STATE OF INDIANA		)	SS:	BEFORE THE INDIANA DEPARTMENT OF
		)
COUNTY OF MARION		)		ENVIRONMENTAL MANAGEMENT
COMMISSIONER OF THE DEPARTMENT					)
OF ENVIRONMENTAL MANAGEMENT,					)
					)
Complainant,					)
					)
	v.				)	Case No. 2023-29521-H
					)
PARAGON MEDICAL, INC.-INSTRUMENTS					)
AND IMPLANTS,					)
					)
Respondent.					)

AGREED ORDER

Complainant and Respondent desire to settle and compromise this action without hearing or adjudication of any issue of fact or law, and consent to the entry of the following Findings of Fact and Order. Pursuant to Indiana Code (“IC”) 13-30-3-3, entry into the terms of this Agreed Order does not constitute an admission of any violation contained herein. Respondent’s entry into this Agreed Order shall not constitute a waiver of any defense, legal or equitable, which Respondent may have in any future administrative or judicial proceeding, except a proceeding to enforce this order.

I. FINDINGS OF FACT

1. Complainant is the Commissioner (“Complainant”) of the Indiana Department of Environmental Management (“IDEM”), a department of the State of Indiana created by IC 13-13-1-1.

2. Respondent is Paragon Medical, Inc.-Instruments and Implants which operates the company with EPA ID No. INR000149831, located at 8 Matchett Drive in Pierceton, Kosciusko County, Indiana (“Site”).

3. IDEM has jurisdiction over the parties and the subject matter of this action.

4. Pursuant to IC 13-30-3-3, IDEM issued a Notice of Violation (“NOV”) via certified mail on November 28, 2023 to:

Dan Blum, Vice President for	C T Corporation System,
Paragon Medical, Inc.	Registered Agent for
8 Matchett Industrial Park Drive	Paragon Medical, Inc.
Pierceton, Indiana 46562	334 North Senate Avenue
dan.blum@paragonmedical.com	Indianapolis, Indiana 46204

5. Respondent notified EPA of Small Quantity Generator (“SQG”) activities on February 25, 2022.

6. Respondent is a manufacturer of medical devices, which are made of stainless steel and titanium.

329 Indiana Administrative Code (“IAC”) 3.1 incorporates federal hazardous waste management requirements found in 40 Code of Federal Regulations (“CFR”) Parts 260 through 270 and Part 273, including those identified below.

7. During an investigation including an inspection on June 1, 2023, conducted by a representative of IDEM, the following violations were found:

a. Pursuant to 40 Code of Federal Regulations (“CFR”) 262.11, a person who generates a solid waste must determine if that waste is a hazardous waste at the point of waste generation, before any dilution, mixing, or other alteration of the waste occurs, and at any time in the course of its management that it has, or may have, changed its properties as a result of exposure to the environment or other factors that may change the properties of the waste such that the RCRA classification of the waste may change.

As noted during the inspection, fourteen (14) chromium-contaminated filters (D007) were observed drying out on a secondary containment device in the EDM filter storage area. It was undetermined if the draining’s within the device contained hazardous waste.

On July 7, 2023, documentation dated June 16, 2023, was submitted showing that the filter draining’s are non-hazardous. Facility has eliminated the secondary container and eliminated the drying process of the EDM filters. The filters will be placed in the hazardous waste collection container in the 180-day storage area. Absorbents will be placed at the bottom of each collection container to minimize or eliminate the amount of free liquid.

b. Pursuant to 40 CFR 262.15(a)(5)(i), a generator must mark or label its satellite hazardous waste containers with the words “Hazardous Waste”.

As noted during the inspection, the following was not labeled with the words “Hazardous Waste”:

One (1) 55-gallon drum used to collect isopropyl alcohol (“IPA”) prior to reclamation near the oil dispensing area.

On July 7, 2023, documentation dated June 1, 2023, was submitted showing one (1) 55-gallon drum near the oil dispensing area labeled with the words “Hazardous Waste.

c. Pursuant to 40 CFR 262.15(a)(5)(ii), a generator must mark or label its satellite hazardous waste containers with an indication of the hazards of the contents.

As noted during the inspection, the following was not labeled with the indication of its hazards:

One (1) 55-gallon drum used to collect IPA prior to reclamation near the oil dispensing area.

On July 7, 2023, documentation dated June 1, 2023, was submitted showing indication of hazard (DOT placard #3) on one (1) 55-gallon drum near the oil dispensing area.

d. Pursuant to 40 CFR 262.16, a small quantity generator may accumulate hazardous waste on site without a permit or interim status, and without complying with the requirements of parts 124, 264 through 267, and 270 of this chapter, or the notification requirements of section 3010 of RCRA, provided that all the conditions for exemption listed in this section are met.

e. Pursuant to IC 13-30-2-1(10), every hazardous waste generator, transporter, or owner or operator of a hazardous waste facility shall notify the commissioner of its hazardous waste activity on the approved forms.

f. Pursuant to 40 CFR 270.1(c), a permit is required for the treatment, storage and disposal of any hazardous waste as identified or listed in 40 CFR Part 261.

As noted during the inspection, in the EDM filter storage area, fourteen (14) chromium-contaminated filters were observed drying out on secondary containment, and four (4) additional filters were observed drying on top of a drain which leads to the facility’s oil separator and outfall 002. The facility does not have a transfer storage disposal facility (“TSDF”) permit.

On July 7, 2023, documentation submitted stating that the facility does not allow filters to be dried over floor drain leading to the POTW and was done in opposition to established rules. Employees retrained verbally and instructions on how to properly collect and handle EDM filter waste to be included in July 17, 2023 training by 3^rd party consulting firm. Facility has also removed the secondary container and eliminated the drying process of the EDM filters.

g. Pursuant to 40 CFR 262.16(2), a small quantity generator may accumulate hazardous waste on site without a permit or interim status, and without complying with the requirements of parts 124, 264 through 267, and 270 of this chapter, or the notification requirements of section 3010 of RCRA, provided that hazardous waste is placed in a container, tank, drip pad or containment building.

As noted during the inspection, in the EDM filter storage area, eighteen (18) waste chromium-contaminated filters (D007) of which fourteen (14) waste filters were observed placed on a secondary containment device. Four (4) waste filters were observed placed on a drain that leads to the facility’s oil water separator and outfall 002. None of the filters were placed in containers.

On July 7, 2023, documentation submitted stating that all eighteen (18) EDM filters were placed in collection containers. Facility has also removed the secondary container and eliminated the drying process of the EDM filters.

h. Pursuant to 40 CFR 262.16(b)(i)(A), a small quantity generator may accumulate hazardous waste on-site for 180 days or less without a permit, provided that, while being accumulated on-site, each container is labeled or marked clearly with the words "Hazardous Waste."

As noted during the inspection, the following was not labeled with the words “Hazardous Waste”:

Eighteen (18) waste chromium-contaminated filters (D007) in the EDM filter storage area observed not in containers.

Three (3) gaylord boxes of waste chromium-contaminated filters within the 180-day storage shipping container.

One (1) 55-gallon drum (D001) within the IPA reclamation area.

One (1) 15-gallon drum waste still bottoms (D001) within the IPA reclamation area.

On July 7, 2023, documentation dated June 1, 2023, submitted showing that the three gaylord boxes of EDM filters within the 180-day storage shipping container and the eighteen (18) EDM filters were placed in collection containers, one (1) 55-gallon drum IPA waste, and one (1) 15-gallon drum of still bottoms all labeled with the words “Hazardous Waste”.

i. Pursuant to 40 CFR 262.16(b)(6)(i)(B), a small quantity generator may accumulate hazardous waste on-site for 180 days or less without a permit, provided that, while being accumulated on-site, each container is labeled or marked with an indication of the hazards of the contents.

As noted during the inspection, the following was not labeled with the indication of its hazards:

Eighteen (18) waste chromium-contaminated filters (D007) in the EDM filter storage area observed not in containers.

Three (3) gaylord boxes of waste chromium-contaminated filters within the 180-day storage shipping container.

One (1) 55-gallon drum (D001) within the IPA reclamation area.

One (1) 15-gallon drum waste still bottoms (D001) within the IPA reclamation area.

On July 7, 2023, documentation dated June 1, 2023, submitted showing that the three gaylord boxes of EDM filters within the 180-day storage shipping container and the eighteen (18) EDM filters were placed in collection containers, one (1) 55-gallon drum IPA waste, and one (1) 15-gallon drum of still bottoms all labeled with the indication of their hazards.

j. Pursuant to 40 CFR 262.16(b)(6)(i)(C), a small quantity generator must mark or label its containers with the date upon which each period of accumulation begins clearly visible for inspection on each container.

As noted during the inspection, the following was not labeled with the accumulation start date:

Eighteen (18) waste chromium-contaminated filters (D007) in the EDM filter storage area observed not in containers.

Three (3) gaylord boxes of waste chromium-contaminated filters within the 180-day storage shipping container.

One (1) 55-gallon drum (D001) within the IPA reclamation area.

One (1) 15-gallon drum waste still bottoms (D001) within the IPA reclamation area.

On July 7, 2023, documentation dated June 1, 2023, submitted showing that the three gaylord boxes of EDM filters within the 180-day storage shipping container, the eighteen (18) EDM filters were placed in collection containers, one (1) 55-gallon drum IPA waste, and one (1) 15-gallon drum of still bottoms all labeled with accumulation start dates. The facility noted that the 15-gallon drum of still bottoms is being managed as a SAA and did not become full until May 2023.

k. Pursuant to 40 CFR 262.16(b)(9)(ii), the small quantity generator must post the following information next to the telephone: (1) the name and phone number of the emergency coordinator; (2) location of fire extinguishers and spill control material and, if present, fire alarm; (3) the telephone number of the fire department, unless the facility has a direct alarm.

As noted during the inspection, emergency information was not posted in areas directly involved in the generation and accumulation of hazardous waste.

On July 7, 2023, documentation dated June 9, 2023, submitted showing emergency information posted in the following areas: 180-day hazardous waste storage, Wire EDM room, maintenance, alcohol recycler, alcohol pre-reclaim satellite, and receiving desk. The following locations have an emergency phone: near the EDM room and fitness center.

1. Pursuant to 40 CFR 262.16(b)(9)(iii), the small quantity generator must ensure that all employees are thoroughly familiar with proper waste handling and emergency procedures, relevant to their responsibilities during normal facility operations and emergencies.

As noted during the inspection, employees responsible for hazardous waste management were not thoroughly familiar with proper waste handling procedures.

On July 7, 2023, documentation submitted that employees responsible for hazardous waste management attended DOT/RCRA classes on April 3, 2022. On July 17, 2023, employees on all three shifts to be retrained by consultant. Training to cover proper storage and management of hazardous waste (including labeling) as well as universal, non-hazardous, used oil, and other regulated wastes. Additionally, DOT hazardous materials certification training will also be conducted for all identified “Hazmat Employees”.

On December 5, 2023, documentation of completed employee training submitted.

m. Pursuant to IC 13-22-4-3.1(b), a person that in any one (1) or more calendar months of a calendar year generates more than one hundred (100) kilograms but less than one thousand (1,000) kilograms of hazardous waste; less than one (1) kilogram of acute hazardous waste; or less than one hundred (100) kilograms of material from the cleanup spillage of acute hazardous waste; or accumulates at least one thousand (1,000) kilograms of hazardous waste or less than one (1) kilogram of acute hazardous waste; shall, before March 1 of each year, submit to the department on forms provided by the department a report, containing no more than a compilation of information from the Uniform Hazardous Waste Manifest form described in section 1(a) of this chapter, that summarizes the person's hazardous waste shipments during the previous calendar year.

As noted during the inspection, waste still bottoms (D001), and pre-reclaimed IPA (D001) were not included in the Annual Report for HW activities in 2022.

On July 7, 2023, documentation submitted that the waste still bottoms listed as paint solids/pucks from distillation-suitable for fuel. This was a combined waste stream with paint solids. The Facility is now separating the two waste streams. Both the waste still bottoms and the pre-reclaimed IPA listed as a second waste stream.

n. Pursuant to 329 Indiana Administrative Code (“IAC”) 3.1-16-2(4), each lamp or

a container or package in which such lamps are contained must be labeled or marked clearly with the phrase "Universal Waste-Lamp(s)" or "Waste Lamp(s)" or "Used Lamp(s)" or with other words that accurately identify the universal waste lamps.

o. Pursuant to 40 CFR 273.14(e), each lamp or a container or package in which such lamps are contained must be labeled or marked clearly with one of the following phrases: “Universal Waste-Lamp(s)”, or “Waste Lamp(s)”, or “Used Lamp(s)”.

As noted during the inspection, seven (7) boxes of Universal Waste lamps were not labeled with the words “Universal Waste-Lamp(s)” or “waste Lamp(s)” or “Used Lamp(s)” near the EDM filter storage.

On July 7, 2023, documentation dated June 1, 2023, submitted stating that three boxes were good lamps. The other four were used and labeled “Used Bulbs”. Those four boxes now labeled “Universal Waste” and include the words “Used Lamps”.

p. Pursuant to 40 CFR 273.15(a), a small quantity handler of universal waste may accumulate universal waste for no longer than one year from the date the universal waste is generated, or received from another handler, unless the requirements of paragraph (b) of this section are met.

(b) A small quantity handler of universal waste may accumulate universal waste for longer than one year from the date the universal waste is generated, or received from another handler, if such activity is solely for the purpose of accumulation of such quantities of universal waste as necessary to facilitate proper recovery, treatment, or disposal. However, the handler bears the burden of proving that such activity is solely for the purpose of accumulation of such quantities of universal waste as necessary to facilitate proper recovery, treatment, or disposal.

(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 accumulated from the date it becomes a waste or is received. The handler may make this demonstration by:

(1) Placing the universal waste in a container and marking or labeling the container with the earliest date that any universal waste in the container became a waste or was received;

(2) Marking or labeling each individual item of universal waste (e.g., each battery or thermostat) with the date it became a waste or was received;

(3) Maintaining an inventory system on-site that identifies the date each universal waste became a waste or was received;

(4) Maintaining an inventory system on-site that identifies the earliest date that any universal waste in a group of universal waste items or a group of containers of universal waste became a waste or was received;

(5) Placing the universal waste in a specific accumulation area and identifying the earliest date that any universal waste in the area became a waste or was received; or

(6) Any other method which clearly demonstrates the length of time that the universal waste has been accumulated from the date it becomes a waste or is received.

As noted during the inspection, no method maintained clearly demonstrating the length of time the seven (7) boxes of universal waste lamps became a waste.

On July 7, 2023, documentation dated June 1, 2023, submitted stating that three (3) boxes were good lamps. The other four (4) boxes were used and labeled “Used Bulbs”. Those four (4) boxes now labeled “Universal Waste” and include the words “Used Lamps” and accumulation start dates.

q. Pursuant to 40 CFR 273.13(d)(1), a universal waste handler must contain

wastes in containers that are in good condition, compatible with the waste, closed, and lack evidence of leakage.

As noted during the inspection, five (5) boxes of universal waste lamps were observed open near the EDM filter storage.

On July 7, 2023, documentation dated June 1, 2023, submitted showing that three (3) boxes were good lamps, closed, and labeled. The two (2) used lamp boxes were closed and labeled as well.

r. Pursuant to 329 IAC 13-4-3(d), generators must label all used oil containers and aboveground tanks with the words “Used Oil.”

As noted during the inspection, nineteen (19) 55-gallon drums of used oil within the 180-day storage shipping container were not labeled with the words “Used Oil.”

On July 7, 2023, documentation dated June 1, 2023-June 2, 2023, submitted showing the nineteen (19) 55-gallon drums of used oil labeled with the words “Used Oil.”

8. Orders of the Commissioner are subject to administrative review by the Office of Environmental Adjudication under IC 4-21.5; however, in recognition of the settlement reached, Respondent acknowledges notice of this right and waives any right to administrative and judicial review of this Agreed Order.

II. ORDER

1. This Agreed Order shall be effective (“Effective Date”) when it is approved by Complainant or Complainant’s delegate and has been received by Respondent. This Agreed Order shall have no force or effect until the Effective Date.

2. Respondent shall comply with the statute and rules listed in the findings of fact above.

3. All submittals required by this Agreed Order, unless IDEM notifies the Respondent otherwise in writing, shall be sent to:

Jodi Pisula, Enforcement Case Manager

Office of Land Quality

Indiana Department of Environmental Management

100 North Senate Avenue

Indianapolis, IN 46204-2251

4. Pursuant to IC 13-30-4-1, Respondent is assessed and agrees to pay a civil penalty of Eighteen Thousand Eight Hundred Dollars ($18,800). After this Agreed Order is adopted (signed by the Assistant Commissioner of the Office of Land Quality), Respondent shall pay by the due date printed on the Invoice that will be attached to the adopted Agreed Order.

Civil and stipulated penalties are payable to the “Indiana Department of Environmental Management” by:

Mail:

Civil penalties are payable by check to the “Indiana Department of Environmental Management.” Checks shall include the Case Number of this action and shall be mailed to:

Indiana Department of Environmental Management

Accounts Receivable

P.O. Box 3295

Indianapolis, IN 46206

Online:

Accounts Receivable is accepting payments online by e-Check, Master Card, Visa or Discover. Please visit www.in.gov/idem. Under Online Services, click Online Payment options and follow the prompts. A processing fee of $0.40 plus 2.06% will be charged for credit card payments.  A processing fee of $0.15 will be charged for eCheck payments.

The Case Number is required to complete the process.

Phone:

You may also call us at 317-234-3099 and follow the instructions for Master Card, Visa or Discover payments. A processing fee of $0.40 plus 2.06% will be charged for credit card payments.  A processing fee of $0.15 will be charged for eCheck payments.

The Case Number is required to complete the process.

5. In the event that the monies due to IDEM pursuant to this Agreed Order are not paid on or before their Due Date, Respondent shall pay an additional penalty of 10 percent, payable to “Indiana Department of Environmental Management,” and shall be payable to IDEM in the manner specified in Paragraph 4, above.

6. Signatories to this Agreed Order certify that they are fully authorized to execute this Agreed Order and legally bind the party they represent.

7. This Agreed Order shall apply to and be binding upon Respondent and all successors and assigns. Respondent shall provide a copy of this Agreed Order, if in force, to any subsequent owners, successors, or assigns before ownership rights are transferred.

8. No change in ownership, corporate, or partnership status of Respondent shall in any way alter the Respondent’s status or responsibilities under this Agreed Order.

9. Respondent shall ensure that all contractors, firms, and other persons performing work under this Agreed Order comply with the terms of this Agreed Order.

10. In the event that any terms of this Agreed Order are found to be invalid, the remaining terms shall remain in full force and effect and shall be construed and enforced as if this Agreed Order did not contain the invalid terms.

11. This Agreed Order is not and shall not be interpreted to be a permit or a modification of an existing permit. This Agreed Order, and IDEM’s review or approval of any submittal made by Respondent pursuant to this Agreed Order, shall not in any way relieve Respondent of the obligation to comply with the requirements of any applicable permits or any applicable Federal or State laws or regulations.

12. Complainant does not, by its approval of this Agreed Order, warrant or aver in any manner that Respondent’s compliance with any aspect of this Agreed Order will result in compliance with the provisions of any permit, order, or any applicable Federal or State law or regulation. Additionally, IDEM or anyone acting on its behalf shall not be held liable for any costs or penalties Respondent may incur as a result of Respondent’s efforts to comply with this Agreed Order.

13. Nothing in this Agreed Order shall prevent or limit IDEM’s rights to obtain penalties or injunctive relief under any applicable Federal or State law or regulation, except that IDEM may not, and hereby waives its right to seek additional civil penalties for the violations specified in the NOV.

14. Nothing in this Agreed Order shall prevent IDEM or anyone acting on its behalf from communicating with the U.S. Environmental Protection Agency (U.S. EPA) or any other agency or entity about any matters relating to this enforcement action. IDEM or anyone acting on its behalf shall not be held liable for any costs or penalties Respondent may incur as a result of such communications with the U.S. EPA or any other agency or entity.

15. This Agreed Order shall remain in effect until IDEM issues a Resolution of Case letter to Respondent.

REMAINDER OF PAGE LEFT BLANK INTENTIONALLY

TECHNICAL RECOMMENDATION:			RESPONDENT: Paragon Medical, Inc.-Instruments and Implants
Department of Environmental Management
By:			By:
	Jennifer Reno, Chief		Printed:
	Land Enforcement Section		Title:
	Compliance Branch
	Office of Land Quality
Date:			Date:
			COUNSEL FOR RESPONDENT:
			By:
			Printed:
			Date:
APPROVED AND ADOPTED BY THE INDIANA DEPARTMENT OF ENVIRONMENTAL
MANAGEMENT THIS		DAY OF		, 20_____
			For the Commissioner:
			Signed 12/14/2023
			Peggy Dorsey
			Assistant Commissioner
			Office of Land Quality