Document 0kzgeaw8JpNB9YEYxOpMX0Lk

UNTSO iwn 5CV**f4M*NT Memorandum u.s. ccnsuwk^ **ceuct IAF17Y CCMMlSSiCN WASHINGTON. ac 8CaC7 Tot Bert G* Simaon Throughs Through: Through: Andrew G. ulsamer# H Rita A, Orzclf HSHE 17'*TV.< ' Lakshni C. Kishra, HSHE APR 191S85 from* hurray S. Cohn, ESHS Subject* Commissioner Statler' s rquiet for carcinogen hazard comparisons As requested by Commissioner Statler# attached is a table ranking consumer products containing carcinogens of present or previous concern to CISC. Bankings of four factors are provided for each products 1. Potency - defined as the milligrams (mg) per kilogram (kg) body weight per day tor life# cf a carcinogen# leading to an estimated 10% chance of developing cancer. The methodology for calculating potency end the uncertainties inherent in this methodology are described in the paper on potency previously provided at Commissioner Statler*a request (see attachment). 2. Exposure - defined as the estimated total numbmx of mg of carcinogen to which a consumer is exposed ffrcm use of a product. cpf J 3. Humber of Persons Exposed per Year's Sale - defined either as; a) the estimated total number of units sold par year# with the assumption that each unit is used# and that the exposure par use leads to the mg value for exposure in (2)# or b) the estimated total number of persons who# in a particular year# are added to that population which, is exposed to a carelriogen cue to manufacture of a product. Once a person becomes a member of this population# the exposure is assumed to last for a certain period of time# depending on the product# which may exceed a year. The total exposura in mg for the duration of use of the product is the value in (2). The difference between categories "a" and "b" is illustrated by the following examples. In the case of benzene in paint recovers, it is assumed that each unit of product sold will# upon use, result in a particular exposure in mg to the person using the product. In other words# one unit of produet sold leads to one person exposed to the number of mg in (2). Thus# method (a) would be applied. In the case of urea-formaldehyde f 5am insulation (UFPI), the number of persons newly exposed per year is different ffrcm the number of units of produce (installations) sold per year, since more than one person resides in a home. Also# the exposure is estimated to last over a nine year period# based on data from UFFZ homes. Thus# method (t) would be applied# with the total number of ng being that to which a person living in a UTTI home is exposed over the nine your period. AP00019885 * *t'tv V- l . .< . '* -1- By utilizing the two procedures described, the total number of persons exposed per ysarfs sale, and thus the estimated number of eases of cancer per year's sale of the different types of products (with respect to usage and exposure pattern) ean be directly compared. One thus does not have to worry about how many years the products have been sold in the past, or will be sold in the future, to compare their estimated adverse effects on the population. >4. Cases per year - defined as the number of cases of cancer estimated to result due to one year's sale of a product. For each of the categories, potency information was taken from, or calculated in the same fashion as the values in, the table of potencies previously provided at Cocxnissloner Statler*s request (see attachment). The exposure was directly taken from previous CFSC materials, or calculated from preliminary data for methylene chloride; if necessary, conversion from the units of exposure previously used to mg was made for purposes of consistency. The number of persons exposed per year's sale was again either taken directly from previous cfsc materials, or estimated by Economics staff in the case of methylene ehloride. Finally, the number of cases of cancer per year's sale was taken from previous CFSC materials as veil, or calculated in the case of methylene chloride. Basically, the estimated number of cases per year's sale is directly proportional to the exposure and number of persons exposed as defined in (2) and (3). Factoring in the effect of potency into projecting the number of cancer cases per year also depends upon the shape of the dose-response curve, and other characteristics of the particular chemical as described in the paper on potency (see attachment) For methylene chloride, the preliminary estimates will change as more data become available. For other chemicals, information from previous CFSC materials, which reflects the exposure generally occurring when CFSC initiated its investigation, vas used, although use of different techniques and more recent data might change the results if reevaluated today. It can be seen from the table that, except for benzidine-based dyes, where the exposure is virtually zero, a predominant factor in formulating the final rankings is the estimated number of persons exposed per year's sale. Potency alone has little bearing on the overall magnitude of the adverse effect on the consumer population as a whole, and it must be considered together with the other factors. These rankings are to be considered as a guide only, and for this reason rankings, rather than numerical values, are displayed in the table. Numerical values upon which these rankings are based are, of course, subject to the uncertainties inherent in the data from which they are derived. APOObf9886 AP00019887 Consumer Product Safety Comnissfon Murray S, Cohn June 19, 1985 Table of Estimated Potency, Exposure, Humber Exposed, and Cases of Cancer/Yoar Rankings Due to Use of Products Evaluated by the Consumer Product Safety Commission Chemical/Product Benzidine Based Dyee/Home Dying Asbestos/Hairdryers DEHP/Paclfiera Formaldehyde/UPPI Hitrosamines/Paciflers Bensene/Palnt Removers Vinyl Chloride/Aerosols Methylene Chlorlde/Aerosol Paints Tris/Sleepwear Asbestos/Patchlng Compounds Methylene Chloride/Paint Removers Potency Medium High Low High High Medium Medium Low Medium High low 2 Exposure Low Low Medium High Low High High Medium Low Low High Number Exposed. Per Year's Sale3 High* Medium?* Medium Low Medium** Low3 Low3 High3 High3 High3 High Cases/Year Low Low Medium Medium Medium Medium Medium High High High . High High Medium Low g/kg/day C1 1-100 > 100 mq/use > 1000 100 - 1000 < 100 nuaber/year > 10,000,000 1,000,000 - 10,000,000 < 1,000,000 casee/year > 100 10 - 100 <. 10 mg/kg/day to give a risk of 0.1, by the methodologies described, and subject to the uncertainties expressed, in the _ paper on potency comparisons? the higher the number, the lover the potency. mg/use calculated by either estimating the total exposure of a newly exposed person to a product over the product*a j lifetime, or by the total exposure per use of one unit of product sold. number of newly exposed people per year's sale of a product, or number of units of product sold per year, assuming all units sold per year are used, "a" indicates the basis was number of units sold per year? "b* indicates the basis was . number of people exposed per year. See text (section 3) for details, all data leading to this final ranking ara the result of estimates, and thus these final rankings are subject to uncertainty. The final ranking is a result of consideration of the data from which potency, exposure, and number of persons exposed as ranked In the first three columns is derived.