OF THE EPA ALSEA II STUDY AND REPORT CI 0 'I -O-CH2C-OH C) -1 0 2,4,5-T C C' CI CH3 0/, I SILVEX CI (I) H r -K cii7%i .-0 0 TCDD n1University ENVIRONMENTAL HEALTH SCIENCES CENTER OCTOBER 25, 1979 A SCIENTIFIC CRITIQUE OF THE EPA ALSEA II STUDY AND REPORT Sheldon Sheldon L. L. Wagner, Wagner, M.D. M.D. Research Professor, Environmental Health Sciences Center Oregon State University, Corvallis James James M. N. Witt, Ph.D. Professor, Department of Agricultural Chemistry Oregon State University, University, Corvallis Corvallis Logan A. Norris, Ph.D. Supervisory Research Chemist Pacific Northwest Forest and Range Experiment Station USDA Forest Service, Corvallis James E. Higgins, Ph.D. Assistant Professor, Department of Epidemiology and Statistics University of South Carolina, Columbia Alan Agresti, Ph.D. Associate Professor, Professor, Department Department of of Statistics Statistics University of Florida, Gainesville and Visting Associate Professor, Department of Statistics Oregon State State University, University, Corvallis Corvallis Oregon Meichoir Ortiz, Jr., Melchoir Jr., Ph.D. Ph.D. Assistant Professor, Department of Experimental Statistics New Mexico State University, University, Las Las Cruces Cruces October 25, 1979 ENVIRONMENTAL HEALTH SCIENCES CENTER Oregon State University Corvallis FORWARD Health is a very precious possession of the human. It should not be needlessly jeopardized but rather protected by every rational means. Increasingly, we have been concerned with chronic effects produced by environmental agents - physical, biological, and chemical. In recent years, much attention has been focused on chemical agents in the environment, particularly particularly the the man-made man-made chemicals chemicals that, that, by by one one means means or or another, find their way into the environment. The Environmental Health Sciences Center at Oregon State University, established over a decade ago, has as its primary mission the study of the toxicology of environmental chemicals in order to assess possible hazards and provide a basis for developing strategies to prevent these hazards. The Center, supported by Oregon State University and grants from the National Institute of Health, pursues this mission through research, training, and a number of other activities. From From time time to to time, time, special special problems problems arise calling for study and evaluation by interdisciplinary task forces. Such task forces bring their expertise to bear on the problem of collecting and analyzing the relevant information and then preparing a report for public use. For some years, the use of the herbicide 2,4,5-T has been under serious challenge by some segments of the public and the scientific community. Many studies using laboratory animals and doses above that experienced in in the the environment environment have have been been carried carried out out on on the the toxicology toxicology of of 2,4,5-T 2,4,5-T and its low level contaminant, TCDD. However, some some individuals individuals have have However, claimed to have suffered ill effects from exposure to 2,4,5-T in the environment. One such claim involving spontaneous abortions resulted in the Environmental Protection Agency "Alsea II Study." The results of this study played a prominent role in the Agency's decision to suspend the use of 2,4,5-T in forestry. AA number number of of individual individual scientists scientists and and groups, groups, not not only only in in this this country country but in other countries as well, challenge the study and its conclusion. Consequently, because of this sharp difference of opinion and the familiarity of staff staff members members and and associated associated investigators investigators of of the the Environmental Health Sciences Center with the area and the problem, it was felt that the Center should undertake its own independent study. Accordingly, an interdisciplinary task force to study this problem was formed. It was composed of Sheldon L. Wagner, M.D. (toxicologist); James M. Witt, Ph.D. (environmental toxicologist/hazard assessment); Logan A. Norris, Ph.D. (environmental chemist/forestry); James E. Higgins, Ph.D. (statistician); Alan Agresti, Ph.D. (statistician); and Melchoir Ortiz, Jr., Ph.D. (statistician). After detailed study, consultation with many colleagues and the development of new information, this task force prepared the following report. We believe that it adds substantive new information that would be of wide interest of those concerned with the problem. V. H. Freed, Ph.D. Director, Environmental Health Sciences Center Oregon State University 11 TABLE OF CONTENTS SUMMARY............................................................ STJMNARY............................................................ INTRODUCTION ....................................................... ....................................................... PART 1. THE THE DEVELOPMENT DEVELOPMENT AND AND COMPARISON COMPARISON OF OF THE THE HOSPITALIZED HOSPITALIZED SPONTANEOUS ABORTION INDICES ....................................... DESCRIPTION OF THE THREE AREAS INCLUDED IN THE ALSEA II STUDY......................................................... Description of the the Study Study Area Area ............................ ............................ Description of the the Control Control Area Area .......................... .......................... Description of the Urban Area ............................ 10 Comparisons Among the Three Areas ........................ 13 THE HOSPITALIZED SPONTANEOUS ABORTION (HSAb) DATA BASE ........ 14 The Hospitalized Spontaneous Abortion Index (HSAI) ....... 15 Medical Practice Profile ................................. 16 Physician Physician Distribution .............................. .............................. 16 16 Hospitalization Rate for HSAb Patients .............. 17 TheStudy The Study Area Area ................................. ................................. 17 The Urban Area Area ................................. ................................. 18 TheUrban The Control Area ............................... 19 COMPARISON OF HSAb, HSAI DATA ANONG AMONG AREAS ..................... 20 PART 2. SEASONAL SEASONAL CYCLIC CYCLIC PEAKS PEAKS IN IN THE THE HSAI HSAI ......................... ......................... 25 25 CYCLIC PEAKS .................................................. 25 THE JUNE PEAK ................................................. 27 PART 3. RELATION BETWEEN HSAI HSAI AND AND 2,4,5-T 2,4,5-T USE USE IN IN THE THE STUDY STUDY AREA... AREA 31 31 LENGTH LENGTH OF OF GESTATION GESTATION ........................................... ........................................... 31 31 2,4,5-T SPRAY DATA DATA ............................................ ............................................ 32 THE HSAI VERSUS 2,4,5-T SPRAY DATA ............................ 35 POTENTIAL POTENTIAL FOR FOR HUMAN HUMAN EXPOSURE EXPOSURE .................................. .................................. 39 39 CONCLUSIONS ........................................................ 43 APPENDIX 1 - Population Statistics ................................. ................................. 47 47 APPENDIX 2 - Hospitalized Spontaneous Abortion Statistics .......... 53 APPENDIX 3 - 2,4,5-T 2,4,5-T Use Use Statistics Statistics ................................ ................................ 75 75 iii A SCIENTIFIC CRITIQUE OF THE EPA ALSEA II REPORT-i' STUDY AND REPORT-' by Sheldon L. Wagner, James M. Witt, Logan A. Norris James E. Higgins, Alan Agresti, and Melchoir Meichoir Ortiz, Jr. SUMMARY In 1978, women living near Alsea, Oregon, a forested area in which 2,4,5trichlorophenoxyacetic acid (2,4,5T) is used seasonally, noted an 2,4,5trichiorophenoxyacetic apparent temporal relationship between their spontaneous abortions and the use of this herbicide on adjacent land. A twopart investigation of this incident was conducted by the U.S. Environmental Protection Agency (EPA). The first part (Alsea I) did not find a relationship between spraying and abortions. In the second part (Alsea II) EPA reported (a) the abortion rate was higher in the Study area than in either the Control or Urban area (b) there was a seasonal fourmonth cycle of - (c) abortions with an outstanding peak in June in the Study area and (c) there is a significant crosscorrelation between the spontaneous abortion index and the pattern of 2,4,5T use in the Study area. Our Aisea critique does not support any of the three conclusions from EPA's Alsea II study. This critique shdws that EPA reached erroneous conclusions from the Alsea Alsea II study because of: (1) failure to account for differences in the characteristics between the Study area and the Rural and Urban control spontaneous data on on spontaneous areas, (2) inaccuracies in the collection of data abortions, (3) failure to account for marked differences in the medical data on on 2,4,5T 2,4,5T practice among areas, (4) incomplete and inaccurate data magnitude of the monthly monthly use, use, and and (5) (5) failure failure to to recognize recognize that that the the magnitude contributions by by Scott Scott Overton, Overton, Ph.D., Ph.D., Professor, Professor, Department Department 'Inc1udes contributions !"Includes of Statistics, Oregon State University, Corvallis, Oregon. variations in rates of hospitalized spontaneous abortions (HSAb) in all three areas is no greater than would be expected due to random variations. When corrections for some of these problems are applied, we find the rate of spontaneous abortions in the Study area area does does not not appear appear to be related to the use of 2,4,5T. Retrospective studies studies such such as as the the Alsea Alsea II II study study are are exceedingly exceedingly difficult to conduct. The net effect of attempting a comparison among several poorly identified populations is to obscure the potentially significant data by the mass of other data containing no information. When poorly done, these studies confuse rather than clarify issues, Issues, in this case the risks from using agricultural chemicals in our country. The original contention of the women from Alsea, Aisea, Oregon, namely that there is a relationship between herbicide use and miscarriages, is not supported by the data in EPA's Alsea II Report. INTRODUCTION Controversy, both technical and philosophical, has surrounded the use of 2,4,5T in in forestry forestry since since the the late late 1960's. 196Os. It was was heightened heightened by by (1) (I) the the It use of of "Agent "Agent Orange" Orange" (a (a herbicide herbicide formulation formulation containing containing 2,4,5T) in use Vietnam and (2) the discovery that 2,4,5T contained the highly toxic trace contaminant, 2,3,7,8tetrachlorodibenzopdioxin (TCDD). In 1978, EPA issued a Rebuttable Presumption Against Registration of 2,4,5T as provided for in the Federal Insecticide, Fungicide, and Rodenticide Act as amended. EPA stated that pesticide products containing 2,4,5T and/or TCDD could produce oncogenic or other toxic effects (including reproductive effects) in laboratory species and therefore presumably could do so in humans. humans. In July, 1978, EPA began an investigation into a possible cause/effect relationship between spontaneous abortions in humans and the use of 2,4,5T on forests forests in in the the Alsea Alsea area area of of western western Oregon. Oregon. The investigation was precipitated by a letter signed by eight women living in the area who felt there was a temporal relationship between miscarriages and forest spraying between May 1973 and March 1978. The The investigation was conducted by the EPA Office of Pesticide Programs, Benefits and Field Studies Division, Human Effects Monitoring Branch, Epidemiologic Studies Program. It was divided into two phases. The first phase, called Alsea I, was conducted by (1) (I) having the women who raised the issue complete a lengthy health questionnaire, (2) determining the amount and timing of 2,4,5T use in the 400 squaremile Alsea Basin, and (3) having the data reviewed by 10 Universitybased obstetricians and/or clinical epidemiologists. The reviewers unanimously concluded there was no cause/effect relationship between the miscarriages noted by the women and the use of 2,4,5T and "that there was no real evidence of an epidemic based on the data presented." Several, however, commented that most of the abortions in this sample occurred in the spring, and EPA staff noted a possible temporal relationship between the miscarriages described by these women and the application of 2,4,5T in the spring. P The second phase, called Alsea II, was initiated in October 1978. It was to investigate the possible relationship between spontaneous abortions within the first 20 weeks of gestation and the use of 2,4,5T over a substantially larger geographic area and population base than that included in the Alsea I study. The Alsea II study is an observationalretrospective study of spontaneous abortions and the use of 2,4,5T in forest spraying. Most ecological and sociological data come from observational studies, in which experimental controls cannot be exercised. The mechanics of analysis of such data may be the same as that of formal experiments, but the inferences are substantially different, as are many of the associated methods and protocol. For example, associations may be proven from observational data, but causality of an observed association may be inferred only by assumption. In such cases all possible alternate explanations of the association must be examined. If they can be rejected the explanation by causality is more tenable, but it stil.l is not proven. It is proper to use observational, studies to pose hypotheses, and to express the results only in terms of the identified associations. Retrospective studies require a greater subjective element in the analysis and greater ingenuity and insight on the part of the investigator. Analysis of experimental, data is dictated by the design of the experiment; analysis of data from retrospective studies is guided by the perspective of the system being studied. Review and interaction with peers is an important part of observational studies. The Alsea II study suffers serious shortcomings in both these regards. Alsea II is not only a retrospective study, it is comparative in that data on spontaneous abortions in one area were compared with similar data from other areas. A basic assumption in any comparative study is that those data being compared are either comparable directly or are adjusted on on aa rational, rational basis basis to to make make them them comparable. Three kinds of data were collected by EPA for use in the Alsea II study. They are: 1. HospItalized spontaneous abortions following no more than 20 Hospitalized weeks of gestation. 2. Live Live births occurring in the same area. area. 3. The timing and magnitude of the use of 2,4,5T in the Alsea Aisea Basin Basin portion portion of of the the Study Study area. area. uses of of each each of of these these data data and and how how they they were were analyzed analyzed The sources and uses are examined in later parts of this critique. The Alsea II study covered the time period 1972-1977, and an area of approximately approxImately 1600 1600 square square miles miles including including all all of of the the area area in in the the Alsea Alsea II study. This was called the Study area. area were also included for comparison. A rural Control and an Urban At the conclusion conclusion of of the the Alsea Alsea II study, the results were given in "Report of Assessment of a Field Investigation of SixYear Spontaneous Abortion Rates in Three Oregon Areas in Relation to Forest 2,4,5T Spray Practices" dated February 27, 1979 (Alsea II Report). 1. I. In this report, EPA concluded: The 1972-1977 abortion rate index was significantly higher in In the Alsea II Study area than in either a rural Control or a nearby nearby Urban area. 2. There was a statistically significant seasonal cycle in the abortion index in each of the areas with a period of about 4 months. In particular, there was an outstanding peak in June in the Study area. 3. There was a statistically significant crosscorrelation between the spontaneous abortion index in the Study area and the pounds of 2,4,5T applied by months in the Alsea basin, 1972-1977, after aa lag lag time time of of two two to to three three months. months. The results of the Alsea II study added substantially to the controversy regarding the use of 2,4,5T in forestry. It was an important factor in the EPA decision to issue an emergency suspension of the uses of 2,4,5T in forests, pastures, and rightsofway in the United States. The purpose of this critique is to examine the methods, data, assumptions, and analysis of the data in the Alsea II Report to determine if there is an adequate basis for the conclusions reported by EPA. This critique has three major parts, one for each of the EPA conclusions: Part 1 reviews the areas studied and the hospitalized spontaneous abortion indices (HSAI) (HSAI) to to determine determine if if differences differences in in the the indices indices among geographic areas can be detected based on the methods and data in the study. study. Part 2 examines the HSAI for the various areas for cyclic trends with particular attention to the reported June peak in the Study area. Part 3 examines the pattern of 2,4,5T use in the Study area to determine if there is a relationship between either the amount or timing of timing of the the use use of of 2,4,5.-T 2,4,5T and and the the HSAI HSAI in in the the Study area. area. Appendices which include both basic data and data analysis are provided for the reader who who wishes wishes to to pursue pursue certain certain aspects aspects of of this this critique critique in in more detail. These appendices include the basic data collected by EPA on hospitalized spontaneous abortions (HSAb) by month and year for each area. These data were not included in the Alsea II Report, but are essential for the reader wishing to independently evaluate the EPA conclusions. We also include more accurate and more complete demographic and 2,4,5T use data than that reported by EPA in the Alsea II Report. For the convenience of readers wishing to carry out independent data analyses involving the abortion rate, we have included the necessary EPA data on live births from the Alsea II report. Since this data was inaccurate, we have also included live birth data collected by EPA after the Alsea II Report was prepared. PART 1. THE DEVELOPMENT AND COMPARISON OF THE HOSPITALIZED ThE SPONTANEOUS SPONTANEOUS ABORTION ABORTION INDICES INDICES DESCRIPTIONS OF THE THREE AREAS INCLUDED IN THE ALSEA II STUDY The study was conducted in three areas identified as the Study area, the EPA concluded that that the the Study Study area area and and Control area, and the Urban area. the Control Control area area were were similiar. similiar. the They included an Urban area as an additional unit for comparison. The Urban area was not specified as a control, but it was utilized for that purpose. DESCRIPTION OF STUDY AREA The Study area in Alsea II was intended to represent an enlarged version of the Alsea I study area. It includes 1600 square miles of mostly 20 deeply dissected, heavily forested, mountain land which encompasses 20 postal zip code areas areas (Figure (Figure 1). 1). included. All of the Alsea I study area is The The western western boundary boundary is is the the Pacific Pacific Ocean. Ocean. The terrain level, however, humans live ranges ranges up up to to more more than than 4037 4037 feet feet above above sea sea level, almost exclusively along the coast or in canyon bottoms along streams at elevations of less than 750 feet. Climatologically the study area is cool and moist with a mean annual high and low temperature of 49°F and 36°F for January and 66°F and 51°F for July. The The mean annual precipitation is 75 75 inches. inches. Most of the precipitation falls as rain between October and May. The image of homesteads scattered through the Study area conveyed to some some by by the the Alsea Alsea II II Report Report is is misleading. misleading. Although the Alsea Alsea II II Report characterized the Study area as "predominantly rural," the population population data data we we assembled assembled reveal reveal aa different different picture picture (Appendix (Appendix I, I, Tables 1 and 2). The Study area was characterized by EPA as containing 16,150 16,150 persons persons in in urban urban settings. settings. More accurate population estimates in rural 19,000 in show that there are 34,000 persons in urban settings and 19,000 settings in the Study area. The The human human population population in in the the Study Study area area is is I c .. g?34 ... rJ çt --- ,1 - / 4 \ , 9'24 -.-----'.. -. ..... k-s' / Figure area. Figure 1--The 1--The Study Study area. FLNC I r 9a 9131 qT3Gb 9?34I --k,1,ni r.. L_ 02 46 I 97310 (_ I £) _) STUDY /IPE/ Figure 2--The Figure 2--The Control Control area. area. AL51A II STUOT AL51* RURAL CONTROL AREA concentrated in four urban centers (Florence, Waldport, Newport, and Lincoln City) which front on the Pacific Ocean. Residents served by by the the four zip codes of these coastal communities account for 2/3 of the population of the Study area. The coastal population predominates over the inland population population (35,000 (35,000 to to 18,000). 18,000). In terms of population (but the Study Study area area should should be characterized as an not geography), not geography) , the urban/coastal area rather than a rural/forest area. The The potential potential for for exposure of coastal residents to 2,4,5T from forest spraying is substantially different than for individuals living in the heavily forested, forested, interior interior portions portions of of the the Study Study area. area. Business in the coastal area is concentrated in tourism and fishing rather than forestry. Because of tourism, the population of the coastal portion of the Study area increases (at least doubles) during the summer months. DESCRIPTION OF THE CONTROL AREA The Control area is Is located in Malheur County, adjacent to the Idaho Oregon border, approximately 400 miles east of the Study area (Figure 2). The EPA described the Control area area as as being being topographically topographically similar similar to the Study area, area, being being of of similar similar elevation elevation and, and, although although not not rolling mountainous, having having rugged rugged terrain terrain comprised comprised of of escarpments, escarpments, rolling hills, arroyos, and canyons; covering approximately 1,000 square miles and consisting of 90% rangeland and sagebrush; cropland accounts for a small but important important percentage percentage of of the the area area along along stream stream and and river river courses. The The EPA EPA description description is Is reasonably reasonably accurate accurate for for Malheur Malheur County County as a whole, but it is not accurate for the area designated as the rural ContrQl area (the area served by zip codes 97914, 97913, 97918, 97906). Control The Control area is, in fact, that portion described by EPA as a small but important Important area of cropland along stream and river courses. The The control area area is is flat, flat, intensively intensively cultivated, cultivated, lies lies along along the the Malheur, Malheur, control Owyhee, or Snake Rivers, RIvers, consists of about 350 square miles, and is about 85% cultivated land. Only Only incidental incidental amounts amounts of of escarpments, escarpments, code zones. arroyos, and sagebrush are included in the zip code The The zip code zones include homes receiving mail service, and there are very few, if any, homes outside the area of irrigated cropland. Domestic water supplies are lacking on the rugged, sagebrush covered land adjacent to the cultivated, irrigated areas. feet. feet. Elevations range from 2,100 to 2,500 The area has cold dry winters, and hot dry summers. The mean high and low temperatures are 36°F and 19°F in January and 92°F and 57°F in July. Mean annual precipitation is 10 inches. The human population in the Control area was characterized in the Alsea II Report as 13,000 persons in three urban centers. No figures were given for the rural population, even though one of the reasons reasons EPA EPA selected this area as the Control area was that they believed it was primarily rural. Our estimate is that there are 16,500 persons living in urban settings and 6,000 in rural settings (Appendix I, Tables 1 I and 3). DESCRIPTION OF THE URBAN AREA The Urban area is adjacent to the eastern boundary of the Study area (Figure 3). The mean high and low temperatures are 45°F and 34°F in January and 82°F and 52°F in July. inches. Mean annual precipitation is 40 It includes the city of Corvallis and adjacent areas in zip code 97330 which is largely in Benton County, but includes as as well well aa small part of Linn County. code 97321 (Albany). The Urban area also includes some of zip How much of 97321 is included is not known. The map of the Urban area in the Alsea II Report appears to include only those parts of zip codes 97321 and 97330 which are in Benton County. This would include North Albany, a small unincorporated suburb of Albany in Benton County but would exclude all of the city of Albany and that that portion of zip code 97330 in Linn County. Only data from Good Samaritan Hospital in Corvallis were used for the Urban area. Almost all residents of 97330 would use this hospital, but only a few individuals from 97321 would be included because most would use the Albany General Hospital which was not included in the study. The use of a small but unidentified segment of the population from zip zip 10 11 code area 97321 (Albany) has the result of making it impossible to accurately define the Urban area either demographically or geographically (and provides no apparent benefit in the collection of the HSAb data). The The Alsea Alsea II II study study also also appears appears to to have have excluded excluded Oregon Oregon State State University University students students housed housed in in dormitories dormitories which which use use zip zip code code 97332 97332 in in Corvallis. Corvallis. The exclusion of this zip code may not be significant, however, since the Medical Records Department at Good Samaritan Hospital also ignores that zip code and uses 97330 for all, patients with an address in the ci-ty of city of Corvallis. Corvallis. The impact of Oregon Oregon State State University University upon upon the the Urban Urban area area was was not not discussed (and presumably, therefore, not considered) in the Alsea II Report. Population levels of both students and townspeople fluctuate considerably during considerably during the the year, year, with with aa substantial substantialdecrease decreaseininthe thesumnier summer months. &ur population estimates (Appendix I, Tables I and 3) for the Urban area Our area show show 46,310 46,310 persons persons in in urban urban settings settings and and 5,229 5,229 persons persons (lI7) (lI7) in in rural rural settings in zip code 97330 (Corvallis). Our figure for the Urban area is too small because because the the persons persons from from Albany Albany zip zip code code 97321 97321 using using the the Corvallis hospital represent an unknown proportion of that population. On the other hand, a sum of the Corvallis and Albany populations would exaggerate the size of the Urban area population. This make it impossible to precise1y precisely define the size of the population of the Urban area. In contrast to the impression conveyed by the Alsea II Report, the population population of of the the Study Study area area (53,463) (53,463) is is about about the the same the same as for the Urban area (51,539, urban and rural components of Corvallis population only). According to the Alsea II Report, the investigators recognized at least some facets of the limited utility of the data collected from the Urban area. However, these limitations were disregarded in the analysis and discussion of the data, and in some cases data from the Urban and 12 Control areas were combined in making comparisons with data from the Study area. COMPARISONS A1{ONG AJ(ONG THE THREE AREAS In considering the three areas included in the Alsea II study, we find substantive differences in their climatic, topographic, demographic, ethnic, and economic factors, and their cultural, industrial, and agricultural practices. We believe these factors were not considered as important in the Alsea II Report because they were not discussed. These factors are important because they influence the character of the human populations examined. Neither the Study nor the Control areas have predominantly rural populations as described by the Alsea II Report. Report. More importantly, their rural components are not comparable. The principal valid point noted by EPA is that little or no 2,4,5T was used in the Control area between 1972 and 1977. in We believe there are real differences in life styles, particularly in the rural populations, populations, among among areas. areas. These may be reflected in different attitudes, attitudes, social social mores, mores, food food usage, usage, shelter, shelter, and and living living conditions. conditions. These differences are likely to affect reproductive success and could result in misleading conclusions about these populations from the study of reproductive statistics. THE HOSPITALIZED SPONTANEOUS ABORTION (HSAb) DATA BASE The true number of spontaneous abortions in a large human population is difficult to determine because many are not detected medically and others are handled in outpatient facilities where records are less easily retrievable. The data on hospitalized spontaneous abortions were collected only from inpatient records in seven hospitals, four in the Study area, two in the Control area, and one in the Urban area. Patients were assigned to a particular area based on the zip code of their residence, not the hospital in which they were treated. Thus, data on patients from the Study area who were treated in the Urban area hospital by Urban area physicians were, in fact, included in the Study area data base. Statistics on spontaneous abortions from different areas or time periods are difficult to compare because the number of abortions which occur and which are reported vary with the level of medical practice for the area, the number of pregnancies, and a wide range of social, economic, and biologic factors. The ages of the patients included in the study illustrate the variability of some of these factors. Table 8 of the Alsea II Report lists hospitalized spontaneous abortion cases for the Study, Urban, and Control areas by the age groups of the patients. There is a disproportionate number of spontaneous abortion cases occurring in the Study area for patients in the age group of 10-19 years. This age group of patients constitute 21.8%, 6.7%, and 12.8% of all patients from the Study, Urban, and Control areas, respectively. This difference in age groups is not accounted for in the analyses which compare the data from the three areas. If there is a larger number of individuals in the young age group in the study area, then an elevation of the HSAI in the Study area would have greater meaning than a similar increase in the Urban or Control areas because a younger age group should have fewer abortions. The relatively large number of 10 to 19year old mothers in the Study area may also reflect different cultural mores or socioeconomic factors, e.g., the population in the Study area may tend to marry at a 14 younger age. The marriage rate may increase during the early summer months following high school graduation. Residents in the Study area have a lower average income compared to the Urban area in particular. socloeconomic groups have higher rates of spontaneous abortion. Lower socioeconomic This variable, and other factors needing study, may be important. THE HOSPITALIZED SPONTANEOUS ABORTIONINDEX INDEX (HSAI) (HSAI) SPONTANEOUS ABORTION EPA devised a Hospitalized Spontaneous Abortion Index (HSAI) as a relative measure of the spontaneous abortions which occurred in each of the three areas included in this study. This index is the ratio of the number of hospitalized spontaneous abortions (HSAb) to the weighted average of the number of live births, multiplied by 1,000 (HSAb is defined by EPA as as occurring occurring at at less less than than 20 20 weeks weeks gestation, gestation, but but it it appears that in the study the 20th week was included). More specifically: 1. 1. The numerator nwnerator is the number of hospitalized spontaneous abortions of 20 weeks gestation or less from a particular area (based on patient patient zip codes). The data was collected only from patient records from each of the seven hospitals in the study for each month during the years 1972 through 1977. Data Data on on spontaneous spontaneous abortion abortion patients patients treated treated in in hospital hospital emergency emergency rooms, rooms, clinics, clinics, or or physician offices were excluded from the study. The single exception exception was was the the emergency emergency room room records records from from the the Toledo, Toledo, Oregon, Oregon, hospital. Here, Here, both both outpatient outpatient and and inpatient inpatient records records were were included. included. 2. The denominator is a fivemonth movingaverage of the live births derived from Oregon State Health Division vital vita' statistics and birth birth data data for for what what was was believed believed to to be be the the same same area area and and period period of of time. Knowing the source and meaning of the data used for calculating the HSAI is extremely important in determining if the comparisons EPA attempted 15 It appears the number of in the Alsea II Report can logically be made. HSAb's were counted correctly, but they were not adjusted for differences in medical practice among areas. in the Alsea II Report is Is incorrect. The live birth data used We have included the live birth data used in the Alsea II Report and an example of a set of corrected data compiled by EPA after the Alsea II Report was released (Appendix 2, Tables Ia, ib, and and 2). 2). MEDICAL PRACTICE PROFILE In order to conduct an epidemiological study of hospitalized spontaneous abortions it is necessary to consider variations in medical practice within each area if comparisons among areas are to be made. Some differences were recognized by EPA investigators, several others were not. Errors associated with erroneous assumptions and unperceived differences in medical practice seriously complicate both the data and their analysis. Physician Distribution The Aisea Alsea II report report infers infers the the populations populations of of each each area area are are served served exclusively or largely by physicians that practice within that area. A medical profile of the Urban and Study areas performed in 1974 by the Comprehensive Health Planning Agency (now Western Oregon Health Systems Agency), Oregon Oregon District District 4, 4, shows shows this this was was not not the the case. case. Agency), The latter report demonstrated that 50% of all obstetrical care in western Benton County and in Lincoln County was performed by physicians in the Urban area, i.e., Corvallis. Corvallis. According to the Alsea II Report, EPA assumed that the medical care in the Control and Study areas were essentially identical. This assumption is based on the investigators understanding that 'both areas are predominantly rural and therefore similar. In fact, neither area area is is predominantly rural in terms of the human population studied. 16 16 The Study area has a shortage of physicians. The western part of Benton County was an area of physician shortage, and two physicians began practicing there after 1977 under the National Health Services Act. In the remainder of the Study area, there are a total of 39 physicians, including both general practitioners and specialists. In the Control area, by contrast, the Oregon Medical Association Directory lists a total of 60 60 physicians. physicians. Based on Census Bureau statistics, there are substantially fewer doctors in the Study area (1 (I doctor per 1,370 persons) than in the Contro1 Control area (I doctor per 378 persons) on a per capita basis. This apparent shortage of doctors is less real than the physician per capita analysis suggests because a high percentage of the medical care in the Study area is delivered in the Urban area. Nevertheless, a substantially different level of medical care is delivered in In these two areas, a factor likely to influence the level of prenatal care and the number of spontaneous abortion patients hospitalized, hospitalized, and, and, therefore, therefore, the the number number counted counted in in this this study. study. Hospitalization Rate for HSAb Patients Hospital records account for only a portion of the spontaneous abortion patients seen by physicians. EPA used physician interviews to estimate the proportion of spontaneous abortion patients that are hospitalized and would therefore be counted in the Alsea II study. We have not been able to corroborate the results of the EPA physician interviews and believe they they are are in in substantial substantial error. error. believe The Study Area The Alsea II Report states "in the study area, 19 of 27 (70%) of the physicians--all general practitioners--were contacted." are only 17 general practitioners in the Study area. In fact, there We contacted nine of of them, them, all all of of whom whom have have now, now, or or have have had had in in the the past, past, aa large large obstetrical practice. practice. with EPA investigators. Only four recall an interview (one via telephone) The interviews must have been brief, and it is likely the physicians did not understand and study fully the questions put to them. 17 Based upon these interviews, EPA reached the conclusion that the medical practice profile in in the the Study Study area area would would be be to to hospitalize hospitalize 70% 70% of of patients who are undergoing a spontaneous abortion. Of the nine general practitioners we contacted in the Study area, only three estimated that they hospitalize 70% of all spontaneous abortion patients; the hospitalization rate estimated by six others ranges from 25 to 50%. The hospitalization rate of spontaneous abortion patients from the Study area is further confounded because, as noted earlier, physicians, principally the practicing obstetricians, in the Urban area handled 50% of the obstetrical care for the Study area during the study period. This would likely likely include include those those same same patients patients undergoing undergoing aa spontaneous spontaneous abortion as well. The obstetricians in the Urban area estimate only a 10% hospitalization hospitalization rate rate because because the the majority majority of of this this medical medical practice practice is handled in the the Good Good Samaritan Samaritan Hospital Hospital emergency emergency room room or or the the physician's office. Thus, 90% of these abortions would not be counted in the EPA study. study. The incompleteness of the HSAb data base for the Study area is illustrated illustrated by by comparing comparing the the Alsea Alsea II and and Alsea Alsea II II studies. studies. The Alsea I study dealt with 13 medically confirmed abortions, Il 11 of which occurred within the first 20 weeks of gestation in the years covered by the Alsea II Report. Of these 11, only 3 appeared in the hospital records used in the Alsea II study. The assumed hospitalization hospitalization rate rate of of 70% 70% for for spontaneous abortion patients from the Study area (as indicated in the Alsea II Report) is substantially incorrect. The Urban Area In the Urban area, the Alsea II Report estimates 30% of all spontaneous abortion patients were hospitalized. This is based on the assumption that 70% of all spontaneous abortions seen by general practitioners are hospitalized while 10% of the cases seen by obstetricians are hospitalized. The estimated 70% 70% hospitalization hospitalization rate rate for for cases cases seen seen by by general practitioners was (according to the Alsea II Report) based on is interviews with five general practitioners out of what EPA believed to be a total population of 24 general practitioners. During the study period, the number of general practitioners in the Urban area ranged between five and eight people, not all of whom had an obstetrics practice. There were only six fulltime general practitioners, only one of whom engaged in the practice of obstetrics in the Urban area at the time of the investigation. EPA's assumption of 24 fulltime general practitioners in the Urban area, all of whom practice obstetrics, introduces 30% hospitalization an important error into the weighted estimate of 30% rate for the Urban area that they derived. We contacted every general practitioner in the Corvallis portion of the Urban area regarding the EPA interviews. Only one recalled any type of interview with investigators from the EPA team. This particular physician does not have an obstetrics practice. In our interview, the one general practitioner in Corvallis with a large obstetrics practice estimated 25% of the spontaneous abortion patients he sees are actually hospitalized. The hospitalization rate of 30% for spontaneous abortion patients from the Urban area is substantially incorrect. The Control Area The EPA investigators made an assumption that medical practice in the Control area was similiar to the Study area. all were conducted by EPA. No physician interviews at We contacted three physicians who have a large obstetrics practice in the Control area. One estimated 70% of all spontaneous abortion patients are hospitalized, the other two estimated a 50% hospitalization rate. 19 COMPARISON OF HSAb AND HSAI DATA AMONG AREAS The Alsea II Report showed graphs of the HSAI. The HSAI is derived from the actual number of hospitalized spontaneous abortions, but is expanded to a common base of 1,000 live births. This is a reasonable analytical approach, but it does not accurately convey to the reader the magnitude of the events actually measured. The image conveyed conveyed to to some some readers readers by by the Alsea II Report, i.e., that 40 or 50 abortions occurred in the late spring in the Study area, is misleading. The mean of the actual number of hospitalized spontaneous abortions per month are 2.6, 2.4, and 1.5 for the Study, Urban, and Control areas areas (Appendix (Appendix 2, 2, Table Table 33 and and Figures Figures 1 to 3). We have included in Appendix 2 HSAb data compiled by area, zip code, month, and year (Appendix 2, Tables 4 to 11). Similarly, the image is conveyed by the Alsea II Report that the spontaneous abortion rate is much higher in the Study area than in the Control area. In fact, the overall ratio of HSAb/live births in the Study area (188/2,334) is only 22.6% higher than the corresponding ratio in the Control area (109/1,666), and this is not a large enough difference at these sample sizes to be statistically significant (based on analysis of the odds ratio). the HSAI, HSAI, month month by by A comparison of the month, reveals that the Study area had the higher value in 42 months and the Control area had the higher value in 30 months. The proportion (42/72) of months is not not months in in which which the the Study Study area area had had the the larger larger }ISAI HSAI is (according to the "sign" test) significantly different from 0.5, the proportion corresponding to the same random variation of HSAI's in the two areas. two The conclusion in the Alsea II report that the HSAI in the Study area is higher than the Control area is based on an analysis of variance of HSAI by period, area, and month. That analysis is invalid, however, due to the inclusion of "Urban" as one of the area categories. The Alsea II Report states that the magnitude of the HSAI values for the Urban area are not comparable to Study and Control area HSAI's due to the more frequent handling handling of of spontaneous spontaneous abortions abortions in in clinics clinics in in the the Urban Urban area. area. frequent 20 Nevertheless, these values for the Urban area were used in the analysis of variance, resulting in a highly inflated sum of squares (and Fvalue) for "areas." The nimber number of hospitalized spontaneous abortions were determined from data collected exclusively from records for inpatients hospitalized from from the the seven seven hospitals hospitals within within the the three three areas areas included included in in this this study. study. We do believe the actual numbers determined by EPA in this study are correct; that is, is, they they are are the the number number of of hospitalized hospitalized spontaneous spontaneous abortions of 20 weeks gestation or less which occurred in the hospitals included in the study. However, we believe a number of corrections to the data need to be made before they can be used as a guide to the true number of spontaneous abortions occurring in each of the three areas and Some of these before before the the data data from from the the three three areas areas can can be be compared. compared. corrections must account account for: for: a. Differences in the age distribution of the populations b. Differences in the rates of hospitalization of spontaneous abortion patients as reflected by physician interviews. The degree to which health care in the Study area is confounded by health care provided by physicians from the Urban area. The effect of failing to make these corrections can easily be illustrated using the data from the Alsea II Report. According to that report, there were 188 hospitalized spontaneous abortions recorded for patients patients from from the the Study Study area area and and 180 180 in in the the Urban Urban area. area. These numbers reflect (according Report) aa 70% 70% and and aa 30% 30% (according to to the the Alsea Alsea lit II Report) hospitalization rate respectively. Logically, before these numbers can be compared (or used for computing a hospitalized spontaneous abortion index) they must be adjusted to a common hospitalization rate. Failure to do so results in a substantial underestimate of the number of abortions in In the Urban area compared to the Study area. Using the 2.3) (70%/30% = 2.3) uncorrected EPA data, the HSAI should be about 2.3 times (70%130% 21 higher in the Study area than in the Urban area. If EPA had corrected the HSAb data for these differences in hospitalization rate, they would have found the HSAI is higher in the Urban area than in the Study area area (Appendix 2, Table Table 12). 12). comparable basis. basis. Clearly the basic data must be adjusted to a Failure Failure to to do do so so means means the the HSAb HSAb data data represents represents aa different percentage of the total number of abortions in one area than in another. When the data are corrected to a common hospitalization rate (100%) and the total number of hospitalized spontaneous abortions are expressed as a percentage of live births, the values are: Study area 11.4% Urban area 14.0% Control area 9.3% 9.3% In the United States, the common range of values is 15-25%. It should be kept in mind that statistical comparisons of HSAI in the Study and Control areas is based on the unverifiable and possibly unjustified assumption that the rates of hospitalization of spontaneous abortion abortion patients patients are are identical identical in in the the two two regions. regions. The more in error this assumption is, the more biased the results will be. Suppose, for Suppose, example, that there is actually a 70% hospitalization rate in the Study area and a 40% hospitalization rate In in the Control area. The actual ratio of HSAb/live births would have been 42.7% higher in the Control area than the Study area, a statistically significant higher rate (in terms of the odds ratio). Comparisons made at a finer level of aggregation (in time or space) would similarly be affected. It is possible that differences In in hospitalization hospitalization rates rates introduce introduce measurement measurement error into the analysis of such a magnitude magnitude as as to to make make meaningless meaningless attempts to compare HSAI in these areas using finelytuned statistical procedures. Based on the discussion discussion above, above, it it is is clear clear that that the the hospitalized hospitalized spontaneous abortion indices in the Alsea II Report are in substantial error and the basic data are not comparable among areas because (I) 22 22 there are differences in the areas and populations studied and (2) data for hospitalized spontaneous abortions collected on the basis of zip codes represent different percentages of the total number of abortions in each area. We conclude: The basic data collected in the Alsea II study are not comparable and therefore are not adequate for determining if differences exist among the hospitalized spontaneous abortion indices for the three areas included in this study. 23 SEASONAL CYCLIC PEAKS IN THE HSAI PART 2. The Alsea II report concluded there was a significant seasonal cycle in the HSAI in each area with a period of about four months. In particular, they noted an outstanding peak in June in the Study area. CYCLIC PEAKS A relatively wide range of variation is common in biological systems and occurs in the frequency I. frequency of of spontaneous spontaneous abortions abortions in in humans humans as as wel well. EPA noted ticyclic trends" in in the the monthly monthly HSAI HSAI based on sixyear cumulative "cyclic trends" cumulative data. We believe these cyclic peaks should be repeated annually if they are real. The use of sixyear composite monthly means reduces the sensitivity of the analysis and there is the possibility that a greater thanexpected abortion rate for month X in one year will "match" an unusual spray application in month X in another year. The HSAb data in the Alsea II Report was presented only as the total number of abortions over the sixyear period by month. This summation prevented readers from evaluating the variation within the data which is essential for determining whether or not a particular excursion is an abnormal event or merely a part of the normal variation. Unless a particular particular event event is is an an abnormal abnormal deviation, deviation, no no meaningful meaningful correlations correlations with possible causal agents are possible. We compiled the HSAb and HSAI data by month by year (Appendix 2, Table 13 to 15 and Figures 1 to 3). These data show substantial variation in the timing of peak HSAb or HSAI among years with regard to both the existence of peaks and the cyclic nature of their occurrence. We analyzed the data for cyclic trends by computing autocorrelations of various lags for the 72 monthly HSAI values from each of the three areas. No significant cycling was detected. Thus, there is insufficient evidence to warrant the sine wave model used by EPA in the Alsea II Report. 25 We plotted the monthly HSAI for each of the six sIx years for each of the three areas (Appendix 2, Figure 4 to 6). The The variation variation in in HSAI HSAI in in any any one month month over over the the six-year sixyear period period is is so so large large that a hypothesis hypothesis of of seasonal cyclic peaks is tenuous and of doubtful biological significance. To examine whether the frequency of HSAb's was unusually high (or low) in certain certain months, months, we we conducted conducted aa chi-square chisquare goodness of fit fit test test of of the null hypothesis of a uniform distribution of HSAb's across the 72 months. Data from the Study Study and and Control Control areas areas show show no no evidence evidence of of nonnon uniformity, i.e., there are no peaks which are unaccounted for by sampling error from a uniform probability distribution. The uniform distribution does not adequately model the data from the Urban area. EPA reached the same conclusion, but they used only 12 data points rather than 72. The results are not not significantly significantly altered altered by by adjusting adjusting the theoretical proportions proportions (1/72) (1/72) to to account account for for differential differential month month lengths lengths or or differences differences in in birth birth rate rate between between months months within within areas. areas. The expression of the data as HSAI rather than HSAb added to the impression received by many readers that cyclic peaks existed. For For instance, in the Control area the actual number of hospitalized spontaneous abortions recorded averaged 1.5 per month and ranged from 0 to 6 in any one month. Out of the 72 months in the study period, only 2 months had more than four hospitalized spontaneous abortions recorded. This means that in 70 months, the only numbers recorded were 0, or 4. 1, 2, 3, If a I is recorded in March and a 3 is recorded in April, it appears, graphically, to be a peak, particularly when it is expressed as HSAI. In the Control area, I HSAb = an HSAI of about 45. Thus the change in HSAb from March to April in this example corresponds to an increase in HSAI of of 90, 90, giving giving the the distinct distinct impression impression of of aa tpeaklt "peak" particularly if I or 2 HSAb's (the most likely values if the mean is 1.5) occur in June. This concept is illustrated in Appendix 2, Figures 1 to 3. lto3. 26 THE JUNE PEAK The "June peak" in the Study area needs special attention for two reasons: (1) EPA attached special significance to it and the use of 2,4,5T in the Study Area and, more importantly, (2) it illustrates clearly the likelihood of reaching an erroneous conclusion because of reliance on highly variable data. The "June "June peakt' peak" in in the the study study area is an HSAI of 130.4 (based on cumulative data for six years). This "peak" represenis represenls 24 hospitalized spontaneous abortions detected in June in the Study area in the sixyear study period. While Lit it is variety of of is vital vital to to test test data data for for significance significance by a variety appropriate statistical procedures, it is equally important to examine the actual or untransformed data. I. Examination of this data reveals: The magnitude of the "June Peak" in the study area represents, on the average, an increase of 1.4 abortions each June compared to the mean of 2.6 for all months. 2. The peak resulted from a substantial increase in abortions which occurred occurred in in only only one one year year -- 1976. 1976. which 3. Each of the three areas studied have a peak of HSAB of similar relative magnitude for at least one month of the sixyear periods (Table 1). I). 27 Table Table 1--Peak i--Peak monthly monthly HSAb HSAb data.-!! data..!! Year Study area (June) Control area (September) Urban area (January) 1972 3 11 88 1973 3 6 5 1974 3 2 3 1975 2 2 2 1976 1976 10 0 5 1977 3 1 2 Mean for this month 4.0 4.0 2.0 4.2 Mean for all months months 2.6 1.5 2.4 Peak as % of mean for all months 385 385 400 333 !"Underlined value in each column is the largest single HSAb value for each area. Averaging the June data in the Alsea II Report gives the impression the period increase occurred throughout the study period. f act that fact that it it occurred occurred only only once in June June 1976. 1976. It misrepresents the If we assume that any month is equally likely to display the maximum HSAI and that the number of times that the maximum HSAI appears in June follows a binomial distribution, then the probability of observing a maximum HSAI in at least one June in six years is about 0.41. That is, it is not an unusual occurrence to find a June peak in one of of the the six six years. years. The occurrence of the "June peak" in the Study area is critical, to to two two of the three conclusions reached by EPA in the Aisea II Report. Without the June 1976 abortion data, the Study area no longer shows three distinct peaks in the HSAI, thereby making attempts to "align" the data from from the the Study Study area area with with the the data data from from the the other other two two areas futile. The The third EPA conclusion concerning correlation with 2,4,5T use is also strongly dependent on the June peak. This conclusion is evaluated in Part 3, below. 28 28 Despite the weakness of the "cyclic trends," the investigators shifted the time scale of the HSAI for the various areas to "align" the cycles seemed to occur when the data are presented as sixyear cumulative which 8eemed values. The purpose of alignment alignment was was to to permit permit comparison comparison of of the the magntude magnitude of of monthly monthly HSAI HSAI between between areas. EPA used a "cross correlation" analysis of the differences between the two two series series and and the the program program of of herbicide herbicide application application in in the the Study Study area. area. Phase shifting or aligning the two index series before taking The The nominal nominal rationale rationale is is clear; clear; if if the the two two differences is questionable. series have different different underlying under'ying structures, structures, with with an an additive additive effect effect of of the "treatment," then a more sensitive analysis of the treatment effect can be obtained by subtracting the underlying structure from each series. But in the presence of a treatment effect, the structure is "underlying't modified by that effect, and one cannot easily take out the "underlying" the structure (this is analogous to the use of covariance analysis when when the "independent" variable is affected by the treatment, a serious violation of statistical principles). The simple alternative to the "phase shift" procedure is to assume that the two series have the same underlying structure, and search for evidence that the the differences differences are are associated associated with with the the "treatment." "treatment." the July difference of 102 HSAI (Appendix 2, Table 12). Note This is created by a very low index in the Urban data, which can hardly be associated with spray in the Study area. The Urban area low of November and high of January, and the Study area lows of January, April, and September and high of June are of particular interest. Whatever the value of the correlation coefficient, one would have difficulty in believing that a meaningful association exists. The The basic basic flaws flaws in in the the HSAI HSAI data data and and the the weakness weakness of of the the cyclic cyclic trends trends makes such comparisons not only meaningless but also misleading because detail may may those not able to to study study the the Al Alsea sea II II Report Report and and its its data data in in detail believe the results of such comparisons are sound. 29 We We conclude: conclude: Regularly recurring cyclic peaks in HSAI are not detectable in data from the areas included in the Alsea II Report. The "June peak" of HSAI in the Study area occurred only once in 6 years and its inclusion in the sixyear average misrepresents its meaning for purposes of this study. PART 3. RELATION BETWEEN HSAI MID 2,4,5T USE IN THE STUDY AREA The third conclusion in the Alsea II Report is the most important because it deals directly with the possible relation between the HSAI and the use of 2,4,5T in the Study area. EPA concluded there was a statistically significant correlation between the HSAI and the pounds of 2,4,5T applied per month (after a lag time of 2 or 3 months) when the sixyear cumulative data were used. Further, they concluded the results were "confirmed tIconfied and and enhanced" enhanced" by by the the analysis analysis of the data in two two three three year aggregates. These conclusions are based on analyses that require two kinds of data, (a) monthly HSAI and (b) pounds of 2,4,5T used by month in the Study area, and a temporal relation between spraying and an increase in abortions. The bases for the monthly HSAI were examined in both parts 1 and 2 of our critique. The length of the gestation provides some insight into the temporal relationship. LENGTH OF GESTATION The Alsea II Report concluded there was a 2 to 3 month time lag following the use of 2,4,5T and the increased frequency of hospitalized spontaneous abortions in the Study area. The fetus is most susceptible to abortifacients during the early stages of gestation. 2,4,5T is not believed to be so strong an abortifacient as to cause spontaneous abortions at any time during the gestational period. If the incidence of spontaneous abortions increases 2 to 3 months after spraying, there should be a proportionately greater number of abortions of fetuses of 5 to 13 weeks of age. This should be reflected reflected in in the the length length of of the the gestation before the abortion occurs. 9 from the Alsea II Report. No such peak is evident in Table The The gestational gestational age age class class of of 55 to to 13 13 weeks, weeks, Is slightly smaller proportionally in the Study area as compared to the is Urban Urban or or Control Control areas. areas. These data do not support the third conclusion of the Alsea II report. 31 2,4,5T SPRAY DATA In the Alsea I Study, EPA collected 2,4,5T spray data for a 400 square mile area (called the Alsea Basin) around the residences of the women involved in that study. No additional data data on on spray spray use use was was collected collected in the Alsea II Study. EPA apparently assumed that the spray data used in the Alsea I study is representative of the 2,4,5T use in the much larger Alsea II Study area. We compiled and plotted (to the nearest section) data from both public and private forest land management groups on 2,4,5T use for the entire 1600 square mile Study area. Data were collected from USDA Forest Service, USD1 Bureau of Land Management, Oregon State Department of Forestry, Starker Forests, Willamette Industries, Georgia Pacific, Publishers Paper, Boise Cascade, and Champion International (Appendix 3, Table I, 1, and Figures 1 to 6). For purposes of this critique, we have combined use data for silvex and 2,4,5T together and Labelled labelled it 2 ,,4 4, 2 , 5T. 5T. The data used by EPA does not compare well with the data we collected (Table 2). We divided the annual use data into two periods, spring (before June 30), and summer (after July 1) to reflect the two major periods of use and because the "June peak" in the study area would reflect spring, but not summer, spraying. This This table table shows shows the the following following important important facts: facts: 1. EPA substantially underestimated the use of 2,4,5T in the Study area and failed to detect the increasing proportion of spraying done after July 1 between 1972 and 1976. Clearly the statistics for the "Alsea Basin" developed by EPA in the Al sea I study are not a good indicator of 2,4,5T use in the Alsea II Study area. 32 2,4,5T use use for for the 400square mile Table 2--Comparison of statistics on 2,4,5T the entire entire1600 1600 square square mile mile "Study "Study Area." Area." "Alsea ttAlseaBasin't Basin" as used by EPA and for the 2.4.5T used in 2,4,5T Year Season (pounds) (pounds) 1972 1973 1974 1975 1976 1977 Alsea Basin-' Basin' Area! Study Area1"1 (pounds) % of use in Study area) spring 11,151 11,151 406 3.6 5 umme r summer 2,758 2,758 363 13.2 spring 20,580 20,580 444 2.2 s umme r summer 3,429 3,429 50 1.6 spring 7,970 7,970 207 2.6 5 umme r summer 2,201 2,201 240 10.9 spring 12,305 12,305 760 6.2 summe r summer 5,380 5,380 211 3.9 spring 18,731 18,731 4,131 22.1 summe r summer 9,333 9,333 0 spring 14,519 14,519 3,104 0 summer summe r 1"2,4,5T '2,4,5T (and silvex) use data we compiled for the entire study area. 12,4,5T use data as compiled by EPA and reported in Alsea II Report. 33 -21.4 -- 2. The proportion of the total 2,4,5T use In the Study area which EPA detected based on use in the Alsea Basin changed markedly markedly over time. The effect Is pronounced in In the two threeyear aggregates (1972-1974, 1975-1977) EPA used in their analysis. In the first threeyear period, 2,4,5T use in the Alsea Basin was 2.7% 2.77 of the use In in the Study area, but in the second threeyear period, use In in the Alsea Basin was 17.5% l7.57 of the use in the Study area, more than a sixfold increase. Increase. EPA reported there was a marked increase In in spring spraying in the second of the threeyear periods (according to EPA, 1,057 lbs in 1972-1974 versus 7,995 lbs in 1975-1977, a 7.6fold 7.&fold increase). reality, there was little change. In The actual pattern of use was 39,621 lbs in 1972-1974 compared to 45,555 lbs In in 1975-1977 (a 1.15fold increase). The increase In in 2,4,5T use in the second threeyear period reported by EPA is obviously the result of a larger fraction of the total 2,4,5T use occurring in the Alsea Basin portion of the Study area (EPA used only the Alsea Basin as the data source for both the Alsea I and II studies). studie8). 34 SPRAY DATA THE HSAI HSAI VERSUS VERSUS 2,4,5T 2,4,5T SPRAY DATA THE EPA's comparison of patterns of use relative to the "June peak" of abortions for these 2 threeyear aggregates is faulty for two reasons which, because of the errors they involve, reinforce each other. reasons are: The The (1) the June peak of HSAI occurred only because of the 1976 data, therefore, it is obvious that the second of the 2 threeyear thethe first, first, (1975-1977) will will have have aa much much higher higher June June HSAI HSAI than than aggregates (1975-1977) the EPA EPA data on 2,4,5T use is six times closer to being and (2) the level complete for-the second aggregate; therefore, it appears that the level of 2,4,5T use increased substantially in the second threeyear aggregate when, in fact, it did not. 2,4,5T was 1973, not 1976. The year of highest spring use of Conclusions Conclusions which which use use comparisons comparisons based based on on the spray data collected by EPA are in error. The EPA investigators concluded that there was a significant association between the pounds pounds of of 2,4,5T 2,4,5T applied applied arid and the the HSAI HSA1 22 to to 33 months months later later in in the study area. The fundamental pieces of evidence EPA used to reach herbicide this conclusion are: (1) that the maximum application of the herbicide summing pounds used in April was in the month of April (determined by summing (2) the the maximum maximum HSAI over the 6 years covered by the study), and (2) appeared roughly 2 months later in June (determined by summing hospitalized spontaneous abortions and live births over the 6 years to for June, 1972-1977). HSAI for 1972-1977). calculate a single HSAI Their conclusions are weakened when the data are analyzed in less aggregated form. In Table 22 of the Alsea II Report, where the HSAI is based on two threeyear periods (rather than a single sixyear period), only one of ten Spearrnan correlations of of HSAI HSAI with with spray spray amount amount achieve achieve Spearman correlations significance at the 0.05 level. Even if all actual correlations were zero, it would not not be be unusual unusual for for one one of of aa sample sample of of ten ten correlations to achieve significance at that level. Whatever associations were observed between 2,4,5T use and HSAI are of dubious meaning due due to to the the level level of of aggregation aggregation of of the the data data over over time time and space; for sixyear six-year totals totals of of HSAb's HSAb's (or space; i.e., i.e., computing computing1-ISAI HSAI for (or at at best two three-year threeyear totals) totals) and and over over aa large large geographic study study region region in in which application application of of the the spray spray was was highly highly non-uniform. nonuniform. The dangers of attributing this this type type of of macro-unit macrounit association association (so-called (socalled '1ecological attributing '1ecological correlations") to individuals have received much attention in the statistical literature. The Alsea Alsea II II Report Report reveals reveals the the effect effect of of using using three-year threeyear rather rather than than sixyear aggregated six-year aggregated data. data. To illustrate this point further and to emphasize the effect of the June 1976 observation in the Study area, we disaggregated the data to the monthly level, yielding 72 observations of HSAI. Due to problems previously discussed, we did not compare HSAI among areas but only considered the Study area in investigating the effect use on on HSAI. HSAI. effect of of 2,4,5-T 2,4,5T use Despite other problems with the basic data collected by EPA, we assume here for purposes of illustration that the HSAI data are adequate for statistical analysis. With this assumption, we examined the HSAI data for an association with the actual pounds of 2,4,5T used 2,4,5-T used in in the the Study Study area. area. In Appendix 3, Table 2, we show monthly HSAI and actual pounds of 2,4,5T used 2,4,5-.T usedininthe theStudy Studyarea areaonona acumulative cumulativebasis basis covering covering 1.5, 1.5, 2.5, 2.5, and 3.5 months prior to the monthly HSAI's. The cumulative use values are intended to account for time lags between herbicide use and a possible spontaneous abortion response as well as accumulated exposure. For example, example, aa 2.5-month 2.5month accumulation accumulation of of 2,4,5-T 2,4,5T use use corresponding corresponding te to the HSAI for June of 1972 represents the total pounds of herbicide used in April, May, and half of that used in June of 1972. The combined use information for information for the the months months March-April MarchApril and and May-June MayJune was was apportioned apportioned on a monthly basis in a manner compatible with the monthly use distribution given in Table 4 and Figure 8 of the Alsea II Report. Specifically, for the March-April MarchApril combination, combination, 30% 30% was was attributed attributed to March and and 70% 70% to to April; for for the the May-June MayJune combination, combination, 75% 75% was was attributed to May May and and 25% 25% to June. 36 We plotted monthly HSAI values and the 1.5, 2.5, or 3.5 month cumulative use data to determine if there was a relationship between use of 2,4,5T and HSAI (Appendix 3, Figures 7 to 9). There is no relationship between HSAI and pounds of 2,4,5T used except as influenced by the HSAI of June 1976. That point on each plot is distinctively apart from the remaining points. Formal linear regression and correlation analysis were conducted to investigate the degree and statistical significance of the relationship between HSAI and pounds of 2,4,5T use. In order to assess the influence of the June 1976 observation, these analyses were conducted both including and omitting that observation. The resulting Pearson correlations are given in Table 3, for the three time lags. When the June observation is omitted, the Pearson correlation values are small in magnitude and statistically nonsignificant. Table 3Correlation between HSAI and 2,4,5T use for three time lags, including including and and omitting omitting June June 1976 1976 observation. observation. Cumulative period of Including June 1976 Omitting June 1976 2,4,5T use before abortions -----Pearson -----Pearson correlation correlation ------------------------1.5 months 0.0120 2.5 months 02047 0.2047 3.5 months 0.2707* -0.0014 0. 1349 0.1349 *P < 0.05 (Particularly when one realizes that the squares of these correlations represent the proportion of the variance in HSAI that is "explained" by 2,4,5T use). When the June 1976 observation is included, the correlations all increase in magnitude and the 3.5 month time lag shows significance at the 0.05 level. The June 1976 observation also has a large effect on the least squares lines. The regression lines for the three time lags that are obtained both including and excluding the June 1976 observation are plotted on Figures 7 to 9 (Appendix 3) and the regression equations are in Table 3 (Appendix 3). For the 3.5 month time lag, the slope of the line based on all 72 points is 2.4 times larger in magnitude than the slope of the line when the June 1976 point is excluded. We believe this analysis shows that the sixyear cumulative data fail to meet meet the the criteria criteria of of annual annual recurrence. recurrence. In fact, the June 1976 HSAI dominates the data (Appendix 3, Figure 10). 38 POTENTIAL FOR HUMAN EXPOSURE Why was there such an increase in HSAI in June 1976? The answer is not known because there are many factors which could cause such an increase to be recorded. For purposes of this critique, however, it is most important to examine the spray data data to to determine determine if if it it varies varies in in some some way that might account for the increase in HSAI in June 1976. The EPA spray use data suggests 1976 was the heaviest period of 2,4,5T use in 1972-1977. Our data also shows 1976 was the highest year in total, but it is the spring spray period that is of predominant importance importance for for HSAI HSAI values values for for early early summer summer months. months. Our data shows 1973 as the peak year for for spring spring spraying spraying (20,292 (20,292 Ibs) Ibs) followed followed by by 1976 1976 (18,731 ibs) and 1977 (14,519 ibs). Ibs). both 1973 and 1977. The peak HSAI occurs before May in On this basis, it appears the timing of peak monthly HSAI values are not particularly related to either timing or amount of spraying. The area where the patient lived (based on zip code) is important in determining determining the the likelihood likelihood that that exposure exposure to to spray spray material material would would occur. occur. We tallied the number of hospitalized spontaneous abortions by month, year, and zip code in the Study area (Appendix 2, tables 4 to 9). In June 1976, 10 spontaneous abortions were recorded; 8 were in zip cocLe areas for the 4 urban areas adjacent to the ocean (Florence, Waidport, Waldport, Newport, and Lincoln City). areas. The other two were inland urban or rural The geographic distribution of hospitalized spontaneous abortions in abortions in the the Study Study area area in in June June for for 1972-1977 1972L977 are in Table Table 4. 4. 39 Table 4--Qeographic distribution of HSAb in Study area for June, 1972-1977. Year Number of of hospitalized hosita1ized spontaneous spontaneous abortions abortions for June Four urban coastal areas All other parts of Study area TQtal 1972 1 2 3 1973 1 2 3 1974 2 1 33 1975 2 0 2 1976 8 2 10 1977 2 1 3 16 8 24 TOTAL The number of hospitalized spontaneous abortions are relatively constant in the inland urban and rural areas of the Study area. they are also quite constant in the coastal uthan areas. Except for 1976, The reason for the umusual1y uusua11y large large rmrnber number of of HSAb's HSAb's in in the the coastal coastal urban uran areas areas in in June June 1976 is not known, but the likelihood of 2,4,5T involvement seems remote. The number of spontaneous abortions, which occurred in June 1976 in each of these four cities, is not larger than those occurring at other times, but the occurrence of high values in three cities in the same month is unique. unique. A plot of the 2,4,5T use by site within each of the zip code "zones" in the Study area revealed several associations concerning proximity of 2,4,5T use and population centers (Appendix 3, Figures 1 to 6). EPA attempted to show proximity and, therefore, probable exposure (and possible cause) by simply presenting the fact that 2,4,5T was used and spontaneous abortions occurred in an area approximately 60 miles long and and 30 miles wide. Exposure potential would be shown more clearly by identifying the residence and activities of each person suffering an RSAb in relation to the most proximate sites of 2,4,5T use. not not possible possible in in this this study. study. 40 This is We took the next best method, which is to associate HSAb's and sites of 2,4,5T use by zip code (Appendix 3, Table 4). There are 5 zip code areas in which no 2,4,5T was used and 67 HSAb's or 36% of the total occurred. Five zip code areas included 81% of the 2,4,5T use sites and 51 (27%) (277) of the HSAb's. One One of of these these five five zip zip code code areas, areas, 97439 97439 (Florence), accounts for 33 of the 51 HSAb's in that set. Since there were no 2,4,5T spray sites within 2 miles of Florence and only 2 sites within 4 miles, one can observe that the remaining 4 "high use" zip code areas account for 70% of all the 2,4,5T spray sites in the Study area and only 9.67 9.6% of the the HSAb's HSAb's (Table (Table 5). 5). Table 5--Number of sites treated with 2,4,5T and number HSAb for the six years, a comparison of zip codes with the fewest and the most sites treated. Zip code Sites treated H SAb Fewest sites treated 97391 0 97388 0 97341 0 97369 0 97365 Total 40 0 2. 0 Most sites treated 97390 97390 134 97343 97343 86 97324 224 97394 121 97439 Total 33 653 If the HSAb's in the four urban coastal areas (Lincoln City, Newport, Waldport, and Florence) are distributed proportionally between the urban 41 and rural components of those populations, then 76 HSAb's involved urban residents of those cities. There were no sites of 2,4,5T use within 2 miles of any of those cities. About 56% 567 of the total HSAb's detected in the study area were in the four urban coastal areas. Only l.57 1.5% of the 2,4,5T use sites were within 3 miles of these urban areas. This method of viewing probable exposure is not as precise as we would like, but it is substantially more precise than the method used by EPA in the Alsea II study. Based on this discussion and analysis it is clear to us that EPA's third conclusion is wrong. There is no substantive difference in the pattern of 2,4,5T use in the spring between the 1972-1974 and the 1975-1977 periods; thus, conclusions that an increase In in HSAI reflects or is correlated with increased use of 2,4,5T is in error. Furthermore, we find there is no June peak of HSAI in the Study area except in 1976. The increase in June 1976 occurred exclusively in the four coastal urban communities where exposure to 2,4,5T spray material is least likely to occur. We conclude: There There is is no no demonstrable demonstrable relation relation between between the the patterns patterns of of 2,4,5T use and HSAI in the Study area. 42 CONCLUS IONS The conclusions we reached as a result of this critique are geared to the three conclusions EPA reached in the Alsea II Report. EPA Conclusion I - "The 1972-1977 abortion rate index for the Study Area is significantly higher than those for either the Control or the Urban Area." We found: a. There are differences in topography, climate, and demography among the three areas which make comparisons among these areas tenuous. b. There are substantive differences in medical practice among these areas and EPA failed to account for the high percent of the medical care for residents of the Study area which is delivered in the Urban area. Consequently, the data are incomplete and the actual percentages of spontaneous abortion abortion patients patients who who are are hospitalized for the three areas are incorrect in the Alsea II Report. The hospitalization hospitalization rates rates given given in in the the Alsea Alsea II II Report Report are are sufficiently different among areas to completely offset the unadjusted difference in the HSAI between the Study and Urban area reported by EPA. EPA's finding of a significant difference in HSAI between the Study and the Control Control areas areas is is invalid. invalid. We conclude: The EPA HSAI values are not reliable because of incomplete data collection and failure to account for patterns of and differences in medical practice among areas. Conclusions arising from comparisons of data among the three areas are error. likely to be in error. 43 EPA Conclusion II - "There is a statistically significant seasonal cycle in the abortion index in each of the areas with a period of about 4 months. In particular, there is an outstanding peak in June in the Study area.'t Study area." We found: a. There is substantial variation in the magnitude of the HSAI for any one month (all Januarys, all Februarys, etc.) among the 6 years in the study. In the Study area the peak monthly HSAI for the year occurred in 5 different months for the 6 years of the study. June had the peak HSAI only in 1976. b. What appears to be a peak HSAI in June in the Study Area is, in fact, fact, the the consequence consequence of of aa single single large large excursion excursion from from the the norm norm which occurred only in 1976. If the June 1976 data point is recognized for what it is, the basis for alignment of the data from the Study area with the data from the other two areas disappears. Therefore, the EPA conclusion that there is a seasonal cycle of HSAI with a period of four months in the Study area is faulty, because it rests solely on the June 1976 data point. We conclude: The seasonal cyclic peaks seen by EPA in the sixyear cumulative data are. are consistent consistent with with aa model model of of random random variation. The data are highly variable from area to area and from year to year. The "June peak" in the Study area occurred only in one year of of the the sixyear sixyear study study and and should should not not be be presented pesented as a repetitive event. EPA Conclusion III - "There is a statistically significant crosscorrelation between the Study area spontaneous abortion index and the spray patterns in terms of pounds applied by months in the Alsea Basin, 1972-1977, after a lag time of 2 or 3 months. The results based based on the sixyear aggregate of abortion and spray data are confirmed and enhanced by the analysis of the two threeyear aggregates." 44 We found: a. The spray data EPA collected in the 400squaremile Alsea Aisea Basin gave a seriously misleading conception of the spray data for the According to the EPA data 9,052 1600squaremile Study area. pounds of 2,4,5T were used in March, April, and May, but according to the records of all the major forest land owners in the Study area 85,176 lbs were used. b. More seriously, the spray data EPA collected represents only 2.7% of the actual use for the 1972-1974 aggregate, but 17.5% for the 1975-1977 1975-1977 aggregate. EPA's incomplete spray data should not have been compared between time periods. The alleged increased use of 2,4,5T during the 1975-1977 seasons was actually due to more complete collection of spray data rather than increased use. Complete data show that there was little difference in the amount of 2,4,5T sprayed in the spring in the two threeyear aggregates (39,621 pounds in 1972-1974 versus 45,555 pounds in 1975-1977). d. There is no statistically significant cross correlation between the Study area HSAI and our more complete data on 2,4,5T use excepting for the apparent increase in June HSAI. In the second threeyear aggregate of data, this was wholly due to a single high HSAI value which occurred in 1976. All other June HSAI values appear usual, despite the fact 1973 was the year of peak use of 2,4,5T during the spring. Deletion of the single single June June 1976 HSAI value removed the significant correlation between the amounts of 2,4,5T used and the magnitude of the monthly HSAI which was reported by EPA. The increase in HSAI in June 1976 occurred only in four coastal urban community zip code areas where exposure to spray materials is least likely to occur. 45 We conclude: There is no significant correlation between the pattern of 2,4,5T use use and and the the HSAI HSAI in in the the Study Study area. area. EPA's conclusion is faulty because (1) their data on 2,4,5T spray use is seriously incomplete and in substantial error, and (2) the "June peak" is based on an event which occurred in only I of the 6 years. The three conclusions of the Alsea II Report are expressed in statistical terms by EPA. of the data. This implies Implies a careful and unbiased analysis There are other, and and perhaps perhaps more more appropriate appropriate methods methods of of statistical analysis than the ones used by EPA; however, we believe the most serious flaws in the study are in the incomplete and inaccurate data which were used in the data analysis. The conclusions of any study can be no better than the quality of the basic data, regardless of the sophistication of the data analysis. We believe EPA investigators erred by failing to analyze, with sufficient care and logic, the characteristics of the three areas, the comparability of the various data bases for abortion statistics, and the completeness of the spray data before it was subjected to statistical analysis. EPA erred seriously in each of the three conclusions in the Alsea II Report. If there is a relationship between herbicide use and miscarriages in the "Alsea Basin" and its surrounding area, it is not apparent and cannot be tested using the data from the Alsea II study. ri APPENDIX APPENDIX 11 POPULATION STATISTICS from census different from Since census data are not available for units different tracts for for areas areas outlined outlined by by zip zip codes codes (which defined the boundaries of tracts estimation the the Study Study area) area) or or for for unincorporated unincorporated villages, villages, aa method of estimation employed by county planning agencies was used. The number of post delivery routes, routes, and the office office boxes boxes in in city city delivery delivery routes, routes, rural rural delivery by aa factor (in this case the post office itself can be multiplied by factor used was 2.3) to estimate population. Such Such estimates estimates are are not not precise because some rural routes start from the center of a small town, some P.O. boxes are used by rural dwellers, and some nonresidences (i.e., business offices) cannot be subtracted from other deliveries. However, the estimates so derived are sufficiently accurate to characterize a region. Our figures are based on the most recent Post Office data or 1970 census figures. The population levels undoubtedly changed during the 1972-1977 study period but precise data are not available. 13 towns and Table 4, shows the the comparative comparative population population figures figures for for 13 The villages in the 3 studied areas from 3 different sources. differences for Ontario are probably typical. The figure of 8200 8200 is is an an older census figure, 8900 is a more recent census figure, and both of the urban area; 11,474 these figures are bounded by the city limits, not the incorporates the area known locally as "greater metropolitan Ontario." 2, and and 33 in in text text and and Figures Figures The zip zip code code boundaries boundaries on on maps maps (Figures (Figures 1, 1, 2, The 1 to 6 in Appendix 3) are arbitrary to the extent that the boundaries roads serviced by post approximate crest crest lines lines halfway halfway between between the the roads office rural deliveries. The Post Office definition definition of of zip zip codes codes is is by by roads, not by areas fitted together like the pieces of a puzzle. in "zip code maps" prepared by means there are some discrepancies in various various groups groups studying studying this this problem. problem. 47 This This Table 1--Population distribution based on estimates from Post Office Statistics Population Location Study area and Rural) Rural) Coastal (Urban and 35,327 35,327 Inland (Urban and Rural) 18,136 TOTAL 53,463 Urban (Coast & Inland) 34,212 Rural (Coast & Inland) 19,251 TOTAL TOTAL 53,463 Urban area Corval lis us Corval Urban 46,310 Rural 5,229 TOTAL TOTAL 51,539 Control area Urban 16,559 Rural 6,143 TOTAL 48 22,702 Table 2--Population distributions among urban and rural components I' the Study Study area.2-' area. in the Zip code Urban centers (Population <2000) Components Rural. Urban Total Total COASTAL ZONE COASTAL ZONE 97367 Lincoln City 8,758 474 9,232 97365 Newport 6,725 1,625 8,350 97394 Waldport 2,696 1,085 3,781 97439 Florence 3,542 5,040 8,582 21,721 8,224 29,945 3,21 I 24,932 2,161 L0,385 5,372 35,317 Subtotal Villages (Population <2000) 97341, 97341, 97366 97369 97388 and 97487 Subtotal TOTAL INLAND INLAND ZONE ZONE Urban centers 97370 Philomath 1,943 3,758 5,701 97391 Toledo 4,545 1,468 1,468 6,013 Subtotal 6,488 5,226 11,714 Subtotal TOTAL 2,828 9,316 3,594 3,594 8,820 6,422 18,136 34,248 19,205 53,453 Villages Villages 97324, 97326, 97343 97357, 97380, 97390 97453 & 97480 GRAND TOTAL GRAND TOTAL FOR FOR STUDY STUDY AREA AREA .!iEstimates -'Estimates from Post Office statistics Table 3--Population distribution among urban and rural components in the Urban and Control areas' Zip code Community Components Components Rural Urban 97330 Corvallis 42,550 97332 0.S.U. Dorms 97321 Albany 5,229 47,779 3,760 3,760 TOTAL FOR URBAN AREA Total 34,001 4,837 38,838 80,311 10,066 90,377 11,474 2,500 13,974 CONTROL AREA 97914 Ontario 97913 Nyssa 2,941 1,718 4,659 97918 Vale 2,075 2,075 1,764 3,839 97906 Harper 69 161 230 16,559 6,143 22,702 TOTAL FOR CONTROL AREA Estimates from from Post Office statistics - Estimates 50 Table 4Comparison of urban population estimates from various sources. Location Portland State University Population Research Center Post Office statistics Alsea II Report Study area Lincoln City 8,758 4,890 4,200 Newport 6,725 7,150 5,200 aldport 2,696 1,250 No listing 1istin Florence 3,542 3,900 2,250 2,250 Depoe Bay 1,033 730 No listing Yachats 955 525 No listing Siletz 844 900 No No listing listing Corvallis 42,550 40,500 37,000 Albany 34,001 34,001 26,150 21,000 11,474 8,950 8,200 Nyssa 2,941 3,000 2,900 Vale 2,075 1,900 1,850 1,850 Urban area Control area Ontario Harper No listing 69 51 250 APPENDIX 2 HOSPITALIZED HOSPITALIZED SPONTANEOUS SPONTANEOUS ABORTION ABORTION STATISTICS STATISTICS The hospitalized spontaneous spontaneous abortion abortion data data was was taken taken from from the the individual individual Alsea II II anonymous case records records compiled compiled by by the the EPA EPA as as part part of of the the Alsea study. The totals obtained by us differ from the EPA totals as follows: Study area, 188 vs 188; Urban area, 174 vs 180; and Control area, 107 vs 109. The source of these differences could not be determined since the EPA did not publish their detailed compilations, i.e., by month, by year in the Alsea II Report. We do not believe these differences are purposes of of this this critique. critique. important for purposes 53 Table lATotal number of births by months for the Study, Urban, and 1972_1977..!." Control areas, 1972_1977..1" Urban area Study area Control area January 194 338 124 February 188 188 353 124 124 March 202 344 126 126 April 189 335 131 131 May 201 201 357 155 June 228 378 378 145 July 203 315 315 156 August 212 351 351 131 September 204 342 154 October October 170 343 136 November 172 337 155 December Deceniber 181 327 129 2,344 4,120 1,666 Sixyear Total !"From Table 10 of EPA Alsea Alsea II II Report. Report. Table lBExample set of corrected sixyear total number of births compiled by EPA (May, 1979) subsequent to the Alsea II study. Sixyear Total Difference Difference Study area Urban area Control area 2,902 3,803 2,044 +558 317 +378 54 2-Number of Table 2--Number of births births corresponding corresponding to to the the month month of of spontaneous spontaneous abortions abortions l9721977))' in the Study, Urban, and Control areas (Oregon l972_l977).2J' Urban area area Urban Study area Control area January 208.8 208.8 338.3 338.3 146.3 146.3 February 206.8 345.0 142.6 142.6 March 191.8 341.5 145.6 April 177.8 340.4 143.6 May 177.9 334.8 142.3 June 184.0 334.3 130.5 July 189.7 342.0 126.5 August 193.0 345.7 125.4 September 195.6 342.5 129.0 129.0 October 196.7 196.7 346.9 346.9 138.7 November 208.7 358.1 147.3 December 213.4 350.7 350.7 148.1 148.1 2,344.0 4,120.0 1,666.0 Total Total !"From 'From Table 11 of EPA Alsea II Report. 55 Table 3--Hospitalized Spontaneous Abortions (HSAb) (raw data). Year JAN FEB MAR 2 2 1 1 5 2 2 JUNE Month JUL APR MAY AUG SEPT 3 3 3 3 4 0 4 3 5 4 33 2 1 1. 2 1 1. 3 3 1 1. 2 3 2 2 2 6 OCT NOV DEC 00 2 5 5 3 4 2 3 1 3 11 4 1 33 00 5 1 1. 3 TOTAL Study area 1972 1973 1974 1975 1976 1.977 1977 TOTAL Average 1 4 4 1 1 10 10 22 22 2 1 1. 3 2 4 3 3 3 33 4 1 2 22 1 2 2 37 34 23 31 32 31 ]0 10 17 1.7 18 11 16 24 20 17 1.7 9 15 16 15 188 1.7 2.8 3.0 3 1.8 2.7 4.0 3.3 2.8 1.5 2.5 2.7 2.5 2.5 31.3/year 2.6/month Urban area 1972 8 4 44 22 0 4 5 2 33 43 5 0 47 3 1973 1.973 2 3 2 4 33 3 1 1. 4 38 1974 1.974 3 5 3 1 4 55 5 6 3 1 2 L975 1976 I977 2 4 3 1 1. L 1 1 0 22 2 2 38 18 5 2 ] 1 0 0 1 1 0 3 20 1 1 4 Z 2 00 2 0 3 0 0 0 2 0 0 2 5 1 11 17 25 16 15 L6 16 1.5 15 4 10 16 19 7 15 15 174 TOTAL Average 4.2 2.7 2.7 5 2.5 2.7 2.7 2.5 0 0 3 1 2.7 3.2 1.2 2.5 29.0/year 2 .4/month 2.4/month 2 1 0 2 2 1 6 1 2 2 3 2 1 1 33 1 2 2 2 4 2 0 0 0 0.7 1.7 1.7 00 1 1 0 Control area 1972 1973 1.974 974 1.975 1975 1976 1.977 1977 TOTAL Average 0 1. 1 2 0 0 0 3 0 1 3 5 2 3 1 3 2 1 2 0 1.1 4 0 1 1 22 0 0 1 9 19 26 25 8 2 22 2 4 0 0 3 1 11 2 1 2 20 12 4 5 6 12 12 1.2 6 S 14 1.4 107 0.8 1.0 1.0 1.0 1.3 2.0 0.7 14 1.2 2.3 2.3 1.5 2.0 2.0 56 2.0 2.3 2.3 17.8/year I .5/month 1.5/month ii: Cl) :i: u' C 0 8 0 mean necn HSAb 6 2.6 U, 0 C 0 4C 0 rAl 0. C,, -o .!:: 2 0 40. U, 0 n 0 0 0 20 30 40 60 50 70 Months Since January I, 1972 I 2 -, 2 1972 I 2 1973 1974 -) -) 1975 1976 1977 Figure 1--Monthly Hospitalized Spontaneous Abortions (HSAb) in Study area, 1972-1977. 57 URBAN AREA largest Jorgest single value 2 mean HSAb=2.5 2.5 mean HSAb U) 0 a, I I 20 tO 40 30 60 50 50 70 Months Since January 1, 1972 z Iii z W z w z z Iii -, 1972 1973 1974 -) 1975 976 1977 Figure 2--Monthly 2--Monthly Hospitalized Hospitalized Spontaneous Spontaneous Abortions Abortions(IISAb) (USAb) In in Urban Urban area, 1972-1977. 58 CONTROL CONTROL AREA largest single largest single value volue mean HSAb 0 20 10 40 30 60 Months Since January 70 1972 wz -) 1972 972 _D 1973 973 -) -D 1974 _) -) -) 1975 _) -) _D 1976 -) 1977 Figure 3--Monthly Hospitalized Spontaneous Abortions (HSAb) in Control area, 1972-1977. 59 Table 4-1972 Hospitalization Spontaneous Abortions (HSAb) in the Study area area by by nionth month and zip code of patient. Location & zip code JAN FEE MAR APR MAY Month JUNE JUL AUG SEP OCT NOV DEC TOTAL 1 2 1 7 1. 3 URBAN Coast 97367 (Lincoln City) 97365 (Newport) 97394 (Waldport) 97439 (Florence) 1 1 1 1 1 1 1 1 3 I I 22 9 Subtotal 21 Inland 97391 (Toledo) 97370 (Philomath> (Philomath) 1 1 2 1 1 3 1 1 1 Subtotal Urban Subtotal 6 9 30 RURAL Coast 97341 97366 97369 97376 97388 97498 Subtotal Inland 97324 97326 97343 97357 97380 97390 97453 97480 GRAND TOTALS 2 2 3 3 3 3 5 4 0 2 Subtotal 5 Rural Subtotal 37 55 5 37 Table 5-1973 Hospitalized Spontaneous Abortions (HSAb) in the Study area by month and zip code of patient. Location & zip code JAN FEB MAR MAY Month JUNE NOV JULY DEC TOTAL URBAN Coast 97367 97365 97394 97439 5 3 1 1 1 2 Subtotal 5 14 I Inland 97391 97370 1 1 66 3 1 Subtotal 9 Urban Subtotal 23 RURAL Coast 97341 97366 97369 97376 97388 97498 0 0 0 0 Subtotal Subtotal Inland Inland 97324 97326 97343 97357 97380 97390 97453 97480 3 2 0 0 0 2 1 1. GRAND TOTAL Subtotal 9 Rural Subtotal 11 4 61 2 33 34 Table Table 6-1974 6-1974 Hospitalized Hospitalized Spontaneous Spontaneous Abortions Abortions (HSAb) (HSAb) in in the the Study Study area area by by month month and zip code of patient Month JAN FEB MAR APR JULY JULY AUG SEPT SEPT OCT NOV DEC 1 TOTAL 2 1 2 6 0 I 1 LL Subtotal 8 T16 1 44 1 Subtotal 5 Urban Subtotal 21 21 0 1 00 00 0 0 Subtotal TT 0 0 0 0 1 0 0 0 Subtotal T Rural Subtotal Subtotal Rural 2 1 62 62 4 1 23 23 Table 7-1975 Hospitalized Spontaneous Abortions (HSAb) in the Study area by month and zip code of patient. JAN FEB FEB MAR APR MAY Month JULY JUNE JIJNE AUG SEP OCT NOV 1 1 1 I DEC I1 4 2 11. Sub total Subtotal 1 Subtotal Urban Subtotal 1 Subtotal Sub total 1 Subtotal. Subtotal Rural Subtotal 0 63 5 13 TOTAL Table 8-1976 Hospitalized Spontaneous Abortions (HSAb) in the Study area by month and zip code of patient. Month JAN FEB MAR APR MAY JUN JULY 2 1 2 AUG SEP 1 11 OCT NOV 1 TOTAL 7 1 6 2 Subtotal 18 18 1 1 DEC 1 33 3 5 1 I Subtotal 6 Urban Subtotal 24 24 2 0 00 0 0 22 1 Subtotal 0 0 00 00 22 22 00 0 Subtotal Rural Subtotal 1 64 2 2 1 8 32 32 Table 9-1977 Hospitalized Spontaneous Abortions (HSAb) in the Study area by month and zip code of patient. Location & zip code JAN FEB MAR APR MAY Month JuN JUL JUN AUG SEP SE OCT NOV DEC TOTAL 1 7 Coast 97367 97365 97394 97439 1 I. 1 5 1 2 1 4 I 1 Subtotal 18 Inland 1 97391 97370 1 1 1 1 4 1 I Subtotal Urban Subtotal Subtotal RURAL 23 Coast 00 97341 97366 97369 97376 97388 97498 0 0 0 1 Subtotal 2 Inland 0 97324 97326 97343 97357 97380 97390 97453 97480 0 0 0 2 0 2 2 Subtotal Rural Subtotal 2 GRAID TOTAL GRAND 65 1 2 2 8 31 Table 10Hospitalized lORospitalized Spontaneous !bortions Pbortions (HSAb) in the Urban area by month, year, and zip zip code code of of patient patient Location & zip code JAN FEB 1 0 MAR APR MAY JUN Month JUL AUG SEP OCT NOV DEC TOTAL 1972 97330 9730 35 (G&ya11js) (Gr,allis) 9321 9Th21 ,1 1. 845342O45 (Alhany) (Aihany) TOTALS ,03 1 1. 0 1 0 2 0 1 8 L 1. 2343 19fl L93 97330 97321 TOTALS 5 0 33 7 2 33 2 33 0 3 3 0 11 33 1 0 0 0 0 1 0 0 0 4 Y7 0 5 1 3 2 3 2 4 3 3 1 4 38 97330 97321 TOTALS 2 2 3 11 2 44 11 1 0 00 2 1 0 0 11 s 5 I 1 3 T 33 2 3 3 0 0 5 1 3 27 11 TT 1 0 0 0 00 00 2 11 1 11 11 1 1 0 1 0 T T 0 1 1 7 0 0 1 00 0 3 15 15 0 0 00 0 1 0 0 1 1 1. 0 33 5 20 0 0 0 5 0 1 5 1 11 0 1 00 0 0 0 2 3 5 1i 1 4 10 10 16 16 19 35 1974 733O 1 3 97-321 97-21 1 1 33 0 TOTALS 2 4 T 3 2 1 2 3 2 0 0 1 1 5 2 1 3 4 0 00 00 00 0 2 11 00 1 00 T T 1976 97330 97321 TOTALS 0 1977 1.977 97330 97321 TOTALS GRAND TOTAL 2 1 1 00 0 0 22 11 1 25 16 15 ! i 16 16 15 15 66 7 15 iS 1-5 15 2 17 174 174 Table llHosptalized llHosptalized Spontaneous Spontaneous Abortions Abortions (}1SAb) (HSAb) in in the the Control Control area by month, year, and zip code of patient Year, location & zip code JAN FEB MAR APR MAY Month JUN JUL AUG SEP OCT NOV DEC TOTAL TOTAL 2 5 1972 97914 (Ontario) 97913 (Nyssa) 97918 (Vale) 97906 97906 (Harper) TOTALS 1 33 1 1 0 0 1 0 0 0 0 0 1 1 1 11 2 1 0 2 2 9 4 1 1 1 1 10 1 11 66 11 22 2 1.9 1 1 2 1973 1973 97914 97913 97918 97906 TOTALS 1 1 11 1 2 0 0 3 1 1 11 11 1 0 1 6 2 2 1 l 3 2 3 0 19 1974 97914 97913 97918 97906 1 3 1 5 4 3 26 3 1 20 1 3 00 1 1 3 5 97914 97913 97918 97906 2 1 2 4 22 TOTALS 33 TOTALS TOTALS 16 2 22 1 3 2 2 1 11 1975 1 1 1 2 3 0 1 33 4 2 11 1 1 0 1 2 2 2 2 4 25 1976 97914 97913 97918 97906 11 TOTALS 2 0 1 1 0 97914 97914 97913 97918 97906 22 22 2 33 TOTALS 22 22 22 4 0 0 0 3 3 11 1 1 2 11 2 2 20 12 4 7 14 9 5 6 10 12 6 8 14 107 4 1 1 1 2 1 1 2 0 11 1 1. 0 2 0 3 11 1 0 0 0 11 8 11 2 17 17 1977 1977 GRAND TOTALS 1 1 1 2 1 0 67 Table 12--Monthly HSAI adjusted to 100% hospitalization rate.1' Study area Urban area Difference JAN 68.7 246.3 178 FEB 117.4 164.3 MAR 134.0 146.3 146.3 APR 88.4 156.7 MAY NAY 128.4 169.3 47 12 68 41 JUN 186.3 149.7 149.7 37 37 JUL 150.6 48.7 102 AUG 125.9 106.0 20 SE? SE? 65.7 165.3 165.3 100 OCT 108.9 182.7 74 NOV 109.6 65.3 44 DEC 100.4 152.0 Average 115.4 146.0 52 31 1"Monthly HSAI x 0.1 = Hospitalized spontaneous spontaneous abortion abortion as as aa percentage of live births. Table 13--Hospitalized Table 13--Hospitalized Spontaneous SpontaneousAbortion AbortionIndex'' Index''by bymonth monthand andyear yearfor forthe the Study Studyarea. area. 27.9 27.9 49.7 49.7 34.9 34.9 58.8 58.8 36.3 36.3 42.3 42.3 93.8 93.8 62.0 62.0 90.1 90.1 130.3 130.3 106.3 106.3 88.0 88.0 46.0 46.0 76.2 76.2 76.6 76.6 70.3 70.3 80.8 80.8 62.5 62.5 135.1* 135.1* 101.4 101.4 97.7 97.7 94.9 94.9 126.2 126.2 61.4 61.4 30.5 30.5 57.5 57.5 56.2 56.2 80.5 80.5 325.0 125.0 33.8 33.8 33.8 33.8 325.7* 325.7* 63.3 63.3 93.2 93.2 30.7 30.7 61.0 61.0 57.5 57.5 28.1 28.1 93.8 93.8 67.6 67.6 67.6 67.6 65.2 65.2 189.9* 189.9* 93.2 93.2 0 0 152.4 152.4 28.7 28.7 84.3 84.3 79 88 79 62.5 62.5 33.8 33.8 101.4 101.4 97.7 97.7 31.7 31.7 31.1 31.1 92.0 92.0 30.5 30.5 114.9* 114.9* 28.1 28.1 59.2 59.2 0 135.1 135.1 97.7 97.7 100.0 100.0 62.1 62.1 92.0 92.0 122.0 122.0 57.5 57.5 84.3 84.3 93.8 93.8 101.4 101.4 101.4 101.4 97.7 97.7 158.2* 158.2* 124.2 124.2 0 61.0 61.0 143.7 143.7 140.5 140.5 94.8 94.8 31.0 31.0 29.6 29.6 29.6 29.6 30.7 30.7 31.6 31.6 12.2 12.2 32.6 32.6 32.8 32.8 34.8 34.8 35.6 35.6 March April April May June June July July August August September September October October November Ijeceinber December ratio of the *Indic5 tea *Indic5 ten births for index for for aa given spontaneous abortion abortion index given year. year. the largest the largest hospitalized hospitalized spontaneous amongthe the 66 years. been divided divided equally equally among interval have have been yeirs. births for the the 6-year 6-year interval as abortions/bOO abortions/bOO births. births. births based based on on a a 5-month 5-month moviug moving average, average, and and is is expressed expressed as numberofoflive live births to the to the corresponding corresponding number study, the iosptalized The monthly The numberofof hospitalized hospitalized spontaneous spontaneous abortions abortions index is is the the ratio of the number abortion Index defined by defined by the theEPA EPA study, the iosptaIized spontaneous spontaneous abortion Average Average 42.6 42.6 43.3 43.3 50.1 50.1 96.6 96.6 42.7 42.7 82.1 82.1 87.0 87.0 115.9 115.9 51.9 51.9 29.0 29.0 144.9* 144.9* 57.9 57.9 34.7 34.7 February February 125.0 125.0 44.8 44.8 47.8 47.8 57.4 57.4 28.7 28.7 57.4 57.4 57.4 57.4 28.7 28.7 57.4 57.4 34.8 34.8 January January Standard Standard Deviation Deviation Mean number Mean number of of births births Average Average 1972-1977 IL8 Month I 8 1U?A Z161 cii L61 9161 L61 1161 39.1 39.1 28.9 28.9 0 0 0 0 17.4 17.4 86.8 86.8 69.4 69.4 00 57.6 57.6 August August 42.7 42.7 42.3 42.3 17.1 17.1 24.8 24.8 51.2 51.2 29.3 29.3 34.2 34.2 34.2 34.2 55.6 55.6 68.3 68.3 55.5 55.5 51.2 51.2 62.8 62.8 58.5 58.5 December December for aa given index for *Indicate spontaneous abortion abortion index hospitalized spontaneous *Indicates the given year. year. the largest largest hospitalized the 6 6 years. years. have been been divided divided equally equally among among the interval have for the for the 6-year 6-year interval as abortions/ 1000births. births. abortions/l000 expressed as and is births based is exprqssed based on on aa 5-month 5-month moving average, and to the of live live births to the corresponding corresponding number number of moving average, births The The monthly monthly births spontaneous abortions abortions tndexisis the the ratio of the qumber abortion index qumberofof hospitalized hospitalized spontaneous the hospitalized hospitalizedspontaneous spontaneous abortion theEPA EPA study, defined defined by by the study, the ratio of the 17.9 17.9 19.5 19.5 16.7 16.7 0 0 33.5 33.5 16.7 16.7 16.7 16.7 33.5 33.5 59.7 59.7 November November Average Average 12.6 12.6 54.8 54.8 86.5* 86.5* 17.3 17.3 34.6 34.6 51.9 51.9 51.9 51.9 86.5 86.5 7.8 57.8 October October 27.7 27.7 46.7 46.7 35.0 35.0 17.5 17.5 0 0 105.1* 105.1* 52.5 52.5 70.1 70.1 57.1 57.1 September September 37.8 37.8 18.1 18.1 11.7 11.7 0 0 0 0 0 0 0 0 35.1 35.1 35.1 35.1 57.0 57.0 July July V9Z 0 0 33.6 33.6 44.8 44.8 35.9 35.9 0 0 17.6 17.6 89.8 89.8 53.8 53.8 71.8 71.8 55.7 55.7 June June 21.7 21.7 47.8 47.8 35.8 35.8 71.7 71.7 17.9 17.9 71.7 71.7 35.8 35.8 53.8 53.8 55.8 55.8 May May 50.7 50.7 47.0 47.0 0 0 52.9 52.9 0 0 17.6 17.6 123.5* 123.5* 88.1 88.1 56.7 56.7 April April 21.5 21.5 43.9 43.9 17.5 17.5 17.5 17.5 52.7 52.7 52.7 52.7 70.2 70.2 52.7 52.7 56.9 56.9 March March 34.2 34.2 46.4 46.4 17.4 17.4 34.8 34.8 69.6* 69.6* 86.9 86.9 0 0 69.5 69.5 5.5 57.5 February February 41.7 41.7 73.8 73.8 35.4 35.4 88.6* 88.6* 88.6 88.6 141.8* 141.8* 35.4 35.4 Standard Standard Deviation Deviation 53.2 53.2 Average Average 1972-1977 1972-1977 56.4 56.4 births, biizths, ntunber of of Mean ntunbr January January Month Index1' by by month andyear yearfor forth.e tke Urban Urban area. area. month and Table Spoütaneoua Abortion Abortion Index1" Table 14--Hospitatzed. 14--Hospitaied. Spoütaneous L6T A £L6 I '.'L61 9L61 cLbT 1L61 I-. 78.9 34.5 60.0 63.3 38.2 47.4 0 0 142.2 42.2 45.9 0 0 84.4 45.9 0 93.0 86.6 211.0* 91.7 94.8 143.5 93.0 43.2 40.7 42.2 45.9 0 47.8 279.1* 43.2 81.3 81.0 67.3 00 0 47.4 957* 46.5 0 81.3 81.3 81.0 32.8 23.7 21.8 21.1 20.9 21.5 23.1 24.6 24.7 May June July August September October November December 39.1 39.1 97.6 38.7 33.2 41.8 79.7 93.0 43.3 54.2 94.5 64.1 47.8 46.5 86.6 40.7 81.0 71.7 0 0 40.5 29.0 81.3 161.9 88.1 121.5 94.1 *Indicates the largest hospitalized spontaneous abortion index for a given year. for the 6-year interval have been divided equally among the 6 years. to the corresponding number of live births based on a 5-month moving average, and is expressed as abortions/1000 births. The monthly births defined by the EPA study, the hospitalized spontaneous abortion index is the ratio of the number of hospitalized spontaneous abortions Average 77.9 97.6 167.4* 0 167.4* 167.4' 125.5 125.5 0 23.9 April 957* 48.3 48.2 82.6 41.3 124.0 41.3 0 0 24.2 March 47.8 34.3 28.0 84.0 0 42.0 0 0 42.0 23.8 February 44.9 82.0 82.0 82.0 82.0 0 123.0 Standard Deviation 123.0 Average 1972-1977 1911 1916 1975 Year 1974 24.4 24.4 Mean number of births January January Month year for for the the Control Control area. area. Index.0 by month and year Table 15--Hospitalized Spontaneous Abortion Index21 0 0 MONTHS LEGEND deviation standard One -6 -5 Cr) ' Mean for /972-1977 MonThly HSA// Monthly HSA /972 - /977 /972-1977 Figure 4--Monthly Hospitalized Spontaneous Index (HSAI) and Hospitalized Spontaneous Abortions (HSAb) in the Study area, 1972-1977. The HSAb is approximate because of monthly shifts in the live birth rate used to calculate HSAI. :i: U) 4 200 300 MONTHLY HSA / IN STUDY A REA J F M A M J MONTHS J A S 0 N One J standard deviation Mean for /972 -/977 X ® Monthly HSA/ 0 (I) C') [IJ 21 3 4 t 7 8 Figure 5--Monthly Hospitalized Spontaneous Abortion Index (HSAI) and Hospitalized Spontaneous Abortions HSAb is is approximate approximate because because of of monthly monthly shifts in (HSAb) in the Urban Urban area, area, 1972-1977. 1972-1977. The ilSAb the the live live birth birth rate rate used used to to calculate calculate HSAI. HSAI. I Cl) 'I /972-1977 LEGEND L. E6'ENO MONTHLY HSA HS4 I / IN URSA URSA NN AA REA REA J F M standard deviation fOne A X Mean for /972-/977 ® Mofh/y H$A / LEGEND M j MONTHS J A S 0 N D 4 I I (t) Figure 6--Monthly Hospitalized Spontaneous Abortion Index (HSAI) and Hospitalized Spontaneous Abortions (HSAb) in the Control area, 1972-1977. The HSAb is approximate because of monthly shifts in the live birth rate used to calculate HSAI. I U, 300- MONTHLY HSA I IN CON TROL AREA, /972-1977 APPENDIX 3 2,4,5T USE STATISTICS The 2,4,5T use statistics were supplied by the major forest land owners in the Study area. Data were supplied by USDA Forest Service, USD1 Bureau of Land Management, Oregon State Department of Forestry, Starker Forest, Georgia lamette Industries, Industries, Publishers Publishers Georgia Pacific, Pacific, Wil Willamette Paper, Boise Cascade, and Champion International. Spray sites were plotted to the nearest section in most cases. Figures 1 to 6 show the 2,4,5T use sites and the zip code boundaries. In most instances, sites were plotted in the center of the section, thus the sites are accurate to within one mile. drawn with arbitrary guidelines. The zip code boundaries were Contrary to the implication implication of of the the maps, zip codes cover delivery routes or roads and not necessarily contiguous areas. They are transformed into "areas" which appear to be contiguous by constructing arbitrary boundaries between delivery routes, usually along ridge lines. The choice of where to draw the boundary line can, therefore, include or exclude a considerable amount of area, some which may have been sprayed with 2,4,5T. 75 Table 1Table 1- 2,4,5-T 2,4,5-Tuse useinin Study Studyarea.!! areaY Suer Spring Year MAR APR (dormant) (4ormant) MAY & JUN AUG JUL TOTAL SEP (foliar) (foliar) 2,4,5-T Use in in Acres Acres 2,4,:5-T Use 1972 1972 1973 1973 1974 1975 1976 1977 TOTALS 4,198 4,198 4,085 4,085 1,782 1,782 3,486 3,486 7,242 7,242 6,479 6,479 6,671 6,671 3,838 3,838 3,896 3,896 2,643 2,643 1,298 1,298 27,272 27,272 18,773 18,773 421 87 128 606 5,652 5,652 11,919 11,919 6,487 6,487 9,198 9,198 13,099 13,099 7,777 7,777 1,858 1,858 1,644 1,644 1,356 1,356 00 0 0 0 50 0 0 60 0 0 0 2,606 2,606 5,371 5,371 ilO 110 477 1,112 1,112 261 384 384 284 5,304 5,304 1,646 1,646 3,118 3,118 1,817 1,817 4,916 4,916 4,029 4,029 13,379 13,379 6,502 6,502 4,273 4,273 3,600 3,600 3,255 3,255 1,140 1,140 0 0 0 65,721 65,721 19,247 19,247 7,345 7,345 15,526 15,526 230 427 112 1,026 1,026 739 54,132 54,132 acres acres 2,4,5-T Use 2,4,5-T Use in in Pounds Pounds j972 j972 1973 1974 1975 1976 1977 TOTALS 10,674 L0,674 13,790 13,790 3,697 3,697 8,705 8,705 L5,476 0 50 0 180 0 13,909 13,909 23,721 23,721 10,171 10,171 17,685 17,685 28,064 28,064 14,519 14,519 108,069 108,069 pounds pounds !'USDI bureau 11USDI 8ureauofofLand LandManagement Management forsilvex silvex-- silvex silvex and datadata is is for and 2,4,5-T 2,4,5-Tare arecxnbined cxnbined in in this this critique. critique. 76 II STUDY IAREA LSA/-\ 'A LS/-\ LINCOLN CITY ZIP CODE BOUNDARIES SPRING /972 SUMMER /972 / A A A - SILETZ 9734I; 97367 A/-A AA / I r ,' 97380 3a 97365 ( ( Aa ('-'-. 1/ NEWPORT £ t .J97391 AQLIINA RIVER 97326 H L N / a A L / ,'ILOMATN Lu a 97394 a 1/ / I I :, -' I.-' '1 AL.SEA liI I ALSE L 7 RIVER A£ 4J324 4J 324 --, £ A £ A A LI- LA 97439 ) 1 S / ,,1' ) A 974. ./' 974O - S / ,'. S S .7 ) S i;;::c. 1SIUSLAW 1S/USLAW ) -N- çRIVER SCALE IN MILES - ) Figure l--2,4,5-T Figure l--2,4,5-T use use plotted plotted by by section section and and season season in in Study Study area, area, 1972. 1972. 77 LS/-\ II STUDY AREA £Aa/I A a SPRING /973 SPRING /973£ J SUMMER I a /973' RIVER A a A L a. 97326 A a 97343 A a ----.. A\ *1 '- S . afl 97370 *l Lu A394 a394 a aa LA AA aa A a A a LA "" aa 9739tA AJJ, : Li 'i- c) -' 1_.gL 1_á\ // AAA 4 AAAA 4. AAAA aaaa -, Pa 974 :974 AAK a aaf A -N- A a 0246 SCALE IN MILES Figure 2--2,4,5-T 2--2,4,5T use use plotted plotted by by section section and and season season in in Study Study area, area, 1973. 1973. 78 ii STUDY AREA LINCOLN CITY ZIP CODE BOUNDARIES SPRING SPR'ING /974 1974 tA/I SUMMER SUMMEfi /974 1974 ge0 S/LETZ RIVER NEN& A .A A N SSAL A 97376 i IiJ A £ .4*L 4a* LA LA I t I c) .-_J La £ / 394 I a : /a A A WALOPORT ,/ 97370 A 7 £ / I £ £ £ A £ £ I I -- _J A £ £ 197394 .1 At* ? (1 1 c) £ LA /.cFA RIVER A / \ 9739 I 97324 :1 4 '.- S k.--&--. I 0246 SCALE IN MILES Figure 3--2,4,5T use plotted by section and season in Study area, 1974. 79 Figure 4--2,4,5-T use plotted by section and season in Study area, 1975. LSA II STUDY IAREIA LINCOLN £ CITY / AZIP &Z7PCODE CODEBOUNDARIES BOUNDARIES , SPRING /976 SPRING /976A a ) J SUMMER /976 1976 :S/LETZ (R/VER 97341' 97367 aL:a 97369 - V..-a 365 NEWPORT :' .1CV/N a' '.--..__ R''CR 97326 a 97366,. \ 97376 Lu (U I a-..S W394 Aa La / I ---.-.. LA La A A /PHILOMATH L / A a / / WALDPORT a 973w 1 "4 . A / a A a 7 / / / _I a -- A 97394 , a 5ç..jJ'4A -,4LSEA £ .. af RIVER 97324 -: '4- a A r .... 4aaa £ c) a / --.La A :>- 97439 97480 A La a a 7' ". ) .0 'I t ..e. .:, 97453 '\ -.. .' a '\ SIUSLAW (R/VER A PLDREN ..... . .- ,_..' - o 6 SCALE IN MILES / Figure 5--2,4,5T use plotted by section and season in Study area, 1976. 81 II STUDY AE L,NCOLN!LSE CITY/I / ZIP CODE BOUNDARIES fj SPRING /977 A ) SUMMER /977 j ,JSILETZ ) 734Ij4 L-%A\ ft I 97380L1 I / '-S. 97343 NEWPORt\ LJ 97343 SAS /£ LJ £1 9T394;11 c) A / A A A AAA / / £ A' WALOPORT / / ,. _/ 97394 *6 97390 A 6A 9P32 A A LL 9M39 97480 97453 O 24 6 SCALE IN MILES Figure 6--2,4,5-T use plotted by section and season in Study area, 1977. 82 Table Table 2-IiSAI 2-IiSAIand and2,4,5-T 2,4,5-Tuse useinin the the Study Study area. area. Cumulative 2,4,5'-T Cumulative 2,4,5-.T use use for for selected time selected time periods periods prior prior 1' Year Year Month HSAI 2,4,5-T1' 2,4,5-T-' used to to 1.5 1.5 L973 1973 January January February March April April May May June June July July August August September Septnber October October November December 57.4 57.4 57.9 57.9 93.8 93.8 101.4 101.4 101.4 101.4 97.7 97.7 158.2 158.2 124.2 124.2 January January February Aprili April1 May June June July July August August September September October October November December 28.7 28.7 144.9 144.9 125.0 125.0 0 135.1 135.1 97.7 97.7 100.0 100.0 62.1 62.1 92.0 92.0 122.0 122.0 57.5 57.5 84.3 84.3 January January February February March April April May June June July July August August September September October October November December 57.4 57.4 29.0 29.0 62.5 62.5 33.8 33.8 101.4 101.4 97.7 97.7 31.7 31.7 31.1 31.1 92.0 92.0 30.5 30.5 114.9 114.9 28.1 28.1 MII% 1974 0 61.0 61.0 143.7 143.7 140.5 140.5 0 00 10,67 10,674 2.5 2.5 3.5 3.5 months months months poundspounds- pounds pounds 1972 1972 abortion' abortion1 0 0 1,601 1,601 0 0 00 0 1,601 1,601 6,938 6,938 10,853 10,853 7,889 7,889 1,033 1,033 2,054 2,054 2,758 2,758 1,646 1,646 0 0 1,601 1,601 6,938 10,853 10,853 11,091 11,091 8,505 8,505 2,412 2,412 2,877 2,877 2,758 2,758 1,646 1,646 0 0 1,112 1,112 1,646 0 0 0 0 6,938 6,938 7,651 7,651 417 675 1,935 1,935 1,646 1,646 0 0 0 0 0 0 0 0 0 0 2,068 2,068 8,964 8,964 12,091 5,689 5,689 1.756 1.756 1,820 1,820 3,143 3,143 2,068 2,068 13,790 13,790 0 8,964 8964 16,228 16228 15,342 L5,342 6,632 6,632 3,446 3,446 3,404 3,404 3,168 3,168 50 0 0 0 0 0 0 00 6 502 6 502 ' 261 3,118 3,118 50 0 0 0 3,697 3,697 4 273 4 273 ' 384 1,817 1,817 0 0 0 0 50 00 405 405 1,753 1,753 3,490 3,490 3,739 3,739 1,452 1,452 1,293 1,293 1,817 1,817 1,753 1,753 4,299 4,299 5,627 5,627 4,465 4,465 2,361 2,201 2,201 1,817 1,817 0 0 0 0 0 0 2,068 2,068 8,964 8,964 16,228. 16,228. 19,479 19,479 16,285 16,285 8,322 8,322 5,030 5,030 3,429 3,429 3,168 3,168 50 0 0 405 405 1,753 1,753 4,299 4299 6,436 6,436 6,353 6,353 5,566 5,566 3,269 3,269 2,201 2,201 1,817 1,817 0 Table 2-(Continued) Table 2-(Continued) Cumulative 2,4,5-T Cumulative 2,4,5-T use use for for selected time selected time periods periods prior prior abortion-' to abort.Lon' to 3.5 2.5 1.5 months Year pounds pounds pounds pounds 1975 L975 L976 1976 January January February March April April May June June July July August August September September October October November December 57.4 57.4 57.9 57.9 93.8 93.8 67.6 67.6 67.6 67.6 65.2 65.2 l89.2 l89.2 93.2 93.2 0 152.4 152.4 28.7 28.7 84.3 84.3 January February March April April May June June July July August August September October October November December 28.7 28.7 115.9 L15.9 125.0 125.0 33.8 33.8 33.8 325.7 325.7 63.3 63.3 93.2 93.2 30.7 30.7 61.0 61.0 57.5 57.5 28.L 28.1 January January February February March Iarch April April May June June July July August August September September October October November November December 57.4 57.4 87.0 87.0 62.5 62.5 135.1 135.L 101.4 101.4 97.7 97.7 94.9 94.9 124.2 124.2 6L.4 61.4 30.5 30.5 57.5 57.5 56.2 56.2 Septber L977 1977 ounds 7i'ounds 0 0 0 0 0 0 0 0 1,306 5,658 7,444 7,444 3,150 3,L50 L,042 1,042 2,742 2,742 5,006 5,006 180 L80 0 0 1,306 5,658 10,055 L0,055 9,244 9,244 3,742 3,742 3,642 3,642 5,290 5,290 5,096 5,096 180 L80 0 0 1,306 5,658 10,055 L0,055 Ll,855 11,855 9,835 9,835 6,342 6,342 6,190 6,190 5,380 5,380 5,096 5,096 180 L80 0 0 0 0 0 0 0 0 0 0 2,321 2,32L 10,059 L0,059 12,053 12,053 2,848 2,848 3,466 3,466 7,319 7,319 4,029 4,029 0 0 0 2,321 2,321 10,059 L0,059 16,697 L6,697 13,681 13,681 5,907 5,907 8,132 8,132 9,333 9,333 4,029 4,029 0 0 0 2,321 10,059 10,059 16,697 16,697 18,324 18,324 16,740 16,740 L0,574 10,574 10,147 10,147 9,333 9,333 4,029 4,029 0 0 0 0 0 0 0 2,007 2,007 8,696 9,793 9,793 998 285 0 0 00 0 0 2,007 2,007 8,696 13,807 13,807 10,363 L0,363 L,140 1,140 285 0 0 0 0 8 700 8' 3 600 3 600 ' 284 4,916 180 L80 0 0 L5 476 1 ' ' 3 255 3 255 ' 5,304 5,304 4,029 0 3 379 11 months months ' 1 140 L40 ' 0 0 0 0 0 0 and May-June March-April and of 2,4,5-T are are combined combined for for March-April May-June of 2,4,5-T as apportioned 30/70 30/70 for for March-April March-April and and 75/25 75/25 for forMay-June May-June as are apportioned 1Pounds are in Alsea in Alsea II II Report. Report. 0 0 0 2,007 2,007 8,696 L3,807 13,807 14,377 14,377 10,505 10,505 L,140 1,140 285 0 0 0 ® ® a ® 2,4,5-T USED (lbs.) .i.I. 16,000 Without June /976 With June /976 20,000 in the of 2,4,5-T 2,4,5-T sprayed sprayed in Figure 7--Monthly Hospitalized Spontaneous Abortion Index (HSAI) and pounds of previous 1.5 months in the Study area, 1972-1977. Multiple points indicated by( ). 000t7 00 I. 0008 (9, (/) (ci) °® 300 000' 00O' k®® (t (F 00 () ()cXD® ® 2) ® ®® ® ® ®® - 12,000 12,000 2,4,5-1 2,4,5-1 USED USED (lbs.) (lbs.) 8000 Without June /976 W/tb June /976 Figure 8--Monthly 8--Monthly Hospitalized Hospitalized Spontaneous Spontaneous Abortion Abortion Index Index (HSAI) (HSAI) and and pounds pounds of of 2,4,5-T 2,4,5-T sprayed sprayed In inthe the previous 2.5 months in the Study area, 1972-1977. Multiple points indicated by( ). I U) I. I. -.' Dl:, 2,4,5-1 USED (lbs.) [o Without June /976 Figure 9--Monthly Hospitalized Spontaneous Abortion Index (HSAI) and pounds of 2,4,5-T sprayed in the previous 3.5 months in the Study area, 1972-1977. Multiple points indicated byS( ). I U) 20C 30C Table 3Regression equation (least squares) of cumulative 2,4,5T use and HSAI. Including June Including June 1976 1976 Omitting June 1976 - 1.5 month nonth H 80.110 0.0003017T 80.110 + + 0.0003Ql7T H - 77.886 - 0.0000188T 77.886 2.5 month H 71.900 + 71.900 + 0.0023896T H = 75.523 I- 0.0006487T 75.523 O.0006487T 3.5 month H - 67.354 + 0.O0Z580lT O.0025801T a R - 72.447 + 0.00l0751T 72.447 B T - HSAI - pounds of 2,4,5T used in the indicated period of time prior to occurrence of HSAb. 90 1972 973 974 I.1CAI ,,,S 4 _ r ii 1,, 975 A, 976 977 Figure Figure 10--Monthly 10--Monthly Hospitalized Hospitalized Spontaneous Spontaneous Abortion Abortion Index Index (HSAI) and and 2,4,5-T 2,4,5-T use use in in Study Study area, area, 1972-1977 1972-1977 100 100 150 150 200 200 250 250 300 300 0 5 I 0 I I 0 0 0 0 0 00 0 0 0 0 17 Il 0 0 0 0 0 0 0 97341 97343 97357 97365 97366 97366 97367 97369 97370 97376 97380 0 0 3 0 0 0 0 0 0 0 0 00 0 0 t 0 3 I 0 0 18 0 0 0 0 0 1 0 0 66 0 2 0 9 0 24 0 17 0 0 0 8 0 5 6 2 0 0 13 0 0 0 0 3 97388 97390 97391 97394 97439 97453 97480 97480 97498 TOTALS I 0 0 5 00 I 9 Il I 6 0O 35 0 45 141 3 107 1 33 2 13 6 15 4 0 I IS 107 2 0 27 22 II I 10 15 26 2 13 26 16 0 0 0 0 106 3 0 51 0 0 0 II Il 21 4 17 0 0 0 86 0 67 0 0 0 6 0 0 0 0 19 00 0 0 8 0 0 0 0 0 0 0 0 0 77 0 0 12 0 8 0 0 6 0 1 0 I 0 2 0 0 0 00 0 2 0 0 0 0 0 0 2 0 0 0 0 0 0 0 2 0 0 0 0 0 Snnmer 1 19/7 19 0 5 0 0 61 Spring 2 Summe 3 1976 0 5 0 0 1 0 0 4 46 Spring 0 0 0 0 0 0 5 II Il 6 0 0 0 0 0 4 0 12 28 4 Summer 1$ 19/5 Spring Summer Spring 1974 code. 0 I S'immer 2!tp 3 913 by sengon season and 3 97326 5 9 97324 2,4,5To SprLng 0 Summer 3 1972 35 Spring 8 Zip code Table 4Number of aites treated with