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Highlights

Pursuant to a congressional request, GAO reviewed the Environmental Protection Agency's (EPA) regulation of the efficacy of disinfectants, focusing on: (1) controversies regarding EPA-recommended methods and performance standards for testing disinfectant efficacy; (2) EPA efforts to obtain objective research to resolve the controversies; (3) EPA internal controls to ensure the quality and integrity of registrant-submitted efficacy data; (4) EPA and states' post-registration efforts to ensure disinfectant efficacy; and (5) the need and options for a laboratory to research and test disinfectant efficacy.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Environmental Protection Agency To increase the degree of certainty that disinfectant efficacy test methods and standards are valid, the Administrator, EPA, should develop a detailed plan, including cost estimates and milestones, to resolve the controversies surrounding existing methods and standards. The plan should include a research strategy that addresses problems with the alleged variability in test methods, adequacy of laboratory tests to simulate actual use, and the validity of performance standards.
Closed - Implemented
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.
Environmental Protection Agency The Administrator, EPA, should convene the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel to assist in developing the plan and overseeing the research strategy direction and management.
Closed - Implemented
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.
Environmental Protection Agency The Administrator, EPA, should develop and publish a policy that establishes specific criteria for evaluating the validity of new disinfectant efficacy test methods and modifications to methods, including criteria for determining when independent laboratory data, such as data from a collaborative study, are needed to demonstrate the validity of proposed methods and modifications.
Closed - Implemented
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.
Environmental Protection Agency To improve EPA controls over the quality and integrity of registrant-submitted data, the Administrator, EPA, should implement a preregistration testing program to verify selected disinfectant efficacy data. The Administrator could target preregistration tests on those claims that are of the greatest public health significance and products with suspected efficacy problems.
Closed - Implemented
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.
Environmental Protection Agency To improve the effectiveness of the data review, laboratory inspection, and data audit programs, the Administrator, EPA, should: (1) direct the Laboratory Data Integrity Assurance Division (LDIAD) to identify all laboratories that have performed efficacy studies submitted to EPA to support disinfectant registrations and meet the LDIAD goal of inspecting those laboratories at least every 2 years; and (2) at a minimum, direct LDIAD to use the Office of Pesticide Programs Pesticide Document Management System, which contains the best available information for identifying the laboratories.
Closed - Implemented
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.
Environmental Protection Agency To improve the effectiveness of the data review, laboratory inspection, and data audit programs, the Administrator, EPA, should direct LDIAD to establish a check sample program as part of the laboratory inspection program to better assess the ability of laboratories to perform disinfectant efficacy tests.
Closed - Not Implemented
EPA does not intend to establish a check sample program. EPA continues to believe that it can more effectively ensure the quality of efficacy data through inspections of laboratories that are targeted through the Office of Pesticide Programs Pesticide Document Management System (PDMS) data base.
Environmental Protection Agency To improve the effectiveness of the data review, laboratory inspection, and data audit programs, the Administrator, EPA, should direct the Office of Compliance Monitoring to review its internal controls for ensuring that inspections and audits are processed on time. For example, the office should ensure that inspectors and auditors are held accountable in their performance standards and appraisals for meeting processing time frames.
Closed - Implemented
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.
Environmental Protection Agency To improve the effectiveness of the data review, laboratory inspection, and data audit programs, the Administrator, EPA, should direct the Office of Pesticide Programs and the Office of Compliance Monitoring to: (1) develop and implement specific guidance for data reviewers, laboratory inspectors, and data auditors to follow; and (2) develop, publish for comment, and implement detailed policies and guidelines to decide what registration and enforcement action to take on the basis of findings from laboratory inspections and data audits.
Closed - Implemented
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.
Environmental Protection Agency In his next annual internal control report to the President, the Administrator, EPA, should report the lack of sufficient controls to ensure the quality and integrity of registrant-submitted disinfectant efficacy data as a material weakness.
Closed - Implemented
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.
Environmental Protection Agency The Administrator, EPA, should include in his report to the President a plan delineating specific corrective actions and time frames.
Closed - Implemented
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.
Environmental Protection Agency The Administrator, EPA, should develop, publish for comment, and implement an enforcement strategy to ensure that marketed disinfectants work as claimed. This strategy should specify the: (1) mechanisms and procedures for identifying potentially ineffective disinfectants; (2) procedures for investigating and verifying complaints about potentially ineffective disinfectants, including, where necessary, the use of independent laboratory testing; and (3) criteria and procedures for initiating registration and enforcement action against disinfectants found to be ineffective.
Closed - Implemented
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.
Environmental Protection Agency In light of federal budget constraints, the Administrator, EPA, should explore options for pooling resources from the states, user groups, and industry to implement a national disinfectant efficacy enforcement strategy.
Closed - Implemented
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.
Environmental Protection Agency The Administrator, EPA, should develop a detailed cost-benefit analysis of alternatives for operating a laboratory facility to research and test the efficacy of disinfectants, including the option of charging fees to register disinfectants to help finance such a facility, and submit the results of its analysis to Congress so that Congress may weigh the advantages and disadvantages of various alternatives.
Closed - Implemented
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.

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