STATE OF INDIANA

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SS:

BEFORE THE INDIANA DEPARTMENT OF

 

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COUNTY OF MARION

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ENVIRONMENTAL MANAGEMENT

 

COMMISSIONER OF THE DEPARTMENT

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OF ENVIRONMENTAL MANAGEMENT,

 

)

 

 

 

)

 

Complainant,

 

)

 

 

 

)

 

 

v.

 

)

Case No. 2024-30265-H

 

 

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medline industries, lp,

 

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)

 

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.

 

1.                  Respondent is Medline Industries, LP (“Respondent”), which owns/operates the facility, with EPA ID No. INR000148148, located at 251 Hilton Drive, in Jeffersonville, Clark County, Indiana (“Site”)

 

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

 

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

 

Mozart GP, LLC, General Partner

Corporation Service Company, Registered Agent

Medline Industries, LP

Medline Industries, LP

3 Lakes Drive

135 North Pennsylvania Street, Suite 1610

Northfield, IL 60093

Indianapolis, IN 46204

 

4.                  Respondent notified EPA of Small Quantity Generator activities on July 6, 2023.

 

5.                  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.

 

6.                  During an investigation including an inspection on June 11, 2024, conducted by a representative of IDEM, the following violations were found:

 

a.         Pursuant to 40 CFR 262.13, a generator must determine its generator category. A generator's category is based on the amount of hazardous waste generated each month and may change from month to month.

 

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, Respondent notified as a small quantity generator on July 6, 2023.  A review of hazardous waste manifests for the year 2023 indicated that Respondent operated as a large quantity generator of hazardous waste in May 2023 and failed to accurately determine their generator category and failed to notify the commissioner of its hazardous waste activity.

 

Respondent submitted documentation of compliance with this citation on September 10, 2024.

 

b.         Pursuant to 40 CFR 266.502(a)(1)(i), a healthcare facility that already has an EPA identification number must notify the EPA Regional Administrator, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility as part of its next Biennial Report, if it is required to submit one: or if not required to submit a Biennial Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

 

As noted during the inspection, Respondent, a healthcare facility, with an existing EPA identification number, failed to notify as a healthcare facility within 60 days of the effective date of this subpart [Indiana: February 14, 2021], or within 60 days of becoming subject to this subpart.

 

Respondent submitted documentation of compliance with this citation on September 10, 2024.

 

c.         Pursuant to 40 CFR 266.502(b), a healthcare facility must ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals 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, Respondent failed to train employees regarding the management of hazardous waste pharmaceuticals.

 

d.         Pursuant to 40 CFR 266.502(d)(3), a healthcare facility must keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.

 

As noted during the inspection, Respondent failed to close and secure five (5) non-creditable hazardous waste pharmaceuticals containers in the hazardous waste storage area.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

e.         Pursuant to 40 CFR 266.502(e), a healthcare facility must label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”

 

As noted during the inspection, Respondent failed to label/mark five (5) non-creditable hazardous waste pharmaceuticals containers with the phrase “Hazardous Waste Pharmaceuticals.”

 

f.          Pursuant to 40 CFR 266.508(a)(2)(ii), a healthcare facility shipping non-creditable hazardous waste pharmaceuticals must write the word “PHARMS” in Item 13 of EPA Form 8700-22.

 

As noted during the inspection, Respondent failed to write the word “Pharms” in Item 13 for non-creditable hazardous waste pharmaceuticals shipped on February 21, 2024 (Manifest #018688820FLE).

 

g.         Pursuant to 40 CFR 262.17(a)(6) referencing 40 CFR 262.260(a), a large quantity generator must have a contingency plan for the facility. The contingency plan must be designed to minimize hazards to human health or the environment from fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water.

 

As noted during the inspection, Respondent became a LQG in May of 2023 and did not have a contingency plan developed.

 

h.         Pursuant to 40 CFR 262.17(a)(7)(i)(A), facility personnel must successfully complete a program of classroom instruction, online training (e.g., computer-based or electronic), or on-the-job training that teaches them to perform their duties in a way that ensures compliance with this part. The large quantity generator must ensure that this program includes all the elements described in the document required under paragraph (a)(7)(iv)(C) of this section.

 

As noted during the inspection, due to becoming a large quantity generator in May of 2023, Respondent’s current hazardous waste training program was not sufficient for employees involved in hazardous waste management.

 

i.          Pursuant to IC 13-22-4-3.1(c), 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.

 

As noted during the inspection, Respondent most recently notified of SQG activities at the Site on July 6, 2023. Respondent generated an LQG amount of hazardous waste in May 2023 and failed to submit the required biennial hazardous waste report for 2023.

 

Respondent submitted documentation of compliance with this citation on September 10, 2024.

 

j.          Pursuant to 40 CFR 262.20(a)(1), a generator that transports, or offers for transport a hazardous waste for offsite treatment, storage, or disposal, or a treatment, storage, or disposal facility that offers for transport a rejected hazardous waste load, must prepare a Manifest (OMB Control number 2050-0039) on EPA Form 8700-22, and, if necessary, EPA Form 8700-22A.

 

Pursuant to IC 13-30-2-1(12), a person may not cause or allow the transportation of a hazardous waste without a manifest if a manifest is required by law.

 

As noted during the inspection, Respondent failed to include the required hazardous waste code (D001) on manifest 023912715JJK, as required by

                        Manifest (OMB Control number 2050-0039), EPA Form 8700-22 instructions.

 

Respondent submitted documentation of compliance with this citation on September 11, 2024.

k.         Pursuant to 40 CFR 262.16(b)(2)(iii)(A), a container holding hazardous waste must always be closed during accumulation, except when it is necessary to add or remove waste.

 

As noted during the inspection, Respondent failed to store closed six (6) containers of hazardous waste.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

l.          Pursuant to 40 CFR 262.16(b)(6)(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/record review, Respondent accumulated eight (8) hazardous waste containers on-site, without a permit, and failed to mark hazardous waste containers with the words "Hazardous Waste."

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

m.        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, Respondent accumulated hazardous waste on-site, without a permit, and failed to clearly mark eight (8) hazardous waste containers with an indication of the contents.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

n.         Pursuant to 40 CFR 262.16(b)(6)(i)(C), a small quantity generator may accumulate hazardous waste on-site for 180 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, Respondent accumulated hazardous waste on-site, without a permit, and failed to clearly mark eight (8) hazardous waste containers with accumulation start dates.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

o.         Pursuant to 40 CFR 262.16(b)(8)(vi)(B), a small quantity generator shall maintain records documenting the arrangements with the local fire department as well as any other organization necessary to respond to an emergency. This documentation must include documentation in the operating record that either confirms such arrangements actively exist or, in cases where no arrangements exist, confirms that attempts to make such arrangements were made.

 

As noted during the inspection, Respondent failed to maintain records documenting that arrangements were made with local emergency organizations.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

p.         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, Respondent failed to post the required information next to the telephone.

 

Respondent submitted documentation of compliance with this citation on June 11, 2024.

 

7.                  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.         Within thirty (30) days of Effective Date, Respondent shall comply with 40 CFR 266.508(a)(2)(ii). Specifically, Respondent shall amend Item 13 for non-creditable hazardous waste pharmaceuticals shipped on February 21, 2024 (Manifest #018688820FLE) with the word “Pharms.” Documentation of completion shall be submitted to Order Paragraph #8. Stipulated penalties as stated in Order Paragraph #10 will begin on the 31st day from the Effective Date and will continue until the documentation is submitted as required by this paragraph.

 

4.         Within thirty (30) days of Effective Date, Respondent shall comply with 40 CFR 266.502(b). Specifically, Respondent shall amend the personnel training program to include training applicable employees in the handling of hazardous waste pharmaceuticals. Documentation of completion shall be submitted to Order Paragraph #8. Stipulated penalties as stated in Order Paragraph #10 will begin on the 31st day from the Effective Date and will continue until the documentation is submitted as required by this paragraph.

 

5.         Upon the Effective Date, Respondent shall comply with 40 CFR 266.502(e). Specifically, Respondent shall label all hazardous waste pharmaceuticals with the appropriate terminology.

 

6.         Respondent shall comply with 40 CFR 262.17(a)(6) referencing 40 CFR 262.260(a). Upon (or on discovery of) a change in generator status, Respondent shall ensure compliance with 40 CFR 262 (small quantity generator or large quantity generator requirements), to include creation of a Contingency Plan and a Quick Reference Guide.

 

7.         Respondent shall comply with 40 CFR 262.17(a)(7)(i)(A). Upon (or on discovery of) a change in generator status, Respondent shall ensure compliance with 40 CFR 262 (large quantity generator requirements), to include creation of a training program for personnel working with hazardous waste.

 

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

 

Linda McClure, Enforcement Case Manager

Office of Land Quality

Indiana Department of Environmental Management

100 North Senate Avenue

Indianapolis, IN 46204-2251

 

9.                  Pursuant to IC 13-30-4-1, Respondent is assessed and agrees to pay a civil penalty of Seven Thousand and Two Hundred Dollars ($7,200). 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.

 

10.              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:

 

Paragraph

Stipulated Penalty

Order paragraph #3

$150 per week

Order paragraph #4

$150 per week

 

11.              Stipulated penalties shall be due and payable no later than the thirtieth day after Respondent receives written notice that Complainant has determined a stipulated penalty is due; at which time, a separate invoice will be issued. Complainant 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 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.

 

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 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 9, 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 the 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.

 

REMAINDER OF PAGE LEFT BLANK INTENTIONALLY

 

TECHNICAL RECOMMENDATION:

RESPONDENT:

Department of Environmental Management

 

 

 

 

By:

 

 

By:

 

 

Jennifer Reno, Chief

Printed:

 

 

Land Enforcement Section

Title:

 

 

Compliance Branch

 

 

 

Office of Land Quality

 

 

Date:

 

10/11/2024

 

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 11/7/2024

 

 

 

 

 

 

 

 

Brian Wolff

 

 

Assistant Commissioner

 

 

Office of Land Quality