Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline EPA Reviewer: Abdallah Khasawinah, Ph. D. Signature: Reregistration Branch 4, HED ( 7509C) Date: EPA Secondary Reviewer: William Dykstra, Ph. D. Signature: Reregistration Branch 4, HED ( 7509C) Date:

TXR#: 0051041 DATA EVALUATION RECORD STUDY TYPE: Hepatocellular Proliferation  Mouse ( Non guideline)

DP BARCODE: D284584, D286951, D287541 SUBMISSION CODE: S619276, S625382, S627058 P. C. CODE: 111901 TOX. CHEM. NO.: 497AB TEST MATERIAL ( PURITY): Imazalil Technical ( 96.2% purity)

SYNONYMS: R023979; ( ± )  2 ethoxy 2,3 dihydro 3,3 dimethylbenzofuran 5 ylmethanesulfonate ( IUPAC)

CITATION: O'Neill, T. P. ( 2002) Cell Proliferation Study in Male CD 1 Mice After Administered Imazalil in the Diet for 2 or 13 Weeks  Final Report: Lab Study Number: WIL 436001. WIL Research Laboratories, Inc. ( Ashland, OH) 574 pages. July 9, 2002. MRID 45713701. Unpublished.

O'Neill, T. P. ( 2002) Cell Proliferation Study in Male CD 1 Mice After Administered Imazalil in the Diet for 2 or 13 Weeks  Interim Final Report: Lab Study Number: WIL 436001. WIL Research Laboratories, Inc. ( Ashland, OH) 573 pages. June 27, 2002. MRID 45708401. Unpublished.

O'Neill, T. P. ( 2002) Cell Proliferation Study in Male CD 1 Mice After Administered Imazalil in the Diet for 2 or 13 Weeks  Addendum to the Final Report: Supplement to MRID 45713701, Lab Study Number: WIL 436001. WIL Research Laboratories, Inc. ( Ashland, OH) 40 pages. October 11, 2002. MRID 45783801. Unpublished.

O'Neill, T. P. ( 2002) Cell Proliferation Study in Male CD 1 Mice After Administered Imazalil in the Diet for 2 or 13 Weeks  Addendum II to the Final Report: Supplement to MRID 45713701, Lab Study Number: WIL 436001. WIL Research Laboratories, Inc. ( Ashland, OH) 55 pages. December 17, 2002. MRID 45822503. Unpublished SPONSOR: Janssen Pharmaceutica N. V., B 2340, Beerse, Belgium EXECUTIVE SUMMARY: In a nonguideline hepatocellular proliferation study ( MRID 45713701, 45708401, 45783801 & 45822503) conducted to investigate the mechanism of liver tumor induction observed at same dosage levels in oncogenicity studies, groups of male Crl: CD 1R( ICR) BR mice ( 10/ dose/ sacrifice time) were given imazalil ( purity 96.2%, Lot. No. ZR023979G3H771) in the diet ad libitum at concentrations of 0.0, 100, 200, 400, 600 or 1200 ppm ( 0, 18.7 ± 1.1, 38.3 ± 2.7, 73.4 ± 5.13, 110.4 ± 11.7, 233.2 ± 24.5 mg/ kg/ day) for 2 or 13 weeks. Bromo deoxyuridine ( BrdU) in sterile phosphate buffered saline ( 30 mg/ mL) was Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 2 of 14 administered subcutaneously ( through an implanted osmotic minipump) seven days prior to the appropriate mice sacrifice period. Animals were sacrificed after 2 week interim period; 4 week recovery period ( the 0 and 1200 ppm group only); 13 week primary sacrifice; 17 week recovery period ( the 0 and 1200 ppm group only). At sacrifice, the animals were weighed and the liver removed, weighed, and sections prepared for serial review by Hematoxylin and Eosin or BrdUimmunohistochemical and Proliferating Cell Nuclear Antigen ( PCNA) staining of hepatocytes.

Administration of imazalil to male mice in their diets for up to 13 weeks affected survival and body weight only at the 1200 ppm level. Clinical findings, food consumption and macroscopic changes were not affected by the imazalil treatment. The primary organ of imazalil toxicity in this test was the liver. Imazalil produced microscopic changes ( centrilobular hepatocellular hypertrophy and hepatocellular vacuolation, and hepatocellualr necrosis) in a dose related manner. Liver enzymes levels ALD and SDH were elevated but not LDH. With the exception of a single hepatocellular nucleus in a 200 ppm animal positive for BrdU labeling, none was positive in all the 100, 200, 400, and 600 ppm groups. BrdU labeling in the high dose group of 1200 ppm was lower than in the control group at both the interim sacrifice of two weeks or the 13 week primary sacrifice. The 4 week and 17 week recovery sacrifices were negative for any BrdU labeling in both the control and 1200 ppm groups. This was confirmed by repeating the staining procedure for the control and high dose groups at the interim and 13 week sacrifices. The BrdU staining procedure was also verified by producing positive results in cells taken from duodenum sections. It was observed that control animals had a higher labeling percentage than the highest imazalil dose tested.

PCNA labeling index as an indicator of hepatic cell proliferation was ( statistically significant) lower in the imazalil tested dose groups than in the control group. This demonstrates the lack of induction of hepatic cell proliferation by imazalil. " There was a decreased proportion of PCNAlabeled hepatocyte nuclei and fewer hepatocyte nuclei overall in like sized total areas of the livers of the 200, 400, 600 and 1200 ppm group mice compared to mice in the control group", suggesting an inhibition of cell proliferation in the imazalil treated mice.

The LOAEL for imazalil in the male mice is 200 ppm ( 38.3 ± 2.7 mg/ kg/ day) based on its hepatotoxicity ( centrilobular hepatocellular hypertrophy and hepatocellular vacuolation, and hepatocellualr necrosis and elevated sorbitol dehydrogenase levels). The NOAEL is 100 ppm ( 18.7 ± 1.1 mg/ kg/ day).

This study is considered Acceptable/ Non Guideline for the intended purpose.

COMPLIANCE: Signed and dated GLP, Quality Assurance, Data Confidentiality, and Flagging statements were provided. Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 3 of 14 I. MATERIALS AND METHODS A. MATERIALS:

1. Test Material: Imazalil technical ( R023979) Description: Clear, viscous, orange yellow liquid Lot #: ZR023979G3H771 Purity: 96.2% a. i. Stability of compound: considered stable at room temperature CAS #: 35554 44 0 Structure:

2. Vehicle: PMI Certified Rodent LabDiet ® ( No. 5002) was used for preparing the test diet mixtures.

3. Test animals: Species: Male mice Strain: Crl: CD 1R( ICR) BR Age at study initiation: 60 Days Weight at study initiation: 21.5  35.4 g Source: Charles River Laboratories, Inc., Kingston, NY Housing: Individually housed in clean cages suspended above cage board or other suitable material Diet: PMI Certified Rodent LabDiet ® ( No. 5002), ad libitum Water: Tap water filtered by reverse osmosis, ad libitum Environmental conditions: Temperature: 21.7 22.8oC ( recorded daily) Humidity: 20.7  67.4% ( recorded daily) Air changes: Not reported Photo period: 12 Hour light/ dark cycle Acclimation period: 13 Days B. STUDY DESIGN 1. In life dates  Start: 09/ 14/ 2001 End: 04/ 24/ 2002 2. Animal assignment Prior to initiation of treatment, the mice were weighed and examined in detail for physical abnormalities. Mice judged suitable for assignment to the study were selected by the study director and assigned to the test groups shown in Table 1 using a computer based randomization procedure that ensured the homogeneity of group means for body weight. Individual body weights at randomization were within ± 20 % Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 4 of 14 of the mean.

Table 1. Study Design.

Group # Treatment Dose ( ppm) Number of Mice 2 Week Necropsy 4 Weeka Necropsy 13 Week Necropsy 17 Weeka Necropsy 1 Untreated 0 40 10 10 10 10 2 Imazalil 100 20 10 10 3 Imazalil 200 20 10 10 4 Imazalil 400 20 10 10 5 Imazalil 600 20 10 10 6 Imazalil 1200 40 10 10 10 10 a Recovery Groups 3. Test Diet Preparation and Analysis A premix of imazalil and diet was prepared by homogenizing appropriate amounts of imazalil and rodent feed. Desired dietary concentrations were then prepared by homogenizing premix amounts with known quantities of the rodent feed. Samples for homogeneity analysis were taken from the top, middle and bottom of each diet. Samples for stability analysis were taken from the middle portion of each diet and stored under laboratory conditions for 8 and 10 days. Samples for concentration analysis were collected weekly from each dosing formulation for study weeks 0, 1, 2, 3, 8 and 12. The test diets were prepared weekly and stored at room temperature in properly labeled storage bags.

The analytical data indicated that the variance between nominal and actual dose to the animals was acceptable.

Results   Homogeneity: The concentrations of imazalil were within  3 to 7.5% of target concentrations in samples from the top, middle and bottom of the batch indicating they were homogeneously distributed throughout the diet.

Stability: Imazalil was considered to be stable within the diet for a period of 10 days. The mean concentration of the stored formulations ranged from 86.0 to 97.5% of the time zero concentrations.

Dose concentration:  All diets were found to be within 90.3 106% of nominal concentrations except for one time reading of 116% in group 4.

4. Dose selection rationale The objective of the study was to identify a mode of action and dose response characteristics for imazalil induced liver tumor response in the same strain of mice used in the previous bioassay. Increased incidences of hepatocellular neoplasms were found in a carcinogenicity study with male mice fed 200 or 600 ppm imazalil ( MRID Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 5 of 14 42972001). The doses for the present study were chosen to correspond with the doses in the bioassay study. The doses of 100, 400 and 1200 ppm were selected to provide additional dose response information.

4. Statistics The body weight, body weight change, food consumption, clinical pathology and liver weights were analyzed by ANOVA followed by Dunnett's test ( p

0.05) to detect significant differences. PCNA data was analyzed using two tailed tests for minimum significance levels of 1% and 5%, comparing each test article treated group to the control group. The total number of labeled nuclei and labeling index data were subjected to a prametric one way analysis of variance to determine intergroup differences.

C. METHODS 1. Animal observations All mice were observed twice daily for moribundity and death examined and once daily for clinical observations. Detailed physical examinations were done weekly on all mice.

2. Body weight and food consumption Body weights and food consumption were recorded weekly starting two weeks prior to dietary administration of imazalil. In addition, daily food consumption and daily intake of test material were calculated.

3. Animal preparation Animals were anesthetized using isoflurane. A 30 mg/ mL solution of bromodeoxyuridine ( BrdU) in sterile phosphate buffered saline was loaded in osmotic minipumps which were then implanted subcutaneously seven days prior to the appropriate mice sacrifice period.

4. Sacrifice and pathology At sacrifice, mice anesthetized by carbon dioxide and blood collected from the vena cava for evaluation of alanine aminotransferase, lactate dehydrogenase and sorbitol dehydrogenase. The liver from scheduled and unscheduled sacrifices was removed and weighed. Portions (~ 5 mm in thickness) from the left lateral, right lateral, median and caudate portions of the liver, as well as a portion of the small intestine, were excised, fixed in 10% neutral buffered formalin, and embedded in paraffin. For unscheduled deaths, the remaining liver was minced, placed in a cryovial, flash frozen in liquid nitrogen and stored at  70oC for possible future analysis.

Serial sections of each liver portion were prepared according to standard operating procedures and stained with Hematoxylin and Eosin or immunohistochemically stained for BrdU labeled nuclear DNA, both with ( test) and without ( negative control) the presence of anti BrdU antibody. " Established immunohistochemical methods were used to identify cells in the S phase using a monoclonal antibody raised against a Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 6 of 14 purified form of BrdU". Labeling index ( LI) was used to measure the percentage of cells in the DNNA replicative or S phase thet had incorporated BedU, an exogenous DNA precursor. The duodenum was processed similarly and served as a BrdU positive control. Slides of the liver and duodenum were scanned by light microscopy to verify BrdU incorporation.

Liver sections were scanned for uniform BrdU labeling in hepatocytes of the different lobes of the liver. Once the BrdU labeling was qualitatively determined to be uniform between the three lobes of the liver, only the left lobe was scored for BrdU incorporation. At least 2000 hepatocellular nuclei per animal were counted and scored with the investigator blind to the animal treatment.

Because of insufficient staining techniques utilized for the BrdU labeling, all liver and duodenum samples were restained using an improved staining procedure ( not described in the report). BrdU labeling was re evaluated for the control and high dose groups at the 2 and 13 week sacrifice.

Proliferating Cell Nuclear Antigen ( PCNA) immunostaining of hepatocytes to determine the effects of imazalil on hepatocyte proliferation was conducted after the finding that imazalil did not increase ( induce) BrdU incorporation. Tissue blocks containing samples of liver from four sections and small intestine ( as positive control) from the control group and the high dose group ( all necropsies) were submitted by the sponsor to Experimental Pathology Laboratories, Inc. ( EPL ® ) for PCNA immunostaining using a commercial kit ( Zymed ® PCNA staining kit) ( MRID 45783801. Hepatocyte nuclei ( labeled and unlabeled) were counted microscopically in a grid fashion. Subsequent to the finding that the high dose group animals had decreased PCNA labeling compared to the control group animals, PCNA immnonstaining was performed on the other test groups for week 2 and week 13 necropsies ( MRID 45822503).

II. RESULTS A. OBSERVATIONS One animal in the 1200 ppm group was sacrificed in extremis on day 5 of treatment exhibiting hypo activity, tremors, dermal atonia, shallow respiration, emaciation, body cool to touch, prostration and unkempt appearance attributable to the imazalil treatment. One animal in the 200 ppm group was found dead on day 65 and was not treatment related. No other mortalities or clinical symptoms were reported that would be related to treatment.

B. BODY WEIGHT AND FOOD CONSUMPTION There were sporadic and inconsistent body weight changes among groups reaching statistical significance ( p< 0.05 0.01) in a non dose related manner. The body weight gain in the 1200 ppm group was 18.3%  26.7% lower than the untreated group during the first 2 weeks of imazalil administration then became comparable throughout the remainder of the study. With the exception of statistically significant ( p< 0.05 or p< 0.01) increases in food consumption in the 200  1200 ppm groups during study weeks 6 and 7, there were no treatment related effects on food consumption by the mice. Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 7 of 14 C. COMPOUND CONSUMPTION The calculated mean compound consumption over the 13 week feeding period ( calculated by the reviewer from table 17A of the study report) for the 100, 200, 400, 600 and 1200 ppm groups is 18.7 ± 1.1, 38.3 ± 2.7, 73.4 ± 5.13, 110.4 ± 11.7, 233.2 ± 24.5 mg/ kg/ day, respectively.

D. CLINICAL CHEMISTRY The serum chemistry parameters are presented in Table 2. A statistically significant ( p< 0.01) increase ( 97% over the control) in alanine transferase ( ALT) levels were reported in the 1200 ppm imazalil group at the 13 week sacrifice and returned to normal levels after 4 weeks of recovery period. Mean sorbitol dehydrogenase levels were elevated ( 114  380% of the controls) in all imazalil groups at both sacrifice times but were statistically significant only at the 600 (< 0.05) for the 2 week sacrifice and 1200 (< 0.01) ppm for the 2 and 13 week sacrifices. Their levels returned to normal during the recovery periods. Mean lactate dehydrogenase levels were statistically and significantly lower in the 600 and 1200 ppm imazalil groups compared to the control, but were comparable to the control group values at the 13 week sacrifice suggesting that this decrease was an anomaly rather than treatment related. Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 8 of 14 Table 2. Summary of serum chemistry values in male mice fed diets containing imazalil up to 13 weeksa Week of Sacrifice Alanine Transferase ( U/ L)

0 100 ppm 200 ppm 400 ppm 600 ppm 1200 ppm 2 43 ± 6.9 ( 7) 39 ± 6.1 ( 10) 36 ± 7.8 ( 10) 29 ± 8.2 ( 10) 41 ± 13.3 ( 10) 44 ± 16.8 ( 10)

4 ( recovery) 32 ± 7.2 ( 10) NA NA NA NA 35 ± 7.5 ( 10)

13 43 ± 6.5 ( 10) 39 ± 7.2 ( 10) 45 ± 23.3 ( 9) 43 ± 9.3 ( 10) 40 ± 18.0 ( 10) 77 ± 31.2** ( 10)

17 ( recovery) 39 ± 10.9 ( 10) NA NA NA NA 42 ± 11.6 ( 9)

Sorbitol Dehydrogenase ( U/ L)

2 5.6 ± 1.78 ( 3) 12.1 ± 5.96 ( 6) 11.9 ± 3.17 ( 4) 13.3 ± 6.51 ( 10) 18.2 ± 6.70* ( 10) 21.3 ± 9.22** ( 10)

4 ( recovery) 10.2 ± 4.62 ( 10) NA NA NA NA 9.8 ± 6.30 ( 9)

13 36.4 ± 7.92 ( 10) 41.7 ± 8.86 ( 10) 53.2 ± 25.64 ( 10) 51.8 ± 14.43 ( 10) 58.2 ± 12.27 ( 10) 96.4 ± 36.48** ( 10)

17 ( recovery) 26.8 ± 1.54 NA NA NA NA 29.4 ± 5.20 Lactate Dehydrogenase ( U/ L)

2 1573 ± 925 ( 7) 1407 ± 702 ( 10) 1683 ± 452 ( 10) 682 ± 412* ( 10) 418 ± 136** ( 10) 365 ± 88** ( 10)

4 ( recovery) 166 ± 97 ( 10) NA NA NA NA 425 ± 139 ( 10)

13 423 ± 95 ( 10) 590 ± 266 ( 10) 484 ± 168 ( 9) 608 ± 177 ( 10) 579 ± 246 ( 10) 643 ± 409 ( 10)

17 ( recovery) 491 ± 192 ( 10) NA NA NA NA 432 ± 115 ( 9)

Reproduced from Table 20, MRID 45713701 * p

0.05, ** p

0.01 NA Not Applicable D. ORGAN WEIGHT AND PATHOLOGY 1. Liver weight As shown in Table 3, there was a statistically significant increase in the absolute liver weight ( 36.7%, 13.6% and 48.6% increase) and relative to final body weight ( 40.6%, 12.6% and 31.7% increase) at the 2 week interim sacrifice, 4 week recovery sacrifice and 13 week primary sacrifice, respectively, in the 1200 ppm treated mice compared to the control animals. Liver weights ( absolute and relative) were comparable to the control group at the 17 week sacrifice time. Increased liver weights relative to body weight were noted in the 600 ppm group at study weeks 2 and 13 necropsies ( 14.6% and 13.5% increase, respectively). Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 9 of 14 Table 3. Absolute and relative liver weights of male mice fed diets containing imazalil up to 13 weeksa Week of Sacrifice Absolute ( g) 0 100 ppm 200 ppm 400 ppm 600 ppm 1200 ppm 2 2.066 2.093 2.053 2.164 2.290 2.824**

4 ( recovery) 2.035 NA NA NA NA 2.312*

13 2.301 2.243 2.310 2.562 2.566 3.289*

17 ( recovery) 2.104 NA NA NA NA 2.096 Relative to final body weight g%

2 5.844 5.923 5.938 6.234 6.699** 8.216**

4 ( recovery) 5.599 NA NA NA NA 6.294**

13 5.725 5.474 5.548 6.135 6.499** 8.380**

17 ( recovery) 5.026 NA NA NA NA 5.141 Data from Tables 26 33, MRID 45713701 * p

0.05, ** p

0.01 a Based on 10 mice/ group except for the 200 ppm group 13 week sacrifice was 9 mice 2. Liver pathology Macroscopic examination did not reveal any liver lesions in the imazalil treated animals.

3. Histopathology Histopathological findings of the liver are summarized in Table 4. All mice in the 200, 400, 600 and 1200 ppm groups developed treatment related centrilobular hepatocellular hypertrophy with increasing incidence and severity at the 2 week interim sacrifice. Hepatocellular vacuolation with increasing incidence and severity were also noted in mice treated with 400, 600 or 1200 ppm of imazalil. Minimal hepatocellular necrosis was observed at low incidence in the 600 and 1200 ppm groups. At the 4 week recovery necropsy minimal to moderate centrilobular hepatocellular hypertrophy and hepatocellular vacuolation was seen in all the 1200 ppm animals, while hepatocellular necrosis incidence was similar to the control group. At the 13 week necropsy examination centrilobular hepatocellular hypertrophy and hepatocellular vacuolation occurred with increasing incidence and severity in all animals treated with 200 ppm of imazalil and above and a slightly higher incidence of minimal hepatocellular necrosis in the 1200 ppm group. Hepatocellular vacuolation with lower incidence and severity persisted during the recovery period at 17 weeks sacrifice. Minimal hepatocellular hypertrophy was note only in one animal at the 17 weeks recovery necropsy with an absence of hepatocellualr necrosis. Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 10 of 14 Table 4. Summary of Microscopic Findings ( Liver)

Week 2 of Sacrifice 0 100 ppm 200 ppm 400 ppm 600 ppm 1200 ppm No. examined Hypertrophy, hepatocellular Minimal Mild Moderate Necrosis, Minimal Inflamation, Subacute, Minimal Vacoulation, Hepatocellular Minimal Mild 10 0 None None None 000 None None 10 0 None None None 000 None None 10 33 None None 0 None 0 None None 10 10 82 None 0155 None 10 10 37 None 22 10 55 10 10 None 3711844 Week 4 of Sacrifice ( Recovery)

No. examined Hypertrophy, hepatocellular Minimal Mild Moderate Necrosis, Minimal Inflamation, Subacute, Minimal Vacoulation, Hepatocellular Minimal Mild Inflamation, Chronic, Mild Mineralization, Minimal 10 0 None None None 120 None None 00 0 0 0 0 10 10 3521132111 Week 13 of Sacrifice No. examined Hypertrophy, hepatocellular Minimal Mild Moderate Severe Necrosis, Minimal Inflamation, Subacute, Minimal Vacoulation, Hepatocellular Minimal Mild Moderate Severe Inflamation, Chronic, Mild 10 0 None None None None 120 None None None None 0 10 0 None None None None 120 None None None None 0 922 None None None 0 None 3210 None 2 10 972 None None 139351 None 0 10 10 253 None 13 10 154 None 0 10 10 None None 2834 10 None 3430 Week 17 of Sacrifice ( Recovery)

No. examined Hypertrophy, hepatocellular Minimal Vacoulation, Hepatocellular Minimal Mild Moderate 10 0 None 0 None None None 0 0 0 0 9 117223 Reproduced from Tables 34  37, MRID 45713701 Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 11 of 14 5. Hepatocellular Proliferation The labeling indices for imazalil shown in Table 5. With the exception of a single hepatocellular nucleus in a 200 ppm animal positive for BrdU labeling, none was positive in all the 100, 200, 400, and 600 ppm groups. BrdU labeling in the high dose group of 1200 ppm was similar or lower than in the control group at both the interim sacrifice of two weeks or the 13 week primary sacrifice. The 4 week and 17 week recovery sacrifices were negative for any BrdU labeling in both the control and 1200 ppm groups. According to the study report, nuclear labeling with BrdU was demonstrated in the crypts of the duodenum of all but one animal, indicating both exposure of the animals to BrdU and the adequacy of the staining method.

As a result of the negative results regarding BrdU labeling of hepatocytes, livers from the control and 1200 ppm mice at the interim and 13 week sacrifice were restained using an improved procedure ( was not described). Following re staining, the mean labeling index for the control animals and the 1200 ppm animals at the 2 week sacrifice was 10.79 and 7.10 BrdU positive cells per 1000 hepatocytes, respectively. At the 13 week primary sacrifice, the labeling index was 31.12 and 13.96 BrdU positive cells per 1000 hepatocytes for the control and 1200 ppm animals, respectively.

TABLE 5. Percent of BrdU labeled nuclei ( ± standard deviation) in hepatocytes of mice fed diets containing imazalil up to 13 weeksa Week of Sacrifice Control 100 ppm 200 ppm 400 ppm 600 ppm 1200 ppm 2 0.99 ± 1.1994 0.00 0.00 0.00 0.00 0.71 ± 0.3823 4 ( recovery) 0.00     0.00 13 3.11 ± 2.5509 0.00 0.00 0.00 0.00 1.394 ± 1.1497 17 ( recovery) 0.00     0.00 * Data from Tables 53 56, MRID 45713701 calculated by the reviewer Based on 10 mice/ group except for the 200 ppm group 13 week sacrifice was 9 mice To further demonstrate the potential effects of imazalil on hepatocytes cell proliferation, the sponsor subjected liver sections from the control and imazalil test groups to PCNA immunostaining using readily commercial staining kits. The results of this demonstrated that the PCNA labeling index in the high dose group was lower than in the control group demonstrating the lack of hepatic cell proliferation by imazalil. The results are summarized in Table 6. Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 12 of 14 TABLE 6. Summary of Hepatocyte Nuclei Counts and PCNA Labeling Indices Treatment Group Sacrifice Week Unlabeled plus Labeled Nuclei PCNA labeled Nuclei Labeling Index % Number of Grid areas Counted for PCNA Labeled Nuclei Control Group 2 2811 9 ± 11.2 0.3 ± 0.40 32 4 2592 9 ± 9.2 0.4 ± 0.37 32 13 2496 20 ± 15.0 0.8 ± 0.72 32 17 2613 4 ± 3.6 0.15 ± 0.18 32 100 ppm 2 2817 9 ± 13.8 0.3 ± 0.54 32 13 2679 12 ± 6.8 0.4 ± 0.28 32 200 ppm 2 2702 7 ± 8.5 0.2 ± 0.27 32 13 2457 9* ± 5.7 0.3* ± 0.23 33 400 ppm 2 2435 7 ± 8.8 0.3 ± 0.40 32 13 2216 4** ± 3.6 0.2** ± 0.18 34 600 ppm 2 2243 1 ± 0.8 0.0 ± 0.04 33 13 2151 3** ± 2.4 0.1** ± 0.12 36 1200 ppm Group 2 2454 1 ± 0.7 0.0 ± 0.03 32 4 2383 1* ± 2.8 0.0* ± 0.13 33 13 2124 7** ± 12.4 0.3* ± 0.56 40 17 2152 1 ± 0.8 0.1 ± 0.05 34 Reproduced from Tables 65 & 66 on pages 15 & 16 and Table on page 41 of Study Report MRID 45822503. Labeling Index = Total Number of PCNA Labeled nuclei X 100% Total Number of Unlabeled and PCNA Labeled Nuclei * = Significantly different from the control group at 0.05 using Dunnett's test. ** = Significantly different from the control group at 0.01 using Dunnett's test.

III. DISCUSSION and CONCLUSIONS A. INVESTIGATORS' CONCLUSIONS:

Administration of imazalil to mice in their diets for up to 13 weeks affected survival and body weights only at the 1200 ppm level. Clinical findings, food consumption, mean lactate dehydrogenase levels, macroscopic changes and BrdU labeling were not affected by the imazalil treatment. Higher SDH levels ( compared to controls) were noted at 100 ppm and above. However, at the 100 ppm the increased SDH levels were not accompanied with microscopic findings or other increases in liver enzymes. Alanine transferase was statistically significantly increased at the 1200 ppm after 13 weeks of exposure and returned to normal levels during the recovery period. There was a statistically significant increase in the absolute liver weight ( 36.7%, 13.6% and 48.6% increase) and relative to final body weight ( 40.6%, Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 13 of 14 12.6% and 31.7% increase) at the 2 week interim sacrifice, 4 week recovery sacrifice and 13 week primary sacrifice, respectively in the 1200 ppm treated mice compared to the control animals. Increased liver weights relative to body weight were noted in the 600 ppm group at study weeks 2 and 13 necropsies ( 14.6% and 13.5% increase, respectively). Microscopically, all mice in the 200, 400, 600 and 120 ppm groups developed treatment related centrilobular hepatocellular hypertrophy with increasing incidence and severity at the 2 week interim sacrifice. Hepatocellular vacuolation with increasing incidence and severity were also noted in mice treated with 400, 600 or 120 ppm of imazalil. Minimal hepatocellular necrosis was observed at low incidence in the 600 and 1200 ppm groups. At the 4 week recovery necropsy minimal to moderate centrilobular hepatocellular hypertrophy and hepatocellular vacuolation was seen in all the 1200 pm animals, while hepatocellular necrosis incidence was similar to the control group. At the 13 week necropsy examination centrilobular hepatocellular hypertrophy and hepatocellular vacuolation occurred with increasing incidence and severity in all animals treated with 200 ppm of imazalil and above and a slightly higher incidence of minimal hepatocellular necrosis in the 1200 ppm group. Hepatocellular vacuolation with lower incidence and severity persisted during the recovery period at 17 weeks sacrifice. Minimal hepatocellular hypertrophy was noted only in one animal at the 17 weeks recovery necropsy with an absence of hepatocellualr necrosis. The investigators concluded that the NOAEL for the dietary oral administration of imazalil to male Crl: CD 1 ( ICR) mice for 2 or 13 weeks is 100 ppm ( mg/ kg/ day). Imazalil did not increase BrdU nuclear staining of hepatocytes in the liver of any treatment group, nor it increased PCNA labeling in liver cells. Contrary to expectations, there was a decrease of BrdU staining of the hepatocytes in the high dose group compared to the control group. The statistically significant decrease in proportion of hepatocyte labeled hepatocyte nuclei was considered " paradoxical" suggesting an inhibition of cell proliferation in the imazalil treated male mice.

B. REVIEWER COMMENTS:

The reviewer finds the investigator's conclusions acceptable and supported by the study data. The primary organ of imazalil toxicity in this test was the liver. Imazalil produced microscopic changes ( centrilobular hepatocellular hypertrophy and hepatocellular vacuolation, and hepatocellualr necrosis) in a dose related manner. Liver enzymes levels ALT and SDH were elevated but not LDH. Imazalil did not induce any BrdU nuclear labeling of hepatocytes at any of the doses tested. This was confirmed by repeating the staining procedure. The BrdU staining procedure was also verified by producing positive results in cells taken from duodenum sections. It was observed that control animals had a higher labeling percentage than the highest dose tested.

PCNA labeling index as an indicator of hepatic cell proliferation was lower in the imazalil treated groups at all dose levels than in the control group at all sacrifice times. This demonstrates the lack of induction of hepatic cell proliferation by imazalil.

The LOAEL for imazalil in the male mice is 200 ppm ( 38.3 ± 2.7 mg/ kg/ day) based on its hepatoxicity ( centrilobular hepatocellular hypertrophy and hepatocellular vacuolation, and hepatocellualr necrosis and elevated sorbitol dehydrogenase levels). The NOAEL is 100 ppm ( 18.7 ± 1.1 mg/ kg/ day).

C. STUDY DEFICIENCIES: Imazalil / PC 111901 Hepatic Cell Proliferation ( Male Mice) ( 2002) Non guideline Page 14 of 14 No deficiencies were found that would affect the interpretation of the study. The improved staining BrdU staining procedure was not described.

This study is considered Acceptable/ Non Guideline for the intended purpose.


[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Rules and Regulations]
[Pages 32563-32565]
[FR Doc No: 2018-14686]

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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
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Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0003; Product Identifier 2017-CE-033-AD; Amendment
39-19326; AD 2018-14-06]
RIN 2120-AA64

Airworthiness Directives; American Champion Aircraft Corp.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) (AD) 2017-07-
10 for certain American Champion Aircraft Corp. (ACAC) Model 8KCAB
airplanes. AD 2017-07-10 required fabrication and installation of a
placard to prohibit aerobatic flight, inspection of the aileron hinge
rib and support, and a reporting requirement of the inspection results
to the FAA. This AD requires repetitive inspections of the aileron
hinge support, installation of the aileron hinge support reinforcement
kit, and incorporation of revised pages into the service manual. This
AD was prompted by a report of a cracked hinge support and cracked
hinge ribs, which resulted in partial loss of control with the aileron
binding against the cove. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective August 17, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 17,
2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of April
12, 2017 (82 FR 17542, April 12, 2017).

ADDRESSES: For service information identified in this final rule,
contact American Champion Aircraft Corp., P.O. Box 37, 32032 Washington
Ave., Rochester, Wisconsin 53167; telephone:<PHONE_NUMBER>; fax: (262)
534-2395; email: [email protected]; internet: http://www.americanchampionaircraft.com/service-letters.html. You may review
copies of the referenced service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0003.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0003; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, M-30, West Building Ground
Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wess Rouse, Small Airplane Program
Manager, 2300 East Devon Avenue, Room 107, Des Plaines, Illinois 60018;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to remove AD 2017-07-10, Amendment 39-18849 (82 FR 17542, April
12, 2017) (``AD 2017-07-10''), and add a new AD. AD 2017-07-10 applied
to certain American Champion Aircraft Corp. (ACAC) Model 8KCAB
airplanes. AD 2017-07-10 required fabricating and installing a placard
to prohibit aerobatic flight, inspecting the aileron hinge rib and
support, and reporting the inspection results to the FAA. We issued AD
2017-07-10 to prevent failure of the aileron support structure, which
may lead to excessive deflection, binding of the control surface, and
potential loss of control.
    The NPRM published in the Federal Register on January 11, 2018 (83
FR 1311). The NPRM was prompted by a report of a cracked hinge support
and cracked hinge ribs, which resulted in partial loss of control with
the aileron binding against the cove. The NPRM proposed to retain the
placard and one-time inspection requirements of AD 2017-07-10 and
remove the reporting requirement. The NPRM also proposed to require
repetitive inspections of the aileron hinge support, installation of
the aileron hinge support reinforcement kit, and incorporation of
revised pages into the service manual. We are issuing this AD to
address the unsafe condition on these products.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Remove the Reinforcement Kit Requirement

    Scott Austin, Chris Murley, Moritz Bartsch, David Trost, and an
anonymous individual requested the AD not require installation of the
reinforcement kit. In support of this request, the commenters state the
airplanes with failures that prompted the AD had different horsepower,
different wingtips, and were used repeatedly in ``hard'' aerobatic
operations. The commenters felt that airplanes with these design
differences and those used in normal operations would be safely
mitigated with repetitive inspections and installation of the
reinforcement kit only if cracks are found.
    We do not agree. The commenters did not provide data to support a
position that the unsafe condition is affected by the differences in
horsepower or wing design. Additionally, all Model 8KCAB airplanes are
certificated to the same operational limits. We have no safety basis to
only rely on 100-hour/annual inspections to mitigate the unsafe
condition. We have not changed this AD based on this comment.

Additional Changes Made to This AD

    We have deleted paragraph (g)(1) of the NPRM and renumbered
paragraphs (g)(2) and (g)(3) to (g)(1) and (g)(2) respectively in this
AD. Paragraphs (g)(2) and (g)(3) of the NPRM basically presented the
actions that were

specified in paragraph (g)(1) of the NPRM, thus making it redundant and
unnecessary.
    We have also corrected minor typographical errors in paragraphs
(h)(1), (h)(3), and (h)(4) in this AD.
    Lastly, we have clarified the document title of the airworthiness
limitations in paragraphs (h)(6) and (h)(7) in this AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed, except for the changes described
previously. These changes are consistent with the intent of the
proposals in the NPRM and will not increase the economic burden on any
operator nor increase the scope of the AD.

Related Service Information Under 1 CFR Part 51

    We reviewed American Champion Aircraft Corp. Service Letter 442,
Revision A, dated August 18, 2017 (ACAC SL No. 442); American Champion
Aircraft Corp. Service Letter 444 Initial Revision, dated August 18,
2017 (ACAC SL No. 444); and page 4-1, Manual Revision B, of the
Airworthiness Limitations section and page 5-9, Manual Revision B, of
the Time and Maintenance Checks section, both dated October 3, 2017,
and included in American Champion Aircraft Corporation SM-601 8KCAB
Service Manual, Reissue B, dated October 3, 2017. ACAC SL No. 442
describes procedures and inspection intervals for inspection of the
aileron hinge rib and hinge support. ACAC SL No. 444 provides
instructions for the installation of the aileron hinge reinforcement
kit. Page 4-1 and page 5-9 are revised pages that add a repetitive
inspection to the 8KCAB Service Manual, SM-601, Reissue B, dated
October 3, 2017. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 64 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Fabrication of placard, inspection   2 work-hours x $85 per hour            $100         $270.00         $17,280
 of aileron hinge rib and support.    = $170.00.
Repetitive 100-hour TIS inspections  1.5 work-hours x $85 per                N/A          127.50           8,160
                                      hour = $127.50.
Installation of aileron hinge        50 work-hours x $85 per               2,200           6,450         412,800
 support reinforcement kit.           hour = $4,250.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-07-10, Amendment 39-18849 (82 FR 17542, April 12, 2017), and
adding the following new AD:

2018-14-06 American Champion Aircraft Corp.: Amendment 39-19326;
Docket No. FAA-2018-0003; Product Identifier 2017-CE-033-AD.

(a) Effective Date

    This AD is effective August 17, 2018.

(b) Affected ADs

    This AD replaces AD 2017-07-10, Amendment 39-18849 (82 FR 17542,
April 12, 2017) (``AD 2017-07-10'').

(c) Applicability

    This AD applies to any American Champion Aircraft Corp. Model
8KCAB airplane, certificated in any category, that either has:

    (1) A serial number in the range of 1116-2012 through 1120-2012
or 1122-2012 through 1170-2017; or
    (2) Is equipped with part number 4-2142 exposed balance
ailerons.

 (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    AD 2017-07-10 was prompted by a report of a cracked hinge
support and cracked hinge ribs, which resulted in partial loss of
control with the aileron binding against the cove. This AD
incorporates a newly designed aileron hinge support reinforcement
kit. We are issuing this AD to prevent failure of the aileron
support structure, which may lead to excessive deflection, binding
of the control surface, and potential loss of control.

(f) Compliance

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

(g) Restrict Airplane Operation

    (1) Before further flight after April 12, 2017 (the effective
date retained from AD 2017-07-10), fabricate a placard using at
least \1/8\ inch letters with the words ``AEROBATIC FLIGHT
PROHIBITED'' on it and install the placard on the instrument panel
within the pilot's clear view.
    (2) This action may be performed by the owner/operator (pilot)
holding at least a private pilot certificate and must be entered
into the aircraft records showing compliance with this AD in
accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439.

(h) Inspection and Reinforcement

    (1) Within the next 10 hours time-in-service (TIS) after April
12, 2017 (the effective date retained from AD 2017-07-10), inspect
the aileron hinge rib and support for cracks or other damage by
following American Champion Aircraft Corporation Service Letter (SL)
442, dated February 16, 2017, or American Champion Aircraft Corp.
Service Letter (SL) 442, Revision A, dated August 18, 2017 (ACAC SL
No. 442, Revision A).
    (2) If no cracks or other damage is found during the initial
inspection required in paragraph (h)(1) of this AD, the placard
prohibiting aerobatic flight required in paragraph (g)(1) of this AD
can be removed.
    (3) Within 100 hours TIS from the initial inspection required in
paragraph (h)(1) of this AD or within 10 hours TIS after August 17,
2018 (the effective date of this AD), whichever occurs later, and
repetitively thereafter at intervals not to exceed 100 hours TIS,
inspect the aileron hinge rib and support for cracks or other damage
following ACAC SL No. 442, Revision A.
    (4) If cracks or other damage is found during any inspection
required in paragraph (h)(1) or (3) of this AD, before further
flight, replace any retained parts or structure that are cracked or
damaged, and install the aileron hinge reinforcement kit by
following American Champion Aircraft Corp. Service Letter 444, dated
August 18, 2017 (ACAC SL No. 444). Unless already removed as
specified in paragraph (h)(2) of this AD, after completing the
corrective actions required by this paragraph, the placard
prohibiting aerobatic flight required in paragraph (g)(1) of this AD
can be removed.
    (5) Within 400 hours after the initial inspection required in
paragraph (h)(1) of this AD, if not already done as required in
paragraph (h)(4) of this AD, install the aileron hinge reinforcement
kit following the procedures in ACAC SL No. 444.
    (6) After installation of the aileron hinge reinforcement kit
required in paragraph (h)(4) or (5) of this AD, as applicable,
insert page 4-1, Manual Revision B, of the Airworthiness Limitations
section and page 5-9, Manual Revision B, of the Time and Maintenance
Checks section, both dated October 3, 2017, from the American
Champion Aircraft Corporation SM-601 8KCAB Service Manual, Reissue
B, dated October 3, 2017, into the maintenance program (service
manual).
    (7) Installing the aileron hinge reinforcement kit as required
in paragraph (h)(4) or (h)(5) of this AD and the insertion of page
4-1, Manual Revision B, of the Airworthiness Limitations section and
page 5-9, Manual Revision B, of the Time and Maintenance Checks
section, both dated October 3, 2017, of the American Champion
Aircraft Corporation SM-601 8KCAB Service Manual, Reissue B, dated
October 3, 2017, into the maintenance program (e.g., service
manual), as required in paragraph (h)(6) of this AD is terminating
action to this AD. The revised Airworthiness Limitations section
includes a 100- hour/annual inspection requirement for the aileron
hinge supports.

(i) Reporting Requirement

    Although ACAC SL No. 442, Revision A, and ACAC SL No. 444
specify submitting certain information to the manufacturer, this AD
does not require that action.

(j) Special Flight Permit

    No aerobatic flight permitted with a special flight permit.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO, send it to the attention of the person
identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Wess Rouse, Small
Airplane Program Manager, 2300 East Devon Avenue, Room 107, Des
Plaines, Illinois 60018; telephone:<PHONE_NUMBER>; fax: (847) 294-
7834; email: [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) American Champion Aircraft Corp. Service Letter 442,
Revision A, dated August 18, 2017.
    (ii) American Champion Aircraft Corp. Service Letter 444,
Initial Revision, dated August 18, 2017.
    (iii) Page 4-1, Manual Revision B, of the Airworthiness
Limitations section of American Champion Aircraft Corporation SM-601
8KCAB Service Manual, Reissue B, dated October 3, 2017;
    (iv) Page 5-9, Manual Revision B, of the Time and Maintenance
Checks section of American Champion Aircraft Corporation SM-601
8KCAB Service Manual, Reissue B, dated October 3, 2017.
    (3) The following service information was approved for IBR on
April 12, 2017 (82 FR 17542, April 12, 2017).
    (i) American Champion Aircraft Corporation Service Letter 442,
dated February 16, 2017.
    (ii) Reserved.
    (4) For service information identified in this AD, contact
American Champion Aircraft Corp., P.O. Box 37, 32032 Washington
Ave., Rochester, Wisconsin 53167; telephone:<PHONE_NUMBER>; fax:
(262) 534-2395; email: [email protected]; internet: http://www.americanchampionaircraft.com/service-letters.html.
    (5) You may view this referenced service information at the FAA,
Policy and Innovation Division, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on June 29, 2018.
Melvin J. Johnson,
Deputy Director, Policy & Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-14686 Filed 7-12-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Rules and Regulations]
[Pages 39415-39417]
[FR Doc No: 2012-16299]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0419]
RIN 1625-AA00

Safety Zone: Independence Day Fireworks Celebration for the City
of Richmond, Richmond Inner Harbor, Richmond, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters of Richmond Inner Harbor near Richmond, CA in support
of the Independence Day Fireworks Celebration for the City of Richmond
on July 3, 2012. This safety zone is established to ensure the safety
of participants and spectators from the dangers associated with the
pyrotechnics. Unauthorized persons or vessels are prohibited from
entering into, transiting through, or remaining in the safety zone
without permission of the Captain of the Port or their designated
representative.

DATES: This rule is effective on July 3, 2012. This rule will be
enforced from 9:30 p.m. to 10 p.m. on July 3, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0419. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ensign William Hawn, U.S. Coast Guard Sector San
Francisco; telephone<PHONE_NUMBER> or email at<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register

NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.''
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The Coast Guard received the
information about the fireworks display on May 5, 2012, and the
fireworks display would occur before the rulemaking process would be
completed. Because of the dangers posed by the pyrotechnics used in
this fireworks display, the safety zone is necessary to provide for the
safety of event participants, spectators, spectator craft, and other
vessels transiting the event area. For the safety concerns noted, it is
in the public interest to have these regulations in effect during the
event.

B. Basis and Purpose

    The legal basis for the proposed rule is 33 U.S.C 1231; 46 U.S.C
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1, which collectively authorize
the Coast Guard to establish safety zones.
    The City of Richmond will sponsor the Independence Day Fireworks
Celebration for the City of Richmond on July 3, 2012, on Lucretia
Edwards Park near Richmond, CA in position 37[deg]54'34'' N,
122[deg]21'17'' W (NAD 83) as depicted in National Oceanic and
Atmospheric Administration (NOAA) Chart 18649. Upon the commencement of
the fireworks display, the safety zone will encompass the navigable
waters around the launch site within a radius of 420 feet. The
fireworks display is meant for entertainment purposes. This restricted
area around the launch site is necessary to protect spectators,
vessels, and other property from the hazards associated with the
pyrotechnics. The Coast Guard has granted the event sponsor a marine
event permit for the fireworks display.

C. Discussion of the Final Rule

    The Coast Guard will enforce a safety zone in navigable waters
around the land based launch site on Lucretia Edwards Park near
Richmond, CA. Upon the commencement of the 20 minute fireworks display,
scheduled to take place from 9:30 p.m. to 9:50 p.m. on July 3, 2012,
the safety zone will encompass the navigable waters around the
fireworks launch site within a radius 420 feet from position
37[deg]54'34'' N, 122[deg]21'17'' W (NAD 83) for the Independence Day
Fireworks Celebration for the City of Richmond. At the conclusion of
the fireworks display the safety zone shall terminate.
    The effect of the temporary safety zone will be to restrict
navigation in the vicinity of the launch site until the conclusion of
the scheduled display. Except for persons or vessels authorized by the
Coast Guard Patrol Commander, no person or vessel may enter or remain
in the restricted area. These regulations are needed to keep spectators
and vessels away from the immediate vicinity of the launch site to
ensure the safety of participants, spectators, and transiting vessels.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect the economic impact of this rule does not rise to the
level of necessitating a full Regulatory Evaluation. The safety zone is
limited in duration, and is limited to a narrowly tailored geographic
area. In addition, although this rule restricts access to the waters
encompassed by the safety zone, the effect of this rule will not be
significant because the local waterway users will be notified via
public Broadcast Notice to Mariners to ensure the safety zone will
result in minimum impact. The entities most likely to be affected are
waterfront facilities, commercial vessels, and pleasure craft engaged
in recreational activities.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
    This rule may affect owners and operators of waterfront facilities,
commercial vessels, and pleasure craft engaged in recreational
activities and sightseeing. This safety zone would not have a
significant economic impact on a substantial number of small entities
for the following reasons. This safety zone would be activated, and
thus subject to enforcement, for a limited duration. When the safety
zone is activated, vessel traffic could pass safely around the safety
zone. The maritime public will be advised in advance of this safety
zone via Broadcast Notice to Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone of limited size and
duration. This rule is categorically excluded from further review under
paragraph 34(g) and 35(b) of Figure 2-1 of the Commandant Instruction.
An environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

 List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add temporary Sec.  165.T11-504 to read as follows:

Sec.  165.T11-504  Safety zone; Independence Day Fireworks Celebration
for the City of Richmond, Richmond Inner Harbor, Richmond, CA.

    (a) Location. This temporary safety zone is established for the
navigable waters of Richmond Inner Harbor near Richmond, CA as depicted
in National Oceanic and Atmospheric Administration (NOAA) Chart 18649.
From 9:30 p.m. until 9:50 p.m. on July 3, 2012, the temporary safety
zone will encompass the navigable waters around the fireworks launch
site in position 37[deg]54'34'' N, 122[deg]21'17'' W (NAD 83) within a
radius of 420 feet.
    (b) Enforcement Period. The zone described in paragraph (a) of this
section will be enforced from 9:30 p.m. through 10 p.m. on July 3,
2012. The Captain of the Port San Francisco (COTP) will notify the
maritime community of periods during which this zone will be enforced
via Broadcast Notice to Mariners in accordance with 33 CFR 165.7.
    (c) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer on a Coast Guard
vessel or a Federal, State, or local officer designated by or assisting
the COTP in the enforcement of the safety zone.
    (d) Regulations. (1) Under the general regulations in 33 CFR part
165, subpart C, entry into, transiting or anchoring within this safety
zone is prohibited unless authorized by the COTP or a designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or a designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or a designated representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or a designated representative. Persons and vessels
may request permission to enter the safety zone on VHF-23A or through
the 24-hour Command Center at telephone<PHONE_NUMBER>.

    Dated: June 20, 2012.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2012-16299 Filed 7-2-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 49 (Thursday, March 12, 2020)]
[Rules and Regulations]
[Pages 14418-14420]
[FR Doc No: 2020-04854]

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

40 CFR Part 52

[EPA-R04-OAR-2019-0214; FRL-10006-31-Region 4]

Air Plan Approval; Alabama: Revisions to Cross-State Air
Pollution Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving
revisions to the Alabama State Implementation Plan (SIP), submitted by
the State of Alabama, through the Alabama Department of Environmental
Management (ADEM), via two letters dated August 27, 2018, and October
25, 2018. The SIP revisions make technical amendments to the State's
Cross-State Air Pollution Rule (CSAPR) regulations. This action is
being taken pursuant to the Clean Air Act (CAA or Act).

DATES: This rule is effective April 13, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2019-0214. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Steven Scofield, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9034. Mr. Scofield can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 26, 2019 (84 FR 65061), EPA proposed to approve changes
to the Alabama SIP that were provided to EPA through two letters dated
August 27, 2018, and October 25, 2018.\1\ Specifically, EPA proposed to
approve two SIP revisions that include changes to Alabama's CSAPR
regulations, found in ADEM Administrative Code Rules 335-3-5-.13, 335-
3-8-.14, 335-3-8-.40, and 335-3-8-.46.\2\
---------------------------------------------------------------------------

    \1\ EPA received ADEM's submissions on September 7, 2018 and
October 30, 2018, respectively.
    \2\ EPA notes that the Agency received other revisions to the
Alabama SIP submitted with the August 27, 2018, letter. EPA will
consider action on the remaining revisions in separate actions.
---------------------------------------------------------------------------

    Alabama's August 27, 2018, SIP revision makes changes to ADEM's
CSAPR regulations by adding the term ``Group 2'' in several places to
Rule 335-3-8-.40 to make the terminology consistent with EPA's CSAPR
NOX Ozone Season Group 2 Trading Program regulations.
Alabama's October 25, 2018, SIP revision changes the CSAPR regulations
in Rules 335-3-5-.13, 335-3-8-.14, and 335-3-8-.46 by explicitly
addressing the disposition of any allowances that remain after
allocations to all existing units have reached their historical
emission caps as well as any allowances set aside for new units in
Indian country within the State and not used for that purpose. In
addition, the October 25, 2018, SIP revision makes minor and
administrative changes, such as correcting typographical errors.
    The details of the Alabama submission and the rationale for EPA's
action are explained in the notice of proposed rulemaking. Comments on
the proposed rulemaking were due on or before December 26, 2019. EPA
received one adverse comment on the proposed action.

II. Response to Comments

    EPA received one adverse comment from an anonymous commenter on the
proposed rule published on November 26, 2019. See 84 FR 65061. This
comment has been included in the docket for this action.
    Comment: The Commenter asserts that CSAPR has been vacated by the
recent rulings in Wisconsin v. EPA and New York v. EPA and states that
EPA is therefore precluded from approving Alabama's requested changes
because the State's program is based on an illegal federal plan. The
Commenter makes several additional statements that are outside the
scope of this action, including references to Aloha Power v. EPA.
    Response: EPA disagrees with this comment. In Wisconsin v. EPA, the
court remanded the CSAPR Update to EPA but did not vacate it, and the
remand does not concern any aspect of the CSAPR Update rulemaking
relevant to the minor SIP changes at issue in this action. 938 F.3d
303, 336 (D.C. Cir. 2019). In New York v. EPA, the court vacated a
related action known as the CSAPR Close-out, but the vacatur does not
extend to CSAPR or the CSAPR Update. 781 Fed. Appx. 4 (D.C. Cir. 2019).
Thus, the Wisconsin and New York decisions do not bar approval of the
requested changes to Alabama's SIP.
    With respect to the commenter's discussion on endangerment
findings, the comment is out of scope of this action, as EPA's action
did not relate to an endangerment finding. Further, to the extent the
Commenter intended to raise concerns other than those related to
endangerment findings in its discussion of a possible U.S. Supreme
Court decision named Aloha Power v. EPA, the commenter did not provide
a citation and EPA is unable to find such a decision based on the
description provided by the Commenter.

III. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of ADEM
Administrative Code Rules 335-3-5-.13, 335-3-8-.14, and 335-3-8-.46,
state effective on December 7, 2018, and 335-3-8-.40, state effective
on October 5, 2018, which make the following revisions to Alabama's
SIP: Add the term ``Group 2'' to the State's rules, consistent with
EPA's CSAPR NOX Ozone Season Group 2 Trading Program
regulations; address the disposition of any allowances that remain
after allocations to all existing units have reached their historical
emission caps as well as any allowances set aside for new CSAPR
NOX Ozone Season Group 2 units in Indian country within
Alabama and not used for that purpose; and make other minor changes.
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 Office
(please contact the person identified in the For Further Information
Contact section of this preamble for more information). Therefore,
these materials have been approved by EPA for inclusion in the State
implementation plan, have been incorporated by reference by EPA into

that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\3\
---------------------------------------------------------------------------

    \3\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Final Action

    EPA is approving the aforementioned changes to ADEM Administrative
Code Rules 335-3-5-.13, 335-3-8-.14, 335-3-8-.40, and 335-3-8-.46.
These changes are consistent with the CAA.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. These actions merely
approve state law as meeting Federal requirements and do not impose
additional requirements beyond those imposed by state law. For that
reason, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having significant economic impacts
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandates or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. These actions are not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 11, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. These actions may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides.

    Dated: February 27, 2020.
Mary S. Walker,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart B--Alabama

0
2. In Sec.  52.50 amend the table in paragraph (c) by revising the
entries for ``335-3-5-.13, TR SO2 Allowance Allocations'',
``335-3-8-.14, TR NOX Annual Allowance Allocations'', ``335-
3-8-.40, TR NOX Ozone Season Group 2 Trading Program--
Applicability'', and ``335-3-8-.46, TR NOX Ozone Season
Group 2 Allowance Allocations'' to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Alabama Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State
       State citation             Title/subject       effective      EPA approval date          Explanation
                                                         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
335-3-5-.13................  TR SO2 Allowance          12/7/2018  3/12/2020, [Insert      Both sections of 335-3-
                              Allocations.                         citation of             5-.13 are included in
                                                                   publication].           the approved SIP.

                                                  * * * * * * *
335-3-8-.14................  TR NOX Annual             12/7/2018  3/12/2020, [Insert      Both sections of 335-3-
                              Allowance Allocations.               citation of             8-.14 are included in
                                                                   publication].           the approved SIP.

                                                  * * * * * * *
335-3-8-.40................  TR NOX Ozone Season       10/5/2018  3/12/2020, [Insert      ......................
                              Group 2 Trading                      citation of
                              Program--Applicabilit                publication].
                              y.

                                                  * * * * * * *
335-3-8-.46................  TR NOX Ozone Season       12/7/2018  3/12/2020, [Insert      ......................
                              Group 2 Allowance                    citation of
                              Allocations.                         publication].

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

* * * * *
[FR Doc. 2020-04854 Filed 3-11-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Page 7375]
[FR Doc No: 2021-01876]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ Memorandum regarding ex parte communication from July 2020
with Ted Glick.
    \2\ Memorandum regarding ex parte communication from July 2020
with Jordan Bale.
    \3\ Memorandum regarding ex parte communication from July 2020
with Kaley Holmes.
    \4\ Memorandum regarding ex parte communication from July 2020
with an individual named Vanessa, from the Southern Oregon region.
    \5\ Memorandum regarding ex parte communication from July 2020
with Faith Strigler.
    \6\ U.S. Representatives Debbie Dingell, Haley Stevens, Brenda
Lawrence, Andy Levin, and Daniel T. Kildee.
    \7\ Telephone Memorandum dated 1/4/2021 regarding voicemail from
Ms. Amira Oun, Michigan Department of Environment, Great Lakes, and
Energy.

------------------------------------------------------------------------
          Docket Nos.               File date    Presenter or  requester
------------------------------------------------------------------------
                               Prohibited
------------------------------------------------------------------------
1. CP17-494-000, CP17-494-003,        1-19-2021  FERC Staff.\1\
 CP17-495-000, CP17-495-003.
2. CP17-494-000, CP17-494-003,        1-19-2021  FERC Staff.\2\
 CP17-495-000, CP17-495-003.
3. CP17-494-000, CP17-494-003,        1-19-2021  FERC Staff.\3\
 CP17-495-000, CP17-495-003.
4. CP17-494-000, CP17-494-003,        1-19-2021  FERC Staff.\4\
 CP17-495-000, CP17-495-003.
5. CP17-494-000, CP17-494-003,        1-19-2021  FERC Staff.\5\
 CP17-495-000, CP17-495-003.
------------------------------------------------------------------------
                                 Exempt
------------------------------------------------------------------------
1. ER21-424-000................      11-23-2020  U.S. Congress.\6\
2. P-3409-000..................        1-8-2021  FERC Staff.\7\
------------------------------------------------------------------------

    Dated: January 22, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-01876 Filed 1-27-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18303-18304]
[DOCID:fr11ap06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-287-000]

ANR Pipeline Company; Notice of Tariff Filing

April 5, 2006.
    Take notice that on March 31, 2006, ANR Pipeline Company (ANR)
tendered for filing as part of its FERC Gas Tariff, Second Revised
Volume No. 1, Eleventh Revised Sheet No. 153 and Seventh Revised Sheet
No. 153A, to become effective on May 1, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission,

888 First Street, NE., Washington, DC 20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5311 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Page 13275]
[FR Doc No: 2018-06187]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ17-10-003]

City of Dover, Delaware; Notice of Filing

    Take notice that on March 12, 2018, the City of Dover, Delaware
submitted its tariff filing: Compliance Filing Docket Nos. NJ17-10-002
and EL17-78-000 to be effective 6/1/2017.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the website 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 protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 2, 2018.

    Dated: March 22, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-06187 Filed 3-27-18; 8:45 am]
 BILLING CODE 6717-01-P