Document GzB5odVeQMoYwp8Lxggp0Y54x

v- m-1- a OSPA.. Office cf Consurer Affr-ire Doehet Ro. i!- 000 Hoorn 8. 36'3.'; U . S , Departr-env of L- bor 'third Street end Core,i-1lutior. Washington, D.C. 20310 Kg; Proposcd 29 CPR Bari 1993 Notice of Irion tier it Appear Gentlemen: You are hereby notified thet\ I.:.:: Products c.r Inc. (''Air Products") intends to appear and testpublic hearing on the. subject or the proposed /.-!! 1. The name, address and telephone numb:.: of the person who tviil appear on behalf of Air Products 1::; Richard Fleming Executive Vice President Air Produc ts at'd ClieinLea\a, Don 538 Allentown, PA 13,105 (2.15) 398-8502 Xn.c . John T. Barr Assistant Dxvi'cvor c;."..u.. for Plratice Air Product:; "V.6 fr.r.. '' 538 r PA V'-'.' ' (21:';) 3S8-KIf? 2. `lie; cap a cl iy in wVh: . .. :-'vjear t-/.`"!. 1 he an a '.'oorrrcrA.,-.;.- t- 3, The: anprerirute erramCr: oduchs ' orc-ncntatioa is forty . 1 A. `Pb.rt yoocifi.c icono dl:l V it'oteurtlc'-) nodi Mor.i ion of .1 .; rr--- ; iVl' I ' '' * <.)' AP00048443 f. .tr. : r ' : - - ' > c. ' cl- . .. ;,,.l j_ii no-.; -r j ; "..L j, r-i Pc: zi -wily X mfe-'-uJ. Vi o 1 . . . Vi.vb-uc Lr, ' >jos Lion o.\ L'io. force ;<'nc; Imsuc.-::-; i ~ pn 'L.Uv' :: p. > ; our i ..iLKj.':'u;i. c thou ro^;LfLaLiont derive 1 ?.c - . _ J.-ro. i lous nn-1 co:,-;^. t,,-:.'. t amfi/oLr of nil avali-u r u... cu'i Ui\. /\nyd.> r.v.vi-rei leo c os co. l*.o o .. the :; all 1 war t fields, e.g., r.' L.rjrX-:-..L do--.:;;'' . , r.-uparn. Liv; rvdhr.ibolis::-., bios La cl; Lios . In that the .. .-ou -.cito skill:; are nob strongly r"V).:i-s..inlcd .in. rcga.l --.toe y agencies , and brer, ess scientific judgicuvt shoci-.;. ir.o.parsLed from regulatory responsibility, we auppo: avi independent pan si of exports, largely from ae-'d Lo evaluate all data pertaining to substances prr vufed by O.SHA for classif ication. b. 'the Proposal is overly rigid, and fails to as tnbl.lrj h prio.'? Lli.oj for regulatory action- SubnLc.nhielly r.ore then LOvJ substances on the NIOSH list can be expected i.o fn11 into Category I, overwhelming G3J-JA. with required rofj .' ' o. ry ac Livity. Un s ub- Ln t ia had sub.-mi Gaio.uu by intern led persons automatically trigger the clusuifica- i lo.- p- '.east. til Category I and II clansification-; ; ~ \ 1 ly trigger regulatory action frresoectiv ; of :/ of L'l-.o substances, the quality of the tor., c I a. '' br r~ in 'mr. :rtiori used for orbeg oriso Lionr 1 " c' !:-uv- u. or the nUi-Coor* of 'orkei ; AP00048444 O l'.o- nr.: .'i-Sr . ea . ho.. - qiooal y ;*n : :;i. L.L'.'j; oo...- . L. v > 0 pa ..-.'I J.C; . ;> ;. ' ! :. .'.iia-'i v.. : re a ; : . * ho iO.it.- b '.''.in.r. fee poai:.-'U.j' riny .:ut CVt /-jric.lv Sitioo 1 L < *. t LlIiot' y of Air It;:a.-. .i.LOfO iv i 11 be ;jiierr. .v.'j.porfive a ' fate. pro.TM e.'if.vci by the 7:iv. o.. > riel t: -yy!. th Coiw: ' 1 ; Clt 'I 1 refer to a :r c-iiir - Dr bof til ' t. 1. lie iesti:.r- iv, v-o ray hae.t tho Air 3? fit. r to yt b sahoduIaJ .d: tar the cor ail no ion o: : th'-i A.L 'Ji O ii n V-& t J.i If you huve a.ry ir.ions e.boui the or furthor isiforniation, ple-ese contact John T. far.:.- v/horjo erilrcer, and t jlsph.ors narti''.rvc appear in Sc:c Lion .1 of this .letter. e Very truly yours, AIR PRODUCTS I\P.D CilDMICALS, XXC. Rtf/RlISsertb By: id Riohci rd F .1:v \r- i n g Pvri'Mif-i vp. V.`i.r:^--3 AP00048445 Prepared Testimony of Richard Fleming Executive Vice President Air Products and Chemicals, Inc. on the OSHA Proposed Rule on Identification, Classification and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk AP00048446 Comments on the Proposed OSHA Regulation on Toxic Substances Outline I. Introduction Air Products opposes the Proposal, supports AIHC, and offers comments. II. The Proposal Will Not Utilize the Best Available Scientific Resources An independent classification should be utilized to assure adequate evaluation of the facts. III. The Proposal is Administratively Unsound OSHA will be overwhelmed with mandated regulatoryaction. The proposal is unduly rigid, and a host of absurdities will result. The present regula tory powers are adequate. IV. The Proposal is Legally Wrong OSHA does not have the authority to ban substances. The proposal is faulty because of imprecise defi nitions and is in conflict with several laws and Executive orders. The Proposal is not Economically Feasible No incremental justification is provided for the level of regulation proposed, nor have adequate economic or environmental inputs been prepared. AP00048447 1 Vk Detailed Comments on Specific Issues raised 'by OSHA, 'and on the Mods! Standards [Written testimony only.] VII. Conclusion____ We urge vithdravzal of the Proposal and substitu tion of normal proceedings using the guidelines suggested by AIKC. AP00048448 Comments on the Proposed OSHA Regulation cn Toxic Substances i Introduction Air Products and Chemicals, Inc., opposes the proposal by OSFA to promulgate a new general regulation for toxic substances as published in 42FR54148. This position is based on the following points: 1. It will not utilize the best available scientific resources. 2. The proposal is unsound administratively. 3. OSHA does not have the legal authority to carry out several important parts of the proposal. 4. No economic justification can be shown for the extent of regulation that is proposed. Our oral testimony will touch on each of these principal points; our written testimony contains more detailed information on each subject, and, in addition, addresses number of other items which are of concern to us, teluding comments on issues raised by OSHA in this Proposal and detailed comments on the model standards. -1- AP00048449 We.^believe that carrying forward this Proposal, as written, would be a grave error on the part of OSHA. from its standpoint alone. There is no need for this I unnecessarily rigid Proposal, which will hamstring the operation of OSHA by forcing extensive regulatory activity for materials not significant Industrially. As written, the Proposal will foreclose the incorporation of future advances in science in OSHA's regulatory process, and thus eventually require the repudiation of the resulting regulation. We generally support the comments and recommendations made by the American Industrial Health council in this matter, which we believe present a sound alternative course for OSHA to follow, and in addition, will offer some suggestions ourselves as to how OSHA should best proceed. The OSHA Proposal will not utilize the best available scientific resources. fee broad sweep and rigid structure of the proposed regulation precludes proper evaluation of either the hazards or the best means of reducing these hazards for -2- AP00048450 individual materials. OS HA would not have the time nor does it have the expertise for proper biomedical evalua tion of the data available, or the determination . of ti-..; data needed to make a proper decision on the regulatory action required. Wo, therefore, support the proposal by AIHC for an independent Classification. Panel to ba charged with the scientific decision making. Such a panel could well serve the scientific appraisal needs of all agencies of the Federal government concerned with health regulation. Generic regulations, because of their wide application, must be especially sound, thoroughly reasoned, and promptly responsive to advances in science. On this basis, we strongly recommend that the scientific evalua tion of toxicological and epidemiological data in the classification of compounds and the determination of carcinogenic potency be entirely divorced from political, ethical, and administrative processes which weigh the indicated risk and societal benefits, and prescribe iffiEfork practices or workplace conditions - V.'a adhere to the principle that scientific data from all sources must be scrutinized in the light of the most current knowledge and that it is the responsibility of OSHA to -3 - AP00048451 assure that state-of-the-art expertise is applied in 6iiis process. Inadequate data or dubious scientific critique or appraisal are appropriate neither as a basis for the protection of people at work, customers, or neighbors nor as grounds for dislocation of the industry. Obviously, complete and impeccable data are not always available, and if one must choose between protection and no protection, one must err on the side of health conservation. But the necessary judgements must be administrative. OSHA must not cloak an administrative judgement in a fabric of biased or selected data, uncritical data acceptance, faulty interpretations, or regulation by rote. In other words, make policy judge ments, if necessary but don't torture the data in an attempt to justify what is not justifiable. We have seen examples in which regulatory agencies have appeared to be less than objective or critical in their internal scientific evaluation of data: consider OSRA's exam.inaKapn of beryllium carcinogenicity data or EPA's appraisal vinyl chloride epidemiological surveys and the ethylene oxide toxicity data. We believe that administra tive judgments or positions of advocacy are ill-suited -4- AP00048452 tenths analysis of scientific data. Advocacy and j^olitical-ethical-sccial judgements based uwon such I data may be appropriate when data have been subjected to prior competent critique and interpretation. This means to us that there must be a panel of experts qualified to assess the scientific data which pertain to compounds under review. The composition of the panel must reflect state-of-the-art knowledge in such fields as biochemistry, comparative pharmacology, statistics, and epidemiology, to name but a few. Forthe most part members will come from academic institutions and the laboratories of the National Institute of Health or our National Laboratories such as Oak Ridge and Brookhaven. They should be selected for their ability to reach objectively based, scientifically sound judgments and interpretations concerning the toxicological data and its interpretation in terms of human health risk. Specific affiliation with industry, labor or other groups should represent no special j^pprier if the skill is needed and present. An under standing of work-place circumstances of exposure and exposure control methodology is also important. The panel must be prepared to deal with the species selection, -5- AP00048453 ntQphanisms of carcinogenesis, experimental design and prediction of hum.vn h.v:\lfh risk. They are not to ) consider societal beuerits of compounds/ costs/ alterna tives, or any of the myriad legal-political-ethical variables which are the clear prerogative of the regula tors . It is not my intent to dwell upon such issues as whether or not exposure to the Category I carcinogens, aflatoxin (in agriculture) or saccharin (in soda making) constitutes a "grave danger." Some regulators and the Congress evidently do not think so. However I am interested in the work by Dow showing that vinyl chloride administered at high levels saturates normal detoxification mechanisms and enters a pathway which leads to the production of carcinogenic metabolites. I would .like to see these data weighed by an export panel and observe the regulatory consequences. Do tho enzymatic systems responsible for cancer induction also operate at low levels of exposure? If so, what is the significance of that ^jjpct? If not, what is the significance? When this 'critique has been completed, along with others of equal importance, then and only then, should one pass the issue to the regulators for their phase of the decision-making process. .- 6 - AP00048454 I recoqnize that the determination, of the most effective placement of the panel within Vhe organizational pattern ! of the Federal government is a difficult matter. . However, except for the jurisdictional and territorial imperative concerns of specific organizations, the placement of the panel is not of great importance. But the panel must be placed where it is immune to political, commercial, or economic pressure groups, environmental advocates of every persuasion, and influence by the research funding hierarchy of the Federal government. It must be capable of dealing with the frontiers of scientific development in relevant areas. I do not see other routes to state-of-the-art critiques of scientific data adequate to form the foundation, of important regulation. In addition, one would hope that the activities of this panel would be made available to, and \Tsed by all of the standard-setting agencies, the Federal Government, and also the individual states. We are now faced vzith >rass of overlapping and inconsistent regulation *tg developed on an ad hoc basis. The early promises of cooperation from the IRLG have not yet borne fruit. All further regulatory action regarding health risk/benefit -7- AP00048455 assessment should be dona under a coherent and consistent policy v/hich is utilised by all of the -iy jucies conjr.ed, i with the assistance of the best scientific thinking that this nation can provide. III. This Proposal is Administratively Unsound OSHA has given as its primary reason for this proposal its concern that present procedures are too slow and require too much regulatory effort to be effective in protecting the health of workers; OSHA therefore intends to increase its capacity and, it supposes, its effective ness in fulfilling its mission by these new rules. We believe that precisely the opposite will result. This proposal is so rigid and unwieldly, and is so insensitive to the real needs of society and to the state of medical science, that the future activity of OSHA will be even less productive than in the past. OSHA will be so overwhelmed with nondiscretionary lemaking, and so constricted in its responses as the suit of this action that the regu.lato'/y output will be of far poorer quality. Worse than, th.i;, G3:i.\ '..ill visit these same problems on the society it. is supposed to be serving. -8 - AP00048456 t * B^pps^d Section 103 requires that there be regulatory agti o". an the ires all: of the receipt of any information, i regardless of its quality or relevance, on any compound. This receipt of information sets in motion a chain of events that leads to categorization and rulemaking after publication of a notice in 'the Federal Register and a hearing. If the information is significant and adequate, the compound is placed in Category I and an Emergency Temporary Standard ("ETS") is published. If the information is not significant, the compound is required to be placed in Category II. If the information is both insignificant and inadequate, the compound is placed in Category III. (See Section III.) The Secretary has no alternative, and cannot question the source or reliability of the information received. Any rebuttal is permitted only at a public hearing. All compounds arc presumptively Category I unless rebutted. Ic is implicit throughout the proposed rule, and explicit in the third column of page 54181, that all existing dinogens will b: subject to new rulemaking procedures. r; every substance presently listed in Subpart Z of Parc 1910 will require an immediate ETS, to be followed by public hearings and a new permanent standard within six months of the promulgation of this rule. -9- AP00048457 In. addition, there are over 160 commercial compounds on th'6 NIOSII Suspected Carcinogen List, with which carcino genic response has been reported in two or more species. These are required to be put in Category I, requiring immediate publication of an ETS, public hearings anu a permanent standard within six months. Obviously, all of these do not offer the same risk to the worker, or to the same number of workers, but under this rule, all of them would require the same immediate regulatory action. Every substance which has ever given a positive test in a rodent, regardless of the dosage, becomes a "potential occupational carcinogen" and presumptively in Category II at least, requiring a notice of proposed rulemaking within 60 days of the promulgation of this rule. There are hundreds of these substances. All other substances for which "information" has been submitted fall into Category III, and require that 1SH, EPA, CPSC, and FDA start an immediate search for formation that will permit their reclassification into more restrictive categories. - 10 - AP00048458 i Tjj^pse results certainly v;:Lll give os HA, the "speedy =&- approach" to rulemaking lor which it pror.anserl a desire, i but it p.lso is cort.-u'.u that it will .increase, not reduce its workload, and it will certainly not improve the quality of its output. An official of QSKA has been quoted in the December 1977 issue of Job Safety and Health as saying "A prelim inary review of the NIOSH list of suspected carcinogens indicates about 100 would belong to Category I. Another 300-400 would belong to Category II, and the remainder would be in Category III or IV." If this estimate is. correct a new public hearing will begin almost every workday for the six months the proposed rule allows between publishing the one hundred-plus ETS1s and promulgating the final standards for the mandatory Category I materials alone. The rigidity of the proposed approach will totally .contravene the spirit of the Proposal. It forces ^jj^^ersion of the resources of OSEM, industry, and society as a whole, tower.d subst noes which may have no practical significance in the total carcinogen problem, and precludes a rational approach to serious problems. \ - 11 - AP00048459 A far better approach would be for NIOSH and OSHA to cJ^pporate in determining a system of priorities for regulation based on extent and degree of exposure, utilizing the best medical and scientific data on potency and mechanism of tumorgenicity, and which can respond to advances in knowledge as they develop. This can best be done through the independent Classification Panel suggested by many which would assist OSHA in the development of priorities through a careful evaluation of toxic potential. The immense workload caused by this Proposal will be further exaggerated by the selection of the standards by which OSHA will categorize the suspected carcinogens. Compounds are required to be put in Category II where the data arc "only suggestive" (1990.111(b). Suggestive is defined as "less than persuasive or not statistically significant..." (1990.102.) Thus statistically insignifi cant data require a permanent standard and a public hearing (1990.122.). The rationale to support such a is very difficult to discern. These public hearings are to be held 30 to 60 days after publication of the notice that the information - 12 - AP00048460 been received (1990.103(2)). This period is totally inad.eqv.ate for either the public or OSHA to obtain data, evaluate it, and to prepare and review testimony. OSHA has been developing this Proposal for wall over a year, and yet it finds that it cannot have its testimony ready until 45 days after the period when the public must have submitted its documents, and more than five months after publication of the proposal. In addition, the testing and reporting recxuirements of TSCA will force a great deal of data of varying degrees of reliability and significance to be reported, adding to the burden already placed on the administrative mechanism from already published information. Rigid application of these proposed rules leads to a host of absurdities with which OSHA must be prepared to deal if it persists in this rulemaking. -Ji^ccharin will fall in Category I, and thus must bo id if there is a suitable substitu- There are substitutes, thus, the handling or serving o: snc-churi must be banned in any place under the jurisdiction, of OSHA, at a time when Congress denies FDA the power to ban the ingestion of the material. - 13 - AP00048461 AH. dried vegetable matter, when inirned, generates p^^fftyclle coa^oiuids and vinyl chloride, in trace \ amounts. Thus open tires and smelting must be banned. Similarly, the use of coal as a fuel must be forbidden, and the steel industry must be shut down, since we can buy it from abroad. Internal combustion engines cannot be permitted, since electrical drives are technically feasible. Handling of peanuts and several major grain and nut crops would not be permitted because of the aflatoxinproducets that grow on them in storage. Substitutes exist, so these crops must be banned. Yet, the FDA permits human consumption at measurable concentrations. These absurdities arise because OSHA has not provided for risk/benefit calculations in its rules, nor has it provided for the exemption of low levels of impurities or mixtures in its effort to write one standard and be jjj,d of u'io problem for all time. Careful re-thinking of v.\ t full implications of this Proposal is required by - 14 - AP00048462 Bgessnt Procedures are Adeeraate. OSHA already has more l!&an adequate regulatory power to accomplish its assinged task.. In this Proposal OSHA has criticized I itself for poor performance and used this as a justifica tion for this Proposal. The facts are that OSHA has only recently turned its attention to health matters, and in the past had concentrated on the encodification and enforcement of a great number of industrial concensus standards. A major source of difficulty in the area of healthrelated regulation has been the perennial dispute as to whether or not there is a threshold level for response to materials which at higher levels are shown to be carcinogens. There is evidence on both sides of the issue, and we are not likely to achieve consensus on the matter in the course of these 'hearings. I suspent that in the final analysis some carcinogens will be shown to have a no-effect level of exposure, others perhaps may not. Again it appears that the elucidation mechanisms of disease induction v;ill prove the issue since we cannot ever test a sufficient number of animals to establish conclusively, that cancer cannot possibly occur. - 15 - AP00048463 Ag^. we see it, the central issue is not " threshold" but rather level of rich. CSIIA must make the effort to acceptable in terms of over-all societal gain. C5HA must make the effort to determine whether or not additional controls are justifiable in terns of incremental achieve ments in risk reduction. V'e believe that it is a valid goal to reduce incremental risk to the point where it is statistically indistinguishable against the background of other risks which are part of life. Socially advan tageous regulation is not achieved by committing resources to reduction of exposures so as to obtain theoretical risks below background. It is obviously appropriate to consider the commitment of societal resources to the reduction of the background, but that is quite another matter. IV. The QSHA Proposal is Legally Wrong Section 6S5(b)(5) of the OccupationaJ Safety and Health Act provides that standards dealing with toxic materials .all be based on the "best available evidence" and the latest available scientific data" ii it ware conceded that the ilro-oosal reflects the 1 sst available current scientific thinking on carcinogens (which we 16 AP00048464 1 most certainly --do -n--o---t concede), the Proposal is defective iC't.hr.t it forecloses consideration of advances ir, l scientific thinking \7trich may have occurred by -the time of rulem.hking on a particular chemical. In fact, the inclusion of lab oratories under the general standard will seriously hamper future research into the mechanisms and possible prevention of cancer. Proposed Section 1990.111 violates the `'best available evidence" requirement of the Act by requiring Category II regulatory action on the basis of data that is merely "suggestive". Section 556 of the Administrative Procedures Act places the burden of proof on the proponent of a regulation. Proposed Section 1990.110 improperly shifts the burden of proof to industry through its presumption of Category I classification. OSHA does not have legal authority to do this. posed Section 1990.114(a) permits the Secretary to t:ermine whether thare are suitable substitutes fo:: a Category I substance, and to set a no exposure limit for any use or class of use for which suitable substitutes - '17 - AP00048465 1 ajfte available. A no-enposure limit would result in oSJlA's banking of the substance, an action for which I there i-r, absolutely no statutory authority. An cy;pcu'urr level is either the lowest feasible level, or it is not; to require on exposure level lower than the lowest feasible level is contrary to Section 665(b) (5) of the Act, which requires that standards be feasible. Proposed Section 1990.112 provides for the mandatory issuance of an Emergency Temporary Standard at the time a substance is classified as Category I. This provision directly conflicts with Section 655(c)(1) of the Act which reserves the extraordinary ETS procedure (which is exempt from the due process protections of the Administrative Procedures Act) for instances of "grave danger11. Automatic and routine resort to an Emergency Temporary Standard in the case of every Category I substance, without regard to the degree of danger presented, is ^jontrary to the Act, and constitutes a denial of a dm inlet,rative due process. - 18 - AP00048466 i V. Economic Aspects Atcrit.ical deficiency of tr,s pr-posal is the lock of -- y) an. economic. evcvlu.vkica of the cone^cruer.ces, and the failure to perform any cost/benefit analyses to assist in determining an optimum regulatory level. We have participated in the industry-sponsored economic evaluation of this proposal conducted by Booz-Allen, and have identified 17 materials of interest to us in their list of S9 most important chemicals that were abstracted from the NIOSH suspect carcinogen list. Three of these are products, the remainder are raw materials. We have attempted to estimate the cost of compliance, over and above our present expenditures for the protection of our employees, and find that we are unable to do so with any precision. In fact, we are unable to predict accurately to what level we can reduce exposures, r-uch i^ss the cost to do so. do know that wo aio spending in excess of thirteen tlion, dollars in capital alone on environmental fiealth programs Cor enp chemical, vinyl chloride, and we cannot predict how much more would be required to achieve some yet-to-be defined lowest feasible exposure. . 19 - AP00048467 I Wg^bslieve these costs to bo representative in an industry for which we represent only 4 percent of the i capacity. And ws do luicw that the bast available; data assures us that we have achieved a situation where there is no present significant risk to our employees. The very least that industry can expect before it expends resources that may be many times that necessary to provide adequate protection to its personnel is that some justification be provided for the incremental expenditure in terms of its necessity to produce an improved quality of life. This OSHA has steadfastly refused to do while holding to the position that only zero exposure can be acceptable. There is no question that these funds should be spent if it is clear that the material i-n question constitutes a significant danger to health. It is not clear, however, that unlimited resources should be expended merely because OSHA will not take sufficient time to j^jj|plore the appropriate regulatory requirements for a particular material. - 20 - AP00048468 We .believe that a thorough case-by-cane study with an failing of this proposal. VI. Comments on Specific Issues Our written submittal contains comments on the specific issues raised by OSKA in the preamble to the proposed regulation, and several detailed comments on the draft model standard. In the interest of time these will not be presented orally, but we request your serious considera tion of these comments. One point we do wish to emphasize here. As written, the regulation would cover every exposure no hat tor howslight or infrequent. We strongly urge that ar. action level be established below which most requirements of the standards would not apply, and separate provisions should be made for laboratory use of toxic chemicals;. tilarly, exemption should be made for mixtures v/hlcli Eo-not contain enough of the toxic materi-1 to can exposure above the action'level with lic.r.al ui;, In addition, recognition should be made that it is necessary 21 AP00048469 ffor service personnel and regulatory officers to enter jCT' sSfiul&tod arsas. These persons are not. employees of the operator and thus their medical records are not > under his control. Further details on these points are in our written comments. VII. Conclusion In summary, then, we respectfully urge the- consideration of the following points. 1. Regulations must derive from a meticulous and competent analysis of all available scientific data. Analysis must reflect the state of the art in all relevant fields, e.g., experimental design, comparative metabolism, biostatistics. In that the requisite skills are not strongly represented in regulatory agencies, and that scientific judgement should be separated from the regulatory responsi bility, we support an independent panel of experts, largely from academe, to evaluate all data pertaining to substances presented by OSHA for classification. 2. The Proposal is overly rigid, and fails to establish priorities for regulatory action. Substantially - 22 - AP00048470 mere than 100 substances on the NIOSH list can be jfra?*' expected to fall into Category I, overwhelming OSH?, with required regulatory activity. Uncubstiai-tiatad submissions by interested persons automat ically trigger the classification process. All Category I and II classifications automatically trigger regulatory action irrespective of the potency of the substances, the quality of the data, the degree of worker exposure, or the number of vrorkers exposed. 3. OSHA has neither the authority nor the expertise to determine "suitable substitutes" or the impact of their imposition. OSHA has no authority to ban substances by requiring zero emissions. OSHA has no authority to regulate an employer's relations with parsons other `than his employees. By fore closing individual consideration of specific substances OSHA is violating administrative due process. Automatic recourse to an STS for all Category I substances is contrary to law. 4. OSHA has failed to consider the economic feasibility of the proposed policy and the model standards - 23 - AP00048471 1 jjr ' :rT issued thereunder. Once reasonable protection has -hear, achieved a m.vjor ei'f-jct is not justified to achieve fur i:her .incrcment-al reductions . 5. The regulatory agencies should work tog-ether to formulate a coherent federal policy on carcinogens in keeping wirt the Executive Order of October 1977 . 6. This proposal should be withdrawn, and rulemaking continued under normal procedures, with the assistance of the Classification Panel. A complete reevaluation of OSHA's policies should be undertaken in light of the evidence obtained at this meeting. - 24 - AP00048472