[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Proposed Rules]
[Pages 86274-86278]
[FR Doc No: 2023-27396]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 /
Proposed Rules

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2023-2251; Notice No. 25-23-05-SC]

Special Conditions: Aerocon Engineering Company, Airbus Model
A330-300 Series Airplane; Lower Deck Crew Rest Compartment Installation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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SUMMARY: This action proposes special conditions for the Airbus Model
A330-300 series airplane. This airplane as modified by Aerocon
Engineering Company (Aerocon) will have a novel or unusual design
feature when compared to the state of technology envisioned in the
airworthiness standards for transport category airplanes. This design
feature is an installation of a lower deck crew rest compartment
(LDCRC) under the passenger cabin floor in the cargo compartment. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These proposed
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: Send comments on or before January 29, 2024.

ADDRESSES: Send comments identified by Docket No. FAA-2023-2251 using
any of the following methods:
    Federal eRegulations Portal: Go to www.regulations.gov and follow
the online instructions for sending your comments electronically.
    Mail: Send comments to Docket Operations, M-30, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to Docket Operations in Room W12-140 of the
West Building Ground Floor at 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Daniel Jacquet, Cabin Safety, AIR-624,
Technical Policy Branch, Policy and Standards Division, Aircraft
Certification Service, Federal Aviation Administration, 2200 South
216th Street, Des Moines, Washington 98198; telephone and fax (206)
231-3208; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested people to take part in this rulemaking
by sending written comments, data, or views. The most helpful comments
reference a specific portion of the proposed special conditions,
explain the reason for any recommended change, and include supporting
data.
    The FAA will consider all comments received by the closing date for
comments and will consider comments filed late if it is possible to do
so without incurring delay. The FAA may change these special conditions
based on the comments received.

Privacy

    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in title
14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all
comments received without change to www.regulations.gov, including any
personal information, you provide. The FAA will also post a report
summarizing each substantive verbal contact received about these
special conditions.

Confidential Business Information

    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
these special conditions contain commercial or financial information
that is customarily treated as private, that you actually treat as
private, and that is relevant or responsive to these special
conditions, 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 the indicated comments will not be
placed in the public docket of these special conditions. Send
submissions containing CBI to the individual listed in the For Further
Information Contact section. Comments the FAA receives, which are not
specifically designated as CBI, will be placed in the public docket for
these special conditions.

Background

    On July 5, 2022, Aerocon applied for a supplemental type
certificate for the installation of a LDCRC in the Airbus Model A330-
300 series airplane. The Airbus Model A330-300 series airplane is a
twin-engine, transport-category airplane with a maximum takeoff weight
of 533,518 pounds and maximum seating for 440 passengers.

Type Certification Basis

    Under the provisions of 14 CFR 21.101, Aerocon must show that the
Airbus Model A330-300 series airplane, as changed, continues to meet
the applicable provisions of the regulations listed in Type Certificate
No. A46NM or the applicable regulations in effect on the date of
application for the change, except for earlier amendments as agreed
upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Airbus Model A330-300 series
airplane because of a novel or unusual design feature, special
conditions are

prescribed under the provisions of Sec.  21.16.
    Should the applicant apply for a supplemental type certificate to
modify any other model included on the same type certificate to
incorporate the same novel or unusual design feature, these special
conditions would also apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Airbus Model A330-300 series airplane must comply with
the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and
the noise-certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Airbus Model A330-300 series airplane will incorporate the
following novel or unusual design feature:
    Installation of a LDCRC under the passenger cabin floor in the
cargo compartment.

Discussion

    Section 25.819 applies to lower deck service compartments
(including galleys) but is not directly applicable to LDCRC. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. Special
conditions are required for the certification of the LDCRC to
supplement part 25.
    The LDCRC will be located under the passenger cabin floor in the
cargo compartment of the Airbus A330-330 model series airplane. It will
be removable from the cargo compartment. Occupancy of the LDCRC will be
limited to a maximum of eight crew members, and it will only be
occupied in flight, i.e., not during taxi, takeoff, or landing. A smoke
detection system, fire extinguishing system, oxygen system, and
occupant amenities will be provided.
    The LDCRC will be accessed from the main deck via a stair house.
The floor within the stair house has an access hatch that leads to
stairs, which occupants use to descend into the LDCRC. This hatch locks
automatically in the open position when fully opened. In addition,
there will be an emergency hatch, which opens directly into the main
passenger cabin area. The LDCRC also has a maintenance access/ground
loading door, which allows access to and from the cargo compartment.
The intended use of this door is to allow cargo loading and maintenance
personnel to enter the LDCRC from the cargo compartment when the
airplane is on the ground, and not moving.
    The proposed special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

Applicability

    As discussed above, these proposed special conditions are
applicable to the Airbus Model A330-300 series airplane for which they
are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would apply to the other model as well.

Conclusion

    This action affects only certain novel or unusual design feature on
one model A330-300 airplane. It is not a rule of general applicability
and affects only the applicant who applied to the FAA for approval of
these features on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, and
44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for Airbus Model A330-300 series airplanes as modified by Aerocon
Engineering Company.
    (a) Occupancy of the LDCRC is limited to a maximum of eight. There
must be an approved seat or berth able to withstand the maximum flight
loads when occupied for each occupant permitted in the crew rest
compartment.
    (1) There must be appropriate placards displayed in a conspicuous
place at each entrance to the LDCRC compartment to indicate:
    (i) The maximum number of occupants allowed.
    (ii) That occupancy is restricted to crewmembers that are trained
in the evacuation procedures for the crew rest compartment.
    (iii) That occupancy is prohibited during taxi, take-off, and
landing.
    (iv) That smoking is prohibited in the crew rest compartment.
    (v) That hazardous quantity of flammable fluids, explosives, or
other dangerous cargo is prohibited from the crew rest compartment.
    (vi) That the crew rest area must be limited to the stowage of crew
personal luggage and must not be used for the stowage of cargo or
passenger baggage.
    (2) There must be at least one ashtray located conspicuously on or
near the entry side of any entrance, usable in-flight, to the crew rest
compartment.
    (3) There must be a means to prevent passengers from entering the
compartment in the event of an emergency or when no flight attendant is
present.
    (4) There must be a means for any door installed between the crew
rest compartment and passenger cabin to be capable of being quickly
opened from inside the compartment, even when crowding occurs at each
side of the door.
    (5) For all doors installed in the evacuation routes, there must be
a means to preclude anyone from being trapped inside the compartment.
If a locking mechanism is installed, it must be capable of being
unlocked from the outside without the aid of special tools. The lock
must not prevent opening from the inside of the compartment at any
time.
    (b) There must be at least two emergency evacuation routes, which
could be used by each occupant of the crew rest compartment to rapidly
evacuate to the main cabin and be able to be closed from the main
passenger cabin after evacuation. In addition--
    (1) The routes must be located with one at each end of the
compartment, or with two having sufficient separation within the
compartment and between the routes to minimize the possibility of an
event (either inside or outside of the crew rest compartment) rendering
both routes inoperative.
    (2) The routes must be designed to minimize the possibility of
blockage, which might result from fire, mechanical or structural
failure, or persons standing on top of or against the escape route. If
an evacuation route utilizes an area where normal movement of
passengers occurs, it must be demonstrated that passengers would not
impede egress to the main deck. If a hatch is installed in an
evacuation route, the point at which the evacuation route terminates in
the passenger cabin should not be located where normal movement by
passengers or crew occurs (main aisle, cross aisle, passageway or
galley complex). If such a location cannot be avoided, special
consideration must be taken to ensure that the hatch or door can be
opened

when a person, the weight of a ninety-fifth percentile male, is
standing on the hatch or door. The use of evacuation routes must not be
dependent on any powered device. If there is low headroom at or near an
evacuation route, provisions must be made to prevent or to protect
occupants of the crew rest area from head injury.
    (3) Emergency evacuation procedures, including the emergency
evacuation of an incapacitated occupant from the crew rest compartment,
must be established. All of these procedures must be transmitted to the
operator for incorporation into their training programs and appropriate
operational manuals.
    (4) There must be a limitation in the airplane flight manual or
other suitable means requiring that crewmembers be trained in the use
of evacuation routes.
    (c) There must be a means for the evacuation of an incapacitated
person (representative of a 95th percentile male) from the crew rest
compartment to the passenger cabin floor.
    The evacuation must be demonstrated for all evacuation routes. A
flight attendant or other crewmember (a total of one assistant within
the crew rest area) may provide assistance in the evacuation.
Additional assistance may be provided by up to three persons in the
main passenger compartment. For evacuation routes having stairways, the
additional assistants may descend down to one half the elevation change
from the main deck to the lower deck compartment, or to the first
landing, whichever is higher.
    (d) The following signs and placards must be provided in the crew
rest compartment:
    (1) At least one exit sign, located near each exit, meeting the
requirements of Sec.  25.812(b)(1)(i) at Amendment 25-58, except that a
sign with reduced background area of no less than 5.3 square inches
(excluding the letters) may be utilized, provided that it is installed
such that the material surrounding the exit sign is light in color
(e.g., white, cream, light beige). If the material surrounding the exit
sign is not light in color, a sign with a minimum of a one-inch wide
background border around the letters would also be acceptable.
    (2) An appropriate placard located near each exit defining the
location and the operating instructions for each evacuation route.
    (3) Placards must be readable from a distance of 30 inches under
emergency lighting conditions.
    (4) The exit handles and evacuation path operating instruction
placards must be illuminated to at least 160 micro lamberts under
emergency lighting conditions.
    (e) There must be a means in the event of failure of the aircraft's
main power system, or of the normal crew rest compartment lighting
system, for emergency illumination to be automatically provided for the
crew rest compartment.
    (1) This emergency illumination must be independent of the main
lighting system.
    (2) The sources of general cabin illumination may be common to both
the emergency and the main lighting systems if the power supply to the
emergency lighting system is independent of the power supply to the
main lighting system.
    (3) The illumination level must be sufficient for the occupants of
the crew rest compartment to locate and transfer to the main passenger
cabin floor by means of each evacuation route.
    (4) The illumination level must be sufficient with the privacy
curtains in the closed position for each occupant of the crew rest to
locate a deployed oxygen mask.
    (f) There must be means for two-way voice communications between
crewmembers on the flight deck and occupants of the crew rest
compartment. There must also be public address (PA) system microphones
at each flight attendant seat required to be near a floor level exit in
the passenger cabin per Sec.  25.785(h) at Amendment 25-51. The PA
system must allow two-way voice communications between flight
attendants and the occupants of the crew rest compartment, except that
one microphone may serve more than one exit provided the proximity of
the exits allows unassisted verbal communication between seated flight
attendants.
    (g) There must be a means for manual activation of an aural
emergency alarm system, audible during normal and emergency conditions,
to enable crewmembers on the flight deck and at each pair of required
floor level emergency exits to alert occupants of the crew rest
compartment of an emergency situation. Use of a public address or crew
interphone system will be acceptable, provided an adequate means of
differentiating between normal and emergency communications is
incorporated. The system must be powered in flight, after the shutdown
or failure of all engines and auxiliary power units (APU), or the
disconnection or failure of all power sources dependent on their
continued operation (i.e., engine & APU), for a period of at least ten
minutes.
    (h) There must be a means, readily detectable by seated or standing
occupants of the crew rest compartment, which indicates when seat belts
should be fastened. In the event there are no seats, at least one means
must be provided to cover anticipated turbulence (e.g., sufficient
handholds). Seat belt type restraints must be provided for berths and
must be compatible for the sleeping attitude during cruise conditions.
There must be a placard on each berth requiring that seat belts must be
fastened when occupied. If compliance with any of the other
requirements of these special conditions is predicated on specific head
location, there must be a placard identifying the head position.
    (i) In lieu of the requirements specified in Sec.  25.1439(a) at
Amendment 25-38 that pertain to isolated compartments and to provide a
level of safety equivalent to that which is provided occupants of a
small, isolated galley, the following equipment must be provided in the
crew rest compartment:
    (1) At least one approved hand-held fire extinguisher appropriate
for the kinds of fires likely to occur.
    (2) Two protective breathing equipment (PBE) devices approved to
Technical Standard Order (TSO)-C116 or equivalent, suitable for
firefighting, or one PBE for each hand-held fire extinguisher,
whichever is greater.
    (3) One flashlight.

    Note: Additional PBEs and fire extinguishers in specific
locations, (beyond the minimum numbers prescribed in special
condition (i)) may be required as a result of any egress analysis
accomplished to satisfy special condition (b)(1).

    (j) A smoke or fire detection system (or systems) must be provided
that monitors each occupiable area within the crew rest compartment,
including those areas partitioned by curtains. Flight tests must be
conducted to show compliance with this requirement. Each system (or
systems) must provide:
    (1) A visual indication to the flight deck within one minute after
the start of a fire;
    (2) An aural warning in the crew rest compartment; and
    (3) A warning in the main passenger cabin. This warning must be
readily detectable by a flight attendant, taking into consideration the
positioning of flight attendants throughout the main passenger
compartment during various phases of flight.
    (k) The crew rest compartment must be designed such that fires
within the compartment can be controlled without a crewmember having to
enter the compartment, or the design of the access

provisions must allow crewmembers equipped for firefighting to have
unrestricted access to the compartment. The time for a crewmember on
the main deck to react to the fire alarm, to don the firefighting
equipment, and to gain access must not exceed the time for the
compartment to become smoke-filled, making it difficult to locate the
fire source.
    (l) There must be a means provided to exclude hazardous quantities
of smoke or extinguishing agent originating in the crew rest
compartment from entering any other compartment occupied by crewmembers
or passengers. This means must include the time periods during the
evacuation of the crew rest compartment and, if applicable, when
accessing the crew rest compartment to manually fight a fire. Smoke
entering any other compartment occupied by crewmembers or passengers
when the access to the crew rest compartment is opened, during an
emergency evacuation, must dissipate within five minutes after the
access to the crew rest compartment is closed.
    (1) Hazardous quantities of smoke may not enter any other
compartment occupied by crewmembers or passengers during subsequent
access to manually fight a fire in the crew rest compartment (the
amount of smoke entrained by a firefighter exiting the crew rest
compartment through the access is not considered hazardous).
    (2) There must be a provision in the firefighting procedures to
ensure that all door(s) and hatch(es) at the crew rest compartment
outlets are closed after evacuation of the crew rest compartment and,
during firefighting to minimize smoke and extinguishing agent from
entering other occupiable compartments.
    (3) During the 1-minute smoke detection time, penetration of a
small quantity of smoke from the crew rest compartment into an occupied
area is acceptable. Flight tests must be conducted to show compliance
with this requirement.
    (4) If a built-in fire extinguishing system is used in lieu of
manual firefighting, then the fire extinguishing system must be
designed so that no hazardous quantities of extinguishing agent will
enter other compartments occupied by passengers or crew. The system
must have adequate capacity to suppress any fire occurring in the crew
rest compartment, considering the fire threat, volume of the
compartment and the ventilation rate.
    (m) There must be a supplemental oxygen system equivalent to that
provided for main deck passengers for each seat and berth in the crew
rest compartment. The system must provide an aural and visual warning
to warn the occupants of the crew rest compartment to don oxygen masks
in the event of decompression. The warning must activate before the
cabin pressure altitude exceeds 15,000 feet. The aural warning must
sound continuously for a minimum of five minutes or until a reset push
button in the crew rest compartment is depressed. Procedures for crew
rest occupants in the event of decompression must be established. These
procedures must be transmitted to the operator for incorporation into
their training programs and appropriate operational manuals.
    (n) The following requirements apply to crew rest compartments that
are divided into several sections by the installation of curtains or
partitions:
    (1) To compensate for sleeping occupants, there must be an aural
alert that can be heard in each section of the crew rest area
compartment that accompanies automatic presentation of supplemental
oxygen masks. A visual indicator that occupants must don an oxygen mask
is required in each section where seats or berths are not installed. A
minimum of two supplemental oxygen masks is required for each seat or
berth. There must also be a means by which the oxygen masks can be
manually deployed from the flight deck.
    (2) A placard is required adjacent to each curtain that visually
divides or separates, for privacy purposes, the crew rest area
compartment into small sections. The placard must require that the
curtain(s) remains open when the private section it creates is
unoccupied.
    (3) For each crew rest section created by the installation of a
curtain, the following requirements of these special conditions must be
met with the curtain open or closed:
    (i) Emergency illumination (Special condition (e)).
    (ii) Emergency alarm system (Special condition (g)).
    (iii) Seat belt fasten signal or return to seat signal as
applicable (Special condition (h)).
    (iv) The smoke or fire detection system (Special condition (j)).
    (4) Crew rest compartments visually divided to the extent that
evacuation could be affected must have exit signs that direct occupants
to the primary stairway exit. The exit signs must be provided in each
separate section of the crew rest compartment and must meet the
requirements of Sec.  25.812(b)(1)(i) at Amendment 25-58. An exit sign
with reduced background area as described in special condition (d)(1)
may be used to meet this requirement.
    (5) For sections within a crew rest compartment that are created by
the installation of a partition with a door separating the sections,
the following requirements of these special conditions must be met with
the door open or closed:
    (i) There must be a secondary evacuation route from each section to
the main deck, or alternatively, it must be shown that any door between
the sections has been designed to preclude anyone from being trapped
inside the compartment. Removal of an incapacitated occupant within
this area must be considered. A secondary evacuation route from a small
room designed for only one occupant for short time duration, such as a
changing area or lavatory, is not required. However, removal of an
incapacitated occupant within this area must be considered.
    (ii) Any door between the sections must be shown to be openable
when crowded against, even when crowding occurs at each side of the
door.
    (iii) There may be no more than one door between any seat or berth
and the primary stairway exit.
    (iv) There must be exit signs in each section meeting the
requirements of Sec.  25.812(b)(1)(i) at Amendment 25-58 that direct
occupants to the primary stairway exit. An exit sign with reduced
background area as described in special condition (d).(1) may be used
to meet this requirement.
    (v) Special conditions (e) (emergency illumination), (g) (emergency
alarm system), (h) (fasten seat belt signal or return to seat signal as
applicable), and (j) (smoke or fire detection system) must be met with
the door open or closed.
    (vi) Special conditions (f) (two-way voice communication) and (i)
(emergency firefighting and protective equipment) must be met
independently for each separate section except for lavatories or other
small areas that are not intended to be occupied for extended periods
of time.
    (o) Where a waste disposal receptacle is fitted, it must be
equipped with a built-in fire extinguisher designed to discharge
automatically upon occurrence of a fire in the receptacle.
    (p) Materials (including finishes or decorative surfaces applied to
the materials) must comply with the flammability requirements of Sec.
25.853 at Amendment 25-66. Mattresses must comply with the flammability
requirements of Sec.  25.853(b) and (c) at Amendment 25-66.
    (q) If a lavatory is installed, all lavatories within the crew rest
are required to meet the same requirements as those for a lavatory
installed on the

main deck except with regard to special condition (j) for smoke
detection.
    (r) When a crew rest compartment is installed or enclosed as a
removable module in part of a cargo compartment or is located directly
adjacent to a cargo compartment without an intervening cargo
compartment wall, the following applies:
    (1) Any wall of the module (container) forming part of the boundary
of the reduced cargo compartment, subject to direct flame impingement
from a fire in the cargo compartment and including any interface item
between the module (container), and the airplane structure or systems,
must meet the applicable requirements of Sec.  25.855 at Amendment 25-
60.
    (2) Means must be provided so that the fire protection level of the
cargo compartment meets the applicable requirements of Sec. Sec.
25.855 at amendment 25-60, 25.857 at amendment 25-60 and 25.858 at
amendment 25-54 when the module (container) is not installed.
    (3) Use of each emergency evacuation route must not require
occupants of the crew rest compartment to enter the cargo compartment
in order to return to the passenger compartment.
    (4) The aural warning in special condition (g) must sound in the
crew rest compartment in the event of a fire in the cargo compartment.
    (s) Means must be provided to prevent access into the Class C cargo
compartment during all airplane operations and to ensure that the
maintenance door is closed during all airplane flight operations.
    (t) All enclosed stowage compartments within the crew rest that are
not limited to stowage of emergency equipment or airplane-supplied
equipment (e.g., bedding) must meet the design criteria given in the
table below. As indicated by the table below, this special condition
does not address enclosed stowage compartments greater than 200 ft\3\
in interior volume. The in-flight accessibility of very large, enclosed
stowage compartments and the subsequent impact on the crewmember's
ability to effectively reach any part of the compartment with the
contents of a hand fire extinguisher will require additional fire
protection considerations similar to those required for inaccessible
compartments such as Class C cargo compartments.

                                                          Stowage Compartment Interior Volumes
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Fire protection features                  Less than 25 ft\3\                   25 ft\3\ to 57 ft\3\                  57 ft\3\ to 200 ft\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Materials of Construction \1\........  Yes..................................  Yes.................................  Yes.
Detectors \2\........................  No...................................  Yes.................................  Yes.
Liner \3\............................  No...................................  No..................................  Yes.
Locating Device \4\..................  No...................................  Yes.................................  Yes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Materials of Construction: The material used to construct each enclosed stowage compartment must at least be fire resistant and must meet the
  flammability standards established for interior components per the requirements of Sec.   25.853. For compartments less than 25 ft\3\ in interior
  volume, the design must ensure the ability to contain a fire likely to occur within the compartment under normal use.
\2\ Detectors: Enclosed stowage compartments equal to or exceeding 25 ft\3\ in interior volume must be provided with a smoke or fire detection system to
  ensure that a fire can be detected within a one-minute detection time. Flight tests must be conducted to show compliance with this requirement. Each
  system (or systems) must provide:
(a) A visual indication in the flight deck within one minute after the start of a fire;
(b) An aural warning in the crew rest compartment; and
(c) A warning in the main passenger cabin. This warning must be readily detectable by a flight attendant, taking into consideration the positioning of
  flight attendants throughout the main passenger compartment during various phases of flight.
\3\ Liner: If it can be shown that the material used to construct the stowage compartment meets the flammability requirements of a liner for a Class B
  cargo compartment, then no liner would be required for enclosed stowage compartments equal to or greater than 25 ft\3\ in interior volume but less
  than 57 ft\3\ in interior volume. For all enclosed stowage compartments equal to or greater than 57 ft\3\ in interior volume but less than or equal to
  200 ft\3\, a liner must be provided that meets the requirements of Sec.   25.855 at Amendment 25-60 for a class B cargo compartment.
\4\ Location Detector: Crew rest areas which contain enclosed stowage compartments exceeding 25 ft\3\ interior volume and which are located away from
  one central location such as the entry to the crew rest area or a common area within the crew rest area would require additional fire protection
  features and/or devices to assist the firefighter in determining the location of a fire.

    Issued in in Kansas City, Missouri, on December 8, 2023.
Patrick R. Mullen,
Manager, Technical Policy Branch, Policy and Standards Division,
Aircraft Certification Service.
[FR Doc. 2023-27396 Filed 12-12-23; 8:45 am]
BILLING CODE 4910-13-P


Human Exposure Assessment for a Reregistration Submission for 1,2 Benzisothiazolin 3 one ( BIT)

Antimicrobials Division Office of Pesticide Programs U. S. Environmental Protection Agency 1921 Jefferson Davis Highway Arlington, VA 22202 September 1, 2005 2 EXECUTIVE SUMMARY 1,2 Benzisothiazolin 3 one ( BIT) is an industrial preservative that is recommended to control the growth of microorganisms in the preserved product. BIT is recommended for use as an industrial preservative for the protection of water based adhesives, caulks, sealants, grouts, spackling, readymixed cements, ready mixed wallboard compounds, aqueous compositions such as emulsion paints, aqueous slurries, home cleaning and car care products, inks, photographic processing solutions, paints and stains, titanium dioxide slurries, oil in water emulsions, latices, gas/ oil drilling fluids, metalworking fluids, casein/ rosin dispersions, textile spin finish solutions, laundry detergent, pesticide formulations, tape joint compound, leather processing solutions, and for preservation of fresh animal hides and skins.

The application rates used in this assessment are intended to reflect the upper range of the labeled rates. A wide range of registered labels ( approximately 33) were available for review. Table 4 presents the conversion the maximum labeled rates to pounds of active ingredient ( ai) handled.

The Occupational and Residential Exposure Chapter of the BIT Reregistration Eligibility Decision Document ( RED) addresses potential exposures and risks to humans who may be exposed to BIT in " occupational settings" and the general population in " residential settings." This occupational and residential exposure assessment provides estimates of exposures and risks to: ( 1) handlers ( mixers, loaders, applicators) of BIT products; and ( 2) individuals who are involved in postapplication activities or occupy areas where BIT containing products have been recently applied.

Toxicity endpoints for dermal, inhalation and incidental ingestion for all time periods are extrapolated from the systemic subchronic oral NOAEL of 5 mg/ kg/ day based on emesis and clinical chemistry alterations of both male and female dogs at the LOAEL of 20 mg/ kg/ day. The Revised Report of the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC), dated April 22, 2005, recommended the use of the selected oral endpoints for the dermal and oral routes of exposure, assuming 100 percent absorption by the inhalation route and 41 percent by the dermal route.

An uncertainty factor or " target" margin of exposure ( MOE) of 100 is based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation) for dermal endpoints. Thus MOEs of greater than 100 do not exceed the Agency's level of concern for dermal occupational or residential uses ( all exposure durations). The target MOE for incidental short and intermediate term exposures is 300. For inhalation exposures the target MOE is 100 for all durations. However, an additional 10x uncertainty factor for inhalation is needed to account for the route to route extrapolation from an oral endpoint to determine if a repeat inhalation toxicity study is warranted ( Note: Inhalation toxicity study is not warranted). This chemical was classified as Group D carcinogen, meaning it is not classifiable as to human carcinogenicity. Group D is used for agents with inadequate human and animal evidence of carcinogenicity or for which data are not available. 3 At present, the Agency does not have available chemical specific residential and occupational handler or postapplication exposure studies for BIT. Therefore, exposures were estimated using surrogate data from Chemical Manufacturers Association ( CMA); surrogate data from Pesticide Handlers Exposure Database ( PHED) Version 1.1; U. S. EPA's Residential Exposure Assessment Standard Operating Procedures ( SOPs); application rates from EPA registered product labels; EPA estimates of daily amounts of product handled; and ChemSTEER model for metal working fluids. The exposure scenarios risks are summarized as outlined below.

Occupational Handlers. In order to estimate handler exposures, PHED data were used to evaluate paint brush and airless sprayer painting scenarios while, CMA data were used to evaluate occupational handlers involved in mixing/ loading liquids for general preservatives used in industrial processes and water systems and metalworking fluids. The exposure and risk assessments for occupational handlers were conducted using product label application rates, use information, CMA and PHED unit exposure data, and the ChemSTEER model. The dermal MOEs were greater than 100 ( commercial painting MOE = 90 for airless sprayer) and the inhalation MOEs were greater than 1,000; therefore, they do not exceed the Agency's level of concern. For each job function, the total MOE was used to present total risk resulting from dermal and inhalation exposures. All total MOEs for BIT are greater than 100, except for commercial use of the airless sprayer ( total MOE = 85).

Residential Handlers. The Residential Exposure Assessment Standard Operating Procedures ( SOPs) ( U. S. EPA, 1997a) were used to estimate exposures for residential handler scenarios. The residential handler scenarios are similar to those developed for occupational handlers; only the amounts handled and clothing/ glove scenarios are somewhat different. MOEs were greater than 100 for dermal and 100/ 1,000 for inhalation exposures in all of the scenarios listed. For each job function, the total MOE was used to present total risk resulting from dermal and inhalation exposures. All total MOEs for BIT are greater than 100, and therefore, not of concern.

Occupational Postapplication Exposure. Postapplication inhalation exposures may occur in the industrial settings around the water systems via inhalation, and dermal exposures may occur while maintaining industrial equipment. However, occupational postapplication dermal and inhalation exposures to BIT are likely to be minimal compared to handler exposure because of dilution during processing. No postapplication exposure data have been submitted to the agency to determine the extent of postapplication exposures in the industrial settings. Inhalation exposures are expected to be minimal because aerosol generation is not expected and the vapor pressure of BIT is low.

Residential Postapplication Exposure. Residential exposures result when children contact areas in which the pesticide end use product has been recently applied. The residential postapplication scenario considered representative of high end exposure in this assessment is based on toddler exposure to residues from hard surfaces ( i. e., floors) that have been mopped with a product containing BIT. The toddler dermal MOE was above the target of 100 and incidental oral MOEs were above the target of 300, and therefore, are not of concern. The Aggregate Risk Index ( ARI) method was used to present the total risk ( incidental oral + dermal exposure) because the target 4 MOEs were different for the dermal and incidental oral routes. ARIs greater than 1.0 do not exceed the Agency's level of concern. The ARI for children playing on a BIT treated floor is 48, and therefore, not of concern.

BIT labels also include a microbiocide use in laundry detergents, fabric softeners, and stain removers. The incidental oral MOE as a result of mouthing treated fabric is 1,700 and is not of concern. The dermal MOEs calculated for both toddler and adult scenarios are also not of concern ( MOEs = 7,200 and 11,000 for toddlers and adults, respectively). Finally, t he ARI is 5.2, and therefore, not of concern ( i. e., an ARI greater than 1 is not of concern).

Data Gaps, Uncertainties, and Limitations Chemical specific data are not available to assess exposure for BIT. At present, surrogate data are the only option to assess postapplication exposures for BIT. Specific data gaps and limitations with the surrogate data and the assumptions are presented in Section 4.0. 5 1.0 BACKGROUND Purpose This document, which is for use in EPA's development of the 1,2 Benzisothiazolin 3 one ( BIT) Reregistration Eligibility Decision Document ( RED), presents EPA's results of its review of the potential human health effects of occupational and residential exposure to BIT.

Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure risk assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For BIT, both criterion are met.

1.1 Summary of Toxicity Concerns Relating to Occupational Exposures Acute Toxicology Categories Table 1 presents the acute toxicity categories as outlined in the 1,2 Benzisothiazolin 3 one  Report of the Hazard Identification Assessment Review Committee ( HIARC) dated September 25, 2002.

Table 1. Acute Toxicity Categories for BIT Guideline No. Study Type MRID#( s) Results Toxicity Category 870. 1100 Acute Oral Toxicity 41022101 42858101 LD50 = 670 mg/ kg ( M)

LD50 = 784 mg/ kg ( F) III 870. 1200 Acute Dermal Toxicity 41022102 42858102 LD50> 2000 mg/ kg III 81 3 Acute Inhalation Toxicity waiver granted 81 4 Primary Eye Irritation 42905102 severe eye irritant I 81 5 Primary Skin Irritation 42905101 slight irritant IV 81 6 Dermal Sensitization 41750001 42858103 moderate dermal sensitizer  6 Summary of Toxicological Endpoint Selection The 1,2 Benzisothiazolin 3 one  Revised Report of the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC), dated April 22, 2005, indicates that there are toxicological endpoints of concern for BIT ( USEPA 2005). The endpoints, and associated uncertainty factors, used in assessing the risks for 1,2 Benzisothiazolin 3 one are presented in Table 2.

Table 2. Toxicological Endpoints for Assessing Occupational and Residential Exposures/ Risks Exposure Scenario Dose Used In Risk Assessment ( mg/ kg/ day) Target MOE or UF Study and Toxicological Effects Dietary Risk Assessments Incidental Oral ( Short and intermediate  term NOAEL = 5 UF = 300 ( 10x interspecies extrapolation, 10x intra species variation, FQPA SF of 1, and data base UF of 3x)

Acute RfD = 0.017 mg/ kg/ day Co Critical studies:

Subchronic toxicity , dog , NOAEL = 5 mg/ kg/ day based on increased incidence of emesis and clinical chemistry alterations at 20 mg/ kg/ day.

and Subchronic toxicity , rats , NOAEL = 8.42 mg/ kg/ day based on macroscopic and microscopic lesions in the nonglandular and glandular regions of the stomach Non Dietary Risk Assessments Dermal All Time Periods ( occupational and residential) NOAEL = 5a MOE = 100 ( 10x inter species extrapolation, 10x intra species variation) Co Critical studies:

Subchronic toxicity , dog , NOAEL = 5 mg/ kg/ day based on increased incidence of emesis and clinical chemistry alterations at 20 mg/ kg/ day.

and Subchronic toxicity , rats , NOAEL = 8.42 mg/ kg/ day based on macroscopic and microscopic lesions in the nonglandular and glandular regions of the stomach Inhalation All Time Periods ( occupational and residential) NOAEL = 5 MOE = 100 ( 10x inter species extrapolation, 10x intra species variation)

An additional 10x route to route extrapolation is used to determine if an inhalation toxicity study is warranted.

Cancer No cancer data available for 1,2 benzisothiaolzin 3 one a The dermal absorption is 41 percent. 7 1.2 Summary of Use Pattern and Formulations Type of Pesticide/ Targeted Pest/ Use Sites BIT is used as a material preservatives in several types occupational and residential products. BIT is an industrial preservative that is recommended to control the growth of microorganisms in the preserved product. BIT is recommended for use as an industrial preservative for the protection of water based adhesives, caulks, sealants, grouts, spackling, ready mixed cements, ready mixed wallboard compounds, aqueous compositions such as emulsion paints, aqueous slurries, home cleaning and car care products, inks, photographic processing solutions, paints and stains, titanium dioxide slurries, oil in water emulsions, latices, gas/ oil drilling fluids, metalworking fluids, casein/ rosin dispersions, textile spin finish solutions, laundry detergent, pesticide formulations, tape joint compound, leather processing solutions, and for preservation of fresh animal hides and skins.

Formulation Types and Percent Active Ingredient BIT is a water soluble, liquid organic biocide ( also called an antimicrobial or in can preservative). BIT is formulated as a soluble liquid and is available in formulations containing between 0.9 percent to 84 percent active ingredient.

1.3 Method and Types of Equipment Used for Mixing/ Loading/ Applying The Agency determines potential exposures to pesticides handlers by identifying exposure scenarios from the various application equipment types that are plausible, given the label uses. The occupational and residential use patterns of BIT are identified in Table 3. The exposure scenarios 1 5 are based on CMA data and scenarios 6 7 are based on PHED data.

Table 3. Exposure Scenarios for Occupational and Residential Handlers Exposure Scenarios Use Site Category Scenario Descriptions Data Source Liquid Pour for Preservatives Material Preservatives Scenario involves adding an in can preservative to paints, adhesives, slurries, oil/ gas drilling fluids, etc. Exposure occurs when pouring the biocide into the slurry. CMA gloved data for liquid pour of preservatives are used ( U. S. EPA 1999). *

Liquid Pump for Preservatives Material Preservatives For large oil/ gas drilling fluid secondary recovery operations the preservative is added via a closed loading system CMA gloved data for liquid pump preservatives are used ( U. S. EPA 1999).*

Liquid Pour for Metal Working Fluids Material Preservatives Exposure occurs either via loading and filling bulk tanks or machine sumps, direct dermal or inhalation contact of cutting oils, or setup/ maintenance of the automatic metering systems. CMA gloved data for liquid pour and pump of metalworking fluids are used ( U. S. EPA 1999).* Table 3. Exposure Scenarios for Occupational and Residential Handlers Exposure Scenarios Use Site Category Scenario Descriptions Data Source 8 Daily Dermal Exposure Dermal Unit Exposure mg ai lb ai x Use Rate lb ai =

( ) Wiping for Disinfectants Material Preservatives Janitorial & residential use of cleaning products containing BIT. CMA ungloved data for wiping are used ( U. S. EPA 1999).

Mopping for Disinfectants Material Preservatives Janitorial and residential use of cleaning products containing BIT. CMA ungloved data for mopping are used ( U. S. EPA 1999).

Painting ( brush/ roller) Material Preservatives Scenario involves painting with a paint brush ( representative of painting with a roller). PHED, 1997 for painting Commercial painters based on long pants, long sleeved shirts, and no gloves Residential painters based on short pants, short sleeved shirts, and no gloves Airless Painting Material Preservatives Scenario involves painting with an airless sprayer. PHED, 1997 for airless spraying Commercial painters based on long pants, long sleeved shirts, and no gloves Residential painters based on short pants, short sleeved shirts, and no gloves * Pump liquid is not assessed because target MOE for pouring is not exceeded.

2.0 Handler Exposures AD assessed the risks to the occupational and residential handlers using the dermal and inhalation exposure data for loading liquid formulations using the Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( DP Barcode: D247642) and PHED Handlers Exposure Database ( PHED V1.1). Table 3 also presents the exposure scenarios for occupational/ residential handlers presenting the AD use site category and the associated data source used to develop the exposure dose. These exposure scenarios were used to assess the handler risks to BIT's antimicrobial uses.

Potential daily inhalation and dermal exposures were calculated using the following formulae: 9 ARI IncidentalOralT etMOE OralMOE DermalT etMOE DermalMOE =

+

    1 arg arg Daily Inhalation Exposure InhalationUnit Exposure mg ai lb ai x Use Rate lb ai =

( )

The potential daily inhalation and dermal exposures to BIT for handlers were used to calculate the potential doses by dividing by the body weight of 70 kg. The Margin of Exposure ( MOE) was calculated by dividing the NOAEL by the inhalation or dermal daily dose using the following formula:

MOE NOAEL mg kg day Daily Dose mg kg day = ( / / )

( / / )

Since the dermal and inhalation toxicological endpoints have the same effect, the total risk from both routes of exposure must be evaluated. The total risk ( inhalation dose + dermal dose) was evaluated for the handler scenarios using the " total" MOE approach because the uncertainty factors are the same. The incidental oral route and dermal route for children are also based on the same effect, however, the incidental oral route has an additional 3x data base uncertainty factor. Therefore, the Aggregate Risk Index ( ARI) method was used because the target MOEs were different for the dermal and oral routes. ARIs greater than 1.0 do not exceed the Agency's level of concern. ARIs were calculated using the following formula:

The assumptions used for calculating the exposures and risks in this assessment are provided in Table 4. The results of the MOE and ARI analyses are presented in Table 5. All inhalation and dermal MOEs were greater than100, respectively, and do not exceed the Agency's level of concern for occupational and residential uses ( Note: commercial painting with an airless sprayer has a dermal MOE of 90). For each job function, the total MOE was used to estimate total risk resulting from dermal and inhalation exposures. All of the scenarios indicate no risks of concern ( Note: commercial painting with an airless sprayer where the total MOE = 85). 10 Table 4. Exposure Estimates/ Assumption for the Daily Amount of Preservative Handled Exposure Scenarios Use Site Category Pounds Active Ingredient ( ai) Used Liquid Pour for Preservatives Material Preservatives This use category includes industrial process intermediate materials ( dispersions, slurries, emulsions, solutions, etc.) and resulting products including paints, coatings, adhesives, textiles, paper, etc. The Agency typically assumes 10,000 lb of slurry are treated per day. EPA Reg 67071 24 indicates that 1 5 lb ( 10% ai) of material preservative are used per 1,000 lbs of slurry. The maximum amount of active ingredient handled is 5 lb ai. Equation is as follows: 5 lb/ 1,000 lb slurry x 10,000 lb slurry x 10% ai= 5 lb ai.

Industrial Processes and Water Systems This use category includes industrial process water from leather and photo processing uses. The Agency typically assumes 10,000 lb of slurry are treated per day. EPA Reg 67071 22 indicates that 0.25 2 lb ( 20% ai) of product are used per 1,000 lb of slurry. The maximum amount of active ingredient handled is 4 lb ai. Equation is as follows: 2 lb/ 1,000 lb slurry x 10,000 lb slurry x 20% ai = 4 lb ai.

Oil/ gas Drilling Fluids Biocides are typically added directly to drilling rig mud tanks via open pouring. Over a 3 to 6 week period a 13,000 ft well will require 1 to 2 drums ( 1 drum = 42 gallons) of biocide if microbiological problems are encountered. Therefore, the short term exposure assessment used 5.6 gallons for the amount of biocide handled per day by the drilling rig worker [ i. e., ( 2 drums x 42 gal/ drum) / ( 5 days/ week x 3 weeks) = 5.6 gal/ day]. Note: A separate intermediate term assessment was not performed because the endpoint is the same for all durations and the exposures are expected to be less because the amount handled would be less than the high end assumed for short term.

Since the amount handled are in terms of gallons, it is necessary to convert these values into terms of pounds by using water density of 8.34 lb/ gal. Thus, for the water based drilling fluid scenario, the amount of biocide handled per day is 46.7 lbs ( where 5.6 gal x 8.34 lb/ gal) for the short term duration. EPA Reg 67071 23 indicates the 20% ai product be applied at 0.05 to 0.15 percent per 1000 lbs treated. The maximum amount of active ingredient handled is 0.014 lb ai. Equation is as follows: 0.15% product x 20% ai x 46.7 lbs = 0.014 lb ai.

Liquid Pump for Preservatives Oil/ gas Drilling Fluids, Secondary Recovery For large secondary recovery operations the amount of produced water treated via metering pump can exceed 420,000 gallons/ day. For the secondary recovery scenario, the amount of water treated per day is 3,502,800 lbs ( where 3,502,800 lbs = 420,000 gal x 8.34 lb/ gal). The maximum amount of active ingredient handled is 1050 lb ai. Equation is as follows: 0.15% product x 20% ai x 3,502,800 lbs = 1050 lb ai.

Liquid Pour for Metal Fluids Material Preservatives This use category includes metal working fluids. The Agency typically assumes 300 gallons ( where density is assumed to be 8.3 lb/ gal; 2,490 lb) of metalworking fluids are use per day. EPA Reg 49403 26 indicates that treated metalworking fluid should consist of 0.08 0.36% of the formulated preservative ( 9% ai). The maximum amount of ingredient handled is 0.81 lb ai. Equation is as follows: 2,490 lb metal working fluid x 0.36% preservative x 9% ai = 0.81 lb ai. Table 4. Exposure Estimates/ Assumption for the Daily Amount of Preservative Handled Exposure Scenarios Use Site Category Pounds Active Ingredient ( ai) Used 11 Wiping for Cleaning Products Material Preservatives Scenario involves wiping with cleaning products containing the biocide. The Agency typically assumes 1liter or 0.26 gallons ( where density is assumed to be 8.3 lb/ gal; 2.2 lbs) of liquid are used by commercial handlers. EPA Reg 67071 22 indicates that 0.15 lb ( 20% ai) are added to 1,000 lb of cleaning solution. The maximum amount ingredient handled is 0.000066 lb ai. Equation is as follows: 2.2 lb cleaning solution x 0.15 lb/ 1000 lb cleaning solution x 20% ai = 0.000066 lb ai.

The Agency typically assumes 0.5liter or 0.13 gallons ( where density is assumed to be 8.3 lb/ gal 1.1 lbs) of liquid are used by residential handlers. The maximum amount ingredient handled is 0.000033 lb ai. Equation is as follows: 1.1 lb cleaning solution x 0.15 lb/ 1000 lb cleaning solution x 20% ai = 0.000033 lb ai.

Mopping for Cleaning Products Material Preservatives Scenario involves mopping home cleaning products containing the biocide. The Agency typically assumes 2 gallons ( where density is assumed to be 8.3 lb/ gal; 16.6 lbs) of liquid are used by commercial handlers. EPA Reg 67071 22 indicates that 0.15 lb ( 20% ai) are added to 1,000 lb of cleaning solution. The maximum amount ingredient handled is 0.0005 lb ai. Equation is as follows: 16.6 lb cleaning solution x 0.15 lb/ 1000 lb cleaning solution x 20% a i= 0.0005 lb ai.

The Agency typically assumes 1 gallon ( where density is assumed to be 8.3 lb/ gal; 8.3 lbs) of liquid are used by residential handlers. The maximum amount ingredient handled is 0.00025 lb ai. Equation is as follows: 8.3 lb cleaning solution x 0.15 lb/ 1000 lb cleaning solution x 20% a i= 0.00025 lb ai.

Painting ( brush/ roller) Material Preservatives Scenario involves using biocide in paint. The Agency typically assumes 5 gallons with a brush/ roller for commercial painters ( where paint density is assumed to be 10lb/ gal; 50 lbs). EPA Reg 67071 24 indicates that 1 5 lb ( 10% ai) of material preservative are used per 1,000 lb of paint. The maximum amount for commercial handlers is 0.025 lb ai. Equation is as follows: 50 lb paint x 5 lb/ 1,000 lb paint x 10% ai = 0.025 lb ai.

The Agency typically assumes 2 gallons of paint for residential painters ( where paint density is assumed to be 10lb/ gal; 20 lbs). The maximum amount for residential handlers is 0.01 lb ai. Equation is as follows for residential handler: 20 lb paint x 5 lb/ 1,000 lb of paint x 10% ai = 0.01 lb ai.

Airless Sprayer Painting Material Preservatives Scenario involves using biocide in paint as an in can preservative. The Agency typically assumes 50 gallons of paint sprayed by commercial painters ( where paint density is assumed to be 10lb/ gal; 500 lbs). EPA Reg 67071 24 indicates that 1 5 lb ( 10% ai) of material preservative are used per 1,000 lb of paint. The maximum amount for commercial painter is 0.25 lb ai. Equation is as follows: 500 lb paint x 5 lb/ 1,000 lb paint x 10% ai = 0.25 lb ai.

The Agency typically assumes 15 gallons of paint sprayed by homeowner ( where paint density is assumed to be 10lb/ gal; 150 lbs). The maximum amount for residential handlers is 0.075 lb ai. Equation is as follows: 150 lb paint x 5 lb/ 1,000 lb paint x 10% ai = 0.075 lb ai. 12 Table 5: Summary of Short and Intermediate term Occupational and Residential Exposures and MOEs Scenarios Use Site Category Use Rate ( lbs ai/ day) a Inhalation Unit Exposureb ( mg/ lb ai) Dermal Unit Exposureb ( mg/ lb ai) Short term and Intermediateterm Inhalation Dosec ( mg/ kg/ day) Short term and Intermediateterm Absorbed Dermal Dosec ( mg/ kg/ day) Short and Intermediateterm Inhalation MOEd Short and Intermediateterm Dermal MOEe Total MOEf Occupational Liquid Pour for Preservatives Material Preservatives 5.00 0.00346 0.135 0.00025 0.0040 20,000 1,300 1,200 Industrial Processes 4.00 0.00346 0.135 0.00020 0.0032 25,000 1,600 1,500 and Water Systems Oil/ gas Drilling Fluids 0.01 0.00346 0.135 7E 7 1E 5 7E+ 6 4.5E+ 5 4.2E+ 5 Liquid Pump Oil/ gas Drilling Fluids,

Secondary Recovery 0.01 0.000403 0.00629 6E 3 0.039 830 130 110 Liquid Pour for Material Preservatives 0.81 0.00854 0.184 0.00010 0.00087 51,000 5,700 5,100 Metalworking Fluids Wiping for Janitorial Products Material Preservatives 0.000066 67.3 2870 6.3E 05 0.0011 79,000 4,500 4,300 Mopping for Material Preservatives 0.0005 2.38 71.6 1.7E 05 0.00021 290,000 24,000 22,000 Janitorial Products Painting Material Preservatives 0.025 0.28 180 0.00010 0.026 50,000 190 190 Airless Painting Material Preservatives 0.25 0.83 38 0.0030 0.056 1,700 90 85 Residential Wiping for Material Preservatives 3.3E 05 67.3 2870 3.2E 05 0.00055 160,000 9,000 8,500 Cleaning Products Mopping for Material Preservatives 0.00025 2.38 71.6 8.5E 06 0.00010 590,000 48,000 44,000 Cleaning Products Painting/ brush Material Preservatives 0.010 0.28 230 4.0E 05 0.013 130,000 370 370 Airless Painting Material Preservatives 0.075 0.83 79 0.00089 0.035 5,600 140 140 a Use Rate based on label information and assumptions on daily amounts handled ( see Table 4).

b Unit exposures based on CMA and PHED data for inhalation and dermal. Occupational PPE for the liquid pour includes long pants ( LP), long sleeved shirts( LS), and gloves ( G), all other scenarios are based on LP, SL, and no gloves, except for residential painting which assumes short pants, short sleeved shirt, no gloves. 13 c Short term and Intermediate term Inhalation and/ or Dermal Dose ( mg/ kg/ day)= Unit Exposure ( mg/ lb ai) * Application Rate ( lb ai)/ Body Weight ( 70 kg). Note: 41 percent dermal absorption is used to estimate the absorbed dermal dose.

d Short term and Intermediate term Inhalation MOE= Inhalation NOAEL ( 5 mg/ kg/ day)/ Short and Intermediate term Inhalation Dose ( mg/ kg/ day). Target MOE= 1000.

e Short term and Intermediate term Dermal MOE= Dermal NOAEL ( 5 mg/ kg/ day)/ Short and Intermediate term Abs. Dermal Dose ( mg/ kg/ day). Target MOE= 100.

f Total MOE = NOAEL 5 mg/ kg/ day / ( absorbed dermal dose + inhalation dose); where the total target MOE = 100. 14 Metal Working Fluids ( Machinists):

The USEPA/ OPPTS Chemical Engineering Branch ( CEB) model was used to perform screening level assessments for chemicals in occupational settings ( U. S. EPA, 1991). This is the approach recommended by the Antimicrobial Division ( AD). The CEB model uses measured and/ or assumed airborne oil mist concentrations for metal working operations. Since no measured concentrations are available for BIT the high end oil mist concentration is based on the OSHA's Permissible Exposure Limit ( PEL) of 5 mg/ m3 ( NIOSH, 1998). EPA Reg 72674 15 indicates that 0.25% ( i. e., 0.0025) of the label product is added to metal working fluids and of that, only 19.3% is the active ingredient ( 1,2 benzisothiazolin 3 one). Therefore, the upper bound air concentration of BIT that a worker is exposed to is 5 mg/ m3 x 0.0025 x 0.09 or an air concentration of 0.0011 mg/ m3. Potential dose rates for inhalation were calculated as follows:

ADR pot =( C x IR x ED ) / ( BW)

where:

ADR pot = Acute potential dose rate ( mg/ kg day);

C = Concentration ( mg/ m3);

IR = Inhalation rate ( m3/ hr);

ED = Exposure duration ( hrs);

BW = Body weight ( kg); and,

The following assumptions were made: inhalation rate for adults  1.25 m3 / hr; exposure duration  8 hours; and body weight  70 kg. Using this exposure algorithm, the long term inhalation dose was calculated to be 1.6E 4 mg/ kg/ day, resulting in a long term inhalation MOE of 31,000 which is larger than the inhalation target MOE ( 1,000).

A screening level long term dermal exposure estimate was derived from the 2 Hand Dermal Immersion in Liquid Model in ChemSTEER ( EPA/ OPPT). The model is available at http:// www. epa. gov/ opptintr/ exposure/ docs/ chemsteer. htm. The weight fraction of BIT in metal working fluids is 0.00048 ( 0.0025 formulated product added to oil x 0.193 ai in formulated product = 0.00048), calculated from EPA Reg. No. 72674 15. Based on the model for emersion of hands in metal working fluids, the long term absorbed dermal dose is estimated at 0.025 mg/ kg/ day. The longterm dermal MOE is 200 ( i. e., oral NOAEL of 5 mg/ kg/ day / potential dose of 0.025 mg/ kg/ day). The dermal MOE is above the target MOE of 100, and therefore, not of concern. The total risk ( NOAEL /( inhalation dose + absorbed dermal dose)) for the machinist is also presented. The total MOE for machinists is 200, and therefore, not of concern.

3.0 Postapplication Exposures Postapplication exposures refer to those potential exposures which may occur to handlers while involved in postapplication or reentry activities following application of the pesticide concentrate or formulated end use product. Postapplication exposures to individuals can also occur from contact 15 to treated surfaces and while occupying areas where pesticide end use products have recently been applied.

Occupational Postapplication Exposure Postapplication inhalation exposures may occur in the industrial settings around the water systems via inhalation, and dermal exposures may occur while maintaining industrial equipment. However, occupational postapplication dermal and inhalation exposures to BIT are likely to be minimal compared to handler exposure because of dilution during processing or during the use of MWFs by machinists. No postapplication exposure data have been submitted to the agency to determine the extent of postapplication exposures in the industrial settings. Inhalation exposures are expected to be minimal because aerosol generation is not expected and the vapor pressure of BIT is low.

Residential Postapplication Exposure The Food Quality Protection Act ( 1996) sets an explicit standard for assessing risks from potential exposures to children. EPA must determine whether exposures to pesticides are safe for children and includes an additional safety factor for children, consider special sensitivities and exposures to pesticide chemicals. Specifically, FQPA requires EPA to give special consideration to exposure to " ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue..."

Postapplication exposures to individuals can occur from contact to treated surfaces where pesticide end use products have recently been applied. The residential post application scenarios considered in this assessment are exposure to residue from hard surfaces ( i. e., floors) that have been mopped with a product containing BIT and the residues from laundry additives ( liquid laundry detergents, fabric softeners and conditioner, and stain removers). Although residential floors are believed to be washed/ moped on an intermittent basis ( perhaps weekly), facilities such as day care centers may clean the floors more often. Therefore, both the short and intermediate term exposure durations have been presented.

Floor Cleaner Dermal Exposure There is the potential for dermal exposure to toddlers crawling on the floor. Although residential floors are believed to be washed/ moped on an intermittent basis, facilities such as day care centers may clean the floors more often. Therefore, both the short and intermediate term exposure durations are assessed. To determine toddler exposure to residues on treated floor, the following equation was used:

PDD FR x SA BW = 16 where PDD = Potential daily dose FR = Flux rate of chemical from material ( mg/ m2/ day)

SA = Surface area of the body which is in contact with floor ( m2)

BW = Body weight ( kg)

The following conservative assumptions were made in calculating the exposures/ risks due to limited data:

° Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). A body surface area of 0.657 m2 has been assumed, which is the median value.

° Based on EPA Reg 67071 22 label, 0.15 lb of preservative that contains 20% BIT is added to 1000 lb of cleaner ( weight fraction = 0.15 lb product x 0.2 ai/ 1000 lb cleaner = 0.00003 or 0.003 percent). It was assumed that the density of the cleaner is 8.3 lbs/ gal. Therefore, the use amount for the application of treated cleaning products is 0.00025 lb ai/ gallon ( weight fraction 0.00003 x 8.3 lb/ gal density). It was assumed that the resulting solution is applied at a rate of 1 gallon per 1000 sq. ft.

° No data could be found regarding the quantity of solution residue left on the floor after treatment. It has been assumed that 25% of the cleaner remains after the final mopping.

° No transferable residue data were available that could be used to estimate the skin transfer of BIT from the floor. Therefore, Residential SOPs estimate of 10% of the amount on the hard surface is available for dermal transfer.

The calculations of the dermal dose and the dermal MOE are presented in Table 6. The dermal MOE is estimated to be 9,100 which is above the target MOE of 100, and therefore not of concern.

Table 6. Short and Intermediate term Risks Associated with Postapplication Dermal Exposure on Treated Floors.

Parameter Value Rationale Application Rate 1000 ft2/ gallon of solution USEPA Assumption Cleaning Solution 0.00025 lb ai/ gallon Maximum rate listed on label ( EPA Reg. No. 67071 22)

Transferable Residues ( TR) 0.030 mg/ m2/ day (( 0.00025 lb ai/ gal)/( 1000ft2/ gal)) * ( 25% remaining)* ( 10% transfer) * ( Conversion Factors)

Surface Area of Body in Contact with Carpet 0.657 m2 Median surface area of toddler Parameter Value Rationale 17 Body Weight 15 kg Median body weight of toddler Absorbed Dermal Dose 0.00055 mg/ kg/ day TR * SA * 41% dermal abs/ BW Dermal NOAEL 5 mg/ kg/ day Dermal MOE 9,100 ( Dermal. NOAEL) / ( Abs Dermal. Dose). Target MOE = 100.

TR = [(( 0.00025 lb ai/ gal / 1000ft2/ gal) x ( 454 g/ lb) x ( 1000 mg/ g) x ( 1 ft2 / 0.093 m2)) x ( 0.25 remaining) x ( 0.1 transferable)]

Incidental Ingestion In addition to dermal exposure, infants crawling on treated floors will also be exposed to BIT via incidental oral exposure. To calculate incidental ingestion exposure to BIT due to hand to mouth transfer, the scenarios established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments were used. These scenarios use assumptions that are similar to those used in calculating exposures due to dermal contact of BIT from toddlers crawling on treated floors. The assumptions above in the dermal assessment ( Table 6) estimates the transferable residues as 0.0030 : g/ cm2 ( equivalent to 0.030 mg/ m2). The estimated potential ingestion dose rate immediately after application would be calculated as follows:

PDR norm = ISR t x SA x FQ x SE x ET x 0.001 mg/: g BW where:

PDR norm = Potential dose rate ( mg/ kg/ day);

ISR t = Indoor Surface Residue (: g/ cm2) at time 0;

SA = Surface area of the hands that contact both the treated area, and the individuals mouth ( cm2/ event);

FQ = Frequency of hand to mouth events ( events/ hr);

SE = Saliva extraction efficiency of 50%;

ET = Exposure Time ( 4 hrs/ day); and BW = Body weight ( 15 kg)

Based on the data provided in EPA's Residential SOPs, the surface area used for each hand tomouth event is 20 cm2. It is assumed that there are 20 hand to mouth exposure events per hour ( 90th percentile) for short term exposure duration and 9.5 events per hour ( mean) for the intermediate term duration. The short and intermediate term incidental oral NOAEL of 5 mg/ kg/ day ( target MOE = 300) should be used as the toxicity endpoint for this scenario because of the intermittent nature of cleaning the floor. The potential dose rate ( PDR) using this equation is 18 0.00016 mg/ kg/ day for short term and 7.7E 5 mg/ kg/ day for the intermediate term duration resulting in a hand to mouth MOEs for toddlers of 31,000 ( ST) and 65,000 ( IT). The incidental oral exposure is of not concern ( i. e., above the target MOE of 300).

The ARI methodology is used to determine the total risk to children playing on BIT treated floors ( i. e., incidental oral + dermal exposure). The short term dermal MOE reported above is 9,100 ( target MOE is 100) and the short term incidental oral MOE is 31,000 ( target MOE is 300). The ARI is 48, and therefore, not of concern [ 1/(( target dermal MOE/ dermal MOE) + ( target oral MOE/ oral MOE)), ARI greater than 1 is not of concern]. Note: the intermediate term MOE is greater than the short term MOE because of the frequency of hand to mouth activities is less over time ( 90th percentile used for short term and mean used to represent intermediate term) but the toxicological endpoints are the same for both time periods.

Clothing/ Textile BIT labels also include a microbiocide use in laundry detergents, fabric softeners, and stain removers ( EPA Reg. No. 67071 23). To determine dermal and incidental oral exposure to treated clothing, the guidance provided in Human and Environmental Risk Assessment ( HERA) Guidance Document ( 2003) was used for indirect skin contact from wearing clothes and oral exposure from mouthing or sucking on treated fabric. HERA ( 2003) provides the following basic equations.

Dermal Exposure Dermal Exposure ( mg/ kg/ day) = [(( M x F1 x FD)/ WI) x S der x F2 x F3 x F4]/ BW where M = amount of undiluted product used ( e. g., laundry detergent), 150,000 mg ( HERA 2003)

F1 = weight fraction of ai applied ( EPA Reg 67071 23, 0.15% product by weight x 20% ai = 0.03% or 0.0003),

FD = fabric density for mixed cotton and synthetics ( 10 mg/ cm2) ( HERA 2003),

WI = total weight of fabric estimate ( 1E+ 6 mg) ( HERA 2003),

Sder = Surface area of the body which is in contact with clothing ( 5670 cm2 child and 16,900 cm2 adult),

F2 = weight fraction transferred from clothing to skin ( 0.01 or 1%) ( HERA 2003),

F3 = weight fraction remaining on skin ( 1 or 100%) ( HERA 2003),

F4 = dermal absorption of BIT ( 0.41 or 41%), and BW = Body weight ( kg)

Ingestion/ Mouthing 19 Oral Exposure ( mg/ kg/ day) = [(( M x F1 x FD)/ WI) x Fm x SE]/ BW where M = amount of undiluted product used ( e. g., laundry detergent), 150,000 mg ( HERA 2003)

F1 = weight fraction of ai applied ( EPA Reg 67071 23, 0.15% product by weight x 20% ai = 0.03% or 0.0003),

FD = fabric density for mixed cotton and synthetics ( 10 mg/ cm2) ( HERA 2003),

WI = total weight of fabric estimate ( 1E+ 6 mg) ( HERA 2003),

Sder = fabric area mouthed ( 100 cm2) ( HERA 2003),

SE = saliva extraction efficiency ( 1 or 100%) ( HERA 2003), and BW = Body weight ( 15 kg)

Data on which these calculations could be based were generally unavailable; therefore, a number of conservative assumptions have been made:

( 1) Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). The median surface area for a 3 year old, minus the head, is 0.567 m2. Median values for body weights and surface areas for adults have been used ( 70 kg and 1.69 m2, not including head surface area).

( 2) No leaching data were available that could be used to estimate a flux rate of the chemical from clothing. Therefore, HERA's assumption of 1% transfer was used.

( 3) No dissipation data were available, therefore, the amount of BIT remaining on the skin is assumed to be 100 percent.

( 4) No information is available to estimate the amount of product remaining after a wash rinse cycle. The HERC document provides an estimate for this variable as " the water mass left after spin cycle ( kg) / total water mass initially present ( kg)". This variable could be estimated using default assumptions if risks were identified in the future. Moreover, the registrant indicated in the public comments that " washing is normally carried out at high pH, around 10, rinsing is usually pH 7 and softening at the end of the wash may be slightly acidic, pH 6   7. Under all these pH conditions, BIT will not have a positive charge. All of the common fibers used for clothing have either a negative charge, or are not charged. These fibers will have no ionic attraction for BIT. There will not be any significant hydrogen bonding and BIT does not have the extended planar aromatic structure required by dyestuffs for substantivity to cotton ( usually 3 or more aromatic rings) thus BIT will not be able to " dye" the anionic or neutral fibers. Under laundry conditions, BIT will not adsorb onto any of these fibres. From the above, BIT remains in the wash water and the vast majority is discharged to drain after draining/ spinning. Only a small amount of BIT will be present in the residual entrained wash water and this will be readily removed in any rinse cycle. Since all textile washing incorporates some element of rinsing, it is likely that the potential for deposited residues of BIT on textiles is very low." Therefore, the estimates provided below are considered to be screening level and an overestimate of the true risks. 20 The calculation of the short and intermediate term oral and dermal doses and MOEs are presented in Table 7. The incidental oral MOE as a result of mouthing treated fabric is 1,700 and is not of concern. The dermal MOEs calculated for both toddler and adult scenarios are also not of concern ( MOEs = 7,200 and 11,000 for toddlers and adults, respectively). However, the percent transfer of residues from clothing to skin is considered a data gap and is necessary to appropriately confirm these dermal exposures.

The ARI methodology is used to determine the total risk to children wearing clothing treated with BIT ( i. e., incidental oral + dermal exposure). The ARI is 5.2, and therefore, not of concern [ i. e., 1/(( target dermal MOE/ dermal MOE) + ( target oral MOE/ oral MOE)), ARI greater than 1 is not of concern]. 21 Table 7. Short and Intermediate term Risks Associated with Postapplication Exposure to Laundered Clothing Parameter 3 yr old Toddler Adult Rationale Body Weight 15 kg 70 kg Median body weight Surface area, minus head 5,670 cm2 16,900 cm2 Median surface area Surface area of cloth mouthed 100 cm2 NA HERA 2003 Concentration on clothing 4.5E 4 mg/ cm2 ( 150,000 mg product x 0.03% ai x 10 mg/ cm2 cloth density)/ 1E+ 6 mg weight of fabric. EPA Reg. No. 67071 23. Note: Some fraction of the chemical is lost due to the rinse cycle in the wash but there are no data at this time to estimate the amount.

Daily Dermal Dose 0.00070 mg/ kg/ day 0.00045 mg/ kg/ day ( concentration on clothing mg/ cm2 x surface area cm2 x transfer efficiency 1% to skin and 100% to mouth) * ( 41% dermal absorption or 100% oral absorption) / Body Weight Incidental Oral Ingestion ( mouthing) 0.003 mg/ kg/ day NA ( Qty. a. i.) / ( Body Weight)

Dermal NOAEL 5 mg/ kg/ day Oral endpoint selected Oral NOAEL 5 mg/ kg/ day Oral endpoint selected Dermal MOE 7,200 11,000 ( NOAEL) / ( Dose). Target MOE = 100.

Incidental Oral MOE ( mouthing) 1,700 NA ( NOAEL) / ( Dose). Target MOE = 300.

4.0 Summary of Data Gaps and Uncertainties Toxicology ° For inhalation, the uncertainty factor or " target" margin of exposure ( MOE) of 100 is based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation). Because of the need for route to route extrapolation, an additional 10x uncertainty factor is applied to determine if a route specific inhalation toxicological study is warranted ( i. e., if estimated inhalation MOEs are greater than 1000, an inhalationspecific toxicological study will not be needed). 22 ° For dermal, the uncertainty factor or " target" margin of exposure ( MOE) of 100 is based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation).

° For oral, the uncertainty factor or " target" margin of exposure ( MOE) of 300 is based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation), and 3x for data base uncertainty factor.

° The dermal absorption factor of 41 percent was not adjusted to account for the potential reduction of the bioavailability of BIT in paint because of a lack of chemical specific data. It is believed that the paint matrix has the potential to reduce the dermal exposure.

Handler Exposure Estimates ° The maximum use amounts provided by labels were used to assess the overall amount of preservative handled.

° The dermal exposure/ risks for the residential clothing scenario utilized HERA's assumption of 1% residue transferred from clothing. However, based on the conservative assumptions in this scenario ( i. e., BIT does not adsorb to clothing and the assessment does not account for the residues lost during a washing rinse cycle), confirmatory data on residue transfer is not necessary to support this percent transfer parameter.

° For screening assessments, the Agency typically may have to make professional judgements on the amount of substance that is used by a handlers in a work day for a particular antimicrobial use unless the registrants have provided information in meetings with the Agency or have expressed assumptions in written memos or documentation provided to the Agency. The Agency typically makes professional judgement assumptions that are assumed to be upper bound estimates.

° There are no representative unit exposure data for chemical metering into secondary recovery oil operations. Because the volume of water being treated in secondary recovery operations is so large, the available CMA data can not be reliably extrapolated without the potential to overestimate the exposure. However, for BIT, even when the exposures are extrapolated to the large volumes in the secondary recovery oil operation, the MOEs are not of concern.

Chemical Manufacturers Association ( CMA) Data No chemical specific handler or postapplication exposure data are available. Surrogate dermal and inhalation data from Chemical Manufacturers Association ( CMA) and PHED databases, were used to assess handler exposure. Note that CMA surrogate data have the following deficiencies:

° The inhalation concentrations were typically below the detection limits, so the unit exposures for the inhalation exposure route could not be accurately calculated. 23 ° The quality of the CMA data may have QA/ QC problems including lack of either/ or field fortification, laboratory recoveries, and storage stability information and the insufficient amount of replicates.

Post Application Scenarios ° Since no measured use concentrations are available for BIT, the high end oil mist concentration is based on the OSHA's Permissible Exposure Limit ( PEL) of 5 mg/ m3. The upper bound air concentration of BIT that a worker is exposed to is 5 mg/ m3 times 0.36% times 9% or an air concentration of 0.00162 mg/ m3.

5.0 REFERENCES HERA, 2003. Human and Environmental Risk Assessment, Guidance Document Methodology, April 22, 2002 ( http:// www. heraproject. com/ files/ Guidancedocument. pdf).

NIOSH, 1998. NIOSH Pocket Guide to Chemical Hazard. U. S Department of Health and Human Services. Centers for Disease Control. www. cdc. gov/ niosh/ npg/ npgd0472. html.

PHED Surrogate Exposure Guide. 1997. Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1. May 1997.

U. S. EPA. 1991. Chemical Engineering Branch Manual for the Preparation of Engineering Assessments. Prepared for the OPPT by IT Environmental Programs, Inc.

U. S. EPA, 1997a. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Prepared for the Office of Pesticide Programs, Health Effects Division. Contract No. 68 W6 0030.

U. S. EPA, 1997b. Exposure Factors Handbook. Volume I II. Office of Research and Development. Washington, D. C. EPA/ 600/ P 95/ 002Fa.

U. S. EPA. 1999. Evaluation of the Chemical Manufacturers Association Antimicrobial Exposure Assessment Study ( Amended on December 8, 1992). Memorandum from Siroos Mostaghimi, Ph. D., Environmental Engineer to Julie Fairfax, PM # 36. November 4, 1999.

U. S. EPA. 2000. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Office of Pesticide Programs, Health Effects Division. April 2000. 24 U. S. EPA, 2005. 1,2 Benzisothiazolin 3 one  Revised Report of the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC), dated April 22, 2005.


[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Page 70888]
[FR Doc No: 2022-25278]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-1565]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Mitsubishi MU-
2B Series Airplane Training Requirements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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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 renew an information
collection. The collection of information is necessary to document
participation in, completion of, and compliance with the pilot training
program for the MU-2B series airplane.

DATES: Written comments should be submitted by January 20, 2023.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Christopher Morris, AFS-850, 800 Independence Ave. SW,
Washington, DC 20591.
    By email: [email protected].

FOR FURTHER INFORMATION CONTACT: Paul Penner by email at:
[email protected]; 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: 2120-0725.
    Title: Mitsubishi MU-2B Series Airplane Special Training
Requirements.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal.
    Background: In response to the increasing number of accidents and
incidents involving the Mitsubishi MU-2B series airplane, the Federal
Aviation Administration (FAA) began a safety evaluation of the MU-2B in
July of 2005. As a result of this safety evaluation, on February 6,
2008 the FAA issued Special Federal Aviation Regulation No. 108--
Mitsubishi MU-2B Series Special Training, Experience, and Operating
Requirements. This Special Federal Aviation Regulation (SFAR)
established a standardized pilot training program. The collection of
information is necessary to document participation in, completion of,
and compliance with the pilot training program for the MU-2B under
subpart N of part 91, issued on September 7, 2016, which superseded
SFAR No. 108.
    Respondents: Approximately 15 part 91 training providers, and
approximately 250 active MU-2 pilots.
    Frequency: Every year (pilots); every two years (training
providers).
    Estimated Average Burden per Response: Pilots: Logbook endorsement
and training course final phase check = 10 minutes. Training providers:
Submission of training program = 4 hours.
    Estimated Total Annual Burden: Pilots: 21 hours. Training
providers: 30 hours. Total: 51 hours.

    Issued in Washington, DC, on November 16, 2022.
D.C. Morris,
Project Manager, Flight Standards Service, General Aviation and
Commercial Division.
[FR Doc. 2022-25278 Filed 11-18-22; 8:45 am]
BILLING CODE 4910-13-P