\ / Pesticide Reregisl Progress Report ------- ------- I. INTRODUCTION This is the third in a series of periodic reports produced by the Special Review and Reregistration Division (SRRD), Office of Pesticide Programs (OPP), U.S. Environmental Protection Agency (EPA), on the progress towards pesticide reregistration as mandated under the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A/ This report will show the status of reregistration through the fourth quarter of the 1991 fiscal year. B/ Further information on the reregistration process and descriptions of technical terms have been provided in the Technical Appendix at the end of this document. Please refer to the corresponding reference letters as indicated in the document. These letters are printed in boldface type, followed by a slash mark. A. Current Status Of Reregistration Figure 1 shows the status of the chemical cases in Lists A, B, C, D, and all lists combined through the fourth quarter fiscal year 1991. Each column shows the total number of chemical cases currently on the List, as well as the percentage of cases in each stage of the process. The five-phase process described in the Technical Appendix has been compressed in Figure 1 into three general stages: Unsupported, Awaiting Data/Data in Review, and Reregistration Decision . C/ While the process for List A chemical cases is less formal than that for Lists B, C, and D, it involves a similar sequence of events. List A cases are subject only to Phases 1 and 5. List B, C, and D cases must pass through each of the five phases. Figure 1 Current Status of Reregistration - Chemical Cases - Fourth Quarter FY 91 PERCENT OF CHEMICAL CASES LIST A LISTB LISTC LISTD ALL LISTS Reregistration (7) Decision/ 3.6% REDs Awaiting Data/ (149) Data in Review Unsupported (38) (Total 194) (44) (Total 149) %• (67) (Total 149) (58) (Total 120) (207) (Total 612) Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may result from rounding. ------- Figure 2 shows the status of the total number of chemical cases by the end of the fourth quarter fiscal year 1991. Figure! Total Chemical Cases - Fourth Quarter FY 91 Reregistration 13 Decision AwaitingData/ Data In Review Unsupported Total # of cases: 612 The following is a brief description of the terms used in Figures 1 and 2, D/ Unsupported A chemical case is considered unsupported and is proposed to be cancelled if the registrant (pesticide producer registering the chemical with EPA) fails to submit data in response to EPA's "Data Call-In" (DCI) request. DCI is a term which refers to EPA's request for studies on a chemical case. The implementation of mandatory Maintenance Fees in 1991 resulted in the cancellation of 1,277 registrations for non-payment. The Cancellation Notice for these registrations was published in the Federal Register on October 17,1991. EPA also announced a 90-day deferral of cancellation for ten other registrations. This period will provide an opportunity for affected users to persuade the registrants to continue support for the registrations. Awaiting Data/Data in Review The Awaiting Data/Data In Review category is used in this report to represent the entire review process for cases in all lists. For List A chemical cases, this stage involves reviewing data submitted in response to the Registration Standards and requiring new data where appropriate. Lists B, C, and D are subject to a five-phase formal process. For the purpose of simplification, phases 2 to 4 have been compressed into the Awaiting Data/Data in Review category of Figures 1 and 2. Chemical cases in these lists do not have Registration Standards. Reregistration Decision Once all of the data are evaluated and all the requirements are met for a chemical case, EPA makes a reregistration decision in the form of a Reregistration Eligibility Document (RED). This report measures progress in terms of issuing REDs or reregistration eligibility decisions. Table 2 on page 8, Risk Reduction Measures, shows a summary of the REDs produced by the end of the fourth quarter fiscal year 1991. ------- II. REREGISTRATION PROGRESS A. List A Figure 3 shows a further breakdown of the categories described on the List A column of Figure 1. E/ EPA made a total of seven reregistration eligibility decisions for List A cases by the end of September 1991. The Special Issues category includes chemical cases that are in litigation or have data requirements that are under review (e.g., changes in use patterns/sites). Figure 4 provides an overview of studies EPA has received in response to DCIs. These studies are broken down into the seven major scientific disciplines, which include TOX (CORT), TOX (Non-CORT), Ecological Effects, Environmental Fate, Non-Dietary Exposure, Residue Chemistry, and Special Studies. TOX (CORT) - These studies monitor Chronic feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Tpxicity (Teratology). Essentially, these studies measure exposure to a pesticide over an extended period of time. TOX (Non-CORT) - These studies measure toxicity of pesticides in other than CORT studies. Generally, this category includes studies which measure the effects of acute or limited exposure to the pesticide. Ecological Effects - These studies measure the toxicity to wildlife and aquatic organisms. Environmental Fate - Also referred to as "Environmental Chemistry," these studies measure how the chemicals are broken down and released into the environment Non-Dietary Exposure - Also referred to as "Occupational and Residential Exposure," these studies measure human contact with pesticides either at work or in a domestic setting other than being exposed to the chemical via the diet Residue Chemistry - These studies measure the amount of the pesticide remaining on a crop or commodity and how the pesticide is broken down within the crop or domestic animal. Special Studies - These studies include additional data not required unless specifically requested by EPA. Figures Status of List A - Fourth Quarter FY 91 REDs In Progress 2 Unsupported Special Issues 6 DCIs In 4 Progress 7 REDs Completed DCIs Issued/ Chemicals Awaiting Data Total* of Cases: 194 Figure 4 - List A Studies Received - by Discipline Fourth Quarter FY 91 Special Studies 123 TOX (Non-CORT) TOX (CORT) Residue Chemistry Ecological Effects Non-Dietary Exposure *— 185 ivironmental Fate Total* of Studies: 6,839 ------- Figure 5 shows the total number of studies by discipline that have been reviewed and the total number that are awaiting review. Of the studies that have been reviewed, Figure 6 shows by discipline those that were considered acceptable, upgradable, or unacceptable to EPA. Due to the high rate of rejected studies, EPA has begun a project to analyze the factors that cause a study to be rejected. This project is due to be completed by early 1992. FigureS List A Review Status of Received Studies by Discipline • Fourth Quarter FY 91 3 o 1 E 1400 1200 1000 800 600 400 200 - 0 Reviewed Studies Awaiting Review 1228 799 Environmental Ecological TOX TOX Non-Dietary Residue Special Fate Effects (Non-CORT) (CORT) Exposure Chemistry Studies Figure 6 List A Results of Reviewed Studies by Discipline - Fourth Quarter FY 91 Upgradable or Supplementary Studies Unacceptable Studies Acceptable Studies Unknown 285 Environmental Ecological TOX TOX Non-Dietary Residue Special Fate Effects (Non-CORT) (CORT) Exposure Chemistry Studies ------- B. Lists B, C, and D As shown in Figure 7, the Phase 4 review of List B is complete. Figure 8 shows a breakdown of the categories described in the List B column of Figure 1. F/ Figure 9 provides an overview of studies EPA has received in response to DCIs for List B. These studies are broken down into the six major scientific disciplines as discussed on Page 3. Figure 10 shows the total number of studies by discipline that have been reviewed and the total number that are awaiting review. Of the studies that have been reviewed, Figure 11 shows by discipline those that were considered acceptable, upgradable, or unacceptable to EPA. Figure 8 Current Status of List B - Fourth Quarter FY 91 Revived Cases 3 Unsupported DCIs Issued/ Chemicals Awaiting Data Total # of Cases: 149 Figure 7 FY 91 List B DCI Completion Status (Schedule vs. Actual) - Fourth Quarter FY 91 Figure 9 List B Studies Received in Response to FIFRA 88 by Discipline • Fourth Quarter FY 91 Actual DCIs Completed Quarter Quarter Quarter Quarter TOX (Non-CORT) Ecological Effects TOX (CORT) Residue Chemistry Non-Dietary Exposure 26 Environmental Fate Total # of Studies: 3,518 Total # of pre-FIFRA 88 studies rejected by registrants: 4,337 ------- Figure 10 List B Review Status of Received Studies by Discipline - Fourth Quarter FY 91 9 I C* •s I 600 T Reviewed Studies Awaiting Review Environmental Ecological TOX TOX(CORT) Non-Dietary Residue Fate Effects (Non-CORT) Exposure Chemistry Figure 11 List B Results of Reviewed Studies by Discipline - Fourth Quarter FY 91 348 Upgradable or Supplementary Studies Unacceptable Studies Acceptable Studies 213 Environmental Ecological TOX TOX (CORT) Non-dietary Residue Fate Effects (Non-CORT) Exposure Chemistry ------- C. Registration Eligibility Decisions C-l. REDs Schedule Figure 12 shows the REDs scheduled by quarter and the actual number of REDs completed each quarter. By the end of the fourth quarter fiscal year 1991, a total of 13 REDs had been completed. Figure 12 REDs Scheduled and Completed - Fourth Quarter FY 91 i as •s | 8, • 6. f 4. 2. 0 Schedule for FY91 ["-""I = Actual REDs Completed 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter C-2. Chemical Cases with REDs Scheduled Since FlFRA '88 was enacted, the number of supported chemical cases has been reduced by about 200 cases to approximately 400. The number of supported chemical cases is still changing as some chemical cases become unsupported. Table 1 shows seven chemical cases that had REDs completed in the fourth quarter fiscal year 1991. The seven chemical cases are listed with the number of chemicals (active ingredients) within each case that are eligible for reregistration. Also listed are the total number of products that contain the chemical and the number of tolerances or food uses associated with each chemical case. The Total Tolerances/Food Uses category does not capture exemptions. EPA grants tolerance exemptions if the toxicology database or other studies do not indicate any toxic effects. Table 1 REDs Completed - Fourth Quarter FY 91 CASE Carbon/ CO2 Nitrates/ Nitrites Propionic Acid Sodium Di acetate Silica Gel & Silicon Dioxide Dried Blood Hypo- chlorites Chemicals Completed 2 2 1 1 2 1 2 Total Products 9 6 4 2 75 3 770 Total Tolerances/Food Uses 0 0 0 0 0 0 0 Source: Reregistration Eligibility Documents (REDs) ------- Table 2 shows the risk reduction measures that would result from reregistering the products in accordance with the requirements specified in the REDs. The key below indicates the measures brought about by actions required in the REDs. These actions range from No Changes/Not Applicable to Major Changes. The No Changes/ Not Applicable measure indicates the absence of an existing standard or that the existing standard was not changed. An example of a Major Change is the imposition of a restricted use classification when uses were previously unclassified. Refer to the key for the amount of change. The table summarizes the risk reduction measures with regard to dietary exposure, non-dietary exposure, and environmental fate and ecological effects. G/ Table 2 Risk Reduction Measures Brought About by the REDs Completed • Fourth Quarter FY 1991 CASE Carbon/C02 Nitrates/Nitrites Propionic Acid Sodium Diacetate Silica Gel & Silicon Dioxide Dried Blood Hypochlorites Dietary Exposure Tolerance Reduction Pre Harvest Interval Adjustment Other f*»*ji Non- Dietary Exposure Re-entry Y//// Protective Clothing Y/////, Y/////, w///, Restricted Use Other y&/s Environmental Fate and Ecological Effects Restricted Use Label Modification Other 7^y2/// Y////// W////, Y////// Source: Reregistration Eligibility Documents (REDs) Key: Based on risk assessment f~) — No changes/Not applicable Q — Major changes ^ — Minor changes * Deletion of use in sugar syrup and raw sugar since an appropriate FDA food additive regulation has not been sought or established. Proposal to remove sodium hypochlorite from 180.2 GRAS list and establish either an exemption or finite tolerances. ** Require standard aquatic invertebrate toxicity statement. Require statement of practical treatment on front panel of label. While Table 2 shows individual cases for the fourth quarter fiscal year 1991, Table 3 shows the cumulative number of cases with REDs completed by list and the resulting risk reduction measures. The numbers in the boxes represent the chemical cases that required change to date for each category. For each list, chemical cases can fall into multiple categories. For example, a chemical case may have a protective clothing requirement and a label modification requirement. The first column is the total number of REDs completed to date. All REDs completed so far have been from List A and List D. Table 3 Results of Reregistration (Cumulative Summary) - Fourth Quarter FY 1991 LISTS List A ListB ListC ListD Total Total Cases with REDs 7 6 13 Dietary Exposure Tolerance Reduction Pre Harvest Interval Adjustment Other 4 4 Non- Dietary Exposure Re-entry 1 1 2 Protective Clothing 3 3 6 Restricted Use Other 2 2 Environmental Fate and Ecological Effects Restricted Use Label Modification 6 5 11 Other Source: Reregistration Eligibility Documents (REDs) ------- D. Minor Uses The early notification network, jointly established by the U.S. Department of Agriculture (USDA), EPA, and the National Agricultural Chemicals Association (NACA), communicates registrant actions that would impact on pesticide usage to those affected (particularly the pesticide users). This notification is intended to afford end users of pesticides sufficient time to try to affect decisions. USDA and EPA have two free telephone lines to provide further information on minor uses and reregistration and to learn of growers' minor use pesticide needs. The USDA line is 1-800-262-0216, and the EPA line is 1-800-552-8879. Table 4 lists the chemicals and products that are proposed to be cancelled and the uses that would be affected by these cancellations. Table 4 Proposed Cancellations Affecting Minor Uses - Fourth Quarter FY 91 Chemical Triallate Methomyl Sethoxydim Fluvalinate Dictofop Linuron Triadimefon DCNA Benomyl Products FAR-GO All products POAST Mavrik 2E Hoelon 3EC All products BAYLETON BOTRAN 75W, 75WDC BENLATE WP TERSAN WP Affected Uses Canary Grass Watercress Ginseng, Plantago, Ovata All uses Lentils, dry peas (field peas), Austrian winter peas and flax Cotton Almonds All uses AH ornamental uses All dip, drench, container, and green house uses ID. SIGNIFICANT REGULATORY DECISIONS Another area that relates to reregistration is the special review process for chemicals which have met or exceeded the risk criteria of unreasonable adverse effects as set forth in 40 CFR 154. This section gives a summary of significant regulatory decisions on special review chemicals made within the fourth quarter fiscal year 1991. For further information on Special Review chemicals call (703) 308-8010. Parathion - EPA reached a settlement agreement with the registrants of the pesticide paratnion (ethyl parathion) in September 1991, whereby most uses of this product were voluntarily cancelled. Action was taken on parathion after it was determined to be one of the most acutely toxic chemicals registered with EPA, causing an unacceptable number of poisonings of agricultural workers. Parathion is an organophosphate pesticide which had been used as an insecticide and miticide. EPA has also pronounced its intent to cancel the remaining uses of parathion in the near future. Of the approximately 90 crops for which parathion use has been registered to control insects, the September agreement eliminates all but nine uses. ------- IV. CALENDAR OF EVENTS (FY 92) 1st Quarter 1992 1. The revised Rainbow Report is scheduled for completion. H/ 2nd Quarter 1992 1. The second public Reregistration Workshop is planned. 2. Rejection Rate Study will be completed. V. FURTHER INFORMATION For further information on reregistration issues related to this progress report, please contact the following sources: Pesticide Reregistration pamphlet April. 1991 Available from SRRD/OPP, U.S. EPA, or from EPA's Public Information Center (PIC) 401 M Street, SW (PM-2118) Washington, DC 20460 (202) 475-7751 Reregistration Eligibility Documents (REDs) and RED Fact Sheets Carbon/CO2, Nitrates/Nitrites, Propionic Acid, Sodium Diacetate, Silica Gel/Silicon Dioxide, Dried Blood, Hypochlorites. Published REDs and RED fact sheets are available from the Docket, FOD/OPP (H7506C) U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 (703) 557-2805 Rejection Rate Study For information contact Peter Caulkins, Deputy Director, SRRD (703) 308-8000 Federal Register Publication of Lists A. B. C and D List A: FR 2/22/89, pages 7740-7750 List B: FR 5/25/89, pages 22706-22714 List C: FR 7/24/89, pages 30846-30855 List D: FR 10/24/89, pages 43388-43396 U.S. Government Printing Office 732 North Capitol Street, NW Washington, DC 20401 National Pesticide Telecommunications Network (NPTN) For information about pesticide poisoning symptoms and general information: Tel: 1-800-858-7378; Fax 806-743-3094 USDA/EPA/NACA Early Notification Network For information about minor uses and reregistration: USDATel: 1-800-262-0216 EPA Tel: 1-800-552-8875 Rainbow Report For information contact: (703) 308-8000 Comments Comments EPA welcomes your comments on this progress report or on activities related to reregistration. Please address your comments to: Attention: Pesticide Reregistration Progress Report Special Review and Reregistration Division (H7508W) United States Environmental Protection Agency 401 M Street, SW Washington, DC 20460 10 ------- Technical Appendix (A) FIPRA is the statute under which EPA regulates the marketing and use of pesticides in the United States. (B) This report describes the progress of reregistration in terms of "chemical cases," which are groups of structurally similar chemicals or active ingredients. (C) Formal Pesticide Reregistration Process: Phase 1: EPA publishes lists of pesticides. Phase 2: Registrants decide to support chemicals by agreeing to conduct the required studies and by paying maintenance fees. Phase 3: Registrants summarize and reformat existing studies and certify access to raw data. The registrants flag potential adverse effects data and pay an additional fee to keep chemicals registered. Phase 4: EPA reviews Phase 2 and 3 submissions and identifies additional data needs. EPA publishes lists of missing studies and notifies registrants of required studies. Phase 5: All chemical studies must be submitted before this phase. Product-specific (E) studies are required. Once these studies are reviewed and deemed acceptable, products will be reregistered. (D) When a chemical is unsupported, it is proposed for cancellation and may ultimately be cancelled by EPA. The number of unsupported chemical cases is constantly changing. Chemical cases can drop out of the reregistration process if a registrant decides it is not cost effective to produce the necessary data. However, it is possible for another registrant to support a chemical case by submitting the appropriate data and fees to EPA. This is considered a "revived case." The formal review process is different for List A chemical cases than for Lists B, C, and D. List A chemical cases had Registration Standards completed prior to the 1988 FIFRA amendments. Registration Standards were comprehensive reviews of the data available, decisions on label amendments, and requests for new data to be submitted. By the end of 1988, these had been issued on most of the important food-use chemicals. REDs are produced once the data on a chemical case have been reviewed and no significant issues remain concerning the use of the pesticide chemical. REDs summarize the findings of the review process and reflect EPA's decision to impose any new conditions on the use of a chemical (e.g., reduction of tolerances), to call in product specific data, or to take other regulatory action. Once a chemical case has a completed RED, EPA essentially has determined that the active ingredient does not pose any unreasonable risk when used under its established terms and conditions. The reregistration process makes a determination that products which contain a particular active ingredient are eligible for reregistration. End-use products are reregistered by the Registration Division upon completion of applicable product-specific data and compliance with the terms and conditions specified by RED. List A consists of the active ingredients for which EPA issued Registration Standards as of December 24,1988. The 194 chemical cases in List A cover 350 individual active ingredients as listed in the Federal Register on February 22, 1989. These active ingredients are primarily food-use chemicals. EPA conducted an inventory on List A in 1989-90 to identify further actions needed to reregister List A chemical cases. For List A chemicals, payment of reregistration fees has been the principal indicator of registrant support for reregistration. Failure to pay the fees results in cancellation of all products containing the active ingredient. TA-1 ------- Technical Appendix, cont. (F) Lists B, C, and D include the remaining chemical cases subject to reregistration. These chemicals were registered for the first time before November 1984, but did not have reviews completed under the Registration Standards program. Chemicals appearing on the three lists currently make up 418 chemical cases, including 802 active ingredients. Each successive list represents chemicals with use patterns that generally have less human and environmental exposure. Thus, chemical List D represents chemicals of least exposure. List B chemicals generally are characterized as the less significant food-use pesticides, outdoor non-food crop, and indoor use pesticides. List C chemical cases are predominantly antimicrobial, which includes disinfectants and wood preservatives among other things. List D chemical cases are a mixture of other outdoor and indoor use pesticides and antimicrobial pesticides. List D also includes many biochemical and microbial pesticides. (G) Definitions, of Risk Reduction Measures I. Dietary Exposure A. Tolerance Reduction: This measure indicates where EPA has reduced the maximum acceptable residue level on food/feed products below the previously existing level. B. Pre-Harvest Interval Adjustment: This measure refers to the amount of time since the last pesticide application before a crop can be harvested. Adjustment usually would result in the establishment of a longer period of time to avoid worker and consumer exposure to unacceptable levels of pesticide on a crop. C. Other: This measure may track label modifications or other tolerance changes. II. Non-dietary Exposure A. Re-entry: This measure may result from requiring workers to delay entering a field where crops have been treated with pesticides. B. Protective Clothing: This measure is intended to reduce pesticide exposure to mixers, loaders, applicators, and field workers. C. Restricted Use: This classification generally limits sale and use of a pesticide to certified applicators or persons under their direct supervision. D. Label Modification: This measure refers to changes required in a pesticide label. (H) Rainbow Report This annual report will list and describe the status of each pesticide in the reregistration process and under special review. This report is called the Rainbow Report because it was traditionally printed on multi-colored paper. TA-2 ------- |