UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:	04/01/2008

Subject:		PP#7E7227; Bifenthrin (128825). Section 3 Registration Request for Application of Bifenthrin to Bushberry (Crop Subgroup 13B), Juneberry, Lingonberry, Salal, Aronia Berry, Lowbush Blueberry, Buffalo Currant, Chilean Guava, European Barberry, Highbush Cranberry, Honeysuckle, Jostaberry, Native Current, Sea Buckthorn, and Leaf Petioles (Crop Subgroup 4B) and FMC Corporation’s Field Trial Data on Head Lettuce.  Summary of Analytical Chemistry and Residue Data.

Petition No.	7E7227	Decision No:	379758

DP No.:	342661	40 CFR:	§180.442

Chemical No.:	128825	Class:	Synthetic Pyrethroid

Trade Name:	Capture 2EC, Capture LFR, Brigade 2EC, Brigade WSB	EPA Reg. No.: 	279-3069; 279-3313; 279-3108, 279-3302

MRIDs:	47144501, 47144502, and 47144503

From:		William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

Through:	George Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

To:		Daniel Rosenblatt/Shaja Brothers (RM 05)

	Registration Division (7505P)

This document was originally prepared under contract by Dynamac Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850; submitted 01/09/2008).  The document has been reviewed by the HED and revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Bifenthrin is a broad-spectrum, non-systemic insecticide/miticide in the class of synthetic pyrethroids.  It is registered to FMC Corporation for use as foliar applications on a variety of field, fruit, and vegetable crops.

The Interregional Research Project No. 4 (IR-4), on behalf of the Agricultural Experiment Stations of FL, MI, NJ, OR, TN, and TX, has submitted requests for Section 3 registrations for the application of bifenthrin to leafy petiole vegetables, subgroup 4B, [celery, cardoon, Chinese celery, celtuce, Florence fennel, rhubarb, and Swiss chard] and bushberries, subgroup 13B [blueberry (highbush and lowbush), currant, elderberry, gooseberry, and huckleberry].  In conjunction with this request, the petitioner has proposed the establishment of tolerances for bifenthrin [(2-methyl[1,1’-biphenyl]3-yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-pro penyl)-2,2-dimethyl-cyclopropanecarboxylate)] in/on:

Bushberry subgroup 13B	2.0 ppm

Juneberry	2.0 ppm

Lingonberry	2.0 ppm

Salal	2.0 ppm

Aronia berry	2.0 ppm

Blueberry, lowbush	2.0 ppm

Buffalo currant	2.0 ppm

Chilean guava	2.0 ppm

European barberry	2.0 ppm

Highbush cranberry	2.0 ppm

Honeysuckle	2.0 ppm

Jostaberry	2.0 ppm

Native currant	2.0 ppm

Sea buckthorn	2.0 ppm

Leaf petioles subgroup 4B	3.0 ppm

Concurrently,   SEQ CHAPTER \h \r 1 IR-4 requests the amendment of the following end-use products (EPs) containing bifenthrin as the active ingredient (ai) in order to include new uses on leafy petiole vegetables and bushberries:  Capture® 2 EC (emulsifiable-concentrate formulation) Insecticide/Miticide (EPA Reg. No. 279-3069), Brigade® 2EC (EPA Reg. No. 279-3313), Brigade® WSB (water-soluble bag, EPA Reg. No. 279-3108), and Capture® LFR Insecticide (EPA Reg. No. 279-3302).  These EPs are proposed for multiple broadcast foliar applications at maximum seasonal rates of 0.5 pound (lb) ai/acre (A) using ground or aerial equipment.  The proposed pre-harvest intervals (PHIs) are 1 day for bushberries and 7 days for leafy petiole vegetables.

This summary document also addresses the adequacy of magnitude of the residue data for head lettuce, which was submitted by FMC Corporation in support of a request to register the use of bifenthrin on head lettuce grown in CA.  It is noted that adequate field trial data supporting the use of bifenthrin on head lettuce in the U.S. except CA were previously reviewed (PP#1F6313, D278385, M. Nelson, 8/15/03).  Based on these data, the Agency established a 3.0 ppm tolerance for bifenthrin on head lettuce.

Tolerances for residues of bifenthrin are currently expressed in terms of bifenthrin per se.  Permanent tolerances are established for bifenthrin residues in/on several food commodities under 40 CFR §180.442(a)(1).  The established tolerances for plant and livestock commodities, under §180.422(a)(1), range from 0.05 ppm (various plant and poultry commodities) to 25 ppm (coriander, dried leaves).  A tolerance of 0.05 ppm is also established for residues of bifenthrin in food/feed handling establishments under §180.422(a)(2).  In addition, time-limited tolerances for residues of bifenthrin have been established under §180.422(b) in connection with Section 18 emergency exemptions; these include tolerances for orchardgrass, forage and hay each at 0.05 ppm with a 12/31/09 expiration date.

The nature of bifenthrin residues in plants and livestock is understood based on the previously-submitted apple, corn, cotton, potato, hen, and goat metabolism studies.  The residue of concern is bifenthrin per se in primary crop commodities and in livestock.

The nature of the residues in rotational crops is adequately understood.  Based on the confined rotational crop study, HED has concluded that the residue of concern in rotational crops is the parent compound only.  Based on a maximum seasonal use rate of 0.5 lb ai/A for annual crops, the confined study and the available field rotational crop study on wheat support the current rotational crop restrictions on the labels.  Crops having bifenthrin tolerances may be replanted at any time, and all other crops may be replanted 30 days following the last application of bifenthrin.  No rotational crop tolerances are required.

Adequate gas chromatography (GC)/electron-capture detection (ECD) methods are available for enforcing tolerances of bifenthrin in plant and livestock commodities.  The available methods for plant commodities generally involve extraction of the sample with acetone, partitioning with hexane, purification using a Florisil column, and analysis of residues by GC/ECD.  The limit of quantitation (LOQ) for these methods is 0.05 ppm.

Samples from the current field trials were analyzed for residues of bifenthrin using FMC methods PC-2132M (blueberry and celery) and P-3694 (head lettuce) that are modifications to one of the current enforcement methods (P-2550 M), with variations in extraction solvents and detection methods.  For each of the above methods, the validated LOQ for bifenthrin is 0.05 ppm, and the reported limit of detection (LOD) is 0.01 ppm.  The methods were adequately validated in conjunction with analysis of samples from the field trials.

The Food and Drug Administration’s PESTDATA database dated 10/99 (Pesticide Analytical Manual (PAM) Vol. I, Appendix II) indicates that bifenthrin is completely recovered using MRM Section 303 (Mills, Onley, and Gaither Method; Protocol E, non-fatty food) and that recoveries using Section 302 (Luke Method; Protocol D) are variable.  No information pertaining to the recovery of bifenthrin using Section 304 (Mills Method; Protocol E, fatty food) is available.  Additional MRM data for bifenthrin are not required.  The MRM methods are adequate for enforcement of bifenthrin tolerances.

Analytical standards for bifenthrin are currently available in the EPA National Pesticide Standards Repository.

The submitted supplemental residue data for head lettuce grown in CA (Zone 10) are adequate.  They indicate that the established tolerance of 3.0 ppm for bifenthrin residues in/on head lettuce will not be exceeded when the 2 lb/gal EC formulation is applied according to the registered use pattern.  There are now adequate residue data for head lettuce grown in CA (Zone 10); therefore, the label restriction prohibiting the use of bifenthrin on head lettuce in CA may be removed.

The submitted residue data for celery are adequate, and the trials conducted reflect the proposed use pattern for leaf petioles subgroup 4B.  The number and locations of celery trials are in accordance with the requirements specified in the previous petition review (PP#6E4630; DP# 277993, 8/15/02, S. Levy).

The submitted residue data for blueberry are adequate, and the trials conducted reflect the proposed use pattern for bushberry subgroup 13-07B.  The number and locations of crop field trials are in accordance with OPPTS Guideline 860.1500.

There are adequate storage stability data to validate the storage conditions and durations of raw agricultural commodities (RAC) samples collected from the field trials.

There are no livestock feedstuffs associated with the proposed uses on bushberries and leafy petiole vegetables.  Therefore, data requirements pertaining to meat, milk, poultry, and eggs are not relevant to this tolerance petition.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of a revised Section B (see requirements under 860.1200 Directions for Use), a revised Section F (see requirements under 860.1550 Proposed Tolerances), there are no residue chemistry issues that would preclude granting a conditional registration for use of this insecticide on the subgroups requested or the establishment of tolerances for bifenthrin per se as follows:

Bushberry subgroup 13-07B	1.8 ppm

Leaf petioles subgroup 4B	3.0 ppm

860.1200  Directions for Use

•	There are now adequate residue data supporting bifenthrin use on head lettuce grown in CA.  Therefore, the petitioner may submit a revised Section B to remove the existing restriction prohibiting use of bifenthrin on head lettuce grown in CA.

•	Label revisions are required to remove the statement that emulsified oil may be substituted for water for aerial applications; the submitted crop field trials do not reflect the use of emulsified oil.

860.1550  Proposed Tolerances

•	The petitioner is required to submit a revised Section F to amend the proposed tolerance for Bushberry subgroup 13-07B and to reflect correct commodity definition as reflected in Table 9.

A human-health risk assessment is forthcoming.

Background

The chemical structure and nomenclature of bifenthrin are presented in Table 1.  The physiochemical properties of the technical grade of bifenthrin are presented in Table. 2.

Table 1.		Bifenthrin Nomenclature.

Chemical structure

Common name	Bifenthrin

Company experimental name	FMC 54800

IUPAC name	2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclop ropanecarboxylate

or

(2-methyl[1,1′-biphenyl]-3-yl)methyl (1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyc lopropanecarboxylate

CAS registry number	82657-04-03

End-use product (EP)	2.0 lb ai/gal emulsifiable-concentrate formulation (Capture® 2EC; EPA Reg. No. 279-3069 and Brigade® 2EC; EPA Reg. No. 279-3313)

10% wettable-powder formulation  (Brigade® WSB, EPA Reg. No. 279-3108)

1.5 lb/gal flowable-concentrate (Capture® LFR; EPA Reg. No. 279-3302)

<0.1 μg/L

	Solvent solubility	8.9 in heptane and methanol

125 in acetone, chloroform, ether, methylene chloride, and toluene

	Vapor pressure	2.41 x 10-5

	Dissociation constant, pKa	Not applicable

	Octanol/water partition coefficient, Log(KOW)	>1 x 10 6

	UV/visible absorption spectrum	NA

	1 NA = information not available.

860.1200  Directions for Use

The petitioner has submitted draft labels for the 2 lb/gal EC formulations (Capture® 2EC Insecticide/Miticide; EPA Reg. No. 279-3069 and Brigade® 2EC Insectide/Miticide; EPA Reg. No. 279-3313), the 10% WP formulation (Brigade® WSB Insectide/Miticide; EPA Reg. No. 279-3108), and the 1.5 lb/gal FlC formulation (Capture® LFR; EPA Reg. No. 279-3302).  Information pertaining to the proposed EPs is listed in Table 3.  A summary of the proposed use patterns is included in Table 4.

Table 3.  Summary of Proposed End-Use Products.

Trade Name	Reg. No.	ai (% of formulation)	Formulation Type	Target Crops Target Pests	Label Date

Capture®

2 EC Insecticide/

Miticide	279-3069	25.1% (equivalent to 2 lb ai/gal) Emulsifiable-concentrate (EC)	Bushberries:  blueberry, highbush and lowbush, currant; elderberry; gooseberry; huckleberry

Leafy petiole vegetables:  celery; cardoon; Chinese celery; celtuce; Florence fennel; rhubarb; Swiss chard

Head lettuce	Insects controlled: aphid species, army cutworm, armyworm species, blueberry maggot, corn earworm, crickets, cucumber beetles, cutworm species, diamondback moth, flea beetles, fruitworms, ground beetles, grubs, imported cabbageworm, Japanese beetle, leaf hoppers, leaf rollers (obliquebanded, red banded, and variegated), lecanium scale (crawlers), lettuce root aphids, loopers, Lygus Spp., plum curculio, root maggot, salt marsh caterpillar, spanworm, stink bugs spp., tarnished plant bugs, thrips, tobacco budworm, whitefly, wireworm (adults), whiteflies

Mites controlled: bank grass mite, bulb mites, carmine mite, Pacific spider mite, two-spotted spider mite	5-11-07 draft label

Brigade® WSB Insecticide/

Miticide	279-3108	10%	Wettable-powder

(WP)

	5-17-07 draft label

Brigade® 2EC Insecticide/

Miticide	279-3313	25.1% (equivalent to 2 lb ai/gal)	EC

	5-11-07 draft label

Capture® LFR Insecticide	279-3302	17.15% (equivalent to 1.5 lb ai/gal) Flowable-concentrate (FlC)

	5-17-07 draft label

Table 4.   Summary of Proposed Directions for Use of Bifenthrin.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Max. Single Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

Foliar, Broadcast, Ground (≥10 gal/A) or aerial (≥2 gal/A)	2 lb/gal EC

[279-3069]	0.10	Not specified

(NS)	0.5	1

	10% WP

[279-3108]	0.10	NS	0.5	1

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	1

	1.5 lb/gal FlC

≥10 gal/A) or aerial (≥2 gal/A)	2 lb/gal EC

[279-3069]	0.10	NS	0.5	7

	10% WP

[279-3108]	0.10	NS	0.5	7

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	7

	1.5 lb/gal FlC

[279-3302]	0.10	NS	0.5	7

	Use Directions and Limitations:  For aerial applications, 1-2 quarts of emulsified oil may be substituted for 1-2 quarts of water in the finished spray.  A minimum 7-day RTI is specified.

Lettuce, head

Foliar, Broadcast, Ground (≥15 gal/A for 2 lb/gal EC and ≥20 gal/A for 10% WP) or aerial (≥5 gal/A)	2 lb/gal EC

[279-3069]	0.10	NS	0.5	7

	10% WP

[279-3108]	0.10	NS	0.5	7

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	7

	Use Directions and Limitations:  For aerial applications of the EC formulation, 1-2 quarts of emulsified oil may be substituted for 1-2 quarts of water in the finished spray.  A minimum 7-day RTI.

At planting

Soil banded, in-furrow, or broadcast soil surface

Ground	1.5 lb/gal FlC

[279-3302]	0.08	NS	(at plant)

0.5 (at plant + foliar applications of other bifenthrin products)	NS

	Use Directions and Limitations:  Applications may be made as a 5-7 inch band over an open furrow (T-band), in-furrow with the seed, or broadcast over the entire acre on the soil surface.

The following rotational crop restriction is specified for the 2 lb/gal EC, 10% WP, and 1.5 lb/gal FlC formulations:  Crops for which bifenthrin tolerances exist may be rotated at any time.  All other crops may be rotated 30 days following the final application of bifenthrin.  The labels specify a restricted-entry interval (REI) of 12 hours for all formulations.

The labels state that the products may be tank mixed with other products approved for use on registered crops.  All restrictions and precautions must be observed which appear on the labels of these products.  No specific tank mix partners are specified.

The draft labels for the 2 lb/gal EC formulations prohibit use in CA.  In addition, these labels specify that the product may be applied through sprinkler including center pivot, lateral move, end tow, side (wheel) roll, traveler, big gun, solid set, or hand move irrigation systems.  The draft labels for the 10% WP and 1.5 lb/gal FlC formulations specify that application through any type of irrigation system is prohibited.

HED notes that the draft label for 1.5 lb/gal FlC formulation states under Directions for Use that product is for ground application only, and application by air is prohibited, but indicates under the specific use directions for leafy petiole vegetables and bushberries that the product may be applied by air.

Conclusions.  The proposed use directions are adequate to allow evaluation of the residue data relative to the proposed use.  However, since adequate field trial data are now available to support the use of the 2 lb/gal EC formulation on head lettuce grown in CA (Zone 10); label revisions are required to remove the restriction prohibiting use in CA from the product label.  Label revisions are required for the proposed EPs to remove the statement that emulsified oil may be substituted for water for aerial applications; the submitted crop field trials do not reflect the use of emulsified oil.

860.1300 Nature of the Residue – Plants and Livestock

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate studies are available depicting the metabolism of [14C]bifenthrin in apples, corn, and cotton.  The nature of the residue in plants is adequately understood based on previously submitted plant metabolism studies on corn, cotton, apple and potato.  HED has determined that for purposes of the tolerance expression and risk assessment, the residue of concern in cotton and apple commodities is bifenthrin per se.  The HED Metabolism Committee in 1993 re-examined the cotton and apple metabolism data and examined additional corn metabolism data; the Committee determined that the residues of concern in plant commodities for tolerance setting and risk assessment are bifenthrin per se (Memo, M. Flood, 7/23/93).

The qualitative nature of the residue in livestock is adequately understood based on goat and hen metabolism studies.  The HED Metabolism Committee determined that for purposes of tolerance expression and risk assessment, the residue of concern in livestock is bifenthrin per se (Memo of M. Flood, 7/23/93).

860.1340 Residue Analytical Methods

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate GC/ECD methods are available for enforcing tolerances of bifenthrin in plant and livestock commodities.  The available methods for plant commodities generally involve extraction of the sample with acetone, partitioning with hexane, purification using a Florisil column, and analysis of residues by GC/ECD.  The limit of quantitation (LOQ) for these methods is 0.05 ppm.

Samples from the current field trials were analyzed for residues of bifenthrin using FMC methods PC-2132M (blueberry and celery) and P-3694 (head lettuce) that are modifications to one of the current enforcement methods (P-2550 M), with variations in extraction solvents and detection methods.  Residues of bifenthrin in/on blueberry and celery were determined using a GC/ECD method (FMC Report P-2132M).  For this method, residues are extracted with hexane using the Dionex ASE-200, concentrated, and cleaned up using a Florisil column, then analyzed by GC/ECD.  Residues in/on head lettuce were determined using a GC/mass-selective detection (MSD) method (FMC Report P-3694).  For this method, a NaCl solution is added to the sample and residues are extracted with acetone, partitioned with hexane, concentrated, and purified on an aminopropyl solid-phase extraction (SPE) cartridge.  The residues are eluted with hexane and analyzed by GC/MSD using the m/z 181 and m/z 165 ions for quantitation.  For each of the above methods, the validated LOQ for bifenthrin is 0.05 ppm, and the reported LOD is 0.01 ppm.  Each of these methods was adequately validated in conjunction with analysis of samples from the field trials.

860.1360 Multiresidue Methods

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

The Food and Drug Administration’s PESTDATA database dated 10/99 (Pesticide Analytical Manual (PAM) Vol. I, Appendix II) indicates that bifenthrin is completely recovered using MRM Section 303 (Mills, Onley, and Gaither Method; Protocol E, non-fatty food) and that recoveries using Section 302 (Luke Method; Protocol D) are variable.  No information pertaining to the recovery of bifenthrin using Section 304 (Mills Method; Protocol E, fatty food) is available.  Additional MRM data for bifenthrin are not required.  The MRM methods are adequate for enforcement of bifenthrin tolerances.

860.1380 Storage Stability

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

HED Memo (DP# 277993, 8/15/02, S. Levy)

The maximum storage duration from harvest to analysis was 82 days (2.7 months) for blueberry, 232 days (7.6 months) for celery, and 339 days (11.2 months) for head lettuce.  The storage durations and conditions of samples from the crop field trials submitted to support this petition are presented in Table 5.

Table 5.   Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies.

Matrix 	Storage Temperature

(°C)	Actual Storage Duration	Interval of Demonstrated Storage Stability

Blueberry	-27 to -15	37–82 days

(1.2–2.7 months)	188 days

(6.2 months)

Celery	- 27 to -16	83-232 days

(2.7-7.6 months)	562 days

(18.5 months)

Head Lettuce	~ -18	44-339 days

(1.4-11.2 months)	36 months

No storage stability data were submitted with the subject petition.  Storage stability data for residues of bifenthrin in/on a variety of commodities are available.  In the Bifenthrin TRED  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 , HED has concluded that residues of bifenthrin are stable during frozen storage for up to:  12 months in corn flour, meal, oil, and starch; 18 months in/on oranges (whole) and orange dried pulp, juice, and oil; 24 months in/on cottonseed; 34 months in/on corn grain; 36 months in/on lettuce, pecans, and potatoes; and 49 months in/on apple, corn silage, and corn stover.  Storage stability studies conducted concurrently with crop field trial studies indicate that residues of bifenthrin are stable during frozen storage for up to:  147 days in/on artichoke; 196 days in/on lima beans (shelled); 142 days in/on snap beans; 294 days in/on head and stem Brassica vegetables; 136 days in/on canola; 369 days in/on cantaloupe; 361 days in/on cucumbers; 136 days in/on eggplant; 176 days in/on grapes; 127 days in/on green and dried hops; 300 days in/on head lettuce; 192 days in/on shelled peas; 166 days in/on bell peppers; 200 days in/on non-bell peppers; 188 days in/on raspberries; 359 days in/on squash.  In addition, the available storage stability data (DP# 277993, 8/15/02, S. Levy) indicate that residues of bifenthrin are stable under frozen storage conditions for a maximum of 562 days (18.5 months) in/on celery.

Conclusions.  The storage conditions and durations of samples from the blueberry, celery, and head lettuce field trials are supported by adequate storage stability data.  Additional storage stability data are not required.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed uses on bushberries and leafy petiole vegetables.  Therefore, data requirements pertaining to meat, milk, poultry, and eggs are not relevant to this tolerance petition.

860.1500 Crop Field Trials

Lettuce, head

Residue Chemistry Memo, DP# 257714, 1/31/00, Y. Donovan (PP#9E6030, 9E6031, 9E6016, 9E6034)

Residue Chemistry Memo, D278385, 8/15/03, M. Nelson, PP#1F6313

DER Reference List:  47144503.der.doc

Adequate field trial data are available supporting the use of bifenthrin on head lettuce in the U.S. (PP#1F6313, D278385, M. Nelson, 8/15/03).  Based on these data, the Agency established a 3.0 ppm tolerance for bifenthrin on head lettuce.  Although a Federal tolerance has been established, FMC Corporation indicated that additional head lettuce field trials conducted in CA were needed to obtain a state registration.  Subsequently, additional residue data in support of a registration for use of the 2 lb/gal EC formulation on head lettuce grown in CA/Zone 10 were submitted, pertinent parts of the Executive Summary of the study DER are reproduced below.

FMC Corporation has submitted supplemental field trial data (MRID 47144503) for the use of bifenthrin on head lettuce.  Four field trials were conducted in the U.S. in Zone 10 (AZ and CA) during the 2003 and 2004 growing seasons.  Each plot consisted of one untreated and one treated plot.  At each trial site, five broadcast foliar applications of 2 lb/gal EC formulation of bifenthrin were made at 6- to 8-day retreatment intervals (RTIs) to head lettuce at 0.10 lb ai/A/application, for a total seasonal rate of 0.50 lb ai/A.  Applications were made using spray equipment in ~20–21 gal/A spray volumes without an adjuvant.

Lettuce samples were harvested at commercial maturity, 6- to 8-days after the last application of bifenthrin.  Additional samples were harvested from one trial at 1, 3, and 14 days after the last application of 2 lb/gal EC formulation to evaluate decline.  Samples of head lettuce were analyzed for residues of bifenthrin using GC/MSD method contained in FMC Report P-3694 (MRID 46960404).  The method is adequate based on acceptable concurrent recovery data.

The results of the lettuce field trials are summarized in Table 6.  Following five broadcast foliar applications of 2 lb/gal EC formulation, at 0.1 lb ai/A/application, for a total seasonal rate of 0.5 lb ai/A, residues of bifenthrin were <0.05-0.77 ppm and <0.05-0.41 ppm, for lettuce with wrapper leaves and lettuce without wrapper leaves, respectively.  Residue decline data indicate that bifenthrin residues in/on lettuce heads decline with increasing PHIs.

Table 6.   Summary of Residue Data from Lettuce Trials with Bifenthrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Residue Levels1 (ppm)

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:   Maximum Seasonal Rate of 0.5 lb ai/A with a 7-day PHI.

Lettuce w/ wrapper leaves	0.50	6-8	8	<0.05	0.77	0.76	0.29	0.30

Lettuce w/o wrapper leaves

	8	<0.05	0.41	0.40	0.20	0.14

1  For calculation of the HAFT, median, mean, and standard deviation, the LOQ (<0.05 ppm) was used for any value reported as <LOQ or between the LOD and LOQ in Table C.3.

2  HAFT = Highest-Average Field Trial result.

Conclusions:  The submitted supplemental residue data for head lettuce grown in CA/Zone 10 are adequate.  They indicate that the established tolerance 3.0 ppm for bifenthrin residues in/on head lettuce will not be exceeded when the 2 lb/gal EC formulation is applied according to the registered use pattern.  There are now adequate residue data for head lettuce grown in CA/Zone 10; therefore, the label restriction prohibiting the use of bifenthrin on head lettuce in CA may be removed.

Leafy petioles subgroup 4B

Celery

Residue Chemistry Memo, DP# 221185, 3/26/96, W. Wassell (PP#6E04630)

Residue Chemistry Memo, DP# 277993, 8/15/02, S. Levy (PP#6E04630)

DER Reference List	47144502.der.doc

IR-4 has submitted field trial data for the use of bifenthrin on celery in response to a data gap specified in DP# 277993 (8/15/02, S. Levy).  Four side-by-side field trials were conducted in the U. S. in Zones 3 (FL; 1 trial), 5 (OH; 1 trial), and 10 (CA; 2 trials) during the 2004 growing season.  Each trial site consisted of one untreated plot and two treated plots.  At each treated plot, five foliar directed/broadcast applications of either the 2 lb/gal EC or 10%WP formulation of bifenthrin were made at 6- to 8-day RTIs to celery at 0.096-0.106 lb ai/A/application, for a total seasonal rate of 0.497-0.515 lb ai/A.  Applications were made using spray equipment in 35–53 gal/A spray volumes without an adjuvant.

Celery samples were harvested at commercial maturity, 6- to 8-days after the last application of bifenthrin.  It is noted that the above-cited HED memo requested that all field trials should reflect a 7- and 14-day PHIs.  Samples of celery were analyzed for residues of bifenthrin using a modification of the GC/ECD enforcement method (FMC Corporation Method P-2132M).  The method is adequate based on acceptable concurrent and method validation recovery data.

The results of the celery field trials are summarized in Table 7.  Following five foliar direct applications of 2 lb/gal EC or 10% WP formulation, at ~0.1 lb ai/A/application, for a total seasonal rate of 0.5 lb ai/A, residues of bifenthrin were 0.11-1.78 ppm and 0.06-1.16 ppm, respectively.

Table 7.   Summary of Residue Data from Celery Trials with Bifenthrin.

Commodity	EP	Total Applic.

Rate

(lb ai/A)	PHI

(days)	Residue Levels (ppm)

n	Min.	Max.	HAFT1	Mean	Std. Dev.

Proposed Use Pattern:   Maximum Seasonal Rate of 0.5 lb ai/A with a 7-day PHI.

Celery	2 lb/gal EC	0.497-0.514	6-7	8	0.11	1.78	1.49	0.75	0.54

Celery	10% WP	0.499-0.515	6-7	8	0.06	1.16	1.07	0.56	0.38

1  HAFT = Highest-Average Field Trial result.

Conclusions:  The submitted residue data for celery are adequate, and the trials conducted reflect the proposed use pattern for leaf petioles subgroup 4B.  The number and locations of celery trials are in accordance with the requirements specified in the previous petition review (PP#6E04630; DP# 277993, 8/15/02, S. Levy).

The aggregate of residue data for celery were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet recommends an individual tolerance of 3.0 ppm for residues in/on celery.  Thus, HED recommends a tolerance of 3.0 ppm for residues of bifenthrin per se in/on leaf petiole subgroup 4B based on the residue data from celery.  This tolerance level recommendation is identical to the level proposed by the petitioner.

Bushberry subgroup 13

Blueberry

DER Reference List	47144501.der.doc

IR-4 has submitted field trial data for the use of bifenthrin on blueberries.  Nine field trials were conducted in the U.S. in Zones 1 (ME; 1 trial), 2 (NC and NJ; 3 trials), 5 (MI; 3 trials), 10 (CA; 1 trial), and 12 (OR; 1 trial) during the 2004 growing season.  Trials consisted of one untreated plot and either one (5 sites) or two (4 sites) treated plots.  At each trial site, five foliar directed/broadcast applications of the 2 lb/gal EC formulation were made at 4- to 8-day RTIs to blueberries at 0.093-0.106 lb ai/A/application, for a total seasonal rate of 0.498-0.507 lb ai/A.  At four trials, a second treated plot received five foliar direct/broadcast applications of 10% WP at 0.096-0.102 lb ai/A/application, with 6- to 8-day RTIs, for a total seasonal rate of 0.492-0.499 lb ai/A.  All applications were made using spray equipment in 21-51 gal/A spray volumes without an adjuvant.

At each trial, one control and two treated blueberry samples were harvested at commercial maturity, 1 day after the last application of bifenthrin.  Samples of blueberry were analyzed for residues of bifenthrin using a modification of the GC/ECD enforcement method titled “Analytical Method for the Determination of Bifenthrin in/on Various Crops and Soils” (FMC Corporation Method P-2132M).  The method is adequate based on acceptable concurrent and method validation recovery data.

The results of the blueberry trials are summarized in Table 8.  Following five foliar direct applications of the 2 lb/gal EC or 10% WP formulation, at ~0.1 lb ai/A/application, for a total seasonal rate of ~ 0.5 lb ai/A, maximum residues of bifenthrin were 1.61 ppm and 1.06 ppm, respectively.

Table 8.  Summary of Residue Data from Blueberry Field Trials with Bifenthrin.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	EP	Residue Levels  (ppm)

n	Min.	Max.	HAFT1	Mean	Std. Dev.

Proposed Use Pattern:  Maximum Seasonal Rate of 0.5 lb ai/A with a 1-day PHI.

Blueberry	0.498-0.509	1	2 lb/gal EC	18	0.36	1.61	1.36	0.80	0.34

	0.492-0.499	1	10% WP	8	0.37	1.06	0.91	0.65	0.28

1  HAFT = Highest-Average Field Trial result.

Conclusions.  The submitted residue data for blueberry, which is the representative commodity of bushberry subgroup 13-07B, are adequate.  The number and locations of crop field trials are in accordance with OPPTS Guideline 860.1500.  The trials reflect the proposed use pattern.

The residue data for blueberry were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet recommends an individual tolerance of 1.8 ppm for residues in/on blueberry.  Thus, HED recommends a tolerance of 1.8 ppm for residues of bifenthrin per se in/on bushberry subgroup 13-07B based on the residue data from blueberry.  This tolerance level recommendation is lower than the level proposed by the petitioner.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities associated with head lettuce, celery, or blueberry.  Therefore, data requirements for processed food and feed are not relevant to this tolerance petition.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference Standards

Analytical standards for bifenthrin are currently available in the EPA National Pesticide Standards Repository (personal communication with Dallas Wright, ACB, 11/13/07).  Analytical reference standards of bifenthrin must be supplied and supplies replenished as requested by the Repository.  The reference standards should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Frederic Siegelman at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850 and 860.1900 Confined/Field Accumulation in Rotational Crops

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate confined and field rotational crop studies are available.  Based on the confined study, HED has concluded that the residue of concern in rotational crops is the parent compound only.  Based on a maximum seasonal use rate of 0.5 lb ai/A for annual crops, the confined study and the available field rotational crop study on wheat also support the current rotational crop restrictions on the labels.  Crops having bifenthrin tolerances may be replanted at any time, and all other crops may be replanted 30 days following the last application of bifenthrin.  No rotational crop tolerances are required.

860.1550 Proposed Tolerances

Tolerances for residues of bifenthrin are currently expressed in terms of bifenthrin per se.  Permanent tolerances are established for bifenthrin residues in/on several food commodities under 40 CFR §180.442(a)(1).  The established tolerances for plant and livestock commodities, under §180.422(a)(1), range from 0.05 ppm (various plant and poultry commodities) to 25 ppm (coriander, dried leaves).  A tolerance of 0.05 ppm is also established for residues of bifenthrin in food/feed handling establishments under §180.422(a)(2).  In addition, time-limited tolerances for residues of bifenthrin have been established under §180.422(b) in connection with Section 18 emergency exemptions; these include tolerances for orchardgrass, forage and hay each at 0.05 ppm with a 12/31/09 expiration date.

The tolerances proposed by the petitioner in the current petition are listed below in Table 9, along with HED’s recommended tolerance levels.   SEQ CHAPTER \h \r 1  The petitioner must submit a revised Section F reflecting the revised tolerances and commodity definitions presented in Table 9.  The Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels for bushberry (subgroup 13-07B) and leaf petioles subgroup 4B; see Appendix I.  The Agency’s tolerance spreadsheet was not used to determine a tolerance level for head lettuce since the supplementary head lettuce residue data for CA   SEQ CHAPTER \h \r 1 indicate that the established tolerance of 3 ppm will not be exceeded.

The Agency has finalized the revision to the existing bushberry subgroup 13B (Federal Register Vol. 72, No. 235, pages 69150-69158; 12/7/07) to include the following commodities:  aronia berry; blueberry, lowbush; buffalo currant; Chilean guava; European barberry; cranberry, highbush; honeysuckle, edible; jostaberry; Juneberry; lignonberry; native currant; salal; and sea buckthorn.  Separate tolerances for these individual commodities are no longer needed.  In addition, the final rule changes the subgroup name from “bushberry subgroup 13B” to “bushberry subgroup 13-07B.”

The submitted field trial data for blueberry, the representative commodity of bushberry subgroup 13-07B are adequate.  The field trial data for blueberry were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet recommends an individual tolerance of 1.8 ppm for blueberry which may be used to support a tolerance for bifenthrin in/on the bushberry subgroup 13-07B.  This tolerance level recommendation is lower than the level proposed by the petitioner.

The submitted field trial data for celery, the representative commodity of leaf petiole subgroup 4B are adequate.  The field trial data for celery were entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet recommends an individual tolerance of 3.0 ppm for celery which may be used to support a tolerance for bifenthrin in/on the leaf petiole subgroup 4B.  This tolerance level recommendation is identical to the level proposed by the petitioner.

There are currently no established Codex, Canadian, or Mexican maximum residue limits (MRLs) for bifenthrin in/on the proposed commodities.  Therefore, harmonization is not an issue.  An International Residue Limit (IRL) form is appended to this Summary Document and follows this section.

Table 9. 	Tolerance Summary for Bifenthrin

Crop Group or Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Bushberry subgroup 13B	2.0	1.8	Bushberry subgroup 13-07B

Juneberry	2.0	Not needed	Separate tolerances for new commodities listed in crop subgroup 13-07B are no longer required; refer to the Final Rule published in the Federal Register 12/7/07.

Lingonberry	2.0

Salal	2.0

Aronia berry	2.0

Blueberry, lowbush	2.0

Buffalo currant	2.0

Chilean guava	2.0

European barberry	2.0

Highbush cranberry	2.0

Honeysuckle	2.0

Jostaberry	2.0

Native currant	2.0

Sea buckthorn	2.0

Leaf petioles subgroup 4B	3.0	3.0

References

DP#:	221185

Subject:	PP#6E04630  Bifenthrin (Brigade® WSB, EPA Reg. No. 279-3108) in Celery.  Evaluation of Analytical Methodology and Residue Data.  Chemical 128825.

From:	W. Wassell

To:	H. Jamerson  SEQ CHAPTER \h \r 1

Date:	3/26/96

MRIDs:	43844101

DP#s:	257714, 257830, 257516, and 257926

Subject:	PP#9E6030, 9E6031, 9E6016, 9E6034  Bifenthrin – Proposal for Tolerances of Residues in/on Bell and Non-bell Peppers, Lettuce (head), Grapes, and Caneberries.  Residue Chemistry Reviews.

From:	Y. Donovan

To:	H. Jamerson  SEQ CHAPTER \h \r 1

Date:	1/31/00

MRIDs:	44859801, 44859802, 44869601, 44869602, 448870500-448870503, 44875100, and 44875101

DP#:	277993

Subject:	PP#6E04630  Bifenthrin in/on Leaf Petioles Subgroup 4B.  Evaluation of Residue Data and Analytical Methods.  Chemical 128825.  Case 287170.  Submission S603553.

From:	S. Levy

To:	G. LaRocca  SEQ CHAPTER \h \r 1

Date:	8/15/02

MRIDs:	45286701

DP#:	283808

Subject:	Bifenthrin (PC Code:  128825).  Residue and Product Chemistry Considerations for the Tolerance Reassessment Eligibility Decision (TRED).  Case# 819530.  Submission# S617493.

From:	S. Levy

To:	T. Myers  SEQ CHAPTER \h \r 1

Date:	8/21/02

MRIDs:	None

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

RDI: RAB1 Chemists:  03/05/2008

Petition Number:  7E7227

DP Number:  342661

PC Code:  128825

Template Version September 2005

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:   (2-methyl[1,1-biphenyl]3-yl) methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethyl-cyclopropane carboxylate	Common Name:

Bifenthrin	√ Proposed tolerance

( Reevaluated tolerance

( Other	Date: 11/12/07

Codex Status (Maximum Residue Limits)	U. S. Tolerances

 No Codex proposal step 6 or above

√ No Codex proposal step 6 or above for the crops requested	Petition Number:  PP#7E7227

DP#:  342661

Other Identifier:

Residue definition (step 8/CXL):  Bifenthrin (fat-soluble) Reviewer/Branch:  W. Wassell/RAB1

	Residue definition:  Bifenthrin per se  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Bushberry subgroup 13B	2.0

Juneberry	2.0

Lignonberry	2.0

Salal	2.0

Aronia berry	2.0

Blueberry, lowbush	2.0

Buffalo, currant	2.0

Chilean guava	2.0

European barberry	2.0

Highbush cranberry	2.0

Honeysuckle	2.0

Jostaberry	2.0

Native currant	2.0

Sea buckthorn	2.0

Leaf petioles subgroup 4B	3.0

Limits for Canada	Limits for Mexico

√  No Limits

 No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition:  N/A	Residue definition:  Bifentrina

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:  S.Funk, 11/13/2007.

Appendix I.  Tolerance Assessment Calculations.

Bushberry (Subgroup 13-07B)

Blueberry

The dataset used to establish a tolerance for bifenthrin on bushberry subgroup 13-07B consisted of field trial data for blueberry, the representative of subgroup 13-07B.  The data reflect application rates of 0.492-0.509 lb ai/A (5 applications at 0.093-0.106 lb ai/A/application) of an EC or WP formulation with a 1-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI, respectively.  The residue values used to calculate the tolerance are provided in Table I-1.

All field trial sample results for blueberry were above the LOQ (LOQ = 0.05 ppm).

The bifenthrin-blueberry dataset was entered into the tolerance spreadsheet.  Visual inspection of the lognormal probability plot (Figure I-1) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure I-2) confirmed that the assumption of lognormality should not be rejected.

Since the field trial data for bifenthrin on blueberry represent a large dataset (26 samples) and are reasonably lognormal, the minimum of the 95% upper confidence limit (UCL) on the 95th percentile and the point estimate of the 99th percentile should be selected as the tolerance value.  Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL on the 95th percentile rounds to the value 1.8 ppm and the point estimate of the 99th percentile rounds to the value 1.9 ppm (Figure I-2).  Because the 1.8-ppm value was the minimum value, 1.8 ppm is the recommended tolerance level for bifenthrin on blueberry.  A crop subgroup tolerance is appropriate for bushberry subgroup 13-07B.  The recommended value is 1.8 ppm, the maximum of the recommended individual tolerance.

Table I-1.	Residue data used to calculate tolerance for bifenthrin on bushberry subgroup 13-07B.

Regulator:	EPA

Chemical:	Bifenthrin

Crop:	Blueberry (EC and WP)

PHI:	1 Day

App. Rate:	0.492-0.509 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47144501

	Residues of Bifenthrin (ppm)

	0.500

	0.360

	1.100

	1.610

	0.950

	0.880

	0.870

	1.430

	0.800

	0.960

	0.420

	0.540

	0.710

	0.600

	0.790

	0.890

	0.520

	0.480

	0.640

	1.030

	1.060

	0.760

	0.480

	0.390

	0.430

	0.370

Figure I-1.  Lognormal probability plot of bifenthrin field trial data for blueberry.

Figure I-2.   Tolerance spreadsheet summary of bifenthrin field trial data for blueberry.

Leaf petioles subgroup 4B

Celery

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application rates of 0.493-0.515 lb ai/A (5 applications at 0.096-0.106 lb ai/A/application) of an EC or WP formulation with a 6- to 8-day PHI.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI, respectively.  The residue values used to calculate the tolerance are provided in Table I-2.

All field trial sample results for celery were above the LOQ (LOQ = 0.05 and 0.1 ppm).

The bifenthrin-celery dataset was entered into the tolerance spreadsheet.  Visual inspection of the lognormal probability plot (Figure I-3) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure I-4) confirmed that the assumption of lognormality should not be rejected.

Since the field trial data for bifenthrin on celery represent a large dataset (40 samples) and are reasonably lognormal, the minimum of the 95% upper confidence limit (UCL) on the 95th percentile and the point estimate of the 99th percentile should be selected as the tolerance value.  Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL on the 95th percentile and the point estimate of the 99th percentile round to the value 3.0 ppm (Figure I-4).  Therefore, 3.0 ppm is the recommended tolerance level for bifenthrin on celery.  A crop subgroup tolerance is appropriate for leaf petiole subgroup 4B.  The recommended value is 3.0 ppm, the maximum of the recommended individual tolerance.

Table I-2.	Residue data used to calculate tolerance for bifenthrin on leaf petiole subgroup 4B.

Regulator:	EPA

Chemical:	Bifenthrin

Crop:	Celery (EC and WP)

PHI:	6-8 Days

App. Rate:	0.493-0.515 lb ai/A

Submitter:	IR-4

MRID Citation:	MRIDs 43844101, 45286701 & 47144502

	Residues of Bifenthrin (ppm)

	1.780

	1.200

	0.710

	0.650

	0.730

	0.690

	0.110

	0.150

	1.160

	0.970

	0.430

	0.470

	0.690

	0.580

	0.060

	0.130

	0.470

	0.430

	0.570

	0.190

	0.250

	0.300

	0.340

	0.280

	1.130

	1.000

	1.230

	1.260

	0.640

	0.650

	0.790

	0.760

	0.260

	0.310

	0.870

	0.910

	0.280

	0.610

	0.110

	0.220

Figure I-3.  Lognormal probability plot of bifenthrin field trial data for celery.

Figure I-4.   Tolerance spreadsheet summary of bifenthrin field trial data for celery.

Bifenthrin	Summary of Analytical Chemistry and Residue Data	DP#:  342661

Page   PAGE  1  of   NUMPAGES  24


[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Proposed Rules]
[Page 22449]
[FR Doc No: 2015-09248]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2015-C-1154]

E. & J. Gallo Winery; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by E. & J. Gallo Winery,
proposing that the color additive regulations be amended to provide for
the safe use of mica-based pearlescent pigments as color additives in
certain distilled spirits.

DATES: The color additive petition was filed on March 19, 2015.

FOR FURTHER INFORMATION CONTACT: Salome Bhagan, Center for Food Safety
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SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food,
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E. & J. Gallo Winery, c/o Keller and Heckman LLP, Three Embarcadero
Center, Suite 1420, San Francisco, CA 94111. The petition proposes to
amend the color additive regulations in Sec.  73.350 Mica-based
pearlescent pigments (21 CFR 73.350) to provide for the safe use of
mica-based pearlescent pigments at a level of up to 0.07 percent by
weight in distilled spirits containing not less than 18 percent and not
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    We have determined under 21 CFR 25.32(k) 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.

    Dated: April 15, 2015.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2015-09248 Filed 4-21-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
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Food and Drug Administration

[Docket No. FDA-2021-N-0584]

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indicators that will reduce time for respondents and allow us to more
quickly process information and determine impacts at the Agency level.
As information will be requested of actively funded projects, it may
become necessary to request additional information for a particular
project to complete the performance evaluation(s) in a timely manner.
To ensure data is sufficient, on a case-by-case basis, FDA anticipates
a need for followup questionnaire(s) to supplement the progress reports
as instruments of collection are developed and fine-tuned through this
effort.
    In the Federal Register of July 29, 2021 (86 FR 40853), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        Awardee activity             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Report..................             400               1             400              10           4,000
Updated Reports.................             400               2             800              40          32,000
Supplement or Followup Report                100               1             100              10           1,000
 (if applicable)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          37,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We estimate that 400 respondents will participate under this pilot
project and will submit an average of 3 to 4 reports within a single
budget year (table 1). To ensure adequate reporting will be achieved
over the course of this pilot, the option for a supplement or followup
report is included in the estimated reporting burden; however, the need
for these reports will be determined on a case-by-case basis with the
FDA project manager.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Number of      Records per    Total annual
              Awardee activity                recordkeepers   recordkeeper       records          Average  burden per  recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records related to Initial Report..........             400               1             400  0.5 hour (30 minutes)......................             200
Records related to Updated Reports.........             400               2             800  0.5 hour (30 minutes)......................             400
Records related to Supplement or Followup               100               1             100  0.5 hour (30 minutes)......................              50
 Report (if applicable).
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ..............  ..............  ...........................................             650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Recordkeeping activities include storing and maintaining records
related to submitting a request to participate in the project and
compiling reports. Respondents should use current record retention
capabilities for electronic or paper storage to achieve these
activities. We assume it will take 0.5 hour/year to ensure the
documents related to submitting a request to participate in the program
are retained properly according to their existing recordkeeping
policies,

but no less than 3 years, as recommended by FDA (table 2).

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
        Awardee activity            respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
Coordination with partnering                 300               2             600               8           4,800
 entities related to Initial
 Report.........................
Coordination with partnering                 300               4           1,200               8           9,600
 entities related to Updated
 Reports........................
Coordination with partnering                 100               2             200               8           1,600
 entities related to Supplement
 or Followup Report (if
 applicable)....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          16,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For those pilot projects that involve a participant composed of
partnering entities in the program, FDA is taking into consideration
the time that partnering entities will spend coordinating with each
other in a pilot project. We estimate that 300 respondents will work
with their respective partnering entities and the average number of
partnering entities will be 2. We assume each respondent will spend 8
hours coordinating with each partnering entity on each response for
this pilot. We estimate that seven respondents will need to coordinate
with an average of two partnering entities to create updated reports
and the final report to submit to FDA (table 3).

    Dated: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13642 Filed 6-24-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)]
[Rules and Regulations]
[Pages 27775-27776]
[FR Doc No: 2017-12743]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-1036]

Safety Zones, Recurring Marine Events in Captain of the Port Long
Island Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce five safety zones for fireworks
displays in the Sector Long Island Sound area of responsibility on the
date and time listed in the table below. This action is necessary to
provide for the safety of life on navigable waterways during the

events. During the enforcement periods, no person or vessel may enter
the safety zones without permission of the Captain of the Port (COTP)
Sector Long Island Sound or designated representative.

DATES: The regulations in 33 CFR 165.151 Table 1 will be enforced
during the following dates and times listed in the table in
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Petty Officer Katherine Linnick, Waterways Management
Division, U.S. Coast Guard Sector Long Island Sound; telephone 203-468-
4565, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.151 Table 1 on the specified dates and times
as indicated.
    Under the provisions of 33 CFR 165.151, the fireworks displays
listed below are established as safety zones. During the enforcement
period, persons and vessels are prohibited from entering into,
transiting through, mooring, or anchoring within these safety zones
unless they receive permission from the COTP or designated
representative.
    This notice is issued under authority of 33 CFR 165 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
this enforcement period via the Local Notice to Mariners or marine
information broadcasts. If the COTP determines that these safety zones
need not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

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

---------------------------------------------------
7.1 Point O'Woods     Date: July 3, 2017.
 Fire Company
 Summer Fireworks
                      Rain Date: July 5,
                      2017.
                      Time: 08:45 p.m. to
                      10:30 p.m.
                      Location: Waters of
                      the Great South Bay, Point
                      O'Woods, NY in approximate
                      position 40[deg]39'18.57''
                      N., 073[deg]08'5.73'' W. (NAD
                      83).
------------------------------------------------------------------------
7.6 Sag Harbor        Date: July 1, 2017.
 Fireworks
                      Rain Date: July 2,
                      2017.
                      Time: 8:30 p.m. to
                      10:45 p.m.
                      Location: Waters of
                      Sag Harbor Bay off Havens
                      Beach, Sag Harbor, NY in
                      approximate position
                      41[deg]00'26'' N.,
                      072[deg]17'9'' W. (NAD 83).
------------------------------------------------------------------------
7.29 Mashantucket     Date: July 8, 2017.
 Pequot Fireworks
                      Rain Date: July 9,
                      2017.
                      Time: 8:45 p.m. to
                      10:45 p.m.
                      Location: Waters of
                      the Thames River, New London,
                      CT in approximate positions
                      Barge 1, 41[deg]21'03.03''
                      N., 072[deg]5'24.5'' W. Barge
                      2, 41[deg]20'51.75'' N.,
                      072[deg]5'18.90'' W. (NAD
                      83).
------------------------------------------------------------------------
7.33 Groton Long      Date: July 15, 2017.
 Point Yacht Club
 Fireworks
                      Rain Date: July 17,
                      2017.
                      Time: 9:00 p.m. to
                      10:30 p.m.
                      Location: Waters of
                      Long Island Sound, Groton, CT
                      in approximate position
                      41[deg]18'05'' N.,
                      072[deg]02'08'' W. (NAD 83).
------------------------------------------------------------------------
7.40 Rowayton         Date: July 4, 2017.
 Fireworks
                      Rain Date: July 5,
                      2017.
                      Time: 9:00 p.m. to
                      11:00 p.m.
                      Location: Waters of
                      Long Island Sound south of
                      Bayley Beach Park, Rowayton,
                      CT in approximate position
                      41[deg]03'11'' N.,
                      073[deg]26'41'' W. (NAD 83).
------------------------------------------------------------------------

    Dated: June 5, 2017.
A.E. Tucci,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2017-12743 Filed 6-16-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Proposed Rules]
[Pages 22426-22428]
[FR Doc No: 2018-10298]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0411; Product Identifier 2017-NM-157-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A319-115 and -132 airplanes, and Model A320-214, -
216, -232, and -233 airplanes. This proposed AD was prompted by a
report indicating that certain modified airplanes do not have
electrical ground wires on the fuel level sensing control unit (FLSCU),
which adversely affects the fuel gravity feeding operation. This
proposed AD would require modification of the FLSCU wiring. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by June 29, 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,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93
44 51; email: [email protected]; internet: http://www.airbus.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195.

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-
0411; 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: Sanjay Ralhan, 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-2018-0411;
Product Identifier 2017-NM-157-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
2017-0216, dated October 30, 2017 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Airbus Model A319-115 and -132
airplanes, and Model A320-214, -216, -232, and -233 airplanes. The MCAI
states:

    Airbus introduced mod 154327 on A319 and A320 aeroplanes which
substituted the pump fuel feed system from the centre fuel tank with
a jet pump transfer system, based on the Airbus A321 design.
Following the modification introduction, it was discovered that the
modified aeroplanes do not have electrical ground signals that
replicate those from the deleted centre tank pump pressure switches.
These signals are used as part of the fuel recirculation inhibition
request logic. Subsequent investigation determined that ground wires
had not been installed on the fuel level sensor control units
(FLSCU) of post-mod aeroplanes, due to a drawing error on the fuel
system recirculation principle diagram. Without these ground wires
providing inputs, the FLSCU logic is not correctly implemented for
gravity feeding operation.
    This condition, if not corrected, could lead to reduced fuel
pressure at the engine inlet, possibly resulting in an uncommanded
in-flight shut-down when flying at the gravity feed ceiling levels,
as defined in the Aircraft Flight Manual (AFM).
    To address this potential unsafe condition, Airbus issued AFM
Temporary Revision (TR) 695 Issue 1 and AFM TR 699 Issue 1 to
prohibit the use of Jet B and JP4 fuel, and AFM TR 700 Issue 1 to
provide instructions for amendment of the gravity feed procedure for
the other fuels.
    Consequently, EASA issued AD 2016-0205 [which corresponds to FAA
AD 2016-25-23, Amendment 39-18749 (81 FR 90971, December 16, 2016)
(``AD 2016-25-23'')], requiring amendment of the applicable AFM to
include the new gravity feed procedure and to reduce the list of
authorised fuels.
    Since that [EASA] AD was issued, Airbus developed a wiring
modification to restore the intended FLSCU logic, and issued Service
Bulletin (SB) A320-28-1242, later revised, providing instructions to
modify affected aeroplanes.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2016-0205, which is superseded, and requires
modification of FLSCU wiring. This [EASA] AD also allows, after that
modification, to remove the previously inserted AFM TR's from the
applicable AFM.

    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-
0411.

Relationship Between Proposed AD and AD 2016-25-23

    This NPRM would not supersede AD 2016-25-23. Rather, we have
determined that a stand-alone AD would be more appropriate to address
the changes in the MCAI. This NPRM would require modification of the
FLSCU wiring. Accomplishment of the proposed actions would then
terminate all of the requirements of AD 2016-25-23.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A320-28-1242, Revision 01, dated
October 3, 2017. The service information describes procedures for
modification of the FLSCU wiring. 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 58 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modification..........................  14 work-hours x $85 per             $204          $1,394         $80,852
                                         hour = $1,190.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    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: Docket No. FAA-2018-0411; Product Identifier 2017-NM-157-AD.

(a) Comments Due Date

    We must receive comments by June 29, 2018.

(b) Affected ADs

    This AD affects AD 2016-25-23, Amendment 39-18749 (81 FR 90971,
December 16, 2016) (``AD 2016-25-23'').

(c) Applicability

    This AD applies to Airbus Model A319-115 and -132 airplanes, and
Model A320-214, -216, -232, and -233 airplanes, certificated in any
category, all manufacturer serial numbers on which Airbus
modification 154327 has been embodied in production, except those on
which Airbus modification 158740 has been embodied.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by a report indicating that certain
modified airplanes do not have electrical ground wires on the fuel
level sensing control unit (FLSCU), which adversely affects the fuel
gravity feeding operation. We are issuing this AD to prevent reduced
fuel pressure at the engine inlet, potentially resulting in an
uncommanded in-

flight shutdown when flying at the fuel gravity feed ceiling levels.

(f) Compliance

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

(g) Modification

    Within 24 months after the effective date of this AD, modify the
FLSCU wiring in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-28-1242, Revision 01, dated October 3,
2017.

(h) Terminating Action for AD 2016-25-23 and Amendment of the Airplane
Flight Manual (AFM)

    Modification of an airplane as required by paragraph (g) of this
AD terminates all of the requirements of AD 2016-25-23 for that
airplane. After modification of an airplane as required by paragraph
(g) of this AD, remove Airbus A318/A319/A320/A321 Temporary Revision
TR695, Issue 1.0, dated August 1, 2016; or Airbus A318/A319/A320/
A321 Temporary Revision TR699, Issue 1.0, dated August 1, 2016; as
applicable; and Airbus A318/A319/A320/A321 Temporary Revision TR700,
Issue 1.0, dated August 1, 2016, from the applicable AFM of that
airplane.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Airbus Service Bulletin A320-28-1242, dated
December 21, 2016.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email 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's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0216, dated October 30, 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-2018-0411.
    (2) For more information about this AD, contact Sanjay Ralhan,
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, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 44 51; email: [email protected];
internet: http://www.airbus.com. You may view this service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on May 8, 2018.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2018-10298 Filed 5-14-18; 8:45 am]
 BILLING CODE 4910-13-P