[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Rules and Regulations]
[Pages 4339-4341]
[FR Doc No: 2013-00729]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2011-0033; FRL-9770-8]

Approval and Promulgation of Implementation Plans; New Mexico;
Revisions to the New Source Review (NSR) State Implementation Plan
(SIP); Prevention of Significant Deterioration (PSD) and Nonattainment
New Source Review (NNSR) Permitting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving revisions to the New Mexico SIP to update the
New Mexico NNSR and PSD SIP permitting programs consistent with federal
requirements. EPA finds that these revisions to the New Mexico SIP meet
the Federal Clean Air Act (the Act or CAA) and EPA regulations, and are
consistent with EPA policies. New Mexico submitted the PSD and NNSR SIP
permitting revisions in two SIP submittals on June 11, 2009 and May 23,
2011. EPA is finalizing this action under section 110 and parts C and D
of the Act.

DATES: This final rule will be effective February 21, 2013.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R06-OAR-2011-0033. All documents in the docket are listed in
the www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at www.regulations.gov or in hard copy at the Air Planning Section
(6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in the FOR FURTHER INFORMATION
CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER> to make an
appointment. If possible, please make the appointment at least two
working days in advance of your visit. There will be a fee of 15 cents
per page for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202.
    The State submittal is also available for public inspection during
official business hours by appointment: New Mexico Environment
Department, Air Quality Bureau, 1301 Siler Road, Building B, Santa Fe,
New Mexico 87502.

FOR FURTHER INFORMATION CONTACT: Ms. Adina Wiley, Air Permits Section
(6PD-R), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax number
214-665-6762; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' means EPA.

Table of Contents

I. Background for Final Action
II. Final Action
III. Statutory and Executive Order Reviews

I. Background for Final Action

    The background for today's action is discussed in detail in our
October 12, 2012 proposal (77 FR 62200). In that notice we proposed to
approve portions of two submittals from New Mexico, dated June 11, 2009
and May 23, 2011, that update the New Mexico Nonattainment New Source
Review (NNSR) and Prevention of Significant Deterioration (PSD)
permitting SIP rules consistent with federal requirements.
Specifically, these SIP submittals address federal PSD and NNSR
permitting requirements promulgated in EPA's Phase 2 8-hour Ozone
Implementation Rule (70 FR 71612, November 29, 2005), NSR
PM2.5 Rule (73 FR 28321, May 16, 2008), PM2.5 PSD
Increment--Significant Impact Levels (SILs)--Significant Monitoring
Concentration (SMC) Rule (75 FR 64864, October 20, 2010) and Reasonable
Possibility in Recordkeeping Rule (72 FR 72607, December 21, 2007).
    Our October 12, 2012 proposal provides a detailed description of
all relevant submittals and the rationale for EPA's proposed actions,
together with a discussion of the opportunity to comment. The public
comment period closed for this action on November 13, 2012; we did not
receive any comments.

II. Final Action

    EPA is approving portions of two revisions to the New Mexico SIP
submitted by the Governor of New Mexico on June 11, 2009 and May 23,
2011. EPA has made the determination that the submitted regulations are
approvable in accordance with section 110 and parts C and D of the Act
and EPA's regulations, and consistent with EPA guidance. EPA is
approving revisions to Part 74 of the New Mexico Administrative Code
(NMAC), Title 20 (Environment Protection), Chapter 2 (Air Quality)
except for revisions to <IP_ADDRESS>3(A) NMAC submitted on May 23, 2011.
EPA is approving revisions to Part 79 NMAC, Title 20, Chapter 2
submitted on June 11, 2009 and May 23, 2011.
    Specifically, EPA is approving the following revisions to Part 74
submitted on May 23, 2011. These revisions satisfy

the PM2.5 PSD requirements under EPA's May 16, 2008 and
October 20, 2010 final PM2.5 PSD permitting implementation
rules, and EPA's December 21, 2007 Reasonable Possibility in
Recordkeeping Rule.
     <IP_ADDRESS> NMAC--Definitions;
     <IP_ADDRESS>0 NMAC--Obligations of Owners or Operators of
Sources;
     <IP_ADDRESS>3 NMAC--Ambient Impact Requirements;
     <IP_ADDRESS>6 NMAC--Monitoring Requirements;
     <IP_ADDRESS>3 NMAC--Additional Requirements for Sources
Impacting Class I Federal Areas;
     <IP_ADDRESS>2 NMAC--Significant Emission Rates;
     <IP_ADDRESS>3 NMAC--Significant Monitoring Concentrations;
     <IP_ADDRESS>4 NMAC--Allowable PSD Increment; and
     <IP_ADDRESS>5 NMAC--Maximum Allowable Increases for Class I
Waivers.
    EPA is approving the following revisions to Part 79 submitted June
11, 2009. These revisions satisfy EPA's November 29, 2005 Phase 2 8-
hour Ozone Implementation Rule for nonattainment areas.
     <IP_ADDRESS> NMAC--Definitions;
     <IP_ADDRESS> NMAC--Applicability; and
     <IP_ADDRESS> NMAC--Emission Offsets.
    EPA is also approving the following revisions to Part 79 submitted
May 23, 2011. These revisions satisfy EPA's PM2.5 NNSR
requirements under EPA's May 16, 2008 and October 20, 2010 final
PM2.5 NSR permitting implementation rules, and the December
21, 2007 Reasonable Possibility in Recordkeeping Rule. New Mexico also
made some nonsubstantive changes in 2011 to <IP_ADDRESS> NMAC as adopted
and submitted in 2009, and we are approving these nonsubstantive
changes.
     <IP_ADDRESS> NMAC--Definitions;
     <IP_ADDRESS> NMAC--Applicability; and
     <IP_ADDRESS> NMAC--Tables.
    EPA explained in the proposal for this action that it is severing
the revisions to <IP_ADDRESS>3(A) NMAC submitted on May 23, 2011 relating
to PM2.5 significant impact levels (SILs). These revisions
are equivalent to the provisions EPA has requested the DC Circuit Court
in pending litigation to remand and vacate at 40 CFR 51.166(k)(2) that
were promulgated on October 20, 2010, and conflict with our intentions
for the use of SILs to demonstrate compliance with CAA section 163(a).
(Sierra Club v. EPA, Case No 10-1413, DC Circuit). Therefore,
<IP_ADDRESS>3 NMAC as adopted by NMED on January 1, 2011, and SIP-
approved by EPA on July 20, 2011, remains the SIP-approved section. See
76 FR 43149. The NMED continues to retain the ability to implement the
PM2.5 SILs at <IP_ADDRESS> NMAC consistent with EPA's
interpretation of CAA section 163(a). Further, the revisions to
<IP_ADDRESS>3(A) NMAC submitted on May 23, 2011, will remain before EPA
for review. EPA will revisit these submitted revisions after the court
addresses EPA's request for remand with vacatur or EPA initiates
rulemaking to revise 40 CFR 51.166(k)(2).

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after its is published in the Federal
Register. This action is not a ``major rule: As defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 25, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Particulate
matter, Reporting and recordkeeping requirements.

    Dated: January 3, 2013.
Ron Curry,
Regional Administrator, Region 6.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart GG--New Mexico

0
2. Section 52.1620(c) is amended by revising the entries for Parts 74
and 79 under the first table titled ``New Mexico Administrative Code
(NMAC) Title 20--Environment Protection Chapter 2--Air Quality''.
    The revisions read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (c) * * *

                                       EPA Approved New Mexico Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
                                                           approval/
          State citation              Title/subject        effective     EPA approval date         Comments
                                                             date
----------------------------------------------------------------------------------------------------------------
          New Mexico Administrative Code (NMAC) Title 20--Environment Protection Chapter 2--Air Quality
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Part 74..........................  Permits--Prevention        6/3/2011  1/22/2013 [Insert    Revisions to
                                    of Significant                       FR page number       <IP_ADDRESS>3(A)
                                    Deterioration.                       where document       NMAC submitted 5/
                                                                         begins].             23/2011, effective
                                                                                6/3/2011, are NOT
                                                                                part of SIP.
                                                                                <IP_ADDRESS>3 NMAC
                                                                                submitted 12/1/
                                                                                2010, effective 1/
                                                                                1/2011, remains
                                                                                SIP approved (6/20/
                                                                                2011, 76 FR
                                                                                43149).

                                                  * * * * * * *
Part 79..........................  Permits--Nonattainm        6/3/2011  1/22/2013 [Insert    ...................
                                    ent Areas.                           FR page number
                                                                         where document
                                                                         begins].

                                                  * * * * * * *
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* * * * *
[FR Doc. 2013-00729 Filed 1-18-13; 8:45 am]
BILLING CODE P


[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21335-21339]
[FR Doc No: 2016-08281]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0316; FRL-9944-37]

Tetrachlorvinphos (TCVP); EPA Proposal To Rely on Data From Human
Research on TCVP Exposure From Flea Control Collars

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with EPA's rule for protection of human
subjects, EPA is providing an opportunity for public comment on EPA's
proposal to rely on data from human research on tetrachlorvinphos
(TCVP) exposure from flea control collars.

DATES: Comments must be received on or before May 11, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0316, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For information on EPA's Rule for
Protection of Human Subjects contact: Maureen Lydon, Human Research
Ethics Review Officer, Office of Pesticide Programs (7501P),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For information on the EPA risk assessment contact: James Parker,
Chemical Review Manager, Pesticide Re-Evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 306-0469; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult a contact listed under FOR FURTHER INFORMATION CONTACT.

 B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is conducting its registration review of TCVP pursuant to
section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq., and the Procedural Regulations for
Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5) (7
U.S.C. 136a(c)(5)). When used in accordance with widespread and
commonly recognized practice, the pesticide product must perform its
intended function without unreasonable adverse effects on the
environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

III. EPA's Proposal To Rely on Published TCVP Human Research

    During the public meeting of the Human Studies Review Board (HSRB)
held on January 12-13, 2016, EPA's Office of Pesticide Programs
provided an overview and science and ethics review of the research
discussed in the article ``Assessing Intermittent Pesticide Exposure
From Flea Control Collars Containing the Organophosphorus Insecticide
Tetrachlorvinphos (TCVP).'' This research article was authored by M.
Keith Davis, J. Scott Boone, John E. Moran, John W. Tyler and Janice E.
Chambers and published in 2008 in the

Journal of Exposure Science and Environmental Epidemiology (2008) 18,
pages 564-570. EPA presented Davis et al. research to the HSRB for
their review, along with a request for the HSRB to respond to questions
posed by EPA.
    The Davis et al. research measured TCVP exposures in children and
adults that could occur from contact with pet dogs wearing TCVP-
containing flea control collars. The research was based on two studies
conducted by the Center of Environmental Health Sciences, College of
Veterinary Medicine, Mississippi State University (MSU). Although the
families involved in the studies already used flea collars, the
researchers provided specific flea collars to the participating
families and asked that their dogs wear them during the studies.
    In study 1, conducted in 1998, TCVP residues were measured by
rubbing/petting dogs' fur with a gloved hand. The sampling was
conducted by volunteer technicians from MSU veterinary school who
stroked the animals in a standardized, prescribed manner, in a marked
10 x 4 inch area with clean, white, cotton gloves for a continuous 5-
minute period. The dogs were rubbed in three specific locations: Near
the base of the tail, at the neck with the flea collar removed, and at
the neck with the flea collar in place. Study 1 also measured dog
plasma cholinesterase. There were 23 pet dogs included in this study,
one from each of the 23 participating households.
    Under study 2, conducted in 2002, volunteer technicians from MSU
veterinary school collected TCVP residues by rubbing/petting dogs' fur
with a gloved hand, and used the same methods as those employed by
study 1. The collection of the glove residue data did not involve
children in either study 1 or study 2. However, study 2 also quantified
TCVP residues on tee shirts worn by children and included biomonitoring
of the TCVP metabolite 2,4,5-trichloromandelic acid (TCMA) in urine of
participating children and adults. Study 2 included 1 child and 1 adult
from each of the 22 participating families and 22 pet dogs.
    EPA proposes to use only the glove residue data from the Davis et
al. research in its risk assessment of TCVP because it is chemical-
specific and results in the highest computed risks when compared to the
other data in Davis et al. and all the approaches considered in the
assessment; as a result, it supports the most protective risk
characterization. The research complied with the ethical standards in
place at the time the studies were conducted and meets the substantive
acceptance standards. As described in the Davis et al. research, the
data were derived in a manner that makes the research scientifically
valid and are appropriate for use in EPA's risk assessment.
    In the Federal Register of January 20, 2016 (81 FR 3128, FRL-9940-
81), EPA sought public comment on EPA's draft human health and
ecological risk assessment for the registration review of TCVP. The
public can view the draft human health risk assessment and supporting
documents, as well as comments received, in the docket established for
the reregistration review of TCVP (see docket ID number EPA-HQ-OPP-
2008-0316). EPA has determined that relying on the glove residue data
from the Davis et al. research is crucial to a decision to potentially
impose a more stringent regulatory restriction that would improve
public health protection than could be justified without relying on the
data. EPA currently does not have other pet collar glove residue data
which are chemical-specific or that would lead to the same potential
regulatory action to improve public health protection. For this reason,
the glove residue data are crucial to EPA's decision.

IV. Reason for Review by the HSRB

    EPA chose, in this case, to obtain the views of the HSRB concerning
EPA's proposal to rely on the TCVP glove residue data from studies 1
and 2 for the following reasons. First, the proposal submitted to EPA's
Science to Achieve Results (STAR) grants program for funding of the
research discussed correlating the residues from the rubbing procedure
with the gloves, the residues from the tee shirts worn by children
participating in the studies, and the urinary metabolites of the
children and adults in the participating households and described these
activities under the umbrella of one research project. Moreover,
although EPA is relying only on the TCVP glove residue data from both
studies, study 2 further involved children wearing tee shirts and
providing urine samples, and, at least for that portion of the study,
is considered research involving intentional exposure to human
subjects. Therefore, even though EPA does not wish to rely on the data
involving children (namely the tee shirt and urinary data), EPA chose
in this case to assume that the prohibition in 40 CFR 26.1703 and the
process in 40 CFR 26.1706 apply, including submission of the research
to the HSRB for review.
    40 CFR 26.1703 prohibits EPA reliance on data from any research
involving intentional exposure of any human subject who is a pregnant
woman (and therefore her fetus), nursing woman, or child, except as
provided in 40 CFR 26.1706. 40 CFR 26.1706 explains that EPA may rely
on data that are unacceptable under the standards in 40 CFR 26.1703
through 26.1705 only if EPA has: (a) Obtained the views of the HSRB;
(b) provided an opportunity for public comment on the proposal to rely
on the otherwise unacceptable data; (c) determined that relying on the
data is crucial to a decision that would impose a more stringent
regulatory restriction to protect public health than could be justified
without the data; and (d) published a full explanation of the decision
to rely on the data, including a thorough discussion of the ethical
deficiencies of the underlying research and the full rationale for
finding that the standard in item (c) was met.
    EPA sought and obtained the views of the HSRB during the public
meeting of the HSRB on January 12-13, 2016. The HSRB documents their
views in meeting minutes and a final report before EPA publishes the
explanation required by 40 CFR 26.1706(d). Pursuant to 40 CFR
26.1706(b), EPA is hereby providing an opportunity for public comment
on EPA's proposal to rely on the TCVP glove residue data from the Davis
et al. research. EPA proposes to rely on chemical-specific data from
human research to potentially impose a more stringent regulatory
restriction that would improve public health protection than could be
justified without relying on the data.

V. Background on Ethical Conduct of Research

    The research was funded by EPA's STAR grants. EPA's Office of
Research and Development (ORD) reviewed the grant proposal, which
involved human research and funding from EPA. EPA's ethics review of
the Davis et al. research presented at the January HSRB meeting relies
in part on EPA's ORD file because it contains draft consent forms used
during study 2 and recruitment information. At the January 2016 HSRB
meeting, EPA discussed the role of the veterinary students, the
societal value of the Davis et al. research, and ethical considerations
regarding recruitment of study participants, the independent ethics
review, informed consent, respect for subjects and compensation for
participation in the study.
    EPA reviewed with the HSRB the role of the veterinary students in
rubbing the dogs. The technicians who rubbed the dogs in study 1 and
study 2 were students enrolled at MSU's College of

Veterinary Medicine. Both the researchers and the Institutional Review
Board (IRB) viewed the veterinary students as technicians in the study,
not as human subjects. The abstract for the research submitted to EPA
for funding is included in the ORD file and states, on page 14, that
``the samplers will be trained so that consistency in the sample
collection is maintained among dogs and among samplers.'' As discussed
in the research article, the technicians wore gloves and stroked the
animals in a standardized, prescribed manner: ``in a marked 10 x 4 inch
area with clean, white, cotton gloves for a continuous 5-min period.''
The dogs were rubbed in specific locations (near the base of the tail,
at the neck with collar removed, and at the neck with the collar in
place). Under 40 CFR 26.1102(e), the term ``human subject'' is defined,
in part, as ``a living individual about whom an investigator . . .
conducting research obtains . . . data through intervention or
interaction. . . .'' The Primary Investigator for the research
confirmed that she did not obtain data about the technicians, nor did
she intend to do so. The pattern of rubbing does not resemble the
typical human-pet interaction or provide information about how a person
would normally interact with a pet. EPA noted during the HSRB meeting
that the researchers were not collecting data about the technicians in
this study and concluded that there is no indication from the research
article, the ORD file or EPA's interview with the Primary Investigator
that the study collected data about the veterinary students who worked
as technicians in the study. Instead, the researchers collected data
only about the residues on the glove as an indication of how much
residue was available for transfer from the pet.
    With regard to the societal value of the Davis et al. research, the
objective was to assess the amount of exposure to TCVP that could occur
in children and adults from the use of a TCVP-containing collar on a
pet dog. Regarding recruitment, the research article states that ``the
studies were conducted in Oktibbeha County, Mississippi (USA), with
volunteer households having pet dogs'' and that ``participating
families were volunteers who routinely used flea control products on
their pet dogs.'' ``One child and one adult were selected from each
participating family'' for study 2, which included 44 subjects. EPA's
file on the STAR grant, page 13, states that: ``Dogs selected for this
study will be owned by professional (DVM) or graduate students enrolled
in the College of Veterinary Medicine, or staff/faculty members of
Mississippi State University with a child aged 4-10 years in the
household who routinely plays with this dog.'' It goes on to state that
``students or staff should be the most reliable group of owners (in
contrast to the general public) in that they are accessible daily,
their dogs can readily be treated and sampled when the students are in
class or the staff members are at work, and as members of the academic
community, the compliance and appreciation of the value of research
should be high.'' EPA's file further states that ``dogs participating
in this study must be enrolled in the Small Animal Community Practice
Health Maintenance Program, so that their health status and vaccination
history are known.''
    Regarding the independent ethics review, the IRB for Research on
Human Subjects at MSU reviewed and approved the sampling protocols and
consent forms, and the EPA's ORD, the National Center for Environmental
Research and Quality Assurance (NCERQA) reviewed the STAR grant
proposal focusing on this research. ORD supported the research
dependent on the incorporation of NCERQA comments on the consent forms.
The protocol was distributed to each participating household, informed
consent was obtained from the adults, and children were informed
verbally of the procedures and oral or written assent was obtained from
them. The IRB for Research on Human Subjects at MSU approved all
sampling protocols and informed consent forms. The ORD file contains a
draft consent form for adults and a Minor's Assent Form. The consent
form states that the study involves research and identifies its
purpose, expected duration, number of urine and tee shirt samples to be
provided, states that research results will be coded, participants are
free to withdraw, provides a contact for information, and specifies
compensation of $150 for each participating household. The consent
form, entitled ``Authorization for Participation in Research Project,''
also states that ``no risks are anticipated to the participants.'' The
implication is that since families already used flea collars on their
dogs, there was no added risk from participating in the study. In the
abstract that the researchers submitted to ORD, however, page 4 states
that ``the residues of insecticides available for intermittent transfer
to children from the fur of dogs treated by either a spot treatment or
a collar for flea control will be appreciable and of a magnitude
necessitating inclusion in cumulative risk assessments of pesticides to
children; secondly, that the fur rubbing procedure developed to
quantify dislodgeable residues provides a useful estimate of
insecticide residues which could be transferred from the fur of dogs to
children.''
    Although the families involved already used flea collars registered
by EPA, in the interest of transparency, it would have been preferable
for the researchers to have shared their hypothesis with the parents of
the participating children and included it in the consent form. It is
unknown whether the information was stated in the protocol provided to
the families. The Minor's Assent Form states that the researchers
``will specifically obtain assent from the children recruited to our
project . . . We will explain that the child's parent or guardian has
given us permission to request his/her help participation (sic) in the
research project. We will then explain the urine collection protocol
and the tee shirt protocol to the children in language appropriate to
the age of the child and obtain his/her assent to participate. We will
not explain the connection to the pesticide residues on the dog so as
not to alter the behavior of the child with the dog. We will obtain the
children's assent orally because of the age range of the children
involved.''
    The researchers demonstrated respect for subjects participating in
the study in several ways. The researchers: Did not reveal subjects'
identities; obtained informed consent from participating subjects;
provided light weight short-sleeve tee shirts to children for use
during the study; gave written assurance that urine samples would only
be used to quantify insecticide urinary metabolites; and provided
compensation for participation in the study. Compensation included $100
equivalent of veterinary care provided by the Animal Health Center of
MSU College of Veterinary Medicine and $150 to participating households
in Study 2.

VI. Summary of Discussion on Ethics-Related Questions

    As documented on page 27 of the minutes of the January 2016 HSRB
meeting, in response to EPA's science charge question, the HSRB stated
that, ``The research is scientifically sound and, if used
appropriately, the pet fur transferable residue data from the rubbing
protocol can provide useful information for evaluating potential
exposures of adults and children from contact with dogs treated with

tetrachlorvinphos containing pet collars.'' The HSRB noted that, ``the
limitations of the data would be discussed in the Board's report.'' The
minutes of the January 12-13, 2016 public HSRB meeting are available on
the HSRB Web site at http://www.epa.gov/osa/january-12-13-2016-meeting-human-studies-review-board.
    The EPA also asked the HSRB if they had any comments on the
determination that the samplers (who petted/rubbed the dogs) were not
human subjects. During the public meeting, as documented on pages 27-28
of the minutes, ``Questions were raised by several committee members
about the PI's ([primary investigator's) and the IRB's (Institutional
Review Board's) determinations that the samplers were not human
subjects in the study; rather they were viewed as study staff. Some
members of the board asserted that the students/technicians, by virtue
of being potentially exposed to the pesticide as part of the conduct of
the study, should have been considered human subjects. Furthermore, if
they had been treated as subjects, they might have been considered
`vulnerable' due to their status as students.'' The HSRB noted that the
flea control collars were ``commercially available at the time, and
that the potential exposure to the pesticide residues through petting
the dogs for 5 minute periods wearing cotton gloves was likely much
less than average exposure of a pet owner. There is no information
available about whether there was any `bleed through' of pesticide from
the cotton gloves to the skin of the samplers and therefore the actual
exposure is unknown. Considering all of these factors, the committee
felt that the risks of exposure were not greater than those experienced
in everyday life. Thus, even if the determination regarding the status
of the samplers as study staff rather than subjects was mistaken, the
committee did not believe this resulted in any material harms and so
this question should not prevent the EPA from using the pet fur
transferable residue data derived from the study for making a decision
to impose a more stringent regulatory restriction than could be
justified without the data.''
    EPA asked the HSRB if they had any comments on the ethical conduct
of the research. As noted on page 28 of the meeting minutes,
``Committee members observed that the records from correspondence with
EPA staff regarding the study suggest the consent form was amended to
include disclosure to parents about the risks of pesticide exposure,
although the final approved consent form was not available. A question
was raised about the decision made to provide incomplete assent to the
minor subjects following parental permission. Study documents suggest
this was an intentional choice (`We will not explain the connection to
the pesticide residues on the dog . . .'), which was made, according to
study documents, in order to avoid confounding the results by causing
alterations in the children's behavior around their dogs. Board members
noted that the amount and type of information provided to children in
an assent process will vary depending on the age of the child; the
children enrolled in the study were between the ages of 3 and 11 years
old and therefore would have had varying levels of capacity to process
the information about the study. It was noted that FIFRA, which existed
at the time of these studies, states that it's unlawful to use any
pesticide in tests on humans unless they are fully informed of the
nature and purposes of the test. Although some board members viewed the
assent as incomplete in this case, because parents are presumed to have
given fully-informed permission,'' and given that the flea control
collars were ``commercially available at the time and already in use in
the households recruited to the study, the committee felt that the
risks of exposure were not greater than those experienced in everyday
life. Thus, the committee did not believe this resulted in any material
harms and so this question should not prevent the EPA from using the
pet fur transferable residue data derived from the study for making a
decision to impose a more stringent regulatory restriction than could
be justified without the data.''

VII. Standards Applicable to Ethical Conduct and Reliance on Data

    With regard to the standards applicable to the conduct of the
research, study 1 was conducted in 1998 and study 2 was conducted in
2002, both before EPA's Rule for Protection of Human Subjects (40 CFR
part 26, subparts B through Q) became effective in 2006. Thus, 40 CFR
part 26, subparts B through Q, did not apply when this research was
conducted. However, EPA's codification of the Common Rule at 40 CFR
part 26 subpart A was in place and applies to the underlying research
that received EPA's STAR grant funding. Key elements of the Common Rule
include IRB oversight and prior approval, an acceptable informed
consent process, risk minimization, a favorable risk-benefit balance,
equitable subject selection, and fully informed and voluntary
participation by subjects. In addition, FIFRA section 12(a)(2)(P),
which states that it is unlawful to use any pesticide in tests on
humans unless they are fully informed of the nature and purposes of the
tests, as well as of any reasonably foreseeable physical and mental
health consequences, and that participants freely volunteer, existed at
the time of these studies. The Davis et al. research complied with the
standards in place at the time the research was conducted.
    The substantive acceptance standards which apply to the research
include: 40 CFR 26.1703, which, except as provided in 40 CFR 26.1706,
prohibits relying on data involving intentional exposure of pregnant or
nursing women or of children; 40 CFR 26.1704, which, except as provided
in 40 CFR 26.1706, prohibits reliance on data if research was
fundamentally unethical or deficient relative to prevailing standards
at the time; and FIFRA section 12(a)(2)(P), which makes it unlawful to
use a pesticide in human tests without fully informed, fully voluntary
consent. 40 CFR 26.1706 states that EPA may rely on data that are
unacceptable under the standards in 40 CFR 26.1703 through 26.1705 only
if EPA has: (a) Obtained the views of the HSRB, (b) provided the
opportunity for public comment on the proposal to rely on the otherwise
unacceptable data, (c) determined that relying on the data is crucial
to a decision that would impose a more stringent regulatory restriction
to protect public health than could be justified without the data, and
(d) published a full explanation of the decision to rely on the data,
including a thorough discussion of the ethical deficiencies of the
underlying research and the full rationale for finding that the
standard in item (c) was met. Regarding 40 CFR 26.1703, study 2
involved tee shirt and urine samples that came from children. As
explained previously, even though EPA only intends to rely on the glove
residue data from study 1 and study 2, which did not involve children,
EPA chose in this case, out of an abundance of caution, to proceed
under 40 CFR part 26, subpart Q.
    Regarding 40 CFR 26.1704, clear and convincing evidence that the
pre-rule research was fundamentally unethical or deficient relative to
prevailing ethics standards does not exist, and the research complied
with FIFRA section 12(a)(2)(P). In satisfaction of 40 CFR 26.1706(a),
EPA sought and obtained the views of the HSRB during the public HSRB
meeting on January 12-13, 2016. The HSRB documents their views in
meeting minutes and a final report before EPA publishes the explanation
required by 40 CFR 26.1706(d).

Pursuant to 40 CFR 26.1706(b), EPA is providing an opportunity for
public comment on EPA's proposed decision to rely on the glove residue
data.
    Regarding 40 CFR 26.1706(c), EPA has determined that relying on the
glove residue data from the Davis et al. research is crucial to a
decision to potentially impose a more stringent regulatory restriction
that would improve public health protection than could be justified
without relying on the data, as explained in EPA's draft human health
and ecological risk assessment for the registration review of TCVP.

VIII. Availability of HSRB Meeting Materials

    In accordance with the requirements of the Federal Advisory
Committee Act (FACA), 5 U.S.C. Appendix 2, the minutes of the HSRB
public meeting held on January 12-13, 2016, including a description of
the matters discussed and conclusions reached by the Board, must be
certified by the HSRB meeting Chair and made public within 90 days of
the meeting. The HSRB meeting Chair in fact certified those meeting
minutes on February 24, 2016. The HSRB also will prepare a final report
in response to questions posed by the EPA, which will include the
Board's review and analysis of materials presented. The approved
minutes, final report and other materials from the January 12-13, 2016
HSRB meeting are or will be available in docket ID number EPA-HQ-ORD-
2015-0588 and on the HSRB Web site at http://www.epa.gov/osa/human-studies-review-board.

IX. Other Related Information on TCVP

    The public can view EPA's draft human health and ecological risk
assessment and supporting documents for the registration review of TCVP
in the docket at http://www.regulations.gov (see docket ID number EPA-
HQ-OPP-2008-0316). Information on the Agency's registration review
program and its implementing regulation is available at https://www.epa.gov/pesticide-reevaluation/registration-review-process.

    Authority: 7 U.S.C. 136 et seq.

    Dated: March 28, 2016.
Jack E. Housenger,
Director, Office of Pesticide Programs, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2016-08281 Filed 4-8-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 12, 2007 (Volume 72, Number 70)]
[Notices]
[Page 18474-18475]
[DOCID:fr12ap07-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

April 6, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12783-000.
    c. Date filed: March 5, 2007.
    d. Applicant: Inglis Hydropower, LLC.
    e. Name of Project: Inglis Hydropower Project.
    f. Location: On the Withlacoochee River, in Levy County, Florida.
    g. Filed Pursuant To: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Dean Edwards, Inglis Hydropower, LLC , P.O.
Box 1565, Dover, FL 33527,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for Filing Comments, Protests, and Motions to
Intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12783-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) An existing 3500-foot-long, 22-foot-high Inglis Bypass Dam, (2) an
existing impoundment having a surface area of 4,000 acres, with a
storage capacity of 41,000 acre-feet and normal water surface elevation
of 27.5 feet mean sea level, (3) an existing 320-foot-long, 45-foot-
wide, and 12-foot deep intake channel, (4) a proposed power house
containing two generating units having a total installed capacity of
2,000 kilowatts, (5) an existing bypass channel, (6) a proposed 0.45-
mile-long, 12.47 kilovolt transmission line, and (7) appurtenant
facilities. The proposed project would have an estimated average annual
generation of 12.3 gigawatt-hours, which would be sold to a local
utility.
    l. Location of Application: This filing is available for review at
the Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or e-mail<EMAIL_ADDRESS>For TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item h above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the

particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-6922 Filed 4-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Proposed Rules]
[Pages 47424-47427]
[FR Doc No: 2021-18226]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0696; Project Identifier MCAI-2021-00032-T]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-
500-1A11 airplanes. This proposed AD was prompted by reports of loose
or disconnected powerplant FIREX interconnection hoses. This proposed
AD would require replacing certain existing FIREX hose assemblies with
a newly designed FIREX hose assembly, as specified in a Transport
Canada Civil Aviation (TCCA) AD, which is proposed for incorporation by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by October 12,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For TCCA material that will be incorporated by reference (IBR) in
this AD, contact TCCA, Transport Canada

National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario
K1A 0N5, Canada; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet
https://tc.canada.ca/en/aviation. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0696.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0696; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Siddeeq Bacchus, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0696; Project Identifier
MCAI-2021-00032-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Siddeeq Bacchus, Aerospace Engineer, Mechanical Systems and
Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-
794-5531; email<EMAIL_ADDRESS>Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    TCCA, which is the aviation authority for Canada, has issued TCCA
AD CF-2021-01, dated January 8, 2021 (TCCA AD CF-2021-01) (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), to correct an unsafe condition for certain Airbus Canada
Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.
    This proposed AD was prompted by reports of loose powerplant FIREX
interconnection hoses, and in one instance a hose was found
disconnected. An investigation by the manufacturer determined that if
the instructions for connecting the FIREX hose are not followed
properly, hoses can become loose or disconnected. The FAA is proposing
this AD to address the possibility that fire extinguishing agent may
not be effectively applied should a fire occur within a powerplant
assembly that has a partially or completely disconnected FIREX hose,
which could result in the inability to put out a fire in the engine.
See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    TCCA AD CF-2021-01 describes procedures for replacing certain
existing FIREX hose assemblies on each powerplant with a newly designed
FIREX hose assembly with provisions for the installation of safety
cables at each end, in order to prevent the hose from becoming loose or
disconnected.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in TCCA AD CF-2021-01 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and the European Union
Aviation Safety Agency (EASA) to develop a process to use certain EASA
ADs as the primary source of information for compliance with
requirements for corresponding FAA ADs. The FAA has since coordinated
with other manufacturers and civil aviation authorities (CAAs) to use
this process. As a result, TCCA AD CF-2021-01 will be incorporated by
reference in the FAA final rule. This proposed AD would, therefore,
require compliance with TCCA AD CF-2021-01 in its entirety, through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this proposed AD. Service information
specified in TCCA AD CF-2021-01 that is required for compliance with
TCCA AD CF-2021-01 will be available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0696 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 36 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................         $13,012          $13,437         $483,732
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Canada Limited Partnership (Type Certificate Previously Held
by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.):
Docket No. FAA-2021-0696; Project Identifier MCAI-2021-00032-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by October 12, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership (type
certificate previously held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11
airplanes, certificated in any category, as identified in Transport
Canada Civil Aviation (TCCA) AD CF-2021-01, dated January 8, 2021
(TCCA AD CF-2021-01).

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by reports of loose or disconnected
powerplant FIREX interconnection hoses. The FAA is issuing this AD
to address the possibility that fire extinguishing agent may not be
effectively applied should a fire occur within a powerplant assembly
that has a partially or completely disconnected FIREX hose, which
could result in the inability to put out a fire in the engine.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, TCCA AD CF-2021-01.

(h) Exceptions to TCCA AD CF-2021-01

    (1) Where TCCA AD CF-2021-01 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where TCCA AD CF-2021-01 refers to ``hours air time,'' this
AD requires using ``flight hours.''

(i) No Reporting Requirement

    Although the service information referenced in TCCA AD CF-2021-
01 specifies to submit certain information to the manufacturer, this
AD does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or TCCA; or Airbus Canada Limited Partnership's TCCA
Design Approval Organization (DAO). If approved by the DAO, the
approval must include the DAO-authorized signature.

(k) Related Information

    (1) For information about TCCA AD CF-2021-01, contact TCCA,
Transport Canada National Aircraft Certification, 159 Cleopatra
Drive, Nepean, Ontario K1A 0N5, Canada; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>internet https://tc.canada.ca/en/aviation. You
may view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket on the
internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0696.
    (2) For more information about this AD, contact Siddeeq Bacchus,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on August 18, 2021.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-18226 Filed 8-24-21; 8:45 am]
BILLING CODE 4910-13-P