Alabama Administrative Code Chapter 335-17-8 — Registration and Permits

335 Alabama Department of Environmental Management

Ala. Admin. Code r. 335-17-8-.01 Registration Requirements

(1) Generators.

(a) Any facility or person that meets the definition of a medical waste generator as defined in 335-17-1-.02 shall register with the Department within thirty (30) days of the commencement of operation.

(b) Application for the medical waste generator registration shall be submitted electronically to the Department utilizing ADEM Form 410.

History

• Author: James L. Bryant, Ashley S. Powell, Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12.
• New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.02 Requirements for a Permit

(1) As part of submitting an application for an initial issuance of a medical waste storage or treatment permit, the prospective permittee shall provide to the Department documentation of host government approval, as provided in the Code of Alabama 1975, §§ 22-27-48 and 48.1.

(2) Storage Facilities: Any medical waste storage facility, as defined in 335-17-1-.02, shall apply for and obtain a medical waste storage permit prior to storing medical waste.

(3) Transporters: Any medical waste transporter, as defined in 335-17-1-.02, shall apply for and obtain a medical waste transporter permit prior to transporting medical waste.

(4) Treatment Facilities: Any medical waste treatment facility, as defined in 335-17-1-.02, shall apply for and obtain a medical waste treatment permit prior to treating medical waste.

History

• Author: James L. Bryant, Ashley S. Powell, Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48, 22-27-48.1.
• New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.03 Permit Applications

(1) Any person who requires a permit pursuant to 335-17 shall complete, sign, and submit to the Department an application for each permit required under 335-17-8-.02.

(a) Storage Facilities: Application for the medical waste storage permit shall be submitted electronically to the Department utilizing ADEM Form 413.

(b) Transporters: Application for the medical waste transporter permit shall be submitted electronically to the Department utilizing ADEM Form 411.

(c) Treatment Facilities: Application for the medical waste treatment permit shall be submitted electronically to the Department utilizing ADEM Form 412.

Note: Prior to or concurrently with the submission of an application for a new storage or treatment facility permit, documentation of host governmental approval as provided in Code of Alabama 1975, §§ 22-27-48 and 22-27-48.1 must be provided to the Department.

History

• Author: James L. Bryant, Ashley S. Powell, Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48, 22-27-48.1.
• New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.04 Issuance of Permits

(1) When the Department determines that an application is complete, it shall make a determination to issue or to deny a permit for the operations and activities described in the application. The Department shall notify the applicant of this determination.

(2) As determined by the Director, substantial non-compliance with Department regulations or permits at any facility owned or operated by the applicant, including any facility for which the pending permit application is requested, will be grounds for denial of the application, or alternatively, for suspension of further consideration of the application until such non-compliance is corrected.

(3) Duration of Permits.

(a) Transporter permits shall be valid for three (3) years.

(b) Treatment facility permits and storage facility permits shall be valid for five (5) years.

(4) Continuation of Expiring Permits. The terms and conditions of an expiring medical waste permit are automatically extended pending issuance of a new permit if the permittee has submitted a complete application for reissuance of a permit in accordance with 335-17-8-.03 at least ninety (90) days prior to permit expiration, and the delay in permit issuance has not been caused by the actions of the permittee. A complete application is one that contains all items required in the permit application and its accompanying instruction, and the items contain enough information to allow the Department to conduct a detailed review of the application. Failure to submit a complete renewal application and reapply at least ninety (90) days prior to permit expiration may result in expiration before reissuance.

History

• Author: James L. Bryant, Ashley S. Powell, Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48.
• New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.05 Changes to Registrations and Permits

(1) Application for the modification or transfer of a Medical Waste Registration shall be submitted utilizing Form 410 to the Department at least thirty (30) days prior to the change.

(2) Transfer of a Treatment, Storage, or Transporter Permit. Permits are not transferable except as follows:

(a) A notification must be submitted to and approved by the Department prior to any proposed permit transfer from one person or company to another or the name change of any permitted facility subject to the fee in 335-1-6-.04(2).

(b) The notification must be submitted to the Department at least thirty (30) days prior to the proposed transfer or name change.

(c) Information regarding the transfer or name change must be submitted on form(s) designated by the Department.

(d) Treatment and Storage permits are attached to the property to which it pertains and may not be transferred from one location to another.

(3) Permit Modification. The Department may modify a permit after receiving a satisfactory request that is found in compliance with the Department rules and regulations. Permit modifications shall be requested in writing utilizing application forms designated by the Department when the permittee proposes to modify its operations in any of the ways listed in 335-17-8-.05.

(a) Major Modifications

1. The following are causes for major modification of a storage facility permit:

(i). Material and substantial alterations or additions to the permitted facility that occur after permit issuance.

2. The following are causes for major modification of a treatment permit:

(i) Material and substantial alterations or additions to the permitted facility that occur after permit issuance.

(ii) The change of treatment methods or the addition of treatment methods.

(iii) Change in the types of medical waste to be treated.

(b) Minor Modifications

1. The following are causes for minor modifications for permitted facilities:

(i) Correction of typographical errors and informational changes as requested by the permittee.

(ii) Changes to remove permit conditions to conform with Department guidance or regulations (i.e. permit conditions that are no longer applicable because the standards upon which they were based are no longer applicable to the facility).

(iii) Changes, by the permittee, to approved applicable plans as included in the permit application, that increase the frequency, duration, or stringency of the action covered by the applicable plan.

(iv) The office or place of business has moved.

(4) Procedures. The Permittee shall request a permit modification in accordance with the following procedures:

(a) Submit a request for modification to the Department at least thirty (30) days prior to the proposed change.

(b) Identify each part of the permit or plans to be modified.

(c) Submit revised plans and narratives as required by the Department.

Note: Major modifications as listed in 335-17-8-.05(3)a are subject to the provisions of 335-17-8-.08 for public notice and may require a public hearing under 335-17-8-.09.

History

• Author: James L. Bryant, Ashley S. Powell
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48.
• New Rule: Filed December 12, 2011; effective January 16, 2012. Amended: Published December 31, 2024; effective February 14, 2025. Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.06 Permit Denial, Suspension, or Revocation

(1) Conditions. The Department may deny, suspend or revoke any permit if:

(a) The permittee is found to be in violation of any of the permit conditions.

(b) The permittee fails to perform the permitted activity in accordance with 335-17.

(c) The permittee fails in the application or during the permit issuance process to disclose fully all relevant facts, or the permittee’s misrepresentation of relevant facts.

(d) A change in a condition that requires either a temporary or a permanent cessation of activities controlled by the permit.

(e) The permittee fails to submit a complete application to include additional information, or items requested by the Department.

(f) A determination that continued operation of the facility or activity endangers human health or the environment.

(g) The permittee fails to submit a complete renewal application at least ninety (90) days prior to permit expiration.

History

• Author: Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48.
• Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.07 Permit Fees

(1) No permit application as described in 335-17-8-.03 is complete without payment of the permit application fees specified in 335-1-6.

(2) An initial permit shall be submitted with the applicable fee specific for that permit, along with a Greenfield fee.

History

• Author: Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-27-9, 22-27-12, 22-27-48.
• Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.08 Public Notice

(1) Notice Requirements.

(a) The Department shall provide notice and an opportunity to comment and request a public hearing on any medical waste treatment or storage facility permit initial issuance, renewal, a modification listed in 335-17-8-.05(3)(a)to the facility permit, or if otherwise determined necessary to meet the requirements of this Division.

(b) The following procedures shall be observed:

1. The Department shall send a copy of the notice to persons on a mailing list developed by:

(i) Including those who request in writing to be on the list;

(ii) Notifying the public of the opportunity to be put on the mailing list through the Department’s website, periodic publication in the public press and in such publications as regional and state funded newsletters, environmental bulletins, or state law journals (the Director may update the mailing list from time to time by requesting written indication of continued interest from those listed and may delete from the list the name of any person who fails to respond to such a request).

2. The Department shall notify interested and potentially interested persons of the proposed permit action for a medical waste treatment or storage facility by posting a notice to the Department’s website. The draft permit action shall be posted on the website for the duration of the public comment period.

3. The notice shall be given not less than thirty-five (35) days prior to the proposed issuance of a permit action.

4. The notice shall contain the specific type and nature of the medical waste treatment or storage facility, the owner or operator requesting the permit action, and the description of the facility, address and telephone number of the Department, and how the public may submit comments and request a public hearing on the proposed permit action.

(2) Departmental Action. After the comment period closes, the Department shall review, consider and respond to all public comments received by the close of the comment period and take one of the following actions:

(a) Issue the permitting action if the application complies with this Division; or

(b) Deny the permitting action, stating in writing the reasons for denial and informing the person requesting the permitting action of appeal procedures described in 335-2-1;

(c) Require additional information or additional elements of design for the facility. If required, the applicant must specify procedures for inclusion into the permit of any additional information prior to issuance of the permit action.

History

• Author: Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-22A-5, 22-27-7.
• Amended: Published June 30, 2025; effective August 14, 2025.

Ala. Admin. Code r. 335-17-8-.09 Public Hearing

(1) Authorization. The Department shall authorize a public hearing at its discretion, or upon receipt of significant number of technical requests as provided in 335-17-8-.09(2).

(2) Procedures.

(a) Requests for public hearings shall be submitted in writing to the Department.

1. Frivolous or nontechnical requests shall be denied by the Department.

2. Requests for public hearings must be submitted within thirty-five (35) days after the publication of the public notice and must contain the following:

(i) The name, address and telephone number of the person requesting the hearing.

(ii) A brief statement of the person’s interest and the information the person wishes to submit.

(iii) The person’s signature, if an individual, or the signature of a responsible officer of an organization or legal entity.

(b) When a hearing has been authorized, the Department shall appoint a hearing officer to conduct the hearing and shall establish a time, date, and location for the hearing. The location for the hearing shall comply with the requirements of the Americans with Disabilities Act.

(c) The Department shall give notice of the public hearing in the manner set forth in 335-17-8-.08(1), and to the persons requesting the hearing in 335-17-8-.09(2). The notice shall be given not less than thirty-five (35) days prior to the time of the public hearing and shall include:

1. A summary of the proposed permitting action.

2. The place, time, and date of the hearing.

3. The name, address, and telephone number of an office at which interested persons may receive further information.

(3) Departmental Action. After the public hearing and close of the comment period, the Department shall review, consider, and respond to comments received by the close of the comment period and take one of the following actions:

(a) Issue the permitting action if the application complies with this Division; or

(b) Deny the permitting action, stating in writing the reasons for denial and inform the person requesting the permitting action of appeal procedures described in 335-2-1;

(c) Require additional information or additional elements of design for the facility. If required, the applicant must specify procedures for inclusion into the permit of any additional information prior to issuance of the permit action.

History

• Author: Clethes Stallworth
• Authority: Code of Ala. 1975, §§22-22A-5, 22-27-7.
• Amended: Published June 30, 2025; effective August 14, 2025.