Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 1 Appendix A. Benchmark Dose Modeling Results Introduction Benchmark dose ( BMD) modeling was performed to identify potential critical effect levels as alternatives to the study NOAEL/ LOAELs for derivation of the HAs for DBAN, DCAN, and TCAN. No adequate studies were available to support a quantitative dose response assessment for BCAN. Individual modeling output for each endpoint is provided in Appendix B.

Methods Benchmark Dose The haloacetonitrile data sets considered for dose response modeling were all continuous endpoints. The modeling was conducted according to draft EPA guidelines ( U. S. EPA, 2000c)

using Benchmark Dose Software ( BMDS version 1.3.1), available from the U. S. EPA ( U. S. EPA,

2001). The methods and models applied to the continuous endpoints are presented here.

The continuous endpoints of interest with respect to haloacetonitrile toxicity were quantitatively summarized by group means and measures of variability ( standard errors or standard deviations). Since all of the endpoints that were modeled were continuous rather than quantal ( e. g., incidence data) in nature, the Hill, power, and polynomial models were used for each data set. Linear fits to the data were incorporated into the analysis by allowing the power and polynomial models to simplify to linear equations as dictated by the data ( for short term studies). The linear model option in BMDS was also run separately for the longer term studies, Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 2 since this provided the advantage of obtaining goodness of fit p values ( since the number of parameters is smaller for the linear model) for the longer term data sets in which the high dose was removed; insufficient degrees of freedom were available for calculation of p values for the power or polynomial models for these data sets. An attempt to fit the data using a hybrid modeling approach for the longer term studies failed to compute a BMDL estimate. The hybrid approach defines the benchmark response ( BMR) directly in terms of risk, as opposed to the standard approach, which defines the BMR in terms of a change in the mean. Furthermore, the hybrid model software in BMDS is still undergoing Beta testing, and was not considered sufficiently validated to have used a BMDL from this model as the basis for the quantitative doseresponse assessment.

These mathematical models fit to the data are defined here. In all cases, µ ( d) indicates the mean of the response variable following exposure to dose d.

The polynomial model is defined as:

µ ( d) =   0 +   1 d + ... +   n dn where the degree of the polynomial, n, was set less than or equal to the number of dose groups in the experiment being analyzed. Note that U. S. EPA ( 2000c) recommends the use of the most parsimonious model that provides an adequate fit to the data. It may appear that the use of a polynomial model with degree possibly as great as the number of dose groups would not yield the Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 3 most parsimonious model. However, allowing the model to have that degree is not the same as forcing the model to have that degree; in the model fitting, if fewer parameters ( e. g., a lower degree polynomial) is adequate and consistent with the data, then the fitting will reflect that fact and a more parsimonious model will be the result. For these analyses, the values of the   parameters allowed to be estimated were constrained to be either all nonnegative or all nonpositive ( as dictated by the data set being modeled, i. e., nonnegative if the mean response increased with increasing dose or nonpositive if the mean response decreased with increasing dose).

The power model is represented by the equation:

µ ( d) =   +  d  where the parameter   is restricted to be nonnegative. [ The linear model is obtained when   is fixed at a value of 1. The linear model was not separately fit to the data; if the result of fitting the power model does not result in the linear form,   = 1, then the linear model does not fit as well as the more general power model, by definition.]

The Hill model is given by the following equation:

µ ( d) =   + ( vdn) / ( dn + kn))

where the parameters n and k are restricted to be positive ( in fact, n > 1). Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 4 In the case of continuous endpoints, one must assume something about the distribution of individual observations around the dose specific mean values defined by the above models. The assumptions imposed by BMDS were used in this analysis: individual observations were assumed to vary normally around the means with variances given by the following equation:

  i 2 =  2

[ µ ( d i)]   where both  2 and   were parameters estimated by the model.

Given those assumptions about variation around the means, maximum likelihood methods were applied to estimate all of the parameters, where the log likelihood to be maximized is ( except for an additive constant) given by L =   [( N i/ 2)

ln(   i 2) + ( N i  1) s i 2/ 2  i 2 + N i{ m i  µ ( d i)} 2/ 2  i 2]

where N i is the number of individuals in group i exposed to dose d i, and m i and s i are the observed mean and standard deviation for that group. The summation runs over i from 1 to k ( the number of dose groups).

Goodness of Fit Analyses For these continuous models, goodness of fit was determined based on a likelihood ratio statistic. In particular, the maximized log likelihood associated with the fitted model was Drinking Water Criteria Document for Haloacetonitriles 1 If and when BMDS suggested that a homogeneous variance model was appropriate, the log likelihood of the fitted model was compared to the likelihood maximized assuming independent means but a single, constant variance for all dose groups ( the fitted model also assumed that to be the case in such cases).

EPA/ OW/ OST/ HECD Final Draft A 5 compared to the log likelihood maximized with each dose group considered to have a mean and variance completely independent of the means and variances of the other dose groups. 1 It is always the case that the latter log likelihood will be at least as great as the model associated loglikelihood but if the model does a reasonable job of fitting the data, the difference between the two log likelihoods will not be too great. A formal statistical test reflecting this idea uses the fact that twice the difference in the log likelihoods is distributed as a chi square random variable. The degrees of freedom associated with that chi squared test statistic are equal to the difference between the number of parameters fit by the model ( including the parameters  2 and   defining how variances change as a function of mean response level) and twice the number of dose groups ( which is equal to the number of parameters estimated by the model assuming independence of dose group means and variances). Parameters hitting boundary values were not included for determining degrees of freedom.

Acceptable fit was defined as a goodness of fit p value greater than or equal to 0.1, or a perfect fit when there were no degrees of freedom for a statistical test of fit. Choice of 0.1 is consistent with current U. S. EPA guidance for BMD modeling ( U. S. EPA, 2000c). If a model was judged to provide a reasonable BMDL estimate, but the p value criterion of 0.1 was not met,

the rationale for waiving the p value criterion is provided in the discussion of the results. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 6 Goodness of fit statistics are not designed to compare different models, particularly if the different models have different numbers of parameters. Within a family of models, adding parameters generally improves the fit. BMDS reports the Akaike Information Criterion ( AIC) to aid in comparing the fit of different models. The AIC is defined as  2L+ 2p, where L is the loglikelihood at the maximum likelihood estimates for the parameters, and p is the number of model parameters estimated ( ignoring parameters assuming values at the boundaries of their allowable ranges). When comparing the fit of two or more models to a single data set, the model with the lesser AIC was considered to provide a superior fit.

Definition of the BMR and Corresponding BMD and BMDL For the continuous models, BMDs were implicitly defined as follows:

  µ ( BMD)  µ ( 0)   =    1 where   1 is the model estimated standard deviation in the control group. In other words, the BMR was defined as a change in mean corresponding to some multiplicative factor of the control group standard deviation.

The value of   used in this analysis was 1.0. This value was chosen based on EPA draft guidelines for BMD analyses ( U. S. EPA, 2000c), in the absence of a clear biological rationale for selecting an alternative response level. It is roughly consistent with ( though slightly more conservative than) a choice of 1.1, which according to Crump ( 1995) corresponds to an additional Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 7 risk of 10% when the background response rate was assumed to be 1%, with normal variation around the mean ( and constant standard deviation).

Choice of BMDL The following guidance was followed with regard to the choice of the BMDL to use as a point of departure for calculation of a health advisory. This guidance is consistent with recommendations in U. S. EPA ( 2000c). For each endpoint, the following procedure is recommended:

1. Models with an unacceptable fit are excluded.

2. If the BMDL values for the remaining models for a given endpoint are within a factor of 3,

no model dependence is assumed, and the models are considered indistinguishable in the context of the precision of the methods. The models are then ranked according to the AIC, and the model with the lowest AIC is chosen as the basis for the BMDL.

3. If the BMDL values are not within a factor of 3, some model dependence is assumed, and the lowest BMDL is selected as a reasonable conservative estimate, unless it is an outlier compared to the results from all of the other models. Note that when outliers are removed, the remaining BMDLs may then be within a factor of 3, and so the criteria given in item 2. would be applied.

4. The BMDL values from all modeled endpoints are compared, along with any NOAELs or LOAELs from data sets that were not amenable to modeling, and the lowest NOAEL or BMDL is chosen. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 8 Modeling Results for Short term Studies This modeling was done to support the derivation of the Ten Day HAs. BMD modeling was conducted only for toxicologically relevant endpoints that could be used to derive the HAs.

Adequate short term studies for modeling were available only for DBAN, DCAN, and TCAN.

No suitable studies were available for derivation of the Ten day HA for BCAN. As a result,

BMD modeling was not performed for BCAN. The BMD modeling results for the short term studies are presented in Table A 1 and described below.

DBAN The endpoints modeled for DBAN in the Hayes et al. ( 1986) 14 day study were body weight in males and relative liver weight in females. Modeling was done for relative liver weight for completeness, although as discussed in Chapter V, the relative liver weight changes for DBAN were not considered to be sufficiently adverse to serve as the basis for the HA.

The body weight response to DBAN in males did not appear to have constant variance;

the variability in the highest dose group was much greater than that observed in the other groups.

Even when a dose dependent variance was included, however, the polynomial model did not predict standard deviations that matched well with the observed values, contributing to the significant lack of fit of that model ( p = 0.004). The power model did a much better job of fitting the observed standard deviations, as well as the observed means, yielding a p value for goodnessof fit of 0.07. The Hill model did not provide an adequate fit. The BMD and BMDL ( 26 and 16 mg/ kg/ day, respectively) from the power model are preferred for this data set. The goodness of Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 9 fit statistic for the power model was below the current p value criterion of 0.1 recommended in current EPA guidance ( U. S. EPA, 2000c). However, the results of the power model were considered adequate for use in the quantitative dose response assessment. This consideration was based on the observation that the visual fit to the data was reasonably good, and that the modelpredicted means and standard deviations were similar to the observed values ( i. e. as indicated by low values for the chi square residuals).

For the relative liver weight in female rats, all the models fit the data extremely well (

pvalues all greater than 0.45). Because of the extra parameters in the Hill model ( which visually looked essentially the same as the polynomial or power models), the AIC for the Hill model was substantially higher than the AICs for the polynomial or power models. In addition, the BMDL calculation failed for the Hill model. The polynomial mode gave a slightly better fit than the power model, and consequently the BMD and BMDL from the polynomial model ( 31 and 17 mg/ kg/ day, respectively) are the estimates of choice for this data set.

In summary, for the DBAN Ten day HA, only the modeling results for decreased body weight reported in Hayes et al. ( 1986) were considered for use in the quantitative dose response assessment. The estimate of choice for this data set was the BMD of 26 mg/ kg/ day with the corresponding BMDL of 16 mg/ kg/ day obtained from the power model. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 10 DCAN The endpoints modeled for DCAN in the Hayes et al. ( 1986) 14 day study were body weight in males and relative liver weight in males and females. Modeling was done for each of these effects since they were considered to be toxicologically relevant.

A constant variance model was used for the analysis of the DCAN body weight endpoint in male rats ( Hayes et al., 1986). The mean weights showed a non monotonic dose response,

with the lowest positive dose group having a mean weight greater than that in controls. This caused some difficulty in fitting the models ( p values all less than or equal to 0.02). However, in this case, the fits might be judged to be adequate for BMD estimation for several reasons. First,

the poor statistical fit was driven largely by one point, while the visual fits were reasonable.

Second, the BMD estimates ( ranging from 32 36 mg/ kg/ day) were very consistent among the models, suggesting that the fits were not model dependent. Third, the BMDL estimates were associated with a response that corresponded almost exactly to one standard deviation below the control group mean, using the observed values of the control group mean and standard deviation.

The AIC for the power model was slightly better than those for the other models, and the BMD of 36 mg/ kg/ day and BMDL of 25 mg/ kg/ day from the power model are recommended as the best estimates for this data set.

For the female rats exposed to DCAN, a non monotonic dose response was observed for increased relative liver weight ( with, essentially, a plateau of effect for the highest three dose groups after little change in the low dose group compared to controls). Moreover, the observed Drinking Water Criteria Document for Haloacetonitriles 2 A bug in BMDS resulted in three different values for the log likelihood of model A3 ( independent means but modeled variances) across the three model runs. The fit of model A3 should be the same regardless of the model being fit, so it is not possible to know with certainty what the correct likelihood for A3 is. In all cases, however, it was significantly worse than that for model A2 ( independent means and independent variances).

EPA/ OW/ OST/ HECD Final Draft A 11 standard deviation in the high dose group was three to four times greater than the standard deviation in the other groups. As a result, the variance modeling approaches available in BMDS were not capable of fitting the observed dose variance pattern. 2 The linear models to which the polynomial and power models defaulted could not fit the dose response pattern. However, the Hill model did reflect the dose response pattern well enough and the predicted standard deviation was reasonably close to the observed standard deviation for the control group, which would make that model acceptable for BMD estimation. The BMD estimate was 14 mg/ kg/ day, but the Hill model failed to derive a BMDL estimate. As an alternative, the high dose group was removed and the dose response models were refit to the reduced data set. Without the highest group,

BMDS suggests that a constant variance model is appropriate. The polynomial and power models still defaulted to linearity, and still did not fit the data ( p = 0.002). However, the Hill model passes exactly through all of the observed means and yields a BMD and BMDL of 13 and 11 mg/ kg/ day, respectively. These estimates are reasonable values to use for this data set, given the similarity of the BMD estimate for the truncated data set as compared to that of the Hill model fit to all the doses.

For the male rats exposed to DCAN, a monotonic dose response pattern was observed for the relative liver weight, but again the responses tended to plateau at the top two dose levels. The best estimates that the polynomial or power models can produce in such cases are based on a Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 12 linear fit which, in this case, severely over estimated the response observed at the high dose and underestimated the response at the penultimate dose. The Hill model provides an excellent fit to the data, but failed to estimate a BMDL estimate to go with the BMD estimate of 8.4 mg/ kg/ day.

For consistency, the male data were also considered with the high dose group ignored ( as was done for the females exposed to DCAN). The results of analyzing the reduced male data set were as follows. The linear model to which the polynomial and power models defaulted provided an adequate fit to the data ( p = 0.14). The Hill model also fit the data pretty well ( p = 0.06), but because it required additional parameters, its AIC value was slightly greater than that for the linear model. The elimination of the highest dose resulted in an acceptable linear model fit but reduced the BMD to 7.8 mg/ kg/ day, which was similar to the BMD from the Hill model that fit the complete data set very well. Given that similarity, that BMD and the associated BMDL of 5.0 mg/ kg/ day from the linear model fit to the reduced data set are considered to be adequate values to characterize this data set.

In summary, for the Ten day HA for DCAN, the modeling results for the endpoints of decreased body weight and increased relative liver weight ( Hayes et al., 1986) were considered for use in the quantitative dose response assessment. Changes in relative liver weight in males was the most sensitive endpoint. The estimate of choice for the short term data sets for DCAN was the BMD of 7.8 mg/ kg/ day with the corresponding BMDL of 5.0 mg/ kg/ day obtained from the power and polynomial models for increased relative liver weight in males. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 13 TCAN For TCAN, the developmental study by Christ et al. ( 1996) was selected as the most appropriate basis for deriving the Ten day HA. A number of maternal and developmental parameters were affected by TCAN. Comparison of NOAELs across these endpoints suggested that adjusted maternal body weight gain was the most sensitive effect. Therefore, BMD modeling results are described in detail for this endpoint. Results of modeling with BMDS suggested a constant variance approach. The polynomial model defaulted to a linear fit, which was very good ( p = 0.70). The power model estimated a power just greater than 1 ( 1.04), and so was not exactly linear. The power model fit was not substantially better than the polynomial model, so the AIC for the power model was greater than that for the linear model ( because of the extra parameter). Similarly, the Hill model used extra parameters to achieve a marginally better fit to the data; it too yielded an AIC greater than that for the linear ( polynomial) model. Since the extra parameters resulted in only marginal improvements in fit, the linear model estimates derived from the polynomial model run are the preferred ones, with a BMD of 21 mg/ kg/ day and a BMDL of 17 mg/ kg/ day.

Visual inspection of the data for other maternal or developmental endpoints affected by TCAN in this study suggested that the critical effect levels for these additional endpoints would likely be greater than for adjusted maternal body weight gain. To verify this, BMD modeling was performed for the following endpoints: maternal relative liver weight, post implantation loss, live fetuses/ litter, male and female fetal body weight, male and female crown rump length, and incidence of external malformations. Best fit BMDL estimates for all of these endpoints were Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 14 greater than the BMDL of 17 mg/ kg/ day for maternal adjusted weight gain, and thus these other endpoints would not be appropriate as the basis for deriving the Ten day HA. For this reason, we do not describe these additional modeling results in detail here, but the output from BMDS for these endpoints are presented in Appendix B.

In summary, for the TCAN Ten day HA modeling results for numerous maternal and developmental endpoints reported in Christ et al. ( 1996) were considered for use in the quantitative dose response assessment. The most appropriate endpoint to serve as the basis for the Ten day HA was adjusted maternal body weight gain. The BMD was 21 mg/ kg/ day with a corresponding BMDL of 17 mg/ kg/ day, derived using the linear model estimates from the polynomial model. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 15 Table A 1 Benchmark Dose Modeling Results for DBAN, DCANa, and TCANb Endpoint and Model AIC P value BMDc BMDL DBAN  Body Weight Males Hill 323.095 < 0.001d Failede Failede Power 279.347 0.07 26 16 Polynomial 284.303 0.004 30 15 DBAN  Relative Liver Weight Females Hill  11.853 0.52d 32 Failed Power  13.885 0.45 31 17 Polynomial  14.037 0.53 31 17 DCAN  Body Weight Males Hill 343.446 0.01 32 22 Power 343.290 0.02 36 25 Polynomial 343.538e 0.02 33 25 DCAN  Relative Liver Weight Females Hill 61.811 0.06 14 Failed Power 65.850 0.04e 13 8.4 Polynomial 65.582 0.01e 13 8.4 DCAN  Relative Liver Weight Females ( without highest dose)

Hill 15.440 1.0f 13 11 Power 24.058e 0.002e 15 11 Polynomial 24.058e 0.002e 15 11 DCAN  Relative Liver Weights Males Hill 10.291 0.93 8.4 Failed Power 26.962 0.0001 16 8.4 Polynomial 26.962 0.0001 16 8.4 DCAN  Relative Liver Weight Males ( without highest dose)

Hill 4.948 0.06d 8.4 Failed Drinking Water Criteria Document for Haloacetonitriles Endpoint and Model AIC P value BMDc BMDL EPA/ OW/ OST/ HECD Final Draft A 16 Power 4.859e 0.14e 7.8 5.0 Polynomial 4.859 0.14e 7.8 5.0 TCAN  Adjusted % Maternal Weight Gain Hill 320.867 0.89d 22 14 Power 319.562e 0.40 21 17 Polynomial 317.582e 0.70e 21 17 a Modeling for BCAN and DCAN based on data from Hayes et al. ( 1986).

b Adjusted % Weight Gain for TCAN based on data from Christ et al. ( 1996).

c BMD and BMDL are based on benchmark response of 1SD. Results are presented in units of mg/ kg/ day. BMD and BMDL estimates in bold type are the estimates judged to be the best estimates to use for the quantitative dose response assessment for each chemical. Failed indicates that BMDS was unable to produce the estimate or the information required to be able to present a value.

d Based on a comparison of the fitted model to the model maximizing the likelihood ( i. e. model with independent means and variances for each dose group, model A2 from BMDS).

e Corrected from erroneous BMDS output. Errors were identified in the degrees of freedom ( DF) provided in the output for the fitted model in several cases. For these cases, the AIC was calculated independently using the log likelihoods provided in the output and the correct number of DF. Similarly, the goodness of fit p values were corrected by calculating manually the chi square p value using the appropriate number of DF.

f A fit that maximizes the likelihood is assigned a p value of 1.0, even if there were no degrees of freedom for a formal statistical test. The maximized likelihood is given by model A1 for constant variance models and model A2 for non constant variance models. Models A1 and A2 are independent of the model chosen to fit the data ( e. g., power, polynomial, Hill model) and provide the best match possible to the mean and standard deviation for each dose level.

Modeling Results for Longer term Studies BMD modeling was done to support the derivation of the Longer term and Lifetime HAs.

Adequate longer term studies that would support BMD modeling were available only for DBAN and DCAN. No studies of suitable duration were available for derivation of Longer term or Lifetime HAs for BCAN or TCAN. As a result, BMD modeling was not performed for these two Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 17 HANs. The BMD modeling results for the longer term studies are presented in Table A 2 and described below.

DBAN As noted in Chapter V, the only endpoint that was considered to be toxicologically relevant for DBAN in the single available subchronic study ( Hayes et al., 1986) was the observed decrease in body weight in male rats. A constant variance model was appropriate for modeling the data set. The Hill, polynomial, and power models all gave similar BMD and BMDL estimates.

Visual inspection in the region of the BMDL indicated that the fit was adequate for all three of these models, and was better for these models than for the linear model. The goodness of fit pvalues for the polynomial and power models were very good, and model fit for the Hill model was not very good. The polynomial model provided a slightly better fit than the polynomial model,

with fewer parameters as indicated by the lower AIC and higher p value, and the BMD of 29 mg/ kg/ day and the BMDL of 20 mg/ kg/ day for the polynomial model was selected as the best estimate for this data set.

In summary, decreased body weight in males was the only endpoint judged to be of sufficient toxicological significance to be modeled for DBAN. Therefore, the BMDL of 20 mg/ kg/ day for this endpoint is the most appropriate basis for the Longer term and Lifetime HAs. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 18 DCAN Decreased body weight reported in Hayes et al. ( 1986) was considered to be a toxicologically relevant response to DCAN. A constant variance model was appropriate for modeling the data set for body weight in males. However, none of the continuous models provided an adequate visual fit in the dose range of interest. Only the Hill models had an adequate goodness of fit statistic, but this model was not selected due to the model dependence of the BMDL estimate, which relied on a sigmoid curve that could not be supported based on the underlying biology. The poor fits were due to the non monotonic nature of the data; the mean body weight was higher in the low dose group than in the controls. Therefore, no adequate BMDL estimate for decreased body weight in males was obtained. Further optimization of the models for decreased body weight that provided poor fits was not done since it became apparent in the course of the preliminary modeling that increased relative liver weight would yield significantly lower BMDLs than decreased body weight, and thus the modeling for body weight would not drive the assessment.

Initial modeling for body weight in females was conducted separately assuming either constant or non constant variance. For all four mathematical models fit to the data, modeling results using the constant variance model suggested that a non homogenous variance model should be used. However, when this was done, the test statistic for the variance model ( test 3)

was inadequate. This result is consistent with the absence of a clear dose dependent ( i. e.

meandependent trend in the group standard deviations. The outcome of these modeling efforts indicates that neither the constant variance nor modeled variance options in BMDS provided an Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 19 adequate estimate of the variance around the best fit curve. An adequate estimate of the variances is critical for relying on the BMDL, since the computation of the BMDL is dependent on the estimated variance for the fitted model. ( As noted above, the BMR was defined as a change in the mean of one standard deviation, a measure related to the variance.) As a result, even though the linear, power, and polynomial models yielded adequate goodness of fit p values ranging from 0.11 to 0.22, none of these models was viewed as providing a reliable estimate of the BMDL.

The NOAEL/ LOAEL analysis indicated that increased relative liver weight was the most sensitive indicator of toxicity for DCAN ( see discussion in Chapter V). Since increases in liver weight were observed in both males and females and this effect was judged to be toxicologically relevant, modeling was performed for the relative liver weight data for both sexes.

The relative liver weight data for males was modeled using a non constant variance model,

based on visual inspection of the group standard deviations and BMD modeling results in initial runs. The overall fit to the data achieved using the full data set was inadequate for all of the continuous models that were run, except the Hill model, which did not calculate a BMDL estimate. The poor model fits appeared to arise from the inability of these models to accommodate the plateau in the dose response curve at high doses. Therefore, consistent with the approach used for the short term studies, modeling was done using a truncated data set ( i. e.

without the high dose). The Hill model was not run using the truncated data set, since this model requires at least four data points to calculate a BMDL estimate and the truncated data set contained only three doses. The linear, power, and polynomial models performed very well when Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 20 the high dose data were removed, based on visual inspection and review of the chi square values for residuals at the individual data points. Although goodness of fit statistics were not calculated by BMDS for the polynomial and power models, independent calculation of the p values ( as presented in Table A 2) confirms the good statistical fit. Since the BMDL estimates were the same for all three models, the model with the lower AIC was selected as providing the best estimate. Therefore, the BMD of 6 mg/ kg/ day and the BMDL of 4 mg/ kg/ day for the linear model were selected as the best estimates for the dose response assessment.

For modeling of relative liver weight in females, the initial BMDS results indicated that a non constant variance model would be most appropriate. However, for all four of the mathematical models fit to the data, the test statistic for the variance model was inadequate with this option selected, reflecting the absence of a clear dose dependent ( i. e. mean dependent) trend.

As described above for modeling of female body weight for DCAN, the inability to get an appropriate model of the variance precludes identifying the BMDL estimate with confidence.

Regardless of this consideration, none of the modeling results using the full data set provided an adequate fit to the data. Although the Hill model yielded a curve that went through the points,

the curve had a sigmoid shape that was highly dependent on the model and that could not be supported based on the underlying biology. Since there was an apparent plateau in the doseresponse data, a truncated data set was modeled with the high dose group removed. This approach provided an adequate visual fit. However, similar to the modeling with the full data set,

the variance model could not adequately describe the data. Therefore, none of these models was viewed as providing a reliable estimate of the BMDL. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 21 In summary, based on the evaluation of these BMD modeling results for DCAN, increased relative liver weight in males is the most sensitive endpoint. The BMD of 6 mg/ kg/ day and the corresponding BMDL of 4 mg/ kg/ day for the linear model was selected as the most appropriate basis for the Longer term and Life time HAs. Drinking Water Criteria Document for Haloacetonitriles EPA/ OW/ OST/ HECD Final Draft A 22 Table A 2 Benchmark Dose Modeling Results for DBAN and DCANa Endpoint and Model AIC P value BMDb BMDL DBAN  Body Weight in Males Linear 716.297e 0.15 20 16 Hill 716.713 0.06c 30 21 Power 714.705 0.61 30 20 Polynomial 714.681e 0.63 29 20 DCAN  Body Weight in Males Linear 777.801e 0.022 17 15 Hill 775.374 0.12c 32 21 Power 776.405 0.028 25 18 Polynomial 777.462e 0.015 24 16 DCAN  Body Weight in Femalesd Linear 717.621e 0.22 46 34 Hill 721.120 < 0.001c 55 31 Power 719.090 0.11 55 35 Polynomial 718.907e 0.13 52 33 DCAN  Liver Weight in Males Linear 117.429 < 0.0001 7 5 Hill 118.869 0.59c 8 Failed Power 117.429e 0.02e 7 5 Polynomial 117.974 < 0.0001 6 4 DCAN  Liver Weight in Males ( without highest dose)

Linear 37.993 0.44 6 4 Power 39.388 1.0f 7 4 Polynomial 39.388 1.0f 7 4 DCAN  Liver Weight in Femalesd Linear 86.720e 0.00039 32 25 Drinking Water Criteria Document for Haloacetonitriles Endpoint and Model AIC P value BMDb BMDL EPA/ OW/ OST/ HECD Final Draft A 23 Hill 75.031 1.0f 8 6 Power 86.720e 0.0004e 32 25 Polynomial 86.720e 0.0004e 32 25 DCAN  Liver Weight in Females ( without highest dose) d Linear 64.218e 0.50 16 12 Power 64.218e 0.50 16 12 Polynomial 65.757e 1.0f 12 6 a Modeling was performed based on body and organ weight at terminal sacrifice in the subchronic study by Hayes et al. ( 1986).

b BMD and BMDL are based on benchmark response of 1SD. Results are presented in units of mg/ kg/ day. BMD and BMDL estimates in bold type are the estimates judged to be the best estimates to use for the quantitative dose response assessment for each chemical. Failed indicates that BMDS was unable to produce the estimate or the information required to be able to present a value.

c Based on a comparison of the fitted model to the model maximizing the likelihood ( i. e. model with independent means and variances for each dose group, model A2 from BMDS).

d The modeling results for DCAN shown here are for the constant variance model. Neither the constant nor non constant variance models yielded a reliable BMDL estimate.

e Corrected from erroneous BMDS output. Errors were identified in the degrees of freedom ( DF) provided in the output for the fitted model in several cases. For these cases, the AIC was calculated independently using the log likelihoods provided in the output and the correct number of DF. Similarly, the goodness of fit p values were corrected by calculating manually the chi square p value using the appropriate number of DF.

f A fit that maximizes the likelihood is assigned a p value of 1.0, even if there were no degrees of freedom for a formal statistical test. The maximized likelihood is given by model A1 for constant variance models and model A2 for non constant variance models. Models A1 and A2 are independent of the model chosen to fit the data ( e. g., power, polynomial, Hill model) and provide the best match possible to the mean and standard deviation for each dose level.


[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Proposed Rules]
[Pages 62667-62669]
[FR Doc No: 2011-26105]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1065; Directorate Identifier 2011-NM-007-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Boeing Model 747-400 series airplanes. This proposed AD was
prompted by reports of water leaking into electrical and electronic
equipment in the main equipment center, which could result in an
electrical short and potential loss of several functions essential for
safe flight. This proposed AD would require modifying the floor panels,
removing drains; installing floor supports, floor drain trough
doublers, drain troughs, and drains; and sealing and taping the floor
panels. We are proposing this AD to correct the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by November 25,
2011.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet: https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Francis Smith, Aerospace Engineer,
Cabin Safety & Environmental Systems Branch, ANM-150S, Seattle Aircraft
Certification Office (ACO), FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-1065;
Directorate Identifier 2011-NM-007-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of water leaking into electrical and
electronic equipment in the main equipment center on Model 747-400
Boeing Converted Freighter (BCF) airplanes. The water leaked through
the main deck floor panels, fasteners, and floor fittings. The source
of the water includes rain and snow coming in through the main deck
doors, as well as wet cargo. This condition, if not corrected, could
result in an electrical short and potential loss of several functions
essential for safe flight.

Relevant Service Information

    We reviewed Boeing Special Attention Service Bulletin 747-25-3586,
dated November 12, 2010. This service information describes procedures
for the following actions at stations 210 and 530.
     Modifying by removing and reworking floor panels
     Removing drains
     Installing new floor supports
     Installing floor drain trough doublers, and drain troughs
     Installing new drains

Additionally, in certain areas between stations 140 and 640, this
service information describes installing sealant and tape.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    We estimate that this proposed AD affects 12 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Action                          Labor cost          Parts cost            Cost per product                 Cost on U.S.  operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Floor panel reworking and sealing;      Up to 644 work-hours x         $64,033  Up to $118,773.....................  Up to $1,425,276.
 installing drains, drain trough         $85 per hour = $54,740.
 doublers, and drain troughs.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

The Boeing Company: Docket No. FAA-2011-1065;
    Directorate Identifier 2011-NM-007-AD.

(a) Comments Due Date

    We must receive comments by November 25, 2011.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 747-400 series
airplanes, certificated in any category, as identified in Boeing
Special Attention Service Bulletin 747-25-3586, dated November 12,
2010.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 25, Equipment and Furnishings.

(e) Unsafe Condition

    This AD was prompted by reports of water leaking into electrical
and electronic equipment in the main equipment center. We are
issuing this AD to prevent water from entering the main equipment
center, which could result in an electrical short and potential loss
of several functions essential for safe flight.

(f) Compliance

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

(g) Floor Panel Sealing

    Within 24 months after the effective date of this AD: Modify the
floor panels; remove drains; install floor supports, floor drain
trough doublers, drain troughs, and drains; and seal and tape the
floor panels; at the applicable locations; in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 747-25-3586, dated November 12, 2010.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be e-mailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Francis Smith,
Aerospace Engineer, Cabin Safety & Environmental Systems Branch,
ANM-150S, Seattle Aircraft Certification Office (ACO), FAA, 1601
Lind Avenue SW., Renton, Washington 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone:
206-544-5000, extension 1; fax: 206-766-

5680; e-mail<EMAIL_ADDRESS>Internet: https://www.myboeingfleet.com.You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue, SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on September 30, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-26105 Filed 10-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16289-16291]
[FR Doc No: 2015-06858]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0083; FRL-9924-73-Region 9]

Revisions to the California State Implementation Plan, Placer
County Air Pollution Control District and the Ventura County Air
Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the Placer County Air Pollution
Control District (PCAPCD) and Ventura County Air Pollution Control
District (VCAPCD) portions of the California State Implementation Plan
(SIP). These revisions concern volatile organic compound (VOC)
emissions from the surface coating of plastic parts and products,
metalworking fluids (MWF) and direct-contact lubricants (DCL). We are
approving local rules that regulate these emission sources under the
Clean Air Act (CAA or the Act).

DATES: This rule is effective on May 26, 2015 without further notice,
unless EPA receives adverse comments by April 27, 2015. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2015-0083, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, (415)
947-3024<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?

    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rules
    D. Public Comment and Final Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this Submittal with the dates
that they were adopted by the local air agencies and submitted by the
California Air Resources Board.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
           Local agency                Rule number             Rule title             Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
PCAPCD............................  249..............  Surface Coating of                 8/8/13         5/13/14
                                                        Plastic Parts and
                                                        Products.
VCAPCD............................  74.31............  Metalworking Fluids and          11/12/13         5/13/14
                                                        Direct-Contact
                                                        Lubricants.
----------------------------------------------------------------------------------------------------------------

    On July 18, 2014, EPA determined that the submittals for PCAPCD
Rule 249 and VCAPCD Rule 74.31 met the completeness criteria in 40 CFR
part 51 Appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    There are no previous versions of PCAPCD Rule 249 or VCAPCD Rule
74.31 in the SIP.

C. What is the purpose of the submitted rules?

    VOCs help produce ground-level ozone and smog, which harm human
health and the environment. Section 110(a) of the CAA requires States
to submit regulations that control VOC emissions. Rule 249 establishes
VOC content limits and workplace standards for the surface coating of
plastic parts and products. It also describes related recordkeeping,
reporting, and monitoring requirements. Rule 74.31 establishes VOC
content limits and usage for MWF and DCL. Rule 74.31 applies to any
person who uses MWF and DCL commercially or industrially and to any
manufacturer or supplier who supplies, sells, or offers for sale either
MWF or DCL for use at industrial or commercial facilities. Such persons
must use compliant fluids as specified by rule 74.31. EPA's technical
support documents (TSDs) have more information about these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    40 CFR 81.305 describes PCAPCD as regulating an ozone nonattainment
area classified as Severe and VCAPCD classified as Serious for the 8-
hour ozone National Ambient Air Quality Standard (NAAQS) (2008
Standard). SIP rules must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules must require Reasonably Available Control
Technology (RACT) for each category of sources covered by a Control
Techniques Guidelines (CTG) document as well as each VOC major source
in ozone nonattainment areas classified as moderate or above (see
sections 182(b)(2) and 182(f)).
    Guidance and policy documents that we use to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,''
(57 FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).
2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations'' (``the Bluebook,'' U.S. EPA, May 25, 1988; revised
January 11, 1990).
3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies'' (``the Little Bluebook'', EPA Region 9, August 21,
2001).
4. ``Control Techniques Guidelines for Miscellaneous Metal and
Plastic Parts Coatings'' (CTG), September 2008. (EPA 453-R-008-003).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant policy and
guidance regarding enforceability, RACT, and SIP relaxations. The VOC
content limits and usage requirements in Rule 249 are equivalent or
more stringent to the relevant sections of EPA's 2008 metal parts CTG,
implement RACT and strengthen the SIP. Rule 74.31 strengthens the SIP
because the VCAPCD did not have a SIP approved rule regulating MWF and
DCL and there exists no relevant CTG, but we also believe Rule 74.31
implements RACT. The TSDs associated with each rule have more
information on our evaluation.

C. EPA Recommendations To Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for
the next time the local agencies modify the rules but are not currently
the basis for rule disapproval.

D. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rules. If we
receive adverse comments by April 27, 2015, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on May 26, 2015. This will incorporate these
rules into the federally enforceable SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In

accordance with requirements of 1 CFR 51.5, the EPA is finalizing the
incorporation by reference of the PCAPCD and VCAPCD rules described in
the amendments to 40 CFR 52 set forth below. The EPA has made, and will
continue to make, these documents available electronically through
www.regulations.gov and in hard copy at the appropriate EPA office (see
the ADDRESSES section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 26, 2015. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: February 27, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(441)(i)(B)(3) and
(c)(441)(i)(C)(2) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (441) * * *
    (i) * * *
    (B) * * *
    (3) Rule 249, ``Surface Coating of Plastic Parts and Products,''
adopted on August 8, 2013.
    (C) * * *
    (2) Metalworking Fluids and Direct-Contact Lubricants,'' adopted on
November 12, 2013.
* * * * *
[FR Doc. 2015-06858 Filed 3-26-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Page 23244]
[FR Doc No: 2012-9271]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR12-22-000]

 Atmos Energy Colorado/Kansas Division; Notice of Revised
Baseline Filing

    Take notice that on April 10, 2012, Atmos Energy Colorado/Kansas
Division (Atmos) filed a revised baseline filing of their Statement of
Operating Conditions for services provided under section 311 of the
Natural Gas Policy Act of 1978 (NGPA) to comply with a Delegated Letter
Order issued March 29, 2012, in Docket No. CP12-53-000 (138 FERC ]
62,319).
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Monday, April 23, 2012.

    Dated: April 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-9271 Filed 4-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25041-25043]
[FR Doc No: 2023-08648]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-508, OMB Control No. 3235-0565]

Proposed Collection; Comment Request; Extension: Rule 482

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Like most issuers of securities, when an investment company
(``fund'') \1\ offers its shares to the public, its promotional efforts
become subject to the advertising restrictions of the Securities Act of
1933 (15 U.S.C. 77) (the ``Securities Act''). In recognition of the
particular problems faced by funds that continually offer securities
and wish to advertise their securities, the Commission has previously
adopted advertising safe harbor rules. The most important of these is
rule 482 (17 CFR 230.482) under the Securities Act, which, under
certain circumstances, permits funds to advertise investment
performance data, as well as other information. Rule 482 advertisements
are deemed to be ``prospectuses'' under Section 10(b) of the Securities
Act (15 U.S.C. 77j(b)).
---------------------------------------------------------------------------

    \1\ ``Investment company'' refers to both investment companies
registered under the Investment Company Act of 1940 (``Investment
Company Act'') (15 U.S.C. 80a-1 et seq.) and business development
companies.
---------------------------------------------------------------------------

    Rule 482 contains certain requirements regarding the disclosure
that funds are required to provide in qualifying advertisements. These
requirements are intended to encourage the provision to investors of
information that is balanced and informative, particularly in the area
of investment performance. For example, a fund is required to include
disclosure advising investors to consider the fund's investment
objectives, risks, charges and expenses, and other information
described in the fund's prospectus, and highlighting the availability
of the fund's prospectus. In addition, rule 482 advertisements that
include performance data of open-end funds or insurance company
separate accounts offering variable annuity contracts are required to
include certain standardized performance information, information about
any sales loads or other nonrecurring fees, and a legend warning that
past performance does not guarantee future results. Such funds
including performance information in rule 482 advertisements are also
required to make available to investors month-end performance figures
via website disclosure or by a toll-free telephone number, and to
disclose the availability of the month-end performance data in the
advertisement. The rule also sets forth requirements regarding the
prominence of certain disclosures, requirements regarding
advertisements that make tax representations, requirements regarding
advertisements used prior to the effectiveness of the fund's
registration statement, requirements regarding the timeliness of
performance data. In addition, rule 482(b) describes the information
that is required to be included in an advertisement, including a
cautionary statement under rule 482(b)(4) disclosing the particular
risks associated with investing in a money market fund.
    On October 26, 2022, the Commission adopted rule and form
amendments that modernize the requirements for annual and semi-annual
shareholder reports provided by open-end management investment
companies.\2\ The Commission also adopted amendments to the advertising
rules for registered investment companies and business development
companies to promote more transparent and balanced statements about
investment costs. The advertising rule amendments require that
investment company advertisements providing fee and expense figures
include: (1) the maximum amount of any sales load or any other
nonrecurring fee; and (2) the total annual expenses without any fee
waiver or expense reimbursement arrangement. Under the amendments to
rule 482, investment company fee and

expense presentations in advertisements must include timely and
prominent information about a fund's maximum sales load (or any other
nonrecurring fee) and gross total annual expenses, based on the methods
of computation that the company's Investment Company Act or Securities
Act registration statement form prescribes for a prospectus.
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    \2\ Tailored Shareholder Reports for Mutual Funds and Exchange-
Traded Funds; Fee Information in Investment Company Advertisements,
Investment Company Act Release No. 34731 (Oct. 26, 2022), 87 FR
72758 (Nov. 25, 2022) (the ``Adopting Release'').
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    Rule 482 advertisements must be filed with the Commission or, in
the alternative, with the Financial Industry Regulatory Authority
(``FINRA'').\3\ This information collection differs from many other
federal information collections that are primarily for the use and
benefit of the collecting agency.
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    \3\ See note to rule 482(h) under the Securities Act, which
states that ``these advertisements, unless filed with [FINRA], are
required to be filed in accordance with the requirements of Sec.
230.497.'' See also rule 24b-3 under the Investment Company Act (17
CFR 270.24b-3), which provides that any sales material, including
rule 482 advertisements, shall be deemed filed with the Commission
for purposes of Section 24(b) of the Investment Company Act upon
filing with FINRA.
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    Rule 482 contains requirements that are intended to encourage the
provision to investors of information that is balanced and informative,
particularly in the area of investment performance. The Commission is
concerned that in the absence of such provisions fund investors may be
misled by deceptive rule 482 advertisements and may rely on less-than-
adequate information when determining in which funds they should invest
money. As a result, the Commission believes it is beneficial for funds
to provide investors with balanced information in fund advertisements
in order to allow investors to make better-informed decisions.
    The table below summarizes our estimates associated with the
amendments to rule 482 that the Adopting Release addresses:

                                                                 Rule 482 PRA Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Internal
                                         initial hour      Internal annual  burden \1\            Wage rate \2\                Internal time costs
                                            burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              FINAL ESTIMATES FOR RULE 482
--------------------------------------------------------------------------------------------------------------------------------------------------------
New general requirements re: fee and           9 hours  6 hours \3\......................  $381 (blended rate for       $2,286
 expense figure disclosure.                                                                 compliance attorney and
                                                                                senior programmer).
Number of responses to rule 482 that                    x 36,492 \4\ responses...........                               x 36,492 responses
 include fee/expense figure disclosure.
                                       -----------------------------------------------------------------------------------------------------------------
    Total burden of new requirements    ..............  218,952 hours....................  ...........................  $83,420,712
     for fee and expense disclosure.
--------------------------------------------------------------------------------------------------------------------------------------------------------
New requirements for disclosure of fee         6 hours  4 hours \5\......................  $381 (blended rate for       $1,524
 waivers/expense reimbursement                                                              compliance attorney and
 arrangements.                                                                              senior programmer).
Number of responses to rule 482 that                    x 36,492 responses...............                               x 36,492 responses
 disclose fee waivers/expense
 reimbursement arrangements.
                                       -----------------------------------------------------------------------------------------------------------------
    Total burden of annual              ..............  145,968 hours....................  ...........................  $55,613,808
     requirements for disclosure of
     fee waivers/expense reimbursement
     arrangements.
                                       -----------------------------------------------------------------------------------------------------------------
        Total annual burden...........  ..............  364,920 hours....................  ...........................  $139,034,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   TOTAL FINAL ESTIMATED BURDENS INCLUDING AMENDMENTS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current burden estimates..............  ..............  212,927 hours....................  ...........................  $74,098,735
Revised burden estimate...............  ..............  577,847 hours....................  ...........................  $213,133,255
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
\1\ Includes initial burden estimates annualized over a 3-year period.
\2\ These PRA estimates assume that the same types of professionals would be involved in preparing advertisements (reflecting the proposed and final
  amendments to rule 482) that we believe otherwise would be involved in preparing a fund's advertisements. The Commission's estimates of the relevant
  wage rates are based on salary information for the securities industry compiled by the Securities Industry and Financial Markets Association's Office
  Salaries in the Securities Industry 2013. The estimated figures are modified by firm size, employee benefits, overhead, and adjusted to account for
  the effects of inflation. See Securities Industry and Financial Markets Association, Report on Management & Professional Earnings in the Securities
  Industry 2013.
\3\ This estimate assumed that, after the initial 9 hours that an entity would spend on the proposed fee and expense disclosure, which we annualize over
  a 3-year period, the entity would incur 3 additional burden hours associated with ongoing compliance with these requirements per year. The estimate of
  6 hours is based on the following calculation: ((9 initial hours/3) + 3 hours of additional ongoing burden hours) = 6 hours.
\4\ The Commission estimates that there was a total of 41,953 responses to rule 482 that either were filed with FINRA or with the Commission in 2021. Of
  those, the Commission estimates that 1,124 were responses from closed-end funds and BDCs, and that 2,816 were responses from variable insurance
  contracts. The number of responses filed with the SEC is based on the average number of responses filed with the Commission from 2019-2021. The
  Commission assumes that, moving forward, closed-end funds and BDCs will choose to use free writing prospectuses under rule 433, and also that variable
  insurance contracts will not be subject to the amendments to rule 482. Therefore, we exclude closed-end funds, BDCs, and variable insurance contracts
  from the total responses to rule 482 for purposes of this estimate. For purposes of estimating the burden of the final rules amendments, we estimate
  that 38,013 responses to rule 482 are filed annually. We estimate that approximately 96% of these rule 482 responses provide fee and expense figures
  in qualifying advertisements and would, therefore, be required to comply with the final rule amendments regarding such information (for example,
  ensuring that the fee and expense figures are presented in accordance with the prominence and timeliness requirements in the amendments to rule 482).

\5\ This estimate assumed that, after the initial 6 hours that an entity would spend on the proposed fee waiver and expense reimbursement requirements,
  which we annualized over a 3-year period, the entity would incur 2 additional burden hours associated with ongoing compliance with these requirements
  per year. The estimate of 4 hours is based on the following calculation ((6 initial hours/3) + 2 hours of additional ongoing burden hours) = 4 hours.

    The table above summarizes our PRA initial and ongoing annual
burden estimates associated with rule 482, as amended. In the
aggregate, we estimate the total annual burden to comply with amended
rule 482 to be 577,847 hours, at an average time cost of $213,133,255.
    The information provided under rule 482 will not be kept
confidential. The provision of information under rule 482 is necessary
to obtain the benefits of the safe harbor offered by the rule.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. 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.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by June 26, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: April 19, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-08648 Filed 4-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Notices]
[Page 76311-76312]
[DOCID:fr20de06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-177-000]

NCSU Energy, Inc.; Notice of Issuance of Order

December 14, 2006.
    NCSU Energy, Inc. (NCSU) filed an application for market-based rate
authority, with an accompanying tariff sheet. The proposed market-based
rate tariff provides for the sale of energy and capacity at market-
based rates. NCSU also requested waivers of various Commission
regulations. In particular, NCSU requested that the Commission grant
blanket approval under 18 CFR part 34 of all future issuances of
securities and assumptions of liability by NCSU.

    On December 14, 2006, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under part 34. The Director's order also
stated that the Commission would publish a separate notice in the
Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard or to protest
the blanket approvals of issuances of securities or assumptions of
liability by NCSU should file a motion to intervene or protest with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is January 16, 2007.
    Absent a request to be heard in opposition by the deadline above,
NCSU is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
NCSU, compatible with the public interest, and is reasonably necessary
or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of NCSU's issuance of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21693 Filed 12-19-06; 8:45 am]

BILLING CODE 6717-01-P