[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Proposed Rules]
[Pages 51794-51800]
[FR Doc No: 2017-24341]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2017-0346; FRL-9970-56-OAR]
RIN 2060-AT65

Oil and Natural Gas Sector: Emission Standards for New,
Reconstructed, and Modified Sources: Three Month Stay of Certain
Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of data availability.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing this
notice of data availability (NODA) in support of the proposed rule
titled ``Oil and Natural Gas Sector: Emission Standards for New,
Reconstructed, and Modified Sources: Three Month Stay of Certain
Requirements,'' which was published on June 16, 2017. In this document,
the EPA is providing additional information on topics raised by
stakeholders and is soliciting comment on the information presented.

DATES: Comments must be received on or before December 8, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2017-0346, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Peter Tsirigotis, Sector Policies
and Programs Division (D205-01), Office of Air Quality Planning and
Standards, Environmental Protection Agency, Research Triangle Park,
North Carolina 27711; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:
    Organization of This Document. The information presented in this
document is organized as follows:

I. Background
II. Legal Authority
III. Stakeholder Input on Sources' Ability To Implement Requirements
    A. Fugitive Emissions Requirements
    B. Well Site Pneumatic Pump Requirements
    C. Professional Engineering Certification Requirements

I. Background

    On June 16, 2017, the EPA proposed to stay for 2 years certain
requirements that are contained within the final rule titled ``Oil and
Natural Gas Sector: Emission Standards for New, Reconstructed, and
Modified Sources,'' published in the Federal Register at 81 FR 35824,
June 3, 2016 (2016 Rule). This action proposed to stay the fugitive
emissions requirements, the well site pneumatic pump requirements, and
the requirements for certification of closed vent systems by a
professional engineer for 2 years, in order to provide the EPA with
sufficient time to propose, take public comment on, and issue a final
action on the issues concerning the specific requirements on which the
EPA has granted reconsideration. 82 FR 27645, June 16, 2017.
    The 2-year proposed stay, if finalized as proposed, would likely be
determined to be a major rule under the Congressional Review Act.
Therefore, the 2-year stay would not take effect until 60 days after
publication or after Congress receives the rule report, whichever is
later. To avoid such a potential delay, the EPA concurrently proposed
on June 16, 2017, a 3-month stay which would not qualify as a major
rule and could become effective upon publication. 82 FR 27641. As such,
the legal and factual basis for the shorter stay are the same as those
for the proposed longer stay, except that the shorter stay is intended
to cover only the period before the longer stay takes effect should the
EPA finalize both rules.
    Subsequent to the June 16, 2017, proposals (82 FR 27641 and 82 FR
27645), the Agency has heard a broad range of questions, concerns, and
constructive suggestions from stakeholders on how the proposed stays
could be improved. Since the legal and factual basis for both the
proposed shorter and longer stays are the same, this feedback is
relevant to both proposals. Therefore, we are issuing a NODA regarding
this feedback in both rulemakings. Similar to the NODA for the proposed
2-year stay also published today, this NODA for the proposed 3-month
stay is not intended to address all of the issues that have been
raised. Rather, the purpose of this document is to describe and seek
comment on several ideas with respect to the proposed stay raised by
stakeholders that may go beyond those for which the Agency sought
comment in the June 16, 2017, proposals. In this document, we describe
the specific issues and ideas raised by stakeholders and explain which
of those ideas we consider to be within or possibly beyond the scope of
comment already requested. The purpose of this document is to bring
these ideas to the attention of other stakeholders and the public so
that they may also provide comments to assist in developing a final
rule.

    The feedback the EPA has received since proposing the stays relates
to the EPA's legal authority to stay these requirements and lack of
clarity and other challenges in implementing these three requirements.
With respect to the implementation challenges, the commenters
recommend, as an alternative to the proposed stays, that the EPA amend
the 2016 Rule to extend the periods currently provided in the 2016 Rule
for establishing the necessary infrastructure and phasing in the
requirements for conducting the initial monitoring survey of fugitive
emissions and for routing well site pneumatic pump emissions to onsite
controls or processes. The feedback similarly suggests the need for a
phase-in period to allow a scale-up of the number of qualified
professional engineers to meet the demand imposed by the 2016 Rule. The
EPA is soliciting comments on this recommendation. Specifically, the
EPA is soliciting relevant data and information, in particular those
related to the EPA's analyses and assumptions that were used to
establish the phase-in periods in the 2016 Rule, to help inform the EPA
why the appropriate duration of these periods may have been
underestimated, as the feedback suggests. Further, with respect to the
requirement for certification of closed vent systems by a professional
engineer, while in the preamble to the 2015 proposed new source
performance standards (NSPS) the EPA had suggested such certification
as a potential remedy where a storage vessel is improperly designed,\1\
the final 2016 Rule requires such certification for demonstrating
compliance with not only the storage vessel emission standards, but a
number of other emission standards, thereby affecting a large number of
affected sources.\2\ According to the feedback received, the immediate
high demand for qualified professional engineers to meet this
certification requirement has made implementation of this requirement
quite challenging. In light of the feedback, the EPA is soliciting
comments, data, and any other information that would help the EPA
determine whether a phase-in period for this requirement is needed and,
if so, the length of such period.
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    \1\ 80 FR 56649, September 18, 2015.
    \2\ 40 CFR 60.5411a(d).
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    As in the NODA for the proposed 2-year stay, the EPA is soliciting
comment on this feedback, including whether a phase-in period would be
an appropriate alternative to the proposed stay. The EPA is soliciting
comment on whether a phase-in period would provide relief for
implementation challenges described in this NODA and expedite
regulatory certainty for owners and operators. While the comment period
on the June 16, 2017, proposal for a 3-month stay closed on August 9,
2017, comments on this notice may include additional comments on
statements made in that proposal.

II. Legal Authority

    The EPA received comments from stakeholders on our legal authority
to stay these requirements or otherwise amend the 2016 Rule to extend
the ``phase-in'' periods currently provided in that rule.\3\ See Docket
ID No. EPA-HQ-OAR-2010-0505-10577. Specifically, noting that these
requirements are not mandated by Clean Air Act (CAA) section
111(b)(1)(B), the commenter interprets CAA section 111 as authorizing
the EPA to extend compliance deadlines or establish future compliance
dates. The commenter also cites section 705 of the Administrative
Procedure Act (APA) to provide the EPA authority to stay these
requirements pending judicial review. The commenter interprets the term
``postpone'' in section 705 of the APA to include ``delay, defer,
adjourn, shelve, table, and put on hold.'' Id. at 7. Lastly, the
commenter argues that the EPA's general rulemaking authority under
section 301(a) of the CAA authorizes a rulemaking staying these
requirements because ``Congress has not written a `clear impediment to
the issuance' '' of such stay. Id. at 12 (citations omitted). The EPA
solicits comments on these legal theories provided in this comment
document. See Docket ID No. EPA-HQ-OAR-2010-0505-10577.
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    \3\ While this document specifically addresses the proposed 2-
year stay (82 FR 27645, June 16, 2017), it is discussing the EPA's
legal authority to stay a rule and, as such, is relevant to the
proposed 3-month stay.
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    For the reasons stated below, the EPA has legal authority to amend
the 2016 Rule to either stay certain provisions or otherwise revise
certain aspects of the rule. The EPA promulgated the 2016 Rule pursuant
to section 111(b)(1)(B) of the CAA in accordance with the notice-and-
comment rulemaking procedures under section 307(d) of the CAA. 81 FR
35828, June 3, 2016. The EPA is using the same statutory authority and
following the same procedures in the present rulemaking to amend the
2016 Rule to stay certain requirements for 3 months (as described in
the June 16, 2017, notice) or make the suggested changes to aspects of
these requirements as described in this action (i.e., extension or
provision of ``phase-in'' periods). In addition, section 301(a) of the
CAA provides the Agency with broad authority to prescribe regulations,
including revisions to prior rulemakings, as necessary to carry out the
Administrator's authorized functions under the statute. ``The power to
decide in the first instance carries with it the power to reconsider.''
Trujillo v. Gen. Elec. Co., 621 F.2d 1084, 1086 (10th Cir. 1980); see
also, United Gas Improvement Co. v. Callery Properties, Inc., 382 U.S.
223, 229 (1965); Mazaleski v. Treusdell, 562 F.2d 701, 720 (D.C. Cir.
1977).
    Section 111 of the CAA requires the EPA to list a source category
under that section if, ``in [the EPA Administrator's] judgment it
causes, or contributes significantly to, air pollution which may
reasonably be anticipated to endanger public health or welfare.'' Once
a source category is listed, CAA section 111(b)(1)(B) requires that the
EPA promulgate ``standards of performance'' for new sources in such
source category. In addition, CAA section 111(b)(1)(B) requires the EPA
to ``at least every 8 years review and, if appropriate, revise''
performance standards unless the ``Administrator determines that such
review is not appropriate in light of readily available information on
the efficacy'' of the standard. In 1979, the EPA published a list of
source categories, including Oil and Natural Gas, under section 111(b)
of the CAA. See Priority List and Additions to the List of Categories
of Stationary Sources, 44 FR 49222 (August 21, 1979) (``1979 Priority
List''). In 1985, the EPA promulgated NSPS for this source category
that addressed volatile organic compound(s) (VOC) emissions from
leaking components at onshore natural gas processing plants (40 CFR
part 60, subpart LLL) and sulfur dioxide emissions from natural gas
processing plants (40 CFR part 60, subpart KKK). In 2012, the EPA
conducted its required review under CAA section 111(b)(1)(B), and
promulgated NSPS subpart OOOO, which included updates to subparts KKK
and LLL standards, as well as additional VOC standards for this source
category.
    In addition to the mandatory obligations described above, the EPA
has discretion under CAA section 111(b)(1)(B) to add new standards of
performance for additional pollutants or emission sources not
previously covered concurrent with, or independent of, the 8-year
review. Pursuant to section 111(b)(1)(B) of the CAA, the EPA has
promulgated new performance standards for previously unregulated
sources concurrent with the 8-year review. See, e.g., 71 FR 9866
(February

27, 2006) (new particular matter standards for boilers); 73 FR 35838
(June 24, 2008) (new nitrogen oxide standards for additional sources at
refineries); 77 FR 49490 (August 16, 2012) (new VOC standards for
additional sources at oil and gas facilities). However, the appropriate
time for promulgating such new standards may not always align with the
8-year review cycle. See, e.g., 73 FR 35838, 35859. (The EPA did not
promulgate performance standards for greenhouse gas emissions as part
of the 8-year review of the NSPS for refineries because the Agency was
still in the process of gathering information and reviewing controls.)
While the EPA could conduct the required periodic review sooner than
every 8 years, which would potentially allow the EPA to conduct the
review and set additional standards concurrently, the EPA does not
believe that the schedule for the statutorily required review should be
driven by the timing for promulgating additional performance standards
that are discretionary. On the other hand, there is no reason that the
EPA's authority and discretion to promulgate such standards should be
constrained by the timing of the 8-year review. The EPA, therefore,
reasonably interprets CAA section 111(b)(1)(B) to allow the Agency to
exercise its discretion to promulgate new performance standards for
additional sources or pollutants when appropriate (concurrent with or
independent of the 8-year review).
    Pursuant to this authority under section 111(b)(1)(B) of the CAA,
the EPA promulgated the 2016 Rule which contained, among other things,
a number of new performance standards for emission sources not
previously covered, including the fugitive emissions components at well
sites and compressor stations, as well as pneumatic pumps at well
sites.\4\ The EPA promulgated the fugitive emissions requirements for
well sites and compressor stations pursuant to section 111(h) of the
CAA, which authorizes the EPA to set a design, equipment, work
practice, or operational standard where it is not technically feasible
to prescribe or enforce an emission standard. 80 FR 56593, 56637
(September 18, 2015). A work practice standard generally consists of a
set of activities that sources must perform and a time period for
completing the activities. See, e.g., 40 CFR 60.632 (180 days from
initial startup to comply with the requirements to detect and repair
leaks at onshore oil and natural gas processing plants). Similar to
existing work practice standards, the fugitive emissions requirements
in the 2016 Rule specify a set of activities (e.g., developing an
emission monitoring plan, conducting initial and subsequent surveys,
repair or replacement, and resurvey of fugitive emissions components
according to the plan) and time frames for performing the activities.
40 CFR 60.5397a. Specifically, the 2016 Rule specifies a period of time
(i.e., until June 3, 2017, or 60 days after starting up production,
whichever is later) for sources to establish the necessary
infrastructure, develop a monitoring plan, secure the required
personnel and equipment, and conduct the initial monitoring survey of
fugitive emissions components at well sites and compressor stations. 81
FR 35858-9 and 35863.
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    \4\ The 2016 Rule also includes standards for reducing methane
emissions from the oil and natural gas sector, as well as revisions
to the previously promulgated Oil and Natural Gas NSPS (40 CFR part
60, subpart OOOO).
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    The 2016 Rule similarly did not establish an emission limit for
well site pneumatic pumps, but instead requires that emissions from
well site pneumatic pumps be routed to an available control or process
onsite, unless a qualified professional engineer certifies that it is
not technically feasible to do so. As with the fugitive emissions
requirements, the 2016 Rule similarly provided a period of time (until
November 30, 2016) for owners and operators to conduct the ground work
required for routing well site pneumatic pumps to an available onsite
control or process (or, if it is not technically feasible to do so, for
obtaining a certification by a qualified engineer of the technical
infeasibility). 81 FR 35859, June 3, 2016.
    The 2016 Rule also added a requirement that all closed vent systems
routing emissions from storage vessels, compressors, and pneumatic pump
affected facilities be certified by a qualified professional engineer.
This certification requirement is not an emission standard under CAA
section 111(a)(1) or a design, equipment, work practice, or operational
standard under CAA section 111(h); it is a compliance measure that
would provide additional assurance that sources are meeting the
emission standards for storage vessels, compressors, and pneumatic
pumps. Some of these emission standards, such as those for storage
vessels and compressors, were promulgated in 2012 under section
111(b)(1)(B) of the CAA.
    Through the two June 16, 2017, actions, the EPA is proposing to
amend the 2016 Rule to stay for 3 months and 2 years, respectively, the
fugitive emissions requirements, the well site pneumatic pump
requirements, and the certification requirement described above. Since
then, the EPA has received suggestions that, instead of staying these
requirements, the EPA extend the current phase-in periods for the
fugitive emissions requirements and well site pneumatic pump
requirements, as well as providing one for the requirement for
certification of closed vent systems by a professional engineer.
Agencies have inherent authority to reconsider past decisions and to
revise, replace, or repeal a decision to the extent permitted by law
and supported by a reasoned explanation. FCC v. Fox Television
Stations, Inc., 556 U.S. 502, 515 (2009); Motor Vehicle Mfrs. Ass'n v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983) (``State
Farm''). This includes a decision regarding the appropriate length of
the phase-in periods provided in the 2016 Rule for specific
requirements, as well as whether to provide one for phasing in an
additional compliance assurance measure, or whether to stay these three
requirements at issue while they are being revised through rulemaking.
    Section 301(a) of the CAA provides the EPA with broad rulemaking
authority to carry out the CAA. Notwithstanding the potential
constraint that other parts of the CAA may have on the EPA's authority
to stay a rule pursuant to section 301(a), See Natural Resources
Defense Council, Inc. v. Reilly, 976 F.2d 36, 41 (D.C. Cir. 1992),
there is no such constraint here with respect to staying the fugitive
emissions requirements, the well site pneumatic pump requirements, and
the certification requirement in the 2016 Rule, the promulgation of
which was discretionary and not compelled by CAA section 111(b)(1)(B).
In a case analyzing a similar general rulemaking authority granted to
the Federal Reserve Board by the Truth in Lending Act, the Supreme
Court held quite broadly that, where ``the empowering provision of a
statute states simply that an agency may make such rules and
regulations as necessary to carry out the provisions of an act, the
validity of a regulation promulgated thereunder will be sustained so
long as it is `reasonably related to the purposes of the enabling
legislation.' '' Mourning v. Family Publications Service, Inc., 411
U.S. 356, 369 (1973) (quoting Thorpe v. Housing Authority of City of
Durham, 393 U.S. 268, 280-81 (1969)). In a CAA section 301(a) case, the
District of Columbia Circuit Court of Appeals held that CAA section
301(a) authorizes the EPA to use rulemaking to issue the enhanced
vehicle inspection and maintenance programs guidance under section 182
of the CAA. Natural Res. Def. Council, Inc.

v. EPA, 22 F.3d 1125 (D.C. Cir. 1994). Noting the absence of any
provision in CAA section 182 preventing issuing such guidance through
rulemaking, the Court deferred to the Agency's determination that the
regulation was necessary as long as it provided a reasoned explanation.
Id. at 1148.
    The EPA's proposed stay of the three requirements at issue, as well
as the stakeholder-suggested extension or provision of ``phase-in''
periods for these requirements, is consistent with the purposes of the
CAA and, therefore, authorized under section 301(a) of the CAA. The EPA
promulgated these requirements for purposes of achieving meaningful
emission reductions under the regulatory schemes established in the
2016 Rule to complement other emission reduction efforts and address
certain challenges (e.g., technical infeasibility and time needed for
building up for necessary equipment and trained personnel). For
instance, the EPA promulgated both the fugitive emissions requirements
and a process for applying and obtaining an alternative means of
emissions limitations (AMEL) with the clear intent to achieve emission
reductions from currently uncontrolled sources while still allowing
sources subject to effective existing state fugitive emissions programs
an avenue to continue implementing such programs, as well as to
encourage the use of innovative technology. Therefore, in promulgating
the fugitive emissions requirements, the EPA clearly intended and
anticipated the implementation of alternatives in lieu of such
requirements. However, stakeholders indicated that this purpose of the
2016 Rule was frustrated by the fact that the current AMEL provisions
are not sufficiently clear to allow sources to take advantage of them.
Stakeholders suggested that further revision or clarification would be
required before sources can apply and obtain approval to use an
innovative technology or implement their current state program in lieu
of the 2016 Rule requirements. The EPA received input from stakeholders
stating that without staying the fugitive emissions requirements
pending the EPA's reconsideration, the regulated entities would incur
significant and potentially unnecessary additional costs and compliance
burden to implement the 2016 Rule, and, in some cases, at the expense
of disrupting or complicating compliance with applicable state
programs, just to later revert back to what they were doing in the
first place. These were the consequences that the EPA sought to avoid
by promulgating the AMEL in the 2016 Rule. While not all states have
fugitive emissions programs, considering that many states with high oil
and gas production do have such programs in place,\5\ it is not clear
that the marginal additional emission reductions achieved during the
EPA's reconsideration process outweigh the potential disruption to
existing state programs and company-specific programs. In light of the
discussion above, the EPA believes that the proposed stay of the
fugitive emissions requirements pending its reconsideration process is
reasonable and authorized under sections 111 and 301 of the CAA.
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    \5\ Including California, Colorado, North Dakota, Ohio,
Pennsylvania, Texas, Utah, and Wyoming.
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    With respect to the well site pneumatic pump requirements, the 2016
Rule acknowledges that routing the pneumatic pump emissions to an
available onsite control or process may not always be technically
feasible and, therefore, provides a technical infeasibility exemption
for such routing except for pneumatic pumps located at a ``greenfield
site.'' However, some sources could not tell based on the 2016 Rule
definition of ``greenfield site,'' which was not proposed for notice
and comment, whether they are ``greenfield sites,'' even though they
are encountering technical infeasibility, and, therefore, risk being in
noncompliance. Delaying these requirements until the EPA resolves this
potential problem through its reconsideration process is consistent
with the 2016 Rule to require emission reductions from well site
pneumatic pumps only where it is technically feasible to do so.
    Lastly, as mentioned above, the closed vent certification by
professional engineer requirement is a compliance measure included in
the 2016 Rule to provide additional assurance that sources are meeting
the emission standards for a wide range of equipment, some of which
have been in place since 2012. The EPA granted reconsideration of this
requirement because the EPA had not considered its cost and whether the
additional assurance justifies such expenditure. The EPA's proposed
stay while conducting this evaluation is clearly consistent with
section 111 of the CAA, which expressly identifies cost as a factor for
consideration when promulgating emission standards. See CAA section
111(a)(1).
    For the reasons stated above, both the proposed stay and the
suggestion by stakeholders to extend (or provide) the phase-in periods
are lawful exercises of the EPA's statutory authority and discretion
under the CAA. The EPA solicits comment on the EPA's legal authorities
for taking these actions. In addition, as mentioned above, the EPA
solicits comment on stakeholder input \6\ on the EPA's legal
authorities to take these actions.
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    \6\ See, for example, Docket ID No. EPA-HQ-OAR-2010-0505-10577
and Docket ID No. EPA-HQ-OAR-2017-0346-0329.
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III. Stakeholder Input on Sources' Ability To Implement Requirements

    In the June 16, 2017, proposal for the 3-month stay, the EPA
referenced the proposed 2-year stay, in which the EPA explained that it
is proposing to stay the requirements at issue pending reconsideration
due to its concern that sources should not be compelled to comply with
these requirements pending the EPA's reconsideration of issues
associated with these requirements, as these issues impact the ability
of a wide range of sources to achieve and show compliance with their
applicable standards. 82 FR 27642; 82 FR 27646-8, June 16, 2017. As
explained above, unlike the proposed 2-year stay, the 3-month stay was
not intended to reflect the time for completing the reconsideration
process or to resolve the implementation issues discussed in this NODA,
but rather to help avoid a delay for the proposed longer stay to take
effect; otherwise, the legal and factual bases for the stay in both
proposed actions are the same. Therefore, as in the NODA for the 2-year
stay, the EPA similarly solicits comments on the legal and factual
bases for the proposed 3-month stay, as well as comments and
information on the challenges raised in the feedback received since
proposing the stay.
    Since proposing to stay the requirements pending reconsideration,
the EPA received feedback from some stakeholders indicating that there
are additional issues affecting sources' ability to implement the above
mentioned requirements besides those for which the EPA has granted
reconsideration.\7\ Some stakeholders suggested that the EPA should
amend the 2016 Rule by extending the ``phase-in'' periods provided in
the 2016 Rule for a build-up of the number of trained personnel (i.e.,
certified monitoring survey contractors, qualified professional
engineers) and equipment (i.e., monitoring instruments) required to
meet the demand imposed by the fugitive emissions requirements and the
well site pneumatic pump requirements.

The EPA had anticipated that during these periods, ``sources will begin
to phase in these requirements as additional devices and personnel
become available.'' 81 FR 35859 and 35863. As in the NODA for the
proposed 2-year stay, we similarly solicit comment on whether more time
(and how much more) is needed for ``phasing in'' these requirements. In
addition, the EPA solicits comments in this NODA on whether an
extension of these phase-in periods rather than the stay for 3 months
would provide more certainty to the regulated community should there be
a delay before the longer stay (or extension), if finalized, would take
effect. Some stakeholders suggested that these concerns may also exist
with respect to other provisions requiring professional engineer
certifications.
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    \7\ See, for example, Docket ID No. EPA-HQ-OAR-2010-0505-11108
and Docket ID No. EPA-HQ-OAR-2010-0505-12337.
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    As mentioned above, the EPA previously anticipated that some of
these issues might be present for a more limited period and, therefore,
provided in the 2016 Rule a ``phase-in'' period for both the fugitive
emissions requirements and the pneumatic pump requirements. 81 FR
35851, 35858-9, 35863, June 3, 2016. Specifically, in regards to the
fugitive emissions requirements, in light of the large number of
sources, the EPA concluded that time was needed to allow an increase in
production of the required equipment and scale-up of trained personnel,
as well as for sources to establish the groundwork and secure the
necessary monitoring equipment and personnel. The 2016 Rule, therefore,
provided a ``phase-in'' period by allowing sources to conduct initial
monitoring by June 3, 2017, or within 60 days after production starts,
whichever is later. 81 FR 35858-9, 35863, June 3, 2016. Some
stakeholders suggested that some sources continue to have difficulty
securing the necessary equipment and/or personnel to conduct the
required monitoring survey of fugitive emissions. For a similar reason,
the 2016 Rule provided a phase-in period until November 30, 2016, to
connect well site pneumatic pumps to an existing control or process
onsite. 81 FR 35851, June 3, 2016.
    However, some stakeholders suggested that the time provided in the
2016 Rule may not have been adequate to accommodate the number of
affected sources subject to these requirements. In addition, some
stakeholders indicated that sources that must now comply with these
requirements upon startup may be particularly affected by these
challenges. Therefore, the EPA solicits comment and information on
these challenges that sources are experiencing in carrying out these
requirements. Further, the EPA is soliciting comment on whether, in
light of the numerous ongoing compliance issues, the EPA should amend
the above mentioned phase-in periods in the 2016 Rule instead of simply
staying the requirements. The EPA additionally is soliciting comment on
the appropriate length of a phase-in period to address the challenges
sources are experiencing in carrying out the requirements in the 2016
Rule.
    Some stakeholders suggested that the challenges regarding acquiring
necessary equipment and trained personnel may also exist with respect
to the requirement of certification of closed vent systems by a
professional engineer. We note that the 2016 Rule does not have a
phase-in period associated with the closed vent system certification by
professional engineer requirement, which must be met by a wide range of
sources (i.e., storage vessels, compressors, and pneumatic pumps), even
though the EPA acknowledged that securing such professional engineer
certification may take time. 81 FR 35851, June 3, 2016. The EPA,
therefore, solicits comment on whether time (and how much) should be
provided to allow a further building up of the number of professional
engineers experienced in these requirements to meet the demand posed by
this certification requirement.
    A stay would mean that sources do not have to comply while the stay
is in place. It would not, however, change any dates in the 2016 Rule.
This could create some uncertainty for sources regarding their
obligations upon expiration of the stay. A change to the phase-in
periods (or the addition of such a period where the rule does not
currently provide one) could provide greater certainty to sources. In
light of this, the EPA solicits comment on whether it is more
appropriate to extend the phase-in periods in lieu of issuing a 3-month
stay. The EPA additionally solicits comment on whether a phase-in
period will provide additional relief and certainty to the regulated
community. As mentioned above, the EPA solicits comment on the
appropriate length of time needed to address the challenges sources are
experiencing in carrying out these requirements in the 2016 Rule and
the suggestion to extend the ``phase-in'' periods established in the
2016 Rule for the fugitive emissions requirements and the well site
pneumatic pump requirements, as well as the suggestion to provide a
phase-in period for the requirement for certification of closed vent
systems by a professional engineer.

A. Fugitive Emissions Requirements

    The EPA proposed to stay the fugitive emissions requirements at
well sites and compressor stations while it reconsiders the process and
criteria for requesting and receiving approval for the use of an AMEL
and the applicability of the fugitive emissions requirements to low
production well sites. 82 FR 27642-3 and 27646, June 16, 2017. These
issues determine the universe of sources that must implement the
fugitive emissions requirements. 82 FR 27646. The EPA has received
feedback from some stakeholders that securing certified monitoring
survey contractors and monitoring instruments has been more difficult
than predicted, and, therefore, the EPA is soliciting comment on the
availability of contractors and monitoring instruments, and the impact
on owners and operators complying with the requirements of the 2016
Rule. The EPA is soliciting comment on extending the phase-in period
and the appropriate length of the phase-in period to allow for an
adequate build-up of the personnel and equipment required for meeting
the fugitive emissions requirements. Specifically, the EPA solicits
comment on whether the impact of this requirement and any feasibility
issues are relevant to few sources or a systemic issue related to many
sources.
    The EPA also received feedback regarding the applicability of the
fugitive emissions requirements to third-party equipment at well sites
which is ancillary to production (e.g., equipment such as meters owned
by midstream operators). The 2016 Rule requires that all fugitive
emissions components at a well site be monitored and repaired, but
there has been confusion as to the appropriate scope of components that
are included in the definition of the well site for the fugitive
emissions requirements. During the public comment period on the 2016
Rule, the EPA received feedback that ancillary midstream assets (e.g.,
meters) should be excluded from the fugitive emissions requirements
because they are owned by legally distinct companies from the well site
owner and operator and could have limited emissions.\8\ The EPA's
response to this comment was to state in its Response to Comments that
``the resolution for any leaking components identified during surveys
can be managed by the operator through cooperative agreements with
other potential owners at the site.'' \9\ The EPA

has since received feedback that there are complicated site
configurations and contractual arrangements that the EPA did not
consider in the 2016 Rule that could prevent compliance, including
situations where the third-party equipment could be made subject to the
2016 Rule based on actions made by another operator.\10\ The EPA is
soliciting comment on this feedback, specifically, legal and logistical
issues that could prevent midstream operators, or other operators of
ancillary third-party equipment, from compliance with the 2016 Rule,
and suggestions for addressing this issue. The EPA additionally
solicits comment on the number of contracts that would need to be
renegotiated and associated burden. The EPA is further soliciting
comment on whether, in light of the above, the EPA should stay or
otherwise extend the phase-in period as it applies to third-party
equipment on well sites until after the EPA has addressed this
compliance issue.
---------------------------------------------------------------------------

    \8\ See Docket ID No. EPA-HQ-OAR-2010-0505-7237.
    \9\ See Docket ID No. EPA-HQ-OAR-2010-0505-7632, p. 4-282.
    \10\ See Docket ID No. EPA-HQ-OAR-2010-0505-12245 and Docket ID
No. EPA-HQ-OAR-2017-0346-0328.
---------------------------------------------------------------------------

    The EPA additionally received feedback regarding technical, safety,
and environmental issues associated with the delay of repair provisions
in the 2016 Rule. The EPA proposed that if ``repair or replacement [of
a leaking fugitive emissions component] is technically infeasible or
unsafe to repair during operation of the unit, the repair or
replacement must be completed during the next scheduled shutdown or
within 6 months, whichever is earlier.'' 80 FR 56668, September 18,
2015. Stakeholders responded with concerns about ``delays lasting
longer than six months due to availability of supplies needed to
complete repairs and information regarding the frequency of delayed
repairs. Some commenters also indicated that in some cases, requiring
prompt repairs could lead to more emissions than if repairs were able
to be delayed, for example if a well shut-in or vent blow-down is
required.'' 81 FR 35858, June 3, 2016. In response to these comments,
the EPA extended the time a component can be placed on delay of repair
from 6 months to 2 years, and, in conjunction with this extension,
added that ``however, if an unscheduled or emergency vent blowdown,
compressor station shutdown, well shutdown, or well shut-in occurs
during the delay of repair period, the fugitive emissions components
would need to be fixed at that time.'' Id.
    Since publication of the 2016 Rule, the EPA has received feedback
that requiring repair or replacement of fugitive emissions components
during unscheduled or emergency vent blowdowns could result in natural
gas supply disruptions, safety concerns, and increased emissions.\11\
In particular, stakeholder feedback suggests that compliance with this
provision could result in prolonged shutdowns impacting natural gas
supply if necessary parts and skilled labor is unavailable, and
avoidable blowdowns resulting in greater emissions than the leaking
component.\12\ This feedback additionally indicates that these events
may not necessarily result in the blowdown of all equipment located
onsite and, thus, the equipment needing repair may not been affected by
the blowdown.13 14 The EPA is soliciting comment on this
feedback, specifically, the shutdown, shut-in, or blowdown scenarios
that result in the technical, safety, and environmental issues
described, and suggestions for addressing these issues. The EPA is
further soliciting comment on whether, in light of the above, the EPA
should stay or otherwise extend the phase-in period as it applies to
equipment requiring delay of repair at well sites and compressor
stations until after the EPA has addressed this compliance issue.
---------------------------------------------------------------------------

    \11\ See Docket ID No. EPA-HQ-OAR-2017-0346-0328 and Docket ID
No. EPA-HQ-OAR-2010-0505-12245.
    \12\ Id.
    \13\ Id.
    \14\ Blowdown refers to the release of entrained gas from
equipment that causes a reduction in system pressure or a complete
depressurization. For example, a blowdown may occur to reduce line
pressure and discharge gas to ensure safe working conditions during
maintenance and repair activities.
---------------------------------------------------------------------------

    As the need for a proposed 3-month stay is contingent upon the EPA
concluding that either a 2-year stay or an extension of the phase-in
period is warranted, the comments that the EPA is soliciting are
equally relevant to this rulemaking. In addition, the EPA solicits
comment on whether the potential delay is better addressed through a
short stay or extension of the current phase-in period.

B. Well Site Pneumatic Pump Requirements

    The EPA proposed to stay the requirements for well site pneumatic
pump standards while it reconsiders the technical infeasibility
exemption and the definition of ``greenfield site.'' 82 FR 27647, June
16, 2017. The EPA acknowledges that the technical infeasibility
exemption that the EPA finalized in the 2016 Rule adopted a different
approach than previously applied to the oil and gas industry and
created an unanticipated and unnoticed distinction between
``greenfield'' (new development) and ``non-greenfield'' sites. For a
discussion on the technical infeasibility exemption provided in the
2016 Rule, please see 81 FR 35844-5, June 3, 2016. Some stakeholders
have suggested that this distinction has caused confusion among owners
and operators on what sites qualify for the technical infeasibility
exemption. The EPA received stakeholder feedback that some owners and
operators may have been unintentionally restricted in the design of new
sites that, for technical reasons, could not employ controls or
processes for certain pneumatic pump installations. The EPA is
soliciting comment on technical constraints of new ``greenfield'' sites
and specific site designs such as these which present challenges in
implementing the well site pneumatic pump requirements in the 2016
Rule. The EPA is, therefore, soliciting comment on extending the phase-
in period for 2 years, the time period the EPA estimates its
reconsideration process and the issuance of the resulting rule would
take, so that the EPA may provide the necessary clarification or
revision in conjunction with its reconsideration process, thereby
addressing all issues in one rulemaking. As the need for a proposed 3-
month stay is contingent upon the EPA concluding that either a 2-year
stay or an extension of the phase-in period is warranted, the comments
that the EPA is soliciting are equally relevant to this rulemaking. In
addition, the EPA solicits comment on whether the potential delay is
better addressed through a short stay or extension of the current
phase-in period. The EPA is also soliciting comment on extending the
phase-in period and the appropriate length of the phase-in period for
the well site pneumatic pump requirements as an alternative to the
proposed stay of these requirements.

C. Professional Engineering Certification Requirements

    The EPA proposed to stay the requirement for closed vent system
certification by professional engineer while the EPA evaluates the
benefits, as well as the cost and other compliance burden, associated
with this requirement. 82 FR 27647, June 16, 2017. Such costs and
associated burden are significant in light of the number of affected
sources. Based on the EPA's estimates, approximately 16,000 affected
sources (i.e., pneumatic pumps, compressors, and storage vessels) came
online between the proposed rule and the final 2016 Rule, not counting
those that have and will come online since.

The EPA received feedback that owners and operators had to reanalyze
and potentially redesign the closed vent systems in order to meet this
certification requirement. Subsequent to the proposed stay, the EPA
received feedback from some stakeholders that owners and operators have
struggled to obtain professional engineers to complete these
certifications primarily because of a shortage of professional
engineers certified in each state of operation with experience in the
design of these systems. In light of this, the EPA is soliciting
comment on the availability of professional engineers qualified in each
state of operation and experienced in the oil and gas field and the
costs associated with completing the certification requirements in the
2016 Rule. The EPA additionally solicits comment on the costs of
reanalyzing and redesigning sites in order to comply with the
requirements of the 2016 Rule. Lastly, in light of the challenges
described above, the EPA is soliciting comment on providing a period to
phase in this certification period as an alternative to staying this
requirement. As the need for a proposed 3-month stay is contingent upon
the EPA concluding that either a 2-year stay or a provision of a phase-
in period is warranted, the comments that the EPA is soliciting are
equally relevant to this rulemaking. In addition, the EPA solicits
comment on whether the potential delay is better addressed through a
short stay or provision of a phase-in period. The EPA emphasizes that
neither the proposed stay (or, in the alternative, provision of a
phase-in period) for this certification requirement would affect
sources' obligation to meet the underlying applicable emission
standards during that time frame. As explained above, this
certification requirement is not an emission standard, but a compliance
measure to provide additional assurance that the emission standards are
being met.

    Dated: November 1, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017-24341 Filed 11-7-17; 8:45 am]
 BILLING CODE 6560-50-P


standards. Therefore, FMCSA did not consider the use of voluntary
consensus standards.

Q. Environment (National Environmental Policy Act of 1969 (NEPA), Clean
Air Act (CAA), Environmental Justice)

    FMCSA analyzed this rule for the purpose of NEPA (42 U.S.C. 4321 et
seq.) and determined this action is categorically excluded from further
analysis and documentation in an environmental assessment or
environmental impact statement under FMCSA Order 5610.1 (69 FR 9680,
March 1, 2004), Appendix 2, in paragraphs 6(b) and 6(s)(7). The content
in this rule is covered by the Categorical Exclusions (CEs) in
paragraphs 6(b) and 6(s)(7) and the final action does not have any
effect on the quality of the environment. The CE determination is
available for review in the docket.
    FMCSA also analyzed this rule under section 176(c) of the CAA, as
amended (42 U.S.C. 7506(c)), and implementing regulations promulgated
by the Environmental Protection Agency. Approval of this action is
exempt from the CAA's general conformity requirement because it does
not affect direct or indirect emissions of criteria pollutants.
    Under E.O. 12898, Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations, each Federal agency
must identify and address, as appropriate, ``disproportionately high
and adverse human health or environmental effects of its programs,
policies, and activities on minority populations and low-income
populations'' in the United States, its possessions, and territories.
FMCSA evaluated the environmental justice effects of this rule in
accordance with the E.O., and has determined that no environmental
justice issue is associated with this final rule, nor is there any
collective environmental impact that would result from its
promulgation.

List of Subjects in 49 CFR Part 391

    Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor
carriers, Reporting and recordkeeping requirements, Safety,
Transportation.

PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE
(LCV) DRIVER INSTRUCTORS

0
1. The authority citation for part 391 continues to read as follows:

    Authority: 49 U.S.C. 504, 508, 31133, 31136, 31149, 31502; sec.
4007(b), Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114, Pub. L.
103-311, 108 Stat. 1673, 1677; sec. 215, Pub. L. 106-159, 113 Stat.
1748, 1767; sec.

32934, Pub. L. 112-141, 126 Stat. 405, 830; secs. 5403 and 5524,
Pub. L. 114-94, 129 Stat. 1312, 1548, 1560; sec. 2, Pub. L. 115-105,
131 Stat. 2263; and 49 CFR 1.87.

0
2. Revise Sec.  391.41(b)(3) to read as follows:

Sec.  391.41  Physical qualifications for drivers.

* * * * *
    (b) * * *
    (3) Has no established medical history or clinical diagnosis of
diabetes mellitus currently treated with insulin for control, unless
the person meets the requirements in Sec.  391.46;
* * * * *

0
3. Revise Sec.  391.45 to read as follows:

Sec.  391.45  Persons who must be medically examined and certified.

    The following persons must be medically examined and certified in
accordance with Sec.  391.43 as physically qualified to operate a
commercial motor vehicle:
    (a) Any person who has not been medically examined and certified as
physically qualified to operate a commercial motor vehicle;
    (b) Any driver who has not been medically examined and certified as
qualified to operate a commercial motor vehicle during the preceding 24
months, unless the driver is required to be examined and certified in
accordance with paragraph (c), (d), (e), (f), or (g) of this section;
    (c) Any driver authorized to operate a commercial motor vehicle
only within an exempt intra-city zone pursuant to Sec.  391.62, if such
driver has not been medically examined and certified as qualified to
drive in such zone during the preceding 12 months;
    (d) Any driver authorized to operate a commercial motor vehicle
only by operation of the exemption in Sec.  391.64, if such driver has
not been medically examined and certified as qualified to drive during
the preceding 12 months;
    (e) Any driver who has diabetes mellitus treated with insulin for
control and who has obtained a medical examiner's certificate under the
standards in Sec.  391.46, if such driver's most recent medical
examination and certification as qualified to drive did not occur
during the preceding 12 months;
    (f) Any driver whose ability to perform his or her normal duties
has been impaired by a physical or mental injury or disease; and
    (g) Beginning June 22, 2021, any person found by a medical examiner
not to be physically qualified to operate a commercial motor vehicle
under the provisions of paragraph (g)(3) of Sec.  391.43.

0
4. Add Sec.  391.46 to read as follows:

Sec.  391.46  Physical qualification standards for an individual with
diabetes mellitus treated with insulin for control.

    (a) Diabetes mellitus treated with insulin. An individual with
diabetes mellitus treated with insulin for control is physically
qualified to operate a commercial motor vehicle provided:
    (1) The individual otherwise meets the physical qualification
standards in Sec.  391.41 or has an exemption or skill performance
evaluation certificate, if required; and
    (2) The individual has the evaluation required by paragraph (b) and
the medical examination required by paragraph (c) of this section.
    (b) Evaluation by the treating clinician. Prior to the examination
required by Sec.  391.45 or the expiration of a medical examiner's
certificate, the individual must be evaluated by his or her ``treating
clinician.'' For purposes of this section, ``treating clinician'' means
a healthcare professional who manages, and prescribes insulin for, the
treatment of the individual's diabetes mellitus as authorized by the
healthcare professional's State licensing authority.
    (1) During the evaluation of the individual, the treating clinician
must complete the Insulin-Treated Diabetes Mellitus Assessment Form,
MCSA-5870.
    (2) Upon completion of the Insulin-Treated Diabetes Mellitus
Assessment Form, MCSA-5870, the treating clinician must sign and date
the Form and provide his or her full name, office address, and
telephone number on the Form.
    (c) Medical examiner's examination. At least annually, but no later
than 45 days after the treating clinician signs and dates the Insulin-
Treated Diabetes Mellitus Assessment Form, MCSA-5870, an individual
with diabetes mellitus treated with insulin for control must be
medically examined and certified by a medical examiner as physically
qualified in accordance with Sec.  391.43 and as free of complications
from diabetes mellitus that might impair his or her ability to operate
a commercial motor vehicle safely.
    (1) The medical examiner must receive a completed Insulin-Treated
Diabetes Mellitus Assessment Form, MCSA-5870, signed and dated by the
individual's treating clinician for each required examination. This
Form shall be treated and retained as part of the Medical Examination
Report Form, MCSA-5875.
    (2) The medical examiner must determine whether the individual
meets the physical qualification standards in Sec.  391.41 to operate a
commercial motor vehicle. In making that determination, the medical
examiner must consider the information in the Insulin-Treated Diabetes
Mellitus Assessment Form, MCSA-5870, signed by the treating clinician
and, utilizing independent medical judgment, apply the following
qualification standards in determining whether the individual with
diabetes mellitus treated with insulin for control may be certified as
physically qualified to operate a commercial motor vehicle.
    (i) The individual is not physically qualified to operate a
commercial motor vehicle if he or she is not maintaining a stable
insulin regimen and not properly controlling his or her diabetes
mellitus.
    (ii) The individual is not physically qualified on a permanent
basis to operate a commercial motor vehicle if he or she has either
severe non-proliferative diabetic retinopathy or proliferative diabetic
retinopathy.
    (iii) The individual is not physically qualified to operate a
commercial motor vehicle up to the maximum 12-month period under Sec.
391.45(e) until he or she provides the treating clinician with at least
the preceding 3 months of electronic blood glucose self-monitoring
records while being treated with insulin that are generated in
accordance with paragraph (d) of this section.
    (iv) The individual who does not provide the treating clinician
with at least the preceding 3 months of electronic blood glucose self-
monitoring records while being treated with insulin that are generated
in accordance with paragraph (d) of this section is not physically
qualified to operate a commercial motor vehicle for more than 3 months.
If 3 months of compliant electronic blood glucose self-monitoring
records are then provided by the individual to the treating clinician
and the treating clinician completes a new Insulin-Treated Diabetes
Mellitus Assessment Form, MCSA-5870, the medical examiner may issue a
medical examiner's certificate that is valid for up to the maximum 12-
month period allowed by Sec.  391.45(e) and paragraph (c)(iv) of this
section.
    (d) Blood glucose self-monitoring records. Individuals with
diabetes mellitus treated with insulin for control must self-monitor
blood glucose in accordance with the specific treatment plan prescribed
by the treating clinician. Such individuals must maintain blood glucose
records measured with an electronic glucometer that stores all
readings, that records the date and time of readings, and from which
data can be electronically downloaded. A printout of the electronic
blood glucose records

or the glucometer must be provided to the treating clinician at the
time of any of the evaluations required by this section.
    (e) Severe hypoglycemic episodes. (1) An individual with diabetes
mellitus treated with insulin for control who experiences a severe
hypoglycemic episode after being certified as physically qualified to
operate a commercial motor vehicle is prohibited from operating a
commercial motor vehicle, and must report such occurrence to and be
evaluated by a treating clinician as soon as is reasonably practicable.
A severe hypoglycemic episode is one that requires the assistance of
others, or results in loss of consciousness, seizure, or coma. The
prohibition on operating a commercial motor vehicle continues until a
treating clinician:
    (i) Has determined that the cause of the severe hypoglycemic
episode has been addressed;
    (ii) Has determined that the individual is maintaining a stable
insulin regimen and proper control of his or her diabetes mellitus; and
    (iii) Completes a new Insulin-Treated Diabetes Mellitus Assessment
Form, MCSA-5870.
    (2) The individual must retain the Form and provide it to the
medical examiner at the individual's next medical examination.

0
5. Amend Sec.  391.64 as follows:
0
a. Revise paragraph (a) introductory text and add paragraph (a)(3); and
0
b. Effective November 19, 2019, remove and reserve paragraph (a).
    The revision and addition read as follows:

Sec.  391.64   Grandfathering for certain drivers participating in
vision and diabetes waiver study programs.

    (a) Until November 19, 2019, the provisions of Sec.  391.41(b)(3)
do not apply to a driver who was a participant in good standing on
March 31, 1996, in a waiver study program concerning the operation of
commercial motor vehicles by insulin-controlled diabetic drivers;
provided:
* * * * *
    (3) On November 19, 2019, the provisions of paragraph (a) of this
section are removed, and any medical examiner's certificate issued
under Sec.  391.43 of this part on the basis that the driver is
qualified by operation of the provisions of 49 CFR 391.64(a), related
to insulin-controlled diabetic drivers, is void.
* * * * *

Appendix A to Part 391 [Amended]

0
6. Remove and reserve paragraph II.C. of appendix A to part 391.

    Issued under authority delegated in 49 CFR 1.87 on September 11,
2018.
 Raymond P. Martinez,
Administrator, FMCSA.
[FR Doc. 2018-20161 Filed 9-18-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Page 30296]
[FR Doc No: 2019-13525]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0196]

Agency Information Collection Activities: Requests for Comments;
Clearance of Approval of New Information Collection: For the
Information Collection Entitled, Website for Frequency Coordination
Request (WebFCR), Pursuant to FAA Order 6050.32B

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to allow a new information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on April 19, 2019. The FAA has developed and deployed an
information system, The Web-based Frequency Coordination Request
(WebFCR) system to collect certain broadcast frequency information
originally collected on form 7460-1, under OMB control number 2120-
0001. It was determined that several broadcast applications from
proponents not associated with construction, alterations and/or
obstructions were not being properly captured with the required
frequency data impacting the initiation of aeronautical studies, hence
this defined new collection.

DATES: Written comments should be submitted by July 26, 2019.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Victor Hinton by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-XXXX.
    Title: Website for Frequency Coordination Request (WebFCR)
webfcr.faa.gov.
    Form Numbers: Prior associated with FAA Form 7460-1.
    Type of Review: Request for a new information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on April, 19 2019 (FR 16557). 49 U.S.C. Section 44718(c)
under Broadcast Applications and Tower Studies states, ``In carrying
out laws related to a broadcast application--the Administrator of the
Federal Aviation Administration and the Federal Communications
Commission shall take action necessary to coordinate efficiently--(1)
The receipt and consideration of, and action on, the application; and
(2) The completion of any associated aeronautical study. The previous
broadcast radio frequency data via OMB Control 2120-0001 only addressed
non-Federal requests related to construction, alterations and
obstructions, not capturing military, federal agency broadcast
applications which require consideration, analysis or aeronautical
studies pursuant to 49 U.S.C. Section 44718(c).
    Respondents: Approximately 1,200 annually nationwide. The
Respondents are engineers, analysts, consultants, stakeholders or
federal agency managers, including military services, who have a need
to transmit on a radio frequency which is within the National
Telecommunications and Information Administration's (NTIA) Aviation
Assignment Group (AAG) frequency band assigned to the FAA for civil
aviation use. The response to this data collection is required for the
proponent to obtain FAA concurrence to use a radio frequency that
impacts civil aviation. The information collected through the WebFCR
portal supports the engineering, modeling, validation and workflow
management of the request to evaluate if the request interferes or
impacts civil aviation operations pursuant to FAA Order 6050.32B.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: .2 hours.
    Estimated Total Annual Burden: 240 hours.

    Issued in Washington, DC, on June 20, 2019.
Victor Hinton,
Spectrum Engineer, Automation Lead, Spectrum Engineering and Policy,
AJW-1C2.
[FR Doc. 2019-13525 Filed 6-25-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 3, 2008 (Volume 73, Number 42)]
[Notices]
[Page 11454-11456]
[DOCID:fr03mr08-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57382; File No. SR-BSE-2008-11]

Self-Regulatory Organizations; Boston Stock Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Substitution of a Term in the
Rules of the Boston Options Exchange

February 26, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 21, 2008, the Boston Stock Exchange, Incorporated
(``Exchange'' or ``BSE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the BSE. The BSE has designated this proposal as one that
neither significantly affects the protection of investors or the public
interest nor imposes any significant burden on competition, under
Section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(6).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The BSE proposes to amend Section 4 (Appointment of Market Makers)
of Chapter VI of the Rules of the Boston Options Exchange (``BOX'') to
substitute the term ``issue'' for ``class.'' The text of the proposed
rule change is available on the Exchange's Web site http://
www.bostonstock.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the BSE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The BSE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend the BOX Rules applicable to the
appointment of Market Makers on BOX. The Exchange is proposing to
replace the term ``issue'' in Section 4(f) of Chapter VI of the BOX
Rules with the term ``class.'' As the BOX Rules currently read, this is
the only instance in which the term ``issue'' is used as a noun to
convey this particular meaning. The proposed rule change substitutes
the use of the term ``class'' and its meaning with one that is more
consistent with the terms used throughout the BOX Rules.
    The BOX Rules define the term ``class of options'' to mean all
options contracts of the same type and style covering the same
underlying security. This is the precise meaning that this instance of
the term ``issue'' is meant to convey. The terms ``class of options''
and ``option class'' are also used throughout the BOX Rules to convey
this same meaning. This current use of the term ``issue'' is unclear
and inconsistent with references used throughout the BOX Rules.
    Therefore, the removal of the term ``issue'' and replacement with
the term ``class'' in its place will create greater consistency within
the BOX Rules. Such a substitution will also clarify the intended
meaning of this particular subsection of the BOX Rules by using a term
with an accepted definition that more closely conforms to the concept
being discussed.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\5\ in general, and
furthers the objectives of Section 6(b)(5),\6\ in particular, in that
it is designed to promote just and equitable principles of trade, to
prevent fraudulent and manipulative acts, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule does not (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, it has become effective pursuant to Section
19(b)(3)(A) of the Act and Rule 19b-4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-BSE-2008-11 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BSE-2008-11. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
the BSE. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BSE-
2008-11 and should be submitted on or before March 24, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-3962 Filed 2-29-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Page 46405]
[FR Doc No: 2013-18290]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of a New Approval of Information Collection: Helicopter Air
Ambulance Operator Reports

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The FAA Modernization and Reform Act of 2012 included a mandate to
begin collection of operational data from Air Ambulance operators. FAA
is to summarize the data and report to Congress no later than February
14, 2014, and annually thereafter.

DATES: Written comments should be submitted by September 30, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-XXXX.
    Title: Helicopter Air Ambulance Operator Reports.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Clearance of a new information collection.
    Background: The FAA Modernization and Reform Act of 2012 mandates
that all helicopter air ambulance operators must begin reporting the
number of flights and hours flown, along with other specified
information, during which helicopters operated by the certificate
holder were providing helicopter air ambulance services. The helicopter
air ambulance operational data provided to the FAA will be used by the
agency as background information useful in the development of risk
mitigation strategies to reduce the currently unacceptably high
helicopter air ambulance accident rate, and to meet the mandates set by
Congress.
    Respondents: 73 helicopter air ambulance certificate holders.
    Frequency: Information is collected quarterly.
    Estimated Average Burden per Response: 6 hours.
    Estimated Total Annual Burden: 2,352 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on July 24, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-18290 Filed 7-30-13; 8:45 am]
BILLING CODE 4910-13-P


Study Title

Publicly Releasable Summary of the Petition

for Establishment of a Tolerance for Dodine

in or on the Raw Agricultural Commodity:

Stone Fruits (Group 12) and Tree Nuts (Group 14)

EPA Registration Action References

Petition for Establishment of Tolerances

Dodine in or on Stone Fruits and Tree Nuts

(PP# to be assigned)

Author

Bert Volger, Ph.D.

Document Date

May 9, 2011

Prepared by

CERES International LLC

1087 Heartsease Drive

West Chester, PA 19382

Submitted by

Agriphar S.A.

Rue de Renory 26

B-4102 Ougree

Belgium

EPA Registration Division contact: Mary Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone
number:

(703) 305–1825; e-mail address<EMAIL_ADDRESS>
AGRIPHAR S.A.

PP (to be assigned)>

EPA has received a pesticide petition (PP # to be assigned) from
AGRIPHAR S.A., c/o CERES International LLC, 1087 Heartsease Drive, West
Chester, PA 19382, proposing pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing a tolerance for residues of dodine (dodecylguanidine
acetate) in or on the raw agricultural commodity, stone fruits (Group
12) at 5 parts per million (ppm), tree nuts (Group 14, except almond
hulls) at 0.3 ppm, and almond hulls at 12 ppm. EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition.

A.	Residue Chemistry

	1.	Plant Metabolism

The qualitative nature of the residue of dodine in plants is adequately
understood based on acceptable apple, pecan and strawberry metabolism
studies. These plant metabolism studies have demonstrated that dodine
does not metabolize and is non-systemic (does not translocate within the
plant). The results observed in the plant and livestock metabolism
studies show similar metabolic pathways. The residue of concern, which
should be regulated, is the parent compound, dodine, per se.

2.	Analytical Method

An adequate enforcement method using gas chromatography with mass
selective detection (GC/MSD, Method 45137) is available for determining
dodine residues in or on plant commodities. Concerning tree crops, a
method using liquid chromatography with tandem mass spectrometric
detection (LC/MS/MS; METH1595.02) after the samples were extracted with
methanol, was submitted. The limit of quantitation (LOQ = 0.01 ppm) was
taken as the lowest level validated by this method, and the limit of
detection (LOD) was 0.003 ppm.

Adequate data collection method validation, independent laboratory
validation (ILV), and radio-validation data for the method has been
submitted. Since there is no reasonable expectation of finding residues
of dodine in livestock or poultry, no analytical method for animal
tissues is required.

	3. 	Magnitude of Residues

For stone fruits (Group 12) and tree nuts (Group 14), complete sets of
residue data have been submitted in support of the petitioned
tolerances.

3.1.    	Stone Fruits

There is an adequate residue data base in support of a crop group
tolerance for stone fruits (Group 12 - representative commodities:
cherries, peaches, plums).

Regarding cherries, a total of nine sweet cherry trials were conducted
in 1997 covering EPA Regions 5, 10, and 11. Six sequential applications
were made on a 6 to 14-day schedule at the target rate of 1.3 lbs
a.i./acre, and a seasonal rate of 7.8 lbs a.i./acre. The measured dodine
residues were in the range of 0.34 to 2.2 ppm, below the established
tolerance for cherries of 3 ppm. In a more recent study (2008, 2009),
four sweet cherry trials were conducted in Michigan (EPA Region V), New
York (EPA Region I) and Washington (EPA Region XI) comparing the
magnitude of dodine residues in or on cherries following six sequential
applications of Syllit FL and Syllit 65W (side by side) at a total
seasonal application rate of 5.2 lbs a.i./acre and a pre-harvest
interval (PHI) of 7 days. The detected average dodine residues were in
the range of 1.5 to 2.9 ppm.

Regarding peaches, a total of twelve trials were conducted in 1997
covering EPA Regions 1, 2, 5, 6, and 10. Five sequential applications
were made at 1.3 to 2.6 lbs a.i./acre, a total seasonal application rate
of 6.5 to 9.1 lbs a.i./acre, and a PHI of 14 to 15 days. The measured
dodine residues were in the range of 0.43 to 4.04 ppm, below the
established tolerance for peaches of 5 ppm. In the recently submitted
2008 field residue study, three trials were conducted in locations
representative of the major peach production areas in the United States:
New York (EPA Region I), Georgia (EPA Region II) and Michigan (EPA
Region V) comparing the magnitude of dodine residues in or on peaches
following five in season applications of Syllit FL and Syllit 65W at a
total seasonal application rate of 7.8 lbs a.i./acre and a PHI of 15
days. The detected average dodine residues were in the range of 0.75 to
1.1 ppm.

Regarding plums, a total of six plum trials were conducted in 1995
covering EPA Regions 5, 10, and 12. Six sequential applications were
made at 1.3 lbs a.i./acre, a total seasonal application rate of 7.8 lbs
a.i./acre, and a PHI of 7 days. The measured dodine residues were in the
range of 0.36 to 1.84 ppm. However, the submitted residue data base is
complete and adequate in support of the Stone Fruits Group tolerance.

3.2.    	Tree Nuts

There is an adequate residue data base in support of a crop group
tolerance for tree nuts (Group 14 - representative commodities: almonds,
pecans).

Regarding almonds, in 2010 a total of five field trials were conducted
in Region 10 representing most of the US almond production.  In each
trial, four applications were made to the almonds at a rate of 1.88 lbs
a.i./acre, resulting in a total seasonal application rate of
7.52 lbs a.i./acre.  Applications were made at full bloom, petal fall,
2 weeks after petal fall and 5 weeks after petal fall.  Samples were
collected at normal harvest, with the exception of the decline trial, in
which samples were also collected 10 days before normal harvest, 5 days
before normal harvest, 5 days after normal harvest and 10 days after
normal harvest.  Dodine was detected at low levels in almond nutmeat
(range <0.01 ppm to 0.106 ppm) and at higher levels in almond hulls
(range 1.2 ppm to 12.2 ppm, average 4.8 ppm).

Regarding pecans, there are field trials from 12 different locations
covering the major US pecan growing areas (EPA Region 4, and 6),
depicting dodine residues in or on pecan nutmeat and shells. These
studies were conducted in 1967 following one to eight air blast
applications at 0.5 to 4.0 lbs a.i./acre before shuck split. The
measured residues at various post-treatment intervals did not exceed 0.8
ppm for nutmeat and shells combined. In a pecan metabolism study, pecans
were treated 3 times prior to shuck split at a nominal rate of 1.7 lbs
a.i./acre yielding a dodine residue level of 0.04 ppm in the nutmeat.
Therefore, the tolerance for dodine residues in nutmeat was established
at 0.3 ppm.

It can be concluded, when almond residue data are combined with
previously submitted pecan data, the proposed tolerance of 0.3 ppm on
tree nuts (Group 14) is adequately supported.  The data also support the
proposed tolerance of 12 ppm for almond hulls.

B.	Toxicological Profile

	1.	Acute Toxicity

Dodine has moderate acute toxicity (Category III) in oral (LD50 = 1,456
mg/kg), dermal (LD50 > 2,000 mg/kg), and inhalation studies (LC50 = 1.05
mg/kg). No significant differences exist between females and males. The
only potential systemic toxicity observed in the acute dermal toxicity
study was a slight decrease in body weight at the limit dose. Dodine is
a severe eye irritant in rabbits and a severe dermal irritant or
sensitizer (both Category I).

	2.	Genotoxicity

The mutagenic potential of dodine was investigated in several in vivo
and in vitro studies.  Results for gene mutation from in vitro mammalian
gene mutation tests as well as from a structural chromosomal aberration
assay with and without metabolic activation were negative. Negative
results also occurred in a mouse bone marrow chromosomal aberration
test. Based on all of these assays, dodine is considered to have no
potential to induce mutagenicity.

3.	Reproductive and Developmental Toxicity

	i.   A two generation rat reproduction study was conducted with dose
levels of 0, 200, 400, and 800 ppm (0, 13, 26, and 53 mg/kg/day for
males and females, respectively).  There were no effects on fertility or
pregnancy at any dose level in rats over two generations.  There was a
decrease in parental body weight, body weight gain or food consumption
in both generations of rats. The offspring of both generations
demonstrated decreased body weight in the high dose group. The no
observed adverse effect level (NOAEL) was determined to be 400 ppm for
systemic effects (26 mg/kg/day for parents and offspring), and (800 ppm
for reproductive parameters ((53 mg/kg/day, LOAEL can not be
determined).

	ii.  Teratology studies were conducted in the rat and rabbit.  No
treatment-related mortalities were observed in either study.  No effect
on survival, development or growth of fetuses was noted in either
species in either study.  The maternal and fetal NOAEL was determined to
be (80 mg/kg/day (highest dose tested, LOAEL can not be determined) in
the rabbit study.  In the rat study, the maternal and fetal NOAEL was 10
mg/kg/day based on decreased body weight, body weight gain, and food
consumption (parents) and decreased body weight (pups).  These two
studies demonstrate that dodine was not teratogenic in either rats or
rabbits.

	4.	Subchronic Toxicity

Rats, mice and dogs all show the same toxicologic response.  The most
common effects for intermediate- or long-term oral toxicity studies were
a decrease in food consumption, body weight and /or body weight gain.
There were some clinical signs observed including excessive salvation
(dog and mice) and hunched posture/hypoactivity (rats), but only the dog
showed treatment-related dose response.

In a 28-day dermal study in rats treated with dodine, no clinical signs
were observed in males or females. Body weight, body weight gain, food
consumption, hematology and clinical chemistries showed no significant
changes. Histopathological adnormalities were limited to the dermal
lesions. The incidence and severity of dermal irritation increased with
the dose. The established systemic NOAEL was ≥200 mg/kg/day (highest
dose tested, LOAEL could not be determined). Based on severe dermal
irritation the dermal LOAEL was 50 mg/kg/day (lowest dose tested, NOAEL
could not be identified).

	5.	Chronic Toxicity

i.   Chronic toxicity and oncogenicity was evaluated in the rat, mouse
and dog.  The rat chronic toxicity and oncogenicity was conducted with
dose levels of 0, 200, 400, and 800 ppm (Male: 0, 10, 20, and 42
mg/kg/day; Female: 0, 13, 27, and 54 mg/kg/day).  The NOAEL was 20
mg/kg/day based on decreased body weight gain (LOAEL = 42 mg/kg/day for
males and 54 mg/kg/day for females).  There was no evidence of
carcinogenicity in this study.

ii.  A mouse chronic toxicity study was conducted with dose levels of 0,
200, 750, and 1500 ppm (Males: 0, 29, 110, and 225 mg/kg/day; Female: 0,
38, 136, and 277 mg/kg/day).  The NOAEL was 110 or 38 mg/kg/day for
males or females, respectively, based on decreased body weight, body
weight gain, and food consumption.  There was also no evidence of
carcinogenicity in this study.

iii.  Chronic toxicity was investigated in dogs using dose levels of 0,
2, 10, and 20 mg/kg/day.  The NOAEL of 10 or 2 mg/kg/day for males or
females was based on decreased food consumption, and decreased weight
gain. There were no treatment-related effects in hematology, clinical
chemistry, urine analysis, ophthalmoscopic examinations, organ weights,
gross - or histopathology in either sex.

	6.	Animal Metabolism

 -recovery after 5 days ranged from 94 to 102% of the administered dose.
Only a small amount (≤3.4%) of the administered dose was found in
tissues, mainly in the gastrointestinal tract (0.16 to 1.1%), muscle
(0.02 to 0.61%), and skin (0.06 to 0.21%).

7.	Metabolite Toxicology

There are no metabolites of toxicological concern, and therefore no
metabolites need to be included in the tolerance expression and require
regulation.

8. 	Endocrine Disruption

Special studies investigating potential estrogenic or other endocrine
effects of dodine have not been conducted.  However, in-life data from
the available toxicology studies for dodine do not indicate that dodine
is an endocrine disruptor.  Specifically, endocrine organ weights (e.g.,
thyroid, testes, ovaries, pituitary from the two-generation study) were
not adversely affected by dodine.  Milestones of sexual development were
not affected by dodine, and reproduction was not adversely affected.
Based on these observations, there is no evidence to suggest that dodine
has an adverse effect on the endocrine system.

C.	Aggregate Exposure

	1.	Dietary Exposure

A tolerance is proposed for residues of dodine in or on stone fruits
(Group 12), tree nuts (Group 14 - except almond hulls), and almond
hulls. For the purpose of assessing the potential dietary exposure (food
+ water) for these proposed tolerances, an exposure assessment was
conducted using Exponent’s Dietary Exposure Evaluation Model (DEEM –
FCID version 2.16), consumption data derived from the 1994 -1998 USDA
Continuing Surveys of Food Intake by Individuals (CSFII), dodine
residues at proposed tolerance levels, DEEM default processing factors,
percent crop treated values for registered uses (100% for proposed
crops), and an Estimated Drinking Water Concentration (EDWC) point
estimate for drinking water contribution.

Food

a.  Acute Dietary Exposure.  No acute dietary assessments were conducted
since no toxicological endpoint attributable to a single exposure was
identified in the available toxicology studies, including the rat and
rabbit developmental studies.

b.  Chronic Dietary Exposure.  The chronic dietary endpoint is based
upon the NOAEL of 2 mg/kg/day from the one-year dog study, and an
uncertainty factor of 100 (10X for inter-species extrapolation and 10X
for intra-species variation and 1X FQPA Safety Factor). Therefore, the
chronic Population Adjusted Dose (cPAD) was calculated as 0.02
mg/kg/day.  The chronic dietary exposure estimate for the overall US
population is 3.4% of the cPAD of 0.02 mg/kg/day.  Children 1-2 years
old, the most exposed population subgroup, utilize 20.4% of the cPAD.
The chronic exposure estimates for the overall US population and 32
population subgroups, including infants and children, were less than 21%
of the cPAD.  Based on these exposure estimates, AGRIPHAR concludes that
there is reasonable certainty of no harm for the use of dodine on stone
fruits and tree nuts.

ii.        Drinking Water

Because of its high soil adsorption, and given the application pattern
of dodine (applied to full crop canopy), its potential to reach surface
and/or ground water is very limited. Therefore exposure via drinking
water is negligible. There are no monitoring data for dodine, so
Estimated Drinking Water Concentrations (EDWC) were calculated using
FIFRA Index Reservoir Screening Tools (FIRST) to estimate dodine
concentrations in surface water, and also using the Screening
Concentration In Ground Water (SCI-GROW) model for estimates in ground
water.  EPA calculated a chronic EDWC value of 4 ppb and 0.08 ppb for
surface and ground water, respectively, assuming the maximum use rate of
13 lbs a.i/acre/year based on the application rate for peaches, pecans,
and walnuts. This annual application rate is twice the rate of the
presently used or proposed for stone fruits and tree nuts (label range
from 3.9 to 7.8 lbs a.i./acre/year).  However, worst-case estimated
dodine residues of 4 µg/L in drinking water were included in the
chronic dietary exposure assessment.

Non-Dietary Exposure

Not applicable. There are no current non-food uses for dodine registered
under FIFRA, as amended, and no non-food uses are proposed for dodine.

D.	Cumulative Effects

To our knowledge there are currently no available data or other reliable
information indicating that any toxic effects produced by dodine would
be cumulative with those of other pesticides; thus only the potential
risks of dodine have been considered in this assessment of its aggregate
exposure.

E.	Safety Determination

	1.	US Population

No acute dietary assessment was conducted because there is no
toxicological endpoint attributable to a single exposure.  A
conservative chronic exposure analysis was conducted, using tolerance
level residues, with percent crop treated information for the registered
crops obtained by EPA-BEAD (apricots = 1%, apples = 5%, bananas = 100%,
cherries = 5%, nectarines = 1%, peaches =1 %, peanuts = 100%, pears =
10%, pecans = 5%, plums = 1%,  walnuts = 5%), and no adjustment for tree
nuts other than walnuts and pecans (100% treated).  The overall chronic
dietary exposure (food + water) to dodine is low, accounting for 1.7% to
20.4% of the cPAD, depending on the population subgroup. The chronic
exposure for the general US population is 0.000685 mg/kg/day, which uses
3.4% of the cPAD (0.02 mg/kg/day).  The most sensitive population
subgroup, children 1 to 2 years of age, have a chronic exposure (food +
water) of 0.004081 mg/kg/day, which utilizes only 20.4% of the cPAD.

 Based on the lack of acute toxicity and the chronic exposure analyses,
AGRIPHAR concludes that there is reasonable certainty that no harm will
result from acute and chronic exposure to dodine.

	2.	Infants and Children

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!mals were more sensitive to dodine than adult animals. The data taken
collectively clearly demonstrate that application of a Food Quality
Protection Act (FQPA) uncertainty factor for increased sensitivity of
infants and children is not necessary for dodine.>

F.	International Tolerances

At present, there are Codex maximum residue limits (MRLs) established
for dodine on cherries at 3 ppm, nectarines, peaches and pome fruits at
5 ppm. There is no Codex maximum residue limit (MRL) established for
dodine on tree nuts. Therefore, international harmonization is not an
issue at this time.

  PAGE   \* MERGEFORMAT  1