Document DMRdbjGLZyDY2K7G6zwXGKVnM

JOSEPH E KELLER JEHOME H HECKMAN CHARLES M MEEB*V WILLIAM H BORCPE5AN1 JR ROBERTS TIEHNAN WAYNE V BLACK DAVID L HILL MARTIN W 8E8COVICI PETER M NEHEOV Joseph e. Hadley ccarole Harris PETER THOMAS SMITH MICHAEL Y MORRONE LaRHT S SOLOMON LAW OPTIC KS Keller and Heckman USO ITT" STREET. N\ W SUITE IOOO WASHINGTON, D. C . SOO'Al/'' December 23, 1975 TELEPHONE sos u^-aioo Cable addbtss relman TO: All Members ors^CM/PVC Mailing List Ladies and Gentlemen: Firstly, please accept my apologies for doing a little "over-writing" in the past few days. Unfortunately, we have just learned that we were guilty of omitting a document referred to in our December 19, 1975 letter (No. 8) and have received sufficient calls on the matter so that we thought it would be best to take care of this problem with all of you. At the same time, mention of a few other items of interest can be made. To correct the December 19 omission, enclosed herewith is a copy of the set of Comments the Environmental Protection Agency filed with the Food and Drug Administration. If you check your files, you will note that we made mention of the EPA statement on page 4 of our earlier communication. Following up on the information conveyed on page 5 of letter No. 8, John Lawrence of the Staff of the Society of the Plastics Industry, Inc. has now advised us that he has arranged for duplication of the complete set of our SPI Comments. We gather that copies will be available by next week and that the charge for the same will be $75 to nonmembers of the Society. The charge to members will be $45. As another "straw in the wind" bit of information, we have also been informed that, in response to an official inquiry by a foreign government, the Food and Drug Adminis tration has advised that it expects to take final action of some type on the PVC rulemaking proposal in "three to six months." Obviously, this conflicts with earlier indications SPI-24602 December 23, 1975 Page Two by some FDA Staffers who predicted action within 30 days. However, as those of you who are familiar with FDA pro cedures will realize, we put very little credence in the 30 day prediction and would not be shocked if the three to six month projection proves wholly inaccurate, one way or another. Finally, this is to let you know that, on the basis of a personal check I made this morning, neither the Health Research Group nor any other organized consumer interest entity has yet filed substantive Comments in Docket No. 75 N-0190. We definitely do anticipate such filings so we will be watching carefully for them and will keep you posted on whatever we learn. Enclosure SPl-24603 Hoarink Clor'e Toed sad 1. rug Administration Room 4-r.o 5000 Ushers Lane RockviUa, Maryland 20322 l.'ear Sir: The Knvlronrnc.otal Protection Agency, Office of Water Supply Is pleased to comment on the proposed regulations titled Vinyl Ch'orUe Totyrooro In Contact with I'ootf, 21 CHI Part 121, Pocket No. 75N-C10C. In response to concerns about tho possibility of via? I cMorldc leaching from liVC pipe Into drinking '.valor, SFA's Water Supply Research rivlalon In Cincinnati has developed methods of analysis for vinyl chloride In wolor, These metiiods allow differentiation of vinyl chloride from cyanogen chloride, which In some cases has boon shown to Inlerfsro with tho analytical determinations. Those method-* provide a limit of detection in tho ranee of 0.02 ng/l, which Is several orders of magnitude more sensitive U\nn tho methods applied to VC detection In olhor media, such no hi food simulating solvents (20 ppb), and In polyvinyl chloride (350 ppb), 2i CFR Tarl 121, plCS3f. To date only preliminary data have boon obtained on Iho occurrence of vLnyl chloride la water contacting in-use PVC pips, as reported below. These sites- wore selected because of known locations and egc of instnUe PVC plpoond nmbiant water temperature variations. v,*c nolo that.in each case except for Jonah Walor Supply Corp., Y/lUl&xns County, Texas, where tho pipe U rather new, little or no difference was found betr.cen tho VC concentration in tho source water versus water that had traversed the I-VC plpo and oven in that case tho resulting coucentraJlcn r.aa low (1.2 ppb). X;i olhor cases where VC was found, tovots were welt below l ppb. Those levels of vinyl SPI-24604 V in y l C h lo rid e C o n c e n tra tio n in W ater Length nd s iz e W ater Tem perature (D etection lim it 0.03 u g /l) In flu e n t W ater End o f P ip e bo o> 3c o m C o H "m. co a o o o H 06 06 O0 +3 CM 4 HH 4) a) .. G d -oo cc H 60 ,_3 ci o o *1--^v1 9to 0occ) o .. uc<0 rCHw Vcco 4c4G-11 iurVM-ti mm r*> f*. 1f i1 CM cm <N CM 11 co av m 11 rH 1 O' m CM CM 1 CM Vcod 4ocd) m u*i r~- r-- o co rH CM oo rH rH in CH l CM CM 4cod1 4cod1 mm rn is 11 o CO rH CM ti rH rH cn CM H CM 41 MO M4J i--CH| 4) TJ ,fl 41 to 41 (4 M 4ocd1 1o4-1 Ud 41 *a e 4C) 4o) ui r CM rH 1 O rH H ; CM r m u-( o >4-1 oo - sj O '> ao r*i CM u-l + VI Vni 01 >, rH rH (c4 o N M < m V GO *T3 -H rH o o o s -T r -X) Vh O w O -r4 E th Cn r- cm + r n co t j) 4H O M3 4H a O tr, H e^ r + 01 tl) .e Vi 4-1 <4 d 4) o 5H 6 O' 00 X 4) a. h Vi O O >, u a. c 33 VI o r4 u <4 Vi (J a) c 4J O ffl w Vi ts n 0) <4 a> 4= *iH co _ O rH C rH rH O *iH a. ~1 li s ss CO sO CM <H <44 >H ooo tH *H iH ESS rH O rH H CO H ooo M Vi f <4 41 > r-. VI tx4 41 rH . rH O rH TJ O f4 - rH <4 V) rr cncM UH I4H oo iH -h QS O no (0 (H 4 41 >* O' 1 T 0 O 60 41 Vi o 60 M 3 fd 41 V) O SPI-24605 chloric hav* b^rn detected in : -l^r from l.rnn'uvlr.elou |:ix3 in nci'jni ur.e are v,nll be!ov (?,-? levels have been asr'ccirlcu v.Ub nriveva? effect- In experimental animals. T'oeent MrnMed simulation studies have been convicted cur laborotoric'i uGing Uo loops consisting of 109 feet of 3/4 Inch P/C pips. C;m of the systems consists:! of nou-NSF approved C-X'VC pipe with ttC mg/kg residual monomer, while the other system v-.-m NLT approved C-rvC pipe with 3 mgAg rorsirh^ai monomer content, hamplo.-j were In': on daring periods of flow at 6 ml/min one) also after water Mot had been stopped for several dayn. In iho fLrot finnpiplo f 11C mgAs plpo) VC water concentration ranged from a lo*v of 0. 0 ug/l daring flow periods lo a high of 2 ug/l, 22 clays after flow war, stopped. In the second example, (3 mgAg. pipe), after the initial period, values of about 4 ug/1 were obtained 7 days nflcr flow was stopped. Cur preliminary conclusions arc that the concentrations of vinyl chloride la water La contact with TVC pipe tend to increase nr the monomer cent cut of the pipe, temperature pad contact time increase. Indications are that pipe (hat has been manufactured for water use more recently (within the past 0 months) seems to have a lower free vinyl chloride content than pipe manufactured earlier. However, additional data, especially In existing installations, v;Hl he retired bofore final conclusions can bo readied. JSa part of EX'A'b forthcoming ThHloaal Monitoring Study of Chomicn1 l\ r rial: tag V-.atsr, vinyl chloride will be among a number of flpcclfic chemicals that will be analysed for la approximately 100 major water supply sysiozns across the country. This study will be commencing shortly and. will bo coruploted by September 1970. I understand that a largo scale monitoring effort Is to be conducted by PVC pipe manufac turers. Wo b'Uero that future studies should Include sampling both lsi distribution cystoma and at the tap of homo plumbing a/rstoir.s containing TVC pipe of various ages and types so that an auaoasmont of actual expouuro from those sourcos cau bo made. Sincerely yours. Victor J. Kimm Lepuly Ac.stalrmt Administrator for Vvntor Supply (\7U-10) JACof 't vo :m e:! 2-1 *3- 7 5 SPI-24606