CRS-18 The draft report repeatedly mentions that the quality and sensitivity of data are increasing. This general point was not disputed in the hearing record. However, a few particular points were raised and were of some concern in the report and repeated at the hearing. One point raised concerned the Laboratory Audit Program, which is to inspect laboratories conducting pesticide experiments to assure that accepted laboratory procedures are being followed. Resources for this activity have been greatly reduced (currently only one full time position is allocated) and the number of audits conducted per year has generally declined.* The report (p. 7) recommends that this program be given a higher priority by EPA, if for no other reason than to reinforce the institutional credibility of the program. The report also finds that among the most resource intensive activities of program scientists are evaluations of statistical claims or analytical procedures used in the submitted data which are at variance with those regularly employed by the EPA and other Federal regulatory agencies (Report: p. 111). This is mentioned in the context of whether OPP has sufficient resources to assess submitted data adequately and thoroughly. A related problem emerged in 1982, when OPP became aware that some reviewers had conducted "cut and paste" reviews of some industry-submitted reports. That is, that summaries from registrant-provided studies had been used in their entirety as the review scientists' own conclusions about the study. It is presently unclear how many reviewers proceeded in this way, or the number of reviews involved. It is even more uncertain to what extent this practice represents a lack of review by that scientist. As Mr. Johnson noted at the hearing (transcript, p. 17): It is not apparent immediately, however, that they EPA is currently conducting an extensive examination, done by an independent, outside contractor, of all reviews on major studies conducted *65 audits in FY 1978, 33 in FY 1979, 17 in FY 1980, 4 in FY 1981, and 10 in FY 1982 (14 are projected for FY 1983). CRS-19 during the last several years, to determine how widespread this practice has been. It might also be noted that a newspaper report about differences in hearing testimony between Dr. Todhunter and Mr. Johnson on this particular issue was misleading. The newspaper article implied a great difference of opinion about the extent of this practice, while a reading of the hearing transcript does not reveal a significant difference between the views of the two witnesses. However, this "cut and paste" incident does raise the question of sufficiency of resources in OPP at the present time. As workloads have increased dramatically in recent years, the question arises of whether or not program demands invite such operating procedures as one way (albeit unsanctioned by or unknown to management) to cope with the increased workload. The report (p. 12) finds that the combination of reduced budgets and increased workload caused the average OPP empolyee now to handle about two actions in the time available for one action in FY 1980. Specifically, the report (p. 198) notes: The magnitude of workload pressures on OPP employees If trends continue as forecasted by OPP, personnel Also according to the report (p. 195), from its peak level of personnel resources in FY 1980, the program has been reduced by 29 percent by FY 1982. Personnel levels in the Registration Standard and Tolerance Program functions declined by 29 percent and 38 percent respectively from FY 1980 to FY 1982. The overall question raised is: How can OPP handle greater workloads with reduced resources while being sure that its scientific assessments and CRS-20 other regulatory outputs are of adequate quality? Testimony by Mr. Johnson indicates that OPP has tried to absorb most of its budget reductions outside of its scientific assessment area. He cited a 31 percent reduction in nonscientific staff versus a 12 percent reduction in the program's Hazard Evaluation Division (which houses most program scientists). However, the question remains about the quality of overall program outputs. As mentioned, the report noted a major reduction in the resources devoted to registration standards and tolerance petitions. The report and hearing record also noted the absence of any new RPAR's being issued in the last two years. EPA does indeed seem to be "doing more with less." However, the hearing record material indicates little dispute that the program could utilize more resources only not to ease the increased workload burdens, but also to help maintain the caliber of program staff through additional training, library support materials, and other staff development items. EPA representatives nevertheless stated that additional resources were unnecessary at this time, and that assessments and other outputs of adequate quality were being maintained. However, it has been reported that after the hearing, Dr. Todhunter requested additional resources from the then Acting Administrator, Dr. Hernandez. A March 14, 1983 memo sent to Dr. Hernandez requested 30 additional scientists and five additional clerical support personnel over the number currently in place at the Hazard Evaluation Division. The memo states: "During the past 18 months, through attrition and "Finally, many important special projects requiring scientific effort have been deferred. These events have resulted in an urgent need to increase the staffing of toxicologists, chemists, biostatisticians, and associated clerical support personnel." Dr. Todhunter's memorandum added: "The proposed increase to scientific staff would also substantially improve confidence in OPP's scientific reviews Subcommittee on Department Operations, Research, and Foreign Agriculture Attention: Charles M. Benbrook, Staff Director American Law Division A Legal Analysis of the Tolerance Procedures in the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 346, 346a, and 348) and the Rebuttable Presumption Requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as Amended by the Federal Environmental Pesticide Control Act of 1972 (FEPCA) (7 U.S.C. 136 et seq.) Pursuant to your request, we have examined the administrative procedures regarding (1) the issuance of tolerances under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 346, 346a, and 348, and (2) the rebuttable presumption mechanism in, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by the Federal Environmental Pesticide Control Act of 1972 (FEPCA), 7 U.S.C. 136 et seq. You specifically asked us to review these procedures in the context of whether they constitute rulemaking as defined by the Administrative Procedure Act, as amended (APA), 5 U.S.C. 551 et seq. In this legal memorandum, we shall first set out the pertinent provisions in the APA which relate to rulemaking and the agencies' obligations thereunder. This discussion will be followed first by an explanation of the tolerance procedures under the FDCA and second by a description of the rebuttable presumption against registration mechanism provided for in FEPCA. Finally, the latter two procedures will be evaluated in terms of the types of rulemaking permitted by the APA in an effort to ascertain under which category each fits. I. RULEMAKING UNDER THE APA A "rule" is defined in the APA as: ...the whole or a part of an agency statement |