1. Regulatory Agencies What are regulatory issues? Types of agencies How they affect you Top 10 regulatory issues

2. What are Regulatory Agencies? O 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. O Note: Populace and community may be environment, human and/or animal.

3. Types of Agencies O FDA O USDA-APHIS O EPA O IBC O IACUC O NIH O OSHA

4. FDA O Food and Drug Administration O Authority under congress to regulate products regardless of how they are made. O A new drug may not be sold to the public unless it is proven to be safe and effective. O 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.

5. USDA O U.S. Department of Agriculture O Additives to animal food and drugs administered to animals are licensed through the USDA. O Any substances administered to animals used for human consumption must be authorized through the USDA. O 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. O Shipments of various agents must follow USDA shipping/receiving and storage regulations.

6. APHIS O Animal and Plant Health Inspection Services O A division of the USDA O Insures all agriculture are not exposed to invasive pesticides and diseases.

7. EPA O Environmental Protection Agency O 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. O EPA functions through a registration system that requires identification and regulation of potential hazards pesticides. O 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.

8. IBC O Institutional Biosafety Committee (IBC) O Compliance agency in biosafety for researchers, students, and potential human subjects. O 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.

9. IACUC O Institutional Animal Care and Use Committee O Insures a humane and compliant environment for research animals, and teaching programs that use animal subjects. O Each institution has their own IACUC consisting of 5 people appointed by the institution: O A veterinarian with expertise in the species used. O A practicing scientist experienced in animal research. O A member who has primary concerns that are in nonscientific areas. O A member must have no relation with the institution except for serving on the committee. O One member can fulfill more than one duty, but the committee must still consist of at least 5 members.

10. IACUC (cont.) O Each animal use must be reviewed by full IACUC committee at lease every three years. The protocol must cover valuable points: O Identify the species and number of animals used. O Reason for using animals and number of animals instead of going a “non animal” route. O Living situations for each species in the project. O Complete procedure explained. O Assure that discomfort and injury will be limited if pain is unavoidable to include anesthetics and tranquilizing drugs. O Description of any euthanasia method used in the study.

11. NIH O National Institute of Health O Government agency responsible for biomedical and health related research. O Gives 80% of their funding to non-federal research facilities.

12. OSHA O Occupational Safety and Health Association O 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. O 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.

13. How do they affect me? O Audits. O Funding. O Animal care and protection. O Health and Safety. O Continuing studies for biological level classification laboratories. O Government compliance; fines.

14. Top 10 common regulatory issues O Equipment maintenance O Proper labeling O Proper disposal of substances O PPE O Biohazard/radioactive labeling O Documentation of laboratory maintenance O Documentation of experimentation O Explanation of in house reagents O Calibrations O Proper training

15. Regulatory Issues are like a maze, don’t get caught in the corner with no way out!! Questions???