Document vGdB9GN6aKkdzaz6j8JGD7wZ

Cleary, Gottlieb, Steen a Hamilton 1250 CONNECTICUT AVENUE, N W WASHINGTON, O. C. 30036 no*! (uoooe October 12, 1982 07 MEMORANDUM ON LEGISLATIVE CONCERNS ARISING FROM THE "GRAD REPORT" An area of potential legislative concern to corrpanies that manufacture or use hazardous substances arises from the recent report of the "Superfund S301(e) Study Group" on the improvenent of legal remedies for injuries and damages from hazardous wastes. The Group was established under Section 301(e) of the Comprehensive Environmental Response, CLcuensation and Liability Act of 1980 (the "Superfund legislation") to study the adequacy of existing cumcm law and statutory remedies in "providing legal redress for harm to man and the environment caused by the release of hazardous substances into the environment". The report of the Study Group (connonly referred to as "the Grad Report", after the reporter. Professor Frank P. Grad of Columbia Law School) finds that current statutory and legal remedies pose significant impediments to recovery for injuries arising from hazardous wastes and proposes a series of federal and state statutory reforms which would significantly alter existing law. These proposals have at least two significant implications. First, if legislation were adopted along the lines of the Grad Report recoranendations, it would impose very significant burdens on corrpanies involved in generating, transporting, and disposing of hazardous wastes. Second, the ideas proposed by the Study Group may well have an impact on the development of the law in areas not directly covered by the Report such as product liability and workmen's aorrpensation. AP00051791 o: In very broad terns, the Report proposes the establishment of a two-tier system of compensation for harm occasioned by exposure to hazardous wastes. The first tier would be a system of no-fault administrative compensation, similar to vortanen's ccrnpensation. It would be financed out of a hazardous waste p^rpari<ga>*^<niri fund, established by taxes on the production of hazardous or *-<**H'~ chemicals and crude oil and by a tax on the disposal of hazardous wastes. For claims arising frcm exposure that occurred after adoption of the proposed legislation, the < rn^urwH^rin fund would be entitled to assert a claim for contribution or subrogation against the party responsible for the exposure. Thus conpanies involved in the chemical and petroleum industries and all companies that generate hazardous wastes would the cost of maintaining the condensation fund at whatever level was deemed appro priate. In addition, individual companies (including waste transporters and disposers) could face substantial claims for coerpensatian in individual cases. The second tier which would be established under the Grad Report would be the continuation of existing tort law causes of action in state courts/ but with significant substantive and procedural modifications vdiich would make it generally easier for plaintiffs to recover. Thus the proposed differs significantly fran the traditional worJonen* s ccnpensation systems on which the Tier One remedy is based. Under workmen's ccnpensation laws, the no-fault liability that cenpensates victims of occupational injury or disease is aecocipanied by a bar against tort law recovery frcm the employer. The Study Group proposal would prevent cumu lation of Tier One and Tier Two awards and contains provisions intended to discourage claimants fran frivolously pursuing tort law claims under Tier Two. It scans likely, however, that adoption of the proposal vould lead to increased exposure to liability on the part of companies involved in hazardous wastes. For purposes of the Tier One administrative remedy, the Grad Report recentmends the adoption of rebuttable presumptions for the purpose of establishing -2 - AP00051792 causation ant ocher factors. These presumptions would not be applicable to Tier Two tort actions. Their acceptance, however, in federal legislation 03 could affect the development of case law and state legislation in a variety of contexts, including product liability. The foregoing briefly summarizes a lengthy and complex set of proposals, which should be considered in detail in making an assessment of their potential inpact. Such an examination should be included by companies interested in hazardous substances in any consideration of possible legislative activity with reference to federal product liability or workman1 s compensation law. Although the Grad Seport does not purport directly to affect either of these areas, it is likely to play a role in congressional deliberation on these related areas insofar as hazardous substances are concerned. -3 AP00051793 Cleary, Gottlieb, Steen & Hamilton l?52 N STREET, N. W. WASHINGTON. O. C- 20036 (202; 736-2700 November 18, 1982 10 MEMORANDUM FOR AIHC BOARD OF DIRECTORS Re: Legislative Issues in 1983 The attached tabulation describes in brief form the principal legislative provisions concerning chronic health hazard science issues, agency listing and science panels that are contained in legislation expected to be reconsidered during the 98th Congress. An Executive Summary of these provisions is also provided. R, Bruce Dickson Eric C. Jeffrey John A. Menke AP00051794 MAJOR RELEVANT LEGISLATION TO BE RECONSIDERED IN THE 98TH CONGRESS Executive Summary 1) Environmental Research, Development and Demonstration Authorization Act, 42 U.S.C. 4365 2) Clean Air Act, 42 U.S.C. 7401 et seq. 3) Federal Water Pollution Control Act, U.S.C. 1251 et seq. 4) Resource Conservation & Recovery Act,"42 U.S.C. 6901 et aeg. 5) Safe Drinking Water Act, 42 U.S.C. $ 300f et seq. Sets up Science Advisory Board requires EPA to use it for determinations under specified tutes . and sta a) Ambient Air Quality Standards -- EPA sets standards necessary to protect the public health. b) Hazardous Air Pollutants -- EPA controls air pollutants which may be expected to cause an increase in mortality or illness. c) Halocarbons -- EPA controls substances which may be expected to affect the stratosphere. d) Motor Vehicles -- EPA sets standards for pollutants that may be anticipated to endanger health or welfare. a) Toxic Effluents -- EPA lists toxic pollutants and subjects them to effluent limitations based on best available technology. b) Toxic Discharges -- Discharges of substances presenting "an immi nent and substantial danger" to health or welfare are prohibited. EPA establishes criteria for hazar dous waste and sets standards for its generation# transport# and dis posal . a) Drinking Water Standards -- Standards for contaminants which "may have any adverse effect" on health are to be set at levels at which no adverse effects on health occur. ll AP00051795 6 ) Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. 4 136 et~ sea. 7) Toxic Substances Control Act, 15 u7sTc"r"TT601 et aeq. S) Ocean Dumping Act, 33 U.S.C. S 1401 et see. 9) Consumer Product Safety Act, 15 U.S.C. 2051 et see. 10) Food, Drug & Cosmetic Act, 21 U.S.C. 301 et aeq. b) Imminent hazards -- EFA may act to protect people from contaminants which present an "imminent and sub stantial" danger to health. EPA may control use of or ban pes ticides that create "any unrea sonable risk to man or the environ ment. " a) Toxic Substances -- EFA may test and regulate substances pre senting "unreasonable risk of injury1' to health or environment. Priority is given to substances presenting "a significant risk of serious or widespread harm to human beings." b) Manufacturing and Processing Notices -- EPA may temporarily pro hibit or limit manufacture of new chemicals until evidence on their health and environmental effects is available. EFA may issue permits for ocean dumping if it will not "unrea sonably degrade or endanger" health, welfare, or the ocean environment. Commission may control or ban prod ucts that present an "unreasonable risk" of injury. a) Adulterated Food -- Food is considered adulterated if it con tains any substance that is injur ious to health or unsafe. b) Food Additives -- An additive is deemed to be unsafe if, after appropriate teats, it is found to induce cancer in man or animals. c) Color Additives -- An additive will be considered unsafe if, after appropriate teats, it is found to induce cancer in man or animals. -2- CO MAJOR RELEVANT LEGISLATION TO BE RECONSIDERED JN THE 90171 CONGRESS Statutes Environmental Research, Development and DemonatratI on AuthorJgat ion Act -- Science Advisory Board, 42 U.S.C. $ 4365 Clean Air Act, 42 U.S.C. 7401 et eeq. Scientific Criteria for Regulation Regulatory Lists Science Panels Requires Administrator of EPA to establish Science Advisory Board (SAB) and to refer to it any docu ment, standard, limita tion or regulation under the Clean Air Act, the Federal Vator Pollution Control Act, the Resource Conservation and Recovery Act of 1976, the Noise Control Act, the Toxic Substances Control Act, the Safe Drinking Water Act and any other author ity of EPA. SAB must prepare advice and com ments on the adequacy of the ecientific and tech nical bases of the pro posed criteria, document, standard, limitation or regulation. $ 7400, 7409 (National ambient air quaiity atanilardtt) -- Administrator hall prescribe national primary air quality standards for air pol lutants, the attainment and maintenance of which, based on air quality criteria reflecting the latest scientific knowledge of identifiable health effects and allowing an adequate margin of safety, are requisite to protect the public health. Pollutants to be considered are those which are I 740B -- Administrator shall publish and revise a list of air pollutants which are emitted by numeroue mobile or sta tionary sources, which may reasonably be antici pated to endanger public health or welfare, and for which air quality criteria have not been issued. Criteria must be issued within 1? months | 7409(d) -- Administrator shall appoint a seven member independent scientific review committee which, on January ), 19R0 and at five year intervals thereafter, shall com plete a thorough review of the criteria estab lished under $7400 and the ambient air quality standards. The committee 0> r- j i o o o o CL < i i AP00051798 i 1 emitted from numerous mobile or stationary sources and cause or contribute to air pollution which nay reasonably be anticipated to endanger public health or welfare. | 7411 (Standards of performance) -- The Administrator shall estab lish standards of performance for new stationary sources of air pol lutants . The standards "shall reflect the degree of emission limitation and the percentage reduction achievable through appli cation of the best technological eysten of continuous emission reduction." f 7412 (National emiesion standards for hazardous air pollutants) -- Administrator shall establish emis sion standards for air pollutants not covered by ambient air quality standards which cause, or contri bute to. air pollution Which nay reasonably be anticipated to result in an increase in snrt.ality or an increase in serious irreversible, or incapacitating reversible, illness. The emission standards shall provide "an ample margin of safety to protect the public health;" If an emission standard is not feasible, a design, work practice, or operational standard which la "adequate to protect the public health ... with an ample margin of safety" must be promul gated. after the pollutant is placed on the list. f 7412 -- Administrator shall publish and revise a list Including each hazardous pollutant for which he intends to es tablish an emission standard. 4 7422 -- Radioactive pollutants, cadmiuai, arsenic, and polycyclic organic aiatter shall be included on the list es tablished by 1740* if the Administrator finds that they cause or contribute to sir pollution which my reasonably be antici pated to endanger public health. shall make such recommendations to the Administrator as are appropriate. f 7417 (Advisory commit tees) -- Administrator shall, from time to time, establish advisory com mittees to provide assistance in the development and imple mentation of the purposes of the Clean Air Act including air quality criteria, recommended control techniques, and to encourage continued efforts on the part of industry to Improve air quality. Committee mem bers must Include persons who are "knowledgeable concerning air quality from the standpoint of health, welfare, econom ics, or technology." | 7457 (Halocarbons) -- Administrator shall propose regula tions for the control of a -2- substance, process, practice, or activity which say reasonably be expected to affect the stratosphere (especially ozone) If such effect say reasonably be expected to endanger public health or welfare. The regulations suet "take Into account the feasibility and the costs of achieving such control." f 7521 (Emission standards for new motor vehicles) -- Administrator shall set emission standards for air pollutants emitted from any class of new Motor vehicles or engines which cause, or contribute to, sir pollution which may rea sonably be anticipated to endanger public health or welfare. Such etandarda must take effect after euch period aa is necessary to per mit development end application of the requisite technology, giving appropriate consideration to the cost of compliance, standards for particulate matter emissions in 1981 and later must reflect the greatest degree of emission reduc tion achievable through the appli cation of technology that will be available, giving appropriate con sideration to the cost of applying such technology within the necessary period of time. Emission con trol devices which will cause or contribute to an unreasonable risk to public health, considering increases in unregulated pollutants and the availability of alternative devices, may not be used to ccnply with such standards. -3- O) h- 10 o o C<L CO Federal Water Pollution Control Act, 33 U.S.C. $ T25I et seg. $ 7545 (Regulation of fuel and fuel additives) -- Administrator nay control Dr prohibit manufacture or ale of fuel or fuel additives an emission product of which "causes or contributes to air pollution Which aay reasonably be anticipated to endanger the public health or welfare." The Administrator must consider all relevant medical and scientific evidence available to him and must consider technologi cally or enomically feasible means of achieving emissions standards under $7521. Control or prohibi tion of a fuel or fuel additive may not cause the use of any other fuel or fuel additive which will produce emissions that endanger public health to the same or greater degree. } 7571 (Aircraft emission stand ards) -- Administrator shall set emission standards for sir pol lutants emitted by any class or classes of aircraft engines which cause or contribute to air pol lution reasonably anticipated to endanger public health or welfare. The standards shall take effect after such period as the Administrator finds necessary to permit the development and applica tion of the requisite technology, giving appropriate consideration to the cost of compliance. I 1917 (Toxic effluent standards) -- Administrator shall publish list of toxic pollutants listed in NPDC Consent Decree and any others which -4- I 1316 (National stand ards of performance) -- Administrator will publish and revise a list i i ] AP00051800 Resource Conversation t> Recovery ftct Trcfa) 42 U. S.C*! > 6901 et: aeq- "cause death, disease, behavioral abnormalities, cancer, genetic mutations, physiological malfunc tions (including malfunctions in reproduction) or physical deforma tions, in such organisms or their offspring." Administrator may add or remove pollutants from the list talcing into account toxicity, per sistence, degradability, presence and importance of affected organlams, and nature and extent of effects. Listed toxic pollutants must be subjected to effluent limi tations baaed on beet available technology. Administrator My im pose more stringent effluent stand ards on toxic pollutants, taking Into account same factors, and in addition the extent to which effective control la being or may be achieved under other regulatory authority. Any such effluent standard shall provide "an ample margin of safety." | 1321 (Hazardous substance liabil ity! -- Discharge of hazardous sub stances Into navigable waters in "reportable quantities," aa deter mined by the Administrator, is pro hibited. Hazardous substances ars those compounds which. When dis charged in any quantity into navi gable waters "present an imminent and substantial danger to the pub lic health or welfare." IS 6921 - 6924 (Standards for hazardous waste and waste generators, transporters and treatment, storage and disposal facilities) -- Administrator shall develop -5- of categories of pollution sources, including, at a minimum, those stated In the sta tute. After a category la included in the list, the Administrator shall establish standards of performance for new sources within such cate gory. The standards must reflect the cost of achieving the required effluent reduction. t 1317 -- see discussion in Column II. * 6921 (Listing hazardous waste) -- Administrator shall list haxardous wastes that are subject to regulation, hastes AP00051801 criteria for identifying hazardous waste and list particular hazardous wastes subject to regulation. "Hazardous waste** is defined aat "Solid waste, or combination of solid wastes, which because of its quantity, concentration, or physi cal, chemical or infectious charac teristics may (A) cause, or signif icantly contribute to, an increase in mortality or an increase in ser ious irreversible, or incapacitat ing reversible, illness, or (6) pose a substantial present or potential hazard to Inman health or the environment when improperly treated, stored, transported, or disposed of, or otherwise swnaged." Criteria for identifying character istics of hazardous wastes must take into account "toxicity, per sistence, and degradability in nature, potential for accumulation in tiasua, and other related fac tors such as flammability, corro siveness, and other hazardous char acteristics." Regulations Identifying the characteristics of hazardous wastes and listing par ticular hazardous wastes must be baaed on the criteria. Standards for generators and transporters of hazardous waste treatmnt, storage, and disposal facilities shall be established "as may be necessary to protect human health and the environment." f 300g-l(a), (b) (National primary drinking water standards) -- Administrator shall, within 1BO days of the Act * b passage, issue national interim primary drinking my be added to the liet upon petition by the Governor of any state. f 300j-5 (National drinking water advisory council) -- A fifteen member council, with five members from appropriate AP00051802 CT) i water standards governing contaminants Jn drinking water which "stay have any adverse effect on the health of persona." The standards were to "protect health to the extent feasible" oslng gen erally available technology, treatment techniques and other means which BPA found to be gen erally available (considering costs). Based on an HAS report, BPA is to establish recommended maximu* contaminant levels at which "no known or anticipated adverse effects" on the health of person* occur and which allow* an adequate margin of safety. The national primary drinking water regulations are to *et actual staxlsum contami nant levels ae close to the recom mended maximum as 1* "feasible" with the nee of the best generally available technology, treatment technique# and other mesne which BPA finds are generally available (considering costs). These regula tions are to be revised whenever changes in technology, treatment techniques and other means permit greater protection of the health of persons. | 3001 (Emergency powers) -- If state and local authorities have not acted, the Administrator nay take such actions ae he deene necessary to protect the health of affected persons from any contami nant which is present in or likely to enter a public water system and "which may present an lsnninent and substantial engenderment to the health of persons." -7- state and local agencies, five members from the general public, and five members from private organisations demonstrat ing an active interest in the field of water hygiene and public water eupply. The council shall advise, consult with, and make recosistendations to the Administrator on matters under this subchapter. I AP00051803 AP00051804 0 01 Federal Insecticide, Fungicide and Bodenticlde Act TfIfpa), 7 U.S.C. 136 et eeg. Toxic Substances Control Act Ttsca), 15 U.S.C. P 2601 et eeg. | 136a(c) (Registration), $ 1364(b) (Cancellation) -- Registration shall be denied or cancelled If the pesticide poses "any unreasonable risk to sian or the environment, taking into account the economic, social and environmental costs and benefits." f 136a(d), S 136d(b) (Classification) -- A registrable pesticide will be classified for restricted use if, absent regu latory restrlctione in addition to lnetructiona on usa, it may gen erally cause unreasonable risks to the environment. f 135d(c) (Suspension) -- A pes ticide whose use poses an "imminent hazard' nay be suspended if contin ued use "would be likely to result in unreasonable adverse effects on the environment" pending cancel lation proceedings. f 3603(aHTestlng) -- The Administrator may require testing of a substance which "stay present an unreasonable risk of Injury to health or the environment" (or to which human or envlronstent exposure may be "significant" or "substan tial") If the data to be provided by the tests are neceaeary to assess whether there is an unrea sonable risk. f 2603(f) (Priority regulation) -Whenever Information demonstrates "that there may be a reasonable basis" to conclude that a substance presents "a signiflciant risk of I 2603(e) (Priority list) -- A committee of eight members from various federal agencies shall develop a list of chemi cal substances, based on several factors focusing on the quantity manu factured and the threat and extent of exposure, in the order that FPA should take action under f?603(a) with respect to the substances. In making up the list, the committee should give priority to those -8- 136w(d)-- Administrator must aubmlt-to Scientific Advisory Panel notices of Intent to cancel, actions to suspend and proposed and final regulations. 21 s e rio u s o r w id e s p re a d harm to h tn a n su b sta n ce s and m ix tu re s b e in g s fro m c a n c e r, gene m u ta tio n s , th a t "a re known to cauai ffft -- --* O 0 to fl0 *0 -3 0 -- SI ff rr 0*8 fl 0 0 a *3 ft ff 000 1 > 033 9 flft U ff *3 ff 0 rr 5 m 0 r* 0 3 an & -- & 1 fl 0 ff 0 -- 0 1 ut 0 ff 0 -- 009 -- B fl -- 0 -- O 3 * * t < 9 0ft ft -- n rr s -- *1* ff a -- 0 Q, W 0 -- -- fl fl 0a 9 ft 0 ( >t 3 0 -- --.a a 9<< >- 9 --9 9 9 u* rr- * r) 0 >v J O---- 9 -- ft 0 aia )1 O > nil b ----c fl wn, a 0-- -- It 6 E s0 *3 ff it --a0 o 0 3 it *1 & M0-- --* --0 9 nio rr * -- < fl --3 -- W 9 *B 9M-- 3 -- *10 s* rr a f* i 10 *10 _ o --s *g o IJlwOlf a 90000-- SoS 9 *1 B 90 B ff C a 9 < ft -- 3 0 Q 9 Qt hi i -- n ff fl fl 9 'C -- -- 0 rr a,^ *i I - B M a. B fl fl fl 0 * * I AQlS^lCtt 0 fl 0 fl ff 0 o 3 C09 9 3 9 9 0. fl B 3 A 0 0 ft 5 It 0 3 < 0 9-- -- c 3 O 0 fr0 -- 0 3* 13 fl 0. 0 3 0 Mis' -- Or -- -- fl fl 0 fl 00 fl fl 9 -- -- 0 --5 awflirtr o i -- 0 <3 0 0 >09 fl.fl03>-05-3 _ 0ff*< -K rr *fol --9 efl rr _ --13 on 9-- 0 3 0 ff 0 9 fl 3 j* 5 _<-u0 00 I Ts I flNl 0 -- 9 1 nni 01 i > 3 0 . -- 039 *<99 fl ft > 1 IftM-H 0 0 0 9 00 HIT fli rr h 5 C fl g. 0 0 --O 0 fl*Q. o' 1- * c fl 9 n rr MU 0 K 0 0 0 fl ff*B W 9fi 0 3 ft rr S 3 0 -- < 0 0 3 rr OS' *3* rr 3 0 fl> 3 fl 0 0 fl* 0 (* g, 0 9 ---- 0 m0 --o It* I1 9* 0 M0 0 fl 0IT V fl C 9 --0 09 fl rr 00 fl O 0 3 A 0 3 0 n 0 0 ,,fii O--' rra.0 9 0 fl 0 >< rr n 9 0 33 "s."m 9 <A ff o, -- 9 --a 9 rr a rr 8 ? 0 rr ir a -- 0 0 0 fl -- -- -- 9 *3 <2 990 * ff ae --0 0 c < 0 fl M mt fl. 3 1* 9 0--3 -- rr | . 02 -- 9 3* 0C9 rs 3 n 9 iS r* .rr 9 0 o at 0 0 fl) < 9-- 3? ff n o 0 0 --0 A a a fl a , 0 5* 8 o 58 o/Sft 9 rr 0 mi 3 n -- 1 a 0 ,, o* 0 ff n 1 e rr c rr 0 c rr ft -- 1? 09 1 rrifi 0Ml 20" O 3 rr 0 n n 0 5 0 fl c. o5 a AP00051805 cI CM Ocean Dumping Act, 33 U.S.cTT 1401 et~eeq. present an unreasonable risk of Injury to health or the environ ment, " after consideration ofi (1) effects on health and the magnitude of human exposure} (2) effects on the environment and the magnitude of environmental exposure} (3) the benefits of the substance and the availability of substitutes! and (4) the reasonably ascertainable economic consequences, considering the effects on the national economy, email business, technolog ical innovation, the environment and public health, SPA shall regu late the eubatance "to protect ade quately against such risk using the least burdensome requirements." f 2606 (Imminent hazards) - EPA say start a civil action againat the manufacturer or processor for sei zure of chemicals that are "immin ently hazardous" or for other relief. A' court may grant any relief necessary to protect health or the environment from an unrea sonable risk. | 2607(e) (Substantial risk notifi cations) -- Any manufacturer, processor or distributor of a chem ical who obtains information which "reasonably supports" the conclu sion that that chemical preaents a "substantial risk of injury to health or the environment" must immediately inform EPA of such information. 1412--13 (Permits) -- Administrator may issue permits for dumping if it will not -10- AP00051806 "unreasonably degrade or endanger Hunan health, welfare, or ameni ties. or the marine environment, ecological systems, or economic potentialities." | 2056 (Consumer product safety standards) -- Commission may promulgate standards containing requirements expressed in tersis of performance requirements or requirements relating to clear and adequate warnings and instruction. Any requirement shall be "rea sonably necessary to prevent or reduce an unreasonable risk of injury associated with such prod uct ." f 2057 (Banned hazardous products) -- Commission may ban a consumer product that presents an "unrea sonable risk" of Injury and for which no feasible consumer product safety standard would adequately protect the public from the risk. $ 2061 (imminent hazards) -- Commission may File a court action for seizure of an "issslnently hazardous consumer product" (defined as a product vihich "pre sents lsmlnent and unreasonable risk of death, serious illness, or severe personal injury"). f 342 (Adulterated food) -- Pood is considered to be adulterated, if Inter alia, (1) it contains any poisonous or deleterious substance which may render it injurious to health (or, in the case of an intrinsic substance, the quantity ( 376 (Color additives) -- Secretary is to create separate lists of color additives certified for use in or on food, for use in or on druga, and for use in and on | 2077 (Chronic hazard advisory panels) -- Commission shall appoint a seven member panel made up of Independent scientists to advise the CoawtJssion on issues relating to the chronic Hazards of cancer, birth defects, and gene muta tions associated with consumer products. The Commission may not issue proposed regulations relating to cancer, birth defecta, or gene mutation until It has received the report of an advisory panel. * 346 (Tolerances) -- Upon request of a peti tioner or if the Administrator deems it necessary, the Administrator shall sub mit data to an advisory AP00051807 **1 Cl of ouch substance ordinarily renders It injurious to health)j (2) If It hears any added poisonous or deleterious substance which la unsafe (other than certain otherwise regulated substances)} and (3) If it consists in whole or in part of any filthy* putrid or decomposed substance* or Is otherwise unfit for food. ) 346 (Tolerances) -- Tolerances may be set for poisonous or dele terious substances added to food. If substances cannot reasonably be avoided in the production of the food, at the level necessary for tbs protection of public health. f 348 (Pood additives) -- The Secretary say Issue a regulation prescribing the conditions under which a food additive nay be used, if the food additive has been ade quately shown through scientific procedures to be safe under the conditions of its intended use. An additive will not be considered safe "if it Is found to induce can cer when ingested by man or animal, or it is found, after tests which are appropriate for the evaluation of the safety of food additives* to induce cancer in man or animal." f 376 (Listing and certification of color additives) -- A regulation allowing the use of a color addi tive My be put Into effect if the color additive is safe under pro posed conditions of use. A color additive shall be considered unsafe "for any use which will or may 12- cosmetics* baaed on whether they are safe and suitable for such uses. committee to perform an independent study of the data. The advisory com mittee is to consist of competent experts selec ted by the NAS and must contain one or more rep resentatives from landgrant colleges. The report and recom mendations of the commit tee are to be considered by the Adminstrator In the decision as to an appropriate tolerance level. 376 (Color additives) -- Upon request or at the Secretary's initiative, scientific questions regarding color additives are to be referred to the advisory committee of qualified experts* to be selected by the NAS. The Sub-Cabinet Working Group has pro posed that a Pood Science Advisory Committee be created to advise the Secretary on cancer and other food safety issues. If further data eval uation is needed, a Science Evaluation Committee Is to be formed. Where a food additive is thought to induce cancer* the Secretary must submit the data to the Pood Science j AP00051808 |Q vl result Id Ingestion of all or part of such additive. If the additive Is found by the Secretary to Induce cancer when ingested by nan or ani mal, or if It is found by the Secretary after tests which are appropriate for the evaluation of the safety of additlvea for use in food, to induce cancer in man or animal* and ahall be considered unsafe "for any use which will not result in Ingestion of any part of such additive, if, after teats which are appropriate for such use, or after relevant expoeure of man or animal to euch additive, it la found by tha Secretary to induca cancer in man or animal,* The Sub-Cabinet Working Group's latest proposals for an adminlatrative position include! (1) definition of **eafe" aa "a rea sonable certainty of no significant risk, baaed on adequate scientific data, under the intended conditions of use of a substance}* (2) codifi cation of judicial de minimis rule for food contact suBstancea? O) clarification of Delaney Clause as applying (a) to additive ae a whole, (b) only where qualified experts find riek of cancer to man and (e) only Where risks outweigh health benefits from additive use} and (4) allowance of use of risk assessment procedure to determine safety. -13- Advisory Committee or to a Science Evaluation Advisory Committee. AP00051809 Humane C are and D e v e lo p m e n t o f S u b s titu te s fo r A n im a ls in P eeearch A c t. H .R . 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