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STATE OF INDIANA |
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BEFORE THE INDIANA DEPARTMENT OF |
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ENVIRONMENTAL MANAGEMENT |
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COUNTY OF MARION |
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COMMISSIONER OF THE DEPARTMENT |
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OF ENVIRONMENTAL MANAGEMENT, |
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Complainant, |
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v. |
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Case No. 2014-22268-W |
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Monosol Rx,
llc, |
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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 MonoSol Rx, LLC (Respondent), which owns and operates an industrial facility that
manufactures film-based drug delivery systems, located at 6560 Melton Road,
Portage, Porter County, Indiana (the Site).
3.
Respondent
is authorized by its Industrial Wastewater Pretreatment (IWP) Permit No. INP000264
(the Permit), to discharge in accordance with the terms and conditions of the
IWP Permit from its facility located at 6560 Melton Road, Portage Indiana, into
the Portage Publicly Owned Treatment Works (POTW) from outfall 001.
4.
IDEM
has jurisdiction over the parties and the subject matter of this action
pursuant to IC 13-30-3.
5.
Pursuant
to IC 13-30-3-3, IDEM issued a Notice of Violation (NOV) via Certified
Mail/personal service to MonoSol Rx, LLC.
6.
During
an investigation conducted by representatives of IDEM, violations were found,
as described below.
7.
Pursuant
to 327 IAC 5-2-8(1) and Part II.A.1 of the Permit, Respondent is required to
comply with all terms and conditions of its Permit. Any noncompliance constitutes a violation of
the Clean Water Act and IC 13 and is grounds for enforcement action.
8.
Pursuant
to 327 IAC 5-21-4(1) an IWP permit holder shall comply with the requirements of
the IWP permit as issued or modified.
9.
Pursuant
to Part I.A of the Permit, Respondent is required to comply with discharge
limitations contained in the Permit which are applicable to the discharge from
Outfall 001.
IDEM
records, including Discharge Monitoring Reports (DMRs) submitted by Respondent
for the period from May 1, 2012 through December 31, 2013, indicate that
Respondent failed to comply with the discharge limitations contained in the
Permit in violation of 327 IAC 5-2-8(1), 327 IAC 5-21-4(1), Part II.A.1 of the Permit,
and Part I.A of the Permit, as follows:
A.
The
monthly average concentration limitation for Methylene
Chloride was exceeded during May 2012, and February, June, October, and
December 2013.
B.
The
daily maximum concentration limit for Methylene Chloride
was exceeded on one or more days during February, June, October, and December
2013.
C.
The
daily minimum for pH was exceeded on one or more days during February 2013.
D.
The
daily maximum concentration limit for Phosphorus was exceeded on one or more
days during October and December 2012, and March, April, and May 2013.
E.
The
daily maximum concentration for Chemical Oxygen Demand (COD) was exceeded on
one or more days during June 2013.
10.
Pursuant
to Part I.C.6 of the Permit, all records of monitoring activities and results
required by the Permit shall be retained at the permitted facility for a
minimum of three (3) years, and Respondent shall maintain and make available to
IDEM and the City of Portage personnel, records of disposal of all wastewater
generated at the Site. Such records
shall include, but not be limited to, flow monitoring records, flow calibration records, and the volume and
destination of all wastewater hauled off-site.
During
an inspection conducted by IDEM staff on February 19, 2014, the records/reports
evaluation was rated as unsatisfactory because, at the time of the inspection,
the discharge monitoring reports (DMRs), monthly monitoring reports (MMRs),
laboratory analysis, flow data, and self-monitoring records were unavailable for
review.
Respondent’s
failure to retain all records of monitoring activities and results required by
the Permit for a minimum of three (3) years, and failure to make records of
disposal of all wastewater generated at the Site available to IDEM were in
violation of 327 IAC 5-2-8(1), 327 IAC 5-21-4(1), Part II.A.1 of the Permit, and
Part I.C.6 of the Permit.
11.
Subsequent
to the inspection on February 19, 2014, Respondent has confirmed that all
records referenced in Paragraph 10 above have been moved on-site, and Respondent
maintains all records and information at the Site as required by Part I.C.6 of
the Permit.
12.
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 adopted by
Complainant or Complainant’s delegate (as evidenced by signature), and the
adopted Agreed Order has been received by Respondent. This Agreed Order shall have no force or
effect until the Effective Date. In
addition to addressing the violations cited in Paragraphs 9 and 10 of the
Findings of Fact above, this Agreed Order also addresses any additional
violations of these same rules that may have occurred subsequent to the
issuance of the NOV and prior to the Effective Date.
2.
Respondent
shall comply with the statutes, rules and /or permit conditions listed in the
findings above at issue.
3.
In
accordance with Part I.C.B of the Permit, Respondent shall maintain on-site at
all times the previous three years of all records and information resulting
from the monitoring activities required by the Permit. Respondent shall ensure that all records of
disposal of all wastewater generated at the Site are maintained and available
to IDEM and City of Portage personnel.
4.
Within
30 days of the Effective Date, Respondent shall develop and submit to IDEM for
approval a Compliance Plan (CP) which identifies the actions that Respondent
will take to achieve and maintain compliance with its IWP Permit, specifically
including the actions Respondent will take to evaluate and implement means to
consistently meet its permit discharge limits, including a method for
consistently achieving compliance with methylene
chloride and phosphorus discharge limits.
The CP shall include an implementation and completion schedule, including
specific milestone dates.
5.
Respondent
shall, after completion of the work required pursuant to the approved CP from
Paragraph 4 above, demonstrate six consecutive months of compliance (Compliance
Demonstration) with the discharge limitations contained in its IWP Permit. During the Compliance Demonstration period,
Respondent shall be subject to stipulated penalties, as specified below, for
violations of the discharge limitations.
In
the event that Respondent fails to make the Compliance Demonstration,
Respondent shall, within 10 days of becoming aware that the Compliance
Demonstration cannot be achieved, submit notification to IDEM that a discharge exceedance has occurred, and within 30 days of becoming
aware that the Compliance Demonstration cannot be achieved, develop and submit
to IDEM, for approval, an Additional Action Plan which identifies the
additional actions that Respondent will take to achieve and maintain compliance
with the discharge limitations contained in its IWP Permit. The Additional Action Plan, if required,
shall include an implementation and completion schedule, including specific
milestone dates.
6.
The
plans required by Paragraphs 4 and 5 above are subject to IDEM approval. In the event IDEM determines that any plan
submitted by Respondent is deficient or otherwise unacceptable, Respondent
shall revise and resubmit the plan to IDEM in accordance with IDEM’s
notice. After three submissions of such
plan by Respondent, IDEM may modify and approve any such plan and Respondent
must implement the plan as modified by IDEM.
Respondent,
upon receipt of written notification from IDEM, shall immediately implement the
approved plan and adhere to the milestone dates therein. The approved CP and Additional Action Plan
shall be incorporated into the Agreed Order and shall be deemed an enforceable
part thereof. Failure by Respondent to
submit any plan by the specified date, or to meet any of the milestones in the
approved plan, will subject Respondent to stipulated penalties as described
below. Failure to achieve compliance at
the conclusion of work under an Additional Action Plan will subject Respondent
to additional enforcement action.
7.
Respondent
shall submit to IDEM a written report of progress or completion for each
milestone date included in the CP or Additional Action Plan within 10 days of
completion of the requirements of each milestone.
8.
All
submittals required by this Agreed Order, unless Respondent is notified
otherwise in writing by IDEM, shall be sent to:
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Amari Farren, Enforcement Case
Manager |
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Indiana Department of Environmental
Management |
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Surface Water, Operations &
Enforcement Branch |
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Office of Water Quality – Mail Code
60-02W |
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9.
Respondent is assessed and agrees to pay a civil penalty of Seven
Thousand Four Hundred and Forty Dollars ($7,440). Said penalty amount shall be due and payable
to the Environmental Management Special Fund within 30 days of the Effective
Date; the 30th day being a “Due Date.”
10.
In
the event the terms and conditions of the following paragraphs are violated,
IDEM may assess and Respondent shall pay the corresponding stipulated penalty:
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Paragraph |
Violation |
Stipulated
Penalty |
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3 |
Failure to maintain on-site for a minimum of three
years all wastewater monitoring records, or failure to assure all records of
disposal of wastewater generated at the Site are available to IDEM and City
of Portage personnel. |
$250
per violation |
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4 |
Failure
to submit or modify the CP within the required time period. |
$500
per week late, or part thereof. |
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5 |
For
violations of discharge limitations during the Compliance Demonstration
period |
$1,000
per violation |
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5 |
Failure
to submit notification to IDEM that an effluent exceedance
has occurred, within 10 days of becoming aware that the Compliance
Demonstration cannot be achieved |
$250
per violation |
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5 & 6 |
Failure
to submit or modify the Additional Action Plan, if required, within the given
time period. |
$250
per week late |
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6 |
Failure
to meet any milestone date set forth in the approved CP or Additional Action
Plan. |
$500
per week late |
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7 |
Failure
to submit to IDEM a written report of progress or completion for each
milestone date included in the CP or Additional Action Plan. |
$250
per violation |
11.
Stipulated penalties shall be due and payable no later than the 30th day after
Respondent receives written notice that IDEM has determined a stipulated
penalty is due, the 30th day
being a “Due Date.” IDEM may notify
Respondent at any time that a stipulated penalty is due. Failure to notify Respondent in writing in a
timely manner of a stipulated penalty assessment shall not waive IDEM’s right
to collect such stipulated penalty or preclude IDEM from seeking additional
relief against Respondent for violation of this Agreed Order. Neither assessment nor payment of stipulated penalties
shall preclude IDEM 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.
12.
Civil
and stipulated penalties are payable by check to the “Environmental Management
Special Fund.” Checks shall include the
Case Number
2014-22268-W
of this action and shall be mailed to:
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Indiana Department of Environmental
Management |
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Cashier – Mail Code 50-10C |
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13.
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.
14.
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 and any accrued interest 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. The interest shall continue to
accrue on the first of each month until the civil penalty and any interest
accrued are paid in full. Such interest
shall be payable to the Environmental Management Special Fund, and shall be
payable to IDEM in the manner specified above.
15.
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.
16.
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.
17.
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 permit or any
applicable Federal or State law or regulation.
18.
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.
19.
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.
20.
Nothing
in this Agreed Order shall prevent IDEM [or anyone acting on its behalf] from
communicating with the United States Environmental Protection Agency (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.
21.
This
Agreed Order shall remain in effect until Respondent has complied with all
terms and conditions of Order Paragraphs 3 through 12 and IDEM issues a
Resolution of Case (close out) letter.
REMAINDER OF PAGE INTENTIONALLY LEFT
BLANK.
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TECHNICAL RECOMMENDATION: |
RESPONDENT: |
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Department of
Environmental Management |
MonoSol Rx, LLC |
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By: _______________________ |
By: ________________________ |
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Mary E. Hoover, Chief |
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Water Enforcement Section |
Printed:
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Surface
Water, Operations and |
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Enforcement
Branch |
Title:
_______________________ |
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Office of Water Quality |
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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 ______
DAY OF ________________________, 2014. |
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For the Commissioner: |
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Signed on September 4,
2014__ |
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Bruno
Pigott |
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Assistant Commissioner |
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Office of Water Quality |