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STATE OF
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BEFORE THE
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COUNTY OF
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ENVIRONMENTAL
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COMMISSIONER
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OF
ENVIRONMENTAL MANAGEMENT, |
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Complainant, |
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v. |
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Case No.
2018-25477-H |
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kremers urban pharmaceuticals 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 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 Indiana Code (“IC”) 13-13-1-1.
2.
Respondent is Kremers
Urban Pharmaceuticals Inc. (“Respondent”), which owns and/or operates the
company with United States Environmental Protection Agency (“EPA”) ID No.
IND981196793, located at 1101 C Avenue West, in Seymour, Jackson 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 to Isreal Hodges, Environmental Manager
for Kremers Urban Pharmaceuticals Inc. and CT
Corporation System, Registered Agent for Kremers
Urban Pharmaceuticals Inc.
5.
Respondent previously notified EPA of Large
Quantity Generator activities.
6.
Respondent owns and/or operates a facility that
manufactures and packages pharmaceutical products.
7.
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.
8.
During an investigation including an inspection
on May 16, 2018 conducted by a representative of IDEM, the following violations
were found:
a. 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 on May 16,
2018, Respondent operated a hazardous waste facility without having first
obtained a permit from the department. Two (2) 55-gallon drums containing
hazardous waste did not indicate a date on which the storage commenced and,
therefore, are presumed to store hazardous waste over ninety (90) days.
b. 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 on May
16, 2018, Respondent stored two drums containing hazardous waste without indicating
a date on which the storage commenced and, therefore, are presumed to store
hazardous waste on-site for greater than 90 days without complying with 40 CFR
Part 264 and 40 CFR Part 270.
c.
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 on May
16, 2018, Respondent is presumed to have stored hazardous waste identified or
listed in 40 CFR Part 261 without a permit.
d.
Pursuant to 40 CFR 262.34(a)(1)(i) referencing 40 CFR 265.173(a), a container holding
hazardous waste must always be closed during storage, except when it is necessary
to add or remove waste.
As
noted during the inspection on May 16, 2018, Respondent stored hazardous waste
in an open container. One (1) 55-gallon
drum in room 73 was missing a bung.
In
a May 17, 2018 email, the Lannett Company, Inc.
Environmental Health & Safety Director stated that waste located in room 73
were properly labeled, dated, and closed. Field verification will be required
to confirm compliance.
e.
Pursuant to 40 CFR 262.34(a)(2), a generator
may accumulate hazardous waste on-site for 90 days or less without a permit,
provided that the date when the accumulation begins is clearly marked and
visible for inspection on each container.
As noted during the inspection on May
16, 2018, Respondent did not mark hazardous waste containers with the
accumulation start date. Two (2) 55-gallon drums and one (1) 1-gallon container
located in room 73 were missing the accumulation start date. A total of five
(5) 55-gallon drums in room 192 were also missing the accumulation start date.
In a May 17, 2018 email, the Lannett Company, Inc. Environmental Health & Safety
Director indicated that waste described above in room 192 was appropriately
labeled and shipped for destruction.
Waste located in room 73 was properly labeled, dated, and closed. Field
verification will be required to confirm compliance.
f.
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 on May 16, 2018, Respondent failed to label
hazardous waste containers with the words “Hazardous Waste.” A total of five
(5) 55-gallon drums located in room 192 were not properly labeled.
In
a May 17, 2018 email, the Lannett Company, Inc.
Environmental Health & Safety Director indicated that waste described above
was appropriately labeled and shipped for destruction. Field verification will
be required to confirm compliance.
g.
Pursuant to 40 CFR 262.34(a)(4) referencing 40
CFR 265.35, a generator must maintain aisle space to allow the unobstructed
movement of personnel, fire protection, equipment, spill control equipment, and
decontamination equipment to any area of facility operation in an emergency.
As noted during the inspection on May
16, 2018, Respondent failed to provide adequate aisle space in room 192.
In a May 17, 2018 email, the Lannett Company, Inc. Environmental Health & Safety
Director provided a picture of room 192 to document the addition of adequate
aisle space. Field verification will be required to confirm compliance.
h.
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 on May 16, 2018, Respondent failed to include all of the
required information in the contingency plan.
In a July 24, 2018 email, the Lannett Company, Inc. Environmental Health & Safety
Director indicated that the RCRA Contingency Plan was updated with the required
information necessary to achieve compliance. The updated contingency plan must
be submitted for review and approval by IDEM.
i.
Pursuant to 40 CFR 273.13, 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 on May 16, 2018, Respondent failed to store
universal waste lamps in a closed container.
In
a May 17, 2018 email, the Lannett Company, Inc.
Environmental Health & Safety Director indicated that waste described above
was appropriately labeled and shipped for destruction. Field verification will
be required to confirm compliance.
j.
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 on May
16, 2018, Respondent failed to label used oil containers with the words “Used
Oil.” One (1) 55-gallon drum and multiple 5-gallon containers were not properly
labeled.
In a May 17,
2018 email, the Lannett Company, Inc. Environmental
Health & Safety Director indicated that most of the used oil in room 192
was emptied into a 55-gallon drum, labeled, and shipped offsite. The remaining
used oil was added to a new drum and labeled appropriately. Field verification
will be required to confirm compliance.
9. In recognition of the settlement reached,
Respondent 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,
rules, and/or permit conditions listed in the findings above.
3.
Upon the Effective Date, Respondent shall comply
with IC 13-30-2-1(10), 40 CFR 262.34(b), 40 CFR 270.1(c). Specifically,
Respondent shall not store hazardous waste for over ninety (90) days without a
permit.
4.
Upon the Effective Date, Respondent shall
comply with 40 CFR 262.34(a)(1)(i)
referencing 40 CFR 265.173(a). Specifically, Respondent shall close any open
hazardous waste storage containers.
5.
Upon the Effective Date, Respondent shall
comply with 40 CFR 262.34(a)(2). Specifically,
Respondent shall mark hazardous waste containers with the accumulation start
date.
6.
Upon the Effective Date, Respondent shall
comply with 40 CFR 262.34(a)(3). Specifically,
Respondent shall label hazardous waste containers with the words “Hazardous
Waste”.
7.
Upon the Effective Date, Respondent shall
comply with 40 CFR 262.34(a)(4) referencing 40 CFR
265.35. Specifically, Respondent shall provide aisle space in room 192, as
required by the Rule.
8.
Within thirty (30) days of the Effective Date,
Respondent shall comply with 40 CFR 262.34(a)(4)
referencing 40 CFR 265.52. Specifically, Respondent shall submit a contingency
plan with the required components for review and approval by IDEM.
9.
Upon the Effective Date, Respondent shall
comply with 40 CFR 273.13. Specifically, Respondent shall store universal waste
in closed containers.
10.
Upon the Effective Date, Respondent shall
comply with 329 IAC 13-4-3(d). Specifically, Respondent shall label used oil
containers with the words “Used Oil”.
11.
All submittals required by this Agreed Order,
unless Respondent is notified otherwise in writing by IDEM, shall be sent to:
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Amy Elliott, Enforcement Case Manager |
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Office of Land Quality |
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Indiana Department of Environmental
Management |
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100 North Senate Avenue |
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Indianapolis, IN 46204-2251 |
12.
Respondent is assessed and agrees to pay a
civil penalty of twelve thousand eight hundred dollars ($12,800.00). Said penalty amount shall be due and
payable to the Environmental Management Special Fund within thirty (30) days of
the Effective Date; the 30th day being the “Due Date”.
13.
In the event the terms and conditions of the
following paragraphs are violated, Complainant may assess and Respondent shall
pay a stipulated penalty in the following amount:
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Paragraph |
Penalty |
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Order paragraph # 8 |
$100 per week late |
14.
Stipulated penalties shall be due and payable
no later than the 30th day after Respondent receives written notice
that Complainant has determined a stipulated penalty is due; the 30th
day being the “Due Date”. Complainant may notify Respondent at any time that a
stipulated penalty is due. Failure to
notify Respondent in writing in a timely manner of stipulated penalty
assessment shall not waive Complainant’s right to collect such stipulated
penalty or preclude Complainant from seeking additional relief against
Respondent for violation of this Agreed Order. Neither assessment nor payment
of stipulated penalties shall preclude Complainant from seeking additional
relief against Respondent for a violation of this Agreed Order; such additional
relief includes any remedies or sanctions available pursuant to Indiana law,
including, but not limited to, civil penalties pursuant to IC 13-30-4.
15.
Civil and stipulated 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:
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Indiana
Department of Environmental Management |
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Office
of Legal Counsel |
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IGCN,
Room N1307 |
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100
North Senate Avenue |
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Indianapolis, IN 46204 |
16.
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 15, above.
17.
This Agreed Order shall apply to and be binding
upon Respondent and its successors and assigns. Respondent’s signatories to
this Agreed Order certify that they are fully authorized to execute this Agreed
Order and legally bind the party they represent. No change in ownership,
corporate, or partnership status of Respondent shall in any way alter its status
or responsibilities under this Agreed Order.
18.
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.
19.
Respondent shall provide a copy of this Agreed
Order, if in force, to any subsequent owners or successors before ownership
rights are transferred. Respondent shall ensure that all contractors, firms and
other persons performing work under this Agreed Order comply with the terms of
this Agreed Order.
20.
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 its obligation to comply with the requirements of its applicable permits or
any applicable Federal or State law or regulation.
21.
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.
22.
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 same violations specified in the NOV.
23.
Nothing in this Agreed
Order shall prevent IDEM or anyone acting on its behalf from communicating with
the 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 EPA or any other agency or
entity.
24.
This Agreed Order shall remain in effect until
IDEM issues a Resolution of Case letter to Respondent.
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TECHNICAL RECOMMENDATION: |
RESPONDENT: |
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Department of Environmental Management |
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By: _________________________ |
By:
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Nancy
Johnston, Section Chief |
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Enforcement
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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
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For the
Commissioner: |
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__Signed 12/17/18______________ |
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Peggy Dorsey, Assistant Commissioner |
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Office of
Land Quality |
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