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. 2019-26572-H
					)	Case No. 2019-26575-H
					)
ZIMMER BIOMET, INC.					)
					)
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 Zimmer Biomet, Inc. (“Respondent”) which owns and operates the facility with United States Environmental Protection Agency (“EPA”) ID No. IND086782224, located at 56 East Bell Drive, Warsaw, Kosciusko County, Indiana (“Site 1”) and owns and operates the facility, located at 2416 North Boeing Road, Warsaw, Kosciusko County, Indiana (“Site 2”).

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

4. Pursuant to IC 13-30-3-3, on February 21, 2020, IDEM issued a Notice of Violation (“NOV”) via UPS to:

Biomet Biologics, LLC & Biomet Manufacturing, LLC

Attn: Chad F. Phipps, Manager

345 East Main Street

Warsaw, Indiana 46580

Corporation Service Company, Registered Agent

135 North Pennsylvania Street , Suite 1610

Indianapolis, Indiana 46204

5. Respondent notified EPA of Large Quantity Generator activities at Site 1 on July 25, 2019. Respondent did not notify of generator status for Site 2.

6. 329 Indiana Administrative Code (“IAC”) 3.1 incorporates certain 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 inspection of Site 1 and Site 2 on September 18, 2019, conducted by an IDEM representative, the following violations were found:

Case No. 2019-26572-H (Site 1)

a. Pursuant to 40 CFR 262.11, a person who generates a solid waste must determine if that waste is hazardous.

As noted during the inspection, Respondent did not make a hazardous waste determination on several containers stored in the East Barn and acetone contaminated wipes at Site 2, which are solid waste generated by Respondent.

b. Pursuant to 40 CFR 262.20 and IC 13-30-2-1(12), a generator who transports, or offers for transportation, hazardous waste for offsite treatment, storage, or disposal, must prepare a manifest. A generator must designate on the manifest one facility which is permitted to handle the waste described on the manifest. A generator may designate an alternate facility to handle his waste in the event that an emergency prevents delivery of the waste to the primary designated facility.

As noted during the inspection, Respondent transported hazardous waste for offsite treatment, storage, or disposal without preparing a manifest. Specifically, between January 1, 2018 and September 18, 2019, Respondent shipped eight (8) shipments of D001, D018, D039, and D040 hazardous waste for disposal without a manifest.

c. Pursuant to IC 13-22-4-3.1(c) and 329 IAC 3.1-7-14, a hazardous waste large quantity generator (LQG), i.e., a person that generates, in any one or more calendar months of a calendar year:

a) more than one thousand (1,000) kilograms of hazardous waste;

b) at least one (1) kilogram of acute hazardous waste; or

c) at least one hundred (100) kilograms of material from the cleanup spillage of acute hazardous waste; or

accumulates at least six thousand (6,000) kilograms of hazardous waste or at least one (1) kilogram of acute hazardous waste shall, before March 1 of each year, submit to the department either the biennial report concerning the person's waste activities during the previous calendar year, or an annual report on forms provided by the department, that summarizes the person's hazardous waste shipments during the previous calendar year. LQGs are required to submit the Hazardous Waste Biennial Report by March 1 of each even numbered year and the IDEM annual manifest report by March 1 of each odd numbered year.

Respondent most recently notified IDEM of LQG activities on July 25, 2019. As noted during the inspection, Respondent failed to include a summary of all the hazardous waste shipped in 2018. Specifically, the report is missing information on wastes sent to the TSD’s and does not properly detail the types and volumes of waste shipped.

d. Pursuant to 40 CFR 262.34(b), a generator who accumulates hazardous waste for more than 90 days is an operator of a storage facility and is subject to the requirements of 40 CFR Part 264 and the permit requirements of 40 CFR Part 270 unless he has been granted an extension to the 90 day period.

As noted during the inspection, Respondent accumulated hazardous waste on-site for greater than 90 days without complying with 40 CFR Part 264 and 40 CFR Part 270. Specifically, Respondent accumulated:

1. Several bottles of 59% hydrogen peroxide (east barn) with a date range from 7/12/18 to 2/16/19;

2. One (1) 85-gallon over pack of research chemicals (east barn), dated 10/10/2018;

3. Two (2) 55-gallon containers of potassium hydroxide (east barn), dated 8/24/2018;

4. Three (3) 55-gallon containers of titanium powder and debris (east barn), dated 6/30/2018; and

5. One Half (1/2) 55-gallon container of Spor-Klenz, dated 10/28/2018.

e. Pursuant to 40 CFR 262.34(a)(3), a generator may accumulate hazardous waste on-site for 90 days or less without a permit, provided that, while being accumulated on-site, each container and tank is labeled or marked clearly with the words "Hazardous Waste."

As noted during the inspection, Respondent accumulated hazardous waste on-site, without a permit, and did not label or clearly mark spent coliform containers in the east barn with the words "Hazardous Waste."

f. Pursuant to 40 CFR 262.34(a)(1)(i) referencing 40 CFR 265.174, a generator must inspect areas where containers are stored, at least weekly, looking for leaks and deterioration caused by corrosion or other factors.

As noted during the inspection, Respondent failed to conduct weekly inspections of the hazardous waste storage area of the east barn. In addition, Respondent stored hazardous waste containers in such a manner as to prevent inspection.

g. Pursuant to 40 CFR 262.34(a)(4) referencing 40 CFR 265.52, the content of the contingency plan must include the following: a description of appropriate actions, arrangements with local emergency response teams, contact information for the emergency coordinators, emergency equipment, and an evacuation plan.

As noted during the inspection, Respondent's contingency plan did not include all of the required information.

h. Pursuant to 40 CFR 262.34(a)(4) referencing 40 CFR 265.16(d)(1-4), certain hazardous waste training related documents and records including job title, job descriptions, a description of the type and amount of required training, and completion documents with respect to the hazardous waste management training must be maintained on-site.

As noted during the inspection, Respondent did not maintain all of the required hazardous waste training related documents and records on-site.

i. Pursuant to 40 CFR 262.34 and 40 CFR 268.7, a generator of hazardous waste must determine if the waste has to be treated before it can be land disposed. With the initial shipment of hazardous waste to each treatment or storage facility, the generator must send a one-time written notice to each treatment or storage facility receiving the waste, and place a copy in the generator’s file.

As noted during the inspection, in 2018 and 2019 Respondent shipped hazardous waste without the required one-time written land-ban notice.

j. Pursuant to IC 13-30-2-1(10), a person may not commence or engage in the operation of a hazardous waste facility without having first obtained a permit from the department.

As noted during the inspection, Respondent had accepted hazardous waste from an off-site facility, Site 2, without having first obtained a permit from the department.

Case No. 2019-26575-H (Site 2)

k. Pursuant to 329 IAC 3.1-1-10, 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.

As noted during the inspection, per manifested shipments of unused methyl methacrylate, spent acetone, and spent acetone contaminated wipes, Respondent operated as a Small Quantity Generator (SQG) in 2018 and 2019 without notifying the Commissioner of its hazardous waste activity on the approved forms.

l. Pursuant to 40 CFR 262.20 and IC 13-30-2-1(12), a generator who transports, or offers for transportation, hazardous waste for offsite treatment, storage, or disposal, must prepare a manifest. A generator must designate on the manifest one facility which is permitted to handle the waste described on the manifest. A generator may designate an alternate facility to handle his waste in the event that an emergency prevents delivery of the waste to the primary designated facility.

As noted during the inspection, Respondent allowed the transportation of hazardous waste from Site 2 to Site 1 without preparing a manifest.

m. Pursuant to IC 13-22-4-3.1(b), hazardous waste small quantity generator (SQG), i.e., a person that generates, in any one or more calendar months of a calendar year:

A. more than one hundred (100) kilograms but less than one thousand (1,000) kilograms of hazardous waste;

B. less than one (1) kilogram of acute hazardous waste; or

C. 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 that summarizes the person's hazardous waste shipments during the previous calendar year.

As noted during the inspection, Respondent operated as a small quantity generator of hazardous waste in 2018, but failed to submit the required annual manifest report.

n. Pursuant to 40 CFR 262.11, a person who generates a solid waste must determine if that waste is hazardous.

As noted during the inspection, Respondent did not make a hazardous waste determination on spent acetone contaminated wipes, which are a solid waste generated by Respondent.

o. Pursuant to 40 CFR 262.34 and 40 CFR 268.7, a generator of hazardous waste must determine if the waste has to be treated before it can be land disposed. With the initial shipment of hazardous waste to each treatment or storage facility, the generator must send a one-time written notice to each treatment or storage facility receiving the waste and place a copy in the file.

As noted during the inspection, in 2018 and 2019 Respondent had shipped hazardous waste to a TSD facility through Site 1 without sending the required one-time land-ban written notice or placing a copy in the file.

p. Pursuant to IC 13-30-2-1(11), a person may not do any of the following: Deliver any hazardous waste to a hazardous waste facility that (A) is not approved; or (B) does not hold a permit from the department.

As noted during the inspection, Respondent transported shipments of hazardous waste to a facility (Site 1) that is not permitted to accept hazardous waste.

8. Effective December 26, 2019, IDEM’s Hazardous Waste Updates final rule (LSA Document #18-481) amended 329 IAC 3.1, 329 IAC 10, 329 IAC 11, and 329 IAC 13 in response to the United States Environmental Protection Agency’s Hazardous Waste Generator Improvements Rule, 81 Fed. Reg. 85732 (Nov. 28, 2016).  As a result, the requirements that now apply to Respondent(s) might differ from the requirements that applied at the time of the alleged violations cited above.

9. On June 19, 2020, Respondent submitted documentation demonstrating compliance with violations cited in Case # 2019-26572-H and 2019-26575-H.

10. 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 statutes and rules listed in the findings of fact above.

3. Upon the Effective Date, Respondent shall not deliver any hazardous waste to a hazardous waste facility that (a) is not approved; or (B) does not hold a permit from the Department.

4. Upon the Effective Date, Respondent shall not store hazardous waste for more than 90 days without a permit.

5. Upon the Effective Date, Respondent shall ensure hazardous waste manifests are prepared in accordance with the instructions in the appendix of 40 CFR 262.

6. Upon the Effective Date, Respondent shall submit a one-time Land-Ban written notice, when and where applicable, to receiving TSD facilities and also place a copy in the file.

7. Upon the Effective Date, Respondent shall ensure containers are labeled or marked as required by 40 CFR 262.17(a)(5). [See Findings of Fact Paragraph # 8].

8. Upon the Effective Date, Respondent shall ensure containers of hazardous waste are stored closed during storage, except when it is necessary to add or remove waste.

9. Upon the Effective Date, Respondent shall conduct weekly inspections of the hazardous waste storage area of the East Barn, inspecting for leaks and for deterioration caused by corrosion or other factors. Respondent shall ensure containers are stored in a manner to allow inspection.

10. Pursuant to IC 13-30-4-1, Respondent is assessed and agrees to pay a civil penalty of Twenty-Eight Thousand Two Hundred Dollars ($28,200). Said penalty amount shall be due and payable to the “Environmental Management Special Fund” within thirty (30) days of the Effective Date; the thirtieth day being the “Due Date.”

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

Indiana Department of Environmental Management

Accounts Receivable

IGCN, Room 1340

100 North Senate Avenue

Indianapolis, IN 46204

12. 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 interest on the unpaid balance at the rate established by IC 24-4.6-1. The interest shall be computed as having accrued from the Due Date until the date that Respondent pays any unpaid balance. Such interest shall be payable to the “Environmental Management Special Fund,” and shall be payable to IDEM in the manner specified in Paragraph 11 above.

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

14. 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.

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

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

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

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

TECHNICAL RECOMMENDATION:				RESPONDENT:
Department of Environmental Management
By: _________________________				By: _________________________
	Jennifer Reno, Section Chief
	Enforcement Section				Printed: ______________________
Office of Land Quality
				Title: ________________________
Date:				Date: _______________________
				COUNSEL FOR RESPONDENT:
				By: ________________________
				Date: ______________________
APPROVED AND ADOPTED BY THE INDIANA DEPARTMENT OF ENVIRONMENTAL
MANAGEMENT THIS		______	DAY OF	________________________,		20__.
				For the Commissioner:
				Signed September 21, 2020
				Peggy Dorsey, Assistant Commissioner
				Office of Land Quality