convention, which contains requirements aimed at reducing the use of
mercury. The convergence of such historic trends and actions, as well
as continued downward trends in mercury use in products in more recent
years, helped identify categories of mercury-added products of greatest
concern and guided the development of the EPA Strategy.
    3. The EPA Strategy: Development and implementation. In developing
the EPA Strategy, the Agency did not believe it made sense to
promulgate a comprehensive information-gathering rule for mercury, on
top of the existing regulatory and statutory information collection
requirements applicable to chemical substances generally. Rather, EPA
decided to adopt a more targeted approach and to create a framework
that was flexible and adaptive to observed trends in the use of
mercury. As a result, the EPA Strategy seeks to build on the
``demonstrated success for more than three decades of reducing mercury
use in traditional product and process categories . . . to further
reduce mercury use in products and certain processes in order to
prevent future releases to the environment'' (Ref. 2).
    The EPA Strategy consists of five phases: (1) Update EPA's
information on

mercury products and certain processes; (2) analyze updated mercury use
information; (3) plan and prioritize mercury reduction activities; (4)
take non-regulatory actions to reduce use; and (5) take regulatory
actions to reduce use, if needed (Ref. 2). The Strategy is structured
to provide a logical progression from the gathering of information to
taking actions to reduce the use of mercury and, as necessary, mercury
compounds. However, the Strategy is also intended to allow for
proceeding immediately to such use reduction options should information
warrant such actions, as well as reassessment of an intended course of
action (e.g., methodology for gathering information) at any point
during its implementation.
    The EPA Strategy specifically targets updating data regarding
mercury quantities in ``new products entering the market, with
particular attention to switches and relays'' and ``as appropriate,
processes that use mercury as a catalyst'' (Ref. 2). For example, the
use of mercury in switches and relays (including thermostats) sold in
the United States decreased from approximately 68 metric tons in 2001
to approximately 18 metric tons in 2010--a nearly 74 percent decrease
in under a decade. However, at 33 percent of mercury used in products
sold in the United States, switches and relays also represent the
largest category of mercury-added products. In fact, in joining the
Minamata Convention, the United States demonstrated that mercury used
in eight of nine subject categories was reduced to de minimis levels.
The lone category for which such a demonstration was not made was
switches and relays. As a result, the Agency identified switches and
relays as a priority category of mercury use in the EPA Strategy.
    The Agency has sufficient information on the use of mercury in
certain categories of other mercury-added products (e.g., batteries,
lamps, measuring devices). Yet, despite the aforementioned downward
trend of use of mercury in products and manufacturing processes in
general, EPA is interested in learning more about mercury-added
products that continue to enter the market (i.e., new products) and the
prevalence of the use of mercury and mercury compounds in catalysts.
    The Agency is currently in the first phase of implementing its
Strategy, which lists priority mercury-added product and process
categories (switches, relays, new products, and catalysts), describes
the progression of stakeholders from whom information is to be
collected (mercury manufacturers and importers, mercury processors, and
other stakeholders), and commits to conducting outreach throughout the
implementation of the Strategy (Ref. 2). Following this phase, EPA will
assess information gathered and compare data to existing Agency
baselines derived from IMERC, the TRI program, the CDR Rule, and other
research (Phase 2). Results of the second phase will be used to define
or modify product categories and identify remaining data gaps or other
limitations that could affect the planning and prioritization of
reduction activities (Phase 3). At this juncture, the Agency could
consider the use of voluntary efforts to reduce the use of mercury
(Phase 4), as well as a Section 8(a) rule or other appropriate
regulatory measure (Phase 5). At this point in time, however, EPA
believes the implementation of the EPA Strategy, which uses a variety
of both voluntary and regulatory measures as needed, is sufficient to
carry out TSCA.
    4. The EPA Strategy is working and will continue to work. The
petitioners accurately identify the Agency's goals to continue to
collect and analyze information to better understand the current and
future use of mercury. However, the petitioners focus exclusively on
the voluntary information-collection component within the first of five
phases to conclude that ``the voluntary approach has not worked thus
far, and there is no reasonable basis to believe it ever will'' and
``the need for and the utility of a rulemaking that would require
mandatory reporting from all mercury, mercury-compound, and mercury-
mixture manufacturers has been demonstrated'' (Ref. 1). By focusing on
the Agency's preference to initially proceed on a voluntary basis, the
petitioners overlook that the Strategy contemplates ``additional
available regulatory steps being necessary'' (Ref. 2). In fact, the
Agency finds that the best approach is to employ voluntary or
regulatory mechanisms to collect information based on particular
circumstances. For example, after publishing the EPA Strategy in
September 2014, the Agency conducted a series of letter requests and
teleconferences with companies identified as nine key players in the
mercury marketplace in October and November 2014.
    While the petitioners express skepticism with this approach due to
its initiation with only nine companies, this was a strategic approach
that the Agency expected to yield relevant information. The initial
list of nine was derived from more than one hundred potential companies
based on thorough research and professional judgment to identify
companies likely to provide a reasonably complete picture of the
domestic market for recycling and selling mercury. This approach
allowed for the systematic elimination of companies less likely to have
significant information from consideration and minimized the potential
burden to both stakeholders and the Agency. In fact, the information
received led EPA to further narrow its investigation to five companies
it believes to be the primary recyclers and distributors of mercury in
the United States. Based on those efforts--and the failure of certain
companies from the narrowed list of five to voluntarily provide agreed
to information--EPA issued subpoenas in March 2015 to those five
companies (Ref. 5).
    5. Effective use of regulatory tools via the EPA Strategy. The
subpoenas consisted of twelve information requests designed to
ascertain specific information on quantities of mercury manufactured
(including imported), processed, stored on-site, or distributed in
commerce (including transferred off-site, sold and exported), as well
as lists of customers to whom mercury was sold (Ref. 5). The activities
related to mercury were selected to cross-reference with similar
reporting requirements for the TRI program and CDR Rule. Of particular
interest to the Agency were quantities reported for mercury
manufactured and processed (e.g., recycled from various waste streams),
sold, imported, and exported, which represents key aspects of the
domestic mercury marketplace. EPA requested this information to better
understand how mercury flows through the five primary facilities that
recycle and sell mercury with the goal of identifying the amount of
mercury likely being used to produce mercury-added products or in
manufacturing processes in the United States. The subpoenas requested
that annual totals of mercury in pounds for such activities be reported
for 2010 and 2013. These years were selected to not only coincide with
IMERC reporting years, but also because they could provide a before-
and-after illustration of how two mercury-related measures affected the
domestic mercury market place: MEBA and the conclusion of the
negotiation of the Minamata Convention. The reporting years also were
selected to allow a trend comparison for reported quantities without
creating undue burden on the companies subject to the subpoenas. The
subpoenas also requested customer lists for each company as of January
1,

2015. This date was selected as a fixed and recent date relative to the
issuance of the subpoenas in March 2015. Each of the five companies
subject to the subpoenas supplied the information requested in full.
    Due to extensions granted to certain companies, some responses were
submitted after the initial 30-day deadline. This resulted in the
initial completion of the full data set at the end of June 2015, only
days after the petitioners submitted their petition that concluded that
certain approaches outlined in the EPA Strategy were inadequate. The
Agency is currently evaluating the information submitted in response to
the five March 2015 subpoenas. As necessary, EPA has followed up with
companies and clarified responses submitted. Based on its initial
review of submitted information, the Agency now has a better
understanding of the flow of mercury in the U.S. marketplace and has an
inventory of recent lists of companies that purchase elemental mercury
from the five companies, including volumes and trends of mercury in key
channels of commerce (e.g., manufactured, stored, sold, imported, and
exported). The Agency understands that this information collection
approach cannot account for imports of mercury-added products or
mercury compounds that are not processed by the five companies subject
to the March 2015 subpoenas. However, EPA intends to collect such data
either through voluntary compliance with letters or through subpoenas,
as it determines to be necessary for an adequate understanding of
mercury use in the United States through further implementation of EPA
Strategy and use of existing Agency resources.
    The petitioners express disappointment with the ``months'' that
elapsed since the initiation of the voluntary inquiries to companies in
October 2014 and the submission of their petition in June 2015 (Ref.
1). In fact, the Agency conducted the voluntary portion of data
collection between October 2014 and December 2014. When that process
was not fruitful, the subpoenas were sent in March 2015. Responses to
the March 2015 subpoenas were received by the end of June 2015. For
comparison, new federal rulemakings often take several years to
complete from development through the proposal, public comment, and
finalization phases. A final information collection rule would then
need to provide for some period of time following promulgation for the
submission of the required information. EPA notes that it already
collected data on mercury voluntarily and via subpoena and, based on
that experience, could expeditiously issue any further needed
subpoenas, whereas the timing of a rulemaking process is less
predictable. The Agency gathered information via its Strategy in
several months, new data to be collected by the petitioners' requested
rule--or another Section 8(a) rule--may not be obtained for several
years. For those reasons, EPA believes that the current approach used
to collect information from companies that manufacture, recycle, and
distribute in commerce elemental mercury has been successful, is more
efficient than the development of a new rule, and is sufficient--with
some adaptation of the substance of information requests for companies
that use mercury in products and processes--to carry out TSCA.
    6. The EPA Strategy avoids unnecessary or duplicative reporting.
Based on the above discussion, EPA disagrees that there is ``no other
federal or state mechanism in place that collects the data on mercury
production and use in the United States necessary to inform risk-
reduction activities'' (Ref. 1). As articulated by the petitioners,
IMERC, the TRI program, and the CDR Rule each collect data in whole or
in part related to mercury and mercury compounds. All of these
reporting mechanisms are accessible online. While a single information
collection and reporting apparatus identical to the petitioners'
requested rule does not currently exist, existing tools, as implemented
through the EPA Strategy, are sufficient to gather such data as
necessary for the effective implementation of TSCA. EPA is committed to
gathering such data, including--as appropriate--through the future use
of TSCA section 8. For the same reasons, EPA also disagrees that the
EPA Strategy ``implicitly acknowledges that the CDR Rule and its other
existing reporting mechanisms are not sufficient to gather the data
necessary to make sound decisions about mercury risk-reduction
activities'' (Ref. 1).
    The petitioners also describe various ways in which the TRI program
and CDR Rule collect data on mercury and mercury compounds yet how
idiosyncrasies within each program prevent the reporting of the
specific information they request to be collected. Where the
petitioners see insufficiency, the Agency sees opportunity to use
existing tools and resources to pinpoint specific data gaps, which may
or may not require new regulatory or voluntary actions to gather
information. EPA is using quantitative and qualitative information,
particularly activity and use information reported to the TRI program,
to help narrow the scope of potential stakeholders to be contacted as
needed to collect information that EPA determines to be necessary. For
example, EPA is reviewing information reported to the TRI program to
identify and prioritize how to gather such information.
    The TRI program requires facilities that manufacture, process, or
otherwise use more than 10 pounds of mercury or mercury compounds
during the calendar year to report amounts released to the environment
or managed through recycling, energy recovery and treatment (Ref. 6).
While the TRI program does not require quantitative reporting for all
manufacturing, processing, or use categories, a facility is required to
report activities and uses of the toxic chemical including, but not
limited to ``import,'' ``for sale/distribution,'' ``as a reactant,''
``as an article component,'' and ``as a chemical processing aid'' (Ref.
7). In this instance, EPA does not see the lack of quantitative
reporting as a dead end, but rather as a tool to narrow the number of
companies to ask for more specific information related to the use of
mercury in their products and processes. For example, a review of data
submitted to the TRI program for ``mercury'' in 2013 yields 447
facilities that manufactured, processed, or otherwise used mercury.
That number can be narrowed to 60 facilities that processed mercury
``as an article component'' (e.g., used in a product). When the same
search is conducted for ``mercury compounds,'' more than 1,100
facilities can be narrowed to 48 facilities reporting processing into
articles. The use of such data allows EPA to reduce the scope of
potential manufacturers of mercury-added products by more than 90
percent that under the petitioners' proposed rule would be required to
supply detailed, quantitative data. EPA will perform similar data
sorting among facilities that report ``import'' and ``for sale/
distribution'' of mercury or mercury compounds, which will help further
describe how such materials flow through the domestic marketplace. The
Agency also plans to examine uses ``as a reactant'' and ``as a chemical
processing aid'' to help identify the use of mercury or mercury
compounds in manufacturing processes. As these examples demonstrate,
the Agency believes that it can use existing data to better identify
individual facilities for more targeted efforts to collect information.
    It is important to note that the 2016 reporting cycle for the CDR
Rule (applicable to production volume information for calendar years
2012,

2013, 2014, and 2015; submission period from June 1, 2016, to September
30, 2016) will collect information from persons who manufacture mercury
in quantities greater than or equal to 2,500 pounds (Ref. 4); the
reporting threshold for mercury in the previous cycle was 25,000 pounds
and 100,000 pounds for process and use information. As such, the Agency
anticipates receiving quantitative data on mercury in the domestic
marketplace from a larger pool of companies that manufacture (including
import) and process mercury. In conjunction with the analysis of TRI
program data, EPA plans to use the identities of companies reporting
per the lowered threshold to further clarify the pool of potential
entities from whom to collect more detailed information. Thus, EPA
finds its existing resources, such as the TRI program and CDR Rule, can
be instrumental not only in carrying out TSCA, but also to tailor
future efforts to collect information on discrete categories of mercury
products and processes.
    7. EPA intends to target specific information requests to specific
entities. EPA anticipates that subsequent efforts to gather information
from companies that produce or import mercury-added products and use
mercury or mercury compounds in manufacturing processes may require
contacting more entities than the nine EPA contacted in late 2014. EPA
anticipates using a similar process of research and professional
judgment to identify and prioritize companies to contact and will
follow appropriate procedures to reach as many companies as needed to
obtain relevant information, as necessary. For example, EPA is
considering using TSCA section 11 to ask other companies the same kinds
of questions posed in the March 2015 subpoenas, but with an emphasis on
quantities of mercury and mercury compounds used in the production of
products or in manufacturing processes.
    Looking at the specific information requested in the petition, the
petitioners request two sets of notification requirements between two
categories: (1) Mercury, mercury compounds, and mixtures containing
mercury; and (2) mercury-added products. The petitioners' request of
eight notification requirements for information to be reported for
mercury, mercury compounds, and mixtures containing mercury can be
broken down into three general categories. The first category consists
of location and contact information for company headquarters,
facilities that manufacture or process such substances, and technical
staff. For mercury and mercury compounds, information comparable to the
requests in the first category of notification requirements is reported
to the TRI program and the CDR Rule. The second category includes
quantitative data on such substances manufactured and processed for
distribution in commerce, sold or transferred off-site, and stored on-
site. Due to the similarity with questions posed in the March 2015
subpoenas, EPA is satisfied that it ascertained sufficient quantitative
information for how mercury is used in such activities. For mercury
compounds, EPA believes that information reported to the TRI program
for activities and uses can be used to identify and prioritize
companies and facilities that could be contacted using the same
approach that the Agency used when reaching out to and ultimately
issuing subpoenas to individual recyclers and distributors of mercury.
The third category requests narrative descriptions of manufacturing and
processing processes and end uses of such materials. EPA is not
persuaded that such information for mercury or mercury compounds is
necessary to carry out TSCA. In particular, it is more appropriate to
pose questions regarding end uses to companies or facilities that use
mercury or mercury compounds in products or manufacturing processes and
not companies that recover mercury from various waste streams. Finally,
the Agency is not persuaded that information on mixtures containing
mercury is necessary to carry out TSCA. To the best of the Agency's
knowledge, the only point in the cycle of mercury manufacture, use,
recovery, and reuse when mixtures play a significant role is when
mercury is recovered from mercury waste such as contaminated soil or
impure laboratory mercury. The resulting elemental mercury is used, but
EPA is not aware of any significant manufacture, processing, or use of
mercury mixtures. As EPA reviews the information it has and will
collect on mercury and mercury compounds, it will assess the need for
information on mixtures and pursue such data as needed.
    For mercury-added products, the petitioners also request eight
notification requirements. As discussed in regard to mercury, mercury
compounds, and mixtures containing mercury, the notification
requirements for location and contact information for company
headquarters and technical staff pertain to comparable information
reported to the TRI program or the CDR Rule. The Agency agrees that
collection of the kinds of information listed in three of the eight
notification requests suggested by the petitioners can be valuable:
Quantities of mercury used in products (per unit and total for all
units produced in a calendar year), descriptions of product categories
produced, and a breakdown of products manufactured (including
imported), sold domestically, and exported. Such requirements would
provide quantitative information that would benefit the implementation
of TSCA by helping to define the overall volume of mercury used,
particularly in the priority category of switches and relays. EPA also
agrees that it is helpful to ascertain information related to whether
switches or relays are ``manufactured or processed solely for the
purpose of replacement where no feasible mercury-free alternative for
replacement is available'' (Ref. 1). This information would help the
Agency better estimate costs and benefits associated with not only
ongoing uses of the switches and relays themselves, but also the larger
equipment and systems that use them as components. However, the Agency
is not persuaded that notification requirements for descriptions of
mercury-added components, including the number of and location in
larger products, is necessary. At this time, EPA anticipates that
quantitative data on amounts of mercury contained in or added to such
products and processes is likely to be sufficient to make regulatory
determinations.
    As previously discussed, switches and relays are the largest
remaining domestic use of mercury in products by volume in the United
States. Better defining the total quantity of mercury in that category,
especially given the cessation of reporting of such information via
IMERC, is a priority data point within a priority product category.
Regardless, even in instances where EPA agrees with the notification
requirements proposed by the petitioners, the Agency is not persuaded
that the overarching proposed Section 8(a) rule is the appropriate
means to collect such information. At this time, the Agency continues
to implement its Strategy to determine its next steps, including, but
not limited to using TSCA section 11, to collect information from
additional companies on mercury used in products and processes. The
assessment of information collected to date under the EPA Strategy will
inform next steps in the current and future phases of the
implementation. In so doing, the Agency is employing the variety of
existing tools, including IMERC, the TRI program, and the CDR Rule, as
well as the aforementioned voluntary outreach and targeted

subpoenas, as necessary. This process is expedient, efficient, and does
not duplicate the reporting requirements of IMERC, the TRI program, and
the CDR Rule. As the assessment of collected information dictates, the
Agency continues to use the tools currently available, while not
eliminating the possibility of implementing other voluntary and
regulatory options if deemed necessary. Thus, EPA disagrees with the
petitioners' conclusions as to the ultimate efficacy of the EPA
Strategy, its sufficiency to carry out TSCA, and the need for EPA to
immediately pursue a TSCA section 8(a) rulemaking.
    8. The EPA Strategy minimizes undue burdens. The Agency also
disagrees with the petitioners' claim that their requested TSCA section
8(a) rule ``would result in substantial benefits'' (Ref. 1). As
previously stated, the Agency agrees that there is value in gathering
more information for certain, individual categories of mercury-added
products and processes identified by the petitioners. However, EPA is
not persuaded that a TSCA section 8(a) rule at this time--as opposed to
continued implementation of the EPA Strategy--would produce substantial
or different benefits associated with collecting and reporting
information on the use of mercury in products and processes. The EPA
Strategy intends to provide for flexibility in the approach to ``better
understand continuing uses of mercury in . . . products and processes''
and ``further reduce mercury use in products and certain processes in
order to prevent future releases to the environment'' (Ref. 2). The
Strategy allows for a dynamic and iterative process that can be adapted
to specific categories of concern and makes clear that ``initiation of
future phases may not necessarily be dependent on preceding phases''
(Ref. 2). Where the petitioners see a TSCA section 8(a) rule as the
remedy to existing EPA resources that do not deliver the data they seek
in the format they prefer, the Agency is wary of the potential for
duplication of reporting requirements. The rule outlined by the
petitioners not only creates potential overlap in the kind of data
being submitted under the TRI program and CDR Rule, but also adds
another mercury-based reporting requirement, with an incongruous
reporting timeline, on top of these two established information-
gathering programs. This scenario would require reporting under TSCA
section 8(a)(1) that is unnecessary and, in some instances,
duplicative. Thus, where the petitioners may interpret the measure of
benefit for the rule they request to derive from the breadth and depth
of information collected, the Agency is focusing on more discrete areas
of need (i.e., individual product and process categories) that can
provide for less burdensome requirements for potential stakeholders and
a more efficient approach for the Agency to carry out TSCA in regard to
mercury and mercury compounds. As a result, the petitioners' requested
TSCA section 8(a) rule would be unduly burdensome both to the Agency
and regulated entities.
    9. Petitioners failed to demonstrate the requested rule is
necessary to protect against unreasonable risk. EPA disagrees that
``there is a reasonable . . . basis to conclude that a section 8(a)
reporting rule for mercury is necessary to protect health and the
environment against an unreasonable risk of injury to health and the
environment from ongoing domestic uses of mercury in products and
processes'' (Ref. 1). Central to the petitioners' claim is that:

    The lack of adequate data on mercury use in products and
processes prevents a complete accounting of the full extent of the
human health risks from exposure to mercury . . . [and] EPA cannot
fully address the health and environmental risks from mercury
exposure without adequate data about ongoing mercury uses . . . In
addition, such data collection is necessary to allow EPA to monitor
any development of new mercury uses, so that the agency can assess
the risks to human health that may be presented by such new uses.
(Ref. 1).

    The petitioners go on to state ``incomplete and non-comprehensive
data hampers EPA's ability to effectively assess risks from exposure to
mercury'' (Ref. 1). The petitioners then cite various EPA statements
regarding risk management decision-making that speak to the
availability and adequacy of information, as well as the EPA Strategy
and its intent to gather more and updated information related to
mercury used in products and processes (Ref. 1). The petitioners then
conclude that without ``comprehensive national data about ongoing
mercury uses in products and processes . . . EPA cannot make informed,
sound decisions about how to further reduce risks from mercury
exposure'' (emphasis added) (Ref. 1). The Agency disagrees with this
conclusion. EPA is unaware of statutory authority, applicable case law,
or Agency policy that would preclude risk assessment or actions to
reduce risk based on the fact that available information is limited.
While EPA risk assessment guidance lists the quality and
comprehensiveness of data as factors that can diminish uncertainty, an
``acceptable data set is one that is consistent with the scope, depth,
and purpose of the assessment, and is both relevant and adequate''
(Ref. 8). In this context, adequacy can be determined ``by evaluating
the amount of data available and the accuracy of the data'' (Ref. 8).
The same guidance also states that ``[d]ata of insufficient quality
will have little value for problem solving, while data of quality
vastly in excess of what is needed to answer the questions asked
provide few, if any, additional advantages'' (Ref. 8). To achieve its
stated goals to ``acquire a more robust baseline of mercury quantities
used in products and processes . . . [and] enhance data on manufacture,
export, and import for certain categories of mercury use'' (Ref. 2),
the Agency's current approach will provide data on mercury that are not
only adequate and relevant, but also more narrowly tailored to products
and processes of greatest concern (e.g., switches, relays, new
products, and catalysts). While EPA recognizes that these products and
processes are not exhaustive, these are the categories that EPA has
rationally chosen to focus on first. EPA is aware that mercury may be
added to other products listed by the petitioners (e.g., rotational
balancers, wheel weights, and additives in a variety of children's
products). If EPA determines that additional information targeted to
these products is necessary, EPA will take steps necessary to collect
it.
    At this stage of implementing the strategy, the Agency also is
uncertain what, if any, information is needed on mercury compounds
beyond use as catalysts in manufacturing processes. Where products are
concerned, for example, the product category of greatest concern
(switches and relays) contains elemental mercury, not mercury
compounds. Although certain batteries contain mercury oxide, that
product group is of lesser concern than switches and relays. EPA will
collect information on use of mercury compounds in products if, in the
course of carrying out its Strategy, the Agency determines such
information to be necessary. At this stage, requiring reporting for
mercury compounds in all products while an Agency assessment of needs
for such information is pending would require unnecessary reporting
under TSCA section 8(a)(1).
    Thus, while the Agency is mindful of the petitioners' analysis of
mercury-related concerns (e.g., toxicity, exposure, risks presented by
releases into the environment, and risk reduction), EPA cannot reach
the petitioners' conclusion that ``a section 8(a) reporting rule for
mercury is necessary to protect health and the

environment against an unreasonable risk of injury to health and the
environment from ongoing domestic uses of mercury in products and
processes'' (Ref. 1). While the petitioners articulate how the
collection of comprehensive and national data could provide the Agency
with more information to weigh in determining unreasonable risk, EPA
finds that its current approach could be equally successful while
imposing considerably less burden on both EPA and the regulated
community in its implementation of TSCA, as well as allowing the Agency
to move more quickly on the highest priority product categories. To
date, this approach has yielded satisfactory information and the Agency
expects that continued implementation of the EPA Strategy will be an
appropriate and effective means to acquire the information needed to
allow EPA to better understand continuing uses of mercury, to further
reduce such uses, and to prevent potential exposure and risk for human
health and the environment linked to releases of mercury into the
environment.
    Furthermore, while the petition discusses the toxicity and
potential risk associated with exposure to mercury and methylmercury,
it does not provide a basis for finding that there is a reasonable
basis to conclude that the requested rule is necessary to protect
against an unreasonable risk. The finding of unreasonable risk under
TSCA encompasses consideration of both the anticipated benefits of
action under consideration as well as the anticipated costs. In this
instance, the petition would need to provide a basis for EPA to
conclude that any additional risk reduction that would be achieved by
the requested rule, beyond that which will be achieved by EPA's current
efforts, would justify the additional costs to EPA and the regulated
community.
    In discussing risks associated with releases of mercury, the
petitioners describe how mercury releases during the product lifecycle
``significantly'' contribute to the total reservoir of ``mercury
pollution'' (Ref. 1). After release, the petitioners describe how
mercury cycles through environmental media, can be converted to
methylmercury, and can potentially contaminate fish and humans (Ref.
1). The petitioners provide an estimate of the number of newborns
exposed to methylmercury (376 to 14,293 cases annually) from all
sources and the costs to care for children exposed to levels of
methylmercury associated with cognitive impairment considered mental
retardation ($500 million to $17.9 billion annually) (Ref. 1). The
petitioners then cite several EPA significant new use rules (SNURs)
applicable to mercury used in various motor vehicle switches (Ref. 9);
flow meters, natural gas manometers, and pyrometers (Ref. 10); and
barometers, manometers, hygrometers, and psychrometers (Ref. 11), to
demonstrate previous Agency efforts to reduce risks from mercury based
on potential releases of mercury during the product lifecycle (Ref. 1).
The petitioners also cite estimated reporting costs for a TSCA section
8(a) rule of ``approximately $8,000 to $9,000 per report for the
initial cycle . . . and between $5,000 and $6,000 for each reporting
cycle'' (Ref. 1). However, the information provided in the petition on
the impacts of mercury exposure, including the monetized risk estimate,
relates to all sources of mercury pollution; it provides limited
information to support the need for the requested rule to collect
information as to ongoing uses. In addition, the petition does not
provide a basis to conclude that the requested rule would provide for
any additional risk reduction beyond that which will be achieved by
EPA's current efforts, or that any such reduction would justify the
additional cost to EPA and the regulated community. EPA notes in this
regard that the petition misstates the baseline for judging the
benefits of the requested rule by not accounting for the significant
reduction in the CDR reporting threshold for mercury, as discussed
above.
    10. EPA will continue its successful voluntary and regulatory
efforts. Furthermore, the Agency is already taking voluntary and
regulatory measures related to mercury, some of which are listed in the
petition (e.g., SNURs for various mercury-added products, proposed rule
for dental effluent guidelines, emission standards for hazardous air
pollutants from coal- and oil-fired electric utility steam-generating
units, and the March 2015 subpoenas) (Ref. 1). EPA leads a voluntary
initiative to phase out use of mercury in industrial and laboratory
thermometers, which led to the development of the document ``A Guide
for Federal Agencies on Replacing Mercury-Containing Non-Fever
Thermometers'' (Ref. 12). The Agency also collaborates in voluntary
programs such as the Energy Star Program co-sponsored by EPA and the
Department of Energy, under which participating manufacturers agree to
limit the mercury content of lamps, and the National Vehicle Mercury
Switch Recovery Program and follow-on initiatives, which manages, on a
nationwide basis, programs to collect, transport, retort, recycle, or
dispose of elemental mercury from automotive switches. Finally, EPA
leads the mercury in products partnership within the United Nations
Environment Program's Global Mercury Partnership, an international,
voluntary effort that strives to phase out and eventually eliminate
mercury in products and to eliminate releases during manufacturing and
other industrial processes via environmentally sound production,
transportation, storage, and disposal procedures (Ref. 13).
    In sum, the Agency finds that the requested promulgation of a TSCA
section 8(a) is neither timely nor warranted to carry out TSCA pending
the continued implementation of the approaches set forth in the EPA
Strategy.

V. References

    The following is a listing of the documents that are specifically
referenced in this document. 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. NRDC/NEWMOA. Petition to Promulgate Reporting Rules for Mercury
Manufacturing, Processing, and Importation Under Section 8(a) of the
Toxic Substances Control Act. June 24, 2015.
2. EPA. EPA Strategy to Address Mercury-Containing Products.
September 2014. Available at http://www.epa.gov/mercury/pdfs/productsstrategy.pdf.
3. EPA. Toxic Chemical Release Reporting; Community Right-to-Know.
Federal Register. 53 FR 4500, February 16, 1988 (FRL-3298-2).
4. EPA. TSCA Inventory Update Reporting Modifications: Chemical Data
Reporting. Federal Register. 76 FR 50816, August 16, 2011 (FRL-8872-
9).
5. EPA. Subpoena and Information Request. March 20, 2015. Available
at http://www.epa.gov/mercury/pdfs/Hg_FormalRequest_SIGNED_03-20-2015.pdf.
6. EPA. Emergency Planning and Community Right-to-Know Act--Section
313: Guidance for Reporting Toxic Chemicals: Mercury and Mercury
Compounds Category. August 2001. Available at http://www.epa.gov/tri/reporting_materials/guidance_docs/pdf/2001/2001hg.pdf.
7. EPA. Form R. Available at http://www2.epa.gov/sites/production/files/2015-01/documents/2014_form_r.pdf.

8. EPA. Guidelines for Exposure Assessment. May 29, 1992. Available
at http://www.epa.gov/raf/publications/pdfs/GUIDELINES_EXPOSURE_ASSESSMENT.PDF.
9. EPA. Mercury Switches in Motor Vehicles; Significant New Use
Rule. Federal Register. 72 FR 56903, October 5, 2007 (FRL-8110-5).
10. EPA. Elemental Mercury Used in Flow Meters, Natural Gas
Manometers, and Pyrometers; Significant New Use Rule. Federal
Register. 75 FR 42330, July 21, 2010 (FRL-8832-2).
11. EPA. Elemental Mercury Used in Barometers, Manometers,
Hygrometers, and Psychrometers; Significant New Use Rule. Federal
Register. 77 FR 31728, May 30, 2012 (FRL-9345-9).
12. EPA. A Guide for Federal Agencies on Replacing Mercury-
Containing Non-Fever Thermometers. June 2013. Available at http://epa.gov/mercury/pdfs/Non-Fever-Mercury-Thermometers-Guide-for-Federal-Agencies-FINAL.pdf.
13. UNEP. Mercury-Containing Products Partnership Area Business
Plan. June 28, 2013. Available at http://www.unep.org/chemicalsandwaste/Mercury/GlobalMercuryPartnership/Products/tabid/3565/language/en-US/Default.aspx.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: September 21, 2015.
James J. Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-24849 Filed 10-6-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Page 10352]
[FR Doc No: 2011-4080]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-2641-000]

Duke Energy Carolinas, LLC; Notice of Filing

    Take notice that, on February 10, 2011, Duke Energy Carolinas, LLC
filed to supplement its filing, in the above captioned docket, with
information required under the Commission's regulations. Such filing
serves to reset the filing date in this proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 23, 2011.

    Dated: February 16, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-4080 Filed 2-23-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26559-26561]
[FR Doc No: 2023-09170]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0297]

Smoking Cessation and Related Indications: Developing Nicotine
Replacement Therapy Drug Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Smoking
Cessation and Related Indications: Developing Nicotine Replacement
Therapy Drug Products; Guidance for Industry.'' The document provides
guidance to assist sponsors in the clinical development of nicotine
replacement therapy (NRT) drug products, including but not limited to
those intended for smoking cessation and related chronic indications.
This guidance finalizes the draft guidance of the same title issued on
February 22, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on May 1, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0297 for ``Smoking Cessation and Related Indications:
Developing Nicotine Replacement Therapy Drug Products.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9

a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Heather Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20903-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Smoking Cessation and Related Indications: Developing
Nicotine Replacement Therapy Drug Products.'' This guidance reflects
the FDA's current thinking regarding overall development programs to
support the approval of NRT drug products for smoking cessation and
related chronic indications. There are several FDA-approved
prescription and nonprescription NRT drug products for cessation of
smoking cigarettes, but the Agency encourages the development of
additional NRT drug products, which could help more smokers quit.
    The guidance focuses on drug development and trial design issues
that are specific to the study of NRT drug products. NRT drug products
are typically studied and labeled for use as adjuncts to behavioral
self-help materials and to date have involved single treatment regimens
that begin on the patient's quit day (first day without a cigarette).
Alternate treatment regimens (e.g., pretreatment before quit day,
quitting by gradual reduction (reduce to quit), using multiple NRT drug
products together) are discussed in the guidance.
    As outlined in the guidance, NRT drug products can be developed for
smoking cessation and/or reduction in risk of relapse. NRT drug
products that first have demonstrated efficacy for at least one of
these indications can also include additional information in labeling
by demonstrating efficacy in certain secondary endpoints. Sponsors can
evaluate reduction in the urge to smoke or relief of cue-induced
craving in former smokers as secondary endpoints. Additionally,
sponsors that can demonstrate, via a secondary endpoint, that the drug
product provides relief of withdrawal symptoms in smokers who are not
trying to quit smoking may be able to include labeling instructions to
address situations when such individuals are required to abstain and
therefore experience withdrawal symptoms (e.g., while traveling on an
airplane).
    FDA is aware of the serious risks associated with smoking and is
committed to facilitating the development of therapies to support
smoking cessation efforts. Both the regulatory pathway for an NRT drug
product and the amount of nonclinical or clinical data needed to
support approval will depend on the characteristics of the proposed NRT
drug product relative to an approved NRT drug product. This guidance
outlines general considerations for NRT drug development and trial
design, and FDA encourages sponsors to contact FDA for feedback on
their proposed development plans. Sponsors developing nonprescription
drug product should bear in mind that it is often not possible to
answer all regulatory questions in a single trial, and additional
sequential steps may be needed.
    This guidance finalizes the draft guidance entitled ``Smoking
Cessation and Related Indications: Developing Nicotine Replacement
Therapy Drug Products'' issued on February 22, 2019 (84 FR 5693). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include
clarification that the document does not address the development of NRT
to aid in the cessation of non-combustible tobacco products (e.g., e-
cigarettes); information regarding the pathway described in section
505(b)(2) (21 U.S.C. 355(b)(2)) of the Federal Food, Drug, and Cosmetic
Act and reliance on published literature; and clarification regarding
mode of administration and route of administration. In addition,
editorial changes were made to improve clarity. This guidance is being
issued consistent with FDA's good guidance practices regulation (21 CFR
10.115). The guidance represents the current thinking of FDA on
``Smoking Cessation and Related Indications: Developing Nicotine
Replacement Therapy Drug Products.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 pertaining to the submissions of
investigational new drug applications, including clinical trial design
and study protocols, have been approved under OMB control number 0910-
0014. The

collections of information in 21 CFR part 314 regarding the submission
of new drug applications including formal meetings with sponsors and
applicants for Prescription Drug User Fee Act products, abbreviated new
drug applications and supplemental applications have been approved
under OMB control number 0910-0001. The collections of information in
21 CFR part 601 pertaining to the submission of biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information relating to expedited program for serious
conditions for drug and biological product development programs have
been approved under OMB control number 0910-0765. The collections of
information pertaining to the submission of special protocol
assessments have been approved under OMB control number 0910-0470. The
collections of information in 21 CFR 201.56 and 201.57 for the
submission of certain prescription drug product labeling have been
approved under OMB control number 0910-0572. The collections of
information in 21 CFR parts 50 and 56 (Protection of Human Subjects:
Informed Consent; Institutional Review Boards) have been approved under
OMB control number 0910-0130. The collections of information pertaining
to good clinical practice have been approved under OMB control number
0910-0843. The collections of information pertaining to adverse events
reporting have been approved under OMB control number 0910-0291.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09170 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Proposed Rules]
[Pages 70785-70786]
[FR Doc No: 2021-26838]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-1097; Airspace Docket No. 19-AAL-64]
RIN 2120-AA66

Proposed Amendment of United States Area Navigation (RNAV) Route
T-233; Kotzebue, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend United States Area Navigation
(RNAV) route T-233 in the vicinity of Kotzebue, AK in support of a
large and comprehensive T-route modernization project for the state of
Alaska.

DATES: Comments must be received on or before January 27, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-1097; Airspace Docket No. 19-AAL-64 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email:
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessening the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-1097; Airspace Docket No. 19-AAL-64) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-1097; Airspace Docket No. 19-AAL-64''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100-Century of Aviation
Reauthorization Act (Pub. L. 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the

nation's air transportation system to make flying safer, more
efficient, and more predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project mission statement states: ``To modernize Alaska's Air Traffic
Service route structure using satellite based navigation Development of
new T-routes and optimization of existing T-routes will enhance safety,
increase efficiency and access, and will provide en route continuity
that is not subject to the restrictions associated with ground based
airway navigation.'' As part of this project, the FAA evaluated the
existing Colored Airway structure for: (a) Direct replacement (i.e.,
overlay) with a T-route that offers a similar or lower Minimum En route
Altitude (MEA) or Global Navigation Satellite System Minimum En route
Altitude (GNSS MEA); (b) the replacement of the colored airway with a
T-route in an optimized but similar geographic area, while retaining
similar or lower MEA; or (c) removal with no route structure (T-route)
restored in that area because the value was determined to be
insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. The FAA proposes to amend RNAV route
T-233 to provide an alternate reporting point, the Bettles, AK, (BTT)
VHF omnidirectional range with distance measuring equipment (VOR/DME),
as well as a new waypoint (WP) the TOMPY WP, in anticipation of the
future decommissioning of the Evansville, AK, (EAV) NDB, and the
Ambler, AK, (AMF) NDB. Additionally, the proposed route would extend
from the TOMPY WP to the new CIBDU WP and then to the Kotzebue, AK,
(OTZ) VOR/DME, providing an alternate for VOR Federal airwayV-401 with
a lower GNSS MEA.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend RNAV
route T-233 in the vicinity of Kotzebue, AK in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The proposed route is described below.
    T-233: The FAA proposes to amend T-233 by extending the route from
the Kotzebue, AK, (OTZ) VOR/DME to the CIBDU, AK, WP to the TOMPY, AK,
WP. Due to the positioning of the TOMPY WP, the KORKY WP would no
longer be a turn point, so it will not be included in the proposed
legal description.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021, and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV listed in this document would be published subsequently in FAA
Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-233 Kotzebue, AK to Bettles, AK

Kotzebue, AK (OTZ)            VOR/DME             (Lat. 66[deg]53'08.46'' N, long. 162[deg]32'23.77'' W)
CIBDU, AK                     WP                  (Lat. 66[deg]52'57.45'' N, long. 161[deg]03'44.52'' W)
TOMPY, AK                     WP                  (Lat. 67[deg]06'18.81'' N, long. 157[deg]51'52.03'' W)
ENCOR, AK                     WP                  (Lat. 66[deg]55'58.35'' N, long. 152[deg]19'54.35'' W)
Bettles, AK (BTT)             VOR/DME             (Lat. 66[deg]54'18.03'' N, long. 151[deg]32'09.18'' W)

* * * * *

    Issued in Washington, DC, on December 7, 2021.
Margaret C. Flategraff,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-26838 Filed 12-10-21; 8:45 am]
BILLING CODE 4910-13-P