Document 8j0q98y7NYy5eVyRdzNdKK9k

ftoy T OottMrnan -*m Sector March 22, 1985 To: Robert Buehler @ BF Goodrich, Washington,D.C. George Snider, Ji . @ BF Goodrich, Cleveland Subject: Critique of Repace and Lowery's Paper on Car icers Due to VCM Exposure John Barr, of Air Prc iducts, has reviewed the Repace and Lower] paper at my request. I attach copies of h: s comments and papers he has provided. The conclusion is tha t this paper uses information that is c ated, the estimates are inflated as to ca ncer deaths -- in short, the paper is a biased and erroneous estimate. For your information a nd comments. Regards. fob ClUruJi/ Knj A O'V'S/C - Qf THE SOCIETY OF THE PU .STICS INDUSTRY. INC 355 LEXINGTON AVENUE NEW r: )RK NV 10017 1212) 573-9400 SPI-00150 toy T. Gottmman Ixecutivs Director March 15, 1985 To: Mr. John Barr @ Air Products and Chemicals Dear John: Attached is the Repace and Lowery paper that I discussed with you on the phone today along with the critiques by Elizabeth Anderson and Dr. Sorrel Schwartz of Georgetown Univ. The source of the <27 cancer deaths due to vinyl chloride is the 1975 USEPA Proposed Standard for Vinyl Chloride under NESHAPS. As discussed, I would greatly appreciate your review of the attached, your comments and copies of any publications that discredit this assessment on cancer deaths due to vinyl chloride. As you pointed out, this was an estimate prior to the installation of the control devices to comply with the OSHA and EPA standards. Please return thse papers to me and thanks for your help. esman A Division of THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 355 LEXINGTON AVENUE NEW YORK, N Y 10017 (212) 573-9400 SPI-00151 Air Products artd Cherrvca)s. Inc. A '3105 '' 5i 48' -95 1 & * RECEIVED ___ AIR'-, mar 2ms products!^ DEL EL L .GOJTESlVtAtl iI 18 March 1985 Dr. Roy T. Gottesman Director, The Vinyl Institute 355 Lexington Avenue New York, NY 10017 Dear Roy: I have reviewed the papf r by Repace and Lowray on passive smoking for its reference to vinyl chi or de as being responsible for 27 deaths per year in the general public. There is no support for that number. There is a statement on p. 22 that "table 5 given a comparison of the estimated risk of passive sir*c|king to risks estimated by the US EPA for the carcinogenic hazardous air pc 1 lutants currently regulated under Section 112 of the CAA". This would lead a reader to assume the risks presented in the referenced table are 1|he current risks from those pollutants. The heading to the table states, however, that the mortality is before control, leading to the quest ion of why the data are presented if they are known to be inaccurate. Vinyl chloride is listec as "<27 CDs per year", and the reference is 40 FR 59532, proposed VC stardard. I no longer have that document available to me, but the preamble to the standard as promulgated at 41 FR 46560 says that the EPA estinated by the linear dose response curve a range of "from less than 1 to 10" cases of ASL per year, and 0.1 to 0.01 log prohibit model. They also stated that "an equal number of primary dancer at other sites" is expected "for a total of somewhere between le|ss than one to twenty cases per year". It went on to say that regulations is expected to reduce the amount of VC emitted by 95%, and the number of cas es "at least in proportion" to that reduction. These estimates come froh an unpublished report by Kusmack and McGaughy, in December of 1975 and are based on very scanty, and selected (by them) data. You will fin|d a discussion of that estimate in the paper I presented at New Orleans in 1982, and in a longer discussion in the draft Chapter for the New Enc/'clopedia of PVC whch I sent you last year, Their estimate has been widely quoted as 20, with no "up to" or other qualifier used. SPI-00152 -2- For example, see Ander; on, et al., Risk Analysis 3 277 (1983) table V(b). There VC is listed fi r 20 deaths before regulation, 1 after. This is not exactly nev|/s. As 41 FR 46560 stated in October of 1976, the "up to 20" estimate was expected to be reduced "at least by 95%". Ray Albert, the "father of the CAG group at EPA confirmed this in 1978 in a letter to the Gene ral Counsel of EPA in which he gives the same before/after figures which Anderson published in 1983. The ERA proposal to am(nd the VC standard says at 50 FR 1182 that "the risk attributed to expc sure to VC. . . have been estimated to be 0.28 cases per year for ASL and C .55 cases per year for all cancer". This is based on 95% reduction figur e, but for some reason the starting point had dropped to eleven. If you fjave kept up with our contacts with EPA on this review of the VC standard, will remember that they published data showing that the reduction dctually has been over 99%, in the TRW report EPA-450/3-87-003, February 982. The point must be made that all of these "estimates" are subject to serious questions of vali dity See my APCA paper. The fact is that neither EPA nor CDC has ever found even one person, not to mention 20 per year for 40 years, who has any indication of health effects from ambient exposure to VC. The use of table 5 by Repace and Lowrey can best be characterized as yet another careless misuse jf faulty data in a manner more suited to serving the desired ends of the author than the search for truth. The error is made more egregious by the fact that both Anderson and H. Gribb, the person who actually prep red the "review" of the paper for her, are listed as authors of the 198$ Risk Analysis paper, and thus are presumed to be aware of the data used in their paper. Their failure to recognize the error in this paper sugg ;sts either a lack of concern for the contents of the paper being reviewed )r a disregard for the presence of erroneous data. I paid little attention to the rest of the paper by R&L. The EPA recently has acknowledged thkt it has been following a will'o'wisp in the hazardous air pollutant area and has been busy writing papers trying to justify some new area to regjj late, such as indoor pollution. This is one such self-serving attempt, Ipote that none of the reviewers gave any real support to the basic concepti of the paper. SPI-00153 -3- I hope that this is use ful to you. More details can be furnished if needed, but the basic facts are that the "27" number is wrong, and was used in an incorrect context . If there are any cases, they are "less than" 1 per year by several orders of magnitude. Sincerely yours, Jcrhflr^vBarr, Manager Regulatory Response JTB:csb SPI-00154 a Uai oc o (X_> u>> u Ui alO. OS Ui Q- U</>i ui <S) iSi * 00 < CO Z _J < <> u -1 QC -- > as X CO C<D Ui z Xz m O Ui a. >-- a z* Z <z XX o in H- H* wz 3 Ui a -j O-J o: persons. A nleal s tu d ie s have shown an excess o f tu a o rs a t o th e r s ite s , b u t the low est exposures a t w hich these occur a re c o n s id e ra b ly h ig h e r than th a t fo r ASL. F or e x a a p le , M a lto n i (1979) re p o rte d th e fo llo w in g data: 9 00 0-- 25 aa aaaa a o o o o o o in ooo 9o 9 o O O "<* ooa n---- 9 s *u 0u0u 85 82 0 .. -- 0 0 85i o-- c Ww* ao --* ks k 471 0 k a a 0 x e> u O 3 0 bX a> 0-- -- 21 1 0 Ww 58 M VI o w0 --k- o w w 0 > Wl x -o -- U Ue O U VI VoIII K 0 *1 u. 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S j . |-- c -- 9 w ^ -- <A Tl r"l > - u 90 0* -- -- "O -- 3 W k k -- * oa * c>a o ao ^ "o i3 . -- 41 Wl X -0 2 ^ <0 -- * oc o c < lA 14 O --*0 4J c 0 _ c <4 U *0 3 -- Vw *C U0 U-- 3 4> -- * J^u c wfl <4 S 4> 3 41 C n -- v. UJ <4 -- oe us ee *-- s o i. i -- 4f U w* J a o <4 -- u a* c o 4 3 *4 c a. u k. o *a u UKO C * U viifl o * o. >X j9U 0ui 41 a --O uw o-- c U A. -- O xw a O-- W C r 3 a-- s C <A u O <4 . c--3 -- j <9 <4 91 - C --O 4> aC ^-- --U) -- 3 IA 4A Q.-- x>iS .Oko ac A a. u -*J ' > - U 41 4- -- <4 --{ * 3S 4 uj >.-- Xu a 0 --o <4 A a <_i i- U C2 <4 3 m m 9> M fi (J 51 j! S' X CN CO T- o 0 1 5T (/) o <c0 e -> O3 tA -- XO O CL Is u> x s o** si uj *k C 4) >A -- >k O wA> A- 3 0) -- ini ^ a O -- O xo O u. 0) ss -- o >* OK Jtf 91 tA -- o-- H- I U. X <_> 4 O > >-- A. we 4> <0 4i a-- --o c:zx uj k -51 k k -< QX .O -- lA 4> W 9 i; k O a uu ~-- 0 u. x r* M O 91 ir. <4 01 4> -- OO *J , iA 9 hr e m-- Iw i o1 Uf o I at>. O a k --1 c-- 5 a I s". o c \* c <A a If c 4l O 3 a> o 0* *. <0 IA O 41 C {J <4 41 -- 01 X - UW i/ P*. A CO *1 i <*> 3 3 00*i u Ow o -- 41 -- Lk. <4 -- 4 -- i4 a <j c c 41 -- *o /> X C_) -- a --* a jC r. u --a *-->. co --a > >> o wc ra CO 3! e4> oa a* 41 - w -- UO O 4> __ w|? O 0-- s-H 4* 41 O ax a < j- o o< O <0 t. rx cl a <j k 41 O *J &CD O 41 <1 k ac i &a --a C<0 C CO CCK i: is is s ? Cb 0I XdJ c wl UJ UJ 4x1 b ek Uj o k - -- >* c c-- is* > ** Ul e 14 o uj 3 a M yCD OO i a w oC- C*# **-j > c~ e <e ft -- 3 **V U-- V y~ * o o u "io *w At t: u H * ftW <* w k b 0 s & -- -r e >-- yO * e -- CD i C b* ;M b Wl <-- fv eo --./ O' *ft o O' <* O ft & b u i c e/i -- * ~ W ft 41 * m Ai r TABLE I SUMMARY OF Q U AN TITATIVE RISK ASSESSMENTS FOR VC Sp 1-00164 -3 0z2 >< y>> >5 Zo x S sg i ae 1 i 11 = s o> 5 x xV 8 i oczn o 2 & >c o X -< 8 X Z 2 > z zc s> a> 2HH > 2 a c l > W N> O f_ x *cCT O' -o 8s' -< aaaa >>>> HHHH X C c z> aa >> Y S x0 U ^ X t " - a *51 i S X tow vm? X o o> mO S 2O O r oX to ^ B > < z z aa >> h xc xc s2 >z > Z a > - o r k u ! II III o m Q8 c1 l! TM *n aO R* *o 4 IHI 82 f 9 >C SI? * 5 ?! 8 2l 81 r- O 55 2-?( !T >e o- m... Oo oa -- m r1 oi * * > sWnr m>a zrO> r2 5 n O *a 2-- o > S2O omoo*; O < > nrG . . nn O -5 --O O O 2! z 5 a S Cl Cl ft > a 3 >a > 2 a 5 - 3 Or rO g2 1! |u" u oanO *K rx -- > a> h H> o >z o TABLE II REGULATORY STATUS OF VINYL CHLORIDE AGENCY BATF CPSC FDA EPA OSHA CONTROLLED LEVEL BANNED AS LIQUOR BOTTLE BANNED IN CONSUMER PRODUCTS USE IN RIGID FOOD PACKAGING QUESTIONED APPROXIMATELY 0.2 ppb 1 ppm 8-HR TWO MAX MUM 0.5 ppm ACTION LEVEL PHILOSOPHY ADULTERANT ZERO RISK CONSIDERING ACCEPTABLE RISK BEST AVAILABLE TECHNOLOGY LOWEST FEASIBLE LEVEL T TABLE III EQUATIONS FOR CURVES FITTED TO VARIOUS SINGLE AND COMBINED MALTONI EXPERIMENTS EXPERIMENT LINEAR *b b r LOG PROBIT Pm IN DOSE * b br CONCENTRATION AT 10- RISK. (LOG-PROBIT), ppm BT-1 PLUS CONTROLS to O BT-2 PLUS CONTROLS 0.26 0.27 3.05 1.52 3.36 2.47 -6.59 1.13 0.97 0.97 1.0 0.88 0.35 1.60 2.76 0.88 0.99 1.0 0.03 23 BT-15 PLUS CONTROLS 6.5 5.28 1.06 -0.30 1.0 0.95 0.69 3.46 1.0 0.34 ALL INHALATION STUDIES (4) plus controls 0.26 0.27 3.07 2.80 0.91 0.91 0.27 2.98 0.82 0.002 ALL INGESTION STUDIES (21 PLUS CONTROLS 1.75 1.74 0.15 0.20 0.95 0.95 0.30 3.22 0.88 0.002 ALL STUDIES (6) plus controls 0.29 0.29 3.60 3.41 0.73 0.72 0.27 3.05 0.82 0.001 ALL STUDIES. LOW DOSES ONLY PLUS CONTROLS 1.03 0.97 0.79 0.51 0.17 2.53 2.71 0.75 0.49 0.42 0.0002 to ,-Z R SPI-00165 k,,L> U A * ,v' ' *01 i .w .s<-1 UNITED 5TA* !3 tNV! RCN M ENTAL PROTEC `ION AGENC' WASHINGTON. 0.0. 20-150 1 6 JU?i 137B SUBJECT Compari sc with risk OPTICS CP '=5cA3CH A,NO CEV!_Oia'Ae.NT of vinyl chloride carcinogenic r i s k s from other pollutants. p R CM : bert, C h a rim a n n Assessment Group TO : Ronald S Naveen, Office of General Counsel At your reques 1., we have summarized preliminary risk estimates recently drafted Dy the Carcinogen Assessment Group and compared them with the risks from vinyl chloride. ine carci nogem c risks to vinyl chloride exposure in the ambient air near VC and PVC manufacturing plants can be compared with the r isks to other air pollutants which the age n cy is n ow ex ami ning for possible regulation. Two commonly used me a si res of risk are the lifetime probaoililty of excess cancer de aths in the population with highest exposure and the tc tal number of excess cancer deaths in the entire exposed population. These are summarized in the attached table. In this taole t he risk estimates for pollutants other than vi ny 1 chloride are preliminary and may be modified after p ud1ic .r eview The taole shows that, after regulation, vinyl c hloride is estimated to cause the lowest numoer of total can cer cases of all pollutants considered, and is estimated to cause individual risks to t.ne most heavily exposed peo pie that are about the same as typically seen with the o t h e r pol luta-nts. SPI-00166 (O ~ to- 1 w1 i " ! rz ^ : : 31 1 * --= X , J : ; Z. X --' ; ; 4- ! -- >- ! NsJ tn | _3 | JZ ~>l E wl 3 1 ! i i i ; i i/> | _Z 1 = cl 3 X1 Z uj j 1 1 1 ! 1 > 1 s 31 o1 o ol 3J <*- X 1 o UJ 1 3 (N. CNJ -- X o fsi >, 5v 4* to |\ -- S1 ' to-- j x 1 *" s i0 1 Jr-> ft i JO 1 1 --> 1 1 X ! 1 5 5 ! r-5 c --1 --> .3! * O & ~i 4- <3 i -- 1 _ i t i i ! | ! ?Z ' 1 -- ! 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