Recyeted/Racyclable • Printed with Vegetable OH Based Inks on 100% Recycled Paper (50% Postoonsumer) ------- ------- Contents INTRODUCTION I. PESTICIDE REREGISTRATION A. Reregistration Process Background B. Current Status of Reregistration H. REREGISTRATION PROGRESS A. REDs Completed This Quarter B. RED Candidates for Fiscal Year 1995 C. Suspended Chemical Cases D. Data Submitted for Reregistration OTHER MEASURES OF PROGRESS A. Minor Uses B. Rejection Rate Analysis C. Product Reregistration Status IV. TOPICS OF THE QUARTER A. Avian Granular Risk Reduction Initiative B. Ecological Rejection Rate Analysis - Final Chapter C. New Industry- Wide Task Forces V. SPECIAL REVIEW DECISIONS VI. CALENDAR OF EVENTS (FY 1994) Appendix A. Cumulative Summary of Reregistration Actions Appendix B. Other Sources of Information 2 2 3 4 4 16 16 17 20 20 22 23 24 24 25 25 27 29 30 34 ------- ------- INTRODUCTION The Pesticide Reregistration Progress Report is produced quarterly by the Special Review and Reregistration Division (SRRD), Office of Pesticide Programs (OPP), U.S. Environmental Protection Agency (EPA), to provide information on progress towards pesticide reregistration as mandated under the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Progress is reported both for the current quarter of the fiscal year1 and cumula- tively. This issue of the Progress Report describes the status of reregistration through the fourth quarter fiscal year 1994 (FY 94). Eighty-one REDs have been completed since 1991 representing 120 chemicals/active ingredients (AIs), 3,521 prod- ucts and 500 tolerances. Approximately 601 products have completed the process and have been reregistered. Please see Appendix A for a more detailed cumulative summary. The fiscal year runs from October through September, and is divided into four quarters: the first quarter consists of October, November, December; the second quarter consists of January, February, March; the third quarter consists of April, May, June; and the fourth quarter consists of July, August, September. ------- I. PESTICIDE REREGISTRATION A. Reregistration Process Background EPA is required by law to reregister existing pesticides that originally were registered years ago when the standards for government approval were less stringent than they are today. This comprehensive reevaluation of pesticide safety is critical to protecting human health and the environment. In 1988, Congress amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to strengthen and accelerate EPA's reregistration program. The nine-year reregistra- tion scheme mandated by "FIFRA '88" applies to each registered pesticide product containing an active ingredient initially registered before November 1,1984. In 1988, approximately 600 groups of related pesticide active ingredients, or "cases," repre- senting 1,150 active ingredients in 45,000 formu- lated products, required reevaluation. As FIFRA '88 directed, EPA divided these 600 cases into four lists: List A, B, C and D. List A - List A consisted of the 194 chemical cases (or 350 individual active ingredients) for which EPA had issued Registration Standards prior to the effective date of FIFRA '88. Most pesticides with food-related uses are on List A. List B, C and D - The remaining pesticides were divided into three lists based upon their potential for exposure and other factors, with List B being of highest concern and D of least. Some of the classification criteria included potential for residues of concern in food or drinking water, significance of outstanding data requirements, potential for worker exposure, Special Review or restricted use status, and unintended adverse effects to animals and plants. FIFRA '88 established mandatory reregistration timeframes and duties. The five phases of the reregistration process are: Phase 1: Listing of Active Ingredients - EPA published Lists A, B, C, and D within 10 months of FIFRA '88 and asked registrants of these pesticides whether they intended to, seek reregis- tration. Phase 2: Declaration of Intent and Identification of Studies - Registrants were required to notify EPA whether or not they intended to reregister their products; to identify and commit to provid- ing necessary new studies; and to pay the first installment of the reregistration fee. During this phase, EPA issued guidance to registrants for preparing their Phase 2 and Phase 3 responses. Phase 2 activities were completed in 1990. Phase 3: Summarization of Studies - Registrants were required to submit summaries and refor- matted acceptable studies, "flag" studies indicat- ing adverse effects, re-commit to satisfying all applicable data requirements, and pay the final installment of the reregistration fee. Phase 3 ended in October 1990. Phase 4: EPA Review and Data Call-in's - In Phase 4, EPA reviewed all Phase 2 and 3 submis- sions and required registrants to meet any unful- filled data requirements within four years. Phase 4 was completed in 1994. Phase 5: Reregistration Decisions - In this phase, EPA reviews all the studies that have been submitted for a chemical case, and decides whether or not to reregister products containing the active ingredients in that case.1 A pesticide will be considered eligible for reregistration if its data base is substantially complete, and if it does not cause unreasonable adverse effects to people or the environment when it is used according to product label directions and restrictions. . ------- B. Current Status of Reregistration Figure 1 shows the status of supported chemi- cal cases in Lists A, B, C, D, and all lists com- bined, through the end of fiscal year 1994. Each column shows the total number of supported chemical cases currently on each list. Also shown are the numbers and percentages of those cases that have REDs completed, and cases that are in the category of Awaiting Data/Data in A Review. Of the total of 612 cases (representing 1,138 ATs) that were eligible for reregistration in 1988, 405 (representing 590 AI's) still are sup- ported while 207 are! not supported by their registrants. A list of REDs completed appears in Appendix A, Cumulative Summary of Reregis- tration Actions. Figure 1 Current Status of Reregistration - Supported Chemical Cases - Fourth Quarter FY 94 COMPLETED REDS AND SUPPORTED CHEMICAL CASES LIST A LIST B 3% LIST C LIST D ALL LISTS Reregistration Eligibility Decisions (REDs) Supported: Awaiting Data/Data in Review (Total Supported Cases: 151) Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may result from rounding. This number was originally 611 cases, which became 612 when two active ingredients were separated to become individual cases. ------- II. REREGISTRATION PROGRESS A. REDs Completed This Quarter This section summarizes RED production during the fourth quarter of fiscal year 1994, and summarizes the information in the individual REDs. In reviewing pesticides for reregistration, EPA gathers a substantially complete set of data on each chemical case, examines related health and environmental effects, and attempts to mitigate effects of concern. This evaluation and risk management process is complete when EPA is satisfied that the pesticide(s), used in accordance with approved labeling, will not pose unreason- able risks to human health or the environment. When some or all uses of a pesticide are deter- mined to be eligible for reregistration (or when another regulatory conclusion has been reached), EPA issues a Reregistration Eligibility Decision (RED), usually embodied in a RED document. About 14 months later, once certain product- specific data and revised labeling are submitted and approved, EPA begins reregistering single- active ingredient products containing the pesti- cides included in these REDs. Products that contain active ingredients in addition to these will not be reregistered until all of their active ingredients are eligible for reregistration. FY 94 REDs Production Figure 2 shows the number of REDs scheduled to be completed by quarter during fiscal year 1994, and the number actually completed through the fourth quarter. Twenty REDs were completed in the fourth quarter, covering a total of 21 chemicals and 430 products. Thirty-four REDs were completed in fiscal year 1994. The target for the fiscal year was 38 REDs. A total of 81 REDs have been completed to date. Fur- ther information about the completed REDs can be found in Appendix A, Cumulative Summary of Reregistration Actions. Figure! REDs Scheduled and Completed by Quarter - FY 94 20 T 15 -- 10 -- 5 -- REDs Completed (34) • REDs Scheduled (38) 20 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter ------- 4th Quarter RED Summaries During the fourth quarter of fiscal year 1994, EPA completed the REDs summarized below: Bentazon - Bentazon, or Basagran, is a selec- tive, postemergent herbicide used to control broadleaf weeds and sedges primarily in soy- beans, but also in other food and feed crops including alfalfa, beans, corn, peanuts, peas, peppers, peppermint, rice, sorghum and spear- mint, and on ornamental lawns and turf. All uses are eligible for reregistration. Bentazon is slightly acutely toxic by all routes (Toxicity Category III) and is a skin sensitizer. It is classified as a "Group E" carcinogen—a chemicial showing evidence of non-carcinogenic- ity to humans—but it causes some developmental toxicity effects in rats and rabbits. People may be exposed to bentazon residues through their diets. Based on EPA's dietary risk assessments, however, dietary exposure to the uses supported for reregistration is not of con- cern. Potential developmental toxicity effects among workers also are not of concern based on the Agency's assessment that worker risks are low, and do not warrant the establishment of PPE requirements beyond those required by the WPS. Leaching through soil is a major route of dissipation for bentazon, which has been detected in well water in four out of eight states sampled. Bentazon exceeds levels of concern for ground water quality and also may impact the quality of surface water. EPA's Office of Water has estab- lished a Health Advisory for bentazon. OPP is requiring a ground water label advisory, and is limiting the amount of bentazon that may be applied annually per acre. The registrant has agreed to prepare educational materials for users, dealers and distributors on ground and surface water protection. Use of bentazon is not ex- pected to pose a serious environmental threat. Several confirmatory generic studies are re- quired. For additional information, please . contact Eric Feris by E-Mail at FERIS.ERIC@EPAMAIL.EPA.GOV, or at 703- 308-8048, via relay (1-800-828-1140). Chlorine - Chlorine is used in water treatment to disinfect drinking water, swimming pools and other types of water reservoirs. It is used as a disinfectant and algicide in food processing, pulp and paper mill, and commercial and industrial water cooling systems. Chlorine also is used in washing meat, fresh produce and seeds to control decay-causing microorganisms. All uses are eligible for reregistration. However, chlorine products registered for use in swimming pools and industrial food processing plants are begin classified as Restricted Use Pesticides and must bear appropriate labeling starting between April 30, 1996, and October 31, 1996. Risk to the public is not anticipated from consuming food or water treated with chlorine. However, EPA has serious concerns about applicator and post-application exposure to chlorine gas because it is highly toxic via all routes of exposure. Based on human incident reports, the greatest risk is to applicators, other workers and bystanders from accidental exposure resulting from use of chlorine gas in swimming pools and industrial food settings. To mitigate this risk, EPA is classifying relevant products as Restricted Use Pesticides, and is requiring significant revisions to product labeling so it will contain sufficient specific use information. Chlorine is very highly toxic to fish and fresh- water invertebrates, If acute levels of concern are exceeded in receiving waters from facilities using chlorine, a significant risk to aquatic ------- organisms and endangered aquatic organisms can be expected. However, effluent discharges containing chlorine are regulated under NPDES permits, and the maximum concentration allowed in each effluent stream is set on a site-specific basis to achieve the lowest possible concentra- tions of chlorine in each receiving stream. No significant adverse effects to aquatic organisms are anticipated from discharges of chlorine under this permitting system. For additional informa- tion, please contact Tom Myers at 703-308- 8074. Chloroxylenol - Chloroxylenol is an antimicro- bial used to control bacteria, algae and fungi in adhesives, emulsions, paints and wash tanks. It also is used to sanitize bathroom premises, diaper pails, laundry equipment, human bedding and pet living quarters in households, hospitals and other institutions. Use practice limitations prohibit discharge into lakes, streams or other public waters except under an NPDES permit. All uses of Chloroxylenol are eligible for reregistration. However, EPA is concerned with the potential formation of dioxins and chlori- nated dioxin impurities during the manufacture of Chloroxylenol, and with the effect of these impurities on human health and the environment. The Agency is requiring the registrant to fully satisfy technical chemistry data requirements addressing this concern. A reassessment of the risk posed by Chloroxylenol may be required, depending on the results of these studies. Chloroxylenol generally is of moderate to low acute toxicity, but causes severe eye irritation (Toxicity Category I). Since it is not applied to food or feed crops and is not used in food handling establishments, no dietary risk is ex- pected. FDA regulates the use of this pesticide as a food packaging adhesive. No toxicological endpoints of concern have been identified for Chloroxylenol except eye irritation. Personal protective equipment (PPE) may be required for some end-use products on a case-by-case basis, but is not required for all Chloroxylenol products at this time. Chloroxylenol is practically non-atoxic to birds, moderately toxic to freshwater invertebrates and highly toxic to fish. However, exposure to terrestrial and aquatic organisms is extremely minimal since Chloroxylenol has almost all indoor uses. The sole outdoor use, on pet living quar- ters, will not result in significant environmental exposure. Therefore, when used according to label directions, Chloroxylenol poses only a minimal risk to terrestrial and aquatic organisms. For additional information, please contact Yvonne Brown at 703-308-8073. DBNPA - DBNPA is a biocide used in a variety of industrial processes to control algae, bacteria, fungi and yeasts. Use practice limitations require a National Pollutant Discharge Elimination System (NPDES) permit for discharges to water- ways. Most uses of DBNPA are eligible for reregistration. However, because the risk to non- target organisms outweighs the potential benefits associated with the use of DBNPA in single flow- through cooling towers, this use is ineligible for reregistration. EPA will take appropriate action against DBNPA products labeled for this use. DBNPA is corrosive to the eyes (Toxicity Category I), can kill skin tissue exposed at high levels for a prolonged period of time, and is a developmental toxicant in rabbits which produces structural alterations in fetuses at doses that are not toxic to the mother. Several human incidents have been reported involving acute exposure to DBNPA after spills or misuse. One food-related use, in food grade paper and paperboard, is regulated by FDA. Residential exposure and risk are not of concern since DBNPA has no residen- tial uses. Handlers of DBNPA may be at risk for acute or developmental toxicity effects, particularly those using open pouring methods to add the pesticide ------- to cooling towers. EPA is requiring use of appropriate PPE through the RED to mitigate these risks to workers. Without any mitigation measures, DBNPA poses a high risk to aquatic organisms. To mitigate these risks, EPA is requiring secondary biological treatment of waste water for all uses of DBNPA except use in waste water treatment systems (since biological degradation readily occurs there, anyway); in secondary oil recovery systems (where biological treatment is not feasible, but EPA is less concerned about this use pattern); and in single flow-through cooling tower systems (which is not eligible for reregistration). The use of DBNPA in single flow-through cooling tower systems poses an unacceptable risk to aquatic organisms. Secondary biological effluent treatment is not practical for this use; thus, the risks it poses to aquatic organisms cannot be mitigated. Meanwhile, the benefits it affords are low or non-existent—the amount of DBNPA used for this purpose is negligible and registered alternatives are less costly. Therefore, the use of DBNPA in single flow-through cooling tower systems is not eligible for reregistration, and EPA will take appropriate regulatory action against DBNPA products labeled for this use. For additional information, please contact Rich- ard Gebken at 703-308-8591. DCDIC - Disodium cyanodithioimidocarbonate or DCDIC is a microbicide/microbistat used in water treatment systems. It is used as an indus- trial biocide and slimicide to control slime- forming bacteria, algae and fungi in food pro- cessing water systems (cane and beet sugar mills), pulp and paper mill water systems, other commercial/industrial water cooling systems, and secondary oil recovery injection water. All uses are eligible for reregistration. DCDIC generally is of moderate acute toxicity but causes eye irritation (Toxicity Category I). Although DCDIC has two food uses (sugar beets and sugar cane) and one food tolerance for food contact with food grade paper, paperboard and adhesives, all are under FDA's purview. The open pouring method of applying DCDIC to cooling tower water poses the greatest risk of developmental toxicity to applicators. However, EPA's worst case exposure assessment probably results in an overestimate of risk; the actual risk to workers is expected to be low when appropri- ate protective equipment and clothing are used, as required by the ELED document. The sec- ondary oil recovery use of DCDIC normally would require extensive data regarding potential ground water impacts. However, properly encased injection wells preclude contact between materials placed down the well and any aquifer in the area; so EPA believes the chemical is not likely to present a hazard to ground water through this use. Other aquatic industrial uses carry National Pollutant Discharge Elimination System (NPDES) permit restrictions, limiting industrial discharges to acceptable levels for each site. DCDIC is moderately to highly toxic to aquatic/estuarine invertebrates. Freshwater aquatic invertebrates, estuarine and marine aquatic invertebrates may be at risk from effluent at high exposure sites. In addition, these high exposure case scenarios exceed the levels of concern for endangered fish at certain industrial sites, and those for endangered aquatic inverte- brates at all sites. Effluent containing DCDIC should not be discharged into aquatic habitats where endangered species are known to live. Endangered species labeling may be required in the future. While the use of DCDIC as a pesticide is regulated by EPA's Office of Pesticide Programs under FIFRA, the discharge of effluent contain- ing DCDIC to surface waters is regulated under ------- the NPDES permit program administered by EPA's Office of Water (OW) with the states. The NPDES process takes local conditions into account in issuing permits for the discharge of pollutants to bodies of water. EPA's OPP and OW will share information and cooperate in overseeing the use of biocides such as DCDIC. For additional information, please contact Bonnie Adler at 703-308-8523. Difenzoquat - Difenzoquat is a post-emergent herbicide used to control wild oats in wheat (primarily) and barley. Marketed under the trade name Avenge, difenzoquat is applied by ground or aerially, once per growing season. All uses are eligible for reregistration. Although difenzoquat is used on food/feed crops, people are exposed to only extremely low level residues in their diets, posing no known risks. Difenzoquat generally is of low acute toxicity but poses a risk of acute eye irritation to workers. To mitigate this risk, a 48-hour re- stricted entry interval (REI) will be maintained. People who must reenter treated areas during this time must wear prescribed protective cloth- ing and equipment including protective eyewear. Current uses of difenzoquat do not pose any unreasonable threat to the environment. Since it is a herbicide that is applied aerially, difenzoquat could pose a high risk to terrestrial and aquatic plants, including endangered plant species. Additional, confirmatory data are required to assess these risks. Several other confirmatory studies also are required. For additional informa- tion, please contact Andy Ertman at 703-308- 8063. Fenbutatin-Oxide or Vendex - Fenbutatin- oxide or Vendex is a miticide or acaricide used to control mites, aphids, thrips, mealybugs, whiteflies and scale primarily on orange and grapefruit crops, but also on other citrus, apple, stone fruit, nut tree and food crops, and on ornamentals. To ensure that the risks to fish and aquatic organisms are not unreasonable, EPA is classifying fenbutatin-oxide as a Restricted Use Pesticide and is requiring the registrant to imple- ment certain risk reduction measures. Provided that these measures are implemented, all prod- ucts are eligible for reregistration. Fenbutatin-oxide generally is of low acute toxicity but is a severe eye irritant. It poses no significant chronic health risks and is classified as a Group E carcinogen; that is, a chemical that poses no known cancer risk for humans. Al- though people may be exposed to residues of fenbutatin-oxide in many fruits and other foods, the chronic dietary risk from such exposure is minimal. Workers and other users may be exposed to fenbutatin-oxide during and after application to food crops and ornamentals. To mitigate the risk of eye irritation during these activities, EPA is requiring a 48-hour REI and the use of PPE including protective eyewear for all agricultural uses within the scope of the WPS, and more stringent entry restrictions for non-WPS occupa- tional and residential uses. Fenbutatin-oxide is persistent in the environ- ment, with no major route of dissipation. It also is relatively immobile so it is not expected to leach. However, fenbutatin-oxide is very highly toxic to freshwater, estuarine and marine fish and invertebrates. Since it persists in the environ- ment long after application, the potential for serious contamination of the ecosystem is sub- stantial. To mitigate the risks posed by fenbutatin-oxide to freshwater and estuarine aquatic organisms, EPA is classifying fenbutatin-oxide as a Re- stricted Use Pesticide "due to very high toxicity to aquatic organisms." The Agency also is employing risk reduction measures for uses in the ------- State of Florida including: reducing application rates; requiring label directions to minimize spray drift; and developing additional modeling and monitoring. Several additional generic studies as well as product specific data and implementation of risk reduction measures are required for reregistration. For additional information, please contact Susan Jennings at 703-308-8021. HEXAZINONE - Hexazinone is a herbicide used to control a broad spectrum of weeds including undesirable woody plants in alfalfa, rangeland and pasture, woodland, pineapples, sugarcane and blueberries. It is also used on ornamental plants, forest trees and other non- crop areas. Although a number of risk mitigation measures are imposed by the RED, all uses of hexazinone are eligible for reregistration. Hexazinone generally is of relatively low acute toxicity but is a severe eye irritant (Toxicity Category I). It is not classifiable as to human carcinogenicity (Group D carcinogen) and does not cause other toxic effects of concern. The dietary risk posed by hexazinone is expected to be minimal. Most tolerances were reassessed and other existing tolerances are considered protective until confirmatory data are available for reassessment. A lifetime Health Advisory sets a maximum level of exposure to hexazinone from drinking water. Exposure to workers and other applicators generally is not expected to pose undue risks, due to hexazinone's overall low acute toxicity. However, based on toxicity concerns regarding primary eye irritation, a 48-hour rather than a 24- hour REI is required. Hexazinone exceeds the levels of concern for both aquatic and terrestrial plants, and exceeds levels of concern for small mammals at several of the higher application rates. It also is likely to have a significant impact on ground water qual- ity, and may affect surface water. Therefore, a number of risk mitigation measures are required, including: • All product labels must carry a ground water advisory; • Registrants must report any ground water detections to EPA; • The registrant must prepare a re port summarizing ongoing re search regarding ground water detections in the State of Maine; • The registrant must submit educational materials under development regarding product stewardship and addressing the potential for ground water con tamination; • A prospective ground water monitoring study must be con ducted; • Precautionary label language will be required to address surface water concerns; • To address risks to nontarget plants and small mammals, the maximum application rate must be reduced; • In the future, spray drift manage ment labeling may be required, endangered species precautionary labeling will be required, and hexazinone may be classified as a Restricted Use Pesticide for ground water concerns. A number of confirmatory generic studies are required. For additional information, please contact Andy Ertman at 703-308-8063. Limonene - Limonene is a naturally occurring chemical which is used in many food products, soaps and perfumes for its lemon-like flavor and odor. Limonene also is a registered active ingre- dient in 15 pesticide products used as insecti- ------- cides, insect repellents, and dog and cat repel- lents. These products are used for flea and tick control on pets, as an insecticide spray, an outdoor dog and cat repellent, a fly repellent tablecloth, a mosquito larvicide, and an insect repellent for use on humans. Use practice limitations include a label prohibition against use on weanling kittens and a caution against use of undiluted product. All uses are eligible for reregistration. Limonene is among those pesticide active ingredients for which a reduced set of generic data requirements is appropriate for registration or reregistration. Limonene is naturally occur- ring, has been established as an inert, is exempt from the requirement of a tolerance, and is recognized as safe by FDA. Its effects are well known and documented in scientific literature; additional testing would not likely provide any new findings. Adequate information is available to characterize its risks to humans and animals. Dietary exposure to limonene is not a concern because limonene occurs naturally in foods, is used as a flavoring agent, is generally recognized as safe by FDA, and has only one food-related pesticide use (as an insect repellent impregnating tablecloths) that EPA has exempted from toler- ance requirements. People may be exposed to limonene when applying flea and tick control shampoos, dips or sprays to their pets, when applying animal repel- lent granules or insecticide sprays, or when using impregnated tablecloths. Skin irritation and sensitization or eye irritation may occur from these uses. In addition, adverse reactions may occur in some pets, especially cats, treated with the flea and tick control products. Additional precautionary statements are required on li- monene product labeling to reduce the potential for adverse effects among users and treated pets. Application of the granular product is expected to pose minimal risk to birds, mammals and aquatic species based on limonene's low level or lack of toxicity to these species. The mosquito larvicide use produces an oily filrii that is ex- pected to dissipate rapidly, posing no major ecological concern for freshwater invertebrates or other aquatic species. For additional informa- tion, please contact Emily Mitchell at 703-308-8583. M-Cresol and Xylenol - M-cresol and xylenol, when formulated together, have bacteriostatic activity against agents that cause crown gall, olive knot and burr knot in fruit, ornamental and shade trees and ornamental woody shrubs and vines. The pesticide product that contains these two active ingredients, Gallex, is brushed or painted onto the infected areas of trees and ornamentals. Although usage data are not available, EPA assumes that the volume of use is relatively low. All uses of m-cresbl and xylenol in Gallex are eligible for reregistration. Dietary exposure to m-cresol and xylenol is not a concern since residues of these pesticides do not remain in the fruit or nuts of treated trees. Applicators face acute toxicity hazards to the skin and eyes. However, these risks will be mitigated by use of Personal Protective Equip- ment (PPE), as required by the RED. EPA does not expect significant health risks from short term residential/occupational exposure to m- cresol and xylenol, when used properly as di- rected. EPA did not conduct an environmental risk assessment for m-cresol and xylenol and did not require any data on environmental fate or ecotoxicity. The current use pattern of these pesticides and their low volume of use will result in very low environmental exposure, resulting in no threat to wildlife. Non-target organisms including endangered species are not expected to be adversely affected from this use. For addi- tional information, please contact Paul Lewis at 703-308-8018. 10 ------- Mercaptobenzothiazole - This case includes two active ingredients, the sodium and zinc salts of 2-mercaptobenzothiazole, which are used as fungicides, microbiocides and bacteriostats. They are used as preservatives for adhesives, latex and oil paints, paper products, metal work- ing cutting fluids and textile fibers. All uses are eligible for reregistration. The sodium and zinc salts are not registered for any food or feed related uses, so no dietary risks are posed. The potential for residential exposure and risk is very low. The acid of 2-mercaptobenzothiazole is classified as a non-quantifiable "Group C" or possible human carcinogen. The sodium salt is in Toxicity Category I, indicating the highest degree of acute toxicity, for skin and eye effects. Margins of Exposure (MOEs) were calculated to quantify the risk to certain applicators/mixers/ loaders. The MOEs were found to exceed 100 by several orders of magnitude. An MOE over 100 does not trigger a risk concern. The metal working cutting fluid use of the sodium salt of 2-mercaptobenzothiazole is the only use pattern where effluent containing the chemical is discharged into aquatic environments, potentially exposing non-target aquatic organ- isms, including endangered species. This use pattern under typical exposure scenarios, poses minimal risk to endangered aquatic species. However, under high exposure scenarios, the Level of Concern (LOG) is exceeded. The Agency, therefore, has determined that effluent containing sodium 2-mercaptobenzothiazole should not be discharged into streams and other waterways where endangered aquatic organisms are known to reside. When the Agency com- pletes its Endangered Species Program, addi- tional precautionary labeling may be required to mitigate the risk to endangered species. For additional information, please contact Kathleen Depukat at 703-308-8587. Metalaxyl - Metaiaxyl is a systemic fungicide used to control plant diseases caused by water- mold fungi. It is used on many food and feed crops and on non-food, residential and green- house crops such as tobacco, ornamental plants, trees, shrubs, vines, lawns and turf. All uses are eligible for reregistration. Metalaxyl generally is of low acute toxicity but is an eye irritant. It has been classified as a Group E carcinogen; that is, a chemical showing evidence of non-caircinogenicity for humans. Although people may be exposed to residues of metalaxyl in many foods, the chronic dietary risk from all uses is minimal. Application and post- application risks to workers and others also are minimal because metalaxyl has no lexicological endpoints of concern. Since metalaxyl can irritate the eyes, a 24-hour restricted entry interval (REI) is being imposed and use of personal protective equipment (PPE) is required. Metalaxyl is persistent and mobile, leaches in many soils, has the potential to reach ground water, and has been detected in ground water in five states. To reduce the possibility of ground water contamination,, EPA is requiring a ground water label advisory for metalaxyl end use products, and the registrant will conduct a user education program if levels are detected in groundwater at or above 400 ppb. Metalaxyl poses minimal if any risks to terrestrial and aquatic animals and plants. EPA is requiring a number of confirmatory generic as well as product specific studies for reregistration. For additional information, please contact Judy Loranger at 703-308-8056. Mevinphos - Mevinphos is an insecticide used on vegetables and fruits, mainly lettuce and cole crops. Mevinphos is not eligible for reregistration because all registrations have been voluntarily canceled. However, because it is so acutely toxic that even a small exposure, whether 11 ------- by mistake, accident or through routine activity, can cause serious poisonings, EPA would have found mevinphos ineligible for reregistration. Mevinphos is extremely toxic to mammals by all routes of exposure and has been placed in Toxicity Category I for all acute effects. It has a steep dose-response curve; the difference be- tween a nonlethal and a lethal dose is small. Mevinphos poses no known chronic health effects but may be slightly mutagenic. A prelimi- nary risk assessment for acute dietary exposure indicated a concern, particularly for infants and children. An incomplete database prevented the Agency from fully evaluating mevinphos' risks to wildlife. EPA's Acute Worker Risk Strategy project ranked mevinphos among the five pesticides warranting accelerated action, based primarily on human incident data. When risk reduction measures proposed by the registrant failed to allay Agency concerns, EPA determined mevinphos to be unsafe for any use and was prepared to issue a Notice of Intent to Suspend all registrations on June 30, 1994, when the registrant submitted a request for voluntary cancellation. EPA accepted this request, and on July 1, 1994, issued a Cancellation Order for all mevinphos registrations, effective immediately. Relevant documents were published in the Federal Register on August 1, 1994. No one may sell or distribute existing stocks of canceled rnevinphos products after December 31, 1994. Mevinphos may be used in accordance with previously-approved labeling through February 28, 1995. No one may use existing stocks of canceled pesticide products containing mevinphos after February 28, 1995. For additional information, please contact Josh First at 703-308-8032. Nuosept 145 - Nuosept 145® is an organic preservative registered for industrial indoor, non- food use in latex paint (in cans), resin emulsions, building adhesives, dispersed colors, pigment slurries and ready-to-mix joint cements. This microbiocide/microbiostat is used to control slime-forming bacteria and fungi., All uses are eligible for reregistration. ; Current use practice limitations prohibit dis- charge of effluent containing Nuosept 145® into streams or other public waters except under an NPDES permit, and use in connection with feed, food, or drinking water. Since Nuosept 145® is not registered for any food or feed related uses, no dietary risks are posed. There are no health concerns for residen- tial exposure or for long-term occupational exposure. There is a potential for acute respira- tory, skin and eye effects from occupational exposure to the Nuosept 145® technical, par- ticularly from the open poring method of applica- tion. Based on available data and considering its use patterns, environmental risk posed by Nuosept 145® technical, as it is diluted in the treated product, such exposures do not warrant special restrictions. For additional information, please contact Kathleen Depukat at 703-308-8587. Oil of Citronella - Citronella is one of 31 pesticide active ingredients that EPA has pro- posed to exempt from regulation under FIFRA, pursuant to section 25 (b) of the Act. As ex- plained in the proposed rule published in the Federal Register on September 15, 1994, cit- ronella is used as an insect repellant in candles, and in other products used directly on human skin. Citronella also is widely used for non pesticidal uses such as perfumery. Citronella is an essential oil listed as GRAS (Generally Rec- ognized as Safe) by FDA. Exposure to and effects on humans or the environment attribut- able to use of citronella as an insect repellent are 12 ------- indistinguishable from exposure/effects from its use as a fragrance/perfume. EPA believes it is unnecessary to regulate citronella as a pesticide in order to carry out the purposes of FIFRA. EPA is now considering comments received during the 60 day public comment period. Al- though reregistration of citronella has ceased, products will remain registered until a final decision concerning the deregulation of citronella is made. For additional information, please contact Virginia Dietrich at 703-308-8157. Oryzalin - Oryzalin is a herbicide used to control grasses, weeds, woody shrubs and vines in a variety of fruit, nut and non-food crop sites. Oryzalin is used most on residential and other lawns and turf, almond orchards and grapes. Other use sites include berries and orchard crops, ornamentals and shade trees, Christmas tree plantations, fencerows/hedgerows, nonagricultural rights of way and uncultivated areas. All uses of oryzalin are eligible for reregistration except use on residential lawns and turf, for which EPA does not currently have enough information to make an eligibility deci- sion. Oryzalin generally is of moderate acute toxicity but is carcinogenic in animal studies and has been classified as a Group C, possible human carcino- gen. Although several food crop uses are regis- tered, dietary exposure and risk to the general population are very low. Of greater concern is the risk posed to han- dlers, field workers and others who come into contact with treated foliage, crops or lawns. Exposure and risk to applicators will be miti- gated by the use of personal protective equip- ment (PPE) beyond that required by the Worker Protection Standard (WPS). Post-application reentry workers must observe a 24-hour re- stricted entry interval (REI), which is twice as stringent as that set by the WPS. The residential lawn and turfgrass vise is not eligible for reregistration until post-application exposure studies are submittedtand evaluated. Although parent pryzalin is not mobile, the registrant is conducting a study to determine the leaching potential of its degradates. Since it is a herbicide, oryzalin poses an acute risk to non- target plants, includiing threatened and endan- gered plants, from runoff and spray drift, as well as to endangered aquatic species in shallow water adjacent to treated areas. These risks will be addressed through the Endangered Species Protection Program. The registrant has agreed to take measures to reduce oryzalin's environ- mental risks which include prohibiting aerial application (except to agricultural crops in California) to reduce spray drift, and limiting the amount, frequency a.nd timing of applications per year. Many confirm atoiy studies are required. For additional information, please contact Judy Coombs at 703-308-8046. Piperalin - Piperaliri is a fungicide used to control powdery mildew on ornamental plants, shrubs, vines and trees grown in commercial green houses. Currently, only one product is registered which contains this active ingredient. Use practice limitations include a recommenda- tion to use with three specific surfactants, and prohibitions against entering treated areas with- out personal protective equipment (PPE) for 12 hours, applying the pesticide through any type of irrigation system, applying directly to water or wetlands, and contaminating water, food or feed. Piperalin has no registered food uses so no dietary risks are posed. Even though applicators can be exposed to significant amounts of piperalin, this pesticide poses little toxicity concern. Workers' exposure will be minimized through product labeling requirements. 13 ------- Piperalin is practically nontoxic to birds, highly toxic to fish, and moderately toxic to aquatic invertebrates. However, birds and mammals will not be significantly exposed to piperalin through consumption of insect and plant food containing residues of this pesticide. Exposure to fish and aquatic invertebrates also is not expected to occur since piperalin is used only inside greenhouses, and since labeling prohibits use practices that would contaminate water. No significant risks to birds, fish or aquatic inverte- brates, including endangered species, are ex- pected. For additional information, please contact Sue Rathman at 703-308-8069. Sodium Cyanide - Sodium cyanide is a single dose poison used in the M-44 ejector device on pastures, range and forest land to control coyote, red fox, gray fox and wild dog populations that prey upon (or are likely to prey upon) livestock, poultry or endangered species, or that are vec- tors of communicable diseases. All uses are eligible for reregistration. The currently registered uses of sodium cyanide are subject to multiple use restrictions to minimize potential adverse impacts on man and the environment. As a Restricted Use Pesticide, sodium cyanide may be applied only by trained, certified applicators under the direct supervision of a government agency. Sodium cyanide is not registered for use in residential environments, so risks are not posed to the general population. Risk of acute toxicity to applicators is mitigated by the pesticide's use restrictions and Restricted Use Pesticide classification. Because of the specific nature of sodium cyanide's registered use pattern, the Agency has concerns for the potential risk of acute toxicity to non-target animals. Sodium cyanide is consid- ered a high acute risk pesticide for terrestrial vertebrates, including non-target and endangered species. While the label restrictions were de- signed to minimize risk to non-target species, additional restrictions on the use of sodium cyanide were outlined for species at risk in a March 1993 U.S. Fish and Wildlife Service Biologial Opinion and are being imposed through the RED. The Agency does not anticipate significant environmental exposure to sodium cyanide when it is used as an encapsulated material together with the M-44 ejector device. The environmen- tal impact is expected to be minimal because of sodium cyanide's mode of application, as well as its degradation pattern in the environment. For additional information, please contact Kathleen Depukat at 703-308-8587. (Z)-9-Tricosene or Muscalure - (Z)-9- tricosene is the sex-attractant pheromone of the female housefly. This biochemical pesticide is used for fly control in food/feed handling estab- lishments, livestock premises and residential areas. Label restrictions prohibit use near food and feed. All uses are eligible for reregistration. Certain chemistry issues must be resolved, and the Agency is requiring confirmatory data to correct these deficiencies and accurately charac- terize the technical chemistry of (Z)-9-tricosene. The potential risks to humans from both non- dietary and dietary routes are considered negli- gible. Because the active ingredients are impreg- nated or embedded in a solid polymeric matrix shell, there is low potential for exposure and there are no toxicological concerns. (Z)-9-tricosene has low toxicity to mammalian species. It is practically non-toxic to birds and freshwater fish on an acute oral basis, and to birds on a subacute dietary basis. However, (Z)- 9-tricosene is very highly toxic, even in low doses, to waterfowl for reproductive effects and is also highly toxic to freshwater invertebrates. For (Z)-9-tricosene products that are formu- lated as bait stations and strips, the Agency assumes that exposure to terrestrial and aquatic species will be minimal. For products formulated 14 ------- as crystals or granules, minimal acute effects to terrestrial species can be expected. However, effects to aquatic invertebrates may occur if direct application of the chemical accidentally occurs. These products also could pose a risk of reproductive effects to endangered avian species. Registrants are required to modify their products to substantially reduce exposure to birds. For additional information, please contact Tom Myers at 703-308-8074. 15 ------- B. RED Candidates for Fiscal Year 1995 Table 1 shows the RED candidates for fiscal year 1995. It is likely that for some of these chemicals, REDs will be postponed until the next Table 1 RED Candidates for FY 95 fiscal year. It is also possible that some new chemicals may be added. The target for fiscal year 1995 is a total of 40 REDs. List A Alachlor Amitraz Asulam Bromacil Captan Chlorpropham Copper Compounds n ListB Bis(trichloromethyl)sulfone Ethalfluralin ListC Alkylimida Zolines Ancymidol Bromohydroxyacetophenone Copper Sulfate Coumaphos DCPA Diflubenzuron Diquat Dibromide Ethephon Ethion Fosamine Ammonium O-Benzyl-P-Chlorophenol Cellosolve Ester Chlorhexidine Derivatives Dimethoxane Fenamiphos Fenitrothion Linuron Metolachlor Nabam Naled Picloram Starlicide Torbuthylazine Dowicil 100 Fluoroacetic Acid Propamocarb Prometryn Sodium Omadine Terbufos Trichlorfon Trifluralin 4-CPA and Salts ListD Aliphatic Alcohols Polybutene C. Suspended Chemical Cases EPA may issue a Notice of Intent to Suspend (NOITS) a pesticide product based on a finding that the registrant has failed to submit data under the requirement(s) of a FIFRA section 3(c)(2)(B) or a 4(d)(6) Data Call-in (DCI). Events that may result in the issuance of a NOITS include failing to provide adequate responses or data on time during the reregistration process or the Special Review process. Suspension is an Agency action which affects the legal status of a pesticide product registra- tion. After a suspension becomes final and effective, the pesticide registrant subject to suspension may not legally distribute, sell, use, offer for sale, hold for sale, ship, or deliver to any person the product(s) subject to the suspen- sion. The product registration, however, remains in existence. Suspension of the registration of each product will become final unless, within 30 days of receipt, one of the following actions is taken by the registrant: 1) compliance with the Agency's requirements is shown, 2) the registration is withdrawn, or the use which triggered the re- quirements is withdrawn, or 3) a hearing with EPA is requested. EPA's Office of Enforcement and Compliance Assurance (OECA), formerly the Office of Compliance Monitoring (OCM), has initiated 780 NOITS actions for non-compliance with FIFRA resulting in 112 product suspensions from November 1989 to July 1994. In other cases, various outcomes resulted; for example, suspen- sions did not occur because data were submitted after the NOITS's were issued, or the matters were settled resulting in data submission. 16 ------- D. Data Submitted for Reregistration While EPA has formally evaluated the risks of only 81 chemical cases or 120 active ingredients for which REDs have been completed, the Agency actually has obtained a substantial amount of information on the remaining chemi- cals. Figure 3 shows the total number of studies received, reviewed, and awaiting review by discipline for List A chemicals. The studies were submitted in response to the Registration Stan- dards issued prior to FIFRA "88, as well as subsequent Data Call-in Notices. Figures 4, 5, and 6 show the total number of studies received, reviewed, and awaiting review so far for List B, C, and D chemicals respectively in response to Data Call-Ins under FIFRA "88. Figure 7 shows the cumulative totals of studies received, reviewed, a,nd awaiting review for all lists by discipline and combined totals. Figure 3 List A - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94 I OL 1 CO •5 3 2,632 H Number of Studies Received H Number of Studies Reviewed El Number of Studies Awaiting Review 1,742 ,365 Residue Chemistry Environmental Fate Ecological Effects **TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity (Teratology). * TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies. 17 ------- Figure 4 List B - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94 •a i •8 CO .2 •u 1,393 1,926 • Number of Studies Received IS Number of Studies Reviewed E3 Number of Studies Awaiting Review 1,627 Residue Chemistry Environmental Fate Ecological Effects Figures List C - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94 I $ 1 1 ctf S • Number of Studies Received HNumber of Studies Reviewed QNumber of Studies Awaiting Review 1,041 653 129 Residue Chemistry Environmental Fate Ecological Effects **TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity (Teratology). : * TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies. 18 ------- Figure 6 List D - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94 B Number of Studies Received E5 Number of Studies Reviewed H Number of Studies Awaiting Review 106 ooo 563 Environmental Fate Re-EntryNon- Dietary 282 148 Ecological Effects Figure 7 Lists A, B, C, D - Cumulative Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94 20,000 -, 18,000 - E3 Number of Studies Received B Number of Studies Reviewed D3 Number of Studies Awaiting Review 19,365 4,304 7,883 Ecological EfficU All Disciplines **TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity (Teratology). * TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies. 19 ------- III. OTHER MEASURES OF PROGRESS A. Minor Uses Table 2 provides information from the U.S. Department of Agriculture, National Agricultural Pesticide Impact Assessment Program (NAPIAP). The Reregistration Notification Network (RNN) provides information to inter- ested parties on recent or impending pesticide cancellations. The information here was first published in the RNN, July 1994. For further information on any of the following pesticides, contact your NAPIAP State Liaison Representa- tive or USDA at 301-504-8846. Table 2 Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94 Chemical Products Affected Uses Alachlor Lasso EPA has revoked the tolerances for residues of alachlor on or in COTTON FORAGE, COTTONSEED, SUNFLOWER SEED, PEA FORAGE, PEA HAY, PEAS WITH THE PODS REMOVED, and POTATOES as of 8/3/94. Captan, ethylene oxide, mancozeb, oxyfluorfen, propargite, propylene oxide, simazine EPA is proposing to revoke certain food additive regulations for several pesticides that the EPA has decided induce cancer in animals and is therefore in violation of the Delany Clause of the FFDCA. Those food additive regulations proposed for revocation are captan in RAISINS; ethylene oxide in GROUND SPICES; mancozeb in BRAN of OATS, BARLEY, and RYE; mancozeb in FLOURS of OATS, BARLEY, RYE, and WHEAT; oxyfluorfen in PEPPERMINT, SPEARMINT, SOYBEAN, and COTTONSEED OILS; propargite in DRIED TEA, RAISINS, and DRIED FIGS; propylene oxide in GLACE FRUIT, COCOA, GUMS, PROCESSED NUTMEATS (EX- CEPT PEANUTS), DRIED PRUNES, STARCH, and PRO- CESSED SPICES; and simazine in SUGARCANE MOLAS- SES, POTABLE WATER, and SUGARCANE SYRUP. Carbophenothion Trithion EPA revoked all tolerances for residues of the insecticide carbophenothion as of 7/13/94. The last registered uses of this pesticide were cancelled in 1989. No action levels are being recommended to replace these revoked tolerances. Demeton Systox EPA revoked all tolerances for residues of demeton as of 8/3/94. All product registrations for this insecticide and miticide were cancelled by October of 1989. This pesticide was once registered on over 45 fruits, vegetables, grains, and animal feeds. Disulfoton Di-Syston Miles Inc. plans to delete the use on ALFALFA and CLOVER from its labels of Di-Syston (disulfoton) due to the cost of reregistration on 11/15/94. The only other registrant (a reformulator) of this insecticide-miticide with an alfalfa use is expected to follow their lead. 20 ------- Table 2, cont Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94 Chemical Products Affected Uses Ethylan Perthane EPA has revoked the tolerances for residues of ethylan on or in APPLES, BROCCOLI, BRUSSELS SPROUTS, CAB- BAGE, CAULIFLOWER, CHERRIES, KOHLRABI, LET- TUCE, MEAT, MILK, PEARS, and SPINACH as of 9/30/94. EPA is not recommending action levels for this pesticide. Etridiazole Terrazole EPA has proposed the revocation of the tolerance for residues of etridiazole in or on TOMATOES. Several tolerances and registrations for etridiazole on other crops remain unaffected by this decision. Mancozeb EPA has removed the food additive regulation for mancozeb on RAISINS. It has been determined that this food additive regulation is not needed because: any residues of mancozeb on raisins are covered by the tolerance set for grapes, the raw commodity of raisins. This rule responds to a petition submit- ted by the Mancozeb Task Force, which requested that EPA revoke the food additive regulation for mancozeb on raisins. Mevinphos Phosdrin EPA announced on 6/30/94 that it has received and accepted a formal request from Amvac Chemical Corporation to immedi- ately cancel all registrations of the insecticide-miticide . mevinphos (Phosdrin). EPA has determined that the use of mevinphos products pose an unacceptable risk of exposure to agricultural workers. Amvac has agreed to immediately stop the production of mevinphos for sale or distribution in the U.S. Existing stocks of mevinphos may be sold and distributed through 12/31/94, after which Amvac has agreed to recall all unsold mevinphos products from dealers and distributors. Users may use existing stocks through 2/28/95. o-Phenylphenol Dowicide (R) 1 Antimicrobial, OPP The Dow Chemical Company plans to delete APPLES, CANTALOUPES, CARROTS, CHERRIES, KUMQUATS, PINEAPPLES, and SWEET POTATOES from its labels of o- phenylphenol due to reregistration costs. Dow will defend the uses of OPP on CITRUS crops ajid PEARS. The remaining registered uses of OPP will likely be cancelled as EPA completes a review of other registrants' OPP products. Dealers and users may distribute, sell, and use existing stocks of OPP until such stocks are depleted. 21 ------- Table 2, cont Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94 Chemical Products Affected Uses Oxythioquinox Morestan Miles Inc. plans to delete the use on MACADAMIA NUTS from its labels of Morestan due to the cost of reregistration on 11/15/94. Perfluidone Destun FBI/Gordon Corporation plans to voluntarily cancel the use of perfluidone on TOBACCO due to the cost of reregistration. This is the last registered use of this herbicide; it has not been marketed in the U.S. for several years. Phosmet Imidan The Gowan Company plans to delete from their labels the final labeled use of phosmet on CORN and CITRUS due to the cost of reregistration. This action will be final for this insecticide as of 11/15/94. Terbutryn Igran EPA has proposed the revocation of all tolerances for residues of terbutryn on or in BARLEY, SORGHUM, and WHEAT. Tetrachlorvinphos Rabon EPA has proposed the revocation of tolerances for residues of tetrachlorvinphos on or in APPLES, CHERRIES, CORN, CRANBERRIES, PEACHES, PEARS, and TOMATOES. Tetrachlorvinphos is still registered for a variety of livestock uses. B. Rejection Rate Analysis The Rejection Rate Analysis was conducted to address the high rate of rejected studies submit- ted to OPP during the reregistration process. EPA discovered that the submission of unaccept- able studies is the most significant factor in delaying REDs. Conducting replacement studies can add several years to the reregistration process. EPA's study of rejection rates, with the coop- eration and active involvement of the pesticide industry, is an intensive effort to analyze rejected studies and understand the reasons for rejection. The resulting reports for each discipline should minimize the reoccurrence of deficiencies in future studies as the Agency enters the major data submission phase of reregistration. The Residue Chemistry, Toxicology, Environ- mental Fate, and Occupational and Residential Exposure Chapters of the Rejection Rate Analy- sis all have been completed and are available from U.S. EPA NCEPI, telephone (513) 891- 6561, Fax (513) 891-6685. See Appendix B, Other Sources of Information, for the publication numbers of these documents. : The Ecological Effects chapter was completed this fall and is currently being printed. 22 ------- C. Product Reregistration Status Figure 8 shows the status of products subject to Reregistration Eligibility Decisions (REDs) issued to date. Overall a total of 601 products have been reregistered, 925 have been voluntarily cancelled, 449 have been suspended, and 980 are pending. "Current Decisions" covers those products for which EPA should have made a decision to reregister as of October 3, 1994. In this category, 601 products have been reregis- tered, 11 registrations have been amended, 802 products have been voluntarily cancelled, 424 product registrations have been suspended, and 425 still need a decision, for a total of 2,263 products. "Future Decisions" includes the 703 products for which the Agency's product reregis- tration decision is not yet due. In this category, 123 products have been voluntarily cancelled, 25 suspended, and 555 are progressing toward a reregistration decision. Figure 8 Product Reregistration Status of 2,966 Products for 60 REDs* as of October 3,1994 FUTURE DECISIONS CURRENT DECISIONS SUSPENDED (25) AMENDED (11) OVERDUE (425) CANCELLED (802) SUSPENDED (424) * Involves 97 active ingredients. As of 10/3/94, EPA has issued product specific data call-in's for 60 REDs covering/including 2,966 products. According to FIFRA, the Agency should reach a reregistration decision on each product 14 months after issuance of a RED, provided that the registrant(s) submit(s) acceptable data on time. 23 ------- IV. TOPICS OF THE QUARTER A. Avian Granular Risk Reduction Initiative In May 1992, EPA issued the Comparative Analysis of Acute Avian Risk From Granular Pesticides (AGA). The analysis found that 14 granular compounds pose potentially high risk to birds due to their high acute toxicity and avail- ability in the environment. Field evidence of bird deaths indicate that birds consume pesticide granules as grit or with food items. In many cases, only a few of the tiny granules can kill a bird. Shortly after the AGA was issued, EPA met with the principal registrants of the granular pesticides identified in the analysis to encourage them to initiate voluntary avian risk reduction measures before the Agency considered what further regulatory action would be taken. The avian granular initiative was intended to foster the rapid implementation of interim, common- sense measures to reduce avian exposure, so that these basic measures could be factored into further assessment of the risks posed by these compounds. EPA's objective was to identify and communicate risk concerns early in the regula- tory process, allowing registrants time to address these concerns prior to reregistration decisions or other regulatory action. The Agency's ap- proach was generally well received by the com- panies involved, and it is believed that most companies submitted meaningful avian risk reduction packages. EPA's initiative has produced positive results in a relatively short time. Through a combination of reduced pesticide applications, lower applica- tion rates and more complete incorporation of the granules into the soil, some product labels have shown marked reduction in the amount of pesticide potentially available to birds and other wildlife. In addition to changes to product levels, registrants' responses included ongoing and proposed research and education material for pesticides users. Among the research and educa- tion materials which EPA finds most useful are programs that incorporate pest management strategies focusing on diagnosing pest infestation levels to determine if pesticide applications are needed, and, if so, applying only the amount of pesticide necessary. The focus of the avian granular initiative was limited to one endpoint and one formulation. EPA is currently nearing completion of a project to identify the chemicals that exceed other ecological endpoints of concern. That report will be available by early next year. For further information on the Avian Granular Risk Reduction Initiative contact: Margaret Rice, SRRD/OPP (7508W), EPA, 401 M Street, S.W., Washington, D.C. 20460, telephone (703) 308-8039. 24 ------- B. Ecological Rejection Rate Analysis - Final Chapter This chapter is the joint effort of industry, EFED, and SRRD. In addition to discussing current rejection rates and factors, it also be- came a forum for expressing divergent perspec- tives on the way avian risk is assessed. The chapter notes that rejection rates for some testing requirements, such as avian acute oral toxicity, have improved over time. Rejec- tion rates for others, like avian and aquatic reproduction studies, fish toxicity, and avian chronic dietary testing, have not declined. On average, rejection rates for ecological effects declined from 36% prior to 1986 to the current rate of 20%. EPA and industry scientists met in April 1994 to improve understanding of factors leading to ecological effects study rejection. The rejection rate analysis cites industry comments on each rejection factor and EPA's response to them. . Some issues involving specific elements of testing were worked out during the April meet- ing. Other issues, including methodologies for fish full life-cycle and terrestrial and aquatic non- target plant testing, and the larger issue of avian risk assessment, remain to be resolved. OPP hopes that these outstanding issues can be re- solved in the future; by workgroups in which industry is represented. The Ecological Effects chapter will be avail- able to the public in the next few months. Earlier analyses on Residue Chemistry, Worker Expo- sure, Toxicology, and Environmental Fate can be obtained from NCEPI, PO Box 42419, Cincin- nati, OH 45242-0419, telephone (513) 489-8190. OPP hopes to make all the chapters available on its electronic bulletin board in the future. C. New Industry-Wide Task Forces Outdoor Residential Task Force: An industry-wide Outdoor Residential Expo- sure Task Force has been formed to share the cost of satisfying generic exposure data require- ments for application and reentry activities at residential lawns, grass or turf. These data requirements will be levied through a Data Call- in Notice to be issued the end of the calendar year 1994, to all registrants who have products registered for use on residential lawns, grass or turf. The Notice will require dermal and inhala- tion exposure data from mixing, loading, and applying products at these sites (study guideline numbers 231 and 232); dermal and inhalation exposure data on persons who reenter treated areas (guideline studies 133-3 and 133-4); and foliar dissipation residue data (guideline study 132-l(a)). Those desiring further information may contact: Mr. Harold Himmelman, Task Force Counsel (202) 789-6012; Dr. Timothy Pastoor , Task Force Administrative Chairman (302) 886-5578; or Dr. Monty Eberhart, Task Force Technical Chairman (816) 242-2654. Agricultural Reentry Exposure Task Force: An industry-wide Agricultural Reentry Expo- sure Task Force has been organized to share the cost of developing a generic agricultural reentry exposure data base to satisfy post application reentry data requirements. These data require- ments will be levied through a Data Call-In Notice which will be issued to all registrants who have products registered for use on an agricul- tural crop. The Data Call-in will require dermal and inhalation exposure data on persons who reenter treated areas (guideline 133-3 and 133- 4) and foliar dissipation residue data (guideline 25 ------- 132-l(a)). Those desiring further information on the task force may contact: Mr. Harold Himmelman, Counsel, (202) 780-6012; Dr. Timothy Pastoor, Task Force Administrative Chairman (302) 886-5578; or Dr. Edgar Day, Task Force Technical Chairman (317) 337-3667. 26 ------- V. SPECIAL REVIEW DECISIONS This section summarizes the significant regula- tory decisions made on chemicals in the Special Review, process during the fourth quarter, fiscal year 1994. The formal Special Review process for chemicals which have met or exceeded risk criteria of unreasonable adverse effects is set forth in 40 CFR Part 154. Special Review decisions represent major EPA actions which may ultimately cancel, deny, or reclassify the registration of pesticide products, because uses of the products may cause unrea- sonable adverse effects on human health or the environment. In addition, Special Review decisions may establish policy or guidelines on which other environmental decisions relating to pesticide registrations are based. Figure 9, Special Review Decisions Scheduled and Completed, shows that OPP exceeded the scheduled target completing four special review decisions for the fourth quarter of FY 94. The target for FY 94 was a total of eight special review decisions; 12 decisions were made. For further information on Special Review chemicals, please call (703) 308-8010. Figure 9 Special Review Decisions Scheduled and Completed - FY 94 5 -, A 3 - 2 1 - \' j Special Reviews Completed • Special Review Decisions Scheduled i 4 4 2 2 " ,„ r " z aft : •. •. \ \ \ «. -, -, , ' 'V* ;• M j, ' 1st Quarter 2nd Quarter 3rd Quarter ; 4th Quarter 4th Quarter Special Review Decision Summaries Mevinphos - EPA accepted a request for volun- tary cancellation of all uses of mevinphos from Amvac, the sole technical manufacturer of the chemical. AMVAC submitted this request in response to plans by the Agency to issue Notice of Intent to Suspend or Cancel due to unreason- able risks posed to persons exposed to mevinphos. This voluntary cancellation is also regarded as a Reregistration Eligibility Decision by EPA. As part of the cancellation agreement, all mevinphos products will be subject to recall by Amvac as of December 31, 1994. Last date 27 ------- for use of existing stocks has been set for Febru- ary 28, 1995. EBDC (Leafy Green Decision) - In response to the EBDC Notice of Intent to Cancel/Position Document 4, green growers and processors had requested a hearing on EPA's decision to cancel the uses of EBDC fungicides on leafy greens. After consideration of new residue data that were generated, EPA maintains its original decision to cancel these uses. This decision is based on estimates of risk posed to non-Hispanic blacks from EBDC-treated greens. EBDC (Subpart D Decision) - The Agency granted the subpart D request to allow more than one EBDC fungicide to be used on a particular crop within a growing season. In granting this type of use, the Agency stipulated that the total amount of EBDCs used could not exceed the maximum allowance established in the Position Document 4. Avian Granular Risk Reduction - The Agency issued a progress report which outlined the risk reduction measures that were instituted as a result of the avian granular risk reduction initia- tive. This initiative provided an analysis of the risks posed to avian species from the use of granular pesticides. The final progress report also indicated those areas that still needed ad- dressing by pesticide registrants to. further reduce avian risk. (See separate article under Topics of the Quarter). Tolerance Revocations During the fourth quarter of fiscal year 1994, SRRD processed two tolerance related actions. A description of each follows. Carbophenothion - Effective July 13, 1994, the Agency revoked all raw agricultural commodity tolerances, all food additive tolerances and all feed tolerances for residues of the insecticide carbophenothion because all registered uses of carbophenothion on these commodities have been cancelled. This action, a final rule, was published in the Federal Register on July 13, 1994 (59 FR 35629). The tolerances for these commodities were listed in 40 CFR 180.156, 40 CFR 185.700, and 40 CFR 186.700. Perthane - Effective September 30, 1994, the Agency revoked tolerances for residues of 1, l-dichloro-2,2-bis(p-ethylphenyl)ethane (also known as perthane) in or on raw agricultural commodities because all uses of perthane on these commodities have been cancelled. This action, a final rule, was published in the Federal Register on August 31, 1994 (59 FR 44930). The tolerances for these commodities were listed in 40 CFR 180.139. 28 ------- VI. CALENDAR OF EVENTS (FY 1995) 1st Quarter FY 95 2nd Q uarter FY 95 2 Special review decisions are scheduled to be completed. 10 REDs are scheduled to be completed. 2 Special review decisions are scheduled to be completed. 29 ------- Appendix A. Cumulative Summary of Reregistration Actions The following is a cumulative summary of the reregistration actions completed to date. OPP has completed REDs and summary fact sheets for each of the pesticides (cases) listed below. Copies of the REDs and the fact sheets may be obtained during the public comment period from the Docket, Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC 20460 Tel: (703)305-5805. Electronic copies of all RED fact sheets and all recent fiscal year 1994 REDs can be downloaded from the Pesticide Special Review and Reregistration Information System at 703-308-7224, and also can be reached on the Internet via FEDWORLD.GOVand EPA's gopher server, EARTHl.EPA.GOV. RED documents issued since April 1994 are available free of charge while supplies last from the National Center for Environmental Publications and Information (NCEPI), P.O. Box 42419, Cincinnati, OH 45242-0419, Tel: (513) 489-8190, Fax: (513) 489-8695. After the comment period, documents are available from the National Technical Service (NTIS), Attention: Order Desk, 5285 Port Royal Rd., Springfield, VA 22161, Tel: (703) 487-4650. CUMULATIVE RED TOTALS Total REDs = 81 Total Chemicals/ATs Covered =120 Total Products Covered = 3,521 Total Tolerances Reassessed = 500 DATA CALL-IN SUMMARY Fiscal Year FY 1990 FY 1991 FY 1992 FY 1993 FY 1994 Number of DCIs Issued 27 159 97 93 77 Total 453 30 ------- FY 91 REDs Summary RED Case Name 1. Carbon and Carbon Dioxide 2. Dried Blood 3. Fosetyl-Al (Aliette) 4. Heliothis zea (NPV) 5. Methoprene 6. Potassium Bromide 7. Propionic Acid 8. Silicon Dioxide/Silica Gel 9. Sodium and Calcium Hypochlorites 10. Sodium and Potassium Nitrates 1L Sodium Diacetate 12. Sulfur 13. .Warfarin List D D A A A A D D A D D A A Totals Date Signed 9/91 9/91 12/90 12/90 3/91 6/91 9/91 9/91 9/91 9/91 9/91 3/91 6/91 # Chemicals/ AIs Covered 2 1 1 1 ', 1 1 i ; 2 2 2 1 1 :2 # Products* Covered 9 3 2 1 63 2 14 75 770 6 2 332 76 Total Tolerances 0 0 24 0 23 , 0 0 0 0 0 0 0 0 18 1,355 47 * The number of products listed reflects the number registered at the time the RED was completed. This number is constantly changing. 31 ------- FY 92 REDs Summary REP Case Name 14. Alkyl Amine Hydrochloride 15. Allium Sativum (Garlic) 16. Bone Oil 17. Capsaicin 18. Chlorinated Isocyanurates 19. Citric Acid 20. Ethylene 21. Heptachlor 22. Indole-3-Butyric Acid (IBA) 23. Nosema Locustae 24. Putrescent Whole Egg Solids 25. Soap Salts 26. Sodium Hydroxide 27. Streptomycin 28. Zinc Salts ** Voluntarily cancelled FY 93 REDs Summary RED Case Name 29. Biobor 30. Boric Acid Sl.Butylate 32. Cedarwood Oil 33. Daminozide 34. Eugenol*** 35. Glyphosate 36. Inorganic Halides 37. Iron Salts 38. Menthol 39. OBPA 40. Oxalic Acid 41. Oxytetracycline 42. PEP(phenylethyl Propionate) 43. Silver 44. Sodium Lauryl Sulfate 45. Sulfiiryl Fluoride 46. Thymol 47. Tris(hydroxymethyl)nitromethane List C D C D A D C A B D D D D A D Totals List C A A C A D A D D D A D A C D D A C me c Date Signed 8/92 6/92 ** 6/92 . 9/92 6/92 9/92 3/92 8/92 9/92 6/92 9/92 9/92 9/92 8/92 Date Signed 6/93 9/93 9/93 9/93 9/93 9/93 9/93 9/93 3/93 9/93 6/93 12/92 3/93 9/93 7/93 9/93 9/93 9/93 9/93 # Chemicals/AIs Covered i 1 1 1; 5 1 1 1 1 1 1 2 1 2 2 22 # Chemicals/AIs Covered 2 7 1 1 1 1 2 2 3 1 1 1 3 1 1 1 1 1 1 # Products* Covered 3 , 4 2 8 741 3 8 2 31 6 6 25 9 26 7 881 # Products* Covered 12 189 14 . 5 4 5 : 56 35 : '5 1 15 4 7 5 65 2 1 5 9 Total Tolerances 0 0 N/A 0 0 0 0 0 0 0 1 0 0 14 0 15 Total Tolerances 0 1 3 0 0 1 126 0 0 1 0 0 2 0 0 1 0 0 0 Totals 32 439 135 * The number of products listed reflects the number registered at the time fhe RED was completed. This number is constantly changing. ** Voluntarily cancelled. *** Exempted from regulation as pesticides under Section 25(b) of FIFRA. 32 ------- FY 94 REDs Summary RED Case Name 48. Barium Metaborate 49. Bromine 50. Lithium Hypochlorite 51. Mineral Acids 52. Peroxy Compounds 53. Vegetable and Flower Oils 54. 2-[(Hydroxymethyl) Amino] Ethanol or Ethanolamine 55. Hexadecadienol Acetates 56. Methiocarb 57. Periplanbne B 58. Pronamide 59. Tebuthiuron 60. Maleic Hydrazide 61. N6-Benzyladenine 62. Bentazon 63. Chlorine 64. Chloromxylenol 65. Cosan 145 orNuosept 145 66. Cresol 67. DBNPA 68. DCDIC 69. Difenzoquat 70. Fenbutatin-Oxide or Vendex 71. Hexazinone 72. Limonene 73. Mercaptobenzothiazole 74. Metalaxyl 75. Mevinphos** 76. Muscalure a(z)-a-Tricosene 77. OilofCitronella*** 78. Oryzalin 79. Piperalin 80. Sodium Cyanide 81. Xylenol Totals List A D C D D D C D A B A A A B A D C C D C C A A A C B A A D C A C C D Date Signed 12/93 12/93 12/93 12/93 12/93 12/93 3/94 3/94 3/94 3/94 3/94 3/94 6/94 6/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 9/94 # Chemicals/AIs Covered 1 1 1 4 3 6**** 2 2 1 1 1 1 2 ' 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 # Products* Covered 3 4 40 212 23 32 3 18 22 1 18 12 26 2 14 72 7 2 1 46 80 2 10 20 15 5 81 0 11 17 38 1 7 1 Total Tolerances 0 1 0 0 0 0 0 0 0 0 46 15 4 0 45 0 0 0 0 0 0 22 44 11 0 0 95 0 0 0 20 0 0 0 48 846 303 * The number of products listed reflects the number registered at the time the RED was completed. This number is constantly changing. ** Voluntarily cancelled. \ *** Exempted from regulation as pesticides under Section 25(b) of FIFRA. **** One A.I., "essential oils" will become 24 A.I.s after the RED is issued; many of these will eventually be declared inert ingredients. 33 ------- Appendix B. Other Sources of Information For documents or further information on reregistration issues related to this progress report, please contact the following sources. The following publications are available from: NCEPI P.O. Box 42419 Cincinnati, OH 45242-0419 Tel: (513)489-8190 Fax:(513)489-8695 • Catalog of OPP Publications and Other Infor- mation Media, March 1994 Publication Number: EPA 730-B-94-001 Lists titles and ordering information for many types of documents published by the Office of Pesticide Programs. • Pesticide Reregistration Pamphlet. May 1992 Publication Number: EPA 700-K92-004 • Status of Pesticides in Reregistration and Special Review (Rainbow Report). June 1994 Publication Number: EPA 738-R-94-003 • Rejection Rate Analysis. Residue Chemistry Chapter. June 1992 Publication Number: EPA 73 8-R-92-001 • Rejection Rate Analysis. Residue Chemistry Guidance on Conducting Plant and Livestock Metabolism Studies. July 1992 Publication Number: EPA 73 8-B-92-001. • Rejection Rate Analysis. Residue Chemistry Guidance for: Storage Stability Theoretical Concentration Factors Raw Data Guidance, February 1993 Publication Number: EPA 737-R-93-001. Rejection Rate Analysis. Residue Chemistry/ Environmental Fate Guidance for: Conducting Rotational Crop Studies. February 1993 Publication Number: EPA 738-B-93-001. Rejection Rate Analysis. Environmental Fate Chapter. August 1993 Publication Number: EPA 738-R-93-010 Rejection Rate Analysis. Toxicology Chapter. July 1993 Publication Number: EPA 738-R-93-004 Rejection Rate Analysis. Occupational and Residential Exposure Chapter. August 1993 Publication Number: EPA 738-R-93-008 Rejection Rate Analysis. Residue Chemistry Guidance for: ; Updated Livestock Feed Tables Aspirated Grain Fractions Calculating Livestock Dietary Exposure Number and Location of Domestic Crop Field Trials. June 1994 Publication Number: EPA 738-K-94-001. 34 ------- Federal Register Publication of Lists A. B. C andD List A: FR 2/2/89, pages 7740-7750 List.B: FR 5/25/89, pages 22706-22714 List C: FR 7/24/89, pages 30846-43396 ListD: FR 10/24/89, pages 43388-43396 For information contact: (703) 305-5805 Status of Chemicals in Special Review. April 1994 For information contact: (703) 308-8173 National Pesticide Telecommunications Network For information about pesticide poisoning symptoms and general information: Tel: 1-800-858-7378; Fax: 806-743-3094 Comments EPA welcomes your comments on this progress report and on activities related to reregistration. Please address your comments to: Attention: Ed Setren Pesticide Reregistration Progress Report Special Review and Reregistration Division (7508W) United States Environmental Protection Agency 401 M Street, SW Washington, DC 20460 For more copies of this report (Publication Number: EPA 738-R-94-014) or to be added to the "SRRD MABELS" mailing list, please write or fax to the following address: U.S. EPA, NCEPI P.O. Box 42419 Cincinnati, OH 45242-0419 Telephone: (513)489-8190 Fax: (513)489-8695 35 ------- ------- |