o Stq UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ii:; .iiON 5 77 WEST JACKSON BOULEVARD CHICAGO, IL 60604-3590 US EPA RECORDS CENTER REGION 5 L PRO1 11111111 11111111111 11111 J10
MEMORANDUM REPLY TO THE ATTENTION OF
SUBJECT: ACTION MEMORANDUM: Request for approval of an Emergency Removal Action at the Advanced Medical Systems Site, Cleveland, Cuyahoga County, Ohio (Site ID # C56V)
FROM: Stephen Wolfe, OSC Emergency Response Branch 1, Section 1
THRU: James E. Augustyn, Acting Section Chief Emergency Response Branch 1
TO: Jason H. El-Zein, Chief Emergency Response Branch 1
I. PURPOSE
The purpose of this Action Memorandum is to request and document approval of the selected removal action taken at the Advanced Medical Systems Site (Site) located in Cleveland, Cuyahoga County, Ohio and a ceiling not to exceed $100,000. This response action was necessary to mitigate the imminent threat to the public health, welfare, and the environment posed by the presence of and potential release of cobalt-60 at the Site.
On June 15, 2016, the Ohio Department of Health (ODH) requested EPA assistance in responding to vandalism at the Advanced Medical Systems (AMS) Site. ODH requested additional assistance on July 7, 2016, in connection with additional vandalism. ODH is the regulatory agency at the Site and has documented the presence of radiological hazards since the 1990s.
EPA documented the presence of radiological hazards during a site assessment performed at the facility in 2015. The Removal Action only addressed the emergency response activities requested by ODH. On June 16, 2016, Branch Chief Jason El-Zein verbally approved an initial ceiling of $50,000 for ERRS to initiate response actions. On June 22, 2016, Branch Chief Jason El-Zein approved via electronic mail a ceiling increase to $100,000 (AR#9).1
This Action Memorandum, if approved, will serve as authorization for expenditures by the EPA, as the lead technical agency, for actions described herein to abate the imminent and substantial endangeiment posed by hazardous substances at the Site. The response actions were conducted
1 This removal action has been completed, but is presented as a proposed removal action for approval in this document.
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 50% Recycled Paper (20% Postconsumer) in accordance with Section 104(a)(1) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), 42 U.S.C. § 9604(a)(1) and Section 300.415 of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR 300.415 to abate or eliminate the immediate threat posed to public health and/or the environment by the presence of the hazardous substances, pollutants and/or contaminants. The uncontrolled conditions of the hazardous substances, pollutants and/or contaminants present at the Site require that this action be classified as an emergency removal action. The emergency response work required approximately 20 working days to complete.
There are no nationally significant or precedent setting issues associated with the Advanced Medical Systems Site and the Site is not on the National Priorities List (NPL).
II. SITE CONDITIONS AND BACKGROUND
CERCLIS ID: 0HN000506336 Category: Time-Critical Removal Action
The Site includes an approximate 5-acre lot and includes an approximate 80,000 square foot 2.5 story building that includes a basement. AMS began operations at the Site in 1979 when the United States Nuclear Regulatory Commission (USNRC) granted it a license to manufacture USNRC-approved sealed sources for use in medical equipment.
In October of 1994 the Executive Director of the Northeast Ohio Regional Sewer District (NEORSD) served an Order upon AMS indicating that the NEORSD would no longer provide wastewater treatment services for the AMS facility due to cobalt-60 contamination. NEORSD installed plugs in the AMS connections to the sewage treatment system rendering the facilities drain system non-functional. Since then, AMS ceased source production and concentrated efforts on those that could facilitate a reconnection of the facility to the NEORSD sewage system (AR#2).
In August, 1999, the Ohio Department of Health, Bureau of Radiation Protection became a USNRC Agreement State and assumed regulatory authority over the AMS radioactive materials license. In March, 2003, the Supreme Court of Ohio denied an appeal by AMS of a decision affirming an Ohio Department of Health Order denying AMS' application to renew its Ohio Radioactive Materials License. Since then, the Site has been in stages of decommissioning (AR#2).
Due to the NEORSD sewer plugs, the facility's basement flooded in the 1990's. The water was contaminated with cobalt-60 and required evaporation to remedy the problem. A drainage system was installed such that all Site water would circulate through one point where a composite sampler collected water samples for analysis. The water was then discharged to the ground in the rear of the facility (AR#11).
A Radiation Safety Officer (RSO) was assigned to the Site by AMS and the RSO regularly collected the composite sample and analyzed the sample on site according to plans submitted with the Ohio Department of Health. On June 14th, 2016, the Site's RSO reported to the Ohio
2 Department of Health, Bureau of Environmental Health and Radiation Protection (ODH) that vandals had cut the power lines running to the facility and began stripping copper wire from the facility rendering the water drainage system inoperable. ODH hired a contractor to provide temporary pumping and water storage until the system could be brought back on line.
On June 15, 2016, ODH formally requested EPA assistance in restoring power to the drainage system and further securing the building (AR#4). ODH requested additional assistance on July 7,2016 (AR#8).
A. Site Description
1. Removal Site Evaluation
EPA met with representatives from ODH, Cleveland Fire, and the RSO on June 14th and inspected the Site after AMS reported recent vandalism. Cleveland Public Power was on site and turned off the power to the lines that were cut by the vandals. The entrance the vandals used to gain access to the building was discovered. The backup generator for the facility was inspected and was inoperable. Approximately 1,000 gallons of water was in the Site's sump (3,000 gallon capacity) and inclement weather was predicted overnight. ODH retained the services of a contractor to board the entrance the vandals used and to provide temporary pumping/storage of the Site's drainage water.
ODH and EPA contacted the agent for AMS and was informed that AMS does not have the resources to address the problems caused by the vandalism (AR#s 3,5,6).
2. Physical location
The Site is located at 1020 London Road in Cleveland, Cuyahoga County, Ohio, 44110. The geographical coordinates for the Site are 41° 33' 16.86" North latitude and 81° 33' 48.11" West longitude.
3. Site characteristics
The Site is comprised of an approximate 5-acre parcel of land with an 80,000 square foot building. Residential properties and a community park are located to the north and west of the site. Railroad tracks and other commercial buildings are located to the south and east. The Site is bordered by London Road to the northeast and Mandalay Avenue to the northwest. All sewer drains leading from the Site were plugged in the 1990's by the NEORSD due to cobalt-60 contamination in the sewers.
4. Release or threatened release into the environment of a hazardous substance, or pollutant or contaminant
The Site's water drainage flows through a sample collector prior to discharging to the rear of the facility. The sample is analyzed by the AMS RSO and reported to ODH. The loss of electricity to the building can cause the Site's water drainage to back up, leave the Site and enter nearby residential area. 3 There are several areas of the facility that have not been decommissioned and that have high levels of radioactivity. In addition, several areas that have been decommissioned by AMS have not been released by ODH for unrestricted use. These areas are dangerous to trespassers and there is the potential for removable contamination to be taken out of the building during trespassing activities.
Cobalt-60 is the contaminant of concern at the AMS site and is a hazardous substance (40 CFR § 302.4 [Table 302.4 Appendix B]). Radioactive decay of Cobalt-60 can cause acute radiation syndrome that includes nausea, vomiting, diarrhea, bleeding, coma, and death. Exposure to high levels of cobalt radiation can cause changes in the genetic materials within cells and may result in the development of some forms of cancer (AR#1)
5. NPL status
The Site is currently not on the National Priorities List (NPL).
6. Maps, pictures and other graphic representations
A Map showing the aerial view of the Site is provided.
7. Environmental Justice Analysis
An Environmental Justice (EJ) analysis for the Site is contained in Attachment 1. Screening of the surrounding area used Region 5's EJ Screen Tool. Region 5 has reviewed environmental and demographic data for the area surrounding the Site at 1020 London Road, Cleveland, Cuyahoga County, Ohio, and determined there is a high potential for EJ concerns at this location.
B. Other Actions to Date
1. Previous actions
EPA is performing removal site evaluation in response to a June 9, 2015, request for assistance from ODH, requesting sampling, clean-up removal/response activities at the Site. EPA has conducted on-site assessment activities and is in the process of finalizing a site assessment report. (AR#11).
2. Current actions
ODH requested assistance from EPA to provide resources to restore power to the Site's drainage system, further securing the Site, and to provide means of temporary pumping/storage of drainage water until power is restored (AR#s 4, 8).
4 C. State and Local Authorities' Roles
1. State and local actions to date
ODH is the regulatory authority for the Site and, with the Nuclear Regulatory Commission, has overseen decommissioning efforts to date. ODH provided contracted personnel for initial, limited emergency drainage water control prior to requesting EPA assistance.
2. Potential for continued State/local response
ODH has requested EPA assistance and indicated that they do not have the resources to complete all necessary work (AR#s 4,8). ODH has agreed to provide radiation professionals for the health and safety of EPA contractors during all work.
III. THREATS TO PUBLIC HEALTH OR THE ENVIRONMENT, AND STATUTORYAND REGULATORY AUTHORITIES
The conditions at the Advanced Medical Systems Site presented a substantial threat to the public health or welfare, and the environment, and met the criteria for an emergency removal action as provided for in the NCP, 40 C.F.R. § 300.415(b)(2). These criteria include, but are not limited to, the following:
Actual or potential exposure to nearby human populations, animals, or the food chain from hazardous substances or pollutants or contaminants;
Some of the areas within the AMS building are considered "controlled areas" and these have not been released by ODH for unrestricted use. There are several rooms within the building that emit radiation levels higher than background. These areas present a danger to trespassers as they would be unaware of the dangers present, and would not have proper monitoring and/or PPE.
When the Site's access to local sewer lines was plugged in the 1990s, the basement flooded and the floodwaters were contaminated with Cobalt-60, creating a potential for release of contaminated flood waters into the environment. At that time, AMS was actively engaged in attempting to restart manufacturing operations and corrected the problem by installing a drainage system whereby the Site's drainage lead to a sump. Water from the sump was actively pumped through a composite sampler, analyzed, and released to the environment if it met ODH criteria. With the water drainage system inoperable due to loss of electricity, and initial, limited emergency drainage water control in place, the basement could flood again, and the water could become contaminated with Cobalt-60 again which could release into the environment.
In addition, the Site's drainage system initially gravity feeds to an exterior sump, located near the northeast corner of the building, with a capacity of 3,000 gallons. The sump is located less than 25 feet from a public road. With the water drainage system inoperable, the sump could overflow and release potentially contaminated water out into the road. Weather Conditions that may cause hazardous substances or pollutants or contaminants to migrate or be released;
The main system currently in place to control site drainage was rendered inoperable due to loss of electricity from vandalism. The Site is currently blocked from using local sewer drains (blocks have been in place since the 1990s). Heavy rains/snow melt could cause flooding inside the building, particularly the basement, which has occurred in the past, when flood waters were contaminated with Cobalt-60 in the basement.
The availability of other appropriate federal or state response mechanisms to respond to the release;
On June 15, 2016, ODH initially responded to the Site and provided means for temporary pumping/storage of drainage water — thus providing initial, limited emergency drainage water control. On June 16, 2016, ODH formally requested EPA's assistance in mitigating the potential threats at the Site (AR#4). ODH requested additional assistance on July 7, 2016 (AR#8).
Other situations or factors that may pose threats to public health or welfare of the United States or the environment;
The AMS building is unsecure and is an attractive nuisance for trespassers. Although it is unlikely radioactive material will be removed from the premises, there are areas within the building that present a danger to anyone accessing them, including trespassers, due to the residual Cobalt-60 contamination.
IV. ENDANGERMENT DETERMINATION
Based on the Site conditions, the nature of the known and suspected hazardous substances, pollutants or contaminants onsite, and the potential exposure pathways described in Sections II and III above, actual or threatened releases of hazardous substances, pollutants or contaminants from this Site, if not addressed by implementing the response actions selected in this Action Memorandum, may have presented an imminent and substantial endangerment to public health, welfare, or the environment.
V. SELECTED REMEDIAL ACTIONS AND ESTIMATED COSTS'
A. Situation and Removal Actions to Date
1. Current Situation
The Emergency Removal is complete
2. Removal Actions to Date
2 As indicated above, this removal action has been completed, but is presented as a proposed removal action for approval in this document. 6 At the request of ODH, EPA responded and took actions secure the site and restore electricity to the Site's drainage system.
Between June 16th and July 18th, 2016, EPA completed the following Actions:
a) Provided Site Security; b) Provided personnel to operate the Site's drainage system manually during inclement weather; c) Restored electrical power to the Site's drainage system and provided means that the system could operate from portable generators d) Secured accessible windows to the building with metal bars; e) Secured all exterior doors to the facility (welded shut); Installed motion activated solar lighting to deter trespassers; and g) Removed brush located against the building.
This removal action was conducted in a manner not inconsistent with the NCP. The OSC has initiated planning for provision of post-removal Site control consistent with Section 300.415(1) of the NCP. The property owner will be responsible for providing operation and maintenance of the water management system once power is restored to the facility. In the event that the property owner does not provide qualified personnel for this activity, the ODH will provide oversight to ensure the system is operating as designed.
Off-Site Rule - No hazardous substances, pollutants or contaminants were removed off-Site pursuant to this removal action.
3. Contribution to remedial performance:
The actions taken will not impede future actions, based on available information.
4. Engineering Evaluation/Cost Analysis (EE/CA)
Not Applicable
5. Applicable or Relevant and Appropriate Requirements (ARARs)
All applicable, relevant, and appropriate requirements (ARARs) of Federal and state law were complied with to the extent practicable considering the exigencies of the circumstances.
Federal RCRA Subtitle C SDWA MCLs
7 State On July 6, 2016, EPA asked Mr. Stephen Helmer and Mr. Jim Colleli of Ohio Department of Health, Bureau of Radiation Protection via electronic mail to identify any State of Ohio ARARs. On July 25, 2016, ODH identified ARARs via electronic mail. ARARs identified include elements found in the Ohio Administrative Code Chapter 3701 (AR#s 7,10).
6. Project Schedule
The removal activities required approximately 20 onsite working days.3
7. Disproportionate Funding
The response actions described in this memorandum directly addressed the actual or threatened release at the Site of hazardous substances, pollutants or contaminants, which posed an imminent and substantial endangerment to public health, welfare, or the environment. EPA does not believe that the response actions taken will impose a disproportionate burden on the affected property.
B. Estimated Costs
The detailed cleanup contractor cost is presented in Attachment 2 and the Independent Government Cost Estimate is presented in Attachment 3. Estimated project costs are summarized below:
REMOVAL ACTION PROJECT CEILING ESTIMATE Extramural Costs: Regional Removal Allowance Costs: Total Cleanup Contractor Costs $ 100,000 (This cost category includes estimates for ERRS, subcontractors, Notices to Proceed, and Interagency Agreements with Other Federal Agencies. Includes a 20% contingency)
Other Extramural Costs Not Funded from the Regional Allowance: Total START, including multiplier costs Total Decontamination, Analytical & Tech. Services (DATS) $ 0 Total CLP $ 0 $ 0 Subtotal $ 0 Subtotal Extramural Costs $ 100,000 Extramural Costs Contingency (20% of Subtotal, Extramural Costs rounded to nearest thousand) $ NA TOTAL REMOVAL ACTION PROJECT CEILING $ 100,000
3 As indicated above, this removal action has been completed, but is presented as a proposed removal action for approval in this document. 8 VI. EXPECTED CHANGE IN THE SITUATION SHOULD ACTION BE DELAYED OR NOT TAKEN
Given the Site conditions, the nature and location of the hazardous substances documented on Site, and the potential exposure pathways to nearby populations described in this Action Memorandum, if not addressed by implementing the response actions selected in this Action memorandum, may have presented an imminent and substantial endangerment to public health, welfare, or the environment by increasing the potential that hazardous substances would have been released, thereby threatening the adjacent population and the environment.
VII. OUTSTANDING POLICY ISSUES
None
VIII. ENFORCEMENT
EPA, via a staff attorney from the Office of Regional Counsel and an enforcement specialist from the Superfund Division, provided verbal notice to AMSs agent regarding the vandalism and actions that are required on June 15, 2016 (AR#5). AMS immediately declined to perfolin or fund the operations (AR#4). In addition, ODH issued an Emergency Order to AMS requiring them to perform the work in response to vandalism. AMS also declined to perform the work required in the Emergency Order (AR#2). For administrative purposes, information concerning the enforcement strategy for this Site is contained in the Confidential Enforcement Addendum.
The total EPA costs for this removal action based on full-cost accounting practices that will be eligible for cost recovery are estimated to be $221,525.4
($100,000+ $25,000) + (77.22% x $125,000) = $221,525
DC. RECOMMENDATION
This decision document represents the selected removal action for the Advanced Medical Systems Site, located Cleveland, Cuyahoga County, Ohio. It was developed in accordance with CERCLA, as amended, and is not inconsistent with the NCP. This decision is based upon the Administrative Record for the Site. Conditions at the Site met the NCP Section 300.415(b)(2) criteria for a removal action and I recommend your approval of the removal action.
4 Direct Costs include direct extramural costs and direct intramural costs. Indirect costs are calculated based on an estimated indirect cost rate expressed as a percentage of site-specific direct costs, consistent with the full cost accounting methodology effective October 2, 2000. These estimates do not include pre-judgment interest, do not take into account other enforcement costs, including Depat anent of Justice costs, and may be adjusted during the course of a removal action. The estimates are for illustrative purposes only and their use is not intended to create any rights for responsible parties. Neither the lack of a total cost estimate nor deviation of actual total costs from this estimate will affect the United States' right to cost recovery. 9
• The total removal action project ceiling if approved will be $100,000. Of this, an estimated $100,000 was used for cleanup contractor costs. You may indicate your decision by signing below.
APPROVE C DATE: 9 -2 1- Branch Chief, ERB1, Superfund Division
DISAPPROVE DATE: Branch Chief, ERB1, Superfund Division
Enforcement Addendum
Maps 1. Aerial view of the Site
Attachments
1. EJ Analysis 2. Detailed Cleanup Contractor and START Estimate 3. Independent Government Cost Estimate 4. Administrative Record Index
cc: B. Schlieger, U.S. EPA HQ (email: Brian Schlieger/DC/USEPA/US) L. Nelson, U.S. Department of Interior, w/o Enf. Addendum (email: Lindy [email protected]) Craig Butler, Director, OEPA, w/o Enf. Addendum (email: craig.butler@ epa. state. oh.0 s) Mike DeWine, Ohio Attorney General, w/o Enf. Addendum (email: [email protected])
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ENFORCEMENT CONFIDENTIAL
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MAPS Aerial View of AMS ATTACHMENT 1
EJ ANALYSIS Advanced Medical Systems Cleveland, OH September 2016 ...
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DETAILED CLEANUP CONTRACTOR ESTIMATE
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INDEPENDENT GOVERNMENT COST ESTIMATE
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U.S. ENVIRONMENTAL PROTECTION AGENCY REMOVAL ACTION
ADMINISTRATIVE RECORD FOR THE ADVANCED MEDICAL SYSTEMS SITE CLEVELAND, CUYAHOGA COUNTY, OHIO
ORIGINAL SEPTEMBER, 2016
NO. SEMS ID DATE AUTHOR RECIPIENT TITLE/DESCRIPTION PAGES
1 928938 4/1/04 ATSDR Public ToxFAQs Fact Sheet - Cobalt 2 - CAS #7440-48-4
2 929447 6/26/15 U.S. Nuclear File Site Information Web Page 2 Regulatory for Advanced Medical Commission Systems, Inc. 3 928930 6/15/16 Hodges, R., Stein, S., Letter re: AMS London Road 2 Ohio Advanced Facility Security, Department of Medical Pumping/Sampling Station, Health Systems and Electrical Power Restoration 4 928931 6/15/16 Hodges, R., Mitchell, J., Letter re: Request for 1 Ohio U.S. EPA Immediate U.S. EPA Department of Assistance at the Advanced Health Medical Systems Site 5 928937 6/15/16 Garypie, C., Bown, J., El- Email re: Response to Verbal 7 U.S. EPA Zein, J., and General Notice (with Draft Borries, S., Verbal Notice Attached) U.S. EPA 6 928936 6/16/16 Garypie, C., Qadir, M., Ohio Email re: 6/15/16 Verbal 2 U.S. EPA Department of Notice from U.S. EPA Health
7 928935 7/6/16 Wolfe, S., U.S. Helmer, S., Email re: Request for State 1 EPA Ohio ARARs for the Advanced Department of Medical Systems Site Health 8 928932 7/7/16 Hodges, R., Mitchell, J., Letter re: Update on 1 Ohio U.S. EPA Vandalism and Request for Department of Immediate U.S. EPA Health Assistance at the Advanced Medical Systems Site 9 928934 7/22/16 El-Zein, J., U.S. Wolfe, S., U.S. Email re: Approval of Ceiling 1 EPA EPA Increase for the Advanced Medical Systems Site
10 928933 7/25/16 Helmer, S., Wolfe, S., U.S. Email re: ARARs for the Ohio EPA Advanced Medical Systems Department of Site (ARARs Table Health Attached) 11 U.S. EPA File Site Assessment Report (PENDING)
12 Wolfe, S., U.S. Ballotti, D., Action Memorandum re: EPA U.S. EPA Request for a Time-Critical Removal at the Advanced Medical Systems Site (PENDING)