Administrative Rules of the State of Montana

BEFORE THE DEPARTMENT OF ENVIRONMENTAL QUALITY

OF THE STATE OF MONTANA

In the matter of the adoption of New Rules I through VIII pertaining to infectious waste

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION

(INFECTIOUS WASTE MANAGEMENT)

TO: All Concerned Persons

1. On September 9, 2013, at 9:30 a.m., the Department of Environmental Quality will hold a public hearing in Room 111, 1520 East Sixth Avenue, Helena, Montana, to consider the proposed adoption of the above-stated rules.

2. The department will make reasonable accommodations for persons with disabilities who wish to participate in this public hearing or need an alternative accessible format of this notice. If you require an accommodation, contact Elois Johnson, Paralegal, no later than 5:00 p.m., August 26, 2013, to advise us of the nature of the accommodation that you need. Please contact Elois Johnson at Department of Environmental Quality, P.O. Box 200901, Helena, Montana 59620-0901; phone (406) 444-2630; fax (406) 444-4386; or e-mail [email protected].

3. The proposed new rules provide as follows, stricken matter interlined, new matter underlined:

NEW RULE I APPLICABILITY (1) The purpose of this subchapter is to provide uniform standards for the inspection, transportation, storage, and management, including, but not limited to, treatment and disposal, of infectious waste as defined in 75-10-1003, MCA, for the protection of human health and the environment.

(2) This subchapter does not apply to:

(a) the generation of infectious waste or to storage and transportation of infectious waste regulated under 75-10-1006, MCA; or

(b) the generation of infectious waste by a household.

AUTH: 75-10-204, 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: Section 75-10-208, MCA, requires that the department adopt rules governing the inspection and regulation of the transportation and management of infectious waste. Under this subchapter the department regulates the transportation of infectious waste to treatment facilities prior to final waste disposal. This subchapter complements the rules adopted by other state agencies or licensure boards and programs with responsibility for adopting infectious waste rules identified in Title 75, chapter 10, part 10, MCA.

NEW RULE II DEFINITIONS As used in this subchapter, the following definitions apply:

(1) "Biohazard bag" or "red bag" means a bag marked with a biohazard symbol that meets the requirements of U.S. Department of Labor, Occupational Safety and Health Administration (OSHA) 29 CFR 1910.1030(g)(1)(ii). The biohazard bag must be moisture-proof, disposable, and of a strength sufficient to prevent ripping, tearing, or bursting under normal conditions of use.

(2) "Department" means the Department of Environmental Quality established in 2-15-3501, MCA.

(3) "Inactivate" means to cause the death of an infectious agent.

(4) "Infectious waste" has the meaning given in 75-10-1003, MCA.

(5) "Management" means the storage, treatment, or disposal of infectious waste.

(6) "Noninfectious waste" means treated infectious waste or any waste other than infectious waste.

(7) "Person" has the meaning given in 75-10-1003, MCA.

(8) "Storage" means the short-term containment of infectious waste, prior to treatment, for no longer than 90 days.

(9) "Transport" or "transportation" has the meaning given in 75-10-1003, MCA.

(10) "Transporter" means a person who transports, or engages in transportation or storage of, infectious waste or treated infectious waste.

(11) "Vehicle" means any vehicle, including a truck and trailer or tractor-trailer combination.

AUTH: 75-10-204, 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: The department is proposing NEW RULE II to further identify specific terms necessary to implement the infectious waste rules.

NEW RULE III TRANSPORTER AND STORAGE FACILITY OPERATOR REGISTRATION, DEPARTMENT REVIEW, AND ANNUAL RENEWAL (1) Except as provided in (4), a transporter must register with the department, on a form provided by the department, on or before January 1, 2014, for transporters engaged in transportation or storage on [the effective date of these rules] and for all other transporters, prior to engaging in transportation, and demonstrate that the person is able to meet the requirements of this subchapter by submitting an application for registration that contains the following information:

(a) the name and business address of the applicant;

(b) the location of all waste storage, loading, and handling areas and a certification that the storage areas meet the requirements of [NEW RULE VII];

(c) the location and identity of each person who receives waste from a transporter, including an intermediate point, treatment facility, disposal facility, or other person, and of each person from whom the applicant intends to receive waste;

(d) the vehicle identification number or serial number of all vehicles used to transport infectious waste;

(e) a certification that the vehicles and containers used to transport or store infectious waste meet the requirements of [NEW RULE V] and [NEW RULE VII];

(f) a certification that all vehicles contain a spill containment and decontamination kit;

(g) a certification that all employees involved in the transportation and management of infectious waste have the training required by [NEW RULE V(4)]; and

(h) a copy of the transporter's infectious waste transportation and management plan. The plan must meet the requirements of [NEW RULE IV].

(2) The department shall review the registration application to determine whether the application is adequate. If the application is adequate, the department shall issue a transporter registration number and a vehicle decal. The initial registration period is effective through June 30 following issuance of the registration number.

(3) By February 1 of each year, the department shall mail an annual renewal form to each registered transporter. A transporter who wishes to continue to transport shall submit the information required in (1) to the department with the completed renewal form on or before April 1 for the following twelve-month registration period that begins July 1 and ends June 30.

(4) This subchapter does not apply to a person who:

(a) transports only infectious waste generated from a household;

(b) transports less than 50 pounds of infectious waste a week; or

(c) is a solid waste management system that is licensed by the department to operate an infectious waste treatment facility under the provisions of ARM Title 17, chapter 50, subchapter 4.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: The department proposes NEW RULE III to require certain infectious waste transporters to register with the department by submitting an application and certifying that the transporter is able to meet the minimum standards established in the rule. The department is required, under 75-10-208, MCA, to regulate the transportation of infectious waste not regulated under 75-10-1006, MCA. The registration process allows the department to identify individuals engaged in the transportation of infectious waste and ensure that they have appropriate vehicles, containers, plans, and training in place to protect human health and the environment. The registration requirement applies to transporters who also store infectious or treated infectious waste. The rules exempt from transporter registration requirements individuals who transport household-generated infectious waste, those individuals who transport less than 50 pounds of infectious waste a week, and individuals who are licensed to operate an infectious waste treatment facility or who transport infectious waste to their licensed treatment facility in accordance with the Solid Waste Management Act and its implementing rules. These exemptions are consistent with other exemptions in solid waste management and regulations adopted by other states.

NEW RULE IV GENERAL REQUIREMENTS – TRANSPORTATION AND MANAGEMENT PLAN (1) A transporter shall submit to the department for its review and approval, a management plan meeting the requirements of this subchapter that:

(a) describes the type, sources, and annual volume of infectious waste handled;

(b) describes how infectious waste is segregated from other solid waste, packaging, and labeling procedures;

(c) describes the collection, storage, and transportation procedures to ensure infectious waste is distinguished from noninfectious waste;

(d) describes the treatment or disposal methods used;

(e) identifies the name and location of the facility where the waste will be treated and disposed of;

(f) identifies the person responsible for the transportation and management of infectious waste; and

(g) includes an emergency spill response and decontamination plan that meets the requirements of [NEW RULE VIII].

(2) The management plan described in (1) must be updated and submitted to the department on an annual basis.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: NEW RULE IV provides requirements for the content of the transportation and management plan required in NEW RULE III and establishes a consistent approach to the management of infectious waste by individuals regulated under this subchapter and individuals or facilities licensed by other licensing bodies or state agencies referred to in 75-10-1006, MCA. By requiring a transportation and management plan, the department ensures that persons who transport and manage infectious waste have adopted and abide by contingencies and protocols necessary to protect human health and the environment. Review of the plans required by this rule enables the department to recognize best current practices for management and transportation of infectious waste.

NEW RULE V TRANSPORTATION REQUIREMENTS (1) Infectious waste must be transported according to the provisions of 75-10-1005(6), MCA, and this subchapter.

(2) A transporter may not transport infectious waste in the same vehicle as noninfectious waste unless:

(a) infectious waste is enclosed in a separate container as provided in [NEW RULE VII]; or

(b) the infectious and any noninfectious waste being transported will be treated according to the requirements of 75-10-1005, MCA, and [NEW RULE VI].

(3) A transporter may not accept for transport any container of infectious waste that does not meet the requirements of [NEW RULE VII] or that shows visible signs of damage or leakage or is not properly sealed and labeled.

(4) A vehicle used to transport infectious waste must carry a spill containment and cleanup kit. A person who transports infectious waste must be trained in the use of protective equipment, emergency response, and spill containment and cleanup procedures.

(5) Each vehicle and container used to transport infectious waste must be designed and constructed to preserve vehicle and container integrity in the event of a traffic accident and prevent releases of infectious waste to the environment.

(6) A transporter shall keep records of the loading dates, volumes, sources, waste descriptions, and final destinations of all waste transported. The records must be maintained for five years and be made available for inspection by department personnel upon request.

(7) U.S. Department of Transportation warning and signage requirements for vehicles transporting infectious waste are provided in 49 CFR 172.323.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: In accordance with the legislative directive to adopt rules regulating transportation of infectious waste, NEW RULE V provides specific container, vehicle, and spill response requirements. These requirements are reasonably necessary to protect human health and the environment from contamination from spills of infectious waste.

NEW RULE VI INFECTIOUS WASTE TREATMENT AND DISPOSAL REQUIREMENTS (1) Infectious waste transported or managed under this subchapter must be treated and disposed of according to the provisions of 75-10-1005, MCA, and this section.

(2) Infectious waste that has been treated according to this section and 75-10-1005, MCA, may be disposed of in a licensed solid waste management facility approved by the department to accept treated infectious waste, provided the treated waste is not comingled with hazardous or radioactive waste.

(3) Infectious waste may be discharged into a sewage treatment facility as provided for in 75-10-1005(4)(b), MCA.

(4) Except as provided in (5), infectious waste must be treated using steam sterilization to the temperature, pressure, and time sufficient to ensure, within reasonable scientific probability, inactivation of geobacillus stearothermophilus spores and mycobacteria in the center of the waste load to achieve a 6 Log₁₀ reduction or greater.

(5) The department may approve alternative treatment methods submitted by a person or facility treating infectious waste, if the methods meet the requirements of (6).

(6) An application for alternative treatment methods must be supported by the results of laboratory tests that meet the following requirements:

(a) the laboratory tests shall be conducted:

(i) by qualified laboratory personnel;

(ii) using recognized microbial sterilization techniques documented in peer-reviewed scientific publications;

(iii) using samples inoculated with test organisms and then subjected to the proposed alternative treatment method; and

(b) the results of the tests must document and verify that the proposed alternative treatment method achieves the standards of inactivation provided in (2).

(7) Infectious waste consisting of recognizable human anatomical remains, including human fetal remains, shall be disposed of according to the provisions of 75-10-1005, MCA.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: The department is proposing NEW RULE VI to implement the requirements of 75-10-1005, MCA, and establish treatment standards for infectious waste that would render the waste noninfectious for the purpose of disposal at licensed solid waste management and sewage treatment facilities. The department believes that the standards of inactivation set forth in NEW RULE VI reflect the current industry standards, guidance from public health organizations, and environmental regulatory agencies. The standards are achievable and reasonable in the industry and are sufficient and reasonably necessary to protect human health and the environment.

NEW RULE VII PACKAGING, CONTAINMENT, AND STORAGE REQUIREMENTS (1) Infectious waste must be packaged, contained, and stored according to the provisions of 75-10-1005, MCA.

(2) A transporter or a person who stores infectious waste who is not a generator of infectious waste under 75-10-1006, MCA, shall ensure that infectious waste, other than sharps and liquid or semi-liquid infectious waste, is kept in containers as follows:

(a) in double-walled corrugated fiberboard boxes or equivalent rigid containers such as pails, cartons, or portable bins securely sealed or with tight-fitting covers sufficient to prevent spills, leaks, emission of infectious agents, and degradation; and

(b) reusable containers must be constructed of heavy wall plastic or noncorrosive metal. Reusable containers must be decontaminated after each use.

(3) A transporter or person who stores infectious waste regulated under this subchapter shall ensure that it is stored:

(a) in containers that are packaged and labeled as provided in this subchapter;

(b) separately from noninfectious waste in accordance with this rule and otherwise in accordance with the requirements of 75-10-1005(1) through (3), MCA;

(i) at a temperature of less than 45º Fahrenheit (F);

(ii) for no more than seven days at a temperature between 32º F and 45º F;

(iii) for no more than 30 days at a temperature of less than 32º F; and

(iv) with the temperature of the storage area logged daily in order to meet the requirements of this subsection. The transporter or person shall make the daily temperature logs and be made available to the department upon request.

(4) For (3)(c), time in transport is considered as time in storage.

(5) Infectious waste storage areas must:

(a) protect infectious waste containers from damage or degradation by moisture or from the elements;

(b) be ventilated to outside air;

(d) be marked with prominent warning signs identified by the biohazard symbol; and

(e) be designed to contain spills and have a spill kit that meets the requirements of [NEW RULE VIII] on site.

(6) Treated infectious waste must be bagged and labeled in accordance with 75-10-1005(5)(a), MCA.

(7) Compactors, grinders, or similar devices may not be used to reduce the volume of infectious waste during storage.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: The department is proposing NEW RULE VII to implement the provisions of 75-10-1005, MCA, and establish specific requirements for transporters who store infectious waste prior to and after treatment. The packaging, containment, and storage requirements being proposed provide a clear framework for members of the regulated community to follow to ensure the protection of human health and the environment.

NEW RULE VIII EMERGENCY SPILL RESPONSE AND DECONTAMINATION PLAN -- REQUIRED EQUIPMENT (1) An emergency spill response and decontamination plan must describe, at a minimum, procedures for:

(a) preventing access or exposure to the spill location by unauthorized persons;

(b) the containment of spilled or leaking infectious waste;

(d) reporting the spill or leak to the department and local authorities.

(2) A spill containment and cleanup kit must contain, at a minimum:

(a) absorbent material for spilled liquids;

(b) hospital grade disinfectant;

(d) a shovel, broom, and bucket; and

(e) protective clothing, including gloves, masks, and protective eyewear.

(3) A spill or release of infectious waste during transport, storage, or treatment must be reported to the department within 24 hours of the spill or release.

AUTH: 75-10-208, MCA

IMP: 75-10-1004, 75-10-1005, MCA

REASON: The department believes that these minimum requirements for an emergency spill response and decontamination plan and for spill containment and clean up kits is an efficient and effective means of protecting human health and the environment. Many transporters may not be familiar with the industry standards for contingencies in the event of a spill or leak of infectious waste.

4. Concerned persons may submit their data, views, or arguments, either orally or in writing, at the hearing. Written data, views, or arguments may also be submitted to Elois Johnson, Paralegal, Department of Environmental Quality, 1520 E. Sixth Avenue, P.O. Box 200901, Helena, Montana 59620-0901; faxed to (406) 444-4386; or e-mailed to [email protected], no later than 5:00 p.m., September 16, 2013. To be guaranteed consideration, mailed comments must be postmarked on or before that date.

5. Dana David, attorney, has been designated to preside over and conduct the hearing.

6. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name and mailing address of the person to receive notices and specifies that the person wishes to receive notices regarding: air quality; hazardous waste/waste oil; asbestos control; water/wastewater treatment plant operator certification; solid waste; junk vehicles; infectious waste; public water supplies; public sewage systems regulation; hard rock (metal) mine reclamation; major facility siting; opencut mine reclamation; strip mine reclamation; subdivisions; renewable energy grants/loans; wastewater treatment or safe drinking water revolving grants and loans; water quality; CECRA; underground/above ground storage tanks; MEPA; or general procedural rules other than MEPA. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to Elois Johnson, Paralegal, Department of Environmental Quality, 1520 E. Sixth Ave., P.O. Box 200901, Helena, Montana 59620-0901; faxed to (406) 444-4386; e-mailed to [email protected]; or may be made by completing a request form at any rules hearing held by the department.

7. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

8. With regard to the requirements of Chapter 318, Section 1, Laws of 2013, the department has determined that the adoption of the above-referenced rules will not significantly and directly impact small businesses, because the rules do not impose any fees and require persons regulated under the rule to provide information that those persons already maintain in the course of business operations.

Reviewed by: DEPARTMENT OF ENVIRONMENTAL QUALITY

/s/ John F. North BY: /s/ Tracy Stone-Manning

JOHN F. NORTH TRACY STONE-MANNING, Director

Rule Reviewer

Certified to the Secretary of State, July 29, 2013.