Subchapter B. GENERAL PERMITS


GENERAL

Sec.


284.101.    Authorization for general permits.
284.102.    Nature of a general permit; substitution for individual applications and permits.

ISSUANCE OF A GENERAL PERMIT


284.111.    Application for general permit.
284.112.    Completeness review.
284.113.    Public notice and review period.
284.114.    Approval or denial of an application.
284.115.    Department-initiated general permits.

CONTENT OF GENERAL PERMITS AND WAIVERS


284.121.    Contents of general permits.
284.122.    Waiver or modification of certain requirements.

REGISTRATION AND DETERMINATION OF APPLICABILITY


284.131.    Authorization for persons or municipalities to be included in a general permit.
284.132.    Determination of applicability.
284.133.    Registration.

GENERAL


§ 284.101. Authorization for general permits.

 (a)  In accordance with this subchapter, the Department may issue general permits on a regional or Statewide basis for a category of mobile or stationary infectious waste processing facilities or stationary chemotherapeutic waste processing facilities if the Department determines the following:

   (1)  The processing facilities and the waste to be processed in the category are substantially similar.

   (2)  The processing facilities in the category can be adequately regulated utilizing standard conditions without harming or presenting a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.

   (3)  The processing facilities in the category will comply with the requirements established in the permit and with the standards and requirements for design, construction, operation, maintenance and monitoring in Chapter 283 (relating to resource recovery and other processing facilities) and Subchapter D (relating to processing facilities).

 (b)  The Department may issue a general permit upon its own motion under §  284.115 (relating to Department-initiated general permits) or upon an application from a person or municipality under § §  284.111—284.114.

 (c)  The Department may issue a general permit for the mixing of disinfection products with infectious waste to perform processing.

 (d)  The Department may issue a general permit for the processing of mixtures of the same types of waste that are infectious or residual wastes.

 (e)  The Department may modify, suspend, revoke or reissue general permits under this subchapter as it deems necessary to prevent harm or the threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.

 (f)  The Department will not issue a general permit for a commercial infectious or chemotherapeutic waste processing facility, including commercial incinerators.

Cross References

   This section cited in 25 Pa. Code §  284.114 (relating to approval or denial of an application); 25 Pa. Code §  284.115 (relating to Department-initiated general permits); and 25 Pa. Code §  284.121 (relating to contents of general permits).

§ 284.102. Nature of a general permit; substitution for individual applications and permits.

 (a)  When the Department issues a general permit for an infectious or chemotherapeutic waste processing facility on either a regional or Statewide basis, persons or municipalities who intend to process infectious or chemotherapeutic waste in accordance with the terms and conditions of the general permit may do so without filing an individual application for, and first obtaining, an individual permit.

 (b)  The use of an applicable general permit shall satisfy the requirement to obtain a permit in §  271.101 (relating to permit requirement) if the following are met:

   (1)  The processing activities are conducted in accordance with the terms and conditions of the applicable general permit.

   (2)  The person or municipality conducting the processing activities is authorized to operate under the general permit at the time that the Department issued the general permit or under the applicable general permit in accordance with §  284.132 or §  284.133 (relating to determination of applicability; and registration).

 (c)  Notwithstanding subsections (a) and (b), the Department may require a person or municipality authorized by a general permit to apply for, and obtain, an individual permit when the person or municipality is not in compliance with the conditions of the general permit or is conducting an activity that harms or presents a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.

Cross References

   This section cited in 25 Pa. Code §  284.114 (relating to approval or denial of an application).

ISSUANCE OF A GENERAL PERMIT


§ 284.111. Application for general permit.

 (a)  A person or municipality may apply to the Department for the issuance of a general permit for a specific category of processing of infectious or chemotherapeutic waste.

 (b)  An application for the issuance of a general permit for processing infectious or chemotherapeutic waste shall be submitted on a form prepared by the Department and shall contain the following:

   (1)  A description of the waste.

   (2)  A characterization of the waste as either infectious or chemotherapeutic.

   (3)  An operation plan which contains the following:

     (i)   A description of the proposed processing activity and equipment.

     (ii)   A description of the method proposed to receive infectious or chemotherapeutic waste which ensures the waste is handled separately from other solid waste until processing and disposal, and that prevents unauthorized persons from having access to or contact with the waste.

     (iii)   A description of the procedure for managing containers which arrive in a leaking condition, which includes whether the waste is processed immediately, repacked or rejected.

     (iv)   A description of the method proposed to unload and process infectious or chemotherapeutic waste, limiting the number of persons handling the waste and minimizing the possibility of exposure of that waste to employes and the public using or visiting the facility.

     (v)   A description of the method proposed for disinfecting emptied, reusable infectious waste containers, transport vehicles and facility equipment which are known or suspected to be contaminated with infectious waste.

     (vi)   A description of the method proposed for handling and disposal of infectious or chemotherapeutic waste containers which cannot be reused.

     (vii)   A description of reuse of containers if the surfaces of the containers have been protected from direct contact with chemotherapeutic waste.

     (viii)   A description of the means by which provisions will be made to require the use of clean gloves and clean uniforms along with other protective clothing to provide protection of employes against exposure to infectious or chemotherapeutic waste.

     (ix)   A description of the means by which provisions will be made to require decontamination of a person having had bodily contact with infectious or chemotherapeutic waste while handling that waste at the facility.

     (x)   A description of the method proposed to quantify, on a weight basis, the maximum amount of infectious or chemotherapeutic waste to be stored and processed each month.

     (xi)   A schedule of the operating hours of the facility.

     (xii)   A description of the method proposed to assure that infectious or chemotherapeutic waste received at the facility is consistent with §  283.201 (relating to basic limitations).

     (xiii)   A description of periodic testing using biological indicators which demonstrate effective disinfection of the waste, in accordance with §  284.321 (relating to infectious waste monitoring requirements).

     (xiv)   A description of closure activities which are proposed to be carried out upon cessation of operations, in accordance with §  283.272 (relating to cessation of operations).

     (xv)   A description of how the processing residue will be managed.

     (xvi)   A description of how aerosols will be minimized and controlled during processing activities.

   (4)  A contingency plan which provides procedures to be used for emergency situations including, at a minimum, spills of infectious or chemotherapeutic waste and ruptures of containers containing the waste. The plan shall include procedures for cleanup and disinfection of spill area, protection of personnel, disposal of spill residue and repackaging of the waste. The plan shall also include a description of an alternative waste handling system during periods when the proposed facility is not in operation, including procedures to be followed in the case of equipment breakdown. Alternate waste handling procedures may include use of standby equipment, extension of operating hours and contractual agreements for diversion of infectious or chemotherapeutic waste to other facilities.

   (5)  A personnel training plan which describes the hiring of equipment operators and the training of personnel involved in the handling and processing of infectious or chemotherapeutic waste. The plan shall include a detailed explanation of the operation and contingency plans.

 (c)  A nonrefundable fee in the form of a check payable to the “Commonwealth of Pennsylvania’’ for $1,000 shall accompany the application.

 (d)  The application requirements in subsection (b) may be waived or modified for the mixing of disinfection products with infectious waste to perform processing.

Cross References

   This section cited in 25 Pa. Code §  284.101 (relating to authorization for general permits); and 25 Pa. Code §  284.114 (relating to approval or denial of an application).

§ 284.112. Completeness review.

 (a)  After receipt of an application for the issuance of a general permit, or an application for a determination of applicability under §  284.132 (relating to determination of applicability), the Department will determine whether the application is administratively complete. For purposes of this subchapter, an application is administratively complete if it contains the necessary analyses, fees, documents and information, regardless of whether the analyses, fees, documents and information would be sufficient for the issuance of the permit or the determination of applicability.

 (b)  If the application is not administratively complete, the Department will return it to the applicant, within 60 days of receipt of the application. A written statement of the specific analyses, fees, documents or information that are required to make the application administratively complete will accompany an application which is returned.

 (c)  The Department will deny the application if the applicant fails to provide the analyses, fees, documents and information within 90 days of receipt of the notice in subsection (b).

Cross References

   This section cited in 25 Pa. Code §  284.101 (relating to authorization for general permits); and 25 Pa. Code §  284.114 (relating to approval or denial of an application).

§ 284.113. Public notice and review period.

 (a)  The Department will publish notice of receipt of an application for a general permit in the Pennsylvania Bulletin when the Department determines that the application is administratively complete.

 (b)  The notice shall include:

   (1)  A brief description of the waste and the category of processing of infectious or chemotherapeutic waste which is identified in the application as a candidate for a general permit.

   (2)  The Department’s address and telephone number at which interested persons or municipalities may obtain further information and review a copy of the application for the general permit.

   (3)  A brief description of the procedures for public comment on the general permit application.

   (4)  A statement that interested persons or municipalities may submit comments to the Department within 60 days of the publication of the notice, and may recommend conditions upon, revisions to, approval or disapproval of the general permit application.

 (c)  The Department may hold a public meeting or public hearing on the application for a general permit.

 (d)  Upon issuance of a general permit, the Department will place a notice in the Pennsylvania Bulletin of the availability of the general permit. If a county has made recommendations to the Department concerning conditions, revisions or disapproval of the permit during the 60-day comment period, and the Department has overriden the recommendations, the Department will publish its justification for overriding the recommendations in the Pennsylvania Bulletin.

 (e)  Each applicant for coverage under the general permit shall provide written notice to each municipality in which the applicant intends to operate under a general permit.

Cross References

   This section cited in 25 Pa. Code §  284.101 (relating to authorization for general permits); and 25 Pa. Code §  284.114 (relating to approval or denial of an application).

§ 284.114. Approval or denial of an application.

 The Department may not issue a general permit for a category of processing of infectious or chemotherapeutic waste unless the applicant has affirmatively demonstrated the following:

   (1)  The application for the general permit is accurate and complete.

   (2)  The applicant has complied with the requirements of § §  284.101, 284.102 and 284.111—284.113.

   (3)  The proposed processing activities will be conducted in a manner that will not harm or present a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth through exposure to constituents of the waste during the processing activities and afterwards.

Cross References

   This section cited in 25 Pa. Code §  284.101 (relating to authorization for general permits).

§ 284.115. Department-initiated general permits.

 (a)  The Department may issue or modify a general permit for a category of processing of infectious or chemotherapeutic waste upon its own motion in accordance with this section.

 (b)  At least 60 days prior to the issuance or modification of a general permit under this section, the Department will publish a notice in the Pennsylvania Bulletin of intent to issue or modify a general permit under this section.

 (c)  The notice required by subsection (b) shall include the following:

   (1)  A clear and specific description of the category of processing of infectious or chemotherapeutic waste eligible for coverage under the proposed general permit.

   (2)  The standards in §  284.101(a) (relating to authorization for general permits), and a brief description of the reasons for the Department’s determination that the category of processing is eligible for coverage under a general permit in accordance with these standards.

   (3)  A brief description of the terms and conditions of the proposed general permit.

   (4)  A brief description of the procedures for public comment on the general permit in accordance with this subchapter.

   (5)  The Departmental address and telephone number at which interested persons or municipalities may obtain further information and review a copy of the proposed general permit.

   (6)  A statement that interested persons or municipalities may submit comments to the Department within 60 days of the publication of the notice and may recommend conditions upon, revisions to, and approval or disapproval of the proposed general permit.

 (d)  The Department may hold a public meeting or public hearing on the proposed general permit or proposed modification to the general permit.

 (e)  Upon issuance or modification of a general permit, the Department will place a notice in the Pennsylvania Bulletin of the availability of the new or modified general permit.

Cross References

   This section cited in 25 Pa. Code §  284.101 (relating to authorization for general permits).

CONTENT OF GENERAL PERMITS AND WAIVERS


§ 284.121. Contents of general permits.

 Each general permit issued by the Department will include, at a minimum:

   (1)  A clear and specific description of the category of processing of infectious or chemotherapeutic waste eligible for coverage under the general permit.

   (2)  The standards in §  284.101(a) (relating to authorization for general permits) and a brief explanation of the reasons for the Department’s determination that the category of processing is eligible for coverage under the general permit in accordance with the standards in §  284.101(a).

   (3)  A specification of registration or determination of applicability requirements established in accordance with §  284.131 (relating to authorization for persons or municipalities to be included in a general permit) and the fee imposed on registrants or applicants for coverage under the general permit.

   (4)  An effective date, and a fixed permit term, which may not exceed 10 years from the effective date. If the Department renews a general permit, the term may not exceed the term of the original permit.

   (5)  A set of terms and conditions governing the construction, operation, maintenance, inspection and monitoring of the processing activities covered by the general permit as are necessary to assure compliance with this act, this article and the environmental protection acts.

   (6)  A requirement that persons or municipalities who conduct activities authorized by the general permit shall allow authorized representatives of the Commonwealth, without advance notice or a search warrant, upon the presentation of appropriate credentials, and without delay, to have access to areas in which the activities covered by the general permit will be, are being or have been conducted to ensure compliance with the act and the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. § §  6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations promulgated thereunder and a permit, license or order issued by the Department under the act.

   (7)  A requirement that the activities authorized by the general permit will not harm or present a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.

   (8)  A requirement that waste be accompanied by a properly completed manifest, in accordance with Subchapter H (relating to manifesting for infectious and chemotherapeutic waste), when appropriate.

   (9)  A requirement that waste be delivered by a licensed transporter in accordance with Subchapter G (relating to transporter licensing for infectious and chemotherapeutic waste), when appropriate.

   (10)  A requirement that the processing facility operate in accordance with local, State and Federal requirements.

   (11)  A requirement that the processing residue be disposed of in a landfill that has obtained written approval by the Department to dispose of the waste.

   (12)  A requirement that an up-to-date list of names, addresses and telephone numbers of employes that have been designated by the permittee to respond to emergencies at the processing facility be maintained at the facility.

   (13)  A requirement that individual employe training records be maintained at the processing facility.

   (14)  A requirement for use of additional indicators selected by the Department to monitor the disinfection process.

   (15)  A requirement that daily records of the weight or volume of the waste processed, the method and location of disposal facilities for wastes from the processing facility and waste handling problems and emergencies be maintained for 3 years.

   (16)  A requirement that a log be maintained for each disinfection unit for 3 years that records the following:

     (i)   The date, time and operator for each use.

     (ii)   The dates and results of calibration.

     (iii)   The results of biological indicator spore testing.

     (iv)   Other information that the Department may require relating to the disinfection process.

   (17)  Requirements for closure.

   (18)  A requirement that autoclaves meet the following:

     (i)   Processing of pathological waste is prohibited.

     (ii)   The retention time for processing bulk fluids (greater than 500 ml) allows for the complete vaporization of fluids.

§ 284.122. Waiver or modification of certain requirements.

 (a)  An operation that is approved under this subchapter does not require an individual processing or disposal permit under this article.

 (b)  For an operation that is approved under this subchapter, the Department may waive or modify any application and operating requirements in this article, except the Department may not waive §  271.123 and may not waive or modify Chapter 271, Subchapter A, § §  271.124, 271.125, 271.129 and Chapter 271, Subchapter E.

REGISTRATION AND DETERMINATION OF APPLICABILITY


§ 284.131. Authorization for persons or municipalities to be included in a general permit.

 (a)  A person or municipality is authorized to operate under a general permit if one of the following occurs:

   (1)  If the applicable general permit requires persons or municipalities to register with the Department prior to operating under the general permit, the person or municipality has registered in accordance with the terms of the general permit and the requirements of this subchapter.

   (2)  If the applicable general permit requires persons or municipalities to apply for and obtain a determination of applicability from the Department prior to operating under the general permit, and the Department has made this determination.

 (b)  Registration or application requirements and time limits, if any, shall be set forth in the general permit governing each category of processing infectious or chemotherapeutic waste. The general permit shall also set forth the area or region within which each category of processing is allowed.

 (c)  At a minimum, the registration or application for determination of applicability shall include:

   (1)  The name, address and location of the person or municipality conducting the activity covered under the general permit.

   (2)  A description of the waste, including a characterization of the waste as either infectious or chemotherapeutic, that will be processed in accordance with the general permit.

   (3)  A description of the proposed method of processing of the waste.

   (4)  The name or number of the general permit being utilized for the activity.

   (5)  A demonstration that the activities which the person or municipality intends to conduct are authorized by the general permit.

   (6)  A signed and notarized statement by the person or municipality conducting the activity authorized by the general permit, on a form prepared by the Department, which states that the person or municipality agrees to accept the conditions imposed by the general permit for processing of infectious or chemotherapeutic waste under the general permit.

 (d)  A person or municipality that registers for coverage under a general permit or applies to the Department for a determination of applicability of a general permit shall submit a copy of the registration or application to each municipality in which the processing activity will be located. The submission shall occur at the same time that the person or municipality files the registration or application with the Department.

Cross References

   This section cited in 25 Pa. Code §  284.121 (relating to contents of general permits); 25 Pa. Code §  284.132 (relating to determination of applicability); and 25 Pa. Code §  284.133 (relating to registration).

§ 284.132. Determination of applicability.

 If a general permit specifies that potential users of the permit shall obtain a determination of applicability from the Department prior to conducting the activity authorized by the general permit, the procedures in this section shall be followed in addition to those stated in §  284.131 (relating to authorization for persons or municipalities to be included in a general permit):

   (1)  An application for a determination of applicability shall be accompanied by a nonrefundable fee in the form of a check payable to the “Commonwealth of Pennsylvania’’ for $500.

   (2)  The Department will provide notice in the Pennsylvania Bulletin of each application for a determination of applicability for a general permit which the Department has determined to be administratively complete. The Department may indicate in the notice that interested persons or municipalities may submit comments to the Department within a 60-day period. If a comment period is provided, counties may recommend to the Department conditions, revisions or disapproval of the application. The Department may hold a public meeting or public hearing on an application for determination of applicability for a general permit.

   (3)  The Department will make a determination that a general permit is or is not applicable to an activity for which an application for determination of applicability is filed within 60 days from the publication of the notice under paragraph (2) or, if a comment period is provided, within 120 days after publication of the notice. The time period does not include periods beginning with the date the Department has requested in writing that the applicant make substantive corrections or changes to the application and ending with the date that the applicant submits corrections or changes to the Department’s satisfaction. Failure by the Department to comply with this timetable will not be construed or understood to constitute grounds for a determination that the general permit applies to the proposed activity.

   (4)  The Department will determine that the general permit does not apply to the proposed processing activity and deny coverage under the general permit if the applicant fails to demonstrate the following to the Department’s satisfaction:

     (i)   That the proposed activity is consistent with the terms and conditions of the general permit.

     (ii)   That the activity does not have the potential to harm or present a threat of harm to the health, safety or welfare of the people or the environment of this Commonwealth.

   (5)  The Department will publish notice of its decision regarding each determination of applicability in the Pennsylvania Bulletin. If a county has made recommendations to the Department concerning conditions, revisions or disapproval of the permit during a 60-day comment period, and the Department has overriden the recommendations, the Department will publish its justification for overriding the recommendations in the Pennsylvania Bulletin. The applicant for a determination of applicability for coverage under a general permit shall provide written notice to each municipality in which the applicant intends to operate pursuant to the general permit.

   (6)  The Department may amend, suspend or revoke coverage under a general permit if the waste or the activity is not consistent with the terms and conditions of the general permit.

Cross References

   This section cited in 25 Pa. Code §  284.102 (relating to nature of a general permit; substitution for individual applications and permits); and 25 Pa. Code §  284.112 (relating to completeness review).

§ 284.133. Registration.

 (a)  When a general permit specifies that potential users are required to register with the Department prior to operating under the general permit, the procedures in this section shall be followed in addition to those in §  284.131 (relating to authorization for persons or municipalities to be included in a general permit).

   (1)  A registration to operate under a general permit shall be accompanied by a nonrefundable fee in the form of a check payable to the “Commonwealth of Pennsylvania’’ for $250.

   (2)  The Department will publish notice of each registration to operate under a general permit in the Pennsylvania Bulletin. The registrant under a general permit shall provide written notice to each municipality in which the registrant intends to operate under the general permit.

 (b)  Persons or municipalities may conditionally operate under a general permit in accordance with the terms of the general permit immediately upon registering with the Department.

 (c)  Upon the request of the Department, a person or municipality shall provide sufficient information to demonstrate to the satisfaction of the Department that the person or municipality is authorized to operate under the general permit. The Department may refuse to issue or approve a registration if the person or municipality has failed to demonstrate that the person or municipality is in conformance with the general permit.

 (d)  The Department may amend, suspend or revoke registration under a general permit if the waste or the activity is not consistent with the terms and conditions of the general permit.

Cross References

   This section cited in 25 Pa. Code §  284.102 (relating to nature of a general permit; substitution for individual applications and permits).



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