STATE OF INDIANA |
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BEFORE THE INDIANA DEPARTMENT OF |
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COUNTY OF MARION |
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ENVIRONMENTAL MANAGEMENT |
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COMMISSIONER OF THE DEPARTMENT |
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OF ENVIRONMENTAL MANAGEMENT, |
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Complainant, |
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Case No. 2019-26572-H |
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Case No. 2019-26575-H |
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ZIMMER BIOMET, INC. |
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Respondent. |
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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 |
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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: |
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Department of Environmental Management |
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By: _________________________ |
By:
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Jennifer
Reno, Section Chief |
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Enforcement
Section |
Printed: ______________________ |
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Office of
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Title: ________________________ |
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Date: |
Date: _______________________ |
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COUNSEL FOR RESPONDENT: |
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By: ________________________ |
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Date: ______________________ |
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APPROVED AND ADOPTED BY THE INDIANA
DEPARTMENT OF ENVIRONMENTAL |
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MANAGEMENT
THIS |
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DAY OF |
________________________, |
20__. |
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For the Commissioner: |
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Signed September 21, 2020 |
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Peggy Dorsey, Assistant Commissioner |
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Office of Land Quality |
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