Food and Drug Administration
VERSION NO.: 1.4
ORA's EHS policies reside in the FDA Staff Manual Guide 2130.1. The Staff Manual Guide sets forth the Food and Drug Administration's authority, policy, scope, and assignment of responsibility towards the establishment and management of a comprehensive safety and occupational health program. The link to the Staff Manual Guide is: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm
The following references are promulgated at the National level. They provide general safety information.
The NTEU Collective Bargaining Agreement, Article 47: Health and Safety FDA Intranet Safety web site:
The following references are created by each laboratory for internal use. These references help ensure compliance with various Federal regulations and ORA mandated programs. They are prescriptive in nature, stating steps and guidelines for ensuring compliance. These are the documents for reference and use on a regular basis.
Each laboratory will have documents that cover the described areas; the actual name of the documents may vary from those shown below. In some cases, the documents listed may be sub-components of another reference as well as additional EHS references. Everyone is responsible for following the procedures outlined in the laboratory's version of the following references.
Each laboratory's EHS documents include, but are not limited to the following:
- Chemical Hygiene Program
This document helps provide compliance with the 'Lab Standard', 29 CFR 1910.1450. Information in this document covers general laboratory safety, chemical hazards, personal protective equipment (PPE), safety equipment certification programs, special SOPs for highly hazardous work, safety responsibilities for various personnel, procedures following exposure to a chemical, and other occupational health topics. Every ORA Field Laboratory should have this reference.
- Hazardous Waste Management Program
This document helps provide compliance with various Environmental Protection Agency regulations. The document provides detailed instruction for the safe disposal of laboratory reagents and hazardous substances. Every ORA Field Laboratory should have this reference.
- Evacuation Plan
This document outlines the steps taken when evacuating the building during an emergency. If the laboratory is co-located with a District Office or other tenants in a common building, this document may cover all tenants and therefore will not be particular to the laboratory. Every ORA Field Laboratory should have this reference. (This plan may be combined with the Occupant Emergency Plan at some facilities.)
- Occupant Emergency Plan
This document outlines whom to call during an emergency (e.g. building managers, local fire, police, and emergency medical teams). The plan may also provide questions to ask when receiving a telephone bomb threat, or what to do during an earthquake or severe weather. Every ORA Field Laboratory should have this reference.
- Biosafety Manual
This document outlines the measures that ensure safe handling of biological agents. Every ORA Field Laboratory with a Microbiology component should have this reference.
- Respirator Program
This program ensures compliance with 29 CFR 1910.134 - the Respirator Standard. This program covers the use, care, and fitting of respirators. The first choice for protection from respiratory hazards is engineering controls (e.g. fume hoods). However, if the lab decides that it wants or needs to provide the extra protection of respirators the Respirator Standard is followed.
- Radiation Safety Program
All field laboratories that have radioactive sources on-site have this program. Sources of radiation typically found in ORA field laboratories include P-32, used in the microbiology area, and Nickel-63, used in some gas chromatograph detectors.
Regulations regarding radiological hazards in the work place include:
- 10CFR19: Notices, instructions, reports to workers, inspections.
- 10CFR20: Standards for protection against radiation.
- 10CFR21: Reporting of defects and non-compliance.
- 10CFR71: Packaging and transportation of radioactive materials
- NRC Reg Guide 8.36: Radiation Dose to Embryo/Fetus.
- Department of Transportation (DOT) Shipment of Dangerous Goods
As mandated by DOT, the shipment of microbiological slants and hazardous chemicals requires detailed packaging and labeling. The laboratory may have a work instruction or standard procedure devoted to these requirements.
- Blood-borne Pathogen Program
Although few FDA Field laboratories have this program, the blood-borne pathogen program is followed when the laboratory analyzes products that have been inside a human body, (e.g. ex-planted medical devices or pills that were ingested then expelled, or been in contact with bodily fluids such as blood, saliva, or vomitus), pharmaceuticals that may contain constituents derived from blood products, or sample analyses that use blood products in their analyses (e.g. invitro-diagnostics). Analysts receive blood-borne pathogen training and are able to handle these samples safely prior to analyzing samples in this program area.
- Institutional Animal Care and Use Committee (IACUC) and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Program
Few FDA laboratories have this program. Only those FDA AAALAC laboratories with IACUC approved protocols may perform animal testing.
- Select Agent Program
Any ORA laboratory working with select agents regulated by CDC should have this program in place. The laboratory must be registered with CDC to transfer any select agents listed in their regulations in 42 CFR 72.6. CDC inspects facilities to ensure the facilities are capable of handling these organisms. All receipts, transfers, and disposals of agents are documented on their EA101 form.
Annual refresher on health & safety for hazardous waste site investigation personnel. (2001). New Brunswick, NJ: University of Medicine and Dentistry of New Jersey - School of Public Health, Office for Public Health Practice, Centers for Education and Training, 317 George Street, Plaza II, 08901-2008
U.S. Food & Drug Administration, Office of Regulatory Affairs, Division of Field Investigations. (current edition). Investigations operations manual or the website address, http://www.fda.gov/ICECI/Inspections/IOM/default.htm