Document OE90GOxYOpg6q6MLGZ32popQ1

RCRA Inspection Report 1) Inspector and Author of Report Kayla Acosta Physical Scientist Phone: 404-562-841 Acosta.kayla@epa.gov 2) Facility Information Linvatec Corporation 11311 Concept Blvd Largo, Florida 33773 3) Responsible Officials Andrew Young EHS Site Leader AndrewYoung@conmed.com 4) Inspection Participants Andrew Young, ConMed Mollie Enck, Florida Department of Environmental Protection (FDEP) Leslie Pedigo, FDEP U.S. Environmental Protection Agency (USEPA), Region 4 Enforcement and Compliance Assurance Division Chemical Safety and Land Enforcement Branch RCRA Enforcement Section 61 Forsyth Street, S.W. Atlanta, Georgia 30303 EPA ID#: FLD982075756 NAICS #: 339112 - Surgical and Medical Instrument Manufacturing Warren McNelley, FDEP Brandon Miller, FDEP Kayla Acosta, USEPA 5) Date of Inspection March 12, 2024, at 9:30 AM 6) Applicable Regulations1 Resource Conservation and Recovery Act (RCRA) Sections 3002 (42 U.S. Code - Annotated U.S.C.A. 6925 and 6927), and 40 Code of Federal Regulation (C.F.R.) Parts 260 - 270, 273, 278, & 279; Chapter 403 of the Florida Statutes, Fla. Stat. 403.702 et seq., and rules 62.710.210 -.901, and 62-730 et seq. of the Florida Administrative Code Annotated (Fla. Admin. Code Ann.) Pursuant to Fla. Admin. Code Ann. r. 62-730.020(1) [40 C.F.R. 260.10], a large quantity generator of hazardous waste (LQG) is a generator who generates greater than or equal to 1,000 kilograms (2,200 pounds) of non-acute hazardous waste in a calendar month. 1 As the State's authorized hazardous waste program operates in lieu of the federal RCRA program, the citations of those authorized provisions will be to the authorized State program. However, for ease of reference, the federal citations will follow in brackets. Pursuant to Fla. Admin. Code Ann. r. 62-730.185(1) [40 C.F.R. 273.9], a small quantity handler of universal waste (SQHUW) is a universal waste handler who does not accumulate 5,000 kilograms or more of universal waste (batteries, pesticides, mercury-containing equipment, lamps, or aerosol cans, calculated collectively) at any time. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.15(a)], a generator may accumulate as much as 55 gallons of non-acute hazardous waste in containers at or near any point of generation where wastes initially accumulate, which is under the control of the operator of the process generating the waste, without a permit or without having interim status, as required by Section 403.722 of the Florida Statutes, Fla. Stat. 403.722 [Section 3005 of RCRA, 42 U.S.C. 6925], and without complying with Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.16(b) or 262.17(a)], except as required in Fla. Admin. Code Ann. r. 62730.160(1) [40 C.F.R. 262.15(a)(7) and (8)], provided that the generator complies with the satellite accumulation area conditions listed in Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.15] (hereinafter referred to as the "SAA Permit Exemption"). Pursuant to Section 403.722 of the Florida Statutes, Fla. Stat. 403.722 [40 C.F.R. 262.17], an LQG may accumulate hazardous waste on-site for 90 days or less without a permit or without having interim status, as required by Section 403.722 of the Florida Statutes, Fla. Stat. 403.722 [Section 3005 of RCRA, 42 U.S.C. 6925], provided that the generator complies with the conditions listed in Section 403.722 of the Florida Statutes, Fla. Stat. 403.722 [40 C.F.R. 262.17] (hereinafter referred to as the "LQG Permit Exemption"). Pursuant to Fla. Admin. Code Ann. r. 62-730.030(1) [40 C.F.R. 261.4(b)(18)], solventcontaminated wipes, except for wipes that are hazardous waste due to the presence of trichloroethylene, that are sent for disposal are not hazardous wastes from the point of generation, provided that the conditions listed in Fla. Admin. Code Ann. r. 62-730.030(1) [40 C.F.R. 261.4(b)(18)] are met (hereinafter referred to as the "Solvent-Contaminated Disposable Wipe Exclusion"). 7) Purpose of Inspection The purpose of this inspection was to conduct an unannounced compliance evaluation inspection to determine Linvatec Corporation compliance with the applicable requirements of RCRA and the corresponding Florida regulations. This was an EPA lead inspection. 8) Facility Description Linvatec Corporation, d.b.a CONMED Corporation (known hereinafter as "Linvatec" or "the facility") designs and manufactures a variety of medical devices and products used in several medical fields including but not limited to general surgery, orthopedics, gastroenterology, and foot and ankle. Stainless steel, aluminum, and titanium are some of the raw materials used in the manufacturing of these devices. The facility is comprised of four buildings. Building one is used for the manufacturing of products, buildings two and four are used for the cleaning, packaging, and distribution of products, and building three is an educational building and showroom for products. EPA-RCRA CEI Report March 12, 2024 Page 2 of 15 Linvatec Corporation EPA ID# FLD982075756 Linvatec began operations in 1988 and manages over one thousand employees. The facility operates 24 hours Monday through Friday with three shifts. Weekends are used for overtime operations. The facility first notified FDEP of its regulated waste activity on January 05, 1989, as a small quantity generator of hazardous waste under the name Concepts, Inc. The facility later notified as a LQG on July 30, 2001, and most recently notified as an LQG on February 18, 2022, with its submission of the 2021 Biennial Report. The facility generates universal waste mercury containing lamps, batteries, used oil, used oily soapy water (OSW), spent aerosol cans, excluded solvent-contaminated wipes sent for disposal, and the following hazardous waste streams from cleaning and chemical finishing operations: EPA Waste Type of Code Waste EPA Waste Type of Waste Code D001 Ignitable D022 Chloroform D002 Corrosive D035 Methyl Ethyl Ketone (MEK) D005 Barium F003 Spent solvents and still bottoms: acetone, xylene, methanol D006 Cadmium F005 Spent solvents and still bottoms: MEK D007 Chromium F006 Wastewater treatment sludges from electroplating operations D008 Lead U044 Chloroform D010 Selenium Linvatec has a Pretreatment Discharge Permit with Pinellas County, (Permit No. IE-3014201/2024, expiration date 09/30/2024) for their wastewater treatment unit. 9) Previous Inspection History FDEP has conducted one RCRA CEI at the subject facility between 2019 and 2024. On January 19, 2022, FDEP conducted the most recent RCRA CEI at the subject facility and found three apparent violations of RCRA's requirements for labeling hazardous waste containers, marking hazardous waste containers with an indication of the hazard of the contents, and labeling used oil containers. The facility addressed the corrective actions during EPA-RCRA CEI Report March 12, 2024 Page 3 of 15 Linvatec Corporation EPA ID# FLD982075756 the inspection and as a result, FDEP issued an informal verbal enforcement action since the facility returned to compliance. 10) Opening Conference On March 12, 2024, EPA inspector Kayla Acosta, accompanied by FDEP inspectors Mollie Enck, Leslie Pedigo, Warren McNelley, and Brandon Miller, FDEP Environmental Manager arrived at Linvatec at approximately 9:30 AM. Andrew Young, EHS Site Leader, immediately received the inspectors. The inspectors held an opening conference with Mr. Young where they introduced themselves, showed their credentials, and explained the purpose of the visit. The inspectors described the anticipated use of equipment (iPad) during the inspection and provided a request for records. The EPA inspector explained that the Small Business Regulatory Enforcement Fairness Act's classification of a "small business" is generally set by the Small Business Administration using the business' SIC/NAICS code and annual receipts or number of employees. A copy of the EPA's information sheet for small businesses can be found at https://www.epa.gov/sites/production/files/2017-06/documents/smallbusinessinfo.pdf. The EPA inspector also discussed the company's ability, pursuant to 40 C.F.R. 2.203, to assert a business confidentiality claim for information submitted to EPA. The company did not assert a business confidentiality claim. Mr. Young provided an overview of the facility's history and current operations during the opening conference. The inspection participants also discussed health and safety protocols and required personal protective equipment before Mr. Young led the inspectors on a tour of the facility operations. 11) Inspection Observations BUILDING 4 This building is for specialty assembly and operates several departments including Research and Development, the Molding Department, Implants Department, Blades Department, Grinding Department, Special Assembly, Bead Blast Room, Battery Assembly, and Bio-Absorption Materials Room. Two 90-day hazardous waste central accumulation areas (CAAs) are also located in Building 4--the Main CAA and Flammable Room CAA. Research and Development (R&D) Laboratory: This is an autoclave testing laboratory for product packaging. The laboratory is equipped with environmental chambers that manipulate temperature and humidity to evaluate wear and tear of products. No hazardous waste was observed in this area. Electrical Room: This room is used for universal waste storage. The inspectors observed two 4-foot cardboard boxes of spent mercury containing lamps (Photos 1 &2). The boxes were both closed, labeled "Universal Waste--Spent Mercury Containing Lamps", and were dated 05/16/2023 and 10/03/2023. EPA-RCRA CEI Report March 12, 2024 Page 4 of 15 Linvatec Corporation EPA ID# FLD982075756 Molding Department: Injection molding activities occur in this area. No hazardous waste was observed in this area. Implants Department: The Implants Department contains a satellite accumulation area (SAA) for waste alcohol. The inspectors observed two 3-gallon red containers of waste alcohol (Photo 3). The containers were labeled "Hazardous Waste--Alcohol" and marked with an indication of the hazard of the contents. Implants Packaging Room: This room is located next to the Implants Department and serves as a sterile clean room with an SAA for excluded solvent-contaminated wipes. The inspectors observed one 5-gallon container of excluded solvent-contaminated wipes (Photo 4). The container was closed and labeled "Excluded Solvent Wipes". Excluded solvent-contaminated wipes are disposed of on a weekly basis pursuant to the facility's documented standard operating procedures (SOP). Blades Department: The Blades Department contains several SAAs for cleaning workstations and products. The inspectors observed the following hazardous wastes (Photos 5-7): Two 3-gallon containers of Kwik Solv waste. The containers were closed, labeled "Hazardous Waste--Kwik Solve", and marked with an indication of the hazard of the contents. One 3-gallon container of acetone waste. The container was closed, labeled "Hazardous Waste--Acetone", and marked with an indication of the hazard of the contents. Three 3-gallon containers of alcohol waste. The containers were closed, labeled "Hazardous Waste--Alcohol", and marked with an indication of the hazard of the contents. Blades Department Final Assembly: The inspectors observed two 5-gallon containers of excluded solvent-contaminated wipes. Both containers were closed and labeled "Excluded Solvent-Contaminated Wipes". Special Assembly: The Special Assembly includes an SAA for waste alcohol and waste chloroform. Solventcontaminated wipes are also generated in this area. The inspectors observed the following wastes: Three 3-gallon containers of waste alcohol. The containers were closed, labeled "Hazardous Waste--Alcohol", and marked with an indication of the hazard of the contents. One 5-gallon container of excluded solvent-contaminated wipes. The container was closed and labeled "Excluded Solvent Wipes". EPA-RCRA CEI Report March 12, 2024 Page 5 of 15 Linvatec Corporation EPA ID# FLD982075756 Grinding Packaging Department--Gowning Room: The inspectors observed the following wastes in the Gowning Room: One 3-gallon container of waste alcohol. The container was closed, labeled "Hazardous Waste--Alcohol", and marked with an indication of the hazard of the contents. One 5-gallon container of excluded solvent-contaminated wipes. The container was closed but missing a label. Pursuant to Fla. Admin. Code Ann. r. 62-730.030(1) [40 C.F.R. 261.4(b)(18)(i)], the solventcontaminated wipes, when accumulated, stored, and transported, are contained in nonleaking, closed containers that are labeled "Excluded Solvent-Contaminated Wipes." Facility personnel added a label during the inspection. Grinding Packaging Department--Clean Room: The inspectors observed six 5-gallon containers of excluded solvent-contaminated wipes in the Clean Room. The containers were closed and labeled "Excluded Solvent-Contaminated Wipes". Main (CAA): The facility manages electro-polish waste and used oily soapy water (OSW) from Buildings 2 and 4, spent aerosol cans, and universal waste batteries in the Main CAA. The Main CAA also contains three enclosed evaporators used to remove excess water from used OSW, electropolish wastewater, and electrochemical grinding (ECG) wastewater respectively. Used OSW is collected in a 180-gallon aboveground storage tank before being hard-pied to the OSW evaporator. Electropolish wastewater is manually collected in a 289-gallon above ground storage tank with a top opening and a visual overfill prevention marker to indicate high-level. It is then hard piped to the electro-polish evaporator. Sludge from the electro-polish wastewater and the ECG contain heavy metals and are managed as hazardous wastes. Hazardous wastes are shipped offsite on a weekly basis. The CAA is equipped with an internal communications or alarm system capable of providing immediate emergency instruction to facility personnel; it is equipped with a device capable of summoning emergency assistance from local police departments, fire departments, or state or local emergency response teams; it is equipped with portable fire extinguishers, fire control equipment, spill control equipment, and decontamination equipment; and it is equipped with water to supply water hose streams, or foam producing equipment, or automatic sprinklers, or water spray system. The inspectors observed the following waste: One 289-gallon tank of waste electro-polish wastewater from Building 4. The tank was less than 25% full. The tank was marked with an indication of the hazard of the contents but did not have a Hazardous Waste label (Photo 8). One 180-gallon tank of OSW from Building 4. The tank was labeled "Used Oil, Soap, and Water" (Photo 9). EPA-RCRA CEI Report March 12, 2024 Page 6 of 15 Linvatec Corporation EPA ID# FLD982075756  One 55-gallon container of hazardous waste electro-polish sludge. The container was closed, missing a hazardous waste label, not dated, and missing an indication of the hazard of the contents. This was corrected onsite (Photo 10). One 55-gallon SAA container of used aerosol cans managed as hazardous waste. The container was not securely closed with a locked ring, missing a hazardous waste label, and missing an indication of the hazard of the contents. This was corrected onsite (Photo 11). One 10-gallon container of universal waste batteries. The container was closed but missing a universal waste label and an accumulation start date. This was corrected onsite (Photo 12). One 20-gallon container of used lithium-ion batteries. The container was closed but missing a universal waste label and an accumulation start date. This was corrected onsite (Photo 12). Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.15(a)(4)], a container holding hazardous waste must be closed at all times during accumulation, except: (i) When adding, removing, or consolidating waste; or (ii) When temporary venting of a container is necessary (A) For the proper operation of equipment; or (B) To prevent dangerous situations, such as build-up of extreme pressure. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.17(a)(5)(i)(A-C)], a large quantity generator must mark or label its containers and tanks with the following: (A) The words "Hazardous Waste"; (B) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (i.e., ignitable, corrosive, reactive, toxic); hazard communication consistent with the Department of Transportation requirements at 49 CFR part 172 subpart E (labeling) or subpart F (placarding); a hazard statement or pictogram consistent with the Occupational Safety and Health Administration Hazard Communication Standard at 29 CFR 1910.1200; or a chemical hazard label consistent with the National Fire Protection Association code 704); and (C) The date upon which each period of accumulation begins clearly visible for inspection on each container. Pursuant to Fla. Admin. Code Ann. r. 62-730.185(1) [40 C.F.R. 273.14(a)], universal waste batteries (i.e., each battery), or a container in which the batteries are contained, must be labeled or marked clearly with any one of the following phrases: "Universal Waste-- Battery(ies)," or "Waste Battery(ies)," or "Used Battery(ies);" Pursuant to Fla. Admin. Code Ann. r. 62-730.185(1), Fla. Admin. Code Ann. r. 62-737.400(7) [40 C.F.R. 273.15(c)], a small quantity handler of universal waste who accumulates universal waste must be able to demonstrate the length of time that the universal waste has been EPA-RCRA CEI Report March 12, 2024 Page 7 of 15 Linvatec Corporation EPA ID# FLD982075756 accumulated from the date it becomes a waste or is received. The handler may make this demonstration by using any one of the methods listed in 40 C.F.R. 273.15(c)(1-6). Flammable Room CAA: This CAA is adjacent to the Main CAA in a separate enclosed room and is used to store ignitable hazardous waste. The entire facility is a no smoking facility. The room is equipped with a sprinkler system, spill control, and fire control equipment. It is also equipped with an internal communications or alarm system capable of providing immediate emergency instruction to facility personnel; it is equipped with a device capable of summoning emergency assistance from local police departments, fire departments, or state or local emergency response teams. The inspectors observed the following hazardous wastes (Photos 13-15): One 55-gallon container of waste ethanol heptane. The container was closed, labeled "Hazardous Waste--Ethanol Heptane", marked with an indication of the hazard of the contents, and dated 02/29/24. Two 55-gallon containers of isopropyl alcohol (IPA) waste. The containers were closed, labeled "Hazardous Waste", marked with an indication of the hazard of the contents, and dated 03/11/24 and 03/06/2024 respectively. Bead Blast Room: This room contains a pig mat press used to collect oily pig mats. There is a 55-gallon drum under the pig mat press for the collection of used oily pig mats and an additional 55-gallon drum used to collect used pig mats contaminated with corrosive chemicals. This drum was empty at the time of inspection. No hazardous waste was observed in this area. Battery Assembly Room: In the battery assembly room, the inspectors observed one 5-gallon container of excluded solvent-contaminated wipes. The container was closed and labeled "Excluded Solventcontaminated Wipes" (Photo 16). Grinding Department--Machining Area: In the Machining Area, the inspectors observed an SAA for two 3-gallon containers labeled Kwik-Solve and two 3-gallon containers labeled waste alcohol. The containers were closed, labeled "Hazardous Waste", and marked with an indication of the hazard of the contents (Photo 17). Bio-Absorption Materials Room: The inspectors observed the following wastes in this area: One 3-gallon container of excluded solvent-contaminated wipes. The container was closed and labeled "Excluded Solvent-contaminated Wipes". One 5-gallon container of excluded solvent contaminated wipes. The container was closed but missing a label. This was corrected onsite. EPA-RCRA CEI Report March 12, 2024 Page 8 of 15 Linvatec Corporation EPA ID# FLD982075756  One (1) 1-gallon container of waste alcohol. The container was closed, labeled "Hazardous Waste--Alcohol", and marked with an indication of the hazard of the contents. Pursuant to Fla. Admin. Code Ann. r. 62-730.030(1) [40 C.F.R. 261.4(b)(18)(i)], the solventcontaminated wipes, when accumulated, stored, and transported, are contained in nonleaking, closed containers that are labeled "Excluded Solvent-Contaminated Wipes." Tool Room: The inspectors observed one 55-gallon container of scrap metal. No hazardous waste was observed in this area. BUILDING 2 This product cleaning and assembly building consists of the Capital Products Assembly, Capital Products Warehouse, the Shutt Instruments Department, and the Service Repair Operations Department. Capital Products Assembly: The inspectors observed the following wastes: Four 5-gallon containers of excluded solvent-contaminated wipes. The containers were all closed and but only three were labeled "Excluded Solvent-Contaminated Wipes". This was corrected onsite. Two 3-gallon containers of waste IPA. The containers were closed, labeled "Hazardous Waste--IPA", and marked with an indication of the hazard of the contents. Pursuant to Fla. Admin. Code Ann. r. 62-730.030(1) [40 C.F.R. 261.4(b)(18)(i)], the solventcontaminated wipes, when accumulated, stored, and transported, are contained in nonleaking, closed containers that are labeled "Excluded Solvent-Contaminated Wipes." Shutt Instruments Department: The inspectors observed three 5-gallon containers of excluded solvent-contaminated wipes. The containers were all closed and labeled "Excluded Solvent-Contaminated Wipes". Service Repair Operations Department: This department has an SAA for electro-polish wastewater and waste IPA. The inspectors observed the following wastes (Photos 18): One 30-gallon container used to collect electro-polish wastewater. The container was closed and empty at the time of the inspection. Five 5-gallon containers of excluded solvent-contaminated wipes. The containers were all closed and labeled "Excluded Solvent-Contaminated Wipes". One half-gallon container of IPA waste. The container was closed, labeled "Hazardous Waste--IPA", and marked with an indication of the hazard of the contents. EPA-RCRA CEI Report March 12, 2024 Page 9 of 15 Linvatec Corporation EPA ID# FLD982075756  One 3-gallon container of IPA waste. The container was closed, labeled "Hazardous Waste--Alcohol Solution", and marked with an indication of the hazard of the contents. BUILDING 1--OUTSIDE Located outside, behind Building 1 is the wastewater treatment plant (WWTP). Wastewater entering Pinellas County POTW is tested on a monthly, semi-annual, and annual basis. The WWTP is used to treat the wastewater from chemical rinse tanks for the anodizing process lines. The wastewater goes through pH adjustment in a clarifier tank with the use of sodium hydroxide while heavy metals are made to separate and settle at the bottom of a sludge tank with the use of flocculants. The sludge is then sent to a filter press which generates hazardous waste filter cake. There is separate filter press in the WWTP used for non-hazardous waste sludge from wastewater generated from non-chemical rinse baths. There is also a used oil collection system for OSW generated from Buildings 1 and 2. OSW is sent to a 500-gallon evaporator tank. OSW sludge is collected in a separate 500-gallon tank and used oil is collected in another 500-gallon tank. The inspectors observed one 55-gallon SAA container of hazardous waste wastewater treatment sludge under the filter press for hazardous waste sludge (Photo 19). The container was open but was actively in use. The container was missing a hazardous waste label and an indication of the hazard of the contents. This was corrected onsite. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.15(a)(5)(A-B)], a large quantity generator must mark or label its containers with the following: (A) The words "Hazardous Waste"; and (B) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (i.e., ignitable, corrosive, reactive, toxic); hazard communication consistent with the Department of Transportation requirements at 49 CFR part 172 subpart E (labeling) or subpart F (placarding); a hazard statement or pictogram consistent with the Occupational Safety and Health Administration Hazard Communication Standard at 29 CFR 1910.1200; or a chemical hazard label consistent with the National Fire Protection Association code 704). BUILDING 1--INSIDE Building 1 is used for the Precision Machine Operations (PMO) Factory, Chemical Finishing Department, Metal Finishing Department, and the Facilities Maintenance Department. CNC machines use water and oil-based coolants that are recycled after use. These machines mostly generate OSW which is sent to the WWTP'S used oil collection system. Used oily rags were being collected in containers labeled "Excluded Solvent-Contaminated Wipes". The inspectors explained to facility personnel that the excluded solvent-contaminated wipes label is only for the collection of excluded solvent-contaminated wipes and not for used oily rags. The containers should be re-labeled to state the containers are for used oily rags only. In the PMO Factory the inspectors observed the following wastes (Photo 20-21): EPA-RCRA CEI Report March 12, 2024 Page 10 of 15 Linvatec Corporation EPA ID# FLD982075756  Two 3-gallon SAA containers of waste alcohol. The containers were labeled "Hazardous Waste--Alcohol" and marked with an indication of the hazard of the contents. One 5-gallon container of excluded solvent contaminated wipes. The containers were all closed and labeled "Excluded Solvent-Contaminated Wipes". One 55-gallon closed container of non-hazardous waste spent blast media. The inspectors requested the waste profile for the non-hazardous waste blast media. Facilities Maintenance Department: The facilities maintenance department utilizes a CRC SmartWasher which is a bio-remediation parts washer. The bio-remediation solution is added as needed (Photo 22). BUILDING 3 Building 3 is an education building used to demonstrate the use of Linvatec products and has a showroom for all Linvatec's products. No hazardous waste was observed in this building. 12) Records Review Contingency Plan and Quick Reference Guide (QRG): The actions that facility personnel should take in response to an emergency are described in the facility's Emergency Plan and Hazardous Waste Contingency Plan. Elements of the contingency plan were split between both documents. The plans described actions facility personnel must take in response to fires or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water at the facility but did not describe actions to take in response to an explosion. The plan does not describe arrangements agreed to with the local police department, fire department, other emergency response teams, emergency response contractors, equipment suppliers, local hospitals or the Local Emergency Planning Committee. The Emergency Plan lists the names and emergency telephone numbers for persons identified as emergency coordinators but doesn't designate the primary emergency coordinator and alternates. The Hazardous Waste Contingency Plan includes a list of all emergency equipment at the facility. The list includes fire extinguishing systems, spill control equipment, communications and alarm systems, and decontamination equipment. The list appears to be up to date. The plan includes the location and a physical description of each item on the list, and a brief outline of its capabilities. Neither of the two plans included an evacuation plan for personnel describing signal(s) to be used to begin evacuation, evacuation routes, and alternate evacuation routes. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.261(a, c, d, & f)] (a) The contingency plan must describe the actions facility personnel must take to comply with EPA-RCRA CEI Report March 12, 2024 Page 11 of 15 Linvatec Corporation EPA ID# FLD982075756 262.260 and 262.265 in response to fires, explosions, or any unplanned sudden or nonsudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water at the facility. (c) The plan must describe arrangements agreed to with the local police department, fire department, other emergency response teams, emergency response contractors, equipment suppliers, local hospitals or, if applicable, the Local Emergency Planning Committee, pursuant to 262.256. (d) The plan must list names and emergency telephone numbers of all persons qualified to act as emergency coordinator (see 262.264), and this list must be kept up to date. Where more than one person is listed, one must be named as primary emergency coordinator and others must be listed in the order in which they will assume responsibility as alternates. In situations where the generator facility has an emergency coordinator continuously on duty because it operates 24 hours per day, every day of the year, the plan may list the staffed position (e.g., operations manager, shift coordinator, shift operations supervisor) as well as an emergency telephone number that can be guaranteed to be answered at all times. (f) The plan must include an evacuation plan for generator personnel where there is a possibility that evacuation could be necessary. This plan must describe signal(s) to be used to begin evacuation, evacuation routes, and alternate evacuation routes (in cases where the primary routes could be blocked by releases of hazardous waste or fires). Mr. Young stated that the plans were submitted to an EPA portal website: EPA TRI Reporting Center that distributes the plans to local emergency response. An email was provided from EPA TRI Reporting Center showing confirmation of a submission to provide optional facility-level information. This information appears to be related to reporting source reduction activities that are presented to the public in the TRI Pollution Prevention Tool. The email and website do not appear to indicate that it distributes contingency plans to a facility's local emergency response. Records showing which local emergency responders (local police department, local fire department, local hospital, local emergency planning committee) were not available for review. It is recommended that the facility submit the contingency plan and quick reference guide directly to local authorities either through mail, email, or in person and maintain records showing proof of delivery. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.256(a)] the large quantity generator must attempt to make arrangements with the local police department, fire department, other emergency response teams, emergency response contractors, equipment suppliers, and local hospitals, taking into account the types and quantities of hazardous wastes handled at the facility. Arrangements may be made with the Local Emergency Planning Committee, if it is determined to be the appropriate organization with which to make arrangements. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.256(b)], the large quantity generator shall maintain records documenting the arrangements with the local fire department as well as any other organization necessary to respond to an emergency. This documentation must include documentation in the operating record that either confirms such arrangements actively exist or, in cases where no arrangements exist, confirms that attempts to make such arrangements were made. EPA-RCRA CEI Report March 12, 2024 Page 12 of 15 Linvatec Corporation EPA ID# FLD982075756 The facility was missing a quick reference guide of the contingency plan. Pursuant Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.262(b)], a large quantity generator that first becomes subject to these provisions after May 30, 2017 or a large quantity generator that is otherwise amending its contingency plan must at that time submit a quick reference guide of the contingency plan to the local emergency responders identified at paragraph (a) of this section or, as appropriate, the Local Emergency Planning Committee. The quick reference guide must include the elements listed in 40 C.F.R. 262.262(b)(1-8). Training Records: The inspectors reviewed facility job descriptions and annual training records for Andrew Young, Bernie Rosario, Michael Ingram, and Richard Swiatek. Safety personnel and spill responders receive HAZWOPER training provided by Environmental Resource Center. Hazard Communications training is provided to all employees working in areas that handle hazardous materials and waste. Hazardous Waste Management training is provided to safety personnel, the hazardous waste technician, and backup hazardous waste technicians. The facility provided a written description of the type and amount of both introductory and continuing training to be given to each person filling the positions listed above. The inspectors reviewed records of employee hazardous waste training completed within the last three years. Waste Manifest and Land Disposal Restriction (LDR) Records: The inspectors reviewed available hazardous waste manifest records and land disposal restriction forms for shipments of hazardous waste sent since 2021. Hazardous waste manifest records show that hazardous wastes are routinely shipped to U.S. Ecology Tampa, Inc. in Tampa, FL. The most recent shipment was made on 03/07/2024. No issues were noted with the manifests. Waste Shipping Documents for Non-hazardous Waste: Shipping documents were available for review for scrap metal, used oil, electronic waste, and universal waste. Scrap metal is sent for recycling to Trademark Metals Recycling. Used oil is picked up by Howco Environmental Services. The last shipment was on 01/17/2023. Electronic waste is sent to SIMs Lifecycle Service. The last shipment was on 01/09/2023. Universal waste batteries are picked up by Battery Solutions and were last shipped on 01/10/2023. Universal waste mercury-containing lamps are shipped to Renew & Recycle, Inc. The latest shipment of mercury-containing lamps was conducted on 04/27/2023. Weekly Inspection Records: The inspectors reviewed Linvatec's available records of inspections of the hazardous waste central accumulation areas (CAAs) since 2021. Which includes the date and time of inspection, who conducted the inspections, number of hazardous waste containers, and condition of containers. No issues were noted for weekly CAA inspections. EPA-RCRA CEI Report March 12, 2024 Page 13 of 15 Linvatec Corporation EPA ID# FLD982075756 Daily Tank Inspections: The inspectors reviewed daily tank inspections for the electro-polish hazardous waste tank since 2021. Daily tank inspections were missing for 01/03/2022, the entire first week of August 2022, 08/29/2022, and 10/10/2022. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) 62-730.160(3) [40 C.F.R. 262.17(a)(2)], which incorporates Fla. Admin. Code Ann. r. 62-730.180(2) Fla. Admin. Code Ann. R. 62730.160(3) [40 C.F.R. 265.195(a, b, e)], and is a condition of the LQG Permit Exemption, a generator accumulating hazardous waste in tanks must conduct daily inspections of monitoring and leak detection equipment data, overspill control equipment, above ground portions of the tank, the secondary containment system, and the tank ancillary equipment that is not provided with secondary containment. Mr. Young stated in an April 03, 2024, email that he communicated these requirements to the employee conducting the daily tank inspections and to the two back-up employees. If an employee cannot conduct daily tank inspections due to absence or training, then an alternate employee but conduct the daily tank inspection. The electro-polish waste tank was determined to have a volatile organic concentration of less than 500 parts per million by weight and is therefore not subject to subpart CC--air emission standards for tanks. A waste profile for the electro-polish tank was provided for review from U.S. Ecology. The facility ships out electro-polish wastewater and sludge on a weekly basis and uses the manifests to demonstrate the storage of hazardous waste in the tank is less than 90-days. P.E. Certification: The facility provided the P.E. certification and integrity test for the 289-gallon electro-polish tank after the inspection on 04/03/2024. The P.E. certification and integrity tests were conducted on April 01, 2002, by Jose Morales, P.E. License #42008. Waste Profiles: A waste profile was available for review for the electro-polish hazardous waste tank from U.S. Ecology, detailed the electro polish waste contains less than 500 ppm of VOCs. A waste profile or waste determination documentation could not be located for the nonhazardous spent blast media from the PMO Factory in Building 1. After the inspection, the waste was sent off to Republic Services for laboratory analysis. Pursuant to Fla. Admin. Code Ann. r. 62-730.160(1) [40 C.F.R. 262.11], a person who generates a solid waste, as defined in 40 CFR 261.2, must make an accurate determination as to whether that waste is a hazardous waste in order to ensure wastes are properly managed according to applicable RCRA regulations. A hazardous waste determination is made using the steps listed in 40 C.F.R. 262.11 (a-g). EPA-RCRA CEI Report March 12, 2024 Page 14 of 15 Linvatec Corporation EPA ID# FLD982075756 On May 13, 2024, Mr. Young provided a waste profile from Republic Services and TCLP from Eurofins for the spend blast media from the PMO Factory which demonstrated the waste was non-hazardous. 13) Closing Conference The inspectors conducted the exit meeting with Andrew Young. During this meeting, the inspectors stated their preliminary conclusions of the inspection. Mr. Young agreed to provide the requested records as soon as possible. On 04/03/2024, Mr. Young provided via email a copy of the facility's hazardous waste contingency plan, P.E. certification for the electro-polish tank. On 04/30/2024 Mr. Young provided via email a revised draft contingency plan for review, the first two weeks of April daily tank inspections (requested by FDEP to demonstrate facility is continuing to conduct inspections daily), and photos of drum labeling. 14) List of Attachments Attachment 1 - Photo Log: 15) Signed Digitally signed by KAYLA KAYLA ACOSTA Date: 2024.05.20 14:32:48 ACOSTA -04'00' Kayla Acosta Physical Scientist 16) Concurrence ALAN NEWMAN Digitally signed by ALAN NEWMAN Date: 2024.05.20 15:14:46 -04'00' Alan R. Newman RCRA Enforcement Section EPA-RCRA CEI Report March 12, 2024 Page 15 of 15 Linvatec Corporation EPA ID# FLD982075756 Attachment 1 - Photo Log [22] Photos taken on: March 12, 2024 Photos taken by: Kayla Acosta Photos taken with: iPad EPA Property Tag: SS8386 Photo 1 IMG-2024031210162016202237156.jpg 03/12/2024 10:16 AM (ET) Photographer: Kayla Acosta Building 4--Electrical Room 27.87471048, -82.75843946 4-foot cardboard boxes of spent mercury containing lamps. EPA-RCRA CEI Report March 12, 2024 Appendix1 - Page 1 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 2 IMG-2024031210162616262708164.jpg 03/12/2024 10:16 AM (ET) No CBI No PII Photographer: Kayla Acosta Building 4--Electrical Room 27.87471041, -82.75843947 4-foot cardboard boxes of spent mercury containing lamps. EPA-RCRA CEI Report March 12, 2024 Page 2 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 3 03/12/2024 10:23 AM (ET) No CBI No PII Building 4--Implants Department 3-gallon red containers of waste alcohol. IMG-202403121023012312098469.jpg Photographer: Kayla Acosta 27.87487861, -82.7584505 EPA-RCRA CEI Report March 12, 2024 Page 3 of 22 Linvatec Corporation EPA ID# FLD982075756 Photos 4 IMG-2024031210255725572407816.jpg 03/12/2024 10:25 AM (ET) No CBI No PII Photographer: Kayla Acosta Building 4--Implants Packaging Room 27.8749842, -82.75842047 5-gallon container of excluded solvent-contaminated wipes. EPA-RCRA CEI Report March 12, 2024 Page 4 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 5 03/12/2024 10:31 AM (ET) Building 4--Blades Department 3-gallon containers of Kwik Solv waste. IMG-2024031210313831382302002.jpg Photographer: Kayla Acosta 27.8753456, -82.75839342 EPA-RCRA CEI Report March 12, 2024 Page 5 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 6 03/12/2024 10:31 AM (ET) Building 4--Blades Department 3-gallon container of acetone waste. IMG-2024031210314431442657366.jpg Photographer: Kayla Acosta 27.87547182, -82.75852885 EPA-RCRA CEI Report March 12, 2024 Page 6 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 7 03/12/2024 10:35 AM (ET) Building 4 Three 3-gallon containers of alcohol waste. IMG-2024031210354435442374750.jpg Photographer: Kayla Acosta 27.87537956, -82.75851322 EPA-RCRA CEI Report March 12, 2024 Page 7 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 8 IMG-202403121100170172071002.jpg 03/12/2024 11:00 AM (ET) Photographer: Kayla Acosta Building 4--Main CAA 27.87539708, -82.75830774 289-gallon tank of waste electro-polish wastewater. EPA-RCRA CEI Report March 12, 2024 Page 8 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 9 IMG-202403121101321322208405.jpg 03/12/2024 11:01 AM (ET) Photographer: Kayla Acosta Building 4--Main CAA 27.87544278, -82.75824929 180-gallon tank of Used Oil, Soap, and Water (OSW). EPA-RCRA CEI Report March 12, 2024 Page 9 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 10 IMG-202403121104564562402741.jpg 03/12/2024 11:04 AM (ET) Photographer: Kayla Acosta Building 4--Main CAA 27.87542387, -82.75837 55-gallon container of hazardous waste electro-polish sludge. EPA-RCRA CEI Report March 12, 2024 Page 10 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 11 IMG-202403121107217212282445.jpg 03/12/2024 11:07 AM (ET) No CBI No PII Photographer: Kayla Acosta Building 4--Main CAA 27.8754992, -82.75834023 10-gallon container of universal waste batteries and 20-gallon container of universal waste lithium-ion batteries. EPA-RCRA CEI Report March 12, 2024 Page 11 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 12 IMG-2024031211104510452306710.jpg 03/12/2024 11:10 AM (ET) Photographer: Kayla Acosta Building 4--Main CAA 27.87540086, -82.75830688 55-gallon container of use aerosol cans managed as hazardous waste. EPA-RCRA CEI Report March 12, 2024 Page 12 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 13 IMG-2024031211214421441293800.jpg 03/12/2024 11:21 AM (ET) Photographer: Kayla Acosta Building 4--Flammable Room CAA 27.87543201, -82.75819624 55-gallon container of hazardous waste ethanol. EPA-RCRA CEI Report March 12, 2024 Page 13 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 14 03/12/2024 11:21 AM (ET) Building 4--Flammable Room CAA 55-gallon container of hazardous waste IPA. IMG-2024031211215021501240495.jpg Photographer: Kayla Acosta 27.87543206, -82.75819623 EPA-RCRA CEI Report March 12, 2024 Page 14 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 15 03/12/2024 11:22 AM (ET) Building 4 55-gallon container of hazardous waste IPA. IMG-202403121122032231185137.jpg Photographer: Kayla Acosta 27.87543153, -82.75819503 EPA-RCRA CEI Report March 12, 2024 Page 15 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 16 IMG-2024031211334433441493638.jpg 03/12/2024 11:33 AM (ET) Photographer: Kayla Acosta Building 4--Battery Assembly Room 27.87539453, -82.75832473 5-gallon container of excluded solvent-contaminated wipes. EPA-RCRA CEI Report March 12, 2024 Page 16 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 17 IMG-2024031211374437441161990.jpg 03/12/2024 11:37 AM (ET) Photographer: Kayla Acosta Building 4--Grinding Department Machining Area 27.87523366, -82.75824377 Two 3-gallon containers of Kwik-Solve and two 3-gallon containers of waste alcohol. EPA-RCRA CEI Report March 12, 2024 Page 17 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 18 03/12/2024 12:03 PM (ET) Building 2/Service Repair Operations SAA for IPA waste. IMG-202403121203533531263898.jpg Photographer: Kayla Acosta 27.87358881, -82.75854788 EPA-RCRA CEI Report March 12, 2024 Page 18 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 19 IMG-2024031212131613161306041.jpg 03/12/2024 12:13 PM (ET) No CBI No PII Photographer: Kayla Acosta Building 1--Wastewater Treatment Plant 27.87287397, -82.7578357 55-gallon container of hazardous waste sludge from wastewater treatment plant. EPA-RCRA CEI Report March 12, 2024 Page 19 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 20 IMG-2024031212265126511487390.jpg 03/12/2024 12:26 PM (ET) Photographer: Kayla Acosta Building 1--PMO Factory 27.87269423, -82.75789267 Two 3-gallon containers of hazardous waste alcohol. EPA-RCRA CEI Report March 12, 2024 Page 20 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 21 IMG-2024031212282028201271690.jpg 03/12/2024 12:28 PM (ET) Photographer: Kayla Acosta Building 1--PMO Factory 27.87264966, -82.75810211 5-gallon container of excluded solvent-contaminated wipes. EPA-RCRA CEI Report March 12, 2024 Page 21 of 22 Linvatec Corporation EPA ID# FLD982075756 Photo 22 03/12/2024 12:35 PM (ET) Building 1--Facilities Maintenance Shop Partswasher. IMG-2024031212352435241320328.jpg Photographer: Kayla Acosta 27.87268875, -82.75786375 EPA-RCRA CEI Report March 12, 2024 Page 22 of 22 Linvatec Corporation EPA ID# FLD982075756