[Federal Register Volume 79, Number 79 (Thursday, April 24, 2014)]
[Rules and Regulations]
[Pages 22767-22768]
[FR Doc No: 2014-09152]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0806; Airspace Docket No. 13-ASO-21]

Amendment of Class D and Class E Airspace, and Establishment of
Class E Airspace; Tri-Cities, TN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class D and Class E Airspace, and
establishes Class E airspace at Tri-Cities Regional Airport, Tri-
Cities, TN. Airspace reconfiguration is necessary to alleviate traffic
issues in the surrounding area for Johnson City Airport and Edwards
Heliport so aircraft can navigate in and out of their respective
airports in Visual Flight Rules conditions under 700 feet. This action
enhances the safety and airspace management of aircraft within the Tri-
Cities, TN area.

DATES: Effective 0901 UTC, July 24, 2014. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On February 12, 2014, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class D airspace and
Class E surface area airspace, and establish Class E airspace
designated as an extension to Class D airspace at Tri-Cities Regional
Airport, Tri-Cities, TN. (79 FR 8360). Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received.
    Class D and E airspace designations are published in paragraphs
5000, 6002, and 6004, respectively of FAA Order 7400.9X dated August 7,
2013, and effective September 15, 2013, which is incorporated by
reference in 14 CFR 71.1. The Class D and Class E airspace designations
listed in this document will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class D airspace and Class E surface area airspace, and
establishes Class E airspace designated as an extension to a Class D
surface area at Tri Cities Regional Airport, Tri-Cities, TN. Both the
Class D airspace area and Class E surface area airspace is reduced from
a 6.8-mile radius of the airport to within a 4.3-mile radius of the
airport. This action also establishes Class E airspace designated as an
extension to a Class D surface area within a 4.3-mile radius of Tri-
Cities Airport, with a segment extending from the 4.3-mile radius of
the airport to 6.8 miles northeast of the airport. This action
alleviates congestion for aircraft traveling to/from two neighboring
airports, Edwards Heliport and Johnson City Airport in Visual Flight
Rules conditions under 700 feet.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. 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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant

economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. 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 amends
controlled airspace in the Tri-Cities, TN, area.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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(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 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO TN D Tri-Cities, TN [Amended]

Tri-Cities Regional Airport, TN/VA
    (Lat. 36[deg]28'31'' N., long. 82[deg]24'27'' W.)

    That airspace extending upward from the surface to and including
4,000 feet MSL within a 4.3-mile radius of Tri-Cities Regional
Airport. This Class D airspace area is effective during the specific
days and times established in advance by a Notice to Airmen. The
effective days and times will thereafter be continuously published
in the Airport/Facility Directory.

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

ASO TN E2 Tri-Cities, TN [Amended]

Tri-Cities Regional Airport, TN/VA
    (Lat. 36[deg]28'31'' N., long. 82[deg]24'27'' W.)

    That airspace extending upward from the surface within a 4.3-
mile radius of Tri-Cities Regional Airport. This Class E airspace
area is effective during the specific days and times established in
advance by a Notice to Airmen. The effective days and times will
thereafter be continuously published in the Airport/Facility
Directory.

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.

* * * * *

ASO TN E4 Tri-Cities, TN [New]

Tri-Cities Regional Airport, TN/VA
    (Lat. 36[deg]28'31'' N., long. 82[deg]24'27'' W.)

    That airspace extending from the surface within 2.5-miles either
side of the 043[deg] bearing from Tri-Cities Regional Airport,
extending from the 4.3-mile radius to 6.8-miles northeast of the
airport. This Class E airspace area is effective during specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

    Issued in College Park, Georgia, on April 14, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-09152 Filed 4-23-14; 8:45 am]
BILLING CODE 4910-13-P


Year State Species Metric TonsPounds $ 1980 Delaware BASS, STR 7.6 16,800 15,451 1980 New JerseyBASS, STR 10.7 23,600 30,875 1980 New York BASS, STR 271.2 597,900 974,962 1981 Delaware BASS, STR 10.5 23,100 19,635 1981 New JerseyBASS, STR 6.3 13,900 17,756 1981 New York BASS, STR 373 822,400 1,459,349 1982 Delaware BASS, STR 11.7 25,700 28,373 1982 New JerseyBASS, STR 4.7 10,400 17,119 1982 New York BASS, STR 213.6 470,900 877,811 1983 Delaware BASS, STR 3.1 6,800 9,415 1983 New JerseyBASS, STR 8.9 19,600 43,998 1983 New York BASS, STR 140.4 309,500 669,466 1984 Delaware BASS, STR 16.8 37,000 74,000 1984 New JerseyBASS, STR 4 8,900 19,695 1984 New York BASS, STR 270 595,300 1,337,875 1985 New JerseyBASS, STR 5.5 12,100 16,718 1985 New York BASS, STR 212.8 469,040 862,956 1986 New JerseyBASS, STR 4.5 10,000 18,042 1986 New York BASS, STR 0.5 1,100 1,320 1987 New JerseyBASS, STR 0.2 400 616 1989 New JerseyBASS, STR 0.1 200 123 1989 New York BASS, STR 0.1 300 515 1990 New York BASS, STR 37 81,584 225,989 1991 Delaware BASS, STR 6.8 15,100 22,425 1991 New York BASS, STR 47.7 105,262 263,158 1992 Delaware BASS, STR 11.4 25,200 21,018 1992 New York BASS, STR 102.8 226,613 679,839 1993 Delaware BASS, STR 7.1 15,600 23,400 1993 New York BASS, STR 49.6 109,362 321,525 1994 Delaware BASS, STR 15.4 33,900 50,846 1994 New York BASS, STR 77 169,811 509,433 1995 Delaware BASS, STR 17.3 38,100 72,045 1995 New JerseyBASS, STR 0.1 179 313 1995 New York BASS, STR 227.2 500,980 1,402,804 1996 New York BASS, STR 227.1 500,697 1,251,752 1997 Delaware BASS, STR 75.3 165,998 241,370 1997 New York BASS, STR 208.9 460,451 1,151,135 1998 Delaware BASS, STR 74 163,176 244,807 1998 New York BASS, STR 219.8 484,513 1,254,404 1999 Delaware BASS, STR 80 176,307 270,616 1999 New York BASS, STR 222.1 489,720 1,224,419 2000 Delaware BASS, STR 65.8 145,111 245,230 2000 New York BASS, STR 246.4 543,216 1,510,765 2001 Delaware BASS, STR 90.1 198,618 364,836 2001 New York BASS, STR 287.2 633,093 1,582,739 2002 Delaware BASS, STR 66.3 146,157 336,045 2002 New York BASS, STR 235.2 518,573 1,296,438 2003 Delaware BASS, STR 86.7 191,194 478,607 2003 New York BASS, STR 355.9 784,602 1,967,592


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:  		09-FEB-2011

SUBJECT:	Pyrasulfotole.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action for Use on Grain Sorghum and Grass Grown for Seed.

PC Code:  000692  	DP Barcode:  375390

Decision No.:  425581	Registration No.:  264-1023

Petition No.:  9F7680	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  Dietary Exposure 	Case No.:  7272

TXR No.:  None.	CAS No.:  365400-11-9

MRID No.:  None.	40 CFR:  180.631

FROM:	Jennifer R. Tyler, Chemist

		Risk Assessment Branch 1 (RAB1)

		Health Effects Division (HED; 7509P)

THROUGH:	Yvonne Barnes, Chemist

		Debra Rate, Ph.D., Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

George F. Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

TO:		Allison Nowotarski, Biologist

		RAB1/HED (7509P)

and

Bethany Benbow/Joanne Miller, RM Team 23

		Registration Division (RD; 7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCID(; ver. 2.03) which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  No cancer dietary exposure assessment was performed because pyrasulfotole is not carcinogenic.  The analyses were performed to support Section 3 requests for use of pyrasulfotole on grain, sorghum and grass grown for seed.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization:  An unrefined, acute dietary exposure assessment was performed for the general U.S. population and all other population subgroups (including infants and children) using tolerance-level residues and assuming 100% crop treated (CT) for all registered and proposed uses.  Drinking water was incorporated directly into the dietary assessment using the acute concentration for surface water generated by the FQPA Index Reservoir Screening Tool (FIRST) model.  The results of this assessment indicate that the acute dietary exposure estimates (95th percentile) are below HED’s level of concern [<100% of the acute population-adjusted dose (aPAD)] for the general U.S. population (3% of the aPAD) and all other populations subgroups.  The most highly exposed population subgroup is children 1-2 years old at 9% of the cPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization:  An unrefined, chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using tolerance-level residues and assuming 100% CT for all registered and proposed uses.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for surface water generated by the FIRST model.  The results of the assessment concludes that the chronic dietary exposure estimates are below HED’s level of concern [<100% of the chronic population-adjusted dose (cPAD)] for the general U.S. population (4% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 16% of the cPAD.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (PoD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for pyrasulfotole was conducted by Jennifer Tyler in conjunction with a Section 3 request for the use of pyrasulfotole on small cereal grains (Memo, 6/7/07; D333435).

II.	Residue Information

Registered and Proposed Pyrasulfotole Uses:  Tolerances have been established for residues of pyrasulfotole and pyrasulfotole-desmethyl in/on small cereal grains, including wheat, barley, oat, rye and triticale; as well as several livestock commodities (See Table 1; 40 CFR 180.631).  The current petition is for the use of pyrasulfotole on sorghum and grass grown for seed.  The available residue chemistry database supports the establishment of the permanent tolerances for residues of pyrasulfotole and its metabolite pyrasulfotole-desmethyl as listed in Table 1.

Table 1.  Tolerance Summary for Pyrasulfotole.

Commodity	Current Tolerance (ppm)	Proposed Tolerance (ppm) HED-Recommended Tolerance (ppm)	Comments

(correct commodity definition)

Wheat, grain	0.02	-	-

	Wheat, straw	0.20	-	-

	Wheat, forage	0.20	-	-

	Wheat, hay	0.80	-	-

	Aspirated grain fractions	0.40	-	-

	Oat, grain	0.08	-	-

	Oat, straw	0.20	-	-

	Oat, forage	0.10	-	-

	Oat, hay	0.50	-	-

	Barley, grain	0.02	-	-

	Barley, straw	0.20	-	-

	Barley, hay	0.30	-	-

	Rye, grain	0.02	-	-

	Rye, straw	0.20	-	-

	Rye, forage	0.20	-	-

	Sorghum, grain	-	0.8	0.70	Sorghum, grain, grain

Sorghum, forage	-	1.2	1.5	Sorghum, grain, forage

Sorghum, stover	-	0.35	0.80	Sorghum, grain, stover

Grass, forage	-	10	25

	Grass, hay	-	2.5	3.5

	Milk*	0.01	0.01	0.03

	Cattle, meat	0.02	0.04	see current tolerance

	Cattle, fat*	0.02	0.04	0.03

	Cattle, meat byproducts*	0.06	2	0.70	Cattle, meat byproducts, except liver

Cattle, liver*	0.35	8	3.0

	Goat, meat	0.02	0.04	see current tolerance

	Goat, fat*	0.02	0.04	0.03

	Goat, meat byproducts*	0.06	2	0.70	Goat, meat byproducts, except liver

Goat, liver*	0.35	8	3.0

	Hog, meat	0.02	0.04	see current tolerance

	Hog, fat	0.02	0.04	see current tolerance

	Hog, meat byproducts*	0.06	2	0.05	Hog, meat byproducts, except liver

Hog, liver*	-	8	0.30

	Sheep, meat	0.02	0.04	see current tolerance

	Sheep, fat*	0.02	0.04	0.03

	Sheep, meat byproducts*	0.06	2	0.70	Sheep, meat byproducts, except liver

Sheep, liver*	0.35	8	3.0

	Horse, meat	0.02	0.04	see current tolerance

	Horse, fat*	0.02	0.04	0.03

	Horse, meat byproducts*	0.06	2	0.70	Horse, meat byproducts, except liver

Horse, liver*	0.35	8	3.0

	Poultry, meat	0.02	-	see current tolerance

	Poultry, fat*	0.02	-	0.03

	Poultry, meat byproducts*	0.02	-	0.20

	Eggs	0.02	-	see current tolerance

Nature of the Residue:  For plants and livestock, the residues of concern for tolerances and risk assessment purposes are pyrasulfotole and pyrasulfotole-desmethyl (Memo, J. Tyler et al., 6/8/07; D328640).  The residues of concern in drinking water for risk assessment purposes are parent only.

Percent Crop Treated:  For the acute and chronic assessments, it was assumed that 100% of the registered and proposed crops have been treated with pyrasulfotole.

Residue and PDP Data:  Tolerance-level residues were used for all registered and proposed commodities in the acute and chronic assessments.

™ 7.81 default processing factors were used for all registered commodities.

 Drinking Water Data

The Environmental Fate and Effects Division (EFED) provided Estimated Drinking Water Concentrations (EDWCs) of pyrasulfotole in surface and ground water using the FIRST and Screening Concentration in Ground Water (SCI-GROW) models, respectively (Memo, C. Peck, 8/4/10; D374622).  The assessment was based on the proposed grain sorghum use, which has a maximum proposed seasonal application rate of 0.045 lb ai/A.  EFED calculated the 1- in 10-year peak acute and 1- in 10-year estimated annual mean non-cancer chronic EDWCs for pyrasulfotole in surface water to be 6.9 ppb and 4.8 ppb, respectively.  The ground water EDWC for both acute and chronic exposures in estimated as 2.4 ppb.  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

Table 2.  Summary of Estimated Surface Water and Groundwater EDWCs for Pyrasulfotole.

	Surface Water Concentration (ppb)a	Groundwater Concentration (ppb)b

Acute	6.9	2.4

Chronic (non-cancer)	4.8	2.4

Chronic (cancer)	-	-

a From the Tier I FIRST model.  Input parameters are based on aerial spray applications to grain sorghum at a rate of 0.039 lb ai/A/year.

b From the SCI-GROW model assuming a maximum seasonal use rate of 0.039 lb ai/A, a Koc of 20 ml/gOC, and half-life of 226 days.

IV.	DEEM-FCID™ Program and Consumption Information

Pyrasulfotole acute and chronic dietary exposure assessments were conducted using the DEEM-FCID™, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

A summary of the toxicological doses and endpoints selected for dietary exposure assessment is provided in Table 3.

Table 3.  Summary of Toxicological Doses and Endpoints for Pyrasulfotole for Use in Dietary Human Health Risk Assessments.

Exposure Scenario	Point of Departure	Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment	Study and Relevant Toxicological Effects

Acute Dietary (All populations)	NOAEL = 3.8

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X 	aRfD = aPAD = 0.038 mg/kg/day	Developmental neurotoxicity (rat; dietary) Offspring LOAEL = 37 mg/kg/day based on delayed preputial separation (males), decreased cerebrum length (PND 21 females), and decreased cerebellum height (PND 21 males)

Chronic Dietary (All populations)	NOAEL = 1.0

mg/kg/day	UFA = 10X

UFH = 10X

UFFQPA = 1X	cRfD = cPAD = 0.01mg/kg/day	Combined chronic toxicity/carcinogenicity (rat; dietary) LOAEL = 10/14 mg/kg/day (M/F) based on corneal opacity, neovascularization of the cornea, inflammation of the cornea, regenerative corneal hyperplasia, corneal atrophy, and/or retinal atrophy (both sexes), and hepatocellular hypertrophy along with increased serum cholesterol (males)

Cancer (oral, dermal, inhalation)	Classification:  “Suggestive Evidence of Carcinogenic Potential” based on increased incidences of corneal tumors in male rats (carcinogenicity study) and urinary bladder tumors in male and female mice (carcinogenicity study)

1  UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), UFFQPA = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose.

VI.	Results/Discussion and Conclusions

 assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis:  An acute dietary exposure assessment (using tolerance level residues and 100% CT information for all registered and proposed uses) was conducted for the general U.S. population and various population subgroups (including infants and children).  Drinking water was incorporated directly in the dietary assessments using the acute concentration for surface water generated by the FIRST model.  The results of the acute assessment indicate that the acute dietary exposure estimates (95th percentile) are below HED’s level of concern (<100% of the aPAD) for the general U.S. population (3% of the aPAD) and all populations subgroups.  The most highly exposed population subgroup is children 1-2 years old at 9% of the cPAD.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis:  The chronic dietary exposure assessment (using tolerance level residues and 100% CT information for all registered and proposed uses) was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for surface water generated by the FIRST model.  The results of the chronic assessment indicate that the chronic dietary exposure estimates are below HED’s level of concern (<100% of the cPAD) for the general U.S. population (4% of the cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 16% of the cPAD.

Table 4.  Summary of Dietary Exposure and Risk for Pyrasulfotole.

Population

Subgroup	Acute Dietary1	Chronic Dietary2

	Dietary Exposure

(mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD

U.S. Population (total)	0.001315	3	0.000433	4

All Infants (< 1 year old)	0.002549	7	0.000829	8

Children 1-2 years old	0.003428	9	0.001567	16

Children 3-5 years old	0.002288	6	0.001150	12

Children 6-12 years old	0.001480	4	0.000699	7

Youth 13-19 years old	0.000878	2	0.000352	4

Adults 20-49 years old	0.000695	2	0.000298	3

Adults 50+ years old	0.000616	2	0.000300	3

Females 13-49 years old	0.000698	2	0.000295	3

1 Acute dietary endpoint of 0.038 mg/kg/day applies to the general U.S. population and all population subgroups.

2 Chronic dietary endpoint of 0.01 mg/kg/day applies to the general U.S. population and all population subgroups.

VII.	Characterization of Inputs/Outputs

These analyses are considered to be conservative dietary exposure assessments.  Residues were assumed to be equivalent to the tolerance levels.  Tolerance-level residues should always exceed the residue levels found on food commodities at the time of consumption.  When field trials are performed, the maximum allowable application rate is used and crops are harvested at the minimum preharvest interval (PHI).  Samples are stored frozen until analysis to ensure minimal degradation of residues.  In actual practice, however, growers will not usually use the maximum application rates for economic reasons.  In addition, most crops are not harvested and immediately stored frozen.  Also, 100% CT was assumed for all foods.  For these reasons, HED is confident that this analysis does not underestimate risk to the general U.S. population or any population subgroup.  Further refinement to the analyses could be made through the use of monitoring data, %CT data, and additional empirical processing factors.  Since risk estimates are not of concern to HED, a more highly refined analysis is not needed at this time.

VIII.	List of Attachments

Attachment 1.  Residue File for Acute DEEM-FCID™ Analysis – All Populations.

Attachment 2.  Acute DEEM-FCID™ Analysis – All Populations.

Attachment 3:  Residue File for Chronic DEEM-FCID™ Analysis.

Attachment 4:  Chronic DEEM-FCID™ Analysis.

cc:  J. Tyler (RAB1)

RDI:  DE SAC [Y. Barnes (10/6/10), D. Rate (10/01/10)], G. Kramer (2/09/11)

J. Tyler: S-10943: Potomac Yard:<PHONE_NUMBER>: RAB1

Attachment 1.  Residue File for Acute DEEM-FCID™ Analysis – All Populations.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for Seed\DEEM\000692a.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 10-06-2010/11:14:23/8          Program ver. 2.03

Comment: Proposed use on grain sorghum and grass grown for seed.  FQPA Safety Factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000

15000260 15   Barley, flour                      0.020000   1.000  1.000

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000

15000270 15   Barley, bran                       0.020000   1.000  1.000

21000440 M    Beef, meat                         0.020000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000

21000450 M    Beef, meat, dried                  0.020000   1.920  1.000

21000460 M    Beef, meat byproducts              0.700000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.700000   1.000  1.000

21000470 M    Beef, fat                          0.030000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000

21000480 M    Beef, kidney                       0.700000   1.000  1.000

21000490 M    Beef, liver                        3.000000   1.000  1.000

21000491 M    Beef, liver-babyfood               3.000000   1.000  1.000

40000930 P    Chicken, meat                      0.020000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000

40000940 P    Chicken, liver                     0.200000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.200000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.200000   1.000  1.000

40000960 P    Chicken, fat                       0.030000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.030000   1.000  1.000

40000970 P    Chicken, skin                      0.030000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.030000   1.000  1.000

70001450 P    Egg, whole                         0.020000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000

70001460 P    Egg, white                         0.020000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000

70001470 P    Egg, yolk                          0.020000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000

23001690 M    Goat, meat                         0.020000   1.000  1.000

23001700 M    Goat, meat byproducts              0.700000   1.000  1.000

23001710 M    Goat, fat                          0.030000   1.000  1.000

23001720 M    Goat, kidney                       0.700000   1.000  1.000

23001730 M    Goat, liver                        3.000000   1.000  1.000

24001890 M    Horse, meat                        0.020000   1.000  1.000

28002210 M    Meat, game                         0.020000   1.000  1.000

27002220 D    Milk, fat                          0.030000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000

27012230 D    Milk, nonfat solids                0.030000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000

27022240 D    Milk, water                        0.030000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000

15002310 15   Oat, bran                          0.200000   1.000  1.000

15002320 15   Oat, flour                         0.080000   1.000  1.000

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000

25002900 M    Pork, meat                         0.020000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000

25002910 M    Pork, skin                         0.020000   1.000  1.000

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000

25002930 M    Pork, fat                          0.020000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000

25002940 M    Pork, kidney                       0.050000   1.000  1.000

25002950 M    Pork, liver                        0.300000   1.000  1.000

60003010 P    Poultry, other, meat               0.020000   1.000  1.000

60003020 P    Poultry, other, liver              0.200000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.200000   1.000  1.000

60003040 P    Poultry, other, fat                0.030000   1.000  1.000

60003050 P    Poultry, other, skin               0.030000   1.000  1.000

29003120 M    Rabbit, meat                       0.020000   1.000  1.000

15003280 15   Rye, grain                         0.020000   1.000  1.000

15003290 15   Rye, flour                         0.020000   1.000  1.000

26003390 M    Sheep, meat                        0.020000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.700000   1.000  1.000

26003410 M    Sheep, fat                         0.030000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000

26003420 M    Sheep, kidney                      0.700000   1.000  1.000

26003430 M    Sheep, liver                       3.000000   1.000  1.000

15003440 15   Sorghum, grain                     0.700000   1.000  1.000

15003810 15   Triticale, flour                   0.020000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000

50003820 P    Turkey, meat                       0.020000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000

50003830 P    Turkey, liver                      0.200000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.200000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.200000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.200000   1.000  1.000

50003850 P    Turkey, fat                        0.030000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.030000   1.000  1.000

50003860 P    Turkey, skin                       0.030000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.030000   1.000  1.000

86010000 O    Water, direct, all sources         0.006900   1.000  1.000  6.9 pp

          Full comment: 6.9 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.006900   1.000  1.000  6.9 pp

          Full comment: 6.9 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000

15004020 15   Wheat, flour                       0.020000   1.000  1.000

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000

15004030 15   Wheat, germ                        0.020000   1.000  1.000

15004040 15   Wheat, bran                        0.020000   1.000  1.000

Attachment 2.  Acute DEEM-FCID™ Analysis – All Populations.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for PYRASULFOTOLE                       (1994-98 data)

Residue file: 000692a.R98                             Adjustment factor #2 used.

Analysis Date: 10-06-2010/13:27:12    Residue file dated: 10-06-2010/11:14:23/8

NOEL (Acute) =   3.800000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Proposed use on grain sorghum and grass grown for seed.  FQPA Sa

fety Factor=1x; therefore, aRfD=aPAD and cRfD=cPAD."

======================================================================== =======

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE

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

U.S. Population:

  0.001315    3.46    2888    0.002440    6.42    1557    0.006103   16.06     622

All infants:

  0.002549    6.71    1490    0.004861   12.79     781    0.006513   17.14     583

Children 1-2 yrs:

  0.003428    9.02    1108    0.004806   12.65     790    0.009023   23.74     421

Children 3-5 yrs:

  0.002288    6.02    1661    0.003193    8.40    1189    0.013998   36.84     271

Children 6-12 yrs:

  0.001480    3.90    2567    0.002006    5.28    1894    0.004598   12.10     826

Youth 13-19 yrs:

  0.000879    2.31    4324    0.001309    3.44    2903    0.002168    5.70    1753

Adults 20-49 yrs:

  0.000695    1.83    5470    0.001017    2.68    3737    0.004247   11.18     894

Adults 50+ yrs:

  0.000616    1.62    6164    0.000899    2.37    4228    0.006900   18.16     550

Females 13-49 yrs:

  0.000698    1.84    5442    0.001050    2.76    3618    0.005506   14.49     690

ronic DEEM-FCID™ Analysis.

Filename: C:\Documents and Settings\jtyler\My Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for Seed\DEEM\000692c.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day  NOEL(Acute):  3.8 mg/kg bw/day

Date created/last modified: 10-06-2010/11:14:49/8          Program ver. 2.03

Comment:  Proposed use on grain sorghum and grass grown for seed.  FQPA safety factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

15000250 15   Barley, pearled barley             0.020000   1.000  1.000

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000  1.000

15000260 15   Barley, flour                      0.020000   1.000  1.000

15000261 15   Barley, flour-babyfood             0.020000   1.000  1.000

15000270 15   Barley, bran                       0.020000   1.000  1.000

21000440 M    Beef, meat                         0.020000   1.000  1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000  1.000

21000450 M    Beef, meat, dried                  0.020000   1.920  1.000

21000460 M    Beef, meat byproducts              0.700000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.700000   1.000  1.000

21000470 M    Beef, fat                          0.030000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000

21000480 M    Beef, kidney                       0.700000   1.000  1.000

21000490 M    Beef, liver                        3.000000   1.000  1.000

21000491 M    Beef, liver-babyfood               3.000000   1.000  1.000

40000930 P    Chicken, meat                      0.020000   1.000  1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000  1.000

40000940 P    Chicken, liver                     0.200000   1.000  1.000

40000950 P    Chicken, meat byproducts           0.200000   1.000  1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.200000   1.000  1.000

40000960 P    Chicken, fat                       0.030000   1.000  1.000

40000961 P    Chicken, fat-babyfood              0.030000   1.000  1.000

40000970 P    Chicken, skin                      0.030000   1.000  1.000

40000971 P    Chicken, skin-babyfood             0.030000   1.000  1.000

70001450 P    Egg, whole                         0.020000   1.000  1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000  1.000

70001460 P    Egg, white                         0.020000   1.000  1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000  1.000

70001470 P    Egg, yolk                          0.020000   1.000  1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000  1.000

23001690 M    Goat, meat                         0.020000   1.000  1.000

23001700 M    Goat, meat byproducts              0.700000   1.000  1.000

23001710 M    Goat, fat                          0.030000   1.000  1.000

23001720 M    Goat, kidney                       0.700000   1.000  1.000

23001730 M    Goat, liver                        3.000000   1.000  1.000

24001890 M    Horse, meat                        0.020000   1.000  1.000

28002210 M    Meat, game                         0.020000   1.000  1.000

27002220 D    Milk, fat                          0.030000   1.000  1.000

27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000

27012230 D    Milk, nonfat solids                0.030000   1.000  1.000

27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000

27022240 D    Milk, water                        0.030000   1.000  1.000

27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000

15002310 15   Oat, bran                          0.200000   1.000  1.000

15002320 15   Oat, flour                         0.080000   1.000  1.000

15002321 15   Oat, flour-babyfood                0.080000   1.000  1.000

15002330 15   Oat, groats/rolled oats            0.080000   1.000  1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.080000   1.000  1.000

25002900 M    Pork, meat                         0.020000   1.000  1.000

25002901 M    Pork, meat-babyfood                0.020000   1.000  1.000

25002910 M    Pork, skin                         0.020000   1.000  1.000

25002920 M    Pork, meat byproducts              0.050000   1.000  1.000

25002921 M    Pork, meat byproducts-babyfood     0.050000   1.000  1.000

25002930 M    Pork, fat                          0.020000   1.000  1.000

25002931 M    Pork, fat-babyfood                 0.020000   1.000  1.000

25002940 M    Pork, kidney                       0.050000   1.000  1.000

25002950 M    Pork, liver                        0.300000   1.000  1.000

60003010 P    Poultry, other, meat               0.020000   1.000  1.000

60003020 P    Poultry, other, liver              0.200000   1.000  1.000

60003030 P    Poultry, other, meat byproducts    0.200000   1.000  1.000

60003040 P    Poultry, other, fat                0.030000   1.000  1.000

60003050 P    Poultry, other, skin               0.030000   1.000  1.000

29003120 M    Rabbit, meat                       0.020000   1.000  1.000

15003280 15   Rye, grain                         0.020000   1.000  1.000

15003290 15   Rye, flour                         0.020000   1.000  1.000

26003390 M    Sheep, meat                        0.020000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.700000   1.000  1.000

26003410 M    Sheep, fat                         0.030000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000

26003420 M    Sheep, kidney                      0.700000   1.000  1.000

26003430 M    Sheep, liver                       3.000000   1.000  1.000

15003440 15   Sorghum, grain                     0.700000   1.000  1.000

15003810 15   Triticale, flour                   0.020000   1.000  1.000

15003811 15   Triticale, flour-babyfood          0.020000   1.000  1.000

50003820 P    Turkey, meat                       0.020000   1.000  1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000  1.000

50003830 P    Turkey, liver                      0.200000   1.000  1.000

50003831 P    Turkey, liver-babyfood             0.200000   1.000  1.000

50003840 P    Turkey, meat byproducts            0.200000   1.000  1.000

50003841 P    Turkey, meat byproducts-babyfood   0.200000   1.000  1.000

50003850 P    Turkey, fat                        0.030000   1.000  1.000

50003851 P    Turkey, fat-babyfood               0.030000   1.000  1.000

50003860 P    Turkey, skin                       0.030000   1.000  1.000

50003861 P    Turkey, skin-babyfood              0.030000   1.000  1.000

86010000 O    Water, direct, all sources         0.004800   1.000  1.000  4.8 pp

          Full comment: 4.8 ppb surface water EDWC

86020000 O    Water, indirect, all sources       0.004800   1.000  1.000  4.8 pp

          Full comment: 4.8 ppb surface water EDWC

15004010 15   Wheat, grain                       0.020000   1.000  1.000

15004011 15   Wheat, grain-babyfood              0.020000   1.000  1.000

15004020 15   Wheat, flour                       0.020000   1.000  1.000

15004021 15   Wheat, flour-babyfood              0.020000   1.000  1.000

15004030 15   Wheat, germ                        0.020000   1.000  1.000

15004040 15   Wheat, bran                        0.020000   1.000  1.000

Attachment 4:  Chronic DEEM-FCID™ Analysis.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for PYRASULFOTOLE                    (1994-98 data)

Residue file name: C:\Documents and Settings\gkramer\My Documents\Gk\##Temp\000692c.R98

                                                     Adjustment factor #2 used.

Analysis Date 10-06-2010/13:25:39     Residue file dated: 10-06-2010/11:14:49/8

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

COMMENT 1: Proposed use on grain sorghum and grass grown for seed.  FQPA safety factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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--

U.S. Population (total)                     0.000433                 4.3%

U.S. Population (spring season)             0.000426                 4.3%

U.S. Population (summer season)             0.000434                 4.3%

U.S. Population (autumn season)             0.000444                 4.4%

U.S. Population (winter season)             0.000426                 4.3%

Northeast region                            0.000426                 4.3%

Midwest region                              0.000454                 4.5%

Southern region                             0.000401                 4.0%

Western region                              0.000467                 4.7%

Hispanics                                   0.000518                 5.2%

Non-hispanic whites                         0.000417                 4.2%

Non-hispanic blacks                         0.000442                 4.4%

Non-hisp/non-white/non-black                0.000468                 4.7%

All infants (< 1 year)                      0.000829                 8.3%

Nursing infants                             0.000281                 2.8%

Non-nursing infants                         0.001037                10.4%

Children 1-6  yrs                           0.001259                12.6%

Children 7-12 yrs                           0.000650                 6.5%

Females 13-19 (not preg or nursing)         0.000309                 3.1%

Females 20+ (not preg or nursing)           0.000291                 2.9%

Females 13-50 yrs                           0.000334                 3.3%

Females 13+ (preg/not nursing)              0.000370                 3.7%

Females 13+ (nursing)                       0.000417                 4.2%

Males 13-19 yrs                             0.000392                 3.9%

Males 20+ yrs                               0.000304                 3.0%

Seniors 55+                                 0.000302                 3.0%

Children 1-2 yrs                            0.001567                15.7%

Children 3-5 yrs                            0.001150                11.5%

Children 6-12 yrs                           0.000699                 7.0%

Youth 13-19 yrs                             0.000352                 3.5%

Adults 20-49 yrs                            0.000298                 3.0%

Adults 50+ yrs                              0.000300                 3.0%

Females 13-49 yrs                           0.000295                 3.0%

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

Pyrasulfotole	Dietary Exposure and Risk Assessment	DP Number: D375390

PC Code:  000692

________________________________________________________________________ ___________________

Page   PAGE  1  of   NUMPAGES  13


[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26307-26308]
[FR Doc No: 2011-11102]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0126]

Guidance for Industry on the Submission of Summary Bioequivalence
Data for Abbreviated New Drug Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Submission of
Summary Bioequivalence Data for Abbreviated New Drug Applications.''
The guidance is intended to assist abbreviated new drug application
(ANDA) applicants in complying with the requirements in the final rule
on the submission of bioequivalence data that published in the Federal
Register in January 2009 (74 FR 2849, January 16, 2009). The final rule
requires ANDA applicants to submit data from all bioequivalence studies
(BE studies) the applicant conducts on a drug product formulation
submitted for approval, including both studies that demonstrate and
studies that fail to demonstrate that a generic product meets the
current bioequivalence criteria. The guidance provides recommendations
to applicants planning to include BE studies for submission in ANDAs
and is applicable to BE studies conducted during both preapproval and
postapproval periods.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Aida L. Sanchez, Center for Drug
Evaluation and Research (HFD-650),

Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855,
240-276-8782.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The
guidance provides recommendations to applicants planning to include BE
studies for submission in ANDAs. The guidance provides information on
the following subjects:
     Types of ANDA submissions covered by the regulations on BE
studies;
     Recommended format for summary reports of BE studies; and
     Types of formulations the Agency considers to be the same
drug product formulation for different dosage forms based on
differences in composition.

The guidance is applicable to BE studies conducted for ANDAs during
both preapproval and postapproval periods.
    On April 17, 2009, FDA announced the availability of the draft
version of this guidance (74 FR 17872). The public comment period
closed on July 16, 2009. A few comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. Changes to the guidance were
minor and made to clarify statements in the draft guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on submission of summary bioequivalence data
for ANDAs. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.94(a)(7), 314.96(a)(1), and
314.97 have been approved under OMB control number 0910-0630.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11102 Filed 5-5-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58545-58546]
[FR Doc No: 2013-23058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0636]

Global Unique Device Identification Database; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Global Unique Device
Identification Database (GUDID).'' FDA is issuing this draft guidance
to communicate our current thinking of how the GUDID will operate. The
guidance includes both information about how device labelers (in most
instances, the device manufacturer) will interface with the GUDID, as
well as information on the database elements that must be submitted to
the GUDID and their definitions. We intend to publish a final guidance
after the close of the comment period and our implementation of the
GUDID.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 25, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Global Unique Device Identification
Database (GUDID)'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send
a fax request to<PHONE_NUMBER> to receive a hard copy. Alternatively,
you may submit written requests for single copies of the draft guidance
to the Office of Communication, Outreach and Development (HFM-40),
Center for Evaluation and Research, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3216, Silver Spring, MD 20993-0002, email:
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 226 of the Food and Drug Administration Amendments Act of
2007, 121 Stat. 854, and Section 614 of the Food and Drug
Administration Safety and Innovation Act (FDASIA) of 2012, 126 Stat.
1061, amended the Federal Food, Drug, and Cosmetic Act to add section
519(f) (21 U.S.C. 360i(f)), which directs FDA to issue regulations
establishing a unique device identification system for medical devices
along with implementation timeframes for certain medical devices. The
unique device identification (UDI) system proposed rule was published
on July 10, 2012 (77 FR 40736), followed by an amendment modifying the
implementation timeframe for certain devices, which was published on
November 19, 2012 (77 FR 69393).
    In developing the proposed rule, FDA solicited and considered input
from a variety of stakeholders (e.g., manufacturers, global regulatory
bodies, the clinical community, patient advocates) to ensure that as
many perspectives as possible were incorporated. The GUDID is a
critical component of the UDI System. While the UDI assigned to each
device is a globally unique, yet unintelligent code, the GUDID will
house a uniform set of required attribute information, including the
device identifier (DI) component of the UDI, for the devices reported
to the GUDID. Being unique for each device, the DI component of the UDI
can be effectively used by stakeholders to access the other GUDID
attribute information for that device.
    Labelers will be responsible for submitting information to the
GUDID as part of their UDI requirements. This draft guidance document
describes how labelers would obtain access to the GUDID, how to submit
DI records to the GUDID, and how all stakeholders can search and
retrieve device information. This draft guidance is being issued to
provide general information about the GUDID.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the GUDID.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at http://www.regulations.gov. To receive ``Global
Unique Device Identification Database (GUDID),'' you may either send an
email request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send

a fax request to<PHONE_NUMBER> to receive a hard copy. Please use the
document number 1831 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information
described in FDA's July 10, 2012, proposed rule on the UDI system (77
FR 40736), which this draft guidance is intended to interpret. The
proposed collections of information in the proposed rule are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by
the PRA, FDA has published an analysis of the information collection
provisions of the proposed rule (77 FR 40736 at 40762) and has
submitted them for OMB approval (OMB control number 0910-0720).

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23058 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Proposed Rules]
[Pages 25587-25590]
[FR Doc No: 2018-11699]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0493; Product Identifier 2017-NM-141-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Defense and Space S.A. (Formerly
Known as Construcciones Aeronauticas, S.A.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-
235-300, and C-295 airplanes. This proposed AD was prompted by reports
that cracks were found on the door mechanism actuator shaft assemblies
of the nose landing gear (NLG). This proposed AD would require
repetitive inspections of the NLG door mechanism actuator shaft
assemblies having certain part numbers, and corrective actions if
necessary. This proposed AD would also provide an optional terminating
action for the repetitive inspections for Model CN-235, CN-235-100, CN-
235-200, and CN-235-300 airplanes. We are proposing this AD to address
the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by July 19, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
Defense and Space Services/Engineering Support, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone +34 91 585 55 84; fax
+34 91 585 31 27; email [email protected]. You may view
this referenced service information at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0493; 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 NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0493;
Product Identifier 2017-NM-141-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2017-0181, dated September 18, 2017 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus Defense and Space S.A. Model
CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes The
MCAI states:

    Cracks were reportedly found on nose landing gear (NLG) door
actuator shaft assemblies on CN-235 aeroplanes. The subsequent
design review determined that combined or multiple rupture of the
affected shaft assembly could occur, without this being signalised
to the flight crew.
    This condition, if not detected and corrected, could lead to an
in-flight NLG door opening, possibly resulting in detachment of the
affected door, with consequent damage to, or reduced control of, the
aeroplane and injury to persons on the ground.
    To address this unsafe condition, Airbus Defence & Space (D&S)
issued Alert Operators Transmissions AOT-CN235-32-0001 Revision
(Rev.) 2 and AOT-C295-32-0001 Rev. 2 to provide inspection
instructions.
    For the reasons described above, this [EASA] AD requires
repetitive detailed (DET) or special detailed [rototest] inspections
of the NLG door actuator shaft assembly, as applicable, and,
depending on findings, corrective actions [including replacement of
any cracked component, or cracked NLG door mechanism actuator shaft
assembly with a serviceable part]. This [EASA] AD also introduces a
modification for CN-235 aeroplanes as (optional) terminating action
for the repetitive inspections as required by this [EASA] AD.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0493.

Related Service Information Under 1 CFR Part 51

    Airbus Defence and Space has issued Alert Operators Transmission
(AOT) AOT-CN235-32-0001, Revision 2, dated October 26, 2016; and AOT
AOT-C295-32-0001, Revision 2, dated October 26, 2016. This service
information describes procedures for inspections for cracking of the
door mechanism actuator shaft assemblies of the NLG, and corrective
actions. These documents are distinct since they apply to different
airplane models.
    Airbus Defence and Space has also issued Service Bulletin 235-32-
0031C, dated September 22, 2016. This service information describes
procedures for modification of the NLG door latching mechanism.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 14 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                    Labor cost            Parts cost       Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Inspections...................  21 work-hours x $85     $0................  $1,785 per         $24,990 per
                                 per hour = $1,785 per                       inspection cycle.  inspection
                                 inspection cycle.                                              cycle.
----------------------------------------------------------------------------------------------------------------

                                           Optional Terminating Action
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Modification for Model CN-235 airplanes....  10 work-hours x $85 per hour = $850         $33,626         $34,476
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed
inspections. We have no way of determining the number of aircraft that
might need these replacements:

                                               On-condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement................................  14 work-hours x $85 per hour =              $18,720         $19,910
                                              $1,190.
----------------------------------------------------------------------------------------------------------------

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus Defense and Space S.A. (Formerly Known as Construcciones
Aeronauticas, S.A.): Docket No. FAA-2018-0493; Product Identifier
2017-NM-141-AD.

(a) Comments Due Date

    We must receive comments by July 19, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus Defense and Space S.A. airplanes
identified in paragraphs (c)(1) and (c)(2) of this AD, certificated
in any category, all manufacturer serial numbers.
    (1) Model CN-235, CN-235-100, CN-235-200, and CN-235-300
airplanes.
    (2) Model C-295 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by reports that cracks were found on the
door mechanism actuator shaft assemblies of the nose landing gear
(NLG). We are issuing this AD to address such cracking, which could
lead to an in-flight NLG door opening and possibly result in
detachment of the affected door, and consequent damage to, or
reduced control of the airplane.

(f) Compliance

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

(g) Definition of Affected NLG Door Mechanism Actuator Shaft Assembly

    For the purpose of this AD, an affected NLG door mechanism
actuator shaft assembly has part number (P/N) 35-42311-00 or P/N 95-
42315-00, depending on airplane model.

(h) Detailed and Rototest Inspections

    (1) For any affected NLG door mechanism actuator shaft assembly:
Before exceeding 600 flight hours accumulated by any NLG door
mechanism lever or cam since new, or within 60 flight hours after
the effective date of this AD, whichever occurs later, on the NLG
door mechanism actuator shaft assembly with the NLG actuator shaft
installed, do a detailed inspection for cracking of all installed
NLG door mechanism levers and cams, in accordance with the
instructions in Airbus Defence and Space Alert Operators
Transmission (AOT) AOT-CN235-32-0001, Revision 2, dated October 26,
2016; or AOT AOT-C295-32-0001, Revision 2, dated October 26, 2016;
as applicable. Repeat the inspection thereafter at intervals not to
exceed those specified in figure 1 to paragraph (h)(1) of this AD,
depending on the findings or corrective actions completed, as
specified in paragraphs (i)(1) and (i)(2) of this AD, after the
previous inspection.

Figure 1 to Paragraph (h)(1) of This AD--Repetitive Inspection Intervals
------------------------------------------------------------------------
   Findings/corrective action completed
      (after the previous inspection)                 Interval
------------------------------------------------------------------------
NLG door vibration observed...............  150 flight hours.
(during previous flights).................
No findings...............................  300 flight hours.
Damaged components replaced...............  300 flight hours.
NLG door actuator shaft assembly replaced   600 flight hours.
 by new assembly.
------------------------------------------------------------------------

    (2) For any affected NLG door mechanism actuator shaft assembly:
Before exceeding 1,800 flight hours accumulated by the NLG door
shaft of the NLG door mechanism actuator shaft assembly since new,
or within 60 flight hours after the effective date of this AD,
whichever occurs later, do a rototest or detailed inspection of the
NLG door actuator shaft, in accordance with the instructions in
Airbus Defence and Space AOT AOT-CN235-32-0001, Revision 2, dated
October 26, 2016; or AOT AOT-C295-32-0001, Revision 2, dated October
26, 2016; as applicable. Repeat the rototest or detailed inspection
thereafter at intervals not to exceed those specified in figure 2 to
paragraph (h)(2) of this AD, depending on the inspection method used
during the most recent inspection.

Figure 2 to Paragraph (h)(2) of This AD--Repetitive Inspection Intervals
------------------------------------------------------------------------
             Inspection method                        Interval
------------------------------------------------------------------------
Rototest..................................  900 flight hours.
Detailed..................................  600 flight hours.
------------------------------------------------------------------------

(i) Corrective Actions

    (1) During any detailed inspection required by paragraph (h)(1)
of this AD, if any crack with a length of 18 millimeters (mm) (0.709
inches) or more is found, or if there is more than one crack with a
length of less than 18 mm (0.709 inch) found, before further flight,
replace the cracked component, or replace the NLG door mechanism
actuator shaft assembly with a serviceable part, in accordance with
the instructions of Airbus Defence and Space AOT AOT-CN235-32-0001,
Revision 2, dated October 26, 2016; or AOT AOT-C295-32-0001,
Revision 2, dated October 26, 2016; as applicable.
    (2) During any detailed inspection required by paragraph (h)(1)
of this AD, if a single crack with a length of less than 18 mm
(0.709 inch) is found, within 5 flight cycles after the detailed
inspection when the crack was found, replace any cracked component,
or replace the NLG door mechanism actuator shaft assembly with a
serviceable part, in accordance with the instructions of Airbus
Defence and Space AOT AOT-CN235-32-0001, Revision 2, dated October
26, 2016; or AOT AOT-C295-32-0001, Revision 2, dated October 26,
2016; as applicable.

    (3) During any detailed or rototest inspection required by
paragraph (h)(2) of this AD, if any crack is found, before further
flight, replace the NLG door mechanism actuator shaft with a
serviceable part, in accordance with the instructions of Airbus
Defence and Space AOT AOT-CN235-32-0001, Revision 2, dated October
26, 2016; or AOT AOT-C295-32-0001, Revision 2, dated October 26,
2016; as applicable.

(j) Replacement not Terminating Action

    Accomplishment of any corrective action on an airplane, as
required by paragraph (i)(1), (i)(2), or (i)(3) of this AD, as
applicable, is not terminating action for the repetitive detailed or
rototest inspections required by paragraphs (h)(1) and (h)(2) of
this AD, for that airplane.

(k) Optional Terminating Action

    For Model CN-235, CN-235-100, CN-235-200, and CN-235-300
airplanes: Modification of the NLG door latching mechanism, in
accordance with the Accomplishment Instructions of Airbus Defence
and Space Service Bulletin SB-235-32-0031C, dated September 22,
2016, is terminating action for the repetitive inspections required
by paragraphs (h)(1) and (h)(2) of this AD, for that airplane.

(l) Parts Installation Limitation

    As of the effective date of this AD, installation of an NLG door
mechanism actuator shaft assembly having P/N 35-42311-00 or P/N 95-
42315-00, or any of its components, is allowed, provided that the
part is new; or provided that the assembly or the components, as
applicable, has passed an inspection; in accordance with the
instructions of Airbus Space and Defence AOT AOT-CN235-32-0001,
Revision 2, dated October 26, 2016; or AOT AOT-C295-32-0001,
Revision 2, dated October 26, 2016; as applicable.

(m) Reporting Not Required

    Although Airbus Space and Defence AOT AOT-CN235-32-0001,
Revision 2, dated October 26, 2016; and AOT AOT-C295-32-0001,
Revision 2, dated October 26, 2016; both specify to submit certain
information to the manufacturer, this AD does not include that
requirement.

(n) Credit for Previous Actions

    This paragraph provides credit for the initial inspection
required by paragraph (h)(1) and (h)(2) of this AD, and the
corrective actions required by paragraphs (i)(1), (i)(2), and (i)(3)
of this AD, if those actions were performed before the effective
date of this AD using the applicable service information identified
in paragraphs (n)(1) through (n)(4) of this AD.
    (1) Airbus Space and Defence AOT AOT-CN235-32-0001, dated
September 29, 2015.
    (2) Airbus Space and Defence AOT AOT-CN235-32-0001, Revision 1,
dated February 19, 2016.
    (3) Airbus Space and Defence AOT AOT-C295-32-0001, dated
September 29, 2015.
    (4) Airbus Space and Defence AOT AOT-C295-32-0001, Revision 1,
dated February 19, 2016.

(o) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (p)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus Space and Defense's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(p) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0181, dated September 18, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0493.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus Defense and Space Services/Engineering Support, Avenida de
Arag[oacute]n 404, 28022 Madrid, Spain; telephone +34 91 585 55 84;
fax +34 91 585 31 27; email [email protected]. You may
view this service information at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on May 23, 2018.
James Cashdollar,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-11699 Filed 6-1-18; 8:45 am]
 BILLING CODE 4910-13-P