News

State of Michigan Regulations for Medical Waste

Click on the link below to access State of Michigan Regulations

 

 

http://www.deq.state.mi.us/documents/deq-whm-hwrp-mwRegAct-Rules.pdf

 

 

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Disposal of Controlled Substances; Proposed Rule

Department of Justice

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304 et al.

Disposal of Controlled Substances; Proposed Rule

http://www.gpo.gov/fdsys/pkg/FR-2012-12-21/pdf/2012-30699.pdf

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Comments on the "Notice of Proposed Rulemaking, Disposal of Controlled

4301 Connecticut Avenue, NW, Suite 300, Washington, DC 20008 – 202-364-3724 Page 1 of 2

February 19, 2013

Mr. John W. Partridge

Executive Assistant

Office of Diversion Control (OD/DX)

Drug Enforcement Administration

8701 Morrissette Drive

Springfield, VA 22152

Re: Comments on the "Notice of Proposed Rulemaking, Disposal of Controlled

Substances," Docket No. DEA-316, Published in the Federal Register

on December 21, 2012 at 77 Fed. Reg. 75784

Dear Mr. Partridge:

The Healthcare Waste Institute (HWI) appreciates the opportunity to comment on the Drug Enforcement Administration’s (DEA) proposed rulemaking regarding controlled substances. HWI agrees with the DEA’s goals:

 Providing ultimate users with more options for disposal of controlled substances will prevent misuse, abuse, and accidental ingestion;

 Effectively and securely disposing of unwanted and unused controlled substances requires consistent nationwide standards for disposal; and

 Setting diversion prevention parameters that allow public and private entities to develop a variety of methods for collecting and destroying controlled substances in a secure, convenient, and responsible manner was Congress’ goal in passing the Secure and Responsible Disposal Act of 2010.

HWI is a policy-making group within the National Solid Wastes Management Association, a trade association serving the private recycling and solid waste industry in the U.S. Institute members include medical, hospital, and infectious waste collection, treatment, and disposal companies; manufacturers of products and equipment used for the management of healthcare waste (e.g., containers); consultants providing services to the industry; and pharmaceutical mail-back companies, reverse distributors, and current service providers in take-back events.

Specific Comments

 The DEA’s rules should provide consistent requirements for mail-back and take-back options. To restrict mail-back programs to only those facilities with on-site destruction will limit the availability of these programs. While HWI understands the need to prevent diversion through restrictions on who has access to controlled substances, our members, some of whom are reverse distributors, are equipped to receive, document, and securely store packages designed for use by ultimate users through mail-back programs. Based upon the current proposal that does not allow packages to be opened, incineration is likely the only option for destruction of these materials. As a result of the U.S. Environmental Protection Agency’s Clean Air Act standards, very few incinerators are available and will not likely be installed on-site for purposes of controlled substances destruction.

Healthcare Waste Institute’s DEA Comments February 19, 2013

　

 Reverse distributors that have met the conditions defined in the proposed rule should be allowed to register as collectors for purposes of take-back programs. In addition to retail pharmacies, reverse distributors are well positioned to own, place, and otherwise manage collection receptacles at law enforcement locations, pharmacies, and long-term care facilities. By allowing reverse distributors to operate as collectors more programs can be made available and could be more cost effective if reverse distributors can work directly with law enforcement and long-term care facilities to create effective programs.

 The 14-day destruction requirement is too short and impractical especially for collectors that do not have on-site destruction capabilities, which most do not. Incinerators available for destruction may be hundreds of miles away. HWI would prefer that the time-frame be performance-based using the size of the destruction facility and storage capacity as a self-imposed limit through written agreement with the DEA; however, if this is not sufficient for DEA, HWI recommends that the time frame be at least quarterly.

 Requiring the use of Schedule II controlled substances security requirements for reverse distributors is very costly especially when most of the collected material is not likely be controlled substances. HWI recommends that instead of requiring a vault, the DEA allow for a security II controlled substance cage or a storage area with a distinctive locking system within the larger cage, security cameras, and access only by authorized employees. HWI notes that the DEA has already allowed the use of expanded cages in reverse distribution.

 A number of places in the proposed rule reference the term "non-retrievable." This term needs to be better defined. We agree with the DEA in the summary of the proposed rule that discarding into water is not ideal, but this does not seem to fit well into the term non-retrievable. Once flushed or poured down the drain, access to the controlled substances is not likely. We caution the DEA into banning flushing in the short term before better options are readily available and, instead, allow for a program development period. In addition, the proposed rule refers to chemical and/or physical destruction in the section describing non-retrievable. This should be changed to "chemical and physical or just physical." HWI does not believe that there is sufficient scientific evidence to show that chemical destruction methods are effective by themselves. If possible, HWI recommends that DEA conduct tests to determine the destruction criteria and use a performance-based standard in defining non-retrievable.

Thank you again for your efforts in developing this proposed rule and for including HWI in the DEA’s rulemaking procedures.

Sincerely,

Alice P. Jacobsohn

Director

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EPA Hazardous Waste Pharmaceuticals Wiki

EPA has developed a “Hazardous Waste Pharmaceuticals Wiki” as a platform to facilitate the sharing of expertise among the healthcare industry and other stakeholders to help make accurate hazardous waste determinations for waste pharmaceuticals and increase compliance with hazardous waste regulations among the healthcare community.

In addition to information about which pharmaceuticals are hazardous waste, the Hazardous Waste Pharmaceuticals Wiki will help users find guidance documents, state-specific information, manufacturer’s information, and more. We encourage all healthcare stakeholders to share their expertise, and state-specific approaches in making hazardous waste determinations for pharmaceuticals.

The Hazardous Waste Pharmaceutical Wiki can be viewed by anyone at: http://hwpharms.wikispaces.com (no registration is necessary to view)

Experts who wish to contribute or edit content for the Wiki can register by sending an e-mail request to HWPharmsWiki@epa.gov. Please use a professional email address, not a personal email address, when contacting EPA to request access to the Wiki. Your email address will not be made public.

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A checklist for choosing an Infectious Waste Disposal company

A checklist for choosing an Infectious Waste Disposal company

Does the Infectious Waste vendor provide:

Evidence of expertise in infectious waste?......................................................................................... ____Yes _____No

Provide references or testimonials from customers? ......................................................................... ____Yes _____No

Evidence that they can meet your facility’s pickup schedule?............................................................. ____Yes _____No

Evidence of expertise in environmental and regulatory compliance? ................................................ ____Yes _____No

(Joint Commission, DOT, EPA, state and local agencies)

 

Proof of their compliance record? ...................................................................................................... ____Yes _____No

Provide knowledge of OSHA? ............................................................................................................ ____Yes _____No

Copies of permits for the treatment facility and transportation? ......................................................... ____Yes _____No

Evidence of Emergency Preparedness for back-up plans in the event of a disaster? ....................... ____Yes _____No

Waste tracking and analysis with ongoing reporting? ........................................................................ ____Yes _____No

Specialist who are able to provide training and education for your staff?........................................... ____Yes _____No

Compliance services and waste minimization service:

·         Audits which identify and suggest ideas to maintain waste performance standards............ ____Yes _____No

·         Training programs and materials.......................................................................................... ____Yes _____No

·         Plans for waste segregation and minimization...................................................................... ____Yes _____No

·         Waste minimization references............................................................................................. ____Yes _____No

A full service integrated waste offering:

·         Infectious waste collection.................................................................................................... ____Yes _____No

·         Treatment and disposal of Infectious Waste......................................................................... ____Yes _____No

·         Collection and disposal of expired medication................. .................................................... ____Yes _____No

·         E-waste collection and disposal............................................................................................ ____Yes _____No

·         Hazardous waste removal and disposal............................................................................... ____Yes _____No

·         Document destruction........................................................................................................... ____Yes _____No

·         Collection of fluorescent bulbs, ballasts and small batteries................................................. ____Yes _____No

Proof of insurance:

·         Workers compensation......................................................................................................... ____Yes _____No

·         Commercial General Liability................................................................................................ ____Yes _____No

·         Contractors Pollution Liability............................................................................................... ____Yes _____No

·         Transportation Pollution Liability........................................................................................... ____Yes _____No

Evidence of testing and certification for their employees:

·         Dot Hazardous materials training.......................................................................................... ____Yes _____No

·         Drug Testing.......................................................................................................................... ____Yes _____No

·         OSHA blood borne pathogen training.................................................................................... ____Yes _____No

·         Ongoing medical surveillance................................................................................................ ____Yes _____No

Containers to meet your needs? ......................................................................................................... ____Yes _____No

Accurate scales to measure waste (yearly calibration reports)? ......................................................... ____Yes _____No

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State of Indiana Regulated Medical Waste

Indiana

Infectious Waste

Definition of Infectious Waste

Infectious waste means waste that epidemiologic evidence indicates is capable of transmitting a dangerous communicable disease. The term includes, but is not limited to, the following:

• Contaminated sharps or contaminated objects that could potentially become contaminated sharps;
• Infectious biological cultures, infectious associated biologicals, and infectious agent stock;
• Pathological waste;
• Blood and blood products in liquid and semiliquid form;
• Carcasses, body parts, blood and body fluids in liquid and semiliquid form;
• Bedding of laboratory animals; and
• Other waste that has been intermingled with infectious waste.

Managing Infectious Waste

This rule applies, without regard to quantity, to defined facilities and persons involved in infectious waste activity.

Containment and Labeling; Effective Treatment, Transport, or Disposal

The generator of infectious waste is responsible for the appropriate containment, appropriate labeling, effective treatment, transport, and disposal of infectious waste as required by this rule. A person may provide services to the generator of infectious waste, including the appropriate containment, appropriate labeling, effective treatment, transport, or disposal of infectious waste. Both the generator of infectious waste and the person providing services to the generator of infectious waste are responsible for complying with the requirements set forth in this rule.

Containment

All persons and facilities subject to the infectious waste rule shall:

• Ensure that infectious waste is at all times contained in a manner that will reasonably protect waste handlers and the public from contracting dangerous communicable disease that may result from exposure to the infectious waste.
• Place contaminated sharps or contaminated objects that could potentially become contaminated sharps, infectious biological cultures, infectious associated biologicals, and infectious agent stock in containers that are:
• Leak proof, rigid, puncture-resistant;
• Tightly sealed to prevent expulsion;
• Labeled with the biohazard symbol; and
• Effectively treated in accordance with this rule prior to being stored in an unsecured area and sent for final disposal.
• Place pathological waste; laboratory animal carcasses, laboratory animal� body parts, laboratory animal blood and body fluids, and laboratory animal bedding; human blood; human blood products in liquid or semiliquid form; and human body fluids that are visibly contaminated with blood in containers that are:
• Impervious to moisture;
• Sufficient strength and thickness to prevent expulsion;
• Secured to prevent leakage or expulsion;
• Labeled with the biohazard symbol; and
• Effectively treated in accordance with this rule prior to being placed in an unsecured area and sent for final disposal.

Storage Requirements

If infectious waste is stored prior to final disposal, all persons shall store infectious waste in a secure area that:

• Is locked or otherwise secured to eliminate access by or exposure to the general public; and
• Affords protection from adverse environmental conditions and vermin; and
• Has a prominently displayed biohazard symbol.

In addition:

• Stored in a manner that preserves the integrity of the container, and is not conducive to rapid microbial growth and putrefaction; and
• Disinfect reusable containers for infectious waste each time that they are emptied, unless the surfaces of the reusable containers have been protected from contamination by disposable liners, bags, or other devices that are removed with the infectious waste.

Treatment of Infectious Waste

All persons and facilities subject to this rule shall either effectively treat infectious waste or transport infectious waste off-site for effective treatment.

A treatment is effective if it reduces the pathogenic qualities of infectious waste for safe handling, is designed for the specific infectious waste involved, and is carried out in a manner consistent with this rule. Effective treatment may include:

• Incineration;
• Steam sterilization;
• Chemical disinfection;
• Thermal inactivation;
• Irradiation; or
• Discharge in a sanitary sewer or septic system that is properly installed and operating in accordance with state and local laws.

Applicable persons and facilities may store, transport, and dispose of infectious waste that has been effectively treated in accordance with this rule in the usual manner for waste that is noninfectious.

Transporting Infectious Waste

All persons and facilities subject to this rule shall:

• Transport infectious waste in a manner that reasonably protects waste handlers and the public from contracting dangerous communicable disease; and
• Effectively treat infectious waste in accordance with this rule before it is compacted.

Transporting Infectious Waste Off-Site

All persons and facilities subject to this rule who are transporting infectious waste off-site, whether effectively treated or not, shall:

• Mark containers of infectious waste with a label that states the name, address, and telephone number of the generating facility and treatment facility, if applicable; and
• Provide a form that contains:
• The name, address, and telephone number of the generating facility and treatment facility, if applicable;
• A brief description of the waste and the method of effective treatment; and
• The signature of a responsible person.

Required information may be enclosed between the secondary packaging and the outer packaging, when such packaging is used. The outer packaging must contain a biohazard symbol. �

Written Policies and Procedures, Reporting and Recordkeeping

All persons and facilities subject to this rule shall have written policy and procedures that, at a minimum, contain:

• The requirements of the infectious waste rule; and
• The sanctions, including discipline and dismissal of persons, if warranted, for failure to follow the requirements set forth in this rule;
• Provide necessary instruction and materials, including protective garments, to implement this rule prior to giving a person an assignment where contact with infectious waste is likely;
• Maintain a record of such instruction, including an attendance record of a person's participation in the instruction; and
• Make all records available to the department for inspection

Facility Operator Responsibilities

Facility operators are responsible for informing employees and other applicable persons of the risk of HIV and other infections, and providing appropriate training and education. Detailed responsibilities are contained in the infectious waste rules.

Facility Operator Policies

A facility operator shall develop a written policy that requires the use of universal precautions by a covered individual when performing those professional, employment, training, or volunteer activities or duties that include any reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials. The policy shall also include:

• Sanctions, including discipline and dismissal, if warranted, for failure to use universal precautions; and
• Proscribes the facility operator, or any covered individual acting at or on behalf of the facility, from retaliating against any person, including any professional, employee, trainee, volunteer, or patient, for filing a complaint with the department in good faith under this rule.

Covered Individuals' Minimum Training and Certification Requirements

All covered individuals must complete the training programs which the facility is required to have employees attend under the Indiana occupational safety and health administration's bloodborne pathogens standards. Detailed instructions are contained in the infectious waste rules.

OSHA Regulations: HERC OSHA State Page

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  Indiana is one of 21 states operating an approved occupational safety and health program. This program is operated by the Indiana Occupational Safety and Health Division. OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Indiana Infectious Waste Rule (Article 1, Rule 3)

Indiana Hospital/Medical/Infectious Waste Incinerator Rule

Contacts

Indiana Department of Environmental Management

 

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State of Illinois Regulated Medical Waste

Illinois

Regulated
Medical Waste

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Waste Categories

• The transporter's name,
• The transporter's permit number,
• The transporter's address,
• The transporter's phone number (a 24-hour phone number, if available), and
• For each PIMW package, the shipment date when PIMW initially left the generator's site; or for each shipment, a unique identification number which directly corresponds to the initial date of shipment.

Storage. The following rules are applicable to on-site storage of PIMW at healthcare facilities.  The storage requirements include:

• Store the PIMW in a manner and location that maintains the integrity of the packaging and provides protection from water, rain, and wind.
• Maintain the PIMW in a nonputrescent state, using refrigeration when necessary.
• Limit access to on-site storage areas to authorized employees.
• Store the PIMW in a manner that affords protection from animals and does not provide a breeding place or food source for vectors.
• Multiple generators in the same building may store their PIMW packages in a common storage area.
• Reusable PIMW containers or facility equipment (e.g., carts, squeegees or shovels) which are visually contaminated with PIMW must be cleaned in a designated area.

Transportation. PIMW can only be transported by a licensed PIMW hauler to a permitted transfer, storage, or treatment facility.  Once the PIMW has been treated and the sharps have been packaged properly, it can be placed in a landfill.

A special manifest must accompany all PIMW shipments coming into Illinois, within Illinois, and from Illinois to states not providing their own manifests.  The cost is $4.00 per manifest and must be paid by check, cashier’s check, or money order made payable to Treasurer, State of Illinois.  Any questions should be directed to 217/782-9293 or 217/785-8604.  A manifest request form can be found below under “More information”.  Allow 2 weeks for processing.

Treatment

Treatment facilities are those facilities designed and operated to treat PIMW to eliminate its infectious potential. Hospitals which treat only their own PIMW or that of their medical staff are not required to be permitted by the Illinois EPA. Treatment of PIMW must be conducted in a manner that:

• Eliminates the infectious potential of the waste. A treatment process eliminates the infectious potential of PIMW if the manufacturer/owner/operator demonstrates that an Initial Efficacy Test (IET) and Periodic Verification Test (PVT) have been completed successfully. Refer to Sections 1422.124 and 1422.125 of the Act or the Fact Sheet on Testing Requirements for details on these tests.
• Prevents compaction and rupture of containers during handling operations, except when this is an integral part of the treatment process;
• Disposes of treatment residuals in accordance with all applicable regulations;
• Provides for quality assurance programs that must include a written plan;
• Provides for periodic testing using biological testing;
• Provides for assurances that clearly demonstrate that PIMW has been properly treated; and is in compliance with all Federal and State laws and regulations pertaining to environmental protection.

Disposal

Untreated medical waste cannot be disposed of into any landfill. Untreated PIMW is banned from all landfills in Illinois. Once PIMW has been properly treated to eliminate its infectious potential, it is no longer PIMW (except in the case of sharps) and may be disposed of into any landfill permitted by the Illinois EPA to accept municipal waste. For sharps, both the infectious nature must be eliminated and the sharps must either be rendered unrecognizable or packaged in accordance with the regulations prior to disposal.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  Illinois is one of 26 states covered entirely by the federal OSHA program.  This program is operated by the Occupational Safety and Health Administration.  OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Title 35, Part 1420 - Potentially Infectious Medical Waste - General Provisions

Title 35, Part 1421 - Potentially Infectious Medical Waste - Activity Standards

Title 35, Part 1422 - Potentially Infectious Medical Waste - Design and Operation of Facilities

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Infectious Waste Segregation Guidelines

INFECTIOUS WASTE SEGREGATION

GUIDELINES

PREPARED BY

AMERICAN MEDICAL WASTE PROFESSIONALS LLC

(AMPRO)

5/20/07

 

INFECTIOUS WASTE

 

Infectious waste means waste that epidemiologic evidence indicates is capable of transmitting a dangerous communicable disease (as defined in the Indiana State Department of Health regulations, 410 IAC 1-3-5). The term includes, but is not limited to:

 

1.    Pathological wastes, including tissue, organs, body parts, and blood or body fluids in liquid or semiliquid form that are removed during surgery, biopsy, or autopsy.

 

2.      Biological cultures and associated biologicals.

3.      Contaminated sharps.

4.      Infectious agent stock and associated biologicals.

5.      Blood and blood products in liquid or semi liquid form.

6.      Laboratory animal carcasses, body parts, and bedding.

7.      Infectious wastes as defined in the Indiana State Department of Health regulations (410 IAC 1-3-5).

8.      Other waste that has been intermingled with infectious waste.

Specific examples of these wastes include the following:

·        Saturated or grossly spoiled disposables (bloody gauze, dressings, lab pads, OB and surgical peri-pads and gloves

·        Containers, catheters or tubes with fluid blood or blood products not discarded or flushed (blood sets, suction canisters, and drainage sets)

·        Dialyzers and tubing

·        Microbiology specimens, used culture plates, tubes, bottles and devices

·         Blood spill clean up materials

·         Placentas and surgical specimens

 

PATHOLOGICAL WASTE

The following infectious waste should be further segregated and clearly marked “Must Incinerate” on all four sides of the container. See AMPRO representative to obtain the proper marking.

·        Pathological wastes consisting of consisting of recognizable body parts such as an amputated arm, leg, head or torso that may be of a size to not be properly treated by limited exposure to steam, could create and aesthetic concern for workers moving the bins of infectious that have been processed, or a potential concern at the landfill. Large animal carcasses should also  be labeled for incineration.

 

·        Antineoplastic waste or chemotherapy waste and any items trace-contaminated during the preparation or use of antineoplastic or chemotherapy drugs. Trace contaminated items include the following:

·                  Gowns

·                  Gloves

·                  Masks

·                  Barriers

·                  IV tubing

·                  Empty bags/bottles

·                  Empty drug vials

·                  Spill cleanup materials or kits

·                  HEPA filters from Pharmacy laminar air flow hoods

·                  Needles and syringes

 

·        Infectious waste form the treatment of variant Creutzfeldt - Jakob disease, Creuzfeldt-Jakob Disease, or Mad Cow Disease.

 

 

 

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New Look at P & U Waste

I have been researching a relatively new twist on an old rule that may affect our hospital clients. Recently, there has been a growing concern that small quantities of P or U listed hazardous waste may be finding its way into the infectious waste that we collect from our client hospitals.

 

There are two basic ways that P and U listed waste can end up in AMPRO's infectious waste stream:

 

1.       Through Chemotherapy agents that are in our cytotoxin (yellow) containers. These agents are:

 

Chlorambucil U035

Cyclophosphamide U058

Daunomycin U059

Melphalan U150

Mitomycin C U010

Strepozotocin U206

Uracil Mustard U237

 

As long as the pure agent is not in the container and the container contains only trace amounts of these agents, then the containers are “RCRA empty” and we can collect the material in the yellow containers and process it as infectious waste. If the pure liquid is present, then the waste is considered hazardous and must be handled by a Hazardous Waste transporter and treated by a hazardous waste treatment facility. This may require the nurses in the areas where these agents are being used to segregate this agent from the tubing, bags and syringes that contain only trace quantities of the agent.

 

2. Through the disposal of expired drugs. If any expired drugs contain any U or P listed waste, the expired drugs must be handled as a hazardous waste and transported using a licensed HW transporter and treated by a HW Treatment facility. This may require the pharmacy to segregate drugs containing P and U listed waste from those drugs that don’t have these materials in order to properly handle these materials.

 

One final condition; if the generator (hospital) generates less than 220 lb of these materials per month, then the hospital is a “conditionally exempt generator” and legally does not have to comply with these rules. My recommendation is to comply with these rules no matter what quantity. This may be an issue during accreditation and its better to be on the safe side.

 

I've uploaded some good resources in PDF format on this topic (see links below). The most complete is the document “Managing Pharmaceutical Waste”. The first 22 pages of this document should be studied.  Click to view these documents.

• Managing Pharmaceutical Waste
• P.U. Listed Waste News Article

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