See response to Comment 2 ( Docket ID I D1.002, Part 15) concerning the adequacy of the Colitag   data and Comment No. Docket ID Docket Part Comment Response Notes 45 at that time EPA elected to postpone its response to comments concerning the data submitted in support of the Colitag   method for detecting coliform bacteria and E. coli. In its response to a number of concerns raised by external reviewers EPA indicated that no action would be taken because    ATP guidelines are not legal requirements . This inaction is disappointing due to the significant number of documented failures by the manufacturers to meet the criteria stipulated in the Alternate Testing Procedure ( ATP) protocol. To some degree this decision renders the ATP a guideline without purpose, as manufacturers keen to develop and market new tools for potable water testing are left with no standard against which their products can be evaluated. Moreover, the public health is not served well by this inaction, as products that fail to meet numerous criteria stipulated in the ATP guidelines may nonetheless gain product approval by EPA. In the case of the Colitag   submission, EPA s decision to reconsider the application in light of limited recomputation of the log reductions following chlorine injury is not justified adequately in light of the fact that a key element of the ATP process is to demonstrate that proposed methods are better than or equal to EPA approved reference methods in terms of sensitivity,

specificity and overall applicability for a given analyte. Failure to meet a significant number of ATP criteria suggests that the data presented may not be adequate to justify approval for drinking water testing.  EPA s review of the data.

See response to Comment 8 ( Docket ID I D1.001, Part 02) concerning the scope/ purpose of the December 2002 NODA. See also responses to Comment 2 ( Docket ID I D1.002, Part 15) and Comment 3 ( Docket ID I D1.005, Part 02)

See response to Comment 14 ( Docket ID I D1.004 Part 02) concerning EPA s application of the ATP protocol to previous method evaluations.

See response to Comment 12 ( Docket ID I F. 021, Part 10) concerning the comparability between the reference methods and Colitag   with respect to method sensitivity. As noted in that response, EPA concluded that the studies met the underlying goal of detecting low numbers of bacteria method; those studies produced results that support the Agency s decision to approve the method for drinking water monitoring.

See response to Comment 40 ( Docket ID I D1.002, Part 14) concerning the acceptability of specificity results.

Since Colitag   detects total coliforms and E. coli in drinking water samples in a manner comparable to the reference methods, EPA concluded that it is applicable to these analytes.

36 ID1.002 06   Overall, more than half of the coliform data submitted in support of product approval failed to meet the ATP criteria for comparability testing. In the absence of unambiguous justification, it would not be in the best interest of the public health to accept the submitted data in support of product approval for coliform testing.  See response to Comment 1 ( Docket ID I D1.001, Part 06) concerning EPA s use of the ATP protocol as guidance.

See response to Comment 12 ( Docket ID I F. 021, Part 10) concerning the 25: 75 split guideline; the selection of geographically dispersed sites; and the log reduction results.

See response to Comment 24 ( Docket ID I D1.001, Part 03) concerning   hold time  between initial density Comment No. Docket ID Docket Part Comment Response Notes 46 determination and post chlorination measurement.

See response to Comment 2 ( Docket ID I D1.002, Part 15) concerning the adequacy of the Colitag   data.

Based on the evaluation of the comparability data generated for the Colitag   method, and taking into consideration the public comments received, EPA has concluded that the Colitag   method is acceptable as an alternative to the approved reference methods because the information available to EPA indicates that the performance of the Colitag   method compares favorably to the approved reference methods. EPA has assessed the quality and quantity of the data provided by CPI International, and conducted a thorough statistical analysis of relevant information, all of which was included in the public record. As discussed throughout this document, each of the concerns raised via the public comment process has been addressed to EPA s satisfaction.

37 I F. 022 01   USEPA has proposed approval of two presence/ absence liquid culture methods, Colitag   and ReadyCult Coliforms 100,

summarized in Table 2. Proposed approval of these methods is based on test results submitted following the USEPA Protocol for Alternate Test Procedures for Coliform Bacteria in Compliance with Drinking Water Regulations;

Presence/ Absence Liquid Culture Methods for Finished Waters ( USEPA ATP Protocol). As will be discussed below, the test results for both of these proposed methods deviated from the USEPA ATP Protocol. Hence, by proposing these methods for approval, the agency is concluding that the USEPA ATP Protocol need not be followed as a strict protocol. This is a mistake, and will cause further complications for USEPA and water utilities both small and large.

  In the analytical methods market, manufacturers will seek to develop methods that have advantages over their competitors.

Hence, it is very important from a scientific point of view to See response to Comment 1 ( Docket ID I D1.001, Part 06) concerning EPA s use of the ATP protocol as guidance.

See response to Comment 14 ( Docket ID I D1.004, Part 02) concerning EPA s consistent application of the protocol to method evaluations.

See response to Comment 12 ( Docket ID I F. 021, Part 10) concerning the 25: 75 split guideline; the selection of geographically dispersed sites; and the log reduction results.

See response to Comment 2 ( Docket ID I D1.002, Part 15) concerning the adequacy of the Colitag   data. Comment No. Docket ID Docket Part Comment Response Notes 47 have a consistent performance benchmark, so that the quality of science is maintained and public health protected. Furthermore,

all manufacturers and methods developers must have a standard benchmark, and must not be allowed to cut corners on science ( i. e., use less rigorous science) when their method is approved.

The USEPA ATP Protocol must serve as that benchmark.

  A method developer desiring approval of a new procedure must be required to follow exactly the USEPA ATP Protocol,

otherwise there is no fair basis for comparison of methods.

Examples of key protocol requirements are:

  Proposed methods must demonstrate broad applicability.

Hence, primary effluent samples are required from 10 geographically dispersed sites throughout the US. If this is not followed, then the method cannot be shown to have broad applicability.

  For drinking water, recovery of stressed organisms is particularly important. To demonstrate effective recovery of injured bacteria, a 3 to 4 log10 reduction in cell numbers must be achieved during the injury test. This is an important criterion to ensure a comparable level of ' stress' and/ or injury from one to test to another. If a method cannot detect severely stress organisms following the protocol, then it should not be approved.

  The USEPA ATP Protocol states that it is the intention of the protocol under Option B to achieve a 50%/ 50% split in positive and negative results. But the protocol allows as much as a 25%/ 75% split in either direction. If this is not met, then the data are unacceptable, and the protocol indicates that the proposer must begin again.

  The USEPA ATP Protocol was developed after extensive deliberations with stakeholders and others seeking approval of methods many years prior to the March 7, 2002 notice. This protocol represents an appropriate " bar" that all subsequent Comment No. Docket ID Docket Part Comment Response Notes 48 methods must clear for approval. USEPA should make a firm statement to methods developers that the USEPA ATP Protocol must be followed as written. Otherwise the " bar" a propose method must clear is inconsistent, resulting in less robust methods being approved, and compromising a water systems ability to detect contamination. It also results in a basic unfairness in the marketplace to the developers of new methods. Together, both of these effects will compromise public health protection.

04 DOCUMENTATION OF Colitag   DATA ( e. g., differing false positive/ negative errors cited; use of a poster presentation; documentation of inferences)

38 ID1.002 10   As explained previously for the total coliform data, three samples were tested from Millbrae, California ( two samples but three series of tests). The third test conducted on 12/ 29/ 98 for total coliform analysis was not repeated for E. coli; however, the methods comparability data sheets indicate that the E. coli assays were conducted on 12/ 29 ( rather than the previous week when the E. coli disinfection experiment was conducted). It is unclear where the data originated for the chi square analysis.

This inconsistency should be explained before the data is considered in support of product approval.  As the commenter notes, three series of comparability study tests were performed using samples from Millbrae,

CA: two were associated with sample 982305A; one was associated with sample 982084A.

The statistical evaluation of the comparability study results from sample 982084A is based on the total coliform and E. coli data sheets dated 11/ 11/ 98. The chi squared analysis for total coliforms is based on the 1: 10,000 dilution; the analysis for E. Coli is based on the 1: 1000 dilution. Log reduction for total coliforms,

originally reported as 2.1, was recalculated as 1.8 based on the 1: 10,000 dilution factor. Log reduction for E. coli remains unchanged.

The statistical evaluation of the comparability study results for sample 982305A was originally based on the total coliform and E. coli data sheets dated 12/ 29/ 98 ( this study represents a repeat of experiments associated with data sheets dated 12/ 23/ 98). The analysis was subsequently repeated using data from the 12/ 23/ 98 studies. The chi squared analysis for total coliforms was repeated based on the 1: 1000 dilution data; the analysis for E. coli was repeated based on the 1: 1000 dilution data. Log reduction for total coliforms and for E. coli is as reported in the December 2002 NODA, and is based on the 1: 1000 dilution data set. Comment No. Docket ID Docket Part Comment Response Notes 49 See also response to Comment 24 ( Docket ID I D1.001,

Part 03) for a discussion of a consistent data set ( i. e., one associated with the same dilution) being used for both log reduction and comparability study purposes.

See response to Comment 12 ( Docket ID I F. 021, part 10) concerning the 25: 75 split guideline.

39 ID1.002 11   EPA has revised the log reduction following chlorine pretreatment for sample number 990025A. For this experiment the bacterial concentration used to compute log reductions following chlorine treatment was drawn from a different dilution of the   original sample  titration performed on 1/ 13/ 99. However, the testing laboratory generated a different bacterial concentration for the 500 fold dilution employed in the disinfection experiment conducted one day later ( approximately 30% lower). Nonetheless, EPA used the original, 24 hour old titer in recomputing the log reduction presented in Table 2. Because the actual data is available for the specific dilution used in the experiment ( 1: 500), this data should be used rather than the data drawn from the original assay of the wastewater isolate ( 3.2 log10).

  EA has revised the log reduction following chlorine pretreatment for sample number 990052A. For this experiment the bacterial concentration used to compute log reductions following chlorine treatment was drawn from a different dilution of the   original sample  titration performed on 1/ 20/ 99; however, the disinfection experiment using diluted wastewater was apparently conducted one month later ( 2/ 20/ 99). If this is the case, use of the one month old original titer is completely inappropriate as the microbial concentration in the wastewater will fall appreciably over one month regardless of the storage condition. If the dates are indeed incorrect on the bench sheets, and the true date of the experiment is 1/ 20/ 99, the actual E. coli data indicated for the 1,250 fold dilution of wastewater should be used to compute the pre disinfection titer of test microorganisms ( 1x102 CFU In response to the comments suggesting that it was somehow improper for EPA to calculate the log reductions by using an inferred figure as described in the December 2, 2002 NODA, see response to Comment 25 ( Docket ID I D1.002 part 04) regarding the use of bacterial densities determined from the original density determination.

For an explanation of the time between the initial bacterial density determination of the sample, and the chlorination of the diluted sample for sample 990052A,

see response to Comment 24 ( Docket ID I D1.001 Part 03). See also Attachment 1.

The commenter suggests that the post dilution E. coli measurement ( for the 1250 fold dilution of wastewater)

should be used as the predisinfection density to determine the chlorine stress log reduction. In response to this comment, see response to Comment 25 ( Docket ID I D1.002 part 04) regarding the use of bacterial densities determined from the original density determination. Comment No. Docket ID Docket Part Comment Response Notes 50 per mL in the 1: 1,250 dilution, which would correspond to a log reduction of 1.7 log10. This reduction fails to meet the ATP criterion specified in section <IP_ADDRESS>. Further clarification is needed from the independent testing laboratory to verify the actual date of experimentation. Data from sample 990052A should not be used by EPA in support of product approval.

  EPA has revised the log reduction following chlorine pretreatment for sample number 990095A. No log reduction is presented for E. coli despite the fact that the bench sheet for this sample indicates mFC counts of 9 and 4 for the samples where 1.0 mL and 0.1 mL were plated, respectively. If the 0.1 mL sample is used, a viable titer of 400 CFU/ 100 mL can be computed and then used to compute the log reduction following chlorine treatment. Using the equation presented by EPA in the December 2, 2002 FR notice the log reduction would then be 1.5 log10 which fails to meet the ATP criterion.

Also, it appears that incorrect numbers were used for the chi square analysis. The dilution used for the E. coli experiments was 1: 3,000; however, the chi square tables used the splits from the 1: 7,000 dilution. The chi square should be recomputed using splits of 14: 6 and 7: 13 rather than 14: 6 and 12: 8. EPA and the independent testing laboratory should discuss the missing data and present the corrected bench sheets for external review before proceeding. The testing laboratory should also provide the missing data for the bench sheet ( dates of testing,

microbial concentrations, initials of technicians involved in the testing and documentation effort). In the absence of further clarification, data generated from sample 990095 should not be considered in support of product approval.  In response to the comment suggesting that sample 990052A failed to meet the 3 to 4 log reduction criterion, see response to Comment 12 ( Docket ID IF 021, Part 10) concerning the log reduction results.

The commenter observed that no E. coli log reduction was presented for sample 990095A in the December 2,

2002 NODA although data on the density of bacteria in diluted wastewater used in the chlorination experiment was available. The commenter also mentions that the log reduction from sample 990095A is 1.5 if the prechlorination density determination is used.

While EPA considered the approach suggested by the commenter ( i. e. use the measured pre chlorination value)

EPA decided that it would be more consistent to apply the same methodology for calculating log reductions to each sample. This approach was used by EPA in the calculation of log reduction results presented in the December 2002 NODA. Since an initial density determination for mFC was not available for sample 990095, the log reduction could not be calculated using EPA s standard approach; thus, log reduction for this sample was reported as NA.

The commenter states that incorrect numbers were used for the chi squared analysis. EPA notes that E. coli comparability studies were performed using dilutions of both 1: 3000 and 1: 7000. Data associated with the 1: 7000 dilution was used in EPA s statistical analysis.

Since a log reduction was not reported for this study,

there is no issue of inconsistency between log reduction and chi squared data sets. Thus, EPA stands by its decision to use the 1: 7000 data set. See also the response to Comment 13 ( Docket ID I D1.001, Part 04)

for additional detail concerning this comment. Comment No. Docket ID Docket Part Comment Response Notes 51   EPA has revised the E. coli log reduction following chlorine pretreatment for sample number 9900217A. Again, the log reduction following chlorination was computed using the concentration of E. coli assayed in the wastewater isolate ( albeit more than two weeks after receiving it!). The recomputed log reduction presented in Table 2 is 2.8 log10 but should instead be 1.1 log10 ( the actual datum for the 1: 800 dilution used in the disinfection experiment should be used rather than the original titer from a different dilution of the wastewater isolate). The recomputed log reduction fails to meet the ATP criterion presented in section <IP_ADDRESS>. The bench sheet is also missing QC data including the date of experimentation and researcher initials. Finally, the data violate the 25: 75 rule in that 17 negatives and 3 positives were observed for E. coli under the reference method. Data generated from sample 9900217A should not be considered in support of product approval.

  EPA has revised the log reduction following chlorine pretreatment for sample number 990273A. The recomputed log reduction utilized the data generated from the original enumeration of the E. coli counts in the sample received on 3/ 19/ 99. However, the actual disinfection experiment was carried out three weeks later on 4/ 8/ 99 and resulted in a predisinfection concentration of 400 CFU/ 100 mL in the 1: 80 The commenter points out that data are missing from the log sheets. See response to Comment 28 ( Docket ID I. D1.002, Part 13) concerning incomplete bench sheets.

The missing data were not critical to EPA s evaluation of the method.

The commenter observes that the log reduction calculation for sample 990217A was based on the bacterial concentration in the initial density determination of the original sample. See response to Comment 25 ( Docket ID I D1.002, Part 04) regarding EPA s consistent use of this approach. Concerning the comment that the chlorine stressing of the bacteria occurred more than 2 weeks after the initial density determination, this is addressed in the response to Comment 24 ( Docket ID I D1.001 Part 03). In reference to the comment about the log reduction failing to meet the ATP criterion presented in section <IP_ADDRESS> of the ATP protocol, see response to Comment 1 ( Docket ID I D1.001, Part 06) concerning EPA s use of the ATP protocol as guidance.

The commenter points out that data are missing from the log sheets. See response to Comment 28 ( Docket ID I. D1.002, Part 13) concerning incomplete bench sheets.

The commenter points out that the comparability study data for sample 990217A violate the 25%: 75% split guideline. See response to Comment 12 ( Docket ID I F 021, Part 10) concerning the 25%: 75% split guideline.

The commenter observes that the log reduction calculation for sample 990273A was based on the bacterial concentration in the initial density determination of the original sample. See response to Comment 25 ( Docket ID I D1.002, Part 04) regarding EPA s consistent use of this approach. Concerning the comment that the chlorine stressing of the bacteria Comment No. Docket ID Docket Part Comment Response Notes 52 dilution. The correct log reduction should be 1.6 log10 which fails the ATP criterion. Moreover, it would be incorrect to use the initial titer of E. coli determined upon receipt of the wastewater isolate because this sample was received three weeks prior to the actual disinfection experiment. It would be incorrect to assume that the E. coli concentration in this isolate would remain stable for three weeks and hence any computations that would blend three week old data with fresh determinations of chlorinated test microorganisms should be considered highly suspect. Data generated from this sample should not be considered in support of product approval.

  EPA has revised the log reduction following chlorine pretreatment for sample number 990438A. As before, the log reduction should be computed using the actual sample dilution used for the chlorine injury experiments. Therefore, the mFC count for the 10 mL sample from the 1: 200 dilution ( 1 CFU)

should be used in computing the log reduction. However, it is unclear from the bench sheet how the dilution factors would be used because a different dilution was employed for the postchlorinated sample ( 1: 1,000). If the dilution inconsistencies are typographical errors, then the true log reduction would be 0.7 log10, which fails the ATP criterion. The testing laboratory should provide clarification of the true concentration of E. coli in the disinfected sample and should recompute the log reduction before final external review of the data. Regardless,

the initial titration from the wastewater isolate should not be used to compute the log reduction. Because the date of the E.

coli assays are not indicated in the comparability bench sheets, it is not clear if the same inconsistency exists as was pointed out previously for the total coliform tests on this sample. Without further clarification, data generated from sample 990438A should not be considered in support of product approval.  occurred 3 weeks after the initial density determination,

this is addressed in the response to Comment 24 ( Docket ID I D1.001 Part 03). In reference to the comment about the log reduction failing to meet the ATP criterion presented in section <IP_ADDRESS> of the ATP protocol, see responses to Comment 1 ( Docket ID ID1.001 Part 06) and Comment 3 ( Docket ID I D1.005,

Part 02) concerning EPA s use of the ATP protocol as guidance.

For sample 990438A, the commenter notes that the log reduction calculation should be based on the prechlorination density of bacteria determined after the sample was diluted rather than using the initial bacterial density from the original sample for the log reduction calculation. With regard to this comment, see response to Comment 25 ( Docket ID I D1.002, Part 04) regarding the use of bacterial densities determined from the original density determination.

Per the commenter s observation concerning a potential typographical error in the dilution values identified in the bench sheets for sample 990438A, EPA has reviewed those bench sheets further. EPA notes that the dilution factor associated with the diluted E. coli sample measurement ( part 2 of the worksheet) and the comparability study results is 1: 200, while that listed for the post chlorination measurement ( part 5 of the worksheet) is 1: 1000. The dilution identified in part 6 of the worksheet was originally listed as 1: 1000, but this was crossed out and replaced with 1: 200 ( and initialed by the analyst). One of these figures is apparently an error,

and it appears more likely that 1: 200 is the correct value,

though EPA cannot be certain. Accordingly, EPA examined the impact of the different figures on log Comment No. Docket ID Docket Part Comment Response Notes 53 reduction. EPA did so by substituting a 200 fold dilution into the log reduction calculation in place of the 1000 fold dilution originally used; doing so resulted in a log reduction of 3.4 ( versus the 2.7 log reduction associated with a dilution of 1: 1000). This minor change in log reduction has no impact on EPA s assessment of the method as both values are acceptable. See also the response to Comment 12 ( Docket ID I F. 021, Part 10)

concerning the log reduction criterion.

Concerning the comment on the missing date on the comparability study bench sheet for E. coli for sample 990438A, see response to Comment I. D1.002, Part 13 concerning incomplete bench sheets and response to Comment 24 ( Docket ID I D1.001, Part 03).

40 ID1.002 14   In the previous ( April 2002) review of the data submitted by CPI a number of concerns over the irregular presentation of false positivity and false negativity rates were brought to EPA s attention. For total coliforms the false positivity rate ranged from 2% ( Federal Register notice of March 7, 2002) to 5%

( 08/ 15/ 01 memorandum from C. Woodruff submitted as part of the docket materials). Although the upperbound of these two figures ( 5%) may be considered acceptable by EPA standards, the inconsistency in the presentation of the different rates calls for verification by the manufacturer, especially if neither figure is correct. Similarly the false positivity rates for E.

coli ranged from 0.0% ( Federal Register notice of March 7,

2002) to 17.8% ( 08/ 15/ 01 memorandum). Which number is correct, and where are the supporting data available to substantiate these claims?  Specificity data are part of the data generally reviewed by EPA for evaluation of applications for new ATP tests and, therefore, satisfactorily documented specificity data are generally submitted as part of the ATP evaluation.

EPA included a variety of information concerning false positive and false negative rates ( i. e., specificity) in the public record. In response to public comments concerning specificity, EPA reviewed that information and concluded that the specificity results best supported by the data in the public record are those collected by the Georgia Department of Natural Resources ( false positive rates of 5% and 18% for total coliforms and E.

coli, respectively, and false negative rates of 0% for both).

EPA notes that additional, and perhaps more current,

specificity information may be available through CPI,

developers of Colitag   . EPA does not have a specific standard for acceptable false positive and negative rates;

however, the values determined by the Georgia Department of Natural Resources are consistent with the range of results produced by other EPA approved methods. See, also, response to Comment 41 ( ID IF 004, Part 05).

41 I F. 004 05 4. Colitag   ' s specificity data are not scientifically valid In response to the comment s suggestion that CPI s Comment No. Docket ID Docket Part Comment Response Notes 54   It appears that CPI submitted several sets of data without detailed description regarding what samples were used and how the experiments were conducted to determine the specificity of the Colitag   medium.

  In the communication from Mr. Jim Knight of CPI to Mr.

Robert Bordner of the USEPA dated March 2, 1999, it is claimed that Colitag   has a false positive error of 1.33% and a false negative error of 0% for total coliforms and 2.2% false positive error and 1.4% false negative error for E. coli. There was no information on whether these data were derived from the ATP Comparability Study performed by BioVir Laboratories ( that does not appear to be the case since there is no data in BioVir's raw data set) or from testing with a particular sample types and how these were determined. In a communication from Mr. Bordner of the USEPA to CPI ( dated September 15,

1998), it appears that CPI also submitted two sets of specificity data ( note: these data were collected by the Georgia Department of Natural Resources in March and June, 1998). These two sets of data were combined, because it was concluded that those data were insufficient independently to establish that the false positive errors for Colitag   were 5% ( 7/ 140) for total coliforms and 17.8% ( 25/ 140) for E. coli and that the false negative errors were 0% for both total coliforms and E. coli. It is important to note that all these data were different from what has been published in Federal Register ( Vol. 67, No. 45; March 7, 2002) for public comments. Those data shown in the published proposed rule suggest that Colitag   has a false positive error of 2.0% for total coliforms and 2.0% for E. coli and false negative rates of 0% for both total coliforms and E.

coli. The question is how these data were obtained and what the relationship is between this set of data and the submitted data on Colitag   ' s specificity.

  In addition, it is critical to understand whether the 0% false negative errors for both total coliforms and E. coli as shown in the published proposed rule for Colitag   were determined by using samples containing bacteria that are stressed or injured. specificity data are inconsistent/ incomplete ( and therefore not scientifically valid), EPA has concluded that, among the data in public records, that collected by Georgia Department of Natural Resources ( GDNR)

represents the most appropriate specificity data for Colitag   . GDNR followed an approved study plan,

and the data produced by their study were reviewed by EPA and found to be acceptable. The other specificity data the commenter refers to are not as well documented, and EPA is not relying on these data to reach a decision concerning Colitag   . See also the response to Comment 40 ( Docket ID I D1.002, Part 14)

concerning the specificity data.

EPA notes that the target bacteria in the specificity study are not required to be stressed, because the specificity determination only considers correct identification of target bacteria, and is separate from considerations of detecting stressed bacteria. Comment No. Docket ID Docket Part Comment Response Notes 55 Ideally, the specificity of a proposed method for total coliforms and E. coli is determined through a formal USEPA ATP procedure. Therefore, false negative errors of the proposed method are determined by using spiked water samples that have been chlorinated to reduce the target bacteria ( i. e. total coliforms and E. coli) by 3 4 Log10.

  It is our position that these questions raised here need to be addressed. Otherwise, Colitag   ' s specificity data as published in Federal Register are not scientifically valid.

42 I F. 021 06 Detailed review comments   Colitag   presence/ absence method for detection of coliforms and E. coli Section 2: Summary of Method   § 2.2: It would be more appropriate to present experimental data in support of the product performance claims rather than to refer obliquely to a poster presentation that includes material that has not been processed through rigorous peer review and that is unavailable for review in the context of the USEPA approval process. Is the material from the poster presentation available for review? If so, where can it be found?

  § 2.3: See comment from § 2.2. Performance claims, including the comment that optimized recoveries occur as a function of increased pH, should be accompanied by robust supporting data ( peer reviewed or other) or should be eliminated altogether.  The additional information cited by the commenter ( poster, performance claims of optimized recoveries due to increased pH) is beyond the scope of EPA s method evaluation process, and was not considered in EPA s decision.

43 I F. 021 09 Section 17: Tables, Diagrams, Flow Charts, and Validation Data   False pos: The false positivity rates for total coliforms and E. coli computed in Tables 17.1 and 17.22 are 1.33% and 2.2%,

respectively. Rates reported in the Federal Register Notice of March 7, 2002, are 2.0% and 2.0%. Is supporting documentation available to account for the differences in the performance data?

  False neg: Similarly, the false negativity rates from Tables 17.1 and 17.2 for total coliforms and E. coli are 0% and 1.4%, As explained in the responses to Comment 40 ( Docket ID I D1.002, Part 14) and Comment 41 ( ID I F. 004,

Part 05) the specificity results best supported by the data in the public record are those collected by the Georgia Department of Natural Resources. None of the alternative figures for false positive and false negative rates were derived from studies that followed approved study plans, were reviewed by EPA and have full documentation, in contrast to the Georgia Department of Natural Resources data. Comment No. Docket ID Docket Part Comment Response Notes 56 respectively. The Federal Register Notice of 03/ 07/ 02 indicates rates of 0% for both microbial groups. How can these differences be reconciled?

44 I F. 022 02 Colitag     USEPA has proposed Colitag   , manufactured by CPI International, for approval for total coliform and E. coli.

Information and data obtained from USEPA regarding the ATP comparability data for Colitag   submitted for its consideration of approval for use in detecting total coliforms and E. coli in drinking water was reviewed. There was no comprehensive report prepared to explain exactly what was done in these studies. A series of letters and miscellaneous data sets had to be interpreted. Hence, it is unclear whether the USEPA ATP Protocol was followed. Based on this information, the following comments are offered: EPA reviewed the information provided for Colitag   and concluded that it was sufficient upon which to base a decision. A study plan was prepared, reviewed and executed, and study results were extensively reviewed by EPA. See also the response to Comment 2 ( Docket ID I D1.002, Part 15).

The report recommended by the commenter is beyond the scope of EPA s method evaluation process.

Although the information submitted by CPI is not consistent with the ATP protocol guidelines in every respect, it was sufficient for EPA to conclude that Colitag   performs in a manner comparable to the reference methods. See response to Comment 1 ( Docket ID I D1.001, Part 06).

45 I F. 022 06 4. The Federal Register notice indicates that the method has a false positive error of 2.0 % for total coliforms and 2.0 % for E.

coli and false negative rates of 0 % for both total coliforms and E. coli. However, the data supporting these statements could not be found in the docket. The correspondence and documentation state different results, and false positive results as high as 5 % for total coliforms and 17.8 % for E. coli have been reported. The scientific basis for the specificity data for this method must be provided for public comment and clearly explained. See the responses to Comment 41 ( Docket ID I F. 004,

Part 05) and Comment 40 ( Docket ID I D1.002, Part 14 concerning the appropriateness of the specificity data.

46 I F. 022 08 6. A well documented report is needed that describes the various studies that were conducted, which data was used in the analysis, and that documents how the USEPA ATP Protocol was followed.  EPA requests certain data from manufacturers to determine if a new coliform method should be approved for drinking water analysis. EPA does not specify the format in which this data should be supplied.

EPA determined that the data supplied by CPI met the Agency s needs for evaluating Colitag     s performance.

See also the response to Comment 44 ( Docket ID IF 022, Part 02). Comment No. Docket ID Docket Part Comment Response Notes 57 05 DOCUMENTATION OF Colitag   PROCEDURES ( safety; instrumentation/ equipment/ supplies; quality control measures; calibration;

incubation temperatures and times; shelf life)

47 ID1.001 05   7. Data obtained at 44.5 C is irrelevant, since the method is proposed for 35 C incubation.  The commenter refers to data included in the December 2002 NODA for informational purposes, but not considered by EPA in its evaluation of method comparability between Colitag   and the reference methods. EPA did not rely on this information in deciding to approve the Colitag   method. As such, the comment does not impact the Agency s decision.

48 I F. 004 07   6. Colitag   requires clear definition of the starting incubation temperature

  Colitag   ' s insert [ section 11.0] submitted by CPI to the USEPA claims that the medium and samples must be equilibrated to room temperature ( 24 30 ° C) in order to produce specified results. As demonstrated in ReadyCult's data, the starting temperature could have profound impact on the accuracy of a liquid culture method. It is critical to clearly define this starting temperature requirement and the required ramp up time from 2 8 ° C to this starting incubation temperature including the mechanism, i. e. air circulated incubator or water bath.  The commenter suggests that the starting temperature of incubation could have a profound impact on the accuracy of a liquid culture method. Incubation temperature is generally important for all media, not just Colitag   . To ensure that media are incubated at the proper temperature, EPA has included guidance in the Manual for the Certification of Laboratories Analyzing Drinking Water on how to ensure that samples are incubated at the proper temperature in air incubators.

EPA requires that certified drinking water laboratories be used for compliance monitoring analyses; a certified laboratory was also used to perform the Colitag   comparability studies. In both cases, the expectation is that such laboratories will follow the procedures specified in the aforementioned manual.

49 I F. 006 04 o   Time the Test Requires [ both Colitag   and ReadyCult]

  Substantiation of the required incubation time is critical to the accuracy of the test method. Neither the Colitag   nor ReadyCult tests substantiate its incubation time. This lack of substantiation can lead to a lack of sensitivity that will adversely affect public health protection. The ATP clearly requires this substantiation.

  Colitag   : While the Colitag   test states that it is to be incubated for 24 hours, plus or minus 2 hours, there is no information presented at 22 or 26 hours incubation. In effect,

the Colitag   test claims a 22 hour incubation; substantiation is The commenter suggests that substantiation is required for the incubation time to assure the accuracy of the test method. The ATP comparability study was done for 24 hours at the specified temperature and yielded results comparable to the reference methods. As such, the acceptability of the incubation time was substantiated for Colitag   .

EPA believes that the +/ 2hr range associated with the incubation time is reasonable and is consistent with methods previously approved, including the reference methods for multiple tube fermentation. This is because bacterial growth on different media where growth is Comment No. Docket ID Docket Part Comment Response Notes 58 essential.  adequate in 24 hours would not be expected to differ to any substantial extent between the media at 22 or 26 hours. In EPA s experience with coliform methods,

when a positive result is visible at 24 hours, bacterial growth rates are such that the results are generally observable at 22 hours. Similarly, when bacterial growth is observed at 24 hours, such bacteria continue to be observable at 26 hours.

50 I F. 021 05  ( 4) No details are provided on the experimental studies conducted in support of the contention that Colitag   can be stored in the long term without an adverse impact on product performance. If these data are available, they should be presented along with interpretive material so that the reagent is not used beyond its defined expiration date.  EPA has not taken any action approving or disapproving the long term storage performance of Colitag   . The additional information cited by the commenter is beyond the scope of EPA s method evaluation process and does not impact the Agency s decision.

51 I F. 021 08 Section 5: Safety § 5.2: The manufacturer references Standard Methods for the Examination of Water and Wastewater, 20th edition, but offers the publication date of 1992. The 20th edition was published in 1998 and should be referenced as such.

Section 6: Instrumentation, Equipment and Supplies § 6.3: Handling of glassware and containment vessels is practiced according to guidelines established in Standard Methods. The guidelines in Standard Methods are rigorous and include multiple wash steps ( minimum of 6) and challenge experiments using live cultures of E. aerogenes to establish that vessels do not leach bacteriostatic, nutritive or cytotoxic compounds following repeated autoclaving. The manufacturer suggests in this section that vessels were washed with detergent,

rinsed a single time with tap water, rinsed with reagent water and then sterilized by autoclaving. If the rigorous procedures defined in Standard Methods were in fact used, then this practice should have been stated explicitly. If other procedures were followed, such as those provided in the USEPA Alternative Testing Protocol, they should similarly be stated explicitly. The comment suggesting an error in the publication date for Standard Methods is beyond the scope of EPA s method evaluation process and does not impact the Agency s decision.

The comment suggesting that more information should have been provided on glassware handling is beyond the scope of EPA s method evaluation process and does not impact the Agency s decision. Comment No. Docket ID Docket Part Comment Response Notes 59 Section 7: Reagents and Standards § 7.1 The Colitag   product is described as stable when stored at 25 30 ° C away from light, but no shelf life is described.

For how long can this reagent be stored? Is supporting documentation available to substantiate shelf life stability claims? Section 8: Sample collection, dechlorination, preservation,

shipment and storage § 8.1.1 The description of sample collection bottles is inadequate; sample bottles must not leach cytotoxic, nutritive or bacteriostatic components and must be tested as such ( ATP section 3.4.1).

Section 9: Quality Control § 9.0 An oblique reference to Standard Methods is made with regard to quality control that is not entirely consistent with the recommendations in this section. The manufacturer suggests use of three control tubes, with the first used as a blank, the second used as a ' positive' control and the third as a ' negative' control. The referenced method found in Standard Methods ( section 9223B) includes multiple controls, where at least one microorganism is E. coli, another is a non E. coli representative from the total coliform group, and the third is a noncoliform, for a total of three microbial controls (' negative control' sample blanks containing no microorganisms would be considered a fourth control). Ambiguous references regarding quality control cultures must by all means be removed from manufacturer protocols and also from all product literature, as they will ultimately confuse the end user.

Section 10: Calibration and Standardization § 10.1 The manufacturer refers to section 9.0 to define acceptable product performance, however, the text in section EPA has not taken any action approving or disapproving the long term storage performance of Colitag   . The information requested by the commenter regarding appropriate storage time is beyond the scope of EPA s method evaluation process and does not impact the Agency s decision.

The comment suggesting that more information on the type of sample collection bottles is necessary goes beyond the scope of EPA s method evaluation process and does not impact the Agency s decision.

The comment suggesting that certain quality control provisions are too ambiguous goes beyond the scope of EPA s method evaluation process and does not impact the Agency s decision.

The comment suggesting that certain text regarding inoculation of microorganisms into culture bottles is inadequate goes beyond the scope of EPA s method evaluation process and does not impact the Agency s Comment No. Docket ID Docket Part Comment Response Notes 60 9.0 is inadequate in describing how test microorganisms should be inoculated into culture bottles. How much culture material should be introduced for control reactions? A loopful? More?

Less? Section 11: Procedure § 11.1.1 Manufacturer protocols indicate that samples to be tested must be equilibrated to room temperature ( 24 30 ° C) prior to addition of Colitag   reagent. How is this done? If samples must be equilibrated to room temperature, and prewarming of samples is a critical variable, should sample temperatures be measured with a thermometer? Would the thermometer then need to be sterile? Will sample holding time become an issue as the laboratorian waits for samples to prewarm? These are nontrivial issues, as typical laboratory practice using chromogenic substrates calls for addition of reagent, mixing,

and then introduction into the incubator without prewarming.

Section 13: Method Performance Characteristics § 13.1 False positivity rates for total coliforms and E. coli are reported in the 08/ 15/ 01 memorandum from C. Woodruff to be 5.0% and 17.8%, respectively. False negativity rates for total coliforms and E. coli are reported to be 0% and 0.0%,

respectively. However, the false positivity and negativity rates reported in the Federal Register Notice of March 7, 2002, are significantly different ( 2% false positivity for total coliforms and E. coli, and 0% false negativity for both groups). Which numbers are correct? Is supporting documentation available to substantiate these numbers?  decision.

The commenter suggests that temperature equilibration to room temperature is required for the incubation time to assure the accuracy of the test method. The procedure for this is described in Manual for the Certification of Laboratories Analyzing Drinking Water.

See also the response to Comment 48 ( Docket ID IF 004, Part 07) concerning incubation temperature.

See responses to Comment 40 ( Docket ID I D1.002,

Part 14) and Comment 41 ( ID I F. 004, Part 05) concerning the specificity data.

52 I F. 022 09   7. Documentation regarding Colitag   ' s incubation conditions is needed, as well as validation of the claimed conditions of 24 +/ 2 hours at 35 +/ 0.5C.  See response to Comment 48 ( Docket ID I F. 004, Part 07) concerning incubation temperature and Comment 49 ( Docket ID I F. 006, Part 04) concerning incubation times.

06 OTHER COMMENTS REGARDING Colitag   PERFORMANCE ( substrates allegedly susceptible to hydrolysis; color of solution; Aeromonas interference) Comment No. Docket ID Docket Part Comment Response Notes 61 53 ID2.001 03   My second issue relates to the actual performance of Colitag   .

As part of my company role, we are involved in giving advice to water companies with respect to the use of alternative technologies as they become available. As such we have carried out a limited study of Colitag   in comparison to some other methods. Our experiences are as follows:

1. Approximately 5% of the Colitag   pieces that we encountered had " caked" meaning that water had found its way into the material. The substrates used in these types of products are susceptible to hydrolysis and thus these 5% may have given false negative results. They were not incidentally used in our study.

2. When dissolved the Colitag   product gives a straw colored solution. After incubation this makes discrimination between the original color and a positive result extremely difficult,

particularly if the reaction is weak which it often is at the minimum incubation period. This can lead to both false positive and false negative results unless confirmatory steps are included.

3. When tested with waters containing beta galactosidase producing Aeromonas spp, the Colitag   product has absolutely no inhibition of these organisms. This could be predicted based on the formulation of the product. Indeed during our initial studies all samples which contained glactosidase producing Aeromonas ( even at levels as low as 1 per milliliter) gave a positive result irrespective of the presence of coliforms. Clearly this is completely unacceptable and does little to protect public health. In small communities ( whether in the US or elsewhere)

and in less affluent countries these type of results will lead to confusion and perhaps unnecessary expenditure or other public health measures.  The data in the public record are based on a comparability study plan developed based on the ATP protocol; reviewed and approved by EPA; and executed by an independent, certified laboratory. While EPA appreciates the commenter s insight based on their   limited study,  the Agency does not have adequate information to assess the quality of the data from such study. Accordingly, EPA will rely on the results of the more complete, aforementioned comparability study.

Commenter s concerns regarding   caking  and   straw colored  solution are beyond the scope of EPA s method evaluation process and do not impact the Agency s decision.

EPA further notes the   caking  and the   straw color

suggested by the commenter have not otherwise been identified as issues, nor do they appear to have impacted the successful performance of the aforementioned comparability studies. The potential false negative problem suggested by the commenter was not observed in the comparability study results.

EPA acknowledges that Aeromonas occurs commonly in ambient waters. EPA further notes that potential interference by Aeromonas is not unique to the Colitag   method; at least one coliform method previously approved by EPA has had the same potential for this interference. Based on the judgement of EPA s microbiology experts, however, and based on the false positive and false negative data discussed in the response to Comment 40 ( Docket ID I D1.002, Part 14), EPA determined that this was not a significant concern; the Colitag   method performance was comparable to that of the reference methods, as documented by the results of the comparability study. Comment No. Docket ID Docket Part Comment Response Notes 62 54 I F. 021 07   Section 4: Interferences § 4.1 The manufacturer reports no known interferences in drinking water or source water that may interfere with product performance, however, no supporting data are presented to substantiate this claim. Is it appropriate to accept this contention in the absence of supporting data?  The issue of potential interferences raised by the commenter is generally outside the scope of EPA s method evaluation because EPA experts who evaluate alternative coliform methods generally have not included interferences in the factors to be considered. Moreover,

EPA notes that the Agency did not observe evidence of any interferences in its evaluation of the study results.

07 SOURCE WATER DATA ( lacks data to support approval for source water applications)

55 I F. 004 06   5. Colitag   lacks sufficient data for source water Colitag   lacks sufficient data to support its proposed approval for source water application. Only a limited amount of data ( 23 data points) collected from Oct. 1994 to April 24, 1995 may be relevant for Colitag   ' s approval for source water application.

And there is no detailed description regarding how the study was performed and how the data were interpreted ( no statistical analysis of data). Also, the comparative evaluation of a proposed method against a reference method for source water application needs to be performed in a quantitative manner in order to accurately assess the equivalency between these two methods.

It is not clear whether the specificity data presented in Tables 17.1 and 17.2 represent the specificity of Colitag   in drinking water or source water. This is again due to the lack of a welldocumented report to describe what types of samples were used to derive these data. If the specificity data presented in Tables 17.1 and 17.2 were part of the data derived from the study from Oct. 1994 to April 24, 1995 and these data were used to determine the specificity of Colitag   for drinking water application then this is scientifically inappropriate. The specificity of a proposed method for drinking water application should be determined using a drinking water matrix, preferably following the USEPA ATP protocol and for source water application should be derived from testing with source water samples.

Based on the aspects mentioned above, we believe that Approval of Colitag   is only being sought for drinking water, not source water. Therefore, data for source water was not necessary for EPA to evaluate Colitag     s applicability for drinking water.

The Georgia Department of Natural Resources specificity study was completed using drinking water spiked with target bacteria. EPA experts evaluated the specificity data presented for Colitag   , and found it acceptable to support the use of Colitag   in drinking water applications because the Colitag   satisfactorily detected the target bacteria and did so in a manner comparable to the reference methods. EPA experts concluded that this experiment satisfactorily determined Colitag     s specificity for drinking water. Comment No. Docket ID Docket Part Comment Response Notes 63 Colitag   should not be approved for detecting total coliforms and E. coli in source water.

56 I F. 022 07   5. Data is insufficient to support approval of Colitag   for source water monitoring. Details concerning how the 1994 to 1995 study was performed and how the data were interpreted was not found in the docket and must be provided for public comment.  Approval of Colitag   is only being sought for drinking water, not source water. See also the response to Comment 55 ( Docket ID I F. 004, Part 06).

08 OTHER COMMENTS 57 ID1.003 02   I/ we have some information about Japanese situations per docket ID OW 2002 0031 that was the US EPA s request for additional information.

JWWA( Japan Water Worker s Association) has finished the comparison study about new  formation mediums ( for the detection kit of total coliforms and E. coli in drinking water)

,2( more) years before. At that time, MMO MUG medium ( Colilert) and LB BGLB medium were used for the standard medium.

After this comparison study, they published a new edition of   Standard Test Methods for Drinking Water  at Oug. 23,2001.

And they approved new 3 mediums on this book.

Also, this book is the only one standard procedure that was published in Japan.

The new 3 formulations were following.

1. ONPG MUG medium with IPTG ( named   Colitag     )

2. Xgal MUG medium ( named   Fluorocult LMX Broth )

3. Xgal MUG medium with Pyruvic Acid ( named   EC Blue )

The summary of the comparison study s results ( the details were explained on this book) was following.

1. From   the comparison test of the sensitivity study using standard strain , there has no problems ( about the sensitivity). EPA appreciates the comment, however the data presented from Colitag     s comparability study , and included in the public record, is being used as the basis for EPA s judgement on the acceptability of Colitag   as an alternate drinking water coliform method. None of the information presented by this comment suggest that Colitag   is inappropriate for the purposes described in today s rule; rather, they point to the apparently successful use of Colitag   in Japan. Comment No. Docket ID Docket Part Comment Response Notes 64 And also, has no problems about   the influence of the coexistence strains .

2. From   the comparison test of the sensitivity study suing standard strain that was treated by Chlorine , Colitag   and ( Xgal MUG with Pyruvic Acid)>= MMO MUG> Xgal MUG 3. From   the comparison test of the sensitivity study using source water for drinking water ( 15 surface water, 4 lake water and 4 underground water: those were sampled from 23 sections ( the whole country of Japan)) treated by Chlorine ,

Colitag   ( cultivate: 36' C, 24hr.)>

MMOMUG cultivate: 36' C, 24hr).>=( Xgal MUG with Pyruvic Acid: cultivate: 36' C, 24hr.)>= Xgal

MUG( cultivate: 36' C, 48hr.)>= LB BGLB> Xgal

MUG( cultivate: 36' C, 24hr.)

4. From   the comparison test of the sensitivity study using source water for drinking water ( 15 surface water, 4 lake water and 4 underground water: those were sampled from 23 sections ( the whole country of Japan)) no treated ( raw) water , ( Xgal

MUG with Pyruvic Acid: cultivate: 36' C, 24hr.)>= Colitag   ( cultivate: 36' C, 24hr).> Xga l MUG( cultivate: 36' C, 48hr.)>=

MMOMUG cultivate: 36' C, 24hr).> Xgal

MUG( cultivate: 36' C, 24hr.)>= LB BGLB If you want to know more details, please check this book on p.

641 626 and guide book on p. 841 843.

After the publishing of this new edition of   Standard Test Methods for Drinking Water  at Oug. 23,2001, a few ministry agreed to usage of those new mediums for the quality test of the drinking water and source water for drinking.

Anyhow, depending of this time s approval study and the publishing of this new edition, testing laboratory s workers can extend of there s choice for these kinds of test.

Lastly, Colitag   and the other new( 2) mediums were used on many testing laboratory ( official and public lab), in allover Comment No. Docket ID Docket Part Comment Response Notes 65 Japan, alaready. And extend the marker share instead of MMOMUG medium and LB BGLB.

Because, those mediums were formed with the well known chemicals those were confirmed about safety and usefulness.

And, the usefulness about there s performance was recognized by JWWA.

[ P. S.]

If EPA or someone has some safety information and truecomponent and/ or MSDS about   Solanium , please let me know about this.

58 ID2.001 04   An additional note, a colleague attempted to purchase more Colitag   to extend our study but was told that it would not be available until after the deadline for submission of comments to EPA. I find that statement worrying and wonder about the rationale for it!!  This issue is neither related to the scope of the March 2002 proposal nor the December 2002 NODA. This comment has no bearing on EPA s decision to approve the Colitag   method.

59 ID2.002 02   In an evaluation of Colitag   vs. Colilert, using mEndo and mTEC as control methods, I found Colitag   have a 19%

failure rate in recovery and identification of both E. coli and total coliform. I have attached my data file for your examination.  The data in the public record is based on a comparability study plan developed based on the ATP protocol;

reviewed and approved by EPA; and executed by an independent, certified laboratory. While EPA appreciates the commenter s insight based on their evaluation, the Agency will rely on the results of the more complete, aforementioned comparability study.

The Agency does not have adequate information to assess the quality of the data from the evaluation the commenter cites, nor does EPA know the details of how the commenter s evaluation was performed. EPA notes that the method comparability study data did not show evidence of the suggested failure rate, since the results of the Colitag   comparability study were not statistically different from those of the reference methods. See also the responses to Comment 40 ( Docket ID I D1.002,

Part 14) and Comment 41 ( Docket ID I F. 004, Part 05)

concerning specificity data. 66 67 Notes I F: comments from the March 2002 proposed rule I D: comments from the December 2002 NODA Contents 01 RECOMMENDATIONS REGARDING EPA APPROVAL OF Colitag   , page 2 02 LENGTH OF COMMENT PERIOD/ RESPONSIVENESS TO COMMENTS, page 7 03 EPA'S ALTERNATE TEST PROCEDURES ( ATP) PROGRAM, page 9 03.01 Adherence to Specific ATP Guidelines, page 9 03.01.01 Injury level guidelines( 3 4 log goal; recovery rates; alleged math errors; applicability to natural samples), page 15 03.01.02 Sample source guidelines ( spiked samples;

10 geographically dispersed sites), page 24 03.01.03 Replicate and data selection guidelines ( ability to detect 1 10 TC or achieve 25%/ 75% split; replicate analysis on 3 dilutions; lag time/ inferred bacteria densities), page 25 03.01.04 Calculation of Log10/ Chi Squared Analysis, page 34 03.02 General Comments on Adherence to ATP Guidelines ( e. g., claim that protocol must serve as benchmark), page 43 04 DOCUMENTATION OF Colitag   DATA ( e. g., differing false positive/ negative errors cited; use of a poster presentation; documentation of inferences), page 46 05 DOCUMENTATION OF Colitag   PROCEDURES ( safety; instrumentation/ equipment/ supplies; quality control measures; calibration; incubation temperatures and times;

shelf life), page 55 06 OTHER COMMENTS REGARDING Colitag   PERFORMANCE ( substrates allegedly susceptible to hydrolysis; color of solution; Aeromonas interference), page 59 07 SOURCE WATER DATA ( alleged lack of data to support approval for source water applications), page 60 08 OTHER COMMENTS, page 61


[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Proposed Rules]
[Pages 23395-23398]
[FR Doc No: 2018-10795]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2018-0178]
RIN 1625-AA08

Special Local Regulation; Choptank River, Cambridge, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish special local
regulations for certain waters of the Choptank River. This action is
necessary to provide for the safety of life on the navigable waters
located in Cambridge, MD, during a power boat racing event on July 28,
2018, and July 29, 2018. This proposed rule would prohibit persons and
vessels from entering the regulated area unless authorized by the
Captain of the Port Maryland-National Capital Region or the Coast Guard
Patrol Commander. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 20, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0178 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Mr. Ronald Houck, U.S. Coast Guard
Sector Maryland-National Capital Region; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On February 18, 2018, Kent Narrows Racing Association of Chester,
MD, notified the Coast Guard that it will be conducting power boat
races from 9 a.m. until 6 p.m. on July 28, 2018, and July 29, 2018. The
high-speed power boat racing event consists of approximately 60
participants competing on a designated one-mile oval course in the
Choptank River in a cove located between Hambrooks Bar and the
shoreline at Cambridge, MD. Hazards from the power boat races include
risks of injury or death resulting from near or actual contact among
participant vessels and spectator vessels or waterway users if normal
vessel traffic were to interfere with the event. Details of the
proposed event were provided to the Coast Guard at a meeting on April
10, 2018. There it was learned that during past power boat racing
events in the area, large wakes created from transient vessels
operating on the Choptank River west of the Senator Frederick C.
Malkus, Jr. (US-50) Memorial Bridge have caused great concern for event
planners. Such wakes are hazardous to participants as their presence in
the race area would result in injury or death due to vessel capsizing
or collisions among participant vessels during the high-speed races.
Allowing the proposed power boat racing event to proceed without
including these navigable waters within the regulated area would
adversely affect event participants. The Captain of the Port (COTP)
Maryland-National Capital Region has determined that potential hazards
associated with the power boat races would be a safety concern for
anyone intending to participate in this event or for vessels that
operate within specified waters of the Choptank River at Cambridge, MD.
    The purpose of this rulemaking is to protect marine event
participants,

spectators and transiting vessels on specified waters of the Choptank
River before, during, and after the scheduled event. The Coast Guard
proposes this rulemaking under authority in 33 U.S.C. 1233, which
authorizes the Coast Guard to establish and define special local
regulations.

III. Discussion of Proposed Rule

    The COTP Maryland-National Capital Region proposes to establish
special local regulations to be enforced from 8:30 a.m. until 6:30 p.m.
on July 28, 2018 and July 29, 2018. This special local regulation would
include navigable waters of the Choptank River located between the
Senator Frederick C. Malkus, Jr. (US-50) Memorial Bridge, at mile 15.5,
and Hambrooks Bar Light. The area of the regulated area is
approximately 3,000 yards in length and 3,000 yards in width.
    The regulated area would include all navigable waters within
Choptank River and Hambrooks Bay bounded by a line connecting the
following coordinates: Commencing at the shoreline at Long Wharf Park,
Cambridge, MD, at position latitude 38[deg]34'30'' N, longitude
076[deg]04'16'' W; thence east to latitude 38[deg]34'20'' N, longitude
076[deg]03'46'' W; thence north across the Choptank River along the
Senator Frederick C. Malkus, Jr. (US-50) Memorial Bridge, at mile 15.5,
to latitude 38[deg]35'30'' N, longitude 076[deg]02'52'' W; thence west
along the shoreline to latitude 38[deg]35'38'' N, longitude
076[deg]03'09'' W; thence north and west along the shoreline to
latitude 38[deg]36'42'' N, longitude 076[deg]04'15'' W; thence
southwest across the Choptank River to latitude 38[deg]35'31'' N,
longitude 076[deg]04'57'' W, terminating at the Hambrooks Bay
breakwall. This rule provides additional information about designated
areas within the regulated area, including a ``Race Area,'' ``Spectator
Area'' and ``Buffer Zone,'' and the restrictions that apply to
mariners. The duration of the regulated area is intended to ensure the
safety of event participants and vessels within the specified navigable
waters before, during, and after the power boat races, scheduled to
occur 9 a.m. through 6 p.m. each day. Persons and vessels desiring to
transit, moor, or anchor within the regulated area must obtain
authorization from COTP Maryland-National Capital Region or Coast Guard
Patrol Commander. When authorized to transit the regulated area, all
vessels would proceed at the minimum speed necessary to maintain a safe
course that minimizes wake near the race course. The regulatory text we
are proposing appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive Orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size, location
and duration of the regulated area. Vessel traffic would be able to
safely transit through the regulated area, which would impact a small
designated area of the Choptank River for 20 hours. The Coast Guard
would issue a Broadcast Notice to Mariners via marine band radio VHF-FM
channel 16 about the status of the regulated area. Moreover, the rule
would, when deemed safe to do so by the Coast Guard Patrol Commander,
allow vessel operators to request permission to enter, remain within,
or transit through the regulated area for the purpose of either safely
entering the ``Spectator Area'' or transiting the regulated area at the
minimum speed necessary to maintain a safe course that minimizes wake
near the race course.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a special
local regulation lasting for 20 hours. This category of marine event
water activities includes but is not limited to sail boat regattas,
boat parades, power boat racing, swimming events, crew racing, canoe
and sail board racing. Normally such actions are categorically excluded
from further review under paragraph L61 of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A preliminary Memorandum for
Record is available in the docket where indicated under ADDRESSES. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233; 33 CFR 1.05-1.

0
2. Add Sec.  100.35-T05-0178 to read as follows:

Sec.  100.35-T05-0178   Special Local Regulation; Choptank River,
Cambridge, MD.

    (a) Definitions. (1) Captain of the Port Maryland-National Capital
Region means the Commander, U.S. Coast Guard Sector Maryland-National
Capital Region or a Coast Guard commissioned, warrant or petty officer
who has been authorized by the Captain of the Port to act on his
behalf.
    (2) Coast Guard Patrol Commander means a commissioned, warrant, or
petty officer of the U.S. Coast Guard who has been designated by the
Commander, Coast Guard Sector Maryland-National Capital Region.
    (3) Official Patrol means any vessel assigned or approved by
Commander, Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    (4) Spectator means any person or vessel not registered with the
event sponsor as a participant or an official patrol vessel.
    (5) Participant means any person or vessel participating in the
Thunder on the Choptank event under the auspices of the Marine Event
Permit issued to the event sponsor and approved by Commander, Coast
Guard Sector Maryland-National Capital Region.
    (b) Regulated area. All coordinates reference Datum NAD 1983.
    (1) Coordinates. The following location is a regulated area: All
navigable waters within the Choptank River and Hambrooks Bay bounded by
a line connecting the following coordinates: Commencing at the
shoreline at Long Wharf Park, Cambridge, MD, at position latitude
38[deg]34'30'' N, longitude 076[deg]04'16'' W; thence east to latitude
38[deg]34'20'' N, longitude 076[deg]03'46'' W; thence north across the
Choptank River along the Senator Frederick C. Malkus, Jr. (US-50)
Memorial Bridge, at mile 15.5, to latitude 38[deg]35'30'' N, longitude
076[deg]02'52'' W; thence west along the shoreline to latitude
38[deg]35'38'' N, longitude 076[deg]03'09'' W; thence north and west
along the shoreline to latitude 38[deg]36'42'' N, longitude
076[deg]04'15'' W; thence southwest across the Choptank River to
latitude 38[deg]35'31'' N, longitude 076[deg]04'57'' W, terminating at
the Hambrooks Bay breakwall.
    (2) Race area. Located within the waters of Hambrooks Bay and
Choptank River, between Hambrooks Bar and Great Marsh Point, MD.
    (3) Buffer zone. All waters within Hambrooks Bay and Choptank River
(with the exception of the Race Area designated by the marine event
sponsor) bound to the north by the breakwall and continuing along a
line drawn from the east end of breakwall located at latitude
38[deg]35'27.6'' N, longitude 076[deg]04'50.1'' W, thence southeast to
latitude 38[deg]35'17.7'' N, longitude 076[deg]04'29'' W, thence south
to latitude 38[deg]35'01'' N, longitude 076[deg]04'29'' W, thence west
to the shoreline at latitude 38[deg]35'01'' N, longitude
076[deg]04'41.3'' W.
    (4) Spectator area. All waters of the Choptank River, eastward and
outside of Hambrooks Bay breakwall, bounded by line that commences at
latitude 38[deg]35'27.6'' N, longitude 076[deg]04'50.1'' W, thence
northeast to latitude

38[deg]35'30'' N, longitude 076[deg]04'47'' W, thence southeast to
latitude 38[deg]35'23'' N, longitude 076[deg]04'29'' W, thence
southwest to latitude 38[deg]35'19'' N, longitude 076[deg]04'31'' W,
thence northwest to to and terminating at the point of origin.
    (c) Special local regulations. (1) The Captain of the Port
Maryland-National Capital Region or the Coast Guard Patrol Commander
may forbid and control the movement of all vessels and persons,
including event participants, in the regulated area. When hailed or
signaled by an official patrol, a vessel or person in the regulated
area shall immediately comply with the directions given. Failure to do
so may result in expulsion from the area, citation for failure to
comply, or both.
    (2) The operator of any vessel in the regulated area shall:
    (i) Stop the vessel immediately when directed to do so by any
Official Patrol and then proceed only as directed.
    (ii) All persons and vessels shall comply with the instructions of
the Official Patrol.
    (iii) When authorized to transit the regulated area, all vessels
shall proceed at the minimum speed necessary to maintain a safe course
that minimizes wake near the race course.
    (3) The Coast Guard Patrol Commander may terminate the event, or
the operation of any participant, at any time it is deemed necessary
for the protection of life or property.
    (4) The Race Area is an area within the regulated area defined in
paragraph (b)(2) of this section. The actual placement of the race
course will be determined by the marine event sponsor but must be
located within the designated boundaries of the Race Area. Only
participants and official patrol vessels are allowed to enter the Race
Area.
    (5) The Buffer Zone is an area that surrounds the perimeter of the
Race Area within the regulated area defined in paragraph (b)(3) of this
section. The purpose of a Buffer Zone is to minimize potential
collision conflicts with participants and spectators or nearby
transiting vessels. This area provides separation between the Race Area
and Spectator Area or other vessels that are operating in the vicinity
of the regulated area defined in paragraph (b)(1) of this section. Only
participants and official patrol vessels are allowed to enter the
Buffer Zone.
    (6) The Spectator Area is an area described by a line bounded by
coordinates provided in latitude and longitude that outlines the
boundary of a spectator area within the regulated area defined in
paragraph (b)(4) of this section. All vessels within the Spectator Area
shall be anchored or operate at a no-wake speed while transiting within
the Spectator Area.
    (7) The Coast Guard Patrol Commander and official patrol vessels
enforcing this regulated area can be contacted on marine band radio
VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz). Persons and
vessels desiring to transit, moor, or anchor within the regulated area
must obtain authorization from Captain of the Port Maryland-National
Capital Region or Coast Guard Patrol Commander. The Captain of the Port
Maryland-National Capital Region can be contacted at telephone number
410-576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz).
The Coast Guard Patrol Commander can be contacted on Marine Band Radio,
VHF-FM channel 16 (156.8 MHz).
    (8) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio.
    (d) Enforcement. The Coast Guard may be assisted with marine event
patrol and enforcement of the regulated area by other Federal, State,
and local agencies.
    (e) Enforcement periods. This section will be enforced from 8:30
a.m. until 6:30 p.m. on July 28, 2018, and from 8:30 a.m. until 6:30
p.m. on July 29, 2018.

    Dated: May 2, 2018.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2018-10795 Filed 5-18-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: June 22, 2007 (Volume 72, Number 120)]
[Notices]
[Page 34464-34466]
[DOCID:fr22jn07-57]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2007-0357; FRL-8330-5]

Review of National Dredging Policy

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comments.

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

SUMMARY: On behalf of the National Dredging Team, the U.S.
Environmental Protection Agency (EPA) is requesting comment on the
National Dredging Policy and the National Dredging Team's 2003 Action
Agenda for Dredged Material Management. The National Dredging Policy
was developed by a Federal Interagency Working Group, which was
convened by the U.S. Department of Transportation in the early 1990s to
investigate and recommend methods to improve the dredging review
process. The Group identified the need for a unified national dredging
policy to guide in the development of recommendations and to focus
Federal agency commitments. The findings and principles described in
the National Dredging Policy have been embraced by the Group's
participating agencies. The National Dredging Team (NDT), a Federal
interagency group co-chaired by the EPA and the U.S. Army Corps of
Engineers (USACE), published its Dredged Material Management: Action
Agenda for the Next Decade in 2003. This Action Agenda lays out 22
recommended actions to guide the National Dredging Team and support
implementation of the National Dredging Policy. At the request of the
Cabinet-level Committee on the Marine Transportation System, the NDT is
currently reviewing the National Dredging Policy, as well as the NDT's
Action Agenda, to reaffirm their adequacy in support of the U.S. Marine
Transportation System.

DATES: Comments must be received on or before August 6, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2007-0357, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-
OW-2007-0357.
     Mail: Review of National Dredging Policy, Water Docket,
EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T,
1200 Pennsylvania Ave., NW., EPA West Room 3334, Washington, DC 20460.

     Hand Delivery: Water Docket, EPA Docket Center,
Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC 20004, Attention Docket ID No. EPA-HQ-OW-
2007-0357.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2007-
0357. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov. The

http://www.regulations.gov Web site is an ``anonymous access'' system, which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov, your e-mail

address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Water Docket, EPA Docket

Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC 20004. This Docket Facility is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The Water Docket
telephone number is<PHONE_NUMBER>. The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Water Docket is 202-566-
2426.

FOR FURTHER INFORMATION CONTACT: Molly Madden, Oceans and Coastal
Protection Division, Office of Wetlands, Oceans and Watersheds,
(Mailcode: 4504T), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    Entities potentially interested in today's notice are those who are
involved with dredging for the purpose of navigation or are involved
with waterborne commerce, including port authorities and environmental
interest groups. Categories and examples of entities interested in
today's notice include:

------------------------------------------------------------------------
           Category                 Examples of interested entities
------------------------------------------------------------------------
Federal Government...........  U.S. Army Corps of Engineers, Maritime
                                Administration, U.S. Coast Guard, U.S.
                                Navy, National Oceanic and Atmospheric
                                Administration, Fish and Wildlife
                                Service, U.S. Department of Agriculture,
                                U.S. Geological Survey.
State/Local/Tribal Government  Governments involved in navigational
                                dredging; port authorities; coastal
                                communities.
Industry and General Public..  Shippers, maritime interests, marinas,
                                waterborne commerce groups,
                                environmental interest groups.
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be interested in this
notice. This table lists the types of entities that EPA is now aware
could potentially be interested in this notice. Other types of entities
not listed in the table could also be interested.

B. What Should I Consider as I Prepare My Comments?

    1. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    Dredging is an important issue in the U.S. Marine Transportation
System. Navigational dredging plays a key role in supporting the Marine
Transportation System's effectiveness and reliability for the movement
of people and commerce. In 1993, the Secretary of Transportation
convened an Interagency Working Group on the Dredging Process to
investigate and recommend actions to improve the dredging project
review process. In December 1994, the Interagency Group delivered its
report, The Dredging Process in the United States: An Action Plan for
Improvement to the Secretary of Transportation. This report contained
18 recommendations, and proposed a National Dredging Policy and the
formation of a National Dredging Team. The Group identified the need
for a unified national dredging policy to guide in the development of
recommendations and to focus Federal agency commitments. The
Administration adopted the following findings and principles as a
statement of

National Dredging Policy. The findings are:
     A network of ports and harbors is essential to the United
States' economy, affecting its competitiveness in world trade and
national security. Port facilities serve as a key link in the
intermodal transportation chain and can realize their full potential as
magnets for shipping and commerce only if dredging occurs in a timely
and cost-effective manner.
     The nation's coastal, ocean, and freshwater resources are
critical assets which must be protected, conserved, and restored. These
resources are equally important to the United States by providing
numerous economic and environmental benefits.
     Consistent and integrated application of existing
environmental statutes can protect the environment and can allow for
sustainable economic growth.
     Close coordination and planning at all governmental
levels, and with all aspects of the private sector, are essential to
developing and maintaining the nation's ports and harbors in a manner
that will increase economic growth and protect, conserve, and restore
coastal resources.
     Planning for the development and maintenance of the
nation's ports and harbors should occur in the context of broad
transportation and environmental planning efforts such as the National
Transportation System and the ecosystem/watershed management approach.
    The principles are:
     The regulatory process must be timely, efficient, and
predictable, to the maximum extent practicable.
     Advanced dredged material management planning must be
conducted on a port or regional scale by a partnership that includes
the Federal government, the port authorities, state and local
governments, natural resource agencies, public interest groups, the
maritime industry, and private citizens. To be effective, this planning
must be done prior to individual Federal or non-Federal dredging
project proponents seeking individual project approval.
     Dredged material managers must become more involved in
watershed planning to emphasize the importance of point and non-point
source pollution controls to reduce harbor sediment contamination.
     Dredged material is a resource, and environmentally-sound
beneficial use of dredged material for such projects as wetland
creation, beach nourishment, and development projects must be
encouraged.
    The findings and principles were embraced by all of the Group's
participating agencies. The Federal agencies committed themselves to
the fulfillment of these principles.
    In 2001, the National Dredging Team convened a stakeholder workshop
to assess progress on the 1994 report's 18 recommendations and identify
actions that could address issues impacting dredging and dredged
material management for the foreseeable future. The result is the
National Dredging Team's 2003 Dredged Material Management: Action
Agenda for the Next Decade (2003 Action Agenda), which supersedes the
1994 report. The 2003 Action Agenda contains the National Dredging
Policy and 22 recommendations to assist the National Dredging Team in
implementing the National Dredging Policy. The National Dredging Team
continues to be guided by the 2003 Action Agenda and is actively
addressing these recommendations, many of which require ongoing
activity. The recommendations in the 2003 Action Agenda fall into four
themes: beneficial use of dredged material, sediment management,
strengthening Regional Dredging Teams, and emerging issues. The
National Dredging Team recognizes that additional issues may have
emerged since publication of the 2003 Action Agenda.
    The goals of the National Dredging Team, which is a Federal
interagency group co-chaired by the U.S. Environmental Protection
Agency and U.S. Army Corps of Engineers, are to facilitate
communication, coordination, and resolution of dredging issues among
the participating Federal agencies and to serve as a forum for
promoting the implementation of the National Dredging Policy and the
recommendations in the National Dredging Team's Action Agenda. The
National Dredging Policy and the 2003 Action Agenda can be found at
http://www.epa.gov/owow/oceans/ndt/.

III. Today's Action

    Today's notice announces the review of the National Dredging Policy
and the National Dredging Team's 2003 Action Agenda. The interagency,
Cabinet-level Committee on the Marine Transportation System requested
that the National Dredging Team review the National Dredging Policy
(and the National Dredging Team's 2003 Action Agenda) to reaffirm their
adequacy in support of the U.S. Marine Transportation System. As a key
element in the U.S. Ocean Action Plan, the Committee on the Marine
Transportation System has been directed by the President to improve
federal Marine Transportation System coordination and policies, and
recommend strategies and plans for improvement. Dredging is an
important issue in the Marine Transportation System. The Committee on
the Marine Transportation System looks upon dredging as supporting the
Marine Transportation System's effectiveness and reliability regarding
the movement of people and commerce. Therefore, the Committee on the
Marine Transportation System requested the National Dredging Team take
this action on its behalf. Implementation of the National Dredging
Policy is promoted by the National Dredging Team, which is leading this
review through its co-chairs, the U.S. Environmental Protection Agency
and the U.S. Army Corps of Engineers. The National Dredging Policy
provides a national, unified policy for navigational dredging and
focuses Federal agency commitments. Reviewing this Policy and the
National Dredging Team's 2003 Action Agenda provides an opportunity to
assess our progress in addressing the issues impacting dredging and
dredged material management. As part of its review, the National
Dredging Team will consider the public comments submitted in response
to this notice. As part of the National Dredging Team's review to
reaffirm the adequacy of the Policy and 2003 Action Agenda, the
National Dredging Team will consider whether it should revise the
Policy or publish an Addendum to the 2003 Action Agenda, updating the
Action Agenda as appropriate. If the National Dredging Team develops
any revisions to the National Dredging Policy or any Addendum to the
2003 Action Agenda, EPA would intend to publish a Federal Register
notice requesting comment on such revisions or addenda.

    Dated: June 14, 2007.
Benjamin H. Grumbles,
Assistant Administrator for Water.
 [FR Doc. E7-12157 Filed 6-21-07; 8:45 am]

BILLING CODE 6560-50-P