EnvironmentalProtection Agency

GovernorMary Tayor, Li GovernorScottJ. .,.:. Director

May 31, 2012

Craig MooreGeneral CounselUS Endoscopy5976 Heisley Rd.Mentor, OH 44060

RE: US Endoscopy, 5976 Heisley Rd, Mentor, Ohio, 0HD083221150, CESQG,Notice of compliance, Lake County

And,

US Endoscopy, 6091 Heisley Rd., Mentor, Ohio, OHR0000 15560, CESQG,Notice of violation/Return to compliance, Lake County.

Dear Mr. Moore:

On May 17, 2012, Ohio EPA conducted a hazardous waste compliance evaluationinspection (CEI) at two US Endoscopy facilities, one located at 5976 Heisley Rd.,Mentor, Ohio, and the other at 6091 Heisley Rd., Mentor, Ohio. Ed D'Amato and Irepresented the Ohio EPA's Division of Materials and Waste Management (DMWM).US Endoscopy was represented by Tony Siracusa, Dan Tiber, Robert Bradley, MarkBrooks and you.

US Endoscopy manufactures devices for use in the Cl endoscopy and urology markets.The facility at 5976 Heisley Road no longer generates hazardous waste and the facilitylocated at 6091 Heisley Road is a conditionally exempt small quantity generator ofhazardous waste (CESQG). A CESQG is a generator who generates less than 27gallons of hazardous waste in a calendar month. As long as you remain a CESQG theonly hazardous waste management requirement that applies to U.S. Endoscopy is toensure delivery of hazardous waste to an off-site permitted treatment/storage/disposalfacility.

The purpose of the inspection was to determine US Endoscopy's compliance withOhio's hazardous waste laws as found in Chapter 3734 of the Ohio Revised Code(ORC) and Chapter 3745 of the Ohio Administrative Code (DAC). The inspectionincluded a review of facility operations, as well as written documentation. The USEndoscopy facilities were inspected for the requirements of a CESQG.

Northeast District Office 330 1963 12002110 East Aurora Road 330 1487 0769 (fax)Twinsburg, OH 44087-1924 www.epa.ohio.gov

US ENDOSCOPYMAY 31, 2012PAGE— 2—

Based on the inspection Ohio EPA did not identify any violations at 5976 Heisley Road.Ohio EPA identified the following violation of the used oil rules at 6091 Heisley Road:

1. OAC rule 3745-279-22(C)(1); Containers and above ground tanks that areused to store used oil must be labeled with the words, "Used Oil".

We noted that one 55 gallon drum used to collect used oil was not labeled withthe words "used oil". This violation was abated at the time of the inspection whena label with the words "Used Oil" was placed on the drum. No further action isrequired.

You can find copies of the rules and other information on the division ' s web page athftp://www.epa.state.oh.us/dmwm.aspx

The Division of Materials and Waste Management has created an electronic newsservice to provide you with updates related to hazardous waste activities in Ohio. Youcan find more information and sign up for this free service at the following Web link:http://ohioepa.custhelp.com/cqi-bin/ohioepa.cfci/ph p/enduser/doc serve. php?2=subscriptionpaqe

I have enclosed the completed check sheets used during the inspection for yourreference. Should you have any questions, please feel free to call me at (330) 963-1162or by email at marlene. kin ney(epa state. oh.us

Sincerely,

q)-̂ 40 1'"Marlene M. KinneyEnvironmental SpecialistDivision of Materials and Waste Management

MMK:ddw

ec: Jeff Mayhugh, DMWM, CONyall McKenna, DMWM, NEDONatalie Oryshkewych, DMWM, NEDO

Ohio Environmental Protection AgencySend to Central Office RCRA SUBTITLE C SITE

IDENTIFICATION/VERIFICATION FORM

For Ohio EPA use only

gJred to be submitted to CO should be e-mailed to IEPA ID Number: 0HR000015560Name: United States Endloscopy Group, Inc. j \Nebte www.usendoscopy.com

Street Address: 6091 Heisley Rd. --City, Town, or Village: Mentor State: OHCounty Name: Lake Zip Code: 44060

Private County DistrictFederal Indian Municipal State Other

First Name: Craig Ml:. Last Name: MooreTitle: General CounselPhone Number: 440-639-4494 ] Phone Number Extension: 435E-Mail Address: cmooreusendoscopy.comF ax Number 44 0-639-625 6 ] Fax Number Extension:Street or P, 6 . Box: 5976 Heis ley Rd.City, Town or Village: MentorState: Ohio r Zi p Code: 44060

Completed verification formsSite EPA ID No.Site Name

Site Location Information

Site Land Type(check only one)NAICS code(s)www.census.qov/epcd/ww

Facility Rep

Additional names can berecorded in number 12

Only provide addressinformation if it is differentthan the site address

Operator of the Site.List Additional Ownersand/or Operators in theComment Section or onanother copy of this formpage

Name of Site's Legal Owner:

Owner Private County DistrictType: LI El LIStreet or PO. -Box:-.--.--.,City, Town or Village: rState: OhioName of Site's Operator:Same as site nameOperator Private County District

Type: LI LI LIStreet or P.O. Box:

Date Became Owner(mm/dd/yyyy):Federal Indian Municipal State OtherLI LI LI fl [I

Owner Phone #:Country: ] ZCode:Date Became Operator(mm/dd/yyyy):Federal Indian Municipal State OtherLI LI LI LI LI

City, Town or Village: Operator Phone #:State: Country 1 Zin Code:

VIOLATIONS CITED?

Yes flNo

TYPE OF HANDLER - MARK "X" AS APPROPRIATENot a HW Generator UNKNOWN:

Cited for violation of 3745-52-11Short-Term/Temporary Generator(generates from a short-term orone-time event and not from on-goingprocesses). Check the box for theapplicable generator status and providea comment.

Large Quantity Generator (LQG)

Small Quantity Generator (SQG)Conditionally Exempt Small Quantity GeneratorU.S. lmorter of Hazardous Waste

LIMixed Waste (Hazardous and Radioactive)Generator

TYPE OF REGULATED WASTE ACTIVITY (MARK'El Hazardous Waste TransporterEl Hazardous Waste Transfer FacilityEl Treater, Storer or Disposer of Hazardous WasteEl Recycler of Hazardous WasteEl 72-Hour Recycler

L1LbF THE APPROPRIATE BOXES)El Exempt Boiler and/or Industrial Furnace

El Small Quantity On-Site Burner ExemptionEl Smelting, Melting, Refining Furnace Exemption

El Underground Injection Control FacilityEl Receives Hazardous Waste from Off-site

UNIVERSAL WASTE ACTIVITIES (INDICATE TYPES OF UNIVERSAL WASTE MANAGED(CHECK ALL BOXES THAT APPLY)Z Small Quantity Handler of Universal Waste El Destination Facility for Universal Waste

El Large Quantity Handler of Universal Waste(accumulates 5,000 kg. or more)

CHECK ALL BOXES BELOW THAT APPLY FOR THE TYPES OF UNIVERSAL WASTE THE FACILITY MANAGESEl BatteriesEl PesticidesEl Mercury containing equipment

LampsUSED OIL ACTIVITIES (INDICATE TYPE(S) OF ACTIVITY(S)

Used Oil GeneratorEl Used Oil TransporterEl Used Oil Transfer FacilityEl Used Oil ProcessorEl Used Oil Re-refinerEl Off-Specification Used Oil BurnerEl Used Oil Fuel Marketer who directs shipment of Off-Spec Used OilEl Used Oil Fuel Marketer who first claims the Used Oil meets the specificationsEligible Academic Entities with Laboratories: Facility has previously notified that they are opting into managing laboratory hazardous wastepursuant to OAC rules 3745-52-200 through 3745-52-216. Check the box(es) below to indicate the laboratory type.

El College or UniversityEl Teaching hospital that is owned by or has a formal written affiliation agreement with a college or universityEl Non-profit Institute that is owned by or has a formal written affiliation agreement with a college or universityWaste Codes for Federally Regulated Hazardous Wastes. Please list the codes for the federally regulated hazardous Waste handled at thesite. List them in the order they are presented in the regulations (e.g., D00I D003, F007, UI 12). Use an additional page or list them in the comments ifmore space is needed. If the waste codes are the same as listed in the most recent RcRAlnfo source record, you do not need to list them. Instead justindicate the date of the most recent source record.DOOlCOMMENTS: USE THIS AREA TO DESCRIBE WHETHER THE INSPECTION WAS ANNOUNCED, WHETHER THEWASTE IS STORED IN TANKS OR CONTAINERS, ETC.Announced El Yes M No Additional Facility Representatives: Tony Siracusa, Dan Tiber, Robert

BradleyTanks El Yes M NoContainers El Yes N No

Date of Inspection/TimeName of Inspector(s) Name of Inspector(s) (rnm/dd/yyyy) (hh:mm)Marlene Kinney Ed D'Amato 0511712012

Comments:I violation. 55 gallon drum containing used oil was not labeled as such.

Revised 09.05.10

- SendtoCentraiOffice Ohio Environmental Protection Agency For Ohio EPA use Ony

RCRA SUBTITLE C SITEIDENTIFICATIONIVERIFICATION FORM

Completed verification forms required to be submitted to CO should be e-mailed to brad, hauserpa.stateoh.us .Site EPA ID No EPA ID Number: OH000I 926740Site Name Name: United States Endloscopy Group, Inc. Website: www.usendoscopy.com----------------Site Location Information Street Address: 5976 Heisley Rd.

------------------------------------City, Town, or V illage: Mentor State: OHCounty Name: Lake Zip Code: 44060

Site Land Type Private County District Federal Indian Municipal State Other(check only one) El El El El El El ElNAICS code(s)vww. census. ov/epcdIwww/naics.htmiFacility Representative JM. --Last Name: Moore

Title: General CounselAdditional names can berecorded in number 12 Phone 0639.449-] Phone Number Extension: 435

E-Mail Address: cmoore@usendoscopy.comOnly provide address Fax Number: 440-639-6256 ] Fax Number Extension:information if it is different Street or P.O. Box: 5976 HeisleyRd.than the site address City, Town or Village: Mentor

State: Ohio Zip Code: 44060Legal Owner And Name of Site's Legal Owner: Date Became OwnerOperator of the Site- MY Landholding LLC (mm/dd/yyyy):List Additional Owners Owner Private County District Federal Indian Municipal State Otherand/or Operators in the Type: El El El El El El 10 ElComment Section or on Street or P.O. Box: 5976 Heisley Rd -- -another copy of this form City Town or Village: Mentor --wrierPhone#:440-639-4494page State Ohio Country USA Zip Code 44060

a1f bperator: Date Became OperatorSame as site name (mm/dd/yyyy):Operator Private County District Federal Indian Municipal State Other

Type: El El El El El El El ElStreet or P.O. Box:City, -Town-or-Vi I [age : Operator Phone #:State: Country Zip Code:

VIOLATIONS CITED? Yes El No

TYPE OF HANDLER - MARK "X" AS APPROPRIATENot a HW Generator El UNKNOWN: ElLarge Quantity Generator (LQG)

Cited _for _violation _of_3745-52-1_1El Short-Term/Temporary Generator flSmall Quantity Generator (SQG)

(generates from a short-term or EConditionally Exempt Small Quantity Generator

one-time event and not from on-going I El U.S. Importer of Hazardous Wasteprocesses). Check the box for theapplicable generator status and provide ElMixed Waste (Hazardous and Radioactive)a comment. Generator

TYPE OF REGULATED WASTE ACTIVITY (MARK "X' IN ALL OF THE APPROPRIATE BOXES)El Hazardous Waste Transporter El Exempt Boiler and/or Industrial FurnaceEl Hazardous Waste Transfer Facility El Small Quantity On-Site Burner Exemption

Treater, Storer or Disposer of Hazardous Waste El Smelting, Melting, Refining Furnace ExemptionE Recycler of Hazardous Waste El Underground Injection Control FacilityE 72-Hour Recycler El Receives Hazardous Waste from Off-site

UNIVERSAL WASTE ACTIVITIES (INDICATE TYPES OF UNIVERSAL WASTE MANAGED(CHECK ALL BOXES THAT APPLY)El Small Quantity Handler of Universal Waste El Destination Facility for Universal WasteEl Large Quantity Handler of Universal Waste

(accumulates 5,000 kg, or more)

CHECK ALL BOXES BELOW THAT APPLY FOR THE TYPES OF UNIVERSAL WASTE THE FACILITY MANAGESEl BatteriesEl PesticidesEl Mercury containing equipmentEl LampsUSED OIL ACTIVITIES (INDICATE TYPE(S) OF ACTIVITY(S)El Used Oil GeneratorEl Used Oil TransporterEl Used Oil Transfer FacilityEl Used Oil ProcessorEl Used Oil Re-refinerEl Off-Specification Used Oil BurnerEl Used Oil Fuel Marketer who directs shipment of Off-Spec Used OilEl Used Oil Fuel Marketer who first claims the Used Oil meets the specificationsEligible Academic Entities with Laboratories Facility has previously notified that they are opting into managing laboratory hazardous wastepursuant to OAC rules 3745-52-200 through 3745-52-216. Check the box(es) below to indicate the laboratory type.

El College or UniversityEl Teaching hospital that is owned by or has a formal written affiliation agreement with a college or universityEl Non-profit Institute that is owned by or has a formal written affiliation agreement with a college or universityWaste Codes for Federally Regulated Hazardous Wastes. Please list the codes for the federally regulated hazardous waste handled at thesite. List them in the order they are presented in the regulations (e.g., 0001, 0003, F007, UI 12). Use an additional page or list them in the comments ifmore space is needed. If the waste codes are the same as listed in the most recent RCRAlnfo source record, you do not need to list them. Instead justindicate the date of the most recent source record.

COMMENTS: USE THIS AREA TO DESCRIBE WHETHER THE INSPECTION WAS ANNOUNCED, WHETHER THEWASTE IS STORED IN TANKS OR CONTAINERS, ETC.Announced El Yes Z No Additional Facility Representatives: Tony Siracusa, Dan Tiber, Robert

BradleyTanks El Yes EJ NoContainers El Yes N No

Date of Inspection/TimeName of Inspector(s) Name of Inspector(s) (mm/dd/yyyy) (hh:mm)Marlene Kinney Ed DAmato 05/17/2012

Comments:Non-generator of hazardous waste.

Revised 09.05.10

USED OIL INSPECTION CHECKLISTGENERATORS, COLLECTION CENTERS AND AGGREGATION POINTS

NOTE: A facility is subject to the federal SPCC regulations (40 CFR 112) if it is non-transportation related (e. g., fixed) andhas an aggregate above ground storage capacity greater than 1,320 gallons or total underground storage capacitygreater than 42,000 gallons of oil (including used oil), and there is reasonable expectation of a discharge to navigablewaters.PROHIBITIONS _____________1. Does the generator manage used oil in a surface impoundment or waste pile? Yes LI No J N/A LI

If yes:a Is the surface impoundment or waste pile regulated as a hazardous Yes fl No LI N/A

waste _management _unit? _[3745-279-12(A)]NOTE. For example, used oil contaminated scrap metal stored in a pile.2. Is used oil used as a dust suppressant? [3745-279-12(B)] Yes No Z N/A LI

3. Is off-specification used oil fuel burned for energy recovery in devices specified Yes LI No 0 N/Ain 3745-279-12(C)?

NOTE: Multiple used oil checklists may be applicable if used oil handler is performing multiple tasks (e.g., If generatingused oil and shipping directly to a burner, complete generator and marketer checklists at a minimum).GENERATOR STANDARDS4. Does the generator mix hazardous waste with used oil? If so, Yes LI No 9N/A LI

a. Is the mixture managed as specified in 3745-279-10(B)? [3745-279- Yes LI No LI N/A21(A)]

NOTE: Used Oil mixed with listed (3745-51-30 to 3745-51-35) or characteristic (3745-51-20 to 3745-51-24) hazardouswaste are subject to regulation as a hazardous waste, unless the listed hazardous waste is listed solely because itexhibits a hazardous characteristic, and the resultant mixtures do not exhibit a characteristic. Mixtures of used oil andCESQG hazardous waste are subject to OAC Chapter 3745-279.5. Does the generator of a used oil containing greater than 1,000 ppm total Yes LI No LI N/A

halogens manage the used oil as a hazardous waste unless the presumptionis rebutted successfully? [3745-279-2 1 (B)]

NOTE: If used oil contains greater than 1000 ppm total halogens, it is presumed to be listed hazardous waste until thepros umption is successfully rebutted.6. Does the generator store used oil in tanks; or containers; or a unit(s) subject to Yes LI No 0 N/A

regulation as a hazardous waste management unit? [3745-279-22(A)]7. Are containers and aboveground tanks used to store used oil in good condition Yes >Q No N/A LI

with no visible leaks? [3745-279-22(B)] _____________8.Are containers, above ground tanks, and fill pipes used for underground tanks Yes E] No J NIA LI.J clearly labeled or marked "Used Oil?' [3745-279-22(C)]9. Has the generator, upon detection of a release of used oil, done the following: Yes LI No LI N/A

[3745-279-22(D)]- a. Stopped the release? Yes LI No LI N/A

b. Contained the release? Yes LI No LI N/A

C. Cleaned up and properly managed the used oil and other materials? Yes LI No LI N/A Ed. Repaired or replaced the containers or tanks prior to returning them to Yes LI No LI N/A i1

service, if necessary?ON-SITEBURNING IN SPACE HEATER10. Does the generator burn used oil in used-oil fired space heaters? [3745-279-

2]jf so:a. Does the heater burn only used oil that owner/operator generates or Yes El No F1 NIA

used oil received from household do-it-yourself (D1Y) used oilgenerators?

[Facility Name/Inspection Datel[ID Number]

Used Oil checklist for Generators/June 2008Page o(2

b. Is the heater designed to have a maximum capacity of not more that Yes 1J No fl N/A '0.5 million BTU per hour?

C. Are the combustion gases from heater vented to the ambient air? Yes El No LI N/A JK

NOTE. Ash accumulated in a space heater must be managed in accordance with 3745-279-10(E).GENERATOR TRANSPORTATION11. Does the generator have the used oil hauled only by transporters that have Yes JX No El N/A

obtained a U.S. EPA JD#? [3745-279-24]12. If the generator self-transports used oil to an approved collection site or to an

aggregation point owned by the generator: [3745-279-24]a. Does the generator transport used oil in a vehicle owned by the Yes LI No 0 N/A

generator or an employee of the generator? 13745-279-24]b. Does the generator transport more than 55 gallons of used oil at any Yes No N/A 1'

time? [3745-279-241 NOTE: Used oil generators may arrange for used oil to be transported by a transporter without a U.S. EPA ID # if theused oil is reclaimed under a contractual agreement (i.e., tolling arrangement).COLLECTION CENTERS AND AGGREGATION POINTS13. Is the DIY used oil collection center in compliance with the generator Yes LI No LI N/A

standards in 3745-279-20 to 3745-279-24? [3745-279-30114. Is the non-DIY used oil collection center registered with Ohio EPA? [3745-279- Yes LI No LI N/A

31115. Is the used oil aggregation point in compliance with the generator standards in Yes LI No LI N/A

3745-279-20 to 3745-279-24? 13745-279-321NOTE: Complete Used Oil Generator and any other applicable used oil handler checklist (e.g., marketer, burner, etc.) forused oil collection centers and aggregation points.

IFacility Name/Inspection Dale][ID Number]

Used Oil Checklist for Generators/June 2008Page 2 of 2

5?CONDITIONALLY EXEMPT SMALL QUANTITY GENERATOR REQUIREMENTS

COMPLETE AND ATTACH A PROCESS, WASTE, P2 SUMMARY SHEETCESQG: :51 00Kg. (Approximately 25-30 gallons) of waste in a calendar month or < 1 Kg. of acutely hazardous waste.SQG: Between 100 and 1,000 Kg. (About 25 to under 300 gallons) of waste in a calendar month.LOG: ^ 1,000 Kg. (-300 gallons) of waste in a calendar month or 2^1 Kg, of acutely hazardous waste in a calendar month.NOTE: To convert from gallons to pounds: Amount in gallons x S pecific Gravity x 8,345 Amounts in pounds.Safety Equipment Used: Ms' T-Q QtsitWASTE EVALUATION1. Have all wastes generated at the facility been adequately evaluated? Yes No 0 N/A El

[3745-52-111GENERATOR CLASSIFICATION2. Does the generator produce <100 kg. of hazardous waste per month? Yes No F1 N/A El

[conditionally exempt small quantity generator ("CESQG")]NOTE: If quantities of hazardous waste accumulated on-site at any one time exceed 1,000 Kg. - or the generator producesbetween 100 and 1,000 Kg, of hazardous waste per month, it is operating as a Small Quantity Generator ("SQG"). If so,complete the Small Quantity Generator Requirements checklist.

OFF-SITE SHIPMENT OF HAZARDOUS WASTE3. Does the CESQG ensure delivery of hazardous waste(s) to an off-site Yes No D N/A El

permitted TSD? [3734.02(F)]TREATMENT OF HAZARDOUS WASTE4. Does the generator treat hazardous waste in a:

a. Container that meets 3745-66-70 to 3745-66-77? Yes El No El N/A

b. Tank that meets 3745-66-90 to 3745-66-101 except 3745-66-97(C)? I Yes No 7 N/A

C. Drip pads that meet 3745-69-40 to 3745-69-45? Yes E No El N/A

Containment building that meets 3745-256-100 to 3745-256-102? Yes El No El N/A

NOTE; Complete appropriate checklist for each unit.NOTE: If the CESQG conducts treatment they are subject to the LQG requirements.NOTE: If waste is treated to meet LDRs, use LDR checklist.MIX HAZARDOUS WASTE WITH USED OIL5. Does the CESQG mix its hazardous waste with used oil for the purpose of

burning for energy recovery? [3745-51-05(J)] If so:a. Does the CESQG manage the mixture in accordance with 3745-279-

21?

Yes LI No El N/A El

Yes LI No El N/A El

[Facility Name/Inspection Date][ID number]

CESQG/February 2009Page 1 of 1