Document KJrO8DdzqJQoYjqnzqj5KbBZX

AR226-1388 uu: i) u. bt,bbfc.KK.A J. T. SMITH Z-49 CV I l # dPB> tSTU UM OHOt E. I. du Pont de N emours & Company N. J. IRSCH C. F. REINHARDT - CR&D B. W. KARRH - ER H. E. SERENBETZ J. W. RAINES IN CO R N tA TC O WILMINGTON. DELAWARE 19898 AfL POLYMER PRODUCTS DEPARTMENT May 26, 1981 1582 PERSONAL & CONFIDENTIAL / J. H. TODD POLYMER PRODUCTS DEPARTMENT WASHINGTON WORKS C-8 PROGRAM STATUS It has been several weeks since the announcement of 3M's findings of the teratogenic potential of C-8 and the subsequent reassignment and relocation of affected female employees from the " T e f l o n 11 area. Communi c a t i o n s to employees at that time indicated that we planned further animal testing, further blood sampling, and some follow-up to see if birth defects may have resulted from exposure to C-8. Although these programs are either just under way or still in the discussion stage, a status report is in order. You may choose to share some of the more sensitive information with your immediate staff. Other parts of the program, such as the Haskell activities, may be of more widespread interest. If you wish to prepare a general communication, we will be glad to assist with Medical or Haskell review. RIS K ASSESSMENT (Attachment I) The latest risk assessment letter of May 6 from Drs. C. F. Reinhardt and B. W. Karrh is included for your information. It refers to an earlier letter of April 10, and this is also attached. HASKELL LABORATORY STUDIES (Attachment II) E. D. C h a m p n e y 's mem o of 4/13/81 summarizes the extensive program being undertaken at Haskell Laboratory. EID090076 There's 3 world of t h i n o * w o ' r o H rvinn n m t h i n n aKa h * 000159 AJP002917 J. H. TODD -2- MAY 26, 1981 HASKELL LABORATORY STUDIES (Cont'd.) The inhalation teratology study aimed at determining a no-effect exposure level in female rats is proceeding on schedule. Facilities at the Experimental Station are being used beginning this week for blood analyses to support this study during a two-week period. Although there will be some results at the end of June, the full-term test will not be complete until year end. Screening studies for an alternate dispersing agent have started. In about three months we should know if we have a promising candidate. Full-scale testing of several months would then be required to confirm absence of teratogenic potential. Because of the rapid elimination of C-8 by female rats, it is difficult to relate a no-effect dosage and blood level in rats to an acceptable exposure level and blood level of C-8 in humans. A second species, more closely related to humans, will be chosen shortly. The r adio active C-8 is now available. I nformation about how it is accumulated and held in the body will come from experiments using it. A reproduction study is still in the planning stage. BLOOD SAMPLING RESULTS (Attachment III) Attached is a summary of sampling results available through May 14. As expected from prev i o u s sampling, sites where only the dispersion is being used are indicating low blood levels. Samples from Dordrecht are just being received. When results are available, we will be able to compare this plant, where direct exposure to C-8 is possible, with Washington Works' experi ence . We understand that strategies for further sampling at Washington Works are being discussed. R D I :tps Attachments R. D. INGALLS ENERGY & ENVIRONMENTAL AFFAIRS MANUFACTURING DIVISION EID090077 AJP002918 000160  C S -1S7S ISIMUSMKOaOS E. I. du Pont de N emours 51 Company tNCOMPOftATVD W il m in g t o n , De la w a r e 19898 C E N T R A I . R E S E A R C H Ot D E V E L O P M E N T D E P A R T M E N T HASKELL LABORATORY TOXICOLOGY ANO INDUSTRIAL MEDICINE Page 1 (carbon copies listed on page 3) May 6, 1981 PERSONAL 5 CONFIDENTIAL M E M O TO: H. E. S E RENBETZ PPD, MONTCHANIN 642 FROM : C. F. REINHARDT, MD, CRD, HASK E L L B. W. K A R R H , 'MD, ERD, N- _______ ________ _________FC-143 (Ammonium p e rfluorooctanoate; C-8; CAS-3825-26-1) Ref.: CFReinhardt BWKarrh to HESerenbetz, "FC-143," dated 4/10/81. The reference memo describes a pilot study by 3M in which FC-143 caused abnormal eye lenses in rat fetuses. The memo recommends "that women of childbearing capacity be removed from jobs where it has b een d e m o n s t r a t e d that there is potential for exposure to FC-143 and blood levels of FC-143 are above defined background levels (0-0.4 ppm). Areas where the employees have blood levels of organic fluorine in the backgr o u n d range and w here the airborne c o n c e n t r a t i o n of FC-143 is in compliance with our provisional acceptable exposure limit of 0.01 mg/m3 should present no significant risk to the fetus." Originally we estimated blood concentrations of FC-143 by an imprecise measurement of total organic fluorine. The back ground concentration of organic fluorine, determined by measur ing it in the b l o o d of W i l m i n g t o n office workers, was 0-0.4 ppm (as f l u o r i n e ) . S u b s e q u e n t l y a me t h o d for m e a s u r i n g the b l o o d level of FC-143 itself was developed. It is sensitive to about 0.004 p p m (4 p p b ) , as fluorine. It was p r e s u m e d that b a ckground levels by either method would give values in the same range. However, initial measurements of Wilmington office workers indi cate that the b a c k g r o u n d level of b lood FC-143 is below the level of detection, that is, less than 0.004 ppm. The question has arisen whether the acceptable blood level for female employ ees (0.4 ppm) should be lowered to the detection level of FC-143 (0.004 p p m ) . EID090078 8E T T E R T H IN G S FO R B E TT ER LIVING . . .T H R O U G H C H E M ISTR Y 000161 AJP002919 iAL>IU'l.lU J. Page 2 PERSONAL S CONFIDENTIAL H. E. SERENBETZ -2- Ma y 6, 1981 We advise against this step beca u s e our information is limited. 1. The evidence that FC-143 %3 a teratogen in the rat is inconclusive. Teratogenic tests meeting current standards are being carried out by 3M and Du Pont and results should be available by Q3-81. 2. Even if the preliminary 3U study is assumed to demonstrate teratogenicity3 it is inadequate for setting acceptable exposure standards. The cur rent animal studies should provide a basis for establishment of acceptable workplace standards. The human data now being collected should also help in setting standards. 3. Because of the unusual difference between male and female rats in their rate of excreting FC-1433 the rat may not be the best model for man. A better model is being sought. 4. We need many more measurements before we can say that the background level of FC-143 in the popu lation of the U.S. women is less than 0.004 ppm. 5. FC-143 has been in use for decades without appar ent adverse effects in humans. We recommend that our acceptable blood level of 0.4 ppm not be changed until we have more definitive information. We should have enough information for a decision in a few months. The departments have already taken significant steps to lower exposure to FC-143. A few months, particularly with lowered exposure, should not significantly extend the hazard of a sub stance that has been in use for many years. J. R. Gibson, D i r e c t o r of Health and Safety, concurs w ith our conclusions. CFR/BWK/bj d EID090079 AJP002920 000162 PERSONAL S CONFIDENTIAL H. E. SERENBETZ -3- Page 3 M a y 6, 1981 cc's to: J. R. Gibson, Admn, D-9058 W. E. Tatum, Admn, D-9064 F. E. French, Jr., CP, B-17249 A. L. Dade, FF, B-2202 . A. C. Haven, Inti, D-3047 G. A. Hapka, Legal, B-13373 C. C. Griffith, Photo, RSQ-210 J. T. Smith, P P D , D-12008 J. L. S t o w e l l , PA, D-8112 R. L. Rhodes, Fibr, N-4448 H. E. Simmons, Jr., CRD, D-6036 B. C. McKusick, CR8D, Haskell J. G. Aftosmis, CR$D, Haskell AJP002921 i EID090080 000163 cs-nro Page 1 (CC ' S- listed an page 2) (S T U U S N O M E. I. du Po n t de N emours 51 Company IHCOM B M T M W ILM IN G TO N . DELAW ARE 19898 CENTRAL RESEARCH & DEVELOPMENT DEPARTMENT HASKELL LABORATORY TOXICOLOGY AND INDUSTRIAL M EDICINE April 10, 1981 PERSONAL S CONFIDENTIAL M E M O TO: H. E. S E R E N B E T Z PPD, M-642 FROM C. F. REINHARDT, M.D. , CRD, HASK LL B. W. KARRH, M . D , ERD, N - 1 1 4 0 0 Z E1D090081 _______ _________ _________F C - 143 (Ammonium perfluorooctanoate; C-8; CAS-3825-26-1) At your request, we have reviewed the information pert in ent to w h e t h e r FC-143 is a teratogen. During the many years that Du Pont has used FC-143, there has been no known evidence of adverse health effects from e m p l o y e e exposure. However, our supplier o f FC-143 (3M) informed Du Pont on March 20, 1981, that FC-143 caused defects (abnormal eye lenses) in rat fetuses when fed daily (days 6-15) to p r e g nant rats by stom a c h tube at doses o f 25 or 150 m g/kg body weight. This observation was from a pilot study designed to determine the maximum dosage rate that pregnant females could tolerate in p r e p aration for a full-scale study to assess FC-143's teratogenic potential. On M a r c h 27 two H a s k e l l scientists, Dr. R. E. Staples, Staff T e r a t o l o g i s t , and Dr. T. Chiu, Se n i o r Resea r c h Pathologist, visited 3M and reviewed the data with several 3M scientists. Staples and Chiu concurred with 3M that the lens defects were probably caused by FC-143. Both Du Pont and 3M plan to start full-scale teratogenicity studies promptly. A major goal will be to determine a dosage or exposure concentration of FC-143 that does not cause birth defects and to relate this dosage to blood levels of FC-143. Until we have these data, we have no good basis for setting an acceptable exposure limit (AEL) for women of childbearing capacity. We recom mend that women of childbearing capacity be removed from jobs w h e r e it has b een d e m o n s t r a t e d that there is p o t e n t i a l for e x p o sure to FC-143 and blood levels of FC-143 are above defined back ground levels (0-0.4 ppm). Areas where the employees have blood levels of organic fluorine in the background range and where the airborne concentration of FC-143 is in compliance with our provisional allowable exposure limit of 0.01 mg/m^ should present no significant risk to the fetus. BETTER T H IN G S FO R B ETTER LIVING . . . TH ROUGH CHEM ISTRY 000164 AJP002922 nx Page 2 JL "A PERSONAL 5 CONFIDENTIAL M E M O TO: H. E. SER E N B E T Z -2- April 10, 1981 J. R. Gibson, D i r e c t o r o f H e a l t h and Safety, concurs with our conclusions. CFR/BWK/bj d cc's to: J. R. GIBSON, ADMN, D-90S8 W. E. TATUM, ADMN, D - 9064 F. E. FRENCH, J R . , C$P, B-17249 A. L. DADE, F$F, B- 2202 A. C. HAVEN, INTL, D - 3047 G. A. HAPKA, LEGAL, B - 13373 C. C. GRIFFITH, PHOTO, RSQ-210 J. T. SMITH, PPD, D'-12008 J. L. STOWELL, PA, D-8112 R. L. RHODES, FIBR, N-4448 H. E. SIMMONS, JR., CR8D, D-6036 B. C. McKUSICK, CR$D, Haskell J. G. A F TOSMIS, CR$D, H A S K E L L AJP002923 EID090082 000165 Page 1 Revised 5/14/81 PERSONAL & CONFIDENTIAL C-8 BLOOD SAMPLING RESULTS Births and Pregnancies PPM C-8 in Blood 0.45 0.28 0.078 1.5 0.013 2.5* 0.048 Status Normal child - b o m June 1980. Transferred out of Fluorocarbons 4/79. Normal child - b o m April 1981. Normal child - b o m April 1981. Umbilical cord blood 0.055 ppm. Five months pregnant. Five months pregnant. Child - 2 plus years. Unconfirmed eye and tear duct defect. Child - 4'months. One nostril and eye defect. Current blood level - in fluorocarbons area only one month before pregnancy. R D I :ldr EID090083 000166 AJP002926 Revised 5/14/81 C-8 Level - Current Washington Work* Female Employees Number of Samples 56 Range Average .0. 013 -.5. 1 0. 92 p p m C-8 Number Above tl It 11 II 1 II II 11 0.05 ppm C-8 0.10 It It 0.20 II II 0.30 1 If 0.40 11 II 53 46 35 29 28 AJP002927 R D I :ldr EID090084 000167 rage j r> 5/14/81 C-8 Level Locations Other than Washington Works Location Wilmington Haskell Chestnut Run Spruance Fairfield Toledo Circleville N o . of Samples 32 9 15 27 5 7 10 PPM C-8 Range ND ND - 0.030 ND - 0.043 ND - 0.070 ND - 0.048 ND - 0.014 ND - 0.030 PPM C-8 Average ND 0.007 0.006 0.027 0.014 0.003 0.014 AJP002928 RDI:ldr EID0S(0085 000168