[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Notices]
[Page 1613-1614]
[DOCID:fr09ja08-36]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0547; FRL-8344-6]

Issuance of an Experimental Use Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY: EPA has granted an experimental use permit (EUP) to the
following pesticide applicant. An EUP permits use of a pesticide for
experimental or research purposes only in accordance with the
limitations in the permit.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the information in this action,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0547. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. EUP

    EPA has issued the following EUP:
    71693-EUP-2. Issuance. Arizona Cotton Research and Protection
Council, 3721 East Wier Avenue, Phoenix, AZ 85040-2933. This EUP allows
the use of a total of 240,000 pounds of the antifungal agent containing
approximately 1.92 pounds of the active ingredient, Aspergillus flavus
AF36 on 24,000 acres of corn over the entire three year period to
evaluate the control of aflatoxin-producing colonies of Aspergillus
flavus and concomitant reduction of aflatoxin on corn. The program is
authorized only in the States of Arizona (3,000 acres per year) and
Texas (5,000 acres per year). The EUP is effective from January 4, 2008
to January 4, 2011.

    Authority: 7 U.S.C. 136c.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: December 26, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E8-185 Filed 1-8-08; 8:45 am]

BILLING CODE 6560-50-S


FINAL Analysis of Groundwater Monitoring Data Submitted by the American Portland Cement Alliance Response to EPA Contract No. 68 W 99 001 WA 231 Submitted to:

Eastern Research Group 2200 Wilson Blvd, Suite 400 Arlington, VA 22201 Submitted by:

Tetra Tech EM Inc. 1881 Campus Commons Drive Suite 200 Reston, VA 20191 i TABLE OF CONTENTS Section Page Part I – Introduction .................................................................................................................... I 1 A. Overview ............................................................................................................. I 1 B. Summary of Available Data ................................................................................ I 2 Part II – Analysis of Individual Facility Reports ........................................................................ II 1 I 1 Analysis of Groundwater Monitoring Data Submitted by the American Portland Cement Alliance I. Introduction This report contains summaries of the information gathered from the document Cement Kiln Dust Groundwater Monitoring Summary, produced by the American Portland Cement Alliance (APCA), dated October 2001.

A. Overview Eighteen reports were evaluated. Tetra Tech EM Inc. (Tetra Tech) attempted to determine whether claims made within each facility report were justified by the data and methods found within. Tetra Tech also looked for general characteristics of groundwater quality related to potential influences from cement kiln dust (CKD) activities at each facility. This process consisted of detailed review of geographical information (i. e., site maps and descriptions), geological/ hydrogeological investigations, historical information, sampling methods, analytical methods and analytical result interpretation.

The cement kiln dust groundwater reports reviewed herein include 18 facilities owned by 10 companies, spanning 10 states. The purpose of this review is to determine, if possible, the relative influence CKD landfill facilities have on groundwater. Tetra Tech reviewed groundwater data and compared them to government MCL and HBN regulatory values. In most cases, the reports submitted by the APCA were not detailed enough to make any meaningful determinations. However, Tetra Tech has provided a descriptive summary of all available data. The following summaries include information pertaining to:

° Groundwater constituents measured ° Instances where groundwater concentrations exceeded MCL and HBN standards ° Background information of individual site (if available) ° Overall quality of available report (content, evidence to justify conclusions, etc.)

In general, a reasonable review/ assessment of the influence of CKD facilities cannot be made with respect to these file reports. In order to provide reasonable reviews of groundwater studies at CKD facilities, Tetra Tech recommends that the submitted investigative reports include, at minimum, the following:

° Site map with monitoring well and source area locations should be included with the report ° Groundwater flow direction or groundwater elevations ° Geologic information ° Monitoring well information – i. e., depths screened, specifics of construction ° Brief site history is suggested – historical property use, use of surrounding area, past environmental assessments conducted, regulatory history ° Lab and field QC samples (MS/ MSD, duplicate samples, rinsate samples, blank samples) should be collected and results listed ° Analytical methods stated and should be EPA approved methods (SW 846) I 2 ° Sample collection methods should be stated ° Filtered or not filtered metals samples collected should be stated ° Detection limits should be considerably less than the MCLs ° There should be a consistent list of base line substances to analyze so there is some consistency between sites. Some sites are not analyzing for substances they perhaps should be. ° If statistical models are being used there should be support of the models and not a conclusion statement alone ° If there were soil samples collected from the sources areas one the property the data should presented to determine and assess the groundwater analyses Examples of reports that did meet most or all of these criteria include Lebec, California and Midlothian, Texas. The remaining reports appeared to be either partial sections or abstracts with data tables. More information is required to adequately review these documents.

Based on the limited information available, Tetra Tech can report the following observations:

° Several facilities indicated elevated levels of antimony, arsenic, beryllium, cadmium, lead, selenium, thallium and some others ° A significant number of the reports are inconsistent with regard to sampled constituent (i. e., parameter) ° A number of reports do not include parameters of potential interest to the EPA (various metals and inorganics)

B. Summary of Available Data The following tables show how the available data compare across all facilities. Because adequate information was not made available, there is no comparison between background (or upgradient) constituent concentrations and downgradient samples. Some comparisons are made within individual site reports (next section). These tables also indicate what constituents were sampled at each site (shown by "NA").

Table 1. MCL Summary. This table reports all exceedances by facility, each constituent that was not sampled, and those that were sampled but were found to be below MCL standards. Note that in some cases analytical detection limits are greater than MCL standards.

Table 2. HBN Summary. This table reports all exceedances by facility, each constituent that was not sampled, and those that were sampled but were found to be below HBN standards. Note that in some cases analytical detection limits are greater than HBN standards. I 3 I 4 PART II ANALYSIS OF INDIVIDUAL FACILITY REPORTS II 1 Ash Grove Cement Company – Chanute, KS Summary: This report is thorough as it contains historical information, subsurface descriptions (geology and geochemistry of groundwater), permitting history and documentation, and a summary of groundwater quality, submitted to the facility by ARCADIS (Geraghty & Miller).

Table 1. Overall report quality Subsurface description Yes Total no. of wells sampled 6 Sampling dates or duration Eight sampling events: 8/ 98, 11/ 98, 1/ 99, 2/ 99, 4/ 99, 5/ 99, 6/ 99, and 8/ 99 Upgradient wells specified 2 Downgradient wells specified 2 Site map included No Adequate physical description Fair Contains discussion section Yes Contains conclusions Yes References cited Yes Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background #> Background Inorganic Chemicals Alkalinity N  NL NL

Aluminum Y  NL NL  0.26 – 3 .66; 7 > 3.66 Ammonia N N  NL NL

Antimony Y 0.002 to 0.04 0.006 0.014 60**/ 60** 0.0021 – 0.07 0 > 0.07 Arsenic Y 0.001 to 0.01 0.05 0.0000568 0/ 72** ND – 0.007 5 > 0.007 Barium Y  2 NL 0 0.14 – 0.22 22 > 0.22 Beryllium Y 0.001 to 0.005 0.004 0.004 2/ 55**

Bicarbo nate N  NL NL

Cadmium Y 0.005 0.005 NL 0

Calcium Y  NL NL  47.4 – 5 2.5 1 > 52.5 Carbonate N  NL NL

Chloride Y  NL NL  5.4 – 28 .5 5 Chromium (total) Y 0.005 to 0.01 0.1 40 1/ 0

Copper Y 0.01 1.3 1.0 0/ 0

Fluoride N  4 NL

Iron Y  NL NL  0.39 – 8 .4 3 > 8.4 Lead Y 0.001 to 0.003 0.015 0.015 6/ 6 ND – 0.01 3 > 0.01 Magnesium Y  NL NL  37.3 – 4 1.0 1 > 41.0 Manganese Y 0.01 NL NL  0.026 – 0.171 3 > 0.171 Ash Grove Cement Company – Chanute, KS (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background #> Background II 2 Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0

Nickel Y 0.005 to 0.04 0.1 NL 3 ND – 0.02 3 > 0.02 Nitrate (as nitrogen) N  10 NL

Nitrite (as nitrogen) N  1 NL

Potassium Y  NL NL ND – 15.8 1 > 15.8 Selenium Y 0.002 to 0.005 0.05 0.175 0/ 0 ND 2 > ND Silver Y 0.007 to 0.01 0.05 0.20 2/ 2 ND  500 0 Sodium Y  NL NL  9.5 – 57 .0 47 > 57 .0 Sulfate Y  NL NL  14.4 – 1 7.8 30 > 17 .8 Thallium Y 0.001 to 0.05 0.002 NL 60** ND – 0.145 Vanadium Y 0.01 NL 0.3 0

Zinc Y 0.02 NL 10 0

Field Parameters pH Y  NL NL  6.67 – 7 .5 18 > 7.5; 2 < 6.67 Conductivity Y  NL NL  6.82 – 700 12 > 700 TSS N  NL NL

Note Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: Based on the report which is not dated but apparently submitted after August 2001 by ARCADIS (Geraghty & Miller), the following observations have been made:

Conclusion (1): Hydrogeologic conditions at the site are not conducive for collecting representative groundwater samples; therefore, concentrations of metals and inorganic parameters are highly variable over time.

While it may be true that conditions at the site are not conducive for collecting groundwater samples using EPA approved low flow sampling procedures, the report does not indicate why this fact would result in highly variable concentrations of metals and inorganic parameters. What evidence exists that this is the case in this region? A reference of historical studies is necessary to substantiate this conclusion. Also, since attaining representative groundwater samples is not possible, why should any of the data shown in this report be acceptable?

Conclusion (2): The results of the statistical evaluation of the initial two years of groundwater quality data indicate that none of the 14 metals had concentrations which indicated a Ash Grove Cement Company – Chanute, KS (continued)

II 3 statistically significant increase over background conditions. Therefore, the KDHE did not require ongoing statistical evaluation of additional groundwater quality data.

Although the KDHE decided not to require ongoing statistical evaluations of the groundwater data, the report does not illustrate the degree upon which the observed data statistically differs from background conditions. Again, as commented under Conclusion (1), if the hydrogeologic conditions are not conducive for collecting representative groundwater samples, are the background samples representative of background conditions? It is apparent that time and effort has been expended to explore background conditions; however, the report needs to quantify the degree of uncertainty of all of the reported data, as well as the statistical evaluation of the data.

Conclusion (3): Based on the initial statistical evaluation and comparison to the highly conservative Federal MCLs and Kansas HBLs, a release from the CKD landfill is not apparent.

See next comment (4).

Conclusion (4): Due to the high degree of variability, a long term monitoring program and possible additional statistical analysis will be required to determine whether releases are likely to occur in the future.

Again, the report does not attempt to quantify the degree of variability that is supposedly inherent in groundwater constituent measurements in the vicinity of this site. There is no statement of how long long term monitoring should occur in order to reduce uncertainty to acceptable levels. Therefore, given that the initial and recent measurements of groundwater quality were not necessarily based on long term monitoring, the data may not be adequate to characterize past and present conditions with respect to the landfill. II 4 Ash Grove Cement Company – Montana City, Montana Summary: A 15 acre CKD landfill was constructed on the Ash Grove property and as part of the permitting and sighting process four groundwater monitoring wells, including one upgradient well, were installed adjacent to the landfill. The report states that there is no evidence that leachate from the landfill is impacting local groundwater.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 4 Sampling dates or duration 3 times (12/ 18/ 98, 6/ 28/ 99, 5/ 11/ 00)

Upgradient wells specified 1 (not specified)

Downgradient wells specified 3 (not specified)

Site map included No Adequate physical description Limited Contains discussion section Limited Contains conclusions Limited References cited No Table 2. Summary of reported data Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l # > Background Inorganic Chemicals Alkalinity Y NA NA NL 0/ NA 234 – 251 0 Aluminum N NA NA NL

Ammonia N N NA NA NL

Antimony Y 0.003 0.006 0.014 2/ 2 <0.003 – 0.008 0 Arsenic Y 0.003 0.05 5.68E 5 0/ 7 <0.005 – 0.007 0 Barium Y 0.005 2 NL 0/ NA <0.005 – 0.036 8 Beryllium N NA 0.004 0.004

Bicarbo nate Y NL NA NL 0/ NA 285 – 306 2 Cadmium Y 0.0001 0.005 NL 0/ NA <0.0001 0 Calcium N NA NA NL

Carbonate N NA NA NL

Chloride Y 1.0 NA NL 0/ NA <1.0 – 5.18 9 Chromium (total) Y 0.001 0.1 40 0/ 0 <0.001 3 Copper Y 0.001 1.3 1.0 0/ 0 <0.001 – 0.005 4 Fluoride N NA 4 NL

Iron Y 0.01 NA NL 0 <0.01 – 0.25 6 Lead Y 0.003 0.015 0.015 3/ 3 <0.003 – 0.016 3 Ash Grove Cement Company – Montana City, Montana (continued)

Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l # > Background II 5 Magnesium Y 0.005 NA NL 0/ NA <0.005 – 0.016 9 Manganese N NA NA NL

Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 <0.0002 0 Nickel Y 0.02 0.1 NL 0/ NA <0.02 0 Nitrate (as nitrogen) Y 0.01 10 NL 0/ NA 1.51 – 1 .9 3 Nitrite (as nitrogen) Y 0.01 1 NL 0/ NA <0.01 2 Potassium N NA NA NL

Phosphorus (total) Y 0.01 NA NL 0/ NA <0.01 – 0.05 8 Selenium Y 0.001 0.05 0.175 0/ NA <0.001 2 Silver Y 0.003 0.05 0.20 0/ NA <0.003

<0.01 0 Sodium N NA NA NL

Sulfate Y NL NA NL 0/ NA 289 – 357 5 Thallium N NA 0.002 NL

Zinc Y 0.01 NA 10 NA/ 0 <0.01 4 Field Parameters pH Y NA NA NL  7.62 – 8 .1

Conductivity Y NA NA NL  952 1,052

TSS N  NA NL

Dissolved soilds Y NA NA NL  719  768

COD N  NA NL

Organic Substances (only detected substances listed)

None sampled

Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: The text states that there is one upgradient and three down gradient locations; however, no specific well numbers are specified. Names of the monitoring wells are provided. The well listed with a "U" after its name would appear to represent the upgradient location and the wells with a "D" after their name represent the downgradient. Although this is likely and assumed for performing this review, the text does not state that this is the case.

Groundwater samples were collected from multiple sampling events and analyzed for a reasonable number of parameters with low detection limits. Only two substances (antimony and lead) were detected at concentrations greater than MCLs; however, elevated antimony concentrations were noted in the reference well sample which potentially indicates either high natural levels of the substance or an upgradient contaminant source. Elevated antimony concentrations were only observed during one of the three sampling events. Ash Grove Cement Company – Montana City, Montana (continued)

II 6 The text of the report states that there is no evidence that leachate from CKD is impacting groundwater; however, 14 of the 21 substances analyzed by the laboratory were detected at concentrations greater than background during multiple sampling events or at sample locations indicating that the CKD source area does impact the local groundwater. II 7 CEMEX., Inc.  Charlevoix, Michigan Summary: There are 9 CKD piles on the property. Investigations have been conducted to determine the extent of the impact to the local groundwater and to Lake Michigan. The report overtly states that there has been an impact to the groundwater as a result of CKD and that pH levels and potassium concentrations are the best indicators of the release due to the variability of other metals analyzed.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled Results listed for 19; however, total and dissolved results are not specified Sampling dates or duration 11/ 14/ 96, 5/ 22/ 96, 10/ 15/ 96, 11/ 20/ 96, 12/ 18/ 96, 1/ 13/ 00, 4/ 5/ 00, 10/ 4/ 00, 1/ 10/ 01, 4/ 4/ 01, 7/ 10/ 01 Upgradient wells specified Unknown Downgradient wells specified Unknown Site map included No Adequate physical description No Contains discussion section Limited Contains conclusions Limited References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity   NA NL Aluminum   NA NL Ammonia N   NA NL Antimony   0.006 0.014 Arsenic Y 0.025 0.05 5.68E 5 5/ 89 Barium Y 0.025 2 NL 0/ NA Beryllium   0.004 0.004 Bicarbonate   NA NL Cadmium Y 0.0002 0.005 NL 1/ NA Calcium   NA NL Carbonate   NA NL Chloride   NA NL Chromium (total) Y 0.005 0.1 40 0/ 0 Copper Y 0.025 1.3 1.0 0/ 0 Fluoride   4 NL Iron   NA NL Lead Y 0.005 0.015 0.015 0/ 0 Magnesium   NA NL Manganese   NA NL  CEMEX., Inc.  Charlevoix, Michigan (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 8 Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 Nickel   0.1 NL Nitrate (as nitrogen)   10 NL

Nitrite (as nitrogen)   1 NL

Potassium Y NL NA NL

Selenium Y 0.0025 0.05 0.175 14/ 4 Silver Y 0.0025 0.05 0.2 0/ 0 Sodium Y NL NA NL

Sulfate   NA NL

Thallium   0.002 NL

Zinc Y 0.02 NA 10 NA/ 0 Field Parameters pH Y  NA NL

Conductivity Y  NA NL

TSS   NA NL

Dissolved soilds   NA NL

COD   NA NL

Organic Substances (only detected substances listed) None sampled

Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: In the first paragraph of the report, it is stated that investigations have been conducted on the property in accordance and under the oversight of Michigan Department of Environmental Quality to determine the impact of CKD to the groundwater in the area and nearby Lake Michigan. The results of the investigations should be provided. An explanation about why the Michigan DEQ became involved with the site should be given.

Some portions of the report reference background concentrations in the groundwater at the property, but the background well location is not specified. The background well should be listed to address the impact to the groundwater.

It does appear that a significant amount of sampling has been conducted on the property during multiple sampling events conducted in 1996 and 2000. Based on the information provided, there has been an impact to the groundwater of metals and pH. The pH, as sampled in 1996, indicate levels ranging from approximately 8 to greater than 12 with the majority of results being nearer to 12. pH does not appear to have been analyzed during the 2000 sampling event. It should also CEMEX., Inc.  Charlevoix, Michigan (continued)

II 9 be noted that the number of metals sampled on the property should be increased to better assess the impact and the nature of the impact.

The low HBN concentration for arsenic dramatically increases the number of samples that exceed the criteria. Additionally, the analytical detection limits for the substance are considerably greater than the HBN value.

As stated in the report, groundwater in the vicinity of this property has been affected by the presence of CKD piles. II 10 CEMEX, Inc. – Lyons, Colorado Summary: Colorado Division of Minerals and Geology requested an assessment of the property and the impact of CKD piles to the local groundwater. CKD has been disposed of on the property since 1969.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 2 Sampling dates or duration Unknown Upgradient wells specified Unknown Downgradient wells specified Unknown Site map included No Adequate physical description No Contains discussion section Limited and not relevant to groundwater quality Contains conclusions Limited and not relevant References cited No Table 2. Summary of report data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N  NL NL Aluminum Y  NL NL Ammonia N N  NL NL Antimony Y 0.005 0.006 0.014 0 Arsenic Y 0.003 0.05 5.68E 5 0/ 1 Barium Y  2 NL 0/ NA Beryllium Y 0.004 0.004 0.004 0/ 0 Bicarbonate Y  NL NL Boron Y  NL NL Cadmium Y 0.005 0.005 NL 0/ NA Calcium Y  NL NL Carbonate Y  NL NL Chloride Y  NL NL Chromium (total) Y 0.01 0.1 40 0/ NA Cobalt Y 0.01 NL NL Copper Y 0.01 1.3 1.0 0/ 0 Fluoride Y  4 NL 0/ NA Iron Y  NL NL Lead Y 0.05 0.015 0.015 0/ 0 Lithium Y  NL NL Magnesium Y  NL NL Manganese Y  NL NL  CEMEX, Inc. – Lyons, Colorado (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 11 Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 Molybdenum Y 0.01 NL NL Nickel Y 0.04 0.1 NL 1/ NA Nitrate (as nitrogen) Y 0.01 10 NL 0/ NA Nitrite (as nitrogen) Y 0.01 1 NL 0/ NA Potassium Y 5 NL NL

Selenium Y 0.005 0.05 0.175 0/ 0 Silver Y 0.01 0.05 0.20 0/ 0 Silicon Y  NL NL

Sodium Y  NL NL

Strontium Y  NL NL

Sulfate Y  NL NL

Sulfite Y  NL NL

Sulfide Y  NL NL

Titanium Y 0.01 NL NL

Thallium Y 0.002 0.002 NL 0/ NA Vanadium Y 0.01 NL 0.3

Zinc Y  NL 10

Field Parameters pH Y  NL NL NA Conductivity Y  NL NL NA TSS N  NL NL NA Dissolved solids Y  NL NL NA Total Inorganic Carbon Y  NL NL NA Total Organic Carbon Y 1 NL NL NA COD N  NL NL NA Organic Substances (only detected substances listed) None sampled Other Substances Gross Alpha (pCi/ L) Y  NL NL NA Gross Beta (pCi/ L) Y  NL NL NA Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value. CEMEX, Inc. – Lyons, Colorado (continued)

II 12 Specific Comments: The first paragraph states that the past assessment was "performed to the ultimate satisfaction of the Division (Colorado Division of Minerals and Geology)" but it does not state what the assessment determined and there is no summary of any conclusions that were made.

A chemical analysis, assessment of the local geology and hydrology, and analysis of groundwater impacts have been conducted and are included in the past reports, but no summary is included in this report.

Leachate testing of CKD from the property was performed and a few parameters were found to be at concentrations greater than groundwater standards. This type of sampling and analysis should not be used to replace groundwater sampling. Subsequent sampling appears to have only analyzed for the parameters that were found to be greater than groundwater criteria during the leachate analysis. Groundwater sampling and analysis should be conducted for any possible contaminants, not only the elevated substances detected during the leachate analysis. The groundwater sample results listed in the tables are not addressed, summarized, or referenced in the report. No information is provided about the monitoring wells or samples that have been collected from them.

In the last paragraph, a statement is made that samples have been collected from local surface water and analyzed for the substances detected during leachate analysis of the CKD and that no substances were detected at concentrations greater than the standards. This is not relevant to groundwater quality.

The analytical tables and groundwater sampling events are not summarized in any way in the text of the report and it is not known whether there is any background water quality information. There appears to be only minimal impact to the groundwater based on the given information; however, more information and more data should be collected. The HBN for arsenic is less than the analytical detection limits.

It is difficult to make a conclusion about the quality of the groundwater in the vicinity of the site without more information. Additionally, only two groundwater sampling points would not be able to adequately characterize the groundwater in the area even if the information was available. II 13 Essroc – Logansport, Indiana Summary: Samples were collected quarterly from a number of wells; however, specific information about the sampling events or the placement of the monitoring wells is not provided. The report concludes that the data "indicate the apparent lack of impact on the groundwater of the CKD landfills at the Logansport plant," but the report does not provide sufficient detail to either support or refute the given conclusion.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 12* Sampling dates or duration Five quarterly sampling events  specific dates and times not listed. Upgradient wells specified 3 Downgradient wells specified 8 Site map included No Adequate physical description Limited Contains discussion section Limited Contains conclusions Limited References cited No * One monitoring well not mentioned in the report text is listed in the data tables (EW 3). There is no information concerning the well.

Table 2. Summary of reported data Sampled ? DL* MCL HBN (Landfill) # Exceed MCL/ HBN Background mg/ l #> Background Inorganic Chemicals Alkalinity N NL NA NL  NA Aluminum N NL NA NL  NA Ammonia N N NL NA NL  NA Antimony Y NL 0.006 0.014 0/ 0 BDL 0 Arsenic Y NL 0.05 5.68E 5 0/ 11 BDL. 012 1 Barium Y NL 2 NL 0/ NA 0.16 0.2 14 Beryllium Y NL 0.004 0.0040 0/ 0 BDL 1 Bicarbo nate N NL NA NL  NA Cadmium Y NL 0.005 NL 0/ NA BDL 0 Calcium N NL NA NL  NA Carbonate N NL NA NL  NA Chloride N NL NA NL  NA Chromium (total) N NL 0.1 40  NA Copper N NL 1.3 1.0  NA Fluoride N NL 4 NL  NA Iron N NL NA NL  NA Lead Y NL 0.015 0.015 0/ 0 BDL 0 Magnesium N NL NA NL  NA Manganese N NL NA NL  NA Mercury (inorganic) Y NL 0.002 0.011 0/ 0 BDL 0 Nickel Y NL 0.1 NL 0/ NA BDL 1 Nitrate (as nitrogen) N NL 10 NL  NA Nitrite (as nitrogen) N NL 1 NL  NA  Essroc – Logansport, Indiana (continued)

Sampled ? DL* MCL HBN (Landfill) # Exceed MCL/ HBN Background mg/ l #> Background II 14 Potassium N NL NA NL  NA Selenium Y NL 0.05 0.175 0/ 0 BDL 0 Silver Y NL 0.05 0.20 0/ 0 BDL 0 Sodium N NL NA NL  NA Sulfate N NL NA NL  NA Thallium N NL 0.002 NL  NA Field Parameters pH N NL NA NL  NA Conductivity N NL NA NL  NA TSS N NL NA NL  NA Organic Substances (only detected substances listed) Naphthalene Y NL NA 1.0 NA/ 1 NA 1 1,1 Dichloroethane Y NL NA 9.0E 4 NA/ 1 NA 1 1,1 Dichloroethene Y NL 0.007 NL 0/ NA BDL 1 CIS 1,2 Dichloroethene Y NL 0.07 NL 0/ NA BDL 4 Tetrachloroethene Y NL 0.005 0.40 4/ 0 BDL 4 1,1,1 Trichloroethane Y NL 0.2 NL 0/ NA BDL 4 Trichloroethene Y NL 0.005 0.008 3/ 3 BDL 3 M/ P Xylene Y NL 10 70 0/ 0 BDL 1 NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. BDL = Below detection lim it.

Specific Comments: The report lacks any detailed information concerning the site and the sampling events that occurred on the property. Inorganic contaminants have been detected at concentrations greater than background, but concentrations are less that applicable MCLs. Organic contaminants, not likely attributable to CKD, were detected at concentrations greater than MCLs but this occurrence is not addressed in the report. Due to the very low HBN for arsenic, it is unlikely that the analytical method detection limits were below this value.

The description of the solid waste management units (SWMU) located on the property lacks any information concerning the size of the SWMUs or details of their use including disposal history. Chemical analysis of the waste material would assist in determining the groundwater parameters to analyze. In addition, site specific information concerning property characteristics, including, but not limited to, site geology, topography, the size of the property, and surrounding area is not included.

The description of the eight groundwater monitoring wells and the three off site residential drinking water wells does specify which monitoring wells are considered upgradient of the source areas and that the monitoring wells located on the property are screened within the upper aquifer; however, there is no information to support these statements such as groundwater flow direction or groundwater table elevations. The paragraph does not specify whether the residential wells are screened within the same aquifer as the monitoring wells located on the property. A site map showing the placement of the monitoring wells is necessary to support any conclusions. Essroc – Logansport, Indiana (continued)

II 15 The facility report states that a risk assessment was completed for the property and that EPA has accepted the risk assessment as valid; however, there is no statement of what the risk assessment concluded. The validity of the assessment does not communicate the inherent risk associated with the property. Additionally, a description of the NOD should be included.

The facility report states that only a few substances are detected at concentrations greater than the detection limits, but the detection limits are not specified for any substances. It is necessary for the detection limits to be at concentrations less than the appropriate health based risk criteria for any conclusions to be made. Additionally, there is no mention in the paragraph of the substances that were detected at concentrations greater than the background values. The text portion of the report concludes that there is an apparent lack of impact on the groundwater from the site; however, this cannot be established based on the given information.

The data tables list substances that were not detected at concentrations greater than the detection limits as BDL (below detection levels) but it does not state what the detection limits are. This is important for comparability to MCLs. It also is not stated whether the metals analysis is for unfiltered or dissolved metals and a number of metals which would be important to assess an impact to groundwater were not analyzed (i. e., Fe, Ca, and others). Additionally, it is not known whether EPA approved analytical methods were used by the lab or what sample collection methods were used in the field. II 16 Holnam – Ada, Oklahoma (Webster Facility – Pontotoc County)

Summary: There are two reports submitted which summarize two independent sampling events. These reports include a detailed summary of the statistical analysis of the data results; however, general information concerning the property and the data results is not included. This information is needed to make an accurate assessment of the quality of the report and the conclusions that are made in the report.

There are 4 groundwater monitoring wells on the property; one of which is considered upgradient of potential sources of contamination. Analytical data from two rounds of groundwater sampling is included with the report. The report states that groundwater elevation data also was collected as part of the sampling events; however, this data is not included in the report.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 4 Sampling dates or duration Results for two sampling events provided (08/ 2000, 2/ 2001) (report indicates monitoring is conducted twice per year) Upgradient wells specified 1 Downgradient wells specified 3 Site map included No Adequate physical description No Contains discussion section Statistical analysis discussed Contains conclusions Conclusion of no impact based on statistical analysis References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l #> Backgroun d Inorganic Chemicals Alkalinity Y  NL NL  NA 0 Aluminum N  NL NL  NA NA Ammonia N N  NL NL  NA NA Antimony Y 0.02 0.006 0.014 0/ 0 <0.02 0 Arsenic N  0.05 5.68E 5  NA NA Barium N  2 NL  NA NA Beryllium N  0.004 0.004  NA NA Bicarbo nate Y  NL NL  NA 0 Cadmium N  0.005 NL  NA NA Calcium Y  NL NL  300 330 0 Carbonate Y 0.06 NL NL  <0.06 0 Chloride Y  NL NL  5 – 6 0 Chromium (total) Y 0.01 0.1 40 0/ 0 < 0.01 0 Copper N  1.3 1.0  NA NA Fluoride N  4 NL  NA NA Iron N  NL NL  NA NA Holnam – Ada, Oklahoma (Webster Facility – Pontotoc County) (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l #> Backgroun d II 17 Lead N  0.015 0.015  NA NA Magnesium Y  NL NL  23 – 30 0  ? Manganese N  NL NL  NA NA Mercury (inorganic) N  0.002 0.011  NA NA Nickel N  0.1 NL  NA NA Nitrate (as nitrogen) N  10 NL  NA NA Nitrite (as nitrogen) N  1 NL  NA NA Potassium Y 1.0 NL NL  2.2 – 3.5 0  ? Selenium N  0.05 0.175  NA NA Silver N  0.05 0.2  NA NA Sodium Y  NL NL  6.9  ? 3 Sulfate Y  NL NL  310  ? 0 Thallium N  0.002 NL  NA NA Zinc Y 0.05 NL 10 0/ 5 <0.05 – 0.05 4 Field Parameters pH N  NL NL  NA NA Conductivity Y  NL NL  NA 0 TSS N  NL NL  NA NA Dissolved soilds Y  NL NL  922 – 1,110 0 COD Y  NL NL  25  32 1 Organic Substances (only detected substances listed) None sampled      Note Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ? Due to the poor q uality of the repro duction some concentration are unidentifiable ** Detection limit is greater than regulatory value.

Specific Comments: Both reports contain a relatively lengthy section describing the statistical analysis that was performed on the analytical results from the two sampling events. The analysis indicates the relative variability of the results and exceedances from the predicted values. However, at least a portion of the conclusion should summarize the individual data results in simple terms of greater than background or greater than the applicable regulatory value. For instance, the recorded concentrations of zinc are consistently greater in the downgradient wells than in the concentrations from the reference well during both sampling events. Additionally, the concentrations also are consistently greater than the HBN value. This clearly indicates an impact to the quality of the groundwater and it is not addressed in the data summary report.

A greater number of substances, primarily metals, should be analyzed during the sampling events. Metals that are indicative of CKD were not sampled; thus, no conclusions of the impact of these substances can be determined.

As previously stated, these two reports do not contain site specific background information, geologic information, site maps, or source area descriptions. General information necessary to assess the quality of the report is not included. There is no summary of the sampling methods used during sample collected. Holnam – Ada, Oklahoma (Webster Facility – Pontotoc County) (continued)

II 18 The reports reference past sampling events; however, the data from the past sampling events is not contained in the report. The detection limits for antimony as listed in the data table (0.02 mg/ l) is significantly greater than the MCL for the metal (0.006 mg/ l). To properly assess whether there is an impact of antimony to the property, the detection limit must be below the MCL. Additionally, the report indicates that antimony was detected during past sampling at the property. It is likely that the detection limit used during that analysis is the same as the detection limit used in the subsequent analyses. If that is the case, then there are concentrations of antimony significantly greater that the MCLs present in the groundwater. Any new sampling on the property must properly address antimony before any conclusions of impact to the quality of groundwater can be made.

The report indicates that sampling procedures have been inconsistent: "Additionally, a submersible pump was utilized to purge the wells prior to sampling. This change in well purging may have contributed to the detection of zinc." Sampling methods should not be altered between sampling events and wells should always be purged prior to sampling to ensure that a sample is representative of the natural conditions. It is not stated whether it was the use of the pump for purging the wells that changed or the purging of the wells itself. This should be stated. Purging wells by hand versus purging wells with a pump should not affect the resulting concentration provided adequate sampling techniques are utilized.

Neither report definitively states whether there has been an impact to the groundwater table attributable to CKD stored on the property. The only conclusions of both reports is that groundwater monitoring on the property should continue. First, more information is needed to determine whether an impact to the groundwater table has occurred and second, these reports do not adequately address that question. II 19 Holnam – Clarksville, Missouri Summary: The text portion is brief and provides minimal information. Four wells have been installed on the property for regulatory purposes and to obtain geologic and hydrogeologic information. Wells upgradient or downgradient were not identified in the report. Samples have been collected from the property during five sampling events which have indicated stability of the concentrations.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 4 Sampling dates or duration 5 sample events (11/ 5/ 98, 4/ 27/ 99, 7/ 22/ 99, 10/ 28/ 99, 1/ 10/ 00) Upgradient wells specified Unknown Downgradient wells specified Unknown Site map included No Adequate physical description No Contains discussion section Limited Contains conclusions Not relevant to groundwater quality References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N  NL NL Aluminum N  NL NL Ammonia N N  NL NL Antimony Y 0.005 0.006 0.014 0/ 0 Arsenic Y 0.005** 0.05 5.68E 5 0/ 1 Barium Y 0.010 2 NL 0/ NA Beryllium Y 0.004 0.004 0.004 0/ 0 Bicarbonate N  NL NL Boron N  NL NL Cadmium Y 0.001 0.005 NL 0/ NA Calcium N  NL NL Carbonate N  NL NL Chloride Y 1.00 NL NL NA/ NA Chromium (total) Y 0.005 0.1 40 0/ 0 Cobalt N  NL NL Copper N  1.3 1.0 Fluoride N  4 NL Iron N  NL NL Lead Y 0.003 0.015 0.015 1/ 1 Lithium N  NL NL  Holnam – Clarksville, Missouri (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 20 Magnesium N  NL NL Manganese N  NL NL Mercury (inorganic) Y 0.00002 0.002 0.011 0/ 0 Molybdenum N  NL NL Nickel Y 0.01 0.1 NL 1/ NA Nitrate (as nitrogen) N  10 NL Nitrite (as nitrogen) N  1 NL Potassium Y 1.0 NL NL NA/ NA Selenium Y 0.005 0.05 0.175 0/ 0 Silver Y 0.005 0.05 0.20 0/ 0 Silicon N  NL NL Sodium Y 1.00 NL NL NA/ NA Strontium N  NL NL Sulfate Y 1.0 NL NL NA/ NA Sulfite N  NL NL Sulfide N  NL NL Titanium N  NL NL Thallium Y 0.002 0.002 NL 0/ NA Vanadium N  NL 0.3 Zinc N  NL 10 Field Parameters pH Y NA NL NL NA Conductivity Y NA NL NL NA TSS N  NL NL Dissolved solids Y NA NL NL NA Total Inorganic Carbon N  NL NL Total Organic Carbon N  NL NL

COD N  NL NL

Organic Substances (only detected substances listed) None sampled

Other Substances Gross Alpha (pCi/ L) NL NA NL NA Gross Beta (pCi/ L) NL NA NL NA Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** detection limit is greater than regulatory value Specific Comments: No background monitoring well is identified and there is no site specific information contained in the report or the letter that is provided with the data summary report. Holnam – Clarksville, Missouri (continued)

II 21 The only conclusion made in the report is that the concentrations of the substances detected has remained constant over time, a conclusion that is not relevant to an assessment of impact to the area.

The data itself does not have a significant number of substances detected at concentrations greater than MCL or HBN standards, but without definitive information concerning the location of the wells and the depths screened, for example, a conclusion cannot be made that there is no impact. Additionally, without information concerning the background concentrations of substances, it cannot be determined whether there is an impact to the local groundwater at concentrations less than regulatory standards. II 22 Holnam – Florence, Colorado Summary: The report consists of three short paragraphs that briefly cover permitting status, facility history, and a brief conclusion regarding groundwater quality in the vicinity of the site.

Table 1. Overall report quality Subsurface No Total no. of wells sampled 4 Sampling Dates or duration 3 wells/ 4 quarters; 1 additional well/ 5 th quarter Upgradient wells specified Not specified Downgradient wells specified 1 well, not named Site map included No Adequate physical description No Contains discussion section No Contains conclusions Limited Reference cited No Table 2. Summary of reported data Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity Y  NL NL NA Aluminum Y 0.05 to 0.10 NL NL NA Ammonia N Y NL NL NA Antimony Y 0.01 to 0 .2 0.006 0.014 21**/ 7** Arsenic Y 0.005 to 0.1 0.05 0.0000568 1**/ 21** Barium Y 0.1 2 NL 0 Beryllium Y 0.005 to 0.01 0.004 0.004 21**/ 21**

Bicarbo nate Y  NL NL NA Cadmium Y 0.005 to 0.01 0.005 NL 2**

Calcium Y  NL NL NA Carbonate Y  NL NL NA Chloride Y  NL NL NA Chromium (total) N  0.1 40 NA Copper N  1.3 1.0 NA Fluoride Y  4 NL 0 Iron Y 0.05 NL NL NA Lead Y 0.05 to 0.005 0.015 0.015 5**/ 5**

Magnesium Y  NL NL NA Manganese Y 0.01 NL NL NA Mercury (inorganic) Y 0.0002 to 0.005 0.002 0.011 2**/ 0 Nickel Y 0.04 0.1 NL 0 Nitrate (as nitrogen) Y  10 NL 1 Holnam – Florence, Colorado (continued)

Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN II 23 Nitrite (as nitrogen) N  1 NL NA Potassium Y  NA NL NA Selenium Y 0.005 to 0.1 0.05 0.175 6**/ 0 Silver Y 0.01 0.05 0.20 0/ 0 Sodium Y  NL NL NA Sulfate Y  NL NL NA Thallium Y 0.01 to 0 .1 0.002 NL 21** Field Parameters pH Y  NL  NA Conductivity Y  NL NL NA TSS Y  NL NL NA Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: The quality of this report is very poor due to: (1) absence of site map, (2) absence of locational references associated with monitoring wells, (3) absence of background concentrations, and (4) lack of attention to statistical importance, if any, of results. The conclusion that groundwater in the vicinity of this site is not influenced by placing CKD in the quarry is unfounded based on the report and accompanying data. II 24 Holnam – Laporte, Colorado Summary: The report appears to be abbreviated, as it provides only a summary of analytical data collected over a five quarter period. However, actual data are only shown for the first three quarters, with calculated differences shown for all five quarters in separate tables. The text summary is extremely brief and states only the number and vague locations of wells, period of sampling, and the conclusion that the "monitoring wells were voluntarily sampled for five quarters to show that there is no impact to groundwater."

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 3 Sampling dates or duration Five sampling events: five consecutive quarters beginning with 1 st quarter 2000 Upgradient wells specified 1 Downgradient wells specified 2 Site map included No Adequate physical description None Contains discussion section No Contains conclusions No References cited No Table 2. Summary of reported data Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN Background #> Background Inorganic Chemicals Alkalinity N  NL   Aluminum N  NL   Ammonia N N  NL   Antimony N 0.006 0.014   Arsenic Y  0.05 0.000056 8 1/ 9 0.01 – 0.027 d 3 > 0.027 Barium Y 2 NL 0 ND – 0.014 6 > 0.014 Beryllium N 0.004 0.004 0/ 0

Bicarbo nate N  NL

Cadmium N 0.005 NL

Calcium N  NL

Carbonate N  NL

Chloride Y  NL  25  28 6 > 28 Chromium (total) Y 0.1 40 0/ 0 ND d 0 Copper Y 1.3 1.0 0/ 0 ND d 0 Fluoride Y 4 NL 0 0.5 – 0.7 6 > 0.7 Iron Y  NL 0 ND – 0.1 3 > 0.1 Lead Y 0.015 0.015 0/ 0 ND – 0.013 0 Magnesium N  NL

Manganese Y  NL  0.04 – 0.053 5 > 0.053 Mercury (inorganic) N 0.002 0.011

Nickel N 0.1 NL    Holnam – Laporte, Colorado (continued)

Sampled? DL MCL HBN (landfill) # Exceed MCL/ HBN Background #> Background II 25 Nitrate (as nitrogen) Y 10 NL 0 3.28 – 3.77 0 Nitrite (as nitrogen) Y 1 NL 0 0.04 – 0.66 0 Potassium N  NL   Selenium Y 0.05 0.175 2/ 0 0.046 – 0.101 0 Silver N 0.05 0.20

Sodium N  NL

Sulfate Y  NL  4000  4410 0 Thallium Y 0.002 NL 0 ND – 0.0007 0 Field Parameters pH Y   7.5 – 7.6 6 > 7.6 Conductivity N  NL

TSS N  NL

NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. d Dissolved.

Specific Comments: Based on the report which is not dated, the following observations have been made:

General Conclusion: The groundwater monitoring wells were voluntarily sampled for five quarters to show that there is no impact to groundwater.

However: (1) Not all potentially important chemicals/ compounds were sampled. (2) Only data for first three quarters are explicitly shown. (3) There are several chemicals that indicate higher values within the downgradient sampling areas. Groundwater downgradient of the CDK disposal area appears to be influenced, to some degree, by increases in arsenic, barium, chloride, fluoride, iron, and manganese. (4) There is no information regarding the site description. II 26 Holnam – Three Rivers, Montana Summary: The report essentially consists of poorly labeled data tables. The introductory paragraph states that there are 3 wells (1 upgradient and 2 downgradient). However, the accompanying analytical results show data for 7 monitoring wells with no indication as to their association (relative position). As such, Table 2 cannot be completed for background comparisons.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 3, but data sheets indicate 7 Sampling dates or duration Stated: sampled twice per year Upgradient wells specified 1, not indicated in analytical results Downgradient wells specified 2, not indicated in analytical results Site map included No Adequate physical description None Contains discussion section No Contains conclusions No References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N  NL Aluminum N  NL Ammonia N N  NL Antimony Y 0.003 0.006 0.014 0/ 0 Arsenic Y 0.003 0.05 0.000056 8 0/ 13**

Barium Y  2 NL 0 Beryllium Y 0.001 0.004 0.004 0/ 0 Bicarbonate N   NL Cadmium Y 0.0001 0.005 NL 0 Calcium N   NL Carbonate N   NL Chloride Y   NL Chromium (total) Y 0.001 0.1 40 0/ 0 Copper Y 0.001 1.3 1.0 0/ 0 Fluoride Y  4 NL 0 Iron Y 0.01  NL Lead Y 0.003 0.015 0.015 0/ 0 Magnesium N   NL Manganese N   NL  Holnam – Three Rivers, Montana (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 27 Mercury (inorganic) Y 0.0006 0.002 0.011 0/ 0 Nickel Y 0.02 0.1 NL 0 Nitrate (as nitrogen) N  10 NL

Nitrite (as nitrogen) N  1 NL

Potassium N   NL

Selenium Y 0.001 0.05 0.175 0/ 0 Silver Y 0.003 0.05 0.20 0/ 0 Sodium N   NL

Sulfate Y   NL

Thallium Y 0.003 0.002 NL 0 Vanadium Y 0.1 NL 0.3 0 Zinc Y 0.01 NL 10 0 Field Parameters pH Y

Conductivity Y  NL

TSS N  NL

Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: Based on the report, which is not dated, the following observations have been made:

(1) Not all potentially important chemicals/ compounds were sampled. (2) A comparison of background to downgradient samples is not possible due to a lack of monitoring well identification. (3) There is not sufficient information provided to draw conclusions about the impact of the facility. II 28 Lafarge Midwest, Inc. – Alpena, Michigan Summary: The CKD landfill located at the Lafarge facility is both lined and caped. Groundwater monitoring is conducted according to the State approved Hydrogeologic Monitoring Plan which includes annual sample collected from the network of 12 monitoring wells at the facility which includes background monitoring. Continuous quarry dewatering is also conducted in the vicinity of the CKD landfill which draws groundwater away from the CKD landfill.

Subsurface description No Total no. of wells sampled 12 Sampling Dates or duration 2 (6/ 28/ 00, 6/ 7/ 01)

Upgradient wells specified Not specified Downgradient wells specified Not specified Site map included No Adequate physical description No Contains discussion section Limited Contains conclusions Limited References cited No Summary of Reported Data:

Sampled ? DL* MCL HBN (land fill) # Exceed MCL/ HBN Background mg/ l* #> Background*

Inorganic Chemicals Alkalinity Y 20 NL NL NA/ NA ? ?

Aluminum N  NL NL

Ammonia N Y 0.5 NL NL NA/ NA ? ?

Antimony Y .0023/. 0 092 0.006 0.014 */* ? ?

Arsenic Y .0044/. 0 .013 0.05 5.68E 5 0/* ? ?

Asbestos (> 10 microns) N  7 MFL NL

Barium Y ? 2 NL 0/ NA ? ?

Beryllium Y 0.001 0.004 0.004 0/ 0 ? ?

Bicarbo nate Y 20 NL NL NA/ NA ? ?

Boron N  NL NL

Cadmium Y 0.0002 0.005 NL 0/ NA ? ?

Calcium Y ? NL NL NA/ NA ? ?

Carbonate Y 20 NL NL NA/ NA ? ?

Chloride Y 10 NL NL NA/ NA ? ?

Chromium (total) Y 0.001 0.1 40 0/ 0 ? ?

Cobalt Y 0.015 NL NL NA/ NA ? ?

Copper* Y 0.0022/ 0.001 1.3 1.0 0/ 0 ? ?

Cyanide (as free cyanide) Y .02/. 005 0.2 NL 0/ NA ? ?

Fluoride Y ? 4 NL 0/ NA ? ?

Iron Y 0.020 NL NL NA/ NA ? ? Lafarge Midwest, Inc. – Alpena, Michigan (continued)

Sampled ? DL* MCL HBN (land fill) # Exceed MCL/ HBN Background mg/ l* #> Background*

II 29 Lead* Y 0.001/ 0.0022 0.015 0.015 3/ 3 ? ?

Lithium N  NL NL

Magnesium Y ? NL NL NA/ NA ? ?

Manganese Y 0.020 NL NL NA/ NA ? ?

Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 ? ?

Molybdenum N  NL NL

Nickel Y 0.020 0.1 NL 0/ NA ? ?

Nitrate (as nitrogen) Y 0.08 10 NL 0/ NA ? ?

Nitrogen (Nitrate + Nitrite) Y .037/. 02 11 NL 0/ NA ? ?

Potassium Y ? NL NL NA/ NA ? ?

Selenium Y .042/. 00 28 0.05 0.175 0/* ? ?

Silver Y 0.0005 0.05 0.20 0/ 0 ? ?

Silicon N  NL NL

Sodium Y ? NL NL NA/ NA ? ?

Strontium N  NL NL

Sulfate Y ? NL NL NA/ NA ? ?

Sulfite N  NL NL

Sulfide N  NL NL

Titanium N  NL NL

Thallium Y .0056/. 0 18 0.002 NL */ NA ? ?

Vanadium Y 0.010 NL 0.3 NA/ 0 ? ?

Zinc Y 0.004 NL 10 NA/ 0 ? ?

Field Parameters pH Y NA NL NL NA/ NA ? ?

Conductivity Y NA NL NL NA/ NA ? ?

TSS N  NL NL

Dissolved solids Y ? NL NL NA/ NA ? ?

Total Inorganic Carbon N  NL NL

Total Organic Carbon Y ? NL NL NA/ NA ? ?

COD Y 5 NL NL NA/ NA ? ?

Organic Substances (only detected substances listed)

Total rec overable phenolics Y 0.005 NL NL NA/ NA

** detection limit is greater than regulatory value Specific Comments: The text of the report states that reference/ background data is collected at the site; however, no reference well location is given. As a result no conclusions can be made concerning the quality of the groundwater on the property in relation to background conditions. There are a few instances of accidences of MCL or HBN regulatory criteria for lead. Based on Lafarge Midwest, Inc. – Alpena, Michigan (continued)

II 30 the number of samples collected from the property during the two sampling events there does not appear to be a significant impact from the property to the local groundwater but without significantly more information concerning the location and depth of the monitoring wells, local and regional geology, groundwater flow, background information and source area information no conclusions can be made concerning the impact. II 31 Lafarge – Paulding, Ohio Summary: The text portion of this report is comparatively detailed. The site has 6 monitoring wells (4 of which are upgradient) which are sampled twice annually. The location of upgradient wells are not specified in the text, but their locations are inferred based on the information contained in the report. The wells are set at 115 feet bgs or approximately 10 feet below the base of the landfill.

The report states that, based on statistical analysis of the data, no impact to the groundwater has been observed.

Table 1. Overall report quality Subsurface description Some well information, minimal geologic information Total no. of wells sampled 6 Sampling dates or duration 14 sample events (from 9/ 95 thru 6/ 01); 2 sample events for chemical analysis (dates unknown) Upgradient wells specified Yes (inferred) Downgradient wells specified Yes (inferred) Site map included No Adequate physical description Yes, of the source areas; otherwise limited Contains discussion section Limited Contains conclusions Statement of statistical analysis References cited No Table 2. Summary reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l # > Background Inorganic Chemicals Alkalinity Y NL NL NL 0/ 0 81 230 0 Aluminum N  NL NL   Ammonia N N  NL NL   Antimony N  0.006 0.014   Arsenic Y 0.005 0.05 5.68E 5 0/ 2** <0.005 1 Barium Y 0.010 2 NL 0/ 0 0.008 – 0.319 0 Beryllium N  0.004 0.004   Bicarbo nate N  NL NL   Boron N  NL NL   Cadmium Y 0.0005 0.005 NL 0/ 0 <0.0005 0 Calcium Y NL NL NL 0/ 0 41 – 210 3 Carbonate N  NL NL   Chloride Y NL NL NL 0/ 0 5 – 27 0 Chromium (total) Y 0.010 0.1 40 0/ 0 <0.01 0 Cobalt N  NL NL   Copper N  1.3 1.0   Fluoride N  4 NL   Iron Y 0.01 NL NL 0/ 0 <0.05 6 Lafarge – Paulding, Ohio (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Background mg/ l # > Background II 32 Lead Y 0.005 0.015 0.015 0/ 0 <0.005 0 Lithium N  NL NL   Magnesium Y NL NL NL 0/ 0 34 – 130 2 Manganese Y 0.050 NL NL 0/ 0 <0.05 – 0.03 4 Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 <0.0002 0 Molybdenum N  NL NL   Nickel N  0.1 NL   Nitrate (as nitrogen) N  10 NL   Nitrite (as nitrogen) N  1 NL   Potassium N  NL NL   Selenium Y 0.005 0.05 0.175 0/ 0 <0.005 0 Silver Y 0.010 0.05 0.20 0/ 0 <0.01 0 Silicon N  NL NL   Sodium Y NL NL NL 0/ 0 15 – 69 2 Strontium N  NL NL   Sulfate Y NL NL NL 0/ 0 123 – 680 3 Sulfite N  NL NL   Sulfide N  NL NL   Titanium N  NL NL   Thallium N  0.002 NL   Vanadium N  NL 0.3   Zinc N  NL 10   Field Parameters pH N  NL NL NA  Conductivity N  NL NL NA  TSS N  NL NL   Dissolved solids Y NL NL NL NA 210 1,100 3 Total Ino rganic Carbon N  NL NL

Total Organic Carbon Y NL NL NL NA 1.9 – 11 0 COD Y NL NL NL  19  63 0 Organic Substances (only detected substances listed) None sampled     NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value Specific Comments: The report provides a reasonable amount of detail concerning the source areas on the property. There is some information concerning the depth of the monitoring wells, but no information about the location of the wells in relation to the sources. The text also does not state which of the 6 wells are located upgradient of the sources only that 4 of the 6 are upgradient. The information concerning reference wells can be inferred from the sample summary tables with the exception of MW 1. Additionally, a greater number of wells are located upgradient than downgradient which should be explained. The number of upgradient wells seems excessive, and it appears there should have been more wells installed downgradient of the potential contaminant sources. Based on the analytical information, concentrations of contaminants are below MCL values; however, a number of substances are detected at greater Lafarge – Paulding, Ohio (continued)

II 33 concentrations than reference values indicating that there is an impact to the local groundwater table as a result of the CKD piles. Samples for metals analysis were all field filtered. Unfiltered samples should have been collected as well for comparison to regulatory criteria. Not enough information is available to conclusively determine the impact from the CKD piles. The statistical analysis conducted for contaminants was performed for only a few parameters for which there is extensive data. A second method of analysis should be used to make a determination of the data for which there is only two sampling events. II 34 Lehigh Portland Cement Company – Mitchell, Indiana Summary: Lehigh is located in an area of karst geology; therefore, sampling of the local surface water bodies is a better indicator of groundwater contamination than groundwater monitoring wells and sample collection. Based on a sampling plan for the property, samples would be collected during multiple sampling events from periods of both high and low flow and from areas, both up and downgradient of the property. Due to the amount of time necessary for the transport of the potential contaminant substances from the facility to the sampling locations, the initial sampling event as summarized in the facility report would need to be used to establish base line conditions. As part of the summary report, samples were collected from the low flow period. High flow samples have not yet been collected and would be collected when sufficient conditions exist. Therefore, the data summarized in the data tables cannot be used for determining the impact of CKD to the groundwater table.

It should be emphasized that the location of the landfill in an area of karst geology makes the impact of the landfill very difficult to assess. Also, the data collected and summarized in the report represents base line conditions only and are compared to groundwater regulatory criteria for consistency with other reports.

Table 1. Overall report quality Subsurface description Indicates only karst conditions exist – more information is needed Total no. of wells sampled 0 – Surface water collection points only Sampling dates or duration 3 sample events during low or standard conditions – 30+ samples collected during each event (11/ 9/ 00, 1/ 11/ 01, 1/ 30/ 01) Upgradient wells specified NA – upgradient sample location not specified Downgradient wells specified NA – sample location not specified Site map included No Adequate physical description No Contains discussion section Limited Contains conclusions Only states that no conclusion could be made at this time References cited No Table 2. Summary reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity Y NL NL NL NA/ NA Aluminum N  NL NL Ammonia N N  NL NL Antimony N  0.006 0.014 Arsenic Y 0.005 0.05 5.68E 5 40/** Lehigh Portland Cement Company – Mitchell, Indiana (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 35 Barium Y 0.020 2 NL 0/ NA Beryllium N  0.004 0.004 Bicarbonate Y NL NL NL NA/ NA Boron N  NL NL Cadmium Y 0.005 0.005 NL 0/ NA Calcium Y 1.0 NL NL NA/ NA Carbonate Y 1 NL NL NA/ NA Chloride Y NL NL NL NA/ NA Chromium (total) Y 0.01 0.1 40 0/ 0 Cobalt N  NL NL Copper Y 0.01 1.3 1.0 0/ 0 Fluoride Y NL 4 NL 0/ NA Iron Y 0.10 NL NL NA/ NA Lead Y 0.005 0.015 0.015 0/ 0 Lithium N  NL NL Magnesium Y 1.0 NL NL NA/ NA Manganese Y 0.015 NL NL NA/ NA Mercury (inorganic) Y 0.0005 0.002 0.011 0/ 0 Molybdenum N  NL NL Nickel N  0.1 NL Nitrate (as nitrogen) N  10 NL

Nitrite (as nitrogen) N  1 NL

Potassium Y  NL NL NA/ NA Selenium Y 0.005 0.05 0.175 0/ 0 Silver Y 0.005 0.05 0.20 0/ 0 Silicon N  NL NL

Sodium Y NL NL NL NA/ NA Strontium N  NL NL

Sulfate Y NL NL NL NA/ NA Sulfite N  NL NL

Sulfide N  NL NL

Titanium N  NL NL

Thallium N  0.002 NL

Vanadium N  NL 0.3

Zinc Y 0.02 NL 10 NA/ 0 Field Parameters pH N  NL NL

Conductivity N  NL NL

TSS Y NL NL NL NA/ NA Lehigh Portland Cement Company – Mitchell, Indiana (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 36 Dissolved solids Y NL NL NL NA/ NA Total Inorganic Carbon N  NL NL Total Organic Carbon N  NL NL

COD N  NL NL

Organic Substances (only detected substances listed) None sampled

Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value Specific Comments: Areas of karst geology and the impact from areas of potential contamination are very difficult to assess. This report does not provide enough information concerning the conditions that exist at the site to determine whether the sampling approach is appropriate. For instance, the distance from the site to the sample locations for water bodies should be included and the water bodies receiving groundwater from the site and background location have not been specified. Additionally, the report states that conclusions concerning an impact to the groundwater cannot be made due to the length of time needed for the transport to occur. As a result, there can be no conclusions made at this time concerning the impact or lack of impact to the groundwater in the area. More information and sampling events are necessary. Also, if contaminants are detected they may not necessarily be attributable to the site – groundwater in the vicinity of the site may travel and be received by water bodies other than the few that are sampled. II 37 Lone Star Industries, Inc. – Cape Girardeau, Missouri Summary: This summary report makes two specific claims: (1) the source of elevated metals groundwater concentration does not appear to be the CKD Management Area because background concentrations are elevated, and therefore, not significantly different; and (2) previous studies indicated that metals are not leaching through the CKD to the groundwater. However, the report does not contain a site map, subsurface description, methods of groundwater collection and analyses, or any indication as to the relative locations of monitoring wells to one another with respect to groundwater flow direction. In other words, there is no way to substantiate or refute the claims stated above. The monitoring well data indicate concentrations of arsenic, beryllium, cadmium, and selenium that exceed MCLs. Silicon also is present in relatively high concentrations in some wells.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 11 Sampling dates or duration Annual sampling in most cases Upgradient wells specified Not identifiable Downgradient wells specified Not identifiable Site map included No Adequate physical description None Contains discussion section No Contains conclusions No References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N  NL Aluminum N  NL Ammonia N N  NL Antimony Y 0.1 0.006 0.014 6**/ 6** Arsenic Y 0.001 0.05 0.000056 8 3/ 44**

Barium Y 0.02 2 NL 0 Beryllium Y  0.004 0.004 3/ 3 Bicarbonate N   NL Cadmium Y 0.001 0.005 NL 7 Calcium N   NL Carbonate N  NL NL Chloride N  NL NL Chromium (total) Y 0.01 0.1 40 0/ 0 Copper Y 0.01 1.3 1.0 0/ 0 Lone Star Industries, Inc. – Cape Girardeau, Missouri (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 38 Fluoride N  4 NL 0 Iron Y  NL NL Lead Y 0.1 to 0.001 NL 0.015 13**

Magnesium Y  NL NL Manganese Y  NL NL Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 Nickel Y 0.04 0.1 NL 0 Nitrate (as nitrogen) N  10 NL Nitrite (as nitrogen) N  1 NL Potassium N  NL NL Selenium Y 0.001 0.06 0.175 1/ 0 Silver Y 0.001 to 0.01 0.05 0.20 0/ 0 Sodium N  NL NL Sulfate Y  NL NL Thallium Y 0.1 0.002 NL 0 Vanadium Y 0.05 NL 0.3 0 Zinc Y  NL 10 0 Field Parameters pH Y  NL NL Conductivity Y  NL NL TSS N  NL NL Note Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: Evaluating the likelihood that the metals present in the downgradient groundwater are insignificantly different than background is not possible due to the lack of necessary information (site maps, geologic descriptions, history, etc.). In addition, references to earlier work, or inclusion of past reports, is necessary to review potential historical impacts to the site. II 39 II 40 II 41 Lone Star Industries, Inc. – Pryor, Oklahoma Summary: This report consists of one paragraph that briefly covers permitting status, history, and brief conclusion regarding groundwater quality in the vicinity of the site.

Table 1. Overall report quality Subsurface description No Total no. of wells sampled 7 Sampling dates or duration 1999 Upgradient wells specified Not specified Downgradient wells specified Not specified Site map included No Adequate physical description No Contains discussion section No Contains conclusions Limited Reference cited No Table 2. Summary reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N NA NL NA Aluminum N NA NL NA Ammonia N N NA NL NA Antimony Y 0.005 0.006 0.014 1/ 0 Arsenic Y 0.005 0.05 0.000056 8 4/ 5**

Barium Y  2 NL 0 Beryllium Y 0.001 0.004 0.004 0/ 0 Bicarbonate N NA NL NA Cadmium Y 0.001 0.005 NL 0 Calcium N NA NL NA Carbonate N NA NL NA Chloride Y  NA NL NA Chromium (total) Y  0.1 40 0/ 0 Copper Y 0.005 1.3 1.0 0/ 0 Fluoride N 4 NL 0 Iron Y 0.03 NA NL NA Lead Y 0.002 0.015 0.015 1/ 1 Magnesium N NA NL NA Manganese Y  NA NL NA Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 Nickel Y 0.01  NL NA Lone Star Industries, Inc. – Pryor, Oklahoma (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 42 Nitrate (as nitrogen) N 10 NL 1 Nitrite (as nitrogen) N 1 NL NA Potassium N NA NL NA Selenium Y 0.002 0.05 0.175 0/ 0 Silver Y 0.001 0.05 0.20 0 Sodium N NA NL NA Sulfate Y  500 NL 3 Thallium Y 0.004 0.002 NL 7** Field Parameters pH N NA NL NA Conductivity N NA NL NA TSS Y 4.0 NA NL NA Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: The quality of this report is very poor due to: (1) absence of a site map, (2) absence of geographical references associated with monitoring wells, (3) absence of background concentrations, and (4) lack of attention to statistical importance, if any, of results. The claim that the CKD influenced groundwater at this site is limited to a perched aquifer cannot be confirmed based on the information provided. II 43 National Cement Company of California – Lebec, California Summary: The CKD landfill has been closed and a documented release has occurred. Long term monitoring is being conducted to monitor for any new releases from the source area and to monitor the existing conditions.

Table 1. Overall report quality Subsurface description Yes Total no. of wells sampled 12 Sampling dates or duration 40 (3/ 91 thru 8/ 00) Upgradient wells specified Yes Downgradient wells specified Yes Site map included Yes Adequate physical description Yes Contains discussion section Yes Contains conclusions Yes References cited Yes Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic C hemicals Alkalinity Y  NL NL NA Aluminum N  NL NL Ammonia N N  NL NL Antimony N  0.006 0.014 Arsenic N  0.05 5.68 E 5 Barium N  2 NL Beryllium N  0.004 0.004 Bicarbonate N  NL NL Boron N  NL NL Cadmium N  0.005 NL Calcium Y  NL NL NA Carbonate N  NL NL Chloride Y  NL NL NA Chromium (total) N  0.1 40 Cobalt N  NL NL Copper N  1.3 1.0 Fluoride N  4 NL Iron N  NL NL Lead Y 0.002 0.015 0.015 17/ 17 Lithium N  NL NL Magnesium Y  NL NL NA Manganese N  NL NL Mercury (inorganic) N  0.002 0.011 Molybdenum N  NL NL  National Cement Company of California – Lebec, California (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 44 Nickel N  0.1 NL Nitrate (as nitrogen) Y  10 NL NA Nitrogen (Nitrate + Nitrite) N  11 NL Potassium Y 5.00 NL NL NA Selenium N  0.05 0.175 Silver N  0.05 0.20 Silicon N  NL NL Sodium Y  NL NL NA Strontium N  NL NL Sulfate Y  NL NL NA Sulfite N  NL NL Sulfide N  NL NL Titanium N  NL NL Thallium N  0.002 NL Vanadium N  NL 0.3 Zinc N  NL 10 Field Parameters pH Y  NL NL NA Conductivity Y  NL NL NA TSS N  NL NL Dissolved solids Y  NL NL NA Total Inorganic Carbon N  NL NL Total Organic Carbon N  NL NL COD N  NL NL Organic Substances (only detected substances listed) None sampled Note: Background well locations were not identified. NL = Not listed as having a re gulatory standard (MCL and/ or HB N). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: The report is thorough and relatively complete. It appears that the rationale used for the analytical selection may be sufficient. The level of detail in the report and the amount of sampling that has been conducted is sufficient to support the conclusions that have been made concerning the impact to the groundwater table. However, the facility should be asked to provide any additional information it has to further substantiate that the parameters being monitored are adequate. II 45 North Texas Cement Company – Midlothian, Texas Summary: The summary for the site is fairly brief but included with the summary report is a copy of the RCRA Facility Investigation which is a detailed investigation containing maps, figures, and a complete site summary. The RCRA report states that there is no impact to the local groundwater table as a r esult of the CKD landfill on the property.

Table 1. Overall report quality Subsurface description Yes Total no. of wells sampled 6 Sampling dates or duration 1 (7/ 1997)

Upgradient wells specified Yes Downgradient wells specified Yes Site map included Yes Adequate physical description Yes Contains discussion section Yes Contains conclusions Yes References cited No Table 2. Summary of reported data Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN Inorganic Chemicals Alkalinity N  NL NL Aluminum N  NL NL Ammonia N N  NL NL Antimony Y 0.006 0.006 0.014 0/ 0 Arsenic Y 0.005 0.05 5.68E 5 0/*

Barium Y 0.01 2 NL Beryllium Y 0.003 0.004 0.004 0/ 0 Bicarbonate N  NL NL Boron N  NL NL Cadmium Y 0.005 0.005 NL 0/ 0 Calcium N  NL NL Carbonate N  NL NL Chloride N  NL NL Chromium (total) Y 0.005 0.1 40 0/ 0 Cobalt N  NL NL Copper N  1.3 1.0 Fluoride N  4 NL North Texas Cement Company – Midlothian, Texas (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 46 Iron N  NL NL Lead Y 0.003 0.015 0.015 0/ 0 Lithium N  NL NL Magnesium N  NL NL Manganese N  NL NL Mercury (inorganic) Y 0.0002 0.002 0.011 0/ 0 Molybdenum N  NL NL Nickel N  0.1 NL Nitrate (as nitrogen) N  10 NL Nitrogen (Nitrate + Nitrite) N  11 NL Potassium N  NL NL Selenium Y 0.005 0.05 0.175 0/ 0 Silver Y 0.005 0.05 0.20 0/ 0 Silicon N  NL NL Sodium N  NL NL Strontium N  NL NL Sulfate N  NL NL Sulfite N  NL NL Sulfide N  NL NL Titanium N  NL NL Thallium Y 0.01 0.002 NL 0/ 0 Vanadium N  NL 0.3 Zinc Y 0.02 NL 10 0/ 0 Field Parameters pH NL NL Conductivity N NL NL TSS N NL NL Dissolved solids N NL NL Total Inorganic Carbon N NL NL Total Organic Carbon N NL NL COD N NL NL North Texas Cement Company – Midlothian, Texas (continued)

Sampled ? DL MCL HBN (landfill) # Exceed MCL/ HBN II 47 Organic Substances (only detected substances listed)

None sampled Note: Background well locations were not identified. NL = Not listed as having a regulatory standard (MCL and/ or HBN). NA = Not applicable. ** Detection limit is greater than regulatory value.

Specific Comments: The report is thorough and relatively complete, but there has been only one sampling event and only a few metals were analyzed. The level of detail in the report would be sufficient to support the conclusions if there were a greater number of metals analyzed and the conduct of multiple sampling events. Based on the information contained in the report, it does not appear that a release to the groundwater table has occurred although a greater number of samples should be collected to support that conclusion.


[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20641-20642]
[FR Doc No: 2012-8249]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0331]

Jose Concepcion: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Jose Concepcion for 5 years from providing services in any capacity to
a person that has an approved or pending drug product application. FDA
bases this order on findings that Mr. Concepcion was convicted of
conspiracy to commit an offense against the United States, that the
conduct that served as the basis for the felony conspiracy conviction
relates to the development or approval, including the process for
development or approval, of any drug product and relates to the
regulation of drug products under the FD&C Act, and that the type of
conduct underlying the conviction undermines the process for the
regulation of drugs. Mr. Concepcion was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Mr. Concepcion failed to request a hearing.
Mr. Concepcion's failure to request a hearing constitutes a waiver of
his right to a hearing concerning this action.

DATES: This order is effective April 5, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., rm. 4144, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(II) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds
that the individual has been convicted of a conspiracy to commit a
felony under Federal law for conduct relating to the development or
approval, including the process for development or approval, of any
drug product or otherwise relating to the regulation of a drug product
under the FD&C Act, if FDA finds that the type of conduct that served
as the basis for the conviction undermines the process for the
regulation of drugs.
    On December 1, 2010, based upon a plea of guilty to one count of
conspiracy to commit an offense against the United States, in violation
of 18 U.S.C. 371, judgment was entered against Mr. Concepcion in the
U.S. District Court for the District of New Jersey.
    FDA's finding that debarment is appropriate is based on the
conspiracy conviction referenced herein. The factual basis for the
conviction is as follows: Mr. Concepcion was employed at Able
Laboratories, Inc. (Able) from mid-1998 until January 2005. Able
developed, manufactured, and sold several generic drug products,
including products for cardiac and psychiatric conditions and
prescription pain relievers. Mr. Concepcion was employed as a chemist
in the Quality Control Department performing analytical tests on Able
products to ensure product safety and effectiveness from in or around
mid-1998 to around January 2001. In or around January 2001, Mr.
Concepcion was promoted to group leader and around April 2002, he was
promoted to supervisor in the Quality Control Department.
    As group leader and supervisor in the Quality Control Department,
Mr. Concepcion's responsibilities included supervising numerous
chemists and technicians who performed analytical quality control tests
on Able's generic drug products to ensure product safety and
effectiveness; monitoring the chemists' compliance with current Good
Manufacturing Practices, as required by the FD&C Act and FDA
regulations; and ensuring compliance with Able's standard operating
procedures (SOPs).
    From in or around 1999 through January, 2005, Mr. Concepcion
conspired to cause the introduction and delivery for introduction into
interstate commerce of a drug that was adulterated and misbranded, with
an intent to defraud and mislead, contrary to 18 U.S.C. 371 and 21
U.S.C. 331(a) and 333(a)(2).
    Mr. Concepcion and his co-conspirators impaired, impeded, defeated,
and obstructed FDA's lawful government function to approve the
manufacture and distribution of generic drug products by violating Good
Manufacturing Practices; violating SOPs by failing to properly
investigate, log, and archive questionable, aberrant, and unacceptable
laboratory results so that Able could conceal improprieties and
continue to distribute and sell its drug products; manipulating and
falsifying testing data and information to conceal from FDA failing
laboratory results relating to Able's generic drug products; creating
and maintaining false, fraudulent, and inaccurate test results to make
it appear that drug products had the requisite identity, strength,
quality, and purity characteristics so the drug products could be
distributed and sold to increase Able's sales and profit; and creating
and maintaining false, fraudulent, and inaccurate data and records to
obtain FDA approval to market new product lines.
    In furtherance of the conspiracy, in or around December 2001, Mr.
Concepcion and his co-conspirators falsified and manipulated testing
data relating to stability tests for propoxphene napsylate and
acetaminophen.
    As a result of his conviction, on January 6, 2012, FDA sent Mr.
Concepcion a notice by certified mail proposing to debar him for 5
years from providing services in any capacity to a

person that has an approved or pending drug product application. The
proposal was based on a finding, under section 306(b)(2)(B)(i)(II) of
the FD&C Act, that Mr. Concepcion was convicted of conspiracy to commit
an offense against the United States, that the conduct that served as
the basis for the felony conspiracy conviction relates to the
development or approval, including the process for development or
approval, of any drug product and relates to the regulation of drug
products under the FD&C Act, and that the conduct that served as a
basis for the conviction undermines the process for the regulation of
drugs. The proposal also offered Mr. Concepcion an opportunity to
request a hearing, providing him 30 days from the date of receipt of
the letter in which to file the request, and advised him that failure
to request a hearing constituted a waiver of the opportunity for a
hearing and of any contentions concerning this action. Mr. Concepcion
failed to request a hearing within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(II) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Jose Concepcion has been convicted of a felony under Federal law
for conduct relating to the regulation of a drug product under the FD&C
Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Mr. Concepcion is debarred
for 5 years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see section 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Concepcion, in any capacity during
Mr. Concepcion's debarment, will be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr.
Concepcion provides services in any capacity to a person with an
approved or pending drug product application during his period of
debarment he will be subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Mr. Concepcion during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Concepcion for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 355a(d)(1)) should
be identified with Docket No. FDA-2009-N-0331 and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-8249 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P


Summary of Holy Cross Hospital Site Visit

Site:	Holy Cross Hospital

	Silver Spring, Maryland

Date: 		October 31, 2007

Purpose:	To learn about the generation and management of RCRA hazardous
waste in hospitals and their laboratories

Attendees:

U.S. EPA, Office of Solid Waste

Kristin Fitzgerald

Jessica Biegelson

Meg McCarthy

Nick Hilosky

Christina Kager

American Hospital Association

Robyn Cooke, Senior Associate Director, Executive Branch Relations,

Jose Segarra, Operations Manager, American Society for Healthcare
Environmental Services

Holy Cross Hospital Staff

Glenn Anderson, Senior Director, Clinical Services

Jeff Joyner, Vice President, Patient Support Services

David Meeder, Director, Laboratory Services

Richard Parrish, Director, Pharmacy

Mark Bishop, Assistant Director, Pharmacy

Peter McCaffrey, Director, Environmental Services

Beatrice Miller, R.N., Director, Oncology

Jamie Green, R.N., Nurse Manager, Operating Room/Endoscopy

To begin the site visit, staff from Holy Cross Hospital presented
general overview information about their hospital.  We discussed their
current waste practices within the different departments of the
hospital.  We also talked about what types of labs the hospital has and
what lab waste the hospital generates.

Then we took a tour of the hospital, visiting four areas:

Operating Room

Clinical Laboratory

Pharmacy

Infusion Center

Pharmaceutical waste appears in all of the hospital’s waste streams,
but hazardous wastes are mainly generated in the ER, intensive care unit
and in the pharmacy.  Hazardous wastes comprise less than 2% of their
pharmaceutical waste (the hospital does not use much epinephrine or
nitroglycerine).

Problems/questions with RCRA

Inhalers

Partially-used controlled substances

Listing dosage forms- if a drug is on the federal list in one form (i.e.
pills, capsule, liquid, topical, IV), are the other forms considered
listed, too?

Insulin/steroids- medical waste or hazardous waste?

Further complicated if there’s a sharp involved

TPN-intravenous feeding- are these hazardous wastes?