Document dY3Z5rL3yxJY0jGY1gpeyYLjQ

GLIDDEN-DURKEE DIVISION Of 8 C M CORPORATION Fo k h 136 PuiNito in U.S.A. 4171 pJUasULsfc_ FROM J. E. Peters CITY Cleveland, #30 ANSWERING LETTER OF SUBJECT FDA INQUIRY -Heavy Metals - Paint DATE March 14, 1972 FOR pi. J. Kiefer, UCB Ukt Attached for your review is a publish request from FDA on the subject. Were you aware of this problem? Perhaps we should discuss this before any action is taken. JEP/rem Attach. GUOOlZ*** N 2103 ! V (/ ; v.'?,' 1, !; ( fsmt- /. )rV" ; l >',' G JA; '^77 1J V-< J1* fkj 'v 1 ' ,1 ( *N. Pf:*/ 'V;. r?7 r'-p t ' `ti''1* *;,:=>* <X<'H'iw'&'.t/*.jvT` ";V* v, V'* 'j'iH;. ' ..-v^ - - i Jr '' . i *, " ,*VS -- ' Y,|l < J :v ij ( * >! <>-ry Number 47J--77 1-7-7* Hew Dovelopmenfi FLM Notice 4 1.5 X > : [U 40,623] Food and Drug'Administration Proposed Regulation. Dated February 3, 1072. Published in 37 F. R. 3644, February IS, 1972, . Food Standards--Soda Water--Edible Vegetable Oila--Optional Ingredients--Pro posal.--A proposal to amend the standard of identity for soda water to provide for the use of cdildc vegetable nils as optional ingredients in clouding agents and as carriers for flavoring agents has been issued by the Food and Drug Administration. Views and comments may be fded by April 1R, 1972. '. Sec FDC Act 401, Food volume, ^ 51,051. r ; Notice is given that a petition has been filed by the Aromatics International Manu facturing Co., Iiic., Atlanta, Ga. 30331, proposing that the standard of identity for soda water (21 CFR 31,1) be amended to provide for the use o( edible vegetable oils as optional ingredients in clouding agents and as carriers for flavoring ingredients ' used in soda water. Grounds given in support of the petition are (1) That there is a need for a safe substitute for brominated vegetable oils which arc no longer permitted to be used in soda water in quantity sufficient to pro duce the clouding effect desired and (2) that there is a need for an additional safe, edible, relatively flavorless carrier for flavor ing. Accordingly, it is proposed that 131.1 (21 CFR 31.1) be amended to provide for the optional use of edible vegetable oils as emulsifying, stabilizing, or viscosity-pro ducing agents and as carriers for flavoring ingredients used in soda water. . ,, i, Pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 401, 701, 52 Stat. 1046, 1055, as amended,. 70 Stat. 919, 72 Stat. 94R; 21 V. S. C. 341.37}') and in accordance with authority delegated to the Commissioner of Food and Drugs (21 CFR 2.120), interested persons are in vited to submit their views in writing (preferably in quintuplicate) regarding this proposal within 60 days (April 18, 1972] after its date of Fed er al Re g is t u publica tion. Such views and comments should be addressed to the Hearing Clerk, Depart ment of Health, Education, and Welfare, Room' 6-8B, 5600 Fishers Lane* Rockville, Md. 20852, and may be accompanied by a memorandum or brief in support thereof. Received comments may be seen iii the above office during working hours, Monday through Friday. if'S it- Th\ to.. t "f t - !*?!;'' v1 ; .! , V) i.'i* y.' aft ,ivt ' * l ,. / [(140,624] Food and Drug Administration Request for Data. Dated February ITT 1972. Published In 37 F. R. 3780, February T9, 1972. Hazardous Substances--Paints and Coatings Containing Heavy Metals--Request for Data.--Paint manufacturer* have been asked ]ty the Food and Drug Administration to submit analyses of their interior and general purpose exterior paints and of those paints and coatings applied for use on toys and other children's items and on household items accessible to children. The FDA stated that such data would be of value in preparing a final order based'on proposals made by the agency (sec 140.571). and by a group of private citizens (see 140,572) that certain heavy .metals-containing paints be designated as hazardous substances. Manufacturers were requested to state Ibe total amount of cadi named heavy metal present in the dried paint products, the method used for such determination, the amount of those metals intentionally added, the reason for such addition, and current labels for each analyzed product. The data should, be submitted by April 7, 1972. ____ Hazardous Substances Act 552(f)(1)(A), 2(q)(l)(lA), and 3(a)'and (b), Federal volume, ([9061, 9083, 9091, and 9093. . In the Fed er al Reg is t er of November 2, 1971 (36 F, R. 20985), the Commissioner of Food and. Drugs proposed that certain paints and other surface-coatings contain ing heavy metals he declared hazardous substances that require special labeling for child protection. In the same issue of the Fed er al Kepu t er , (36 Fi : R, 20986), the Food Drug Cosmetic Law Reports ; . Commissioner published s petition sub mitted by Joseph A. Page rt *1., proposing to classify as banned hazardous substances paints which are for household me and contain more tfisn minute traces of lead. Interested persons were allowed 60 days to file written comments regarding these proposals. ' 1 40,624 Mr m >4;.' mi1: q f ;l. ? 4 *) G L DO ,12 5 8 5 < . y *, (i t1'. * f i 4i 2103.01  A'., jt' > 'K ' 1 * w r-_ Tf }f; 4 I, 5 2 0 New Developments HEW Memoranda Numbcr 47J--7I S-7-72 Uy a letter dated February 2, 1972, peti tioners requested that the Commissioner ask paint companies to submit certified analyses of their product lines "[in] order to assist in resolution of the. argument of technical incapacity that the paint industry is making * * V In consideration of this request and in view of the numerous con flicting and apparently irreconcilable com ments received in response td the above proposals, the Commissioner concludes that such data would he of value in preparing the final order. ,'t'hereforc, the Commissioner hereby re quests that all manufacturers of paint and/or other .surface-coatings submit the following information for their interior and geni-ral purpose exterior paints and for those paints and coatings which are sup plied fo industry for use on toys and Other children's articles as well as furniture and other household articles which may he accessible to children: 1 1. The total amount of each of the heavy metals lead, antimony, arsenic, barium, cadmium, mercury, and selenium (all.cal- ciliated as the metal) present in the con tained solids , or dried paint film together with identification of the quantitative method used for such detiermination! . 2. If barium is present, the percentage of the total barium which, is water soluble barium (calculated as,the metal); 1 ,TUo ^amount, if any, of cttch of the above heavy metals that was intentionally added to the product together with the reason for such addition; and 4. At current label for each analyzed product. - Products should be tested for the speci fied heavy metals by any generally accepted quantitative method having a sensitivity of at least 0.01 percent of the metal in the contained solids or dried paint film and a reproducibility of plus or minus 10 percent of tlic'patticular metal. The requested data should be submitted by April 7, 1972, to the Bureau of Product Safety, 5401 Westbard Avenue, Bcthesda, Maryland 20016. [fl 40,025] Department of Health, Education and Welfare Memoranda Regarding Human Drug Biological Products. Dated February . 18, 1972. ^Published in 37 F. R. 4004, February 25, 1972. ... . .' Administration--Human Drug Biological Products--RedelegatIon of Authority-- Jurisdiction of FDA and DBS.--The responsibility for the regulation of human drug biological products under the . FDC- Act has-been redclcgatcd from the Assistant Secretary for Health and Scientific Affairs, Department of Health,: Education .and Welfare, concurrently to the Food and Drug Administration and to the National Institutes of Health Division of Biologies Standards. A nVemorandtlni of understanding between the two agencies provides that regulations pertaining only' to biological* will Tie promulgated by the DUS, wilti FDA approval. All' regulations issued by the FDA regarding luimnii drugs will kpply to biologicals. The DBS will have primary responsi bility for enforcing the FDC Act with respect to biological*. The FDA will not enforce the Act regarding such products unless requested to do so by the DBS. In emergency situations involving the protection of the public from danger td life or health, DBS will ask the FDA to remove (he biological product involved from the market; The agreement also provides for information interchanges between the two agencies; Sec Public Health Service Act.351 and FDC, Act 1902, Federal volume, 1U70 and 2275. . i [Rcdelcgalion of Authority] .. The following authority delegated to the Assistant Secretary for Health and Scien tific. Affairs hy the Secretary of Health, Education, and Welfare under section 6 of Reorganization Plan No. 1 of 1953 and sec tion 2 of Reorganization Plan No. 3 of 1966 is hereby redclcgatcd to the Commissioner of Food and Drugs and the Director, National Institutes of Health, as follows: 1. Effective this date, each of you is hereby concurrently redelegated the au thority vested in me to administer, enforce, and apply all applicable provisions of the Federal Food, Drug and Cosmetic Act, at amended, with respect to those human drugs that are biological products as defined in, and subject to licensing Under, section. 351 of the Public Health Service Act, as amended (42 U. S. C. '262) and the regu lations thereuhder, 42 CFR Fart 73. H 40,625 1972, Commerce Clearing Housfe, Inc. t '" 7 ft.1' . ) 'V'V . ...' r ;.i ", /, : .Veit V 4X.V.. GL DO 12 586 -t .J;--.V: ` `7 *' ' * , + 'i*. 1 V i * IV,U' . V - *- v *' v i f1 ffe-Jf V'-V* '.V-ln-'vS ;' t1; r;J i\,i5>.) 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