General Permit Application for Regulated Medical or Chemotherapeutic Waste Processing Commonwealth of Pennsylvania Department of Environmental Protection Bureau of Waste Management Division of Municipal and Residual Waste The enclosed application form should be used to apply for a general permit for a regulated medical or chemotherapeutic waste processing facility. A general permit is not available for commercial regulated medical or chemotherapeutic waste processing facilities. When applying for a new general permit, or a registration under an existing general permit, you must complete all the items in this form and provide all requested information. If you are applying for registration under an existing general permit, you should fill out all the items in the form excluding Sections C(5), D, E, F, G (1, 3-5), H, I, J, K, L, M, O, P, and Q(1). Please forward the application with the applicable permit application fee to: Bureau of Waste Management Division of Municipal and Residual Waste General Permits/Beneficial Use Section Rachel Carson State Office Building P.O. Box 8472 Harrisburg, PA 17105-8472
COMMONWEALTH OF PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF WASTE MANAGEMENT FORM 20 RMCW GENERAL PERMIT APPLICATION FOR REGULATED MEDICAL/CHEMOTHERAPEUTIC WASTE PROCESSING Date Prepared/Revised DEP USE ONLY Date Received This form must be fully and accurately completed. All required information must be typed or legibly printed in the spaces provided. If additional space is necessary, identify each attached sheet as Form 20 RMCW, reference the item number and identify the date prepared. The date prepared/revised on any attached sheets needs to match the date prepared/revised on this page. General References: 284.101-284.133 SECTION A. SITE IDENTIFIER Applicant/permittee: Site Name: Facility ID (as issued by DEP): A. General Permit: 1. Initial: $1,000.00 B. Registration: $250.00 NOTE: Facility Name: 1. General Permit Title and Number: 2. Pennsylvania Bulletin Notification Date: Township or Municipality: County: Facility ID Number: The Review process will not begin until a complete application and the appropriate fee have been received. Please make the check payable to the Commonwealth of PA. SECTION B. APPLICANT IDENTIFIER SECTION C. GENERAL 1. Is this general permit application for any of the following: Yes No A commercial regulated medical or chemotherapeutic waste (RMCW) processing facility. A commercial RMCW incinerator. If answer is yes to any one of the above items, do not fill out this general permit application. Contact DEP for an appropriate regulated medical or chemotherapeutic waste processing permit application. 2. Is the operation proposed to be used as a mobile facility? If yes, provide information to verify that the facility will not be operated as a commercial processing facility as defined in Section 271.1 3. Locational Information ( 283.202). Is the facility to be located: a. Within the 100-year floodplain of any of the waters of the Commonwealth? Attach a floodplain map showing facility location. b. In or within 100 feet of a wetland? c. (i) Within 300 feet measured horizontally from an occupied dwelling? (ii) If yes, has the present owner of the dwelling been given a written consent that the facility can be closer than 300 feet? Please submit the waiver to this effect from the said owner. d. Within 100 feet of a perennial stream? e. (i) Within 50 feet of a property line? (ii) If yes, will actual processing of waste occur within this distance? 4. a. Waste to be processed. Regulated Medical Chemotherapeutic b. Does the proposed operation intend to accept waste for processing from other generators? If yes, indicate the amount of the total waste proposed to be so received. lbs/day or lbs/month (circle one) - 1 -
SECTION C. GENERAL (Continued) 5. a. Does the processing technology require U.S. EPA approval? If yes, please provide a copy of the approval or registration. If no, please indicate the reasons: Yes No b. Has the technology been approved in any other state in the United States? If yes, please indicate which state(s). If no, is the technology currently used in any other country: If yes, please indicate which country or countries. SECTION D. LEVEL OF TREATMENT The disinfection Standard of Section 284.321(a)(2) requires a 6 Log 10 reduction or greater for mycobacteria; and a 4 Log 10 reduction for Geobacillus stearothermophilus, Bacillus pumilus, or Bacillus atrophaeus spores during regulated medical waste treatment. Does the treatment process meet the disinfection standard? Yes No If no, specify where the disinfection standard is not met. SECTION E. DESCRIPTION OF PROCESSING TECHNOLOGY AND EQUIPMENT 1. Attach a detailed description of the process design and equipment including schematic diagram. Literature included Yes No SECTION F. CHARACTERIZATION OF PROPOSED TREATMENT PROCESS Which of the following processing methods best describe the proposed processing technology? (A processing system may fall under more than one of the categories listed below.) Mechanical Encapsulation Grinder Microwave Steam Irradiation Hammermill Chemical Radiowave Plasma Arc Shredder Heat Incineration Other (specify) SECTION G. PROPOSED TREATMENT PROCESS AND WASTE COMPATIBILTIY 1. Please identify if the proposed system is compatible or non-compatible with the following types of waste, regardless of whether the waste type is proposed to be processed. COMPATIBLE NON-COMPATIBLE Laboratory waste Human or animal specimen cultures Cultures and stocks of infectious agents Wastes from production of bacteria, viruses, use of spores, discarded live and attenuated vaccines, culture dishes, and associated devices Microbiologic specimens Human surgery or autopsy specimens Animal parts, tissues, fluids, carcasses Recognizable fluid blood, blood products, containers, or equipment containing blood Excretions, exudates, secretions from isolated humans or animals Needles, syringes, pipettes, other contaminated broken glass or sharp object Chemotherapeutic waste Other (specify) - 2 -
SECTION G. PROPOSED TREATMENT PROCESS AND WASTE COMPATIBILITY (Continued) 2. What procedures will be used to keep the non-compatible wastes, checked above, out of the processing system? Describe. 3. What waste characteristics present the most challenge to the proposed treatment process: Organic materials Liquids Density/compaction Other characteristics Specify: 4. Describe by composition (i.e., material and percentage) those wastes that would pose the most challenge to the proposed technology. Why? 5. Describe the physical or chemical components of wastes that would interfere, cause mechanical breakdown, or compromise the treatment process or microbial inactivation efficacy. SECTION H. MICROBIOLOGICAL TEST PROCEDURES Any proposed treatment methods shall be capable of inactivating mycobacteria and bacterial spores, and meet the disinfection standard established in Section 284.321(a). A representative from each of the following microbial groups is required for testing. 1. Listed below are several test organisms which have been used as microbiological indicators to determine the effectiveness of a given treatment method. If there are any data either to support or refute the inactivation of any of the biological indicators using the proposed treatment process under normal operating conditions, please check the appropriate space next to the indicator. NOTE: If protocols utilized by the applicant to generate microbial inactivation data are deemed unacceptable by the Department, the Department reserves the right to request that the applicant resubmit data generated from Department-approved protocols. If data has not been procured to support the inactivation of the listed biological indicators below, please contact the Department before initiating efficacy testing to ensure research protocols are in accordance with the Department s requirements. Microbacteria - Mycobacterium terrae - Mycobacterium phlei - Mycobacterium bovis (BCG) (ATCC 35743) Bacterial Spores - Geobacillus stearothermophilus (ATCC 7953) - Bacillus pumilus - Bacillus atrophaeus 2. Laboratory Accreditation Number 3. Were the results certified by an independent health or certified testing laboratory? Yes No If yes, indicate the name, address, and telephone number of the certifying laboratory and attach the test protocol, results of evaluations including original data and an explanation of any available data not supporting the disinfection standard referenced above. SECTION I. CHEMICAL EFFECTIVITY OF THE TREATMENT PROCESSES 1. If the treatment process uses chemical disinfectant, please answer the following: a. Name of the active ingredient b. The concentration to be used and to be maintained c. Contact time necessary to achieve disinfection d. If there is any incompatibility with specific materials and surface, specify e. The ph at which the chemical agent is active f. ph of any end products (i.e., liquid effluents) g. List any additional factors or circumstances that may interfere with the chemical s inactivation potential - 3 -
SECTION I. CHEMICAL EFFECTIVITY OF THE TREATMENT PROCESSES (Continued) 2. What is the active life of the chemical agent after it has been exposed to air or regulated medical waste? 3. Have studies been conducted relative to the long-term effectiveness of the chemical agent while in use? Yes No If yes, please attach a copy of the study and test results. 4. What health and safety hazards may be associated with the chemical (present and long-term)? Specify. MSDS attached? Yes No 5. Is the spent chemical agent registered for this specific use with the US EPA Pesticide Registration Division? Yes No If yes, provide the US EPA registration number: and a copy of the EPA-approved label. 6. Is the spent chemical agent classified as hazardous waste by the US EPA (40 CFR Part 261, as incorporated by reference at 25 Pa. Code Chapter 261a)? Yes No SECTION J. BY-PRODUCTS AND DISCHARGES FROM THE TREATMENT PROCESS 1. Does the process generate by-products and discharges (to air, water or land) other than the processing residue as a result of the processing technology? If the answer is yes, please check the appropriate item below. Stack Emissions Heat Slag Vapors or Fumes Ash Liquid Smoke Aerosols Leachate Dust Odor Steam Chemical Residues 2. If any of the above by-products are generated, how will they be inactivated or destroyed? 3. If there are no by-products or discharges generated, how was this determined? 4. Are any of these by-products or discharges US EPA-listed hazardous wastes (40 CFR Part 261, as incorporated by reference at 25 Pa. Code Chapter 261a), biohazardous wastes, etc.? Yes No If yes, explain need for necessary controls, personal protection equipment, storage, disposal, etc. SECTION K. ENVIRONMENTAL EFFECTS OF THE TREATMENT PROCESS 1. Are any negative effects on the environment anticipated from the use of the treatment process and/or disposal of the treated waste from the treatment process? 2. What environmental, occupational, and/or public health hazards would be associated with a malfunction of the treatment process? Specify. 3. If the treatment process includes the use of water, steam, or other liquids, how will the resulting waste or its discharge be handled (i.e., sewer, recycled, etc.)? Specify. 4. What are the physical characteristics of the waste residues generated from the treatment process (i.e., wet, dry, shredded, powdered, etc.)? Specify. 5. How will the treated waste from this process be disposed of (i.e., landfill, incineration, recycled, etc.)? Specify. 6. Are any by-products classified as hazardous waste (40 CFR 261, as incorporated by reference at 25 Pa. Code 261a.1)? Yes No - 4 -
SECTION L. OCCUPATIONAL HAZARDS 1. What potential hazards are associated to operations of the treatment process? 2. What hazard abatement/reduction strategies will be used during the operation of this treatment process (include engineering controls, personal protection equipment, etc.)? 3. What training will the operator(s) of the treatment process receive? SECTION M. CRITICAL FACTORS OF THE TREATMENT PROCESS 1. What are the critical factors that influence the specific treatment technology? Specify. 2. What are the consequences if these factors are not met? Specify. 3. Explain the ease and/or difficulty of operation of the waste treatment system. Specify. 4. What type of ongoing maintenance is required in the operation of the treatment system, as required by 284.111(b)(3)? Specify. Maintenance Manual Attached? Yes No 5. What emergency measures would be required in the event of a malfunction, as required by 284.111(b)(3)? Specify. 6. How are these measures addressed in an emergency plan or in the operations protocol, as required by 284.111(b)(3)? 7. What is the maximum amount of waste to be treated by this process per cycle? 8. How long is the cycle? SECTION N. QUALITY ASSURANCE AND VERIFICATION OF MICROBIAL INACTIVATION 1. How is the quality assurance of the treatment process addressed? Specify. 2. What is the recommended frequency that a microbiological indicator should be used to confirm effectiveness of the system? Specify. 3. Other than the biological indicators listed in Section H, what other indicators, integrators, or monitoring devices would be used to show that the treatment unit or process was functioning properly? (Please describe and explain.) - 5 -
SECTION N. QUALITY ASSURANCE AND VERIFICATION OF MICROBIAL INACTIVATION (Continued) 4. How is it determined that the processed waste has received proper treatment? [Check the appropriate items.] Temperature indicator: visual only continuous both Pressure indicator: visual only continuous both Time indicator: visual only continuous both Chemical concentration indicator: visual only continuous both Other: Please specify 5. How do the treatment process monitors correlate with biological indicators to ensure effective and accurate monitoring of the treatment process? Specify. 6. What is the established process calibration schedule, and frequency of calibration? 7. How are the process monitors interfaced to the system s operations to effect proper treatment conditions? Explain. 8. What failure mode and effect analyses have been performed on the treatment system? Specify and provide. SECTION O. POST-TREATMENT RESIDUE DISPOSAL, RECLAMATION OR RECYCLING 1. How will the treated wastes from this process be disposed of: Disposal in an approved landfill Incineration Recycled 2. If the wastes are to be recycled, provide additional evidence regarding this strategy. 3. If the wastes are to be recycled, what percentage of the treated waste will be recycled? How will the remainder of the treated waste be disposed of? SECTION P. POTENTIAL ENVIRONMENTAL BENEFITS 1. Has an energy analysis been conducted on the proposed technology? Yes No If yes, specify and provide results of that analysis. 2. Has an economic analysis been performed on the proposed technology? Yes No If yes, specify and provide results of that analysis. 3. How does this treatment technology improve on existing waste treatment and disposal methods? Specify. 4. What is the potential of this proposed technology for waste volume reduction? Specify - 6 -
SECTION Q. OTHER RELEVANT INFORMATION AND COMMENTS 1. Attach all approvals or denials received from other states, counties or agencies concerning any aspect of equipment operation and efficacy. 2. Please include all safety, competency or training requirements for the users/operators, etc. 3. Include a site-specific equipment operation, maintenance and user/operator training plan consistent with Section 284.111(b)(3). 4. Demonstrate that the activity will be conducted in a manner that will not harm or present a threat of harm to the health, safety, or welfare of the people or environment through exposure to constituents of the waste during the activity and afterward. 5. Supply proof of written notice to each host municipality and county where the processing facility is intended to operate. SECTION R. REGISTRATION 1. Demonstrate that the activities which the person or municipality intends to conduct are authorized by the general permit. 2. Provide proof that a copy of the registration has been submitted to each municipality in which the processing activity will be located. (284.131(d)). 3. Provide a signed and notarized statement by the person or municipality conducting the activity which states that the person or municipality agrees to accept all of the conditions imposed by the general permit. SECTION S. CERTIFICATION I,, do hereby certify pursuant to the penalties of 18 Pa. C.S.A. Section 4904 to the best of my knowledge, information, and belief that the information contained in this document is true and correct. Print or Type Name of Responsible Official Signature Title Date IN WITNESS WHEREOF, I have hereunder set my hand and official seal. (SEAL) NOTARY PUBLIC My Commission Expires: DATE - 7 -
ESTABLISHING PROTOCOL FOR MICROBIOLOGICAL TESTING OF REGULATED MEDICAL WASTE PROCESSING TECHNOLOGIES OTHER THAN INCINERATION OR THERMAL PROCESSING In order to properly evaluate prospective methods proposed for the disinfection of regulated medical waste, the Department of Environmental Protection requires that: A. Microbiological testing be performed using select biological indicators. B. All testing be conducted using recognized microbial techniques. C. Methodology employed to determine efficacy of the technology will be developed by the equipment manufacturer to assure the protocols are congruent with the treatment method. Protocols developed for efficacy testing should incorporate recognized standard procedures such as those found in Test Methods for Evaluating Solid Waste, Physical/Chemical Methods, EPA Publication SW846, Third Edition, as amended, and the current edition of Standard Methods for the Examination of Water and Waste Water. D. In establishing testing criteria to evaluate efficacy, the composition of the waste load(s) tested is critically important. The equipment manufacturer should prescribe and use those types of regulated medical waste that present the greatest challenge to the equipment effectiveness as well as present and use protocols that adequately evaluate efficacy under normal operating conditions. If protocols are submitted for evaluation, the DEP reserves the right to accept or modify the prescribed waste types and testing protocols. E. To ensure the required quality control, efficacy testing shall be carried out by an independent laboratory meeting the following criteria: Be experienced in microbiological testing techniques and be familiar with required sampling and testing protocols; Be an accredited laboratory and have experience with product registration through the Federal Food and Drug Administration (FDA) or the USEPA Office of Pesticide Programs; and Be equipped to meet FDA Good Laboratory Practices requirements. - 8 -
Checklist COMMONWEALTH OF PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF WASTE MANAGEMENT FORM 20 RMCW General Permit Application for Regulated Medical/Chemotherapeutic Waste Processing APPLICANT S CHECKLIST Please check the following list to make sure that you have included all the required information. Place a checkmark in the column provided for all items completed and/or provided. Failure to provide all of the requested information will delay the processing of the application and may result in the application being placed on hold with no action, or will be considered withdrawn and the application filed closed. * * * FOR DEP USE * * * Application ID # Stamp Date Application Received ENCLOSE THIS CHECKLIST WITH YOUR APPLICATION FORM. Requirement 1. Permit Application - General Information Form (13000-PM-BIT0001) 2. Form 20 RMCW - General Permit Application for RMCW Processing (2540-PM-BWM0124)) 3. Form B - Professional Certification (2540-PM-BWM0358) 4. Form E-GP - Contractual Consent of Landowner (2540-FM-BWM0217) 5. Form HW-C - Compliance History (2540-FM-BWM0058) 6. Form L - Contingency Plan for Emergency Procedures (2540-PM-BWM0384) 7. Attachments, where appropriate, are included. Check If Included * DEP* USE ONLY I have reviewed the application and the supplemental material and confirm that the appropriately checked items have been provided. Signature - Applicant or Designated Agent Date