EPA Registration Division contact: Sidney Jackson,<PHONE_NUMBER>

Interregional Research Project (IR-4)

PP No. 8E7314 (Revised NOF to address Potato 9/08)
[EPA-HQ-OPP-2008-0272]

	EPA has received a pesticide petition (PP# 8E7314) from IR-4 Project
Headquarters, 500 College Road East, Suite 201 W. Princeton, NJ 08540,
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.493,
by establishing a tolerance for residues of dimethomorph,
[(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]-mo
rpholine] in or on beans, lima at 0.6 parts per million (ppm); ginseng
at 0.85 ppm; grape at 3.5 ppm; grape raisin at 6.0 ppm; and greens,
turnip 20 ppm. Additionally, it is proposed that the existing tolerance
level for potato, wet peel be increased from 0.15 to 0.20 ppm and that a
tolerance for potato at 0.05 ppm be re-established.  EPA has determined
that the petition contains data or information regarding the elements
set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the petition.  Additional data may be
needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Based upon the results of metabolism studies
conducted on potato, grape, and lettuce, the nature of the residues in
lima beans, ginseng, grape, raisin, and turnip greens is considered to
be understood.  The results of the potato metabolism study show only
negligible residues in tubers, 0.01-0.02 parts per million (ppm) total
radioactive residues (TRR).  This is in contrast to the aerial portions
of the plant, which were found to have up to 23.5 ppm TRR, thus
demonstrating that translocation of dimethomorph downward within the
plant was not significant.  Almost all of the radioactive residue
(97.8%) was extractable from the plant at harvest.  In the aerial
portion of the plant, approximately 70% of the TRR was identified as
dimethomorph.  No metabolites were identified that require regulation.

The results of the grape metabolism study showed that the TRR in/on
grapes harvested 35 days following the last of four applications [0.8 lb
active ingredient per acre (ai/A) per application for four consecutive
weeks] for a total rate of 3.2 lb ai/A was 14.6 ppm.  Unmetabolized
dimethomorph accounted for 87.3% of the TRR (12.7 ppm).  No metabolites
were identified that require regulation.

	The results of the lettuce metabolism study showed that the TRR in/on
lettuce leaves harvested 4 days following the last of 4 applications
[approximately 1.0 lb ai/A per application with a 9 to 11 day spray
interval], for a total rate of 4.1 lb ai/A, was 102 ppm.  Of this total
residue, 98.5% was extractable and unmetabolized dimethomorph accounted
for greater than 93% of the extractable TRR.  No metabolites were
identified that require regulation.

	2. Analytical method. A reliable method for the determination of
dimethomorph residues in lima beans, ginseng, grape, raisin and turnip
greens exists; this method is the FDA Multi-Residue Method, Protocol D,
as published in the Pesticide Analytical Manual I.

	3. Magnitude of residues. The residue data for Ginseng submitted to
support this tolerance petition were collected from 4 ginseng studies
conducted in region 5 of the United States.  Trials were conducted using
multiple applications (7) of dimethomorph applied at 0.198 to 0.24 lb
ai/A with a maximum seasonal rate of 1.4 to 1.7 lb ai/A (1.4 to 1.7X the
proposed label rate).  Dimethomorph residues observed in these field
trials for ginseng ranged from 0.28 ppm to 0.62 ppm when harvested 13 to
15 days after the last application.  Therefore, a tolerance of 0.85 ppm
in or on Ginseng is proposed.

The residue data for Lima Bean submitted to support this tolerance
petition were collected from 7 lima bean studies conducted in regions 2
and 5 of the United States.  Trials were conducted using multiple
applications (7 to 8) of dimethomorph applied at 0.2 lb ai/A with a
maximum seasonal rate of 1.4 to 1.6 lb ai/A (1.4 to 1.6X the proposed
label rate).  Dimethomorph residues observed in these field trials for
lima bean ranged from 0.03 ppm to 0.48 ppm when harvested 0 days after
the last application.  Therefore, a tolerance of 0.6 ppm in or on Lima
Bean is proposed.

The residue data for Grape submitted to support this tolerance petition
were previously submitted to establish the current import tolerance for
grape and grape, raisin.  The residue data for grape were collected from
27 grape studies conducted in Europe.  Trials were conducted using
multiple applications (4 to 11) of dimethomorph applied at 0.11 to 0.36
lb ai/A with a maximum seasonal rate of 0.55 to 3.57 lb ai/A (0.55 to
3.57X the proposed label rate).  Dimethomorph residues observed in these
field trials for grape ranged from 0.05 ppm to 2.6 ppm when harvested 0
to 90 days after the last application. Therefore, tolerances of 3.5 ppm
in or on Grape and 6 ppm for Grape, Raisin are proposed.

The residue data for Turnip Greens submitted to support this tolerance
petition were previously submitted to establish the current tolerance
for brassica leafy greens at 20 ppm.  The residue data for leafy
brassica greens were collected from eight (8) mustard green studies
conducted in mustard green producing regions of the United States.
Trials were conducted using multiple applications (7) of dimethomorph
applied at 0.2 lb ai/A with a maximum seasonal rate of 1.4 lb ai/A.
This exceeds the proposed label rate for dimethomorph on turnip greens
(1.0 lb ai/A).  Dimethomorph residues observed in these field trials
ranged from 0.65 to 18.1 ppm after last application on day of harvest.
Therefore, a tolerance of 20.0 ppm in or on Turnip Greens is proposed.

In the Federal Register of March 26, 1997 (62 FR 14418)(FRL-5594-7), EPA
issued a notice pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) announcing the filing of a
pesticide petition (PP 7F4816) for tolerance by American Cyanamid
Company, Agricultural Products Division, P.O. Box 400, Princeton, NJ
08543-0400. The EPA subsequently established tolerances for residues of
potato at 0.05 ppm in a Federal Register of October 13, 1998 (63 FR
54597)(FRL-6036-7).  Since that time the potato tolerance has been
inadvertently removed from 40 CFR part 180.493.  Therefore, a tolerance
for potato at 0.05 ppm is proposed.

B. Toxicological Profile

	1. Acute toxicity.  i. Oral LD50 studies were conducted on dimethomorph
technical:

a. An acute oral toxicity study in the Sprague-Dawley rat for
dimethomorph technical with a LD50 of 4,300 milligrams/kilogram body
weight (mg/kg b.w.) for males and 3,500 mg/kg b.w. for females.  Based
upon EPA toxicity criteria, the acute oral toxicity category for
dimethomorph technical is Category III or slightly toxic.

b. An acute toxicity study in the CD-1 mouse for dimethomorph technical
with a LD50 of greater than 5000 mg/kg b.w. for males and 3699
mg/kg/b.w. for females. Based on the EPA toxicity category criteria, the
acute oral toxicity category for dimethomorph technical is Category III
or slightly toxic.

ii. Oral LD50 studies were conducted on the two isomers (E and Z) alone:

An acute oral toxicity study in the Wistar rat for the E-isomer with a
LD50 greater than 5,000 mg/kg b.w. for males and approximately 5,000
mg/kg b.w. for females.

   	b. An acute oral toxicity study in the Wistar rat for the Z-isomer
with a LD50 greater than 5,000 mg/kg b.w. for both males and females.

An acute dermal toxicity study in the Wistar rat for dimethomorph
technical with a dermal LD50 greater than 5,000 mg/kg b.w. for both
males and females.  Based on the EPA toxicity category criteria, the
acute dermal toxicity category for dimethomorph is Category IV or
relatively non-toxic.

iv. A 4-hour inhalation study in Wistar rats for dimethomorph technical
with a LC50 greater than 4.2 mg/L for both males and females.  Based on
the EPA toxicity category criteria, the acute inhalation toxicity
category for dimethomorph technical is Category IV or relatively
non-toxic.

v. A skin irritation study was performed using New Zealand White
rabbits. Based on the EPA toxicity criteria, the skin irritation
toxicity category for dimethomorph technical in this study is Category
IV or non-to-slightly irritating.

vi. An eye irritation study using New Zealand White rabbits demonstrated
dimethomorph technical produced moderate conjunctival redness, slight to
moderate chemosis and slight discharge three hours after treatment.
Based on the EPA toxicity criteria, the eye toxicity category for
dimethomorph technical is Category III (slightly-to-moderately
irritating)

	2. Genotoxicty.   i. Salmonella reverse gene mutation assays (2
studies) were negative up to a limit dose of 5,000 (g/plate. Chinese
hamster lung V79 cells were negative for mutations at the HGPRT locus at
up to toxic doses in two studies.

Two Chinese hamster lung (V79 cells) structural chromosomal studies were
reportedly positive for chromosomal aberrations at the highest dose
tested (HDT) (160 (g/ml/-S9; 170 (g/ml/+S9).  However, dimethomorph
induced only a weak response in increasing chromosome aberrations in
this test system.  In addition, these results were not confirmed in two
micronucleus tests under in vivo conditions.

Structural Chromosomal Aberration studies were weakly positive in human
lymphocytic cultures, but only in S9 activated cultures treated at 422
(g/ml, the highest dose tested (HDT), which was strongly cytotoxic.  No
increase in chromosomal aberrations was observed in the absence of S9
activation at all doses.  Furthermore, the positive clastogenic response
observed under the in vitro conditions was not confirmed in two in vivo
micronucleus assays.

Micronucleus assay (2 studies) indicated that dimethomorph was negative
for inducing micronuclei in bone marrow cells of mice following i.p.
administration of doses up to 200 mg/kg or oral doses up to the limit
dose of 5,000 mg/kg.  Thus, dimethomorph was found to be negative in
these studies for causing cytogenic damage in vivo.

Dimethomorph was negative for inducing unscheduled DNA synthesis, in
cultured rat liver cells, at doses up to 250 (g/ml, a weakly cytotoxic
level.

Dimethomorph was negative for transformation in Syrian hamster embryo
cells treated, in the presence and absence of activation, up to
cytotoxic concentrations (265 (g/ml/+S9; 50 (g/ml/-S9).

	3. Reproductive and developmental toxicity.  i. A rat developmental
toxicity study with a Lowest-Observed-Effect Level (LOEL) for maternal
toxicity of 160 mg/kg/day and a No-Observed-Effect Level (NOEL) for
maternal toxicity of 60 mg/kg/day.  The NOEL for developmental toxicity
is 60 mg/kg/day.  Dimethomorph is not teratogenic in the Sprague-Dawley
rat.

ii. A rabbit development toxicity study with a LOEL for maternal
toxicity of 650 mg/kg/day and a NOEL for maternal toxicity of 300
mg/kg/day.  The NOEL for developmental toxicity is 650 mg/kg/day, the
highest dose tested.  Dimethomorph is not teratogenic in the New Zealand
white rabbit.

iii. A two-generation rat reproduction study with a LOEL for parental
systemic toxicity of 1000 ppm, or approximately 80 mg/kg/day, and a NOEL
for parental systemic toxicity of 300 ppm, or approximately 24
mg/kg/day.  The NOEL for fertility and reproductive function was 1000
ppm, the highest concentration tested, or approximately 80 mg/kg
b.w./day.

	4. Subchronic toxicity.  i. A 90-day dietary study in Sprague-Dawley
rats with a NOEL of greater than or equal to 1000 ppm, the highest
concentration tested, or approximately 73 mg/kg/day for males and 82
mg/kg/day for females.

ii.  A 90-day dog dietary study with a NOEL of 450 ppm, or approximately
15 mg/kg/day, and a LOEL of 1350 ppm, or approximately 43 mg/kg/day.

	5. Chronic toxicity. i. A 2-year chronic toxicity study in
Sprague-Dawley rats with a NOEL of 200 ppm or approximately 9 mg/kg/day
for males and 12 mg/kg/day for females.  The LOEL for systemic toxicity
is 750 ppm, or approximately 36 mg/kg/day for males and 58 mg/kg/day for
females.

ii. A 1-year chronic toxicity study in dogs with a NOEL of 450 ppm, or
approximately 14.7 mg/kg/day and a LOEL of 1350, or approximately 44.6
mg/kg/day.

iii. A 2-year oncogenicity study in Sprague-Dawley rats with a NOEL for
systemic toxicity of 200 ppm, or approximately 9 mg/kg/day for males and
11 mg/kg/day for females.  The LOEL for systemic toxicity was 750 ppm,
or approximately 34 mg/kg/day for males and 46 mg/kg/day for females.
There was no evidence of increased incidence of neoplastic lesions in
treated animals.  The NOEL for oncogenicity is 2000 ppm, the highest
concentration tested, or approximately 95 mg/kg/day for males and 132
mg/kg/day for females.

	iv. A 2-year oncogenicity study in CD-1 mice with a NOEL for systemic
toxicity of 100 mg/kg/day and a LOEL of 1,000 mg/kg/day.  There was no
evidence of increased incidence of neoplastic lesions in treated
animals.  The NOEL for oncogenicity is 1,000 mg/kg/day, the highest dose
tested.

	6. Animal metabolism. Results from the livestock and rat metabolism
studies show that orally administered dimethomorph was rapidly excreted
by the animals.  The principal route of elimination is the feces.

	7. Metabolite toxicology. There were no metabolites identified in plant
or animal commodities which require regulation.

	8. Endocrine disruption.  Collective organ weights and
histopathological findings from the two-generation reproduction study in
rats, as well as from the subchronic and chronic toxicity studies in two
or more animal species, demonstrate no apparent estrogenic effects or
effects on the endocrine system.  There is no information available that
suggests that dimethomorph technical would be associated with endocrine
effects.

C. Aggregate Exposure

	1. Dietary exposure. An assessment was conducted to evaluate the
potential risk due to chronic dietary exposure of the U.S. population
and sub-populations to residues of dimethomorph.  This analysis included
all current tolerances listed in U.S. 40 CFR § 180.493 including potato
peel and potato and the proposed tolerances for lima beans, ginseng,
grape, grape raisin, and turnip greens.

	i. Food.  Acute Dietary Exposure Assessment

An acute assessment was not needed since the U.S. EPA Toxicological
Endpoint Selection (TES) Committees had previously evaluated the
dimethomorph toxicity data, including developmental and maternal
toxicity in the developmental toxicity studies and determined there was
no toxicological endpoints for acute dietary exposure and a quantitative
acute dietary exposure and risk assessment were not required.

Chronic Dietary Exposure Assessment

A Tier 1 chronic dietary exposure assessment was conducted assuming
tolerance level residues and 100% crop treated factors for all
registered and proposed crops.  The EPA Food Commodity Ingredient
Database (FCID) was also used in Exponent's Dietary Exposure Evaluation
Module (DEEM-FCID) software.  Inadvertent residues in animal commodities
(i.e. meat, meat byproducts, milk, eggs) were not considered as a result
of grain forage since studies have shown dimethomorph does not
accumulate in animal tissues or milk and tolerance values for these
commodities are not required by the EPA.

Dietary exposure estimates were compared against the established
dimethomorph chronic Population Adjusted Dose (cPAD) of 0.11 mg/kg
b.w./day for all populations.  Results of the chronic dietary
assessments are listed in the table below.  The estimated chronic
dietary exposure from crops (both established and proposed tolerances)
was less than 16% of the cPAD for all subpopulations (Table 1).
Additional refinements such as the use of anticipated residues would
further reduce the estimated chronic dietary exposure.  The results in
the Table below demonstrate that there are no safety concerns for any
subpopulation based on established and new uses, and that the results
clearly meet the FQPA standard of reasonable certainty of no harm.

Table 1.  Summary of Chronic Dietary Exposure Assessment considering
crops with established and proposed tolerances for Dimethomorph.

Population sub-group	Chronic Exposure (mg/kg bw/day)	%cPAD

US Population	0.0075910	6.90

All infants (< 1 year)	0.0042140	3.83

Children 1-2	0.0168600	15.33

Children 3-5	0.0132540	12.05

Children 6-12	0.0078260	7.11

Youth 13-19	0.0058480	5.32

Adults 20-49	0.0071590	6.51

Adults 50+ yrs	0.0069390	6.31

Females 13 - 49 yrs	0.0067210	6.11

	ii. Drinking water. The chronic drinking water values used in this
analysis were the values proposed by EPA Federal Register Notice,
September 29, 2003, Volume 68, No. 188.  The chronic drinking water
value used was 28.3 ug/L.

Table 1.  Summary of Chronic Drinking Water Exposure Assessment
Considering the Maximum Estimated Chronic Drinking Water Concentration
for Dimethomorph.

Population sub-group	Chronic Exposure (mg/kg bw/day)	%cPAD

US Population	0.000506	0.46

All infants (< 1 year)	0.001658	1.51

Children 1-2	0.000751	0.68

Children 3-5	0.000703	0.64

Children 6-12	0.000485	0.44

Youth 13-19	0.000366	0.33

Adults 20-49	0.000472	0.43

Adults 50+ yrs	0.000497	0.45

Females 13 - 49 yrs	0.00047	0.43

Acute Aggregate Exposure and Risk (Food and water)

Since the U.S. EPA Toxicological Endpoint Selection (TES) Committees has
evaluated the dimethomorph toxicity data and determined there was no
toxicologic endpoints for acute dietary exposure, the determination of
an acute aggregate exposure and risk evaluation was not required.

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of dimethomorph from food
and water (Table 3). Exposures from residential uses are not included in
the chronic aggregate assessment.  The results demonstrate there are no
safety concerns for any subpopulation based on established and new uses,
and that the results clearly meet the FQPA standard of reasonable
certainty of no harm.

Table 3.  Estimated Chronic Aggregate Exposure and Risk for
Dimethomorph.

Population Subgroup	cPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.11	0.007591	0.000506	0.008097	7.36

All Infants (< 1 yr old)	0.11	0.004214	0.001658	0.005872	5.34

Children 1-2 years	0.11	0.01686	0.000751	0.017611	16.01

Children 3-5 years	0.11	0.013254	0.000703	0.013957	12.69

Children 6 – 12 years	0.11	0.007826	0.000485	0.008311	7.56

Youth 13-19 years	0.11	0.005848	0.000366	0.006214	5.65

Females 13-49 years	0.11	0.007159	0.000472	0.007631	6.94

Adults 20-49 years	0.11	0.006939	0.000497	0.007436	6.76

Adults + 50	0.11	0.006721	0.00047	0.007191	6.54

]

	2. Non-dietary exposure. Dimethomorph is not registered for use on any
sites that would result in residential exposure.  Therefore, a
residential exposure and risk assessment was not conducted.

D. Cumulative Effects

	There is no information to indicate that any toxic effects produced by
dimethomorph would be cumulative with those of any other chemical.  The
fungicidal mode of action of dimethomorph is unique; dimethomorph
inhibits cell wall formation only in Oomycete fungi.  The result is
lysis of the cell wall that kills growing cells and inhibits spore
formation in mature hyphae.  This unique mode of action and limited pest
spectrum suggest that there is little or no potential for cumulative
toxic effects in mammals.  In addition, the toxicity studies submitted
to support this petition do not indicate that dimethomorph is a
particularly toxic compound.  No toxic end-points of potential concern
were identified.

E. Safety Determination

	1. U.S. population. Based on this risk assessment, BASF concludes that
there is a reasonable certainty that no harm will result to the general
population from the aggregate exposure to dimethomorph residues.

	2. Infants and children. Based on this risk assessment, BASF concludes
that there is a reasonable certainty that no harm will result to infants
or children from the aggregate exposure to dimethomorph residues.

F. International Tolerances

	There are no Canadian, Mexican, or Codex MRLs established for
dimethomorph for the commodities associated with this request;
consequently, a discussion of international harmonization is not
relevant.


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Pages 85846-85847]
[FR Doc No: 2020-28745]

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

Federal Aviation Administration

[Docket No. FAA-2020-1199; Airspace Docket No. 20-AEA-21]

Notice of Availability of Written Re-Evaluation and Record of
Decision; New York/New Jersey/Philadelphia Metropolitan Area Airspace
Redesign

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces the
availability of a Written Re-evaluation and Record of Decision (WR/ROD)
for the New York/New Jersey/Philadelphia (NY/NJ/PHL) Metropolitan Area
Airspace Redesign project. This 2020 WR/ROD follows the issuance of a
Final Environmental Impact Statement (EIS) for the project, issued in
July 2007, and a subsequent ROD (September 2007) that approved the
Integrated Airspace Alternative with Integrated Control Complex for
implementation. The September 2007 ROD was followed by a corrected ROD
(October 2007), as well as a WR/ROD (July 2008) that re-affirmed the
original decision in light of new schedule limits at John F. Kennedy
International Airport (JFK) and Newark Liberty International Airport
(EWR).

DATES: The FAA's WR/ROD for the NY/NJ/PHL Metropolitan Airspace
Redesign is effective December 22, 2020.

FOR FURTHER INFORMATION CONTACT: For additional information, contact
Matthew Cathcart, Acting Manager, Operations Support Group, in writing
to Federal Aviation Administration, Eastern Service Center, Operations
Support Group, AJV-E2, FAA Southern Regional Office, P.O. Box 20636,
Atlanta, GA 30320; by telephone, at<PHONE_NUMBER>; or, by electronic
mail, at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The purpose of the NY/NJ/PHL Metropolitan
Area Airspace Redesign project was to increase the efficiency and
reliability of the airspace structure and the Air Traffic Control (ATC)
system, thereby accommodating growth while enhancing safety and
reducing delays in air travel for the NY/NJ/PHL Metropolitan Area. The
Airspace Redesign project was intended to modernize the structure of
the NY/NJ/PHL air traffic environment while laying a foundation for
achieving the Next Generation Air Transportation System (NextGen) in an
environmentally responsible manner.
    While four stages of implementation were originally planned, FAA
paused the project in 2012 in light of air transportation system
changes in the intervening years. While several beneficial elements of
the project were implemented, the National Airspace System evolved
significantly between the 2007 EIS and 2012. New NextGen capabilities,
such as Time Based Metering and advanced satellite based navigation
procedures, and increasing consolidation of the airline industry,
changes in system use, and evolving traffic projections resulted in new
and different airspace and procedures requirements. As a result, the
FAA suspended the Airspace Redesign project in May 2013. The FAA has
determined it is appropriate to end implementation and has prepared the
aforementioned December 2020 WR/ROD. The WR/ROD may be accessed on the
FAA's public website: https://

www.faa.gov/air_traffic/nas/nynjphl_redesign/documentation/.
    This Notice of Availability of the December 2020 WR/ROD also serves
as the response to Section 560 of the FAA Reauthorization Act of 2018,
which imposed the following requirement:
    Not later than 90 days after the date of enactment of this Act, the
Administrator shall develop and publish in the Federal Register a work
plan for the New York/New Jersey/Philadelphia Metropolitan Area
Airspace Project.
    As discussed above, work on the NY/NJ/PHL Metropolitan Area
Airspace Redesign project was suspended in May 2013, and the FAA has
determined it is appropriate to end implementation. There is no work
plan for the project beyond the preparation of the December 2020 WR/ROD
and this Notice.

    Issued in Atlanta, Georgia, on December 22, 2020.
Ryan W. Almasy,
Director (Acting), Eastern Service Center, Mission Support Services,
Air Traffic Organization, Federal Aviation Administration.
[FR Doc. 2020-28745 Filed 12-28-20; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Proposed Rules]
[Pages 49783-49784]
[FR Doc No: 2022-17129]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0922; Airspace Docket No. 22-ASO-15]
RIN 2022-AA66

Proposed Establishment of Class D Airspace, and Proposed
Amendment of Class E Airspace; Selma, AL.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class D airspace for Craig
Field, Selma, AL, as a new air traffic control tower will service the
airport. This action would also amend Class E airspace extending upward
from 700 feet above the surface by updating the radius and geographic
coordinates of the airport. Controlled airspace is necessary for the
safety and management of instrument flight rules (IFR) operations in
the area.

DATES: Comments must be received on or before September 26, 2022.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify Docket
No. FAA-2022-0922; Airspace Docket No. 22-ASO-15 at the beginning of
your comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed on-line at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would establish and amend airspace in Selma, AL, to support IFR
operations in the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2022-0922 and Airspace Docket No. 22-ASO-15) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2022-0922; Airspace Docket No. 22-ASO-015''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA proposes an amendment to Title 14 CFR part 71 to establish
Class D airspace in Selma, AL, as a new air traffic control tower will
service Craig Field Airport. Also, Class E airspace extending upward
from 700 feet above the surface would be amended for Craig Field
Airport, as an airspace evaluation determined the radius required an
increase to 10.2 miles (formerly 7

miles), as well as updating the airport's geographic coordinates to
coincide with the FAA's database. In addition, the city name would be
removed from the second line of the Class E descriptor header, as per
FAA Order 7400.2N.
    Class D and Class E airspace designations are published in
Paragraphs 5000, and 6005, respectively, of FAA Order JO 7400.11F,
dated August 10, 2021, and effective September 15, 2021, which is
incorporated by reference in 14 CFR 71.1. The Class D and E airspace
designations listed in this document will be published subsequently in
FAA Order JO 7400.11F.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order JO 7400.11F, Airspace Designations and Reporting
Points, dated August 10, 2021, and effective September 15, 2021, is
amended as follows:

Paragraph 5000 Class D Airspace

* * * * *

ASO AL D Selma, AL [Established]

Craig Field Airport, AL
    (Lat. 32[deg]20'38'' N, long. 86[deg]59'16'' W)

    That airspace extending upward from the surface up to and
including 3,000 feet MSL, within a 4.3-mile radius of Craig Field
Airport, and within 1.2 miles each side of the 146[deg] bearing,
extending from the 4.3-mile radius to 6.3 miles southeast of the
airport; and within 1-mile each side of the 326[deg] bearing,
extending from the 4.3-mile radius to 6.3 miles northwest of the
airport. This Class D airspace area is effective during the specific
days and times established in advance by a Notice to Air Missions.
The effective days and times will thereafter be continuously
published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth

* * * * *

ASO AL E5 Selma, AL [Amended]

Craig Field Airport, AL
    (Lat. 32[deg]20'38'' N, long. 86[deg]59'16'' W)

    That airspace extending upward from 700 feet above the surface
within a 10.2-mile radius of Craig Field Airport.

    Issued in College Park, Georgia, on August 4, 2022.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2022-17129 Filed 8-11-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Rules and Regulations]
[Pages 79253-79255]
[FR Doc No: 2022-28131]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3130]

Medical Devices; Cardiovascular Devices; Classification of the
Adjunctive Hemodynamic Indicator With Decision Point

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the adjunctive hemodynamic indicator with decision point
into class II (special controls). The special controls that apply to
the device type are identified in this order and will be part of the
codified language for the adjunctive hemodynamic indicator with
decision point's classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective December 27, 2022. The classification
was applicable on March 1, 2021.

FOR FURTHER INFORMATION CONTACT: Shawn Forrest, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the adjunctive hemodynamic
indicator with decision point as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On April 3, 2020, FDA received Fifth Eye Inc.'s request for De Novo
classification of the Analytic for Hemodynamic Instability. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on March 1, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding

21 CFR 870.2220.\1\ We have named the generic type of device adjunctive
hemodynamic indicator with decision point, and it is identified as a
device that identifies and monitors hemodynamic condition(s) of
interest and provides notifications at a clinically meaningful decision
point. This device is intended to be used adjunctively along with other
monitoring and patient information.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Adjunctive Hemodynamic Indicator With Decision Point Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Delayed or incorrect treatment due to    Software verification,
 erroneous output as a result of          validation, and hazard
 software malfunction or algorithm        analysis; Non-clinical
 error.                                   performance testing; Clinical
                                          data; and Labeling.
Delayed or incorrect treatment due to    Usability assessment, and
 user misinterpretation.                  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
Classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.2220 to subpart C to read as follows:

Sec.  870.2220  Adjunctive hemodynamic indicator with decision point.

    (a) Identification. An adjunctive hemodynamic indicator with
decision point is a device that identifies and monitors hemodynamic
condition(s) of interest and provides notifications at a clinically
meaningful decision point. This device is intended to be used
adjunctively along with other monitoring and patient information.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Software description, verification, and validation based on
comprehensive hazard analysis and risk assessment must be provided,
including:
    (i) Full characterization of technical parameters of the software,
including algorithm(s);
    (ii) Description of the expected impact of all applicable sensor
acquisition hardware characteristics on performance and any associated
hardware specifications;
    (iii) Specification of acceptable incoming sensor data quality
control measures;
    (iv) Mitigation of impact of user error or failure of any subsystem
components (signal detection and analysis, data display, and storage)
on output accuracy; and
    (v) The sensitivity, specificity, positive predictive value, and
negative predictive value in both percentage and number form for
clinically meaningful pre-specified time windows consistent with the
device output.
    (2) Scientific justification for the validity of the hemodynamic
indicator algorithm(s) must be provided. Verification of algorithm
calculations and validation testing of the algorithm must use an
independent data set.
    (3) Usability assessment must be provided to demonstrate that risk
of misinterpretation of the status indicator is appropriately
mitigated.
    (4) Clinical data must support the intended use and include the
following:
    (i) The assessment must include a summary of the clinical data
used, including source, patient demographics, and any techniques used
for annotating and separating the data;
    (ii) Output measure(s) must be compared to an acceptable reference
method to demonstrate that the output represents the measure(s) that
the device provides in an accurate and reproducible manner;
    (iii) The data set must be representative of the intended use
population for the device. Any selection criteria or limitations of the
samples must be fully described and justified;
    (iv) Where continuous measurement variables are displayed,
agreement of the output with the reference measure(s)

must be assessed across the full measurement range; and
    (v) Data must be provided within the clinical validation study or
using equivalent datasets to demonstrate the consistency of the output
and be representative of the range of data sources and data quality
likely to be encountered in the intended use population and relevant
use conditions in the intended use environment.
    (5) Labeling must include the following:
    (i) The type of sensor data used, including specification of
compatible sensors for data acquisition, and a clear description of
what the device measures and outputs to the user;
    (ii) Warnings identifying factors that may impact output results;
    (iii) Guidance for interpretation of the outputs, including
warning(s) specifying adjunctive use of the measurements;
    (iv) Key assumptions made in the calculation and determination of
measurements; and
    (v) A summary of the clinical validation data, including details of
the patient population studied (e.g., age, gender, race/ethnicity),
clinical study protocols, and device performance with confidence
intervals for all intended use populations.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28131 Filed 12-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Proposed Rules]
[Pages 8742-8743]
[FR Doc No: 2021-02619]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0528; FRL-10018-15-Region 3]

Air Plan Approval; Maryland; Negative Declaration for the Oil and
Gas Industry

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of Maryland. This revision provides Maryland's determination, via
a negative declaration, that there are no sources within its borders
subject to EPA's 2016 Oil and Natural Gas Control Techniques Guidelines
(2016 Oil and Gas CTG). This action is being taken under the Clean Air
Act (CAA).

DATES: Written comments must be received on or before March 11, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2020-0528 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: David Talley, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2117. Mr. Talley can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 18, 2020, the Maryland Department of
the Environment (MDE) submitted the negative declaration for the 2016
Oil and Gas CTG as a revision to the Maryland SIP.

I. Background

    The CAA regulates emissions of nitrogen oxides (NOX) and
volatile organic compounds (VOCs) to prevent photochemical reactions
that result in ozone formation. Reasonably available control technology
(RACT) is a strategy for reducing NOX and VOC emissions from
stationary sources within areas not meeting the National Ambient Air
Quality Standards (NAAQS) for ozone. EPA has consistently defined
``RACT'' as the lowest emission limit that a particular source is
capable of meeting by the application of the control technology that is
reasonably available considering technological and economic
feasibility.
    Control Technique Guidelines (CTGs) and Alternative Control
Techniques (ACTs) form important components of the guidance that EPA
provides to states for making RACT determinations. CTGs are used to
presumptively define VOC RACT for applicable source categories. CAA
section 182(b)(2)(A) requires that for ozone nonattainment areas
classified as moderate or above, states must revise their SIPs to
include provisions to implement RACT for each category of VOC sources
covered by a CTG document. CAA section 184(b)(1)(B) extends the RACT
obligation to all areas of states within the Ozone Transport Region
(OTR), including Maryland.\1\
---------------------------------------------------------------------------

    \1\ CAA section 184(a) establishes a single OTR comprised of 11
eastern states (including Maryland) and the Consolidated
Metropolitan Statistical Area (CMSA) that includes the District of
Columbia.
---------------------------------------------------------------------------

    States subject to RACT requirements are required to enact controls
for sources subject to CTGs that are at least as stringent as those
found within the CTG either via the adoption of regulations, or by
issuance of single source permits that outline what the source is
required to do to meet RACT.\2\ On March 6, 2016 (80 FR 12264), EPA
issued a final rule entitled ``Implementation of the 2008 National
Ambient Air Quality Standards for Ozone: State Implementation Plan
Requirements'' (2008 Ozone Implementation Rule). In the preamble to the
final rule, EPA makes clear that if there are no sources covered by a
specific CTG source category located in an ozone nonattainment area or
an area in the OTR, the state may submit a negative declaration for
that CTG. See 80 FR 12264, 12278.
---------------------------------------------------------------------------

    \2\ EPA took final action to approve Maryland's SIP revision
addressing VOC RACT requirements (including the other CTGs) for the
2008 8-hour ozone NAAQS on February 20, 2019. See 84 FR 5004.
---------------------------------------------------------------------------

    On October 27, 2016 (81 FR 74798), EPA published in the Federal
Register the ``Release of Final Control Techniques Guidelines for the
Oil and Natural Gas Industry,'' (2016 Oil and Gas CTG).\3\ This CTG
provided information to state, local, and tribal air agencies to assist
in determining RACT for VOC emissions from certain VOC emission source
within the oil and natural gas industry. The 2016 Oil and Gas CTG
replaces an earlier 1983 CTG entitled ``Control of Volatile Organic
Compound Equipment Leaks from Natural Gas/Gasoline Processing Plants.
December 1983.'' EPA-450/3-83-007 (1983 CTG) 49 FR 4432; February 6,
1984. See 2016 Oil and Gas CTG, p. 8-1.
---------------------------------------------------------------------------

    \3\ The CTG is available at https://www.epa.gov/sites/production/files/2016-10/documents/2016-ctg-oil-and-gas.pdf and is
also included in the docket for this action.
---------------------------------------------------------------------------

II. Summary of SIP Revision and EPA Analysis

    The 2016 Oil and Gas CTG divides the industry into four segments:
Production, processing, transmission and storage, and distribution. The
transmission and storage sector includes compressor stations, pipelines
and storage facilities. The distribution sector is the final step in
delivering natural gas to customers and includes gas mains and service
pipelines. See CTG p. 3-1; see also CTG pp. 3-1 through 3-3 for a brief
explanation of each segment. However, not all four segments of the
industry are subject to the requirements of the CTG. The CTG covers
select sources of VOC emissions in the onshore production and
processing segments of the oil and natural gas industry (i.e.,
pneumatic controllers, pneumatic pumps, compressors, equipment leaks,
fugitive emissions) and storage vessel VOC emissions in all segments
(except distribution) of the oil and natural gas industry. These
sources were selected for RACT recommendations because current
information indicates that they are significant sources of VOC
emissions.
    According to Maryland's June 18, 2020 submittal, MDE conducted a
review of potential sources subject to

the 2016 Oil and Gas CTG. This review consisted of a search of
Maryland's oil and gas well records, air permit records, EPA greenhouse
gas reporting records, and the Standard Industrial Classification (SIC)
system.\4\ MDE's search identified a total of 13 facilities in Maryland
operating in the production, processing, or transmission and storage
segments of the oil and natural gas industry. However, none of these
facilities met or exceeded the applicability criteria of the CTG.\5\
MDE identified five facilities in the natural gas transmission sector,
but determined that none of them had storage tanks with the potential
to emit (PTE) more than 6 tons per year (tpy) of VOCs, which is the
threshold for applicability of the CTG. Additionally, MDE identified
eight active individual production wells. None of these exceeded the 15
barrel equivalents per day per well threshold for CTG applicability.
Further, none of the production wells were determined to operate
pneumatic pumps or controllers, or compressors. Finally, with respect
to fugitive emissions, none of the wells exceed the applicability
threshold of a gas to oil ratio (GOR) of 300 or greater.
---------------------------------------------------------------------------

    \4\ See pp. 1-3 of Maryland's submittal, included in the docket
for this rulemaking action.
    \5\ See pp. 1-3 of Maryland's submittal, included in the docket
for this rulemaking action.
---------------------------------------------------------------------------

III. Proposed Action

    EPA's review of this material indicates that it meets all
applicable CAA requirements, including CAA sections 182(b)(2)(A) and
184(b)(1)(B), and that MDE has satisfactorily demonstrated that there
are no sources operating in Maryland subject to the 2016 Oil and Gas
CTG. EPA is proposing to approve Maryland's June 18, 2020 negative
declaration SIP submittal as a revision to the Maryland SIP. EPA is
soliciting public comments on Maryland's negative declaration,
including the adequacy of MDE's search and analysis of the CTG
applicability criteria. Comments concerning the adequacy of the 2016
Oil and Gas CTG itself are not germane to this action and will not be
considered. Relevant comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because this is not a ``significant regulatory
action'' under Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking, pertaining to Maryland's
negative declaration for the 2016 Oil and Gas CTG, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the State, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Volatile organic compounds.

    Dated: February 3, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2021-02619 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38905-38910]
[DOCID:fr05au09-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29173; Directorate Identifier 2006-NM-283-AD;
Amendment 39-15989; AD 2009-16-06]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 767 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Boeing Model 767 airplanes. This AD requires installing an automatic
shutoff system for the auxiliary fuel tank override/jettison fuel pumps
(also referred to as center tank fuel pumps in the airplane flight
manual (AFM)), revising the AFM to advise the flightcrew of certain
operating restrictions for airplanes equipped with an automatic
auxiliary fuel tank pump shutoff control, and, for certain airplanes,
installing a placard to alert the flightcrew of certain fuel usage
restrictions. This AD provides optional terminating actions for certain
requirements. This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent an overheat condition
outside the center tank fuel pump explosion-resistance area that is
open to the pump inlet, which could cause an ignition source for the
fuel vapors in the fuel tank and result in fuel tank explosions and
consequent loss of the airplane.

DATES: This AD is effective September 9, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of September 9,
2009.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
September 4, 2001 (66 FR 39417, July 31, 2001).

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, 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: Douglas Bryant, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6505; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
all Boeing Model 767 airplanes. That NPRM was published in the Federal
Register on September 11, 2007 (72 FR 51725). That NPRM proposed to
require installing an automatic shutoff system for the auxiliary fuel
tank override/jettison pumps (referred to as center tank fuel pumps in
the airplane flight manual (AFM)), revising the AFM to advise the
flightcrew of certain operating restrictions for airplanes equipped
with an automatic auxiliary fuel tank pump shutoff control, revising
the Airworthiness Limitations Section (AWL) of certain maintenance
documents to include new inspections of the automatic shutoff system
for the auxiliary fuel tank override/jettison pumps, and, for certain
airplanes, installing a placard to alert the flightcrew of certain fuel
usage restrictions.

Actions Since NPRM was Issued

    To avoid including redundant requirements in this AD, we have
removed the proposed requirement to revise the AWL section of certain
maintenance documents to include new inspections of the automatic
shutoff system for the auxiliary fuel tank override/jettison pumps.
This AWL revision is already required by AD 2008-11-01, amendment 39-
15523 (73 FR 29414, May 21, 2008), for certain Boeing Model 767-200, -
300, -300F, and -400ER series airplanes, with an original standard
airworthiness certificate or original export certificate issued before
April 22, 2006. Airplanes with a certificate issued on or after April
22, 2006, must already be compliant with the AWL revision because those
limitations were applicable as part of the airworthiness certification
of those airplanes. We have removed the AWL revision requirement from
this AD (which was in paragraph (i) of the NPRM) and re-identified
subsequent paragraphs.
    We have combined the AFM text proposed in paragraphs (h)(1) and
(h)(2) of the NPRM into one paragraph, paragraph (h), in this AD. Doing
this moved the proposed revisions for the Normal Procedures section of
the AFM and placed them with the other proposed revisions for the
Certificate Limitation section of the AFM. We determined that the
Certification Limitation section is the more appropriate section in the
AFM for all of the revisions because the revisions are intended to be
airplane limitations. In the De-fueling and Fuel Transfer section of
the AFM text, we revised the text to address all fuel pumps instead of
only the center tank fuel pumps. The same concern (potential ignition
source) for dry running during de-fueling exists for the main tank
pumps. The limitation revisions required in this AD are similar to the
limitations that have been placed on other Boeing airplane models in
similar AD actions.
    We have also revised the text in paragraph (m) of this AD (the
Alternative Methods of Compliance (AMOC) paragraph) to include more
contact information and further clarification on the AMOC process.
    Boeing issued Revision 2, dated February 12, 2009, to Service
Bulletin 767-28A0083. We have revised paragraph (f) of this AD to
reference Revision 2 of the service bulletin and have revised paragraph
(g) of this AD to provide credit for Boeing Service Bulletin 767-
28A0083, Revision 1, dated April 26, 2007. Revision 2 of this service
bulletin corrects the wiring configuration group for some airplanes,
and adds and corrects some figures and references.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the six commenters.

Request to Clarify Service Bulletin

    TDG Aerospace (TDG) states that after reviewing the requirements in
Section 25.981 of the Federal Aviation Regulations (14 CFR 25.981), it
questions whether the service bulletins (listed in the following table)
referenced in the NPRM are FAA approved.

             Table--Service Bulletins Referenced in the NPRM
------------------------------------------------------------------------
    Boeing Alert Service
         Bulletin--              Revision--             Dated--
------------------------------------------------------------------------
767-28A0083.................  1..............  April 26, 2007.
767-28A0083.................  Original.......  May 3, 2006.
767-28A0084.................  1..............  April 26, 2007.
767-28A0084.................  Original.......  May 3, 2006.
------------------------------------------------------------------------

    We have determined that the service information referenced in this
AD meets applicable requirements and is FAA-approved. No change to this
AD is necessary in this regard.

Request To Exclude Airplanes With Deactivated Center Fuel Tanks

    All Nippon Airways (ANA) and ABX Air request that we exclude
airplanes with deactivated center fuel tanks from the requirements of
the NPRM. ANA suggests that we revise the applicability of the NPRM to
exclude airplanes with deactivated center fuel tanks. ANA states that
the center wing tank pumps of airplanes with deactivated center fuel
tanks do not have power provided to the pumps and, therefore, do not
pose a risk of ignition. ABX Air suggests that we add a paragraph
stating that no action is required for airplanes with center fuel tanks
deactivated in accordance with Boeing Alert Service Bulletin 767-
28A0050, dated December 18, 1997; or Boeing Service Bulletin 767-
28A0050, Revision 1, dated December 22, 1999. ABX Air also states that
if pumps cannot operate, the identified unsafe condition is eliminated.
ABX Air also states that paragraph (j) of the NPRM proposes to require
placards and that requiring placards that refer to AD 2001-15-08,
amendment 39-12342 (66 FR 39417, July 31, 2001) is inappropriate for
airplanes with deactivated fuel tanks.
    We partially agree. We agree that deactivated center tank pumps do
not pose an ignition risk because there is no power provided to these
pumps. But to ensure that power cannot be applied to the pumps, we must
specifically require the method of deactivation. Boeing Alert Service
Bulletin 767-28A0050, dated December 18, 1997; or Boeing Service
Bulletin 767-28A0050, Revision 1, dated December 22, 1999; provide
adequate procedures for deactivating the center fuel tanks.
Deactivation of center tanks in accordance with these service bulletins
is approved as an optional terminating action for the requirements of
paragraphs (f), (h), and (i) of this AD, as indicated in new paragraph
(j) of this AD. For airplanes with tanks deactivated in a different
manner, operators must request approval of an AMOC, as specified in
paragraph (m) of this AD, and provide data to substantiate that the
deactivation methods will ensure the safety of the airplane. We have
also added new paragraph (k) to this AD to address airplanes on which
the center fuel tanks are reactivated.
    In regard to the commenter's statement that requiring placards is
inappropriate for airplanes with deactivated fuel tanks, we agree that
the fuel management placard specified in paragraph (i) of this AD is
not necessary for airplanes with deactivated center fuel tanks. We have
included this information in paragraphs (j) and (k) of this AD
accordingly.

Request To Allow Operating Limitations as Terminating Action

    UPS requests that we revise the NPRM to allow compliance with
certain operating limitations specified in AD 2001-15-08 (shutting off
the pumps below certain fuel weight limits) and AFM limitations
specified in the NPRM as terminating action for paragraphs (f) and (i)
of the NPRM (automatic shutoff system installation and fuel pump
operation limitations). According to UPS:

    The benefit of having the automatic shutoff system is achieved
only if the flight crew fails to follow procedure. In this instance,
the issue becomes a flight crew training issue which needs to be
addressed in a different and more appropriate medium.

    UPS also states that because AD 2001-15-08 limits operation of the
center fuel tank to more than 1,000 pounds of fuel at all times, the
fuel pump is submerged and there is no potential for an ignition
source.
    UPS asserts that, when the pumps remain submerged with 1,000 pounds
of fuel, there is no opportunity for ignition sources to develop from
the pump, and those conditions effectively provide a level of safety
higher than that provided by installing the pump automatic shutoff as
proposed in the NPRM.
    We disagree. AD 2001-15-08 requires, among other things, revising
the AFM to include procedures that will ensure that the center tank
fuel pumps are always operated with useable fuel levels (1,000 pounds
or more). However, that AD addressed a specific problem with the center
tank fuel pumps that could lead to an ignition source in the fuel tank.
Shutting off pumps with 1,000 pounds of fuel remaining is regarded only
as interim action for that specific unsafe condition, until the pump
power control system changes are incorporated. Even in the absence of
specific fuel pump ignition source issues, the fuel pump indication
features and crew procedures in the original design are now considered
to need corrective action to eliminate the reliance on flight crew
procedures to prevent extended dry pump operation. We are aware of
numerous accounts of pilots failing to turn pumps off at the current
requirement of 1,000 pounds. We have, therefore, determined that
installing the automatic shutoff system provides a higher level of
safety because it prevents extended dry running of the fuel pumps. We
have not changed this AD regarding this issue.

Request To Clarify Airplanes Affected by Certain Requirements

    Boeing requests that we revise certain paragraphs of the NPRM to
identify affected airplanes. According to Boeing, Model 767 airplanes
beginning with line number 941 (VR088) have the center tank fuel pump
automatic shutoff system installed in production and should be excluded
from the retrofit requirements.
    We agree, for the reason provided by Boeing. We have revised
paragraphs (f) and (h) of this AD to clarify the airplanes affected by
the requirements of those paragraphs.

Request To Include Means of Compliance for Universal Fault Interrupter
(UFI)

    TDG states that it is currently certifying its UFI for use on Model
767 airplanes. TDG claims that the UFI, already implemented on other
Boeing airplanes, will provide (1) a center tank override pump
automatic shutoff, (2) uncommanded run protection (from control relay
failed in the ``ON'' position), and (3) electrical fault protection
(line-to-ground, line-to-line, open phases, etc.). TDG, therefore,
requests that we include the UFI as a means of compliance, if the
supplemental type certificate (STC) for the Model 767 UFI is approved
before the final rule is issued.
    We disagree with the commenter's request. At this time, the TDG 767
STC has not yet been approved, so we cannot identify it as a method of
compliance for this AD. However, we recognize that a similar TDG STC
has been approved for Boeing Model 757 airplanes and that it was
identified as a method of compliance for a similar AD related to that
model. Once the 767 STC is issued, TDG may apply for approval of an
AMOC for the design, as provided by paragraph (m) of this AD.

Request To Match AFM and NPRM Language

    Japan Airlines (JAL) advises of a discrepancy between the wording
in the corresponding portions of Boeing's current AFM and the original
NPRM. Paragraph (h)(2) of the NPRM states that center tank fuel
``pumps'' must not be on, but the latest revision to the AFM states
that center tank fuel ``pump switches'' must not be on.
    We agree. The current AFM (correctly) contains the word
``switches.'' As the commenter points out, the wording should be
consistent in

both the AFM and this document. We have revised paragraph (h) of this
AD accordingly.

Request To Revise Description of Affected Pumps

    Boeing requests that we revise the Summary and Relevant Service
Information sections of the NPRM. Specifically, reference to the
``auxiliary fuel tank boost pump'' should be changed to the ``override/
jettison fuel pump'' as the appropriate fuel pump in the auxiliary
tank. Boeing adds that references to fuel ``boost pumps'' are typically
associated with fuel pumps located in the main tanks, so referring to
auxiliary fuel pumps as ``boost pumps'' could be confusing.
    We agree that the wording identified by the commenter could be
confusing. We have revised the Summary section and other relevant
sections in this AD as requested. The Relevant Service Information
section, however, is not repeated in this final rule. We have also
revised references to auxiliary tank pumps to ``center tank fuel
pumps'' throughout the rest of this AD for clarity and consistency with
the AFM text.

Request to Correct Paragraph Reference

    JAL points out that Note 2 of the NPRM refers to paragraph (g) of
the AD, but should refer to paragraph (h). We agree and have revised
Note 1 in this AD (which was Note 2 in the NPRM) accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 414 airplanes of U.S. registry.
The following table provides the estimated costs for U.S. operators to
comply with this AD. The fleet cost could be as high as $4,655,016.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Affected airplane                       Average hourly
                    Affected airplanes                           groups           Work hours         labor rate       Cost of parts    Cost per airplane
--------------------------------------------------------------------------------------------------------------------------------------------------------
767[dash]200, 767[dash]300, 767[dash]300F................               1-39                 29                $80            $ 8,924           $ 11,244
                                                                       40-79                 25                 80              8,495             10,495
                                                                       80-81                  3                 80                420                660
--------------------------------------------------------------------------------------------------------------------------------------------------------
767-400ER................................................                All                 23                 80              7,911              9,751
--------------------------------------------------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    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) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 AD:

2009-16-06 Boeing: Amendment 39-15989. Docket No. FAA-2007-29173;
Directorate Identifier 2006-NM-283-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective September 9,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 767-200, -300, -300F,
and -400ER series airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent an overheat condition
outside the center tank fuel pump explosion-resistance area that is
open to the pump inlet, which could cause an ignition source for the
fuel vapors in the fuel tank and result in fuel tank explosions and
consequent loss of the airplane.

Compliance

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

Installation

    (f) For Model 767 airplanes with line numbers 1 through 940
inclusive: Within 36 months after the effective date of this AD,
install an automatic shutoff system for the center tank fuel pump,
in accordance with Boeing Service Bulletin 767-28A0083, Revision 2,
dated February 12, 2009 (for Model 767-200, -300, and -300F
airplanes); or Boeing Service Bulletin 767-28A0084, Revision 1,
dated April 26, 2007 (for Model 767-400ER airplanes); as applicable.

Installation According to Previous Issue of Service Bulletin

    (g) Installing an automatic shutoff system is also acceptable
for compliance with the requirements of paragraph (f) of this AD if
done before the effective date of this AD in accordance with service
information identified in Table 1 of this AD.

              Table 1--Previous Issues of Service Bulletins
------------------------------------------------------------------------
 Boeing service information    Revision level             Date
------------------------------------------------------------------------
Alert Service Bulletin 767-   Original.......  May 3, 2006.
 28A0083.
Alert Service Bulletin 767-   Original.......  May 3, 2006.
 28A0084.
Service Bulletin 767-28A0083  1..............  April 26, 2007.
------------------------------------------------------------------------

Revision of Airplane Flight Manual (AFM)

    (h) For Model 767 airplanes with line numbers 1 through 940
inclusive: Concurrently with accomplishing the actions required by
paragraph (f) of this AD, revise Section 1, Certificate Limitations,
of the Boeing 767 AFM to include the following:
    ``CENTER TANK FUEL PUMPS
    Center tank fuel pump switches must not be ``ON'' unless
personnel are available in the flight deck to monitor low PRESS
lights.
    For ground operations prior to engine start: The center tank
fuel pump switches must not be positioned ON unless the center tank
contains usable fuel. With center tank fuel pump switches ON, verify
both center tank fuel pump low PRESS lights are illuminated and
EICAS CTR L FUEL PUMP and CTR R FUEL PUMP messages are displayed.
    For ground operations after engine start and flight operations:
The center tank fuel pump switch must be selected OFF when the
respective CTR L FUEL PUMP or CTR R FUEL PUMP message displays. Both
center tank fuel pump switches must be selected OFF when either the
CTR L FUEL PUMP or CTR R FUEL PUMP message displays if the center
tank is empty. During cruise flight, both center tank pump switches
may be reselected ON whenever center tank usable fuel is indicated.
    DE-FUELING AND FUEL TRANSFER
    When transferring fuel or de-fueling center or main wing tanks,
the fuel pump low PRESS lights must be monitored and the respective
fuel pump switches positioned to ``OFF'' at the first indication of
low pressure. Prior to transferring fuel or de-fueling, conduct a
lamp test of the respective fuel pump low PRESS lights.
    Intentional dry running of a center tank fuel pump (CTR L FUEL
PUMP or CTR R FUEL PUMP message displayed on EICAS) is prohibited.
    Do not reset a tripped fuel pump or fuel pump control circuit
breaker.''
    This may be done by inserting a copy of this AD into the AFM.

    Note 1: When statements identical to those in paragraph (h) of
this AD have been included in the general revisions of the AFM, the
general revisions may be inserted into the AFM, and the copy of this
AD may be removed from the AFM.

Placard Installation

    (i) For Model 767-200, -300, or -300F airplanes that meet the
conditions of paragraphs (i)(1) and (i)(2) of this AD: Within 30
days after the effective date of this AD, install a placard in the
flight deck adjacent to each pilot's primary flight display, to
alert the flightcrew to follow the procedures required by paragraph
(b) of AD 2001-15-08. The placard must include the following
statement: ``AD 2001-15-08 fuel usage restrictions required.''
Alternative placard wording may be used if approved by an
appropriate FAA Principal Operations Inspector. Alternative placard
methods and alternative methods of mixed fleet configuration control
may be used if submitted for review in accordance with the
procedures specified in paragraph (m) of this AD.
    (1) The airplane is operated in a fleet of airplanes on which
the actions specified in paragraph (f) of this AD have been done on
at least one of the fleet's airplanes.
    (2) The actions specified in paragraph (i) of AD 2001-15-08
(installation of modified center tank override and override/jettison
fuel pumps that are not subject to the unsafe condition described in
this AD) or paragraph (f) of this AD have not been done on the
airplane.

    Note 2: If the actions specified in paragraph (f) of this AD
have been done on all airplanes operated within an operator's fleet,
or if operation according to the fuel usage restrictions of AD 2001-
15-08 is maintained until automatic shutoff systems are installed on
all airplanes in an operator's fleet: No placard is necessary before
removal of the wet shutoff restrictions of AD 2001-15-08.

Optional Terminating Action for Paragraphs (f), (h), and (i) of this
AD: Deactivation of Center Fuel Tanks

    (j) Deactivation of the center fuel tanks, in accordance with
Boeing Alert Service Bulletin 767-28A0050, dated December 18, 1997;
or Boeing Service Bulletin 767-28A0050, Revision 1, dated December
22, 1999; terminates the requirements of paragraphs (f), (h), and
(i) of this AD, except as provided by paragraph (k) of this AD.

Reactivation of Center Fuel Tanks

    (k) For any airplane on which the center fuel tank is
reactivated, the center fuel tank must be reactivated in accordance
with a method approved by the Manager, Seattle Aircraft
Certification Office (ACO), FAA. For any airplane on which the
center fuel tank is reactivated, the requirements of paragraphs (f),
(h), and (i) of this AD must be done before further flight following
the reactivation, or within 36 months after the effective date of
this AD, whichever occurs later. For a reactivation method to be
approved, the reactivation method must meet the certification basis
of the airplane, and the approval must specifically reference this
AD.

Terminating Action for AD 2001-15-08

    (l) For airplanes that have automatic shutoff systems installed:
Accomplishing paragraphs (f) and (i) of this AD terminates the
requirements of paragraphs (b) and (c) of AD 2001-15-08.

Alternative Methods of Compliance (AMOCs)

    (m)(1) The Manager, Seattle ACO, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Douglas Bryant, Aerospace
Engineer, Propulsion Branch, ANM-140S, FAA, Seattle ACO, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone (425) 917-
6505; fax<PHONE_NUMBER>. Or, e-mail information to 9-ANM-Seattle-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.

Material Incorporated by Reference

    (n) You must use Boeing Service Bulletin 767-28A0083, Revision
2, dated February 12, 2009; or Boeing Service Bulletin 767-28A0084,
Revision 1, dated April 26, 2007; as applicable; to do the actions
required by this AD, unless the AD specifies otherwise. If you
accomplish the optional terminating action specified by this AD, you
must use Boeing Alert Service Bulletin 767-28A0050, dated December
18, 1997; or Boeing Service Bulletin 767-28A0050, Revision 1, dated
December 22, 1999; to perform those actions, unless the AD specifies
otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of Boeing Service Bulletin 767-28A0083,
Revision 2, dated February 12, 2009; and Boeing Service Bulletin
767-28A0084, Revision 1, dated April 26, 2007; under 5 U.S.C. 552(a)
and 1 CFR part 51.
    (2) The Director of the Federal Register previously approved the
incorporation by reference of Boeing Alert Service Bulletin 767-
28A0050, dated December 18, 1997; and Boeing Service Bulletin 767-
28A050,

Revision 1, dated December 22, 1999; on September 4, 2001 (66 FR
39417, July 31, 2001).
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (5) You may also review copies of the 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, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on July 24, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-18423 Filed 8-4-09; 8:45 am]

BILLING CODE 4910-13-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Thursday, November 5, 2020 11:18 AM
To:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Palma, Ted<EMAIL_ADDRESS>Subject:
EPA draft 10-29 meeting minutes - coke

Hello David - Attached please find our draft 10-29-20 meeting minutes. Please distribute to your groups in the industry. If we don't hear back from anyone in the next couple weeks, we will assume these are final. Thanks

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

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