Transcript PowerPoint: Regulatory Agencies

REGULATORY AGENCIES
•What
are regulatory issues?
•Types of agencies
•How they affect you
•Top 10 regulatory issues
WHAT ARE REGULATORY AGENCIES?
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Public authority or government agency that assures all activity
within a populace are properly handled for the safety of the
community by instating laws or “rules,” known as regulations.
 Note: Populace and community may be environment, human
and/or animal.
MATC-Topic 1- Regulatory Agencies
TYPES OF AGENCIES
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FDA
USDA-APHIS
EPA
IBC
IACUC
NIH
OSHA
MATC-Topic 1- Regulatory Agencies
FDA
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Food and Drug Administration
Authority under congress to regulate products regardless of how
they are made.
A new drug may not be sold to the public unless it is proven to be
safe and effective.
Various studies such as drug composition, manufacturing and
controls data, animal testing results, training and experience of
investigators, and clinical testing on human subjects must be
completed prior to acceptance by the FDA.
MATC-Topic 1- Regulatory Agencies
USDA
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U.S. Department of Agriculture
Additives to animal food and drugs administered to animals
are licensed through the USDA.
Any substances administered to animals used for human
consumption must be authorized through the USDA.
Data must prove the drug is effective and will not leave any
toxins in edible tissues as well as any additives/procedures
to feed are clearly identified.
Shipments of various agents must follow USDA
shipping/receiving and storage regulations.
MATC-Topic 1- Regulatory Agencies
APHIS
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Animal and Plant Health Inspection Services
A division of the USDA
Insures all agriculture are not exposed to invasive pesticides and
diseases.
MATC-Topic 1- Regulatory Agencies
EPA
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Environmental Protection Agency
The EPA regulates the sale, distribution and use of pesticides in order
to protect the environment and health of a population. This includes
regulation of pesticides that are produced by an organism through
modern biotechnology.
EPA functions through a registration system that requires
identification and regulation of potential hazards pesticides.
Developers/users must identify the manufacturing, processing,
importation, distribution, use, and disposal of all chemicals used or
intended to use for any project or sale.
MATC-Topic 1- Regulatory Agencies
IBC
 Institutional Biosafety Committee (IBC)
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Compliance agency in biosafety for researchers, students, and
potential human subjects.
The IBC is authorized by federal laws and regulations to oversee all
activities involving research with microbiological agents,
recombinant DNA, or toxins of biological origin.
MATC-Topic 1- Regulatory Agencies
IACUC
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Institutional Animal Care and Use Committee
Insures a humane and compliant environment for research
animals, and teaching programs that use animal subjects.
Each institution has their own IACUC consisting of 5 people
appointed by the institution:
 A veterinarian with expertise in the species used.
 A practicing scientist experienced in animal research.
 A member who has primary concerns that are in
nonscientific areas.
 A member must have no relation with the institution
except for serving on the committee.
 One member can fulfill more than one duty, but the
committee must still consist of at least 5 members.
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IACUC (CONT.)
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Each animal use must be reviewed by full IACUC committee at
lease every three years. The protocol must cover valuable
points:
 Identify the species and number of animals used.
 Reason for using animals and number of animals instead of
going a “non animal” route.
 Living situations for each species in the project.
 Complete procedure explained.
 Assure that discomfort and injury will be limited if pain is
unavoidable to include anesthetics and tranquilizing drugs.
 Description of any euthanasia method used in the study.
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NIH
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National Institute of Health
Government agency responsible for biomedical and health related
research.
Gives 80% of their funding to non-federal research facilities.
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OSHA
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Occupational Safety and Health Association
Government agency who was established to prevent work related
injuries, illnesses, and death due to ones occupation by issuing and
enforcing standards for workplace health and safety.
Copy of OSHA right are to be displayed in every institution and can
also be found on line. Please review them for your protection and
your work environment rights.
MATC-Topic 1- Regulatory Agencies
HOW DO THEY AFFECT ME?
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Audits.
Funding.
Animal care and protection.
Health and Safety.
Continuing studies for biological level classification laboratories.
Government compliance; fines.
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TOP 10 COMMON REGULATORY ISSUES
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Equipment maintenance
Proper labeling
Proper disposal of substances
PPE
Biohazard/radioactive labeling
Documentation of laboratory maintenance
Documentation of experimentation
Explanation of in house reagents
Calibrations
Proper training
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REGULATORY ISSUES ARE LIKE A MAZE, DON’T GET CAUGHT IN THE CORNER WITH NO WAY OUT!!
MATC-Topic 1- Regulatory Agencies