[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Rules and Regulations]
[Pages 61985-61993]
[FR Doc No: 2015-26301]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2013-0369; FRL-9935-69-OAR]
RIN 2060-AS44

Protection of Stratospheric Ozone: The 2016 Critical Use
Exemption From the Phaseout of Methyl Bromide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is authorizing uses
that qualify for the critical use exemption and the amount of methyl
bromide that may be produced or imported for those uses for the 2016
control period. EPA is issuing this action under the authority of the
Clean Air Act to reflect consensus decisions of the Parties to the
Montreal Protocol on Substances that Deplete the Ozone Layer at the
Twenty-Sixth Meeting of the Parties in November 2014.

DATES: This rule is effective on January 1, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2013-0369. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and is publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
and Radiation Docket, EPA/DC, EPA West, Room 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<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeremy Arling, Stratospheric
Protection Division, Office of Atmospheric Programs, Mail Code 6205T,
1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number
(202) 343-9055; email address<EMAIL_ADDRESS>You may also visit
the methyl bromide section of the Ozone Depletion Web site of EPA's
Stratospheric Protection Division at www.epa.gov/ozone/mbr for further
information about the methyl bromide critical use exemption, other
Stratospheric Ozone Protection regulations, the science of ozone layer
depletion, and related topics.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

    This rule concerns Clean Air Act (CAA) restrictions on the
consumption, production, and use of methyl bromide (a Class I, Group VI
controlled substance) for critical uses. Under the Clean Air Act,
methyl bromide consumption (consumption is defined under section 601 of
the CAA as production plus imports minus exports) and production were
phased out on January 1, 2005, apart from allowable exemptions, such as
the critical use and the quarantine and preshipment (QPS) exemptions.
With this action, EPA is authorizing the uses that will qualify for the
critical use exemption as well as specific amounts of methyl bromide
that may be produced and imported for those critical uses for 2016.

II. General Information

A. Does this action apply to me?

    Entities and categories of entities potentially regulated by this
action include producers, importers, and exporters of methyl bromide;
applicators and distributors of methyl bromide; and users of methyl
bromide that applied for the 2016 critical use exemption including
growers of vegetable crops, ornamentals, fruits, and nursery stock, and
owners of stored food commodities. This list is not intended to be
exhaustive, but rather to provide a guide for readers regarding
entities likely to be regulated by this action. To determine whether
your facility, company, business, or organization could be regulated by
this action, you should carefully examine the regulations promulgated
at 40 CFR part 82, subpart A. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the preceding section.

III. What is Methyl Bromide?

    Methyl bromide is an odorless, colorless, toxic gas which is used
as a broad-spectrum pesticide and is controlled under the CAA as a
Class I ozone-depleting substance (ODS). Methyl bromide was once widely
used as a fumigant to control a variety of pests such as insects,
weeds, rodents, pathogens, and nematodes.
    Methyl bromide is also regulated by EPA under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes
and regulatory authorities, as well as by States under their own
statutes and regulatory authority. Under FIFRA, methyl bromide is a
restricted use pesticide. Restricted use pesticides are subject to
Federal and State requirements governing their sale, distribution, and
use. Nothing in this rule implementing Title VI of the Clean Air Act is
intended to derogate from provisions in any other Federal, State, or
local laws or regulations governing actions including, but not limited
to, the sale, distribution, transfer, and use of methyl bromide.
Entities affected by this action must comply with FIFRA and other
pertinent statutory and regulatory requirements for pesticides
(including, but not limited to, requirements pertaining to restricted
use pesticides) when producing, importing, exporting, acquiring,
selling, distributing, transferring, or using methyl bromide. The
provisions in this action are intended only to implement the CAA
restrictions on the production, consumption, and use of methyl bromide
for critical uses exempted from the phaseout of methyl bromide.

IV. What is the background to the Phaseout Regulations for Ozone-
Depleting substances?

    The regulatory requirements of the stratospheric ozone protection
program that limit production and consumption of ozone-depleting
substances are in 40 CFR part 82, subpart A. The regulatory program was
originally published in the Federal Register on August 12, 1988 (53 FR
30566), in response to the 1987 signing and subsequent ratification of
the Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol). The Montreal Protocol is the international
agreement aimed at reducing and eliminating the production and
consumption of stratospheric ozone-depleting substances. The United
States was one of the original signatories to the 1987 Montreal
Protocol, and the United States ratified the Protocol in 1988. Congress
then enacted, and President George H.W. Bush signed into law, the Clean
Air Act Amendments of 1990 (CAAA of 1990), which included Title VI on
Stratospheric Ozone Protection, codified as 42 U.S.C. Chapter 85,
Subchapter VI, to ensure that the United States could satisfy its
obligations under the Protocol. EPA issued regulations to implement
this legislation and has since amended the regulations as needed.
    Methyl bromide was added to the Protocol as an ozone-depleting
substance in 1992 through the Copenhagen Amendment to the Protocol. The
Parties to the Montreal Protocol (Parties) agreed that each developed
country's level of methyl bromide production and consumption in 1991
should be the baseline for establishing a freeze on the level of methyl
bromide production and consumption for developed countries. EPA
published a rule in the Federal Register on December 10, 1993 (58 FR
65018), listing methyl bromide as a Class I, Group VI controlled
substance. This rule froze U.S. production and consumption at the 1991
baseline level of 25,528,270 kilograms, and set forth the percentage of
baseline allowances for methyl bromide granted to companies in each
control period (each calendar year) until 2001, when the complete
phaseout would occur. This phaseout date was established in response to
a petition filed in 1991 under sections 602(c)(3) and 606(b) of the
CAAA of 1990, requesting that EPA list methyl bromide as a Class I
substance and phase out its production and consumption. This date was
consistent with section 602(d) of the CAAA of 1990, which, for newly
listed Class I ozone-depleting substances provides that ``no extension
[of the phaseout schedule in section 604] under this subsection may
extend the date for termination of production of any class I substance
to a date more than 7 years after January 1 of the year after the year
in which the substance is added to the list of class I substances.''
    At the Seventh Meeting of the Parties (MOP) in 1995, the Parties
agreed to adjustments to the methyl bromide control measures and agreed
to reduction steps and a 2010 phaseout date for developed countries
with exemptions permitted for critical uses. At that time, the United
States continued to have a 2001 phaseout date in accordance with
section 602(d) of the CAAA of 1990. At the Ninth MOP in 1997, the
Parties agreed to further adjustments to the phaseout schedule for
methyl bromide in developed countries, with reduction steps leading to
a 2005 phaseout. The Parties also established a phaseout date of 2015
for countries operating under Article 5 of the Protocol (developing
countries).

V. What is the legal authority for exempting the production and import
of methyl bromide for critical uses permitted by the parties to the
Montreal Protocol?

    In October 1998, the U.S. Congress amended the Clean Air Act to
prohibit the termination of production of methyl bromide prior to
January 1, 2005, to require EPA to align the U.S. phaseout of methyl
bromide with the schedule specified under the Protocol, and to
authorize EPA to provide certain exemptions. These amendments were
contained in section 764 of the 1999 Omnibus Consolidated and Emergency
Supplemental Appropriations Act (Pub. L. 105-277, October 21, 1998) and
were codified in section 604 of the CAA, 42 U.S.C. 7671c. The amendment
that specifically addresses the critical use exemption appears at
section 604(d)(6), 42 U.S.C. 7671c(d)(6). EPA revised the phaseout
schedule for methyl bromide production and consumption in a rulemaking
on November 28, 2000 (65 FR 70795), which allowed for the reduction in
methyl bromide consumption specified under the Protocol and extended
the phaseout to 2005 while creating a placeholder for critical use
exemptions. Through an interim final rule on July 19, 2001 (66 FR
37751), and a final rule on January 2, 2003 (68 FR 238), EPA amended
the regulations to allow for an exemption for quarantine and
preshipment purposes.
    On December 23, 2004 (69 FR 76982), EPA published a rule (the
``Framework Rule'') that established the framework for the critical use
exemption, set forth a list of approved critical uses for 2005, and
specified the amount of methyl bromide that could be supplied in 2005
from stocks, new production, or through imports to meet the needs of
approved critical uses. EPA has subsequently published rules applying
the critical use exemption framework for each of the annual control
periods from 2006 to 2015.
    In accordance with Article 2H(5) of the Montreal Protocol, the
Parties have issued several Decisions pertaining to the critical use
exemption. These include Decisions IX/6 and Ex. I/4, which set forth
criteria for review of critical uses. The status of Decisions is
addressed in NRDC v. EPA, (464 F.3d 1, D.C. Cir. 2006) and in EPA's
``Supplemental Brief for the Respondent,'' filed in NRDC v. EPA and
available in the docket for this action. In this rule, EPA is honoring
commitments

made by the United States in the Montreal Protocol context.
    Under authority of section 604(d)(6) of the CAA, EPA is now listing
approved critical uses, as well as authorizing the amount of methyl
bromide that may be produced or imported to satisfy those uses during
2016. The critical uses and amounts reflect Decision XXVI/6, taken at
the Twenty-Sixth Meeting of the Parties in November 2014.

VI. What is the critical use exemption process?

A. Background of the Process

    Article 2H of the Montreal Protocol established the critical use
exemption provision. At the Ninth Meeting of the Parties in 1997, the
Parties established the criteria for an exemption in Decision IX/6. In
that Decision, the Parties agreed that ``a use of methyl bromide should
qualify as `critical' only if the nominating Party determines that: (i)
The specific use is critical because the lack of availability of methyl
bromide for that use would result in a significant market disruption;
and (ii) There are no technically and economically feasible
alternatives or substitutes available to the user that are acceptable
from the standpoint of environment and health and are suitable to the
crops and circumstances of the nomination.'' EPA promulgated these
criteria in the definition of ``critical use'' at 40 CFR 82.3.
    In addition, Decision IX/6 provides that production and
consumption, if any, of methyl bromide for critical uses should be
permitted only if a variety of conditions have been met, including that
all technically and economically feasible steps have been taken to
minimize the critical use and any associated emission of methyl
bromide, that research programs are in place to develop and deploy
alternatives and substitutes, and that methyl bromide is not available
in sufficient quantity and quality from existing stocks of banked or
recycled methyl bromide.
    EPA requested critical use exemption applications for 2016 through
a Federal Register notice published on May 31, 2013 (78 FR 32646).
Applicants submitted data on their use of methyl bromide, the technical
and economic feasibility of using alternatives, ongoing research
programs into the use of alternatives in their sector, and efforts to
minimize use and emissions of methyl bromide.
    EPA reviews the data submitted by applicants, as well as data from
governmental and academic sources, to establish whether there are
technically and economically feasible alternatives available for a
particular use of methyl bromide, and whether there would be a
significant market disruption if no exemption were available. In
addition, an interagency workgroup reviews other parameters of the
exemption applications such as dosage and emissions minimization
techniques and applicants' research or transition plans. As required in
section 604(d)(6) of the CAA, for each exemption period, EPA consults
with the United States Department of Agriculture (USDA).\1\ This
assessment process culminates in the development of the U.S. critical
use nomination (CUN). Annually since 2003, the U.S. Department of State
has submitted a CUN to the United Nations Environment Programme (UNEP)
Ozone Secretariat. The Methyl Bromide Technical Options Committee
(MBTOC) and the Technology and Economic Assessment Panel (TEAP), which
are advisory bodies to Parties to the Montreal Protocol, review each
Party's CUN and make recommendations to the Parties on the nominations.
The Parties then take Decisions on critical use exemptions for
particular Parties, including how much methyl bromide may be supplied
for the exempted critical uses. EPA then provides an opportunity for
public comment on the amounts and specific uses of methyl bromide that
the Agency proposed to exempt.
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    \1\ See CAA section 604(d)(6): ``To the extent consistent with
the Montreal Protocol, the Administrator, after notice and the
opportunity for public comment, and after consultation with other
departments or instrumentalities of the Federal Government having
regulatory authority related to methyl bromide, including the
Secretary of Agriculture, may exempt the production, importation,
and consumption of methyl bromide for critical uses.''
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    On January 22, 2014, the United States submitted the twelfth
Nomination for a Critical Use Exemption for Methyl Bromide for the
United States of America to the Ozone Secretariat of UNEP. This
nomination contained the request for 2016 critical uses. In March 2014,
MBTOC sent questions to the United States concerning technical and
economic issues in the 2016 nomination. The United States transmitted
responses to MBTOC in March 2014. In May 2014, the MBTOC provided their
interim recommendations on the U.S. nomination in the May TEAP Interim
Report. These documents, together with reports by the advisory bodies
noted above, are in the public docket for this rulemaking. The critical
uses and amounts approved in this rule reflect the analyses contained
in those documents.

B. How does this rule relate to previous critical use exemption rules?

    The December 23, 2004, Framework Rule established the framework for
the critical use exemption program in the United States, including
definitions, prohibitions, trading provisions, and recordkeeping and
reporting obligations. The preamble to the Framework Rule included
EPA's determinations on key issues for the critical use exemption
program.
    Since publishing the Framework Rule, EPA has annually issued
regulations to indicate which uses meet the criteria for the exemption
and to exempt specific quantities of production and import of methyl
bromide for a particular year.
    This action continues the approach established in the 2013 Rule (78
FR 43797, July 22, 2013) for determining the amounts of Critical Use
Allowances (CUAs) to be allocated for critical uses. A CUA is the
privilege granted through 40 CFR part 82 to produce or import 1
kilogram (kg) of methyl bromide for an approved critical use during the
specified control period. A control period is a calendar year. See 40
CFR 82.3. Each year's allowances expire at the end of that control
period and, as explained in the Framework Rule, are not bankable from
one year to the next.

C. Critical Uses

    In Decision XXVI/6, taken in November 2014, the Parties to the
Protocol agreed ``[t]o permit, for the agreed critical-use categories
for 2015 and 2016 set forth in table A of the annex to the present
decision for each party, subject to the conditions set forth in the
present decision and in decision Ex. I/4 to the extent that those
conditions are applicable, the levels of production and consumption for
2015 and 2016 set forth in table B of the annex to the present
decision, which are necessary to satisfy critical uses. . . .'' Cured
pork and strawberry field production are the uses that are set forth in
table A of the annex to Decision XXVI/6 for the United States for 2016.
    This rule modifies the table in 40 CFR part 82, subpart A, appendix
L to reflect the agreed critical use categories. EPA is amending the
table of critical uses and critical users based on the uses permitted
in Decision XXVI/6 and the technical analyses contained in the 2016
U.S. nomination that assess data submitted by applicants to the CUE
program. For reasons discussed below, EPA is removing the time
limitation in appendix L for the approval of dry-cured pork products as
a critical use to

allow for the continued use of carryover post-harvest methyl bromide
after 2016.
    Specifically, this rule removes the food processing uses that were
listed in the joint 2014/2015 CUE rule as critical uses for 2014. The
California Date Commission as well as all users under the food
processing use (rice millers, pet food manufacturing facilities, and
members of the North American Millers' Association) did not submit CUE
applications for 2016 and therefore were not included in the 2016 U.S.
nomination to the Parties of the Montreal Protocol.
    This rule also removes the remaining commodity uses (walnuts, dried
plums, figs, and raisins). These sectors applied for a critical use in
2016 but the United States did not nominate them for 2016. In addition,
some sectors that were not on the list of critical uses for 2014 or
2015 submitted applications for 2016. These sectors are: Michigan
cucurbit, eggplant, pepper, and tomato growers; Florida eggplant,
pepper, strawberry, and tomato growers; the California Association of
Nursery and Garden Centers; California stone fruit, table and raisin
grape, walnut, and almond growers; ornamental growers in California and
Florida; and the U.S. Golf Course Superintendents Association. EPA
conducted a thorough technical assessment of each application and
considered the effects that the loss of methyl bromide would have for
each agricultural sector, and whether significant market disruption
would occur as a result. Following this technical review, EPA consulted
with the USDA and the Department of State. EPA determined that these
users did not meet the critical use criteria in Decision IX/6 and the
United States did not include them in the 2016 Critical Use Nomination.
EPA notified these sectors of their status by letters dated March 28,
2014. For each of these uses, EPA found that there are technically and
economically feasible alternatives to methyl bromide. EPA refers
readers to the Federal Register Notice ``Request for Methyl Bromide
Critical Use Exemption Applications for 2017'' (79 FR 38887; July 9,
2014) for a summary of information on how the Agency evaluated specific
uses and available alternatives when considering applications for
critical uses for 2016.
    EPA requested comment on the technical assessments of the
applications in the sector summaries found in the docket and the
determination that these users did not meet the critical use criteria.
EPA also requested any new or additional information that the Agency
may consider in preparing future nominations. EPA also sought comment
on the technical analyses contained in the U.S. nomination and
information regarding any changes to the registration (including
cancellations or registrations), use, or efficacy of alternatives that
occurred after the nomination was submitted.
    As EPA noted in the proposed rule, as the market for alternatives
evolves, the thresholds for what constitutes ``significant market
disruption'' or ``technical and economic feasibility'' may change. Such
information has the potential to alter the technical or economic
feasibility of an alternative and could thus cause EPA to modify the
analysis that underpins EPA's determination as to which uses and what
amounts of methyl bromide qualify for the CUE.
    EPA received one comment on the proposed rule. This commenter
highlighted the chemical and non-chemical alternatives in use in the
European Union, including other fumigants, integrated crop management
systems, heat treatment, gamma irradiation, cold storage, resistant
varieties and cultivars, crop rotation, cover crops, soil solarization,
and anaerobic disinfestation. EPA considered these alternatives when
developing the nomination for critical uses for 2016, but concluded
that additional research on alternatives is still necessary for dry
cured ham production, and that additional time to transition to
chloropicrin is needed for California strawberries.
    The same commenter urged the Agency to announce an end date for all
methyl bromide exemptions and, in light of the recent human health
incident in the U.S. Virgin Islands, to end the use of all methyl
bromide in the United States. Neither the Protocol nor the Clean Air
Act establishes a specific end date for the critical use exemption.
However, as noted in Decision Ex. I/4, the Parties intended for the
critical use exemption to be a limited, temporary derogation from that
phaseout. Progress in developing alternatives in key areas of
historical methyl bromide use has been significant and has allowed many
sectors to successfully transition from methyl bromide over the last
decade. Specifically, the number of sectors nominated has declined from
seventeen for 2006 to one for 2017.
    With respect to the commenter's request that EPA end all use of
methyl bromide in the U.S., we note that production for quarantine and
preshipment is excluded from the phaseout under the Montreal Protocol
and that section 604(d)(5) of the Clean Air Act directs EPA to exempt
production for this purpose. EPA continues to support this important
exemption to prevent the introduction and spread of quarantine pests
while encouraging research into alternatives that meet the rigorous
standards for quarantine and preshipment applications.

D. Critical Use Amounts

    Table A of the annex to Decision XXVI/6 lists critical uses and
amounts agreed by the Parties to the Montreal Protocol for 2016. The
maximum amount of new production and import for U.S. critical uses in
2016, specified in Table B of the annex to Decision XXVI/6, is 234.78
MT, minus available stocks. This figure is equivalent to less than 1
percent of the U.S. 1991 methyl bromide consumption baseline of 25,528
MT.
    EPA has determined the level of new production and import according
to the Framework Rule, as modified by the 2013 Rule. Under this
approach, the amount of new production for each control period equals
the total amount permitted by the Parties to the Montreal Protocol in
their Decisions minus any reductions for available stocks, carryover,
and the uptake of alternatives. These terms (available stocks,
carryover, and the uptake of alternatives) are discussed in detail
below. Applying this approach, EPA is allocating allowances to exempt
140,531 kg of new production and import of methyl bromide for critical
uses in 2016, making reductions for available stocks and carryover.
This is the same amount EPA proposed to allocate.
    Available Stocks: For 2016 the Parties indicated that the United
States should use ``available stocks,'' but did not indicate a minimum
amount expected to be taken from stocks. Consistent with EPA's past
practice, EPA considered what amount, if any, of the existing stocks
may be available to critical users during 2016. The latest data
reported to EPA from December 31, 2014, show existing stocks to be
158,121 kg. This shows that 198,440 kg of pre-2005 stocks were sold in
2014.
    The Parties to the Protocol recognized in their Decisions that the
level of existing stocks may differ from the level of available stocks.
Decision XXVI/6 states that ``production and consumption of methyl
bromide for critical uses should be permitted only if methyl bromide is
not available in sufficient quantity and quality from existing stocks.
. . .'' In addition, the Decision states that ``parties operating under
critical-use exemptions should take into account the extent to which
methyl bromide is available in sufficient

quantity and quality from existing stocks. . . .'' Earlier Decisions
also refer to the use of ``quantities of methyl bromide from stocks
that the Party has recognized to be available.'' Thus, it is clear that
individual Parties may determine their level of available stocks.
Section 604(d)(6) of the CAA does not require EPA to adjust the amount
of new production and import to reflect the availability of stocks;
however, as explained in previous rulemakings, making such an
adjustment is a reasonable exercise of EPA's discretion under this
provision.
    In the 2013 CUE Rule (78 FR 43797, July 22, 2013), EPA established
an approach that considered whether a percentage of the existing
inventory was available. In that rule, EPA took comment on whether 0%
or 5% of the existing stocks was available. The final rule found 0% was
available for critical use in 2013 for a number of reasons including: A
pattern of significant underestimation of inventory drawdown; the
increasing concentration of critical users in California while
inventory remained distributed nationwide; and the recognition that the
Agency cannot compel distributors to sell inventory to critical users.
For further discussion, see the 2013 CUE Rule (78 FR 43802).
    EPA believes that 5% of existing stocks will be available in 2016
for the two critical uses. As a result of the changes to the FIFRA
labeling, methyl bromide sold or distributed in 2015 can only be used
for approved critical uses or for quarantine and preshipment purposes.
Except for sectors with quarantine and preshipment uses, California
strawberries is the only pre-plant sector that will be able to use
stocks in 2015 or 2016. EPA does not anticipate stocks to be used for
quarantine and preshipment uses as there are no production allowances
required to manufacture that material and it tends to be less expensive
than stocks. Distributors will therefore likely make stocks available
to California strawberry growers in 2015 and 2016.
    While EPA has not estimated the amount of stocks that will be used
in 2015, EPA believes that at least 5% of stocks will be available in
2016. As discussed in the section on carryover below, demand by
California strawberry growers in 2014 for critical use methyl bromide
was lower than anticipated. For the first time since 2009, not all of
the critical use material produced or imported for a control period was
sold. Decreased demand for critical use methyl bromide in 2014 means
that unsold material already produced will be available in 2015 in
addition to stocks.
    Furthermore, EPA now knows the national distribution and
composition of stocks (e.g. pure or mixed with chloropicrin) due to a
recent information collection request under section 114 of the Clean
Air Act. After reviewing results of the information collection request,
EPA believes there is geographically accessible pure methyl bromide for
ham producers in the Southeastern U.S. as well as pre-plant methyl
bromide for California strawberry producers.
    For these reasons, EPA finds that 5% of the existing inventory is
available for use in 2016. Existing stocks, as of December 31, 2014,
were equal to 158,121 kg. Therefore, EPA is reducing the amount of new
production for 2016 by 7,906 kg, as proposed.
    EPA specifically invited comment on whether between 0% and 5% of
existing inventory will be available to critical users in 2016. EPA did
not receive any comments on that specific issue but did receive a
comment that it is unclear whether the information received by EPA is
an accurate reflection of the existing and available stocks of methyl
bromide in the United States. The commenter encouraged improved
information gathering to better ensure that these stocks are being used
in compliance with the FIFRA labeling and the critical use exemption.
    EPA has undertaken two information gathering requests in 2015 under
section 114 of the CAA. The first request was discussed in the proposed
rule and sought information about the composition (i.e. pure vs mixed
with chloropicrin), quantity, and location of stocks. The new
information provided to the Agency in response to this request has
enhanced EPA's understanding of existing and available stocks of methyl
bromide in the United States. EPA's second request for information
under section 114 of the Clean Air Act was in part a response to the
misuse of methyl bromide in a residential space in the U.S. Virgin
Islands and sought additional sales information from all known methyl
bromide distributors. Specifically, EPA sought the names of all
distributors and third party applicators of CUE, QPS, and pre-2005
stocks in 2014. EPA is currently reviewing responses to this request.
    As a further response, under FIFRA, EPA is also working to
implement changes to methyl bromide commodity labels in order to
clarify uses and provide additional protections for workers and
bystanders. EPA is also looking at how additional reporting could help
ensure compliance with label requirements through EPA's Registration
Review program, which evaluates pesticides on a regular basis.
Information on the review of methyl bromide, along with a schedule of
when the next public comment periods are anticipated, can be found on
regulations.gov at docket number EPA-HQ-OPP-2013-0269.
    Carryover Material: EPA regulations prohibit methyl bromide
produced or imported after January 1, 2005, under the critical use
exemption, from being added to the pre-2005 inventory. Quantities of
methyl bromide produced, imported, exported, or sold to end-users under
the critical use exemption in a control period must be reported to EPA
the next year. EPA uses these reports to calculate any excess methyl
bromide left over from that year's CUE and, using the framework
established in the 2005 CUE Rule, reduces the following year's total
allocation by that amount. Carryover had been reported to the Agency
every year from 2005 to 2009. Carryover material (which is produced
using critical use allowances) is not included in EPA's definition of
existing inventory (which applies to pre-2005 material) because this
would lead to a double-counting of carryover amounts.
    In 2015, companies reported that 442,200 kg of methyl bromide was
produced or imported for U.S. critical uses in 2014. Companies also
reported that 355,857 kg of critical use methyl bromide was sold to
end-users in 2014. EPA calculates that the carryover at the end of 2014
was 86,343 kg, which is the difference between the reported amount of
critical use methyl bromide produced or imported in 2014 and the
reported amount of sales of that material to end users in 2014. EPA's
calculation of carryover is consistent with the method used in previous
CUE rules, and with the format in Decision XVI/6 for calculating column
L of the U.S. Accounting Framework. All U.S. Accounting Frameworks for
critical use methyl bromide are available in the public docket for this
rulemaking. EPA is therefore reducing the total level of new production
and import for critical uses by 86,343 kg to reflect the amount of
carryover material available at the end of 2014, in addition to the
7,906 kg reduction for available stocks discussed above.
    EPA has considered the possibility that there might be methyl
bromide produced in 2015 and 2016 carried over into subsequent years.
Any pre-plant critical use methyl bromide carried over from the 2015
control period could not be subtracted in 2017, as would usually be
done. That is because critical use material produced for a pre-plant
use

must be used on a pre-plant use and the United States has not nominated
a pre-plant use for 2017. Such carryover could be used in 2016 while
California strawberry production is a critical use. Any pre-plant
methyl bromide produced under the authority of this rule in 2016 that
is not used in 2016 would have to be destroyed. EPA has discussed these
matters with methyl bromide distributors, producers, and importers that
reported to EPA that they have carryover material to make them aware of
the need to use all pre-plant critical use methyl bromide by the end of
2016. California strawberry growers represent a large end-use with
capacity to use all remaining pre-plant critical use material by the
end of 2016.
    EPA believes that not all 2014 carryover produced for post-harvest
uses may be used by the end of 2016 given the low volume used by the
ham production sector. As discussed above, EPA has accounted for 2014
post-harvest carryover in this rule and has reduced the production of
new material. EPA is also working to connect dry cured ham producers
with distributors that hold post-harvest carryover to help ensure that
it will be used. However, EPA believes that ham producers should be
allowed to continue to use carryover post-harvest critical use methyl
bromide should any remain after 2016. EPA believes that hams may not
have a technically or economically feasible alternative by the end of
2016 and thus will likely continue to meet the critical use criteria
beyond 2016. Therefore, to provide certainty to the ham producers and
to continue an orderly reduction in methyl bromide produced for
critical uses, EPA will allow the continued use of post-harvest
carryover for hams beyond 2016. Accordingly, EPA is not specifying a
date limitation in appendix L for the approval of dry cured pork
products as critical uses.
    Uptake of Alternatives: EPA considers data on the availability of
alternatives that it receives following submission of each nomination
to UNEP. In previous rules EPA has reduced the total CUE amount when a
new alternative has been registered and increased the new production
amount when an alternative is withdrawn, but not above the amount
permitted by the Parties. Neither circumstance has occurred since the
nomination was submitted for 2016.
    EPA is not making any other modifications to CUE amounts to account
for availability of alternatives. Rates of transition to alternatives
have already been applied for permitted 2016 critical use amounts
through the nomination and authorization process. EPA continues to
gather information about methyl bromide alternatives through the CUE
application process, and by other means. EPA also continues to support
research and adoption of methyl bromide alternatives, and to request
information about the economic and technical feasibility of all
existing and potential alternatives.
    Allocation Amounts: EPA is issuing critical use allowances for new
production or import of methyl bromide equivalent to 140,531 kg to
Great Lakes Chemical Corporation, Albemarle Corporation, ICL-IP
America, and TriCal, Inc in proportion to their respective baselines.
Paragraph 3 of Decision XXVI/6 states that ``parties shall endeavour to
license, permit, authorize or allocate quantities of methyl bromide for
critical uses as listed in table A of the annex to the present
decision. . . .'' This is similar to language in prior Decisions
permitting critical uses. These Decisions call on Parties to endeavor
to allocate critical use methyl bromide on a sector basis.
    EPA is assigning the 7,906 kg reduction for available stocks and
86,343 kg reduction for carryover in proportion to the amounts
indicated in Table A of the annex to Decision XXVI/6. In other words,
both the pre-plant and the post-harvest allocation are reduced by 40%.
Specifically, the pre-plant allocation for California strawberry
production is 138,592 kg and the post-harvest allocation for dry cured
ham is 1,939 kg. Reported data show that the critical use methyl
bromide carried over from 2014 and the existing stocks include both
pre-plant and post-harvest material.
    The proposed Framework Rule contained several options for
allocating critical use allowances, including a sector-by-sector
approach. The Agency evaluated various options based on their economic,
environmental, and practical effects. After receiving comments, EPA
determined in the final Framework Rule that a lump-sum, or universal,
allocation, modified to include distinct caps for pre-plant and post-
harvest uses, was the most efficient and least burdensome approach that
would achieve the desired environmental results, and that a sector-by-
sector approach would pose significant administrative and practical
difficulties. Because there is only one use in the pre-plant sector and
one use in the post-harvest sector, this rule follows the breakout of
specific uses in Decision XXVI/6.
    Emergency Use: The U.S. government is committed to using
flexibility in the Protocol's existing mechanisms as an avenue to
address changes in national circumstance that affect the transition to
alternatives. EPA requested comments and any new information on
specific emergency situations that may necessitate the use of methyl
bromide, consistent with the requirements of the Montreal Protocol, and
which could be difficult to address using current tools and
authorities. EPA did not receive any comments in response to this
request.

E. The Criteria in Decisions IX/6 and Ex. I/4

    Decision XXVI/6 calls on Parties to apply the criteria in Decision
IX/6, paragraph 1 and the conditions set forth in Decision Ex. I/4 (to
the extent applicable) to exempted critical uses for the 2016 control
period. The following section provides references to sections of this
preamble and other documents where EPA considers the criteria of those
two Decisions.
    Decision IX/6, paragraph 1 contains the critical use criteria,
which are summarized in Section III.A of the preamble. The nomination
documents detail how each critical use meets the criteria in Decision
IX/6, paragraph 1 including: The lack of available technically and
economically feasible alternatives under the circumstance of the
nomination; efforts to minimize use and emissions of methyl bromide
where technically and economically feasible; and the development of
research and transition plans. The nomination documents also address
the requests in Decision Ex. I/4 paragraphs 5 and 6 that Parties
consider and implement MBTOC recommendations, where feasible, on
actions a Party may take to reduce the critical uses of methyl bromide
and include information on the methodology they use to determine
economic feasibility.
    A discussion of the Agency's application of the critical use
criteria to the critical uses in this rule appears in Sections III.A.,
III.C., and III.D. of this preamble. The Agency has previously provided
its interpretation of the criterion in Decision IX/6, paragraph
(1)(a)(i) regarding the presence of significant market disruption in
the absence of an exemption. EPA refers readers to the preamble to the
2006 CUE rule (71 FR 5989, February 6, 2006) as well as to the memo in
the docket titled ``Development of 2003 Nomination for a Critical Use
Exemption for Methyl Bromide for the United States of America'' for
further elaboration. As explained in those documents, EPA's
interpretation of this term has several dimensions, including looking
at potential effects on both demand and supply for a commodity,
evaluating potential losses at both an individual

level and at an aggregate level, and evaluating potential losses in
both relative and absolute terms.
    The United States also considered the research and adoption of
alternatives when developing the National Management Strategy submitted
to the Ozone Secretariat in December 2005 and updated in October 2009.
The National Management Strategy addresses all of the aims specified in
Decision Ex. I/4, paragraph 3 to the extent feasible and is available
in the docket for this rulemaking.

F. Emissions Minimization

    Previous Decisions of the Parties have stated that critical users
shall employ emissions minimization techniques such as virtually
impermeable films, barrier film technologies, deep shank injection and/
or other techniques that promote environmental protection, whenever
technically and economically feasible. EPA developed a comprehensive
strategy for risk mitigation through the 2009 Reregistration
Eligibility Decision (RED) \2\ for methyl bromide, available in the
docket to this rulemaking, which is implemented through restrictions on
how methyl bromide products can be used. This approach means that
methyl bromide labels require that treated sites be tarped. The RED
also incorporated incentives for applicators to use high-barrier tarps,
such as virtually impermeable film, by allowing smaller buffer zones
around those sites. In addition to minimizing emissions, use of high-
barrier tarps has the benefit of providing pest control at lower
application rates. The amount of methyl bromide nominated by the United
States reflects the lower application rates necessary when using high-
barrier tarps.
---------------------------------------------------------------------------

    \2\ Additional information on risk mitigation measures for soil
fumigants is available at http://epa.gov/pesticides/reregistration/soil_fumigants/.
---------------------------------------------------------------------------

    EPA will continue to work with the U.S. Department of Agriculture--
Agricultural Research Service (USDA-ARS) and the National Institute for
Food and Agriculture (USDA-NIFA) to promote emissions reduction
techniques. The Federal government has invested substantial resources
into developing and implementing best practices for methyl bromide use,
including emissions reduction practices. The Cooperative Extension
System, which receives some support from USDA-NIFA, provides locally
appropriate and project-focused outreach education regarding methyl
bromide transition best practices. Additional information on USDA
research on alternatives and emissions reduction can be found at:
http://www.ars.usda.gov/research/programs/programs.htm?NP_CODE=303,
http://www.ars.usda.gov/research/programs/programs.htm?NP_CODE=304, and
http://www.csrees.usda.gov.
    Users of methyl bromide should continue to minimize overall
emissions of methyl bromide. EPA also encourages researchers and users
who are using techniques to minimize emissions of methyl bromide to
inform EPA of their experiences and to provide information on such
techniques with their critical use applications.

G. Technical Correction to Recordkeeping and Reporting Provisions

    EPA is making minor technical changes to section 82.13(y) and (z)
related to recordkeeping and reporting under the quarantine and
preshipment exemption. Section 82.13(y) contains a reference to
paragraph (aa) where it should reference paragraph (y). Similarly,
section 82.13(z) contains a reference to paragraph (bb) where it should
reference paragraph (z). This merely corrects a typographical error and
is not a substantive change to the recordkeeping requirements or the
quarantine and preshipment exemption program.

VII. Statutory and Executive Order Reviews

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

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0482. The application, recordkeeping, and reporting
requirements have already been established under previous critical use
exemption rulemakings.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. Since this rule allows the use of methyl
bromide for approved critical uses after the phaseout date of January
1, 2005, this action confers a benefit to users of methyl bromide. We
have therefore concluded that this action will relieve regulatory
burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538. The action imposes no enforceable duty on any
state, local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the 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. This
action allocates allowances for the production and import of methyl
bromide to private entities. This rule also limits the critical uses to
geographical areas that reflect the scope of the trade associations
that applied for a critical use. This rule does not impose any duties
or responsibilities on state governments or allocate any rights to
produce or use methyl bromide to a state government.

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

    This action does not have tribal implications as specified in
Executive Order 13175. This rule does not significantly or uniquely
affect the communities of Indian tribal governments nor does it impose
any enforceable duties on communities of Indian tribal governments.
Thus, Executive Order 13175 does not apply to this action.

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

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the Agency does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action's health and risk assessments are contained in
the Regulatory Impacts

Analysis and Benefits Analysis found in the docket.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy. This action does not pertain to any
segment of the energy production economy nor does it regulate any
manner of energy use.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    EPA believes this action will not have disproportionately high and
adverse human health or environmental effects on minority or low-income
populations because it affects the level of environmental protection
equally for all affected populations. Any ozone depletion that results
from this action will result in impacts that are, in general, equally
distributed across geographical regions in the United States. The
impacts do not fall disproportionately on minority or low-income
populations but instead vary with a wide variety of factors.
Populations that work or live near fields or other application sites
may benefit from the reduced amount of methyl bromide applied, as
compared to amounts allowed under previous critical use exemption
rules.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective January 1, 2016.

List of Subjects in 40 CFR Part 82

    Environmental protection, Chemicals, Exports, Imports, Ozone
depletion.

    Dated: October 5, 2015.
Gina McCarthy,
Administrator.
    For the reasons stated in the preamble, 40 CFR part 82 is amended
as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

0
2. Amend Sec.  82.8 by revising the table in paragraph (c)(1) to read
as follows:

Sec.  82.8  Grant of essential use allowances and critical use
allowances.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                           2016 Critical   2016 Critical
                                          use allowances  use allowances
                 Company                   for pre-plant     for post-
                                              uses *      harvest uses *
                                            (kilograms)     (kilograms)
------------------------------------------------------------------------
Great Lakes Chemical Corp. A Chemtura             84,222           1,179
 Company................................
Albemarle Corp..........................          34,634             485
ICL-IP America..........................          19,140             268
TriCal, Inc.............................             596               8
Total...................................         138,592           1,939
------------------------------------------------------------------------
* For production or import of Class I, Group VI controlled substance
  exclusively for the pre-plant or post-harvest uses specified in
  appendix L to this subpart.

* * * * *

0
3. Amend Sec.  82.13 by revising paragraphs (y) and (z) to read as
follows:

Sec.  82.13  Recordkeeping and reporting requirements for class I
controlled substances.

* * * * *
    (y) Every distributor of methyl bromide (class I, Group VI
controlled substances) who purchases or receives a quantity produced or
imported solely for quarantine or preshipment applications under the
exemptions in this subpart must comply with recordkeeping and reporting
requirements specified in this paragraph (y) of this section.
    (z) Every applicator of class I, Group VI controlled substances who
purchases or receives a quantity produced or imported solely for
quarantine and preshipment applications under the exemptions in this
subpart must comply with recordkeeping and reporting requirements
specified in this paragraph (z) of this section.
* * * * *

0
4. Amend subpart A by revising appendix L to read as follows:

APPENDIX L TO SUBPART A OF PART 82--APPROVED CRITICAL USES AND LIMITING
CRITICAL CONDITIONS FOR THOSE USES

----------------------------------------------------------------------------------------------------------------
               Column A                            Column B                             Column C
----------------------------------------------------------------------------------------------------------------
Approved Critical Uses................  Approved Critical User,         Limiting Critical Conditions
                                         Location of Use.               that exist, or that the approved
                                                                         critical user reasonably expects could
                                                                         arise without methyl bromide
                                                                         fumigation:
----------------------------------------------------------------------------------------------------------------
                                                 PRE-PLANT USES
----------------------------------------------------------------------------------------------------------------
Strawberry Fruit......................  California growers in 2015 and  Moderate to severe black root rot or
                                         2016..                          crown rot
                                                                        Moderate to severe yellow or purple
                                                                         nutsedge infestation

                                                                        Moderate to severe nematode infestation
                                                                        Local township limits prohibiting 1,3-
                                                                         dichloropropene
----------------------------------------------------------------------------------------------------------------
                                                POST-HARVEST USES
----------------------------------------------------------------------------------------------------------------
Dry Cured Pork Products...............  Members of the National         Red legged ham beetle infestation
                                         Country Ham Association and    Cheese/ham skipper infestation
                                         the American Association of    Dermestid beetle infestation
                                         Meat Processors, Nahunta Pork  Ham mite infestation
                                         Center (North Carolina), and
                                         Gwaltney of Smithfield Inc..
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-26301 Filed 10-14-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64394-64396]
[FR Doc No: 2019-25340]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0368]

Hours of Service of Drivers: North Shore Environmental
Construction, Inc.; Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to deny North Shore Environmental
Construction, Inc.'s (North Shore) application for exemption from the
``14-hour rule'' of the hours-of-service (HOS) regulations for drivers
responding to actual and potential environmental emergencies. FMCSA
analyzed the exemption application and the public comments and
determined that the applicant will not achieve a level of safety that
is equivalent to, or greater than, the level that would be achieved
absent such exemption.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Telephone:<PHONE_NUMBER>; Email:
<EMAIL_ADDRESS>If you have questions on viewing or submitting material
to the docket, contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, FMCSA-2018-0368 in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
E.T., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews the safety analyses and public comments
submitted, and determines whether granting the exemption would likely
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by the current regulation (49 CFR 381.305). The
Agency's decision must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to 5
years) and explain its terms and conditions. The exemption may be
renewed (49 CFR 381.300(b)).

III. Request for Exemption

    North Shore Environmental Construction, Inc. (North Shore) seeks an
exemption from the ``14-hour rule'' [49 CFR 395.3(a)(2)] for its
drivers responding to environmental emergencies. North Shore employs 12
commercial driver's license holders and its total number of commercial
motor vehicles (CMVs) is 15. In responding to emergency incidents,
North Shore's technicians work alongside a mix of private industry and
public agencies; their work often has a direct impact on the protection
of both public safety and the environment. North Shore advises that it
is contractually required to provide direct assistance to responsible
parties who are experiencing actual or potential environmental
emergencies. North Shore's employees are hybrid driver/operator/
technicians. Their duties include industrial maintenance, spill
response, sampling, lab packing, and waste management. Per North Shore,
with the current driver shortage, obtaining drivers with these
additional skills and experience has become problematic.
    North Shore requested relief from the ``14-hour rule.'' North Shore
states that the hours-of-service (HOS) rules have always been an issue
for emergency response companies. It requests this exemption to allow
the company to respond to a release or threat of a release of oil and
other hazardous materials (HM), subject to the following conditions for
each driver:
     On-duty period will not exceed 4.5 additional hours for
initial response;
     Any driver who exceeds the 14-hour period would in no case
exceed a total of 8 hours' drive time;
     Drivers would not exceed 70 hours on duty in 8 days;
     Drivers would be required to take 10 hours off duty,
subsequent to the duty day; and
     All activities would be subject to the electronic logging
device rule.
    According to North Shore, the initial response hours are the most
critical in an environmental emergency. North Shore believes that a
tightly managed exemption provides a risk averse situation by
discouraging potentially unmanaged risk taking. If the exemption is not
granted, there could be a disruption of nation/regional commerce
activities, including power restoration activities and protection of
interstate commerce and infrastructure.
    A copy of the North Shore application for exemption is available
for review in the docket for this notice.

IV. Method To Ensure an Equivalent Level of Safety

    To ensure an equivalent level of safety North Shore offers to
implement policies on fatigue and transportation management. North
Shore also offers the maintenance of a multitude of safety, security,
annual medical surveillance, and training plans, as well as
comprehensive drug and alcohol programs compliant with multiple
Department of Transportation regulations.

V. Public Comments

    On December 18, 2018, FMCSA published notice of this application
and requested public comment (83 FR 64925). The Agency received three
comments, all opposing the exemption. The Commercial Vehicle Safety
Alliance (CVSA) argued that the request is both unjustified and
impractical. According to CVSA, ``first and foremost, exemptions from
federal safety regulations have the potential to undermine safety,
while also complicating the enforcement process. The Federal Motor
Carrier Safety Regulations (FMCSRs) and HM Regulations exist to ensure
that those operating in the transportation industry are equipped to do
so safely. If granted, this exemption would place an excessive burden
on the enforcement community and negatively impact safety. The federal
HOS requirements exist to help prevent and manage driver fatigue.''
    The Agency also received comments from Mr. Brian Fuller and Mr.
Michael Millard. Both opposed exemptions from the HOS rules in general.
Mr. Millard also argued that the requested exemption is duplicative of
the emergency relief rule under Sec.  390.23.

VI. FMCSA Response and Decision

    FMCSA has evaluated North Shore's application for exemption and the
public comments submitted and hereby denies the exemption. When the
Agency established the rules mandating HOS, it relied upon research
indicating that the rules improve CMV safety. These regulations put
limits in place for when and how long an individual may drive to ensure
that drivers stay awake and alert while driving and to reduce the
possibility of driver fatigue.
    Based on the body of research the Agency has relied upon in
developing the HOS requirements, there is no basis for granting an
exemption that would allow an individual to drive after the 18th hour
after coming on duty when there is no mandatory off-duty time included
within the 18-hour period. Although the applicant explained that
drivers would not exceed 8 hours of driving time during a work shift,
the Agency does not believe there is a basis for concluding that the 8-
hour limit on driving time offsets the potential

increase in safety risks associated with an 18.5 hour driving window.
    The applicant is essentially requesting that the 14-hour rule be
extended by 4.5 hours in exchange for a 3-hour reduction in the
driving-time limit. The Agency does not find this safety equivalency
claim to be persuasive.
    The North Shore application does not analyze the safety impacts the
requested exemption from the HOS regulations may cause nor does it
provide countermeasures to ensure that the exemption would likely
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by the current regulations. Furthermore, the
applicant did not provide clear parameters that would have to be met to
trigger the exemption.
    For these reasons, FMCSA denied the request for exemption.

    Issued on: November 14, 2019.
 Jim Mullen,
 Deputy Administrator.
[FR Doc. 2019-25340 Filed 11-20-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51182-51183]
[FR Doc No: 2014-20291]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1082]

Highly Multiplexed Microbiological/Medical Countermeasure In
Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Highly Multiplexed
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based
Diagnostic Devices.'' This guidance is to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of highly multiplexed microbiological/medical
countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs)
intended to simultaneously detect and identify multiple pathogen
nucleic acids extracted from a single appropriate human specimen or
culture.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro
Nucleic Acid Based Diagnostic Devices'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Hobson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5560, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance is to provide industry and Agency staff with
recommendations for studies to establish the analytical and clinical
performance of HMMDs intended to simultaneously detect and identify
multiple pathogen nucleic acids extracted from a single appropriate
human specimen or culture. For the purposes of this guidance document,
the multiplex level that is used to define HMMDs is the capability to
detect >=20 different organisms/targets, in a single reaction, using a
nucleic acid-based technology and involves testing multiple targets
through a common process of specimen preparation, amplification and/or
detection, and result interpretation. HMMDs are used

to aid in the diagnosis of infection or screening for colonization.
    The scope of this guidance includes nucleic acid-based devices that
employ technologies such as polymerase chain reaction, reverse-
transcriptase polymerase chain reaction, bead-based liquid arrays,
microarrays, re-sequencing approaches as well as the measurement of
individual targets via a common process of sample preparation, target
or signal amplification, allele discrimination, and collective
interpretation, and are reported out simultaneously. This guidance is
not intended to address devices that utilize detection mechanisms other
than nucleic acid-based approaches. The document does not apply to
devices that are intended to screen donors of blood and blood
components, and donors of human cells, tissues, and cellular- and
tissue-based products for communicable diseases.
    The draft of this guidance was issued on November 9, 2012 (77 FR
67379). The comment period closed on February 7, 2013. Two sets of
comments were received and reviewed by FDA. The guidance was updated to
address comments where appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on HMMDs. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Highly Multiplexed
Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based
Diagnostic Devices'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1803 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20291 Filed 8-26-14; 8:45 am]
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[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Proposed Rules]
[Pages 37340-37342]
[FR Doc No: 2012-15168]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0642; Directorate Identifier 2011-NM-262-AD]
RIN 2120-AA64

Airworthiness Directives; BAE SYSTEMS (OPERATIONS) LIMITED
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain BAE SYSTEMS (OPERATIONS) LIMITED Model BAe 146 series airplanes
and Model Avro 146-RJ series airplanes. This proposed AD was prompted
by hydraulic pipe ruptures in the center of the cabin resulting in
passengers being contaminated with hydraulic fluid. This proposed AD
would require installing a hydraulic fluid containment system. We are
proposing this AD to prevent harmful or hazardous concentrations of
hydraulic fluid or hydraulic vapor from entering the passenger
compartment, possibly resulting in injury to the passengers.

DATES: We must receive comments on this proposed AD by August 6, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact BAE
SYSTEMS (OPERATIONS) LIMITED, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton,

Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0642;
Directorate Identifier 2011-NM-262-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0220, dated November 11, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Cases of hydraulic pipe ruptures in the centre of the cabin of
BAe 146 aeroplanes have been reported, which have resulted in the
passengers being contaminated with hydraulic fluid. The results of
the investigations have shown that the pipe failures were caused by
a combination of seam welded pipes, bends in the pipe runs with
small bend radii and fatigue damage due to pressure variations.
    This condition, if not corrected, could lead to harmful or
hazardous concentrations of hydraulic fluid or hydraulic vapour
entering the passenger compartment, possibly resulting in injury to
the occupants.
    For the reasons described above, this [EASA] AD requires the
installation of a flexible envelope around the hydraulic pipe group
where the failures have occurred to capture and contain any fluid
escaping from a burst pipe and channel it below floor level into the
forward cargo bay.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    BAE SYSTEMS (OPERATIONS) LIMITED has issued Modification Service
Bulletin SB.29-048-30676A, Revision 2, dated December 23, 2010. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1 product of U.S. registry. We also estimate that it
would take about 8 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $5,079 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
parts. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $5,759.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

BAE SYSTEMS (OPERATIONS) LIMITED: Docket No. FAA-2012-0642;
Directorate Identifier 2011-NM-262-AD.

(a) Comments Due Date

    We must receive comments by August 6, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to BAE SYSTEMS (OPERATIONS) LIMITED Model BAe
146-100A, -200A, and -300A airplanes, and Model Avro 146-RJ70A, 146-
RJ85A, and 146-RJ100A airplanes; certificated in any category except
for airplanes operating in a cargo configuration. The requirements
of this AD become applicable at the time an airplane operating in a
cargo configuration is converted to a passenger configuration.

(d) Subject

    Air Transport Association (ATA) of America Code 29, Hydraulic
power.

(e) Reason

    This AD was prompted by hydraulic pipe ruptures in the center of
the cabin resulting in passengers being contaminated with hydraulic
fluid. We are issuing this AD to prevent harmful or hazardous
concentrations of hydraulic fluid or hydraulic vapor from entering
the passenger compartment, possibly resulting in injury to the
passengers.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    Within 4,000 flight hours or 24 months after the effective date
of this AD, whichever occurs first, install the hydraulic fluid
containment system, in accordance with the Accomplishment
Instructions of BAE SYSTEMS (OPERATIONS) LIMITED Modification
Service Bulletin SB.29-048-30676A, Revision 2, dated December 23,
2010.

(h) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD, using the service bulletin specified in
paragraph (h)(1) or (h)(2) of this AD.
    (1) BAE SYSTEMS (OPERATIONS) LIMITED Modification Service
Bulletin SB.29-048-30676A, dated October 18, 2010.
    (2) BAE SYSTEMS (OPERATIONS) LIMITED Modification Service
Bulletin SB.29-048-30676A, Revision 1, dated November 5, 2010.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2011-0220, dated November 11, 2011; and BAE
SYSTEMS (OPERATIONS) LIMITED Modification Service Bulletin SB.29-
048-30676A, Revision 2, dated December 23, 2010; for related
information.
    (2) For service information identified in this AD, contact BAE
SYSTEMS (OPERATIONS) LIMITED, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on June 12, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-15168 Filed 6-20-12; 8:45 am]
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