Disinfectants: EPA Lacks Assurance They Work

EPA has set forth a strategy for test method research and has funded about $1.7 million for cooperative research agreements. EPA anticipates that the research will be complete by the end of fiscal year 1996 and will cost an additional $0.9 million.

A microbiology subpanel of the FIFRA SAP was established in FY 1991. EPA utilized the subpanel expertise in 1991 and again in 1992 for guidance and review of test methodology research cooperative agreements and plans to continue their use in the future.

Although EPA prepared a draft of the policy ("Systematic Process and Criteria to Assess the Validity of EPA/Registrant/Commercial Laboratory Proposed Test Methods and Modifications"), the EPA Office of Pesticide Programs lacks the resources needed to put the policy through the formal rule-making procedure recommended by the EPA Office of General Counsel.

Although EPA arranged for the Indiana State Chemist to perform pre-registration testing to assess the validity of approximately 6 to 10 proposed sterilant claims in 1994, EPA has since discontinued pre-registration testing. EPA has no plans to reinstate pre-registration testing of any proposed disinfectant efficacy claims in the future. Under a June 4, 1993 Memorandum of Understanding (MOU), FDA assumed responsibility for regulating the efficacy of all sterilants except those used on environmental surfaces, such as floors and walls. According to the EPA Antimicrobial Branch, FDA has no plans to perform pre-registration tests to validate proposed sterilant claims.

The Agriculture and Ecosystems Division (AED) of the EPA Office of Enforcement and Compliance Assurance (OECA) identified the laboratories that had conducted antimicrobial efficacy testing to support disinfectant registrations. After mid-1994, methods other than the automated laboratory data base (LISA) were used to target disinfectant efficacy laboratories. These included the EPA Office of Pesticide Programs Pesticide Document Management System (PDMS) data base. However, because of lack of resources, the Laboratory Data Integrity Branch of AED will not be able to conduct the recommended inspections.

EPA indicates that performance standards for GLP inspectors include a requirement for timely processing of inspection reports. However, the agency also indicates that it may not be possible to achieve the standard in the current environment of limited resources.

While EPA has issued written procedures for auditing antimicrobial efficacy studies and inspecting antimicrobial efficacy laboratories, it has not issued standard evaluation procedures for the review of antimicrobial efficacy studies. Further, although EPA issued a formal enforcement response policy for violations of the good laboratory practice (GLP) regulations, it has not issued policies on registration response actions on findings from laboratory inspections and data audits. EPA has no plans to issue further procedural or policy guidance in these areas due to lack of resources.

EPA reported the lack of sufficient controls to ensure the quality of efficacy data as a material weakness in its 1990 report to the President and proposed corrective actions. However, EPA subsequently eliminated this material weakness and did not complete the corrective actions initiated to address the material weakness.

EPA has prepared an executive summary and briefing paper on antimicrobial product testing. The paper sets forth the EPA antimicrobial program testing scheme in order of priority and a proposed schedule for implementation. The EPA initiative, if continued, should help improve the quality and integrity of registrant-submitted disinfectant efficacy data.

EPA has developed and implemented a national program strategy which includes a regulatory and enforcement strategy. The strategy addresses, among other things, the three areas outlined in the recommendation.

Although EPA arranged for limited enforcement testing of marketed disinfectants through cooperative agreements with FDA and some states, all testing has been discontinued. Under EPA's June 4, 1993 MOU with FDA, FDA now has responsibility for enforcing the efficacy of most sterilants. EPA officials indicate, however, that FDA does not plan any enforcement testing. EPA has discontinued all enforcement testing of other types of disinfectants due to lack of resources.

Following issuance of the GAO report, EPA prepared a briefing paper on antimicrobial product testing that outlined options for laboratory testing and proposed establishment of a new laboratory to carry out a wide range of activities and requested Congress to reinstate EPA's authority to collect registration fees to help cover the cost of a testing program. Congress has not given EPA that authority and no legislation to do that has been introduced in the 104th Congress.