Document 71my4zv3VB4NMMpo801j1KDzR

Monsanto M onunto Company BOO N. Lindbarph Boulavard St. Louia, Missouri 83166 Phons: 314) 694-1000 October 15, 1979 OCTWWVTWvOcWvrM CoffT ViJUt. DhtecaMlCt ah Mr. Frank Cagnetti Executive Director Medical Center Fund of Cincinnati 234 Goodman Street Cincinnati, Ohio 45267 Dear Mr. Cagnetti: This letter sets forth the terms and conditions under which the Medical Center Fund of Cincinnati ("Fund'*) under the supervision of Dr. Raymond R. Suskind and his staff will conduct a clinical study involving approx imately 120 present employees of the Monsanto Company ("Monsanto") , W. G. Krummrich plant in Sauget, Illinois ("Study"). Said employees included in the Study are those with past or present exposure to the chlorophenols and pentachlorophenol processes at the W. G. Krummrich Plant, whose expo sure lasted at least six months. , The terms and conditions of this agree ment are as follows: 1. The Study shall be conducted by Dr. Raymond R. Suskind, who shall be the principal investigator (Dr. Suskind and his staff are referred to herein as "Principal Investigator"), in accordance with the attached protocol captioned, "A Study of Workers Involved In the Manufacture of Chlorophenols." 2. The Principal Investigator shall, under the auspices of the Fund, supervise all obligations under this agreement for a total fee amount estimated in the attachment captioned "Budget-Monsanto Study" to be $40,454. Thirty percent (30%) or $12,136 of the estimated budget will be submitted to the Fund at the initiation of the project to cover the initial and on site examination expenses. Thereafter, the Fund shall submit a statement for services rendered and an itemized accounting of expenses incurred during each quarter within 10 days after the end of such quarter. It is agreed that the final 10% of this fee amount shall be paid to the Fund only after Monsanto receives the final report of the Study. Upon receipt of said report, Monsanto will also pay the Fund for reasonable expenses connected with the Principal Investi gators performance under this agreement, actually incurred by the Fund above the estimated budget amount for the expense, upon submission by the Principal Investigator and approval by Monsanto C25479 Gs 015021 of an itemized account of expenses for which payment is sought. The Principal Investigator will provide the Monsanto Medical Department with summaries of individual examinations and objec tive data. This medical information of individual examinations will also be made available to the personal physicians of the participants upon receiving a signed release form from the examinee. 3. Monsanto will provide the Principal Investigator copies of work histories and medical records ("Records'1) for the individuals covered by the Study. 4. The Principal Investigator shall provide Monsanto a preliminary report of the findings of the Study upon completion of a proper analysis of the data. The contents of the preliminary report will be discussed with Monsanto and a final report of the Study will be reviewed with Monsanto by the Principal Investigator before publication. The scientific conclusions and judgments arising out of the Study shall be the sole responsibility of the Principal Investigator. The Principal Investigator will notify Monsanto prior to any verbal or written release to the public concerning the results of the Study. 5. All Records provided from Monsanto files, including all the information contained therein, shall be held in strict con fidence by the Fund and the Principal Investigator and shall not be disclosed to any third party. The Fund and the Principal Investigator warrant that they shall take every reasonable pre caution to maintain said confidentiality within the Fund's organization. Access to the Records within the Fund's organi zation shall be limited to licensed physicians or other persons trained and qualified to deal with data under medical super vision, all of whom shall be bound by the provisions of this agreement. Upon completion of the Study by the Fund, or at any earlier time as requested by Monsanto, the Fund shall return to Monsanto all Records which were provided from its files. Any publication or release to the public by the Fund or the Principal Investigator of any information obtained from the Records shall be strictly limited to a compilation of statis tical health data only and shall neither identify any individual by name, address or other traceable characteristic nor contain any personal or sensitive information with respect to any particular individual. 6. The Fund is, and shall perform this agreement as, an independent contractor and, as such, shall have and maintain complete control over all of its employees and operations. Neither the Fund, the Principal Investigator nor any other person employed by the Fund, shall represent, act or be deemed to be an employee, agent or representative of Monsanto. CONFIDENTIAL c254so G? 015022 -- ---- nonro 7. The'administrative aspects of this agreement for Monsanto shall be under the direction of Dr. George Roush, Jr. 8. Upon receipt of a reasonable request by Monsanto during the Study and for five years after Monsanto receives the final report of the Study, the Fund and the Principal Investigator shall cooperate with Monsanto regarding questions or inquiries by third parties relating to the Study, and the Principal Investigator shall, on a mutually acceptable basis with Mon santo: (a) testify at and participate in proceedings in which Monsanto may be involved, and (b) execute and provide affidavits or similar statements regarding matters relating to the Study. 9. This letter shall constitute the entire agreement with respect to the Study and cancel and supersede all prior negotiations, dealings and agreements whether oral or written regarding the Study and may not be modified unless done in writing signed by the Fund and Monsanto. If the above terms and conditions are in order, it is requested that the Fund and the Principal Investigator indicate their acceptance and agreement to the above terms and conditions by executing and dating this letter in duplicate at the places indicated below and returning one of the signed duplicates to Monsanto. Very truly yours, Monsanto Company> ^ rBy :-! ' \ Title: Director, Department of Medicine and Environmental Health DAY OF S C . U Jc1, 1979 Cagne Ufi Title: Execut ive CVfrrector ACCEPTED AND AGREED TO TH]X 2 DAY OF ' < By ^ftaymCnd Title: Director, Depa skind is 4. ent of Environmental Health CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. 1979 C254S1 G> 015023 BUDGET MONSANTO STUDY, ST. LOUIS A. PERSONNEL: (Includes Preparation, On-Site and Assembly and Analysis of Results and Reports) Professional : Principal Investigator 2 Examining Physicians Program Coordinator 30 Days 12 Days 25 Days $17,920 Technical : 3 Interviewers Photographer 30 Days 5 Days 2,240 Administrative and Secretarial: 105 Days 8,400 TOTAL PERSONNEL COSTS $28,560 B. SERVICES: Epidemiologic and Statistical Services $ 6,000 Dermatology Laboratory: Biopsies: 50 0 $21.00 = Cultures: Mycology - 40 @ $13.00 = Bacterial - 25 @ $10.00 = $1,050 520 250 1,820 TOTAL SERVICE' COSTS $ 7,820 C. OTHER COSTS: Travel: (4 People for 2 Days; 1 Person for 3 Days; 1 Person for 6 Days; 1 Person for 7 Days) Air Fare: 6 $132 = $792 Per Diem: 2 Days 0 $50 = 720 S 1,512 2 Visits of 1 Day Each: Air Fare: . 2 $132 = $264 Per Diem: 2 Days 0 $50 = 100 364 Car Rental (Includes Daily Rental, Mileage Charge): Universj ity Car for 7 Days Office Supplies (Paper, Copying, etc.) 198 2,000 TOTAL OF OTHER COSTS TOTAL BUDGET C25482 $ 4,074 $40,454 CONFIDENT!AT _ .. - /c. A D n C D C=> 015024 UNIVERSITY OF CINCINNATI DEPARTMENT OF ENVIRONMENTAL HEALTH W.G. KRUMMRICH PLANT MONSANTO COMPANY INFORMED CONSENT STATEMENT Before agreeing to participate in this study, it is important that you _ understand the purpose of the examination, its benefits and possible discomforts. The objective of this examination is to determine the health status of the employees of the W.G. Krummrich plant of the Monsanto Company who have been exposed to chlorinated phenols and to identify those conditions which may be related to the work environment. I,________________________________________ , agree to particpate in the medical research study conducted by the University of Cincinnati under the direction of Dr. Raymond R. Suskind. I understand that I will be interviewed and asked a series of questions about rr self and the health of my family. In addition to a physical examination I shall permit blood to be drawn and furnish urine for laboratory examination. If indicated by the physician's examination, skin biopsies and skin scrapings for laboratory diagnosis will be done. The discomfort of the biopsy will be the same as with a skin injection. The University of Cincinnati Medical Center follows a policy of making all decisions concerning compensation and medical treatment for injuries occurring during or caused by participation in biomedical or behavioral research on an individual basis. If I believe I have been injured as a result of research, I will contact Dr. Suskind. Any questions that I may have concerning this study will be answered by Dr. Raymond R. Suskind, phone (513) 872-5701, or his associates I am free to withdraw from this investigation at any time. Should I wish to withdraw, I have been assured that standard therapy for my condition will remain available to me. I have been informed of the probable as well as unpredictable consequences of my withdrawal from the study. Subject Investigator Witness Date SUBJECT TO PROTECTIVE ORDER. C25483 HEALTH STATUS RESEARCH PROGRAM UNIVERSITY OF CINCINNATI EMPLOYEES OF THE W.G. KRUMMRICH PLANT, MONSANTO COMPANY . QUESTIONNAIRE Name: Last -------- First------ Middle Address: Street Apt. # City State Zip Code Telephone Number: 1 area code Social Security Number: Present .Status: (check one) I__I Active hourly |__| Active Salary 1 | Other Current Department:__________________________________ # | | | | | 1 Job Title:___________________________________________ # | I 1 1 Clock Number: | | 1 \ Interviewer Number: 1 1 1 Date of Interview: 1 | | | 1 J__ |_ mo. day yr. CONFIDENTI4 \ SUBJECT TO PROTECTIVE ORDER. c=. 015026 C 254Si A. PERSONAL DATA Birthdate: J__ [_ mo. Sex: I male day yr. I I female Race: White, not of Hispanic Origin Black, not .of Hispanic Origin Hispanic American In/ian or Alaskan Native Asian or Pacific Islander Other Marital Status: single married separated widowed 5. Number of Marriages: J__ 6. Education: Highest grade completed 1 | | Elementary = 0 1 - 0 8 Secondary = 0 9 - 1 2 College = 13 (1 year} 14 (2 years) 15 (3 years) 16 (4 years) 17 (5 years) 18 (6 years) 19 (7 or more years) | divorced CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -2- G 015027 C25485 B. OCCUPATIONAL HISTORY 1. Were you employed in pentachlorophenol production? J__ [ yes J__ \_ no If yes, for how many months? 1 1 1 1 Date of leaving penta work: 1 I 1 1 I I mo. yr. Job Title __________________________ code 1 1 1 1 What was your main job or work :(describe)__________________________ 2. if you are now in the "chlorophenol" department, when did you start? 11I 11I 11I mo. day yr. 3. What is your present job title?______________________________ code 1 1 ( 1 4. Beginning with your first job at the Krummrich plant, give the following information: Department Job Title Dates (from/to) mo/yr/mo/yr What-you did (work description) 3. 4. 5. 6. C O N F ffi N lM ^ C25486 015028 Department Job Title Dates (from/to) mo/yr/mo/yr What you did (work description! -L 9. 10. 5. Previous work history, before Krummrich including Armed Forces: Employer Job Title Dates (from/to) mo/yr/mo/yr Work Description 6. While working at the Krummrich plant were you engaged in other employment? a. mechanical work J__ [ yes J__ |_ no b. farming J__ [ yes J__ |_ no c. other J__ |_ yes J__ [ no (describe ______________________________ 7. In previous employment, were you exposed to dust, solvents, cutting oils, welding or solderinng fumes, fertilizer, weed killers, etc. J__ \_yes J__ [ no If yes, specify which:________________________ _ CONFIDENTIAL ci m !p t t TO PROTECTIVE ORDER. ___________________ C25487 015029 C. AT WORK 1. Do you or did you smoke on the job? 2. Do you or did you eat on the job? 3. Do you or did you drink coffee or soft drinks on the job? 4. Do you or did you wear short sleeves at work? 5. Do you or did you wear long sleeves at work? 6. Have you ever worn gloves on the job? What kind? What job? 7. Have you worn protective sleeves on the job? 8. Have you worn special shoes or boots other than safety shoes at work? 9. Have you ever used a respirator on a job? What job? 10. Do you or did you use special safety glasses or goggles on the job? What job? 11. Do you or did you use waterless hand cleaner? 12. Was soap supplied by the company? What kind? 13. Was soap supplied by you? What kind? 14. Do you or did you wear any protective clothing on the job like an apron or special suit? Which? What job? 15. Do you or did you use a mask at work? What job? 16. Do you or did you use protective creams on your skin at work? often occasionally seldom What brand? - CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. s 1 1 yes 1 | yes 1 ! yes 1 1 yes 1 1 yes 1 1 yes 1 1 no i i no 1 1 no 1 1 no 1 i no 1 1 no 1 1 yes 1 1 yes 1 1 yes 1 1 no 1 1 no 1 1 no 1 1 yes 1 1 yes 1 1 yes 1 1 yes 1 1 no 1 1 no 1 I no I t no * 1 1 yes 1 1 no 1 ! yes 1 1 no 1 1 yes 1 1 no C25438 015030 17. Do you or did you change out of your work clothes regularly before going home? 18. Do you or did you change out of your work shoes regularly before going home? 19. Where are your work clothes laundered? J__ [ home J__ [ company J__ [ commercial laundry 20. Do you or did you shower before going home? 21. Did you ever have an illness you felt was caused by your work? .Describe illness:_______________________________ I I yes yes T no J__ I no J__ I yes J__ 1 no J___I *es J___L no What job?___ Department__ Type of work When D. TOBACCO CONSUMPTION 1. Do you presently smoke cigarettes? J__ [ yes J__ [ no If yes* total years smoking? 1 | 1 packs smoked per day? ] j-1 J__ [ 1-2 ' -J__ [2-3 J__ [3+ 2. If you do not now smoke cigarettes, have you smoked them in the past? J__ [ yes J__ [ no If yes, at what age did you start? | 1 | total years smoked? |j packs smoked a day? J__ [-1. j~ [1-2 J [2-3 J [3+ E. ALCOHOL CONSUMPTION 1. Do you now drink alcoholic beverages? J yes J__ [ no If no, did you ever drink alcoholic beverages? J yes J [ no How old were you when you gave up drinking? [ 1 | CONFIDENTIAL2. How old were you when you first started drinking? | 1 1 <TuaiFr*T TO PROTECTIVE ORDER. C25439 * - 01503 3. About how often do you drink some kind of alcoholic beverage? *- J__ [ almost every day J__ [ three or four times a week J [ once or twice a week J [ once or twice a month J__ [ less than once a month 4. When you drink beer, about how many cans or bottles of beer do you usually drink? J__L J__!>2 J___ L3"4 J__ L5"6 J__l6+ 5. When you drink wine, about how many glasses of wine do you usually drink? 1 10 1 U-2 1 13-4 1 (5-6 I 16+ 6 . When you drink highballs, mixed drinks, or other kinds of liquor, about how many drinks do you usually have? I 10 1 11-2 I 13-4 1 15-6 I 16+ 7. Have your drinking habits changed over time? J [ yes _[ [ no IF YES: 8 . If you reduced your alcoholic intake, indicate year. 19| | 1 9. When you drank beer, about how many cans or bottles did you usually drink? J__ L1-2 I 13-4 J___ [5-6 J__ [6+ 10. When you drank wine, about how many glasses did you usually drink? J__ LI"2 J__ L3"4 J___!_5-6 J__ [6+ 11. When you drank highballs, mixed drinks, or other kindsof liquor, how many did you usually have? I 11-2 I 13-4 | 5-6 | 6+ CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -7- ^ 015032 C25490 F. FAMILY HISTORY Have either your father, your mother, any of your brothers or sisters (including half-brothers and half-sisters), or any of your children had any of the following problems? READ EACH PROBLEM. CHECK A "YES" OR A "NO".RESPONSE. IF "YES", CHECK THE APPROPRIATE RELATIONSHIP(S). IF "YES" FOR A BROTHER OR SISTER, ASK: How many of your brother(s) or sister(s) have (had) this problem? AND ENTER APPROPRIATE RESPONSE. PROBLEM RESPONSE RELATIONSHIP HOW MANY SIBLINGS/CHILDRE! .____________ _______________________________________ HAVE (HAD) THIS PROBLEM IT Asthma | | yes | 1 father r 1 Mother r "T Brother 11 r "T Sister r T Children rr ii 2. Hayfever 1 1 yes 1 T no | | Father ! | Mother | | Brother 1 | Sister | j Children || || 1| 3. Acne (pimples) 1 1 yes \ ! no - | | Father "I T Mother I | Brother 1 T Sister 1 T Children || r "r 1r T. Eczema | | yes I T no I ] [ Father I 1 Mother 1 1 Brother 1 ~ 1 Sister 1 I Children ] ~I |( 5. Hives 1 yes | no | | Father 1 | Mother I ] Brother I I Sister I T Children \[ CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -8- 25491 (* 015033 G. PERSONAL MEDICAL HISTORY 1. Have you been bothered with any of the following conditions? Headaches High Blood Pressure J__ L >es 1 1 yes 1 1 no 1 1 no Bronchitis Pneumonia J__ L *es 1 1 yes 1 1 no 1 I no Pleurisy 1 ! yes 1 1 no Chest Pain I I yes 1 1 no Kidney-Trouble 1 1 yes 1 1 no Bladder Trouble 1 1 yes | | no Diabetes 1 J yes 1 ! no Thyroid Problems 1 I yes 1 I no Stomach Ulcer 1 1 yes 1 I no Constipation ! 1 yes I 1 no Colitis I ! yes 1 1 no Liver Problems 1 1 yes 1 1 no Arthritis ' I ! yes 1 I no Teenage Acne 1 1 yes I | no Skin Boils 1 t yes I | no Poison Ivy or Poison Oak 1 | yes 1 1 no Hives 1 1 yes 1 I no Other Rash 1 1 yes 1 1 no Skin Cancer 1 1 yes I 1 no Other Forms of Cancer 1 1 yes 1 1 no CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -9- C25492 GO 15 03 4 2. Have you ever been hospitalized? J__ [ yes IF YES,'ASK: Why were you hospitalized? In what year were you hospitalized? What was the name of the hospital? Where is the hospital (in what city and state)? CONDITION___________ YEAR HOSPITAL - NAME ~ 191 1 I 191 1 I 191 I 1 191 I I 191 I 1 191 1 | COMMENTS: J__ [ no CITY___________ STATE CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -10- C25493 G015035 3. Do you have headaches? daily? weekly? less than weekly? 4. Do you have trouble sleeping? 5. Are you tired most of the time? 6. Do you need more sleep than usual? 7. Do you have a good appetite? 8. Do you lose your temper easily? 9. Do you feel angry often? yes r ye s yes r yes I yes 1 yes 1 yes - 1 yes 1 yes i yes i | no T"~ 1 no T V ~ T11 no no 1 | no 1 I no 1 I no 1 ! no 1 J no 1 I no H. SOCIAL HISTORY 1. How many times have you been married? 2. How many children do you have? 3. Do you have as many children as you wanted to have? 4. Did your wife have any miscarriages? How many? 5. Were there any stillbirths? 6. Were any of the children born with any birth defects or deformities? Indicate type of birth defect. 1I I1 1 yes 1 yes m1 1 yes 1 .yes 1 ! no ! 1 no -1 1 no 1 1 no CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. - li- C25491 GO 15036 1. MEDICATION HISTORY 1. Do you regularly use health aids such as those for constipation* indigestion, arthritis, or headache (for example aspirin, laxatives, diet pills, etc.)? J__ L yes J__ L no If yes, what kind or brand:_____________________________ ______________ 2. Do you regularly use salves or liniments such as those for itchy skin, burns, abrasions, etc.? ~J__ [ yes J__ |_no If yes, what kind or brand:___________________________________________ 3. Do you have or have you ever had acne? J__ |_ yes J__ [ no If yes, how was it treated?_______ 4. Are you now taking medication(s) prescribed by a doctor? J__ [ yes J__ [ no If yes, specify the name(s) of the medication and the illness(es) being treated:__________________________________________ ______________ 5. Do you have any known allergic reactions to drugs? j__ [ yes J__ [ no If yes, to what drugs (be specific)?_________________________________ CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -12- C255 G01503 7 J. REVIEW OF SYSTEMS AND PHYSICAL EXAMINATION Vital Signs_ Nurse ID# 1 | 1 BP I N I 1 1 1 ItnrnHg 5 min. BP M M MM Height 1 1 1inches Unusual appearance J__ [ yes If yes, describe____________ Date 1 1 1 I I 1 mo. day Pulse 1 | 1 Imin. yr. Resp. j 1 Imin. Weight j | j [pounds J__ ! n0 Temp.I I I U |F o-- Physician Physician Additional History Review of Systems Phjrsical Examination (Indicate Problems and/or Abnormal F:indings) Skin - active or residue of acne other skin abnormalities, nails, hair ! 1 yes ! 1 no Nose, mouth, throat, mucous membranes i 1 yes ! 1 1 1 1 yes 1 1 no I 1 1 yes Eyes ! I 1 CONFIDENTIAL1 1yes 1 I no 1 1 yes 13- 1 1 no I 1 no ! 1 no 2 5 496 G O 15 03 8 Additional History Review of Systems Lymph nodes Physical Examination I__ I yes I I no Other organ systems, if indicated 1 1 yes 1 1 no J__ |_ yes ! 1 1 1 1 yes J__ L no 1 ! no CONFIDENTIAT. SUBJECT TO PROTECTIVE ORDER. -14- G015039 Abnormal Findings From History I i yes Detail: --- no From Physical Examination I | ves Detail: ~-- L yes j__ I no Diagnosis - Impression 1. 2. 3. 4. Comments CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. C254g LABORATORY TESTS Please check if done: Urine Sample 10# I 1 1 Blood Sample ID#! ! i Skin Biops. ID#! ! 1 Skin Scrapings ID#| | | Culture ID#! i | Photograph ID#| | i OTHER TESTS: 1 1 yes 1 1 yes i 1 yes - 1 1 yes 1 ! yes 1 ! yes i i no 1 1 no 1 ! no 1 I no i | no 1 I no COMMENTS: CONFIDENTIAL SUBJECT TO PROTECTIVE ORDER. -16- GO 1504