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Environmental Health & Safety:

Overview, Hot Topics and Relevance to Research Administration

Bruce Backus, Assistant Vice Chancellor Environmental Health and Safety Washington University in St. Louis

Society of Research Administrators International Annual Meeting - Chicago-O'Hare, Illinois October 18, 2010

Learning Objectives

· Role and function of Environmental Health and Safety (EH&S) · Current EH&S issues that are having significant impact on research institutions · EH&S and research administration function overlap

­ Recommendations on how to improve:

· Delivery of services to researchers · Safety and compliance oversight

My Background

· Washington University in St. Louis EH&S

­ 1998 to present

· University of Minnesota EH&S

­ 1988 to 1998

· President-elect Campus Safety Health & Environmental Management Association (CSHEMA), www.cshema.org · Past chair, EPA Colleges and Universities Sector Coordinating Committee

­ ACE, APPA, C2E2, CSHEMA, EPA, HHMI, NACUBO

· Past EH&S consultant · Past adjunct faculty, U of MN

Washington University in St. Louis

· · · · · 7110 undergraduates 6650 grad/prof students 3290 faculty 7700 staff 221 acres

­ Plus 2000 acre ecological research center

· 16M Gross Square Feet

­ 1.4M Lab GSF

· $567M annual research · $2B annual budget · $4.1B endowment

2009 Data

Learning Objective 1

OVERVIEW OF ENVIRONMENTAL HEALTH AND SAFETY

Overview of Environmental Health & Safety (EH&S)

· A Compliance Office · A Service & Operations Department · Typical Divisions

­ Biological & Chemical Safety

· Research & Clinical Safety

­ Environmental Compliance

· Hazardous Materials Management & Disposal

­ Occupational Safety

· Indoor air quality, ergonomic reviews, exposure monitoring, accident investigation, etc.

­ Radiation Safety

Typical EH&S Organization

Director Environmental Health & Safety

Administrative & IS&T Support

Biological & Chemical Safety

Environmental Compliance

Occupational Safety

Radiation Safety

As an alternative, a (very) few organizations cross-train their front line staff to handle all safety/compliance questions/operations/oversight for customer departments, so they do not have the divisional breakout by expertise or compliance area Small schools may have one to three individuals who manage all functions, with assistance by contractors

EH&S Organization Models

· Sometimes, EH&S functions are split into two departments · EH&S may report to:

­ ­ ­ ­ Administration and/or Business Research Facilities Human Resources and/or Insurance ­ Risk Management

· Organizational models do not matter, as long as programs are effective and there are open lines of communication with, and support from, the top levels of the organization

Some of the Regulatory and Accreditation Agencies Impacting Areas of EH&S Oversight

· · · · · Environmental Protection Agency (EPA) Occupational Health and Safety Administration (OSHA) Nuclear Regulatory Commission (NRC) National Institutes of Health (NIH) recombinant DNA (rDNA) Guidelines Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA) and Department of Justice (DOJ) ­ Select Agent (SA) Transfer ­ USA PATRIOT Act SA possession, management and control U.S. Department of Transportation (DOT), Federal Aviation Administration (FAA), International Air Transportation Association (IATA) - Shipping & Transporting Dangerous Goods National Fire Protection Association (NFPA) Building Officials Code Administrators (BOCA) Publicly Owned Treatment Works (POTW) / Metropolitan Sewer District (MSD) College of American Pathologists (CAP) Export Controls: Dept. of Commerce, State Dept., Dept. of Treasury, etc. Granting Agencies: Department of Defense (DOD), National Science Foundation (NSF), American Heart & Lung Assoc., NIH, etc.

· · · Department of Homeland Security (DHS) Chemical Facility AntiTerrorism Standards (CFATS); security concerns State EPA (state environmental & occupational safety agencies) Drug Enforcement Agency (DEA) & State Bureau of Narcotics and Dangerous Drugs (BNDD) ­ acquisition, uses and disposal of regulated narcotics and drugs State Department of Health and Human Services (DHHS), Bureau of Health Services Regulation, & local Departments of Health ­ Coordinate with Infectious Disease Div. - Infection Control for WU Clinics ­ X-ray Safety & Registration, Sanitation FBI, local law enforcement & fire departments ­ Bio-Rad-Chem terrorism & Emergency Preparedness Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) ­ Environment of Care Local fire, building and health codes Alcohol, Tobacco and Firearms (ATF) ­ Alcohol storage and use Federal Emergency Management Association (FEMA) - Disaster planning Lab ventilation & Safety Equipment - American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and American National Standards Institute (ANSI) Standards

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· ·

· · · · · ·

· · · ·

Federal regulatory guidance documents for the environmental protection area alone. Does not include state and local environmental requirements, or other EH&S areas.

Overview of EH&S

· Biological and chemical Safety · Environmental Compliance

­ Air, water, tanks and waste permits ­ Hazardous waste (chemical, infectious & pathological) collection, management and disposal ­ Electronic equipment, white goods, etc., recycling ­ Chemical spill response ­ Laboratory decommissioning ­ Sustainability and recycling ­ Real estate property assessment ­ Training (Research & Clinical safety) ­ Institutional Biological and Chemical Safety Committee (IBC) administration ­ Recombinant-DNA and NIH-required protocol reviews ­ Inspections/audits ­ Grant certifications ­ Select Agents permitting ­ USDA/CDC Import/Export Permits ­ Shipping "Dangerous Goods" ­ Training

Overview of EH&S

· Occupational or General · Radiation Safety Safety ­ Accelerator and x-ray safety

­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ Accident/injury reviews Asbestos management Ergonomic reviews Exposure monitoring Fire & life safety Indoor Air Quality (IAQ) reviews Lock out/Tag out Noise dosimetry Construction Safety Confined Space Respiratory protection Training

­ Nuclear Regulatory Commission (NRC) Broad Scope and unit specific licensing ­ Authorization for Radioactive Material (RAM) use ­ Laser, research magnet, ultra-violet (UV) & extremely low frequency (ELF) safety ­ Delivery of RAM and collection of radioactive waste ­ Radioactive material surveys/inspections ­ Emergency support ­ Training

Institutional Safety Committees

· Several institutional committees usually exist to meet regulatory requirements, to establish policies and to promote safety · EH&S staff usually serve on, or administer, many these safety & compliance committees · Committee membership typically includes:

­ Faculty ­ Staff ­ Public representatives

Institutional Safety Committees

· Animal studies committee

­ At WU, administered through Office of the Vice Chancellor for Research (OVCR) ­ Meet Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) requirements

· Hospital infection prevention committee

­ Usually administered through the hospital

· Institutional Biological and Chemical Safety Committee (IBC):

­ Typically administered through EH&S

Institutional Safety Committees

· Human Subjects Research (Institutional Review Board, IRB, Human Studies)

­ At WU, administered through School of Medicine

· Radiation Safety Committee (RSC)

­ Typically administered through EH&S

· Facilities and Art department safety committees

­ Typically administered by the facilities (physical plant) and Art departments, but EH&S has strong presence on the committees and safety activities

Protocol Approval Processes

Series, or

Biological and Chemical (IBC)

Parallel

Biological and Chemical (IBC)

Final Approval

Rad. Mat. Auth.

Animal Studies

Human Studies (IRB)

Animal Studies Human Subjects (IRB) Radioactive Material Authorization

Time and efficiency considerations: · Most committees meet on a monthly basis for protocol review and approvals · Series process involves a hand off from one committee to the next · If protocol is sent back to the Principal Investigator, can add a month or two to the overall approval process · At WU, Animal Studies and IRB want IBC and Radioactive Material approval before they will approve a protocol

Final Approval

How Much Does EH&S Cost?

· Approximate rule of thumb:

­ About one (1) percent of research revenues ­ Includes labor and hazardous or regulated waste disposal costs

University of North Carolina Chapel Hill Purdue University New Mexico State University Emory University Georgetown University Washington University in St. Louis University of Delaware University of Kentucky University of Pennsylvania University of Michigan University of Alabama Birmingham North Carolina State University Harvard University Arizona State University University of Missouri - Columbia 0.50% 0.57% 0.66% 0.78% 0.78% 0.81% 0.85% 0.86% 0.89% 0.94% 1.00% 1.06% 1.13% 1.28% 1.28%

· Caveat

­ Small population of data

How Big of an EH&S Program?

· The only statistically significant indicators for the size of an EH&S department are:

­ Net Assignable Square Footage (NASF) of laboratory and clinic space ­ NASF all other space ­ Whether an institution has a medical school or veterinary school ­ Whether the institution has Biological Safety Level 3 (BSL3) or higher research facilities ­ Research revenue is NOT a statistically significant indicator

Source: Study by B. Emory, et al, 2009, University of Texas Houston Medical Center

Average EH&S Cost Breakdown

· Regression modeling estimate:

­ $3.12/NASF lab or clinic/year, plus ­ $0.12/NASF all other space/year

· Based on study of approximately 170 colleges and universities

Source: B. Emory, et al, 2009, University of Texas Houston Medical Center

Learning Objective 2

EH&S HOT TOPICS

EH&S Hot Topics

· Safety Concerns · Regulatory Compliance Concerns

­ Escalating enforcement and expectations of perfect compliance ­ Security ­ New regulations

· Programmatic Concerns

­ New science ­ unknown hazards and risk ­ Do more less and proper risk balance for institution

· Other

­ Emergency preparedness ­ Sustainability

Hot Topics

SAFETY CONCERNS

Safety Concerns Laboratory Fires & Explosions

· UCLA Fatality

­ December 29, 2008 ­ lab fire, 23-year old research assistant died Jan. 16, 2009, t-butyllithium transfer

· Pyrophoric; ignites on contact with air

­ No personal protective equipment (PPE)

· Questions about procedure and apparent lack of training

· Texas Tech Injury

­ January 7, 2010 ­ serious burns and lacerations, 29-year old graduate student in critical condition, nickel hydrazine perchlorate exploded

· SIU-Carbondale Hexane Fire

­ June 2, 2010 ­ destroyed lab, $1M damage

· University of Missouri ­ Columbia - Injuries

­ June 28, 2010 ­ hydrogen explosion in laboratory, 4 injured, 1 admitted to hospital for

overnight stay

· http://munews.missouri.edu/news-releases/2010/0709-investigation-of-schweitzer-hall-explosion-complete/

Explosions/Fires in Labs

Fire Safety

· Failure to keep materials 18 inches below fire sprinkler heads and detectors,

­ allows fires to spread

· Blocked egress corridors , · Blocked safety equipment,

­ Eyewash, showers

· And lack of fire drills · Can exacerbate problems

Example of Improperly Secured Gas Cylinders

· Secure at all times using either chains or straps · Cap when not in use · Transport using a cylinder dolly · Do not store incompatible gases together · Label cylinders "empty" and re-cap when gas is depleted · Use correct pressure regulator! · Clearly identify contents of cylinder

· Advance warning about next slide ­ graphic content

Chemical Burns

Laboratory Fires & Explosions

Pyrophoric fire (trimethylgallium and trimethylalluminum)

Sawdust fire (overheated by drying element)

· Issue has gained enough attention that the

­ U.S. Chemical Safety Board, which normally investigates major industrial chemical accidents and explosions, is now investigating college and university laboratories accidents and explosions

"Science" Journal On-line and American Chemical Society editorials

"...the duty to make absolutely certain that all workers from the lowliest sweeper to the most exalted investigator - understand and follow safety rules rests with the lab chief and his or her superiors." · It is Principal Investigator's responsibility to make sure safe practices happen in their research and teaching laboratory and shop areas

Create a Culture of Safety

"Schools have a 10 to 50 times greater frequency of accidents than does the chemical industry, lab safety expert James A. Kaufman says. `It's 100 to 500 times greater than in places like Dow and DuPont,' "Academics are often unwilling to follow rigorous safety protocols established by someone else because it's just not part of the culture. For graduate students, he says the situation is even worse. "Ninety-five percent of the graduate students I have polled said they would not report a safety hazard" because they fear reprisals from faculty or staff, Kaufman recounted." [Emphasis added] - Chemical & Engineering News, American Chemical Society, May 23, 2005, Volume 83, Number 21, pp. 34-35 · Encourage everyone to raise safety and compliance concerns, and to address those concerns promptly

EH&S Safety Training Reminders

· Ensure everyone:

­ Has proper safety and compliance training

· Both institutional/EH&S and · Site-specific (laboratory or workplace) training

­ Uses proper engineering controls and personal protective equipment (PPE) ­ Knows hazards (found in Safety Data Sheets (SDS)) (formerly Material Safety Data Sheets (MSDS)) & follows proper procedures ­ Has the ability to get safety & compliance questions answered promptly ­ Documents training, particularly site-specific training

Safety Question

· What is typically the leading cause of serious accidents at colleges, universities and all industry?

­ Slips, trips and falls ­ OSHA is considering adopting a slip, trip and fall standard

In the first half of 2010, Slips, Trips and Falls account for less than 20% of WU Injuries

However, in the first half of 2010, Slips, Trips and Falls account for over 70% of Loss Costs

Slips, Trips and Falls (STF) (Top 7 STF accidents): 302 Lost Work Days, and 297 Restricted Duty Days in the first 6 months of the year

Other High Priority Safety Concerns

· · · · · · · · · Violence against persons ­ personal security Behavioral health concerns, including depression; alcohol and narcotics use Shooter on campus Disaster preparedness ­ storms, earthquake Infectious diseases, e.g. H1N1 Fire safety, particularly in student housing Carbon monoxide safety Vehicle/driver safety Student events

­ Bubble parties, construction of student projects, catapults, fireworks, international food events prepared onsite by students, special services involving fire, pyrotechnics or candles, all-night dance marathons or relay races, car smashes, certain art projects, etc.

Haz Mat Suicides and Poisonings

· Detergent suicides ­ hydrogen sulfide

­ 2008 and on ­ California, Georgia, Canada, Japan

· Cyanide suicide, 2010

­ Pace University

· HazMat Scare Manhattan subway

· Azide poisonings, 2009

­ Harvard University ­ University of Kansas

What Safety Trends Should You Track?

SAFETY METRICS

Lagging Safety Metrics to Track

· Loss costs associated with worker's compensation injuries · OSHA Recordable Injury-Illness rates

­ Or Days Away, Restricted Duty (DART) rates

Loss Costs Associated with WU Injuries

Injury-Risk Mitigation

· EH&S targets high risk areas for interventions

­ Development of safety teams within departments ­ High level of scrutiny and reporting ­ Accident and illness reviews

Occupational Injury ­ Illness Rate

(Number of OSHA recordable accidents/100 employees)

Healthcare Sector

WUSM College & Univ. Sector (Yellow) WU overall Danforth Campus

WU Has Received 16 Safety and Environmental Awards and Recognitions since 2000

Year 2009 2008 2008 2007 Award 3 National Safety Council Occupational Excellence Achievement Awards Campus Safety Health and Environmental Management Association (CSHEMA) Complete Program ­ Award of Merit Ranked 8th out of 135 colleges and universities, and given a grade of A, in the Reader's Digest 2008 Campus Safety Survey OSHA Voluntary Protection Program (VPP) recognition for Washington University's construction of the BJC Institute of Health and Washington University EPA Regions 6 & 7 Blue Skyways Collaborative Partnership Award EPA Recognition for Environmental Leadership and Commitment to Sustainability Missouri Governor's Award for Environmental Excellence and Pollution Prevention Environmental Excellence Award from the Choose Environmental Excellence Gateway Region

2007 2006 2003 2000

Leading Safety (and Compliance) Metrics to Track

· Numbers trained

­ Classroom, on-line ­ Exam scores to verify knowledge transfer ­ Hands-on training and performance · Ranges from use of fire extinguishers to manipulation of biological safety level - 3 (BSL3) and higher organisms

· Audit results, drills, certifications, surveys, spot checks on performance, risk-based interventions, plans · Active school, department/division safety and compliance committees

­ Track and post trends in positive, as well as negative, behaviors

· Educates faculty, staff on students on positive behaviors

Hot Topics

EH&S REGULATORY COMPLIANCE CONCERNS

Compliance

· Every Federal EH&S-related compliance agency has announced enforcement initiatives and/or escalated penalties /oversight

· EPA, OSHA, etc.

· Environmental Protection Agency (EPA) enforcement initiatives are directed at colleges, universities and hospitals:

· 2000, Enforcement Initiative for colleges and universities · 2000, "Recommendation" to self-audit and report

­ Rutgers University was the first to self audit under this policy

Compliance

· Special focus is being put on the college and university sector by:

· Department of Homeland Security (DHS) · National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) · Federal Aviation Administration (FAA) · Department of Transportation (DOT)

The Number of EH&S-Related Statutes/ Regulations Continue to Increase

Environmental Regulatory Actions YTD: 5,661 9/28/10

WU's Experience ­ Number of Regulatory or Accreditation Inspections by Year

Includes EPA, NRC, OSHA, NIH, Fire Marshal, FAA, DOT, JCAHCO, DEA, etc. Each inspection averages out to the equivalent of at least a week's worth of work on the part of an EH&S staff member

Examples of EPA Hazardous Waste Fines & Penalties

Year

2005 1997 2000 2002 1997 1998 2002 2002 2001 2000 2001 2008 1995

Name

Barnes Jewish Hospital Boston University Brown University Columbia University MIT Stanford University University of Hawaii Univ. of MA ­ Amherst Univ. of MO ­ Columbia Univ. of New Hampshire Univ. of Rhode Island Washington University in St. Louis Yale University

Proposed Penalty

$497,000 Unknown $500,000 $797,029 "Several $ million" Unknown $1,800,000 $262,700 (CAA) $1,000,000 $308,000 $800,000 $147,000 Unknown

Settlement

$92,000 $253,000 $80,000 $100,000 $150,000 $1,000,000 $505,000 $40,000 $582,296 $49,000 $250,000 $15,000 $69,600

Supplemental Environmental Project(s)

Required, documented weekly inspections all labs

$500,000 $285,000 $606,166 $400,000 (reported to be > $1M) Unknown $1,200,000 $128,000 (and new facility, 3 staff, chemical

tracking )

> $1,000,000 $180,000 $550,000 + compliance audit $45,000 clean out chemicals in St. Louis Public Schools $279,000

In each instance, it took several years to reach a settlement ­ WU example, settled in 2010, to be finalized in (?) 2011 to 2012

EPA Academic Laboratories Rule

· Subpart K to the Resource Conservation and Recovery Act (RCRA), December 2008

­ Voluntary opt-in feature

· Many advantages for colleges and universities

­ Estimate annual cost savings of $1,000 to $12,000

· Colleges and universities have been slow to adopt

­ Fear of trading a known, burdensome regulatory system for new system with unknown compliance and enforcement burdens

· Several institutions are testing the new program

­ Applies only to labs, therefore need to operate under two compliance schemes ­ Approximately 19 states have adopted the rule and another 14 in process or in planning

PCBs in Building Materials

· EPA issuing alerts about polychlorinated biphenyl compounds (PCBs) in caulk and other building materials

­ Buildings built between 1950 and 1980

­ http://www.epa.gov/pcbsincaulk/guide/guide-sect1.htm

­ May cost some institutions hundreds of thousands to millions of dollars to address

­ http://www.myfoxboston.com/dpp/news/undercover/toxic-chemicals-used-to-build-oldermass-schools-20100916

Department of Homeland Security

· Chemical Facility Anti-Terrorism Standard (CFATS)

­ http://www.dhs.gov/files/laws/gc_1166796969417.shtm ­ Chemicals of Interest

· Release, Theft or Diversion, Sabotage or Contamination

­ Complete a Top Screen if exceed Threshold Screening Quantities (TSQ)s

· Report within 60 days

­ ­ ­ ­ ­

Tiered I through IV, I being most restrictive/most regulated Security Vulnerability Assessment Site Security Plan - >200 hours to complete Or, Alternate Security Programs DHS concerned colleges and universities have not been diligent in meeting CFATS requirements

Nuclear Regulatory Commission

· Impact of "Increased Controls" security requirements · Accelerator - cyclotron produced materials now under NRC regulatory control · Patient release after treatments with I-131 and administration other radioactive isotopes · Decommissioning requirements · National Source Tracking · New training and experience requirements for Authorized Users, Medical Physicists and Radiation Safety Officers

NRC Increased Controls

· Security background checks for individuals with access to irradiators and sources that could potentially be used to make dirty bombs ("Trustworthy and Reliable" (T&R) authorizations)

­ Affects animal research irradiators, blood banks irradiators, gamma knives, etc. ­ Employee background check, finger prints submitted for FBI review, required training, access control, etc. ­ WU estimates it will cost between $60 to $250 per person to do background checks under proposed guidelines

· Guidance on Proposed Protection of Byproduct Material

­ Part 37 to Title 10 of the Code of Federal Regulations, 75 FR 33902 & 40756

­ Proposed rule would expand requirements to people who have access to multiple locations, where total activity would trigger NRC security requirements

Accelerator - Cyclotron Produced Radioactive Materials

· Roll-out in past two years · NRC now requires separate license (from Broad Scope license for other radioactive material authorizations) · Increased regulatory scrutiny and oversight

Debate over Patient Release

· Patients given high activity, short half-life radioactive materials to treat cancers

­ Dose concerns due to close proximity for short period after patients are released ­ Excrete radioactive material through sweat, saliva, vomit urine and feces ­ "Radioactive Roulette"

· Edward J. Markey (D-MA), Chairman, Subcommittee on Energy and Environment, Energy and Commerce Committee, U.S. House of Representatives, March 18, 2010

­ See also http://www.nytimes.com/2010/01/24/health/24radiation.html?_r=1&pagewanted=2

NRC Decommissioning Requirements

· After decades of using radioactive materials, as companies or universities close out facilities for demolition...

­ NRC notes that documentation at many institutions is insufficient to confirm radioactive material contamination does not exist

· Results in costly surveying of facilities and significant delays in starts of new projects

National Radioactive Source Tracking

· National database

­ http://www.nrc.gov/security/byproduct/nsts.html

· Radiation Safety Officer

­ Security background check ­ Secure card reader and PIN code to enter information into national database

"New" NRC Required Training and Experience Requirements

· Medical Care Facilities (MEDICAL 10 CFR 35.50)

­ Affects:

· Radiation Safety Officers · Medical Physicists · Medical Authorized Users

­ Impact

· Difficult to find qualified individuals · Difficult for physicians to transfer preceptor statements from one medical center to another in order to qualify · NRC agreement states now adopting rule

Drug Enforcement Agency (DEA)

· Requirements in place for a long time, but renewed emphasis

­ http://www.deadiversion.usdoj.gov/21cfr/cfr/2100cfrt.htm

­ Researchers need proper licensing

· Separate from medical care license ­ check state requirements

­ Security measures and inventories need to be maintained ­ Everyone with access must go through DEA Narcotics and Dangerous Drugs Information System (NADDIS) background check ­ Proper addresses on licenses

DEA

· Reviewing institutional programs, if the · Concern about improper diversion

Federal Aviation Administration (FAA)

· Shipping Dangerous Goods · Random Inspections

­ Institutions with proposed penalties

· Examples include: Cornell University, Dartmouth Hitchcock Medical Center, MIT, Northern Arizona University, Stanford University, Texas Tech., Texas A & M University, University of California Berkeley, University of Oklahoma, University of California, and Washington University

­ Often requires extensive compliance and operations programs to be established

· Pushing for centralized shipping of all dangerous goods

Federal Bureau of Investigation (FBI)

· Investigating shipments of research materials out of the country (exports), particularly by graduate students and post doctoral fellows

­ Concerns about reverse engineering and intellectual property issues ­ Concerns about Export Controls

· Major chemical and biotechnology vendors

­ Notified colleges and universities they are reporting suspicious orders to FBI

Proposed Amendments to the Select Agent Rules

· Proposing to Tier biological agents and toxins of concern (existing Select Agents)

­ Potentially can be used as biological warfare agents

­ http://edocket.access.gpo.gov/2010/2010-17728.htm

· Oversight stays with CDC and USDA, but DHS will oversee security requirements · All depends on how the rule will be implemented

­ Will it place more onerous requirements on top of existing rules, or will it relax security requirements for agents deemed not as hazardous (lower tiers)

­ http://cstsp.aaas.org/Competing_Responsibilities/index.html

Biological Safety Concerns

· 2009, University of Chicago researcher dies

­ Vaccine strain of Tularemia + immune deficiency

· 2005, PhD researcher, microbiology, doing research in New Zealand's Meningococcal Vaccine Antibody Testing Laboratory loses legs and arm to infection

­ Meningococcal septicemia

· 2003, federal research facility scientist in coma for one month

­ E. coli O157:H7

Proposed Amendments to NIH Recombinant DNA Guidelines

· Closing loophole that allows synthetically produced biological agents of concern to fall out of NIH guideline requirements

­ Federal Register /Vol. 74, No. 41 /Wednesday, March 4, 2009 /Notices / 9411

· Exempts certain low-risk transgenic rodent breeding experiments from the NIH Guidelines for Research Involving Recombinant DNA Molecules

­ Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices / 42114

Nanotechnology

· New science · Unknown safety risk · For now, using high efficiency particulate absorbance (HEPA) air filtration for most applications · Proposed National Nanotechnology Initiative 2010 budget - $1.76B

­ http://www.nano.gov/

­ http://www.dtsc.ca.gov/technologydevelopment/nanotechnology/index.cfm

Chemical Inventories

· Required by multiple regulatory agencies

­ OSHA, EPA, DEA, DHS, CDC Select Agent toxins, Fire Marshal and Building Code Officials

· Until recently, in many parts of the country, not enforced for colleges and universities · Hundreds-to-thousands of containers in hundreds-to-thousands of laboratory rooms

­ Tremendous time burden to get initial inventory and to maintain on regular basis

­ At least three years to get process running smoothly

Hazardous Material Security Requirements

· Lack of continuity between CDC/USDA , NRC and DHS requirements

­ For example, personal background checks

· CDC/USDA and NRC have different procedures, costs and approval processes for having fingerprint background checks done by FBI · Different personal surety processes · Approval by one does not confer approval by other

­ Security plan requirements

· DHS appears to want more restrictive access control for chemicals, than is required by CDC/USDA for biological agents and NRC for radioactive materials

Hot Topics

EH&S PROGRAMMATIC CONCERNS

Do more with less

900,000

Demand for WU EH&S Services

# of new Permits issued # of new irradiator operators # of new Radiation Workers # of close-out surveys

· WU Example

­ Budget cuts past two years totaling 8% ­ Research protocols, research space and demand for (regulatory required) EH&S services continues to rise

800,000

700,000

# of NOV issued

# of deficiencies cited during inspections

# of lab inspections by Rad Safety

600,000

Radioactive Materials (Waste & Packages, assume 1 lb per package) Rad Carcass DIS (# cubic feet x 20 lbs per cuft)

500,000

Rad Liquid DIS (# of gallons x 9 lbs per gallon)

Rad Dry Decay-in-Storage (pounds - assume 10 lbs per cubic foot)

400,000

Liquid Scintillation Media waste shipped offsite

Dry radwaste shipped offsite

# of radwaste containers received from labs

300,000

# of radioactive packages received

Emergency Preparedness Meetings/Drills

200,000

Fire Drills/Inspections/Evacuations

Asbestos Inspections

HazCom/Safety Reinspections

100,000

HazCom/Safety Inspections

Construction Site Inspections

0 1992 1994 1996 FY98 FY00 FY02 FY04 FY06 FY08 FY10

Construction Meetings

Injury Investigations

Steps to Address Increased Workload

· Risk-based approach to safety and compliance · Increased use of technology

­ Databases ­ Web tools

· On-line training and protocol registrations

Radiation Safety Inspections, Identified Deficiencies & Notices of Violations

350

Total number of inspections reduced with start of authorization inactivation option & general reduction of radioactive material use

300

250

Total number of inspections reduced with transition to riskbased inspection frequencies

200

150

­ Scanning documents

100

· Education and Delegation of responsibilities to departments · Hire right people with "can do" attitude, who think out of the box, have research experience, good people skills and education to give them credibility in this academic environment

50

0

3rd '01 3rd '02 3rd '03 3rd '04 3rd '05 3rd '06 3rd '07 2nd '01 2nd '02 2nd '03 2nd '04 2nd '05 2nd '06 2nd '07 2nd '08 3rd '08 4th '01 4th '02 4th '03 4th '04 4th '05 4th '06 4th '07 4th '08 1st '01 1st '02 1st '03 1st '04 1st '05 1st '06 1st '07 1st '08

0 Points

1-25 Points

>25 Points (NOV)

Repeat Deficiencies (NOV)

Example: Radiation Safety decreases the number of compliance inspections (which required a lengthy Radiation Safety Committee approval and NRC license amendment process), with no measureable reduction in safety or compliance

Sustainability

· EPA requirement to report greenhouse gas (GHG) emissions in 2011

­ Required to track now in 2010

· Institutional sustainability goals ­ WU Example:

­ http://www.wustl.edu/initiatives/sustain/

· External rating programs and initiatives

­ LEED, http://www.usgbc.org/ ­ AASHE STARS, http://www.aashe.org/ ­ College and university presidential climate challenge

Emergency Preparedness

· Tremendous focus

­ EH&S is part of the team and, in some cases, leads the institution's efforts

Higher Education Opportunity Act 2010

· New campus fire and safety requirements

­ Must report annual fire statistics - student housing ­ Must post policy statement about notifying campus community during emergencies

· Procedures to immediately notify campus community

­ Describe process on how notifications will be made ­ Describe process on how information will be shared with larger community

· List titles of those responsible for activating system · List procedures on how the system will be tested

EH&S Program Concerns

· Funding models

­ Often not aligned with workload demands or compliance requirements ­ Sometimes incents "wrong" behavior

· If lab personnel do not get billed for hazardous material disposal costs, they are not incented to minimize these costs, rather purchase chemicals in bulk for cheaper pricing

· Risk balance

­ As you roll back EH&S and other compliance office staffing and resources, what level of risk does that add to the institution?

· A few institutions are addressing this by having an external review to verify risks are not outside of reasonable bounds

EH&S Concerns

· Shortage of educated, trained and experienced job applicants

­ Particularly

· Radiation Safety ­ health physicists and radiation safety officers · Biological Safety ­ Select Agents permitting, with needed viral, bacteriological, fungal, recombinant DNA and chemical risk assessment expertise

­ WU, under a federal grant, developed post doctoral program to train people to become biological safety officers

» http://mrce.wustl.edu/index.php?page=training

Learning Objective 3

EH&S AND RESEARCH ADMINISTRATION FUNCTION OVERLAP

Overlap

· Compliance Offices ­ similar roles

­ Education ­ Policy and procedures development ­ Audit and oversight responsibilities ­ Reporting ­ Both "intrude" in research settings with "unfunded" mandates ­ Sanctions as needed ­ Try to minimize regulatory compliance burdens ­ Compete for resources

Best Practices

· Regularly assemble all area-specific compliance office representatives

­ Share

· Best practices · Benchmarking information and trends · Problem areas

­ Task groups to develop tools to minimize compliance burden on researchers and compliance offices

Best Practices

· Set direction for the consortium of compliance offices at your institution

­ Facilitate compliance with federal, state and local laws, regulations as well as University or School policies

· Provide easy access to the tools necessary to accomplish researcher roles and responsibilities

­ Oversee implementation of strategies to enhance compliance ­ Identify issues that act as barriers to effective compliance ­ Assure communication and coordination between offices and programs responsible for compliance operations ­ Identify risks that need greater attention by compliance offices ­ Establish methods to reduce or manage duplication or conflicts that may arise with the implementation of new compliance policies, regulations or strategies ­

Best Practices

· Create compliance guides · Create a compliance website

­ Links to compliance offices ­ Links to compliance policies ­ Links to guides and compliance profile tools

· Compile a compliance policy inventory

­ Standardize required policy sections and format ­ Define policy approval process

· Assess ways compliance offices can reduce the number of communications and intrusions into research settings

­ Reduce the number of inspections by separate compliance offices and number of reminders about various compliance training requirements

Best Practices

· Ensure compliance databases can communicate with one another ­ improve overall approval process

­ Example, animal studies database cannot communicate or share information with other compliance databases

· Develop a mechanism for identifying individuals or departments with common or repetitive compliance issues

­ Tendency if problem in one compliance area, they have problems in others

· Create single sign-on and verification for college or university (computer) information systems and auto-passing from one system to another

Best Practices

· Make it a cooperative effort in rolling out new compliance programs

­ All compliance programs support one another

· Support roll-outs in compliance area specific communications

· Share resources

­ For example, two or three compliance offices can partner to fund Information Systems and Technology (IS&T) support staff ­ Share communication and education systems

· For example, WU "Research News" and "Research Administrator Forums"

· Develop a mentality and culture of a team working towards a common goal

­ Too easy to get swamped by area-specific compliance requirements, with tight deadlines, and forget all compliances offices often face the same challenge

Best Practice

· Compliance Profile tool!

­ Big return

· Praise by users and departmental administrative officers

­ Major effort

· Multi-year · Multi-compliance office effort

On-line Compliance Profile Tool

· Introduced for faculty in November 2008 · Tool to reduce compliance burden · Web-based questionnaire that identifies compliance and education requirements

­ that have been completed ­ that need to be completed

· Allows easy query capability for faculty and department business managers · Single log-in ID and password (used for all WU systems)

­ Links from WU Research Gateway and other sites

· Over 1,100 faculty currently using the tool

2010 Enhancements to Tool

· Made enhancements recommended by faculty · Profile tool now available for staff, post doctoral fellows, and graduate students with an employee appointment · Roll-out FY11

­ Communication and Education campaigns

· By FY12, mandatory for faculty, staff, graduate students and post doctoral fellows

Compliance Profile Accessed Through Research Gateway and Other Web Links

3

Select

http://research.wustl.edu "Research Gateway"

1

2

Log-in

Benefits

· One location to identify (almost) all compliance requirements

­ Exception: due to open nature of database, NRC Increased Controls requirements are tracked separately

· Direct access by users · Improves compliance reporting for individuals, departments and compliance offices · Same log-in ID and password as used for other university business · Information in tool is customized - based on job position and profile responses

Developed by Several

University Compliance Offices

· Environmental Health and Safety · Research Administration · Office of Physician Billing and Compliance · HIPAA Privacy Office · Medical School Central Technology Services Radiation Safety Office Information Systems Office of General Counsel Human Resources Office University Compliance Office · Tested by selected faculty and staff members · · · · ·

Penn's Counterpart - Penn Profiler

· "Penn Profiler" is the front end of the University's Learning Management System

­ The LMS is "owned" by Penn's Health System ­ EHRS was the driver to establish a web based tool to identify training needs. A paper, then email attempts had been in place since the mid-1990's. Low response rate was a chronic problem. ­ Many offices had a part in developing the Profiler as those offices had training requirements as well. ­ HR does not participate?

PENN Profiler Rollout

Almanac - Journal of record, opinion and news Of Record · March 18, 2008, Volume 54, No. 25 · Penn Profiler is an annual training needs assessment survey that is expected for all faculty and staff at Penn, in accordance with the President, Provost, and EVP. The brief (5-15 min.) online tool proactively promotes safe work practices in conformance with regulatory requirements and best practices. Penn Profiler identifies training needs and assigns the appropriate courses in Penn's Knowledge Link learning management system.... --Amy Gutmann, President --Ronald Daniels, Provost --Craig Carnaroli, Executive Vice President

Thank You!

· Contact Information

­ ­ ­ ­ Bruce Backus [email protected] 314-935-9882 http://ehs.wustl.edu/

· Questions?

Additional Information

EH&S PROFESSIONAL ASSOCIATIONS

EH&S Associations

· Overarching Association

­ Campus Safety Health and Environmental Management Association (CSHEMA)

· http://www.cshema.org/

· Specialty Associations

­ American Biological Safety Association (ABSA)

· http://www.absa.org/

­ American Industrial Hygiene Association (AIHA)

· http://www.aiha.org/Pages/default.aspx

EH&S Associations

· Specialty Associations, continued

­ American Chemical Society (ACS) Chemical Health and Safety (CHAS) Division

· http://www.dchas.org/

­ Institute of Hazardous Materials Management (IHMM)

· http://www.ihmm.org/

­ Board of Certified Safety Professionals

· http://www.bcsp.org/

EH&S Associations

· Specialty Associations, continued

­ International Association of Emergency Managers (IAEM)

· http://www.iaem.com/

­ Health Physics Society (HPS)

· http://www.hps.org/

­ Center for Campus Fire Safety (CCFS)

· http://www.campusfiresafety.org/

EH&S Associations

· Specialty Associations, continued

­ Campus Consortium for Environmental Excellence (C2E2)

· http://www.c2e2.org/

­ Association for the Advancement of Sustainability in Higher Education (AASHE)

· http://www.aashe.org/

­ College and University Hazardous Waste Association (CUHWA)

· http://www.cuhwc.net/

Campus Environmental Resource Center

· Provide educational institutions with knowledge and tools to maintain environmental regulatory compliance, improve management and operate sustainably

­ http://www.campuserc. org/Pages/default.aspx

Partner Associations

· Rule making commentary, education and collaborative projects

­ American Council on Education (ACE) ­ Association of Physical Plant Administrators of Universities and Colleges (APPA) ­ Campus Safety Health and Environmental Management Association (CSHEMA) ­ Howard Hughes Medical Institute (HHMI) ­ National Association of College and University Business Officers (NACUBO)

· Future ­ SRA?

Information

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