Document o9ze8mjRLYNN5r10dVew2p1NX

IH.OtS UNITED STATES ""OVERNMENT Memorandum kecm-v' 'jf FI t 'v* U.S. CONSUMER PRODUCT SAFETY COMMISSION TO THRU * The Commissioners HOV l3 M 0 - : Michael Brown, Executive Director xJUU^J 1. DATE Oct. 31, 1978 FPOM ; Joann H. Langston, Associate EJ^pir., Hazard Identification dc^nalysis.^-^ j/ Don Clay, Acting Associate Exec. Dir., Engineering and Science subject : staff Chemical Screening Procedures and Transmittal of Information on Certain Chemicals The purpose of this memo is to transmit information on two lists of carcino genic chemicals and to Inform the Commission about the procedures that are used by the staff to screen information on chemicals for their carcinogenicity and for their presence in consumer products. Reports and other information on chemicals that have been received periodically by the staff are being processed systemati cally in order to provide the information the Commission needs for its decision making. These procedures are described belowj specific reference is made to the lists which are the result of applying these procedures. On October 5, 1978, the Commission directed the staff to provide information on two lists of chemicals totaling 53, that had come to the Commission's attention. These lists are the International Agency for Research on Cancer (IARC), compilation of 26 known human carcinogens and a current listing of 27 National Cancer Institute (NCI) bioassay reports which show carcinogenic effects in animals. The lists of chemicals and the accompanying information are attached. The lists represent a partial output of the continuing screening process and, as such, they are certain to change as additional information Is acquired. The two lists of 53 chemicals have been separated and recombined into 4 lists in order to show more easily the process status of each chemical. List 1. The original two lists: all 26 chemicals from the IARC human carcinogen list and all 27 chemicals that show carcinogenic responses in animals selected by the staff from 102 bioassays received from NCI. List 2. Those chemicals from List 1 for which the staff has determined Cl , CO f-N. LJ that the Commission has no jurisdiction. > List 3. Those chemicals from List 1 for which regulatory action has been, l: cj * -- cCuO z CO or is being, taken by CPSC or another agency. List U. The remaining chemicals that are of interest to CPSC because they may be possible candidates for remedial action. These chemicals need additional investigation or research work to further establish their priority rankings, determine whether they are in consumer products and determine whether they may pose a hazard to consumers. AP00011094 2- - The IARC list of 26 is, for the most part, an old list which incorporates many of the well known carcinogens that have long been the target of concern by this agency, other agencies and the IRLG. Several have been regulated by CP5C. Eight of the chemicals are considered by the staff to require some additional investigation to determine their precise status with regard to hazards, the jurisdiction of CPSC and possible remedial alternatives. The list of 27 chemicals was derived by the staff of Hazard Identification and Analysis (HIA) and Engineering and Science (ES)over the past two months from 102 NCI bioassay reports that had been received by August 1978. The 27 have reached an interim stage in the ongoing screening process of the carcinogen policy. They are chemicals that have the possibility of being in consumer products and that are possible carcinogens. Since screening is Incomplete on ail these chemicals, no definite answer to the likelihood of their being candidates for remedial action can be made at this time. The 75 other chemicals from the J02 bioassay reports have been dropped from further consideration on the basis of jurisdiction or Jack of evidence of carcinogenicity. List 4 contains the 8 chemicals from the IARC listj on which further infor mation must be developed, and the 27 chemicals selected from the bioassay reports. We emphasize that these chemicals are now in the process of being assessed for their remedial requirements. List 4 arrays these chemicals in a preliminary ordering for further study which will provide the toxicological, use, and exposure data with which the Commission can make decisions on whether to pursue remedial action. As new bioassay reports and other information are received, additions will be made to the group that List 4 represents. For example, two other groups of bioassay reports, totaling 31, were started through the screening process in October and an additional group of 37 was received last week and are about to start the process. The procedure that the staff is using to handle all candidates for screen ing is essentially as follows: (1) New (NCI) bioassay reports (or reports indicating a carcinogenic con cern from any source) are received by ES or HIA and a copy is immediately sent to the National Injury Information Clearinghouse for retention with notice of the transfer sent to other HIA and ES staff and OPM. The report is then handied by each unit according to its assigned function. (2) A list of these new bioassay reports is prepared by EpidemiologyProgram Analysis and, in consultation with Economic Analysis, each report is given a preliminary priority ranking. (3) This initial list (the 102 bioassays was such a list) is forwarded to Health Sciences for a preliminary indication as to whether the substance may be carcinogenic (yes-no) (the list of 27 chemicals from the bioassay reports is the result of this step in the screening process). AP00011095 -3- The purpose of the first three steps is to organize the chemical data, start them through the formal screening process and eliminate those chemicals which definitely do not warrant further CPSC consideration, thus conserving resources. (4) Program Analysis processes the "yes" chemicals by searching several computer data bases for toxicological, product and use information, and provides these data to Economics, (5) On the basis of this and other information, Economics makes a deter mination of whether each chemical is in a consumer product and prepares a written report to that effect. Lists of those chemicals which are eliminated because of jurisdiction (i.e., drugs, pesticides, etc.) are forwarded to the Office of the General Counsel for its concurrence. (6) If the chemical is found to be contained in a consumer product, the package of data and the report are forwarded to Health Sciences, which, in turn, makes a definitive determination and prepares a report on the chemical's carcino genicity on existing information, if possible, or indicates what additional informa tion must be sought or developed. These searches and assorted analyses are in process for the 35 chemicals on List 4. (7) These two reports form the basis upon which the Office of Program Management, working with the Chronic Hazards Team, develops a briefing package that informs the Commission about the chemical and provides priority recom mendations and regulatory options. These procedures represent how reports that are received periodically are handled by the staff. The essential guiding principle is immediate communication among all functional units at this early stage in the process of handling carcinogens so that items are dealt with promptly, tracking of items is established, and resource expenditures are conserved. cc: OPM AP00011096 ] 1/1/78 CARCINOGENS FROM IARC LIST OF HUMAN CARCINOGENS AND BIOA5SAYS . A. IARC List (26) of Human Carcinogens Aflatoxins Aminobiphenyi Arsenic Compounds Asbestos Aurainine Benzene Benzidine Bis (chloromethyl) ether Cadmium Chlora Amphenicol Chloromethyl Ether Chromium Cyclophosphamide Diethylstilbestrol ^ C( t/. a Hematite Mining (Radon) Isopropyl Oils Melphalan Mustard Gas 2-Naphtylamine Nickel (Refining) N-N Bis (2 Chloroethyl) 2 Naphthalamine Oxymetholone Phenacetin Phenytoin Soot, Tars, Oils Vinyl Chloride ? B. Aniline Hydrochloride 3-Amino-r-EthoxyacetaniIide ,5-Nitroacenapthene 1,5-Napthalene Diamine 2,4-Dinitro-Toluene 4-Chloro-m Phenylene Diamine 4-Amino-2-Nitrophenol 2-Aminoanthaquinone Trimethyl thiourea Tri methyl Phosphate 5-ChJoro-o-Toluidine 1,1,2-Trichloroethane Hexachloroethane 3,3,~Dimethoxybenzidine-4,V- Diisocyanate pjvaloiactone NCI Bioassay Data ft* -- 3-Am ino-9-Ethylcarba zole (Hydrochloride) Hydrazobenzene p-Cresidine 2.4-Diaminoanisole Sulfate m-Cresidine O-Anisidine Hydrochloride 2-Methyl-l-Nitroanthraquinone 1.2-Dibromoethane Nitrotriacetic Acid (NTA) and Nitrilotriacetic Acid, Trisodium Salt, Monohydrate 1.4-Dioxane Cupferron N-N'-Diethyl thiourea Daminozide 1.1.2.2-Tetrachloroethane AP0001I097 List 2. Carcinogens for Which CPSC Lacks Jurisdiction ]ARC List of Human Carcinogens n/i/78 Substance Af XatoMins Carcinogen Data I.iver carcinogen Use Bloavaliability Potential exposure Food microorganism toxin Ingestion and Uptake Not In consumer productn. B1 s (cMoto* net hyl) ether I.ung cancer Ocrupat lotinl exposures Odor ,vnl^plteidcol Hemopoietic system Oiloro-- ethyl ether hung cancer Occupational exposure: Cyclo Bladder phosphamide Dlethyl- Uterus, vagina etllbestrol Hematite H l n 1 rM (Ratlut*?) Isopropyl ol Is Melphalan I.ung Occupational exposure Nasal, larnyx ,'Hemopoetlc . system Monlard (|a {2 ch loreethy'D 2 ! naphtha l * ami ne Uinq, larnyx Bladder 1 Chemical Intermediate Medicinal Chemical intermediate Medicinal Medicinal Ore production By product Medicinal War gas Medicinal inhalation Injection Inhalation Injection Oral Inhalation Inhalation Injection Inhalation Oral Mot In consumar products. Not In consumer products. Not In consumer products. Hot in consumer products. Not In consumer products. Not In consumer products. (Hado or Hematite) Not in consumer products. Not In consumer products. Not in consumer products List 2. Carcinogens for Which CPSC Lacks 3urisdiction 1AUC List'of Human Carcinogens Substance Carcinogen l>at a Oxyme t Ivolone Liver Plienacet 1 n Kidney Piicnytoi n I.ymjihoret lcular tissues Soot, Inrs, and oils l,unq skin (scrotun) Use Medicinal Medicinal Medicinal Hy products tiloavallablltty Oral Oral Oral Injection Inhalation, skin Potent ial Exftosure Hot In constwnrr products. Not in coMiper products. Not in consumer products. Environmental. AP00011100 List 3. Carcinogens llcing Regulated by CPSC or Other Agencies IARC List of Human Carcinogens `) Substance Asbestos Carclnoqen Data Use Human epidemiology Lung cancer Insulation, fire resistant fabrics, brake linings, etc. Benzene Leukemias by occupational exposures Petrochemical Inter mediate and solvent Vinyl cMor Lde l.lver, lung Occupational ex|x>sure Chemical Intermediate Bioavallebl1Ity Polentlal P.K|>onurfl Inhalation, little movement thereafter Skin absorption, Inhalation, ingest Ion Inhalation Naturally occurrinq conta minant. Wide consumer exposure. Occurs naturally In petro chemicals. Previously regulated. Apooot n o t Snbstnnro J List *i. Ranking of Carcinogens for Further Atienion IAUC List of Human Carcinogens CrcimH|on Itato ttefl Rlonvnllubll I ly i i. l"<*leiil |n| r.x|Hinoin Atiranlne lllnilili'r cmicer OccupAt lon.il e*lo3ure Dyfin, |Hpsr, c.irdltoard /J. I foy.i tlclaljollzed by mwwi 1 s ]iK|Rsllon Nfde. |tn;. ll 1 itc nnltie cancer OcctipaLloua I ex|K>snres I Bladder cancer Omiyatlonsl fx|K>sure Nlf-kc) (l C f inimj) H.irifll, Innq nx|msuie l>ye Jitter Mediate t>ye JnterMcdJate Hetiil plating, alloys chentcals Arreitlc (Ainq and akin cancer Occupat Icmnl axpORUlea Fuiiqlclde Inhalation, Iwiustlon akin absorption Inhalation akin oral I Inhalation l i I I CjhImIim Cltronluw rrontrate cancer occupational exposure Iahki, nose cancer Occ|uit l on* l exposure I'latlnq, dyes, fiiT|lcldee| Inhalation Metal plating, alloys ctienlcels Inhalation Anl itobiplieity 1 Bladder rnnncr - Occupa~ L tonal exposures Hultlter antioxidant Inhalation, skin alxiorpt Jon Fabric, leather, p,titer dye -- very wide. /4e. Widespread an notel In conaunnr proilticly Naturally occtiirliiq contentnant. Wide expomire lit conmtwer |irodi*-u ns anlLs and netal. ftjm4 /Us p4Ai/ t 8* % 0 % u i I IM OX II 09 5' a 5 9 ii ! 33 XX aa ll * % ft as 99 XX aa ll * sft a** aa 33 X3 aj LL ft ft) a5 ! f- 3'i_~Sc9. aC.--S' 3^r* 9ft 3Vi o *< * -- s. r a oa-ft m $--as aas o raa -- y-- 1f*t a m * x IV --a i; rf rf aa a Sft -- a f* -- a v e id IfTt S--cn' 53 s --r "-t--I *la>* i noica<* aa a ? ~k a 52 wan eft o 0rrs-iu.-5si--ao^----is' 17 * < a < a ^* COO & ft -- *r 3 ai 9 IrS s rs a s ff s II j: s * H a* ta X-- <a s* a 3i * a ft ft i a 9 s e ~Z ii 3 *- <9 a *3 t--* >9 ft. > f5t u-- id5. 3 --3 a ft rt--f*t --*r ? r-- --ea a -3>-s ^u --ifat- ~* aft as i-- s < 3-- a8 j-- --:i a O-- 0n ar 3 5--o a -- 33 5 S 3. -- Oft re 3 ift ft s d a. -ft a x ffstefoat aaffttSaa5 fs_fttn^iS --Oaft a --o t> a i To 5 - S t > r v i-O s na ssft it < a > - 1* a --< S=. s--s ---- -- ft --a3 a --a e = ?a ?5 3f -- rT .5 ? Ui i 2 S Tft *- s* 5 3 ft & f 0fot* if-t 5w reft- 3aa a--5 36 II . &CS aSt** gSi gft *i*g ft >--55 fot* cfat rt-ft 7aot* -es 9_y- .si a -c , 33 : ---- . QUO *8x1 ft -- 09 fl O B. S' ' l*ir I ?E = 3a AP00011I02 AP00011103 StlllSt AIIC'C* Carcinogen Data Htn llloAiiSAIf UATA tine Dleave I tail I Illy pot ant I nl EM|KkSiire Nil rotriaocl.li; Acid (WTA) ami Nitriletriacetlc Acid, TrI sodium Salt, Monohydrato TrimthyL Flioaphate W-M'-IJlothyltliiourea (4) In M ami F rat n (I) In M and F mice Hoplacomont for phos|hatc9 in iletpr(|cnl!i. Major K>n-<tctergent uses Include water treat wilt, teat I la treatment, metal plating and cleaning, aiul pulp ami paper prnreAninq. Ijiathcr tanning, photographic develop ment, synthetic nihher production, manufacture o f pliarmaceut lea 19, agriculture, ami separation of rare earth elements. IF present, avail able For absorption Significant* (7) In M rota (fibromas of sub cutaneous tissue) (-) In F rats (-) In H mice (1) F mice in Alkylating agent used as a gasoline additive, a methylating agent, an Intermediate for the production of polymuthyl polyphoiiphates, flame retardant In polymers. Known to cause sterility In mice, rats, and ralibl ts, | produces chromosomal abnormalities in the hone marrow cells of rats am! dominant lethal effects In mice. Available commercially, but no longer Kinufaclmeil in the 11.S. It9 production nml t mlustr J al a|>pl I callous could result In the exposure of workers lit llio chemical industry. (4) In H ami F rats (-) In M and F mice Corrosion Inhibitor for ferrus metals and a vulcanization accelerator In tlte { manufacture of j elastomers. 1 I Createst for workers mapii factor log tills compound, ami (or others using corrosion lull I ll 11 ve solutions. Workers In e las' Industry. Substance 1, ?-fl)bro*dethane NCI UIPASbAY DA IA Carcinogen Oat* (4-) in H and P rats (t) In H and P mica I, Uso Bioavaltabillty ! Used in gasoline as a lead scavenger* alao used as a soli and grain fumigant* lias been used as a solvent ami chemical Intermediate. Probably high. Severe irritant* inducing blisters subsequent to der~ mal exposure* upon inhalation* It causes pulmonary lesions and mild central nervous system depression* Potential Rxpoaure I I ! Extensive potential for Inman e*|>oaiir*. i AP00011104 SllltSl rltlCC Pivnlolactoiie l.J'-nlinetlioJiybenrldiite-4,4 ' Dliaocyaiiate llexactiloroethane Carcinogen IXnta NCI R10A5SAY PAYA Use Bloavoiiabl|J ty j Folentlal ttx|K>niire (l) In H and T rata <-) In H and F alcn (*-> *ln M ami P rats (-) In H and F nice Preparation of co(olymers for sutures* prosthetic devices* etc.* and as a pjastlclrer for cyanoacrylate adhesives. Probably low because it is used as co-polymers. Greatest fur workers engaged In tl*# pepnraLlon of this cnn|K>mtd or co polymers. Upon not appear to be produced nr sold in the U.S. In large quant ltles. Used In the nyntbes Is Toxic by Inhalation Hot currently produced of railway car and ingestion at high In large conmercial * couplers* polyure- I thane gaskets and temperatures. irritant. Skin quant. 11 lee. P.x[io8ura limited to researchers* ' seals, aerosol particularly those | mounting cups, lacquere for steel xrsut 1 involved in the experi- ' mental synthesis of cans, and antl- elastomers and |>o 1 y- reflectlve coating merle coatings. for color photo graphs. (-) in H and r rats (+) in N and F nice Veterinary anthel mintic* solvent, a camphor substitute In tlte preparation of Celluloid'*, * rubber vulcanLzJng accelerator, a fermentation retarding agent, nnd used In the production of expIos1ves, py cotechnics, and smoke devices. Risk of Inhalation minimal because the com pound is a solid . with a relatively low vajwrr pressure. Exposure would occur primarily through der mal contact or ingestion. Risk of exposure greatest for workers |n the chemical, rubltnr* plastics, pharmaceutical and explosives Industries, jim! for those |K?raous using the cmqKmnd for veterinary purposes. ! | s APOOOII(05 AP00011106 NCI BIOASSAV DATA ffyd rn zo b e n zM ie (4 ) M aim ) P r a t s (-} in H ami (41 In p nice liy n p vo tm ra o r am i Ontg precutaor. M ot know n, b u t a lK io rb m l follow ing ingestion o r d rm l expoavte. t.ar<j |*o p u 1 a tlo , b u t low ctm u su tra tlo n o u t" sttls o f Ilia In d u s tria l e n viro m a e n t am i ilru y n s a rs . AP00011107 Sul>9 larai! Carcinogen Pnla NCI 1MOASSAV DATA Use Illaava Liability Potential R|Mijinre 5-Nl troncenapllieitc 1, 5-NapthaIcue 01 nmlitf! (4) In H ami P rats |-| Jit N Mint (<) In P Mice '(-) In N and |i) In r< rffcta O) in H ami F mice None In U.S. bye Intermediate Jit Japan. Dye nml 1riKj Intel Mediate Not known, hut absorbed following Ingestion. f.lmlted 1o im*nirli iidern. i r Not known. I<arqe population, Init low concentration nutaide of 11hi Industrial environment ami ilrinf 4-Chloro-m MMiiyletis Diamine p-Cres Idtue () |n H ami 1-1 In T rata (-) In H end (+1 In P Mice (I) in H ami P rata In H ami P nice llye Intermediate. Dye Intermediate Hot known. barge population, hut low concentration out side of the Industrial envlronment. Not known, hut absorbed following Ingestion or dermal exposure. I.urge population, hut low concentration out side of the Industrial environment. Aniline Hydrochloride 111 in H ami P rata (-) In M ami P nice Dye intermediate and drily precursor. Not known, but absorbed following Ingestion, inhalation, or dermal exposure. barge population, but low concentration out side of Hie industrial environment. 5-Chloro-oTolfiJdltte (-) In M and P rata (4) in N ami T nice Dye Intermediate- greatest for worker* In the chemical and dye manufacturing and textile industries. 3-/MmI no-4- Ktlioayacetfliil 1 Ide 'CresIdIno |-| in M ami P rats (4) in H ami P nice pyn intermediate Cor textiles. (4) in H ami P rat.n (?)* in H and <-> P nice Dye Intermediate. Not known, but absorbed following Ingestion. large population, hut low concent rat Ion out side of Hie Industrial environment. Not known, but absorbed following ingestion. large population, hut low concentration out side of thn Industrial environment. AP00011108 StlUsl.Hlt.Y! Carclnogen Data NCI BIOASSAY DATA Use nioavatlability I'Otanttal RMfKISIII R 4-Amlno-2-Ni t ropltenol |<) In H ami (?)*** P rots (-1 In H and F nice In Oxidation iKine For fur dying and In hair dyes. Hot known, hut. absorbed following ingestion. Limited population outnl<le of the Indent rl al environment and Imlr dye users. 2-Hetby1-1-NltroantliracjuiiMme 2 , A-Di ii 11 ro-Toluene () iii M and <-) in r rat*. (Mon-malignant tuaor H and T) t (-) in H and F rats (Mon-malignant tmori in H and F) (-) in N and F nice Dye Intermediate. Hot known, Init al>sorlied following ingestion. tatge population, but low concentration out side of tlie industrial environment. Dye precursor and explosive modifier. Hot known, but absorbed following Ingestion. (.arge population, but low concentration out side of the Industrial environment. i