Two Generation Toxicity Study in Sprague-Dawley Derived Rats

with n-Propyl Bromide (nPB)

Summary and Conclusions

Two generations of Sprague-Dawley derived rats (F0 and F1) were exposed to n-propyl bromide (nPB) for 6 hours/day, 7 days/week via whole body inhalation for at least 70 days prior to mating, throughout mating, and through most of gestation and lactation.

Exposure was temporarily stopped during the parturition period, from gestation day (GD) 20 to postnatal day (PND) 5. F1 pups were culled on PND 4 and were exposed via lactation until PND 21 and then directly via inhalation until study termination. F2 pups were exposed via lactation until PND 21 and sacrificed. Targeted ambient air nPB concentrations were 0, 100, 250, 500, and 750 ppm; nominal mean exposure concentrations were measured and shown to be close to the target concentrations: F0 generation – 0, 99, 252, 505, and 750 ppm, respectively; F1 generation – 0, 100, 252, and 502 ppm, respectively.  No live litters were produced in the F0 750 ppm generation; therefore, there was no F1 treatment group exposed to this dose.

Three deaths unrelated to treatment occurred during the experiment: one F0 500-ppm female and two F1 males (1 control and 1 at 500 ppm). At 750 ppm, F0 males displayed a decrease in mean weekly body weights and cumulative body weight gain throughout the study; F0 females exhibited a reduction in mean body weight during pre-mating weeks 5-10 and decreased cumulative weight gain throughout the pre-mating period.  At 500-ppm, F0 females showed a non-significant reduction in mean body weight, weight gain, food consumption, and food efficiency during pre-mating, gestation, and lactation. Small, nonsignificant reductions in mean weekly body weight gains were also observed in the F1 males and females in this dose group. Weight loss in the F0 and F1 500-ppm females during late gestation was associated with a reduction in the mean litter size.

In the F0 generation, there was a statistically significant dose-response decrease in male and female fertility indices at 500 and 750 ppm and in the mating index at 750 ppm. Infertility was 100% in the 750 ppm group and 52% in the 500 ppm group.  At 500 ppm, the mean number of implantation sites and size of live litters was also statistically significantly reduced.  In the F1 generation, no statistically significant decrease in the fertility or mating index was observed at any dose, although, there was a significant reduction in the number of implantation sites and size of live litters at 500 ppm.

Statistically significant changes in female reproductive parameters included a decrease in absolute and relative ovary weights at 750 ppm in the F0 generation and an increase in the length of the estrus cycle at ≥ 500 ppm in F0 females.  Estrus cycle length was increased at 500 ppm in F1 females; however, the increase was not reported to be statistically significant relative to controls.  Estrus cycling was not observed in 2 F0 females in the 500 ppm group, 3 F0 females in the 750 ppm group, 3 F1 females in the 250 ppm group, and 4 F1 females in the 500 ppm group.  Analysis of estrus cycle length by the study authors excluded ammenorheic females.  ICF reanalyzed these data and included data from ammenorheic females in the analysis.  Both estrus cycle length and mean number of estrus cycles within a 3-week period prior to mating (following 7 weeks exposure) were evaluated.  The mean number of estrus cycles that occurred within the 3-week period of observation was statistically significantly decreased at ≥ 250 ppm in F0 females and at 500 ppm in F1 females. ICF conducted a second analysis in which data from ammenorheic females were excluded; statistically significant decreases occurred at the same doses although the mean number of estrus cycles was slightly increased.  ICF considered these findings to be toxicologically significant.

The number of primordial follicles and corpora lutea were compared between high-dose groups (750 ppm for F0 females and 500 ppm for F1 females) and controls; a statistically significant increase in primordial follicles and a decrease in corporal lutea were observed. However, these end points were not examined in lower dose groups and thus, a dose-response could not be determined.

 generation at exposures ≥ 500 ppm, and in the F1 generation at exposures; (2) decreased number of normal sperm at exposures ≥ 250 ppm in F0 generation and at 100 and 500 ppm in the F1 generation; (3)  reduction in the absolute weight of the left and right cauda epididymes at exposures ≥ 500 ppm and in the relative weight of the right cauda epididymis at 750 ppm in the F0 generation, and in the absolute weight of both epididymes at 500 ppm in the F1 generation; (4) decreased absolute, but not relative, prostate weights in F0 (≥ 250 ppm) and F1 (500 ppm) males,  and (5) decreased seminal vesicle weights in F0 males at 750 ppm and F1 males at 250 ppm males.  In general, most of the organ weight changes were in absolute values, and were not statistically significant when weights were expressed relative to body weight, and did not show a clearcut dose-response.  No associated macroscopic or microscopic tissue changes were observed except in the prostate gland which showed acute inflammation in F1, but not F0, males exposed to 500 ppm.  The study authors concluded that the biological significance of these findings was unclear.   Although the number of normal sperm in the F0 generation was statistically decreased in the three highest dose group relative to concurrent controls, these numbers were within the normal background range and thus this finding was not considered to be toxicologically significant.

≥ 250 ppm) and F1 (≥ 100 ppm) males and in F0 females at 750 ppm and F1 females at 500 ppm ; (2) decreased absolute pituitary weights in F0 (750 ppm) and F1 (500 ppm) males, and (3) increased absolute and relative thymus weights in F1 males.    Most of these changes did not show a clear dose-response and none were associated with pathologic or histopathologic changes.  Therefore, the authors concluded that the biological significance of these findings was unclear.  Relative kidney weights were increased in F0 males and females at 750 ppm and absolute kidney weight was increased in F1 males at 500 ppm. Microscopic changes in the kidney were also observed and included significant increases in the incidence of minimal-to-mild pelvic mineralization, and/or secondary transitional epithelial hyperplasia following exposure to ≥ 500 ppm in F0 females and increased mononuclear cell infiltrate at 500 ppm in F1 males; however, most of these effects did not show a clear dose-response and were not considered to be biologically significant by the study authors.  Hepatic effects were also observed in both F0 and F1 males and females. An increase in mean relative liver weight occurred in F0 animals at exposures ≥ 500 ppm and in F1 animals at 500 ppm.  Histopathology was observed in the F1 generation and consisted of an increased incidence of minimal-to-mild centrilobular hepatocellular degeneration at ≥ 250 ppm in males and at 500 ppm in females.  These findings were considered to be toxicologically significant.  An increase in hepatic glycogen was also observed at 500 ppm in F1 males and ≥ 100 ppm in F2 females; however, the biologic significance of this result is unclear.

Based on decreased sperm motility in F1 males, decreased mean number of estrus cycles in F0 females, and mild liver histopathology, the study NOAEL is 100 ppm, with a LOAEL of 250 ppm. A summary of reproductive and developmental NOAELs for toxicologically-relevant end points for F0, F1, and F2 generations is presented in Table S.1.   One selected reproductive endpoint below is post-natal weight for F1 and F2 generation pups at certain exposure levels.  Pup weight was measured every seven days and compared with controls. A statistically significant decrease in weight was observed for both generations of the 500 ppm females’ pups, on post-natal day (PND) 28 in the F1 generation and PND 14 and 21 in the F2 generation.

Table S.1   Selected Reproductive and Related Endpoints

for F0, F1, and F2 Generations

F0 Generation

Reproductive Endpoints

Female Endpoints (Measure)	NOAEL

(ppm)	LOAEL

(ppm)

Decrease in fertility Index (%)

	250	500**

Increase in mean estrus cycle length (days)b

	250	500*

Decrease in mean no. of estrus cycles within 3- week period prior to mating – all females (N)c	100	250**

Decrease in mean no. of estrus cycles within 3- week period prior to mating – excluding acyclic females (N)c	100	250**

Decrease in mean no. implantation sites (N/animal)	250	500**

Decrease in litter size (N/litter)	250	500**

Male Endpoints	NOAEL

(ppm)	LOAEL

(ppm)

Decrease in fertility index (%)	250	500**

Decrease in sperm number in left. epididymis (no. sperm x 106/gram tissue)	500	750**

Decrease in motile sperm (%)	250	500**

Selected Organ Weights (n=25)a

Male	NOAEL

(ppm)	LOAEL

(ppm)

Final mean body wt (g)  (mean % decrease)	500	750**

Decrease in relative left testis  (g/100 g)	500	750*

Decrease in absolute right cauda epididymis  (g) 	250	500**

Decrease in relative right cauda epididymis

(g/ 100 g)	500	750**

Decrease in absolute left cauda epididymis (g)	250	500**

Decrease in absolute prostate gland (g) 	100	250**

Femalea	NOAEL

(ppm)	LOAEL

(ppm)

Decrease in relative liver (g/100 g)	500	750**

Decrease in relative kidney (g/100 g)	500	750**

Decrease in absolute ovary (g)

	500	750**

Decrease in relative ovary  (g/100 g)  	500	750**

Other Important Endpoints	NOAEL

(ppm)	LOAEL

(ppm)

Liver histopathology	100	250*

F1 Generation

Reproductive Endpoints

Female Endpoint (Measure)	NOAEL

(ppm)	LOAEL

(ppm)

Mean length of estrus cycles (days)	500 	N/A

Decrease in mean no. of estrus cycles within 3 weeks -all femalesc

	250	500*

Decrease in mean no. of estrus cycles within 3 weeks -excluding  acyclic femalesd

	250	500*

Decrease in Implantation sites

	250 	500 **

Decrease in number of pups born

	250 	500 **

Male Endpoint 	NOAEL

(ppm)	LOAEL

(ppm)

Decrease in motile sperm (%)

	100 	250*

Other Important Endpoints	NOAEL

(ppm)	LOAEL

(ppm)

Liver histopathology	250	500*

Selected Organ Weights (n=25)a

Male (Measure)	NOAEL

(ppm)	LOAEL

(ppm)

Decrease in relative liver  (g/100 g)	250	500 **

Decrease in absolute right cauda epididymis (g)

	250	500**

Decrease in absolute left cauda epididymis (g)

	250	500**

Pup Weight for F1	NOAEL

(ppm)	LOAEL

(ppm)

Decreased pup weight at postnatal day 28	250	500**

F2 Generation

Pup Weight for F2	NOAEL

(ppm)	LOAEL

(ppm)

Decreased pup weight at postnatal day 14 and 21	250	500**

N/A = not available

a There were no statistically significant changes in mean final body weights of in any of the dose groups in either generation, with the exception of 750-ppm  F0 males.

b Statistical analysis calculated by ICF

c Calculated by ICF Poisson regression model

d Calculated by ICF excluding females that did not have a full estrus cycle and analyzed using a quasi-likelihood Poisson-like regression model

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

*** Significantly different from control, p<0.001.

Materials and Methods

In a two-generation reproductive toxicity study (Stump, 2001), groups of 25 male and female rats (Crl:CD((SD) IGS BR) were exposed to 99.8% pure n-propyl bromide (nPB) via whole-body inhalation for 6 hours/day, 7 days/week at target concentrations of 0, 100, 250, 500 or 750 ppm.  Compound impurities were as follows: 0.015% 2-bromopropane; unknown propyl ether 0.002%; 0.017% propyl ether; 0.004% 1,2-dibromopropane; 0.062% unknown 1,2-dibromopropanes; 0.046% unknown 1,2,3-tribromopropanes. These values are within the Office of Prevention, Pesticides and Toxic Substances (OPPTS) health effects guideline standards of purity and stability (OPPTS, 1998).

The animals were acclimatized for 15 days after receipt; all animals were housed singly except at mating and weaning.  Animal husbandry and care were in accordance with appropriate OPPTS health effects harmonized guidelines (OPPTS, 1998). Exposure chambers were constructed of wire mesh and the animals were not given either water or food during exposures periods. The concentrations were monitored during exposure and the measured mean exposure concentrations were as follows: F0 generation – 0, 99, 252, 505, and 750 ppm; F1 generation – 0, 100, 252, and 502 ppm.  There was no 750 ppm group for the F1 generation because no live litters were produced at this exposure level in the F0 generation.  Homogeneity of the test article’s distribution within 4 different areas in the exposure chamber was measured during method development prior to exposures. The test article was distributed evenly in the exposure chamber, with a mean percent deviation from the reference concentration ranging from – 4.6% to + 4.3%.

The F0  generation was ~ 6 weeks old at the start of exposure and exposed for 70 days prior to mating (1:1).  Exposure to male animals of both generations continued throughout mating to the day prior to study termination.  Exposure to female animals in both generations continued throughout mating, from gestation day (GD) 1- 21, and from postnatal (PND) 4 through the day prior to study termination.  Thus, exposure was temporarily stopped around the time of parturition (GD 21-PND4).   In the F1 generation, pups were directly exposed via whole body inhalation to nPB on PND 22, following weaning on PND 21.  Selected F1 generation animals (4 pups/sex/litter, culled on PND 4) were exposed for 70 days prior to mating; females were not exposed during the period GD 21-PND 4.  F2 pups were exposed via lactation until PND 21 and sacrificed at that time.

All animals were observed twice daily for clinical signs, appearance, behavior, and mortality. Body weights, food consumption values were recorded daily. Developmental landmarks (balanopreputial separation and vaginal patency) were also evaluated.  Culled F1 pups were necropsied on PND 21 or 28 and culled F2 pups were necropsied on PND 21.  Parental animals were necropsied after weaning and selected organs were weighed and/or examined macroscopically and microscopically. Measured reproductive endpoints included sperm motility, morphology and numbers for males in all dose groups and ovarian primordial follicle counts and corpora lutea counts in the control and high-dose F0 and F1 females.  Estrus cycle stage and length were monitored during the 3-week period prior to mating (following 7 weeks exposure) in both F0 and F1 groups

Statistical Analyses

Most analyses by Stump were conducted using two-tailed tests for a minimum significance level of 5% comparing each treated group to the control group.  Each mean was presented with the standard deviation and the number of animals used to calculate the mean.  Data obtained from nongravid animals were excluded from statistical analyses following the mating period.  Statistical analyses were not performed when weekly food or body weight data for one or more animals were not available because the animals remained in the lactation phase.  Statistical tests were performed using appropriate computing devises or programs and are referenced in the report tables. The following analyses used different statistical tests:

Table 1.  Statistical Tests Used in Analyses

Statistical Test

	Parameter

Chi-square test with Yates correction factor	Parental Mating and Fertility Indices

One-way ANOVA with Dunnet’s Test	Parental Weekly Body Weights and Weight Changes, Gestation and Lactation Body Weights, Parental Food Consumption, Food Efficiency, Gestation length, Pre-coital Interval, Implantation Sites, Unaccounted Sites, Offspring Weights and Weight Changes, Absolute and Relative Organ Weights, Live Litter Size, Sperm Production Rate, Epididymal and Testicular Sperm Numbers, Ovarian Primordial Follicle Counts, Number of Pups Born, Balanopreputial Separation, Vaginal Patency

Kruskal-Wallis Test with Mann-Whitney U-Test	Sperm Motility, Percent Morphologically Normal Sperm, Pup Sexes at birth (% Males per litter), Proportional Postnatal Survival

Fisher’s Exact Test	Histopathological Findings

Study Results

F0 Generation

One 500-ppm F0 female was euthanized in extremis due to an abnormality of the eye that was not considered to be treatment-related. No clinical signs of toxicity were noted that were considered to be treatment-related. In the F0 animals, mean body weights in the 750-ppm males were reduced by 5.4-12.7% from week 3 through study termination (at week 19), which correlated with sporadic decreases in weekly weight gains and food efficiency.  The 750-ppm males displayed reduced cumulative weight gains throughout the study. Generally, the 750-ppm F0 males and females displayed comparable food consumption as compared to controls, showing only sporadic reductions in food efficiency. The mean body weight of 750-ppm females was reduced by 5.0-5.8% during weeks 5-10, as compared to controls, with associated reductions in cumulative weight gains during the pre-mating period.  The 750-ppm females were never pregnant; therefore no data on weight and weight gain during parturition and/or lactation were available. The 500-ppm males displayed a general decrease in weight (4.7-6.3% during study weeks 12-19) and weight gain, but the data were only sporadically statistically different from controls. The 500-, 250-, and 100-ppm females and 250- and 100-ppm males did not display a treatment-related reduction in weight, weight gain, food consumption, or food efficiency.  During gestation, a reduction in weight gain was observed on GD 11-14, 14-20, and 0-20 for the 500- and 250-ppm females.  However, the only statistically significant finding was a decrease at 500 ppm on GD 14-20 and GD 0-20; these results correlated with a statistically significant reduction in overall food consumption during these periods. Reduced gestation weights were statistically significant in the 500-ppm females on GD 14 and 20, and were attributed to a reduction in litter size. During lactation, slight nonsignificant reductions in body weight were observed in the 500-ppm females (Lactation Day (LD) 1-4 and LD 7-14).

Table 2. F0 Females Reproductive Endpointsa

Endpoint	0 ppm	100 ppm	250 ppm 	500 ppm	750 ppm

Fertility index (%)

N	92.0

25	100

25	88.0

25	52.0**

25	0.0**

25

Mating index (%)

N	96.0

25	100

25	100

25	84.0

25	68.0*

25

Evidence of mating w/out delivery (no.)	1	0	3	10	17

Estrus cycle length (days)b

N	4.2(0.49

25	4.5(1.05

25	4.7(0.90

25	5.5(2.17*

23	5.6(1.79*

22

Mean no. of estrus cycles within 3 weeksc

N	3.96(0.54

25	3.84(0.62

25	3.52(0.65**

25	2.88(1.17***

25	2.56(1.26***

25

Mean no. of estrus cycles within 3 weeks excluding  ammenorheic femalesd

N	3.96(0.54

25	3.84(0.62

25	3.52(0.65**

25	3.00(1.02***

24	2.78(1.04***

23

Implantation sites

N	15.3(2.53

23	14.3(3.09

25	13.8(4.23

22	9.0(4.54**

11	NA

Number of born

N	15.0(2.42

23	13.6(3.09

25	12.5(4.27

22	8.5(4.41**

11	NA

Unaccounted Sites

N	0.3(0.57

23	0.7(0.95

25	1.3(1.36**

22	0.5(0.69

11	NA

a Data were provided on pp. 123-124, 207

b Statistical analysis calculated by ICF

c Calculated by ICF and analyzed using a quasi-likelihood Poisson-like regression model

d Calculated by ICF excluding females that did not have a full estrus cycle and analyzed using a quasi-likelihood Poisson-like regression model

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

*** Significantly different from control, p<0.001.

Table 3. Primordial Follicles and Corpora Luteaa for the F0 Animals

N=25	0 ppm	500 ppm	750 ppm

Primordial follicles	107.8(55.80	NA	134.2(58.29

Corpora lutea	178.9(51.61	156.8(56.03	126.9(67.49**

a Data were derived from pp. 245 of the study report

**Significantly different from control, p<0.01.

A decrease in reproductive performance was statistically significant in the 500- and 750-ppm animals with fertility indices (both male and female) of 52.0 and 0.0%, respectively. No live litters were produced at 750 ppm.  Historical control fertility indices for males and females were 89.3% and 90.4%, respectively. Mating indices (both male and female) for the 500- and 750-ppm animals were 84.0% and 68.0%, respectively; however, only the 750-ppm value reached statistical significance as compared to controls (96.0%) and was lower than historical control data (96.0 and 97.0% for males  and females, respectively). An increase in the number of females that displayed evidence of mating without delivery was observed and 2 females from the 500-ppm group were nongravid (i.e., showed no evidence of implantation). The mean number of days between pairing and coitus were extended in the 500- and 750-ppm groups, to 4.3 and 4.8 days, respectively, as compared to concurrent control (mean of 3.4 days) and historical control mean of 2.0-3.5 days) data.  The mating interval could not be determined for 1 female in the control group, 4 females in the 500 ppm group, and 8 females in the 750-ppm group, because there was no evidence of mating. Implantation sites were reduced in the 500-ppm females and the mean number of unaccounted-for sites was comparable to controls. An increase in the number of unaccounted- for sites in the 250-ppm females was statistically significant with a slight decrease in the number of implantation sites; however, a clear dose-response was not apparent.

An increase in estrus cycle length was statistically significant in the 500- and 750-ppm females; the data are summarized in Table 2. However, the estrus cycle data reported by the study authors excluded females who showed no evidence of cycling (2 and 3 for the 500- and 750-ppm groups, respectively). Therefore, ICF evaluated the individual data by (1) counting the number of estrus cycles within the three-week period prior to mating; (2) including females who did not complete an estrus cycle; and (3) conducting statistical analysis of dose-response using a Poisson regression model.  ICF also analyzed the F1 generation estrus cycle data in a similar manner (See F1 generation section for these results).  A dose-dependent decrease in the number of estrus cycles was observed in females exposed to  ( 250-ppm.  For comparison purposes, ICF conducted a second analysis of the estrus cycle data, excluding acyclic females. Although exclusion of these individuals skewed the data, the statistical significance of the findings stayed at the same concentration levels.  A similar dose response was observed that was significantly higher than controls at ( 250 ppm.

Table 4. F0 Males Reproductive Endpointsa

Endpoint 	0 ppm	100 ppm	250 ppm 	500 ppm	750 ppm

Fertility index (%)

N	92.0

25	100

25	88.0

25	52.0**

25	0.0**

25

Mating index (%)

N	96.0

25	100

25	100

25	84.0

25	68.0*

25

Evidence of mating w/out delivery (no.)	1	0	3	8	17

L. Epididymis (no. sperm in million/gram tissue)

N	471.9(81.11

25	459.4(101.94

25	480.1(80.21

25	429.3(101.46

25	369.6(90.66**

25

Motile sperm (%)

N	86.8(11.90

25	88.8(7.22

25	83.4(10.41

25	71.9(9.27**

23	53.2(19.59**

15

Normal sperm

N	99.7(0.6

25	99.7(0.52

25	99.3(0.83*

25	98.2(2.59**

24	90.6(8.74**

24

Normal shaped head separated from flagellum

N	0.2(0.46

25	0.2(0.36

25	0.4(0.54

25	1.4(2.15

24	4.8(4.28

24

Head absent from flagellum

N	0.1(0.22

25	0.1(0.24

25	0.3(0.46

25	0.5(0.77

24	4.6(5.91

24

a Data were provided on pp. 123, 195, 197-198

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

Spermatogenic analysis showed a reduction in sperm motility and in the mean number of  morphologically normal sperm from the 750-ppm males.  There were two types of sperm abnormalities; one in which abnormal heads were separated from the flagellum and another in which normal flagella were without the head. The 500-ppm males displayed a reduction in sperm motility and number of morphologically normal sperm cells,  similarly abnormal sperm cell types. The number of normal sperm was statistically decreased in the 250-ppm males; however, they were very close to control values and not considered to be toxicologically significant.  Relative to controls, the right epididymes were small on two 750- and one 500-ppm males. A 750-ppm male had a small left epididymis. The testes were small in one 500- and 750-ppm males and one 500-ppm male had soft testes.

Table 5a. Selected F0 Male Organ Weights (n=25)a

Organ	0 ppm	100 ppm	250 ppm	500 ppm	750 ppm

Final Body Wt (g)	548(56.0	526(52.3	530(63.3	515(61.3	483(44.6**

Brain (g)	2.19(0.091	2.15(0.114	2.08(0.087**	2.10(0.177*	2.05(0.091**

Relative brain (g/100 g)	0.403(0.0401	0.411(0.0384	0.398(0.0554 0.410(0.0446	0.428(0.0453

Liver (g)	20.09(3.206	18.63(3.008	19.42(2.934	20.85(4.147	21.25(2.953

Relative liver (g/100 g)	3.662(0.4292	3.538(0.4238	3.675(0.4573 4.034(0.4949*	4.401(0.4206**

Kidney (g)	3.77(0.418	3.58(0.358	3.59(0.274	3.62(0.334	3.62(0.329

Relative kidney

(g/100 g)	0.690(0.0649	0.684(0.0654	0.684(0.0629	0.708(0.0862 0.7454(0.0706**

Spleen (g)	0.91(0.167	0.86(0.144	0.85(0.120	0.87(0.110	0.92(0.157

Relative spleen

(g/100 g)	0.167(0.0291	0.164(0.0231	0.162(0.0212	0.170(0.0231 0.192(0.0353**

L. testis (g)	1.79(0.186	1.79(0.217	1.69(0.146	1.77(0.227	1.75(0.188

Relative L. testis (g/100 g)	0.329(0.0413	0.343(0.0474	0.323(0.0422 0.348(0.0666	0.364(0.0426*

R. Cauda Epididymis (g)	0.3327(0.03631	0.3311(0.4453	0.3053(0.04188 0.2912(0.05206**	0.2405(0.04804**

R. Cauda Epididymis

(g/ 100 g)	0.61(0.0096	0.064(0.0121	0.059(0.0098	0.057(0.0120 0.050(0.0097**

L Cauda Epididymis (g)	0.3252(0.03673	0.3242(0.03149	0.3050(0.03556 0.2877(0.03170**	0.2401(0.03529**

L. Cauda Epididymis

(g/ 100 g)	0.060(0.0100	0.062(0.0087	0.058(0.0096	0.056(0.0084 0.050(0.0068

Prostate (g)	1.33(0.247	1.27(0.241	1.14(0.169**	1.14(0.232*	1.14(0.178**

Prostate

(g/ 100 g)	0.244(0.0525	0.245(0.0597	0.218(0.0442	0.224(0.0503 0.237(0.0405

a Data were provided on pp.208-211 and 214-216 of the study report

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

A decrease in the absolute brain weight was statistically significant in males at  (250 ppm as compared to controls; the study authors attributed this finding to a decrease in body weight and did not consider it to be toxicologically significant. However, the extent of the decrease in brain weight prompted further histopathological examinations of the brain to determine if any lesions could explain the weight loss.  No corresponding lesions were found. A decrease in the absolute adrenal and relative spleen weights of the 750-ppm males was statistically significant; these decreases were also attributed to general weight loss relative to controls as no macroscopic or microscopic lesions were noted at necropsy.

Decreases in the absolute prostate ((250 ppm), right epididymis ((500 ppm), pituitary (750 ppm), and seminal vesicles/coagulating gland (750 ppm) weights were statistically significant although relative weights of these organs/tissues were not.  Further, none of these decreases were dose related. A decrease in the left and right cauda epididymes absolute weights was statistically significant as compared to the controls. These decreases were considered to be treatment-related based on that spermatogenic effects observed in the 500- and 750-ppm males. Other organ weight changes included an increase in the relative left testis weight (750 ppm) and in relative liver ((500 ppm), kidney (750 ppm), and spleen (750 ppm) weights as compared to concurrent controls. The liver and kidneys displayed microscopic lesions; these findings are summarized in Table 5a and 5b and discussed further below.

Table 5b. Selected F0 Female Organ Weights (n=25)a

Organ	0 ppm	100 ppm	250 ppm	500 ppmb	750 ppm

Final Body Wt (g)	331(20.7	330(22.3	327(24.8	332(38.3	319(25.5

Brain (g)	1.96(0.078	1.92(0.094	1.94(0.084	1.89(0.105*	1.86(0.072**

Relative brain (g/100 g)	0.595(0.0446

	0.585(0.0458	0.595(0.0454	0.577(0.0674

	0.586(0.0431

Liver (g)	12.55(1.292	13.08(1.443	12.91(1.199	12.86(1.595	13.70(1.735

Relative liver

(g/100 g)	3.800(0.3414	3.958(0.3716	3.948(0.2402	3.888(0.3862 4.302(0.4402**

Kidney (g)	2.22(0.211	2.27(0.244	2.25(0.177	2.27(0.217	2.37(0.253

Relative kidney

(g/100 g)	0.672(0.0548	0.686(0.0660	0.692(0.0734	0.688(0.0646 0.746(0.0861**

Ovaries (g)	0.1227(0.02592	0.1265(0.02404	0.1152(0.02360	0.1119(0.01514 0.09575(0.0.02798**

Relative ovaries

 (g/100 g)	0.037(0.0078	0.038(0.0068	0.035(0.0072	0.034(0.0056 0.031(0.0079**

a Data were provided on pp.212-213 and 218-219 of the study report

b N=24

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

An increase in the relative liver and kidney weights was statistically significant in the 750-ppm females. The 750-ppm females also displayed a significant decrease in relative ovary weights that correlated with the infertility of these animals. The 750-ppm females displayed a decrease in absolute brain weight that was attributed to the decreased weight of these animals and was not considered by the study authors to be toxicologically significant. A dose-dependent decrease in absolute (22%) and relative ovary weights (16%) was observed in the 750-ppm females, relative to controls.

Table 6. Selected Histopathology Data for the F0 Animals (n=25)a

	Male	Female

	0 ppm	100 ppm	250 ppm	500 ppm	750 ppm	0 ppm	100 ppm	250 ppm	500 ppmb 750 ppm

Kidneys

Pelvic Mineralization	1	0	1	2	6	2	3	5	12*	14*

Transitional Cell Hyperplasia	0	0	1	3	4	1	0	2	6*	5

Testes

Seminiferous Tubules Degeneration 	1	2	0	3	6	N/A

Ovaries

Decreased Corpora Lutea	N/A	3	0	3	6	11*

Luteinized Follicular Cyst	N/A	2	4	3	5	9*

Follicular Cyst	N/A	7	1*	3	3	6

Interstitial Hyperplasia	N/A	3	0	0	3	7

Liver

Centrilobular Hepatocellular Vacuolation	0	0	7*	22*	24*	0	0	0	6*	16*

Increased Glycogen	14	14	20	21	24*	15	18	22	23*	23*

a Data were derived from pp. 227-244 of the study report

*Significantly different from control, p<0.05.

The males manifested a slight nonsignificant increase in minimal mineralization of the pelvic kidney and the females displayed a minimal-to-mild increase that was statistically significant at (500 ppm. The kidneys of treated males had a slight nonsignificant increase in the incidence of minimal transitional cell hyperplasia. The females displayed a more pronounced effect and the incidence for the 500-ppm females was statistically significant from controls.  However, statistical significance for this end point was not achieved at 750 ppm, indicating a lack of dose-response.  Statistically significant increases in the incidence of mild-to-minimal centrilobular hepatocellular vacuolation was noted in males ((250 ppm) and females ((500 ppm). An increase in liver glycogen was statistically significant for males at 750 ppm and for females at (500 ppm.

Increases in incidence and severity of seminiferous tubules degeneration were noted in the treated males at (500 ppm; although these incidences were not statistically significantly different from controls, the study authors considered these changes to be treatment-related because of spermatogenic effects observed at these doses. A statistically significant decrease in corpora lutea and an increase in luteinized follicular cysts were observed in the ovaries of 750 ppm females. Microscopic determination of the number of primordial follicles and corpora lutea in the ovaries are presented in Table 6; a significant increase in primordial follicles and decrease in corpora lutea was observed at 750 ppm, relative to controls. However, lower doses were not analyzed for these end points; therefore, no dose-response conclusions can be made.

F1 Generation

One control male (at week 22) and one 50-ppm male (at week 18) were euthanized in extremis and the deaths were not attributed to treatment. In the F1 animals, the 500-ppm group displayed a significant reduction in live litter size, attributed to reductions in body weight.  Postnatal survival was unaffected by treatment. Body weights were increased in the 500-ppm pups during PND 1 (both sexes) and 4 (females), and decreased in the 250- and 500-ppm males on PND 28. Body weight gains were decreased in 500-ppm males on PND 4-7, 7-14, and 21-28; decreases in body weight gains were also observed at PND 21-28 in (100-ppm males and 750-ppm females, although mean body weights did not differ from controls. The absolute brain weights of the ( 100-ppm F1 males and 100-ppm females sacrificed at PND 21 displayed a statistically significant reduction; however, relative weights were unaffected. An increase in the average day at balanopreputial separation of the 500-ppm males was statistically significant as compared with concurrent controls (9% increase); however, there was no dose-response. Vaginal patency was increased in the 500-ppm females by 5% compared with concurrent controls; however, this delay was not statistically significant.

Mean body weight gains were reduced in the 500-ppm F1 males (weeks 19-20 and 20-21) as compared to controls; percent decrease in body weights gains ranged from 9.3-18.5% during weeks 19-37; 500-ppm females displayed reduced body weight gains (weeks 19-28) with a 6.7-11.8% decrease in body weight being observed, as compared to controls, during weeks 19-28. The 100-ppm males displayed a reduction in body weight during weeks 26-37; however, the decrease was not dose-related and not attributed to treatment. F1 500-ppm females displayed reduced weight gain (during GD 7-11, 11-14, 14-20, and 0-20) and body weight (at GD 14 and 20) that coincided with a decrease in litter size (42%), number of implantations (37%), and food efficiency.  Further, mean body weights and food consumption were reduced in the F1 500-ppm females through LD 4, 7, and 14. The 250-ppm females displayed a reduction in mean body weight gains during GD 14-20 with a slight reduction in food efficiency (GD 7-11, 11-14, and 14-20) and a significant overall reduction in food efficiency (GD 0-20).  The 100-ppm females displayed a reduction in mean body weight gains during GD 4-7 with a slight reduction in food efficiency (GD 4-7 and 11-14). However, weight gain and food efficiency data of the 250- and 100-ppm females were comparable to controls.

Table 7. F1 Females Reproductive Endpointsa

Endpoint	0 ppm	100 ppm	250 ppm 	500 ppm

Fertility index (%)

N	100.0

25	84.0

25	80.0

25	100.0

25

Mating index (%)

N	88.0

25	68.0

25	64.0

25	72.0

25

Evidence of mating w/out delivery (no.)	3	4	4	8

Estrus cycle length (days)b

N	4.5(1.25

24	4.5(0.91

24	4.9(1.43

22	5.1(1.68

21

Mean no. of estrus cycles within 3 weeksc

N	3.64(1.15

25	3.68(1.11

25	2.88(1.36

25	2.68(1.35*

25

Mean no. of estrus cycles within 3 weeks excluding  ammenorheic femalesd

N	3.64(1.15

25	3.68(1.11

25	3.13(1.10

23	2.91(1.12*

23

Implantation sites

N	15.5(2.11

22	15.8(3.29

17	13.5(4.12

16	9.8(4.93**

17

Number of born

N	14.9(1.97

22	15.1(3.35

17	13.1(4.12

16	8.6(4.51**

17

Unaccounted Sites

N	0.5(0.86

22	0.6(1.22

17	0.4(0.63

16	1.2(1.09

17

a Data were provided on pp. 272-275 and 356 of the study report

b Statistical analysis calculated by ICF

c Calculated by ICF Poisson regression model

d Calculated by ICF excluding females that did not have a full estrus cycle and analyzed using a quasi-likelihood Poisson-like regression model

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

Mating, fertility, and number of unaccounted-for implantation sites were unaffected by treatment. Estrus cycle length was extended by 13% in the 500-ppm females (historical controls range is 4.1-5.1 days); however, the data were not significantly different from concurrent controls. Three 250-ppm females and four 500-ppm females did not complete an estrus cycle; the study authors excluded the data from these individuals from their statistical analysis. ICF re-evaluated the estrus cycle data by determining the number of estrus cycles within the 3 weeks prior to mating, including data from all females, and performing a statistical analysis of dose-response using a Poisson regression model. A significant reduction in estrus cycle number was observed at 500 ppm.  ICF performed further analysis of the estrus cycle data; results from acyclic females were excluded from this analysis.  Although exclusion of the results from these individuals skewed the distribution of the data, the statistical significance remained at the same concentration levels. Gestation length was not affected by treatment; only one 250-ppm female experienced dystocia, which was not considered by the study authors to be treatment-related.

Table 8. F1 Males Reproductive Endpointsa

Endpoint 	0 ppm	100 ppm	250 ppm 	500 ppm

Fertility index (%)

N	87.5

24	68.0

25	64.0

25	70.8

24

Mating index (%)

N	100.0

24	84.0

25	80.0

25	100.0

24

Evidence of mating w/out delivery (no.)	3	8	9	7

L. Epididymis (no. sperm in million/gram tissue)

N	640.1(141.82

23	609.1(115.22

23	573.7(97.17

24	635.3(160.50

24

Motile sperm (%)

N	88.9(4.52

24	86.4(4.96

25	84.8(6.02*

25	74.4(14.06**

24

Normal sperm (%)

N	99.5(0.79

24	98.9(0.95**

25	99.1(1.13

25	95.3(6.51**

24

Normal shaped head separated from flagellum (%)

N	0.2(0.47

24	0.5(0.68

25	0.4(0.73

25	1.6(4.12

24

Head absent from flagellum (%)

N	0.2(0.57

24	0.6(0.75

25	0.4(0.61

25	2.0(2.99

24

a Data were provided on pp. 274, 345-348 of the study report

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

Spermatogenic analysis indicated a reduction in sperm motility and the number of morphologically normal sperm in 500-ppm males. There were two types of sperm abnormalities; one in which sperm had a normal head separated from the flagellum and another in which normal flagella were without the head. The mean testicular and epididymal sperm counts were comparable among all treatment and control groups. The 250-ppm males displayed a significant reduction in sperm motility. At 100-ppm, males also showed a significant decrease in number of morphologically normal sperm cells; however, this value was within the range of historical control values, and there was no clear dose-response. Therefore, this finding was not considered to be toxicologically significant.

Table 9a. Selected F1 Male Organ Weightsa

Organ	0 ppm	100 ppm	250 ppm	500 ppm

Final Body Wt (g)

N	583(65.7

24	543(63.9

25	562(55.3

25	526(43.3

24

Brain (g)

N	2.21(0.092

24	2.11(0.111**

25	2.12(0.109**

25	2.01(0.079**

24

Relative brain (g/100 g)

N	0.382(0.0379

24	0.392(0.0401

25	0.379(0.0365	0.384(0.0313

24

Liver (g)

N	20.18(3.353

24	18.54(2.304

25	19.94(2.994

25	21.25(4.126

24

Relative liver (g/100 g)

N	3.455(0.3775

24	3.424(0.3348

25	3.538(0.3198	4.017(0.5570**

24

Kidney (g)

N	3.73(0.455

24	3.37(0.354**

25	3.52(0.349

25	3.40(0.450*

24

Relative kidney (g/100 g)

N	0.640(0.0548

24	0.624(0.0672

25	0.627(0.0523

25	0.645(0.0587

24

R. Cauda Epididymis (g)

N	0.3178(0.03778

24	0.3129(0.0.3862

25	0.3029(0.03885

25	0.2720(0.03787**

24

Relative r. Cauda Epididymis (g/ 100 g)	0.055(0.0075

24	0.058(0.0104

25	0.054(0.0083

25	0.052(0.0073

24

L Cauda Epididymis (g)

N	0.3304(0.03279

24	0.3325(0.03912

25	0.3221(0.03981

25	0.2967(0.04462**

24

Relative l. Cauda Epididymis (g/ 100 g)

N	0.057(0.0061

24	0.062(0.0111

25	0.058(0.0089

25	0.056(0.0075

24

Thymus (g)

N	0.2319(0.05952

24	0.2463(0.06420

25	0.2702(0.05165

25	0.2762(0.05771*

24

Relative thymus (g/100 g)

N	0.040(0.0114

24	0.045(0.0110

25	0.048(0.0091*

25	0.052(0.0102**

24

Prostate (g)

N	1.16(0.258

24	1.00(0.285

25	1.06(0.243

25	1.05(0.205

24

 Relative prostate (g/100 g)

N	0.200(0.0405

24	0.187(0.0595

25	0.190(0.0502

25	0.201(0.0371

24

a Data were provided on pp. 357-360, 363-366 of the study report

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

The kidneys (100- and 500-ppm males) displayed a decrease in absolute weight that was not considered to be treatment-related or toxicologically significant, due lack of a dose-response and absence of macroscopic or microscopic kidney lesions. Mean absolute brain weights were reduced in a non-dose related fashion for the (100-ppm males and 500-ppm females; therefore, these change were not considered to be toxicologically significant. A decrease in absolute pituitary weight was statistically significant in the 500-ppm males; however, no lesions were found that suggested an association with treatment. No microscopic or macroscopic lesions were observed in the epididymides but the effect was similar to those observed in the F0 males. Absolute and relative thymus weights were increased in the 500-ppm F1 males; however, no macroscopic or microscopic lesions were noted in this gland.

Table 9b. Selected F1 Female Organ Weights (N=25)a

Organ	0 ppm	100 ppm	250 ppm	500 ppm

Final Body Wt (g)	321(27.3	325(28.1	318(26.7	309(29.5

Brain (g)	1.97(0.076	1.96(0.073	1.92(0.067	1.89(0.102**

Relative brain (g/100 g)	0.615(0.0.520	0.606(0.0549	0.608(0.0470 0.617(0.0588

Liver (g)	12.27(1.571	12.57(1.559	12.44(1.641	12.53(1.894

Relative liver (g/ 100 g)	3.811(0.2847	3.873(0.3744	3.914(0.4246 4.059(0.4546

Ovaries (g)	0.1131(0.01554	0.1077(0.03170	0.1056(0.02791	0.1062(0.02302

Relative ovaries (g/100 g)	0.035(0.0027	0.022(0.0032	0.022(0.0042 0.021(0.0045

a Data were provided on pp. 361-362, 367-369 of the study report

**Significantly different from control, p<0.01.

The F1 males and females exposed to 500 ppm displayed an increase in relative liver weight as compared to controls; however, the values for females were not statistically significant.  These increases were considered treatment-related, because associated histopathology was observed, consisting of an increase in hepatic centrilobular vacuolation. An statistically significant increase in the number of primordial follicles (19%) relative to controls was observed in the 500 ppm group. However, this end point was not measured in lower dose groups, and thus a dose-response could not be determined.

Table 10. Primordial Follicles and Corpora Luteaa for F1 Animals

N=25	0 ppm	500 ppm

Primordial follicles	105.6(44.96	141.8(50.26*

Corpora lutea	171.7(40.89	171.7(49.18

a Data were derived from p. 390 of the study report

**Significantly different from control, p<0.01.

The liver ((250-ppm males and (100-ppm females) and kidneys (500-ppm males and (250-ppm females) displayed treatment-related lesions that correlated with lesions found in the F0 generations.

Table 11. Selected Histopathology Data for the F1 Animalsa

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㓿ۖĀ̊l倃曾ĴᄀPelvic Mineralization	0	1	0	3	4	5	7	8

Mononuclear Infiltrate	11	9	1*	20*	5	5	5	7

Transitional Cell Hyperplasia	1	1	2	1	2	3	2	2

Prostate

Acute Inflammation	3	-	-	13*

	Ovaries

Decreased Corpora Lutea

3	3	7	4

Luteinized Follicular Cyst

2	3	2	3

Follicular Cyst

5	5	7	10

Interstitial Hyperplasia

12	10	13	18

Liver

Total Centrilobular Hepatocellular Vacuolation	0	0	15*	23*	0	0	2	6*

Increased glycogen	19	18	17	24*	16	24*	23*	23*

a Data were provided on pp. 375- of the study report. N=24, 25, 25, 24 males treated with 0, 100, 250, 500 ppm of nPB and 25 all treated females

*Significantly different from control, p<0.05.

**Significantly different from control, p<0.01.

In the F2 animals, a 41% decrease in live animals born per dam (PND 0) was observed in the 500-ppm pups. The 500-ppm pup weights were reduced at PND 14 (16% males and 14% females) and PND 21 (18% males and 15% females); weight gain was reduced in the 500-ppm pups at PND 4-7 (33% males and 31%), 7-14 (26% males and 24% females), and 14-21 (20% males and 16% females). The absolute brain, thymus, and spleen weights were reduced in the 500-ppm F2 males and the absolute thymus and splean weights were decreased in 500-ppm females. A decrease in the relative brain and spleen weights in 500 ppm males and in relative spleen weights in 500-ppm females was also statistically significant.

References

National Research Council (1996) Guide to the Care and USE of Laboratory Animals, Institute of Laboratory Animal Resources, Commission of Life Sciences. National Academy Press, Washington, D.C.

The Office of Prevention, Pesticides and Toxic Substances (OPPTS) Harmonized Test Guidelines, Series 870 Health Effects Test Guidelines -- Final Guidelines EPA 712–C–98–189 August 1998

Stump D.G.  2001.  An Inhalation Two-Generation Reproductive Toxicity Study of 1-Bromopropane in Rats.  Conducted by WIL Research Laboratories, Inc., Sponsored by Brominated Solvents Consortium.  May 24, 2001.

Appendix 1:  List of Acronyms

ANOVA	 Analysis of Variance

Crl:CD((SD) IGS BR	 Type of Sprague Dawley Rat Species

FSH	 Follicle Stimulating Hormones

GD	 Gestation Day

LD	 Lactation Day

LOAEL	 Low Observable Adverse Effect Level

nPB	 normal-Propyl Bromide

PND	 Postnatal Day

PPM	 Parts per Million

NOAEL	 No Observable Adverse Effect Level

OPPTS	The Office of Prevention, Pesticides and Toxic Substances

September 24, 2004

  PAGE  3


[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Rules and Regulations]
[Pages 12965-12967]
[FR Doc No: 2013-04326]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-8271]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
Part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial

FIRM for the community as having flood-prone areas (section 202(a) of
the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as
amended). This prohibition against certain types of Federal assistance
becomes effective for the communities listed on the date shown in the
last column. The Administrator finds that notice and public comment
procedures under 5 U.S.C. 553(b), are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
            Region I

New Hampshire:
    Albany, Town of, Carroll           330174  May 17, 1993,      March 19, 2013........  March 19, 2013
     County.                                    Emerg; March 1,
                                                1995, Reg; March
                                                19, 2013, Susp.
    Bartlett, Town of, Carroll         330010  April 21, 1976,    ......do..............   Do.*
     County.                                    Emerg; May 1,
                                                1979, Reg; March
                                                19, 2013, Susp.
    Brookfield, Town of,               330179  April 22, 1976,    ......do..............   Do.
     Carroll County.                            Emerg; May 17,
                                                1977, Reg; March
                                                19, 2013, Susp.
    Conway, Town of, Carroll           330011  December 2, 1974,  ......do..............   Do.
     County.                                    Emerg; April 16,
                                                1979, Reg; March
                                                19, 2013, Susp.
    Effingham, Town of, Carroll        330012  July 9, 2008,      ......do..............   Do.
     County.                                    Emerg; August 1,
                                                2009, Reg; March
                                                19, 2013, Susp.
    Freedom, Town of, Carroll          330013  August 20, 1992,   ......do..............   Do.
     County.                                    Emerg; December
                                                1, 1992, Reg;
                                                March 19, 2013,
                                                Susp.
    Hart's Location, Town of,          330213  May 30, 1996,      ......do..............   Do.
     Carroll County.                            Emerg; March 2,
                                                1998, Reg; March
                                                19, 2013, Susp.
    Jackson, Town of, Carroll          330014  August 21, 1975,   ......do..............   Do.
     County.                                    Emerg; July 2,
                                                1979, Reg; March
                                                19, 2013, Susp.
    Madison, Town of, Carroll          330220  May 19, 2005,      ......do..............   Do.
     County.                                    Emerg; August 1,
                                                2005, Reg; March
                                                19, 2013, Susp.
    Moultonbor ough, Town of,          330015  April 8, 1999,     ......do..............   Do.
     Carroll County.                            Emerg; March 1,
                                                2000, Reg; March
                                                19, 2013, Susp.
    Ossipee, Town of, Carroll          330016  April 30, 1975,    ......do..............   Do.
     County.                                    Emerg; June 17,
                                                1991, Reg; March
                                                19, 2013, Susp.
    Sandwich, Town of, Carroll         330017  November 3, 1975,  ......do..............   Do.
     County.                                    Emerg; July 17,
                                                1986, Reg; March
                                                19, 2013, Susp.
    Tamworth, Town of, Carroll         330018  July 21, 1976,     ......do..............   Do.
     County.                                    Emerg; July 16,
                                                1991, Reg; March
                                                19, 2013, Susp.
    Tuftonboro, Town of,               330234  June 15, 1976,     ......do..............   Do.
     Carroll County.                            Emerg; May 4,
                                                1989, Reg; March
                                                19, 2013, Susp.
    Wakefield, Town of, Carroll        330019  November 22,       ......do..............   Do.
     County.                                    1976, Emerg;
                                                June 17, 1991,
                                                Reg; March 19,
                                                2013, Susp.
    Wolfeboro, Town of, Carroll        330239  November 26,       ......do..............   Do.
     County.                                    1976, Emerg; May
                                                17, 1989, Reg;
                                                March 19, 2013,
                                                Susp.

           Region III

West Virginia: Mineral County,         540129  December 30,       ......do..............   Do.
 Unincorporated Areas.                          1975, Emerg;
                                                September 27,
                                                1991, Reg; March
                                                19, 2013, Susp.

           Region IV

Kentucky:
    Cadiz, City of, Trigg              210354  December 15,       ......do..............   Do.
     County.                                    1997, Emerg;
                                                July 1, 2001,
                                                Reg; March 19,
                                                2013, Susp.
    Trigg County,                      210315  December 15,       ......do..............   Do.
     Unincorporated Areas.                      1997, Emerg;
                                                July 1, 2001,
                                                Reg; March 19,
                                                2013, Susp.

           Region VI

Louisiana:
    Benton, Town of, Bossier           220032  September 10,      ......do..............   Do.
     County.                                    1975, Emerg;
                                                July 26, 1977,
                                                Reg; March 19,
                                                2013, Susp.
    Bossier City, City of,             220033  June 26, 1974,     ......do..............   Do.
     Bossier County.                            Emerg; April 4,
                                                1983, Reg; March
                                                19, 2013, Susp.
    Bossier Parish,                    220031  February 14,       ......do..............   Do.
     Unincorporated Areas.                      1975, Emerg;
                                                April 18, 1983,
                                                Reg; March 19,
                                                2013, Susp.

          Region VIII

Montana:
    Belt, Town of, Cascade             300009  May 13, 1975,      ......do..............   Do.
     County.                                    Emerg; December
                                                5, 1979, Reg;
                                                March 19, 2013,
                                                Susp.
    Cascade County,                    300008  May 22, 1975,      ......do..............   Do.
     Unincorporated Areas.                      Emerg; April 15,
                                                1980, Reg; March
                                                19, 2013, Susp.
    Great Falls, City of,              300010  May 19, 1972,      ......do..............   Do.
     Cascade County.                            Emerg; September
                                                30, 1977, Reg;
                                                March 19, 2013,
                                                Susp.
    Neihart, Town of, Cascade          300183  May 6, 1997,       ......do..............   Do.
     County.                                    Emerg; N/A, Reg;
                                                March 19, 2013,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*-do- =Ditto.
Code for reading third column: Emerg. --Emergency; Reg. --Regular; Susp. --Suspension.

    Dated: January 30, 2013.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2013-04326 Filed 2-25-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43822-43823]
[FR Doc No: 2012-18319]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2012-0033; FRL-9706-4]

Proposed Information Collection Request; Comment Request; Valuing
Improved Water Quality in the Chesapeake Bay Using Stated Preference
Methods (New)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Valuing Improved Water Quality
in the Chesapeake Bay Using Stated Preference Methods (New)'' (EPA ICR
No. 2456.01, OMB Control No. 2010-NEW) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. On May 24, 2012 EPA solicited public comments for 60
days on the proposed ICR. Certain supporting documents were not
available for public review in the docket during the first 30 days of
the comment period, thus EPA is re-opening the comment period for an
additional 30 days from the publication of this notice. Public comments
are being solicited on specific aspects of the proposed information
collection as described below. This is a request for approval of a new
collection. An Agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before August 27, 2012.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OA-
2012-0033 online using www.regulations.gov (our preferred method); by
email to<EMAIL_ADDRESS>by fax at<PHONE_NUMBER>; or by mail to
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Dr. Nathalie Simon, National Center
for Environmental Economics, Office of Policy, (1809T), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package

will then be submitted to OMB for review and approval. At that time,
EPA will issue another Federal Register notice to announce the
submission of the ICR to OMB and the opportunity to submit additional
comments to OMB.
    Abstract: The Clean Water Act (CWA) directs EPA to coordinate
Federal and State efforts to improve water quality in the Chesapeake
Bay. In 2009, Executive Order (E.O.) 13508 re-emphasized this mandate,
directing EPA to define the next generation of tools and actions to
restore water quality in the Bay and describe the changes to be made to
regulations, programs, and policies to implement these actions. In
response, EPA is undertaking an assessment of the costs and benefits of
meeting established pollution budgets, called Total Maximum Daily Loads
(TMDL), of nitrogen, phosphorus, and sediment for the Chesapeake Bay.
    The Chesapeake Bay watershed encompasses 64,000 square miles in
parts of six states and the District of Columbia. While efforts have
been underway to restore the Bay for more than 25 years, and
significant progress has been made over that period, the TMDLs are
necessary to continue progress toward the goal of a healthy Bay. The
watershed states of New York, Pennsylvania, Delaware, West Virginia,
Virginia, and Maryland, as well as the District of Columbia, have
developed Watershed Implementation Plans (WIPs) detailing the steps
each will take to meet its obligations under the TMDLs. EPA has begun a
new study to estimate costs of compliance with the TMDLs. A multitude
of benefits may also be anticipated to arise from restoring the
Chesapeake Bay. It is important to put cost estimates in perspective by
estimating corresponding benefits.
    EPA's National Center for Environmental Economics (NCEE) is
undertaking a benefits analysis of improvements in Bay water quality
under the TMDLs, as well as of ancillary benefits that might arise from
terrestrial measures taken to improve water quality. As part of this
analysis, NCEE plans to conduct a broad-based inquiry into benefits
using a state-of-the-art stated preference survey. Benefits from the
TMDLs for the Chesapeake will accrue to those who live on or near the
Bay and its tributaries, as well as to those who live further away and
may never visit the Bay but have a general concern for the environment.
The latter category of benefits is typically called ``non-use values''
and estimating the monetary value can only be achieved through a stated
preference survey.
    In addition, a stated preference survey is able to estimate ``use
values,'' those benefits that accrue to individuals who choose to live
on or near the Bay or recreate in the watershed. Stated preference
surveys allow the analyst to define a specific object of choice or
suite of choices such that benefits are defined in as precise a manner
as feasible. While use benefits of water quality improvements in the
Chesapeake Bay watershed will also be estimated through other revealed
preference methods, the stated preference survey allows for careful
specification of the choice scenarios and will complement estimates
found using other methods. Participation in the survey will be
voluntary and the identity of the participants will be kept
confidential.
    Form Numbers: None.
    Respondents/affected entities: Individuals 18 years of age or
older, residing in one of 18 east coast states and the District of
Columbia.
    Respondent's obligation to respond: voluntary.
    Estimated number of respondents: Primary survey: 2,400 respondents;
400 non-response survey.
    Frequency of response: one time collection.
    Total estimated burden: 1,034 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $24,123 (per year), includes $0 annualized
capital or operation & maintenance costs.

    Dated: July 20, 2012.
Al McGartland,
Director, National Center for Environmental Economics, Office of
Policy.
[FR Doc. 2012-18319 Filed 7-25-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20754-20755]
[FR Doc No: 2021-08253]

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

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10938; 34-91583; File No. 265-32]

SEC Small Business Capital Formation Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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

SUMMARY: The Securities and Exchange Commission Small Business Capital
Formation Advisory Committee, established pursuant to Section 40 of the
Securities Exchange Act of 1934 as added by the SEC Small Business
Advocate Act of 2016, is providing notice that it will hold a public
meeting by videoconference. The public is invited to submit written
statements to the Committee.

DATES: The meeting will be held on Friday, April 30, 2021, from 10:00
a.m. to 2:30 p.m. (ET) and will be open to the public. Written
statements should be received on or before April 30, 2021.

ADDRESSES: The meeting will be conducted by remote means
(videoconference). Members of the public may attend the meeting by
viewing the webcast on the Commission's website at www.sec.gov. Written
statements may be submitted by any of the following methods:

Electronic Statements

     Use the Commission's internet submission form (https://www.sec.gov/rules/submitcomments.htm); or
     Send an email message to<EMAIL_ADDRESS>Please
include File Number 265-32 on the subject line; or

Paper Statements

     Send paper statements to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street, NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-32. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method. The Commission will post all statements on the SEC's website at
www.sec.gov.
    Statements also will be available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. (ET). All statements received will be posted without change;
we do not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Jenny Choi, Attorney, Office of the
Advocate for Small Business Capital Formation, at<PHONE_NUMBER>,
Securities and Exchange Commission, 100 F Street, NE, Washington, DC
20549-3628.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public.
Persons needing special accommodations because of a disability should
notify the contact person listed in the section above entitled FOR
FURTHER INFORMATION CONTACT. The agenda for the meeting includes
matters relating to rules and regulations affecting small and emerging
companies and their investors under the federal securities laws.

    Dated: April 16, 2021.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2021-08253 Filed 4-20-21; 8:45 am]
BILLING CODE 8011-01-P


MEMORANDUM

DATE:		February 25, 2015

TO:		Clean Power Plan for Existing Power Plants; Docket ID: OAR - 2013-0602

FROM:	Anita Lee, EPA Region 9

SUBJECT:	February 25, 2015 Webinar between Western Resource Advocates and EPA Region 9  --------------------------------------------------------------------------------

SUMMARY

Western Resource Advocates (WRA) provided an overview of their "Carbon Reduction Credit Program" which was submitted by WRA to the Clean Power Plan docket prior to the close of the comment period. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014 and published in the Federal Register on June 18, 2014.        ATTENDEES

Western Resource Advocates    1. Steven Michel    2. Stacy Tellinghuisen    3. Bob Johnston

EPA Region 9    1. Amy Zimpfer    2. Ben Machol    3. Ray Saracino    4. Anita Lee

Attachment   (none)


[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7735-7737]
[FR Doc No: 2017-01268]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9355; Airspace Docket No. 16-ANM-8]

Proposed Amendment of Class D and Class E Airspace; Hailey, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class D airspace, Class E
surface area airspace, and Class E airspace extending upward from 700
feet above the surface at Friedman Memorial Airport, Hailey, ID, to
support the implementation of new Area Navigation (RNAV) Global
Positioning System (GPS) standard instrument approach procedures for
Instrument Flight Rules (IFR) at the airport.

DATES: Comments must be received on or before March 9, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2016-9355; Airspace Docket No. 16-ANM-8, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would

amend Class D and Class E airspace at Friedman Memorial Airport,
Hailey, ID.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2016-9355/
Airspace Docket No. 15-ANM-6.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at  http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class D airspace, Class E
surface area airspace, and Class E airspace extending upward from 700
feet above the surface at Friedman Memorial Airport, Hailey, ID, to
support implementation of new RNAV (GPS) standard instrument approach
procedures at the airport. The new RNAV (GPS) procedures require
additional Class D airspace in the vicinity of the airport for circling
maneuvers, but require less airspace upward from 700 feet above the
surface to support IFR arrival and departure aircraft. Class D airspace
would be expanded from the surface to and including 7,800 feet MSL to
within a 4.9-mile radius (increased from a 4.1-mile radius) of the
airport, with an extension from the 4.9-mile radius increased from 6
miles to 6.3 miles southeast.
    Class E surface area airspace would be reduced to within a 4.9-mile
radius of the airport, with a segment increased from 6 miles to 6.3
miles southeast of the airport to provide controlled airspace when
Class D airspace is not in effect.
    Class E airspace extending upward from 700 feet above the surface
would be reduced to within a 4.9-mile radius of the airport (from the
5.5-mile radius), with the southeast segment reduced from 15.5 miles to
11.3 miles from the radius of the airport. Additionally, the geographic
coordinates for the airport listed in the Class D description would be
updated to coincide with the FAA's aeronautical database.
    Class D and Class E airspace designations are published in
paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11A,
dated August 3, 2016 and effective September 15, 2016, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ANM ID D Hailey, ID [Modified]

Friedman Memorial Airport, ID
    (Lat. 43[deg]30'14'' N., long. 114[deg]17'44'' W.)

    That airspace extending upward from the surface to, and
including, 7,800 feet MSL within a 4.9-mile radius of Friedman
Memorial Airport, and that airspace within 2.1 miles west and 1.4
miles east of the 155[deg] bearing from the airport extending from
the airport 4.9-mile radius to 6.3 miles southeast of the airport.
This Class D airspace area is effective during the specified dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement (previously called Airport/Facility Directory).

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

ANM ID E2 Hailey, ID [Modified]

Friedman Memorial Airport, ID
    (Lat. 43[deg]30'14'' N., long. 114[deg]17'44'' W.)

    That airspace extending upward from the surface within a 4.9-
mile radius of Friedman Memorial Airport, and within 2.1 miles west
and 1.4 miles east of the 155[deg] bearing from the airport,
extending from the airport 4.9-mile radius to 6.3 miles southeast of
the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM ID, E5 Hailey, ID [Modified]

Friedman Memorial Airport, ID
    (Lat. 43[deg]30'14'' N., long. 114[deg]17'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 4.9-mile radius of Friedman Memorial Airport, and within
2.5 miles each side of the 155[deg] bearing from the airport
extending from the airport 4.9-mile radius to 11.3 miles southeast
of the airport; and that airspace extending upward from 1,200 feet
above the surface bounded by a line beginning at lat. 44[deg]00'00''
N., long. 114[deg]55'00'' W., to lat. 44[deg]00'00'' N., long.
113[deg]53'00'' W., to lat. 43[deg]00'00'' N., long. 113[deg]49'00''
W., to lat. 43[deg]00'00'' N., long. 114[deg]55'00'' W., thence to
point of beginning.

    Issued in Seattle, Washington, on January 10, 2017.
Richard Roberts,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-01268 Filed 1-19-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25115-25116]
[FR Doc No: 2013-10025]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69424; File No. SR-FICC-2013-01]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change Amending the Mortgage-Backed
Securities Division Fails Charge Rule To Reflect Recommendation of the
Treasury Market Practice Group

April 22, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 12, 2013, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by FICC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of the proposed rule change is to amend the existing
fails charge rule in FICC's Mortgage-Backed Securities Division
(``MBSD'') Clearing Rules in order to reflect the recent recommendation
from the Treasury Market Practices Group (``TMPG'') relating to the
removal of the resolution period for fails charges.\3\
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    \3\ The text of the proposed rule change is provided as Exhibit
5 to this filing and is available at www.dtcc.com/downloads/legal/rule_filings/2013/ficc/SR_FICC_2013_01.pdf.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in section (A),
(B) and (C) below, of the most significant aspects of such
statements.\4\
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    \4\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    To address the persistent settlement fails in agency debt and
mortgage-backed securities (``MBS'') transactions and to encourage
market participants to resolve such fails promptly, the TMPG
recommended in February 2012 that the MBS market impose a fails charge
in an effort to reduce the incidence of delivery failures and support
liquidity in the markets.\5\ MBSD amended Rule 12 (Fails Charges) of
MBSD's Clearing Rules in March 2012 to reflect TMPG's

recommendations.\6\ The fails charge for MBS transactions applies to
certain trades settled in the MBSD central counterparty (``CCP'')
(i.e., settlement of pools versus FICC involving failing agency MBS
issued or guaranteed by Fannie Mae, Freddie Mac and Ginnie Mae.)
Consistent with the TMPG's initial recommendation, MBSD's Rule 12 does
not currently impose a fails charge if delivery occurs on either of the
two business days following the contractual settlement date. The two
business days are sometimes referred to as the ``resolution period.''
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    \5\ The TMPG is a group of market participants active in the
treasury securities market sponsored by the Federal Reserve Bank of
New York.
    \6\ See Securities Exchange Act Release No. 66550 (March 9,
2012), 77 FR 15155 (March 14, 2012) (File No. SR-FICC-2008-01).
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    However, on March 1, 2013, the TMPG issued a new recommendation to
remove the two-day resolution period from the current practice.\7\ The
TMPG has advised that the revised recommendation should apply to
transactions in agency MBS transactions entered into on or after July
1, 2013, as well as to transactions that were entered into prior to but
remain unsettled as of July 1, 2013.
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    \7\ Press Release, Federal Reserve Bank of New York, TMPG
Revises Agency MBS Fails Charge Trading Practice (March 1, 2013)
(available at www.newyorkfed.org/tmpg/03_01_2013_Fails_charges_press_release.pdf).
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    The purpose of this proposed rule change is to amend the existing
fails charge rule to reflect TMPG's most recent recommendation. In
order to maintain symmetry with the MBS marketplace, FICC is now
proposing to amend MBSD's Rule 12 in order to remove the two-day
resolution period provision from the rule. Consequently, an agency MBS
settlement fail will be subject to a fails charge for each calendar day
that the fail is outstanding, even if the delivery occurs on either of
the first two business days following the contractual settlement date.
FICC is also proposing that the proposed rule change will be effective
as of July 1, 2013, in accordance with the TMPG's recommendation. All
other provisions of the agency MBS fails charge rule, including the
fails charge rate and trading practices, remain unchanged.
    FICC believes the proposed rule change is consistent with Section
17A of the Act and the rules and regulations thereunder because it
would facilitate the prompt and accurate clearance and settlement of
securities transactions by discouraging persistent fails of agency MBS
transactions in the marketplace.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed rule changes have not
been solicited or received. FICC will notify the Commission of any
written comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
file Number SR-FICC-2013-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FICC-2013-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with Commission, and all written communications relating to the
proposed rule change between the Commission and any person, other than
those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing will also be
available for inspection and copying at the principal office of FICC
and on FICC's Web site at http://www.dtcc.com/downloads/legal/rule_filings/2013/ficc/SR_FICC_2013_01.pdf. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FICC-2013-01 and should be submitted on
or before May 20, 2013.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-10025 Filed 4-26-13; 8:45 am]
BILLING CODE 8011-01-P