Document DDN0djV8L2ZK5YLqpDgMvZ9D5

\ c The U.S. Environmental Protection -4gencv must first act dustq. Some chemicals makers fear that EP.4 tvill be too inflesible on on se\-era1 key fronts, such as setting test protocols this; they note that for some spe- and defining "significant ne\v uses" of existing chemicals, cialty chemicals production of several hundred pounds a year would before the chemical process industries can even begin to Pram the imDact of the iust-enacted law. be commercial, \\.bile for many highvolume substances output of several hundred thousand pounds yearly might still be developmental. The Xct`s too new for EP.4 to have 0The Tosic Substances Control the Scarsdale, S . Y . , based Synthetic done much to resolve such thorny Act (TSC.4) okayed by President Organic Chemical lfanufacturers points. For instance, the agency has Ford in mid-October rates as one of Assn. (SOC1l.A). `.But," he contin- "not yet addressed" a number of the most far-reaching pieces of legis- ues, "in order to make a real deter- questions, such as whether it will lation ever to hit the U.S. chemical mination of the Xct`s impact. any lean toward chemical categorization, process industries (CPI). TSC.4 re- number of EP.4 regulations have to says Glenn Sch\\-eitzer, chief of its quires industr). to notify the Envi- issue." Office of Tosic Substances. ronmental Protection Agency before GuESsIsc-SOw, industry c a n But EP.4 maintains it will tread marketing new chemicals or com- only speculate about how strongly lightly. Indeed, earlier this year the mercializing "significant new uses`.' EPA will move on the Act. Points agency's administrator, Russell E. of existing chemicals; under certain out one industr). executive: "Every Train, promised a "go slo\v" enforce- conditions, EP.4 is empowered to re- action that the .4dministrator of ment (Chem. Eng., Mar. 15, pp. quire testing, and to delay or ban EPA can take within this bill, he can 53-54). .And even if it wanted to chemicals manufacture or marketinq take with respect to categories of move faster and more broadly, the (see the bos starting on p. 82 for .I chemicals or \\-ith individual chem- agency couldn't because of lack of synopsis of rhe .\ci I. icals. I think common sense dictates money, notes a n EPX official- The President's signature eritltd that he's going to be discrete in \\.ha< through fiscal 19T9, it only has an sis years of fierce battling on Capitol he classifies as categories, and you're average of about SI3 million/yr to Hill, resulting in a compromise law not going to find enormous cate- spend on tosics control. that most CPI firms have labeled gories such as alcohols. ethers, esters LnDlL\RKS-These early indus- "tough but workable." But the mag- or aldehydes. But \\.hen you start try speculations should be resolx-ed nitude of the Act's impact is uncer- narrowing down the classifications, over the nest fe\c years as EPA and a tain, and likely will remain so for at there`s where you can indeed get into federal interagency committee* start least another three years. The key: problems,. because just as EP.4 gen- issuing regulations required by the EPA's interpretation of what is eralizes PCBs, it could generalize Act. meant by Congress's mandate to equally well some others. That kind One of the first major clari- carry out the Act "in a Kasonable of categorization is probably what fications will come by Sovember and prudent manner." you are $ing to see-limited b u t still 1977 \\.hen EP.1 must publish a n in- "In broad terms, things are a lot fairly broad." ventor). list of esisting chemical sub- clearer now than they were, say, \\`orries another: "\\-e don't know stances. Until that time, manufac- when \ve were dealing with alierna- yet what tests will be required. how turers will not know for certain rives in t h e S e n a t e versus the many, what methods, etc. This could whether their products will fall into House," notes George S. Dominguez, Ciba-Gei3 Corp.'s (Ardsley, N.Y.) director of government relations for safety. health and environment, and director of environmental policy for have a big impact on costs." And since the Act exempts re- search and development chemicals, the definition of commercial quantities rates as a crucial point for in- Composed of rcprcjcntaiiva from E P h the Occupational Safety and Health Adminirirarion. the Sational Institute for Occupltional Safety and Health, the Council on Environmental Quality. the Dept. of Commerce. the Saiional Science Founda- tion. the Institutc Sational Cancer Imritoie of Envirnnmrniil Hcallh and the Sation Sciences. al Q O ? ? A l ! 81 Here's a Chtmical Engincrrin,< attempt' to boil down the major sections of the 53-page-longToxic Substances Control Act (Public Law 94-469): Section 1-Short title and table of contents. Xlerely cites [he .Act's name, and labels its 31 sections. Section ?-Findings, policy and intent. In this section, Congress directs that because , .people and the environment are esposcd to many chemicals. some of \vhich mav ~ o saen .'unreasonable risk" to health or the environment, manufacturers and processors of these marcrials must develop data to assess these risks. The Environmental Protection .Agency \\-ill have authority to regulate these chemicals, but should c a r y out the .\ct **ina reasonable and prudent manner. . . [and] not impede unduly or create unnecessary economic barriers to technological innovation.'' Section 3-Definitions. Subsections (~1,J and (.2,)define chemical substances to include organic or inorganic compounds and any element or uncombined radical. but esclude mistures, pesticides, tobacco and tobacco products, nuclear motrrials, foods, food additives. drugs and cosmetics. The definition of mistures [subsection ( 8 j ] rates as one of the more important concessions \con by industrv. Conp"ress \\.anted EP.A to have authoritv over a \vide range of substances, but industr) didn't want to be overburdened by a definition that would require ever)- minor formulation change to be viewed as a ne\\. substance. So, the .Act defines chemical substances and mistures separately. It labels a misture as any combination of two or more chemical substances that are not found in nature and do not chemicalls react with each other. .A change in the proportion of inert ingredients forms a ne\\-misture, not a new chemical substance. T h e combination is also defined as a misture even if a chemical reaction takes place. providing that the -reactants form '.esisting" (rather than **ne\\.") .+lapred in pan irom '.Summan and Analvsir of rnr Toxic Subsranccj Conirol .+cI" by Clear?-.Corrlieb. S ~ c m& Hxnilron for ihr S i n I hcric Organic Chrnical .\lanufacrurcrs Arsn. substanccs. and providing that these ..csisting" substanccs could have been made without a chemical reaction. .Also, if EP.4 determines that a misture must be esamincd for tosic potcntial, the agency must decide whether the questions can more readily be resolved by looking at the niisture's ingredicnts-data for Ivhich are much morc likely to already be available. Under subsection !9j **ne\\c.hemical substance" is defined to mean any chemical substance not included in the inventor) list [see section 8(b) for fur1hrr details]. bcciioii 4-Testing of chtniical suhstances and mistures. Cnder subsecrion (a)?if EP.\ finds that a chemical substance or rnisture may pose a n '.unreasonable risk" to health or the environment, and there are insufiicient data available to assess possible effects. the .Administrator \\.ill order testing. Or, if the material is made in --substantial quantities." raising the risk of possible significant human and en\.ironmental esposure. and there aren't enough data around to predict irs impact, testing i\-ill be mandated. Subsection ( b )requires EP.A to set standards for the development of test data. Subsection (c) allows the agency to esempt firms making or processing a given substance from providing duplicative data: if nrcessar), EP.A must then determine fair cost allocations among the manufacturers or processors of that material. Subsection (e) creates a Federal interagency advisor\- committee that must prepare a list of priority substances and mistures that the Administrator should consider for rule promulgation. T h e first list, which gives priority to those materials suspected of causing cancer. gene mutations or birth defects. is required by Oct. 1. 1957 [see test]. EfTectiveJanua? 1.1979, under subsection I f), '\the .Administrator must take action on suspect substances and mistures. \\-ithin 180 days of receipt of data that indicate a material may pose a n unreasonable risk. EP.A must either initiate action to the "esisting" or "new" categories.. By definition. materials not on the list will be considered "new." \\-ithin thirty days of issuance of the list, manufacturers of new chemical sub-: stances must notify EPX before they begin marketing. llean\\.hile, by October 1955, the interagency committee is mandated to publish a list of esisting sub- stances or mistures for testing, desisnating up to 50 of them as highest- priority test candidates. T\\.elve months later, EP.4 either must issue a rule requiring testing of the chemicals on this list o r esplain why it is esempting any of them. Therefore. it \oil1 be nearly m.0 years from now before chemicals makers know for certain \\.herher their esisting products \\.ill require testing to stay on the market. \\'bile these gears are in motion. EP-A will be defining .-significant new uses" of esisting substances-another action of great moment to the CPI. Although the bill doesn't stipulate when EP.4 must d o this, indus- try officials feel that .the definition \\.ill probably come out in about a year or so. .llso. \\.bile the Act doesn't reql;ire EP.4 to issue the testing rules until October 1978, they \\-ill likely be available within the nest year. This is because much of the legislatian hinges on the testing of possibly h x ardoussubstances. -411in all, the CPI \\.ill start to feel the Act's effects during late 197T and through 1978. with the real clout probably coming by the beginnins d5 rhe IICW Tosic Substances Control Act prevent or reduce such risk, or esplain M.hy it doesn't consider the risk to be unreasonable. Section 5-3Ianufacturing and proccssing notices. The major thrust of this section-the preniarketnotification provisions of the Act-requires that industry give EP.4 90-day advance notice of intention to manufacture all new products and, all esisting products that are to be put to *.significant new use.'' By giving EP.A notice before commercial production begins. the agency can take action against dangerous chemicals w.ithout significantl! undcrmining jobs and capital investments. Congress reasons. EP.4 can estend the premarket notification period by 90 d2ys if it sh0u.s "good cause" [subsection (c)]. .As the premtrket notification period comes to an end. the .Administrator is authorized under subsection (e) to issue an order restricting or prohibiting the manufacture. marketing or use of a new chemical substance. or the proposed significant new use of an existing chemical, if enough information is not available to evaluate the health and environmental effects. If the manufacturer objects, the Administrator must seek a n injunction. The injunction \\-auld be dissolved after the manufacturer had submitted adequate test data. Subsection t f >requires EP-A to take various actions, such as limiting or banning a net1 chemical substance or a proposed significant ne\\' use of an existing substance that may present an imminent, unreasonable risk. Cnder subsection (g), the .Administrator must explain at the end of the notification period his reason for not prohibiting or limiting the manufacture. processing. distribution, use or disposal of the chemical substance. Subsection (hi provides various esemptions, including: the submission of duplicative data; chemicals produced in small quantities and used solely for research and development; chemicals not deemed to pose an unreasonable risk; and shortlived intermediates. Section 6-Regulation of hazardous chemical substances and mixtures. Cnlike section 5 , c$.hich applies only 10 new chcrnicals and significant new uses of existing chemicals, section 6 provides EP.4 with a w.ide array of weapons to prohibit, limit or othem-ise regulate a gamut of substances-esisting and new chemicals and mistures, alike. Subsection (a) dictates that the Administrator use the "least burdensome" method to protect against risk. while subsection (c) requires EP.A to consider the regulation's effect on the national economy. small business, technological innovation. the environment and public health. I n subsection (e). the .ict calls for the eventual phaseout of polychlorinated biphenyls. with manufacture to cease by Jan. 1, 1979. and processing and distribution prohibited by J u l y 1 of that year. (Ho\vever. the sole C.S. producer of PCBs. l l o n s z n t o Chemical Co., already has pledged to be out of the business by the end of 19ii-see Chm. Eng.. Aug. 30. pp. 66.68). Section 7-Imminent hazards. This section gives the .Administrator further authority KOquickly regulate against chemical substances or mistures that *'presentan imminent and unreasonable risk of serious or n idebpread injur).." Even before rule-making is initiated under section 6, EP.4 can file suit for c0rrectir.e remedies, such as seizure or recall of chemicals. Section 8- Reporting and retention of information. This section gives the .Administrator the por\-er to get the information he needs to accomplish the goals of the .Act. For esample. subsections (a). (c) and (d) require manufacturers and processors to submit reports and health studies to EPA, and keep a wide range of records for periods of up to 30 years. It minimizes these burdens for small businesses. Under subsection (b), the Administrator is mandated to compile, keep up to date, and publish a list of e\-er). chemical substance made in the U.S. Sections 9-31--.4dministrative provisions of the .Act. 2 T h e rest of the -Act deals with TSCX's administrative aspects. including coordination with other federal agencies, penalties, judicial revie\\.: citizens' civil actions, and the like. of the nest decade. Xt that time. in- dustry should be able to put some firm figures on TSC.A's actual costsin terms of money, nianpo\$.er, staffing changes, lost innovbtion, a n d similar aspects. IS~TIALEFFORTS--.& best they can, industry trade organizations already are t n i n g to get a n early reading for their members of \\.hat the .Act will mean. For esample, \\ithin weeks of TSC.A's passage SOCll.A's legal counsel, Clear?, Gottlieb. Steen & Hamilton t\\'arhington, D.C.), is- sued an 80-page report analyzing and summarizing the .Act. \\-bile spelling out the new law's possible impact on chemicals makers. In addition, the lianufacturing Chemists .-lssn. (\\-sihin,aton, D.C. t now is planning to present three ineetings titled .*The .Approaching Tosics Era," the first of which at presstime was slated to be held on Sov. 11 in Houston. Tes., \vith the others to follow on Dec. 5 in \\'ash- ington, D.C., and Jan. 13 in Los .+- geles. Also, l l C . 1 has formed a Chemical Regulations Advisory Committee that had its first meeting about TSC.4 on October 20, to start \\ark on a study of how the legisla- tion might affect company staffing. record keeping, reporting, data gathering and various other functions. At presstime, a task force within this advisoT committee was firming up plans for a series of meetings to be held across the c o u n t n beginning in February. The topic: 'Corporate readiness for TSC.4." Larry J. Ricci . -