Document evEX3KQzBeVQEDZdd9pVrN50e

JotWH A. PAGE mmocutc nufttiM or uw GEORGETOWN UNIVERSITY LAW CENTER WASHINGTON. D. C. 2QOG1 10 April 1972 Hearing Clerk apartment of Health, Education and Welfare *' Room 6-83 5600 Fishers lane .. Rockville, Kd. 20852 . / This letter constitutes a.formal objection to the Commissioner's order in ( the Hatter of Faint Containing Lend. 37 F.R. 5229, March 11, 1972. These objections are legal objections only and do not constitute & request for a hearing. Our decision not to request a hearing, however, should in" no way be construed as a waiver of our right to participate and to present `evidence and legal argument should a. hearing to granted on the objections. legally sufficient to justify the relief sought, of any other person^ I. VD ABE PERSONS ADVERSELY AFFECTED BY THE ORDER " a. Joseph A. Page is an associate professor of law at Georgetown V University Law Center. He teaches a course entitled "Regulation of Hazardous Products" and a seminar entitled "Lawyering in the Public Interest Seminar," In this latter role ho was the principlo proponent f the Page proposal (36 F.R. 20986) which called for a ban (except for minute traces which no reasonable manufacturer could precludo from his product) of lead in paint packaged or intended for household use. Ho is adversely affected by the Commissioner's order inasmuch as .the Pago proposal was denied and substituted in its place was an ordor .itrQs.hich only partially offectuatos the mandate of the Federal Haccrdous >n. Substances Act (hereinafter referred to as the FHSA) in that it /obviates the intent of Section 15 of that Act and is therefore contrary % to the public interost. Ho objects as & public citizen who has consistently demonstrated anLinterest in the proper administration of justice. ' b, Anthony L. Young is a second-year law student at Georgetown Univorcity Law Csntor and was a fellow petitioner with Joseph A. Page (36 F.R. 2C986). Ho objects for the eamo reasons as Joseph A. Pfego and additionaly is the owner of one can of paint intended and packaged - . in & fora suitable for use in the household which ho submits, upon ' ^information and ballcf, contains lead compounds of which the lead content . (calculated as the metal) is in excess of 0.06 percent of the total weight of the contained solids or dried paint, film. He objects on behalf of all persons similarly situated. ^r c. Mary-Vin O'Brien is a third-year lew student at the Georgetown University Law Center and was a fellow petitioner with Joseph A. Page (36 F.R. 20986). She is adversely affected for the same reasons as Joseph A, Pbgc and additionally is'tho owner of a bicycle which is an article intended for use by children which she submits, upon infor mation and belief, bears paint containing lead compounds of which the $ r 0000-NLI-000020962 Hoaxing Clerk - Objections of Bago, et al. 10 April 1972 Bage 2 :' I . lead content (calculated as the metal) is in excess of 0.06 percent of the total weight of the dried paint film. She objects on behalf of nil persons similarly situated,, C* * d, Judith D, Pried is the mother of and legal guardian of Carrie'^ Susan Pried, age two, and Matthew Evan Pried, age four months,. Carrie Susan Fried and Matthew Evan Pried arc the possessors of numerous toys and otter articles intended for vise by children which ,their nothsr submits, upon information and belief, bear paint or other surface-' coating materials containing lead compounds of which the load content (calculated as the metal) is in oxcess of 0,06 'porcent of the total weight of the dried paint film. She objects on behalf of all others similarly situated. _ .* . U. BROVISIOKS OF THE ORDER PEEKED OBJECTIONAS^ ' .| #c^ ` s, Tho provision denominated in the final order as Sec. 191.9 (a) <6) (i) (b). b. The provision denominated in the final order as Sec. 191*9 (a) (6),(ii) (b). c. The phrase in Sec. 191*9 (a) (6) (i) (a) reading "Is shipped in interstate commerce after December 31* 1973. and*'. d. The phrase in See. 191.9 (*) (6) (ii) (a) reading "Is shipped in interstate commerce after Decorator 31, 1973. and". e. In order to ensure clarity, an order which the undersigned would not doom objectionable would read as follows* - (6) (i) Any paint or other similar surface-coating material intended, or packaged in a form suitablo, for vise in or around the household that contains lead compounds of which the lead content (calculated as- the m2tal) is in excess of 0.06 percent of the total weight of the contained solids or dried paint film*. (ii) Any toy or other article intended for use by-children that boars any paint or othcr,,similar surface coating material containing load compounds of which the load content (calculated as the metal) is in excess of 0.06 percent of the total weight of the contained solids or dried paint filn. T m. GROUNDS FOR OBJECTION .* The Commissioner has found that the health hazard. from lead in paint for household use will not be effectively limited by cautionary labeling requirements. Ho has determined that 0,06 porcent lead is the maximum level that will provide a margin of safety for children. Ho has determined that ezitorior as well as interior paints and surfaco-coatings must bo * provided for. By proceeding under the provisions of Sec. 2(q$Jl)(B) of the\ Jr< FHSA he has automatically triggered the provisions of Soe, 2(q)(l)(A). y_ Finally, tha Commissioner has correctly concluded that the FHSA makes no exception for economic hardship on the affoctod Industry. VIth thhsot findings vo have no quarrol, *. r A. The Commissioner Has Disregarded Section 15 of the FHSA Section 15 of the^HSA provides for the repurchase of banned hazardous articles or substances. The final order of the Commissioner is written in such a way 0000-NLI-000020963 Hearing Cleric - Objections of Pago, et al 10 April 1972 . ' ' * as to obvinto the thrust of that provision and is therefore contrary to the V intent of the Congress. Ihe plain import of tho order is that repurchase vould only apply to those tanned hazardous substances "shipped in interstate comncrco after" the dates provided. This means that consumers, such as those objecting herein, are denied their right to refund under Section 15 (a)(3) of the FHSA. % The preface "Is shipped in interstate commerce" is unnecessary to the proper operation of the FHSA. Section 4(a) and (c) aro automatically operative p upon completion of the rule raking. Shipment of a banned hazardous substance after an order has become effective is punishablo as a misdemeanor under Section 5(a) of the FHSA. - -Tho Commissioner has found that "paints and other surface-coatingsmaterials \do not present an imminent hazard to the public health." Vhen 29 percont of the children tested in the District of Columbia in 1971 were found to have elevated blood-lead levols and vhen those blood-load levels can be correlated directly to the ingestion of peeling and flaking paint in housing, the Commissioner's finding is, at bast, questionable. Perhaps tha mother - of a young child who. is now permanently institutionalized in a mental hospital could shed some reality on the situation. Section 15 of the FHSA, however, makes no distinction between banned hazardous substances .which arc proceeded against under Section 2(q)(2) and those proceeded against under Section 2(q)(l).. The Commissioner's mistaken finding of a lack of inninent hazard is therefore irrelevant to the matter at issue. Section 15 of the FHSA provides the consumer, the dealer and the distributor * a means by which he can dispose of banned hazardous articles or substances. The statute specifically grants the right of refund for an article or substance which has been banned whether or not it was such at the time of its sale. Tho Food and Drug Administration has consistently made efforts to obfuscato Section 15 of tho FHSA, The prime example of the commitment to obfuscato . is the priority which the Bureau of Product Safety hat* givon to publishing - implementing regulations under Section 15, Another example is Kalcolm Jensen, paraphrased in Fortune. February 1972. at 146, cs wanting repurchase to apply only iff tho consumer purchased the toy after November, 19&9i vhen that section of the Act was passed. This interpretation is plainly contrary to the dear language of the statute. Finally, Bureau of Product Safety's news release, HStf Nei?s Release #72-16. on proposed regulations concerning garments containing asbestos fibres, indicates recall of tho offensive garments is not anticipated. No mention is made of the right-granted to the consumer by Section 15 of the FHSA, and In that latter case alone the potential loss to consumers is approximately 24 million dollars. 'tyy* *! It is quite apparent that either legal error has/been mado in interpreting a difference between imminently banned hazardo"**"end banned hazardous substances, or there is concern over threats of protracted litigation, ~ Or. that someone-has engrafted upon the FHSA a perverted policy of protecting small business at the expense of tho nation's children.. The industry at \ issue here, however has a poor track .record to receive flavored treatment by \ the Food and Drug Administration for'any reason. This industry is perhaps J second only to the pharmaceutical industry in wrecking havoc on America's young. Tho human cost does not appear on their books, but if one looks - closely it is apparent that there is blood on thoir balance sheets, y 0000-NLI-000020964 Hearing Clerk - Objections of Page, ct al 10 April 1972 Riga 4 * \ ..... . . i Yilliara Hart, mayor of East Orange, New Jersey, pinpointed the problem in docision-making when he testified befdre the Senate Subcommittee on Health on extension of the Lead-Eased Paint Poisoning Prevention Act.' After listening to the Lead Industries Association poorwouth the findings 'of the American Academy of Pediatrics, tho Environmental Protection Agency, the Bureau of Community and Environmental Management, and tho DHETs? Ad Hop Committee (of which Associate Commissioner for Science Lloyd Topper was a member) and bemoan the impact on the paint industry of a 0.06 percent lead level, Kayor Hart noted that there was a manufacturer of soup in his conraunity that placed several poisonous cans of soup into interstate^ commerce, resulting in tho death and injury of two parsons. That company was bankrupted due to the Food and Drug Administrations aggressive enforcement policies against adulterated food. But Mayor Hart's main - point was this 1 Bon Yivant's 6oups were primarily consumed by the wealthy, tho poor did not buy it. He then noted that the childron who have died from leadibased paint poisoning have almost universally been poor and . predominantly, Black, .f f Ve submit that the time has cone for the paint industry to pay the piper. The FDA did not hesitate to bankrupt Bon-Yivant,or to destroy the swordfish industry in the United States. There was little hesitation with cyclanatss, E1S0, or fb.no.lta; (these latter cases in ths face of tremendous political pressure). But in tho area of product safety, the Food and Drug Administration seems to see its mandate as one of protecting industry. See disregarded memorandum dated November 25, 1969% from Hearing Examiner William E, Brennan to Commissioner Ley, In the Matter of Carbon Tetrachloride: Dockot No. FDC-FS-1. Ye cannot sit idly by and viatch the public trust abused. There can be no more carbon tetrachloride fiascos. Th9 FHSA requires repurchase of banned hazardous articles or substances. That mandate must be executed. In an . opinion dealing with the lack of implementation of tho National Environmental Policy Act by the Atomic Energy Commission, Judge J. Skelly Wright pinpointed tho pioblem'at issue here, "It seems an unfortunate affliction of large organizations to resist new procedures and to envision massive roadblocks to their adoption." Calvert Cliffs * Coord. Con, v. United States A.E.C.. 449 F.2d 1109, 1121 (D.C. Cir. 197lji B. . The Staggering of the Effective Date of the Order by tho Commissioner Is Arbitrary and Capricious and Eased Upon Irrelevant Considerations . There is no section of the JTISA giving the Commissioner discretion as to the effective date of tho regulation based upon grounds of alleged technical incapacity or economic hardship on small businessman. Nor could the Commissioner grant an extension of time as to the effective date : of tho order in order to allow retailers time to disposo by sale of existing inventories of the hazardous products at issue. Congress provided amply for tho retailer with Section 15 of tho FHSA. The retailer is fully protected from economic injury by the statutory scheme, ` , Sections 2(f), (q)(l) and (q)(2) of tho FHSA and Sections 701(e), (f) and (g) of the Federal Food, Drug aiid Cosmetic Act provide procedures for effectuating tho ban of a household substance. Section 701 (e) gives the Commissioner discretion as to the effective dato of the. regulations Issued under that section. Discretion cay be exercised, however, only within the .standards dictated by the substantive statutory grant. 0000-NLI-000020965 Hoaxing Clerk - Objections of Page, ct al 10 April 1972 fcgo 5 The degree of the hazard from load in paint is great. Assuming, arguendo, that paints marketed today do not have as high a load content as paints marketed boforo i960, the degree of the hazard remains the sar.9 duo to the presence of elevated blood-lead levels in a substantial portion of the population at risk. Eight percent of the children tested in Boston have blood-lead concentrations above 50 nicrograns per 100 ml. of blood. The figuro is much higher in How York City. In the District of Columbia, 29 percent of the surveyed childron had elevated blood-lead lovcls. This means that any additional environmental insult from lead that is added can bring the child closer to a medical emergency and permanent brain damago. Ve will assume the risk is not so groat in Potomac, Maryland. ^ - -> * Tho nature of the hazard is that of an insidious poison. Once the paint is on the vail or tho toy, warning labels become irrelevant. A label on the can of paint is no longer efficacious after application) a label on a toy ' can't be read by the population at risk. . Medical evidence and opinion have shown that paint containing lead in quantities greater than 0,06 percent is toxic. It is reasonably foreseeable that children with pica (50 percent of the nation's children) will ingest chips or flakes of paint. If that paint contains lead in an amount greater than 0,06 percent it may cause substantial personal injury or substantial illness as a result of reasonably foreseeable continued ingestion by children. This lattor factor, is especially truo if the child ingesting, tho paint is already suffering from an elevated blood-lead level duo to other environmental insults from lead, as many children are. Tho above is a complete recitation of the considerations relevant to the ban of a hazardous household article or substance, Tho Commissioner, however, has added & new consideration; "each manufacturer, prior to marketing * consumer products, must take steps to determine that any Substitute for lead has been adequately tested for safety and ehotrri-to bo' safe." So concur in that statement as a. moral principle. It is the least that one would ask of an industry that has been responsible for the deaths of so many children, Ve would submit, however** that this statement is being utilized as a dodge to give'the paint industry time to comply with the regulation and -to give retailers of. toys and paints time to dispose of existing stocks of hazardous articles or substances. The effective dates of the regulation have been staggered in order to protect the paints, coatings and toy industries from economio insult, a consequence which the FHSA, by its clear terms, does not call into consideration. In so doing tho Commissioner has disregarded the environmental Insult that is endangering the lives and well being of the natioris children by the continued presence . on the marketplace of hazardous articles end substancos. Even if, however, economic considerations are brought into play, and ve make no concession in that regard, the comments of the affected industry clearly indicate that a substantial portion of existing inventory meets the 006 percent standard. The Enterprlso Faint Manufacturing Co. in a.letter to the FDA dated February 17, 19?2,. indicates that 76 porcent of its interior and 73 percent of its exterior paints meet that standard. The Eherwin-Villians Company in a February 17 1972, letter indicates 87 percent of its interior paints and 40 percent -df its oxterior paints meet the standard. DeSoto, Inc. in a letter dated February 16, 1972, Indicates that 91* 8 percent of its interior paints and 77.5 of its extorior paints aeot the standard, tfe would submit that the staggering of the effective . 0000-NLI-000020966 Hearing Clerk - Objections of Page, et al. 10 April 1972 . fee 6 .. , dato ,/of the regulations protects those companies vhich, under the broad classification of calling themselves small businessmen at risk, are' the conpanics that have taken the loast interest in' the welfare of children and have in fact been responsible for a substantial part of the death and destruction that lead in paint has yrought. Ve also believe the Coamissloner is naive to think that the industry affected by his order will test replacenents for lead for safety. This industry Is concerned that replacements for lead will be less effective end less durable. See Concheneo Coatings letter to the Hearing Clerk dated January 3, 1972, This is the general theme that pervades most of industry's - comments to the regulations. One comment even goes so for as to allege "that the chrome yellow paint on pencils has been caton and onjoyed * by several generations of school children as they merrily chewed the * bright yellow lacquer off their wooden yellow pencils. Seo Essex Chemical Corp. letter to the Hearing Clerk dated December 28, 1971. (Emphasis added). To allow the marketing of paint containing 0.5 percent lead for one more year is a gross abuse of discretion, Tho difference between that standard, . if it can be so called, and the 0.06 percent standard is 833 percent. Only one purpose is served by the one year interim st?-ndardj industry is given time to reformulate their products in order to ensure their quality. ^ C, Rewriting the Regulation so as to Effectuate Section 1 of the Federal hazardous Substances Act is Hot Eeyond tho Scope of the Regulations Proposed at 36 F.R. 209S6'TlIovemtor 2, 1971? - Ve note that the Commissioner has recently concluded in several final orders that comments raised on proposed regulations "go beyond tho scops of the proposal", Ve would like to note that the Riga proposal, by invoking /procedures under Section 2(q)(l)(B) of the FHSA, automatically brought v Section 15 of the statute into play. The National Joints and Coatings . ' Association acknowledged this provision in a letter to tho Commissioner dated February 16, 1972. The Toy Manufacturer's Association, the National Association of Children's Home Playground Manufacturers, Inc,, the National Association of Doll Manufacturers end ths Stuffed Toy Manufacturer's .Association also acknowledged this provision and its operation in a letter dated March 2, 1972. In tho latter joint comment, Mr. Aaron Locker, Counsel for the above nado the following statement) "Retroactivity would raise serious issuos of procedural prftr^g *nA violation of other constitutional '"safeguards and would undoubtedly lead to protracted litigation between industry and government." Because the Commissioner found that it was necessary for him to proceed with "voluntary" regulation of the cosmetic industry due to a similar potential of lengthy litigation, thus erroneously making the threat of litigation a consideration in rule making, we believe --it is necessary to sake the following observations onllr. Locker's threat! a* Failure to sake Section 15 of the FHSA operative in tho rule making .* at issue would raise grave questions of administrative abdication. and moral bankruptcy. r . . ** * *, bi While ve do not beliovo that there has been any violation of constitutional safeguards in the rt&d making at issue, we would point out that the Commissioner's duty is to effoctuato the mandate of the- Congress. In any event, thoro is no criminal sanction for filling tg repurchase unccr the mandate of the statute* 0000-NLI-000020967 *. * 'Hearing Clerk - Objections of I*Lge, et al. 10 April 1972 . Jhgo 7 Section 15 of the FHSA onvisions civil remedios only, and-there is no prohibition of retroactive civil obligations or .penalties. The regulation * does not make an action done before its effective date criminal. The . _ ^4 ~jU*J regulation does not egreravato a crime, or rake it greater than it was / 7\uhen committed. The jfcgulatfon^docs not chango the punishment, and inflict ,*y (l`"^'greater punishment/ than the lav annexed to a crime wham committed. The . //lav does not alter the rules of evidence which the law required at the time of the commission of the offense, in order to convict the offender, KJr^ Hr. Justice Chase made the following observation! "Every ex post facto V.'. law must necessarily be retrospective! but every retrospective law is not an ex post facto lawj the former only are prohibited. Every lav: that takes away or impairs rights vested, agreeable to existing lavs, is retrospective, ^ and is generally unjust, and may be oppressive! and it is a good rule, that "** lev should have no retrospects but there are cases in which laws may .justly, and for the benefit of the community, and also of individuals, -relate . to & time antecedent to their commencement! as statutes of oblivion or pardon," Caldor v. Bull. 2 U.S. (Dallas) 385, 590 (l?98). The Federal Hazardous Substances Act is such a case. - c. The courts are open to everyone-. When administrators abdicate, the people will litigate,. Objections filed, Joseph A. Pago Anthony 1,. Young Mary-Vin O'Brien Judith D. Fried 0000-NLI-000020968