RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[ 25 PA. CODE CHS. 271, 272, 273, 284, 285, 287, 288 AND 299 ]
Regulated Medical and Chemotherapeutic Waste
[44 Pa.B. 7021]
[Saturday, November 8, 2014]The Environmental Quality Board (Board) amends Chapters 271, 272, 273, 284, 285, 287, 288 and 299 to read as set forth in Annex A.
The final-form rulemaking amends Chapter 271 (relating to municipal waste management—general provisions) to add and clarify terms and definitions in § 271.1 (relating to definitions). The final-form rulemaking amends 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 that are processing small quantities of waste; transfer facilities; and organizations that generate regulated medical waste at multiple locations. The amendments to Chapter 284: 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 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 to Chapters 285 and 299 (relating to storage, collection and transportation of municipal waste; and storage and transportation of residual waste) revise signage requirements for transportation vehicles to be consistent with amendments to Chapter 284. Finally, the amendments to Chapters 272, 273, 287 and 288 replace all references to ''infectious'' waste with ''regulated medical'' waste to be consistent with amendments to Chapters 271 and 284.
This final-form rulemaking was adopted by the Board at its meeting on July 15, 2014.
A. Effective Date
This final-form rulemaking will be effective upon 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 Despot, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Persons with a disability may use the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final-form rulemaking is available on the Department of Environmental Protection's (Department) web site at www.dep.state.pa.us (select ''Public Participation'').
C. Statutory Authority
This final-form 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 of The Administrative Code of 1929 (71 P. S. § 510-20) 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 Summary
The final-form rulemaking represents a comprehensive revision of the Commonwealth's existing infectious and chemotherapeutic waste regulations, which is necessary for several reasons.
The Federal government identifies infectious waste as ''regulated medical waste.'' This final-form rulemaking includes revisions that identify ''infectious waste'' as ''regulated medical waste,'' making the terminology consistent with Federal requirements. This change in terminology simplifies the labeling requirements on containers that are used to collect, transport, process and dispose of the waste for persons managing regulated medical waste across multiple jurisdictions. This uniform practice reduces the costs borne by generators and other persons managing regulated medical waste because the same containers and labels can be used to satisfy Federal and Commonwealth requirements.
This final-form rulemaking streamlines the transportation and shipment requirements for regulated medical and chemotherapeutic waste in several respects. The amendments allow generators, transporters and those involved in storage, processing and disposal of regulated medical and chemotherapeutic 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 of regulated medical or chemotherapeutic waste use a manifest to track waste through the shipping process to the disposal facility. The 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 is more efficient for all persons managing this waste stream.
In addition, the amendments authorize the transportation of regulated medical waste 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 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 provides generators, especially those generating small quantities of medical waste, with an alternative method for transporting and disposing of medical waste.
The 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. The amendments allow for generators to store regulated medical and chemotherapeutic 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 revisions promote more efficient business practices by eliminating the requirement to transport lightly or partially filled containers every 30 days. These final-form regulations allow generators to completely fill containers and only ship when necessary, which results in a cost savings for the generators.
The amendments allow haulers to transport containerized regulated medical waste and chemotherapeutic waste along with other containerized wastes in the same vehicle. This reduces 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 amendments 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.
Finally, in response to public comments, the Department made several revisions to accommodate the unique activities conducted at facilities engaged in the research and development or production of vaccines and other biologics, hereinafter referred to as ''biologics facilities.'' Biologics facilities generate large quantities of cultures, containers and other wastes that have come into contact with vaccine components, such as live attenuated preparations of viruses, inactivated whole or subunit virions, purified recombinant proteins or synthetic antigens. The former infectious and chemotherapeutic waste regulations defined these materials as ''infectious waste'' because the materials have come in contact with ''infectious agents,'' which is defined as ''an organism, such as a virus or bacteria, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.''
The Department recognizes that improvements in practices and technologies employed in biologics facilities have increased the safety of vaccine viruses so that many vaccine agents that were once infectious have been attenuated to the point that they are no longer capable of being communicated by replication or invasion in healthy humans. The Department also recognizes that the wastes generated by biologics facilities are unlike the wastes generated at hospitals, clinics and patient care facilities, and biologics facilities are subject to additional standards imposed by Federal governmental agencies that ensure a high level of protection for public health and safety. The United States Environmental Protection Agency in the Medical Waste Tracking Act of 1988 has excluded from regulation as regulated medical waste those materials that do not pose an appreciable risk of causing disease, including materials classified as Biosafety Level (BSL) 1, citing the Centers for Disease Control's (CDC) Biosafety in Microbial and Biomedical Laboratories (BMBL), as guidance in this determination. The CDC defines BSL-1 as ''the basic level of protection and is appropriate for agents that are not known to cause disease in normal, healthy humans.'' Therefore, the Board amended the definitions of ''infectious agents'' and ''infectious waste'' in § 271.1 to exclude agents classified as BSL-1 by a biologics facility and wastes, mixtures of wastes and cell lines from biologics facilities where no agent in the waste is classified as BSLs 2—4 as determined by the CDC's BMBL. In addition, plasticware generated by biologics facilities that has not been in contact with agents classified as BSLs 2—4 as determined by the CDC's BMBL has been excluded from the category ''used sharps'' in the definition of ''infectious waste.''
E. Summary of Changes to the Proposed Rulemaking
The following outlines the regulatory requirements that have been amended in the final-form rulemaking and describes the basis for the amendments.
The term ''sharps'' has been deleted and its provisions incorporated into the definition of ''used sharps'' under the definition of ''Infectious waste.'' All references to ''sharps'' have been replaced with ''used sharps'' throughout Chapters 271, 272, 273, 284, 285, 287, 288 and 299.
§ 271.1. Definitions
The definition of ''infectious agent'' has been amended to exclude agents classified as BSL-1 by a biologics facility as determined by the protocols in the CDC's BMBL.
In the final-form rulemaking, the definition of ''regulated medical waste'' is ''infectious waste'' and thereby incorporates the existing definition of ''infectious waste.'' The following changes have been made to the definition of ''infectious waste'' in the final-form rulemaking:
• The category of ''cultures and stocks'' has been reformatted for clarity and amended to add the term ''cell lines.'' Clarification on residues in emptied containers has also been added. In the final-form rulemaking, a determination is made on whether a container is empty by applying the criteria in 40 CFR 261.7(b)(1) or (2) (relating to residues of hazardous waste in empty containers).
• The proposed exclusion of certain preserved tissues from the category of ''pathological wastes'' was deleted in the final-form rulemaking.
• In the category of ''animal wastes,'' the proposed deletion of ''during research'' was reinstated in the final-form rulemaking.
• The definitions of ''sharps'' and ''used sharps'' were combined in the final-form rulemaking. Used sharps are no longer limited to those generated at medical, research or industrial laboratories. The term now excludes broken or unbroken plasticware generated at biologics facilities where no agent in the waste is classified as BSLs 2—4 as determined by the protocols established in the most recent edition of the CDC's BMBL.
• Subparagraph (iii)(L) has been added to the exceptions provided under the definition of ''infectious waste'' and applies to wastes, mixtures of wastes and cell lines from biologics facilities that produce or conduct research and development of vaccines or other biologics, provided no agent in the waste is classified as BSLs 2—4 in accordance with the most recent edition of CDC's BMBL.
The term ''regulated medical waste aggregation facility'' has been renamed ''regulated medical and chemotherapeutic waste aggregation facility,'' and the definition of the term has been amended to include facilities that accept, aggregate or store chemotherapeutic waste.
The definition of ''sharps'' has been incorporated into the category of ''used sharps'' under the definition of ''infectious waste.''
The reference to ''sharps'' in the definition of ''unrecognizable regulated medical waste'' has been changed to ''used sharps'' in the final-form rulemaking.
§ 271.101. Permit requirement
Subsection (b)(5) is amended in this final-form rulemaking to change ''facility'' to ''facilities.''
§ 271.114. Transition period
The former regulation established a time frame for waste disposal facilities authorized to operate under a permit that was issued by the Department prior to December 23, 2000, to comply with radioactive material monitoring and detection requirements which became effective on December 23, 2000. These facilities were required to modify their permits in accordance with this section by December 23, 2002. All the dates provided for compliance with this section have passed. Therefore, the section is no longer necessary and has been rescinded.
§ 272.532. Limitations on acceptable waste
Subsection (a)(2) is amended in this final-form rulemaking to specify that regulated medical waste, hypodermic needles and syringes may not be accepted at a household hazardous waste collection event.
§ 273.511. Processed regulated medical waste disposal
A typographical error is corrected in subsection (a).
Subsection (d) is reworded for clarity and unused hypodermic needles or syringes are added.
§ 284.2. Permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements
In subsection (a)(4), ''infectious waste'' and ''medical waste'' have been replaced with ''liquid blood and body fluids'' for clarity. Subsection (a)(4)(iii) has been added to clarify that chemotherapeutic waste may not be processed under this subsection.
In subsection (a)(5), a requirement to maintain regulated medical and chemotherapeutic waste in a manner that does not attract vectors was added for consistency with other changes made uniformly throughout the final-form rulemaking.
In subsection (b)(2), the term ''manifest'' has been changed to ''log and shipping paper'' to mirror the changes made to § 284.701(b)(5) (relating to scope).
Subsection (c)(8) was amended in the final-form rulemaking to delete ''manifested'' and ''manifesting'' to reflect the changes made to the heading of Chapter 284, Subchapter H (relating to tracking of regulated medical and chemotherapeutic waste).
§ 284.3. Regulated medical or chemotherapeutic waste aggregation facilities
Chemotherapeutic waste has been added throughout this section, including the section's heading, to maintain consistency with the amendments to the definition of ''regulated medical and chemotherapeutic waste aggregation facilities'' in § 271.1.
In subsection (c), ''generator'' has been replaced with ''operator'' for clarity.
§ 284.111. Application for general permit
In subsection (b)(3)(viii), ''infectious'' has been changed to ''regulated medical'' in accordance with the changes that have been applied uniformly throughout the final-form rulemaking.
§ 284.121. Contents of general permits
In paragraph (8), ''manifest'' has been changed to ''log or shipping paper'' in accordance with the changes that have been applied uniformly across the final-form rulemaking. ''Manifesting for'' has been replaced with ''tracking of'' to maintain consistency with the changes made to the heading of Chapter 284, Subchapter H.
§ 284.122. Waiver or modification of certain requirements
The phrase ''waiver or modification'' in the section heading has been reinstated in the final-form rulemaking.
In subsection (b), the proposed deletion of ''waiver or'' and the mandatory provisions regarding 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 were not adopted in the final-form rulemaking. Therefore, these provisions remain mandatory.
§ 284.131. Authorization for persons or municipalities to be included in a general permit
In subsection (c), ''must'' has been added to correct a typographical error.
§ 284.230. Storage requirements
This section has been added to clarify that a transfer facility may store regulated medical or chemotherapeutic waste for up to 72 hours provided that the waste remains in its original packaging, is not putrescent and does not attract vectors. This section maintains consistency with § 284.2(a)(5) (relating to permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements) for transfer facilities operating under a permit-by-rule and the changes applied uniformly to the final-form rulemaking.
§ 284.321. Regulated medical waste monitoring requirements
In subsection (g), ''after disinfection'' has been deleted for clarity.
Subsection (n) was reorganized and revised in the final-form rulemaking to require autoclave validation at a frequency specified by the manufacturer of the autoclave. Language was added to subsection (n)(2) to clearly state when the autoclave validation procedure shall be performed.
Proposed subsection (n)(3) was deleted in the final-form rulemaking because the requirement to repeat the autoclave validation procedure at a frequency specified by the manufacturer of the autoclave was incorporated into subsection (n). The requirement to repeat the autoclave validation procedure annually was deleted from the final-form rulemaking.
Proposed subsection (n)(4) was deleted to eliminate the ambiguity of the phrases ''significant change'' and ''problem is evident.'' Specific language regarding when the autoclave validation procedure shall be performed was added to subsection (n)(2) in the final-form rulemaking.
Alternate disinfection requirements for biologics facilities that produce or conduct research and development of vaccines have been established in subsections (p) and (q) to allow these facilities, under certain conditions, to utilize alternate disinfection protocols that are specific to the infectious agent or organism present in a facility's waste.
§ 284.322. Autoclave validation testing requirements
Paragraph (8) was added to allow biologics facilities that satisfy the requirements of § 284.321(p) (relating to regulated medical waste monitoring requirements) to establish and validate autoclave operating parameters and residence times based on the requirements determined by the institutional biosafety committee or independent certified biosafety professional, or both, which are specific to the infectious agent or organism present in a facility's waste.
§ 284.411. Segregation
The term ''used'' has been added to subsection (b) to be consistent with changes made to the definition of ''sharps'' and ''used sharps'' in § 271.1.
Provisions for bags storing chemotherapeutic waste have been moved from subsection (c) to subsection (d) and ''pathological waste'' has been added to subsection (c).
Subsection (d) has been added to include requirements for bags storing chemotherapeutic waste and provide flexibility in the colored bag requirements for generators who process chemotherapeutic waste onsite.
§ 284.412. Basic storage requirements
Language has been added to subsection (b) to clarify that containers in enclosures shall be maintained in accordance with § 284.413 (relating to storage containers) and in a manner that minimizes human exposure and vectors.
Subsection (c) has been amended to clarify that regulated medical or chemotherapeutic waste may not be commingled with other wastes in the same container.
For clarity, subsection (d) was revised in the final-form rulemaking to allow regulated medical and chemotherapeutic waste that has been sorted and separately containerized to be stored in the same location as municipal waste, including on a cart.
§ 284.413. Storage containers
In subsection (a), ''and'' has been replaced with ''or.''
Language has been added to subsection (a)(1) to clarify that containers holding regulated medical or chemotherapeutic waste must be leakproof on the sides and bottom and maintained in an upright position.
In subsection (d)(2), ''bag'' has been replaced with ''bags.''
§ 284.414. Marking of containers
Subsection (a) has been reworded for clarity.
Final-form subsection (a)(2) and (3) extends the transition period for generators and transporters to comply with the revised container marking requirements from 1 year to 2 years after the effective date of the final-form rulemaking.
The proposed language in subsection (a)(5) regarding a record of the date on which a roll-off was full or sealed to be maintained at the generating facility was moved to subsection (b)(4).
In the final-form rulemaking, subsection (a)(6) was added to clarify that the requirement to label containers with the name, address and telephone number of the generator only applies 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 placed on the containers.
Subsection (b) was added to the final-form rulemaking to allow a vehicle or conveyance to serve as the outermost container of regulated medical or chemotherapeutic waste for labeling purposes, rather than labeling each container within the vehicle or conveyance. However, the conditions in subsection (b) must be satisfied and include the requirement that the waste is from a single generator and the vehicle or conveyance is transported offsite every 30 days. Subsection (b)(3) was added to specify that the requirements of § 284.513 (relating to transportation of regulated medical and chemotherapeutic waste; additional provisions) apply if the outermost container of regulated medical or chemotherapeutic waste is a vehicle or conveyance, including a roll-off.
§ 284.415. Duration of storage of regulated medical and chemotherapeutic waste for generators
The section heading and language throughout the section have been amended to clarify that the requirements also apply to chemotherapeutic waste.
Proposed subsection (a) was deleted because the language duplicates the requirement of § 284.414(a)(5) and (b)(4) (relating to marking of containers).
§ 284.416. Duration of storage of regulated medical and chemotherapeutic waste for processors
The section heading and language throughout the section have been amended to clarify that the requirements also apply to chemotherapeutic waste.
The storage temperatures in paragraph (1) have been deleted and replaced with ''ambient temperature.'' Language requiring the waste to be immediately transported offsite if it becomes putrescent or attracts vectors has also been added.
The storage temperature in paragraph (2) was added to correct an error in the proposed language.
§ 284.511. Transportation of ash residue from regulated medical or chemotherapeutic waste incineration
A typographical error was corrected in subsection (d).
§ 284.512. Transportation of regulated medical and chemotherapeutic waste; general provisions
A cross-reference to § 284.414(b) has been added to subsection (c)(1)(v).
Subsection (e) clarifies that separately containerized regulated medical or chemotherapeutic waste may be transported in the same vehicle as containerized municipal waste. For clarity, proposed language prohibiting transportation of regulated medical or chemotherapeutic waste in the same vehicle with residual waste has been deleted from the final-form rulemaking.
In subsection (g), chemotherapeutic waste and a requirement that wastes may not attract vectors has been added to maintain consistency with other changes that have been made uniformly in the final-form rulemaking.
§ 284.513. Transportation of regulated medical and chemotherapeutic waste; additional provisions
In subsection (b), ''or conveyances'' has been added to maintain consistency with other transportation requirements referenced throughout Articles VIII and IX (relating to municipal waste; and residual waste management).
Subsection (b)(3) and (4) was added to establish a transition period for transporters to comply with the required signage for vehicles transporting regulated medical waste.
Subsection (d) has been revised to clarify that the cargo area of vehicles transporting regulated medical or chemotherapeutic waste shall be cleaned weekly to ensure that the surfaces of vehicles which are most likely to become contaminated with infectious agents are cleaned on a routine basis.
§ 284.602. License requirement
In subsection (a)(3), ''manifesting'' has been changed to ''log and shipping paper'' in accordance with the changes that have been applied uniformly across the final-form rulemaking.
§ 284.623. Conditions of licenses
In subsection (c), ''drivers'' has been replaced with ''haulers'' for clarity and to accommodate industry's current business practices.
§ 284.632. Regulated medical or chemotherapeutic waste discharges or spills
In subsection (c), ''manifests'' has been changed to ''logs or shipping papers'' in accordance with the changes that have been applied uniformly to the final-form rulemaking.
Chapter 284, Subchapter H. Tracking of regulated medical and chemotherapeutic waste
In the final-form rulemaking, logs or shipping papers, including electronic tracking systems, are recognized as acceptable ways of tracking shipments of regulated medical or chemotherapeutic waste. For clarity, ''manifesting for'' has been replaced with ''tracking of'' in the heading of Chapter 284, Subchapter H.
§ 284.711. Use of logs or shipping papers
The reference to ''manifest'' in the section heading was replaced with ''logs or shipping papers'' in accordance with changes made uniformly to the final-form rulemaking.
§ 284.712. Preparation of logs or shipping paper
The reference to ''manifest'' in the section heading was replaced with ''logs or shipping papers'' to maintain consistency with the change in terminology that has been applied uniformly to the final-form rulemaking.
Subsection (a)(5) was proposed to be deleted. The intent of this paragraph was added to the final-form rulemaking as subsection (a)(4) to require generators and transporters of regulated medical or chemotherapeutic waste to use waste codes on logs or shipping papers. The applicable waste codes have been added in the final-form rulemaking.
In subsection (c), ''manifest'' has been replaced with ''logs or shipping papers'' to reflect the change made to the heading of § 284.722.
§ 284.722. Preparation and use of logs or shipping papers
The reference to ''manifest'' in the section heading was replaced with ''logs and shipping papers'' in accordance with changes that have been applied uniformly to the final-form rulemaking.
The use of electronic signatures or a stamped signature of an authorized representative has been added to subsection (a) as acceptable means of acknowledging that waste has been accepted on logs or shipping papers.
Language requiring a log or shipping paper to also be delivered to a subsequent transporter has been added to subsection (e).
§ 284.731. Scope
''Manifest'' has been changed to ''logs and shipping papers'' in accordance with changes that have been applied uniformly to the final-form rulemaking.
§ 284.732. Use of logs or shipping papers
The reference to ''manifest'' in the section heading was replaced with ''logs or shipping papers'' to maintain consistency with the change in terminology that has been applied uniformly to the final-form rulemaking.
The use of electronic signatures or a stamped signature of an authorized representative on logs or shipping papers has been added to subsection (b)(3) as acceptable means of acknowledging that waste has been accepted.
§ 299.220. Signs on vehicles
The proposed deletion of subparagraph (2)(i) was not adopted in the final-form rulemaking to maintain consistency with the signage requirements in § 285.218 (relating to signs on vehicles).
F. Summary of Comments and Responses on the Proposed Rulemaking
The proposed rulemaking was adopted by the Board on April 16, 2013, and published at 43 Pa.B. 4858 (August 24, 2013). During the comment period, seven commentators provided comments to the Board on the proposed rulemaking, including the Independent Regulatory Review Commission (IRRC). The comments received on the proposed rulemaking are summarized in this section and are addressed in a Comment and Response Document which is available from the Department.
General
Several commentators suggested that all references to ''manifests'' be replaced with ''logs or shipping papers'' for consistency, including references in section headings. The Board replaced ''manifest'' with ''logs or shipping papers'' throughout Article VIII in the final-form rulemaking.
§ 271.1. Definitions
Commentators representing biologics facilities provided pertinent information on their unique activities, asserting that biologics facilities are highly regulated by the United States Food and Drug Administration, the CDC and the National Institutes of Health, which impose stringent requirements and mandate practices to ensure the purity and safety of vaccine products. Therefore, commentators recommended amendments that would include provisions which are applicable only to biologics facilities and afford biologics facilities consideration of their unique circumstances.
In its comments on the proposed rulemaking, IRRC asked the Board to consider the reasonableness of the requirements as they relate to biologics facilities, as well as the fiscal or economic impact of the final-form rulemaking. The Department worked cooperatively with representatives of the impacted biologics facilities during the development of the final-form rulemaking and was able to incorporate revisions into the final-form rulemaking that satisfy the comments submitted on behalf of the biologics facilities and maintain a high level of protection for public health and the environment.
The Board recognizes that improvements in practices and technologies employed in biologics facilities have increased the safety of vaccine viruses so that many vaccine agents that were once infectious have been attenuated to the point that they are no longer capable of being communicated by replication or invasion in healthy humans. Furthermore, biologics facilities shall follow biosafety guidelines set forth by the CDC and the National Institutes of Health which require the facilities to classify infectious agents into one of four biosafety levels based on the risk that the agents pose. According to the CDC's guidelines, BSL-1 agents are those that do not pose a risk of disease and do not require special handling or precautions and, therefore, do not warrant additional management requirements that are imposed on materials subject to the definition of ''infectious waste.'' In response to the comments received, the Board amended the definitions of ''infectious agents'' and ''infectious waste'' in § 271.1 to exclude agents classified as BSL-1 by a biologics facility and wastes, mixtures of wastes and cell lines from biologics facilities where no agent in the waste is classified as BSLs 2—4 as determined by the CDC's BMBL. In addition, plasticware generated by biologics facilities that has not been in contact with agents classified as BSLs 2—4 as determined by the CDC's BMBL has been excluded from the category ''used sharps'' in the definition of ''infectious waste.''
In response to questions raised by commentators concerning how the Board defines ''residue in emptied containers,'' in the definition of ''infectious waste'' under the category of ''cultures and stocks,'' the Board incorporated the criteria of 40 CFR 261.7(b)(1) or (2) in the final-form rulemaking to determine whether or not a container is empty.
Several commentators expressed that the proposed exclusion in the category of ''pathological wastes'' under the definition of ''infectious waste'' required clarification on whether preserved tissues, if excluded from the category ''pathological wastes,'' would also be excluded from the definition of ''infectious waste,'' and, therefore, considered municipal waste for waste management purposes. Commentators also questioned whether autoclave facilities can process preserved tissues under the proposed rulemaking, since those items would no longer be considered pathological wastes. Since agents used to preserve tissues can volatize during autoclaving, processing these materials can pose a threat to worker safety. In response to these comments, the Board did not adopt the proposed amendments in the final-form rulemaking and, therefore, preserved tissues will remain subject to the definition of ''pathological wastes.''
The Board received a comment on the definitions of ''sharps'' and ''used sharps,'' which are existing definitions that were proposed to be amended slightly in the proposed rulemaking. The commentator noted that having two definitions is confusing since only ''used sharps'' are managed as regulated medical waste and ''sharps'' are managed in the same manner as other municipal waste. Therefore, the definition of ''sharps'' was combined into the category of ''used sharps'' under the definition of ''infectious waste'' in the final-form rulemaking.
§ 284.122. Waiver or modification of certain requirements
In response to a question submitted by IRRC concerning the proposed deletion of language in § 284.122 (relating to waiver or modification of certain requirements) regarding the legal right of the Department to enter the permitted area, the identification of interested parties, compliance information, verification of an application and the administration of civil penalties, the Board did not adopt the proposed amendment, thereby withdrawing the amendment to this section. The requirements of § 284.122 will remain mandatory provisions.
§ 284.321. Regulated medical waste monitoring requirements
Several commentators requested revisions to or clarification of § 284.321. Commentators requested the deletion of the proposed requirement of § 284.321(n)(3) to repeat the autoclave validation procedure at least once per year, citing that it is not standard industry practice to regularly validate an autoclave. In the final-form rulemaking, the Board did not adopt the proposed language requiring an annual autoclave validation and deleted proposed § 284.321(n)(3). However, the Board maintained the requirement to repeat the autoclave validation procedure at an ongoing frequency specified by the manufacturer of the autoclave in § 284.321(n).
In its comments on the proposed rulemaking, IRRC expressed that in § 284.321(n)(4) use of the phrase ''when a significant change in the waste stream occurs or a problem is evident'' does not set clear compliance standards for the regulated community and asked the Board to define the phrases or provide examples. In the final-form rulemaking, the Board deleted proposed § 284.321(n)(4) and added language to § 284.321(n)(2) to clarify for the regulated community when the autoclave validation testing requirements of § 284.322 (relating to autoclave validation testing requirements) shall be performed.
A commentator representing biologics facilities requested that additional provisions be added to §§ 284.321 and 284.322 to allow biologics facilities to employ alternate disinfection protocols that are specific to the infectious agents present in the waste generated. IRRC also expressed that the disinfection requirements of the proposed rulemaking may be unnecessarily onerous when applied to the waste streams of biologics facilities, and asked the Board to explain how the provisions are reasonable and necessary for biologics facilities. Recognizing that the wastes generated from a vaccine manufacturing process consist of a single infectious agent that is a known, well-characterized component of a vaccine or other biologic, and biologics facilities are subject to additional standards imposed by Federal governmental agencies that ensure a high level of protection for public health and safety, the Board provided flexibility for biologics facilities to utilize alternate disinfection techniques in the final-form rulemaking, provided that certain criteria are met. These additional provisions are in §§ 284.321(p) and (q) and 284.322(8).
§ 284.411. Segregation
Commentators representing biologics facilities also expressed that under proposed § 284.411(a) (relating to segregation), regulated medical (infectious) and chemotherapeutic wastes shall be segregated when discarded. Biologics facilities conduct research by intentionally combining infectious and chemotherapeutic agents, making it unfeasible to segregate those materials when discarded. The commentators requested that an exception be provided in the final-form rulemaking relieving biologics facilities engaged in this research from the requirement to segregate regulated medical and chemotherapeutic waste. However, the regulations do not require that mixtures of infectious and chemotherapeutic agents be separated from each other when discarded. Rather, mixtures of infectious and chemotherapeutic waste shall simply be managed as chemotherapeutic waste when discarded. Therefore, the exception proposed by the commentator was not adopted in the final-form rulemaking.
To address the concerns raised by commentators regarding the segregation requirements of § 284.411(a), the Board added language to § 284.411 to allow flexibility for facilities that are processing chemotherapeutic waste onsite in a captive incinerator operating in accordance with the permit-by-rule provisions in § 284.2, or in accordance with a permit authorized by the Department. The additional language alleviates the prescriptive colored bag requirements for onsite processing of chemotherapeutic waste since those requirements are only necessary when chemotherapeutic waste is transported to an offsite processing facility where it is handled by workers who are unfamiliar with its contents.
§ 284.412. Basic storage requirements
Several commentators who represented transporters of regulated medical and chemotherapeutic waste submitted comments regarding § 284.412 (relating to basic storage requirements). Existing regulatory language addressing requirements for enclosures used for the storage of regulated medical and chemotherapeutic waste was relocated from § 284.411(b) to § 284.412(b) in the proposed rulemaking. Commentators expressed that the statement in proposed § 284.412(b) requiring exhaust air from storage areas to be ventilated to minimize human exposure is too broad and recommended that the statement be replaced with ''Containers in enclosures must be maintained in a closed upright position when not in use in the storage areas to minimize exposure and vectors.'' The Board adopted language similar in the final-form rulemaking, to that recommended by the commentators, but the Board did not eliminate the requirement to ventilate exhaust air from the storage area, as suggested by the commentators. The Board believes that it is important to ensure that some ventilation in waste storage areas is required and that the requirement has not been problematic in the implementation of this provision.
§ 284.412. Basic storage requirements
§ 284.512. Transportation of regulated medical and chemotherapeutic waste; general provisions
Commentators expressed that the use of ''commingled'' in proposed § 284.412(c) and § 284.512(e) (relating to transportation of regulated medical and chemotherapeutic waste; general provisions) may cause confusion for the regulated community. The language of the proposed rulemaking may be construed in different ways and does not clearly address whether regulated medical or chemothera-peutic waste may be stored near or transported with other types of waste provided that it does not become commingled in the same container. The intention of the Department is to allow other wastes to be stored in the same area and transported in the same vehicle as regulated medical and chemotherapeutic wastes, but prevent the mixing of unconsolidated regulated medical or chemotherapeutic wastes with unconsolidated municipal waste in the same container. For clarity, the Board revised § 284.412(c) in the final-form rulemaking to state that regulated medical and chemotherapeutic waste may not be commingled with other wastes in the same container. Likewise, the Board revised § 284.512(e) in the final-form rulemaking to state that separately containerized regulated medical and chemotherapeutic waste may be transported in the same vehicle as containerized municipal waste.
In response to questions raised by commentators concerning the manner in which generators may move regulated medical, chemotherapeutic and municipal waste onsite, the Board revised § 284.412(d) to clarify that sorted and separately containerized regulated medical or chemotherapeutic waste may be stored in the same location, including on a cart.
§ 284.413. Storage containers
Several commentators who represented the waste transportation industry requested that the container requirements of § 284.413(a)(1) be revised to require containers of regulated medical or chemotherapeutic waste to be leakproof on the sides and bottom only provided that the containers are maintained in an upright position. The modification will align the Pennsylvania requirements with United States Department of Transportation requirements regarding the transportation of regulated medical or chemotherapeutic waste. Therefore, the Board adopted the change in the final-form rulemaking.
§ 284.414. Marking of containers
§ 284.513. Transportation of regulated medical and chemotherapeutic waste; additional provisions
§ 284.724. Transportation limitations
Several commentators representing transporters of regulated medical and chemotherapeutic waste requested that the transition period for compliance with the amended container marking requirements of § 284.414 and § 284.724(a)(2) (relating to transportation limitations), and vehicle signage requirements of § 284.513(b), respectively, be extended from 1 year, as provided in the proposed rulemaking, to 2 years. The Board adopted the extended transition period in the final-form rulemaking to provide generators and transporters with 2 years from the effective date of this final-form rulemaking to appropriately mark all containers and vehicles.
Commentators questioned whether the requirement in § 284.414(a)(5) to label containers of regulated medical or chemotherapeutic waste with the date the container is full or sealed, whichever occurs earlier, is the responsibility of the generator or the transporter and expressed that § 284.724(a)(2) specifies that transporters may not accept waste that is not properly labeled. The commentators note that when trailers are loaded by the generator, the transporter may not be able to inspect all the containers to ensure compliance with § 284.724(a)(2). Section 284.414 was revised to include labeling provisions that apply when waste from a single generator is placed in a vehicle or conveyance, including a roll-off, provided that the vehicle or conveyance is transported offsite every 30 days. This amendment provides flexibility by allowing generators and transporters under certain conditions to label the vehicle or conveyance with required information instead of labeling each individual container inside the vehicle or conveyance. The amendment aligns the Pennsylvania container marking requirements with the regulations imposed by the United States Department of Transportation regarding marking of containers for the transportation of regulated medical and chemotherapeutic waste.
When the waste in a vehicle or conveyance is not from a single generator, the Board believes that the responsibility for marking containers in accordance with § 284.414 belongs to the generator and the transporter. The transporter should, to the extent possible, ensure that containers of regulated medical or chemotherapeutic waste are labeled in accordance with this section prior to transporting the containers and refuse to accept waste that is not properly labeled. The Board recognizes that in some cases, when the generator preloads trailers of waste, it is impractical for the transporter to inspect containers that are located in portions of the trailer which are not amenable to inspection. However, the Board expects generators to ensure that containers are labeled in accordance with § 284.414 to the extent that visual inspection of the containers is possible.
Several commentators requested clarification on the requirement of § 284.513(d) to clean surfaces of vehicles that have not been in direct physical contact with regulated medical or chemotherapeutic waste on a weekly basis. In the final-form rulemaking, the Board amended § 284.513(d) to specify that the cargo area of vehicles used to transport regulated medical or chemotherapeutic waste shall be cleaned weekly to ensure that the vehicle surfaces which are most likely to be contaminated with infectious or chemotherapeutic agents be cleaned on a routine basis.
§ 284.416. Duration of storage of regulated medical and chemotherapeutic waste for processors
Several commentators requested that the temperature range given in § 284.416 (relating to duration of storage of regulated medical and chemotherapeutic waste for processors) for storing unrefrigerated regulated medical or chemotherapeutic waste be replaced with a general standard that waste may be stored for 72 hours at ambient temperature, provided that the waste is not putrescent and does not attract vectors. The Board adopted the requested language in the final-form rulemaking.
§ 284.512. Transportation of regulated medical and chemotherapeutic waste; general provisions
In its comments on the proposed rulemaking, IRRC asked the Board to explain how the proposed deletion of strength and weight requirements on corrugated fiberboard containers in § 284.512(c)(1)(iv) is protective of public health, safety and welfare. The Board does not believe that the regulations must contain a standard prescriptive strength or weight limit for corrugated fiberboard containers to transport regulated medical and chemotherapeutic waste. Rather, the Board believes that a general performance standard, such as that provided in §§ 284.413(a) and 284.512(c)(1)(iv), is sufficient. This standard requires that containers being used to transport regulated medical and chemotherapeutic waste be ''[s]ufficient in strength to prevent puncturing, tearing or bursting during transportation.''
The amendments to § 284.512(c)(1)(iv) eliminate prescriptive strength and weight limits for corrugated fiberboard containers since those limits only apply to corrugated fiberboard containers, but waste may be transported in other types of containers, such as plastics or metal. However, there are not standard strength and weight limits for nonfiberboard containers that could be referenced in this regulation. The Board believes that it is necessary for this regulation to address all types of containers and has provided a consistent performance standard for each type.
Furthermore, the inclusion of prescriptive requirements for fiberboard containers does not guarantee that the performance standard will be satisfied. Even if the prescriptive standards were followed, the containers may still be punctured, torn or burst through mishandling, misuse or other circumstances during the handling of these containers. The Board believes that general performance requirements provide a clear standard for transporters and will eliminate any uncertainty that may result in an enforcement action. In addition, this type of performance standard is commonly used in the Board's regulations, where it is useful to provide the regulated industry flexibility in compliance and where industry standards evolve over time.
§ 284.623. Conditions of licenses
At the request of commentators representing the waste transportation industry, the Board amended § 284.623(c) (relating to conditions of licenses) in the final-form rulemaking to clarify that a license to transport regulated medical and chemotherapeutic waste may not be transferred to subcontracted haulers and haulers who provide their own equipment without prior written approval of the Department. The amendment allows transporters authorized by the Department to transport regulated medical and chemotherapeutic waste to utilize temporary or subcontracted drivers without obtaining prior written approval from the Department.
§ 284.634. Annual report
§ 284.712. Preparation of logs or shipping papers
Commentators noted that in § 284.634(b)(2) (relating to annual report) the quantity of each type of regulated medical or chemotherapeutic waste shall be included in the transporter's annual report. However, the requirement to track the type of waste being transported on logs or shipping papers was proposed to be deleted in § 284.712(a)(5) (relating to preparation of logs or shipping papers). Therefore, the Board added the language from § 284.712(a)(5) to § 284.712(a)(4) in the final-form rulemaking, maintaining the requirement for generators to include the type of waste being transported on logs or shipping papers. By including the waste code on the logs or shipping papers, transporters may continue to include this information in their annual reports, and the Department is able to ensure that regulated medical and chemotherapeutic wastes are processed or disposed of at facilities authorized to accept the waste.
§ 284.732. Use of logs or shipping papers
At the request of several commentators, the Board included the use of electronic and stamped signatures as acceptable forms of acknowledging that waste has been received on logs or shipping papers in final-form § 284.732(b)(3) (relating to use of logs or shipping papers).
§ 284.734. Significant discrepancies
Several commentators who represented the waste transportation industry recommended revisions to § 284.734(b) (relating to significant discrepancies) regarding the manner in which significant discrepancies between the quantity of waste shipped and the quantity of waste listed on the log or shipping paper are handled. In the proposed rulemaking, when a significant discrepancy exists, the processor shall attempt to reconcile the discrepancy prior to processing or disposing of the waste. The Board recognizes that there are instances when the waste is being processed as it is off-loaded and, therefore, operators at the processing facility may not realize that a discrepancy exists until some or all of the waste has been processed. However, if the waste is no longer available for evaluation, it is unrealistic that the discrepancy could be reconciled. The Board believes that once a discrepancy is identified by the processor, processing of the waste should be stopped, and the remaining waste should be held while the processor attempts to reconcile the discrepancy with the generator. Therefore, the language suggested by the commentator was not included and the amendments to § 284.734(b), as proposed, were adopted by the Board in the final-form rulemaking.
F. Benefits, Costs and Compliance
Benefits
The final-form rulemaking simplifies the labeling requirements to reduce costs and ensure consistency with Federal requirements. The amendments allow generators, transporters and those involved in storage and processing of regulated medical and chemotherapeutic waste to use standard business documentation to demonstrate compliance with the regulations instead of the currently prescribed, outdated paper manifest. The 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 deleted. The 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 final-form rulemaking provides a cost savings to the regulated community through: providing consistency with the United States Department of Transportation; reduced transportation costs for generators and transporters due to consolidation of waste in trucks; longer storage times for generators, meaning fewer waste pickups; reduced waste management and disposal costs for biologics facilities; and reduced 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 final-form 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. 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 final-form 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 final-form 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 the notice of proposed rulemaking, published at 43 Pa.B. 4858, to IRRC and the Chairpersons of the House and Senate Environmental Resources and Energy Committees for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the House and Senate Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on September 17, 2014, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on September 18, 2014, and approved the final-form rulemaking.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of the proposed rulemaking published at 43 Pa.B. 4858.
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this preamble.
K. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 271, 272, 273, 284, 285, 287, 288 and 299, are amended by adding §§ 284.3, 284.116, 284.230 and 284.322, by deleting §§ 271.114, 284.132, 284.713, 284.721, 284.723 and 284.733 and by amending §§ 271.1, 271.2, 271.101, 271.103, 271.421, 271.601, 271.611, 271.801, 271.811, 272.223, 272.532, 273.411, 273.511, 284.1, 284.2, 284.101, 284.102, 284.111—284.115, 284.121, 284.131, 284.201, 284.210, 284.220, 284.301, 284.311, 284.320, 284.321, 284.401, 284.411—284.419, 284.501, 284.511—284.514, 284.601—284.603, 284.611, 284.612, 284.623, 284.624, 284.631—284.634, 284.641—284.643, 284.701—284.703, 284.711, 284.712, 284.714, 284.722, 284.724, 284.731, 284.732, 284.734, 285.131, 285.218, 285.221, 287.1, 287.2, 288.423 and 299.220 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(Editor's Note: Section 271.114, which was proposed to be amended in the proposed rulemaking published at 43 Pa.B. 4858, is rescinded in Annex A. The addition of § 284.230 was not included in the proposed rulemaking. The amendment to § 284.122 included in the proposed rulemaking has been withdrawn by the Board.)
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson of the Board shall submit this order and Annex A to IRRC and the Committees as required by the Regulatory Review Act.
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
DANA K. AUNKST,
Acting Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 44 Pa.B. 6306 (October 4, 2014).)
Fiscal Note: Fiscal Note 7-480 remains valid for the final adoption of the subject regulations.
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:
* * * * * Autoclave—A pressure vessel in which 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.
* * * * * 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 establishment—An establishment engaged in nonmanufacturing or nonprocessing business, including, but not limited to, stores, markets, office buildings, restaurants, shopping centers and theaters.
Commercial regulated medical or chemotherapeutic waste facility—A facility that processes regulated medical or chemotherapeutic waste under either of the following conditions:
(i) 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.
Community activities—Events sponsored in whole or in part by a municipality, or conducted within a municipality and sponsored privately, which include, but are not limited to, fairs, bazaars, socials, picnics and organized sporting events that will be attended by 200 or more individuals per day.
* * * * * Disinfection—The treatment or processing of 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. §§ 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—7130.905), 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—1396.19b), the Noncoal Surface Mining Conservation and Reclamation Act (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 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).
Incorporating—Injecting sludge beneath the surface of the soil or mixing sludge with the surface soil.
Industrial establishment—An establishment engaged in manufacturing or processing, including, but not limited to, factories, foundries, mills, processing plants, refineries, mines and slaughterhouses.
Infectious agent—
(i) An organism, such as a virus or bacteria, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.
(ii) The term does not include agents classified as Biosafety Level 1 by a facility engaged in the production or research and development of vaccines or other biologics classified under the North American Industrial Classification System (NAICS) as Code 325414—Biological Product (except Diagnostic) Manufacturing or Code 541711—Research and Development in Biotechnology, as determined by the protocols established in the most recent edition of the Centers for Disease Control's (CDC) Biosafety in Microbial and Biomedical Laboratories (BMBL) existing at the time the waste is generated.
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:
(A) Cultures and stocks. Cultures and stocks of infectious agents and associated biologicals, including the following:
(I) Cultures from medical and pathological laboratories.
(II) Cultures and stocks of infectious agents, and cell lines that have been exposed to infectious agents from research and industrial laboratories.
(III) Wastes from the production of biologicals.
(IV) Discarded live and attenuated vaccines except for residue in emptied containers, as determined by applying the criteria in 40 CFR 261.7(b)(1) or (2) (relating to residues of hazardous waste in empty containers) to the residue remaining in the container.
(V) Culture dishes, assemblies and devices used to conduct diagnostic tests or to transfer, inoculate and mix cultures.
(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.
(C) Human blood and body fluid waste.
(I) Liquid waste human blood.
(II) Blood products.
(III) Items saturated or dripping with human blood.
(IV) Items that were saturated or dripping with human blood that are now caked with dried human blood, including serum, plasma and other blood components, which were used or intended for use in patient care, specimen testing or the development of pharmaceuticals.
(V) Intravenous bags that have been used for blood transfusions, including soft plastic pipettes and plastic blood vials.
(VI) Items, including dialysate, that have been in contact with the blood of patients undergoing hemodialysis at hospitals or independent treatment centers.
(VII) Items saturated or dripping with body fluids or caked with dried body fluids from persons during surgery, autopsy, other medical procedures or laboratory procedures.
(VIII) Specimens of blood products or body fluids, and their containers.
(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, production of biologicals, or testing of pharmaceuticals.
(E) Isolation wastes. Biological wastes and waste contaminated with blood, excretion, exudates or secretions from:
(I) Humans who are isolated to protect others from highly virulent diseases.
(II) Isolated animals known or suspected to be infected with highly virulent diseases.
(F) Used sharps.
(I) Broken glass, hypodermic needles, syringes to which a needle is or can be attached, 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 that have been in contact with infectious agents or that have been used in animal or human patient care or treatment.
(II) The term does not include broken or unbroken plasticware generated at facilities engaged in the production or research and development of vaccines or other biologics and classified under the NAICS as Code 325414—Biological Product (except Diagnostic) Manufacturing or Code 541711—Research and Development in Biotechnology, where no agent in the waste is classified as Biosafety Levels 2—4 as determined by the protocols established in the most recent edition of the CDC's BMBL existing at the time the waste is generated.
(ii) Mixtures.
(A) The term also includes materials identified under subparagraph (i) that are mixed with municipal and residual waste, including disposable containers.
(B) The term also includes mixtures of materials identified in subparagraph (i) with quantities of radioactive waste not subject to regulation.
(iii) Exceptions. The term does not include the following:
(A) Wastes generated as a result of home self-care.
(B) Human corpses, remains and anatomical parts that are intended for interment or cremation, or are donated and used for scientific or medical education, research or treatment.
(C) Etiologic agents being transported for purposes other than waste processing or disposal under the requirements of the United States Department of Transportation (49 CFR 171.1—171.26 (relating to general information, regulations, and definitions)), the Department of Transportation (67 Pa. Code Part I) and other applicable shipping requirements.
(D) Samples of regulated medical waste transported offsite by Commonwealth or United States government enforcement personnel during an enforcement proceeding.
(E) Body fluids, tissues, specimens or biologicals 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 § 284.321 (relating to regulated medical waste monitoring requirements). The ash residue shall be managed as special handling municipal waste.
(G) Reusable or recyclable containers or other nondisposable materials, if they are cleaned and disinfected, or if there has been no direct contact between the surface of the container and materials identified in subparagraph (i). Laundry or medical equipment shall be cleaned and disinfected in accordance with the United States Occupational Safety and Health Administration requirements in 29 CFR 1910.1030 (relating to blood- borne pathogens).
(H) Soiled diapers that do not contain materials identified in subparagraph (i).
(I) Mixtures of hazardous waste subject to Article VII and materials identified in subparagraph (i) shall be managed as hazardous waste and not 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 § 236.521 (relating to minimum requirements for classes of waste).
(K) Mixtures of materials identified in subparagraph (i) and chemotherapeutic waste shall be managed as chemotherapeutic waste in accordance with this article.
(L) Wastes, mixtures of wastes or cell lines from facilities engaged in the production or research and development of vaccines or other biologics and classified under the NAICS as Code 325414—Biological Product (except Diagnostic) Manufacturing or Code 541711—Research and Development in Biotechnology, where no agent in the waste is classified as Biosafety Levels 2—4 as determined by the protocols established in the most recent edition of the CDC's BMBL existing at the time the waste is generated.
Institutional establishment—An establishment engaged in service, including, but not limited to, hospitals, nursing homes, orphanages, schools and universities.
* * * * * Mobile regulated medical waste processing facility—A regulated medical waste processing unit that is moved from one waste generation site to another for the purpose of onsite processing of a generator's regulated medical waste. The term refers to any processing activity designed to disinfect waste in accordance with § 284.321 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 or chemotherapeutic waste aggregation facility—A facility that accepts, aggregates or stores regulated medical or chemotherapeutic waste, or both.
Regulated medical waste—Infectious 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.
* * * * * Sewage sludge—Liquid or solid sludges and other residues from a municipal sewage collection and treatment system; and liquid or solid sludges and other residues from septic and holding tank pumpings from commercial, institutional or residential establishments. The term includes materials derived from sewage sludge. The term does not include ash generated during the firing of sewage sludge in a sewage sludge incinerator, grit and screenings generated during preliminary treatment of sewage sludge at a municipal sewage collection and treatment system, or grit, screenings and nonorganic objects from septic and holding tank pumpings.
Site—The area where municipal waste processing or disposal facilities are operated. If the operator has a permit to conduct the activities, and is operating within the boundaries of the permit, the site is equivalent to the permit area.
* * * * * 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, regulated medical waste, chemotherapeutic waste, ash residue from a solid waste incineration facility, friable 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 regulated medical waste by means of exposure to high thermal temperatures through methods such as ionizing radiation or electric or plasma arc technologies.
* * * * * Unrecognizable regulated medical waste—All components of the waste have been processed to produce indistinguishable and unusable pieces smaller than 3/4 inch, except that all used sharps must be smaller than 1/2 inch. The term does not mean compaction or encapsulation except through:
(i) Processes such as thermal treatment or melting, during which disinfection and destruction occur.
(ii) Processes such as shredding, grinding, tearing or breaking, during or after disinfection occurs.
(iii) Processes that melt plastics and fully encapsulate metallic or other used sharps and seals waste completely in a container that will not be penetrated by untreated used sharps.
* * * * * § 271.2. Scope.
(a) This chapter specifies certain general procedures and rules for persons who operate municipal waste management facilities. This chapter, together with Chapters 273, 275, 277, 279, 281, 283, 284 and 285, specifies the Department's requirements for municipal waste processing, disposal, transportation, collection and storage.
(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.
(1) Construction/demolition waste, except construction/demolition waste with greater than 4 ppm PCBs.
(2) Regulated medical and chemotherapeutic waste.
(3) Leaf waste and grass clippings.
(4) Waste from land clearing, grubbing and excavation, including trees, brush, stumps and vegetative material.
(c) Management of the following types of waste is subject to Article IX instead of this article, and shall be regulated as if the waste is residual waste, regardless of whether the waste is municipal waste or residual waste:
(1) Water supply treatment plant sludges.
(2) Waste oil that is not hazardous waste.
(3) Waste tires and auto fluff.
(4) Contaminated soil.
(5) Used asphalt.
(6) Dredged material.
(d) The disposal, processing, storage and transportation at a municipal waste management facility of the following types of special handling waste is subject to the applicable additional requirements for the disposal, processing, storage and transportation of these wastes in Article IX, and shall be regulated as if the waste is residual waste, regardless of whether the waste is municipal waste or residual waste:
(1) Friable asbestos containing waste.
(2) PCB containing waste.
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