PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[ 25 PA. CODE CHS. 271, 272, 273, 284,
285, 287, 288 AND 299 ]
Regulated Medical and Chemotherapeutic Waste
[43 Pa.B. 4858]
[Saturday, August 24, 2013]The Environmental Quality Board (Board) proposes to amend Chapters 271, 272, 273, 284, 285, 287, 288 and 299 to read as set forth in Annex A.
The proposed rulemaking would amend Chapter 271 (relating to municipal waste management—general provisions) to add and clarify terms and definitions in § 271.1 (relating to definitions). The proposed rulemaking would amend Chapter 284 (relating to regulated medical and chemotherapeutic waste) to provide permits-by-rule for certain processors of regulated medical waste using autoclave, incineration, steam or superheated water, and chemical treatment techniques; generators of regulated medical waste processing small quantities of waste; transfer facilities; and organizations that generate regulated medical waste at multiple locations. The proposed amendments to Chapter 284 would also simplify testing requirements for autoclaves, provide flexibility in both the storage and transportation of regulated medical waste and chemotherapeutic waste, update practices for manifesting, recordkeeping, signage and disinfectant requirements, and delete provisions that are under the jurisdiction of the United States Occupational Safety and Health Administration (OSHA) to eliminate any potential inconsistencies. The amendments to Chapter 284 would also provide language that incorporates by reference the United States Postal Service's program for shipping regulated medical waste through the United States Postal Service. The amendments proposed to Chapters 285 and 299 (relating to storage, collection and transportation of municipal waste; and storage and transportation of residual waste) would revise signage requirements for transportation vehicles to be consistent with the recommended changes to Chapter 284. Finally, the proposed amendments to Chapters 272, 273, 287 and 288 would replace all references to ''infectious'' waste to ''regulated medical'' waste to be consistent with the recommended changes to Chapters 271 and 284.
This proposed rulemaking was adopted by the Board at its meeting on April 16, 2013.
A. Effective Date
This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact Ali Tarquino Morris, Bureau of Waste Management, P. O. Box 69170, Rachel Carson State Office Building, Harrisburg, PA 17106-9170, (717) 783-2388; or Susan Seighman, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Information regarding submitting comments on this proposed rulemaking appears in Section J of this preamble. Persons with a disability may use the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposed rulemaking is available on the Department of Environmental Protection's (Department) web site at www.depweb.state.pa.us (select ''Public Participation'').
C. Statutory Authority
This proposed rulemaking is being made under the authority of the following statutes:
The Solid Waste Management Act (SWMA) (35 P. S. §§ 6018.101—6018.1003), which in section 105(a) (35 P. S. § 6018.105(a)) grants the Board the power and the duty to adopt the rules and regulations of the Department to accomplish the purposes and carry out the provisions of the SWMA. Sections 102(4) and 104(6) of the SWMA (35 P. S. §§ 6018.102(4) and 104(6)) provide the Department with the power and duty to regulate the storage, collection, transportation, processing, treatment and disposal of solid waste to protect the public health, safety and welfare.
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 Disposal Law (ICWDL), which in section 4(b) (35 P. S. § 6019.4(b)) grants the Board the power and duty to adopt the rules and regulations of the Department to accomplish the purposes and carry out the provisions of the ICWDL.
Section 1917-A of The Administrative Code of 1929 (71 P. S. § 510-17) authorizes and requires the Department to protect the people of this Commonwealth from unsanitary conditions and other nuisances, including any condition that is declared to be a nuisance by any law administered by the Department. Section 1920-A (71 P. S. § 510-20) of The Administrative Code of 1929 grants the Board the power and duty to formulate, adopt and promulgate rules and regulations as may be determined by the Board for the proper performance of the work of the Department.
D. Background and Purpose
The proposed rulemaking represents a comprehensive revision of the Commonwealth's existing infectious and chemotherapeutic waste regulations, which is necessary for several reasons.
Since solid waste is not always generated, processed and disposed of within this Commonwealth, the proposed revisions allow persons generating and managing infectious and chemotherapeutic waste to do so in a manner that complies with Commonwealth law and is consistent with Federal requirements and the requirements of other states. Other states and the Federal government identify infectious waste as ''regulated medical waste.'' This proposed rulemaking includes revisions that would identify ''infectious waste'' as ''regulated medical waste,'' making the terminology consistent with Federal and other states' requirements. This proposed change in terminology will simplify the labeling requirements on containers that are used to collect, transport, process and dispose of the waste. Persons managing regulated medical waste will no longer need to ensure that Pennsylvania containers and labels are used and kept separate from those employed in other states. This uniform practice should reduce the costs borne by generators and other persons managing regulated medical waste because the same containers and labels could be used to satisfy Commonwealth requirements, Federal requirements and the requirements imposed by other states.
This proposed rulemaking streamlines the transportation and shipment requirements for regulated medical waste in several respects. The proposed amendments allow generators, transporters and those involved in storage, processing and disposal of regulated medical waste to use standard business documentation, including electronic tracking systems, to demonstrate compliance with the regulations instead of prescriptive and outdated paper manifests. A manifest is a document that accompanies a waste shipment and ensures that the waste being shipped is processed or disposed of in the manner intended by the generator. The ICWDL requires that a person who generates, transports, stores, processes or disposes regulated medical waste use a manifest to track waste through the shipping process to the disposal facility. The proposed amendments allow for the manifest requirement to be satisfied with a shipping paper, log or electronic tracking system that provides the required information, allowing the generator to track its waste in accordance with current industry practices. The flexibility added to this process should prove to be more efficient for all persons managing this waste stream.
In addition, the proposed amendments authorize the transportation of regulated medical waste through the United States Postal Service under the United States Postal Service's program and requirements for shipping medical waste. The existing regulations specifically provide that sharps from small quantity generators may be sent through the mail. However, the proposed amendments broaden this authorization to include other types of regulated medical waste in any amount or volume provided that certain conditions are satisfied, including the mailing standards and other relevant regulations of the United States Postal Service. This should provide generators, especially those generating small quantities of medical waste, with an alternative transportation.
The proposed amendments also encourage labor and fuel efficiency by removing certain storage and transportation restrictions. The existing regulations limit storage of regulated medical waste at the generation site for a maximum of 30 days from the date that waste was first placed into the container. This provision governing the duration of storage requires small generators to transport partial loads offsite, thereby incurring additional costs. The proposed amendments allow for generators to store regulated medical waste for up to 30 days from the date that the container is full or the date the generator seals the container, whichever occurs earlier. These proposed revisions provide the generator with more control over the length of time the waste may be stored onsite and promote more efficient business practices by reducing the need to transport partial loads, which will result in a cost savings for the generator.
Additionally, the proposed revisions allow haulers to transport containerized regulated medical waste and chemotherapeutic waste along with other wastes in the same vehicle. This will reduce the number of trips needed to transport waste from generators that have both regulated medical waste and other waste streams which require disposal, provided that the transportation can be done in a manner that does not adversely affect public health and safety or the environment.
The proposed amendments also delete provisions that relate to areas governed by OSHA. This removes the possibility that provisions may be inconsistent or duplicative of OSHA requirements but in no way affects the applicability of OSHA requirements to persons within this Commonwealth.
E. Summary of Regulatory Requirements
The following outlines the regulatory requirements that have been affected by the proposed rulemaking and describes the basis for the amendments.
There has been one global change to the regulations. ''Regulated medical waste'' has been added as a new term and is defined in § 271.1 as ''infectious waste.'' Aside from the definition of ''infectious waste'' in § 271.1, all other references to ''infectious waste'' are proposed to be replaced with ''regulated medical waste'' throughout Chapters 271, 272, 273, 284, 285, 287, 288 and 299. There is no substantive change in the definitions other than minor amendments in the following discussion on § 271.1. This shift in terminology will result in the Commonwealth's labeling requirements being consistent with Federal and other states' requirements.
§ 271.1. Definitions
The Board is proposing to amend certain terms and add additional terms that assist in the identification of materials that are considered regulated medical or chemotherapeutic waste. The terms used to identify these classifications of waste include the following: ''autoclave,'' ''body fluids,'' ''commercial regulated medical or chemotherapeutic waste facility,'' ''disinfection,'' ''general composting facility,'' ''incineration,'' ''infectious waste,'' ''mobile regulated medical waste processing facility,'' ''regulated medical waste,'' ''regulated medical waste aggregation facility,'' ''sharps,'' ''special handling waste,'' ''thermal processing'' and ''unrecognizable regulated medical waste.'' Of these terms, ''autoclave,'' ''disinfection,'' ''general composting facility,'' ''special handling waste,'' ''thermal processing'' and ''unrecognizable regulated medical waste'' include a reference to ''infectious waste'' within their definitions. This reference is proposed to be replaced with ''regulated medical waste.''
The definition of ''body fluids'' is proposed to be amended to include saliva because saliva is a fluid that is capable of containing visible blood.
The definition of ''commercial regulated medical or chemotherapeutic waste facility'' is proposed to be amended to eliminate redundancies and is rewritten for clarity.
The definition of ''environmental protection acts'' is proposed to be amended by citing the relevant sections so that the formatting is consistent with the other citations.
The definition of ''incineration'' is proposed to be added and is defined as the ''act of reducing to ashes by combustion.'' ''Incineration'' has been added to the list of definitions to clarify its meaning throughout Chapter 271.
As indicated previously, the proposed definition of ''regulated medical waste'' is ''infectious waste,'' thereby incorporating the existing definition of ''infectious waste.'' The following changes are proposed to be made to the definition of ''infectious waste'':
• Pathological wastes do not include tissues that have been preserved in formaldehyde or any other approved preserving agents because preserved tissues do not exhibit the pathological characteristics of unpreserved tissues. Therefore, preserved tissues have been explicitly excluded from pathological wastes.
• Components of human blood and body fluid waste have been added. Soft plastic pipettes and plastic blood vials that have been used for blood transfusions will be considered human blood and body fluid waste. Also, tubing that is used to connect the intravenous bag to the patient has been added.
• Under the category for animal wastes, all animal waste known to have been exposed to zoonotic infectious agents or nonzoonotic human pathogens is defined as infectious waste in the proposed rulemaking. The requirement that exposure to these pathogens must have occurred during research for the animal wastes to fall subject to regulation has been removed.
• Used sharps are no longer limited to those generated at medical, research or industrial laboratories.
• Tissues and specimens that are being transported to or stored at a laboratory prior to laboratory testing will be excluded from infectious waste.
• Because regulated medical waste incineration is no longer covered under Chapter 283 (relating to resource recovery and other processing facilities), ash residue from the incineration of regulated medical waste will be regulated under § 284.321 (relating to regulated medical waste monitoring requirements). Therefore, the regulatory reference in subparagraph (iii)(F) is proposed to be corrected to § 284.321.
The term ''mobile infectious waste processing facility'' is proposed to be changed to ''mobile regulated medical waste processing facility.''
The proposed definition of ''regulated medical waste aggregation facility'' is defined as a ''facility that accepts, aggregates or stores regulated medical waste.''
The definition of ''sharps'' is proposed to be amended to clarify an existing ambiguity. Broken glass no longer has to have been in contact with pathogenic organisms to be considered sharps, as are syringes to which a needle is or can be attached. The phrase ''with or without the attached needle, suture needles'' is redundant and is proposed to be deleted. Razors are no longer required to be ''disposable'' to qualify as sharps.
§ 284.1. Scope
References to Chapters 283 and 285 are proposed to be added.
§ 284.2. Permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.
Proposed amendments to this section provide six permits-by-rule for qualifying processing facilities, which implement autoclaves, incinerators, steam and superheated water disinfection, onsite processing of blood and body fluids, short duration storage facilities and small quantity generators that process their own waste.
For autoclaves, incinerators and steam superheated water disinfection operators to qualify for a permit-by-rule under paragraphs (a)(1)—(3), the facility shall process at least 50% of its own regulated medical and chemotherapeutic waste and is limited to accepting not more than 50% of regulated medical waste for processing from small quantity generators. Facilities that process waste shall ensure that the processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste. The operator of the facility shall also provide the Department with the following: a notice of intention to operate under permit-by-rule; the name and address of the facility; a description of the processing activity; and the names and telephone numbers of the individuals responsible for operation of the processing facility.
More specifically, under subsection (a)(1) and (3), autoclave facilities and facilities with steam and superheated water disinfection may not process pathological or chemotherapeutic waste. However, these facilities may process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking. Existing regulations require the waste to be vaporized, but the proposed amendments state ''render the waste unrecognizable'' since, by definition, autoclaves do not vaporize all liquid. Under subsection (a)(2) a processing facility with an incinerator may process other municipal waste generated onsite if the resulting ash is managed as regulated medical or chemotherapeutic waste.
The permit-by-rule available under subsection (a)(4) is for onsite processing of liquid blood and body fluids using chemical treatment techniques that encapsulate or convert liquid blood or body fluids into solids or gels so that no free liquids remain. The proposed amendments provide the Department with the authority to approve the use of other disinfectant-based products under subsection (a)(4) if their effectiveness can be demonstrated. The processed regulated medical waste may be disposed at a municipal waste landfill provided that no free liquids remain in the processed waste, and the landfill has received written approval from the Department authorizing the disposal of this type of processed medical waste.
The permit-by-rule in subsection (a)(5) covers transfer facilities that temporarily store regulated medical or chemotherapeutic waste for up to 72 hours provided that the stored waste remains in its original packaging and is not putrescent.
The permit-by-rule in subsection (b) applies to generators that process and disinfect less than 220 pounds per month of regulated medical waste onsite, but do not render the waste unrecognizable. The generator shall dispose of the processed waste in a landfill or have the waste incinerated by a facility that has written approval from the Department to accept this type of waste. In addition, the generator shall comply with the manifest requirements in § 284.701(b)(5) (relating to scope).
Subsection (c) specifies the operating requirements for the permit-by-rule facilities identified in subsections (a)(1)—(4) and (b). Subsection (c)(1) incorporates the proposed citations that require the facility to comply with Chapter 284, Subchapters E and F (relating to segregation and storage; and collection and transportation) and Chapter 285.
For facilities operating under subsection (a), in addition to the current requirements, proposed amendments to subsection (c)(3)(i) require the written plan used to manage regulated medical waste generated at the facility to also contain the frequency of equipment calibration.
Under subsection (c)(8), for onsite autoclave facilities, ''treated or processed regulated medical waste'' is proposed to replace ''processing residue'' because ''treated or processed regulated medical waste'' more clearly describes waste that has not been rendered unrecognizable.
Subsection (c)(10) and (11) is proposed to be deleted because the compliance criteria have been included in the proposed subsection (a)(1)—(3).
§ 284.3. Regulated medical waste aggregation facilities
This proposed section establishes a permit-by-rule for regulated medical waste aggregation facilities. The regulated medical waste aggregation facilities must comply with the generator standards in Chapter 284, Subchapter E and only accept waste generated onsite or offsite by the operator of the aggregation facility, or waste generated in the same building or complex of buildings by physicians in their private practices or other medical personnel. The Department retains the ability to require an operator to obtain an individual permit, or take other appropriate action, if the generator is not in compliance or harms or presents a threat of harm to the health, safety or welfare of the people or the environment.
§ 284.102. Nature of a general permit; substitution for individual applications and permits
A reference to § 284.132 (relating to determination of applicability), which is proposed to be rescinded in this proposed rulemaking, is proposed to be deleted. A proposed clause clarifies that the Department can require a person or municipality authorized by a general permit to obtain an individual permit if a general permit is not available to conduct the specified activity.
§ 284.111. Application for general permit
A typographical error is proposed to be corrected (''employes'' to ''employees'').
§ 284.112. Completeness review
The Department previously required that potential users of certain general permits obtain a determination of applicability from the Department prior to conducting the activity authorized by the general permit. The Department has since determined that a registration process for the issuance of general permits will be used, as opposed to a determination of applicability. Therefore, the language regarding the determination of applicability is proposed to be deleted from subsection (a).
§ 284.115. Department-initiated general permits
''Departmental'' is proposed to be replaced with ''Department'' in subsection (c)(5) for clarity.
§ 284.116. General permit renewal
Proposed § 284.116 provides a procedure for renewing general permits. The section is based on the existing practices of the Department and is proposed to be added for clarity.
§ 284.121. Contents of general permits
The Department believes that a registration process will increase efficiency in the processing of general permits for both the applicant and the Department. The Department proposes to eliminate determinations of applicability from the process of general permit issuance. Therefore, language regarding determination of applicability is proposed to be deleted in paragraph (3).
The requirement in paragraph (11) that processing residue be disposed of in a landfill is proposed to be deleted and replaced with a requirement for processing residue to be managed in accordance with the SWMA to avoid potential conflicts.
In addition, a typographical error has been corrected in paragraphs (12) and (13) (''employes'' to ''employees'' or ''employee'').
In paragraph (18), the prohibition of processing pathological waste or chemotherapeutic waste in an autoclave has been rewritten for clarity.
§ 284.122. Modification of certain requirements
The term ''waiver'' is proposed to be deleted from the section heading. The Department retains the ability to waive certain requirements when those requirements are inappropriate or otherwise not applicable to the applicant's proposed operation under a general permit. However, in this situation, the Department would modify the applicant's permit conditions to account for requirements that may not apply to the applicant's operation.
Provisions that limit the Department's flexibility to provide applicants with an effective permit are proposed to be deleted from subsection (b). These mandatory provisions relate to the Department's legal right to enter the permitted area, the identification of interested parties, compliance information, verification of the application, and the administration of civil penalties and enforcement actions. Removal of these mandatory provisions will allow the Department to use its discretion in issuing and modifying permits to provide the applicant with a permit that makes sense within the context of the applicant's proposed operation, while complying with the regulations that are in the best interest of the Commonwealth.
§ 284.131. Authorization for persons or municipalities to be included in a general permit
The Department is using a registration process, instead of a determination of applicability, to authorize an applicant's operation under a general permit. Therefore, language regarding determinations of applicability is proposed to be deleted from this section.
§ 284.132. Determination of applicability
The Department has determined that a registration process will be used for the issuance of general permits, instead of a determination of applicability. Therefore, this section is no longer necessary and is proposed to be rescinded.
§ 284.210. Application requirements
A typographical error is proposed to be corrected in this section. The reference to ''§§ 279.101—279.111 (relating to general requirements)'' is proposed to be changed to ''§§ 279.101—279.111.''
§ 284.220. Operating requirements
The proposed amendment to this section references the subchapters in Chapter 279 (relating to transfer facilities) that are applicable to operating requirements for transfer facilities.
§ 284.320. Operating requirements
The proposed amendment to this section references the subchapter in Chapter 283 that is related to operating requirements for processing facilities.
§ 284.321. Regulated medical waste monitoring requirements
Throughout this section, abbreviations of spore names have been spelled out for clarity and the nomenclature of ''Bacillus stearothermophilus'' has been updated to ''Geobacillus stearothermophilus'' to reflect its taxonomy in a new genus.
The current regulations require that microbiological analysis of a composite sample of the processing or ash residue be submitted to the Department quarterly. In the proposed amendment to subsection (b), the requirement to submit these microbiological analyses is reduced to annual submissions to be consistent with the schedule for submission of chemical analyses in subsection (c).
Subsection (f), regarding disinfection, is proposed to be amended to require that sterility indicators, analyzed to verify the effectiveness in the disinfection process, shall be placed within the load where disinfection is most difficult to achieve.
Subsection (m) is proposed to be amended to state that an autoclave facility shall comply with all applicable requirements and is prohibited from processing pathological waste or chemotherapeutic waste.
Autoclave testing requirements are proposed to be added to subsection (n) to ensure that disinfection occurs under the proper operating conditions, with reference to § 284.322 (relating to autoclave validation testing requirements).
§ 284.322. Autoclave validation testing requirements
This proposed section defines the proper protocols and testing conditions that processors shall use to test their autoclaves. The requirements of the section ensure that proper performance criteria have been met and adequate disinfection is achieved. Generally, each autoclave shall be tested individually to establish its operating parameters prior to its first use and regularly thereafter. If a facility uses multiple autoclaves that are identical, an initial validation test may be performed on one of the autoclaves and the results used to establish the operating parameters of all identical autoclaves at the facility.
Chapter 284, Subchapter E. Segregation and storage
Subchapter E is proposed to be reorganized to mirror the steps taken by generators and processors when managing waste, starting with the segregation of waste through its storage. Since segregation by waste type is the first step taken by the generator in managing regulated medical and chemotherapeutic waste, the Department proposes to relocate the section regarding segregation so that it is the first section in Subchapter E following a description of the subchapter's scope. The order of management continues by next addressing basic storage requirements, followed by storage containers, marking of containers, duration of storage, reuse of containers, storage of ash residue and storage of processing residue. The following table summarizes the reorganization of sections in Subchapter E:
Subject of Section Current Regulation Proposed Regulation Segregation § 284.412 § 284.411 Basic storage requirements § 284.411 § 284.412 Storage containers § 284.415 § 284.413 Marking of containers § 284.416 § 284.414 Duration of storage of waste for generators § 284.413 § 284.415 Duration of storage of waste for processors § 284.414 § 284.416 Reuse of containers § 284.417 § 284.417 Storage of ash residue § 284.418 § 284.418 Storage of processing residue § 284.419 § 284.419
§ 284.401. Scope
The description of the references to §§ 285.111—285.115 and 285.121 is proposed to be deleted.
§ 284.411. Segregation
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors. The proposed heading of § 284.411 is ''segregation.''
In addition, the section is proposed to be amended to state that regulated medical and chemotherapeutic waste be separated into the following three categories at the point of origin in the generating facility: (1) regulated medical waste, excluding pathological waste; (2) pathological waste; and (3) chemotherapeutic waste. Sharps that qualify as regulated medical waste may be placed in a chemotherapeutic waste sharps container under the proposed regulations. This section also contains requirements for bags used to store waste, which is discussed in § 284.413 (relating to storage containers).
§ 284.412. Basic storage requirements
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors. Basic storage is the next logical step considered by generators and processors after the waste has been segregated.
Subsection (a) is proposed to be amended to ensure segregation occurs first, and the temperature for refrigeration has been added in degrees Fahrenheit in paragraph (a)(4) for clarification.
§ 284.413. Storage containers
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors.
Subsection (f), regarding protective clothing for persons packaging regulated medical or chemotherapeutic waste, is proposed to be deleted to eliminate any possible conflicts with OSHA regulations or other workplace safety procedures.
§ 284.414. Marking of containers
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors. Throughout § 284.414, ''infectious waste'' is proposed to be replaced with ''regulated medical waste'' with regard to marking containers, and the labeling requirements have been revised so that compliance is more convenient, while maintaining the intention of the regulations.
The proposed amendments provide a 1-year transition period after the effective date of the adoption of the final-form rulemaking for persons to comply with the new labeling requirements.
Also, containers will no longer be labeled with the date the waste was generated; instead, labels must include the date the container was full or the date the generator sealed the container. The exception to this rule is that roll-off containers need not be marked with the date, but a record of the date on which the roll-off was full or sealed must be maintained at the generating facility for at least 1 year.
In the proposed regulation, labeling requirements only apply when waste is transported offsite. For onsite transportation of waste within the same geographical property or facility, such as within a hospital campus, it is no longer necessary for generator and transporter information to be labeled on the containers.
Prescriptive size requirements for container labels have been replaced with performance-based requirements that ensure labeling is clearly legible.
§ 284.415. Duration of storage of regulated medical waste for generators
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors.
Throughout this section, language referring to ''the date that waste was first placed in a container'' is proposed to be changed to ''to the date that the container was full or sealed'' to be consistent with other sections of the proposed rulemaking. Therefore, under this section, generators are required to mark the container with the date on which the container was full or the date that the container was sealed, as required under § 284.414 (relating to marking of containers), and generators may store regulated medical waste onsite for up to 30 days from the date the container was full or sealed. Language relative to freezing as a method to lengthen the duration of storage is proposed to be deleted from § 284.413 because the time periods for storage were difficult to interpret. Temperature standards for storage are proposed to be added to § 284.412 (relating to basic storage requirements). The requirement that putrescent waste be moved offsite within 24 hours has been changed to within 3 business days. The Department believes that the proposed amendments are more easily understood and provide generators sufficient storage times under typical operations while maintaining the intent of the regulations.
§ 284.416. Duration of storage of regulated medical waste for processors
Subchapter E is proposed to be reorganized as shown in the previous table to follow the path of waste as it is handled by generators and processors. Storage temperatures in this section are slightly amended to correct errors in the existing text.
§ 284.417. Reuse of containers
This section currently provides separate subsections addressing the reuse of nonfiberboard containers housing regulated medical waste versus chemotherapeutic waste. The proposed amendments to this section allow the same standards to apply for the reuse of nonfiberboard containers regardless of whether the container houses chemotherapeutic waste or regulated medical waste. Therefore, subsection (d), regarding the reuse of containers housing chemotherapeutic waste, is proposed to be deleted and proposed amendments to subsection (c) add chemotherapeutic waste.
§ 284.418. Storage and containment of ash residue from regulated medical or chemotherapeutic waste incineration
Subsection (a)(2) is proposed to be clarified to indicate that ash residue must be stored on a pad to contain a spill or release of ash and facilitate clean-up.
§ 284.511. Transportation of ash residue from regulated medical or chemotherapeutic waste incineration
Subsection (c) has been rewritten to more clearly state that ash from separate generators must be kept separate. Subsection (d) has been rewritten to more clearly state that municipal waste may be commingled with ash residue from regulated medical or chemotherapeutic waste incineration for transportation, provided that both come from the same generator.
§ 284.512. Transportation of regulated medical and chemotherapeutic waste; general provisions
In subsection (b)(4), a Fahrenheit equivalent is proposed to be added to clarify the temperature required to maintain waste in a nonputrescent state.
The prescriptive strength and weight limits for a corrugated fiberboard container in subsection (c)(1)(iv) is proposed to be deleted. Proposed subsection (c)(1)(v) references § 284.414, regarding marking of containers to ensure that the containers are marked properly for transportation.
Subsection (d) is proposed to be deleted because infectious waste, now labeled as regulated medical waste, and chemotherapeutic waste are required to be segregated into separate containers at the point of generation. Since these wastes are containerized and not commingled, the Department proposes to allow these containerized waste streams to be transported in the same vehicle and has removed the existing prohibition.
Proposed subsection (e) clarifies that, although regulated medical or chemotherapeutic waste may be transported in the same vehicle as municipal waste, it may not be commingled with municipal waste or transported in the same vehicle with residual waste.
In subsection (g), the transport time for regulated medical waste in an unrefrigerated vehicle is proposed to be increased from 48 to 72 hours provided the waste is not putrescent. This allows transporters to more easily comply with the regulations, provided the waste is not putrescent.
§ 284.513. Transportation of regulated medical and chemotherapeutic waste; additional provisions
The reference to OSHA regulations in subsection (b)(2) is proposed to be corrected to accurately cite the applicable OSHA regulation regarding bloodborne pathogens and the standards for biohazard signage.
Subsection (c) is proposed to be amended to state that portable disinfectants must be EPA approved.
Subsection (e) is proposed to be deleted to remove potential conflicts with OSHA regulations or workplace safety procedures.
§ 284.514. Transportation of processing residue from a regulated medical or chemotherapeutic waste facility
Subsection (b) is proposed to be rewritten to more clearly state the requirement that processing residue from chemotherapeutic or regulated medical waste from separate generators shall be transported separately.
§ 284.602. License requirement
A grammatical error, ''onside'' instead of ''onsite,'' is proposed to be corrected and a minor clarification is proposed to subsection (b)(3).
§ 284.623. Conditions of licenses
A grammatical error, ''employes'' instead of ''employees,'' is proposed to be corrected.
§ 284.641. Bond requirement
A heading is proposed to be added for subsection (f).
§ 284.701. Scope
In the proposed amendments, logs or shipping papers, including electronic tracking systems, are recognized acceptable ways of tracking waste for manifesting purposes. Proposed amendments to subsection (b)(4) incorporate by reference the United States Postal Service's program for shipping regulated medical waste. Additional minor clarifications have been made throughout the section.
§ 284.702. Transfer facilities
This section is proposed to be renumbered for clarity. Language in current subsection (a) regarding the existing paper manifest tracking system is proposed to be deleted because shipping papers or logs, including electronic tracking systems, have become acceptable standard business practices for tracking the transportation and delivery of regulated medical and chemotherapeutic wastes. Subsection (b) is proposed to be renumbered as paragraph (2) and rewritten for clarity. Proposed paragraph (1) requires the transfer facility to be permitted by the Department.
§ 284.703. Recordkeeping
The record retention requirement in current subsection (a) is proposed to be reduced from 5 years to 2 years. Proposed amendments to this section clarify that the record is to be retained for 2 years from the date the record was prepared, and records shall be submitted to the Department upon request. Subsection (b) regarding manifests is obsolete and proposed to be deleted.
§ 284.711. Use of manifest
Language regarding manifests is proposed to be deleted because logs or shipping papers, including electronically based tracking systems, are acceptable standard business practices and are acceptable for compliance with the proposed amendments.
§ 284.712. Preparation of manifest
Generators will be required to create a log or shipping paper, which will qualify as a manifest, allowing the use of standard shipping procedures to track regulated medical waste during shipment through to its disposal.
Subsection (a)(10) is proposed to be deleted because, in accordance with proposed § 284.722(f) (relating to preparation and use of manifest), the generator will receive the shipping log back from the transporter after the waste has been delivered to the designated facility. Therefore, the designated facility no longer needs to be included in the original shipping log prepared by the generator.
§ 284.713. Generator's distribution of copies
This section is proposed to be rescinded because the record or shipping log is not required to be distributed to the various parties as previously required.
§ 284.714. Exception reporting
In proposed amendments to subsection (a), a log or shipping paper is to be received by the generator rather than a copy of a manifest since logs or shipping papers will satisfy the manifesting requirement under the proposed regulations and the ICWDL. The time limit for the paperwork to be completed and transmitted to the proper entity is proposed to be extended from 20 days to 30 days based on the amount of time needed for industry practices.
Subsection (b) is proposed to be reworded for clarity.
§ 284.721. Basic requirements
This section is proposed to be rescinded because the provisions to satisfy the manifest requirements are proposed to be amended.
§ 284.722. Preparation and use of manifest
The provisions regarding manifest copies are proposed to be deleted because logs or shipping papers, including electronic tracking systems, qualify as a manifest under the proposed amendments. The transporter shall ensure that processing facilities and generators have been provided with the relevant logs or shipping papers that are required.
§ 284.723. Waste delivery
This section is proposed to be rescinded because the provisions to satisfy the manifest requirements have been amended.
§ 284.724. Transportation limitations
Regulatory citations are proposed to be changed to maintain accuracy with the proposed reorganization of Chapter 284, Subchapter E. Information regarding copies of the manifests is proposed to be deleted since this requirement will be satisfied by logs or shipping papers.
§ 284.731. Scope
Section 284.733 (relating to distribution of copies) is proposed to be rescinded. Therefore, the reference to § 284.733 is proposed to be deleted from this section. Language regarding ''owners'' of waste processing facilities is proposed to be deleted since the owner of the facility may or may not be involved with the daily operations of the facility.
§ 284.732. Use of manifest
Language regarding ''owners'' of waste processing facilities is proposed to be deleted since the owner of the facility may or may not be involved with the daily operations of the facility. A log or shipping paper has been substituted for manifests to simplify documentation procedures.
§ 284.733. Distribution of copies
This section is proposed to be rescinded because the provisions to satisfy the manifest requirements are proposed to be amended.
§ 284.734. Significant discrepancies
In subsection (a)(2), a significant discrepancy is proposed to be defined as more than 1% variation in piece count for batch waste and more than 5% weight discrepancy for bulk waste. The time limits in subsection (b) are proposed to be changed from days to business days, allowing more flexibility for a resolution to be reached in the case of a dispute.
§ 285.218. Signs on vehicles
''Infectious or chemotherapeutic waste'' has been replaced with ''regulated medical or chemotherapeutic waste'' throughout the proposed rulemaking. Therefore, required signage on transportation vehicles must also change. Signs on vehicles transporting regulated medical or chemotherapeutic waste must read ''Regulated Medical/Chemotherapeutic Waste'' under the proposed amendment.
F. Benefits, Costs and Compliance
Benefits
The proposed rulemaking simplifies the labeling requirements to reduce costs and ensure consistency with the requirements of other states and the Federal government. The proposed amendments would allow generators, transporters and those involved in storage and processing to use standard business documentation to demonstrate compliance with the regulations instead of the currently prescribed, outdated paper manifest. The proposed amendments also encourage labor and fuel efficiency by allowing haulers to transport regulated medical waste along with other wastes in the same vehicle and by allowing facilities more time to completely fill a vehicle before the vehicle must be placed into service. To avoid conflicts with OSHA requirements, duplicative requirements are proposed to be deleted. The proposed amendments also provide another convenient shipping option by removing barriers to shipping waste through the mail when authorized by the United States Postal Service.
Compliance Costs
The proposed rulemaking provides a cost savings to the regulated community through: providing consistency with the United States Department of Transportation and other states; reduced transportation cost for generators and transporters due to consolidation of waste in trucks; longer storage times for generators, meaning fewer waste pickups; and reducing transportation costs for collection and processing.
Compliance Assistance Plan
The Department will assist the regulated community by developing fact sheets and continuing to work with industry during program implementation. The Department's field staff will provide compliance assistance during routine facility permitting activities and inspections.
Paperwork Requirements
The proposed rulemaking should result in a reduction of paperwork requirements through the revised provisions for satisfying manifest requirements; the change in terminology from ''infectious'' to ''regulated medical'' waste ensures Pennsylvania signage and labeling requirements align with the requirements of the United States Department of Transportation and the requirements of other states; and the creation of permits-by-rule for qualifying facilities will eliminate the need to issue general or individual permits to those facilities.
G. Pollution Prevention
The Pollution Prevention Act of 1990 (42 U.S.C.A. §§ 13101—13109) establishes a National policy that promotes pollution prevention as the preferred means for achieving state environmental protection goals. The Department encourages pollution prevention, which is the reduction or elimination of pollution at its source, through the substitution of environmentally friendly materials, more efficient use of raw materials or the incorporation of energy efficiency strategies. Pollution prevention practices can provide greater environmental protection with greater efficiency because they can result in significant cost savings to facilities that permanently achieve or move beyond compliance.
This proposed rulemaking will continue to ensure that the citizens and the environment of this Commonwealth experience the advantages of a regulated medical waste regulatory program that is protective of public health and the environment. The proposed rulemaking encourages consolidation of waste for transportation, reducing the number of trips needed to transport waste and thereby reducing air emissions from transportation vehicles.
H. Sunset Review
These regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
I. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 5, 2013, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
J. Public Comments
Written comments. Interested persons are invited to submit comments, suggestions or objections regarding the proposed rulemaking to the Environmental Quality Board, P. O. Box 8477, Harrisburg, PA 17105-8477 (express mail: Rachel Carson State Office Building, 16th Floor, 400 Market Street, Harrisburg, PA 17101-2301). Comments submitted by facsimile will not be accepted. Comments, suggestions or objections must be received by the Board by September 23, 2013. Interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must also be received by September 23, 2013. The one-page summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which the final regulation will be considered.
Electronic comments. Comments may be submitted electronically to the Board at RegComments@pa.gov and must also be received by the Board by September 23, 2013. A subject heading of the proposed rulemaking and a return name and address must be included in each transmission. If an acknowledgement of electronic comments is not received by the sender within 2 working days, the comments should be retransmitted to the Board to ensure receipt.
E. CHRISTOPHER ABRUZZO,
Acting ChairpersonFiscal Note: 7-480. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE VIII. MUNICIPAL WASTE
CHAPTER 271. MUNICIPAL WASTE MANAGEMENT—GENERAL PROVISIONS
Subchapter A. GENERAL § 271.1. Definitions.
The following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
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Autoclave—A pressure vessel in which [infectious] regulated medical waste is disinfected using high temperature steam, directly or indirectly, to maintain specified temperatures for retention times consistent with the waste being processed.
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Body fluids—Liquids emanating or derived from humans and limited to the following: blood; cerebrospinal, synovial, pleural, peritoneal and pericardial fluids; semen and vaginal secretions; and amniotic fluid. The term also includes the following fluids if they contain visible blood: feces, sputum, saliva, urine and vomitus.
* * * * *
Commercial [infectious] regulated medical or chemotherapeutic waste facility—A facility that processes [infectious] regulated medical or chemotherapeutic waste [not generated primarily onsite. The term includes facilities where one of the following exist] under either of the following conditions:
(i) [Of the waste processed, less than 50% on a monthly average was generated onsite.
(ii) Greater than 50% of the waste processed on a monthly average is not generated from entities that are wholly-owned by the owner of the waste processing facility.]
The facility does not generate any of the regulated medical or chemotherapeutic waste that it processes.
(ii) If the facility generates the regulated medical or chemotherapeutic waste that it processes, the amount of waste on a monthly average that is generated onsite and offsite by wholly-owned generators of the facility is less than 50% of the waste that it processes.
* * * * *
Disinfection—The treatment or processing of [infectious] regulated medical waste so that it poses no risk of infection or other health risk to individuals handling or otherwise coming into contact with the waste. The term includes autoclaving; dry heat, gas or chemical disinfection; radiation and irradiation; and incineration.
* * * * *
Environmental protection acts—The act, The Clean Streams Law (35 P. S. §§ 691.1—691.1001), the Municipal Waste Planning, Recycling and Waste Reduction Act [(53 P. S. §§ 4001.101—4001.1904)] (53 P. S. §§ 4000.101—4000.1904), the Hazardous Sites Cleanup Act (35 P. S. §§ 6020.101—6020.1305), the Low-Level Radioactive Waste Disposal Act [(35 P. S. §§ 7130.101—7130.906)] (35 P. S. §§ 7130.101—7130.905), 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 Disposal Law, the Air Pollution Control Act (35 P. S. §§ 4001—4015), the Surface Mining Conservation and Reclamation Act [(52 P. S. §§ 1396.1—1396.31)] (52 P. S. §§ 1396.1—1396.19b), the Noncoal Surface Mining Conservation and Reclamation Act [(35 P. S. §§ 3301—3326)] (52 P. S. §§ 3301—3326), the Dam Safety and Encroachments Act (32 P. S. §§ 693.1—693.27), and other State or Federal statutes relating to environmental protection or the protection of public health, including statutes adopted or amended after April 9, 1988.
* * * * *
General composting facility—A composting facility other than an individual backyard composting facility or yard waste composting facility operating under § 271.103(h) (relating to permit-by-rule for municipal waste processing facilities other than for [infectious] regulated medical or chemotherapeutic waste; qualifying facilities; general requirements).
* * * * *
Household hazardous waste—
(i) Waste generated by a household that could be chemically or physically classified as a hazardous waste under the standards of Article VII (relating to hazardous waste management).
(ii) For the purpose of this definition, the term ''household'' includes those places described as ''households'' in 40 CFR 261.4(b)(1) (relating to exclusions).
Incineration—The act of reducing to ashes by combustion.
Incinerator—An enclosed device using controlled combustion for the primary purpose of thermally breaking down solid waste, and which is equipped with a flue as defined in § 121.1 (relating to definitions).
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Infectious waste—
(i) General. Municipal and residual waste which is generated in the diagnosis, treatment, immunization or autopsy of human beings or animals, in research pertaining thereto, in the preparation of human or animal remains for interment or cremation, or in the production or testing of biologicals, and which falls under one or more of the following categories:
* * * * *
(B) Pathological wastes. Human pathological wastes, including tissues, organs and body parts and body fluids that are removed during surgery, autopsy, other medical procedures or laboratory procedures. The term does not include hair, nails or extracted teeth or tissues that have been preserved with formaldehyde or other approved preserving agents.
(C) Human blood and body fluid waste.
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(V) Intravenous bags that have been used for blood transfusions, including soft plastic pipettes and plastic blood vials.
* * * * *
(D) Animal wastes. Contaminated animal carcasses, body parts, blood, blood products, secretions, excretions and bedding of animals that were known to have been exposed to zoonotic infectious agents or nonzoonotic human pathogens [during research (including research in veterinary schools and hospitals)], production of biologicals or testing of pharmaceuticals.
* * * * *
(F) Used sharps. Sharps that have been in contact with infectious agents or that have been used in animal or human patient care or treatment [, at medical, research or industrial laboratories].
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(iii) Exceptions. The term does not include the following:
* * * * *
(D) Samples of [infectious] regulated medical waste transported offsite by Commonwealth or United States government enforcement personnel during an enforcement proceeding.
(E) Body fluids, tissues, specimens or biologicals [which] that are being transported to or stored at a laboratory prior to laboratory testing.
(F) Ash residue from the incineration of materials identified in subparagraphs (i) and (ii) if the incineration was conducted in accordance with § [283.402] 284.321 (relating to [infectious] regulated medical waste monitoring requirements). The ash residue shall be managed as special handling municipal waste.
* * * * *
(H) Soiled diapers [which] that do not contain materials identified in subparagraph (i).
(I) Mixtures of hazardous waste subject to Article VII (relating to hazardous waste management) and materials identified in subparagraph (i) shall be managed as hazardous waste and not [infectious] regulated medical waste.
(J) Mixtures of materials identified in subparagraph (i) and regulated radioactive waste shall be managed as radioactive waste in accordance with applicable Commonwealth and Federal statutes and regulations, including[, but not limited to,] § 236.521 (relating to minimum requirements for classes of waste).
* * * * *
Mobile [infectious] regulated medical waste processing facility—[An infectious] A regulated medical waste processing unit [which] that is moved from one waste generation site to another for the purpose of onsite processing of a generator's [infectious] regulated medical waste. The term refers to any processing activity designed to disinfect [infectious] waste in accordance with § 284.321 [(relating to infectious medical waste monitoring requirements)] to render the waste noninfectious. The term does not include any permanently placed waste processing units.
* * * * *
Regional groundwater table—The fluctuating upper water level surface of an unconfined or confined aquifer, where the hydrostatic pressure is equal to the ambient atmospheric pressure. The term does not include the perched water table or the seasonal high water table.
Regulated medical waste—Infectious waste.
Regulated medical waste aggregation facility—A facility that accepts, aggregates or stores regulated medical waste.
Related party—A person or municipality engaged in solid waste management that has a financial relationship to a permit applicant or operator. The term includes a partner, associate, officer, parent corporation, subsidiary corporation, contractor, subcontractor, agent or principal shareholder of another person or municipality, or a person or municipality that owns land on which another person or municipality operates a municipal waste processing or disposal facility.
* * * * *
Sharps—Broken glass [that has been in contact with pathogenic organisms], hypodermic needles [and], syringes to which a needle is or can be attached, [with or without the attached needle, suture needles, disposable] razors, pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, culture dishes, suture needles, slides, cover slips and other broken or unbroken glass or plasticware.
* * * * *
Special handling waste—Solid waste that requires the application of special storage, collection, transportation, processing or disposal techniques due to the quantity of material generated or its unique physical, chemical or biological characteristics. The term includes dredged material, sewage sludge, [infectious waste] regulated medical waste, chemotherapeutic waste, ash residue from a solid waste incineration facility, [asbestos containing waste, PCB containing waste] asbestos-containing waste, PCB-containing waste and waste oil that is not hazardous waste.
* * * * *
Thermal processing—A method, technique or process, excluding incineration and autoclaving, designed to disinfect [infectious] regulated medical waste by means of exposure to high thermal temperatures through methods such as ionizing radiation or electric or plasma arc technologies.
* * * * *
Unrecognizable [infectious] regulated medical waste—All components of the waste have been processed to produce indistinguishable and unusable pieces smaller than 3/4 of an inch, except that all sharps must besmaller than 1/2 inch. The term does not mean compaction or encapsulation except through:
* * * * *
§ 271.2. Scope.
* * * * *
(b) Management of the following types of residual waste is subject to this article instead of Article IX (relating to residual waste management), and shall be regulated as if the waste is municipal waste, regardless of whether the waste is a municipal waste or residual waste.
* * * * *
(2) [Infectious] Regulated medical and chemotherapeutic waste.
Subchapter B. GENERAL REQUIREMENTS FOR PERMITS AND PERMIT APPLICATIONS
REQUIREMENT § 271.101. Permit requirement.
* * * * *
(b) A person or municipality is not required to obtain a permit:
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[(4) For temporary storage, which facilitates the transportation or transfer of infectious or chemotherapeutic waste, that does not exceed 24 hours. The stored waste shall remain in its original packaging, as received for storage.]
(5) For the use of waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material if the waste is not hazardous. A person managing waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material, shall implement best management practices. The Department will prepare a manual for the management of waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material which identifies best management practices and may approve additional best management practices on a case-by-case basis. If a person fails to implement best management practices for managing waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material, the Department may require compliance with the disposal, composting, processing and storage operating requirements of this chapter and Chapters 281, 283 and 285 (relating to composting facilities; resource recovery and other processing [facility] facilities; and storage, collection and transportation of municipal waste).
* * * * *
§ 271.103. Permit-by-rule for municipal waste processing facilities other than for [infectious] regulated medical or chemotherapeutic waste; qualifying facilities; general requirements.
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EXISTING FACILITIES § 271.114. Transition period.
A person or municipality possessing a permit for a municipal waste disposal or processing facility which was issued by the Department prior to December 23, 2000, shall file with the Department an application for permit modification to bring the facility operation into compliance with the following requirements for radioactive material monitoring and detection that became effective on December 23, 2000, according to the following schedule, unless the Department imposes in writing an earlier date in a specific situation for reasons of public health, safety or environmental protection:
* * * * *
(5) Resource recovery and other processing facilities. Including [infectious] regulated medical and chemotherapeutic waste processing facilities, an application for a permit modification addressing the requirements of §§ 283.103(20) and 283.113 (relating to maps and related information; and radiation protection action plan) shall be filed by September 23, 2001.
Subchapter E. CIVIL PENALTIES AND ENFORCEMENT
ENFORCEMENT § 271.421. Administrative inspections.
* * * * *
(c) The Department, its [employes] employees and agents intend to conduct inspections under the act of:
* * * * *
(2) Municipal waste processing facilities other than resource recovery facilities, which process or incinerate [infectious] regulated medical or chemotherapeutic waste, at least 2 times per year.
(3) Municipal waste processing facilities other than resource recovery facilities, which do not process or incinerate [infectious] regulated medical or chemotherapeutic waste, at least once per year.
(4) Hospitals where [infectious] regulated medical or chemotherapeutic waste is generated, at least 2 times per year.
(5) Locations other than hospitals where [infectious] regulated medical or chemotherapeutic waste is generated, at least once per year.
* * * * *
(7) Facilities and beneficial use areas subject to permit-by-rule under § 271.103 (relating to permit-by-rule for municipal waste processing facilities other than for [infectious] regulated medical or chemotherapeutic waste; qualifying facilities; general requirements), a general permit for beneficial use or processing, or both, under Subchapter I (relating to beneficial use), or a permit for the land application of sewage sludge under Subchapter J (relating to beneficial use of sewage sludge by land application), at least once per year.
* * * * *
Subchapter G. RESIDUAL WASTE
GENERAL PROVISIONS § 271.601. Scope.
* * * * *
(c) The Department may require analyses under this subchapter for special handling waste other than sewage sludge, [infectious] regulated medical waste, chemotherapeutic waste and ash residue from a resource recovery facility.
ADDITIONAL APPLICATION REQUIREMENTS § 271.611. Chemical analysis of waste.
* * * * *
(f) Waiver. The Department may, in writing, waive the requirements of this section for special handling waste, waive or modify the requirements of this section for general permits issued under Subchapter I and waive or modify the chemical analysis requirements under § 271.103 (relating to permit-by-rule for municipal waste processing facilities other than for [infectious] regulated medical or chemotherapeutic waste; qualifying facilities; general requirements).
Subchapter I. BENEFICIAL USE
SCOPE § 271.801. Scope.
(a) This subchapter sets forth requirements for general permits for the processing and beneficial use of municipal waste, except as follows:
(1) This subchapter does not set forth requirements for general permits for the processing or beneficial use of [infectious] regulated medical or chemotherapeutic waste.
* * * * *
GENERAL PERMIT FOR PROCESSING OR BENEFICIAL USE, OR BOTH, OF MUNICIPAL WASTE; AUTHORIZATION AND LIMITATIONS § 271.811. Authorization for general permit.
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(g) The Department will not issue a general permit under this subchapter for the following:
* * * * *
(3) The processing or beneficial use of [infectious] regulated medical or chemotherapeutic waste.
* * * * *
CHAPTER 272. MUNICIPAL WASTE PLANNING, RECYCLING AND WASTE REDUCTION
Subchapter C. MUNICIPAL WASTE PLANNING
PLAN CONTENT § 272.223. Description of waste.
* * * * *
(b) In describing the content of waste, the plan shall specifically address sewage sludge (including septage), [infectious] regulated medical and chemotherapeutic waste, ash from resource recovery facilities, construction/demolition waste other than waste from demolition of an industrial site and other municipal waste.
(c) In describing the origin of waste, the plan shall provide:
* * * * *
(3) An inventory of hospitals in the county, and a representative sampling of different medical specialists, such as clinics, doctors, dentists, funeral directors and veterinarians, for [infectious] regulated medical and chemotherapeutic waste.
* * * * *
Subchapter F. HOUSEHOLD HAZARDOUS WASTE COLLECTION, TRANSPORTATION AND MANAGEMENT
OPERATION OF PROGRAMS § 272.532. Limitations on acceptable waste.
(a) The following wastes may not be accepted at a collection event:
* * * * *
(2) [Infectious waste] Regulated medical, except sharps.
* * * * *
CHAPTER 273. MUNICIPAL WASTE LANDFILLS
Subchapter D. ADDITIONAL APPLICATION REQUIREMENTS FOR SPECIAL HANDLING AND RESIDUAL WASTES
SPECIFIC WASTES § 273.411. Processed [infectious] regulated medical or chemotherapeutic waste disposal.
(a) An application for the disposal of processed [infectious] regulated medical or chemotherapeutic waste shall contain necessary plans and specifications showing how the applicant will comply with § 273.511 or § 273.512 (relating to processed [infectious] regulated medical waste disposal; and chemotherapeutic waste) or both, whichever is applicable.
* * * * *
Subchapter E. ADDITIONAL OPERATING REQUIREMENTS FOR SPECIAL HANDLING AND RESIDUAL WASTES
SPECIFIC WASTES § 273.511. Processed [infectious] regulated medical waste disposal.
(a) [Infectious] Regulated medical waste may not be disposed of at a municipal waste landfill unless:
(1) The waste has been disinfected in accordance with § 284.321 (relating to [infectious] regulated medical waste monitoring requirements).
(2) Prior to initial disposal the landfill operator has obtained the necessary approval for disposal from the Department based on the application provided under § 273.411 (relating to processed [infectious] regulated medical and chemotherapeutic waste disposal).
* * * * *
CHAPTER 284. [INFECTIOUS] REGULATED MEDICAL AND CHEMOTHERAPEUTIC WASTE
Subchapter A. GENERAL PROVISIONS
GENERAL PROVISIONS § 284.1. Scope.
This chapter sets forth application and operating requirements for a person or municipality that operates [an infectious] a regulated medical or chemotherapeutic waste facility. The requirements in this chapter are in addition to the applicable requirements in [Chapter 271] Chapters 271, 283 and 285 (relating to municipal waste management—general provisions; resource recovery and other processing facilities; and storage, collection and transportation of municipal waste).
§ 284.2. [Permit-by-rule for infectious] Permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements.
[(a) If the requirements of this section are met, the following onsite processing facilities for infectious and chemotherapeutic waste shall be deemed to have a municipal waste processing permit under this article:
(1) An onsite autoclave facility, including one which renders waste unrecognizable, which processes at least 50% of its own infectious waste generated onsite and accepts offsite waste for disinfection only from small quantity generators that generate less than 220 pounds per month of infectious waste if the following conditions are met:
(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.
(2) An onsite incineration facility that burns at least 50% of its own infectious or chemotherapeutic waste generated onsite and accepts offsite infectious or chemotherapeutic waste for incineration only from small quantity generators that generate less than 220 pounds per month of infectious or chemotherapeutic waste. This onsite incineration facility may process municipal waste generated onsite as long as the resulting ash is managed as processed infectious and chemotherapeutic waste.
(3) An onsite steam and superheated water disinfection facility which processes infectious waste, including one which renders waste unrecognizable, which processes at least 50% of its own infectious waste generated onsite and accepts offsite waste for disinfection only from small quantity generators that generate less than 220 pounds per month of infectious waste. Processing of pathological waste is prohibited.]
(a) The following processing facilities for regulated medical and chemotherapeutic waste will be deemed to have a municipal waste processing permit under this article if the following requirements in this subsection and subsection (c) are met:
(1) A processing facility with an autoclave if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.
(ii) The facility does not process pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.
(iv) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(v) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(2) A processing facility with an incinerator if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical or chemotherapeutic waste. The facility may not accept more than 50% of regulated medical or chemotherapeutic waste for disinfection from small quantity generators that generate less than 220 pound per month.
(ii) The facility may process other municipal waste generated onsite if the resulting ash is managed as processed regulated medical or chemotherapeutic waste.
(iii) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(iv) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(3) A processing facility with steam and superheated water disinfection if the following requirements are met:
(i) The facility processes at least 50% of its own regulated medical waste. The facility may not accept more than 50% of regulated medical waste for disinfection from small quantity generators that generate less than 220 pounds per month.
(ii) The facility does not process pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process regulated medical waste to render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.
(iv) The processed waste is disposed of or processed in a landfill or incinerator authorized to accept the waste.
(v) The operator of the facility provides notice to the Department that includes the following:
(A) An intention to operate under permit-by-rule.
(B) The name and address of the facility.
(C) A description of the processing activity.
(D) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(4) Onsite processing of liquid blood and body fluids using a glutaraldehyde-based or hypochlorite-based product that encapsulates or converts liquid blood or body fluids into solids or gels so that no free liquids remain. The Department may approve the use of other disinfectant-based products under these provisions if their efficacy can be demonstrated. The processed infectious waste may be disposed of at a municipal waste landfill provided:
(i) No free liquids remain in the processed waste.
(ii) The landfill has received written approval from the Department authorizing disposal of the processed medical waste.
(5) Transfer facilities that temporarily store regulated medical or chemotherapeutic waste for less than 72 hours provided the stored waste remains in its original packaging and it is not putrescent.
(b) Generators that process and disinfect less than 220 pounds per month of [infectious] regulated medical waste onsite and render the waste unrecognizable will be deemed to have a municipal waste processing [permits] permit under this article if the requirements under [subsections (c)—(g)] subsection (c) are met. Generators that process and disinfect less than 220 pounds per month of [infectious] regulated medical waste onsite without rendering the waste unrecognizable will be deemed to have a municipal waste processing [permits] permit under this article if the [requirements under subsections (c)—(g)] following requirements under this subsection and subsection (c) are met [and if the following requirements are met]:
(1) The generator [may] shall dispose of the processed waste in a landfill or have the waste incinerated in a facility that has [obtained] written approval from the Department to accept [the] this type of waste.
* * * * *
(c) The following requirements shall be met by facilities identified in subsections [(a)] (a)(1)—(4) and (b) to operate under a permit-by-rule:
(1) The facility complies with [Chapter 285 and Subchapters E and F (relating to storage, collection and transportation of municipal waste; storage; collection and transportation)] Subchapters E and F (relating to segregation and storage; and collection and transportation) and Chapter 285 (relating to storage, collection and transportation of municipal waste).
* * * * *
(3) The operator maintains at the facility in a readily accessible place the following information:
(i) For a processing facility identified in subsection (a), a written plan for managing [infectious] regulated medical waste generated at the facility, including waste handling, equipment operation and maintenance, processing method, disinfection monitoring procedures including quality assurance procedures, frequency of calibration and a description of how noninfectious waste is managed to prevent commingling.
* * * * *
(5) The waste is disinfected in accordance with § 284.321 (relating to [infectious] regulated medical waste monitoring requirements).
* * * * *
(8) Remaining waste is managed in accordance with the act and the regulations promulgated thereunder. For onsite autoclave facilities [which] that do not render the waste unrecognizable, the [processing residue] treated or processed regulated medical waste shall be manifested in accordance with Subchapter H (relating to manifesting for [infectious] regulated medical and chemotherapeutic waste).
(9) For incineration facilities, an air quality permit shall be obtained as required under the Air Pollution Control Act (35 P. S. §§ 4001—4015).
[(10) For facilities identified in subsection (a), notice is provided to the Department by the operator of a facility which indicates an intention to operate under permit-by-rule and which includes the following information:
(i) The name and address of the facility.
(ii) A description of the processing activity.
(iii) The names and telephone numbers of the individuals responsible for operation of the processing facility.
(11) For facilities identified in subsection (a), the processed waste is disposed of in a landfill or processed in an incinerator that has obtained written approval from the Department to dispose or process the waste.]
(d) Chapter 271, Subchapter E (relating to civil penalties and enforcement) is applicable to facilities subject to permit-by-rule.
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(f) [Generators who qualify for a permit-by-rule may render the waste unrecognizable by processes such as thermal treatment, melting, encapsulation, shredding, grinding, tearing or breaking.
(g)] The requirements under Chapter 271, Subchapter D (relating to financial assurances requirements) [which] that relate to bonding and insurance are waived for facilities [which] that are deemed to have a permit under this section.
(Editor's Note: The following section is new and printed in regular type to enhance readability.)
§ 284.3. Regulated medical waste aggregation facilities.
(a) Applicability. This section applies to operators of regulated medical waste aggregation facilities.
(b) Permit-by-rule for regulated medical waste aggregation facilities. The operator of an aggregation facility may operate under a permit-by-rule. For the operation of a regulated medical waste aggregation facility to be authorized by a permit-by-rule, the owner or operator shall:
(1) Comply with the generator standards in Subchapter E (relating to segregation and storage).
(2) Only accept the following regulated medical waste generated:
(i) Onsite or offsite by the operator of the aggregation facility.
(ii) By physicians in their independent practices or other medical personnel within the same building or complex of buildings.
(c) Noncompliance. The Department may require the operator of an aggregation facility operated under permit-by-rule to apply for and obtain a permit, or take other appropriate action, when the generator is not in compliance with the requirements for the permit-by-rule 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.
Subchapter B. GENERAL PERMITS
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] regulated medical waste processing facilities or stationary chemotherapeutic waste processing facilities if the Department determines the following:
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(c) The Department may issue a general permit for the mixing of disinfection products with [infectious] regulated medical 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] regulated medical or residual wastes.
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(f) The Department will not issue a general permit for a commercial [infectious] regulated medical or chemotherapeutic waste processing facility, including commercial incinerators.
§ 284.102. Nature of a general permit; substitution for individual applications and permits.
(a) When the Department issues a general permit for [an infectious] a regulated medical or chemotherapeutic waste processing facility on either a regional or Statewide basis, persons or municipalities who intend to process [infectious] regulated medical 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:
* * * * *
(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 if a general permit is not available to conduct an activity, when the person or municipality is not in compliance with the conditions of [the] a 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.
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] regulated medical or chemotherapeutic waste.
(b) An application for the issuance of a general permit for processing [infectious] regulated medical or chemotherapeutic waste shall be submitted on a form prepared by the Department and shall contain the following:
* * * * *
(2) A characterization of the waste as either [infectious] regulated medical or chemotherapeutic.
(3) An operation plan which contains the following:
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(ii) A description of the method proposed to receive [infectious] regulated medical 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.
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(iv) A description of the method proposed to unload and process [infectious] regulated medical or chemotherapeutic waste, limiting the number of persons handling the waste and minimizing the possibility of exposure of that waste to [employes] employees and the public using or visiting the facility.
(v) A description of the method proposed for disinfecting emptied, reusable [infectious] regulated medical waste containers, transport vehicles and facility equipment which are known or suspected to be contaminated with [infectious] regulated medical waste.
(vi) A description of the method proposed for handling and disposal of [infectious] regulated medical or chemotherapeutic waste containers which cannot be reused.
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(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] employees 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] regulated medical 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] regulated medical or chemotherapeutic waste to be stored and processed each month.
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(xiii) A description of periodic testing using biological indicators which demonstrate effective disinfection of the waste, in accordance with § 284.321 (relating to [infectious] regulated medical waste monitoring requirements).
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(4) A contingency plan which provides procedures to be used for emergency situations including, at a minimum, spills of [infectious] regulated medical 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] regulated medical 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] regulated medical or chemotherapeutic waste. The plan shall include a detailed explanation of the operation and contingency plans.
* * * * *
(d) The application requirements in subsection (b) may be waived or modified for the mixing of disinfection products with [infectious] regulated medical waste to perform processing.
§ 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].
* * * * *
§ 284.113. Public notice and review period.
* * * * *
(b) The notice shall include:
(1) A brief description of the waste and the category of processing of [infectious] regulated medical or chemotherapeutic waste which is identified in the application as a candidate for a general permit.
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§ 284.114. Approval or denial of an application.
The Department may not issue a general permit for a category of processing of [infectious] regulated medical or chemotherapeutic waste unless the applicant has affirmatively demonstrated the following:
* * * * *
§ 284.115. Department-initiated general permits.
(a) The Department may issue or modify a general permit for a category of processing of [infectious] regulated medical or chemotherapeutic waste upon its own motion in accordance with 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] regulated medical or chemotherapeutic waste eligible for coverage under the proposed general permit.
* * * * *
(5) The [Departmental] Department address and telephone number at which interested persons or municipalities may obtain further information and review a copy of the proposed general permit.
* * * * *
(Editor's Note: The following section is new and printed in regular type to enhance readability.)
§ 284.116. General permit renewal.
(a) A person or municipality that plans to process regulated medical or chemotherapeutic waste after the expiration of the term in the general permit shall file notice to the Department of intent to continue operating under the permit at least 180 days before the expiration date of the permit. The notice must include updated registration information on forms provided by the Department, a check payable to the ''Commonwealth of Pennsylvania'' for $250 and any suggested changes to the terms or conditions of the permit.
(b) A permit renewal may include all persons or municipalities that have applied for renewal within the time period provided in subsection (a). A person or municipality that does not meet the time period in subsection (a) shall be required to register under a renewed general permit.
(c) At least 120 days prior to the permit expiration, the Department will provide public notice of the permit renewal along with an update of the terms or conditions in accordance with the public notice requirements of § 284.115 (relating to Department-initiated general permits.)
(d) General permits will be renewed for a maximum term of 10 years.
(e) If the Department is unable to reissue the general permit prior to its expiration date, the Department may extend the term of a general permit for a period not to exceed 1 year for any permittee that is operating in compliance with the terms and conditions of the general permit and the environmental statutes and regulations of the Commonwealth.
CONTENT OF GENERAL PERMITS AND [WAIVERS] MODIFICATIONS § 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] regulated medical or chemotherapeutic waste eligible for coverage under the general permit.
* * * * *
(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.
* * * * *
(8) A requirement that waste be accompanied by a properly completed manifest, in accordance with Subchapter H (relating to manifesting for [infectious] regulated medical 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] regulated medical and chemotherapeutic waste), when appropriate.
* * * * *
(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] managed in accordance with the Solid Waste Management Act (35 P. S. §§ 6018.101—6018.1003) and the regulations promulgated thereunder.
(12) A requirement that an up-to-date list of names, addresses and telephone numbers of [employes] employees 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] employee training records be maintained at the processing facility.
* * * * *
(18) [A requirement that autoclaves meet the following:] A prohibition against processing pathological waste or chemotherapeutic waste in an autoclave.
[(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] Modification of certain requirements.
* * * * *
(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] regulated medical 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] must include:
* * * * *
(2) A description of the waste, including a characterization of the waste as either [infectious] regulated medical or chemotherapeutic, that will be processed in accordance with 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] regulated medical 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.
§ 284.132. [Determination of applicability] (Reserved).
[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.]
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