[Federal Register Volume 84, Number 175 (Tuesday, September 10, 2019)]
[Notices]
[Pages 47502-47503]
[FR Doc No: 2019-19477]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC19-135-000.
    Applicants: Avangrid Renewables, LLC, Avangrid Arizona Renewables,
LLC, Poseidon Wind, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Avangrid Renewables, LLC, et al.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5213.
    Comments Due: 5 p.m. ET 9/24/19.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-179-000.
    Applicants: Thermo Cogeneration Partnership, L.P.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Thermo Cogeneration Partnership, L.P.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5073.
    Comments Due: 5 p.m. ET 9/25/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-2733-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2019-09-03 Energy Storage
and Distributed Energy Resources Phase 3 Amendment to be effective 11/
13/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5164.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2377-001.
    Applicants: Midcontinent Independent System Operator, Inc.,
Michigan Electric Transmission Company.
    Description: Tariff Amendment: 2019-09-04_SA 3330 Assembly Solar
LLC-METC Substitute E&P (J796) to be effective 7/2/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5049.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2734-000.
    Applicants: Stream Energy Columbia, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5182.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2735-000.
    Applicants: Stream Energy Delaware, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5183.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2736-000.
    Applicants: Stream Energy Illinois, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5184.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2737-000.
    Applicants: Stream Energy New Jersey, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5186.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2738-000.
    Applicants: Stream Energy New York, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5189.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2739-000.
    Applicants: Stream Ohio Gas & Electric, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/4/2019.
    Filed Date: 9/3/19.
    Accession Number: 20190903-5192.
    Comments Due: 5 p.m. ET 9/24/19.

    Docket Numbers: ER19-2740-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: PSC-COGRN-Revised ISA-146-
0.1.0-Agrmt to be effective 11/4/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5002.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2741-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits 14 ECSAs,
Service Agreement Nos. 5335, 5404, 5405, et al to be effective 11/3/
2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5010.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2742-000.
    Applicants: Stream Energy Connecticut, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Stream Energy Connecticut, LLC.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5028.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2743-000.
    Applicants: Stream Energy Indiana, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Stream Energy Indiana, LLC.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5031.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2744-000.
    Applicants: Stream Energy Massachusetts, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Stream Energy Massachusetts, LLC.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5037.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2745-000.
    Applicants: New Creek Wind LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Filing to be effective 11/4/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5062.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2746-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 5453, Non-queue NQ159 to be effective 12/31/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5063.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2747-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3593 Frontier Windpower II
GIA to be effective 8/23/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5064.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2748-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3595 Skeleton Creek Wind GIA
to be effective 8/23/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5067.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2749-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 5463;
Queue No. AB2-190 to be effective 8/9/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5081.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2750-000.
    Applicants: SGE Energy Sourcing, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/5/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5121.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2751-000.
    Applicants: Stream Energy Maryland, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/5/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5122.
    Comments Due: 5 p.m. ET 9/25/19.

    Docket Numbers: ER19-2752-000.
    Applicants: Stream Energy Pennsylvania, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 9/5/2019.
    Filed Date: 9/4/19.
    Accession Number: 20190904-5124.
    Comments Due: 5 p.m. ET 9/25/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 4, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19477 Filed 9-9-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Pages 73472-73473]
[FR Doc No: 2012-29706]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming teleconference meeting of a
public advisory committee of the Food and Drug Administration (FDA). At
least one portion of the meeting will be closed to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

DATES: Date and Time: The teleconference meeting will be held on
January 15, 2013 from 2 p.m. to 5:30 p.m., Eastern Time.
    Location: National Institutes of Health (NIH), Building 29B,
Conference Room C, 9000 Rockville Pike, Bethesda, MD 20892. The public
is welcome to attend the meeting at the specified location where a
speakerphone will be provided. Public participation in the meeting is
limited to the use of the speakerphone in the conference room.
Important information about transportation and directions to the NIH
campus, parking and security procedures is available on the internet at
http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
Visitors must show two forms of identification, one of which must be a
government-issued photo identification such as a Federal employee
badge, driver's license, passport, green card, etc. Detailed
information about security procedures is located at http://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking,
visitors are encouraged to use public transportation.
    Contact Person: Gail Dapolito, Center for Biologics Evaluation and
Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike,
Rockville MD 20852,<PHONE_NUMBER>, or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out further information regarding FDA advisory committees. A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On January 15, 2013, the committee will meet in open
session to hear updates of research programs in the Laboratory of
Immunology, Division of Therapeutic Proteins, Office of Biotechnology
Products, Center for Drug Evaluation and Research, FDA.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On January 15, 2013, from 2 p.m. to 4:30 p.m. (Eastern
Time) the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Written submissions may be made to the contact
person on or before January 8, 2013. Oral presentations from the public
will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
December 31, 2012. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by January 2, 2013.
    Closed Committee Deliberations: On January 15, from 4:30 p.m. to
5:30 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of
intramural research programs and make recommendations regarding
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Gail Dapolito at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29706 Filed 12-7-12; 8:45 am]
BILLING CODE 4160-01-P


50
values for the ionophores are
generally low, often not higher than 2 to 3 times the recommended dosage in
various species (Loyd-Evans, 1991). The diagnostic approach to ionophore
intoxication relies on the combination of non-pathognomonic clinical signs,
histopathological changes, recovery of the animals when the feed is changed,
and analysis of potentially toxic levels of coccidiostats in the feed. There is
no efficient, specific treatment for ionophore intoxication in any species
(Langston
ET½AL
, 1985). Withdrawal of the suspected feed and supportive
treatment is recommended (Langston
ET½AL
, 1985).
Accidental intoxication with ionophores has been described in many
different animal species, e.g. chickens, turkeys, ostriches, cattle, sheep, deer,
pigs, horses, dogs and cats (Muylle
ET½AL
, 1981; Glover and Wobeser, 1983;
Galitzer and W., 1984; Langston
ET½AL
, 1985; Chalmers, 1988; Novilla, 1992;
Baird, 1997). There is considerable species variation in susceptibility to
ionophore toxicity (table 7.II). Horses are very susceptible to ionophores and
great care is warranted at the feed mill to ensure that cross contamination of
equine feed is avoided.
Table 7.II.
¹
Species and substance variation of toxicity following oral dosing
of monensin and lasalocid (mg/kg body weight) (from Galitzer and W., 1984;
Fowler, 1995)
4ABELL½))½6ARIATION½I½TOXICITET½MELLAN½ARTER½OCH½SUBSTANSER½EFTER½ORALT½INTAG
AV½MONENSIN½OCH½LASALOCID½MGKG½KROPPSVIKT
(från Galitzer and W., 1984;
Fowler, 1995)
3PECIES
-ONENSINY,$

-ONENSINY,$

,ASALOCIDY,$

Chicken
200
150
72
Mouse
125 or 61-110
*
146
Rabbit
40
*
40
Rat
35 (25-43)
*
122
Goat
24-26
10
*
Sheep
12
3-4
*
Cattle
22-80
10
*
Swine
16-17 or 50
4 or 8
*
Horse
2-3
1
22
Dog
20
20
*
* data not available

SOU 1997:132
7. Coccidiostats
173
Ionophore toxicity in poultry
Intoxication with ionophores is a well known problem in poultry (among
others Howell
½ET½AL
, 1980; Hanrahan
½ET½AL
, 1981; Halvorson
½ET½AL
, 1982;
Braunius, 1989; Dowling, 1992). The prevalence of ionophore toxicity in
broiler chickens may be higher than what is generally considered, but hidden
due to diagnostic difficulties.
When exposed to sub-lethal toxic doses of ionophoric antibiotics chickens
show growth depression and decreased feed intake (Langston
ET½AL
, 1985).
At higher doses clinical signs include anorexia, leg-weakness,
incoordination, drowsiness, depression, diarrhoea and sometimes even
deaths. Sternal recumbence with neck and hind legs outstretched may also be
seen (Langston
ET½AL
, 1985). Gross pathology lesions are often inconclusive.
Pathological changes include emaciation, congestion, myocardial ventricular
dilatation, pallor and streaking of skeletal and heart muscle, and ascites
(Langston
ET½AL
, 1985). Histopathological changes are variable. In many
cases scattered foci of acute myonecrosis can be seen. In other cases severe
muscle and myocardial degeneration and necrosis are observed (Langston
ET
AL
, 1985). The clinical signs are reversible  and usually disappear once the
feed containing toxic levels of the ionophore is removed.
Ionophores may also negatively interfere with reproduction in poultry.
Reduced fertility (Jones
½ET½AL
, 1990; Perelman
ET½AL
, 1993), reduced or
completely lost egg production (Howell
ET½AL
, 1980; Fowler, 1995) and
reduced hatchability (Howell
ET½AL
, 1980; Jones
ET½AL
, 1990; Perelman
ET½AL
,
1993) have been reported. This is not a problem in commercial production,
since breeders and layers are not treated with ionophores during the egg-
laying period. However, in cases when layer feed has been contaminated
with ionophores reproductive disturbances have been reported (Perelman
ET
AL
, 1993).
Remarkable differences in toxicity may be seen within the group of
ionophores, when used in the same animal species. For example, in turkeys,
ionophore intoxication has been recorded when standard dosages of narasin
and salinomycin have been used (Davis, 1983; Horrox, 1984), while other
ionophores, such as monensin, maduramicin and semduramicin, are better
tolerated.
Ionophore toxicity in other animal species
As mentioned, ionophore toxicity has been described in many non-target
species including ostriches (Baird, 1997), sheep (Nation
½ET½AL
, 1982; Confer
ET½AL
, 1983), captive white-tailed deer (Glover and Wobeser, 1983), horses
(Muylle
ET½AL
, 1981; Kamphues
½ET½AL
, 1990), dogs (Chalmers, 1988; Karsai
and Papp, 1990; Safran
½ET½AL
, 1993) and cats (Wheeler, 1996). Intoxication

7. Coccidiostats
SOU 1997:132
174
with ionophores in non-target species can cause a variety of
clinicopathological changes.
Horses may develop hypovolemic shock and toxic tubular nephrosis, as
well as cardial and skeletal muscle changes when given low doses of
ionophores. As a lingering effect of ionophore toxicity in horses cardiac
fibrosis has also been reported (Muylle
ET½AL
, 1981). There are also clear
indications that cats show remarkable sensitivity to ionophores. In 1996 an
outbreak of feline neuropathy was linked to cat feed containing traces of
salinomycin (detection limit 2 ppm Wheeler, 1996).
Ionophore intoxication has also been described in cattle (Galitzer
½ET½AL
,
1986; Schlosberg
½ET½AL
, 1992). A primary cardiomyopathic syndrome has
been described in beef cattle fed dried broiler manure containing ionophore
residues (Perl
ET½AL
, 1991; Schlosberg
ET½AL
, 1992). This syndrome is
characterised by sudden death, exercise intolerance and subcutaneous
oedema. There are also reports describing intoxication with ionophores in
swine (Van Fleet
½ET½AL
, 1983).
Interactions of ionophores with other medicinal substances
Some ionophores interact with antibiotics and chemotherapeutic agents
(Meingassner
½ET½AL
, 1978; Frigg
½ET½AL
, 1983; Umemura
½ET½AL
, 1984; Miller
½ET
AL
, 1986; Miller, 1990; Fowler, 1995 and others). The mechanism of
interaction between ionophores and other chemically defined substances has
not been fully clarified. However, in an
IN½VITRO
study the elimination of
monensin in rat liver was reduced by 60% when tiamulin was added
(Meingassner
ET½AL
, 1978). In combination with the narrow safety margin for
ionophores the reduced elimination of ionophores poses an increased risk of
intoxication. Monensin, narasin and salinomycin can interact with antibiotics
such as chloramphenicol, erythromycin and oleandomycin (Prescott and
Baggot, 1993). Other examples of interaction include lasalocid with
chloramphenicol, lasalocid and monensin with furaltadone and furazolidone,
lasalocid with sulphadimethoxine, and monensin with sulphaquinoxaline,
sulphamethazine and sulphadimethoxine (Frigg
ET½AL
, 1983; Miller, 1990).
7.3.2
Toxicity of other coccidiostats
Non-specific signs of toxicity, such as depressed growth rate, reduced feed
intake, weakness and depression, have been observed in birds and mammals
following exposure to some of the non-ionophoric substances (Fowler,
1995). Furthermore, more specific toxic signs are reported with certain
substances. One such example of toxicity is the reduction of the skin tensile
strength of broiler chickens by the interference of halofuginone with the
collagen synthesis (Angel
½ET½AL
, 1985; Granot
½ET½AL
, 1991; Christensen
½ET½AL
,

SOU 1997:132
7. Coccidiostats
175
1994). As a consequence, the birds suffer skin tears during slaughter and
processing. In a recent study it was also shown that halofuginone
supplementation is associated with an increase in skin scratches and sores in
the birds
IN½VIVO
(Pinion
½ET½AL
, 1995). Unpublished Swedish observations
when this product was used in the middle of the 80s are consistent with these
findings. Due to problems with carcass quality that were put in connection
with the use of halofuginone, the product was abandoned by the industry
(Björn Engström, personal communication, 1997 ). The animal welfare
1
aspect of halofuginone toxicity should also be considered.
Halofuginone and arprinocid are known to be toxic for ducks and geese
(Behr
½ET½AL
, 1988). Robenidine, arprinocid and in particular halofuginone
have been reported to be toxic to chicken embryos (Atef
½ET½AL
, 1989; Granot
ET½AL
, 1991; Christensen
ET½AL
, 1994). Additionally, halofuginone is toxic to
fish (Fowler, 1995).
Nicarbazin interferes with the thermoregulatory balance at high ambient
temperatures which can, in a dose dependent way, cause decreased weight
gain and feed efficiency as well as increased mortality (Wienernusz and
Teeter, 1995). At therapeutic dosage nicarbazin also interferes with the
reproduction of hens by causing decreased egg production and hatchability
(Jones
ET½AL
, 1990).
7.3.3
Residues
To avoid residues of coccidiostats in meat, withdrawal periods before
slaughter of the animals are assigned (table 7.I.). Eggs are, however, a
special problem. Maximum age levels and restrictions on usage in layer feed
may not always be enough to ensure that eggs are free of coccidiostats.
Laying might commence shortly after, or even before, the maximum age is
reached. Moreover, withdrawal right before laying starts may not be
sufficient for substances that persist for a long time in the tissues of the
animals.
Ionophores
It has been suggested that residues of ionophores in food could cause adverse
effects on the health of humans since these substances possess potent
cardiovascular properties (Kabell
½ET½AL
, 1979; Fahim and Pressman, 1981).
Monensin induces coronary vasodilatation in dogs and rabbits at low
concentrations. Inotropic effects of lasalocid on human heart muscle has
been demonstrated
IN½VITRO
(Levy and Inesi, 1974) but there are no reports in
1
Björn Engström, Senior Veterinary Officer, Department of Poultry, National Veterinary Institute,
Sweden

7. Coccidiostats
SOU 1997:132
176
the literature describing ionophore toxicity in humans associated with meat
consumption.
Ionophores are absorbed from the gut and may be found in various organs
at zero withdrawal time (Davison, 1984; Donoho, 1984; Lynch
½ET½AL
, 1992;
Atef
½ET½AL
, 1993). However, if withdrawal times are respected, presence of
toxic residues would not be expected.
For narasin, passage into egg yolk has also been reported (Catherman
½ET
AL
, 1991).
Other substances
Some of the non-ionophoric coccidiostats are absorbed from the gut of the
target animals. However, most substances appear to have low toxicity, why
residues would not be expected to give rise to any toxic effects.
Decoquinate is only absorbed to a small extent (Seman
½ET½AL
, 1989) and is
reported to have very low toxicity (Fowler, 1995).
Low toxicity is also reported for diclazuril (Fowler, 1995).
Feeding of radiolabelled arprinocid at concentrations between 60 and 80
ppm has been reported to result in residues of 0.1-0.5 ppm in liver after 3-5
days withdrawal time (Jacob
½ET½AL
, 1982).
In one study, meticlorpindol in chicken feed at 125 ppm for 34 days
resulted in residues in liver and muscle of 0.5 ppm and 0.1 ppm, respectively,
at 2 days withdrawal (Ekström
½ET½AL
, 1984). Thereafter, there was a slow
decrease in residue concentrations, which were measured until 10 days after
withdrawal. Low toxicity of meticlorpindol after oral intake is reported
(Fowler, 1995).
Amprolium, may be found in eggs up to 10 days after withdrawal from the
feed (Kan
½ET½AL
, 1989). Amprolium is reported to be fairly atoxic, and it is
not permitted in the feed after the beginning of egg laying, but no withdrawal
time has been assigned for eggs.
Passage of halofuginone into eggs has also been reported (Lindsay and
Blagburn, 1995). No withdrawal time for eggs has been established.
For some substances, such as lasalocid, maduramicin, narasin and
halofuginone, withdrawal times are shorter in Swedish national regulations
than in EU regulations. As a conservative approach may be preferable in this
case, it is advisable to adjust the Swedish withdrawal times to the EU
regulations.
7.3.4 Allergy
Ionophores may cause irritation and allergic reactions in humans, and may
thereby be an occupational hazard for feedmill workers and other people that
come into contact with these substances on a daily basis (Mancuso
½ET½AL
,

SOU 1997:132
7. Coccidiostats
177
1990; Fowler, 1995). Protective clothing and dust masks are recommended
when handling ionophores. Dust formation might be reduced by changes in
the galenic formulation used. For some coccidiostats the maximum dusting
properties allowed when handling the substances, as determined by the
Stauber Heubach method, have been fixed.
Amprolium, meticlorpindol, robenidine and halofuginone may cause
irritation of the skin and eyes by direct contact or through aerosols (Mancuso
ET½AL
, 1990; Fowler, 1995) and care should be taken to avoid contact, by
using masks and protective clothing while handling these substances.
Clinical reports of allergic reactions to non-ionophoric coccidiostats appear
to be less frequent. However, this does not necessarily mean that such
reactions are rare.
The toxicological safety margins of ionophores are comparatively narrow.
Ionophores are toxic for many non-target species.
Some ionophores interact with antibiotics and chemotherapeutics which may
increase the risk of intoxication.
Some non-ionophore coccidiostats are toxic for ducks, geese and fish.
Halofuginone causes skin damage in the target species. This is unacceptable
from an animal welfare point of view.
Most coccidiostats are absorbed from the gut, and may be found in various
tissues at zero withdrawal. It is therefore important that withdrawal times are
respected.
For some substances, withdrawal times for eggs should be considered.
Ionophores, and some non-ionophores may cause irritation and/or allergic
reactions in man.
7.4
Environmental aspects
Since poultry manure is extensively used as fertilisers, coccidiostats and their
degradation products are likely to reach soil and water. Therefore, it is
important to identify potential effects on terrestrial and aquatic environments,
including flora, fauna and microbes. However, very few studies have been
published regarding the environmental fate of coccidiostats, which makes it
difficult to evaluate their possible impact in this respect.

7. Coccidiostats
SOU 1997:132
178
7.4.1
Environmental aspects on ionophores
Ionophores are excreted in poultry manure (Donoho, 1984; Perl
ET½AL
, 1991;
Schlosberg
ET½AL
, 1992). Biodegradation studies indicate that monensin is
degradable, under aerobic conditions, in soil with or without manure
(Donoho, 1984). No traces of monensin were found in soil 33 days after the
deposition and the monensin concentrations declined in manure piles during
natural weather conditions (Donoho, 1984). However, in manure piles under
relatively anaerobic conditions monensin levels declined slowly (Donoho,
1984). It is, however, reasonable to presume that the microbiological activity
in the soil may be altered initially, which may influence the release of
nutrients.
As ionophores are active against anaerobic bacteria, interference with
anaerobic microbial processes, such as in biogas production or wastewater
treatment might be expected. A reduction in the biogas conversion efficiency
of UASB-(Upflow Anaerobic Sludge Blanket) reactors  by 20% when
monensin was added has been reported (Thaveesri
½ET½AL
, 1994). Additionally,
the acclimatisation period was twice as long and total volatile acid
concentrations were twice as high compared to the control.
Direct effects on plants, fruits and vegetables are generally not expected,
but an inhibitory effect of monensin on apple pollen has been reported
(Speranza and Calzoni, 1992; Ciampolini
½ET½AL
, 1993).
No published information about persistence or effects of ionophores in
aquatic environment have been found.
7.4.2
Environmental aspects on other coccidiostats
It has been shown that some non-ionophore coccidiostats, e.g. decoquinate
and amprolium, are excreted in active form in poultry manure (Warman
½ET
AL
, 1977; Hobson-Frohock and Johnson, 1983).
During simulated field conditions it was found that amprolium was
adsorbed in the upper layers of the soil and amprolium could be recovered
from the soil up to 80 days post deposition (Warman
ET½AL
, 1977). No effect
on soil respiration or soil microflora was shown.
Halofuginone is known to be acutely toxic to fish at low doses (acute
toxicity to carp at 0.7 ppm) (Fowler, 1995). The possible impact of this on
the aquatic environment is not known.
Available data indicate that ionophores are degradable under aerobic
conditions.
Ionophores may interfere with anaerobic systems such as biogas production

SOU 1997:132
7. Coccidiostats


[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Rules and Regulations]
[Pages 11289-11291]
[FR Doc No: 2020-03936]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0872; Product Identifier 2019-NM-156-AD; Amendment
39-19848; AD 2020-03-24]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and
20-F5 airplanes. This AD was prompted by a determination that new or
more restrictive airworthiness limitations are necessary. This AD
requires revising the existing maintenance or inspection program, as
applicable, to incorporate

new or more restrictive airworthiness limitations. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective April 2, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 2,
2020.

ADDRESSES: For service information identified in this final rule,
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet
https://www.dassaultfalcon.com. You may view this service information
at the FAA, Transport Standards 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 on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0872.

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-2019-
0872; 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 final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2019-0201, dated August 20, 2019 (``EASA AD 2019-0201'') (also
referred to as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Dassault
Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes,
on which the Supplemental Structural Inspection Program (SSIP)
(Dassault Service Bulletin 730) has been embodied into the airplane's
maintenance program. You may examine the MCAI in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0872.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Dassault
Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes.
The NPRM published in the Federal Register on November 19, 2019 (84 FR
63822). The NPRM was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The NPRM proposed
to require revising the existing maintenance or inspection program, as
applicable, to incorporate new or more restrictive airworthiness
limitations. The FAA is issuing this AD to address fatigue cracking,
damage, and corrosion in principal structural elements, which could
result in reduced structural integrity of the airplane. See the MCAI
for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. An anonymous commenter indicated support for the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Chapter 5-40-01, Airworthiness
Limitations, of the Dassault Falcon 20 Retrofit 731 Maintenance Manual,
Revision 10, dated January 1, 2019. This service information describes
airworthiness limitations for safe life limits and certification
maintenance requirements. This service information 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.

Costs of Compliance

    The FAA estimates that this AD affects 57 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD.
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the FAA recognizes that this number may vary from operator to
operator. In the past, the FAA has estimated that this action takes 1
work-hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), the FAA has
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, the FAA estimates the total cost per
operator to be $7,650 (90 work-hours x $85 per work-hour).

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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):

2020-03-24 Dassault Aviation: Amendment 39-19848; Docket No. FAA-
2019-0872; Product Identifier 2019-NM-156-AD.

(a) Effective Date

    This AD is effective April 2, 2020.

(b) Affected ADs

    This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR 79952,
December 21, 2010) (``AD 2010-26-05'').

(c) Applicability

    This AD applies to Dassault Aviation Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes, certificated in any category, on
which the Supplemental Structural Inspection Program (SSIP)
(Dassault Service Bulletin 730) has been embodied into the
airplane's existing maintenance or inspection program.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking, damage, and corrosion
in principal structural elements, which could result in reduced
structural integrity of the airplane.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 5-40-01,
Airworthiness Limitations, of the Dassault Falcon 20 Retrofit 731
Maintenance Manual, Revision 10, dated January 1, 2019. The initial
compliance time for doing the tasks is at the time specified in
Chapter 5-40-01, Airworthiness Limitations, of the Dassault Falcon
20 Retrofit 731 Maintenance Manual, Revision 10, dated January 1,
2019, or within 90 days after the effective date of this AD,
whichever occurs later.

(h) No Alternative Actions or Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (j)(1) of this AD.

(i) Terminating Action for Certain Requirements of AD 2010-26-05

    Accomplishing the actions required by this AD terminates the
requirements of paragraph (g)(1) of AD 2010-26-05 only for Model
MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes on which the
SSIP has been embodied into the airplane's existing maintenance or
inspection program.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (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, International
Section, Transport Standards Branch, FAA; or the European Union
Aviation Safety Agency (EASA); or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2019-0201, dated August 20, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2019-0872.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Chapter 5-40-01, Airworthiness Limitations, of the Dassault
Falcon 20 Retrofit 731 Maintenance Manual, Revision 10, dated
January 1, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact Tom
Rodriguez, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 14, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-03936 Filed 2-26-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Rules and Regulations]
[Pages 18701-18704]
[FR Doc No: 2019-08973]

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

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2019-0152; Special Conditions No. 25-744-SC]

Special Conditions: Greenpoint Technologies, Inc., Boeing Model
787-8 Airplane; Dynamic Test Requirements for Single-Occupant, Side-
Facing Seats With Airbag Devices in Shoulder Belts

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Boeing Model 787-8
airplane. This airplane, as modified by Greenpoint Technologies, Inc.
(Greenpoint), 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 single-
occupant, side-facing seats with airbag devices in shoulder belts, and
a floor-level, leg-flail-prevention device to limit the axial rotation
of the upper leg. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for this design
feature. These 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: This action is effective on Greenpoint Technologies, Inc. on May
2, 2019. Send comments on or before June 17, 2019.

ADDRESSES: Send comments identified by Docket No. FAA-2019-0152 using
any of the following methods:
     Federal eRegulations Portal: Go to http://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>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket website, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478).
    Docket: Background documents or comments received may be read at
http://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: Shannon Lennon, Airframe & Cabin
Safety Section, AIR-675, Transport Standards Branch, Policy and
Innovation Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions is
impracticable because the substance of these special conditions has
been published in the Federal Register for public comment in several
prior instances with no substantive comments received. The FAA
therefore finds it unnecessary to delay the effective date and finds
that good cause exists for making these special conditions effective
upon publication in the Federal Register.

Comments Invited

    We invite 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 special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On June 15, 2017, Greenpoint applied for a supplemental type
certificate for single-occupant, side-facing seats with airbag devices
in shoulder belts, and a floor-level, leg-flail-prevention device to
limit the axial rotation of the upper leg, installed in Boeing Model
787-8 airplanes. The Boeing Model 787-8 airplane, which is a derivative
of the Boeing Model 787 currently approved under Type Certificate No.
T00021SE, is a twin-engine, transport-category airplane with a maximum
takeoff weight of 502,500 pounds. The airplanes, as modified by
Greenpoint, will have a business-jet interior with a maximum seating
capacity of 41.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Greenpoint must show that the Boeing Model 787-8 airplane,
as changed, continues to meet the applicable provisions of the
regulations listed in Type Certificate No. T00021SE, 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 (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Boeing Model 787-8 airplane
because of a novel or unusual design feature, special conditions are
prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model 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 also apply to the other model under
Sec.  21.101.

    In addition to the applicable airworthiness regulations and special
conditions, the Boeing Model 787-8 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 Boeing Model 787-8 airplane, as modified by Greenpoint, will
incorporate the following novel or unusual design features:
    Single-occupant, side-facing seats with airbag devices in shoulder
belts.

Discussion

    Amendment 25-64, dated June 16, 1988, revised the emergency-landing
conditions that must be considered in the design of the airplane. It
revised the static-load conditions in Sec.  25.561 and added a new
Sec.  25.562, requiring dynamic testing for all seats approved for
occupancy during takeoff and landing. The intent was to provide an
improved level of safety for occupants on transport-category airplanes.
Because most seating on transport-category airplanes is forward-facing,
the pass/fail criteria developed in Amendment 25-64 focused primarily
on forward-facing seats. Therefore, the testing specified in the rule
did not provide a complete measure of occupant injury in seats that are
not forward-facing, although Sec.  25.785 does require occupants of all
seats that are occupied during taxi, takeoff, and landing not suffer
serious injury as a result of the inertia forces specified in
Sec. Sec.  25.561 and 25.562.
    For some time the FAA granted exemptions for the multiple-place
side-facing-seat installations because the existing test methods and
acceptance criteria did not produce a level of safety equivalent to the
level of safety provided for forward- and aft-facing seats. These
exemptions were subject to many conditions that reflected the injury-
evaluation criteria and mitigation strategies available at the time of
the exemption issuance. The FAA also issued special conditions to
address single-place side-facing seats because we believed that those
conditions provided the same level of safety as for forward- and aft-
facing seats.
    Continuing concerns regarding the safety of side-facing seats
prompted the FAA to conduct research to develop an acceptable method of
compliance with Sec. Sec.  25.562 and 25.785(b) for side-facing seat
installations. That research has identified injury considerations and
evaluation criteria in addition to those previously used to approve
side-facing seats (see published report DOT/FAA/AR-09/41, July 2011).
One particular concern that was identified during the FAA's research
program, but not addressed in the previous special conditions, was the
significant leg injuries that can occur to occupants of both single-
and multiple-place side-facing seats. Because this type of injury does
not occur on forward- and aft-facing seats, the FAA determined that, to
achieve the level of safety envisioned in Amendment 25-64, additional
requirements would be needed as compared to previously issued special
conditions. Nonetheless, the research has now allowed the development
of a single set of special conditions applicable to all fully side-
facing seats.
    On November 5, 2012, the FAA released PS-ANM-25-03-R1, ``Technical
Criteria for Approving Side-Facing Seats,'' to update existing FAA
certification policy on Sec. Sec.  25.562 and 25.785(a) at Amendment
25-64 for single- and multiple-place side-facing seats. This policy
addresses both the technical criteria for approving side-facing seats
and the implementation of those criteria. The FAA methodology detailed
in PS-ANM-25-03-R1 has been used to establish a new set of proposed
special conditions.
    These 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 special conditions are applicable to
Boeing Model 787-8 airplanes modified by Greenpoint. Should Greenpoint
apply at a later date for a supplemental type certificate to modify any
other model included on Type Certificate No. T00021SE to incorporate
the same novel or unusual design feature, these special conditions
would apply to that model as well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model of airplanes. 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, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Boeing Model 787-8 airplanes modified
by Greenpoint.
    In addition to the airworthiness standards in Sec. Sec.  25.562 and
25.785, special conditions 1 and 2 apply to all side-facing seat
installations, and special conditions 3 through 16 apply to side-facing
seats equipped with an airbag system in the shoulder-belt system and an
airbag system in the leg-flail arresting device.
    1. Additional requirements applicable to tests or rational analysis
conducted to show compliance with Sec. Sec.  25.562 and 25.785 for
side-facing seats:
    a. The longitudinal test(s) conducted in accordance with Sec.
25.562(b)(2) to show compliance with the seat-strength requirements of
Sec.  25.562(c)(7) and (8), and these special conditions must have an
ES-2re Anthropomorphic Test Dummy (ATD) (49 CFR part 572, subpart U) or
equivalent, or a Hybrid-II ATD (49 CFR part 572, subpart B, as
specified in Sec.  25.562) or equivalent, occupying each seat position
and including all items contactable by the occupant (e.g., armrest,
interior wall, or furnishing) if those items are necessary to restrain
the occupant. If included, the floor representation and contactable
items must be located such that their relative position, with respect
to the center of the nearest seat place, is the same at the start of
the test as before floor misalignment is applied. For example, if floor
misalignment rotates the centerline of the seat place nearest the
contactable item 8 degrees clockwise about the airplane x-axis, then
the item and floor representations must be rotated by 8 degrees
clockwise also to maintain the same relative position to the seat
place. Each ATD's relative position to the seat after application of
floor misalignment must be the same as before misalignment is applied.
To ensure proper loading of the seat by the occupants, the ATD pelvis
must remain supported by the seat pan, and the restraint system must
remain on the pelvis and shoulder of the ATD until rebound begins. No
injury-criteria evaluation is necessary for tests conducted only to
assess seat-strength requirements.

    b. The longitudinal test(s) conducted in accordance with Sec.
25.562(b)(2), to show compliance with the injury assessments required
by Sec.  25.562(c) and these special conditions, may be conducted
separately from the test(s) to show structural integrity. In this case,
structural-assessment tests must be conducted as specified in paragraph
1a, above, and the injury-assessment test must be conducted without yaw
or floor misalignment. Injury assessments may be accomplished by
testing with ES-2re ATD (49 CFR part 572, subpart U) or equivalent at
all places. Alternatively, these assessments may be accomplished by
multiple tests that use an ES-2re at the seat place being evaluated,
and a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in Sec.
25.562) or equivalent used in all seat places forward of the one being
assessed, to evaluate occupant interaction. In this case, seat places
aft of the one being assessed may be unoccupied. If a seat installation
includes adjacent items that are contactable by the occupant, the
injury potential of that contact must be assessed. To make this
assessment, tests may be conducted that include the actual item,
located and attached in a representative fashion. Alternatively, the
injury potential may be assessed by a combination of tests with items
having the same geometry as the actual item, but having stiffness
characteristics that would create the worst case for injury (injuries
due to both contact with the item and lack of support from the item).
    c. If a seat is installed aft of structure (e.g., an interior wall
or furnishing) that does not have a homogeneous surface contactable by
the occupant, additional analysis and/or test(s) may be required to
demonstrate that the injury criteria are met for the area which an
occupant could contact. For example, different yaw angles could result
in different injury considerations and may require additional analysis
or separate test(s) to evaluate.
    d. To accommodate a range of occupant heights (5th percentile
female to 95th percentile male), the surface of items contactable by
the occupant must be homogenous 7.3 inches (185 mm) above and 7.9
inches (200 mm) below the point (center of area) that is contacted by
the 50th percentile male size ATD's head during the longitudinal
test(s) conducted in accordance with paragraphs a, b, and c, above.
Otherwise, additional head-injury criteria (HIC) assessment tests may
be necessary. Any surface (inflatable or otherwise) that provides
support for the occupant of any seat place must provide that support in
a consistent manner regardless of occupant stature. For example, if an
inflatable shoulder belt is used to mitigate injury risk, then it must
be demonstrated by inspection to bear against the range of occupants in
a similar manner before and after inflation. Likewise, the means of
limiting lower-leg flail must be demonstrated by inspection to provide
protection for the range of occupants in a similar manner.
    e. For longitudinal test(s) conducted in accordance with Sec.
25.562(b)(2) and these special conditions, the ATDs must be positioned,
clothed, and have lateral instrumentation configured as follows:
    i. ATD positioning--Lower the ATD vertically into the seat while
simultaneously:
    1. Aligning the midsagittal plane (a vertical plane through the
midline of the body; dividing the body into right and left halves) with
approximately the middle of the seat place.
    2. Applying a horizontal x-axis direction (in the ATD coordinate
system) force of about 20 lb (89 N) to the bottom of the feet of the
ES-2re Hybrid-II, to compress the seat back cushion.
    3. Keeping the lower and upper legs nearly horizontal by supporting
at the bottom of the feet.
    ii. Once all lifting devices have been removed from the ATD:
    1. Rock it slightly to settle it in the seat.
    2. Bend the knees of the ATD.
    3. Separate the knees by about 4 inches (100 mm).
    4. Set the ES-2re's head at approximately the midpoint of the
available range of z-axis rotation (to align the head and torso
midsagittal planes).
    5. Position the ES-2re's arms at the joint's mechanical detent that
puts them at approximately a 40 degree angle with respect to the torso.
Position the Hybrid-II ATD hands on top of its upper legs.
    6. Position the feet such that the centerlines of the lower legs
are approximately parallel to a lateral vertical plane (in the airplane
coordinate system).
    iii. ATD clothing: Clothe each ATD in form-fitting, mid-calf-length
(minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 kg)
total. The color of the clothing should be in contrast to the color of
the restraint system. The ES-2re jacket is sufficient for torso
clothing, although a form-fitting shirt may be used in addition if
desired.
    iv. ES-2re ATD lateral instrumentation: The rib-module linear
slides are directional, i.e., deflection occurs in either a positive or
negative ATD y-axis direction. The modules must be installed such that
the moving end of the rib module is toward the front of the airplane.
The three abdominal-force sensors must be installed such that they are
on the side of the ATD toward the front of the airplane.
    f. The combined horizontal/vertical test, required by Sec.
25.562(b)(1) and these special conditions, must be conducted with a
Hybrid II ATD (49 CFR part 572, subpart B, as specified in Sec.
25.562), or equivalent, occupying each seat position.
    g. Restraint systems:
    i. If inflatable shoulder and leg-flail restraint systems are used,
they must be active during all dynamic tests conducted to show
compliance with Sec.  25.562.
    ii. The design and installation of seat-belt buckles must prevent
unbuckling due to applied inertial forces or impact of the hands/arms
of the occupant during an emergency landing.
    2. Additional performance measures applicable to tests and rational
analysis conducted to show compliance with Sec. Sec.  25.562 and 25.785
for side-facing seats:
    a. Body-to-body contact: Contact between the head, pelvis, torso,
or shoulder area of one ATD with the adjacent-seated ATD's head,
pelvis, torso, or shoulder area is not allowed. Contact during rebound
is allowed.
    b. Thoracic: The deflection of any of the ES-2re ATD upper, middle,
and lower ribs must not exceed 1.73 inches (44 mm). Data must be
processed as defined in Federal Motor Vehicle Safety Standards (FMVSS)
571.214.
    c. Abdominal: The sum of the measured ES-2re ATD front, middle, and
rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be
processed as defined in FMVSS 571.214.
    d. Pelvic: The pubic symphysis force measured by the ES-2re ATD
must not exceed 1,350 lbs (6,000 N). Data must be processed as defined
in FMVSS 571.214.
    e. Leg: Axial rotation of the upper-leg (femur) must be limited to
35 degrees in either direction from the nominal seated position. The
leg-flail-prevention mechanism must:
    i. Be shown to function as intended in consideration of post-
structural deformation of the seat assembly.
    ii. Retract such that it does not impede rapid egress of occupants.
    f. Neck: As measured by the ES-2re ATD and filtered at CFC 600 as
defined in SAE J211:
    i. The upper-neck tension force at the occipital condyle (O.C.)
location must be less than 405 lbs (1,800 N).

    ii. The upper-neck compression force at the O.C. location must be
less than 405 lbs (1,800 N).
    iii. The upper-neck bending torque about the ATD x-axis at the O.C.
location must be less than 1,018 in-lbs (115 Nm).
    iv. The upper-neck resultant shear force at the O.C. location must
be less than 186 lbs (825 N).
    g. Occupant (ES-2re ATD) retention: The pelvic restraint must
remain on the ES-2re ATD's pelvis during the impact and rebound phases
of the test. The upper-torso restraint straps (if present) must remain
on the ATD's shoulder during the impact.
    h. Occupant (ES-2re ATD) support:
    i. Pelvis excursion: The load-bearing portion of the bottom of the
ATD pelvis must not translate beyond the edges of its seat's bottom
seat-cushion supporting structure.
    ii. Upper-torso support: The lateral flexion of the ATD torso must
not exceed 40 degrees from the normal upright position during the
impact.
    3. For seats with a shoulder and leg-flail airbag system, the
shoulder and leg-flail airbag system must deploy and provide protection
under crash conditions where it is necessary to prevent serious injury.
The means of protection must take into consideration a range of stature
from a 2-year-old child to a 95th percentile male. The airbag systems
in the shoulder belts must provide a consistent approach to energy
absorption throughout that range of occupants. At some buttock
popliteal length and effective seat-bottom depth, the lower legs will
not be able to form a 90-degree angle with the upper leg; at this
point, the lower-leg flail would not occur. The leg-flail airbag system
must provide a consistent approach to prevention of leg flail
throughout that range of occupants whose lower legs can form a 90-
degree angle relative to the upper legs when seated upright in the
seat. Items that need to be considered include, but are not limited to,
the range of occupants' popliteal height, the range of occupants'
buttock popliteal length, the design of the seat effective height above
the floor, and the effective depth of the seat bottom cushion. When the
seat system includes an airbag system, that system must be included in
each of the certification tests as it would be installed in the
airplane. In addition, the following situations must be considered:
    a. The seat occupant is holding an infant.
    b. The seat occupant is a pregnant woman.
    4. The airbag system in the shoulder belt must provide adequate
protection for each occupant regardless of the number of occupants of
the seat assembly, considering that unoccupied seats may have an active
airbag system in the shoulder belt.
    5. The design must prevent the airbag system in the shoulder belt
from being either incorrectly buckled or incorrectly installed, such
that the airbag system in the shoulder belt would not properly deploy.
Alternatively, it must be shown that such deployment is not hazardous
to the occupant, and will provide the required injury protection.
    6. It must be shown that the shoulder and leg-flail airbag system
is not susceptible to inadvertent deployment as a result of wear and
tear, or inertial loads resulting from in-flight or ground maneuvers
(including gusts and hard landings), and other operating and
environmental conditions (vibrations, moisture, etc.) likely to occur
in service.
    7. Deployment of the shoulder and leg-flail airbag system must not
introduce injury mechanisms to the seated occupant, or result in
injuries that could impede rapid egress. This assessment should include
an occupant whose belt is loosely fastened.
    8. It must be shown that inadvertent deployment of the shoulder and
leg-flail airbag system, during the most critical part of the flight,
will either meet the requirement of Sec.  25.1309(b) or not cause a
hazard to the airplane or its occupants. This also includes preventing
inadvertent airbag deployment from a static discharge.
    9. If the airbag system is connected to the dynamic seat and must
inflate through 9g static structure, then the static structure must not
fail in such a way that it could impede egress or otherwise present a
hazard to the occupants or to the airbag system.
    10. The shoulder and leg-flail airbag system must be protected from
lightning and high-intensity radiated fields (HIRF). The threats to the
airplane specified in existing regulations regarding lighting, Sec.
25.1316, and HIRF, Sec.  25.1317, are incorporated by reference for the
purpose of measuring lightning and HIRF protection.
    11. The shoulder and leg-flail airbag system must function properly
after loss of normal airplane electrical power, and after a transverse
separation of the fuselage at the most critical location. A separation
at the location of the airbag system in the shoulder belt does not have
to be considered.
    12. It must be shown that the shoulder and leg-flail airbag system
will not release hazardous quantities of gas, sharp injurious metal
fragments, or particulate matter into the cabin.
    13. The shoulder and leg-flail airbag system installation must be
protected from the effects of fire such that no hazard to occupants
will result.
    14. A means must be available for a crewmember to verify the
integrity of the shoulder and leg-flail airbag system activation system
prior to each flight, or it must be demonstrated to reliably operate
between inspection intervals. The FAA considers that the loss of the
airbag-system deployment function alone (i.e., independent of the
conditional event that requires the airbag-system deployment) is a
major-failure condition.
    15. The inflatable material may not have an average burn rate of
greater than 2.5 inches/minute when tested using the horizontal
flammability test defined in part 25, appendix F, part I, paragraph
(b)(5).
    16. The shoulder and leg-flail airbag system, once deployed, must
not adversely affect the emergency-lighting system (i.e., block floor
proximity lights to the extent that the lights no longer meet their
intended function).

    Issued in Des Moines, Washington, on April 23, 2019.
Victor Wicklund,
Manager, Transport Standards Branch, Policy and Innovation Division,
Aircraft Certification Service.
[FR Doc. 2019-08973 Filed 5-1-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 157 (Tuesday, August 14, 2012)]
[Notices]
[Pages 48567-48568]
[FR Doc No: 2012-19959]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, August
16, 2012 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Gallagher, as duty officer, voted to consider the
items listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
August 16, 2012 will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: August 9, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-19959 Filed 8-10-12; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57193-57194]
[FR Doc No: 2022-20173]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2020-0031; FRL-10096-01-OECA]

Proposed Information Collection Request; Comment Request;
Proposed Information Collection Request; Comment Request; State Review
Framework

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Proposed Information
Collection Request; Comment Request; State Review Framework'' (EPA ICR
No. 2185.08, OMB Control No. 2020-0031 to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection as described
below. This is a proposed extension of the ICR, which is currently
approved through April 30, 2023. An Agency may not conduct, or sponsor
and a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before November 18, 2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OECA-
2020-0031, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460 and (2)
OMB via email to [email protected]. Address comments to OMB
Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Dave Hoffman, Office of Enforcement
and Compliance Assurance, Office of Compliance, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register

notice to announce the submission of the ICR to OMB and the opportunity
to submit additional comments to OMB.
    Abstract: The State Review Framework is an oversight tool designed
to assess state performance in enforcement and compliance assurance.
The Framework's goal is to evaluate state performance by examining
existing data to provide a consistent level of oversight and develop a
uniform mechanism by which EPA Regions, working collaboratively with
their states, can ensure state environmental agencies consistently
implement the national compliance and enforcement program to meet
agreed-upon goals. Furthermore, the Framework is designed to foster
dialogue on enforcement and compliance performance between states to
enhance relationships and increase feedback, which will in turn lead to
consistent program management and improved environmental results. This
request will allow OECA to review and collect information from state
and local agency enforcement and compliance files, to support the State
Review Framework implementation from FY 2024 to FY 2027. It will also
allow EPA to make inquiries to assess the State Review Framework
process, including consistency achieved among the EPA Regions and
states, resources required to conduct reviews, and overall
effectiveness of the program.
    Form Numbers: None.
    Respondents/affected entities: States, localities, and territories.
    Respondent's obligation to respond: Required as part of program
authorization under the Clean Water, Clean Air, Safe Drinking Water and
Resource Conservation and Recovery Acts.
    Estimated number of respondents: 213 (total).
    Frequency of response: Once every 5 years.
    Total estimated burden: 12,993 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $546,729 (per year).
    Changes in Estimates: There is an increase in total estimated
response burden hours from 218 to 305 per respondent due to the
addition of the safe drinking water act enforcement review pilot, which
wasn't captured in the previous ICR. This pilot isn't formally part of
the SRF, but the agency believes this ICR is an appropriate forum to
collect input, due to their similarities in workload and purpose. At
the conclusion of the pilot, the agency will review the program and if
necessary, revise this ICR. In addition, there is an increase in the
number of respondents from 54 to 213 due to inclusion of all media
(CAA, CWA, RCRA and SDWA) for 50 states and 4 territories, and 14 local
air districts. Previous ICR's included a single response for each
state/territory, whereas this ICR utilized a different methodology to
capture the burden more accurately. The burden estimates for CAA, CWA
and RCRA are unchanged.

John Dombrowski,
Director, Office of Compliance.
[FR Doc. 2022-20173 Filed 9-16-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Rules and Regulations]
[Pages 22370-22372]
[FR Doc No: 2023-07745]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0012; Project Identifier MCAI-2022-01317-T;
Amendment 39-22387; AD 2023-06-01]
RIN 2120-AA64

Airworthiness Directives; ATR--GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain ATR--GIE Avions de Transport R[eacute]gional Model ATR42-500
and ATR72-212A airplanes. This AD was prompted by in-service experience
that has shown that the lateral flight guidance of the flight director/
auto pilot may not limit HI BANK turns in severe icing conditions. This
AD requires the replacement of the affected new avionics suite (NAS),
as specified in a European Union Aviation Safety Agency (EASA) AD,
which is incorporated by reference. This AD also prohibits the
installation of the affected NAS on any airplane. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective May 18, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 18,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0012; 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 final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For EASA material incorporated by reference in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu.
     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<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2023-0012.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation Branch,
2200 South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain ATR--GIE Avions
de Transport R[eacute]gional Model ATR42-500 and 72-212A airplanes. The
NPRM published in the Federal Register on January 13, 2023 (88 FR
2295). The NPRM was prompted by AD 2022-0206, dated October 7, 2022,
issued by EASA, which is the Technical Agent for the Member States of
the European Union (EASA AD 2022-0206) (also referred to as the MCAI).
The MCAI states that in-service experience has shown that the lateral
flight guidance of the flight director/auto pilot may not limit HI BANK
turns in severe icing conditions. The airplane is only protected during
LO BANK turns. This condition, if not addressed, could result in loss
of control of the airplane.
    In the NPRM, the FAA proposed to require the replacement of the
affected NAS, as specified in EASA AD 2022-0206. The NPRM also proposed
to prohibit the installation of the affected NAS on any airplane. The
FAA is issuing this AD to address the unsafe condition on these
products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0012.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from the Air Line Pilots Association,
International (ALPA) who supported the NPRM without change.

Conclusion

    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 this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comment received, and determined that air safety requires adopting this
AD as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on this product. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM. None of the changes will
increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0206 specifies procedures for replacement of the
affected NAS with NAS standard 2.2 or 3.1, or later-approved NAS
standard. EASA AD 2022-0206 also prohibits the installation of the
affected NAS on any airplane. 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 ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 20 airplanes of U.S.
registry. The

FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................            * $0              $85           $1,700
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost estimates for the parts specified in this
  AD.

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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:

2023-06-01 ATR--GIE Avions de Transport R[eacute]gional: Amendment
39-22387; Docket No. FAA-2023-0012; Project Identifier MCAI-2022-
01317-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 18, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to ATR--GIE Avions de Transport R[eacute]gional
Model ATR42-500 and ATR72-212A airplanes, certificated in any
category, as identified in European Union Aviation Safety Agency
(EASA) AD 2022-0206, dated October 7, 2022 (EASA AD 2022-0206).

(d) Subject

    Air Transport Association (ATA) of America Code 31, Instruments.

(e) Unsafe Condition

    This AD was prompted by in-service experience that has shown
that the lateral flight guidance of the flight director/auto pilot
may not limit HI BANK turns in severe icing conditions. The FAA is
issuing this AD to address the lateral flight guidance not limiting
HI BANK turns in severe icing conditions. The unsafe condition, if
not addressed, could result in loss of control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, EASA AD 2022-0206.

(h) Exceptions to EASA AD 2022-0206

    (1) Where EASA AD 2022-0206 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0206.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0206
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation 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 International
Validation Branch, send it to the attention of the person identified
in paragraph (k) of this AD. Information may be emailed to: [email protected]. 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, International
Validation Branch, FAA; or EASA; or ATR--GIE Avions de Transport
R[eacute]gional's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(k) Additional Information

    For more information about this AD, contact Shahram Daneshmandi,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0206,
dated October 7, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0206, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) 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<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 14, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07745 Filed 4-12-23; 8:45 am]
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