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Compliance and MIT. William VanSchalkwyk Managing Director, EHS Programs Mitchell Galenek Associate Director, EHS Programs. Why are there regulations?. Protection of the public good Level conditions for commerce Enforcement provisions for offenders Deterrence Punishment Consequences.

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Compliance and MIT

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compliance and mit

Compliance and MIT

William VanSchalkwyk

Managing Director, EHS Programs

Mitchell Galenek

Associate Director, EHS Programs

why are there regulations
Why are there regulations?
  • Protection of the public good
  • Level conditions for commerce
  • Enforcement provisions for offenders
    • Deterrence
    • Punishment
    • Consequences
compliance requirements and complexity example us environmental regulatory history
Compliance requirements and complexity example: US environmental regulatory history


History of the Dow Jones Industrial Average: 1900 - 2007

many regulations do not a ppear to make s ense and they d on t
Many regulations do not appear to make sense (and they don’t!)
  • Inventory of biological materials for bio-security requirements (proposed HR 5057)
  • Reporting requirements of American Reinvestment & Recovery Act (aka stimulus bill)
  • H.U. fined $8,000 for LN₂ release outdoors
lab compliance 101
Lab Compliance 101
  • ‘Lab’ is a broad term: bio, chem, engineering, spectroscopy, laser, etc.
  • Compliance means several programs may need to be in-place
    • Biological governance and approval process
    • NRC/DPH license & permit for radiation
    • OSHA Laboratory Standard program
    • EPA/State waste management programs
    • Sewer use permits/ WW treatment
lab compliance 101 cont d
Lab Compliance 101, cont’d.

Be on the lookout for teaching or research involving:

  • Biology
  • Chemistry
  • Materials Science or development
  • Lasers
  • Radiation, including Xrays
  • Cryogenics
  • Magnets (MRI)
  • Electrical
  • Personal protective equipment
  • Vacuum systems
  • Compressed gases
  • Use of sharps
  • Regulated waste generation
lab compliance 101 cont d1
Lab Compliance 101, cont’d.
  • Labs require special design, ventilation, physical controls, and sometimes containment
  • Cowboy Lab work is so 1970s
  • PI’s are responsible for the safety and compliance of their work and staff
  • EHS is not to be a shrinking violet
  • RM/LC is a strong ally for us EHS folk
  • Pick up an MIT EHS Inspection Checklist
recent incidents
Recent incidents
  • UCLA Fatal Lab fire December 2009
    • Cal OSHA findings
    • PI Responsibility
    • Prospect of Criminal Charges
  • Texas Tech Lab Explosion January 2010:
    • Investigation by US Chemical Safety Board
    • Likely recommendations to the entire C/U sector
  • New: First U.S. Cowpox Infection
    • Acquired From Lab Contamination by Sara Reardon on 17 February 2011, 12:59 PM
recent incidents cont d
Recent incidents cont’d
  • MIT Labs:
    • Explosion with serious injury
      • FBI involvement due to chemical mixture
    • Fall from lab equipment resulting in fatality
      • OSHA citations/fines
    • Chemical Spill with injury
      • Bromine spill on skin
      • CFD response/Transport to MGH
      • Lab closure by CFD
non compliance
  • Government enforcement
  • Your ability to continue to receive funding
  • Cascades and dominoes
  • Individual and Institute reputation
non compliance cont d
Non-compliance cont’d

UW-Madison professor barred from lab for potentially dangerous experiments

A UW-Madison professor who studies an infectious disease lost his laboratory privileges for five years after conducting unauthorized experiments with a potentially dangerous drug-resistant germ.

Wisconsin State Journal / May 12, 2010

CDC suspends work at Texas A&M biodefense lab

Lisa Schnirring   Staff Writer

Jul 3, 2007 (CIDRAP News) – The US Centers for Disease Control and Prevention (CDC) on Jun 30 ordered a biodefense research laboratory at Texas A&M University to stop all work on select agents and toxins while the CDC investigates reports of lab workers infected with the category B bioterror agents Brucella and Coxiella burnetti.

The FBI's Art AttackOffbeat Materials at Professor's Home Set Off Bioterror Alarm

By Lynne DukeWashington Post Staff WriterWednesday, June 2, 2004; Page C01

….. Police and emergency personnel responded, and what they saw in the Kurtz home has triggered a full-blown probe -- into the vials and bacterial cultures and strange contraptions and laboratory equipment. The FBI is investigating. A federal grand jury has been impaneled. Witnesses have been subpoenaed, …..

why this is important and what you can do
Why this is important and what you can do?
  • Use the Institute’s management systems
  • Get trained and be sure others needing training get it!
  • Don’t leave doubt. Ask.
getting your lab up and running and your r esearch s tarted
Getting your lab up and running and your research started
  • Biological Materials
    • Exposure Control Plan
    • Ordering SA toxins
  • Animal Research
    • IACUC & DCM
    • Animal Biosafety
  • Human Subjects
    • COUHES
getting your l ab u p and running and your r esearch s tarted cont d
Getting your lab up and running and your research started cont’d
  • Chemicals
    • Chemical Hygiene Plan
    • Chemical Inventory, SARA reporting, DHS Chemicals of Concern
    • Chemical waste management
  • Ionizing Radiation
    • Radioactive material authorization by RPC
    • Registration of radiation producing equipment
  • Non-ionizing Radiation
    • Registration with RPC for class 3&4 lasers, RF sources, magnets
  • EHS staff will help you to complete applications and registrations to the various institute committees
ehs compliance p rograms what to do
EHS compliance programs-What to do?
  • Visit the EHSsite
  • Find out what applies
  • Get training

Always call us with questions: 2-3477