The Issue The issue in this case is whether the Petitioner has the actual experience required for certification as a Class B domestic wastewater treatment plant operator.
Findings Of Fact By application filed September 16, 1991, James H. Redden applied for certification as a Class B domestic wastewater treatment plant operator. At the time of the application, Mr. Redden was employed as a laboratory technician at a Class B Collier County regional wastewater treatment facility. From August 15, 1978, to July 31, 1989, Mr. Redden was employed at the Colgate-Palmolive Company facility at Jeffersonville, Indiana. The Colgate-Palmolive treatment facility is an Indiana Class D industrial wastewater treatment plant. Mr. Redden is certified by the State of Indiana as a Class D industrial wastewater treatment plant operator. During his employment at the Jeffersonville facility, Mr. Redden held positions as an associate chemist, senior chemist/plant microbiologist, and wastewater treatment plant supervisor. His duties included daily operations and supervision of personnel, scheduling and performance of maintenance activities, budgeting, ordering, materials balance, sludge management, laboratory analysis, quality assurance and quality control programs, and compliance with various state and federal reporting requirements. Mr. Redden has no experience either in the operation of a drinking water or domestic wastewater treatment plant, or at a DER-permitted industrial wastewater treatment plant.
Recommendation Based on the foregoing, it is hereby: RECOMMENDED that the Department of Environmental Regulation enter a Final Order denying the application of James H. Redden for certification as a Class B wastewater treatment plant operator. DONE and RECOMMENDED this 9th day of April, 1992, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of April, 1992. APPENDIX The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner: The Petitioner did not file a proposed recommended order. Respondent: The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 2-4. Rejected, unnecessary. COPIES FURNISHED: Carol Browner, Secretary Dept. of Environmental Regulation 2600 Blair Stone Road Tallahassee, Florida 32399-2400 Daniel H. Thompson, General Counsel Dept. of Environmental Regulation 2600 Blair Stone Road Tallahassee, Florida 32399-2400 James H. Redden 1362 Chesapeake, Avenue Naples, Florida 33962 Francine M. Ffolkes, Esq. Assistant General Counsel 2600 Blair Stone Road Tallahassee, Florida 32399
The Issue Whether Respondent committed the violations as set forth in the Citation for Violation, Onsite Sewage Program/Sanitary Nuisance dated April 28, 2000.
Findings Of Fact Petitioner is authorized and given the jurisdiction to regulate the construction, installation, modification, abandonment, or repair of onsite sewage treatment and disposal systems, including drainfields, by septic tank contractors. At all times material hereto, Respondent was a registered septic tank contractor and, as such, he was authorized to provide septic tank contracting services, including the installation and repair of drainfields. On or about November 2, 1995, Petitioner issued a permit (Permit No. RP648-95) to Wilmar Rodriguez for the repair of a septic tank system at 417-421 Perry Avenue, Greenacres, Florida. The property was a triplex, which was purchased by Mr. Rodriquez in 1981. Mr. Rodriguez has no knowledge as to whether any drainfields were installed or replaced on the property, prior to 1981. The Permit included the installation of a new multi- chambered septic tank, a dosing tank, a lift station, and a new drainfield. The Permit was also for a filled system and called for the drainfield to be 700 square feet. Respondent was indicated as the "agent" on the Permit. Respondent and/or his employees performed the work under the Permit. Respondent was the septic tank contractor for the repair of the septic tank system under the Permit. On November 9, 1995, the construction of the septic tank system was approved by one of Petitioner's inspectors, who was an Environmental Specialist I. Petitioner's inspectors are not present during the entire construction or repair of a septic tank system or drainfield. Usually, inspections are made after the completion of the construction or repair of the septic tank system. Additionally, the inspection of a drainfield is usually performed after the rock has been placed on top of the drainfield. On February 2, 1996, the same inspector performed the inspection after the completion of the construction of the septic tank system, including after the placing of the rock on top of the drainfield. Even though the Permit reflects a filled system, the filled/mound system section on the inspection sheet was crossed out. The inspector considered the system to be a standard system, not a filled or mound system, and, therefore, inspected it as a standard system. In inspecting a drainfield, the inspection by an inspector includes checking to ensure that a drainfield has 42 inches of clean soil below the drainfield. An inspector uses an instrument that bores down through the rock and brings up a sample of the soil, which is referred to as augering. Augering is randomly performed at two locations. For the instant case, the inspector performed the augering in two random locations of the drainfield, which were in the area of the middle top and the middle bottom. The samples failed to reveal anything suspect; they were clean. On February 2, 1996, the inspector issued a final approval for the septic tank system. Final approval included the disposal of "spoil" and the covering of the septic tank system with "acceptable soil". The inspector mistakenly inspected the system as a standard system. He should have inspected the system as a filled system.1 After the repair and installation of the septic tank system by Respondent, Mr. Rodriguez continued to have problems with the septic tank system. He contacted Respondent three or four times regarding problems with the system, but the problems persisted. Each time, Respondent was paid by Mr. Rodriguez. Sewage water was flowing into the street where the property was located and backing-up into the inside of the triplex. Having gotten no relief from Respondent, Mr. Rodriguez decided to contact someone else to correct the problem. Mr. Rodriguez contacted Richard Gillikin, who was a registered septic tank contractor. On October 14, 1999, a construction permit was issued to Mr. Rodriguez for the repair of the septic tank system. Mr. Gillikin was indicated as the agent. Mr. Gillikin visited the property site of the triplex and reviewed the problem. He determined that the drainfield was not properly functioning, but he did not know the cause of the malfunctioning. With the assistance of Petitioner's inspectors, Mr. Gillikin and Mr. Rodriguez attempted to determine the best method to deal with the problem. After eliminating options, Mr. Rodriguez decided to replace the drainfield. To replace the drainfield, Mr. Gillikin began excavating. He began removing the soil cover and the rock layer of the drainfield. Mr. Gillikin also wanted to know how deep he had to dig to find good soil. After digging for that purpose and for 10 to 12 inches, he discovered a drainfield below Respondent's drainfield. The drainfield that Mr. Gillikin discovered was a rock bed 12 inches thick in which pipes were located and, as indicated, 10 to 12 inches below Respondent's drainfield. Mr. Gillikin also dug a hole two to three feet deep, pumped the water out of the hole, and saw the old drainfield. Mr. Gillikin determined that the old drainfield extended the full length of Respondent's drainfield. As a result of Mr. Gillikin's determining that the old drainfield was below Respondent's drainfield, both drainfields had to be removed and the expense of a new drainfield increased. Leon Barnes, an Environmental Specialist II for Petitioner, who was also certified in the septic tank program, viewed the drainfield site. He determined that the old drainfield was below Respondent's drainfield and that, therefore, Respondent had not removed the old drainfield. On or about November 6, 1999, Mr. Barnes' supervisor, Jim Carter, and co-worker, Russell Weaver, who is an Engineer, also visited the drainfield site. Mr. Weaver determined that the old drainfield covered a little more than 50 percent of the area under Respondent's drainfield. On November 8, 1999, a construction inspection and a final inspection of the system installed by Mr. Gillikin were performed. The system was approved. Respondent admits that a new drainfield is prohibited from being installed over an old drainfield. However, Respondent denies that he installed a new drainfield over the old drainfield on Mr. Rodriguez's property. In 1995, Respondent failed to completely remove the old drainfield before he installed the new drainfield. The soil and rocks from the old drainfield, which was not functioning, were contaminated spoil material. Because the old drainfield was not completely removed, the contaminated spoil material remained in the drainfield and was used as part of the material in the installation of the new drainfield. Leaving the contaminated spoil material in the new drainfield, prevented the sewage water from being able to percolate through the ground, which is a method of cleansing the sewage water. Without being able to percolate through the ground, the sewage water remained on the surface of the drainfield, creating a serious sanitary nuisance and health hazard. The sewage water spilled onto the street and backed-up into the triplex. Respondent was issued a Citation for Violation, Onsite Sewage Program/Sanitary Nuisance by Petitioner.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Palm Beach County Health Department, enter a final order: Affirming the Citation for Violation, Onsite Sewage Program/Sanitary Nuisance and finding that Noel Sanfiel violated Section 381.0065, Florida Statutes (1995), and Rule 10D- 6.0571(4), now Rule 64E-6.015(6), and Rule 10D-6.0751(1)(l)1, now 64E-6.022(1)(l)1, Florida Administrative Code. Imposing a fine of $500. DONE AND ENTERED this 13th day of February, 2001, in Tallahassee, Leon County, Florida. ERROL H. POWELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of February, 2001.
The Issue The issue is whether Respondent's treatment of a patient diagnosed with a fecal impaction deviated from the applicable standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician, holding license number ME 0016053. He has been in practice for 33 years. He is Board Certified in Family Practice. Late in the afternoon of July 6, 1997, M. D., a 58- year-old female, presented to the emergency room at North Shore Medical Center in Miami, complaining of lower and upper abdominal pain, vomiting, and constipation. She reported taking a Fleets enema, but to no effect. She had been experiencing this discomfort for two or three days. Emergency room staff conducted a physical examination of M. D. and ordered blood work and abdominal x-rays. The results of the physical examination and blood work were generally within normal limits, except for generalized abdominal tenderness. M. D. also had an elevated respiration rate and a subtly elevated component of the white blood cell count. The abdominal x-rays revealed what was likely to be a fecal cast in the sigmoid colon, and the radiologist noted the possibility of a partial occlusion in the distal colon. Emergency room staff contacted Respondent for the first time at 10:30 p.m. on July 6. During the conversation, Respondent learned of M. D.'s presence in the hospital emergency room. He learned about her general history and that the results of her physical examination and blood work were generally normal, except for diffuse abdominal tenderness. He also learned generally of the results of the abdominal x-rays. Although the radiologist's report was not available, Respondent understood that the report was consistent with her complaints of constipation. A member of the emergency room staff informed Respondent of the diagnosis of fecal impaction. The staff person reported that they had found no evidence of any other acute processes and asked if Respondent wanted to admit M. D. to the hospital so that they could clear out her impaction. Respondent ordered that the hospital admit M. D. He ordered a liquid diet to rehydrate M. D. and her stool, routine monitoring of M. D.'s vital signs, bathroom privileges, Tylenol as needed for pain, a barium enema, and a standard preparation for a barium enema. The barium enema requires a clear colon. Otherwise, fecal material would show as lumps, which would be indistinguishable from colon masses. The standard preparation for a barium enema takes place over one to two days prior to the administration of the enema. Over this period of time, the patient follows a liquid diet to reduce the amount of fecal material, then takes a laxative, and finally one or more tap water, Fleets, or soap-suds enemas to clear fecal material from the lower bowel. Given the time constraints present in this case, largely due to M. D.'s discomfort, Respondent ordered a barium enema the next morning. He did not want M. D. to receive a laxative, due to the possibility of a bowel obstruction, so he ordered tap water enemas until clear. After giving the orders, Respondent planned to see M. D. at 8 a.m. the next day. Unknown to Respondent, the standard practice at the hospital was to prepare the patient for the barium enema with a laxative, even if the physician ordering the enema did not expressly request one and did expressly request a tap water enema. At 12:30 a.m. on July 7, a hospital nurse administered a saline laxative in the form of a Fleets Phospho-Soda. This gentle laxative is an osmotic agent that draws fluid into the bowel, although it also generates some gastrointestinal peristalsis, by which muscular bowel contractions propel the bowel's contents from the upper portion of the intestinal tract to the rectum. Hospital staff administered a tap water enema to M. D. at 4:00 a.m. on July 7. She did not tolerate the enema well and began to complain of stomach cramps. The record is not entirely clear whether M. D. underwent a second tap water enema at 6:00 a.m.; it appears that her previous discomfort prevented the administration of the second enema. Shortly after 7:00 a.m., M. D.'s condition suddenly deteriorated. Her blood pressure and pulse increased, and her respiration decreased. Her breathing was labored, and her skin became cool and clammy. At 7:57 a.m., a member of the hospital staff telephoned Respondent's answering service and reported M. D.'s deteriorating condition. A minute later, staff summoned an emergency resuscitation team. Two minutes later, staff summoned an emergency cardiac arrest team. However, all attempts to resuscitate M. D. were unsuccessful, and she expired at this time. An autopsy revealed that M. D. died of fecal peritonitis caused by a perforated rectal carcinoma. M. D. had an undiagnosed tumor in her intestinal tract that had killed sufficient tissue so that the intestinal tract had lost its integrity. It is unclear whether the tissue was perforated by the peristalsis caused by the laxative. The mild abnormality in one component of the white blood cell count may have been an early indication of an infection consistent with a spontaneous failure of the weakened intestinal tract, but other white blood cell counts suggest a failure of the intestinal tract long after the administration of the laxative. Clearly, if the weakened intestinal tract withstood the laxative, it could not withstand the cumulative effects of the laxative followed by the tap water enema a few hours later. It is undisputable that the intestinal tract would have failed catastrophically, sooner or later, even without the administration of a laxative or enema. It would have been within the applicable standard of care for Respondent to have sent M. D. home rather than admit her to the hospital. It was within the applicable standard of care for Respondent to visit M. D. anytime within the first 24 hours of her admission to the hospital. It was within the applicable standard of care for Respondent to order a barium enema and tap water enema, even with a gentle laxative, such as the one used. It was within the standard of care for Respondent to treat this case as a simple matter of constipation caused by fecal impaction. The applicable standard of care did not require Respondent to rule out other highly uncommon conditions, such as the loss of tissue due to undiagnosed carcinoma, prior to undertaking the treatment plan that he undertook in this case.
Recommendation It is RECOMMENDED that Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 2nd day of July, 2002, in Tallahassee, Leon County, Florida. ___ ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of July, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Bruce A. Campbell, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Ricardo Torres, Jr., Esquire 7975 Northwest 154th Street Suite 340 Miami, Florida 33016
The Issue The issue is whether Respondent Florida Power & Light Company is entitled to Permit No. 247895-007-UC for the conversion of an exploratory well to an injection well, the construction of a second injection well, and the operational testing of both wells, which are intended to inject industrial wastewater from a power plant into the Boulder Zone of the Upper Floridan Aquifer.
Findings Of Fact Applicant is Florida's largest electric utility. It provides service to over 4.4 million customer accounts in 35 counties. Applicant operates 14 electric-generating sites in Florida to satisfy its statutory obligation to furnish each person applying for service reasonably sufficient, adequate, and efficient service upon the conditions set forth by the Public Service Commission. By Final Order Approving Certification dated December 26, 2006, the Siting Board granted full and final certification to Applicant for the location, construction, and operation of the WCEC project, Units 1 and 2, to an immediate capacity of 2500 megawatts and to an ultimate capacity of 3300 megawatts (3800 megawatts, according to the Stipulation). Applicant anticipates obtaining permits for a third deep injection well and second dual zone monitoring well when the third generating unit is constructed. Units 1 and 2 at the WCEC will be combined cycle power plants that produce power by the ignition of a combination of natural gas and compressed air that force expanding air through turbines that are connected by shafts to generators. The waste heat produced by this process is recovered by steam generators that, using steam turbines, turn shafts connected to other generators, thus improving the efficiency of the power- production process. Applicant owns and operates 12 combined cycle power plants. The certification issued by the Siting Board authorizes Applicant to power the plant by natural gas or ultra-low sulfur light fuel oil, which is diesel fuel. Diesel fuel is a backup source if natural gas is unavailable. The WCEC will store 12.6 million gallons of diesel in two onsite tanks, which are segregated from the rest of the site by secondary containment in the form of reinforced concrete that contains no drains. The Final Order of the Siting Board describes, but does not itself permit, an onsite wastewater disposal process using a deep well injection system consisting of two 3200-foot deep injection wells and a dual zone monitoring well. WCEC Units 1 and 2 would be the first power units operated by Applicant to use deep well injection for the disposal of wastewater associated with the production of power. Other plants operated by Applicant use cooling ponds, such as a 6000-acre cooling pond at its power plant in Martin County. The WCEC sits on only 220 acres, so Applicant could not have constructed a sufficiently large onsite pond to accept the wastewater from the operation of Units 1 and 2. Although Applicant operates power plants on smaller sites, such as the 350-megawatt Cutler plant on 40 acres, the WCEC is a very small site given the power generating capacity of the facility. The WCEC is in west Palm Beach County 20 miles due west from the Atlantic Ocean and 25 miles southeast of Lake Okeechobee. Draining Lake Okeechobee, the L-10/L-12 canal passes immediately adjacent to the WCEC site on the south side of State Road 80, which runs along the southern border of the WCEC site. Immediately across State Road 80 from the WCEC site, about 1000 feet to the south, is the Arthur R. Marshall Loxahatchee National Wildlife Refuge (National Wildlife Refuge). The WCEC abuts a quarry operated by Palm Beach Aggregates (PBA Quarry). Already located adjacent to the WCEC is Applicant's Corbett transmission substation and high-voltage transmission lines. Petitioner Coalition is a member-based, unincorporated association that has been in existence for at least five years and serves, among other things, as an umbrella organization for other environmental organizations. As an umbrella organization, Petitioner Coalition facilitates the coordination, among these other organizations, of efforts to educate the public about the environment, assess threats to the environment, take action to protect the environment, and participate in recreational activities involving regional natural resources. Petitioner Coalition directly performs these tasks and engages in these activities, as well. Petitioner Coalition conducts monthly meetings that are attended by 15-25 persons, although it maintains a mailing list of about 400 persons, who constitute its membership. About 80-90 percent of the members of Petitioner Coalition reside in Palm Beach County; two members reside within 1.5 miles from the WCEC site. Many more members reside in the Loxahatchee and "Acreage" areas, which are not far from the National Wildlife Refuge and WCEC site. Petitioner Coalition does not charge dues, but collects donations from members and other persons. Each year, Petitioner Coalition conducts two larger conferences, which are open to the public. Members of Petitioner Coalition regularly use the L-8 canal, which borders the east side of the WCEC site. The "20-mile bend" entrance to the National Wildlife Refuge is one-half mile west of the WCEC site, and many members of the Coalition use this entrance to enter the refuge for hiking, running, biking, bird-watching, canoeing, fishing, and other outdoor activities. The vast National Wildlife Refuge forms important headwaters for the Everglades. Petitioner Tsolkas is the chairperson of Petitioner Coalition and engages in the member activities described above. Petitioner Larson resides in Loxahatchee, about 2.5 miles east of the WCEC site. She resides on a 1.63-acre lot and relies for her potable water on a well drilled about 125 feet deep into the surficial aquifer. Petitioner Christensen resides about 3 miles from the WCEC site. He has hiked and observed wildlife in the National Wildlife Refuge, as well as drawn spiritual comfort from this natural resource. As noted in the Preliminary Statement, the permitting of IW-1 and IW-2 is at issue in these cases. The proposed injection well system comprises these wells and DZMW-1, which has been permitted and is under construction. One other well is of interest in this case, Exploratory Well 1 (EW-1). On April 25, 2006, Applicant commenced the drilling of EW-1. The purpose of this project was to obtain data to determine the suitability of the WCEC for the onsite, deep well injection of non-hazardous industrial waste. For EW-1, Applicant obtained from DEP Permit No. 247895-001-UC, which was issued on January 11, 2006. Applicant intended to drill EW-1 to a depth of 3400 feet, determine that the location was suitable for an injection well system, and convert EW-1 to a dual zone monitoring well, but EW-1 instead became what could be deemed a functional alternative injection lesson (FAIL) well. The most immediate information derived from this FAIL well was that, at 2230 feet depth, a dredge zone existed at the location of EW-1. Although the bore hole initially reached 2510 feet, the well itself could not be extended deeper than 2220 feet. A dredge zone is a fracture zone of uncertain thickness in a confining unit. At the site of EW-1, the dredge zone extends through at least much of the upper half of the confining unit directly above the proposed injection. Thus, Applicant did not obtain from EW-1 a complete picture of the critical confining zone. However, Applicant obtained information, from top to bottom, about the depths of the surficial aquifer, upper and lower limits of the Upper Confining Unit, upper and lower limits of the Upper Floridan Aquifer, and depth of the point at which, near the bottom of the Upper Floridan Aquifer, total dissolved solids (TDS) exceed 10,000 mg/L. As noted in the conclusions of law, the depth at which the water crosses this TDS threshold marks the deepest extent of an underground source of drinking water (USDW). The data obtained from drilling EW-1, especially the geophysical logs, supported analysis that the top of the Upper Floridan Aquifer is 920 feet deep and the bottom is 1700 feet deep, the top of the Middle Floridan Confining Unit is 1700 feet deep and the bottom is 2005 feet deep, the base of the USDW is 1890 feet deep, and the top of a "fractured and transmissive" interval (i.e., the dredge zone) is 2005 feet and the bottom is 2240 feet deep. FPL Exhibit 13, Technical Memorandum from David McNabb, LBFH, Inc., to DEP and Applicant dated December 14, 2006, page 10. As noted below, the analysis of the data was incorrect as to the bottom of the Middle Floridan Confining Unit, probably because drilling of EW-1 did not extend past the dredge zone. Also, as noted below, later water quality testing established a slightly deeper USDW, between 1930-1941 feet deep. The unconsolidated material in a dredge zone tends to fall into the drill hole after penetration by the drill bit. The inflow of material slows the drilling because it is necessary to grind up and remove the material that has fallen into the drill hole. The small drill bit used for EW-1 meant that the grinding and removal process was slow. A dredge zone does is not necessarily indicative of vertically extensive fractures or fissures or poor confinement in the formation containing the dredge zone. Also, a dredge zone typically extends only a limited distance laterally. Thus, the significance of the dredge zone is largely restricted to the impediment that it presented to drilling. FPL Exhibit No. 13 is the EW-1 Final Report. Attachment K sets forth the pilot hole water quality field data and laboratory analysis. The TDS values are all under 10,000 mg/L. The highest TDS value is 9234 mg/L, which is at 1930 feet deep. This is the deepest point from which a pilot hole water sample was taken. FPL Exhibit No. 13, Attachment L to sets forth the data and analysis from straddle-packer testing (packer testing) Packer testing is a more elaborate testing process that involves inserting two rubber stoppers, or packers, at intervals into the well and inflating them, so as to isolate the interval between them. Prior to testing, the water is allowed to settle from the disturbance of drilling. The rate at which the water level recovers in the interval is a measure of permeability and indicates whether the packers are in a confining unit or an aquifer. Packer testing examines only the native groundwater, not the drilling-bit coolant, so it produces more reliable water-quality data than testing of pilot hole water. The deepest packer test is 1924-1941 feet, at which interval TDS are 18,696 mg/L. At 1848-1865 feet, TDS are 9664 mg/L. At 925-1055 feet, which is the only other interval tested, TDS are 4148 mg/L. After several weeks of trying unsuccessfully to penetrate past the dredge zone and given the exigencies of time, Applicant abandoned the project to drill EW-1 to a sufficient depth that it could be incorporated into an injection well system. By "Minor Modification" to Permit No. 247895-001-UC, dated August 10, 2006, DEP permitted Applicant to convert EW-1 to a monitoring well in the Upper Floridan Aquifer, which Applicant anticipates may be tapped by water supply wells on the site sometime in the future. Applicant then backplugged the pilot hole to create a monitoring interval of 1015-1100 feet depth. After successfully pressure testing EW-1, Applicant filed a Well Completion Report showing a completion date of August 22, 2006. On December 11, 2006, Applicant began drilling EW-2. Applicant chose a location 6000 feet south of EW-1 for the location of EW-2 to avoid the dredge zone that it had encountered when drilling EW-1. In an abundance of caution, though, Applicant used a larger-diameter drill bit, so that, if it encountered another dredge zone, it would be able to grind and remove the fallen materials more easily. The permit number for EW-2 is 247895-002-UC, which was issued on December 6, 2006. FPL Exhibit No. 16 is the Final Report on EW-2. Applicant successfully drilled the pilot hole at EW-2 to a depth of 3411 feet and completed drilling on May 4, 2007. The data obtained from EW-2 established the bottom of the Upper Confining Unit at 975 feet deep, the top of the Upper Floridan Aquifer at 975 feet and the bottom at 1905 feet, the base of the USDW at 1932-1959 feet, the top of the Middle Floridan Confining Unit at 1905 feet and the bottom at 2665 feet, and the top of the Lower Floridan Aquifer, which is known as the Boulder Zone in this region, at 2665 feet. The drilling, which stopped at 3411 feet, did not establish the bottom of the Boulder Zone. Because EW-2 was not permitted, at that time, as an injection well, Applicant could not inject fluids into the well to learn more of the nature of the injection zone. However, it is clear that the Boulder Zone is a highly transmissive (due to its thickness), fractured, and cavernous interval within the Lower Floridan Aquifer. These factors militate against a build-up in pressure at an injection site in the Boulder Zone. It is also clear that the Boulder Zone presents low horizontal hydraulic conductivity, which suggests that injected fluid will travel only a few feet per year. FPL Exhibit No. 16, Attachment N contains the pilot hole water quality data. The pilot hole water quality data reveals an abrupt increase in TDS from 4800 mg/L at 2030 feet to 13,000 mg/L at 2060 feet. After remaining at least 30,000 mg/L from 2100 feet to 2300 feet, TDS drops abruptly to 20,000 mg/L at 2330 feet and then drops steadily (with one minor increase) from 2330 feet to 2630 feet, where TDS falls to 9860 mg/L. TDS remains below 10,000 mg/L from 2630 feet to 2730 feet; at 2800 feet, TDS reaches 30,000 mg/L and remains at this level (with two minor exceptions) to the deepest sampling depth of 3400 feet. The pilot hole testing does not suggest that a deeper USDW occurs at 2330-2630 feet; rather, these data signal an extremely unproductive layer within the Middle Floridan Confining Unit. Applicant drilled these wells using a closed circulation system, which necessitates the introduction at specific intervals of external-source freshwater to cool the drilling bit. The rate of introduction may reach 50 gallons per minute. The EW-2 Final Report notes the "extremely unproductive nature of the test interval" sampled by the last packer test, which is noted below to be at 2624-2642 feet, where the sampled zone produced less than a quart of water per minute with 175 of water level drawdown. FPL Exhibit No. 16, page 18. If Applicant were introducing anything approaching 50 gallons per minute at this depth, the pilot hole water test was essentially of the introduced freshwater, not native groundwater. FPL Exhibit No. 16, Attachment P contains the packer test data. Applicant packer tested five intervals: 1914-1932 feet, 1959-1987 feet, 2009-2027 feet, 2169-2187 feet, and 2624-2642 feet. TDS values for each of these intervals are 8060 mg/L, 21,400 mg/L, 24,100 mg/L, 37,300 mg/L, and 32,800 mg/L.2 These results confirm the base of the USDW at around 1930 feet and confirm that no USDW exists at 2624-2642 feet. FPL Exhibit No. 16, Attachment R reports the results from the sampling of the groundwater after the withdrawal of 130,000 gallons from the bottom of EW-2. TDS is 35,000 mg/L, which is the TDS of saltwater, and pH is 8.16, which is slightly base. The sampling revealed iron, sodium, zinc, arsenic, barium, chromium, manganese, chloride, fluoride, ortho- phosphate, sulfate, cyanide, two nitrogens, and phosphorus. The water sample also tested positive for radium-226 and radium-228. FPL Exhibit No. 16, Attachment O is the Core Sample Laboratory Report. This covers multiple samples from four rock cores: one core within the Upper Floridan Aquifer, two cores within the Middle Floridan Confining Unit, and one core within the Boulder Zone. Analysis of these samples indicates the vertical hydraulic conductivity of the rock cores within each of these units. The first rock core includes three samples from three depths: 1956 feet, 1960 feet, and 1962 feet. The tested vertical hydraulic conductivities are in the range of 10-6 to 10-7 cm/second.3 According to the information obtained from drilling EW-2, these depths are the lower part of the Upper Floridan Aquifer. (According to the information obtained from drilling EW-1, which is 6000 feet to the north, these depths are in the Middle Floridan Confining Unit.) The second rock core includes three samples from three depths: 2048 feet, 2062 feet, and 2065 feet. The tested vertical hydraulic conductivities are 10-3, 10-9, and 10-8 cm/second,4 respectively, even though, according to the information obtained from drilling EW-2, these depths are all in the upper part of the Middle Floridan Confining Unit. The third rock core includes two samples at two depths: 2193 feet and 2200 feet. The tested vertical hydraulic conductivities are 10-6 and 10-4 cm/second,5 respectively. The third rock core is also in the upper part of the Middle Floridan Confining Unit. The fourth rock core includes one sample: at 2828 feet, which is 100 feet into the Boulder Zone. The tested vertical hydraulic conductivity is 10-8 cm/second.6 The rock core data evidently present an incomplete picture of the hydrogeology. For instance, although the third rock core is 200 feet down from the top of the Middle Floridan Confining Unit, it displays higher tested vertical hydraulic conductivities than those displayed by the rock core taken from the Upper Floridan Aquifer. The second lowest vertical hydraulic conductivity among rock cores is found, not in the Middle Floridan Confining Unit, but in the Boulder Zone (which militates further against upward migration of the injected fluid). However, the highest vertical conductivity among rock cores is found, not in an aquifer, but in the Middle Floridan Confining Unit, although within 50 feet of the top of this unit (suggestive perhaps of some unevenness in the top of this confining unit). Two of the three values for vertical hydraulic conductivity in the rock core of the Upper Floridan Aquifer are one to three orders of magnitude lower than the values for vertical hydraulic conductivity in the rock core 200 feet below the top of the Middle Floridan Confining Unit. All of these results are assessments of only a few feet of rock within hundreds of feet of aquifer and confining unit and do not reflect other factors, such as porosity, which is a measure of how much rock is open space. FPL Exhibit No. 16, Attachment I is the Lithologic Log for EW-2. This log reports the composition of formations, as well as porosity and permeability. For the most part, the materials above 2000 feet are limestone with moderate to high porosity that are poorly to moderately consolidated. A band of dolomite, mostly well consolidated, replaces limestone from 1670 feet to 1720 feet. After a couple of hundred feet of limestone, dolomite again predominates over limestone at about 1900 feet and extends down nearly 2200 feet, where a 70-foot band of dolomite occurs, followed by a band of predominantly limestone from 2620 feet to 2840 feet. From 2840 feet down, which is the Boulder Zone, dolomite predominates. From 2870 feet to 2910 feet, the unit is of low porosity and well consolidated. The only reports of permeability at these depths indicate poor or fairly poor permeability from 2620 feet to 2700 feet, then predominantly poor permeability with some fair permeability from 2700 feet to 2760 feet, and then fair permeability from 2760 feet to 2790 feet, which is the lowest 30 feet of the Middle Floridan Confining Unit. FPL Exhibit No. 16, Attachment D states that the pilot and reamed holes deviates only 1/4 of a degree through 3400 feet. This is important because, if the reaming for the well casing does not follow the pilot hole, the uncased pilot hole may be left as a vertical passage for water to penetrate through confining units. The construction of EW-2 includes the installation through the duration of the well of progressively smaller steel casings with the following diameters, from top to bottom: 72 inches, 60 inches, 48 inches, 36 inches, and 20 inches (which runs nearly the entire length of the well). The thickness of the casing wall is 3/8 inch, except for the final segment which is 1/2-inch thick and seamless. The inside and back of all casings, except the final casing, are encased in American Society of Testing and Material (ASTM) C150 Type 2 cement, which is suitable for use in saline water. The final casing (the 20-inch diameter) is encased only on the back. The cement on the outside of the exterior casing is added in such quantities to ensure that it forms a tight bond between the casing and the confining formation wall. To ensure the efficacy of the bonds formed by the cement, Applicant conducts temperature tests, a video survey, and radio tracer surveys. On the inside wall of the 20-inch casing, upon conversion of EW-2 to IW-1, will run a reinforced fiberglass pipe or tube. At the base, a packer isolates the fluid-filled annulus, or space, between the injection tubing and the final casing, and a corrosion inhibitor is injected into that space. No injection well using this form of tubing and packer construction has ever provided a vertical channel for water from the injecting zone (or above) to pass up through a confining bed and into an USDW. After final analysis of all of the available data, the Final Report for EW-2 concludes that the top of the Boulder Zone is at 2790 feet, the top of the Middle Floridan Confining Unit is at 2000 feet and the bottom is at 2790 feet, and the base of the USDW is 1932-1959 feet. These depths are all credited, although the top of the Middle Floridan Confining Unit is probably 100 feet deeper, so that the thickness of this unit is around 700 feet, not 800 feet. The Final Report recommends that EW-2 be converted to a Class I deep injection well, with an injection zone from 2778 feet to 3411 feet, for the disposal of non-hazardous waste from the WCEC. On March 2, 2007, Applicant submitted an application for the construction and operational testing of DZMW-1 at the site of EW-1. This application resulted in the issuance of proposed Permit No. 247895-006-UC, which, as noted above, became final when another petitioner in two other cases withdrew its challenge to the proposed permits for DZMW-1 and IW-1 and IW-2. Pending completion of the analysis of the data from EW-2, the proposed permit for DZMW-1, which is dated June 5, 2007, states that the upper monitoring zone is anticipated to be 1955-1975 feet deep, and the lower monitoring zone is anticipated to be 2160-2180 feet deep. These depths represent, respectively, conservatively deep values for the base of the USDW and the top of the Middle Floridan Confining Unit (even if it is 100 feet deeper than reported). The record contains no reports from the construction of DZMW-1, perhaps because work had not progressed very far at the time of the final hearing. On April 25, 2007, Applicant submitted the Application, which is FPL Exhibit No. 19. The Application is for approval to convert EW-2 to IW-1, construct IW-2, and operationally test both wells. Besides completed forms, the Application comprises the Supporting Information for Construction Permit Applications for a Class I Deep Injection Well System at the Florida Power & Light Company West County Energy Center (Supporting Information), one table, 11 figures, and ten attachments. As stated in the Stipulation, the Application was signed by a responsible corporate officer of Applicant, and Applicant has also satisfied all financial-responsibility requirements. As stated in the Stipulation, a public meeting on the Application took place on September 10, 2007. DEP received public comments on the Permit and submitted a written response to these comments. On September 13, 2007, DEP issued the Notice of Intent for Permit. DEP also prepared a fact sheet for the proposed Permit. Attachment F describes the construction specifications for IW-1, which, as EW-2, was largely finished at the time of the Application, and IW-2. For the conversion of EW-2 to IW-1, Applicant proposed to install 2770 feet of 16-inch diameter fiberglass reinforced pipe and fill the annular space between this tubing and the 20-inch casing with a specified solution, as well as conduct various tests of annular pressure and the injection well. For the construction of IW-2, Applicant proposed almost the same technique already described as to IW-1, although the casings were smaller in diameter, probably due to the elimination of concerns about encountering a dredge zone. The Supporting Information discusses the overall injection well system. The DZMW-1 is to monitor intervals above and below the base of the lowermost USDW at the site. DZMW-1 will be 145 feet west of EW-2 and will provide monitoring for IW-2, which, according to Figure 2, will be within 150 feet west of DZMW-1. The injection capacity of each injection well is 7.29 million gallons per day (mgd) at an injection velocity of 10 feet per second. Supporting Information, page 2. Based on projected power demands, Applicant anticipates that each operating injection well will operate at an average rate of 5 mgd. Average and maximum injection pressures will probably be 40 pounds per square inch (psi) and 50 psi. The purpose of IW-2 is to serve as a "back-up" to IW-1. Supporting Information, pages 2 and 5. Applicant is constructing two injection wells so that "when one well is out of service, flows will be diverted to the operating well." Supporting Information, page 5. As authorized by the certification issued by the Siting Board, the principal water sources for WCEC Units 1 and 2 are the Upper Floridan Aquifer and the L-10/L-12 canal, as the South Florida Water Management District determines that this surface water is available for withdrawal. Applicant will also obtain potable water from Palm Beach County. WCEC Units 1 and 2 require 14.5 mgd of water. The principal water uses of the WCEC Units 1 and 2 are cooling tower water and process water, as well as potable water for use in the administration building. The cooling tower wastewater (also known as "blowdown") is the water that has cooled the power generating equipment and itself been cooled in the cooling towers. Cooling tower blowdown makes up 88 percent of the wastewater generated by the WCEC Units 1 and 2. The process water is water that has been demineralized by reverse osmosis and makes up for the water lost in the steam-generating process. The resulting wastewater is the heat recovery steam generator (HRSG) blowdown, which makes up 6.5 percent of the wastewater generated by WCEC Units 1 and 2. The power generating process recycles its cooling and process waters, but constantly removes slipstream to maintain balanced chemistry and avoid scaling from excessively base water that will damage the equipment. Another 5 percent of the wastewater generated by WCEC Units 1 and 2 will be derived from the reverse osmosis process, which generates water for the HRSG. The remaining 0.5 percent of wastewater is derived from miscellaneous wastewater streams. The Supporting Information states that an analysis of the injection fluid is not available and is not anticipated to be available prior to plant start-up. However, the Supporting Information states: "A sample of the injection fluid will be collected within the first 30 days of commercial operation of the power generating facility." FPL Exhibit No. 19, Supporting Information, page 5. FPL Exhibit No. 19, Attachment G identifies anticipated wastestreams. Based on "analytical characterization" of "historical data," Applicant will determine that the cooling tower blowdown, HRSG blowdown, demineralizer and reverse osmosis water, pretreatment wastewater, steam cycle water treatment, and miscellaneous wastewater streams are not hazardous and dispose of them into IW-1 or IW-2. Based on its vendors' "analytical characterization" of the chemicals that they supply, Applicant will determine that the cooling system water ("biocide additional chlorine, scale inhibitor, pretreatment chemicals") and leak-tracing dyes are not hazardous and dispose of them into IW-1 or IW-2. Based on "process knowledge," Applicant will determine that its treated sanitary wastewater is not hazardous and dispose of it into IW-1 or IW-2. This is the only non-industrial wastewater that Applicant proposes to inject into the injection well system, and the only wastewater whose hazardous/non-hazardous determination will be based explicitly on "process knowledge." Lastly, based on "analytical characterization" of the "wastestream," Applicant will determine whether the wastewater from the chemical cleaning of the HRSG and pre-boiler piping is hazardous. If so, Applicant will dispose of this wastewater by a licensed approved vendor. If not, Applicant will dispose of this wastewater into IW-1 or IW-2. Although an industrial wastewater, this chemical- cleaning wastewater is the only wastewater that Applicant or its agent will test and the only wastewater that Applicant anticipates may be hazardous. Attachment G adds that intermittent shock chlorine or other biocides will be used to prevent biofouling of the cooling system, and a chlorine solution will be fed into the cooling tower. A scale inhibitor, including sulfuric acid, will be added to the circulating water system to control the formation of calcium carbonate scales that can adhere to heat-transfer surfaces and impede cooling. Treated sanitary wastewater from an onsite package plant will be recycled to the cooling tower or disposed of directly through the injection well system. The chemical cleaning of the HRSG and pre-boiler piping is done during commissioning and periodically during the life of the plant. According to testimony, such cleaning, which may release chromium from the boiler tubes, is performed once every ten years. FPL Exhibit No. 19, Attachment H is the Proposed Monitor Program. For IW-1 and IW-2, at start-up, Applicant will test for primary and secondary drinking water parameters and standards. Continuously, Applicant will test these wells for flowrate and wellhead pressure. For the wastestream entering IW-1 and IW-2, Applicant will test weekly for TDS, chloride, specific conductivity, pH, and temperature. For DZMW-1, Applicant will test for primary and secondary drinking water parameters and standards prior to start-up. Continuously, Applicant will test this well for water level. Weekly, Applicant will test DZMW-1 for the five items for which it tests the wastestream plus total phosphorous, sulfate, sodium, calcium, magnesium, potassium, carbonate, and bicarbonate. After operational testing and DEP approval, Applicant will decrease the frequency of testing from weekly to monthly. The Supporting Information calculates the Area of Review by determining the "zone of endangering influence," which is the lateral area in which the buoyant forces or increased pressure in the injection zone may cause migration of the injected or formation fluid into a USDW. The Area of Review is the land overlying the zone of endangering influence. The calculations are conservative because they assume that IW-1 and IW-2 are operated at each well's maximum permitted injection rate (7.29 mgd each) for ten years. Using a 200-foot high injection zone and 20 percent porosity for the injection zone, Applicant calculated that the radius of the bubble of injected fluid, from the point of injection, would extend 7526 feet. Applicant rounded this result off to two miles. No well, besides EW-2/IW-1, penetrates to the Middle Floridan Confining Unit within two miles of the proposed injection well system. Thus, Applicant was not required to undertake any Corrective Action to preclude the possibility that such wells could allow fluid to enter the USDW. The Permit is for the conversion and operational testing of EW-2 into IW-1, construction and operational testing of IW-2, and eventual incorporation of DZMW-1 into the subject injection well system. The Permit notes that the anticipated depth of IW-2 is 3250 feet, although field data will determine the final depth required for this injection well. The Permit notes that IW-1 is 3400 feet. The Permit states that the injection level for each well will be in the Boulder Zone from about 2775 feet to the total depth of each well, which is a vertical range of around 600 feet, at last as to IW-1. The Permit states that the Class I injection well system is designed for use at the WCEC for non-hazardous wastewater, primarily cooling tower blowdown. Permit Specific Condition 1.a requires proper operation and maintenance, including adequate staffing and training and adequate laboratory and process controls. Specific Condition 1.d prohibits any injection that causes or allows movement of fluid into a USDW, except as authorized by 40 C.F.R. §§ 146.15 and 146.16.7 Permit Specific Condition 2.h specifies the requirements to convert EW-2 to IW-1. These include taking a video survey of the length of the 20-inch diameter casing, installing 2770 feet of 16-inch diameter fiberglass reinforced pipe tubing, filling the entire annulus between the fiberglass reinforced pipe tubing and the final casing with a specified solution, conducting a pressure test of the fluid-filled annulus, performing a radioactive tracer survey, and conducting a preliminary capacity injection test. Permit Specific Condition 2.i specifies the requirements to construct IW-2. These are similar to those described above in the construction of EW-2/IW-1 except that the initial casings are somewhat smaller. Permit Specific Condition 2.j requires Applicant to add DZMW-1 to this Permit, either separately under its permit number or under the Permit number. This condition requires Applicant to take samples and determine the ambient groundwater quality in both zones of the DZMW-1 prior to the injection of any fluids into IW-1 or IW-2. Four weeks prior to use of IW-1 or IW-2, Applicant must start weekly sampling of the monitoring zones. Permit Specific Condition 2.l requires packer tests in the anticipated confining zone. Permit Specific Condition 2.m provides that Applicant shall use the DZMW-1 to monitor the confinement of the injection zone from overlying aquifers. The upper zone is the compliance point as to the USDW, and the lower zone is the compliance point as to vertical movement out of the injection zone. Permit Specific Condition 2.n requires Applicant to demonstrate confinement for IW-2 by using lithologic properties, geophysical evidence, and tests performed while pumping the formation. These requirements require proof of confinement during the drilling of IW-2. Permit Specific Condition 4.g requires DEP approval, pursuant to Florida Administrative Code Rules 62-528.401(4)(c), 62-528.420(4)(c), and 62-528.605(2), of the final selection of specific injection intervals. Permit Specific Condition 4.i requires that Applicant provide certain justifications for each request of a short-term injection test for IW-1 and IW-2. Generally, justification consists of the documentation to assure that confinement above the injection zone is intact. Permit Specific Condition 5.b imposes requirements on Applicant to obtain DEP approval for operational testing. Specific Condition 5.b.1-4 requires Applicant to provide DEP with certain materials prior to the approval of DEP for the commencement of operational testing. These are generally the documentation to assure that confinement above the injection zone is intact and the results of the short-term injection test. This condition notes that, under normal operating conditions, the velocity of each injection well may not exceed ten feet per second, although, in a multiple well system, each may run at 12 feet per second when the other well is inoperative due to testing or maintenance. During the injection test, Specific Condition 5.b.1-4 requires Applicant to collect injection flow rate, injection wellhead pressure, and monitoring well pressures in both zones. Also prior to obtaining DEP approval for operational testing, Specific Condition 5.b.6 requires Applicant to submit to DEP "[i]nformation concerning the compatibility of the injected waste with fluids in the injection zone and minerals in both the injection zone and the confining zone." Specific Condition 5.b.9 requires Applicant to provide DEP with a copy of a draft operation and maintenance manual. Specific Condition 5.b.13 requires Applicant to submit to DEP background water quality data from the monitoring and injection zones and analysis of these data for primary and secondary drinking water standards and minimum criteria parameters. Specific Condition 5.c imposes requirements on Applicant prior to starting operational testing. Specific Condition 5.c requires compliance with Florida Administrative Code Rule 62-528.450(3)(a), (b), and (c), which requires, among other things, "wastestream analysis." Specific Condition 5.d imposes requirements on Applicant within 90 days of starting plant operations. This condition refers to Florida Administrative Code Rules 62-528.425(1)(a) and 62-528.450(2)(f)3 and requires a wastewater stream analysis for primary and secondary drinking water standards. Specific Condition 6 imposes requirements on Applicant during operational testing. Specific Condition 6.a.4 requires Applicant to monitor the flow to the injection well at the wellhead and to control the flow to ensure that it does not exceed the rate at which the well was tested. Pursuant to Florida Administrative Code Rule 62-528.425(1)(b), Specific Condition 6.a.5 requires Applicant to continuously monitor the injection well system by recording and totalizing devices for effluent flow rate and volume and recording devices for injection and monitoring zone pressures. Specific Condition 6.a.9 provides: "The injectate shall be non-hazardous in nature at all times, as defined in 40 CFR, Part 261 and as adopted in Chapter 26-730, F.A.C." Specific Condition 6.a.10 requires mechanical integrity prior to injection. Specific Condition 6.a.11 requires Applicant to monitor and control the pressure at the wellheads to ensure that it does not exceed 66 percent of the tested pressure on the final casing. Specific Condition 6.a.13 requires Applicant to monitor the injection system and submit monthly operating reports to DEP concerning the flow, volume, and wellhead pressure of the injection well; chemical characteristics of the wastewater stream in terms of TDS, chloride, specific conductance, three types of nitrogen, phosphorous, pH, and sulfate; physical characteristics of the monitoring well, including daily and monthly maximum, minimum, and average pressures; and chemical characteristics of the upper and lower monitoring zones in terms of, weekly, the items listed above plus total coliform and field temperature and, monthly, sodium, calcium, potassium, magnesium, iron and bicarbonate. Specific Condition 6.a.13.c provides that, after at least six months of weekly monitoring of the monitoring zones, Applicant may, based on a showing of groundwater stability, request that DEP reduce the monitoring frequency to monthly. Specific Condition 6.a.19 requires Applicant to submit annually to DEP a wastewater stream analysis for primary and secondary drinking water standards and minimum criteria, as identified on a list attached to the permit. The list identifies 95 primary drinking water items, including chromium, and 17 secondary drinking water items, including pH. The list also identifies 24 municipal wastewater items, such as ammonia, several volatile organics, two pesticides, biological oxygen demand, and temperature, which presumably are added because the wastewater will include effluent from Applicant's onsite package plant. Petitioners have identified two relevant issues. The first issue concerns the integrity of the Middle Floridan Confining Unit in its present state and after construction of the wells (i.e., well integrity), so as to prevent the injected fluids from migrating upward into the USDW. The second issue concerns the composition and volume/pressure of the wastewater stream (i.e., whether it will meet the Permit criterion prohibiting hazardous wastes and, even if the injected fluids meet this criterion, whether the fluids, in terms of their composition and volume/pressure, will adversely affect the Boulder Zone and the bottom of the Middle Floridan Confining Unit). Applicant has provided reasonable assurance that the bottom of the Upper Floridan Aquifer is about 2000-2100 feet deep, and the USDW is in the lower reaches of the Upper Floridan Aquifer at around 1950 feet deep. The water samples from the packer test preclude the existence of a deeper USDW. Applicant has provided reasonable assurance that the Middle Floridan Confining Unit extends from no deeper than 2100 feet to about 2800 feet deep, for a minimum thickness of 700 feet. Applicant has also provided reasonable assurance that the injecting zone will be in the Boulder Zone of the Lower Floridan Aquifer, and the confining unit of the Middle Floridan Confining Unit will prevent the upward migration of the injected fluids into the Upper Floridan Aquifer and, thus, the USDW. The Middle Floridan Confining Unit is not homogenous. At places, it is fractured. At other places, it exhibits greater permeability and porosity than it does elsewhere. But, at the location of the proposed injection well system, the 700- foot thick Middle Floridan Confining Unit is ample insurance against upward migration of the injected fluids. DEP Program Manager for Underground Injection Control for the relevant district is Joseph May. Mr. May testified that he gets "nervous" when confining zones are only 300 feet thick, "antsy" when they are only 200 feet thick, and skeptical of the eligibility for a deep well injection permit when the confining zones are less than 200 feet thick. These are not rule criteria, nor did Mr. May intend them to be, but these values are useful in these cases, if only to suggest the suitability of this relatively thick confining unit to prevent the upward migration of injected fluids. Other factors, of course, contribute to the efficacy of the confining unit. First, the Boulder Zone is highly transmissive, a function of the vast thickness of this zone. The characteristic tends to reduce the effect of pressure at the point of injection, relieving the force of pressure that might otherwise drive the injected fluid up through hundreds of feet of confining unit. On the other hand, the thickness of the Boulder Zone and low horizontal hydraulic conductivities suggest that the injected fluids will not travel far within the Boulder Zone, so the likelihood of the injected fluid's encountering a chimney is diminished over time. And, as time passes, the fluids will take on the characteristics of the native fluids in the Boulder Zone to the point that they are indistinguishable from these native fluids. This is particularly important as to TDS; as the differential in TDS between the injected and native fluids decreases, so will the buoyancy of the injected fluids. Nor will the injected fluid be especially buoyant. After five cycles, according to FPL Exhibit No. 25, the water drawn from the Upper Floridan Aquifer will have 24,505 mg/L of TDS, which is close to the TDS level of the native groundwater in the Boulder Zone. After five cycles, according to FPL Exhibit No. 24, the water drawn from the L-10/L-12 canal will have 4605 mg/L of TDS, so it will be buoyant, but many times less buoyant than if not recycled at the power plant. Petitioners rely on the failures of other deep injection wells as a basis for contending that Applicant has failed to provide reasonable assurance in this case as to the integrity of the confining unit. In an interesting turn, they rely on a recent work by one of Applicant's expert witnesses, Dr. Thomas Missimer. Dr. Missimer is a prominent licensed geologist with many years' field experience in Florida's geology and hydrogeology. Dr. Missimer recently co-authored (with Robert G. Malivea and Weixing Guo) an article, "Vertical Migration of Municipal Wastewater in Deep Injection Well Systems, South Florida, USA," published in Hydrogeology Journal (2007) 15: 1387-96. The focus of this article is on the vertical migration of municipal wastewater injectate. This low salinity, high density injection fluid is buoyant relative to the high salinity, low density water of the Boulder Zone of the Lower Floridan Aquifer, where the fluid is injected. In the article, Dr. Missimer states that southeastern Florida hosts 32 active Class I injection wells. Based on his review of the data, he finds that injected wastewater has migrated upward into the USDW at three sites: one in Palm Beach County and two in Dade County. Dr. Missimer finds that injected wastewater has migrated upward into the monitor zone below the USDW at another seven sites, all in Broward and Palm Beach counties. Dr. Missimer emphasizes that municipal wastewater is susceptible to upward migration due to its greater buoyancy than the saline water native to the Boulder Zone. Dr. Missimer characterizes the Boulder Zone as an area of high transmissivity that has received injected fluid wastes since 1943. A consequence of this high transmissivity is that the Boulder Zone "allows for minimal increases in pressure during injection." Coalition Exhibit No. 2, page 1391. Dr. Missimer notes that vertical hydraulic conductivities in the Middle Floridan Confining Unit vary by eight orders of magnitude with the dolostones having lower vertical hydraulic conductivities than the limestones. However, the main point of the article is to account for the fact that predicted vertical hydraulic conductivities in some failed injection wells, based on analyzed rates from core plug data, understated the actual migration rate of injected fluids by four orders of magnitude. Coalition Exhibit No. 2, page 1393.8 Dr. Missimer finds that enhanced vertical hydraulic conductivity in the Middle Floridan Confining Unit is likely due to fracturing in zones that may have a limited horizontal extent, creating a chimney through which buoyant injected fluid can migrate up relatively quickly. Suggesting that well- construction problems and possibly regional tectonic effects may have contributed to this fracturing, Dr. Missimer concludes: "The focus of confinement analysis should, therefore, be on the extent and distribution of fracturing rather than analyses of the properties of the rock matrix." Coalition Exhibit No. 2, page 1395. Most difficult for Petitioners' contentions is the testimony of Dr. Missimer concerning the thickness of the Middle Floridan Confining Unit at the subject site and the absence of fracturing in this unit, based on the sonic logs from EW-2/IW-1. Dr. Missimer testified that, based on the sonic logs in particular, there is over 700 feet of unfractured confining unit over the injection zone, and he has a "high level of confidence" that no material fracturing exists to undermine the integrity of this confining unit. Logically, the possibility of a relevant fracture decreases with the thickness of the confining unit. Nor does the construction of IW-1 and IW-2 provide a chimney through which the injected fluids can escape the Boulder Zone and migrate into the USDW. In no respect do the construction plans for IW-2 or construction or conversion plans for IW-1 depart from the requirements of DEP's rules or sound engineering and construction practices. These matters have been adequately addressed above. In particular, the DEP-imposed requirement to monitor and document the absence of any deviation in the orientation of well from the bore hole promises to eliminate a likely cause of past problems in the construction of deep wells. Finally, as to the integrity of the Middle Floridan Confining Unit, Petitioners contend that tectonic forces from blasting at the PBA Quarry threaten the integrity of the wells.9 Applicant purchased the WCEC site from the owner-operator of the PBA Quarry, which is an active limestone-mining operation on land adjacent to the WCEC site. In connection with the purchase, Applicant entered into a blasting agreement with the owner-operator of the PBA Quarry. This agreement imposes certain requirements on the owner-operator concerning the maximum size of blasts, minimum separation distances from the power plant (5000 feet starting June 1, 2006, and 7500 feet starting June 1, 2007), and coordination and notification provisions. Although Applicant has no experience with power plants located in close proximity to blasting operations, for two reasons, Applicant has provided reasonable assurance that the nearby blasting will not damage the injection wells (or either confining unit). First, as noted by the Black & Veatch geotechnical engineer retained by Applicant to examine the effects of blasting on the WCEC, excessive vibration, from any source, trips relays that protect equipment from damage due to excessive vibration. The most sensitive equipment at the plant will be the large rotating steam turbines. The Black & Veatch geotechnical engineer noted that the level of vibration that will trip these relays is much less than the amount that could cause any structural damage. These relays will effectively protect the injection wells from damage from blasting. Long before vibration from blasting could threaten the integrity of these wells (and certainly the Middle Floridan Confining Unit), the relays would trip, and Applicant would need to deal with the blasting before restarting the turbines. Second, Dr. Missimer examined the work of the Black & Veatch geotechnical engineer as to the extent of vibrations from blasting at the PBA Quarry. Explaining that the economics of blasting necessitates the use of just enough explosive material to loosen the substance to be mined, Dr. Missimer testified that the explosive forces dissipate in intensity and magnitude very quickly from the point of detonation. The maximum depth of the mining is 60 feet. Agreeing with the Black & Veatch analysis, Dr. Missimer determined that the force of blasting would be spent by 10,000 feet, and the nearest blasting will be 14,000 feet from the wells. Dr. Missimer noted that mining typically is allowed to within 500 feet of public supply wells, which are not built to the standards of Applicant's injection wells, and he has not found any documented reports of blasting-induced damage to such wells. Dr. Missimer testified that the force of the PBA Quarry blasting would not affect the Middle Floridan Confining Unit either. Lastly, Petitioners focus on the composition and volume/pressure of the injected fluids. These are important matters for two reasons. Excessive pressures or corrosive elements in the injected fluids could undermine the integrity of the Middle Floridan Confining Unit at the location of the injection wells. Also, the injection of hazardous waste, in addition to violating the Permit, would intensify the consequence of an upward migration of injected fluids. More than once, testimony in support of reasonable assurance justifiably emphasized the common characteristics of the injected fluids and the native groundwater. Notwithstanding its confidence in the integrity of the Middle Floridan Confining Unit at the location of IW-1 and IW-2 and the high transmissivity of the Boulder Zone, DEP has imposed, based on the law, significant restrictions on Applicant in terms of the injection fluids. In all but two respects, Petitioner's concerns as to the composition and volume/pressure of the injected fluids are misplaced because Applicant and the Permit provide reasonable assurance that the composition and volume/pressure of the injected fluids will comply with applicable law and will not cause any injected fluids to migrate up into the USDW. The two exceptions, for different reasons, are minor and easily corrected. In general, Petitioners' evidence failed to reveal any flaws in the analysis of the experts of Applicant that the pressures in the injection zone will adversely affect the Boulder Zone. However, one issue concerning volume/pressure arises due to what appears to be inadvertence in drafting the Permit. Applicant has applied for approval of two injection wells because it needs one well to serve as a back-up to the other well, not to operate both wells simultaneously. The reliability of the WCEC to produce power is dependent on, among other things, the ability of Applicant to dispose of vast volumes of wastewater produced daily by plant operations. Applicant has not previously predicated the uninterrupted operation of one of its many power plants on the operation of an injection well, so it understandably sought the comfort of redundancy: if one injection well goes out of service, the other well can be activated, and the plant can continue operating without interruption. Applicant has proposed an injection well system with a single-well capacity (although that could be achieved by both wells operating simultaneously at a combined rate not to exceed the permitted rate of a single well). Applicant intends for the proposed injection well system to pump at a rate of 10 feet per second, not 20 feet per second--or 12 feet per second during emergencies, not 24 feet per second. The 10/12 feet per second pumping rate is consistent with the testimony of Applicant's primary expert on this point. David McNabb, a licensed geologist retained by Applicant, testified that the Boulder Zone could receive water at the rate of 10 feet per second or 12 feet per second during emergencies. Mr. McNabb added that, during the injection test, Applicant would operate only one well at a time. He also calculated the zone of endangering influence using the maximum pumping rate of 10 feet per second, not 20 feet per second. Mr. McNabb specifically confirmed during cross-examination that only one well would be pumping at a time. However, the Permit implies the injection well system is approved for 20 feet per second, as did Mr. May's testimony at one point. The confusion arises for two reasons. First, the Permit nowhere explicitly sets the maximum rate for the injection well system or the two injection wells individually. Second, Permit Specific Condition 5.b.4 states that each well may be tested at 12 feet per second (which is approved by a DEP rule cited below) "since, in a multiple well system, this can be allowed when one of the other injection wells is inoperable due to planned testing or maintenance." It is in this explanation that the problem arises. The explanation implies that an emergency arises when a well requires service and Applicant can no longer obtain a combined rate of 20 feet per second out of both wells, so it may then at least obtain 12 feet per second out of the well that remains operative. The subject injection well system will be a multiple well system, but with only one well operating at a time (or both wells operating at the permitted rate of a single well). The DEP rule, quoted below, allows the increased rate of 12 feet per second for testing, maintenance, or emergencies. In the system proposed by Applicant, the servicing of the other well is not an emergency and does not justify operating the activated well at 12 feet per second. This condition is not an emergency because Applicant always intended that the other well, and its 10 feet per second capacity (12 feet per second in an emergency) serve in a backup capacity. This is a minor problem that is easily corrected by adding language to the Permit specifying that the maximum rate of pumping is 10 feet per second (12 feet in an emergency) whether one or both injections are pumping at any given time and the unavailability of one of the wells is not an emergency that would allow pumping at the rate of 12 feet per second. The other issue concerning the composition of the wastewater is more substantial theoretically, but not practically on the facts of these cases. This issue involves how Applicant is to determine that the wastewater disposed into the injection wells is free of hazardous waste. Except as to hazardous waste, there is no issue as to the composition of the injected fluids or wastewater. Applicant will strive to maintain neutrality in the recycled cooling and process waters to avoid damage to the plant equipment. Too acidic, the water will induce corrosion. Too base, the water will induce scaling. Dr. Missimer testified that the injecting fluid would likely be neutral and not affect the formations into which it comes into contact. Applicant intends to use descalers, which are necessarily acidic, but Dr. Missimer testified that, in the unlikely event that somewhat more acidic water were injected into the Boulder Zone, the predominantly dolomitic Middle Floridan Confining Unit and Boulder Zone would withstand acidity better than would the limestone that prevails at subsurface higher elevations. Nor is the problem here an omission of the prohibition against injecting hazardous waste. Unlike the situation with the maximum pumping rate, the Permit addresses hazardous waste and flatly prohibits its injection into the injection wells. The problem is whether this prohibition, even if coupled with Applicant's succinct description in Attachment G of its approach to hazardous-waste determinations, provides reasonable assurance that this provision of the Permit will work. If reasonable assurance were satisfied by a mere restatement of the requirements of law, this Permit could have been shortened to: "Applicant may inject wastewater pursuant to law." Or, perhaps a little more generously, the Permit could be reduced to a minor restatement of Specific Condition 1.d: "Pursuant to law, Applicant may inject wastewater, but not so that it causes or allows the movement of fluid into an USDW." Essentially, the Permit addresses hazardous wastes by prohibiting them. The lone provision in the Permit concerning hazardous waste is Specific Condition 6.a.9, which states bravely: "The injectate shall be non-hazardous in nature at all times " The incorporation of Attachment G into the Permit would provide reasonable assurance of actual testing of the chemical cleaning residue and probably of the cooling system water and leak-tracing dyes, which is based on vendors' representations, but would not provide any assurance as to the other wastestreams. Process knowledge of sanitary wastewater treatment, if based on Applicant's knowledge, means little given the fact that Applicant is a power company. For the remaining wastestreams, unidentified analysis of undisclosed "historical data" means nothing and, thus, provides no assurance whatsoever. For all of these wastestreams, including the chemical cleaning wastestream, reasonable assurance requires a plan for periodically obtaining reliable data and conducting valid analysis, or obtaining such data and analysis from other parties such as reliable vendors or governmental agencies; the implementation of such a plan; and the documentation of the implementation, including the recordation of the data sources relied on, the analytic processes undertaken and by whom, the resulting determination as to whether a discrete wastestream is a hazardous waste, and the manner of disposition of any such hazardous waste. The procedures described in the preceding paragraph provide reasonable assurance because, although consistent with DEP's evident reliance on permittees to self-police as to hazardous wastes, they supply reasonably broad guidelines for how permittees are to discharge their hazardous-waste responsibilities, thus improving the likelihood of effective compliance, and some reasonable basis for enforcement, in the event of noncompliance. At present, the Permit's treatment of hazardous wastes leaves Applicant largely on its own and little, if any, opportunity for effective monitoring and enforcement by DEP, given that the wastewater, once injected, is 3000 feet under the surface of the earth where, under the facts of these cases, it will remain for geologic time. For several reasons, the deficiencies in the Permit concerning hazardous waste appear more consequential than they are in reality, based on the present record. First, the source water for the WCEC is not likely to produce hazardous waste. The Upper Floridan Aquifer contains only one substance that is on the hazardous waste list, as it is presently constituted, and the substance does not approach the concentration required for listing. The L-10/L-12 canal contains several listed substances, but, as Dr. Missimer pointed out, the concentrations, even after five cycles through the plant, are several orders of magnitude below the concentrations that are necessary for listing. Although the composition of the canal water, which drains Lake Okeechobee, is far more variable than the composition of the Upper Floridan Aquifer, neither source presents a real risk of introducing hazardous waste into the wastestream to be injected into the Boulder Zone. Additionally, the Permit already requires extensive water-quality testing of the wastewater, although not as extensive as would be necessary to rule out, on the basis of laboratory testing alone, the presence of any hazardous waste in the wastewater. Second, Applicant does have considerable knowledge, if not of sanitary wastewater treatment processes, of the process involved in the production of energy. For those relatively few components that come into direct contact with cooling or process water, reasonable assurance as to hazardous wastes does not require much from Applicant. Initially and when introducing new equipment that comes into contact with the wastestream, Applicant may easily document, based on vendors' representations, that the substances contributed from these components into the wastewater are not listed or, if listed, are not contributed at rates approaching the listed concentrations. For wastewater from the package plant, Applicant may undertake the same process, again relying on the expertise of vendors or other parties, unless Applicant can demonstrate expertise in sanitary wastewater that it has not demonstrated in this record. Third, the volume of water to be disposed of daily is vast. Aside from the depth of the wells and the difficult-to- conceive vastness of the Lower Florida Aquifer, the fact that best describes the scale of this project is the vertical height of the injecting zone, which will be at least 200 feet high, or the height of a 20-story building. From this scale, one can infer the scale of the amount of wastewater that Applicant will be disposing of daily. This is not to suggest that a little hazardous waste is not especially important given the vastness of scale of this project. Rather, it is to acknowledge that it is extremely unlikely that these high volumes of wastewater, at the moment of entry into the injection well, would ever contain a hazardous waste due to the fact that the characteristic wastes, listed for toxicity, are expressed in concentrations, although the wastes may reach listed concentrations at early points, such as in the boiler immediately after chemical cleaning or in the package plant. For these three reasons, the failure of the Permit to provide reasonable assurance as to hazardous wastes is a minor deficiency, more of theoretical than actual importance, and is easily remedied by a few Permit additions, whose phrasing is properly left to the discretion of DEP.
Recommendation It is RECOMMENDED that the Department of Environmental Protection enter a final order issuing Permit No. 247895-007-UC or issuing Permit No. 247895-007-UC with the recommended revisions. DONE AND ENTERED this 3rd day of March, 2008, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of March, 2008.
The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2002),1 and, if so, what discipline should be imposed.
Findings Of Fact Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2007). At all times material to the Amended Administrative Complaint, Dr. Brignoni was licensed to practice medicine in the State of Florida pursuant to Chapter 458, Florida Statutes, having been issued license number ME 59140. Dr. Brignoni is board-certified in obstetrics and gynecology. On September 5, 2002, patient C.W. presented to Dr. Brignoni, who diagnosed her with severe dysplasia, vulvar intraepithelial neoplasia. Dr. Brignoni recommended that C.W. undergo a wide local excision of vulva/vaginal lesion. On September 12, 2002, C.W. went to Charlotte Regional Medical Center for Dr. Brignoni to perform the wide local excision of vulvar intraepithelial neoplasia. Prior to the surgery, Dr. Brignoni had issued a card which indicated the supplies and instruments that he would need for a procedure such as the one that he was going to perform on C.W. The card is kept at Charlotte Regional Medical Center so that the supplies and instruments can be prepared and available at the time the procedure is scheduled to be performed. The card called for acetic acid to be supplied for the procedure, but no strength was specified. Acetic acid is commonly used during gynecological procedures to highlight abnormal areas. In the instant case, it would be used to highlight the lesion that was to be excised. When acetic acid is used for such a purpose, the acceptable concentration is approximately three-to-five-percent. Typically, when Dr. Brignoni arrives in the operating room to perform a procedure, all liquids and instruments required for the procedure are prepared and ready for use. A surgical technician is responsible for assembling the liquids and instruments needed for the procedure. When Dr. Brignoni began the excision on September 12, 2002, the surgical technician had not placed any acetic acid on the cart which housed the supplies and instruments needed for the procedure. Dr. Brignoni requested that acetic acid be obtained, and the circulating nurse went to the pharmacy to procure the acid. Dr. Brignoni did not request any specific concentration of acetic acid. The circulating nurse came back with a bottle of 100 percent acetic acid and decanted the acid into a container which she gave to the surgical technician. Dr. Brignoni took a piece of gauze saturated with the 100 percent acetic acid and swabbed the vulva area. He immediately noticed that area was peeling. This was not the reaction that would have occurred using a three-to-five-percent solution. Dr. Brignoni asked the surgical staff what solution did they give him, and he was shown the bottle containing a 100 percent concentration of acetic acid. Upon learning that he had applied 100 percent acetic acid to C.W.’s vulva area, Dr. Brignoni irrigated the area with over a liter of sterile water. He determined that he could proceed with the procedure, which he did. Prior to proceeding with the procedure, he did not consult with a physician familiar with chemical burns in determining whether it was appropriate to continue with the procedure. Dr. Brignoni did check with an emergency room physician after the procedure to confirm that he treated the burn correctly by irrigating with sterile water. As a result of the use of 100 percent acetic acid rather than a three-to-five-percent solution, C.W. experienced second degree burns in the area of her vulva and buttock. The normal time for the healing of a wide local excision of the vulva area is four to six weeks. C.W. healed in approximately eight weeks. Edward J. Zelnick, M.D., testified as an expert for the Department. Dr. Zelnick was licensed to practice medicine in Florida in 1975 and is board-certified by the American Board of Obstetrics and Gynecology. Currently, Dr. Zelnick is the chief executive officer and clinical researcher at Horizon Institute for Clinical Research. The last time that Dr. Zelnick performed a surgical procedure was in 1998. James Orr, M.D., testified as an expert for Dr. Brignoni. Dr. Orr has been board-certified in obstetrics and gynecology and gynecologic oncology since 1984. Currently, he is the medical director of Lee Cancer Center at Lee Memorial Hospital in Fort Myers, Florida, and is the director of Gynecologic Oncology and Gynecologic Oncology Research at Lee Cancer Center. He is a former associate professor of Obstetrics and Gynecology at the University of Alabama Birmingham School of Medicine and a clinical professor in the Department of Obstetrics and Gynecology at the University of South Florida. Dr. Orr has performed wide local excisions of the vulva area hundreds of times, and teaches this procedure to residents and medical students. It is Dr. Orr’s opinion that it is not standard procedure for a surgeon to specify the concentration of acetic acid for such a procedure. The normal strength of acetic acid used in a wide local excision of the vulva area is understood to be three-to-five-percent, and the standard-of-care requires a physician to simply ask for acetic acid without specifying the concentration. Dr. Orr’s opinion is credited. It was Dr. Orr’s opinion that Dr. Brignoni correctly irrigated the area after the application of the acetic acid and that there was no reason for Dr. Brignoni to stop the procedure after the irrigation. The biggest risk to the patient would have been stopping the procedure and putting the patient under anesthesia for a second time. Dr. Orr’s opinion is credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Brignoni did not violate Subsection 458.331(1)(t), Florida Statutes, and dismissing the Amended Administrative Complaint against Dr. Brignoni. DONE AND ENTERED this 23rd day of April, 2008, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of April, 2008.
The Issue The issue in this case is whether Respondent, Shelly O. Wolland, D.O., committed the violations alleged in an Administrative Complaint dated February 15, 2005, issued by Petitioner, the Department of Health, in DOH Case No. 2004- 50416, and, if so, what disciplinary action should be taken against her.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice osteopathic medicine in Florida.7 Respondent, Shelly O. Wolland, D.O., is, and was at the times material to this matter, an osteopathic physician licensed to practice osteopathic medicine in Florida, having been issued, on September 30, 1987, license number OS 5378. During the parts of 2003 and 2004 relevant to this proceeding, Dr. Wolland worked as an osteopathic physician at Advanced Integrated Medical Center (hereinafter referred to as "Advanced"), located at 1655 East Oakland Park Boulevard, Fort Lauderdale, Florida. She usually worked at Advanced on Tuesdays and Thursdays. The Order of Emergency Restriction of License. On or about March 18, 2002, the Secretary of the Department issued an Order of Emergency Restriction of License (hereinafter referred to as the "ERO") in DOH Case No. 2001- 21687.8 The ERO provides the following restrictions on Dr. Wolland's practice of osteopathic medicine: The license of Shelly O. Wolland, D.O., license number OS 005378, is hereby immediately restricted in the following manner: Dr. Wolland's license is hereby restricted and she is prohibited from dispensing, administering, or injecting any medication except for those medicines that may be required to sustain a patient's life in a bona fide medical emergency. [Emphasis added]. . . . . The ERO clearly prohibits Dr. Wolland from "dispensing . . . any medication," "administering . . . any medication" OR "injecting . . . any medication."9 The rationale for issuing the ERO is also explained in some detail in the Order. In summary, the ERO was issued due to concerns about Dr. Wolland's handling of medications which, while including pre-filled syringes, also include other medications which the Department believed were improperly stored. The Department, while concerned about the pre-filled syringes, was also concerned about medications allegedly found on November 29, 2001, at a clinic allegedly owned by Dr. Wolland, which could be dispensed or administered other than by injection. Reading the ERO in its entirety, it is clear that the Department not only prohibited Dr. Wolland from giving injections, but it also prohibited Dr. Wolland from administering or dispensing any medications except in a medical emergency. The ERO goes on to inform Dr. Wolland of the consequences of her failure to comply with the restrictions placed on her practice: Dr. Wolland's failure to comply with the restrictions placed on her license to practice osteopathic medicine shall constitute grounds for a suspension of her license to practice osteopathic medicine. A proceeding seeking appropriate discipline, including, but not limited to, the suspension or revocation of the license to practice as a physician of Shelly O. Wolland, D.O. shall be promptly instituted and acted upon in compliance with Section 120.60(6), Florida Statutes.[10] The ERO also contains the following "NOTICE OF RIGHT TO JUDICIAL REVIEW": Pursuant to Sections 120.60(6), and 120.68, Florida Statutes, the Department's findings of immediate danger, necessity, and procedural fairness shall be judicially reviewable. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of a Petition for Review in accordance with Rule 9.100, Florida Rules of Appellate Procedure, with the Department of Health and a second copy of the petition accompanied by a filing fee prescribed by law with the District Court of Appeal within thirty (30) days of the date this Order is filed. The ERO was personally served on Dr. Wolland on March 26, 2002, by Department Investigative Manager Christie Jackson. Dr. Wolland was, therefore, aware of the ERO during the times relevant to this matter. The ERO has not been vacated or modified by the Secretary of the Department; it has not been superseded by a Final Order of the Board of Osteopathic Medicine; and it has not been overturned by a District Court of Appeal or any other court of competent jurisdiction. At all times relevant to this proceeding, the ERO has been in effect. Dr. Wolland's Treatment of E.K. On or about November 20, 2003, a Thursday, E.K. presented to Advanced for anti-aging treatment by botox11 injections and to obtain information on testosterone supplementation. Dr. Wolland made the following diagnosis of E.K.: Herniation of L2 and L4 dx by MRI Low back pain, chronic Left shoulder Capsular shift for chronic dislocations History of total knee reconstruction Decreased libido and erections less full. Normal again of face, patient wants botox treatment A treatment plan was established by Dr. Wolland which included administering or dispensing the following medications: Depotestosterone,12 a prescription of Viagra, trigger point injections13 on both sides and iliolumbar on both sides, and botox injections. Except for the Viagra, these medications were to be administered or dispensed via injection. As ordered by Dr. Wolland, E.K. received an injection of 200 mg of Depotestosterone intramuscularly; over ten injections containing Lidocaine, dextrose, and Vitamin B12 on both sides in the iliolumbar region; two injections to the low back/sacral region; and botox injections to the glabellar folds and crows’ feet area of the eyes. Dr. Wolland signed the examination notes and she initialed the SOAP notes for E.K.'s treatments of November 20, 2003. While her signature and initials verify that she ordered these medications be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to E.K. on November 20, 2003, were made by Bach McComb, D.O., another osteopathic physician who was employed at Advanced during the times relevant to this proceeding. Dr. Wolland, at least on this point, testified credibly and convincingly that it was Dr. McComb who actually gave the injections, which Dr. Wolland had ordered and which she actually witnessed. On December 11, 2003, a Thursday, E.K. presented at Advanced for follow-up treatment. After conducting a physical examination of E.K., Dr. Wolland made the following diagnoses of E.K.: Herniation of L2 and L4 dx by MRI Low back pain, chronic Decrease of normal lumbar lordosis curvature. Left shoulder Capsular shift for chronic dislocations History of total knee reconstruction Decreased libido and erections less full. A treatment plan was established by Dr. Wolland which included the administration or dispensing of the following medications and treatments: Depotestosterone, a testosterone gel, prescription of Viagra, trigger point injections on both sides and iliolumbar on both sides, and injection therapy to the lower back. All of these medications and treatments, except the Viagra and the testosterone gel, were to be administered or dispensed via injection. E.K. was also scheduled by Dr. Wolland to return in three weeks "for follow up of botox and prolotherapy"14 and "[p]lan prolotherapy to shoulder " As ordered by Dr. Wolland, E.K. received an injection of Depotestosterone and trigger point injections on both sides and the iliolumbar area of his back. Dr. Wolland signed the examination notes and she initialed the SOAP notes for E.K.'s treatment of December 11, 2003. While her signature and initials verify that she ordered the medications received by E.K. on December 11, 2003, were to be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to E.K. on December 11, 2003, were made by Dr. McComb. Dr. Wolland ordered and actually witnessed the injections. On or about December 30, 2003, a Tuesday, E.K. presented for follow-up treatment scheduled during his December 11, 2003, visit. After conducting a physical examination of E.K., Dr. Wolland made the following diagnoses of E.K.: Herniation of L2 and L4 Low back pain, chronic Decrease of normal lumbar lordosis curvature. Left shoulder Capsular shift for chronic dislocations History of total knee reconstruction Decreased libido and erections less full. Hypercholesterolemia- 218 LDL is 144, HDL 50 PSA - .7 CBC-normal indices A treatment plan was established by Dr. Wolland which included the following medications and treatments: Depotestosterone, intramuscularly, over ten injections containing Lidocaine, dextrose, and Vitamin B12 on both sides in the iliolumbar region and eight injections to the left shoulder; and injections containing Lidocaine, dextrose, and Vitamin B12 to the low back/sacral region. The medications, dextrose, and Vitamin B12 were to be given via injection. All of the injections ordered by Dr. Wolland were received by E.K. on December 30, 2003. Dr. Wolland signed the examination notes and she initialed the SOAP notes for E.K.'s treatment of December 30, 2003. While her signature and initials verify that she ordered the medications received by E.K. on December 30, 2003, were to be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to E.K. on December 30, 2003, were made by Dr. McComb. Dr. Wolland ordered and actually witnessed the injections. On or about March 19, 2004, a Thursday, E.K. presented for follow-up treatment.15 After conducting a physical examination of E.K., Dr. Wolland made the following assessment of E.K.: Chronic Low back pain Herniated lumbar discs Ligamentous instability of sacroiliac and lumbar area right knee knee [sic] instability 2ndry to acl reconstruction and repeated injury left shoulder pain hypotestosterone level facial wrinkling A treatment plan was established by Dr. Wolland which included: modified injection therapy to sacroiliac area bilat facet injection paravertebral bilat at lumbosacral level L4-5 and L5 S1 #4 Ligament injection sacroiliac and lumbar bilat iliolumbar and sacroiliac bilat #4 injection sites. Ozone ot sacroiliac joint bilat Modified injection therapy of lumbar area Modified injection therapy of right knee 6 Injection sites to ligamentous attachments . . . . ozone to right knee joint depotestosterone 200 mg IM Pursuant to Dr. Wolland's orders, E.K. received a 200 mg injection of Depotestosterone intramuscularly; over ten injections on both sides in the iliolumbar region; six injections to the sacroiliac region; four injections to the right knee; ozone to the right knee and sacroiliac joint; joint injection to the right knee; and botox injections to the forehead and other facial areas. Dr. Wolland signed the examination notes and she initialed the SOAP notes for E.K.'s treatment of March 19, 2004. While her signature and initials verify that she ordered the medications received by E.K. on March 19, 2004, were to be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to E.K. on March 19, 2004, were made by Dr. McComb. Dr. Wolland ordered and actually witnessed the injections. E.K.'s final visit to Advanced alleged in the Administrative Complaint took place on or about September 1, 2004, a Wednesday. The evidence failed to prove who ordered or actually administered the treatment received by E.K. on this date. While Dr. Wolland had signed the examination notes and initialed SOAP notes for prior visits, facts that she readily admitted, her signature and initials do not appear on any of the medical records for the September 1, 2004, visit. No credible evidence was offered that would support a finding that Dr. Wolland saw E.K. on September 1, 2004.16 Dr. Wolland's Treatment of B.K. On or about December 11, 2003, B.K., the wife of E.K., presented to Advanced and, in particular, Dr. Wolland for anti- aging treatment. The following "treatment plan" was established by Dr. Wolland for B.K.: Risks and benefits of botox treatment Consent signed Botox treatment given today to crows feet and glabellar fold area Pursuant to Dr. Wolland's orders, B.K. received injections of botox to the crows feet and glabellar fold area of her face. Dr. Wolland signed the examination notes and she initialed the SOAP notes for B.K.'s treatment of December 11, 2003. While her signature and initials verify that she ordered the medications received by B.K. on December 11, 2003, were to be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to B.K. on December 11, 2003, were made by Dr. McComb. Dr. Wolland ordered and actually witnessed the injections. On or about December 30, 2003, B.K. again presented to Advanced and was seen by Dr. Wolland. B.K. made this visit to receive additional botox injections, which she received after Dr. Wolland conducted a physical examination of her. As in the other visit by B.K. and the visits of E.K., Dr. Wolland signed B.K.'s examination notes and she initialed B.K.'s SOAP notes for the medications she received on December 30, 2003. While her signature and initials verify that she ordered the medications received by B.K. on December 30, 2003, were to be given via injection and that they were in fact given, they do not indicate who actually administered the injections. Diagram notes showing where the injections were given to B.K. on December 30, 2003, were made by Dr. McComb. Dr. Wolland ordered and actually witnessed the injections. Dr. Wolland's Violation of the ERO. The evidence clearly and convincingly proved that Dr. Wolland conducted examinations of E.K. and B.K. on several occasions, as discussed, supra, made a diagnosis of their respective conditions, developed and ordered a treatment plan for each, which included administering and dispensing of medications, dextrose, and vitamins via injections, supervised and witnessed the injections, and otherwise ensured that her treatment plan, in particular the administering and dispensing of the prescribed medications, was carried out. While the evidence failed to prove that Dr. Wolland actually gave any injection to E.K. or B.K., she admittedly caused the injections to be given, and, therefore, administered and dispensed the medications. The foregoing activities constitute "administering . . . any medication . . ." an activity prohibited by the ERO except when "required to sustain a patient's life in a bona fide medical emergency." None of the medications administered to E.K. or B.K. were administered to sustain their lives. The common definition of "administer" includes any activity "to manage or supervise the execution, use, or conduct of . . . ." Webster's Ninth New Collegiate Dictionary (1984). With regard to medications, to "administer" means to "give or apply." Wordnet.Princeton.edu/perl/webwn. Dr. Wolland's activities also constitute "dispensing" of medications in violation of the ERO. A physician dispenses medications every time she causes a medication to be given to a patient. Dr. Wolland should have understood that she was dispensing medications whether she physically gave the medications to E.K. or B.K. or, as here, by her action caused someone else to physically deliver the medications via injections. While Dr. Wolland may not have directly given or applied any medications to E.K. or B.K., without her orders, and B.K. would not have received any medications. She did, therefore, by ordering her treatment plans carried out, give, and, therefore, administer and dispense the medications specified in her treatment plans. This finding is supported by Dr. Rose's testimony, which is accepted and credited in this regard, that a reasonably prudent similar physician would understand that the ERO limited not only Dr. Wolland's ability to actually give an injection of medications, but her ability to order or cause anyone else to do so.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Osteopathic Medicine finding that Shelly O. Wolland, D. O., has violated Section 456.072(1)(q), Florida Statutes, as described in this Recommended Order; requiring that she pay a fine in the amount of $5,000.00; placing her license on probation for a period of three years; and requiring that she complete continuing education in subjects as directed by the Board of Osteopathic Medicine. DONE AND ENTERED this 22nd day of August, 2005, in Tallahassee, Leon County, Florida. S _____ LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of August, 2005.
Findings Of Fact B. G. Gross, M.D. is licensed by the Florida State Board of Medical Examiners and the Hearing Officer had jurisdiction over the Respondent and the offenses alleged. Gross is certified by the American Board of Dermatology. Amending Title 21 U.S. Code in 1962 led to the Food and Drug Administration (FDA) curtailing the interstate transportation of liquid silicone by declaring the use of liquid silicone by injection for soft tissue augmentation to be an experimental procedure. This made liquid silicone, intended for this use, a "new drug" as defined in 21 U.S.C. 321(p). Thereafter shipment of such drug could be made only to the seven named clinical investigators (later augmented to eight) approved by FDA for experimenting, under controlled and regulated procedures, on the use of injectable silicone in humans. Injections for mammary augmentation was not included in the approved use. Between 1967 and 1969 Gross engaged in correspondence with Dow to obtain liquid silicone from Dow suitable for injecting. Specifically Gross attempted to obtain Dow-Corning 360 Medical Fluid and be denominated a clinical investigator authorized to experiment with injectable silicone by injecting into humans. In 1967 following the commencement of this correspondence Gross executed an affidavit that he would not inject any Dow-Corning 360 Medical Fluid "hereafter received by me from Dow" into humans but would use same only for experimenting on animals, and Dow forwarded to him one pint of such silicone. Having no further success obtaining silicone shipped to him in Miami from Dow, Gross investigated the possibility of obtaining Dow 360 in Bermuda but here too he was unsuccessful. A subsequent attempt to be designated as a clinical investigator authorized to experiment with injectable silicone designated MDX-4-4011 fluid was also unsuccessful. This latter fluid differs from Dow 360 principally in being shipped in sterile ampules of 1cc and 5cc capacity and being subject to stricter manufacturing controls. Breast augmentation has been performed by some practitioners for many years. The process was greatly discredited in the 1920's when the medical profession became aware of the disastrous results associated with the use of paraffin for breast augmentation. The most experienced practitioner in this discipline today is probably Dr. Sakurai of Tokyo, Japan, who started such work in the mid-1940's. Subsequent to the discovery of silicone Sakurai used silicone to which he added some undisclosed organic oil to create an irritative reaction which would wall off the injected silicone to keep it immobile. The Sakurai Corporation was incorporated in California in 1962 to market this product and in March, 1963 was granted an investigative exemption to permit the use of this product for breast tissue augmentation. This investigational exemption was terminated on May 17, 1963 because the sponsor failed to submit requested data on manufacturing controls, animal toxicity and labeling. Prior to liquid silicone being classified as a "new drug" in 1963 Dow- Corning 360 Medical Fluid was available from drug supply houses and had been used by practitioners in this country as well as in Europe and Japan for breast augmentation. Although silicone is inert, non-toxic, water repellent and does not stimulate immunologic reaction as do many other materials implanted in the body, prior to the time the FDA classified liquid silicone as a "new drug" many scientists had concluded that its use was contraindicated for breast augmentation. Literature forwarded to Gross by Dow (Exhibit 11) when he inquired about the use of liquid silicone contained the following quotations: "Dow Corning does not feel that this material can be recommended for human injection." "... The FDA called a halt to the use of injectable silicone by classifying silicone for injection into humans as 'new drugs'. The agency prohibited the use of silicone on humans until specific research had been undertaken to determine its safety and effectiveness under a claimed investigational exemption." "Recent and preliminary experimental evidence has indicated that silicone fluids may be transported to far removed tissues and organs, but much more work must be completed before definite conclusions are reached." "Cautions Warranted. The present suggested clinical misuses of silicone fluids are as follows: 1. Mammary augmentation.* *Although the results in a selected group of cases injected properly and conservatively (not over 5 to 10 cc at any one time) have been encouraging, the continued use in this respect, since the filing of the IND with the FDA, has been postponed until a long-term follow-up has been established and these earlier results have been completely evaluated." "The contention that a causal relationship may exist between breast implantation and the subsequent development of mammary cancer cannot be answered definitely at this time." "The Federal Food and Drug Administration has stated that the injection of silicone fluids either in the pure form or as mixtures with other materials, con- stitutes a 'drug use'. Therefore the fluid used in this manner is a 'new drug' and specific investigative procedures must be followed to establish its safety and effectiveness." "Furthermore, it is well to note that the use of silicone fluid for breast augmentation has for many years been considered unwise by those clinical investi- gators most experienced with this material, because the volumes required are far in excess of those which were found safe for local administration. More importantly, examination of breasts for natural diseases is made difficult or impossible after injection with silicone fluid because of the distortion of the normal breast architecture which occurs." Dr. Gross has been interested in silicone injections since he was taking his residency in California in 1962. His testimony that he purchased some 5 or 10 gallons of Dow 360 Medical Fluid from a medical supply house in California in 1962 (before Dow took it off the market) in 500 cc (one pint) bottles (the standard size in which this material was packaged) subsequently poured these pint bottles into one gallon Chlorox bottles he had washed out, and transported this material to Florida where he kept these jars in his garage for several years before using it for injection, is simply not credible. Although denied by Gross, more than one of the witnesses testified that Gross told them the silicone he injected contained linseed oil. This would indicate that the silicone used by Gross possibly came from the Sakurai Corporation and was acquired by Gross on the "bootleg" market. Gross' interest in injectable silicone led him, according to his own testimony, to read all medical literature on the subject he could locate. In Exhibits 12, 13, and 18 with which Gross claimed familiarity the following appears: "Abuse of the material must be prevented because most problems and complications from improper use of liquid silicone are difficult to treat since the fluid cannot be retrieved from the tissues once injected." "During the past ten years, a high proportion of women who live here have had some type of 'liquid silicone' injection, despite intensive educational campaigns by physicians, hospitals, and the Medical Society. One estimate is that at least 12,000 women have had 'bootleg silicone injections' mostly in the breast area, and that at least one percent of them developed some type of problem each year." "...the more common localized problems, such as: infection, migration, cyst formation, deep tissue silicoma formation, and degrees of skin involvement from pigmentation to gangrene." "Although the problems we see in clinical practice in Las Vegas are said by Dow Corning representatives to be a result of injections of some type of 'liquid silicone' other than their 'medical grade 360', we have seen a number of the problems definitely from cases originally injected with 'medical grade 360' legitimately released for research several years ago." "The dream of a safe and simple method of correction of contour defects with injection of liquid silicone has not materialized despite ten years of intensive research by qualified investigators." "Examples of migration of silicone from the breasts into the axilla and chest wall are illustrated. At present, injection of silicone for purposes of breast augmentation is prohibited by the Food and Drug Administration. Precise information regarding the purity, type, and quantity of silicone injected is therefore difficult to obtain." "Since the injected silicone is relatively dense and often produces palpable masses, routine mammograms are suggested in patients with a history of silicone injections in the breasts. This examination could serve as a base line for comparison with subsequent studies, should malignant tumor be suspected at a later date." Dr. Gross injected liquid silicone into the breasts of Diane A. Carter, Dorothy Belcher, Ann Kern and Vicki Diaz, in addition to other patients not named in the Complaint. His normal practice was to inject 80 cc of silicone into each breast on the first visit. Many of his patients for breast augmentation returned for three treatments. The complaining witnesses all learned of Gross through friends and most of them first visited Dr. Gross' office in company with a friend. In response to inquiries about the process Gross assured the patients that following the injection of silicone their breasts would be beautiful. Although Gross later commenced using a release form which he had his patients for mammary augmentation sign, "because my lawyer thought it a good idea," even then he did not fully explain the potential hazards of silicone injection to these patients. The patients receiving treatment before the advent of the release (Exhibit 9) likewise were not fully advised of the hazards involved with silicone injections. Gross advised his patients that if lumps formed they could be broken up by finger pressure or squeezing which would break up the silicone into small globules. Initially all complaining witnesses were pleased with the result of the silicone injection. However they developed tenderness, inflammation and lumps in their breasts some months after their injections. None of them returned to Gross for treatment but instead went to family doctors (or plastic surgeons) who referred them to plastic surgeons for consultation. All of these witnesses were advised that the silicone could be removed only by mastectomy and that such drastic procedure was not recommended at the present time with the present discomfort they are suffering. No other method of removing injected silicone is presently available. Dr. Gross testified that he used only Dow Corning Medical Grade 360 silicone, although, since he told at least two of the witnesses in his office that the silicone used contained linseed oil, it is likely that he used both Dow 360 and other silicone. At the hearing Dr. Gross produced a nearly full bottle of Dow Medical Grade 360 silicone which was the bottle he received from Dow after executing the affidavit that he would not use that material for injection into humans. The missing silicone, according to Gross, was given to one of the dermatologists in his office. The amount removed from the 500 cc bottle, approximately 100cc, was not enough for Gross to have done a breast augmentation on one patient. No evidence was adduced that Gross used the Dow Medical Grade 360 received as a result of his affidavit for injection into humans. The Food and Drug Administration has no power to control a doctor engaged in the practice of medicine. Those authors quoted above are technically incorrect when they say the FDA has made the use of liquid silicone unlawful for mammary augmentation. By declaring injectable silicone a new drug the FDC has made it illegal to ship or transport this material in interstate commerce except to those licensed investigators approved to conduct clinical investigations. As stipulated by the parties, Gross was not a licensed investigator authorized to inject liquid silicone into humans. If Gross' testimony is true that he acquired the silicone injected into the breasts of the four complaining witnesses in 1962 while he was a resident in California, this material was moved from California after the effective date of 12 U.S.C. 355, viz Oct. 10, 1962. Exhibit 17, Curriculum Vitae of Bernard G. Gross, shows that Gross was resident in dermatology, Veterans Administration Hospital, Los Angeles, California 1962-1963; Chief Resident in dermatology, Boston City Hospital, Boston, Mass. 1963-1964; and Instructor, Department of Dermatology, University of Miami School of Medicine, Miami, Florida 1964-1965.
The Issue The issue presented for decision herein is whether or not the Respondent, Department of Environmental Regulation (DER), should issue a permit to Respondent, Robert Peterson, to construct a 0.007 MGD wastewater treatment facility with effluent disposal to Dual Class V injection wells in Key Largo, Monroe County, Florida.
Findings Of Fact On January 17, 1986, Robert Peterson, doing business as Peterson's Condominiums, submitted an application to the Florida Department of Environmental Regulation (DER) to construct a 0.007 MGD wastewater treatment plant with effluent disposal to Dual Class V injection wells into G-III groundwater. The proposed site is located at Mile Marker 95.6, U.S. Highway 1, Key Largo, Florida. The sewage treatment plant is to serve a ten unit condominium with provisions for four future units. The designed population to be served is 62. (Permit Application) The Plant is designed to treat the sewage so that after treatment and disinfection, the effluent will, on average contain no more than 20 parts per million biological oxygen demand (BOD-5 day) and 20 parts per million of total suspended solids (TSS). There will be 90 percent removal of these pollutants after treatment. The effluent will be disinfected in a chlorine contact chamber, with chlorine tablets used as the disinfectant. Sludge will be removed by a licensed scavenger truck to Monroe County approved disposal sites. Noise from the plant will be controlled by a blower filter, silencers, and a weather proof hood. (Permit Application). No control is contemplated for odor or aerosol drift other than proper plant operation. No lighting will be provided at the plant. Emergency power `from a rental portable generator will be used if there is an extended power failure. Along with the sewage treatment application, Respondent Peterson also submitted two permit applications for injection of the treated effluent into 2 Class V injection wells. The total volume of treated effluent that would enter into both wells combined is 6500 gallons per day. The 6 inch diameter wells would be 65 feet deep with casing and grout down to a depth of 30 feet. Upon receipt of the permit applications, DER reviewed the application and requested an additional application including groundwater samples measuring total dissolved solids. Peterson submitted two samples, both indicating total dissolved solids significantly greater than 10,000 milligrams per liter. (DER's Exhibits 2, 3 and 4). The samples (TDS) were taken approximately 1 and 6 miles from the proposed site. Based on DER's staff review of hundreds of groundwater quality analyses from the Keys, DER's staff determined that the samples submitted were consistent with other groundwater TDS levels throughout the Keys. (Testimony of Barrone and Me1e). Use of the samples by DER was reasonable and proper. Groundwater in which the TDS is greater than 10,000 milligrams per liter (parts per millions) is classified as G-III groundwater. Such water is considered non-potable. (Testimony of Barrone and Mele; Florida Administrative Code, Rule 17-3.403(1)). After review of the application, DER issued an "intent to issue" Peterson the permits requested on March 5, 1986. (DER's Exhibit 7). The "intent to issue" as drafted by DER established certain conditions to monitor water quality and to test treated effluent before it is discharged to Class V wells. As an example, flow, pH, and chlorine residuals are to be sampled daily; BOD and total suspended solids are to be sampled monthly and fecal coliform is to be sampled once per quarter. Test results are to be submitted to DER on a monthly basis and the analysis program is conditioned to demonstrate substantial compliance with water quality standards as set forth in pertinent sections of the Florida Administrative Code. Provided the monthly reports reveal violation of DER's standards, the permittee will be required to rectify the problems. (DER's Exhibit 7, testimony of Barrone and Mele). Additionally, DER has conditioned its intent to issue on a trial or experimental basis and this project will again be subjected to review in one year. (DER's Exhibit 7, condition 12). Should the permittee fails to bring the facility into full compliance within the one year period, an operational permit will not be issued. DER imposed this condition on the subject wastewater treatment plant, based on the fact that it is a new model and DER does not have extensive experience with the monitoring of this type plant. (Testimony of Barrone and Mele). Evidence introduced reveals that the plant manufacturer, Smith and Loveless, is the largest manufacturer of factory built water and wastewater pump stations and treatment plants. The manufacturer pioneered prefabricated treatment plants with over 30 years experience. Evidence reveals that there are at least three plants in operation in Florida without any operational problems. Upon "issuing the intent to issue", DER directed the permit applicant (Peterson) to publish notice in the Key West Citizen (Peterson's Exhibit 1). Notice of this proposed agency action was published in the Key West Citizen on March 17, 1986, giving any substantially affected party 14 days from that date to file a petition for administrative proceedings with DER's Office of General Counsel. (Petitioner's Exhibit 2). On March 26, 1986, DER received a letter from Petitioner McInerny, Popp and other local citizens (C.C. Waggle) protesting the proposed project. The Objectors indicated that they had heard that the proposed agency action was advertised in the Key West Citizen but that the Key West Citizen was not available in their area. 1/ Based on these protest letters, DER afforded Objectors, including Petitioners, a new point of entry into these proceedings. Petitioners Ohi, Popp and McInery timely petitioned for an administrative hearing challenging the proposed agency action. The challenges by Petitioners, based on DER's second point of entry, were timely filed. When the proposed facility becomes operational, it will not cause foul odors or create a nuisance due to aerosol drift based on the design features. (Testimony of Barrone, Mele and Sikorski. The extended aeration facility, as proposed, is the most reliable type of sewage treatment plant for this type operation. (Testimony of Mele). The expected pollutants produced from domestic sewage are BOD, dissolved solids and to a lesser extent heavy metals, nitrates, phosphorus and bacteria. (Testimony of Mele). After treatment, the effluent from this facility is not expected to be either toxic or carcinogenic. (Testimony of Mele). The Class V wells into which the treated effluent would be placed are approximately 500 feet from the nearest shoreline, the Atlantic Ocean. This is the closest distance to any Outstanding Florida Water. As such, the treated effluent will be diluted prior to its discharge into the Atlantic Ocean. (Permit Application, Testimony of Mele). Respondent Peterson has provided Respondent DER reasonable assurances that the proposed facility, upon operation, will not violate the Department's rules relating to air, noise and water quality standards.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent, Department of Environmental Regulation enter a Final Order issuing Respondent, Robert Peterson, doing business as Peterson's Condominiums, a permit to construct a 0.007 MGD wastewater treatment plant with effluent disposal to Dual Class V injection wells with the conditions as set forth in the DER's "intent to issue" dated March 5, 1986. RECOMMENDED this 1st day of December 1986 in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of December 1986.
The Issue The issue to be determined is whether Respondents, Anthony Crescenzo and Johns by John II, Inc. (collectively, Respondents), violated Florida Administrative Code Rule 64E-6.022(1)(g), (k), (l)2., and (p), and if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the licensing and regulation of the standards for onsite sewage treatment and disposal systems (OSTDS), pursuant to chapters 381 and 489, Florida Statutes, and Florida Administrative Code Chapter 64E-6. Respondent Anthony Crescenzo is a resident of the State of Florida and holds DOH registration number SR0061541, to provide septic tank contracting services in Florida. Mr. Crescenzo owns and operates Johns by John II, Inc. (Johns by John), a Florida corporation located at 6252 Commercial Way, Weeki Wachee, Hernando County, Florida. Johns by John is authorized by the Department to provide septic tank services under Business Authorization number SA0041171. Johns by John provides OSTDS services pursuant to rules adopted by the Department and under the license, registration, and direction of Anthony Crescenzo. Winston and Dianne Wescott reside at 2245 Ring Road in Spring Hill, Florida, and have done so for approximately 19 years. Sometime in April 2014, Mr. Wescott noticed a depression and some saturated soil in his yard, near his septic tank. Mr. Wescott was concerned because of prior sink hole activity. After some telephone calls and an inspection by the insurance adjuster, Mr. Winston called Johns by John. On or about Saturday, June 7, 2014, a worker from Johns by John came to the residence and pumped out the drainfield. At that time, waste was coming out of the ground but was not backing up into the home. After the pump-out was complete, Mr. Wescott showed the technician the depressed area, and an exposed area that revealed that the outlet pipe to the septic system’s distribution box (D-box) was defective. The area had been exposed by either the insurance adjuster or the homeowner before the technician arrived. The technician telephoned Mr. Crescenzo, who advised that he would come out the following Monday or Tuesday to inspect the system and see what additional repairs were necessary. Mr. Wescott paid $205.72 for the pump-out of the drainfield. On Wednesday, June 11, 2014, Mr. Crescenzo met with Mr. Wescott to assess what repairs were necessary. When he arrived, the homeowner had already dug around the area, leaving the tank and the D-box at least partially exposed. Mr. Crescenzo advised that a new drainfield might be necessary, but did not state that it was absolutely required. He also explained that the repair would require a permit, and that they would do what they could to repair, as opposed to replace, the existing system. Mr. Crescenzo also explained that because of the need to obtain a permit, it might be four to six weeks before the job was completed. Mr. Crescenzo prepared, and Mr. Wescott signed, a Work Order/Proposed Drainfield Estimate form. Under “Job Description,” the following handwritten notation was provided: D-box collapsed down [illegible] point may have to replace entire system $2,500-$3,500. System will need to go in the front due to site conditions 4 bedroom house deposit required $1,000. The preprinted text on the form provided the following statements in bold-faced type: * NOT RESPONSIBLE FOR SPRINKLERS, WIRES, BROKEN PIPES, YARD, SOD OR DRIVEWAY DAMAGEDeposits are non-refundable. The form also provided for a 10-year warranty of any work performed. Although the language of the form is not clear, Mr. Crescenzo testified credibly that the warranty was applicable to repairs of the existing system as well as to replacement of the system. While the maximum the homeowner might have to pay is clearly indicated on the form, the costs of a repair short of replacement is not listed. Mr. Crescenzo testified that a $1,000 deposit is required for any job requiring a permit, as the permit itself is $300, and that he told the homeowner that he would not know the extent of the repair needed until he started the work. Mr. Wescott signed the estimate. Despite the language on the estimate that a new drainfield may be needed, Mr. Wescott understood that his drainfield would be replaced. While he admits signing it, he did not recall seeing the statement that deposits are non-refundable, notwithstanding that it is printed in bold type. His understanding appears to be based, in part, on a discussion between Mr. Wescott and Mr. Crescenzo about the continued vitality of the D-box. Mr. Wescott understood Mr. Crescenzo to say that the life of the septic system was approximately 19 years (the age of his home), and that if the drainfield was not replaced, the Wescotts would in all likelihood be calling him back in a matter of months to replace it because it was nearing the end of its expected life-span. He also understood Mr. Crescenzo to say that the D-box was obsolete and would not be replaced when the drainfield was replaced. Mr. Crescenzo, on the other hand, testified that he always maintained that they would try to repair the existing drainfield but may have to replace it. In the event that the system was replaced, D-boxes are no longer used and the existing one would not be replaced. Mr. Crescenzo denied stating that the life of a drainfield is 19 years, stating that drainfields do not have a standard life expectancy.1/ Mr. Crescenzo also emphasized that the work performed, whether a repair to the existing drainfield or a replacement, was subject to a 10-year warranty, thus making any statement that the company would just have to come back in a few months nonsensical. Mr. Crescenzo’s testimony is credited. Mr. Crescenzo applied for a permit on June 18, 2014, which costs $300. The permit application was to repair or replace the distribution box, not to replace the drainfield, and noted that the D-Box had collapsed. Mr. Crescenzo stated on the application that it may be possible to fix the D-Box and remove roots. The permit was issued for OSTDS repair on June 20, 2014. According to Stephen Kataro, an engineer for the septic tank program for Hernando County who approved the application and inspected the repair, the permit gave the option to replace the drainfield if necessary, based upon what was found during the repair. This approval is consistent with Department policy. On approximately July 3, 2014, Jeremiah Blake, a technician for Johns by John, went to the Wescott home to work on the septic system. Mr. Blake drove a Johns by John truck equipped with the standard equipment to install a drainfield. When he arrived at the home, the system was already uncovered. Mr. Blake discussed the repairs with Mr. Wescott, stating that he could do the drainfield or fix the D-Box. He determined that replacement of the outlet pipe leading to the D-Box addressed the problem, and that there was no need to replace the drainfield, as all drains were taking water. Mr. Blake completed the repair and used Mr. Wescott’s garden hose with a jet-spray nozzle to spray inside the D-Box and clean out the lines. There is an alternative repair method referred to as “jetting” that requires a separate permit that Respondents did not obtain. Jetting requires specialized equipment that Respondents do not own. The unrebutted testimony of both Mr. Wescott and Mr. Blake is that Mr. Blake used a simple garden hose to clear the lines. He is familiar with what the Department refers to as jetting, but has never operated jetting equipment. He uses the term “jetting” because it is an easier way to describe what he does with a simple garden hose to clear the D-Box of sand. When Mr. Blake replaced the pipe leading to the D-Box, he broke sprinkler lines in the area. Sprinkler lines are often, if not always, damaged in OSTDS repairs. Respondents had arranged the day before for a timed inspection, for which they paid an additional fee. The purpose of a timed inspection is to be able to complete the job and have it inspected as soon as it is finished. Mr. Kataro came out to the property at approximately 9:00 a.m., inspected the work performed, determined that it met permit requirements to restore function, and approved it.2/ Mr. Kataro left the site before Mr. Blake covered the system, consistent with standard practice. While Mr. Wescott was present when Mr. Kataro arrived to inspect the work, there was no testimony to indicate Mr. Wescott advised the inspector that he was unhappy with the scope of work performed. Mr. Blake had a backhoe on the premises for use in covering the area. He testified that he covered the system, including the broken sprinkler pipes, and that he always does so and then notifies the homeowner about the need to fix the sprinkler pipes. Both Mr. Blake and Mr. Wescott testified that Mr. Wescott asked Mr. Blake to remove some sod for him nearby, and paid him cash for doing so. According to Mr. Blake, Mr. Wescott seemed satisfied at this point. It seems inconceivable that Mr. Wescott would be willing to pay additional funds for Mr. Blake to remove sod if he had not covered the system he was supposed to cover and if he was unhappy with the work (or lack of work) performed, and yet not say anything to Mr. Blake about covering the completed repair. Mr. Wescott expected that since the drainfield was not replaced, he would receive some portion of the $1,000 he paid back. Had he realized that the repair would cost that much, he would have gotten estimates from other contractors. He viewed replacing the drainfield as preventative maintenance. Based on this belief, after Mr. Blake left the premises, Mr. Wescott called Mr. Crescenzo and asked about a refund. He did not complain, however, about the system not being covered. Mr. Crescenzo informed him that there would be no refund, as the work order clearly indicates that deposits are non-refundable. The Wescotts called the Johns by John office to get an itemized receipt for insurance purposes. There was some delay in receiving a receipt, so they went to the office to obtain it in person. Initially, they were given a receipt stating that the D- box had been replaced. When they questioned this and told the person working in the office that the D-box had not been replaced, she made some phone calls to verify the work performed. The office worker prepared a new receipt while speaking to someone, presumably Jeremiah Blake, on the phone. The new receipt stated, “connected tank to distribution box. Leveled D-Box to drainfield. Jetted drainfield lines.” The change in the description appears to have occurred more because the person working in the office misunderstood the scope of work performed, rather than any nefarious intent to defraud. Further, the reference to jetting was consistent with both Mr. Blake and Mr. Crescenzo’s shorthand notation for cleaning the line with the garden hose, as opposed to the alternative repair method requiring additional permitting. As noted in paragraph 16, the sprinkler lines were broken during the repairs. Mr. Wescott replaced the broken pipes, and placed bricks underneath them to hold them in place. He was still unhappy about not having a new drainfield in place, and felt that he had been defrauded. On August 4, 2014, Mr. Wescott filed a complaint with Albert Gray, the Environmental Manager at the Department. At the very end of his two-page letter, Mr. Wescott stated that the broken irrigation pipes have been repaired and the hole is still wide open with the tank cover exposed. The Department does not regulate the prices to be charged for repairs or installation of new systems: that is between the contractor and the homeowner. There is more involved to complete the job than the time that the workman is on the premises actually performing the repair. For example, in addition to the cost of the permit application, additional time is necessary to perform a site evaluation and soil test. Whether or not the drainfield must be replaced, the materials must be available to install should it be necessary, as well as the skilled workman and equipment (truck, backhoe, etc.). Further, it is clear that, had Respondents installed a new drainfield, the cost would have been much higher than what the Wescotts actually paid, not only to pay for the drainfield, but also to replace a large section of sod and a larger portion of the sprinkler system. Regardless of whether a new drainfield is installed, contractors are required to cover the OSTDS when they work on it. As a result of the Wescott’s complaint, Inspector Kataro went back out to the Wescott home to inspect the site. He found that the D-Box was lying open and exposed, with no earth covering the system. He took pictures of the area, which were admitted into evidence as Petitioner’s Exhibits J and K. The pictures show two exposed sprinkler pipes, supported at one end by bricks. One picture shows a bucket positioned over the distribution box, while the other shows the box sealed but not covered. Mr. Kataro testified that the pictures look similar to what he saw when he inspected the property after the repair was completed in July 2014. However, he could not say whether the sprinkler system pipes were broken before, or whether the bricks supporting the pipes were there previously. The testimony is clear that, after the job was inspected, Mr. Wescott made repairs to the sprinkler system that would require the area to be uncovered and Mr. Wescott acknowledged that he placed the bricks under the sprinkler pipes. Mr. Kataro recalled that Mr. Blake had a backhoe on the premises at the time of repair, but Mr. Kataro left the site before the area would have been covered. There is credible testimony that Mr. Blake covered the area and credible testimony that he did not. Other evidence presented is more consistent with a finding that the area was covered, at least minimally. The equipment for covering the area was by all accounts on site, and Mr. Blake used that equipment to remove sod for Mr. Wescott. It makes little sense for him to use the equipment to remove the sod but not use it for covering the D-Box and surrounding area. Moreover, had Mr. Blake covered the area, it would have to be uncovered to fix the sprinkler pipes. The Department did not prove by clear and convincing evidence that Mr. Blake, as an agent of Respondents, failed to cover the D-box. Respondent Crescenzo happened to be at the Department on August 14, 2014, picking up permits when he learned of the complaint from Mr. Wescott. He was very upset about the complaint and immediately wrote a response while still at the Department. In his response, he denied stating that the drain field would definitely be replaced, and emphasized that by repairing the pipe leading to the D-Box the homeowner saved a substantial amount of money, including not only the cost of installing the drain field, but the re-sodding of his yard and more substantial repair of his sprinkler system. Although clearly unhappy about the complaint, Respondent Crescenzo stated, “If the homeowner wants the system just replaced they should have said that at the time of the job. Or we could still do it if they insist for the original agreed price.” Mr. Wescott has not elected to accept Respondents’ offer. In his response, Crescenzo also referred to “jetting,” but used it in the same informal manner as Mr. Blake. His informal reference did not change the unrebutted testimony regarding the scope of work performed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order dismissing the Administrative Complaint. DONE AND ENTERED this 21st day of May, 2015, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 21st day of May, 2015.
