Interregional Research Project Number 4 (IR-4)

PP# 4E8311

	EPA has received a pesticide petition (4E8311) from Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W,  Princeton, NJ 08540  requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.507 as follows:

      By establishing tolerances for residues of flubendiamide, (N[2]-1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N[1]-2-methyl-4-1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethylphenyl-1,2-benzenedicarboxamide) in or on the following: Bushberry subgroup 13-07B at 8.0 parts per million (ppm); Vegetable, fruiting group 8-10 at 0.60 ppm; Fruit, pome, group 11-10 at 1.5 ppm; Fruit, stone, group 12-12 at 1.6 ppm; Nut, tree, group 14-12 at 0.06 ppm; and Sunflower, subgroup 20B at 5.0 ppm.

      Upon the approval of the aforementioned tolerances, to remove the established tolerances for flubendiamide, (N[2]-1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N[1]-2-methyl-4-1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethylphenyl-1,2-benzenedicarboxamide) in or on the following: Fruit, pome, group 11 at 1.5 ppm; Fruit, stone, group 12 at 1.6 ppm; Nut, tree, group 14 at 0.06 ppm; Safflower, seed at 5.0 ppm; and Sunflower, seed at 5.0 ppm

      EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolism in plants was limited, with parent flubendiamide being the major residue observed in all of the studies (tomato, cabbage, apple, and corn).  NNI-0001-des-iodo, a minor metabolite found in the plant metabolism studies, was formed by reductive deiodination of flubendiamide.

	2. Analytical method. Independently validated, analytical methods for crop matrices have been submitted for measuring flubendiamide.  Typically, plant matrices samples are extracted, concentrated, and quantified by LC/MS/MS using deuterated internal standards.

	3. Magnitude of residues. Magnitude of the residue data were conducted on lowbush blueberry and highbush blueberry (Bushberry subgroup 13-07B) according to OPPTS Guideline 860.1500. The data supports revising the requested tolerances.

B. Toxicological Profile

	1. Acute toxicity.  Technical flubendiamide and the formulated products show low acute toxicity (Toxicity Category III or IV) via the oral, dermal and inhalation routes of exposure.  Flubendiamide technical exhibits very low acute oral (LD50: >2,000 mg/kg bw), dermal (LD50: >2,000 mg/kg bw) and inhalative toxicity (LC50: >68.5 mg/m[3] air; the mean maximum attainable concentration) in male and female rats.  Though a slight irritant to the eye, flubendiamide is non-irritating to skin and it shows no skin sensitization potential under the conditions of the guinea pig maximization test.  There were no neurotoxicity concerns based on the acute neurotoxicity study.

	2. Genotoxicty. Flubendiamide was tested for its genotoxic potential in a battery of in vitro or in vivo studies covering all required end-points (gene mutations, chromosomal aberrations, and DNA damage and repair).  There was no evidence of genotoxicity.

	3. Reproductive and developmental toxicity. Flubendiamide shows no evidence of primary developmental or reproductive effects.  In the prenatal developmental toxicity studies in rats and rabbits and in the two-generation reproduction study in rats, toxicity to the offspring occurred at equivalent or higher doses than maternal toxicity.  No effect on embryo/fetal development was observed in rabbits and no evidence to suggest that flubendiamide possesses a teratogenic potential was noted in either species.  There were no neurotoxicity concerns based on the developmental neurotoxicity (DNT) study.

An enlargement of the eyeball (buphthalmia) was noted in rat offspring in the reproductive and DNT studies.  Supplemental studies designed to investigate the cause of the eye effect were able to establish a link to the unique inability of the female rat, unlike other mammalian species including humans, to oxidize the parent compound, resulting in a higher body burden and subsequent exposure to flubendiamide.  As a conservative estimate buphthalmia was selected as the endpoint to establish the acute reference dose (aRfD) using the DNT, two-generation, and one-generation reproduction studies in the rat as co-critical studies with a NOAEL of 99.5 mg/kg (the highest NOAEL) and a LOAEL of 127 mg/kg (the lowest LOAEL). Using the NOAEL for buphthalmia from the DNT study, which had the shortest duration of exposure ( 36 days), in conjunction with the lowest LOAEL observed in the database for this effect result in a more refined acute dietary risk assessment.

	4. Subchronic toxicity. The subchronic toxicity of flubendiamide was investigated via the oral route in 90-day feeding studies in mouse, rat and dog, and via the dermal route in a 30-day dermal toxicity study in rat.  Animals generally responded to exposure to flubendiamide with signs of nonspecific toxicity.  Rats, dogs, and mice tolerated the chemical in excess of the limit dose without mortalities or clinical signs.  Effects were similar in the chronic studies.  In rats, there is a pronounced difference between the sexes in their susceptibility to flubendiamide exposure.  Female rats were much more sensitive to the toxic actions of flubendiamide than male rats, which was principally attributed to a diminished capacity of the female rat to oxidatively metabolize relative to the male rat.  The primary target organ in rats and mice was the liver.  In the rat, liver changes typically observed first in the female rat with respect to dose and time included increased liver weight, periportal (microvesicular) fatty change of hepatocytes, decreased alkaline phosphatase activity, and increased -glutamyl transpeptidase activity.  In the mouse liver, hepatocellular centrilobular hypertrophy, fatty change of hepatocytes, and dark-colored tissue were observed in both sexes.  Alterations in red blood cell parameters were also noted and included declines in mean corpuscular volume, hematocrit and hemoglobin concentration, increased platelet count, and decreased total bilirubin.  A further target in the rat was the thyroid, characterized by the occurrence of follicular cell hypertrophy in both sexes but emerging later in the male with respect to dose and time; the thyroid pathology was not accompanied by alterations in circulating thyroid hormones despite evidence of slightly increased serum TSH levels.  Targets were similar in the 30-day rat dermal toxicity study.  In the dog, moderate liver effects (increased: alkaline phosphatase, triglycerides, liver weight) were also observed; however, generating a pronounced systemic toxicity proved challenging, even using high doses that exceeded the limit dose of 1,000 mg/kg body weight.  The 90-day oral NOAEL was 13.1 mg/kg/based on a indications of a slight hepatotoxicity in the female rat.  In the mouse and dog, the NOAEL was 11.9 and 2.58 mg/kg bw/day, respectively.  The NOAEL was 100 mg/kg/day in the rat dermal toxicity study.

	5. Chronic toxicity. Over the chronic duration via the oral route, the primary target organs across dogs, rats and mice are liver, kidney and thyroid; with an increase in organ weight, fatty change, and hypertrophy. Changes in hematocrit, hemoglobin, mean corpuscular volume and eosinophil counts were noted in the 1-year rat and 2-year rat studies. For the chronic Reference Dose (cRfD), the 1-year chronic toxicity study in the rat, 1-year chronic toxicity in the dog, and the 2-year rat cancer study were selected as three co-critical studies with a NOAEL/LOAEL of 2.4/33.9 mg/kg/day (highest NOAEL of 2.4 mg/kg/day from 1-year chronic rat study and lowest LOAEL of 33.9 mg/kg/day from 2-year chronic rat study; although the 1-year dog had NOAELs of 2.21/2.51 mg/kg/day - the lowest NOAELs from each study was considered when comparing NOAELs among the three studies), respectively, based on the consistent liver toxicity reported across multiple studies, different durations, and multiple species.

The NOAEL in the oncogenic mouse study was 4.44 mg/kg bw/day, based on liver and thyroid effects.  Flubendiamide is not likely to be carcinogenic, based on rat and mouse bioassays as well as negative in vivo and in vitro mutagenic effects.

	6. Animal metabolism. Following oral administration of flubendiamide to rats, blood and plasma levels peaked approximately 6 to 12 hours after dosing followed by continuous decline.  The flubendiamide was fairly well distributed among blood and most of the organs and tissues with some preference for liver, adrenal glands, and fat.  Male rats showed a more rapid clearance of residues than in the female animals.  In general, excretion of flubendiamide residues was rapid, with feces being the predominant excretion route.  Renal excretion accounted for only 2% and <1% of the dose in male and female rats, respectively.  Absorption was demonstrated by bile fistula studies.  Metabolism of flubendiamide in the male rat was primarily by oxidation and that in female rats was by oxidation and glutathione conjugation.  Parent flubendiamide,  NNI-0001-benzylalcohol and NNI-0001-benzoic acid were the major residues identified in the feces.  In the ruminant and poultry metabolism studies, NNI-0001-iodophthalimide was the only significant metabolite, and is included in the risk assessment.

	7. Metabolite toxicology. As the metabolism of flubendiamide was very limited, no significant testing of metabolites has been conducted.  Acute oral and mutagenic testing (bacterial reverse mutation) was conducted on NNI-0001-des-iodo, NNI-0001-3-OH and NNI-0001-iodophthalimide metabolites.  Overall, relative to the parent compound, neither an acute nor a mutagenic concern emerged following toxicological screening of these metabolites derived from exposure to flubendiamide technical.  NNI-0001-des-iodo was the major plant metabolite but it was present at levels of less than 4% of the total residue in field trials.  It was not found in animals but was present as an impurity in flubendiamide technical, the test material for toxicity studies.

	8. Endocrine disruption. The toxicology database for flubendiamide is current and complete.  Studies in this database include evaluation of the potential effects on reproduction and development and an evaluation of the pathology of the endocrine organs following short- or long-term exposure.  At the higher doses, possible endocrine effects following exposure to flubendiamide were noted in the adrenal (increased weight in rats; cortical hypertrophy in dogs), ovary (interstitial cell vacuolation in rats), and thyroid (increased weight and follicular cell hypertrophy in rats).  The reversibility of histological thyroidal effects was demonstrated in subchronically-treated female rats during a four-week recovery period.  Thyroid follicular cell hypertrophy emerged as one major endpoint in all rat studies.  In the case of F344 rats, the activation of the thyroid is consistent with an indirect hypothesis, involving increased TSH secretion from the pituitary in order to restore depressed levels of circulating thyroid hormone brought about by a chemically-induced increase in thyroxine metabolism.  Consistent with this hypothesis, an increase in hepatic UDP-GT activity was measured in female F344 rats in a special 28-day thyroid hormone study.  In general, chemically-induced interference with thyroid regulation, through enhanced metabolism of circulating thyroxine, is considered a greater toxicological concern to rodents than humans.

C. Aggregate Exposure

	1. Dietary exposure. The toxicology database for flubendiamide is complete for the purposes of this risk assessment and the characterization of potential pre- and postnatal risks to infants and children.  Although susceptibility was identified in the toxicological database (eye effects), the selected regulatory points of departure (PODs) are protective of these effects, and therefore, the human health risk assessments are protective.  There are no treatment-related neurotoxic findings in the acute neurotoxicity and developmental neurotoxicity studies in rats.  Based on the data, EPA has reduced the FQPA Safety Factor to 1X and, therefore, an uncertainty factor of 100 is adequate to account for inter- and intra- species variability.  Acute and chronic Population Adjusted Doses (aPAD and cPAD) are, therefore, the same as the reference doses for the populations and subpopulations of interest.  Acute dietary exposure was expressed as a percentage of the aPAD of 0.995 mg/kg bw/day from a highest NOAEL of 99.5 mg/kg bw/day established from the co-critical DNT, one generation and two generation reproductive studies in the rat with an uncertainty factor of 100.  Chronic dietary exposure was expressed as a percentage of the chronic Population Adjusted Dose (cPAD) of 0.024 mg/kg bw/day based on the highest NOAEL of 2.4 mg/kg bw/day established from the co-critical 1-year chronic toxicity study in the rat, 1-year chronic toxicity in the dog, and the 2-year rat cancer study.

      i. Food. Food exposure estimates were calculated using DEEM-FCID Ver. 3.16 software, with NHANES WWEIA 2003 to 2008 consumption data.  Acute assessments assumed that 100% of crops with registered and pending uses of flubendiamide are treated, and that all treated crops contain residues at tolerance level.  In addition, tolerance level residues for livestock commodities were also included in the analyses to account for the potential transfer of plant residues to livestock tissues.  The refined chronic assessments assumed average percent of crops with registered and pending uses of flubendiamide are treated, and that all treated crops contain residues at the average residue levels found in crop field trials.  Experimentally determined processing factors were incorporated, where available.  In addition, Maximum Reasonable Balanced Diet estimation of residues for livestock commodities were also included in the chronic analyses to account for the potential transfer of plant residues to livestock tissues. Acute exposure (95th percentile) for food only utilizes 4% of the aPAD for the US Population and 8.8% for Children 1-2, the most highly exposed subpopulation. Chronic exposure for food only utilizes 3.6% of the cPAD for the US Population and 5.8% of the cPAD for Children 1-2, the most highly exposed subpopulation.

      ii. Drinking water. Estimated Drinking Water Concentration (EDWCs) associated with flubendiamide use on all crops were calculated using PRZM-GW (ver. 1.0). The highest potential drinking water exposure from registered and pending uses of flubendiamide was from ground water using the Wisconsin corn scenario.  For acute exposure, the EDWC of 116 g/L used in the assessment.  For chronic exposure the EDWC of 112 g/L used in the assessment.  EDWCs were incorporated into exposure assessments using DEEM-FCID 3.16.  Incorporation of the acute EDWC of 116 g/L resulted in acute aggregate dietary exposure (food and water) of 4.4% aPAD for the overall U.S. population.  For the most highly exposed population subgroup, children 1 -2 yrs., acute aggregate exposure (food and water) was 9.3% of the aPAD.  Incorporation of the chronic EDWC of 112 g/L into the exposure assessment resulted in chronic aggregate dietary exposure (food and water) of 13% cPAD for the overall U.S. population.  For the most highly exposed population subgroup, children 1 -2 yrs., chronic aggregate exposure (food and water) was 31% of the cPAD.

	2. Non-dietary exposure. The maximum seasonal and single use rate has not changed and no new methods of application or field post application activities are introduced by the additional crops.  There have been updates to the unit exposures as EPA transitions from PHED to AHETF unit exposures and has refined the default post application initial DFR and TC values. However, based on the MOEs originally calculated by the Agency, these refinements do not alter the determination that the MOEs all exceed 100. Hence, a risk to bystanders, field workers, and applicators is not expected to change from the current acceptable levels.

D. Cumulative Effects

	At this time, there is no available information to indicate that flubendiamide or its metabolites have a common mechanism of human toxicity with other substances.  Flubendiamide is a ryanodine receptor agonist belonging to the chemical class of phthalic acid diamides.  The biological mode of action of flubendiamide is not reflected by the results of the multiple-dose feeding studies in rodents and dogs.  For this class of chemistry, EPA has not yet conducted a detailed review of common mechanisms to determine whether it is appropriate, or how to include these chemicals in a cumulative risk assessment.  Flubendiamide does not appear to produce a toxic metabolite produced by other substances.  For the purposes of these tolerance actions, therefore, EPA has not assumed that flubendiamide has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Using the conservative exposure data from GLP conducted trials to determine dietary exposure and conservative models to calculate drinking water exposure and based on the completeness of the toxicity data, it can be estimated that aggregate exposure (dietary plus water) to residues of flubendiamide from all proposed uses will utilize 4.4% of the aPAD for the U.S. population and 13.3% of the cPAD for the U.S. population.  These estimates are well below HED's level of concern (100% of the aPAD or cPAD).  Therefore, there is reasonable certainty that no harm will result to the general U.S. population from aggregate exposure to flubendiamide residues from proposed uses.

	2. Infants and children. Based on the completeness of the database and the conservative nature of the assumptions used in the exposure assessment, the FQPA safety factor for infants and children has been reduced to 1X.  Using the conservative exposure data from GLP conducted trials to determine dietary exposure and conservative models to calculate drinking water exposure, the aggregate (food and water), acute dietary exposure occupies 9.3% of the aPAD for the most highly exposed subpopulation, children 1-2 yrs. and the aggregate (food and water), chronic dietary exposure occupies 31% of the cPAD for the most highly exposed subpopulation, children 1-2 yrs..  These estimates are well below HED's level of concern (100% of the aPAD or cPAD).   Therefore, there is reasonable certainty that no harm will result to infants or children from aggregate exposure to flubendiamide residues from proposed uses.

F. International Tolerances

	International tolerances established for Flubendiamide can be found in the table below.

Crop[a]
                                      US
                                     EU[b]
                                     CODEX
                                   Japan[c]
                                    Taiwan
                                     Korea
APPLE
                                      1.5
                                      0.8
                                      0.8
                                       1
                                       1
                                       1
APRICOT
                                      1.6
                                      0.8
                                       2
                                       2

                                       1
ARTICHOKE, GLOBE
                                      1.6
                                     0.01

                                     0.01

BALSAM PEAR
                                      0.2
                                     0.15
                                      0.2
                                       2

BEAN, ADZUKI, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, BROAD(FAVA BEAN), DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
BEAN, FIELD, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, KIDNEY, DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
BEAN, LABLAB, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, LIMA, DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
BEAN, MOTH, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, MUNG, DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
BEAN, NAVY, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, PINTO, DRY
                                      0.6

                                       1

BEAN, RICE, DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
BEAN, TEPARY, DRY
                                      0.6
                                       1
                                       1
                                       1

BEAN, URD, DRY
                                      0.6
                                       1
                                       1
                                       1

BLUEBERRY, LOWBUSH
                                      1.5
                                     0.01

                                     0.01

                                       1
BROCCOLI
                                       3
                                     0.01
                                       4
                                       5
                                       1
                                       3
BROCCOLI RAAB
                                      25
                                     0.01

                                      25

BRUSSELS SPROUTS
                                       3
                                     0.01
                                       4
                                       4
                                       1

CABBAGE
                                       3
                                       4
                                       4
                                       4
                                       1
                                       1
CABBAGE, CHINESE, BOK CHOY
                                      25
                                     0.01

                                       5
                                       1
                                       3
CABBAGE, CHINESE, MUSTARD, GAI CHOY
                                       3
                                     0.01

                                       1

CABBAGE, CHINESE, NAPA
                                       3
                                     0.01

                                       5
                                       1
                                       1
CANTALOUPE
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
CATTLE, BY PRODUCTS
                                      0.6
                                       1
                                       1
                                       1

CATTLE, FAT
                                      0.7
                                       2

                                       2

CATTLE, KIDNEY
                                      0.6
                                       1
                                       1
                                       1

CATTLE, LIVER
                                      0.6
                                       1
                                       1
                                       1

CATTLE, MEAT
                                     0.08
                                       2
                                       2
                                       1

CAVALO BROCCOLO
                                       3

CELERY
                                      11
                                       5
                                       5
                                       5

                                       5
CHAYOTE, FRUIT
                                      0.2
                                     0.15
                                      0.2
                                       2

CHERRY, SWEET
                                      1.6
                                       2
                                       2
                                       2
                                       1
                                       1
CHERRY, TART
                                      1.6
                                       2
                                       2
                                       2
                                       1
                                       1
CHICKEN, FAT
                                       3
                                     0.01

                                     0.01

CHICKEN, LIVER
                                      0.6
                                     0.01

                                     0.01

CHICKEN, MEAT
                                      0.1
                                     0.01

                                     0.01

COLLARDS
                                      25
                                     0.01

                                      25

CORN SALAD
                                      11
                                     0.01

                                      25

CORN, GRAIN
                                     0.03
                                     0.02
                                     0.02
                                     0.05

                                     0.05
CORN, POP
                                     0.02
                                     0.01

                                     0.05

CORN, SWEET, KERNELS PLUS COB WITH HUSKS REMOVED
                                     0.01
                                     0.02
                                     0.02
                                     0.05

                                     0.02
COTTONSEED
                                      0.9
                                      1.5
                                      1.5
                                       2

                                      1.5
CRESS, GARDEN
                                      11
                                     0.01

CRESS, UPLAND
                                      11
                                     0.01

                                     0.01

CUCUMBER
                                      0.2
                                     0.15
                                      0.2
                                      0.7

                                       1
CUCUMBER, CHINESE
                                      0.2

EGGPLANT
                                      0.6
                                      0.2

                                       1

                                      0.7
EGGS, CHICKEN
                                      0.4
                                     0.01

                                     0.01

ENDIVE (ESCAROLE)
                                      11
                                     0.01

                                     0.01

                                       3
FENNEL, BULB
                                      11
                                     0.01

                                      25

GHERKIN, WEST INDIAN
                                      0.2
                                     0.15
                                      0.2

GRAPE, TABLE
                                      1.4
                                       2
                                       2
                                       2

                                       2
GRAPE, WINE
                                      1.4
                                       2
                                       2
                                       2

                                       2
HOG, BY PRODUCTS
                                     0.15
                                       1
                                       1
                                       1

HOG, FAT
                                     0.15
                                       2

                                       2

HOG, KIDNEY
                                     0.15
                                       1
                                       1
                                       1

HOG, LIVER
                                     0.15
                                       1
                                       1
                                       1

HOG, MEAT
                                     0.03
                                       2
                                       2
                                       1
                                       1

KALE
                                      25
                                     0.01

                                      25

                                       3
KIWIFRUIT, HARDY
                                      1.4
                                     0.01

                                      0.1

                                      0.5
LETTUCE, HEAD
                                      11
                                       7
                                       5
                                      15

                                       5
LETTUCE, LEAF
                                      11
                                       7
                                       7
                                      15

                                      10
LETTUCE, ROMAINE (COS)
                                      11
                                       7

                                      15

                                      10
MELON, CASABA
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
MELON, CITRON
                                      0.2

                                      0.2
                                     0.05

MELON, CRENSHAW
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
MELON, GOLDEN PERSHAW
                                      0.2
                                     0.06

                                     0.05

                                       1
MELON, HONEY BALL
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
MELON, HONEYDEW
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
MELON, MANGO
                                      0.2
                                     0.06
                                      0.2

                                       1
MELON, PERSIAN
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
MELON, PINEAPPLE
                                      0.2
                                     0.06

                                     0.05

                                       1
MELON, SANTA CLAUS
                                      0.2
                                     0.06

                                     0.05

                                       1
MELON, SNAKE
                                      0.2
                                     0.06
                                      0.2

                                       1
MILK FAT, CATTLE
                                       1
                                      0.1
                                       5

MILK, CATTLE
                                     0.15
                                      0.1
                                      0.1
                                      0.1

MUSKMELON
                                      0.2
                                     0.06
                                      0.2
                                     0.05
                                       1
                                       1
MUSTARD GREENS
                                      25
                                     0.01

                                      25

                                       3
MUSTARD SPINACH
                                      25
                                     0.01

                                      25
                                       1

NECTARINE
                                      1.6
                                      0.8
                                       2
                                       2

                                       1
NUT, BEECH
                                     0.06
                                      0.1
                                      0.1
                                      0.1

NUT, BRAZIL
                                     0.06
                                      0.1
                                      0.1
                                      0.1

NUT, BUTTER
                                     0.06
                                      0.1
                                      0.1

NUT, CASHEW
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
NUT, CHESTNUT
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
NUT, HICKORY
                                     0.06
                                      0.1
                                      0.1
                                      0.1

NUT, MACADAMIA
                                     0.06
                                      0.1
                                      0.1
                                      0.1
                                     0.06
                                     0.05
NUT, PECAN
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
NUT, PISTACHIO
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
OKRA
                                      0.3
                                     0.01

                                       2

                                      0.7
ORACH
                                      11

PEA, FIELD, DRY
                                      0.6
                                       1
                                       1
                                       1

                                     0.05
PEACH
                                      1.6
                                      0.8
                                       2
                                     0.05

                                      0.7
PEANUT OIL, EDIBLE
                                     0.03

                                     0.01

PEAR
                                      1.5
                                      0.8
                                      0.8
                                       1

                                       1
PEAR, ASIAN
                                      1.5
                                      0.8
                                      0.8
                                       1

PEPINO
                                      0.6
                                      0.2

                                      0.1
                                       2

PEPPER, BELL
                                      0.6
                                      0.2
                                      0.7
                                       3

                                       1
PEPPER, NON-BELL
                                      0.6
                                      0.2
                                      0.7
                                      10

                                       1
PLUM, CHERRY
                                      1.6
                                     0.01
                                       2
                                       2

PLUM, CHICKASAW
                                      1.6
                                     0.01
                                       2
                                       2

PLUM, DAMSON
                                      1.6
                                     0.01
                                       2
                                       2

PLUM, GREENGAGE
                                      1.6
                                     0.01
                                       2

PLUM, JAPANESE
                                      1.6
                                     0.01
                                       2
                                       2

PLUM, PRUNE, FRESH
                                      1.6
                                     0.01
                                       2
                                       2

                                       1
PLUMCOT
                                      1.6

                                       2

PUMPKIN
                                      0.2
                                     0.06
                                      0.2
                                      0.2

                                       1
QUINCE
                                      1.5
                                      0.8
                                      0.8
                                      0.8

                                      0.5
RADICCHIO (RED CHICORY)
                                      11
                                     0.01

                                       1
                                       3
RAPE GREENS
                                      25
                                     0.01

                                      25

RICE, GRAIN
                                      0.5
                                      0.2

                                      0.5
SAFFLOWER, SEED
                                       5
                                     0.01

                                     0.01

                                     0.05
SHEEP, BY PRODUCTS
                                      0.6
                                       1
                                       1
                                     0.01

SHEEP, FAT
                                      0.7
                                       2

                                     0.01

SHEEP, KIDNEY
                                      0.6
                                       1
                                       1
                                     0.01

SHEEP, LIVER
                                      0.6
                                       1
                                       1
                                     0.01

SHEEP, MEAT
                                     0.08
                                       2
                                       2
                                     0.01

SORGHUM, GRAIN
                                       5
                                     0.01

                                     0.01

                                     0.05
SOYBEAN
                                     0.25
                                     0.01
                                       1
                                       1

                                     0.05
SOYBEAN (IMMATURE SEED)
                                      0.5
                                      0.5
                                       2
                                       5

                                     0.05
SPINACH
                                      11
                                      10

                                     0.01

                                      10
SPINACH, NEW ZEALAND
                                      11
                                      10

                                       5

SPINACH, VINE
                                      11
                                     0.01

                                       5

SQUASH, ACORN
                                      0.2
                                     0.06
                                      0.2
                                      0.2

                                       1
SQUASH, BUTTERNUT
                                      0.2
                                     0.06
                                      0.2
                                      0.2

                                       1
SQUASH, CROOKNECK
                                      0.2
                                     0.15
                                      0.2
                                      0.2

                                       1
SQUASH, HUBBARD
                                      0.2
                                     0.06
                                      0.2
                                      0.2

                                       1
SQUASH, SCALLOP
                                      0.2
                                     0.15
                                      0.2
                                      0.2

                                       1
SQUASH, SPAGHETTI
                                      0.2
                                     0.06
                                      0.2
                                      0.2

                                       1
SQUASH, STRAIGHTNECK
                                      0.2
                                     0.15
                                      0.2
                                      0.2

                                       1
STRAWBERRY
                                      1.5

                                       2

                                       1
SUGAR CANE
                                      0.3
                                     0.01

                                     0.01

SUNFLOWER, SEED
                                       5
                                     0.01

                                     0.01

                                     0.05
SWISS CHARD
                                      11
                                     0.01

                                      25

                                       3
TOMATILLO
                                      0.6
                                      0.2

                                       5

TOMATO
                                      0.6
                                      0.2
                                       2
                                       2

                                      0.7
TURKEY, FAT
                                       3
                                     0.01

                                     0.01

TURKEY, LIVER
                                      0.6
                                     0.01

                                     0.01

TURKEY, MEAT
                                      0.1
                                     0.01

                                     0.01

TURNIP, TOPS
                                      25
                                     0.01

                                      25

WALNUT, BLACK
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
WALNUT, ENGLISH (PERSIAN)
                                     0.06
                                      0.1
                                      0.1
                                      0.1

                                     0.05
WATERMELON
                                      0.2
                                     0.06
                                      0.2
                                     0.05

                                       1
ZUCCHINI
                                      0.2
                                     0.15
                                      0.2
                                      0.2

                                       1
  [a] MRL data extracted from Federal Registry and / or  FAS MRL Database (www.mrldatabase.com)
  [b] Default MRL in Europe = 0.01 ppm
  [c] Default MRL in Japan = 0.01 ppm


[Federal Register Volume 84, Number 54 (Wednesday, March 20, 2019)]
[Rules and Regulations]
[Pages 10259-10262]
[FR Doc No: 2019-05199]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0121; Product Identifier 2019-NM-025-AD; Amendment
39-19591; AD 2019-05-09]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus SAS Model A320-251N and -271N airplanes, and Model A321-253N
airplanes. This AD was prompted by reports of low clearance between the
electrical harness and nearby hydraulic pipes in the inboard trailing
edge of the wing. This AD requires repetitive detailed inspections of
certain electrical harnesses for discrepancies and corrective actions,
if necessary, as specified in an European Aviation Safety Agency (EASA)
AD, which is incorporated by reference. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD becomes effective April 4, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 4,
2019.
    We must receive comments on this AD by May 6, 2019.

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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For the incorporation by reference (IBR) material described in the
``Related IBR Material Under 1 CFR part 51'' section in SUPPLEMENTARY
INFORMATION, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 89990 1000; email<EMAIL_ADDRESS>
internet www.easa.europa.eu. You may find this IBR material on the EASA
website at https://ad.easa.europa.eu. You may view this IBR material at
the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at http://www.regulations.gov.

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-2019-
0121; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (telephone 800-
647-5527) 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:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0035, dated February 15, 2019
(``EASA AD 2019-0035'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A320-251N and -271N airplanes,
and Model A321-253N airplanes. The MCAI states:

    Low clearance between electrical harness and nearby hydraulic
pipes has been detected in the inboard trailing edge of some
aeroplanes.
    This condition, if not detected and corrected, could lead to
chafing of electrical harnesses on hydraulic pipes, eventually
creating an ignition source in the flammable fluid leakage zone
area, possibly resulting in fire or an explosion and loss of the
aeroplane.
    To address this potential unsafe condition, Airbus issued the
AOT [alert operators transmission], providing instructions to
accomplish a detailed inspection (DET) for clearance and damage, and
published the modification SB [Service Bulletin A320-29-1176],
providing instructions to modify the electrical harness routing,
increasing the clearance between electrical harness and hydraulic
pipes.
    For the reasons described above, this [EASA] AD requires
repetitive DET of the electrical harness and modification of the
aeroplane.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0035 describes procedures for repetitive detailed
inspections of certain electrical harnesses for discrepancies
(clearance and damage) and corrective actions, if necessary. Corrective
actions include repairing the electrical harness or replacing the
electrical harness sleeve, and increasing the clearance between the
affected electrical harness and hydraulic pipe. This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section, and it is publicly available through the EASA
website.

FAA's Determination

    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 referenced
above. We are issuing this AD because we evaluated all pertinent
information and determined the unsafe condition exists and is likely to
exist or develop on other products of the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2019-0035 described previously through the incorporated by reference of
EASA AD 2019-0035, except for any differences identified as exceptions
in the

regulatory text of this AD and except as discussed under ``Differences
Between this AD and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA worked with Airbus and EASA to develop a process to
use certain EASA ADs as the primary source of information for
compliance with requirements for corresponding FAA ADs. As a result,
EASA AD 2019-0035 is incorporated by reference in the FAA final rule.
This AD, therefore, requires compliance with the provisions specified
in EASA AD 2019-0035, except for any differences identified as
exceptions in the regulatory text of this AD. Service information
specified in EASA AD 2019-0035 that is required for compliance with
EASA AD 2019-0035 is available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0121.

Differences Between This AD and the MCAI

    EASA AD 2019-0035 specifies to modify the airplane (modification of
the adaptation damper bulkhead fitting for left hand and right hand
wings). For this AD, the modification, which would terminate the
repetitive inspections required by this AD, is optional. However, we
are considering further rulemaking to require this modification. The
planned compliance time for the modification would allow enough time to
provide notice and opportunity for prior public comment on the merits
of the modification. This difference has been coordinated with EASA.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because failure to detect and correct chafing of electrical harnesses
in the vicinity of hydraulic pipes could result in a potential source
of ignition in the flammable fluid leakage zone, and possibly result in
a fire or explosion and loss of the airplane. Therefore, we find good
cause that notice and opportunity for prior public comment are
impracticable. In addition, for the reasons stated above, we find that
good cause exists for making this amendment effective in less than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2019-0121; Product
Identifier 2019-NM-025-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD 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 AD.

Costs of Compliance

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

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
6 work-hours x $85 per hour = $510...........................              $0             $510           $7,140
----------------------------------------------------------------------------------------------------------------

                  Estimated Costs for Optional Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
16 work-hours x $85 per hour = $1,360.          $8,900          $10,260
------------------------------------------------------------------------

    We estimate the following costs for the necessary on-condition
action that would be required based on the results of any required
actions. We have no way of determining the number of aircraft that
might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
           Labor cost               Parts cost       Cost per  product
------------------------------------------------------------------------
Up to 8 work-hours x $85 per              \*\ $0  Up to $680.
 hour = $680.
------------------------------------------------------------------------
* We have received no definitive data that would enable us to provide
  parts cost estimates.

    According to the manufacturer, some or all of the costs of this 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 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 and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-05-09 Airbus SAS: Amendment 39-19591; Docket No. FAA-2019-0121;
Product Identifier 2019-NM-025-AD.

(a) Effective Date

    This AD becomes effective April 4, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus SAS Model A320-251N and -271N
airplanes, and Model A321-253N airplanes, certificated in any
category, as identified in European Aviation Safety Agency (EASA) AD
2019-0035, dated February 15, 2019 (``EASA AD 2019-0035'').

(d) Subject

    Air Transport Association (ATA) of America Code 92, Electric and
electronic common installation.

(e) Reason

    This AD was prompted by reports of low clearance between the
electrical harness and nearby hydraulic pipes in the inboard
trailing edge of the wing. We are issuing this AD to address this
condition, which, if not detected and corrected, could lead to
chafing of electrical harnesses in the vicinity of hydraulic pipes
and could result in a potential source of ignition in the flammable
fluid leakage zone, and possibly result in a fire or explosion and
loss of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0035.

(h) Exceptions to EASA AD 2019-0035

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0035 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0035 does not apply
to this AD.
    (3) Where paragraph (4) of EASA AD 2019-0035 specifies to modify
the airplane in accordance with Airbus Service Bulletin A320-29-
1176, this AD does not require modification of the airplane, but
this AD allows that modification as an optional terminating action
for the required repetitive inspections.
    (4) The provisions of paragraph (6) of EASA AD 2019-0035 are
allowed in the optional modification specified in paragraph (h)(3)
of this AD.

(i) No Reporting Requirement

    Although certain service information referenced in EASA AD 2019-
0035 specifies to submit certain information to the manufacturer,
this AD does not include that requirement.

(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) of this AD. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0035 that contains RC procedures and
tests: Except as required by paragraph (j)(2) of this AD, RC
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

    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>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.

    (i) European Aviation Safety Agency (EASA) AD 2019-0035, dated
February 15, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0035, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 89990 6017; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this EASA AD 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>. EASA AD
2019-0035 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0121.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on March 11, 2019.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-05199 Filed 3-19-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 7, 2010 (Volume 75, Number 108)]
[Rules and Regulations]
[Page 32094-32096]
[DOCID:fr07jn10-4]

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

DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30726; Amdt. No. 3375]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective June 7, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 7, 2010.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM and contained in this
amendment, are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    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.
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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on May 14, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows: Sec. Sec.  97.23, 97.25,
97.27, 97.29, 97.31, 97.33, 97.35 [Amended]
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

    * * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date           State              City                 Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-Jul-10.............  OR             SUNRIVER............  SUNRIVER............       0/0047      5/13/10  RNAV (GPS) RWY 18, ORIG
1-Jul-10.............  CA             LOS ANGELES.........  LOS ANGELES INTL....       0/0069      5/13/10  RNAV (RNP) Z RWY 25L
1-Jul-10.............  TN             KNOXVILLE...........  MCGHEE-TYSON........       0/3627       5/5/10  RNAV (GPS) RWY 5L, AMDT 1
1-Jul-10.............  CA             FULLERTON...........  FULLERTON MUNI......       0/5518      4/15/10  VOR-A, AMDT 7
1-Jul-10.............  CA             FULLERTON...........  FULLERTON MUNI......       0/5519      4/15/10  LOC/DME RWY 24, ORIG
1-Jul-10.............  TX             WINTERS MUN.........  WINTERS MUNI........       0/5809      4/16/10  NDB OR GPS RWY 35, ORIG
1-Jul-10.............  AL             HALEYVILLE..........  POSEY FIELD.........       0/6321      4/20/10  TAKEOFF MINIMUMS AND OBSTACLE DP, ORIG
1-Jul-10.............  AL             HALEYVILLE..........  POSEY FIELD.........       0/6322      4/20/10  VOR/DME OR GPS RWY 18, AMDT 4A
1-Jul-10.............  TX             HOUSTON.............  WILLIAM P HOBBY.....       0/6509      4/20/10  VOR/DME RWY 30L, AMDT 17A
1-Jul-10.............  WI             JANESVILLE..........  SOUTHERN WISCONSIN         0/6510      4/29/10  RNAV (GPS) RWY 32, ORIG
                                                             REGIONAL.
1-Jul-10.............  MO             MARYVILLE...........  NORTHWEST MISSOURI         0/6512      4/20/10  RNAV (GPS) RWY 14, ORIG
                                                             REGIONAL.
1-Jul-10.............  OH             SANDUSKY............  GRIFFING-SANDUSKY...       0/6513      4/29/10  VOR/DME OR GPS RWY 27, AMDT 2A
1-Jul-10.............  OH             NORWALK.............  NORWALK-HURON COUNTY       0/6514      4/29/10  VOR OR GPS-A, AMDT 5A
1-Jul-10.............  OH             SANDUSKY............  GRIFFING-SANDUSKY...       0/6520      4/29/10  VOR RWY 27, AMDT 7A
1-Jul-10.............  MO             MARYVILLE...........  NORTHWEST MISSOURI         0/6521      4/20/10  RNAV (GPS) RWY 32, ORIG
                                                             REGIONAL.
1-Jul-10.............  MO             MOBERLY.............  OMAR N BRADLEY......       0/6522      4/20/10  VOR/DME OR GPS A, AMDT 3
1-Jul-10.............  OH             CIRCLEVILLE.........  PICKAWAY COUNTY            0/6525      4/29/10  VOR OR GPS RWY 19
                                                             MEMORIAL.
1-Jul-10.............  OH             MANSFIELD...........  MANSFIELD LAHM RGNL.       0/6526      4/29/10  NDB RWY 32, AMDT 11C
1-Jul-10.............  MS             INDIANOLA...........  INDIANOLA MUNI......       0/6624      4/20/10  VOR/DME B, AMDT 5
1-Jul-10.............  NE             LINCOLN.............  LINCOLN.............       0/6689      4/21/10  TAKEOFF MINIMUMS AND OBSTACLE DP, ORIG
1-Jul-10.............  TX             DALLAS..............  ADDISON.............       0/6690      4/21/10  TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 5
1-Jul-10.............  MS             PICAYUNE............  PICAYUNE MUNI.......       0/6746      4/27/10  VOR A, ORIG
1-Jul-10.............  FL             DESTIN..............  DESTIN-FORT WALTON..       0/6838      4/27/10  RNAV (GPS) RWY 32, ORIG-B
1-Jul-10.............  FL             DESTIN..............  DESTIN-FORT WALTON..       0/6839      4/27/10  RNAV (GPS) RWY 14, ORIG-C
1-Jul-10.............  WI             LA POINTE...........  MADELINE ISLAND.....       0/6965       5/7/10  RNAV (GPS) RWY 22, ORIG
1-Jul-10.............  NE             LINCOLN.............  LINCOLN.............       0/7018      4/23/10  RNAV (GPS) RWY 36, AMDT 1
1-Jul-10.............  NE             AINSWORTH...........  AINSWORTH MUNI......       0/7019      4/23/10  RNAV (GPS) RWY 13, ORIG
1-Jul-10.............  SD             GREGORY.............  GREGORY MUNI, FLYNN        0/7020       5/7/10  TAKEOFF MINIMUMS AND OBSTACLE DP, ORIG
                                                             FIELD.
1-Jul-10.............  NE             NORTH PLATTE........  NORTH PLATTE RGNL          0/7069      4/23/10  RNAV (GPS) RWY 30, AMDT 1
                                                             AIRPORT LEE BIRD
                                                             FIELD.
1-Jul-10.............  TX             BRYAN...............  COULTER FIELD.......       0/7071      4/23/10  RNAV (GPS) RWY 15, ORIG
1-Jul-10.............  OH             LEBANON.............  LEBANON-WARREN             0/7074       5/7/10  NDB-A, AMDT 5
                                                             COUNTY.
1-Jul-10.............  ND             WAHPETON............  HARRY STERN.........       0/7100       5/7/10  RNAV (GPS) RWY 33, ORIG
1-Jul-10.............  TX             HOUSTON.............  WILLIAM P HOBBY.....       0/7219      4/26/10  ILS RWY 30L, AMDT 5B
1-Jul-10.............  NJ             TETERBORO...........  TETERBORO...........       0/7295       5/5/10  COPTER ILS OR LOC RWY 6, AMDT 1D
1-Jul-10.............  NJ             TETERBORO...........  TETERBORO...........       0/7296       5/5/10  ILS OR LOC RWY 6, AMDT 29C
1-Jul-10.............  OH             NORWALK.............  NORWALK-HURON COUNTY       0/7687       5/7/10  GPS RWY 28, ORIG
1-Jul-10.............  NE             COLUMBUS............  COLUMBUS MUNI.......       0/7703      4/28/10  VOR RWY 32, AMDT 14
1-Jul-10.............  NE             HARTINGTON..........  HARTINGTON MUNI.....       0/7704      4/28/10  VOR/DME RWY 31, ORIG-A
1-Jul-10.............  KS             AUGUSTA.............  AUGUSTA MUNI........       0/7863      4/29/10  VOR OR GPS A, ORIG
1-Jul-10.............  LA             LAKE CHARLES........  LAKE CHARLES RGNL...       0/8270       5/3/10  RNAV (GPS) RWY 33, AMDT 1
1-Jul-10.............  LA             LAKE CHARLES........  LAKE CHARLES RGNL...       0/8271       5/3/10  LOC BC RWY 33, AMDT 19
1-Jul-10.............  IA             SPENCER.............  SPENCER MUNI........       0/8275       5/3/10  ILS OR LOC RWY 12, AMDT 2
1-Jul-10.............  OH             CLEVELAND...........  CLEVELAND-HOPKINS...       0/8282       5/7/10  ILS OR LOC RWY 6L, AMDT 2
1-Jul-10.............  OR             MEDFORD.............  ROGUE VALLEY INTL...       0/8694       5/5/10  TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 9
1-Jul-10.............  KS             ANTHONY MUNI........  ANTHONY MUNI........       0/9193       5/7/10  VOR OR GPS A, AMDT 1

1-Jul-10.............  MN             FOSSTON.............  FOSSTON MUNI........       0/9234      5/12/10  TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 1
1-Jul-10.............  MN             MINNEAPOLIS.........  FLYING CLOUD........       0/9235      5/12/10  ILS OR LOC RWY 10R, AMDT 3
1-Jul-10.............  PA             LOCK HAVEN..........  WILLIAM T. PIPER           0/9245      5/12/10  RNAV (GPS)-1, ORIG
                                                             MEMORIAL.
1-Jul-10.............  FL             MILTON..............  PETER PRINCE FLD....       0/9265      5/12/10  TAKEOFF MINIMUMS AND OBSTACLE DP, ORIG
1-Jul-10.............  NY             MONTGOMERY..........  ORANGE COUNTY.......       0/9280      5/12/10  ILS OR LOC RWY 3, AMDT 3A
1-Jul-10.............  OH             UPPER SANDUSKY......  WYANDOT COUNTY......       0/9415      5/12/10  VOR OR GPS-A, AMDT 3A
1-Jul-10.............  CO             TELLURIDE...........  TELLURIDE REGIONAL..       0/9805      5/11/10  LOC/DME RWY 9, AMDT 1
1-Jul-10.............  ID             LEWISTON............  LEWISTON-NEZ PERCE         0/9806      5/11/10  TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 3
                                                             COUNTY.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-13263 Filed 6-4-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36202-36204]
[FR Doc No: 2022-12873]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0082]

Entry-Level Driver Training: Application for Exemption; Western
Area Career and Technology Center

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA announces that Western Area Career and Technology Center
(WACTC) has requested an exemption from the Theory and Behind-the-Wheel
(BTW) instructor requirements contained in the entry-level driver
training (ELDT) regulations for one prospective instructor. WACTC seeks
an exemption from the requirement that instructors have at least two
years of driving experience of

the same or higher class and/or the same endorsement level as the
commercial motor vehicle (CMV) to be operated to satisfy the instructor
requirements under the ELDT regulations.

DATES: Comments must be received on or before July 15, 2022.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2022-0082 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Operations, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice (FMCSA-2022-0082). Note that DOT posts all comments
received without change to www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001 between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Docket Operations.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards;<PHONE_NUMBER> or [email protected]. If you have questions
on viewing or submitting material to the docket, contact Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2022-0082), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2022-0082'' in the ``Search'' box, and click
``Search.'' When the new screen appears, click on ``Documents'' button,
then click the ``Comment'' button associated with the latest notice
posted. Another screen will appear, insert the required information.
Choose whether you are submitting your comment as an individual, an
organization, or anonymous. Click ``Submit Comment.''
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope. FMCSA will consider all comments
and materials received during the comment period.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant
exemptions from certain Federal Motor Carrier Safety Regulations. FMCSA
must publish a notice of each exemption request in the Federal Register
(49 CFR 381.315(a)). The Agency must provide the public an opportunity
to inspect the information relevant to the application, including any
safety analyses that have been conducted. The Agency must also provide
an opportunity for public comment on the request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to 5
years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. Background

Current Regulation(s)/Requirements

    The ELDT regulations required compliance by February 7, 2022 and
established minimum training standards for individuals applying for
certain commercial driver's licenses (CDL) and defined curriculum
standards for Theory and BTW training. It also established an online
training provider registry (TPR), eligibility requirements for
providers to be listed on the TPR, and requirements for instructors.
Under 49 CFR 380.713, a training provider must use instructors who meet
the definitions of ``theory instructor'' and ``behind-the-wheel (BTW)
instructor'' in 49 CFR 380.605. The definitions of ``theory
instructor'' and ``BTW instructor'' in 49 CFR 380.605 require that
instructors hold a CDL of the same (or higher) class, with all
endorsements necessary to operate the CMV for which training is to be
provided; have either: (1) a minimum of 2 years of experience driving a
CMV requiring a CDL of the same or higher class and/or the same
endorsement; or (2) at least two years of experience as a BTW CMV
instructor; and meet all applicable State qualification requirements
for CMV instructors.

Applicant's Request

    WACTC requests an exemption from the requirement in 49 CFR 380.713
that a training provider use instructors who meet the definitions of
``theory instructor'' and ``BTW instructor'' in 49 CFR 380.605. WACTC
specifies that it would like to use one driver training instructor who
does not have two years of required driving experience.
    WACTC states that it has been difficult to find qualified
instructors. WACTC indicates that it has found one potential
instructor, Drew Ley, who is more than capable of implementing a
curriculum and training program that not only meets the ELDT
regulations but will also ensure safe, knowledgeable, and skilled CMV
drivers. WACTC states that Mr. Ley will meet the ELDT

regulation's requirement for two years of driving experience with a
Class A CDL in August 2022.
    WACTC states that it conducts monthly classes in which students
achieve 160 hours of practical training, with four students per class.
The ratio of instructor to students (1 to 4) ``provides a more
individualized training approach as well as the ability to address
individual student needs and/or concerns as they may arise.'' According
to WACTC, the impact of this exemption being denied would be
devastating not only to its CDL program, but to the Adult Education
Department as a whole. WACTC asserts that its CDL program is the most
popular and successful program offered and helps stabilize other
struggling programs through a steady stream of revenue.
    A copy of the WACTC application for exemption is included in the
docket for this notice.

IV. Equivalent Level of Safety

    WACTC believes that Mr. Ley makes up for his failure to have two
years of required driving experience with his experience with the FMCSA
regulations and his current and previous qualifications. Prior to
FMCSA's implementation of the ELDT regulations, Mr. Ley successfully
trained four WACTC classes and achieved a 100% student completion rate.
As an employee of the Commonwealth of Pennsylvania DOT (PennDOT), Mr.
Ley audited and verified third-party testing sites, routes, and CDL
examiners to assure compliance with PennDOT regulations. He also
assisted in the training and bi-annual reviews of experienced and new
CDL examiners and has extensive knowledge operating Class B vehicles
with school bus and passenger endorsements. In addition, Mr. Ley has
obtained a School Bus Instructor Certification, Certified Inspection
Mechanic (class 7), certification as a licensed private Class C
instructor, and has had a Class A CDL for a year and a half without
restrictions. Furthermore, WACTC indicates that the exemption, if
granted, would only be necessary until August 2022, when Mr. Ley will
have had his Class A CDL for the required two years.

V. Request for Comments

    In accordance with 49 U.S.C. 31315(b), FMCSA requests public
comment from all interested persons on WACTC's application for an
exemption from the requirement in 49 CFR 380.713 to use instructors who
meet the definitions of ``Theory instructor'' and ``Behind-the-wheel
(BTW) instructor'' in 49 CFR 380.605. All comments received before the
close of business on the comment closing date indicated at the
beginning of this notice will be considered and will be available for
examination in the docket at the location listed under the Addresses
section of this notice. Comments received after the comment closing
date will be filed in the public docket and will be considered to the
extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should continue to examine
the public docket for new material.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-12873 Filed 6-14-22; 8:45 am]
BILLING CODE 4910-EX-P