EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

Interregional Research Project Number 4 (IR-4)

Pesticide Petition (PP) #4E8264

	EPA has received a pesticide petition, PP# 4E8264, from Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ  08450 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of prohexadione calcium in or on the raw agricultural commodities strawberry  at 0.3 parts per million (ppm) and watercress at 2.0 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 of prohexadione calcium in plants peanuts and apples) is understood, the residue of concern is the parent compound, prohexadione calcium.

	2. Analytical method. [The method of analysis for strawberry included extraction and LC/MS/MS quantitation.  The limit of quantitation (LOQ) is 0.01 ppm. The method of analysis for watercress included extraction and GC-MS quantitation.  The limit of quantitation (LOQ) is 0.1 ppm.]

	3. Magnitude of residues. [A total of nine residue trials were conducted on strawberries grown in British Columbia, California, Florida, Michigan, New Jersey, Nova Scotia, Ontario, and Quebec in 2010.  Strawberries were treated three times at a rate of 0.032  -  0.036 lbs prohexadione calcium per acre per application and 8  -  15 days between applications.  Whole strawberries were collected 16 to 25 days after the last application for analysis and analyzed by LC/MS/MS.  Residues ranged from 0.03 to 0.16 ppm.  A total of four residue trials were conducted on watercress grown in Florida and Maryland in 2009.  Watercress was treated twice at a rate of 0.135  -  0.143 lbs prohexadione calcium per acre per application and 6  -  7 days between applications per crop.  Watercress leaves and stems were collected 3 days after the second application for analysis and analyzed by GC-MS.  Residues ranged from 0.167 to 1.12 ppm. ]

B. Toxicological Profile

	1. Acute toxicity.  [EPA has evaluated the toxicity database for prohexadione calcium and published assessments in the Federal Register on May 3, 2000, FR Vol. 65, No. 86 pages 25655-25660 and on June 1, 2001, FR Vol. 66, No. 106 pages 29705 through 29712.  The Agency determined that prohexadione calcium is of low acute toxicity.  All tests showed the compound to toxicity category III or IV]
	2. Genotoxicty. [Genotoxicity. Ames Test (1 Study; point mutation): Negative; in vitro V79 Cells CH/HGPRT Locus Mammalian Cell Mutation Assay (1 Study; point mutation): Negative; in vitro CHO Cytogenetic Assay (1 Study; Chromosome Damage): Negative; in vivo Mouse Micronucleus (1 Study; Chromosome Damage): Negative; in vivo Rat Bone Marrow Cytogenetic Assay (1 Study; Chromosomal Damage): Negative; Rec Assay (1 Study; DNA damage and repair): Negative; in vitro Rat Hepatocyte (1 Study; DNA damage and repair): Negative.
	Prohexadione calcium has been tested in a total of 7 genetic toxicology assays consisting of in vitro and in vivo studies. Based on the results described above, it can be stated in summary that prohexadione calcium did not show any mutagenic activity when tested under the conditions of the studies mentioned above. Therefore,
prohexadione calcium does not pose a mutagenic hazard to humans.]
      3. Reproductive and developmental toxicity. [The reproductive and developmental toxicity of prohexadione calcium was investigated in a 2-generation rat reproduction study as well as in rat and rabbit teratology studies. The 2-generation rat reproduction study was conducted at dose levels of 0, 500, 5,000 and 50,000 ppm. There were no adverse effects on reproduction parameters seen even at the dose level of 50,000 ppm (5164 mg/kg bw for males and 5,600 mg/kg bw for females). The No Observed Adverse Effect Level (NOAEL) for parental systemic toxicity was 500 ppm (48 mg/kg bw for males and 51 mg/kg bw for females) and the NOAEL for developmental toxicity was 5,000 ppm (270 mg/kg bw for females). Stomach lesions were observed at 5,000 ppm. Two mid-dose males and two males and one female of the high-dose from the F0 died. Body weight and food consumption changes and slight transient reduction in offspring growth were noted at 50,000 ppm. No impairment of reproductive function was observed at any of the dose levels tested.
	The reproductive and developmental studies are summarized below. A develop-mental study was conducted via oral gavage in rats at dose levels of 0, 100, 300, and the 1,000 highest dose tested (HDT) mg/kg bw. The No Observed Adverse Effect Level (NOAEL) for developmental and maternal toxicity was 1,000 mg/kg bw, HDT. This was based on the fact that there were no signs of maternal toxicity, fetotoxicity or teratogenic effects.  A developmental study was conducted via oral gavage in rabbits at dose levels of 0, 40, 200, and 750 (HDT) mg/kg bw. The NOAEL for development toxicity was 40 mg/kg bw and the NOAEL for maternal toxicity was 40 mg/kg bw based on the following findings. Toxicity in the form of maternal mortality with values 16/20 and 4/20 was excessive in the mid- and high-dose group, respectively. Fetal deaths also occurred. Dose levels believed to exceed MTD; NOAELs for maternal and developmental effects are not considered reliable and useful for risk characterization. No teratogenic effects were noted in this study.
	i. Teratogenicity. Prohexadione calcium had no teratogenic potential at dose levels as high as 1,000 mg/kg bw in the rat and 350 mg/kg bw in the rabbit. The NOAEL for maternal toxicity in the teratogenicity studies is 100 mg/kg bw (rabbit) and 1,000 mg/kg bw (rat), and the NOAEL for fetotoxicity in the teratogenicity studies is 350 mg/kg bw (rabbit) and 1000 mg/kg bw (rat). An additional teratology study in the same strain of rabbits was conducted at dose levels of 0, 30, 75, and 150 mg/kg bw. The NOAEL for development toxicity was 150 mg/kg bw and the NOAEL for maternal toxicity was 30 mg/kg bw based on the following findings. One low-, two mid-, and three high-dose animals died prior to day 29, however, at the high dose group one died of gavage error and another pneumonia, and the reason for the other deaths could not be determined. No teratogenic or fetoxtoxic effects were noted in this study.
	ii. Oral teratology study. An oral range-finding gavage teratology study in the same strain of rabbits (5 animals/dose level) was conducted in another independent laboratory. The dose levels selected were 0, 20, 100, 250, 500, and 1,000 mg/kg bw. This range finding study was conducted with a limited number of animals and a limited scope of examination. Based on these results the dose levels selected for the main study at this independent laboratory were 0, 30, 100, and 350 mg/kg bw. The NOAEL for development toxicity was 350 mg/kg bw and the NOAEL for maternal toxicity was 100 mg/kg bw based on the following findings. At the 350 mg/kg bw dose group transient body weight decreases and two abortions were observed. No teratogenic or fetotoxic effects were noted in this study.
      iii. Conclusions from teratology studies. More than one definitive rabbit teratology study was conducted because issues associated with exceeding the maximum tolerated dose (MTD) in the first study and spurious deaths, apparently not compound-related, in the second study confounded the determination of a NOAEL for maternal toxicity. There were no signs of teratogenic or fetotoxic effects in any study other than the first definitive study in which maternal deaths above the MTD apparently occurred. It is BASF's opinion based on a thorough review of the teratology studies that the following overall NOAELs can be derived for the teratology studies:
	a. NOAEL maternal toxicity. 100 mg/kg body weight (rabbit) and 1,000 mg/kg body weight (rat).
	b. NOAEL prenatal toxicity. 350 mg/kg body weight (rabbit) and 1,000 mg/kg body weight (rat).
	The overall NOAEL of 100 mg/kg bw for maternal toxicity in rabbits is based on the last rabbit study, and is based on reduction of body weight gain and food intake at dose levels of 250 mg/kg body weight onwards. The NOAEL of 350 mg/kg bw for fetotoxic effects in the rabbit is also based on a reduction in body weight gain. Based on the overall study results, it is concluded that there are no developmental effects of concern. Based on preliminary discussions with EPA concerning the rabbit teratology studies, EPA concluded that the definitive NOAEL for maternal toxicity considering all of the studies ranges from 30 to 100 mg/kg/bw. Agency scientists further stated that they needed to review the studies in detail to ultimately determine the definitive NOAEL for maternal toxicity. This uncertainty associated with maternal toxicity in the rabbit teratology studies does not impact risk considerations since the risk assessment is based on a lower NOAEL (20 mg/kg bw) in the chronic dog study.]
	4. Subchronic toxicity. [The subchronic toxicity of prohexadione calcium was investigated in 90-day feeding studies with rats, mice and dogs. In all these studies, prohexadione calcium displayed low toxicity. Prohexadione calcium showed no signs of neurotoxicity in a 90-day neurotoxicity rat study. Additionally, the results seen in four week feeding range-finding studies for rats and dogs were similar to the findings observed in the 90-day studies in the same animals.]
     5. Chronic toxicity. [Based on review of the available data, the Reference Dose (RfD) for prohexadione calcium will be based on a 1-year feeding study in dogs with a threshold No Adverse Effect Level (NOAEL) of 20 mg/kg/day. Using an uncertainty factor of 100, the RfD is calculated to be 0.2 mg/kg/day. The following are summaries of studies submitted to EPA.
	Prohexadione calcium was administered to Beagle dogs at dietary concentrations of 0, 20, 200, and 1,000 mg/kg bw for 12 months. Slight changes were observed for hematological and clinical chemical parameters and dilated basophilic renal tubules (without histopathological concurrence) at dose levels greater than 200 mg/kg bw. The NOAEL was 20 mg/kg bw for the males and female dogs.
	The 24-month Fisher 344 rat chronic/carcinogenic feeding study was conducted at dose levels of 0, 400, 2,000, 10,000, and 20,000 ppm with 80 male and 80 female animals per dose group. After 26, 52, and 78 weeks, 10 animals were sacrificed (satellite groups). The remaining animals were autopsied after 104 weeks of diet administration. The NOAEL for chronic toxicity was 2,000 ppm for males (93.9 mg/kg bw) and 2,000 ppm for females (114 mg/kg bw). The following effects were observed in the 10,000 and 20, 000 ppm groups:
	i. Decreased body weights were observed in both male and female rats at the 20,000 ppm dose level;
	ii. Clinical chemical effects (i.e., lower potassium, bilirubin, and glucose levels) were observed in male and female rats at the 20,000 ppm dose level, in the 10,000 ppm dose level, reduced glucose levels were only seen in the males, and increased albumin/globulin ratios,
sodium, chloride and calcium levels were observed only in the females;
	iii. Increased urine volumes and lower specific gravity were observed in the mid-high and high-dose groups for both male and female rats;
	iv. Minor changes in organ weights were noted for animals of the high dose group only, which consisted of increased relative liver, adrenal and kidney weights, the latter also absolute in females only, at week 26; at the end of the study decreased liver weights and increased relative brain and testis weights were noted and these changes were considered to be associated with the decreased body weights;
	v. Macroscopic findings revealed an increase of pituitary nodules in the high dose group for both male and female rats which was not confirmed histopathologically and submucosal ectopic tissue in the glandular stomach was found in both male and female rats in the highest dose levels that was confirmed by histopathology which showed an increase of squamous cell hyperplasia in males and of basal cell hyperplasia in the forestomach;
      vi. A higher incidence of cellular hyperplasia was observed in the thyroid in the mid-high and high dose levels for male and female rats; and
      vii. No increased incidence of neoplasms occurred at any dose levels tested in this study.
	In the 24-month B6C3F1 mouse feeding study, conducted at dose levels of 0, 400, 2,000, 20,000, and 40,000 ppm with interim sacrifices at 52 and 78 weeks, prohexadione calcium was negative for oncogenicity. The NOAEL for chronic toxicity was 2,000 ppm for males (279 mg/kg bw) and 2,000 ppm for females (351 mg/kg bw). The following effects were observed in the 20,000 and 40,000 ppm groups:
	i. Statistically significant decreases in body weights were observed in male mice at the 20,000 ppm dose level and in female mice at the 40,000 ppm dose level;
	ii. A variety of changes in hematological parameters were noted in the respective investigations at weeks 52, 78, and 104, however, most of the changes were not dose related or consistent over time;
	iii. Increased absolute and/or relative heart, brain, testes, liver, ovary, and kidney weights were observed in the mid-high and highest dose groups with a slight progression of severity to the highest dose group;
	iv. A higher incidence of splenomegaly was observed only in the male mice of the highest dose group;
	v. Histopathological examinations revealed an ectopic proliferation of the mucosal and glandular epithelium in the submucosal layer of the glandular stomach in male and female mice in the highest dose group tested, these changes were assessed to represent heteroplastic, ectopic proliferative changes accompanied by lumen dilatation and cytological degeneration;
	vi. A higher incidence of hyperkeratosis of the forestomach was observed in both male and female mice and hyperplasia of the squamous epithelium of the forestomach of female male mice was observed in the highest dose group tested;
	vii. Vacuolic changes in the exocrine pancreas of the high dose female were observed; and
	viii. No increased incidence of neoplasms occurred at any dose levels tested in this study.
	a. Threshold effects. Based on review of the available chronic toxicity data, BASF believes EPA will establish the Reference Dose(RfD) for prohexadione calcium at 0.20 mg/kg/day. This RfD for prohexadione calcium is based on the 1-year feeding study in dogs with a threshold NOEL of 20 mg/kg/day in male and female dogs. Using an uncertainty factor of 100, the RfD is calculated to be 0.20 mg/kg/day. Based on the acute toxicity data BASF believes that prohexadione calcium does not pose any dietary risks.
	b. Non-threshold effects. Based on EPA Proposed Guidelines For Carcinogen Risk Assessment, BASF believes that prohexadione calcium will be classified as ``Not Likely a Human Carcinogen''. Under the current assessment method BASF believes that EPA will classify prohexadione calcium as Group E, no evidence of carcinogenicity based on studies in two species. There was no evidence of carcinogenicity in mice and rat 24-month feeding studies at the dosage levels tested. The doses tested were adequate for identifying a cancer risk.]
     6. Animal metabolism. [The metabolism in animals (goats and poultry)
is adequately understood.]
	7. Metabolite toxicology. []
     8. Endocrine disruption. [No specific tests have been conducted with prohexadione calcium to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity studies (i.e., subchronic and chronic toxicity, teratology and multi-generation reproductive studies) which would suggest that prohexadione calcium produces endocrine related effects.]

C. Aggregate Exposure

     1. Dietary exposure. [An assessment was conducted to evaluate the potential risk due to chronic dietary exposure of the U.S. population and sub-populations to residues of prohexadione calcium.  Tolerance values for prohexadione calcium have previously been established and are listed in U.S. 40 CFR § 180.547.  ]
	i. Food. [BASF has conducted a prohexadione calcium dietary risk assessment for all currently registered crops and the proposed new tolerances on strawberry at 0.3 ppm and watercress at 2.0 ppm.  The assessment was conducted using 100 % crop treatment factors, tolerance level residues, and default processing factors of 1.  The assessment included all food commodities and water at a concentration of 9.1 ppb.  This water value was determined by the US EPA during the most recent evaluation of a turf use for prohexadione calcium (US EPA, March 30, 2010, "Prohexadione Calcium. Proposed use on commercial and residential turf, golf courses, sod farms, and ornamental bedding plants and bedding plant plugs.").

Acute Dietary Exposure Assessment
The EPA has determined that an acute assessment of prohexadione calcium is not required because there are no toxicological effects attributable to a single oral exposure.

Chronic Dietary Exposure Assessment
The most highly exposed subpopulation was children 1-2 years of age.  The % Chronic Population Adjusted Dose ( cPAD) utilized was  16.6 %.   Table 1 shows the exposure and % cPAD utilized by all sub-populations.
Table 1. 	Results for Prohexadione Calcium Chronic Dietary Exposure (Food + Water) Analysis Considering all Current Tolerances and the New Proposed Tolerances for Strawberry and Watercress.
                                  Population
                               Exposure Estimate
                                     %cPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                 US Population
                                    0.00423
                                      2.1
                           All infants (< 1 year)
                                    0.02110
                                     10.5
                            Children 1-2 years old
                                    0.03317
                                     16.6
                            Children 3-5 years old
                                    0.01833
                                      9.2
                            Children 6-12 years old
                                    0.00711
                                      3.6
                             Youth 13-19 years old
                                    0.00256
                                      1.3
                            Adults 20-49 years old
                                    0.00177
                                      0.9
                                Adults 50+ yrs
                                    0.00184
                                      0.9
                            Females 13-49 years old
                                    0.00194
                                      1.0
cPAD = 0.2 mg/kg bw/day.
* Exposure estimates based on tolerance values, default processing factor, and 100% crop treated values

Results of the analysis show that for the U.S. population and all sub-populations, the exposures are below a level of concern (< 100% cPAD).  Additional refinements in the chronic dietary risk assessment (i.e. utilizing anticipated residue values, process factors, percent crop treated values) would further reduce the estimated exposure values]

	ii. Drinking water. [The human exposure from drinking water was included in the dietary exposure.

Acute Aggregate Exposure
Acute aggregate exposure was not determined because the EPA has determined that there is no toxicological effect resulting from a single oral dose of prohexadione calcium.

Short- and Intermediate Term Aggregate Exposure and Risk (food,water, and residential)
Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure from food and water.  Residential exposure is used to refer to non-occupational and non-dietary exposure.   Prohexadione calcium was registered for uses in 2010 which can result in post-application exposure to the general population and children.  The residential exposure value used in this risk assessment was previously determined by the EPA (US EPA, March 30, 2010, "Prohexadione Calcium. Proposed use on commercial and residential turf, golf courses, sod farms, and ornamental bedding plants and bedding plant plugs.").   The short-term aggregate risk assessment is shown in Table 3.   The MOE values indicate that the aggregate risk from the use of prohexadione calcium is acceptable.

Table 3.  Short-Term Aggregate Risk from the use of Prohexadione Calcium.

                                Sub-Populations
                                   Scenario
                           Short term Aggregate Risk

                                  Dietary MOE
                                  Dermal MOE
                            Oral hand to mouth MOE
                              Total Aggregate MOE
                              General Population
                              Res -post app exp,
                                     9466
                                     11000
                                      NA
                                     5088
                                 children 1 -2
                              Res -post app exp,
                                     1206
                                     14000
                                    180000
                                     1104
                                  youth 13-19
                               Res -post app exp
                                     15645
                                     7400

                                     5024

Chronic Aggregate Exposure:
Chronic aggregate exposure includes exposure from food and drinking water.  The dietary assessment conducted above includes food and water and therefore, is an aggregate exposure.  The aggregate exposure to prohexadione calcium utilized less than 17% of the cPAD for all subpopulations.  ]

     2. Non-dietary exposure. [Residential exposure is used to refer to non-occupational and non-dietary exposure.   Prohexadione calcium was registered for uses in 2010 which can result in post-application exposure to the general population and children.  The residential exposure value used in this risk assessment was previously determined by the EPA (US EPA, March 30, 2010, "Prohexadione Calcium. Proposed use on commercial and residential turf, golf courses, sod farms, and ornamental bedding plants and bedding plant plugs.").  The MOE values from the assessment are presented in the Table 3.

        Table 3.  Residential Exposure and Risk Estimates for Post-Application Uses for Prohexadione Calcium.

                              Population subgroup
                                   Scenario
                           Dermal exp (mg/kg bw-day)
                                  Dermal MOE
                   Oral exp - hand to mouth (mg/kg bw - day)
                                   Oral MOE
Adult
Post-App golfer
                                    0.00364
                                     11000
                                      NA

youth
Post-App golfer
                                    0.00541
                                     7400
                                      NA

Toddler
Post-App Turf
                                    0.00286
                                     14000
                                    0.00044
                                    180001

         ]

D. Cumulative Effects

	[BASF is aware of only one other registered compound, trinexapac-ethyl 4-(cyclopropyl-a-hydroxymethylene)-3,5-dioxocyclohexanecarboxylic acid ethyl ester, that has a structure similar to prohexadione calcium. However, BASF has no information that would indicate that the two compounds have a common mechanism of toxicity. Further-more, trinexapac is registered for use only on turf. Therefore, even if the compounds were considered similar there would be no cumulative dietary exposure issue because of the differences in use patterns. In summary, dietary exposure to prohexadione calcium should not result in cumulative toxicity with other known chemical compounds.]

E. Safety Determination

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

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

F. International Tolerances

	[A maximum residue level (MRL) has not been established for prohexadione calcium in strawberries or watercress by the Codex Alimentarius Commission.]


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date: February 06, 2009

SUBJECT:	Dicloran: HED’s ORE Response to Gowan Company’s October 30,
2008 Letter to the Agency on the Dicloran (DCNA) Generic Data Call-In;
D358358.

PC Code: 031301	DP Barcode:   D358358

Decision No.: 334070	Registration No.: N/A

Petition No.: NA	Regulatory Action: N/A

Risk Assessment Type: 	Case No.: 0113

TXR No.: NA	CAS No.: NA

MRID No.: 47573501	40 CFR: NA

FROM:	Matthew Lloyd

		Risk Assessment Branch 7

		Health Effects Division (7509P)  SEQ CHAPTER \h \r 1

THROUGH:	Michael Metzger

		Risk Assessment Branch 7

		Health Effects Division (7509P)  SEQ CHAPTER \h \r 1

TO:		James Parker

		Reregistration Branch 1

	Special Review and Registration Division (7508P)

This document serves as HED’s Response to occupational exposure issues
raised by Gowan Company’s letter to the Agency on Dicloran (DCNA)
generic Data Call-In (DCI) issues [October 30, 2008].

875.1100 - Dermal Exposure

875.1300 - Inhalation Exposure

875.1600 - Application Exposure Monitoring

Gowan Company is no longer supporting the various dust dicloran products
and is now supporting only two products; Botran 75-W and Botran 5F. As
such, HED no longer has the need to review data on the dermal or
inhalation exposure to dicloran dust products to assess occupational
handler exposures or the dislodgeable foliar residue (DFR) data for
dusts to assess occupational post-application exposures.

HED recommends that SRRD accept the waiver request pertaining to
dicloran dust products by Gowan Company.

875.2100 - Foliar Dislodgeable Residue

Gowan Company is no longer supporting the various dust dicloran products
and is now supporting only two products; Botran 75-W and Botran 5F. As
such, HED no longer has the need to review data on the dermal or
inhalation exposure to dicloran dust products to assess occupational
postapplication exposures.

HED recommends that SRRD accept the waiver request pertaining to
dicloran dust products by Gowan Company.

875.2800 - Description of Human Activity

HED notes that Gowan Company is no longer supporting the various dust
dicloran products and is now supporting only two products; Botran 75-W
and Botran 5F. Description of human activity data is no longer necessary
on activities relating to dust products (i.e., the handheld power
duster, and flaggers from dust applications).

HED has no information to characterize the prevalence of the labeled
uses of the remaining (flowable and wettable powder) dicloran products
through hand-held or backpack equipment on greenhouse seed potatoes.
OPPTS 875.2800 was designed to have registrants submit specific
information on the processes and work activities around a given
operation.

HED believes the data is relevant to assess dicloran occupational
handler exposures for the wettable powder mix/load/apply scenarios for
backpack sprayer and handwand sprayers; HED cannot complete and
occupational risk assessment until that information is available.

This information should include the description of activities including,
but not limited to:

Nature of human activity

Principal source of exposure

Usual environmental conditions of exposure

Level of physical exertion

Expected frequency and duration of activity

HED recognizes Gowan Company’s membership in the Agricultural Handler
Exposure Task Force (AHETF).  Gowan Company makes note of the AHETF’s
intention to develop unit exposure data specific to the scenarios where
data is needed (specifically, AHETF Scenario 18, 19, 34, and 45). HED
has received information that the AHETF does not plan to proceed with
the development of scenario 45 – backpack mist blower (email
communication with Dave Johnson, 1/27/09) that Gowan Company concurs is
important for the occupational exposure assessment. The remaining
hand-held equipment AHETF scenarios (18, 19, 34) are tentatively
scheduled to have HSRB review in January of 2012.

HED recommends that SRRD accept the waiver request pertaining to
dicloran exposure scenarios listed above the receipt and review of the
data by the Agency.  Once HED receives and reviews all the data in the
monograph scenarios mentioned above and HSRB study review is complete,
HED can make a determination as to whether the AHETF scenarios are of
appropriate data quality for risk assessment purposes.

Page   PAGE  1  of   NUMPAGES  3


[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Rules and Regulations]
[Pages 15335-15339]
[FR Doc No: 2022-05737]

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

40 CFR Part 180

[EPA-HQ-OPP-2020-0375; FRL-9472-01-OCSPP]

Bicyclopyrone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
bicyclopyrone in or on banana; broccoli; hop, dried cones; horseradish;
onion, bulb; onion, green; papaya; strawberry; sweet potato, tuber;
timothy, forage; timothy, hay and watermelon. Syngenta Crop Protection,
LLC., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 18, 2022. Objections and
requests for hearings must be received on or before May 17, 2022 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0375, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).

     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0375 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
May 17, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0375, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2021 (86 FR 11488) (FRL-
10020-47), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F8853) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the herbicide bicyclopyrone,
4-hydroxy-3-{2-[(2-methoxyethoxy)methyl{time} -6-(trifluoromethyl)-3-
pyridylcarbonyl{time} bicyclo[3.2.1]oct-3-en-2-one, in or on banana at
0.01 parts per million (ppm); broccoli at 0.01 ppm; garlic, bulb at
0.02 ppm, hops, dried cones at 0.04 ppm; horseradish at 0.015 ppm;
onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01 ppm;
plantains at 0.01 ppm; strawberry at 0.01 ppm; sweet potato, roots at
0.02 ppm; timothy, forage at 0.9 ppm; timothy, hay at 1.5 ppm; and
watermelon at 0.01 ppm.
    That document referenced a summary of the petition prepared by
Syngenta Crop Protection, LLC., the registrant, which is available in
the docket, https://www.regulations.gov. There were no comments
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than requested by
the petitioner, is not establishing several petitioned for tolerances,
and adjusted several commodity definitions. The reasons for these
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for bicyclopyrone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with bicyclopyrone
follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that repeat what
has been previously published in tolerance rulemakings for the same
pesticide chemical. Where scientific information concerning a
particular chemical remains unchanged, the content of those sections
would not vary between tolerance rulemaking and republishing the same
sections is unnecessary and duplicative. EPA considers referral back to
those sections as sufficient to provide an explanation of the
information EPA considered in making its safety determination for the
new rulemaking.
    EPA has previously published a number of tolerance rulemakings for
bicyclopyrone, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to bicyclopyrone and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of bicyclopyrone, see
Unit III.A. of the December 23, 2021, rulemaking (86-FR-72846) (FRL-
9199-01-OCSPP).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. The PODs and levels of concern have not changed from the
previous rulemaking and EPA incorporates the background information in
the December 23, 2021, rulemaking. A summary of the

toxicological endpoints for bicyclopyrone used for human risk
assessment can be found in the document titled ``Bicyclopyrone: Human
Health Risk Assessment for the Establishment of Permanent Tolerances
for Residues in/on Bananas, Broccoli, Dry Bulb Onions, Green Onion,
Hops, Horseradish, Papaya, Strawberry, Sweet Potatoes, Timothy Forage,
Timothy Hay, and Watermelon'' (hereinafter ``Bicyclopyrone Human Health
Risk Assessment'') in docket ID number EPA-HQ-OPP-2020-0375 in
regulations.gov.

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates
have occurred to accommodate exposures from the petitioned-for
tolerance. These updates are discussed in this section; for a
description of the rest of the EPA approach to and assumptions for the
exposure assessment, please reference Unit III.C. of the December 23,
2021, rulemaking.
    EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of bicyclopyrone on banana;
broccoli; hop, dried cones; horseradish; onion, bulb; onion, green;
papaya; strawberry; sweet potato, tuber; timothy, forage; timothy, hay;
and watermelon (see Unit IV. C for an explanation of the differences
between this list and the petitioned for tolerances). The assessment
used the same assumptions as the December 23, 2021, final rule
concerning average field trial residues for registered crops, tolerance
levels for the proposed crops and recently added crops, average
empirical processing factors for registered crops, anticipated residues
for livestock commodities, and percent crop treated (PCT) for
registered crops commodities.

D. Anticipated Residue and Percent Crop Treated (PCT) Information

    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The chronic dietary assessment incorporated the following average
PCT estimates: Barley, 1%; field corn, 10%; sweet corn, 5%; pop corn,
10% (used the higher of the corn PCT); and wheat, 5% (used spring wheat
PCT which was higher than winter wheat PCTs). An estimate of 100% crop
treated was used for all other commodities. The PCT for livestock
commodities is based on the PCT value for the livestock feed item used
in the dietary burden with the highest percent crop treated (field
corn, 10%).
    In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the California Department
of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1. iv have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which bicyclopyrone may be applied in a particular area.
    Dietary exposure from drinking water. EPA has revised the
bicyclopyrone Drinking Water Assessment (DWA) since the December 23,
2021, rule. The 2016 DWA for bicyclopyrone (USEPA, 2016, DP Barcode
428614) recommended moving forward with estimated drinking water
concentrations (EDWCs) for a groundwater scenario that occurred in a
wheat and barley growing area and move away from the existing EDWCs
based on a simulation resulting in the highest groundwater EDWC. The
Human Health Risk Assessment (USEPA, 2022, DP Barcode 459563) used the
highest groundwater EDWCs from the previous 2016 DWA. The maximum acute
and chronic/cancer surface water and groundwater EDWCs associated with
bicyclopyrone use were 7.61 parts per billion (ppb) for the maximum
acute and 6.66 ppb, for the maximum chronic/cancer.
    Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed uses and
bicyclopyrone is not registered for any use patterns that would result
in residential exposure.
    Cumulative exposure. For a discussion of the cumulative exposure
assessment of bicyclopyrone, see Unit

III.C.4 of the December 23, 2021, rulemaking.
    Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D of the
December 23, 2021 rulemaking for a discussion of the Agency's rationale
for that determination.
    Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates
the lifetime probability of acquiring cancer given the estimated
aggregate exposure. Short-, intermediate-, and chronic-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the appropriate points of departure to ensure
that an adequate margin of exposure exists.
    An acute dietary exposure assessment was not conducted as
toxicological effects attributable to a single dose were not
identified. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD: The population subgroup with the highest
exposure estimate was all infants at 16% of the cPAD. Bicyclopyrone is
classified as ``Suggestive Evidence of Carcinogenic Potential''.
However, because the Agency has determined that the chronic reference
dose will be protective of any potential cancer risk and there are no
chronic risks that exceeds the Agency's level of concern, EPA concludes
that there is not a concern for cancer risk from exposure to
bicyclopyrone. There are no registered or new uses of bicyclopyrone
that would result in residential exposure, therefore the aggregate risk
estimates are equivalent to the chronic dietary (food and water) risk
estimates and are not of concern.
    Based on these risk assessments and the information described
above, EPA concludes that there is a reasonable certainty that no harm
will result to the general population, or to infants and children from
aggregate exposure to bicyclopyrone residues. More detailed information
about the Agency's analysis can be found in the Bicyclopyrone Human
Health Risk Assessment in docket ID number EPA-HQ-OPP-2020-0373 in
regulations.gov at https://www.regulations.gov.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A of the December 23, 2021, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    The Codex has not established a MRL for residues of bicyclopyrone
in/on bananas, broccoli, dry bulb onions, timothy forage or hay, green
onion, hops, horseradish, papaya, strawberry, sweet potato, or
watermelon.

C. Revisions to Petitioned-For Tolerances

    FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a
tolerance that varies from that sought by the petition. The petitioner
initially requested to include tolerances for both banana and plantain;
however, a separate tolerance is not required for plantain per 40 CFR
180.1(g). Therefore, the Agency is only finalizing a tolerance for
banana. The petitioner also requested to include tolerances for both
garlic and onion, bulb; however, a separate tolerance is not required
for garlic per 40 CFR 180.1(g). Therefore, the Agency is only
finalizing a tolerance for onion, bulb.
    The proposed commodity definitions for hops, dried cones; sweet
potato, roots; have been modified to hop, dried cones; sweet potato,
tuber, respectively, in order be consistent with Agency nomenclature.
    The petitioner initially requested a tolerance of 0.9 ppm for
timothy, forage and 1.5 ppm for timothy, hay. The petitioner appears to
have calculated the requested tolerance value using input residue
values from the forage and hay decline trials with a longer preharvest
intervals (PHI), which would underestimate the resulting residues. The
Agency used the residue values from the decline trial that had the
shortest PHI. The Agency deems it appropriate to use the more
conservative (i.e., results with the highest residue value) approach
and as a result produced a recommended tolerance of 1.5 ppm for
timothy, forage and 2 ppm for timothy, hay when entered into the OECD
calculator.
    The proposed commodity for horseradish tolerance has also been
modified to be set at the respective limit of quantitation (LOQs), as
there were no residues detected.

V. Conclusion

    Therefore, tolerances are established for residues of
bicyclopyrone, 4-hydroxy-3-[[2-[(2-methoxyethoxy)methyl]-6-
(trifluoromethyl)-3-pyridinyl]carbonyl]bicyclo[3.2.1]oct-3-en-2-one,
including its metabolites and degradates in or on banana at 0.01 ppm;
broccoli at 0.01 ppm; hop, dried cones at 0.04 ppm; horseradish at 0.02
ppm; onion, bulb at 0.02 ppm; onion, green at 0.05 ppm; papaya at 0.01
ppm; strawberry at 0.01 ppm; sweet potato, tuber at 0.02 ppm; timothy,
forage at 1.5 ppm; timothy, hay at 2 ppm; and watermelon at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not

have a substantial direct effect on States or Tribal Governments, on
the relationship between the National Government and the States or
Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, the Agency has determined
that Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 9, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.682 amend Table 1 to Paragraph (a) (1) by adding in
alphabetical order the entries ``Banana''; ``Broccoli''; ``Hop, dried
cones''; ``Horseradish''; ``Onion, bulb''; ``Onion, green'';
``Papaya''; ``Strawberry''; ``Sweet potato, tuber''; ``Timothy,
forage''; Timothy, hay''; and ``Watermelon'' to read as follows:

Sec.  180.682  Bicyclopyrone; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        0.01

                                * * * * *
Broccoli....................................................        0.01

                                * * * * *
Hop, dried cones............................................        0.04

                                * * * * *
Horseradish.................................................        0.02

                                * * * * *
Onion, bulb.................................................        0.02
Onion, green................................................        0.05
Papaya......................................................        0.01

                                * * * * *
Strawberry..................................................        0.01

                                * * * * *
Sweet potato, tuber.........................................        0.02
Timothy, forage.............................................         1.5
Timothy, hay................................................           2

                                * * * * *
Watermelon..................................................        0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-05737 Filed 3-17-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Proposed Rules]
[Page 13684-13689]
[DOCID:fr23mr10-22]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1080; Directorate Identifier 2008-NM-118-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model EMB-135BJ Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier NPRM for the products listed above
that would supersede an existing AD. This action revises the earlier
NPRM by expanding the scope. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The earlier MCAI, Brazilian
Airworthiness Directive 2007-08-01, effective September 27, 2007,
describes the unsafe condition as:

    Fuel system reassessment, performed according to RBHA-E88/SFAR-
88

(Regulamento Brasileiro de Homologacao Aeronautica 88/Special
Federal Aviation Regulation No. 88), requires the inclusion of new
maintenance tasks in the Critical Design Configuration Control
Limitations (CDCCL) and in the Fuel System Limitations (FSL),
necessary to preclude ignition sources in the fuel system. * * *

The new MCAI, Brazilian Airworthiness Directive 2009-08-03, effective
August 20, 2009, describes the unsafe condition as:

    An airplane fuel tank systems review required by Special Federal
Aviation Regulation Number 88 (SFAR 88) and ``RBHA Especial
N[uacute]mero 88'' (RBHA E 88) has shown that additional maintenance
and inspection instructions are necessary to maintain the design
features required to preclude the existence or development of an
ignition source within the fuel tanks of the airplane.
* * * * *

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by April 19, 2010.

ADDRESSES: You may send comments 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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--Putim--
12227-901 S[atilde]o Jose dos Campos-SP--BRASIL; telephone: +55 12
3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-1080;
Directorate Identifier 2008-NM-118-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We proposed to amend 14 CFR part 39 with an earlier NPRM for the
specified products, which was published in the Federal Register on
October 16, 2008 (73 FR 61375). That earlier NPRM proposed to supersede
AD 2008-13-15, Amendment 39-15578 (73 FR 35908, June 25, 2008), to
require actions intended to address the unsafe condition for the
products listed above.
    Since that NPRM was issued, the Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC), which is the aviation authority for
Brazil, has issued Airworthiness Directive 2009-08-03, dated August 20,
2009 (referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    An airplane fuel tank systems review required by Special Federal
Aviation Regulation Number 88 (SFAR 88) and ``RBHA Especial
N[uacute]mero 88'' (RBHA E 88) has shown that additional maintenance
and inspection instructions are necessary to maintain the design
features required to preclude the existence or development of an
ignition source within the fuel tanks of the airplane.
* * * * *
The corrective action is revising the Airworthiness Limitations Section
(ALS) of the Instructions for Continued Airworthiness (ICA) to
incorporate new limitations for fuel tank systems. You may obtain
further information by examining the MCAI in the AD docket.

Additional Actions Since NPRM Was Issued

    Since we issued the earlier NPRM, which included a proposal to
require incorporation of critical design configuration control
limitations (CDCCLs), we have determined that it is necessary to
clarify the proposed AD's intended effect on spare and on-airplane fuel
tank system components, regarding the use of maintenance manuals and
instructions for continued airworthiness.
    Section 91.403(c) of the Federal Aviation Regulations (14 CFR
91.403(c)) specifies the following:

    No person may operate an aircraft for which a manufacturer's
maintenance manual or instructions for continued airworthiness has
been issued that contains an airworthiness limitation section unless
the mandatory procedures have been complied with.

    Some operators have questioned whether existing components affected
by the new CDCCLs must be reworked. We did not intend for the AD to
retroactively require rework of components that had been maintained
using acceptable methods before the effective date of the AD. Owners
and operators of the affected airplanes therefore are not required to
rework affected components identified as airworthy or installed on the
affected airplanes before the required revisions of the ALS of the ICA.
But once the CDCCLs are incorporated into the ALS of the ICA, future
maintenance actions on components must be done in accordance with those
CDCCLs.

Comments

    We have considered the following comment received on the earlier
NPRM.

Request To Revise Actions Specified in Table 2 of the NPRM

    Embraer requests that we revise the actions specified in Table 2 of
the NPRM (functional checks of the fuel conditioning unit and the
ventral fuel conditioning unit). Embraer states that a functional check
of the fuel conditioning unit would not entirely address the unsafe
condition and that a functional check of the safe-life features in
connection with internal and external

inspections is necessary. Embraer notes that Parker revised Component
Maintenance Manual (CMM) 28-41-36 on March 5, 2007, to include a
functional check of the safe-life features for fuel conditioning unit
part number (P/N) 367-934-001. Embraer recommends that a functional
check of the safe-life features and inspections to ensure the safe-life
features be included in Table 2 of the NPRM. Embraer also suggests that
Parker Service Bulletin 367-934-28-110, Revision A, dated December 19,
2006, be included as an optional method of compliance for doing the
safe-life check.
    We agree to revise Table 2 of the supplemental NPRM to include new
actions to check and inspect safe-life features to adequately address
the identified unsafe condition. However, we have not included fuel
conditioning unit P/N 367-934-001, as the part is not installed on
Model EMB-135BJ airplanes. We have revised Table 2 of this AD to
include fuel conditioning unit P/Ns 367-934-002, 367-934-004, and 367-
934-006. However, we have not included Parker Service Bulletin 367-934-
28-110, Revision A, dated December 19, 2006, as an optional method of
compliance because that service bulletin does not refer to a specific
component maintenance manual. Instead, we have included the Parker CMMs
for these part numbers in Table 2 of this AD, as specified in the
following table. We have coordinated this action with ANAC.

                       Parker Service Information
------------------------------------------------------------------------
           Document                Revision                Date
------------------------------------------------------------------------
Parker Component Maintenance   1...............  March 13, 2009.
 Manual 28-41-66 with
 Illustrated Parts List for
 Fuel Conditioning Unit Part
 Number 367-934-004.
Parker Component Maintenance   2...............  March 13, 2009.
 Manual 28-41-69 with
 Illustrated Parts List for
 Fuel Conditioning Unit Part
 Number 367-934-002.
Parker Component Maintenance   Original........  April 3, 2009.
 Manual 28-41-90 with
 Illustrated Parts List for
 Fuel Conditioning Unit Part
 Number 367-934-006.
------------------------------------------------------------------------

    We have also revised the ``Grace Period'' specified in Table 2 of
the supplemental NPRM from ``Within 90 days after December 16, 2008''
to ``Within 90 days after the effective date of this AD.''
    We have also revised paragraph (g)(1) of this AD to clarify that
the new tasks are part of the ALS of the ICA and added a 30-day
compliance time to revise the ALS of the ICA to incorporate the new
tasks.

Clarification of Service Information

    Paragraph (f)(1) of the original NPRM defines the term ``MPG'' as
EMBRAER Legacy BJ-Maintenance Planning Guide (MPG) MPG-1483, Revision
5, dated March 22, 2007. However, instead of using the term ``MPG'' in
this supplemental NPRM, we have used the full document citation
throughout this supplemental NPRM, as appropriate. Therefore, we have
removed paragraph (f)(1) of the NPRM from this supplemental NPRM and
have revised the subsequent paragraph identifiers accordingly.

Explanation of Change to Costs of Compliance

    Since issuance of the original NPRM, we have increased the labor
rate used in the Costs of Compliance from $80 per work-hour to $85 per
work-hour. The Costs of Compliance information, below, reflects this
increase in the specified hourly labor rate.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the earlier
NPRM. As a result, we have determined that it is necessary to reopen
the comment period to provide additional opportunity for the public to
comment on this proposed AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 43 products of U.S. registry.
    The actions that are required by AD 2008-13-15 and retained in this
proposed AD take about 1 work-hour per product, at an average labor
rate of $85 per work hour. Based on these figures, the estimated cost
of the currently required actions is $85 per product.
    We estimate that it would take about 1 work-hour per product to
comply with the new basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of the proposed AD on U.S. operators to be $3,655, or $85 per
product.

Authority for This Rulemaking

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

products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15578 (73 FR
35908, June 25, 2008) and adding the following new AD:

Empresa Brasileira de Aeronautica S.A. (EMBRAER): Docket No. FAA-
2008-1080; Directorate Identifier 2008-NM-118-AD.

Comments Due Date

    (a) We must receive comments by April 19, 2010.

Affected ADs

    (b) This AD supersedes AD 2008-13-15, Amendment 39-15578.

Applicability

    (c) This AD applies to all Empresa Brasileira de Aeronautica
S.A. (EMBRAER) Model EMB-135BJ airplanes, certificated in any
category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (h)(1) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI),
Brazilian Airworthiness Directive 2007-08-01, effective September
27, 2007, states:

    Fuel system reassessment, performed according to RBHA-E88/SFAR-
88 (Regulamento Brasileiro de Homologacao Aeronautica 88/Special
Federal Aviation Regulation No. 88), requires the inclusion of new
maintenance tasks in the Critical Design Configuration Control
Limitations (CDCCL) and in the Fuel System Limitations (FSL),
necessary to preclude ignition sources in the fuel system. * * *

And the MCAI, Brazilian Airworthiness Directive 2009-08-03,
effective August 20, 2009, states:

    An airplane fuel tank systems review required by Special Federal
Aviation Regulation Number 88 (SFAR 88) and ``RBHA Especial
N[uacute]mero 88'' (RBHA E 88) has shown that additional maintenance
and inspection instructions are necessary to maintain the design
features required to preclude the existence or development of an
ignition source within the fuel tanks of the airplane.
* * * * *
The corrective action is revising the Airworthiness Limitations
Section (ALS) of the Instructions for Continued Airworthiness (ICA)
to incorporate new limitations for fuel tank systems.

Restatement of Requirements of AD 2008-13-15

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Before December 16, 2008, revise the ALS of the ICA to
incorporate Section A2.5.2, Fuel System Limitation Items, of
Appendix 2 of EMBRAER Legacy BJ--Maintenance Planning Guide MPG-
1483, Revision 5, dated March 22, 2007, except as provided by
paragraph (g) of this AD. Except as required by paragraph (g) of
this AD, for all tasks identified in Section A2.5.2 of Appendix 2 of
EMBRAER Legacy BJ--Maintenance Planning Guide MPG-1483, Revision 5,
dated March 22, 2007, the initial compliance times start from the
applicable times specified in Table 1 of this AD; and the repetitive
inspections must be accomplished thereafter at the interval
specified in Section A2.5.2 of Appendix 2 of EMBRAER Legacy BJ--
Maintenance Planning Guide MPG-1483, Revision 5, dated March 22,
2007, except as provided by paragraphs (f)(3) and (h) of this AD.

                                          Table 1--Initial Inspections
----------------------------------------------------------------------------------------------------------------
                                                                    Compliance time (whichever occurs later)
            Reference No.                    Description       -------------------------------------------------
                                                                       Threshold               Grace period
----------------------------------------------------------------------------------------------------------------
28-11-00-720-001-A00.................  Functionally Check       Before the accumulation  Within 90 days after
                                        critical bonding         of 30,000 total flight   December 16, 2008.
                                        integrity of selected    hours.
                                        conduits inside the
                                        wing tank, Fuel Pump
                                        and FQIS connectors at
                                        tank wall by
                                        conductivity
                                        measurements.
28-13-01-720-002-A00.................  Functionally Check Aft   Before the accumulation  Within 90 days after
                                        Fuel tank critical       of 30,000 total flight   December 16, 2008.
                                        bonding integrity of     hours.
                                        Fuel Pump, FQGS and
                                        Low Level SW
                                        connectors at tank
                                        wall by conductivity
                                        measurements.
28-15-04-720-001-A00.................  Functionally Check Fwd   Before the accumulation  Within 90 days after
                                        Fuel tank critical       of 30,000 total flight   December 16, 2008.
                                        bonding integrity of     hours.
                                        Fuel Pump, FQGS and
                                        Low Level SW
                                        connectors at tank
                                        wall by conductivity
                                        measurements.
28-21-01-220-001-A00.................  Inspect Wing Electric    Before the accumulation  Within 90 days after
                                        Fuel Pump Connector.     of 10,000 total flight   December 16, 2008.
                                                                 hours.

28-23-03-220-001-A00.................  Inspect Pilot Valve      Before the accumulation  Within 90 days after
                                        harness inside the       of 20,000 total flight   December 16, 2008.
                                        conduit.                 hours.
28-23-04-220-001-A00.................  Inspect Vent Valve       Before the accumulation  Within 90 days after
                                        harness inside the       of 20,000 total flight   December 16, 2008.
                                        conduit.                 hours.
28-41-03-220-001-A00.................  Inspect FQIS harness     Before the accumulation  Within 90 days after
                                        for clamp and wire       of 20,000 total flight   December 16, 2008.
                                        jacket integrity.        hours.
28-46-02-220-001-A00.................  Aft Fuel Tank Internal   Before the accumulation  Within 90 days after
                                        Inspection: FQGS         of 20,000 total flight   December 16, 2008.
                                        harness and Low Level    hours.
                                        SW harness for clamp
                                        and wire jacket
                                        integrity.
28-46-04-220-001-A00.................  Fwd Fuel Tank Internal   Before the accumulation  Within 90 days after
                                        Inspection: FQGS         of 20,000 total flight   December 16, 2008.
                                        harness and Low Level    hours.
                                        SW harness for clamp
                                        and wire jacket
                                        integrity.
----------------------------------------------------------------------------------------------------------------

     (2) Within 90 days after July 30, 2008 (the effective date of
AD 2008-13-15), revise the ALS of the ICA to incorporate Items 1, 2,
and 3 of Section A2.4, Critical Design Configuration Control
Limitation (CDCCL), of Appendix 2 of EMBRAER Legacy BJ--Maintenance
Planning Guide MPG-1483, Revision 5, dated March 22, 2007.
    (3) After accomplishing the actions specified in paragraphs
(f)(1) and (f)(2) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (h) of this
AD.

New Requirements of This AD

Actions and Compliance

    (g) Unless already done, do the following actions.
    (1) Within 30 days after the effective date of this AD, revise
the ALS of the ICA to incorporate Tasks 28-41-01-720-001-A01 and 28-
46-05-720-001-A01 identified in Table 2 of this AD into Section
A2.5.2 of Appendix 2 of EMBRAER Legacy BJ--Maintenance Planning
Guide MPG-1483. After incorporating Tasks 28-41-01-720-001-A01 and
28-46-05-720-001-A01 identified in Table 2 of this AD, Tasks 28-41-
01-720-001-A00 and 28-46-05-720-001-A00 identified in Section A2.5.2
of Appendix 2 of EMBRAER Legacy BJ--Maintenance Planning Guide MPG-
1483, Revision 5, dated March 22, 2007, are no longer required. For
the fuel limitation tasks identified in Table 2 of this AD, do the
initial task at the later of the applicable ``Threshold'' and
``Grace Period'' times specified in Table 2 of this AD.

                                                                  Table 2--Inspections
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Compliance time (whichever occurs later)
             Task No.                            Description                Part No.   -------------------------------------------- Repetitive  Interval
                                                                                Threshold           Grace period         (not to exceed)
--------------------------------------------------------------------------------------------------------------------------------------------------------
28-41-01-720-001-A01..............  Perform an initial functional check    367-934-002  Before the            Within 90 days after  10,000 flight hours
                                     as shown in Testing and Fault                       accumulation of       the effective date    on the FCU since
                                     Isolation sections 1, 2, and 3; an                  10,000 total flight   of this AD.           the most recent
                                     external visual inspection as shown                 hours on the FCU.                           functional check.
                                     in the Check section 2; an internal
                                     visual inspection as shown in the
                                     Repair section 1; a functional
                                     check of the safe-life features as
                                     shown in Testing and Fault
                                     isolation section 4; and a final
                                     functional check as shown in
                                     Testing and Fault isolation
                                     sections 1, 2, and 3; of the fuel
                                     conditioning unit (FCU), in
                                     accordance with Parker CMM 28-41-
                                     69, Revision 2, dated March 13,
                                     2009.
28-46-05-720-001-A01..............  Perform an initial functional check    367-934-004  Before the            Within 90 days after  10,000 flight hours
                                     as shown in Testing and Fault                       accumulation of       the effective date    on the AFCU since
                                     Isolation sections 1, 2, and 3; an                  10,000 total flight   of this AD.           the most recent
                                     external visual inspection as shown                 hours on the AFCU.                          functional check.
                                     in Check section 2; an internal
                                     visual inspection as shown in
                                     Repair section 1; a functional
                                     check of the safe-life features as
                                     shown in Testing and Fault
                                     Isolation section 4; and a final
                                     functional check as shown in
                                     Testing and Fault isolation
                                     sections 1, 2, and 3; of the
                                     auxiliary fuel conditioning unit
                                     (AFCU), in accordance with Parker
                                     CMM 28-41-66, Revision 1, dated
                                     March 13, 2009.

28-46-05-720-001-A01..............  Perform an initial functional check    367-934-006  Before the            Within 90 days after  10,000 flight hours
                                     as shown in Testing and Fault                       accumulation of       the effective date    on the AFCU since
                                     Isolation sections 1, 2, and 3; an                  10,000 total flight   of this AD.           the most recent
                                     external visual inspection as shown                 hours on the AFCU.                          functional check.
                                     in Check section 2; an internal
                                     visual inspection as shown in
                                     Repair section 1; a functional
                                     check of the safe-life features as
                                     shown in Testing and Fault
                                     Isolation section 4; and a final
                                     functional check as shown in
                                     Testing and Fault isolation
                                     sections 1, 2, and 3; of the AFCU,
                                     in accordance with Parker CMM
                                     28[dash]41[dash]90, dated April 3,
                                     2009.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) After accomplishing the actions specified in paragraphs
(g)(1) of this AD, no alternative inspections or inspection
intervals may be used unless the inspections or intervals are
approved as an AMOC in accordance with the procedures specified in
paragraph (h) of this AD.

Explanation of CDCCL Requirements

    Note 2: Notwithstanding any other maintenance or operational
requirements, components that have been identified as airworthy or
installed on the affected airplanes before the revision of the ALS
of the ICA, as required by paragraph (f)(3) of this AD, do not need
to be reworked in accordance with the CDCCLs. However, once the ALS
of the ICA has been revised, future maintenance actions on these
components must be done in accordance with the CDCCLs.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows:
    (1) Brazilian Airworthiness Directive 2009-08-03, effective
August 20, 2009, specifies that actions accomplished before the
effective date of that AD, in accordance with Parker Service
Bulletin 367-934-28-110, Revision A, dated December 19, 2006, are
considered acceptable for compliance with the corresponding actions
specified in the AD. This AD specifies that actions accomplished in
accordance with applicable Parker CMM listed in Table 2 of this AD
are considered acceptable for compliance.
    (2) The applicability of Brazilian Airworthiness Directive 2009-
08-03, effective August 20, 2009, includes models other than Model
EMB-135BJ airplanes. However, this AD does not include those other
models. Those models are included in the applicability of FAA AD
2008-13-14, Amendment 39-15577. We are considering further
rulemaking to revise AD 2008-13-14.
    (3) Although Brazilian Airworthiness Directive 2009-08-03,
effective August 20, 2009, specifies both revising the airworthiness
limitations and repetitively inspecting, this AD only requires the
revision. Requiring a revision of the airworthiness limitations,
rather than requiring individual repetitive inspections, requires
operators to record AD compliance status only at the time they make
the revision, rather than after every inspection. Repetitive
inspections specified in the airworthiness limitations must be
complied with in accordance with 14 CFR 91.403(c).

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1175; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI Brazilian Airworthiness Directives 2007-08-01,
effective September 27, 2007, and 2009-08-03, effective August 20,
2009; Sections A2.5.2, Fuel System Limitation Items, and A2.4,
Critical Design Configuration Control Limitation (CDCCL), of
Appendix 2 of EMBRAER Legacy BJ--Maintenance Planning Guide MPG-
1483, Revision 5, dated March 22, 2007; and the Parker CMMs listed
in Table 2 of this AD; for related information.

    Issued in Renton, Washington, on March 16, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-6308 Filed 3-22-10; 8:45 am]
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[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Page 46939]
[FR Doc No: 2013-18591]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-2027-000]

DWP Energy Holdings, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of DWP Energy Holdings, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is August 15, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 26, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-18591 Filed 8-1-13; 8:45 am]
BILLING CODE 6717-01-P