The primary focus of the Office of Pesticide Program's (OPP) Microbiology Laboratory is centered on the efficacy of antimicrobial products with public health claims that are registered by the EPA – products used to kill or suppress the growth of infectious microorganisms on inanimate objects and surfaces. Applied research on the evaluation and development of methods used to determine the efficacy of antimicrobials is a key priority. Recently, the laboratory has expanded its services to include, among others, major research in response to the anthrax attacks under the Office of Research and Development's Safe Building Program, and work on methods to identify genetically modified plant material.
Location: EPA's Environmental Science Center at Fort Meade, Maryland
- Antimicrobial Testing Program
lacked assurance that antimicrobial products registered by the Agency were efficacious. EPA has focused its efforts on evaluating registered products that are most crucial to infection control (sterilants, tuberculocides, and hospital-level disinfectants). The manufacturer of any product bearing a public health claim is required to submit efficacy data to the Antimicrobials Division of OPP to substantiate the product's effectiveness. The Antimicrobials Division evaluates and registers antimicrobials. OPP’s Microbiology Laboratory, in conjunction with certain state laboratories, perform efficacy tests using the same parameters (contact time, dilution of product) as noted on the product label. If testing demonstrates that a product does not provide acceptable levels of control of target microorganisms, EPA’s Office of Regulatory Enforcement takes action against the manufacturer. The Agency has completed testing of sterilant products, and is currently testing approximately 800 EPA-registered hospital-level disinfectants and 150 tuberculocides. Standard operating procedures (SOPs) used by the OPP Microbiology to determine the efficacy of hard surface disinfectants against infectious microrganisms are found at http://www.epa.gov/pesticides/methods/atmpindex.htm
- Plant Incorporated Protectant Method Validation Program
EPA regulates Plant Incorporated Protectants (PIPs) – materials that enable a plant to protect itself from pests such as insects, viruses and fungi by producing its own pesticide. The Biopesticides and Pollution Prevention Division (BPPD) is responsible for regulating PIPs. A PIP plant in the field, however, cannot be distinquished visually from a conventional plant. So, current PIP registration guidelines require registrants to submit a method for the detection of the unique PIP DNA sequence, as well as a method to detect the protein expressed by that unique DNA sequence. OPP's Microbiology Laboratory validates the detection methods submitted with an application before they are accepted for registration purposes.
- Anthrax Decontamination
In response to the anthrax attacks, OPP received numerous requests for emergency exemptions that would permit the use of antimicrobial chemicals for decontamination of buildings and their contents. OPP’s Microbiology Laboratory evaluated four chemicals (sodium hypochlorite, aqueous chorine dioxide, hydrogen peroxide/peracetic acid, and hydrogen peroxide/quaternary ammonium compounds/organosiline) using the EPA accepted method, the AOAC Sporicidal Activity Test (SAT). The laboratory determined that sodium hypochlorite (bleach) and aqueous chlorine dioxide were effective on hard surfaces against spores of Bacillus subtilis. As a result, these products were used as part of the anthrax remediation efforts, including at the Hart Senate Office Complex on Capitol Hill.
- Sporicidal Methods Research Project
The need to improve performance testing for sporicides became an EPA priority following the intentional release of anthrax spores into indoor environments. In the fall of 2003, the OPP Microbiology Laboratory initiated research, in collaboration with other federal laboratories (US Army, FDA, and Air Force), to explore new methodologies for efficacy testing of sporicides. The focus of the research is to determine the most suitable method and surrogate for evaluating antimicrobial products proposed for remediation of buildings contaminated with anthrax spores.
- CDC Laboratory Response Network
The OPP Microbiology Laboratory has obtained full registration under the CDC Select Agent Rule (Public Health Security and Bioterrorism Preparedness and Response Act of 2002). The laboratory is in the preliminary phases of joining the CDC Laboratory Response Network (LRN) , a nationwide laboratory network for food, veterinary, plant health, and water quality that integrates existing Federal and State laboratory resources and standardizes diagnostic protocols and procedures. The LRN deals primarily with public health needs. As a referral laboratory within the LRN, the Microbiology Laboratory would be limiting its work to analysis of Bacillus anthracis environmental samples.