, o ; o oEPA United Siates Erwiranmental Pratac:tion ? Office af Public Affairs IA-107) Washington DC 20460 Environmental N_ews - FOR RELEASE: o MONDAY, JULY 11, 1983 (202) 382-4355 EPA RELEASES REPORT ON IBT LAB STUDIESi WARNS OF SUSPENSION ACTION The U.S. Environmental Protection Agency today notified pesticide registrants that products supported by invalid health ef_fects studies conducted by the Industrial Bio-Test (IBT) laboratories face suspension action within 90 days unless replaced by other tests or a commitment to further testing. At the same time, the agency released a report showing that major portions of the data base invalidated by IBT have been or are being replaced. Many of the IBT tests no longer need replacing because the chemicals involved are cancelled, suspended, out of production, or are not used in the United States. Beginning in 1976, auditing by the Federal Food and Drug Administration and the EPA discovered the short- comings in the IBT laboratory tests used by companies to support the registration of pesticides and drugs in the u.s. and Canada. In 1978, EPA referred the case to the Justice Department for investigation. To ensure that data providing the foundation of regulatory decisions in the future are adequately pre- pared and scrutinized and to maintain high laboratory standards, EPA and FDA established a joint laboratory audit program in 1977. The audit program includes visits to the laboratories throughout the u.s. to inspect their procedures, facilities and staff qualifications. About 60 audits per year of labs and/or individual pesticide studies are conducted to see if the reports are supported by "raw" data o .. Of the original 1,205 IBT studies identified by EPA, 801 are considered significant to regulatory decisions, such as the induction of tumors, birth defects, genetic mutations, neurotoxicity and other chronic reproductive ?ffects. R-105 (more) A-pf- A-, fv. & .. o -2- .I About 400 studies were eliminated from review because of duplica- tive entries or were found not to be true health effects s'tudies. Also not reviewed were short-term,.acute toxicity tests which generally do not create a significant data gap and which will be replaced by the current agency program of bringing the data on old chemicals (including some tested by IBT) up to current scientific standards. Among the 801 health studies reviewed, 594 have been found invalid by EPA and Canada (EPA and the Health Protection Board of Health and Welfare, Canada, entered into an agreement to jointly reexamine the IBT studies for validity). A total of 212 of invalid IBT studies have been replaced or are in the process of being replaced and 38 studies are under discussion for replacementi 45 studies are no longer required for registration, 140 studies concern pesticides that have been cancelled, discontinued, are not registered for use in the U.S., or are no longer in production. And for 159 studies, the agency has received no previous response or a negative response for a request for replacement studies. The report also shows that a large majority (93 percent) of the pesticides tested by IBT have other data available to support the safety of the pesticide products. Of the pesticides listed with a data base entirely of IBT studies, only five are registered for use in the U.S. and only two of them have an entirely invalid data base. Six of the 17 studies on these five chemicals will be replaced by the agency's ongoing program to keep the data base current on all chemicals. In addition, of the 65.most heavily used pesticides, only 18 have IBT data in one or more significant categories. Of the 18, all but one also have non-IBT data available in some or all of the same cate- gories. Sixteen of the high volume chemicals are the subject of a current regulatory action by EPA to obtain replacement data. There have been suggestions that all chemicals tested in whole or in part by IBT be removed from the market pending retesting. That option is not available under the current law which requires valid evidence of risk as opposed to a lack of information before removing a product from use. For detailed information see attachments. t R-105 --. .-.----. . - .-- .----- t t .'. ., .. .. ,.,. . o. ,. JUL 11 1983 - Send 3(c)(2)(B) N:ltices and Suspend If N:l Agreement Reached Benzadox Brc:m:,propylate Chlorobranurai Glyphosine Irgasan Ma.lonben Methazole .Nemefene N:lrea Perfluidone Phenthoate Pik--Off PPG 124 Praieton Ramrod Randox Santophen Sodi1m1 Chlorate Torah ,. . .. . :. :: ., -. .,..-. ,o. .... .. . " . .. .o - . .. -- . JUL 11 1983 -- Need Further Review/Discussion to Determine Need for Studies . - . Antor Br01Dphenoxin Butyltin oxide Chlorc:picrin cypranid Dantoin D-Phenothrin Fluoridefen MBP Mesurol Meta Systox-R Nicotine Phosphanidon Pranetryn Triforine -. .-? - , ' o o. . ... ' . JUL 11 1983 .. Chemicals for Which Data ?ired Under OCI or RS and Pequirements and CUrrently under Discussion . ' -o . .l\netryn Avadex Bifeoox Coral Desirnidiphan Dicamba Fonretenate HCL Glutaraldyhyde Paraquat Polyram ,. ?; . .. ...-..--? . : .. t . ,; . ? .o .. . o. o o JUL 11 198'3 o o T .. . :. Not Registered, Used or Marketed in the U.S. or Has Been Cancelled or Suspended for All or M::>st uses . -. ?-. . ' Birqiacryl Bux CCA 12223 Chloropropylate Cobex Cycle ?azine Ikepim,n Ethiolate Metobranuron Onadine R:mnel Ryaex (Prodimline) Sl.lllitol Tedion Terruthylazine Vegadex ' . ,.. -. / .- o o'. ... ' ... ... . ? o JUL 11 1983 Chemicals for which no substantial IBT problem continues to exist substantial non-IBT data base, replaceirents sutrnitted or ccmnited, or no IBT studies in major study categories ?- Accel :Alanq, Alar Asulmn Atrazine Averge Azodrin Bacillus Thurirgen Barban Bardike Baygcn Blodex Bolero Brajifacoom (Talon) Busan 74 Butan captan Carbary! Carbofuran Chipco-RP26019 Ollorobenzilate Chlorprcphan Chloropyrifos Chlorothalonil Ciodin CUracron Cyoooel Dasanit OC5700 OCPA ; Delnav Diazinon Dichlobenil Difolatan Dinoseb Diquat Disyston D.:,wco 233 ? .. . o n. lklwc:o 290 &nbark Endothall EPN Ethion Etheprcp Fenitothion Fenvalerate Fluroidanid Folpet Furloe Glyphosate Goodrite 3125 G'.>s sypl.ure Harvade Hinosan Heptachlor Epoxide Krenite Lasso IDrox Machete Methoprene Meth:myl Metolachlar Morestan Maleic Hydrazide K:PA M:PP Merph:is M::mitar MSMA Naled Nemacur Oni te-Cani. te Orthene Oxodiazon PCNB Penncap E Penncap M Permethrine Phemiediphan Phorate Phosolone Picloran Potassiun Azide Potassil.!ll Hexa Profluralin Propham Prowl Pyrethrin Rabon Pesrethrin Sectrol Sencor Simazine Sodil.Ull Azide Sodiun Branide Supracide 'lerbufos 'lerb.ltryn 'lerrazole Thidiazuron Thiodan Thiofanox Thiophanate 'lbxaphene Triallate. Triphenyl tin Hyd Trivax Vapona Vel Velpar Vendex Visco 1152 Visco 1153 Vitavax Vorlex .i, t ., ,-: 2,4-D UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PESTICIDES ANO TOXIC SUBSTANCES SUMMARY OF THE IBT REVIEW PROGRAM OFFICE OF PESTICIDE PROGRAMS JULY 1983 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF P'ESTICICES ANC TOXIC SUBSTANCES The IBT ?eview Program This report summarizes the findings of the joint program conducted by the Environmental Protection Agency (EPA) and the Health Protection Branch of Health and Welfare Canada to reexamine the validity of health effects studies on pesticides tested by Industrial Bio-Test Laboratories, Inc. (IBT). This program is one result of discoveries made during a series of audits beginning in 1976 by the Food and Drug Administration {FDA) and EPA which revealed serious deficiencies in IBT tests conducted to support the registration of numerous pesticides and some drugs in both the United States and Canada. This report assesses the impact of the IBT situation on the registration status of the chemicals involved and describes the steps the Agency has taken to resolve this problem and to prevent its recurrence. Exhibit A shows how many IBT and non-IBT tests are available to EPA in each testing category for the pesticide chemicals having some IBT conducted studies in their data base. As these tables show, a large majority {93%) of the pesticides tested by IBT, also-have non-IBT data available. Only 12 of the pesticides listed have a data base entirely of IBT studies. However, seven of these are either not registered for use in this country or are cancelled or discontinued products. Some of the IBT studies on the remaining five chemicals are at least partially valid or "supplemental", meaning the data can be used to support the findings of other studies. 2 These tables also indicate the pesticides for which new data have been required as a result of EPA regulatory actions. These include risk/benefit reviews undertaken because of specific evidence of a hazard (known as Rebuttable Presumption Against Registration. listed as "RPAR" in tables) or EPA's regular program for reregister- ing all previously registered pesticides (in tables, "Registration Standard" and "Data Call-In"). The reregis- tration program is not specifically connected to the !BT case, but serves the purpose of bringing the data on older chemicals, including some tested by IBT, up to current .scientific standards? Under the authority of section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) the Agency can require additional data to maintain a registration, and may suspend a product's registration if the registrant does not agree to provide the data or if it is not provided pursuant to an agreement with the Agency. Attached is also a list (Exhibit B} of major health effects studies on pesticides conducted by !BT identifying which have been found valid or invalid, and which have been or are in the process of being replaced. This list covers 801 studies on 140 pesticides. An earlier draft list of !BT tests prepared by EPA in May 1983 identified 1205 tests on 212 pesticides. The current list has eliminated duplicative entries, preliminary range finding and similar tests which were not true health effects studies, and short-term, acute toxicity tests which generally do not create a significant data gap and which will be replaced if needed, through the existing reregis- tration program described above. Thus, the current list of 801 studies covers health effects considered significant to regulatory decisions, such as induction of benign or malignant tumors (oncogenicity). birth defects (teratogeni- city), genetic mutations, other adverse reproductive effects, and neurotoxicity. Of the 801 IBT studies in the pivotal categories, 594 (74%} have been found invalid. To date, of the invalid studies, 212 (36%} studies have been replaced or are in progress, 38 (7%) are under discussion for possible replacement, and 45 (7%) are of a type no longer required for registration. One way to assess the impact of IBT is to consider the effect of invalid studies on the data base supporting pesticides used in high volume. Although hundreds of pesticides are registered, only 25 insecticides account for 85i of the actual pounds of insecticides used, 32 herbicides account for 82%, and only 8 fungicides account for 71% of the volume of those products used. Of these 65 most heavily used pesticides, only 18 have IBT data in one or 1 :- 3 more import a nt c a tegories. Of those 18, a ll but one also h a ve non-IBT dat a avail a ble in some or a ll of the s a me cagetories. The exception, prometon, a herbicide not used .on food crops, h a s one p a rti a lly v a lid IBT study and m a ny non-IBT a cute a nd sub a cute studies. Sixteen of these high volume chemic a ls a re the subject of one of the regul a tory procedures described a bove requiring a dditional d a t a . Thus, the d a t a bases for the high volume chemic a ls to which people a re most likely to be exposed a re for the most p a rt un a ffected by the IBT situ a tion, a nd where there is a n imp a ct, EPA h a s t a ken a ctive regul a tory steps to obt a in repl a cement d a t a . The princip a l rem a ining t a sk of the IBT progr a m is to clarify the st a tus of the invalid studies for which registr a nts h a ve indic a ted they do not intend to provide repl a cements, or h a ve not.communic a ted a n intention one way or the other to EPA. Although a round 300 studies a re in this c a tegory, a significant number (140) of neg a tive a nd non-responses involve discontinued or c a ncelled products, or pesticides of such low volume use th a t registr a nts may choose not to invest in further testing needed to m a int a in registr a tions. The repl a cement status column of Exhibit B indic a tes th a t there a re 159 invalid studies (26% of inv a lid IBT tests) for which there is neg a tive or no response. However, a s previously noted, most of these chemic a ls h a ve non-IBT d a t a a vail a ble. Exhibit A shows th a t only five chemicals still registered a nd a ctu a lly used have entirely IBT dat a bases. The 17 studies involved with those 5 chemicals constitute 3% of inv a lid IBT studies. A registr a - tion stand a rd will result in replacement of 6 of these studies. This le a ves only 11 studies or 2% of the inv a lid IBT tests which constitute the sole support of registered peiticides, a nd for which no regul a tory action to generate repl a cement d a t a h a s yet been initi a ted. Sever a l of these 11 are valid or have at le a st supplementary v a lue. This report is being furnished to the registr a nts of the affected chemic a ls for which neg a tive or no responses have been received concerning replacement of invalid !BT studies. We are a lso sending the registrants 3(c)(2)(B) notifications which require a registr a nt to m a ke a specific commitment within 90 d a ys or the registr a tion m. a y be suspended. In some c a ses, EPA a nd a registr a nt may a gree th a t a specific study does not need to be replaced. The IBT c a se c a used serious concern a nd uncert a inty the potential h a zards of the hundreds of pesticides involved, both for EPA and the public. Although it w a s advoc a ted by some th a t a ll 212 pesticides tested i? whole or in p a rt by IBT be removed from the m a rket pending retesting, th a t option is not a v a il a ble under current law. a bout 4 The regulatory response authorized by FIFRA requires valid evidence of risk, as opposed to a lack of information, before removing a product from the market, and allows for . the replacement of inadequate data. As we reach the final resolution of the IBT problem, it appears that this approach was appropriate and adequate to deal with this event. The IBT scandal shook the industry and government regulators. Obviously, steps had to be taken, not just to deal with the IBT situation itself, but to ensure that data providing the foundation of regulatory decisions in the future are adequately prepared and scrutinized. Thus, another result of the IBT case was the establishment in 1977 of a joint EPA-FDA audit program to help ensure that another IBT situation has not occurred and will not in the future. The lab audit program includes visits to laboratories to inspect their procedures, facilities and staff.qualifications, and about sixty audits per year of labs and/or individual pesticide studies to see if the reported results are supported by the "raw" laboratory records and data. In the past six years, we have found the large majority of laboratories to be in compliance with current standards, and producing scientifically valid studies. An important effect of the IBT case has been to make the testing community, the industries which use their services, and government regulators keenly aware of the need to maintain high standards of quality control over health effects testing. EPA ASSESSMENT OF THE 801 MAJOR IBT TESTS SUPPLEMENTAL PENDING REVIEW INVALID REPLACEMENT UNDER DISCUSSION TYPE OF TEST NO LONGER REQUIRED TEST REPLACED OR IN PRCGRESS NEGATIVE RESPONSE NO RESPONSE: BUT REGISTRATION CANCELLED,PROOUCT DISCONTINUED, NO PRODUCT REGISTERED IN U.S., OR NO CURRENT PRODUCTION NEGATIVE RESPONSE: BUT REGISTRATION CANCELLED,POODUCT DISCONTINUED, NO PRODUCT REGISTERED IN U.S., OR NO CURRENT ..RODUCTION STUDIES WITH NO AND NEGATIVE RESPONSES REQUIRING REGULATORY ACTION INVALID IBT STUDIES-+-? PROVIDING SOLE SUPPORT FOR REGISTRATION INVALID 1ST STUDIES ON PESTICIDES WHICH ALSO HAVE NON-I BT STUDIES 5 EPA ASSESSMENT OF EFFECT OF IBT DATA ON 65 LARGEST USE PESTICIDES* PESTICl DES WITH SOME IBT DATA TWO PESTICIDES WITH SOME IBT DATA BUT WITH NO PREVIOUS REGULATORY ACTION IBT PESTICIDES THAT WERE THE SUBJECT OF RPAR, DATA CALL IN, OR REGISTRATION STD. o25 INSECTICIDES ACCOUNTING FOR 85% OF POUNDAGE USED, 32 HERBICIDES ACCOUNTING FOR 82% OF POUNDAGE USED, . AND 8 FUNGICIDES ACCOUNTING FOR 71% OF POUNDAGE USED, IN 1980. 6 SUMMARY STATISTICS.: IBT TOTALS 38 COMPANIES 140 :.CHEMICALS 801 STUDIES STUDY VALIDATION STATUS 131 44 32 16% VALID 8% SUPPLEMENTAL 4% PENDING 74% INVAUD 694 -- 801 100% INVALID STUDY REPLACEMENT STATUS . 212 36% STUDY REPLACED OR IN PROGRESS 6% REPLACEMENT UNDER DISCUSSION 38 45 8% STUDY NO LONGER REQUIRED 116 20% NEGATIVE RESPONSE BUT PRODUCTS ARE CANCELLED, DISCONTINUED, NOT REGISTERED IN THE U.S., OR HAVE NO PRODUCTION. 24 4% NO RESPONSE BUT PRODUCTS ARE CANCELLED, DISCONTINUED NOT REGISTERED IN THE U.S., OR HAVE NO PRODUCTION. 86 14% NEGATIVE RESPONSE AND INVALID T.I 12% NO RESPONSE ANO INVALID -694 100% IBT STUDIES PROVIDING SOLE SUPPORT FOR REGISTRATION - 2% 17 . -6 3% IBT STUDIES PROVIDE SOLE SUPPORT FOR REGISTRATION 1% CHRONIC STUDIES GENERATED BY REGISTRATION STANDARD 11 7 1to St,4,-,. .;f\ ?., i ft i ?? l ? c.," 1'_.'4t PAO,? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF l'ESTICIOES ANO TOXIC SU8STANCE .S ADDITIONAL BACKGROUND ON THE IBT REVIEW PROGRAM In 1976, during a routine lab inspection of one of IBT's facilities, FDA discoverd deficiencies in the manner in which studies were being conducted and discrepancies between those studies and their raw data. In 1977, EPA placed a moratorium on registration actions involving data developed at IBT as a result of this information. In the same year, EPA notified registrants that they were required to audit the raw data and validate both those IBT studies which were pivotal to the data base of pesticides already registered and all those which were supporting new registration actions. In 1978 a joint EPA/FDA audit of IBT's two other facilities uncovered problems similar to those discovered during the initial audit. In March of that year EPA required registrants to submit to EPA the raw data for the IBT studies so that a review of registrant audits could be conducted. EPA referred this case to the Department of Justice for investigation in April 1978. At approximately the same time, the U.S. and Canada were negotiating an agreement to share the task of spot checking registrants' audits of IBT studies. Through these checks, however, it became apparent that registrants' audits routinely overlooked some areas of concern. As a result, Canada and the U.S. agreed to review each audit and study. Mutual agreement was reached as to which studies would be reviewed by each country. It was also decided that each country would accept the other's determination as to validity. However, due to differences in data requirements, each country would independently evaluate whether studies met their regulatory requirements, and determine the need for replacement studies. t 8 After two years experience of the review program a decision was made to reconsider past policies regarding IBT data. A policy statement reflecting decisions made as a result of this analysis was sent to registrants in July 1980. The decisions were: 1) that the moratorium on registration actions was lifted unless a valid IBT study was essential to the approval of a specific action, 2) that registrants would be required to fill data gaps resulting from invalid IBT studies, 3) minor data gaps would be considered through normal registration channels, 4) if the entire data base was invalid, EPA would consider cancellation action, and 5) if previously unreported adverse effects were discovered, the study would have to be replaced, and in addition the Agency would consider initiating either an 'intensive risk/benefit review, or formal hearings on a chemical's registration status. The IBT Review Program consisted of validation review, evaluation review, and data gap review. Validation review was designed to determine whether the information in the final report was supported by the raw data. Evaluation of whether a study met Agency guidelines for studies used to support registration, was performed on studies determined to be valid or at least reliable enough to supplement other valid data. Data gap review was a search through a chemical's entire data base to determine which invalid studies needed to be replaced. Because our experience with data gap review proved it to be extremely time consuming, options for completing the IBT program more expeditiously were considered. As a result, several policy changes were adopted and conveyed to registrants in a letter in April 1982 which stated: 1) that acute IBT studies would no longer be reviewed through the IBT program. Instead, they would be reviewed through normal registration channels; 2) that studies which were considered invalid because the registrant initially chose not to audit them, would not be reviewed by the Agency and our presumption would be that they had to be replaced; 3) that EPA would no longer perform a data gap review of a chemical's data base to determine if other studies existed to replace the IBT studies, instead we would assume that replacement was necessary unless the registrant could convince us otherwise: and 4) that EPA would not review an IBT study if the registrant identified a replacement and agreed to have the IBT study considered invalid. The review stage of the IBT program is essentially complete. The remainder of the program consists of obtaining replacement studies and tracking commitments to rep?ace studies. 9 EXHIBIT A THE DATA BASE FOR INDUSTRIAL BIO-TEST CHEMICALS uh- -- \ Exhibit A quantitatively presents the data base of the chemical compounds for which studies were conducted by Industrial Bio-Test Laboratories. The IBT studies are designated by the letter 0. Studies in the EPA data base done by labs other than IBT are designated by the letter X. The studies are arrayed across six categories of chronic effects. These chronic effects are: oncogenicity, terato- genicity, mutagenicity, reproductive effects, neurotoxicity, and other chronic effects. Some of the chemicals in this exhibit appear to have no IBT studies because the studies conducted for these chemicals by IBT were all in the acute categories. The chemical names used are those that were listed in the IBT records. There is no designation of the validity or invalidity of the IBT studies presented. Specific information of thiss nature is in Exhibit B. Exhibit A also notes any ongoing regulatory activity that will generate chronic data ror these chemicals. The types of regulatory activity that cause the generation of data are: the registration standard program, the data call in program, the rebuttable presumption against registration program, and any special action employing the 3c2b provision of the Federal Insecticide, Fungicide, Rodenticide Act. There are approximately 2830 chronic studies indicated in this data base. CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES: ? QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. ,; ? .... M .... M u c.., CHEMICALS u :z: O. u :z: ill .... ? .... c.., 0 ill ....u ....:z: ? ill c.., < u u :z: ::HI) .... .... ( .. 0 ? .... Of-OU ?ill 0 UCI> 0 e:(U J1.1 ill ill ?- P..U. u. ?? ? .... g! M M ? .... u ., REGULATORY ACTIVITY TO GENERATB CHRONIC DATA XU. ? .... u. OSI-I . .o Accel Alanap Alar X Ametryn X X X xx xx xx X X Registration Standard XXX 0 000 Data Call In 0 Asulam XXX xx XXX X Atrazine X xx xxxxxxx xx Avadex xxxx xx XXX 0 XXX X X xx X xxxxxx xxxx . Avenge Azodrin Bacillus.thurin 0 0 I X Data Call In Data Call In XXX 00 0 xxxxxxx '' Registration Standard X 00 XXX Data Call In XXX Data Call In xxxxx . , Data Call In g o IDT o _...__ __ ?.._ __ ,a __ : CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATO?IES: X QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. I: i r:u .... M oo :z: ? 8 u CiBMICALS O. r:u ? M u M :z: ....:z: ? l!) 0 ? u..J f-4 OU ?? u..J . :z: ?u..J -- xx Bi'fenox xx . 0 Binapacryl . xxxxx X 0 0 0 0 0 I X 00 xx I X 00 XXX I xx 0 ..... ?u 0 u..J 000 X Baygon Bux i ?u..J p..? ?? ..... ? ..... 0 0 xx Bardike Bolero (thiobeicarb) Brodifacoum (Talon) Busan 74 t Of-- ? M ?Cl) ? a (/) .... M l!) Barban Bladex g! M u M :z: u >< ? xxxxxxx 00 0 X REGULATORY ACTIVITY TO GENERATB CHRONIC DATA . Data Call In: I ' ::r: u.. ? xxxxxxxxx xxxxx Carbaryl xxxxxxx Carbofuran xxxxx 00 0 CGA-12223 0 IXXX xx Chipco-RP26019 X IXX XXX Chlorobenz.ilate X Chloropx_:opham xxxx XXX xx Chlorothalionil XXX xx xxxxxxxxx xxxx Chloropyrifos X txx Chloropropylate 00 000 lXXXX xxxx xxxx X 00 ix: ix: u.,J p.. u. u.,J u. ix:? Captan lXXXXXXX 000000 H u Af-4 c( u.,J :z: ? ... u.,J u.,J ... u. 0? REGULATORY ACTIVITY TO GENERATB CHRONIC DATA xxxx RPAR. 3c2b (XXX xxxx Data Call In lr I\. 000 Not marketed in U.S. (XXXXXXXXX < ' u ? ::> U) u.,J l.'.) '. ' I I A o Data Call In TtlT I ' ! CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES: A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES o . ,, ? H u H :z: ? H u H :z: "'-l l!) l!) 0 f- O. ? '1-1 f- '1-1 0 CHEMICALS u :z: Cidial, Phenthoa.1 e 0 Dimethoate Ciodrin X Cobex 00 . Coral Curacron (Profenofos) xx 0 H u u H >< p: '1-1 fl.. ,.,,. ? H u H :z: f- ::> Cl) AfOU '1-1 < l!) 0 f0 "'-l ,.,,. '1-1 :z: p: '1-1 ? 00 X 00 xx o . 0 xx X Cyprazine 0 0 0 00 xxxxxxx xx Xa20 X 00 xxxxxx 0 ? UCI) f- ?u '1-1 '1-1 :i:: ,.,,. f- ,.,,. 0 U-1 't . Registra?ion Stnd RPAR 000 Data Call In-suspended xxxxxx Registration Standard I Discontinued Product I X ' XXX Q XXXXXXXX)I xxxxxx ' ' XXX I xx Data Call In Discontinued Product Data Call In xx .. O o IBT . ' I 0 X 0 xxxx REGULATORY ACTIVITY TO GENERATB CHRONIC DATA X X 0000 X X 0 u H :z: xxxxxxxx xx X Cycoce! DCPA 0 ? H X Cycle Dasanit 0 ? ? ' I i I ' CHEMICAL. COMPOUNDS TBSTED BY INDUSTRIAL BIO-TEST LABORATORIES: AND OTHER LABORATORIES o . ? QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT oo .' ? M u H :z: ? M u M -:z: ... ... J1.1 C> 0 J1.1 C> 0 CHEMICALS u :z: ? J1.1 O. M < Desmedipham Diazinon XXX Dicamba 0 0 00 X xxxxx xxxxxx XXX xxxxx X 000 0 0 ?u 0 ? J1.1 :z: ?? 0 ... 0 ? J1.1 p.. JJ.. J1.1 JJ.. ? u M :z: u H >< =>U, A ... OU J1.1 C> xx Delnav ... u ? M ? u M :z: M ? X Dinoseb . Diqua t X Disyston Dowco 233 xx 0 J1.1 J1.1 :i: JJ.. ... JJ.. Ri.BGULATORY ACTIVITY TO OBNERATB CHRONIC DATA 0? I Xo36 xxxxxx Data Call In xxxx Data Call In xx Data Call In : .1 . I XXX . Data Call In: I i i 0 XXX 00 00000000 xx xxxx X X X xx XXXX. 0 . xxxxxxxx:x xxxxxx Dichlobenil Difolatan 5 U)... ' XXX X 0 X xx 0 xx xxxx xxxxxx XXX I I ! I Data Call In 000 XXX I l I I I t 0 00 X=19 I Data Call In 0 0 . . O o IBT . I I ' LABORATORIES: CHEMICAL. COMPOUNDS TE5TED BY INDUSTRIAL BIO-TEST TO EPA BY IBT AND OTHER LA.BORATORIBS o ED SUBMITT STODiES ? QOANTtTATIVB PRESENTATION OF ?::.... u ....:z: IJ.l CJ 0 CHEMICALS Dowco 290 u :z: O. X Drepanon Embark X Endothall XXX 0 EPN .... ? .... IJ.l CJ z IJ.l ? ....:z: CJ 0 ... IJ.l Af-4 OU 0 X X 0 X X Fenvalerate xx Fenitrothion X X 0 xxxx X :z: P::U ?e! REGULATORY ACTIVITY TO GBNERATB CHRONIC DATA .... Ji. 0? . : 0000 xx X xx 0 0 xxxxxxxxx: xxxxxxxxx? X xx xx I Not Ifogistered l I : xxxx I RPAR X=30 0000 00 I X ::, IJ.l xxxxxxxx xx 00 Ethion. Gu,.... { . 0 p:: 0 X 0 xxxxxx .... 0 p:: p:: IJ.l p.. Ji. IJ.l Ji. p::? ? u :z: 0 ::, U) .... ?:: H u ....>< t; < ? X .... ....u u xx Ethiolate Fluroridamid ?:: .... ..oo I niscontinued Product xxxxxxxxx Data Call In 00 X=-24 X=-23 X?20 XXX Data Call In ' 0 a ,. i ' . . . \ . ! TUT CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES: ? QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES o oo ., ? ? M u CHEMICALS Folpet M O. xx xxxxxx :z: Ul <.:> 0 u :z: FormetanateHCL Furloe (Chloropropham) u z Ul <.:> 0 ? ? Ul ? M ' M xxxxxx Slutaraldehyde ? u M :z: Ul <.:> < ? >< 0 ? 0 ? Ul z ?J.&-1 5cn 0 ? ?u Ul&.ll X X 0 000000 00 xx X XXX 0 xxxx xxxx 0 X Glyphosine 0 0 0 000 Gossyplure 0000 0 REGULATORY ACTIVITY TO GENERATE CHRONIC DATA ?? o JU X 0 X Irgasan M 00 xx Hinosan u u M :z: 0 0 Heptachlor Epox M 00000 Glyphosate . ? M ? u ::, en A? OU ?Ul p. J.l.e Ul J.l.e M xxxx ? : 00 . 00 xxxxx X 0 X D xxxxxxxx xxxx . Data Call In: I Data-Call In Ultra minor non food use XXX 00 0 0 xx 00 00 Data Call In xxxxxxxx 0 X 00 X xx xxxxxxxx xxxxxx I . I I Data Call In X xxxxxxxx xxxxx xx ( . i ! All uses cancelj..ed ! I xx .. 0 O V o IBT - ?oL-- W-L---o--'oo TORIES: . . CHEMICAL. COMPOUNDS TE?TED BY INDUSTRIAL BIO-TEST LABORA A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES o ? ? u z t., u H :z: f-4 t., H J1l 0 u t., 0 u :z: O. X 0 Lorox XXX X xx xx XXX Oen ? ? J1l :i:: .... 0 f-4 ?u J1l 1-L. 1-L. J1l REGULATORY ACTIVITY TO GBNERATB CHRONIC DATA .. : xx 00 Data Call In 000 Data Call In xxxxx xxxxxx xxxxxx X xxxxx X xx Data Call In xxxxxxxx XXX xx X Registration Standard Maleic Hydra. xxxxxx ' 00 0000 xxxxx X I I ' X I xxxxxx Merphos X Mesurol Meta-Systox R 0 0 00000 0 X . ? X XXX 0 MCPP ? f-4 Machete MCPA ?Jl.l ii.. 1-L. J1l 1-L. ?Jl.l ' 0 .... 0 OU X Krenite Lasso J1l u H >< Qf-4 < ? M M J1l u M :z: ? g! t; ::> en ? M M z J1l M CHEMICALS M .oo. XXX 0 0 X 0 0 I X t ' xxxxxxxx xxxxxxx xxxx 00 xxxxxxxx :xx XXX . . bo 0 o TRT . CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES: A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES o .... u ? .... ....z ? H z ? u l.:> ? 0 ..... l.:> 0 CHEMICALS u ? ? :z: ..... O. ....ur: ? ..... u ....z H ? OU < ! I xxxxxxxx 00000 Methomyl xxxxxx xx Methoprene xx xxxxx xx XXXXXXXX)( Metolachlor X 0 xx xx X Mocap (Ethoprop) X . X Monitor (Methami.dophos) X 00 X 0 Naled Nemacur X X 0 X 0 0 0 xx 0 X 0 0 xx X o. xxxxxxxxx xxxxxx xx xxxx XXX 0 0 ' xx 0 X=ll 00 0=7 REGULATORY ACTIVITY TO GENERATB CHRONIC DATA 0 '1-a 0 0 xx :I:'14 ..... J1. ..... c:ii:u ?? 0000 X X 000 ? ? ? :z: . Not register.ed in .U.S.A. ? : 0 xxxxxx X xxxxxxxx xxxx 00000 , L Data. Call In : Registration Standard Registration Standard Registration Standard ' ' .,I Registratio . n Standard . XXX 000 { 0 ..... 0 c:ii: '1-a ? .... u :z: Ull> 0 p::? p.. J1. ?'14 00 X >< Qf-o l.:> Methazole Morestan H ::> ti) Metobrornuron 00 ....ur: .oo. t Data Call In . . 0 o IDT I ' I I CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES: A QUANTITATIVB PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. ? M u M :z: Ill t., 0 u :z: CHBMICALS Nemagon O. . Nemefene t:: M u M X 1,1.l t., 0 ? .... Ill 1: ? ? M u M M u M :z: t; M .... 0 ::, U) Af-4 Ill OU c:ir:: Ill P..J&. ?- i 0 ? Ill Ill JI. :z: c:ir:: 1,1.l XXX . 0 .XXXXXXX 00000000 Omadine u M a u,.... :z: 0 p:: u 1,1.l Ill :cu. .... u. 01,1..1 REGULATORY ACTIVITY TO GENBRATB CHRONIC DATA . xx X xxxx Norea ' t:: xxxx 00 X 0 0 000 xxxxx X X 0 xx X=l2 00000 xxxx X XXX Data Call In xxxx Date Call In X 0rthene (Acephate) xxxx 0 0xadia.zon X xxxx Paraquflt X xxxxx xxxxx xxxxxxx PCNB XXX xxxxxx xxxx xxxx Penncap E (ethyl parathion 0 xx X xx xx 00 xx X xxxx X 0 000 X:a:16 I xx 0 000 Discontinued Product Data Call In 0 i ? I I I 000 0 l ' X=14 Xo37 . Data Call In X 00 0mite-Comite 0 ( .. X 0 o IBT ' .. I , , CHEMICAL. COMPOUNDS TE5TBD BY INDUSTRIAL BIO-TEST LABORATORIES: AND OTHER LABORATORIES. A QUANTITATIVB PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT .. h ? .... .... H u ? z '1l u H :z: CJ 0 '1l CJ 0 CHEMICALS u :z: ? .... '1l O. Penncap M. (methyl parathio n) Permethrine Xz=ll Phorate . Phosalone X ? .... g! .... ? '1l CJ :> (I) A ... OU 0 ... u u H :z: < Pik Off X 0 5cnu... :> ? 0'1.1 0 tic: '1l '1l SJ.. .... SJ.. ::c xx XXX x .. 22 XXX xxxxxxx XoZ3 Xol3 XoZl x-12 X xx X Xo16 xxxx xx XXX Xz:12 000 xxxxxxx xx 0 0 0 .... u :z: ... ,:lG ?'1.1 I X u H >< ?'1.1 p.. SJ.. '1l SJ.. ? Phosphamidon Picloram H 0 (' 0 REGULATORY ACTIVITY TO GENERATB CHRONIC DATA . : Data .Call In Data Call In 0 X Registration Standard 0 Data Call In XXX X 000 Data Call In 0 0 Not Registered 000000 I ' I I I I i I i Piperonyl Butoxide X xxxxx X Plictran X xx XXX Polyram XXX 0 0 X ' xx 0 XXX Xo9 Data Call In r X=9 X ()()() Data. . Call In O o IBT .. CHEMICAL COMPOUNDS TBSTBD BY INDUSTRIAL B10-TBST LABORATORIES: A QOANTJTATIVB PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES o oo ? ? H u H :z: IJ.l t:> 0 CHEMICALS u :z: O. u H % ... ... IJ.l t:> 0 X >< 0 ::;) U) IJ.l t:> Q ... OU < 0 ClG IJ.l Pd'4 IJ.l "- ? IJ.l :z: ClG IJ.l ? a u,... 0 ?u ...?e!"0'11 xx XXX xxxx X Prowl xxxxx 00 X XXX xxxxxx Pyrethrin . X xx 0 X 00 0 Data .Call In . Data Call In I X xxxxxx Ramrod t X Propham 0 o i : X XXX I . !' I .X Rabon . : X 0 REGULATORY ACTIVITY TO GENERATB CHRONIC DATA 0 Prometryn Randox ... H u .... ( u :z: X Prometon I ... H H IJ.l t=.... u ? u H :z: ? PPG 124 Profluralin t= M ., 0 xxxxxx xxxxx xxxxx X 00 X 0 0 0 xxxx xxxxx XXX 0 X::10 I 0 l i xxxxxxx 000 t I .o .. -- 0 i o IBT LABORATORIES: CHEMICAL. COMPOUNDS TBSTBD BY INDUSTRIAL BIO-TEST EPA BY IBT AND OTHBR LABORATORIES o TO TED SUBMIT A QUANTITATIVB PRESENTATION OF STUDIES oo ....u ....:z: ? .. J1l C) 0 u :z: CHBMICALS Resmethrin O. . xxxx San'tophen Sectrol Sencor Simazine Sodium Azide ... ... H J1l Q ... 0 5 ll)... J1l ... Ji. ? ? u :z: C) 0 000 ,:,i:: J1l p,. Ji. J1l Ji. ,:,i:: &,LI ? xxxx 0 X 0 . X X 0 xx 0 XXX Xo2S xx Discontinued Product 0000 Not Registered .X 0 0 xxxxxxx X X=9 xxxxxxx 0 xx X xx XXX 0 xxxxx No Food Use X=9 X=-20 I 0 I ' XXX X I xxxxxxx Data Call In 0 I XXX X Sodium Bromide Sodium Chlorate 0 ILi REGULATORY ACTIVITY TO GBNBRATB CHRONIC DATA xxxxx 0 000. ,:,C:U ul J1l :r:Ji. xxxx 0 XXX :z: 0 XXX 0 00 g; OU C) J1l ... 0 ::> ti) < ? xxxxxx .... ....... ....u J1l ....u .... >< u :z: ? xx Ronne! Rydex (Prodiamine) ....u .... z ? ., ( ' 0 i . . 0 0 o JBT I BIO-TEST LABORATORIES: CHEMICAL. COMPOUNDS TESTED BY INDUSTRIALSUBMIT TED TO EPA BY IBT AND OTHER LABORATORIES o A QUANTITATIVE PRESENTATION OF STUDI?S ? ? H u H :z: J,ll C) 0 CHBMICALS u :z: O. Sumitol Supracide M u M ? .... u ? u H :z: .... ? .... C) 0 u H >< ?t; < ? J,ll p.. J.t.. J,ll J.t.. ?? ? u M :z: 0 .... 5?utl).... ? ? OJl.l 0 ::> ti) J,ll C) J,ll M H M z J,ll ? REGULATORY ACTIVITY TO GBNERATB CHRONIC DATA :x: J,ll J,ll J.t.. t- 0 ,:ii: iii: '1l p..? '1l ? a t/) ? c:ii:u ?:!! ?? O. xx XXX XalO xxxx xx xxxxxxxx 000 X 0000 xxxxxx 000 ? xxxx Trfallate X Triforine X xx Triphenyltin Hydr. X xxxxx ?apona X xx X=ll Velpar XXX X xxxx Vendex XXX XXX xxxx .X 0 xxxxxx 0 X 0 ::> ? ,:ii: '1l X Vinyzine ? ? '1l ? Toxaphene rDDVP) 0 ti) 0 u :z: Torak (dial i for) . u H >< H u H :z: 000000 xx 0'1l xxxx REGULATORY ACTIVITY TO GENERATE CHRONIC DATA . Registration Standard 0 0 00 RPAR 0 0 00 Data Call In xxxx xx xxxxxx xx ' : I I X Xo70 0 X xxxxxx xxxxxx .l Data Call In Registration Stdndatd ' ' I ' Xo9 I xx . . 0 o JBT CHEMICAL. COMPOUNDS TeSTED BY INDUSTRIAL BIO-TEST LABORATORIES: X QUA.NTITATIVB PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER-LABORATORIES. ' l:: H u H z J1l l!> 0 CHEMICALS u z O. l:: u .... z H s i:: 0 J1l ? tOU> t-4 u :z: H l!> ? t-4 J1l ....ul:: H 0 A? OU l!> < i ? 0 ,:ii: J1l ? ? p..? J.ll? ,:ii: J1l u a u, z 0 ? r::ii:u REGULATORY ACTIVITY TO GENERATB CHRONIC DATA ?? ?? OJ1l xx X X Visco 1153 xx X X X XXX XXX xxxxxx .' XXX .XX 0 xxxx 0 X xxxxx xx xxxxxxxx V date (coxamyl) 4-Aminopyridine ?,4-D - . : 1152 . Vorlex {. 11-1 Visco Vitavax . . . ., :' 00 I X 0 X XXX i Registration Standard x-11 xxxxx xxxxx xxxx : ' Data Call In I t ' I I . . . 0 o TRT EXHIBIT IBT TRACKING SYSTEM REPORT !BT TRACKING SYSTEM REPORT CODE DEFINITIONS VALIDATE: a review designed to determine if the information in the final report was supported by the raw data from the study. I Invalid. The information in the final report was not supported by the raw data from the study. P - Pending. The study is still under validation review. S - Supplemental. Portions of the study are valid and can be used independently of the r?mainder of the study. V - Valid. The information in the final report is supported by the raw data from the study. EVALUATE: a review designed to determine if a study meets Agency guidelines for studies to be used in support of pesticide registration. C, CM - Core minimum. The study. meets the regulatory data requirements to support pesticide registration. S, CS - Core supplemental. The study is useful to supplement other studies. I, CI - Core invalid. The study does not meet the regulatory data requirements to support registration. - Pending. The study is still under evaluation review. P NA - Not applicable. The study was not given an evaluation status if the validation process determined it to be invalid. REPLACE: the column indicating the replacement status of the ?tudy. Replaced Discussion Not Req No Resp Neg Resp - Study replaced or in progress Replacement study under discussion Study no longer required No response from registrant Negative response from registrant IJT TRACKIN6 SYSTEN REPORT ROUTE IBLNU!i CHEIIICAL COIIPANY B-1708 B-4715 C-4716 P-4709 2945 ALAR AliETRYN AliETP.YH AliETRYN AliETRYN AHTOR ANTOR AHTOR AIHOR AHTOR ANTOR AN10R ANTOR ATRAZIHE ATRAZINE A1JADEX AVADEX AVADEX Al.'ADEX AVAI!EX AVAUEX AVADEX AVADEX AVADEX AVADEX AVAI!GBPX AVADEX AVADEX AVADEX AVADEX BACILLUS THURING BARBAN BARBAN BARBAN BARBAH B?YGON BENZADOX BENZADOX BEKZADOX BIFENOX BIFENOX BIFENOX BIFENOX BIFENOX BIFEHOX BIFEHOX BIFEHOX BIFEHOX BIFEHOX BlfEHOX BIFEHOX BIHAPACRYL BIHAPACRYL BIHAPACRYL BINAPACRYL UNIROYAL CIBA GEISY ORAL CIBA GEIGY ORAL CIBA GEIGY CIBA GEIGY DERHAL DERMAL BFC ORAL BFC ORAL BFC ORAL BFC ORAL BFC ORAL BFC ORAL BFC ORAL BFC CIBA GEIGY ORAL CIBA GEIGY ORAL ORAL KOHSANTO ORAL IIONSANTO ORAL KOHSAHTO ORAL KOHSAHTO ORAL KOHSAHTO KONSANTO IIOHSAHTO IIONSANTO IIOHSANTO ORAL KOHSANTO ORAL KONSAHTO HEURO MOHSAHTO HEURO KOHSANTO ORAL KONSANTO ORAL MONSANTO ORAL SANDOZ ORAL VELSICOL ORAL VELSICOL ORAL VELSICOL ORAL VELSICOL CHENAGRO DERIIAL GULF ORAL GULF ORAL GULF DERMAL HOBIL ORAL. MOBIL HOBlL ORAL HOBlL KOBIL MOBIL KOBIL ORAL liOBIL ORAL HOBIL MOBIL DERIIAL KOBIL ORAL KOBIL ORAL FKC ORAL FMC ORAL FliC PERCUTAH FHC 601-4274 611-8169 622-0466 622-3059 622-8166 8560-10525 8580-08351 8560-8350 622-6769 8580-8906 59-13 59-13A 59-138 59-13C 622-5250 622-5252 623-6841 651-5254 8530-9030 8580-10580 8532-10762 8580-10813 8580-9119 B-2793 B-585 C-721 1017 563 E-8917 A-5372 B-4381 C-4382 A-1884 B-1474 B-2156 C-1475 E-2155 J-1S48 J-782 621-5S32 621-S533 623-6793 8530-8513 8580-9571 TYPE SPECIES RAT RAT DOG RAT RAT /RAP.BIT RABBIT SUIIACUTE DOG SUBCHRONIC RAT SUBCHROHIC RAT SUBCHROHIC RAT SUBCHRONIC RAT CHRONIC MOUSE CHRONIC RAT RAT CHRONIC NICE CHRONIC DOG SUBCHF:OHIC RAT SUBCHRONIC DOG SUBCHROHIC RAT SUBCHF:ONIC RAT CHRONIC KOUSE KUTAGEHICITY RAT REF'RODUCTION RABBIT TERATOLOGY CHOLINESTERASE RAT DOG CHRONIC IIOUSE HEH HEH RAT DOG RAT SUBACUTE RAT CHRONIC DOG CHRONIC RAT CHRONIC RAT IIOUSE KUTAGEHICITY RABBIT SUBACUTE RAT SUBACUTE DOG SUBCHRONIC RABBIT SUBACUTE RAT SUBCHROHJC RAT 1ERll10lOGY DOS SUWiROHIC KOOSE KU1 AGEHIC ITY HEH CATARACTEGEH HEH CATAF:ACTEGEN DOG CHROHIC RAT CHRONIC RAT REPRODUCTION RABBIT SUBACUTE QUAIL SUBACUTE CAT CHRONIC RAT SUBCHRONIC DOG SUBCHRONIC RABBIT SUBACUTE TERATOLOGY CHRONIC CHRONIC REPRODUCTION VALIDATE 1 1 I 1 1 V V p I V V V I s s I I I I I I V I V EVALUATE REPLACE HA NA HA HA HA p NA HA NA HA HA HA HA HA HA p NA p p HA V I I NA V V I I I I I I I I I V V V I 1 I V I V V I p p p p p p HA HA HA HA NA NA HA NA HA NA NA p p p HA NA HA p NA p HA NA NA NA NA REPLACED DISCUSSION DISCUSSION DISCUSSION NOT F:EO HO RESP REPLACED NO F:ESP REPLACED NO RESP HO RESP NO RESP HO F:ESf. REF'LACE[! HO RESP DISCUSS:Oii DISCUSSION DISCUSSION DISCUSSION DISCUSSION DISCUSSION NO RESP DISCUSSION NO RESF' NO RESP HO RESP NO RESf. HO RESF' REf'LACED NEG RESP REPLACED REPLACED REPLACED REPLA!:ED REF'LACED NEG RESP NO RESP HO RESP NO RESP NEG RESP NO RESP NO RESF. NO RESP NEG RESP NEG RESP NEG f;ESP HO RESP NEG RESP HO RESf. HO RESP HO RESF. NEG RESf. NEG RESP NEG RESF. NEG RESF' IBUIUH CHEIIICAL BIHAPACRYL BIHAPACRYL BIHAPACRYL .BIHAPACRYL BINAPACRYL COHF'ANY ROUTE FIIC ORAL FHC FMC FMC ORAL FHC ORAL SHELL BLADEX BLADEX SHELL CHEVRON ORAL BOLERO B-353 ORAL CHEVRON BOLERO C-610 DERtlAL CHEVRON BOLERO 601-5223 ORAL CHEVRON BOLERO 621-2095 ORAL CHEVRON &oLERO 621-4652 CHEVRON BOLERO 622-2440 CHEVRON BOLERO 622-2440 CHEVRON BOLERO 622-5225 CHEVRON ORAL 651-2096 BOLERO CHEVRON ORAL 651-5143 BOLERO CHEVRON BOLERO 651-5265 CHEVRON 8533-10026 BOLERO CHEVii:OH 651-7433 BOLERO CHEVRON NEUKO 8580-10025 BOLERO ORAL BROIIOPHENOXIl'I CIBA GEIGY C-6581 ORAL BROKOPROF'YLATE CIBA GEIGY B-5433 ORAL BROIIOF'ROPYLAlE CIBA GEIGY 622-5433 BROHOPROF'YLATE CIBA GEIGY 622-6724 BROKOF'ROPYLATE CIBA GEIGY 622-6726 ilROIIOPROf'YLATE CIBA GEIGY 8531-9996 ORAL BUCKHAH BUSAN 74 B-7120 Of.:AL BUCKMAN BUSAN 74 C-7121 GULF ORAL 611-0:Boo BUTAK ORAL 622-03363 BUTAII GULF A-8995 DERMAL BUTYLTIN OXIDE A-3886 CHEVf.:OH BUX DERHAL A-4407 CHEVRON BUX DERMAL B-3422 CHEVRON BUX ORAL B-3653 BUX CHEVRON ORAL B-4130 CHEVRON BUX B-4339 CHEVRON BUX CHEVRON C-3655 ORAL BUX CHEVRON J-4330 BUX CHEVRON BUX J-5536 CHEVRON J-5863 BUX il-2804 AIIER/ SEUI/CHEVROH CAPTAN B-9267 AIIER SEED/CHEVRON ORAL CAPTAN B-9271 CAPTAH AHER SEED/CHEVRON J-139 CAPTAH CHEVRON J-5420 CAPTAN CHGBPVRl)k J-5438 CAPTAN AIIER SEED/CHEVRON P-5397 CAPTAN AKER SEED/CHEVRON P-5398 CAPTAN AIIER SEE[l/CHEVROH P-5570 AHEP. SEHi/CHEVRON CAPTAN VCRF-139 CAPTAH AIIER SEED/CHEVRON 621-5519 CAPTAN AHER SEED/CHEVRON CAPTAH 622-5998 AIIER SEED/CAF'TAN CAPTAN 623-5998 A?ER SEED/CHEVRON KOHSANTO 8530-9030 CARBARYL B-2210- B-2705 C-1426 C-2209 OPF't J-:38 8530-11112 TYPE CHRON!C REPRODUCTION CATARACTEGEN CHRONIC TERATOLOGY TERATOLOGY SUBACUTE SUBACUTE SUBACUTE CHRONIC CHRONIC REPRODUCTION TERATOLOGY KUTAGENICITY CHRONIC CHROHIC TERATOLOGY KUlAGElUCITY SUBCHROHIC CHRONJC CHRONIC REF'ROUUCTION CARCINOGENICITY CHOLINESTERASE SUBCHROHIC SUBCHRONIC SUBACUTE SUBACUTE SUBCHRONIC SUBACUTE SUBACUTE SUBCHRONIC SUBCHROHIC CHOL! HESTERASE REPRODUCTION SUBCHRONIC DEIIYELIHATION TERATOLOGY TERATOLOGY REPRODUCTION CHRONIC CARCJHOGEHIC lEAATOLOGY TERATOLOGY PROGENY TERATOLOGY TERATOLOGY KUTAGEHICITY REPF..'ODUCTN TERATOLOGY DOKIHAHT LETHAL DOHINAHT LETHAL CHOLINESTERASE SPECIES RAT RAT HEH DOG f10G RABBIT RABBil RAT DOG RABBil RAT RAl RAT RAT HOUSE DOG DOG RABBIT HOUSE HEN HEN DOG RAT RAT RAT HOUSE DOG RAT DOG DOG RAT RABBIT RABBIT RABBIT DOG RAT RAT RAT DOG HEH RAT RABBIT RAT RAT HOUSE Rr>tGBPB1T RABBIT DOG RAT RABBT/HAHSTR HOUSE CHICKEN MONKEY KOUSE KOUSE RAT VALIMlE I I I I I I I I I I I I I I I I I I I V s EVALUATE NA NA NA NA HA HA HA NA NA NA HA NA NA NA HA NA NA HA NA V s I HA I NA I I V I I I I I I I I HA NA p p s I I I I I I I I I 1 I I I I I I I I V s NA NA HA NA NA N NA NA HA NA NA NA NA HA NA HA NA NA NA HA NA HA NA NA HA NA p REPLA?( NEG RESF' NEG RESP HEG RESP NEG RfSF' NEG RW' REF'LA[ED REPLACC::rt REPLACrn REPLACElt HEG RESf' REF'LAC[[I REf'LACED REf'LACED REf'LACED REf'LACED REF'LACED REPLACHI REF'LACE[I REf'LACED NEG RESP REPLACED NEG RESP NEG RESP HEG RESP NO RESP NEG RESP NEG RESP REPLACED NO RESP NOT RED HOT REO NO f.:GBPSP NEG RESF. NEG RESP HEG RESF. NEG RESF' NEG RESP HEG r:ESP HEG RESP HEG RESf. HEG RESP REPLACED REf'LACH! REf'LACED REPLACEII HO RESF' HO f.:ESP HO RESf' REPLACEI1 REPLACED HOT f.:EO HO RESP NO RESP NO RESP NO RESP IBT .JIUII A-7099 A-972 B-1590 B-1591 B-3113 B-3637 B-3638 B-400A B-4443 JI-Ml!!i B-9i3 C-3636 C-4H2 E-401A E-401B J-5145 J-6296 11-5183 P-4387 P-4802 P-6315 3891 J-5144 622-5121A 623-07922 8531-09995 8532-07921 611-5122A 8532-10607 8580-10767 C-6785 A-5253 B-5262 C-5264 A-3512 A-4646 90104 P-5821 623-05515 651-05514 c-?645 663-3477 B-8829 B-9341 E-339 J-899? J-9081 J-9402 A-1062 C-8830 J-105 J-2570 17838 611-5122B 611-5922A 62?-5121B 622-6895 CHEMICAL COIIPANY ROUTE TYPE SUBACUTE CHOLINESTERASE ORAL SUBCHROHIC ORAL SUBCHROIIIC ORAL SUBCHROIUC ORAL CHROHIC REF'RODUCTIOH CARCINOGENICITY CHOLINESTERASE ORAL SUBACUTE .FHC CAAJIOFURAf! CHOLINESTERASE FMC CARBOFURAH ORAL FIIC CHRONIC CARBOFURAN CHOLINESTERASE FMC CARBOFURAN HUTAGENICITY FMC CARBOFURAH IIUTAGENICITY FMC CARBOFURAII TERATOLOGY FMC CARBOFURAH REPRO[IUCTIOH FMC CARBOFURAN INHALATION SUBACUTE FHC CARBOFURAN REPRODUCTION FMC CARBOFURAH REPRODUCTION FMC CARf!OFURAH REPRODUCTION FMC CARBOFURAH SUBACUTE PERCUTAN FHC CAF:BOFURAH HEURO FHC CARllOFURAH SUBCHRONIC ORAL CI&A GEIGY CGA-12223 REPRODUCTION CIBA GEIGY CGA-122?3 CHOU NESTERASE CIBA GEIGY CGA-122?3 CARCINOGENIC CIBA GEIGY CGA-12223 ORAL CIBA GEIGY CGA-12223 ORAL CIBA GEIGY CGA-12223 HEURO CIBA GEIGY CGA-12223 KETHEHOGLOBIH CIBA GEIGY CHLORBROHUROH DERl'IAL CIBA GEIGY CHLORBROHUROH ORAL CIBA GEIGY CHLORBROl'\UROH ORAL CIBA GEIGY CHLORBROHUROH DERHAL CHLOROBEHZlLATE CIBA GEIGY DERMAL CHLOROBEHZILATE CIBA GEIGY SUBACUTE ORAL CHLOROPICRIN REPRODUCTION Pf'G CHLOROPROPHAH REPRODUCTION PPG CHLOROPROPHAH CHROHlC ORAL PPG CHLORQPf(OPHAH CHRONIC ORAL CHLOROf'ROPYLATE CIBA GEIGY CHLOf>lIROYAL CHEVRON CHEVRON CHEVRON CHEVRON 0GBP\lf:DH CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON ORAL ORAL ORAL ORAL DERMAL ORAL ORAL ORAL ORAL INHALATION DERMAL ORAL ORAL ORAL ORAL SPECIES RABBIT GUINEA PIG RArPIT RAT TEST HUKAN CARCINOGENICITY KOUSE TERATOLOGY RABBIT MUTAGENICITY KOUSE REf'RODUCTION RAT RE PRODUCTION RAT TERATOLOGf RAT CHRONIC DOG DOG HEN HEN CHRmllC DOG RAT CRONIC RAT REPRODUCTION RABBIT SUBACUTE RAT SUBCHROHIC RAT RAT TERATOLOGY RAT TERATOLOGY MONKEY SUBACUlE RAT TERATOLOGY RAT SUBACUTE KOUSE HUTAGENICITY TESTICULAR LESIO KOUSE RAT TERATOLOGY KOUSE HUTAGENICITY PLACENTAL TRA!lSF RAT PLACENTAL TRANSF PIG PIG TERATOLOGY TERATOLOGY PIG TERATOLOGY PIG PIG TERATOLOGY RAT TERATOLOGY RAT SUBCHROHJC HEN SWINE BIRD SUBACUTE RAT CHOLHiESlEASE RAT TERATOLOGY RAT CHOL1NGBPSTERASGBP RAT CHRONIC RAT SUECHRONIC CARCIHOGEHICITY NICE RAT REPRODUCTION RAT CHOU NESTERASE CHRONIC DOG DOG SUBCHROHIC HICE HUTAGEHICITY QUAIL REPRODUCTION RABBIT TERATOLOGY HUNAN CHOLINESTERASE INHALATION ORAL PATCH TYPE TERATOLOGY SUBACUTE PECUTANEOUS VALIDATE EVALUATE REPLACE I 1 I I I I I I I I I I I u p I I I I I I I I I I I I p I I I I I I I I I V NA NA NA NA NA NA NA NA NA NA NA NA NA V NA NA NA HA NA NA NA NA NA NA HA NA NA NA NA NA NA NA NA NA HA V V V I V I I I I I s V I I I I s V NA p NA NA NA NA NA s p NA NA HA NA HA NEG RESF' NEG RE$f' NEG F:ESF' NEG RESF. NEG RESP REPLACED REPLACED REPLACED NO RESP NO RESP NO F:ESP NO RESf NO RESf NEG Rff NO F:ESf. NEG RESf NEG RESF NEG RESF. NEG RESFo NEG RESP NEG RESP NO RESP NO RESP NO RESP NO RESP NO RESP NO RESP NO RESP HO RESP NO RESP NO RESP NO RESP NO RESP NO RESP NO RESP NO RESP REPLACEII NO RESP NO RESP NO RESP NO FiESP REPLACED HO RESP REPLACED REF'LACED REPLACED REPLACED REF'LACED REPLACED HO RESF' NEG RESP REPLACED NEG RESP REPLACED NEG RESf. IBTJilli\ CHEMICAL 651-4807 J-2042 J-2493 J-513 A-2791 A-3359 A-3686 B-1350 B-3796 C-1351 D-2723 D-3030 D-3030 D-3030 J-131 J-131 651-4020 651-4381 651-5403 J-131 ORTHEHE ORTHEHE ORTHEHE ORTHEHE PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT PARAQUAT J-!Jl B-2068 J-2040 621-4921 A-2267 8562-9315 A-6652 A-7571 B-7149 C-7150 H-7657 B-8882 C-8884 601-4413 601-4524 622-4624 622-5876 623-3513 623-3803 632-4157 651-5785 651-5875 601-3802 8580-8635 C-1292 B-2804 B-6960 C-1382 ORAL C-1444 ORAL D-3082 COIIPANY CHEVROtl CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON CHEVRON ROUTE REPRODUCTION HEURO INHALATION DERHAL DERHAL ORAL SPECIES TYPE SUBCHROIHC SUBACUTE SUBACUlE CHRONIC SUBACUTE CHRONIC SUBACUTE SUBACUTE SUBACUTE SUBACUTE VALIDATE EVALUATE REPLACE DUCK CATTLE PIG HEN RAT/PIG/DOG I V V I RABBIT RAT I RABBIT cow CHEVRON ORAL OOG ORAL CHEVRON cow INHALATION DOG CHEVRON INHALATION GUINEA PIG CHEVRON RAT INHALATION CHEVRON DUCK CHEVRON PHEASANT CHEVROII PHEASANT DIETARY CHEVRON DIETARY PHEASANT CHEVRON HEH CHEVRON CHEVRON DUCK ..GBP1:lfV.F;ON J'HE?SANT .P.A?Allll(;J PENNCAP H PEHWALT ORAL SUBCHROHlC RAT PEHHCAf' II PENWALT ORAL SUBCHROHIC DOG RAT CHROHIC DRAT PEHIIALT PENHCAP H RABBIT SUBACUTE DERHAL 3H PERFLUIDONE RAT lHHALATIOH SUBACUTE 3H PERFLUHIOHE RABBIT SUBCHROIUC DERHAL HOP. AH C PHElfllGBP[11PHAH CHOLINESTERASE RAT HOR AH C PHEHIIEDIF'HAH RAT SUBCHROHIC ORAL NOR AH C PHEHHEDIPHAli DOG SUBCHf@HC ORAL NOR AH C PHEHHEDIf.HAH RAT INHALATION SUBCHROHIC NOR All C PHEHHEDIPHAII RAT CHRONIC ORAL HOHTEDISOH PHEHTHOATE DOG CHRONIC ORAL HONTE1tlSOH PHEHTHOATE RABBIT SUBCHRQHIC DERIIAL HONTEDISOH PHEHTHOATE RABBIT SUBCHROHIC DERIIAL liOHTGBP[1JSON PHENTHOATE HOUSE OHCOGEHICITY MOHTEDISOH PHEHTHOATE HOUSE llUTAGEIUCITY liOHTEDISOH PHEHTHOATE RAT REPRODUCTION HOHTEDISOH PHEHTHOATE RAT REPRODUCTION HOHTE[IISOH PHEHTHOATE IIOUSE HUTAGEHICITY llONTEDISOH PHENTHOATE RAT TERATOLOGY llOHTEDISOH PHEH1HOATE RABBIT TERATOLOGY MONTEDISON PHEHTHOATE RABBIT DERHAL HOHTEI1ISOH PHENTHOATE HEH HEURO HONTEDISON PHEHTHOATE CHOU NESTERASE DOG AHER CYAHIHID PHORATE RAT REf.RODUCTION CHEVRON PHOSPHAIHlJOH CHEVRON PHOSPHAHIDOH NEG RESP HA I CHOLINESTERASE RAT CHEVRON PHOSf'HAMIDOH NEG RESP HA I DOG SUBACUTE CHEVRON PHOSF'HAHIDOH REPLACED HA DOG CHRONIC CHEVRON PHOSfoHAlllDOH HEG RESP HA I CHOLINESTERASE RAT NA V V NA NA NA I I NA HA HA NA NA NA HA HA HA HA I I I I I I I I I V V I I J V V p p NA NA ?A Cl I I I V V V V V I V NA NA NA I I HA s I s s I V I I s I I NA HA NA C s HA HA s I HA p HA HA s NA HA REf'LACrn NO RESP HO RESf' REPLACED REPLACED REf'LACED REPLACED REF'LACED REPLACED REF'LACEII NEG RESf. NEG RESP NEG RESP REPLACED NEG RESF' REPLACED REPLACED REf'LACE[I NEG f:rn. NEG RESF. .m .. ?:Ei1 NO F:ESf HO RESF NO RESF' NEG RESP NO RESP NO RESf' HO RESP REF'LACED REPLACED HO RESP NEG RESP NO RESP NEG RESP NEG RESP NEG RESF' NEG RESP NEG RESF' NEG RESP NEG RESP NEG RESP HEG RESP HEG RESP NEG RESf' HO RESP REPLACED CHEliICAl. COliPAHY CHEVRON RAT/DOG/G,P, CHEVRON HEH CHEVRON HEN CHEl.1RON DOG CHEVRON DOG CHEVRON A-3O85 PHOSF.HAli IDOH SUBACUTE PHOSPHAliIIIOH DENYELINIATIOH PHOSF'HANIDON DENYELIHIATIOH PHOSPHAXIDOH DEliYELIHIATION PHOSPHAHIDOH CHOU HESTERASE PHOSPHAHIDON COl1PAF:ATIVE PHOSPHAIHDOH B-1443 PHOSPHANIDOH IBT_NUli T-3035 INHALATION \ICRF 1?9 IICRF 129R 1002A 1002B 2589 ORAL ORAL B-8799 C-1975 PICLORAli PICLORAH PICLORA!i 1974 PICLORA11 2198 PIK OFF 601-5447 PIK OFF 611-5?77 PIK OFF 611-6090 PIK OFF 622-5276 8533-9:;74 PIK OFF 8513-9375 PIK OFF 8533-9743 PIK OFF 8536-10509 PIK OFF R.C,Rf.-9?7 f, .P.I.LllfF 8533-08317 PIPERONYL BUTOX 663-6080 PIPERONYL BUTOX POLYRAli B-171? B-1715 POLYRAN B-1715A POLYRAl1 POLYRAtl B-2705 B-2766 POLYRAH C-1716 POLYRAli 2178 POLYRAII 2790 POLYRAII B-5366 POTASSIUM AZIDE C-5367 POTASSIUII AZIDE 622-3539 POTASSIUM AZIDE B-6758 POTASSIUli HEXA C-6759 POTASSIUl1 HEXA C-7380 POTASSIUM HEXA Pf'G 124 B-826? PPG 12? C-8262 PRODIAlilNE B-8829 PRODIAHIHE E-399 Pl.HJLOGY SUMCUTE SUBACUTE CHRONI1: CHRONIC KUTAGEHICITY REPRODUCTION SUBCHRONIC NEUROTOX HEUROTOX SUBACUTE SUBCHRONIC VALIDATE EVALUATE REPLACE RAT RAT RAT p l DOG IIOUSE RABBIT RABBIT RABBIT RAT RAT HOUSE HOUSE RAT RAT DOG RAT IIOUSE RABBIT RAT RAT RAT RAT RAT RAT RAT DOG DOG RAT RABBIT RABBIT RAT RABBIT RAT DOG RAT DOG RAT RAT RAT HOUSE RAT RAT DOG DOG DOG IIOUSE RAT HEH RAT CHICKEN CHICKEN RAT RAT V 'IIOUSE HA HA HA I I p I I I I I I I NA HA HA HA NA MA HA NA NA NA HA NA 1 I I I V s p V I HA NA HA I I HA NA 1 V p 1 l NA NA I NA p p I HA I HA HA HA V I I s cs C cs s s s V s s C NA NA NA V I I I p p V V Cl NA V NA V I V I V V I I p ' p HA NA 110 RESF' HO F:GBPSF REF'LACGBP[1 REPLACGBPI1 NO RESP REf'LACE[I REPLACE!I REPLACED REPLACED REPLACED NOT REG NEG RESP DISCUSSION NOT REO NEG RESF. NEG RESP NO RESP REPLACED REF'LACED NEG RESP NO RESP NEG RESF' NEG RESF' NEG RGBPSF. NEG RESP NEG RESP NEG RESP NEG RESP NEG RESF. NEG RESP NEG RESF. REF'LACEII NOT REO REF'LACED REPLACED REF'LACED REPLACED NEG RESF. NOT REO REPLACED NEG RESP REF'LACED REPLACED REPLACED HO RESP HOT REO REPLACED REf'LACED NEG RESP HO RESP NO RESP NOT REO NEG RESF. NEG RESF' IBT_HlJII B-4056 B-4345 C-4007 C-4350 E-4009 F-7110 F-7493 .H529 11-6336 H-7310 f'-4347 WCRF 158 623-3751 A-7308 A-7848 J-6351 2330 2367 2367 2367 2476 632-6451 A-8149 B-4834 C-4835 622-5251 622-5253 623-6842 651-5255 8530-9030 8580-10581 A-6678 A-6679 J-6676 J-6677 651-2842 651-3023 8532-10763 8580-10814 8580-9120 622-5459 663-5460 B-4634 C-3964 C-4343 611-8069 8532-8071 17721 1568 C-4805 621-6954 623-6955 623-7092 651-7093 CHEIIICAL TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TORAK TOXAf>HEHE TOXAf'HEHE TOXAf'HEHE TOXAf'HEHE TOXAPHENE TOXAPHEHE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIALLATE TRIFORIHE TRIFORIHE TRIPHEMYLTIH HYD TRIPHEHYLTIN HYD TRIPHEHYLTIH HYD TRIVAX TRIVAX VAPOHA VAPONA VGBPGADEX VGBPGADEX VGBPGADEX VEGADEX VGBPGADEX COIIPANY BFC BFC BFC BFC BFC BFC BFC BFC BFC ROUTE ORAL ORAL ORAL BFC BFC BFC BFC BFC BFC BFC BFC BFC BFC RFC HERCULES BFC IIOHSAIHO l'IOHSAHTO IIOHSAHTO IIOHSAHTO HOHSAHTO IIOHSAHTO HONSAHlO l'IOHSAHTO IIOHSAHTO KOHSAfCO NOHSAf