Transcript Slide 1

2 March 2005
New Research
Compliance
Issues for
Biological and
Hazardous
Materials
Peter A. Reinhardt, Director
Dept. of Environment, Health & Safety
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Overview of Today
 Shipment/mailing
of research
materials, sample and specimens
 Department of Commerce Export rules
 Select Agent requirements
 “Dual Use” concerns for
biological research
 Institutional controls
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Themes for Today
Why are these changes taking place?
Prevent risks to the public from research
activities and materials
 Address “Dual Use” concerns: Research
activities and materials used for social good
have the potential to be used for social
harm.
 Internal and external controls to prevent
access to dual use materials, technology
and information by those who wish us harm.

2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Shipping/Mailing Research Materials
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Laws for the Transport
of Hazardous
Material...
U.S. Department of transportation (DOT): title
49 of the code of federal regulations (CFR)
 For air transport:



International civil aviation organization (ICAO)
technical instructions
International air transport association (IATA)
dangerous goods regulations
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Preparing Hazardous Materials
for Shipment...
If you prepare or package a shipment, you
must receive additional function-specific
training in:
•
•
•
•
•
Approved packaging materials and procedures
Labeling packages
Marking packages
Preparing shipping papers
Emergencies response contact
information
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
No Vial In Pocket
Monday, September 13, 2004
Professor at U. of Delaware
Pleads Guilty in Case
Involving Smuggled Poultry
Virus
A popular professor of microbiology at the
University of Delaware pleaded guilty last
week to criminal charges related to the
smuggling of a poultry virus from Saudi
Arabia.
If the federal judge presiding over the
case accepts a plea agreement reached
with the U.S. attorney for Maine, the
professor, John K.
Rosenberger, will serve six months of
home detention, be on probation for two
years, and pay a fine of up to $250,000.
Mr. Rosenberger, a former chairman
of the department of animal and food
sciences at Delaware's College of
Agriculture and Resources, is known for
his work on avian disease. He pleaded
guilty in the U.S. District Court in
Bangor, Me., to aiding and abetting the
receipt and concealment of a smuggled
virus -- in this case, a type of avian
influenza that can devastate commercial
flocks -- in his university laboratory.
George T. Dilworth, an assistant U.S.
attorney in Maine, said there are no
bioterrorism connections in the case.
However, he said, before the September
11 terrorist attacks, people were too
cavalier about violating regulations on the
importing of viruses from other countries.
"We now understand why these rules are
as strict as they are," he said.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
U.S. Export Control Laws
Regulate the distribution to foreign nationals and
foreign countries of strategically important
products, services and information for reasons of
foreign policy and national security
Credits: Erica Kropp and Anne Bowden, University of Maryland College Park
Robert Hardy, Council on Government Relations
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
U.S. Export Control Laws
and Agencies
International Traffic in
Arms Regulations (ITAR)
Inherently military
technologies
State
Department
Export Administration
Regulations (EAR)
“Dual-Use”
technologies (primary
civil use)
Commerce
Department
Office of Foreign Assets
Control (OFAC)
Prohibits transactions
with countries subject
to boycotts, trade
sanctions, embargoes
Treasury
Department
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Implications of Export Laws
No effect on 90% of university research
 Impact on:




Ability of foreign students to participate in
research involving a controlled technology
(mostly under ITAR)
Ability to provide services (e.g., training) involving
controlled equipment to foreign nationals (ITAR,
EAR, OFAC)
Ability to send controlled equipment to foreign
countries (ITAR, EAR, and OFAC)
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
ITAR Licensing Requirements for Shipping
Controlled Equipment Out of the U.S.
A
license is required to ship
equipment controlled by ITAR to
any foreign country
 There are few exclusions or
exceptions
 It can take months to obtain a
license from the State Department
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Licensing Requirements for Shipping
Controlled Equipment Out of the U.S.

A license may be required to ship materials,
samples or equipment out of the U.S. under the EAR
depending on whether the equipment is controlled,
where it is being sent and whether an exception
applies.

A license may be required to ship software out of
the US!

The process to classify equipment under the EAR is
very tedious, detailed and time consuming.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
OFAC Prohibitions for Shipping
Controlled Equipment Out of the U.S.
There is a presumption under OFAC laws
that any and all shipments of materials,
equipment and provision of services to
countries subject to US sanctions/boycotts or
persons in those countries are ILLEGAL.
 Balkans, Burma, Cuba, Iran, Iraq, Libya,
Liberia, Sudan, Syria, Zimbabwe

2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Fundamental Research Exclusion
Applies to information resulting from basic and
applied research in science and engineering
conducted at an accredited institution of higher
education (EAR) or higher learning (ITAR) located
in the U.S. that is not restricted for proprietary
reasons or specific national security reasons (EAR)
or subject to specific U.S.G. access and
dissemination controls (ITAR) See 15 CFR 734.8(a)
and 22 CFR 120.11(a)(8).
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Fundamental Research Exclusion

No license is required to disclose to foreign
nationals information which is “published
and which is generally accessible or
available to the public [through, for
example] fundamental research in science
and engineering at universities where the
resulting information is ordinarily published
and shared broadly in the scientific
community.”
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Fundamental Research
Exclusion, continued.

Also note EAR 734.3(b)(3)(ii) exemption for
“publicly available technology” that
“arise(s) during or result(s) from
fundamental research.”
Shipment of controlled materials, samples or other
commodities outside of the U.S. is never excluded.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
The “Deemed Export” Concept

Defined as the transfer or disclosure (including
visually or orally) of controlled “technologies” (EAR)
or “technical data” (ITAR) to a foreign entity or
individual anywhere including in the U.S.
See 15 CFR 734.2 and 22 CFR 120.17.

Technology is specific information necessary for the
“development,” “production” or ”use” of a product
(EAR 772.1)
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
The “Deemed Export” Concept

Technical data is information required for design,
development, production, manufacture, assembly,
operation, repair, testing, maintenance or
modification of controlled articles (ITAR 120.10).

The concept of “deemed export” was added to
export regulations in 1994. The intent apparently
was to cover information needed for commercial
development, production and use of technologies.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Regulated Research On Campus
Foreign Nationals
= “Deemed Export”
Publication
or Participation
Restrictions
Controlled
technologies,
software or
commodities
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Fundamental Research Exclusion
Is destroyed if the University accepts any contract clause that:
Forbids the participation of foreign nationals;
 Gives the sponsor a right to approve
publications resulting from the research; or
 Otherwise operates to restrict participation
in research and/or access to and disclosure
of research results

2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Red Flags for
Export Control Laws

The RFP marked “Export Controlled”

Working with a country subject to a U.S. boycott

Shipping equipment to a foreign country

Collaborating with foreign colleagues in foreign
countries

Sponsor demands pre-approval rights over
publications or the participation of foreign national
students

Training foreign nationals in using equipment
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
If Export Control Red Flags Exit

Determine if the research activity is allowed.

Determine if an export control license is required.

If license is needed, it takes much time and effort of
faculty. It can take months to process.

The license may be denied.

These laws apply to all research
activities—not just sponsored projects
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EAR Penalties
 Civil

violations
Up to $12k per violation for individuals and
the University/corporations
 Criminal


violations (willful)
Up to $1 million for the University
Up to $250K per violation for individuals
and/or up to 10 years in prison
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Trouble on the Horizon
In March 2004, the Department of
Commerce’s Inspector General issued a
report on the status of EAR compliance,
and stated that: “Technology related to
controlled equipment—regardless of how
use is defined—is subject to the deemed
export provisions (and the requirement to
license foreign nationals having access to
that equipment) even if the research
being conducted with that equipment is
fundamental.”
The Four Confirmed Anthrax
Letters
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
2002 Public Health Security and
Bioterrorism Preparedness and
Response Act
12 June 2002: Signed into law
 August 2002: Notification of possession (not
just transfers) of all select agents and toxins
 13 December 2002: New 42 CFR 73 Rules
(replacing Part 72) promulgated as Interim
Final
 7 February-11 November: 42 CFR 73
implementation

2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Examples of Regulated Select Agents
HHS-only







Ebola viruses
Herpes B virus
Variola major virus
(Smallpox virus) and
Variola minor virus
(Alastrim)
Conotoxins
Ricin
Saxitonxin
Tetrodotoxin
HHS-USDA Overlap

Bacillus anthracis

Botulinum neurotoxin
producing species of
Clostridium

Francisella tularensis

Venezuelan Equine
Encephalitis virus

Botulinum neurotoxins
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Implementation of Biological
Registry Requirements at UNC

Campuswide Select Agent survey

Via survey, 465 laboratory Principal Investigators
asked to thoroughly review their stock and report if
they possess a Select Agent or plan to do so

Door-to-door follow-up to ensure
100% response

EHS follow-up of affirmative responses
to determine is the agent was exempt
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
What Constitutes Bona Fide Research?
SEC. 817 of the USA Patriot Act:
(Uniting and Strengthening America by Providing Appropriate
Tools Required to Intercept and Obstruct Terrorism)
“Whoever knowingly possesses any biological agent, toxin, or
delivery system of a type or in a quantity that, under the
circumstances, is not reasonably justified by a prophylactic,
protective, bona fide research, or other peaceful purpose, shall
be fined under this title, imprisoned not more than 10 years, or
both.”
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Welcome 42 CFR 73
Requirements





Background checks—Security Risk Assessments
(SRA)—done by U.S. Attorney General rather than
UNC
Reasonable exclusions for toxins
Largely performance-based: Entity writes the
Safety and Security Plans
Not prescriptive for card access,
video surveillance, etc.
Inventory quantities generally only apply to toxins.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Safety Plans

Our Safety Plan is Chapter 20 of UNC’s Biological
Safety Manual, “Select Agent Management.”

Our Manual references:

CDC/NIH’s Biosafety in Microbiological and Biomedical
Laboratories

OSHA Laboratory Standard (29 CFR 1910.1450)

OSHA Hazard Communication Standard
(29 CFR 1910.1200)

NIH Guidelines for Research Involving Recombinant DNA
Molecules
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
73.11(b) Security Plan
Requirements





Physical security
Procedures for securing the area when no SRAapproved individual is present
Procedures for the loss or compromise of keys,
passwords, combinations, etc.
Protocols for changing access following staff
changes
Provisions for routine cleaning, maintenance,
repairs, security training
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Security Costs
for one building, one <1,000 sq. ft. lab
Card access
$260,000
Replace glazing
$43,500
Close-circuit TV Surveillance
$50,500
Alarms: motion detectors, door contacts, personnel
$5,000
Training for building personnel and O&M
$25,000
Contingency (5%)
$18,000
Design
$40,000
Total Project Cost
$442,000
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Card System Failures
Stolen cards
 Lost cards
 Loaned cards
 Are visitors
issued cards? Is
the card system
used to record
all area
access?

Piggybacking/tailgating–
following someone inside
 Revolving door–entering upon
someone’s exit
 Blocking doors open
 “Innocent” piggybacking—
entry by multiple cardholders
following a single swipe (no
record of cardholders who
don’t swipe)

Security training is required!
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Security Improvements
HARDENING
Typical
Current
University
Laboratory
Typical Current
Federal Government
Laboratory
“When we have a free path, we go forward. If we meet an obstacle, we go
around it. If the object cannot be overcome, we retreat. When the enemy
is unprepared, we surprise him. If he is alert, we leave him alone.”—
Baader-Meinhoff Gang, infamous German urban terrorist organization
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
73.11(b) Security Plan
Requirements, cont.
Procedures for reporting suspicious
persons or activities, loss, theft or release,
or alteration of inventory records
 Procedures for reporting and removing
unauthorized persons
 Cyber security
 Inventory control procedures

2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Select Agent Tracking System
“to account for all vials…origin and destination”
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Physical Inventory Issues

5,000 microcentrifuge tubes for one Principal
Investigator

What’s inside? What can you see through the frost?

Annual joint EHS-PI physical inventories are incredibly
time consuming

5,001 microcentrifuge tubes?

4,999 microcentrifuge tubes?

If a tube is missing, who took it? Inventory records
probably won’t help.
Physical
Inventory
Issues
 Misplaced
vials
 Misrecorded
information
 It will
happen!
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Other Typical Steps
for Select Agent Security

EHS witnesses packing, unpacking and final
destruction of Select Agents

Chain of custody for Select Agent receipt

Laboratory staff carry picture IDs

Visitors must sign logbook, wear temporary
badges and be escorted at all times

EHS annually inspects lab to verify locations, staff
and security and safety measures
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EHS Access Approval Check Off

Security Risk Assessment of individual

Individual’s Occupational Health compliance

EHS Training of individual

Operational lab engineering controls

Operational security system

Principal Investigator compliance




Current Laboratory Safety Plan
Training, occupational health, SRA compliance for all lab
staff
Satisfactory inspection result
Institutional Biosafety Committee approval
Uses in
Clinical
Research


Products
approved under
the Federal Food,
Drug and
Cosmetic Act are
exempt
Upon request, HHS
may exempt
investigational
products on a
case-by-case
basis
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
NIH Bioterrorism Research Funding

President Bush proposed a 0.7% increase for NIH in FY 2006. Not
since 1964 has NIH received an annual increase of less than 1%.

However, NIH’s National Institute of Allergy and Infectious
Diseases, which funds most of its bioterrorism-related research, is
once again the agency's biggest gainer at $4.5 billion, a 1.8%
increase of $57 million.

Budgets for the Strategic National Stockpile and environmental
biosurveillance—also related to bioterrorism—would also increase
by 3.6% to $1.6 billion.

DHHS Secretary Mike Leavitt explained, "We have focused money
on the most urgent priorities."
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Controversial Paper: IL4-Mousepox
Ronald J. Jackson and colleagues at Australia's
Commonwealth Science and Industrial Research
Organization and Australian National University
Journal of Virology, February 2001
In trying to develop a mouse contraceptive to control
pest populations, the researchers inserted a gene for an
immune-system molecule called interleukin-4 into the
mousepox virus. Instead of rendering mice infertile, the
engineered virus was far more deadly than the natural
strain, killing even mice that had been vaccinated
against mousepox.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Controversial Paper:
Synthetic Polio Virus
Eckard Wimmer and researchers at the State University
of New York at Stony Brook
Science, August 9, 2002 (online edition, July 11)
Used the genetic sequence of poliovirus to order pieces
of DNA from a company. By patching the pieces
together and putting the complete DNA chain into a
soup of cellular molecules, the team created poliovirus
particles capable of paralyzing and killing mice.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
NRC Report on
Dual Use Research
Report of the National
Research Council of the
National Academies:
“Biotechnology Research in
an Age of Terrorism:
Confronting the Dual Use
Dilemma” (October 2003)
Gerald Fink, Committee Chair
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
National Science Advisory Board for
Biosecurity (NSABB) Charge

Develop and promulgate national guidelines for local (e.g. IBCs)
and federal oversight of dual use research.

Develop a code of conduct for scientists and laboratory workers
in life sciences research.

Develop and implement programs for education and training in
biosecurity issues for all scientists and laboratory workers at federal
as well as federally funded institutions.

Develop and promulgate guidelines for the appropriate
communication of dual use research methodology and research
results.

Foster the extension of these biosecurity policies to the
international arena.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Experiments That Currently Require Institutional
Biosafety Committee (IBC) Approval

Those using pathogens (biosafety level 2 and higher)

Cloning DNA from pathogens

Transfer of recombinant DNA material into whole
animals;

Transgenic animal production;

Use of transgenic animals that come from other
institutions;

Gene knockout animal experiments that involve transfer
of foreign DNA into whole animals; and

Gene transfer experiments in humans.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
New Experiments of Concern
1.
Would demonstrate how to render a vaccine
ineffective
2.
Would confer resistance to therapeutically useful
antibiotics or antiviral agents
3.
Would enhance the virulence of a pathogen or render
a nonpathogen virulent
4.
Would increase transmissibility of a pathogen
5.
Would alter the host range of a pathogen
6.
Would enable the evasion of diagnostic/detection
modalities
7.
Would enable the weaponization of a biological agent
or toxin
Saturday, February 5, 2005
By Alice Dembner and Stephen Smith,
The Boston Globe
BU Scientists Missed
Bacteria-illness Link Chief Of
Research On Tularemia Quits
Boston University scientists ran tests in
August that showed two laboratory
workers had been exposed to tularemia,
but they did not connect the results to their
illnesses three months earlier because they
were convinced that they were working
with a weakened strain of the bacteria that
could not cause disease, BU officials said
yesterday.
A top university administrator and the
state's leading infectious disease official
said that the test results should have
spurred the researchers to investigate
more thoroughly. But it was not until two
months later, weeks after a third worker
fell ill, that the researchers determined
that the bacteria they were working with
were probably contaminated with the
active, disease-causing form.
Also yesterday, BU said Dr. Peter
Rice, who headed the campus's tularemia
research, had resigned all his positions at
the university and at Boston Medical
Center. BU had placed him on leave and
removed him as head of infectious
diseases at BMC, saying he had allowed
safety lapses in his lab. Rice has worked
at BU for about 30 years.
Rice's lawyer said the infections were
not caused by safety lapses, but "by the
unknown presence of a virulent organism.
in the lab.”
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Medical Surveillance For Biosafety
Level 3 Laboratories
prior to laboratory work







Medical examination
Special consideration for
immunocompromised individuals
Collection of baseline serum sample
Vaccination, if available.
Annual titer measurement.
Illness surveillance and management
Exposure reporting
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
U.S. Nuclear Regulatory
Commission
Enhanced Security Measures for
Certain Radioactive Materials
Licensees
To be implemented in 2005
June 21, 2004
By JEFFRY SELINGO
The Chronicle of Higher Education
Settlement with EPA Will
Cost Fitchburg State College
$205,000
Boston Fitchburg State College will pay
$50,000 in fines and spend $155,000 on
two environmental projects as part of a
settlement with the U.S. Environmental
Protection Agency over hazardous-waste
violations
on
its
campus,
in
Massachusetts.
Last year the EPA proposed fining
Fitchburg State $358,000 for improperly
storing laboratory chemicals that could
have exploded or released toxic vapors
near two active classrooms. Inspectors
also found numerous containers of
unknown materials and improperly
marked wastes, some of which were
stored unsafely. After the EPA inspection,
some 6,500 pounds of hazardous wastes
were shipped off the campus. Some of the
material was so dangerous that crews had
to use a robot to collect it.
"The problems at Fitchburg State
College were severe and put students and
staff at risk," Robert W. Varney, regional
administrator for the EPA's New England
office, said in a written statement on
Friday.
Besides the fine, the college also
agreed
to
have
independent
environmental audits of its facilities
conducted annually for three years and to
put in place a formal environmental…
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Top RCRA Compliance Problems
Satellite Accumulation Area

Unmarked or
unlabeled containers

Open containers

Failure to make a
hazardous waste
determination
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Satellite Accumulation Area
Solution Number One:
Remember the Three L’s

Labels: “Hazardous Waste”

Lids



To prevent fugitive
emissions
Funnels are for
temporary use only
Location: at or near the point of generation
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Storage Without a Permit
Solution Number Two:
Promptly Remove Your Waste

Contract or standing order for
hazardous waste disposal

Regularly scheduled shipments

Publicized waste collection procedure

Education of faculty and staff
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
EHS’ Role in Research
Compliance at UNC

EHS Radiation Safety Section


EHS Industrial Hygiene and
Biological Safety Section


OSHA Chemical Hygiene Officer
EHS Environmental Affairs Section


Receives, processes and delivers all orders
for radioactive materials
Hazardous waste pickup and management
EHS University Employee Occupational Health Clinic
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
UNC Internal Processing Form
Question: Does the proposal involve research with any of the
following materials?

Radioactive Materials

Potential Biological Hazards (viruses, recombinant DNA, etc)

Chemical Hazards (poisons, explosives, reagents, flammables,
carcinogens, etc)

This study involves the use of botulinum neurotoxins, botulinum
neurotoxin producing species of clostridium or preparations or
pharmaceuticals containing botulinum neurotoxins.
If yes, contact EHS for required approvals.
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
UNC Laboratory Safety Plan
A Laboratory Safety Plan is required
for all research in UNC laboratories

Schedule A: Laboratory Project Information

Schedule B: Hazardous Chemicals

Schedule C: Radioactive Materials

Schedule D: X-ray Equipment

Schedule E: Lasers

Schedule F: Biological Hazards

Schedule G: Recombinant DNA

Schedule H: Animals
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Other Laboratory Safety Plan Approvals
Prior to the Start of Research at UNC

Schedule C: Radioactive Materials



University Radiation Safety Committee review and approval
Schedule F: Biological Hazards

Institutional Biosafety Committee (IBC) review and approval

BSL-3 Agent

New BSL-3 Laboratory

Select Agent
Schedule G: Recombinant DNA

Institutional Biosafety Committee (IBC) review and approval
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Other EHS Research Approvals


Certificate of Environmental Compliance

Only certain granting agencies

EHS will sign
Registration Of Human
Gene Transfer Experiments

Co-approval by IBC and IRB
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Personnel Requirements for UNC Research
All UNC employees
Safety orientation training
Exposure to blood
Offer of Hepatitis B vaccine
Annual bloodborne pathogens training;
Work with radioactive
materials
Radiation safety training
Dosimeter, if indicated
Healthcare setting
JCAHO training
Immunization review
Annual PPD test for TB
Work with animal subjects
Annual health assessment
Respirator or N-95 use
Annual review and fit testing
Certain infectious agents
Vaccination
Health surveillance procedures
2 March 2005
REQUIREMENTS FOR HAZMAT IN RESEARCH
Questions?
Peter A. Reinhardt, Director
Department of Environment,
Health & Safety
University of North Carolina
1120 Estes Drive Extension
CB# 1650
Chapel Hill, NC 27517-4440
http://ehs.unc.edu
[email protected]
919-843-5913