Presentation to the Mass Biotech Council 105 CMR 480.00 Minimum Requirements for the Management of Medical or Biological Waste Presentation to the Mass Biotech Council Law & Policy Summit July 9, 2009 Suzanne K. Condon, Associate Commissioner Director, Bureau of Environmental Health Massachusetts Department of Public Health

Outline Purpose and background of medical waste regulations Specific need for changes made in 2008 Issues of interest re: Biotechnology and DPH medical waste regulations Summary

MDPH vs. MDEP Dual Roles in Regulating Medical Waste and Disposal MDEP regulates disposal MDPH regulates efficacy of proposed methods to eliminate any public health threat

Purpose and background of medical waste regulations 105 CMR 480.000 These regulations specify minimum requirements for proper handling, storage and disposal of infectious or physically dangerous medical or biological waste in order to prevent the transmission of disease or the occurrence of injury associated with this material. Originally passed in 1989 pursuant to the authority of the State Sanitary Code (MGL Ch. 111 §127 A). Last amended in 2008, prior to that last revision was in 1994.

Specific need for changes made in 2008 US DOT pre-emption of MA regulations in 2004 Biotechnology by-product effluent (i.e., waste stream) revisions needed Chapter 172 of the Acts of 2006 (“The Pharmacy Access Law”) placed requirements on MDPH for the safe collection and disposal of home-generated sharps Effective 2005, the US EPA no longer recommended that residents throw their used needles in the garbage, but encouraged disposal of used needles through other means; such as, community drop-off programs, household hazardous waste facilities, or sharps mail back programs. An estimated 2 million needles per week are generated due to chronic disease and other medical conditions.

U.S. DOT Pre-Emption Issues The U.S. Department of Transportation issued a decision in 2004 regarding whether MA medical waste regulations relating to transportation of medical waste were pre-empted by federal DOT regulations. DOT concluded that MA medical waste regulations governing manifest and packaging requirements that were not substantially the same as federal regulations were pre-empted. DOT regulations are intended to ensure a uniform standard for shipping requirements applicable in all states.

Biotechnology Issues As biotechnology industry activities have increased, DPH medical waste regulatory requirements were no longer consistent with other regulations or guidance related to biotechnology management and disposal practices (e.g. to be consistent with State Plumbing Code)

Chapter 172 of the Acts of 2006 (Pharmacy Access Law) Changed role of MDPH in medical waste regulation Says that MDEP and MDPH “in conjunction with other relevant state and local agencies…shall design, establish and implement, or cause to be implemented a program for the collection and disposal of spent non-commercially generated hypodermic needles and lancets.” Chapter 172 further stipulated that “The program shall be designed to protect the public health and the environment by providing for the safe, secure, and accessible collection and disposal of hypodermic needles and lancets.”

DPH Advisory Committee on Biotechnology Included: Dr. Claudia Michelson            M.I.T. (former RAC Chair) Rick Mattila                              Genzyme  (also representing MBC) Sam Lipson                             Cambridge Health Department              Anthony Gemmalaro               Boston Public Health Commission Suzanne Condon                     MDPH, Associate Commissioner Director, Bureau of Environmental Health James Ballin                            MDPH, Deputy General Counsel Office of the General Counsel Steven Hughes                        MDPH, Director, Community Sanitation Program, BEH David Williams                        MDPH, Senior Environmental Analyst, Community Sanitation Program, BEH John Reinhardt                           MDEP

Biotechnology Amendments At the request of the Massachusetts Biotechnology Council (MBC), biotechnology by-product effluent (or waste stream) requirements updated and revised for continuity with State Plumbing Code (references added to NIH / CDC) Changes made with input from a MDPH Biotech Advisory Committee Definition of Biotechnology Byproduct Effluent references CDC/NIH Biosafety Lab (BSL) and Risk Group (RG) levels along with wastes “containing rDNA” Created provisions for Institutional Biosafety Committees (IBC) at biotechnology facilities and specified criteria for membership Establishes the Medical and Biological Waste Alternative Treatment Review Group (MBWAT)

III. Issues associated with 105 CMR. 480 of interest to Biotechnology III. Issues associated with 105 CMR 480 of interest to Biotechnology Community include: Disposal Definitions, and Clarification

Establishing an Institutional Bio-Safety Committee (IBC) Smaller firms in particular don’t have established community relationships Some find it difficult to establish a non-partisan membership DPH suggests that MA Biotech Council (MBC) establish an IBC that could serve as an umbrella IBC for firms without one DPH will be flexible in facilitating MBC’s efforts to establish an umbrella IBC The IBC is the foundation of the “due diligence” approach of our Medical Waste Regulations and authorizes an annual IBC protocol compliance review in lieu of a more stringent regulatory approach.

Clarification of disinfection/disposal Risk Group (RG) 1 & RG2 disposal in lab drains is fine if compliance with the MA Plumbing Code and other applicable regulations is maintained and the IBC conducts annual protocol / SOP compliance review Because of the due diligence approach of the regulations, they apply across the board in all respects, regardless of the size of the firm

Biotech by-product effluent (BTBP) disposal requirements DPH’s definition of BTBP remains the same, as in previous versions of 105 CMR 480 If the BTBP is defined as a liquid, and is found by the IBC to be an RG1 or RG2 waste, it can be disposed of in a lab drain without prior treatment or sent off-site for treatment If there is tissue or culture or similar media involving RG1 or RG2 to be removed from the site it must be sent for offsite treatment and logged. If it is an RG3 or RG4 waste it must be treated on-site and logged before disposal

Disposal requirements for animal waste bedding The regulations require that animal bedding be interred or incinerated only when “known to be infected” with designated agents or inoculated with infectious agents DPH will issue written approval of autoclavings as an alternative treatment when presented with acceptable associated policies and procedures (i.e. NBSA’s submission of BMBL Decontamination of Spent Animal Bedding SOP) and QA/AC efficacy data

IV. Summary 2008 amendments update various aspects of regulations to reflect current standards and procedures (including for biotechnology industry), restore documentation requirements related to tracking of medical wastes, and provide for requirements in response to new Pharmacy Access Law MDPH received over 100 comments on proposed amendments and incorporated clarifying language or revisions, where appropriate, in response to comments MDPH will continue to work closely with industry and the council to provide clarification and other information regarding compliance with medical waste regulations via meetings, development of informational materials, and other venues