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* 3* That the disposal of VC containing liquid organic and solid vastes in open pits he prohibited if the VC content of said vastes ex ceeds 10 ppn by veight. It* That the VC content of polymer leaving the stripping section of suspension* hulk end solution FVC plants he United to Uo ppn by veigfrt. - 3* That the EPA VC standard, as modified by the above recommendations, be extended to apply to all chemical manufacturing facilities in Texas vhich emit VC into the atmosphere. If the above recommendations axe implemented, all VC emissions in the state 'vill be subject to a single broad based regulation. The emissions of VC in Texas vill be reduced to approximately ^3S tcas/year or ebout 3? of the 197U total* Furthermore, the EPA's VC standard vill be significantly im proved in that public exposure to airborne VC vill be restricted to a fixed maximal. .The costs to achieve the level of control reconaaeuded in this report have been estimated* The capital costs required are about $10,950,000. The annual operating costs that vould be incurred total about $1,670,000. .r-------- March lU, 1977 ; 111 Sr t- AP00017048 jo < .1- r;--X A - : CPSC Regulation of Cancer Risks in Consumer Products; 1972-1981 . LyXV t' : \ Richard A. Merrill . 1 $> " - X . -X . VIRGINIA LAW REVIEW ASSOCIATION Ml AP00017049 I VIRGINIA LAW REVIEW Volume 67 October 1981 Number 7 CPSC REGULATION OF CANCER RISKS IN CONSUMER PRODUCTS: 1972-1981* Richard A Merrill** After thi* article was set in type, Congress poised the Conturner Product Safety Amendments of 1981, which authorise the Consumer Product Safety Commission to operate through fiscal year 1983, The Amendments also effect important substantive and procedural change* in the laws that the Commission admims ten. These changes, which are summarizsd briefly at the end of the article, render tome of Part II unreliable as a description of current CPSC statutory authority, but they do not undermine its historical accuracy. Furthermore, some of Congress*s amendmsnts ere consistent with recommendations set forth in this article. In addition, and also after work on the article was completed, the Commission itself made changes in its internal structure that re' spond to criticisms advanced here and thus date tome of the die* cussion at notes 30-39 infra. 77te* changes, too, ere discussed briefly in the epilogue. THE U.S. Consumer Product Safety Commission (CPSC) ad ministers several statutes designed to ensure that products * Copyright 1981 by Richard A. Merrill. This Article U Adapted from a chapter of a study on federal rtfulatloo of chaoical eardnogeaa that Profaaaor Merrill b preparing under the auepicaa of the Administrative Conference of the United Stetee. Use Conference ha* prodded research support for tha etndy but has neither reviewed nor adopted Profaaaor Merrill's ftill report of this article. -- Denial Caplin Professor of Law and Dean. University of Virginia School of Law. The author wishas to thank Mark Colley of tha University of Virginia Law School Claw of 1930, who aseiited on the article bom its inception, end Carolyn flury of tha Claw of 1983, who helped prepare the manuscript for publication. Several individuals, including current or for mer employees of the Consumer Product Safety Commission, provided guidance at tha re search stage and commented on earlier draft* and Peter Barton Hurt provided --entlal advice throughout. Hie help of these individuals b gratefully acknowledged, but they are not in any way responsible for errors In the final product 1261 AP00017050 I 1262 Virginia Law Review [VoL 67:1261 marketed for consumer use do not cause injury or illness. The five* member Commission is authorized to disseminate information to the media and to consumers, and to prescribe labeling for, and ban the commercial distribution of, specific products and product for* mulations. On seven occasions in its nine-year history, the Com mission has attempted to regulate products containing substances that it believed posed risks of human cancer.1 As one of the four founding members of the Interagency Regulatory Liaison Group (IRLG),* the agency assumed a visible role in federal efforts to reduce human exposure to cancer-causing chemicals in the late 1970's. The Commission's role in regulation, however, has been subordinate and reactive; most of its actions against carcinogens have followed and relied upon regulatory initiatives by other agencies. This article examines the CPSC's performance in regulating car cinogens. Part I describes the origins, primary functions, and juris diction of the Commission and outlines some of the problems it has faced. Part H reviews the statutes that provide the Commis sion authority to regulate carcinogens and identifies the important regulatory tools available to the agency. Part HI analyzes the CPSC's chronic hazards program as a continuing agency activity, Including its development of a system for identifying chemicals that merit regulation. Part IV examinee the CPSC's various at tempts to regulate chemicals posing risks of human cancer. These case studies identify significant and recurrent problems in the agency's approach to carcinogens. Part V summarizes the deficien- 1 As of Juno 30, 1981, the Commission had initiated regulatory actions aftlnat the following aerosolized products containing vinyl chloride (1974), consumer products contain ing chlorofluorocarbon propdlant* (18TT-1978), THIS*Stated children's garments (1977), patching compound! cad embertrisg materials containing asbeatca (1977), conaumer prod uct! containing benzene (1977), hairdryer* containing asbestos (1979), and urea formaidehyde foam Insulation (1981). * The mm was established la August 1977, by the CPSC, the Food and Drug Adminis tration. tha Occupational Safety and Health Administration, and the Environmental Protec tion Agency. These agentiee joined together with tha announced purpoee of sharing Infor mation and coordinating their regulation cf toxic chemicals, thereby avoiding duplication and achieving oosairtency. Croupe of officials from all (bur agenda wen formed to work in eight areas of common concern, auch aa teat standards, inspections, and enforcement The purpoea of theca groupc la to tnnea data on concapta and methodologies and to develop common criteria, but individual agendas retain the mpossibility for judgments concerning appropriate regulation. In 1979, the Food Safety and Quality Service of the De partment of Agriculture joined the HU.G. 44 Fed. Reg. 39,8W (1979). ! j 1 AP00017051 1981] Cancer Risk* 1263 des in the Commission's statutory authority, organization, internal procedures, and formal public processes. L Tkb Institutional Contzxt A. Origin** of the CPSC The Consumer Product Safety Commission had its genesis in a 1970 report issued by the National Commission on Product Safety.* The National Commission determined that over twenty million Americana wen injured at home each year as a result of inddents connected with consumer products. Of these, 110,000 were permanently disabled and 30,000 were killed. Moreover, the report concluded that no existing mechanisms--industry self-regu lation, common law remedies, or current federal, state, and local regulatory efforts--were adequate to deal with the problem.4 Re medial legislation, according to the report, was too often delayed until after the occurrence of a widely publicized tragedy.* The National Commission recommended legislation to consoli date authority for consumer product safety within a new, indepen dent federal agency. Although this proposal received bipartisan support in Congress,4 there were major disagreements over the structure and jurisdiction of the proposed agency. Both the Senate and House versions of the bill would have created a new indepen' dent agency. The Senate bill would have transferred to it all func tions then performed by the Food and Drug Administration (FDA);? the House version would have likewise established an in dependent agency to deal with consumer product hazards, but would have left FDA intact.* The Conference Committee compro mise, which more closely resembled the House bill, reallocated many fewer authorities than originally suggested by the National * Congraaa authorised Tha National Commission on Product Safety to "conduct a com- prahsMiva study and lavactigation of tha acopa and adaquacy of tnaaauraa now tmployad to protact eoniumars against uaraaaonabla rialc of iajuriaa which may ha cauaad fay hazardous household products.** SJ. Has. 33, Pufc L. No. 90-146, SI 8tat. 466, 467 {1967}. * UiL Natl Coma's oa Prod. Saftty, Flail Raport to tha Praaldant and Congress 2-3, 89 (1970). * Id. * St* S. Rir. Ha 836,92d Cong., 3d Stag. 22, nprinttd in (1972) UA Com Coho. 4 An. Nm 4873. 4894; HA Rn>. No. 1153, 92d Cong., 2d Saaa. 1 (1972). * B. Rxr. No. 835, supra aou 8, at 1, (1972] US. Com Com. 4 Ad. News at 4574. * HR Rip. No. 1153, aupra acta 6, at 24-25. 1264 Virginia Law Review [VoL 67:1261 Commission.* Even so, the Consumer Product Safety Act of 1972 (CPS Act)4* created and conferred upon the CPSC "unprecedented powers to deal with consumer product safety.**11 The CPS Act was intended "to protect the public against unrea sonable risks of injury associated with consumer products.**4* The Act gave the Commission two main responsibilities: (1) the collec tion and dissemination of information about injuries from con sumer products,1* and (2) the promulgation and enforcement of regulations designed to eliminate or reduce ``unreasonable risks** presented by such products.14 R. The CPSC's Authority to Regulate Chronic Hazards All of the product defects that excited congressional concern in 1972 caused* or threatened, immediate injury. For years, the CPSC remained uncertain, and reportedly divided, about whether its mandate extended to longer-term or chronic hazards such as chem ically induced cancer. The Commission's current, broad view of its role developed gradually. The contours of the CPSC*s regulatory jurisdiction are estab lished by Its organic Statute, the CPS Act, and by the Federal Haz ardous Substances Act (FHSA).1* The CPS Act empowers the Commission to regulate all unreasonable risks of injury presented by the large universe of products marketed for consumer use, with several enumerated exceptions.1* The FHSA authorizes the Com mission to regulate various hazards, such as toxicity, flammability, and danger of electric shock, associated with a less clearly defined * SLR R*r. Na 1893,92d Cose* 3d Saw. 38, nprinttd in (1973} U.S. Coot Coho. 4 An. N*W 4596, 4623*2% IS UAC. 2051.2082 (1978 4 Supp. HI 1979). " 8NA, ABC** of Tta Cohsuv** Product Safftt Acer 3 (1973), quattd in J. Traubennan, Regulatory Approach** Under the Cessuser Product Safety Act 2 (August 24, 1978) (unpublished paper) (copy on file with the Virginia Law R*'i*w Association). 16 VAC. | 2051(b)(1) (1976 4 Supp. HI 1979). " Id. i 2054 (1976). Id. i 2056 (Supp. m 1979). " Id. if 1261*1275 (1976 4 Supp. HI 1978). Enforcement of th* FHSA was wawaigned to the CPSC in 1972. Id. | 2079 (1976). " Products under the jurisdiction of FDA, with the exception of medical dericee, are ex. eluded from the scope of the CPSC, as ere specifically exempted product* such a* tobacco. Id. | 2052(a)(1). AP00017053 L 1981] Cancer Risks 1265 univers* of household products*" Although the jurisdictional language of the two statutes differs, for purposes of this article it may be assumed that the two laws cover essentially the same products.1* Neither the CPS Act nor the FHSA describes a readily identifi able category of products over which the agency has jurisdiction.1* Together, however, the two statutes confer authority to regulate an enormous variety of products and activities. Both, statutes author ize the CPSC to regulate technological hazards in the household, and the CPS Act gives the agency regulatory authority over hazards encountered in school end in recreational settings os well** Furthermore, the Commission's jurisdiction continues to grow unpredictably because it expands with the introduction of new consumer products.*1 The Commission's broad but nebulous mandate inhibited its regulation of chronic hazards for many years. Many CPSC officials doubted whether the agency should devots significant resources to regulation of long-term hazards.** This view may in part have re flected a belief that few consumer products were likely to present such risks. In addition, there was concern that the agency lacked the technical capability to evaluate chronic hazards. Finally, it was argued that regulation of chronic hazards lay beyond the agency's central responsibility of regulating products capable of causing acute injuries.** . Id. i 1281(fl.(m). u This is confirmed both by the egtncy'e use of both ststutas to regulate carcinogens end by (to recognition that the FHSA could apply to hazards it has regulated under the CPS Act See notes 867-71 infra sad sceampanjfag tost ** Nor doas aitfasr statue* proscribe May product licensure, as do tho Federal Insecticide, Fungicide, and Rodentidd* Act. 7 U.S.C. J| I38*l3$y (1976), which ertabUshea procedure* for the registrstfan of peeticidee, and the Feed Addltivee Amendment 21 U.S.C. 134$ (1976 A Supp. m 1979), to the Federal Food, Drug, and Coemetie Act CFDAC Act), id. || 301. 392, which aimultoneeusly leneretee esd defines the ctoae ot product* within the agency'* jurisdiction. ** 16 U.S.C, | lMl(fMm) (1976 4 Supp. QI1979); id. ! 348. " St*, rg., Cellule** InauUUos, 16 CP.R. |1404 (I960); Electric Toy*, 19 CFJL { 160$ (I960)', (1979) U. Coniomxb Pnoo. Sarm Comm'n Awl Rzr. (pt 2), app. L, at 129 (fiating product* regulatod by the CPSC). ** Intervitw with Janne Gallagher, Assistant to Comaieeiooer R. David Pittlf, in Wash ington, D.C, (August 14,1979) (hereinafter cited at Gallagher Interview] (copy of notes from interview on ffi# with the Virginia Law Review Association). AP00017054 2266 Virginia Law Review [VoL 67:1261 The CPSC't first attempt* to regulate carcinogens, which were directed at vinyl chloride, asbestos, and chlorofluorocarbon!, did not represent either a redirection of its mission or a major expendi ture of resources. In attacking vinyl chloride and asbestos, title agency relied almost exclusively on evidence already assembled and evaluated by other agencies.*4 Similarly, the joint actions of the Environmental Protection Agency (EPA), FDA, and the CPSC against chlorofluorocarbon propellants relied on experimental and theoretical work conducted by nongovernment researchers, which waa confirmed by the National Academy of Sciences end an inter agency task force.** But the Commission's participation in this suc cessful, coordinated regulatory effort reportedly helped convince internal skeptics that the agency should give greeter emphasis to chronic health hazards.*9 More recently, the CPSC has made clear its conviction that reg ulation of long-term hazards comports with its historic mission. In 1978, the agency published a "cancer policy" describing the scien tific premises that would guide its evaluation of substances posing a risk of cancer.*7 The agency has allocated a substantial portion of its current budget to chronic hazards regulation. In 1979, it employed a new Deputy Associate Executive Director (DAED) for Health Sciences, who was experienced in toxic chemical control, and it created more positions for scientists trained in toxicology, pharmacology, and other disciplines needed to evaluate potential carcinogens.** The five proceedings the agency has initiated to reg- M See text accompanying now 288 a 38S infim. " St* text accompanying notes 310-12 infr*. M Gallagher Interview, tupn note 22. " St* note* 182-231 infru and accompanying text * TUi commitment any be in quadra, however, u indeed may the CommUaion's con tinued existence as ad (fancy. Tbt CPSC'a proposed budget for fiscal yaar 1982 la 30% lea* than th* agency's original "currtnt operating level" requeet The decrees# was demanded by the Office of Management and Budget Tie projected total is 83^983,000, of which the chronic hazards program would receive 32,428,000. This represents only 7.4% of the agency1! budget (up froa 6.8% in fiscal yaar 1981), even though the CPSC considers the program of major Importance. Agency spokesmen assert that work on several identified health heiirdi--parchlowetbylene, benzidine dyse, and asbettoe--would have to be cur tailed under this allocation, u would the Commission's participation la IRLG activities. Stt, .g., [1981] 4 Chsm. Rao. Rax. (BNA) 1621-22; Agsncy Talk Sheet; "Impact of the Proposed Budget Cum on the Consumer Product Safety Commission" <1981) (copy on file with the Virginia Law Review Association). Fox an outline of the Commission's plane before the contraction of its budget, see Htarinft be/ore th* Coruumtr Subcomm. of tht Stnat* ) ) iI AP00017055 1981] Cancer Risks 1267 ulate carcinogens since 1977, its internal review of suspected car cinogens (designed to develop priorities for regulatory action), and its active participation in the IRLG provide further evidence of the Commission*! commitment to regulating chronic hazards. Whether the agency is capable of playing an important role in chronic hazards regulation remains to be seen, however. The un predictable dimensions of the Commission*# jurisdiction have im peded the creation of an efficient organization and a responsive decisionmaking process. Furthermore, the agency's large potential caseload and small budget have reinforced its predominantly reac tive posture; it responds primarily to hazards brought to its atten tion by outside parties and, in the case of most carcinogens, ones that have been addressed previously by other agencies. C. Structure and Administration of the CPSC A general familiarity with the CPSC's structure will aid in evalu ating its performance in regulating toxic chemicals. Tht agency consists of five Commissioners, who are appointed by the Presi dent with the concurrence of the Senate for fixed terms of seven years.** As a multi-member agency, the CPSC is subject to the Government In the Sunshine Act.1* The advance notice and open meeting requirements of this statute, coupled with the agency's historic commitment to a liberal disclosure policy under the Free dom of Information Act,11 have often forced the Commissioners to discuss regulatory strategy in public. The Sunshine Act require ments likewise have impeded communications between the Com- - Comm, on Commerce, Sdtnet a Ttoneportstion, 97th Cons., 1st Seas. (Apr. 3,1981) (etetemsnt of Peter W. Promt, FhJX, Aaaoc. Exec. Director for Health Sdencst, CPSC). * IS UAC. f 2053(a), (b)(1) (1976 4 Supp. IQ 1979). As tn independent regulatory com mission, the CPSC theoretically is low eulnerable to preaidsntial control thou or* moot fedoral regulatory agendas. For oxsmpls, ths President nap raphes Ccmadsnonors only when thoir terms expire or they reeign, or for neglect ot duty or malfeasance in office. Id. S 2063(a). Both Pmidsnt Carter and Pretidant Reagan havt refrained from testing tbs limits of direct presidential oversight of atanciw outside ths Executive Branch, but ths extent of these agencies' lafal immunity from presidential oversight remains * matter-of dispute. ** 5 U.S.C. | 562b (1976). The Sunshine Act applies to any assney "beaded by a collegial body.1* Id. S 652Wa)(l). " St* IS CJUt.1 1015 (1980). The regulation saaounew that "(tjht Comaiidon't policy with respect to requests for records it that disclosure is the rub end withholding b the exception.1* Id. f 1015.1(b). St* gtntmlfy Frssdoa of Information Act, 6 U-S.C. $ 662 (1976 4 Supp. IQ 1979). 1268 Virginia Law Review [VoL 67:1201 missioners and the agency's technical staff.*4 Sandwiched between the Commissioners and the agency's work ing staff are the two offices that have primary responsibility for the development of regulatory actions. The Office of the Executive Director manages most of the agency's staff. Its personnel are di vided into six function- or expertise-oriented "directorates."** The Directorate for Engineering end Sciences, which employs most of the Commission's biological scientists, has two components. The science component works under the direction of a DAED for Health Sciences and consists of approximately fifty employees, fewer than half of whom are trained scientists. This group provides the technical support for the Commission's internal evaluation of toxicological and epidemiological studies and assessment of risks. At the time of this study, however, the DAED for Health Sciences did not have formal responsibility for directing the evaluation of individual chemicals or for preparing documents supporting regu latory actions. That authority then lay with the Commission's Of fice of Program Management (OPM). On the agency's organization chart, the OPM is parallel to the Executive Director, although the OPM apparently reports to the Commissioners through the Execu tive Director. Of the thirty professionals who compose the OPM, few have technical training. These professionals are responsible for defining the work necessary to outline regulatory options for the Commissioners, for developing project schedules, and for coordi nating the work of technical experts made available by the several directorates. The OPM consists of eight sections, each of which has responsi bility for a category of product hazards.*4 On each project, the Pro- m fnfnwqftkM, concsraing A* CPSC'* intama) organisation and oparations earn* from intarviaw* with Pttar W. Prsuu, PhJX, Aasodatt Eucutiva Diractor for Enginaaring and 8danca, In Washington, D.C. (August 3,1979) [harainaftar dtad aa Pmttsa Intarviaw]; Rich ard Hallar, Aaalstant to CPSC Chairman Sums Xing, la Washington, O.C. (August 3,1979) {haxalnaftar dtad as Hsllar Intartiaw]; sod Rory Fausstt, Projact Managar Ut tha CPSC Chronic Hazards Program, in Washington, D.C. (August S3, 1979) [heraina/tar dtad aa Fauaatt Intarviaw] (copy of ootaa from intarrlaw* on Ala with tha Virginia Law Raviaw Association). ** Tha Diraetonta for Hazard Identification. for ninpli, la rtapoosibla for identifying materials usad la consumer products, assessing tha prevalence, lavd, and mannar of thsir use, weeing tha number of injuries potentially attributabla to than, and providing critical infenaatioB about economic effect* of potential regulatory action*, M Coordination of staff work on a propoaal to conaidar regulating a potentially carefao. ganie chemical, for example, historically haa ban performed by tha Program Managar for c 1981] Cancer Risks 1269 gram Manager or an aulataut auumw the role of "team leader" to outline, schedule, and coordinate the work of the specialists as signed by the various directorates. The team's product--typically a "briefing" or "action" memorandum--must be approved by all of the Associate Executive Directors (AEDt) before it is submitted to the Commissioners. Until recently, the CPSC staff assumed that team members would keep the individual AEDs abreast of the work being done on individual projects. Accordingly, it was ex pected that when the team completed Its work, the AEDs would approve it routinely. There was no system for careful, senior-level review after the team assembled the document for the Commis sioners. The problems resulting from this lack of review were ag gravated by the agency's practice of making the staffs documents public at the same time they were forwarded to the Commission's Secretary. In as attempt to combat these problems, several AEDs and the General Counsel have begun meeting informally to review these documents before they ere tent to the Commissioners and released to the public. Three features of the Commission's structure and operations should be noted. First, the Commission is not organized either by product lines or by the kinds of activities it attempts to regulate (ej;., foods, pesticides, water pollution).** Furthermore, the staff as a whole is not structured according to the kinds of hazards about which the agency is concerned. When the Project Manager for Chronic Hazards was responsible for coordinating work on regula tory actions dealing with carcinogens, most of the personnel in volved were assigned temporarily by other components of the agency. This arrangement weakened continuity in staffing. More over, the person responsible for scheduling staff work was not a regular supervisor of the individuals who were responsible for do ing the work. This "matrix" organization may have afforded flexi bility in staffing individual actions, but it also impeded program continuity and inhibited the development within the agency of the technical expertise required to identify and evaluate toxic chemicals.4* Chronic Hsssrda. ** la this rospcet, the Commission differs from EPA and FDA. ** IntsivU* with Asdnw S. Kruiwieh, CPSC Gsmrtl nyrniil. fat Washington. D.C. (October 1979) fhsniaaftsr dtsd ss KruMch InttrTwwJ; Ho&sr latonrisw, supra aott 32; C i APOOO17058 1270 Virginia Lqxo Review (VoL 67:1261 Second, the separation of personnel possessing substantive ex pertise from those performing regulatory management functions, coupled with the absence of regular opportunities for discussion between the Commissioners and the staff, has often produced weak and incomplete documents. The moat common problem has been failure to consider the full range of pertinent scientific issues or to explore all regulatory options. The Intermittent character of com munications between the staff sad the Commissioners has often delayed identification of these deficiencies." Finally, the staff members who determine which issues to raise for agency consideration are remote from those ultimately respon sible for regulatory decisions, the Commissioners. Once a petition for regulatory action is logged by the Secretary and its filing status is confirmed by the Office of General Counsel, it is sent directly to the OPM for the preparation of a briefing package for the Com missioners. The Commissioners may not actually see the petitions, and often they do not discuse them until near the end of the 120day period prescribed by statute for a response to a petition." This delay makes it difficult for the Commiseionera to identify alterna tives not considered by the staff; when a new issue arises during the Commissioners* review, the agency usually must delay action until the matter is investigated." Thus, the Commissioners gener ally have been confined to the framework outlined by the staff. D* Special Problems of the CPSC The CPSC has been slow in determining its proper role in the regulation of chronic hazards and clumsy in implementing actions. The Commission's actions against TKIS-treated childrens' gar ments- and vinyl chloride were invalidated for violations of statu tory procedural requirements,4* Its published cancer policy was overturned on the ground that it failed to comply with the Admin- Ftnti totarriaw, tupn sot* 32. Set notes 34942 infn and eeoBpanyiitf text. ** KroJwich Interview, tupn note 3$ Pzauaa Interview, tupn note 32. " Krolwfeb latarvtevr, tupn note 36. I<L M 5m natas 299400 infn ud accompanying text (vinyl chloride discussion); not** 3S& 74 mfm and accompanying test (THIS discussion). Hit agaocy asespad ehallangt to its regulation of hairdiyara containing aabaatoa beetusa tha pnwpact ot advtr*# publicity prebably influanead maauteeturaia and ratailm not to iaaiat upon tb* procedural safeguards tha CPS Act affords. .1 \ ] AP00017059 1981] Cancer Risks 1271 iatrativa Procedure Act (APA).41 In addition, the agency has never articulated criteria for selecting among the remedies that its two basic statutes provide.4* It was slow to establish a system for iden tifying consumer products that present a risk of cancer, although in the last two yean it has attempted to develop such a program. The agency's miscalculations, however, have not ultimately im peded its primary objective of eliminating targeted materials from consumer products; none of the products that the agency at tempted to regulate before 1981 is currently being marketed for consumer use. This is true even though in three instances the Commission never actually banned the substances.4* There are sev eral explanations for the Commission's "success" in the face of se rious obstacles. 1. Consumer Sensitivity Many products over which the CPSC has jurisdiction enjoy wide recognition among consumers. Although most consumer products are not used in as intimate a fashion as foods, drugs, and cosmet ics, they nonetheless play prominent roles in the lives of many in dividuals. For example, most members of households with hairdry ers are aware of their daily use, and many users handle them two or even three times a day. Consumers are similarly conscious of the use of many aerosolized products. Although not all of the products* ** 41 Dow ChSL, USA v. CPSC, 459 P. 8upp. 378, 3S3 (WJ>. La. 1978). ** Section 30(d) of tbs CPS Act, which governs the CPSC'i choice between using the CPS Act or the FHSA, provides: (d) Regulation by Commission of consumer products is accordance with other provi sions of law. A risk ot infury which is associated with a consumer product end which could be eliminated or reduced to a sufficient extent by action under the Federal Hazardous Substances Act {15 U.S.C. 1251 at seq.I, the Poison Prevention Packaging Act of 1970 {15 U.S.C. 1471 at seq.I, or the Flammable Fabrics Act [15 U&C. 1191 at seq.j may be regulated under this chapter only if the Commission by rule finds that it is in the public interest to regulate such risk of injury under this chapter. Such a rule shall Identify the risk of injury proposed to be regulated under this chapter and shall be promulgated in eooordance with section 553 of title 5; except that the period to be provided by the Commission pursuant to subsection (e) of.such section for the sub mission of data, views, end arguments respecting the rule shall not exceed thirty days from the date of publication pursuant to tuhaection (b) of such section of a notice respecting the rule. 18 UAC. f 2079(d) (1975). ** The Commission never issued formal bans on chlorofluorocarbon propellants, benxeae, end hairdryers containing asbestos. AP00017060 1272 Virginia Law Review [VoL 67:1261 within tha Conmiulon't jurisdiction aro as familiar to consumers ss these example*,44 most are more readily recognized than the substances regulated by other agencies. Furthermore, consumer product hazards often involve convenience items and luxuries, which buyers may dispense with quickly in respons* to reports of a cancer risk. Awareness of this potential market volatility influences the GPSC's performance in two ways. First, it sometimes enables the agency to "ban" a product without resorting to formal regulatory proceedings.4* Manufacturers often have been willing to accede to the agency's demands rather than endure the public attention that would accompany a formal CPSC action. Second, the CPSC's concom about consumer overreaction to publicity about potential product hazards may inhibit it from taking initiatives in close cases* 2. Uncertainty of Exposure The variety of human exposures to consumer products impedes the CPSC's efforts to assess the risks associated with these prod ucts. The agency must ascertain the amount of carcinogenic mate rial present in each product, ita form, whether and how it is shielded from release, and the frequency and duration of the prod uct's use. The agency also must consider whether exposure varies with the age and design of the product. These questions usually can be answered, but the research necessary to obtain answers typ ically requires major expenditures. Moreover, tests performed on one kind of product may yield little information that is helpful in assessing human exposure to another product.4* " For instance^ wallbovd patching compound! ere used In* frequently, by fewer eon* lumen, and probably without much mom of attachment. Nonetheless, * higher degree of caecumar iwinsaH chancterisse the product! within the CPSC'a jurisdiction than, for ex ample, tiic air and water pollutants and pcatieidsa that compose EPA's caseload. M This power of publicity is not unique to the CPSC. For yean, FDA has bees aware of the rcfuletory impact of Ha public warnings and other efforts to disseminate information. See R. Muuu, A P. Htrrr, Food urn Dnuo Lam Cams a*d Materials 793-804 (1980). 44 In this respect, FDA may bare seme advantages over the CPSC. Both agendas often must rely oa scanty evidence in evaluating the toxicity of a chemical. But la uiwiiag human exposure to a chemical in food, FDA usually esn proceed more efficiently. The same sample of food often can be used to measure concentrations of several contaminant*, end information about dietary consumption of one kind of food typically le obtained through survey* that also yield data about the consumption of other foods. .i 1 , j j I j 1 AP00017061 c 1981] Cancer Risks 1273 The CPSC is responsible for a diverse universe of products, and the kinds of exposures to potential toxins are correspondingly di verse. Individuals wear, breathe, handle, sit on, swallow, fondle, and cook with consumer products.47 Furthermore, the forms of materials in consumer products vary. A material may or may not be absorbable through the skin or able to be inhaled, depending on how it is incorporated in a product The difficulty of determining levels of exposure to chemicals in consumer products can slow agency decisionmaking, although the CPSC has sometimes initiated regulatory action before obtaining detailed information about human exposure.4* The problem of measuring exposure also limits the Commission's ability to assess the risks posed by the materials it regulates. Even if the agency can determine the carcinogenic potency of a chemical, it cannot quantify the associated risk of cancer without also learning the levels at which humans are exposed. This difficulty in assessing risks may be one explanation for the Commission's reluctance, un til recently, to perform, or rely on, quantitative risk assessments.4* C 3. The Petition Process Section 10 of the CPS Act permits any interested member of the public to petition the Commission to initiate regulatory action against a product that presents an unreasonable risk of injury or m Th CPS Act** definition of "consumer product" has been construed broadly. An indi vidual may even rid* is a consumer product Srt, 94., CPSC r. Chance Mfg. Co. 441 F. Sapp. 228 (DJD.C. 1977), which holds that an amusement park rid* ia a consumer product because it fulfills tha two statutory criteria, which require a product to b* "produced or distributed (1). .. for sal* to a consumer for us* *...(*) residence, a school, in recrea tion, or otherwise ... or (ii) for the personal use, consumption or enjoyment of a con. aumer." td, it 230 (quoting 16 U&C. | 2052(a)(1) (1976)). The forma of potential human uptake are limited biologically, but they ere still more varied than those with which other agencies must detL Moreover, the CPSC'* small size has prevented the specialization poeai* bis in program* at FDA and EPA, which may deal exclusively with on* kind of hazard or form of exposure. M One example ia aabeatoe In hairdryers, discussed in notes 473-79 infra and accompany ing text, M Compart 42 Fed. Ref. 38,783 (1977) (proposal to ben asbestos) uith 45 Fed. Reg. 39,434 (1980) (to be codified in 18 CJ*Jt 1406) (urea formaldehyde proposal). Set notes 494-507 infra end accompanying text (d'K*1--wg the CPSC* action* against asbestos); note* 503-32 infra and accompanying text (discussing the CPSC's actios* against area formaldehyde). r AP00017062 1274 Virginia Law Review [VoL 67:1261 illness.*9 The statute requires the agency to respond to petitions within 120 days,*1 and permits a disappointed or unanswered peti tioner to seek judicial review of the Commission's action or in action.9* Although the Commission usually misses the statutory deadline, it gives petitions priority over projects generated inter nally and makes a serious effort to respond with reasonable promptness.99 The petition mechanism appears to have played an important role in the Commission's efforts to regulate carcinogens. With one exception, all of the agency's proceedings to control consumer ex posure to carcinogens have followed filings of public petitions." CPSC officials insist that the petitions were not the primary impe tus for any of the agency's actions, asserting that its staff was eval uating each of the substances when the petitions were filed." Most of the petitions relied on published scientific reports and actions by other agencies, either of which probably would have prompted the Commission to act in any case. But petitions clearly have influ enced the timing and, in some instances, the content of the Com mission's actions against carcinogens. This public petition process reinforces the Commission's reactive posture by making the agency's regulatory agenda dependent on demands for action by outside groups. EL The CPSC's Governing Statutes The CPSC is responsible for administering five federal safety laws. The agency's principal statute is the CPS Act," which cre ated the agency and transferred to it the authority" for adminis tering four other statutes: the FHSA," the Poison Prevention Packaging Act of 1970," the Flammable Fabrics Act," and the Re-* * u U&C. | 205tK) (im. * Id, | 2059(d). * Id. | 2059(*). M Ptum Interview, tupra sou 32. " Sc* not* 544 infra and accompanying text. " GalUfhar Interview, tupra not* 22; Heller Interview, supra not* 32. M 1$ US.C. SI 2051-2082 (1978 A Supp. IH 1979). N Til* transfer* ire affected by id, S 2079 (1976). N Id. || 1281-1274 (1978 A Supp. Ill 1979). - Id. |f 1471-1476. M Id. || 1191-1204. APbOO17063 X981] Cancer Risks 1275 frigerator Safety Act.** The Commission has relied on both the CPS Act and the FKSA to regulate carcinogens and has displayed versatility in choosing among the remedies provided by these two laws, invoking four different remedies in the seven proceedings it Baa initiated. A A. The Consumer Product Safety Act 1. Coverage of the Act The CPS Act Is the Commission's organic statute and has largely displaced the FHSA as its primary legal basis for regulating carcin ogens. The Act gives the Commission broad powers to regulate consumer products that pose unreasonable risks of injury or ill ness.** It defines "consumer product" as follows: (a]ny article* or component part thereof, produced or distributed (i) for sale to e consumer for use in or around a permanent or tem porary household or residence* a school* in recreation* or otherwise* or (li) for the personal use, consumption or enjoyment of a con sumer in or around a permanent or temporary household or resi dence, e school, in recreation* or otherwise; but such term does not include-- (A) any article which is not customarily produced or distributed for side to* or use or consumption by* or enjoyment of, a consumer This definition excludes several classes of products regulated by other agencies.*4 In addition, the statute precludes the CPSC from regulating any risk of injury associated with a substance that is, or is contained by, a consumer product "if such risk could be elimi nated or reduced to a sufficient extent by actions taken under the Occupational Safety and Health Act of 1970 (OSH Act)."** Neither the CPS Act's limitation of the Commission's jurisdiction to "con sumer products"4* nor its requirement that the OSH Act be found Id. || 1211-1214 (1976). ** Id. i 2041 (1976 A Supp. d 1979). -Id. | 2092(a)(1), (a)(1)(A) (1976). ** For example. foods and drop ferulatad by FDA. end peetlcidee regulated by EPA, an excluded from the coverage of tha CPS Act. Id. | 2062(a)(1)(D). (H), (I). * Id. | 2080 (1976 4 Supp. HI 1979) (citation omitted). ** Fausstt latarvitw, lupm oota 32; Interview with David Melaick. Office of the General Counsel, la Washington, D.C. (August 14, 1979) [hereinafter cited u Mdnlck Interview] AP000I7064 1276 Virginia Law Review [VoL 67:1261 inadequate to deal with a risk, however, has seriously impeded the agency's regulation of any toxic chemicaL" Z Product Safety Standards and Bans Section 7(a) of the CPS Act authorizes the CPSC to promulgate a consumer product safety standard whenever "reasonably neces sary to prevent or reduce an unreasonable risk of injury" associ ated with a consumer product.** A product safety standard may prescribe requirements for product performance, composition, or design; it may specify warnings or instructions that must be sup plied with a product; or it may combine both requirements.4* If "no feasible consumer product safety standard . . would ade quately protect the public from the unreasonable risk of injury" posed by a consumer product, section 8 empowers the Commission to ban the product from commerce.'* The finding necessary to in voke this authority may be made at the outset of proceedings to effect a ban, or it may be made during proceedings initially begun to establish a product safety standard, after further study con vinces the agency that no feasible standard would prevent the risk posed by the product. These two sections of the CPS Act theoretically provide the Commission quite different methods of regulating consumer prod ucts that pose an unreasonable risk of injury or illness. The agency may devise a standard to reduce human exposure to the dangerous substance, e.g. by prescribing the formulation, use, or performance of a product, or it may ban the product from commercial distribu tion altogether.71 When the risk from a product results from a (copy at notes from Interview on file with th Virginia Law Review Aseodltion), revealed that the lirwitatLiB of the CanunUaien's jurisdiction to "consumer products'* has sometimes occasioned or changed intsrna! debate over the approach the agency should taka. * Doubts about the coverar* of the CPS Act, mo Mtiniek Interview, supra note 60, may have influenced the geccy's choice between that statute and tha FH3A ae the basis for regulating products and materials. " IS US.& f 2056(a)(1) (1976). "Id. Ae noted earlier, m note 45 supra and accompanying text, manufacturers of coo* euaer products may chooee to avoid adverse consumer reaction by chesting products before any regulation takas place. Thus, the threat of regulation may be ae important as its occurrente. See note* 465*99 infra end accompanying text (discussing asbestos in hairdryers). " 15 US.C. S 2057 (1979). " For example. Safety Standards for Matchbooks, 16 CJ.R. | 1202 (1980), prescribes euch features as "(t)he cover shall remain closed without external force/* id. f 1202.4(b), 1981] Cancer Risks 1277 toxic constituent, however, the distinction between a safety stan dard and a product ban can be elusive.7* In practice, the Commis sion rarely has banned a product genus or type; instead, it has usu ally banned only products made in a specific way or containing a specific material. For example, the agency banned only those caulking compounds that contained asbestos. A "safety standard*' for caulking compounds listing permitted ingredients and exclud ing asbestos would have the same effect as the ban that the agency Imposed.7* Furthermore, both kinds of regulatory action result in the issuance of a "consumer product safety rule." In regulating po tential carcinogens under sections 7 and 8 of the CPS Act, the Commission thus far has contemplated only the promulgation of product bans.74 3. Rulemaking Procedures The CPSC follows the same administrative procedure for estab lishing a consumer product safety standard as for banning a prod uct; both are variants of informal rulemaking. Section 9(a)(2) of the CPS Act specifies that proceedings to adopt a consumer prod uct safety rule shall be conducted "pursuant to section 563 of Title 5 [of the APA], except that the Commission shall give interested persons an opportunity for oral presentation of data, views, or ar guments, in addition to an opportunity to make written submis sions,"7* The Commission has succeeded in keeping these proceed ings both informal and brief. The legislative-style hearings are conducted before the entire five-member Commission.7* Witnesses tad "do friction tutorial shill bt located on the iniids of th cover," id. f 1202.4(c). An example of a bio under the CPS Act is Bio of Unitable Refuse Bint, 18 CJt\R. | 1301 (1980). whiah forbids marketing of refuse bios that fail to moat teats for stability enunciated in id. $| 1301.6-.7. Such a bin may bo difficult to differentiate from a standard because it proscribe# only products with specific characteristics rather than banning all product# of a dam or type. " For a discussion of the elusive distinction, see Scalia ft Goodman, Procedure/ Aspects of the Consumtr Produet Saftty def, 20 U.C.L.A. L. Rxv. 899 (1973). ** This is dan trus with respect to nontozlc consumer products. St* Ban of Unstable Refuse Bins, 18 CJ-R. | 1301 (1980). Presumably, performance standard could specify a permissible level of risk of chronic disease front expoeure'to a product. The Com mission, however, has not openly considered this paasibiiity for any carcinogen. ** This may be because such action is limply faster in light of the statutory alternatives and the iubetenets involved. Melnick Interview, supra note 68. * 18 U.S.C. f 2038(a)(2) (1976 ft Supp. m 1979). ** Gallagher Interview, supra note 22. ii APOOO17066 1278 Virginia Law Review [VoL 67:1261 present prepared statements and may then be questioned by the individual Commissioners, though the interrogation is not ordina rily vigorous. Occasionally, another participant may be allowed to question a witness, but no opportunity for traditional cross-exami nation is provided. Hearings rarely last more than two days." Section 7 of the CPS Act" prescribes a unique procedure for the development of proposed consumer product safety standards. Once the Commission publishes its determination that a product safety standard is necessary, consumer or industry groups and other gov ernment agencies may submit an existing standard or offer to de velop anew standard for agency consideration." Congress included this "offeror provision" in the statute because it believed that the CPSC would require the assistance of outside experts to develop requirements for the enormous range of products within its jurisdiction." 4. Petitions Section 10 of the CPS Act*' explicitly invites members of the public to initiate actions against unsafe consumer products by pe titioning the Commission to establish a consumer product safety rule. If the agency fails to act on such a petition within 120 days, or if it denies the petition, the petitioner may sue in federal dis trict court to compel the agency to initiate the action requested." A petitioner in such a suit must prove by a preponderance of the evidence that the consumer product presents an "unreasonable n Tha Commission complitsd in entire rulemaking proeese for banning asbestos la patching compounds and embertrin# materials within approximately six months. Set note* 384-430 infrs and accompanying text. * 15 U.3.C S 205* {1976 & Sopp. Ill 1979). "/il 5088(b). (d). * H.R. Rx. No. 1153. supra note 6, at 33. As originally enacted, the statute required tho Commiialea ordinarily to accept any reasonable after by sn outside party to develop a propoaad standard. Tha complications caused by this arrangement, primarily daisy, prompted Congrats to amand tha CPS Act to permit tha agency graatar discretion in developing pro posed standards internally. Sat Act of Nov. 10,197S, Pub. L. No. 98-831,95 Stat. 3742; HJt, Rip. No. 1184, 95th Cong., 2d Seat. 5-8, reprinted in [1978) US. Coos Como. & An. News 9434, 9434-35. In either form, however, this "offeror provision" has never impeded CPSC regulation of chronic hazards. To data, no Commission action against a carcinogen has in volved tha setting of product safety standards, so tha offeror provisions of } 1 have never bean triggered. IS U.S.C. i 2059(a) (1978). M /d. i 2059(a). 1981] Cancer Risks 1279 risk" and that the Commission's failure to act "unreasonably ex poses . . . consumers to a risk of injury.'** The court may compel the agency to commence rulemaking; it may not prescribe a rule or require the Commission to do so. 5. Criteria for fanning Before the Commission may ban consumer products containing a hazardous substance, it must find that "(1) a consumer product is being, or will be, distributed in commerce and such consumer product presents an unreasonable risk of injury; and (2) no feasible consumer product safety standard under this chapter would ade quately protect the public from the unreasonable risk of injury associated with such product**4 The Act explicitly states that "risk of injury** includes "the risk of death, personal injury, or seri ous or frequent illness,**4* but it does not define "unreasonable risk.**** Nor does the Act prescribe the analysis the Commission should perform in determining whether the risk posed by a prod uct is "unreasonable.** When die agency has relied on section 8 to regulate a carcinogen, it appears to have considered both risks and offsetting benefits.*' But agency representatives insist that the Act does not require a formal balancing of risks and benefits, and its actions indicate that no such analysis is done.** Section 9(c) of the Act, which requires the Commission to make findings on a series of pertinent factual issues and to incorporate these findings in its rule, provides: (1) Prior to promulgating a consumer product safety rule, the "Id. * Id. i 2057. M Id. | 2052fe)(3). ** The Senate-passed version of the legislation tint baeame tba CPS Act contained a defi nition of "unreasoaable risk," but thie provision was sliafauted in conference without ex- planttion. St* H.R. Ret. No. 1393, supra note 9, at 4243, [1972] VS Coon Com. a An. News et 4634-35. The House had tlready decided, in It* version of tho bill, not to define "unreasonable risk." The committee report explained that M[p]retection against unreason able risks Is central to many federal and state safety statute* and the courts have had broad experience in interpreting the term's mttnlng and application." HJL Rip. No. 1153. supra nolo 6, at 33 (1972). ** St* notes 392405 infra and accompanying text (patching compounds and emberizing compounds containing asbestos action); notes 44149 infra and accompanying text (benzene action); notes 522-29 infra and accompanying text (urea formaldehyde action). " Stt, Heller Interview, supra note 32. APOOOI7068 1280 Virginia Law Review [VoL 67:1261 CommfMioa shall consider, isd shall male* appropriate findings for inclusion in such rate with respect to-- (A) tbs degree and nature of th* risk of injury th* rate is designed to eliminate or reduce; (B) the approximate number of consumer products* or types of daniH thereof* subject to such rule; (C) the need of the public for the consumer products subject to such rule* and the probable effect of such rule upon the util ity, cost* or availability of such products to meet such need; and <D) any means of achieving the objective of the order while minimising adverse effects on competition or disruption or dis location of manufacturing and other commercial practices con sistent with the public health end safety. (2) The Commission shall not promulgate a consumer product safety rale unless it finds (and includes such finding in the rule)-- (A) that the rate (including its effective date) Is reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with such product; (B) that the promulgation of the rule is in the public interest; and (C) in the css* of a rule dedaring the product a banned haz ardous product, that no feasible consumer product safety stan dard under this , chapter would adequately protect the public from the unreasonable risk of injury associated with such products.** The statute does not purport to assign specific decisional weight to these elements, and the legislative history is unhelpful. The Senate Report indicates that the Commission is to balance the probability that the risk posed by a consumer product will result in harm and the gravity of such harm against the effect of reducing or eliminating the harm on the product's utility, coat*, and availability to consumers.9* The House Report states that a complete cost-ben efit analysis is not required before the Commission promulgates a safety, standard or ban.91 The report then asserts* however, that - 15 UAC. S 2058(c) 0970). ** H.EL Rtf. No. 1153, supra new 6, at 33. 11 Id. la 197, th* Subcommittee on Oversight tad Investigations of th* House Committ** on IntereUt* ud Foreign Commerce produced report on "regulatory reform," which included a chapter on the CPSC. The report conclude* that formal coet-benefit analysis is not required under eh* CPS Act Subcomm. on Ovzaatoirr and Invwttgations, Housi Comm, on Intzrstatb and Fomicn Couumci, 94th Coxa, 2d See*., F*ss*ai. Rsoulatiom and Rsgulatoky Rtfoftu 193 (Subcomm. Print 1976) [hereinafter cited as Mom Roobt). t I! AP006i7669 c 1981] Cancer Risks 1281 "no standard would be expected to Impost added costs or inconve nience to the consumer unless there is reasonable assurance that the frequency or severity of injuries or illnesses will be reduced."** These delphic instructions have left the agency a wide range of discretion. The case law provides clearer guidance. The central case -- the first to consider the CPSC'a authority to prescribe consumer prod uct safety rules under section 8 -- is Aqua Slide *N* Dive Corp. v. CPSC,** decided by the United States Court of Appeals for the Fifth Circuit in 1978. Aqua Slide involved a challenge to the Com mission's standard for swimming pool slides. The court overturned the standard on the ground that the agency had failed to show, by substantial evidence, that it would curtail admittedly severe but infrequent swimming pool accidents.*4 The majority opinion, writ ten by Judge Roney, focuses on the language in section 9(c)(2) of' the Act, which requires the agency to find that a consumer product safety rule is "reasonably necessary to eliminate or reduce an un reasonable risk of injury associated with" a product.** Use opinion explains: "The Commission does not have to conduct an elaborate cost-benefit analysis .... It does, however, have to shoulder the burden of examining the relevant factors and producing substan tial evidence to support its conclusion that they weigh in favor of the standard.'"*4 With respect to the mandated warning signs, the court contended that the "crucial question ... is whether the ben efit has a reasonable relationship to the disadvantages the sign re quirements pose.**** The court also suggested that the degree of consumer awareness about the products* risk and the extent to which that risk may be avoided are important considerations.** Judge Roney's opinion recognizes that the CPS Act itself pro vides the Commission little guidance in applying the "unreasona ble risk" and "reasonably necessary** criteria, which it character izes as interrelated.** Relying on the legislative history, the opinion ** Hit Rxf. No. 1153, lupiti not* 6, at 33. 569 F,2d 831 (5th Cir. 1978). M Id. at 844. M laL at 638*44. " Id. at 840. " Id. at 842. ** Id. at 639, quotad at text accompanying not* 101 infra. "Id. ( APOOO17070 1282 Virginia Law Review [VoL 67:1281 states: "The necessity for the standard depends upon the nature of the risk, and the reasonableness of the risk is a function of the burden a standard would impose on a user of the product.*11** Judge Roney went on to describe in general terms the kind of anal* ' ysis the agency is expected to perform: {T]he legislative history specifies the coats to consumers that are to be considered: increases in price, decreased availability of a prod uct, and also reductions In product usefulness. . . . Implicit in this analysis is an understanding that the regulation is a feasible method of reducing the risk. ,. . Also, an important predicate to Commission action is that consumers be unaware of either the se verity, frequency, or ways of avoiding the risk. If consumers have accurate information, and still choose to incur the risk then their Judgment may well be reasonable , . . .m As noted above, the majority opinion in Aqua Slid disclaims any requirement that the Commission perform a cost-benefit anal ysis of proposed product safety rules. But Judge Roney did make clear that the agency must weigh the different consequences of its actions to determine "whether the benefit has a reasonable rela tionship to the disadvantages . . ,'na* Judge Wisdom's concurring opinion is more explicit: (T]he Commission is required to do mom than determine whether there art any benefits to its regulation. Congress required it to con sider the economic coats. In this case those costs are the effects on the manufacturers, and the effects on consumers who will be frightened away from purchasing pool slides. The Commission's determination that benefits exist la not the only conclusion that must be supported by substantial evidence. Most importantly, the balance the Commission draws between the benefits and the costs must have such support This Is the argument pressed by Aqua Slide. The benefits from these signs have no reasonable relation ship to the costs they will impose. ... I agree that the coat analy sis done by the Commission is not entitled to consideration. These signs are not so innocuous as to be presumed "inexpensive." With no evidence on the cost side of the ledger, the Commission's costbenefit analysis is without substantial evidence for support.1** " Id Id. " Id. *t 842. *" Id. at 848 (Wisdom, Jw ooocurring). 1931] Cancer Risks 1283 Aqua Slide would have proved influential on ite own terms, but it has gained weight by virtue of the Supreme Court's ruling on the Occupational Safety and Health Administration's (OSHA) occupa tional standard for benzene. In Industrial Union Department, AFLr-CIO v. American Petroleum Institute,194 the Supreme Court upheld another Fifth Circuit decision1** -- which had in turn re lied on Aqua Slide19* -- and overturned OSHA's benzene standard on the grounds that the agency had failed to demonstrate either that the health risk at prevailing exposure levels was "significant" or that the costs of achieving the new standards bore a reasonable relationship to the benefits.1** Although the Supreme Court de clined to reach the coet-benefit Issue,1** its ruling, coupled with its Implicit endorsement of Aqua Slide, has raised doubts about the CPSC'a authority to regulate speculative risks under section 8.1M In the seme year that Aqua Slide was decided, the CPSC re ceived an equivocal boost from the United States Court of Appeals for the District of Columbia Circuit. In ASG Industries, Inc. v. CPSC,119 the court upheld in substantial part a CPSC standard to ensure the safety of architectural gln*fag materials, but ordered a remand to permit the agency to consider the appropriateness of including wired glass within the standard.111 Although Judge Leventhal expressed doubt about the wisdom of this choice, he acknowledged the possibility that it could be sustained even if it meant elimination of a type of product from the market: "[Application of a safety rule is not dependent on technological advance; the sale of a hazardous article may be prohibited even if attainment of the required standard is not feasible because tech nology will not yield a safe product."11* Judge Leventhal's opinion " 448 U.S. 607 (1980). 1M American Petroleum Inst v. OSHA. 681 F-2d 493 (6th Cir. 1978). *" Id at 601*06. *** Id. At 510. > 448 U.S. at 814*16. " The Fifth Circuit overturned the CPSC swimming pool slid# standard becauso it did not eontidar it an effective response to a risk that was aavara but statistically remote. In regulating a carcinogen, it ordinarily should bt aaay for tha CPSC to demonstrate that ita remedy would avart tha risk; showing that tha riak ia "significant" hi quantitative terns or "unreasonable" in light of tha coats of preventing it should ba more difficult. 593 F.2d 1323 (D.C. Cir. 1979). " Id at 1337. Id at 1333*34 (citation omitted). 1284 Virginia Law Review (VoL 67:1261 concludes with the following general observations about the pur pose of the CPS Act: One of the principal functions of CPSA is to promulgate safety rules that have the effect of compelling the internalization of these costs to tbs extent required to meet performance and other safety standards. Internalisation of coats previously disregarded by manu facturers will likely result In a rise In cost and price* and may con strict or eliminate the demand for a particular product as consum ers substitute products that offer the desired utility at the lowest price. Such an outcome would not be contrary to the intent of Con gress so long as the agency has given reasoned consideration to all the pertinent factors and has made the requisite findings sup ported by substantial evidence. A severe economic impact on an industry, or on a significant segment of an industry, would be a materiel factor In appraising the reasonableness of a rule, but it cannot* in and of itself be held to render a safety rule unreasonable^11* 6. Suit to Condemn an VImminent Hazard" The CPS Act contains no provision allowing the Commission to suspend administratively the marketing of a hazardous product prior to the completion of proceedings to promulgate a safety stan dard or ban. Section 12 of the Act*114 however, empowers the agency to initiate suit in federal district court seeking the seizure of "an imminently hazardous consumer product** or injunctive re lief against a distributor. Such a suit may be accompanied by ad ministrative proceedings to establish a product safety standard or ban."* The CPSC haa never invoked this emergency authority against a product containing a suspected carcinogen.11* When the Commis sion haa sought speedier relief than is possible through banning under section 8, it has resorted to other mechanisms available '* u. at 1337. * 15 U.S.C. i 2061(a) (1976). * Id. | 2061(e). " On four occasions, th CPSC has attempted to persuade a court to declare a produce an "Imminent hazard" under | 12 of tho CPS Act. On* action has faded. Sen CPSC v. Anaconda Co* 593 F 2d 1314 (D.C. Cir. 1979) (rejecting the agency'* action on the ground that the challenged electrical wiring was not a "consumer product"). Hie other three suite were settled without decision. See, e.#., CPSC v. Advance Machine Co* Civ. No. 77-1323 (D.D.C. May 3, 1978); CPSC v. AK Elec. Corp.. Civ. No. 74-1206 (OD.C. Sept, 1974). 1981] Cancer Risks 1285 under the CPS Act or the FHSA. It may Mem anomalous to char acterize as an "imminent hazard" a product that poses a risk of cancer that will eventuate, if ever, only many yean after humans axe exposed to it. But judicial opinions construing identical language in the Federal Insecticide, Fungicide, and Rodentiride Act suggest that section 12 would support a suit to restrict a chemical In consumer products if the evidence of carcinogenicity were strong and the potential for human intake apparent.119 The Commission would have the burden of proving these facts by a preponderance of evidence119 rather than enjoy the deference accorded adminis trative findings that would accompany a ban under section 7. Suit to Prevent a "Substantial Product Hazard" Section 15 of the CPS Act authorizes the Commission to order a variety of remedial actions respecting any product that presents a "substantial product hazard."1** Paragraph (a) of the section de fines "substantial product hazard": (1) a failure to comply with an applicable consumer product safety rule which creates a substantial risk of injury to the public, or (2) a product defect which (because of the pattern of defect, the m Sts Environmental Defense Fund* Ida . EPA, 510 7.24 1298 (D.C. Cir. 1975) (con struing f 6(c) of the Federal Insecticide, Fungicide, and Rodentidde Act* 7 U.S.C. 1136d(c) (1976)); Environmental DafcnM Fund, Inc. v. EPA, 465 7*24 52S (D.C. Cir. 1972) (tame), both of which upheld EPA orders summarily upending registration of pesticides aliown through experiments to bo earrinofenic la animals. lM In this sort of suit, whoro tho agency b tho plaintiff, tha usual civil rule* apply. Ths party bringing ths suit has ths burden of proving Its allsgatiena by a preponderance of evidence. Ths rationale for imposing this burdsn of proof, as siplslnsd in ths Ssnsts Report recommending paaoacs of ths CPS Act. b that "[a]fney action affecting intarasta in Ufa and health should bs subject to ths moat assrehirg judicial examination... . [It] justifies s dapartura Cram tbs normal standard of raview." S. Rip. MO. 836, supra not* 6, at 18, [1972] UJJ, Conn Cots*. 5b An. News at 4697. "* Because tbs CPSC must bring an "imminent haxard** procssdlng In court in ths first Instance, its findings ars liksly to receive loss dsftrsecs than on ravisw of a standard or ban. In tha fortstr, tha court will avaluats ths svidtnes dt novo. Whsr* tbs sgsncy has conducted rulemaking, its findings and conclusions will bs rsviswad under ths mors deferential "substantbl evidence" standard. CPS Act, | 11(e). 15 U.S.C. f 2060(c) (1976). *** ItL S 2064. Thsas actions may bs taken only after as opportunity for an adjudicatory hearing baa been afforded to interested parties in accordance with J 554 of the APA. Id. I 2066(0 (1976). For a comprehensive discussion of ths CPSC** powers under -- and use of -- 5 15 of ths CPS Act, see Madden, Contumcr Product Safety Act Section 15 and Sub stantial Product Hazards, SO Cam. tJX. Rxv. 195 (1981), 1286 Virginia Law Review (VoL 67:1261 number of defective products distributed in commerce, the severity of the risk, or otherwise) create* a substantial risk of injury to the public.1** This definition apparently focuses on the seriousness of the risk to consumers in terms either of the severity of the potential harm or of the number of consumers exposed.11* To use fids provision to regulate a product containing a carcinogen, the CPSC would have to characterize the hazard as resulting from a product "defect," because it has established no applicable safety standards. Despite the awkwardness of this language, the agency has used section 15 in one such case. Section 15 affords the Commission a range of remedies to deal with a product presenting a "substantial hazard." The agency may require any manufacturer, distributor, or retailer that is a party to the proceeding to provide written notice of the defect to any other person in the distribution chain or "to every person to whom the person required to give notice knows such product was delivered or sold."11* Furthermore, the Commission may order the manufac turer or any distributor or retailer to repair the defect in all prod ucts distributed, replace the product without cost to the consumer, or refund the consumer's purchase price.1*4 The CPSC has devised an informal enforcement system that or dinarily avoids formal public proceedings under section 15. The Commissioners, either explicitly or informally, customarily author ize the agency's compliance staff to invite die manufacturers or distributors of the investigated product to an Informal conference. At that conference, the staff explains its preliminary conclusion that the product presents a "substantial hazard."1** Because man ufacturers and distributors of consumer products generally desire to avoid the adverse publicity associated with a formal charge that ,M Id. | 2064(a). Tha House Report tdd* little to this definition, stating only that definition look* to the extent of the public exposure w the hazard A lew dafectiva products normally will not provide a proper baais for compeUint notification under this section/* H.2L Rar. Na 1153. iupra not* 6, at 42. " St* H.R. Rep. No. 1153. supra nota 6, at 42. By contrast, { S require* a finding that the risk of a product la unreasonable. 15 UJ5.C. f 2057 (1978). See Je* 18 CJLR. 1 1115.4 (1981). *" 15 U.S.C. | 2064(e)(3) (1S76). ,M Id. f 2064(d). *" St* 16 CF.R. | lll&20(a) (I960), which describee voluntary corrective aetioa plana. Other descriptions were derived from Interview* with CPSC staff membare. 198X] Cancer Risks 1287 the product presents a "substantial hazard," a voluntary recall, typically accompanied by joint public announcement, usually fol lows such a conference.*1* In the rare case where invited firms de cline to take corrective action voluntarily, the Commission autho rises issuance of a formal complaint, which may result in a formal evidentiary hearing.1" Section 18 is not always a practical option for the Commission. That authority is most effective when the suspect product is read ily identified by consumers and when relatively few manufacturers are capable of effecting a recall. Furthermore, a remedial order under section 15 can be issued only against a company that is a party to the agency proceeding; this necessitates personal service of process and an opportunity to participate.11* Section 15 now also provides the Commission an interim rem edy, which can be invoked pending resolution of any contested charges. Once the agency has initiated a formal proceeding for the issuance of a remedial order under section 15(d), it may apply to a district court for a preliminary injunction to restrain distribution of the product pending completion of the administrative process.*1* The injunction will issue if the agency can show that it has "reason to believe" the product "presents a substantial product hazard"*** and if the customary criteria for the issuance of a civil preliminary injunction are met*11 The Commission has never had occasion to seek such preliminary relief, because the informal threat of adverse publicity implied by the staff's recommendation that a product be considered a "substantial hazard" is the CPSC'a real regulatory *** Tin agency used this informal mechanbiB to atop tba distribution of hairdryers eoa* Uinta* asbestos. St* notes 465*93 infn and accompanying tact. m 3** IS C.F.R. t 1115-21 (1930), which describee compulsory oorractiva action plans. Section 15 mandates aa opportunity for an evidentiary hearing befcn official remedial orden may ha Issued, IS U.S.C. ] 2064(0 (197S), but moat partias prefer the informal enforce ment system. >M Kraiwleh Interview, supra note 38. Section 1S<0 of the CPS Act provider that such a remedial order "may be batted only after an opportunity for a hearing in accordance with action 654 of title 5, United Stater Code." 15 (J.S.C. ] 2084(f) (1976). Section 854 requires personal notice of the time, place, and nature of the hearing, aa well as the legal authority for the proceeding and the matters of law and fact asserted. 5 U.S.C. $ 554(b), (c) (1976 4 Supp. HZ 1979). -- 15 U.S.C. | 2064(g)(1) (1978). "* Id. 1,1 The federal amount In controversy requirement, 25 UJ3.C. | 1331 (1976). however, b waived. 15 U.S.C. I 2064(g)(3) (1976 4 Supp. DI1979). 1263 weapon. Virginia Law Review [VoL 67:1261 8. Special and General Orders The Commission has authority to obtain formulation data and to demand the results of safety teste that manufacturers have con ducted independently. Section 27 of the CPS Act authorizes the agency to "require, by special or general orders, any person to sub mit In writing such reports and answers to questions as the Com mission may prescribe.'*1****h* i addition, section 27(e) provides: "The Commission may by rule require any manufacturer of con sumer products to provide to the Commission such performance and technical data related to performance and safety as may be required to cany out the purposes of this chapter . . ,*nu Rely ing on section 27. the Commission has required a large number of manufacturers to disclose information about the quantitative for mulations of their products. The agency has used this authority to discover the composition of products whose use involves significant human exposure, as well as to obtain information about the dosage of known constituents*1*4 It is less clear whether under section 27 the agency can require product manufacturers or users of a specific ingredient to conduct tests in the first instance. Commission officials have argued that section 27(e) provides authority to require such testing,1" but the agency has not ordered testing of any product or ingredient to date. It apparently is inclined to delay any legal test of its power to require testing until an appealing case arises. In evaluating the health effects of carcinogens in consumer products, therefore, the Commission has relied largely on data generated or obtained by other government agencies or available in the scientific literature. . Sometimes the agency conducts its own tests to determine human exposure to a product or it contracts with another organization to do so. In the future, the Commission will continue to depend on outside sources for health effects data, but it hopes to Improve its own capability to measure human exposure to hazardous sub- s* IS U-S.C, 2078(b)(1) (1976). " I<L I 2078(c). *** FauMtt Interview. upn not* 32. m Krulwteb Interview, upra sot* 36. ) AP00017077 1981] Cancer Risks stances in consumer products.1*1 1289 9. Criteria for Preferring the CPS Act Section 30(d) of the CPS Act implies a preference for regulating product hazards under the other statutes transferred to the Com* mission in 1972.m This provision requires the Commission to pro mulgate a rule1*1 determining that the public interest will be served better by regulating a product under the CPS Act thaw under the FHSA.11* Because most toxic materials in consumer products could be regulated under the FHSA, the Commission must issue a section 30(d) ruling when it concludes that the CPS Act is the preferable statutory basis for regulating a carcinogen.14* This step has become almost routine. In its last four actions against carcinogens, the Commission of fered two main justifications, both procedural, for its conclusion that regulation under the CPS Act was "in the public interest,"141 and thus preferred. It emphasized that the FHSA, mriHe* the CPS Act, requires that any rule declaring a material a "banned hazard ous substance" must be promulgated through formal rulemak ing.14* Because the CPS Act permits informal rulemaking, the *** Kruiwieh Interview, tupra act* 36; Preuse Interview, tupra note 32. A risk of injury which if aseoeiated with a conitimer product and which could ba elimiiuted or reduced to a sufficient extant by action under tha Federal Hazardous Sub* stance* Act. . . may be regulated under this chapter only if tha Commission by rule finds that it is in the public intenet to refulata'such risk of injury under this chapter. 15 OS.C. | 2079(d) <1976). " Such a rule muet comport with the proceduree specified by 15U of the APA. See Dote 231 infra. * 15 US.C. 11 2061.2075 (1976 St Supp. HI 1979). For a discussion of tba FHSA'e rape, sat notes 148-51 infra and accompanying tact 144 Although the CFS Act specifies that the period for public comment on tha propoeed rule ahall not exceed 30 days, thie prevision could conceivably delay action by tha Commieion against a product hazard that could ba regulated under either statute. Ul Tha agency relied on the CPS Act in regulating chlorofluorocarbon propellants, 42 Fed. Reg. 21^07 (1977); beotene, 42 Fed. Reg. 2216 (1977); patching and aoberising eonpounds containing asbestos, 42 Fed. Reg. 33,782 (1977), 42 Fed. Rag. 6*54 (1977), 43 Fed. Reg. 21.&& (1978); hairdryers containing asbestos, 44 Fad. Rag. 2629 (1979) (to be codified at 16 CFJL11145); and uraa formaldehyde foam insulation, 46 Fad. Rag. 11.188 (1981) (to be codified at 16 CJF.R. $ 1306). 141 15 U.S.C. | l261(qK2) (1976). Under the applicable provision! of the FDAC Act, for mal rulemaking tequiree both an opportunity for tba submission of written comments and a formal avidentiaxy hearing on material factual disputes raised in objections to a "first" nils. See Hamilton, RuUmeking on a Record by tha Food end Drug Administration, 50 Tax. L. 1290 Virginia Law Review (VoL 67:1261 agency beUeved it could act mora readily under the CPS Act14* In addition, the Commission asserted that the less formal procedures of the CPS Act would better facilitate participation by diverse in terests.*44 The agency also mentioned that persons who violated a CPS ban would be subject to civil penalties.14* 10. Judicial Review The CPS Act provides for a court of appeals review of any con sumer product safety rule (including a ban) upon a petition tiled within sixty days by "any person adversely affected.**14* The re viewing court may order that new evidentiary presentations be made to the Commission. The court may grant any relief appropri ate under chapter 7 of the APA, including suspension of Commis sion action pending review. A product safety rule is to be affirmed if it is supported by substantial evidence on the record taken as a whole. The CPS Act contains its own definition of the rulemaking "record,** which includes the rule, the proposal, the transcripts of any oral hearing and all written submissions, and "any other infor mation which the Commission considers relevant to such rule.'*14* B. The Federal Hazardous Substances Act The FHSA1** is the other statute on which the CFSC has relied to regulate carcinogens. The FHSA contains detailed definitions of "hazardous substance** and "banned hazardous substance,** prescribes mandatory warning labeling for products in the former category, and authorizes the CPSC to initiate enforcement action Riv. 1132 (1972). ** 43 Fed. Re* 2U3S (1978). ** Id. "* Id. *** 15 VSC. | 2060 (1978). "/i ** Id. |) 1291.1275 (1975 A Supp. Ill 1979). The FHSA waa enacted initially as a inf statute. Federal Hazardous Substances Labeling Act, Pub. L. No. 86*613, 74 Stafc. 372 (1960). It originally mi adopted to fill gaps la other federal itatutaa {eg., the FDAC Act, 21 U.S.C. || 301*392 (1978 a Supp. HI 1979); tbs Federal Insecticide, Fungicide, and Rodenti- dda Act, 7 UAC. II 136*136y (1976 A Sup* JO 1979)), and to provide for Ubsling of poisons sod hasardaua oatsrials brought Into the boas. Reacted in I960, ths FHSA was administered originally by FDA, and its draftsmen employsd several of tbs legal concepts used ta the FDJtC Act See HJt K*y. No. 1861. 66tb Cong^ 2d Sta, reprinted in (I960) US. Code Coho. A An. Naira 2833. C 1981} Cancer Risks 1291 against the latter as misbranded As originally enacted, the FHSA was simply a labeling statute. Most of the warnings and cautionary information that appear on household products are prescribed by this law. The Act was later revised, however, to authorize more drastic action to control product hazards.14* The CPSC has relied on this authority to regulate carcinogens twice. 1. Coverage of the FHSA Section 2(f)(1)(A) of the FHSA defines a "hazardous substance" as [alny substance or mixture of substances which (i> is toxic, <i) is corrosive, liil) is an irritant, (iv) a strong sensitizer [or} (v) is flammable or combustible. . if such substance or mixture of sub* stances may causa substantial personal injury at substantial illness during or as e proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable inges tion by children.1** Section 2(g) of the Act defines "toxic" as "any substance (other than a radioactive substance) which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface."1*1 Sections 2(i), 2(j), end 2(k) define "corrosive," "irritant," and "strong sensitizer."1** Sup plementing the FHSA definitions, CPSC regulations1** describe toxicity tests to be performed on white rats and rabbits.1*4 The regulations also state that the term "hazardous substance" applies to any substance shown to be toxic on the basis of human experi ence. A substance that meets either a supplementary definition or The scop* of the FHSA baa bora expanded to cover hazardous substances In general us* in th* bom*, end particularly to protect children from hazardous toyi and products. Poison Prevention Packaging Act of 1970, Pub. L. No- 91*601, 84 StaL 1870 (1970); Child Protection and Toy Sa/ety Act of 1969, Pub. L. No. 91-113, S3 SUL 187 (1989); Child Pro tection Act of 1968, Pub. L. No. 89-758, 80 SteL 1303 <1966). >w 15 U.S.C. I 1261(f)(1)(A) (1976) (emphasis added). Coagnee suggested certain criteria for determining whether a particular eubetanca is "hazardous." The basic test was the stan dard applied in common law civil liability cases, in which a aa&ar must warn potential pur chasers of th* inh*nt danger* of his product. S. Rzr. No. 1158, 86th Cong* 2d Sees. 2 (1960). ' 15 U.S.C. | 1281(g) (1976). " Id. | 1261(1), (j), (k) (1976). 1U Federal Hazardous Subatancaa Act Regulations, 18 CSJL | 1500 (I960). ,M Id. 6 1500.40. AP00017080 1292 Virginia Z,aw Review [VoL 67:1261 the Act's own definition of "toxic" is a "hazardous substance** under the FHSA if it also "may cause substantial personal injury or substantial illness.'*11* A determination that a material is a "hazardous substance" has immediate regulatory consequences. A product containing a haz ardous substance must bear prescribed label warnings to avoid be* ing deemed misbranded. If no label warnings will protect consum ers from the hazard adequately, the CPSC is empowered to declare the product a banned hazardous substance. Z Alternative Banning Approaches The FHSA provides a comprehensive scheme for banning haz ardous substances that are "intended, or packaged in a form suita ble for use Is the household.*11** Indeed, die statute probably could have been relied on to support all of the actions that the CPSC has taken to date against products containing carcinogens. Section 2(q)(l)(B) of the FHSA empowers the Commission to is sue a regulation declaring a product banned if the agency finds that "notwithstanding such cautionary labeling as is or may be re quired . . . the degree or nature of the hazard involved in the pres ence or use of such substance in households is such that the objec tive of the protection of the public health and safety can be adequately served only by keeping such substance . . . out of the channels of interstate commerce."1** Formal rulemaking1** is re quired before a product may be banned as a hazardous substance under the FHSA. The agency first conducts what amounts to an Informal rulemaking proceeding: it issues a proposed rule, enter tains comment, and publishes a "final order." If persons adversely affected by such an order file legally sufficient objections, the Commission must then conduct an evidentiary hearing before an IM Id. | 1300.3(i)(4){})lA). Tbs CPSC has narar conaidarad mindtai it* ragulatloas ta dafln# an carcinogina, *4-, *11 suhatancat littod by EPA or OSHA, as "torte.** It could aba prescribe to*ta for determining suck toxicity. St* Coamtot* on a Preliminary Draft of this article by Pstor Carton Hurt (Oct U, 1980) [hereinafter citod a Hurt Commsntsl (copy on fH* with tb* Virginia Law Raviaw Association). - IS UAC. f 1261(qKl)(B) (1976). td. " Th* procadura for dadaring a product a banned hazardous substance andar } 2(q)(l)(B) must conform to tbs FD&C Act, 21 U.S.C. | 371(a) (1976). IS U.S.C. 11261(q)(2) (1976). Tha FD4C Act raquirts fort&al, or on-tha-raconl, rulemaking. St* not* 142 supra. ) It c 1981] Cancer Risks 1293 administrative law judge. If the Commission must undertake for mal rulemaking to determine that a material is "toxic** under sec tion 3(a) and thus is a hazardous substance, it uses the same pro ceeding to declare that products containing that material are banned hazardous substances.TM During the rulemaking period, the Commission has emergency authority to order its proposed ban effective immediately. Such an order must be based on a rinding that "the distribution for house hold use of the hazardous substance involved presents an immi nent hazard to the public health.'*1** This authority was intended by Congress to enable the agency to prevent very dangerous arti cles from remaining on the market during the rulemaking pro cess.1*1 The CPSC has exercised this emergency power only once and not to regulate a carcinogen.TM Section 2(q)(l)(A) of the FHSA provides a narrower but speed ier basis for banning carcinogens.1** This section contains a special statutory definition of "banned hazardous substance." The defini tion applies to "any toy, or other article intended for use by chil dren . . . which bean or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is entrusted."1*4 Section 2(q)(l)(A) does not set forth a general standard for the agency to apply to specific prod ucts by administrative actios; instead it classifies a category of products as "banned hazardous substances." It thus constitutes a self-executing congressional ban, which the CPSC la empowered to - enforce.1** ,w The Commission combined these two ttipt, for example. In fta regulation of fireworks, 41 Fed Rtf. 22331 (1978), and vinyl chloride, 39 Fed. Rag. 18,116 (1974). *" IS U.S.C. | I261(q)(2) (1976). Ml The House Report on | 2(qXD(B) ttatw Unt "bribers the procedural dtlay involved In plenary would otherwise result in injury to tbs public, the [Commission] would bt authorized to suspend the article bom the market, peading the completion of hearing and review.'" HJt. Rjp. No. 2166, 89th Cong* 2d Sect. 3, reprinted in (1966) UJS. Coon Cong, a An. News 4096, 4096. m The agency issued sa administrative order declaring spray adhesives "imminent hazards" under the FHSA. 38 Fed. Reg. 22,669,23356,25318 (1973). It later rescinded thia order. 39 Fed. Reg. 3582 (1974). 16 U.S.C. S 1281(d)(1)(A) (1978). Stt notea 33642 tn/fe and accompanying tut (dlscuseioa of TRIS in children's garments). m IS U.S.C. S 1261(q)(l)(A) (1978). ta* "Toys or other articles intended for use fay children which bear or contain a hazardous substance are banned by the language of the bill itself . . . HR. Rnr. No. 2166, supra r AP00017082 1294 Virginia Law Review [VoL 67:1281 Although the section requires no administrative action or formal announcement prior to commencing enforcement, some antecedent administrative procedure is permitted and, in some instances, is necessary. For section 2(q)(l)(A) to apply, a material must be "toxic" within the meaning of the definition in section 2(g).1** When there is doubt on this point, the Act's remedies are not trig gered until the CPSC conducts a rulemaking proceeding to estab lish the material's toxicity. Section 3(a) reinforces this requirement by calling for rulemaking to "[avoid or resolve] uncertainty" as to whether a product is a hazardous substance.1** 3. Remedies Against Banned Hazardous Substances Section 4 of the FHSA1** bars banned hazardous substances from interstate commerce and defines "interstate commerce" broadly.1** Section 6 authorizes the seizure of banned hazardous substances.1** Sections 5 and 8 authorize the Commission to seek injunctions1*1 or criminal penalties1** against persons who violate any of the forgoing prohibitions. Section 15 requires the automatic repurchase of banned hazard ous substances, whether banned by statute or by Commission rule under section 2(q)(l).m Manufacturers (including importers for resale), distributors, and retail dealers must repurchase these prod ucts from their customers. Any customer is entitled to a refund of the purchase price and to payment of certain expenses incurred in returning the items. A CPSC regulation, however, gives sellers the option of replacing or repairing banned items instead of repurchas nott 181, (t 3, [1968] UJS. Cods Como. ft Aft Niws it *096. tM 15 U.S.C. | 1281(f) (1976), quottd at tost aceompanyinf not* 191 juprs. Id. 11262(a>(tt <1976). Section 4 prohibit* tb introduction or delivery for introduction into intentata cob. marc* ot a bound hazardous substance; tht doin* of any actios with respect to a hazardous nihafnca while it is in interstate comaarea that raaulta in its being a baztnad hazardous substance; and delivery or proffarad dtUvary for pay or otharwiaa of a banned hazardous aubatanca. Id. | 1263 (1978 & Supp. HI 1979). Id. { 1281(b) (1978). Id. | 1266. m Id. | 1267. " Id. | 1264 (1978 4 Sapp. IQ 1979). IT* Id. | 1274 (1976). This requirement has bsaa changed by th* Consusntr Product Sa/aty Amendments of 19S1, Pub. L. No. --_ { 1211, StaL __ (unindini 19 US.C. f 1274 (1976)). \ AP00017083 1981] Cancer Risks 1295 ing them*174 The Commission also requires that retailers place signs in their establishments informing customers of their repur chase obligation.179 Although the FHSA provides no criminal or civil penalties for violations of repurchase requirements, violations can be enjoined17* Section 15 is one of the most potent, and controversial, weapons in the CPSC's arsenal. .Although this statutory repurchase obliga tion appears to cover products anywhere in the distribution chain, the CPSC has sometimes used the FHSA'i banning provisions to reach only articles that are introduced Into interstate commerce after a specified date.177 Despite precedents to the contrary,179 the agency apparently possesses legal authority to issue regulations de fining products as "banned hazardous substance[s]" without re quiring the repurchase of articles at various stages of distribution and articles already in the hands of consumers.179 4. Judicial Review Any party adversely affected by a rule banning a hazardous sub stance under the FHSA may petition a court of appeals within sixty days for review.19* The reviewing court may order the agency to take additional evidence, or it may grant other appropriate re lief. The FHSA requires the Commission's order to be affirmed if it is based on a fair evaluation of the hearing record. A determina tion by the CPSC that section 2(q)(l)(A) of the FHSA defines a product as "harmed," even though not reached following rulemak ing, can also be challenged in court.191 m 16 CyJL | 1600.203 (1W0). " Id. 6 1500.202. 16 U&C. | 1267(e) (1976). m Krulwieh Interview, supra note 36. m The agency did net follow this approach hi its regulation of vinyl chloride and THIS, the two carcinogen* it hes attempted to rsfulete on the beais of the FHSA. It we* the im~ pect of mandatory repurchase on manufacturer* that precipitated the ultimately macawful judicial challenges to the Commiaiton's actions against thee# two tubstineas. >* Kruiwich Interview, supra not# 36. ** In 15 U.S.C. | 1262(e)(3) (1976), such review is provided apsrincslly with respect to children's toys. For actions tgai&st other hazardous substances, { 1262(a)(2)(B) provides the same rtvisw mechanism throufh incorporation of 21 U.S.C. $ 348(f) (1976). For example, such e contest may occur when UJ. Attornsys initiate enforcement pro ceedings, or the Commission's interpretation may be challenged directly by a suit seeking injunctive end declaratory relief. Sst, r/., United States v. Articles ofHexardout Substance, 568 F.2d 39 (4th Ctr. 1978); Springs Mills, Inc. v. CPSC. 434 7. Supp. 416 (D.S.C. 1977). 1298 Virginia Law Review {VoL 67:1261 C. Summary of Statutory Authorities Tht forgoing discussion of the CPSC's main authorities illus trates the range of options open to the agency in its regulation of consumer products that pose cancer risks. The Commission has ex perimented with most of the remedies afforded by the two stat utes. It relied on section 8 of the CPS Act-to ban caulking and embermng compounds containing asbestos and in proposing to ban benzene in consumer products. It secured the recall of hairdry ers containing asbestos by commencing the initial steps to correct a "substantial product hazard" under section 15 of the CPS Act In regulating vinyl chloride, the agency relied on section 2(q)(l)(B) of the FHSA. Its clumsy attack on THIS in children's sleepwear re lied on an *`interpretation1* of section 2(q}(l)(A)'s statutory ban of toxic substances exposed to children. Although the Commission has developed a general preference for the CPS Act its most re cent actions provide little guidance as to which of the remedies provided by that law it will use customarily. The diversity of products for which the CPSC is responsible may require a variety of regulatory weapons, although it is not clear that the statutes it now administers afford the optimum selection. The Commission has picked and chosen among statutory authori ties partly because none of the laws seems ideally suited. The pro cedures mandated for specific remedies influence strongly, and may sometimes distort, the agency's choice. The statutory proce dures, moreover, often do not mirror accurately the processes by which the Commission actually makes and implements decisions. m. Thb Commission's Chronic Hazards Program This section describes generally the CPSC's efforts to develop criteria for regulating consumer products that pose cancer risks, and it traces the agency's attempts to establish a system for identi fying and evaluating substances that are candidates for regulation. The discussion reveals that only in the past four years has the Commission seriously begun to evaluate its role in controlling ex posure to toxic chemicals. Its current efforts reveal an agency still uncertain about its mission, one that is attempting to move from a posture of reaction to external reports of hazards toward one of responsibility for its own agenda. c 1981] Cancer Risks 1297 A. The 1978 Cancer Policy 1. Background and Content Demands that the federal government develop a uniform "cancer policy" began to receive congressional and media attention during 1975 and 1976. Members of the CPSC, frustrated by their own ex perience with THIS, used tins interest as an opportunity for the agency to develop its own cancer policy.1*1 The policy was to be a statement of the scientific principles the Commission would use in evaluating suspected carcinogens. When published in 1978! how ever, the CPSC policy went beyond a mere statement of scientific principles; it also outlined a framework for evaluation and forecast the regulatory consequences that would fiow from different levels of evidence of carcinogenicity.111 The Commission published its policy in the Federal Register without allowing prior opportunity for public comment, although drafts had been in public circulation for several weeks. The pub lished document invited comment on the agency's scientific princi ples, its framework for evaluation, and its suggested regulatory re, sponses, but the agency also stated that the policy was effective V immediately on an "interim basts," pending consideration of comments.1*4 In this policy, the CPSC announced its intention to prevent known carcinogens from being added to consumer products inten' tionally if such substances could be absorbed, inhaled, or ingested by humans. Use of any carcinogenic substance would be phased out unless "no reasonable substitute" were available and elimina tion of the substance would result in "unacceptable economic and social costs."111 In the latter case, the agency would require that use of the substance be reduced to the "lowest attainable level" until a substitute could be identified.11* The Commission stated " Former CPSC Comniuicntr Barbara Franklin and former Commission Chairman John Byington war* strong proponanta of a govsmment*widt cancer policy. Conuniaaionar R. David Plttlt, who urged fraatav CPSC involvement in the regulation of chronic hazards, was instrumental in persuading the Commission to focus on the creation of Its own policy. Gallagher Interview, supra not* 22. 43 Fad Ref. 25,688 (1978). ** Haller Interview, supra not* 32. The decision to makt the policy immediately effective reportedly was reached os the era of publication. Melnick interview, supra note 66. " 43 Fed. Rag. 25.666. 25.659 (1978). id. r APOOO17086 1293 Virginia Law Review [VoL 67:1261 that it would consider a variety of factors, including the extent to which products containing a carcinogen were used, and by whom; the potency of the substance; the potential for human uptake; the probable effect of regulation; the extent of human exposure to the substance and the availability and adequacy of substitutes; the en vironmental impact; and the potential economic and social effects of regulation,1*9 The CPSC's cancer policy described a system for categorizing in dividual substances based upon the weight of the evidence of their carcinogenic!tyIM and forecast the regulatory action that would be likely to follow a substance's classification in each category.1** Spe cifically, the policy provided that, once questions about a sub stance's carcinogenicity were raised, the CPSC staff would deter mine (1) whether the substance was present is products within the agency's jurisdiction, and (2) whether the agency should refrain from action because another agency was dealing adequately with the potential hazard.1** A substance that survived this preliminary review would be classified into one of four categories.191 Category A would consist of substances for which there was "strong" or "com- polling" evidence of carcinogenicity.1** This category would auto matically include substances that the National Cancer Institute had found to be or human carcinogens. Category A also would cover substances that were determined to increase signifi cantly the incidence or reduce the onset rime of benign or malig nant neoplasms in humans or in soundly conducted experiments on animals.1** Other "compelling evidence," such as dramatic posi tive findings in a single animal study, could warrant a substance's classification in Category A.1** The CPSC thus endorsed the prin- Id. it 25,Ml. 25,664. " This system resembled the oat subeaquaatly adopted by OSHA la its centric eanere policy, 20 CJ.R. | 1990 (1930), and followed by SPA la Its announced criteria for evalua tion of chemical cudnofsns, 40 OJA. $ 61 U979). ' In this respect, the CPSC policy was dissimilar to OSHA'a 43 Fad. Ref. 25,65a, 25,631 U97S). m Id. t 25,663. " Id. ,m To support such a finding, animal data would have to consist of tast results in <1> two sped** of (2) ona species of if replicated in a sacond experiment, or (S) ons spectre of animal if tbs result were supported by a battery of sound short-term teats. Id. *" Id. ! ; j ? ! ) AP000I7087 c 19811. Cancer Risk* 1299 ciple, adopted by other agencies and sustained in the courts,1** that a substance demonstrated to be capable of causing cancer in animal teats should be assumed carcinogenic to humans.1** Simi larly, the agency would regard positive human epidemiological evi dence as a reliable indicator of carcinogenic risk, but it would view negative findings with skepticism.1*1 The CPSC stated that it would act to baa or reduce to the lowest possible level the inten tional addition of a Category A substance to any consumer product.1** Category B was to include substances for which evidence of car cinogenicity was "suggestive" of a risk to humans.1** Such evidence could consist of indicative animal or human data* positive results in a single short-term test not yet confirmed in human or long term animal tests, or positive results in an animal study that were not conclusive enough for Category A classification.*** Category C would include substances that were members of a chemical class containing many known carcinogens, or for which limited experi mental evidence of carcinogenicity existed.**1 Category D would in clude substances that exhibited no evidence of carcinogenicity.** Substances initially classified in Category A, B, or C would be re classified into Category D if further evaluation did not indicate carcinogenic potential.*** The policy announced that the CPSC would seek further testing of substances placed into Categories B and C. The agency asserted ,a* Sn Scientific Bern for Identification of Potential Carcinogens and Estimation of Risks, 44 Fed. Ref. 39,865 (1979) (hereinafter cited as IALG Document). 5tr alto Environ* mental Defense Fund, Inc. . EPA, 610 F.2d 1292 (D.C. Cir. 1978); Environmental Defense Fund, Inc. v. EPA, 465 F.2d 528 (D.C. Cir. 1972). "* The CPSC policy declared that, in evaluating the results of animal testa to determine a lubstanct's possible cardnofen&aty, the agency generally would follow the "General Crite ria for Assessing the Evidence for Carcinogenicity for Chemical Substances/* proposed by the Subcommittee on Environmental Carcinogenesis of the National Cancer Advisory Board for the National Caneer Institute. 66 J. Nat'l Cahcss INet. 461 (Feb. 1977), cited at 43 Fed. Reg. 25,658, 25.662 (1978). m 43 Fed. Reg. 25,658, 23,662 (1978). >* Id. at 26,664-65. * Id. at 25,663. * Id. "Id. *" Id. at 25.665. **" Id. at 25,663. r i AP00017088 1300 Virginia Law Review [VoL 67:1261 that it could either2*4 require manufacturers of products containing the substances to conduct and report tests under section 27(e) of CPS Act,9** or request EPA to require such testing pursuant to its authority under the Toxic Substances Control Act (TSCA).*** The policy contemplated interim regulatory action requiring warnings and special labeling on consumer products containing Category B or Category C substances, as well as mandatory recordkeeping on production and distribution of such products.*** Tbs Commission declared that the evaluation, testing, and regulation of substances in all four categories would be geared to the agency's overall priorities. Classification in Category A, for exampis, usually would result in high priority. Apparent potency, extent of consumer exposure, and potential for human uptake, however, could lead the agency to allocate resources for the investigation of a Category B or C substance ahead of a low-priority Category A substance.*9* 2. Judicial Reversal The first substance that the CPSC considered for provisional categorization under ita new policy was perchloroethylene (PERC), a chemical used in commercial and coin-operated dry cleaning establishments. The agency staff had been evaluating data on PERC prior to issuance of the cancer policy, and the Commissioners had given preliminary indications that they would ultimately classify PERC in Category A.'** Concerned that the material would be in dicted publicly as a cause of cancer, Dow Chemical and the other principal manufacturers of PERC sued to enjoin the Commission from taking any action to categorize suspected carcinogens under its published policy.11* The manufacturers contended that the Commission's failure to provide prior notice and opportunity to comment pursuant to the APAm rendered the policy Invalid.*1* " Id. at 28,665 a 0.8. "* 16 U.S.C. Ji 2061-2082 (1976 * Supp. HI 1979). * Sa Tosie Subataacw Control Act, 15 U.S.C. SI 2601, 2603 (1976). 43 Ftd. H*f. 25,666, 25,666 (1978). " St* id. t 25,664. ** Htllw Interview, tupm cot* 32. *** Dow Chain., USA . CPSC, 459 F. Supp. 378 (W.D. La. 1978). * 5 U.S.C. | 553(b). (c) (1976). *" Dow Chtrn., USA v. CPSC, 469 F. Supp. 378, 383 (W.D. La. 1978). I .t 1 j j j j ! ] j ( ! j ); AP00017089 1981] Cancer Risks 1301 The CPSC responded11* that Its cancer policy was merely a "state ment of policy" and thus exempt from the informal rulemaking re quirements of the APA.m In rejecting the Commission's position. Judge Veron identified several features that belied the agency's description of the policy and required compliance with the APA. First, the policy stated dearly that its provisions, which resembled regulations, would be followed in subsequent proceedings.11* The court expressed con cern that proceedings involving individual substances would focus simply on whether the criteria set forth in the policy were met. Use court stressed the value of prior public comment, observing that many principles endorsed by the policy were still being de bated within the scientific community. It would be improper, in the court's view, to implement regulations that appeared to settle those uncertainties without siring the alternatives that would be raised in public comments. The court expressed concern that the Commission's attempt to categorize PERC pursuant to the policy would cause immediate harm to the plaintiffs.*** Accordingly, it declared that "the interim rules should have been announced only after the informed reflection and genuine dialogue contemplated by the APA,"*1* and entered a preliminary injunction ordering the CPSC to refrain from classifying any substance under the policy.11* In an effort to salvage Its cancer policy, the CPSC published an lu'As'a preliminary matter, tha agency contended that tha i<tl`ri,"p to its policy was premature. Tha court rejected this claim, feeding tha matter ripe for review because tha manufacturer* faced immediate economic hardship if PERC were publicly declared a cancer hazard. Tha court stressed that tha regulations had baas issued is a formal fashion and contained unequivocal language. Indicating that they represented a final decision by tha agency. Id. at 385-87. Thu*, whether the agency had complied with tha APA was a legal question ripe for Judicial determination. Id. at 387. "* Id. at 390. The exceptions to tha informal rulemaking requirements of tha APA, in cluding the exception for "general statements of policy,1* are set forth in 6 U.S.C. f 663(b) (1976). " Dow Cham., USA v. CPSC, 469 F. Supp. 379, 383 (WJ). La. 1978). * Id. llT Id. at 394 (footnote omitted). Id. at 395. Tha court's determination that tha plaintiffs were likely to prevail on tha merits was crucial to its eelaction of injunctive remedy. Id. at 390. Tha eourt also found that (1) plaintiffs would suffer irreparable Injury if PERC provisionally ware listed in Category A; (2> because the policy had taken so long to develop, further delay would barm tha Com mission lass than the plaintiffs; and (3) tha public interest called for protecting the integrity of tha APA rulemaking procedures. Id at 394-95. 1302 Virginia Law Review [VoL 07:1201 ostensibly clarifying notice in the Federal Register.*1* This notice attempted to bulwark the agency's contention that its classification scheme was merely a statement of policy and not a legislative ruley it., that It was intended only to advise the agency staff and inform the public of the Commissioners* current approach toward carcino gens. The CPSC emphasized that the policy would not foreclose evidence or argument on any issues raised by its attsmpts to regu late specific substancee. It also stressed that the provisional classi fication of any chemical would be subject to notice and public comment. Furthermore* the only action triggered by final classifi cation would be further testing or the commencement of regulatory action that would itself be subject to the full procedural require ments prescribed by the CPS Act or the FHSA.*** The explanatory notice also reopened the comment period on the Commission's cancer policy for an additional sixty days.**1 Based on this notice* the CPSC unsuccessfully sought reconsid eration of the district court's injunction.1** Judge Veron declared that because the agency's clarifying statement did not modify the original policy* the policy must continue to be interpreted as writ ten.*1* He asserted that the clarification did not respond to his original conclusion that public rulemaking was essential for such policymaking.**4 Rather than seek appellate review* the Commission withdrew the policy.*** It offered two reasons for this retreat. First* a nonbinding policy was not worth the effort of protracted litigation* particularly because its publication was not essential to the agency's ability to regulate carcinogens.*1* Second* the IRLG planned to publish a similar set of scientific principles for evaluating potential carcino gens; these would be supported by the collective expertise of the four agencies.11* 43 Fad. Raf. 60,433 (1978). " Id. at 60,437. * Id. at 60,438. " Cow Chao* USA . CPSC, 464 7. Supp. 904 (W.D. La. 1973). * Id. at 90S. Id. at 909-10. * 44 Fad Ra*. 23^21 (1979). ** Id. at 23422. m Id. Tha four contributing aganriaa war* tha CPSC. EPA* FDA* and OSHA. Also, tha Food Safety tad Quality Satvte* o( th* Department of Ajricuitura had joiivad tha IStLG shortly bafora tha CPSC withdraw ita policy. Id. ) APOOOf 709f 1961] Cancer Risks X303 Judge Veroa'a ruling is questionable on two grounds. First, its reasoning does not respond adequately to the Commission's legal position. The APA exempts agency "statements of polio/' from in* formal rulemaking requirements. Although the court cited several decisions supporting a nonlitsral reading of the APA's exception,1" it did not explain why such a reading was appropriate in this case. The CPSC*s published policy neither foreclosed the contest of any scientific or economic issue in proceedings to establish safety stan dards, nor banned any product or substance---including PERC. Furthermore, the court's ruling induced the CPSC to submerge rather than clarify its policy concerning carcinogens. Although the agency out of prudence will avoid formal categorization, the deci sion left it free to follow the same criteria in regulating individual substances and to dispense with the opportunity, promised in its published policy, for public comment on the staffs preliminary assessments. The district court's primary concern appeared to be the adverse publicity that manufacturers of PERC might suffer if the Commis sion were to classify preliminarily the chemical in Category A. The decision solved that problem by forbidding the agency from taking any action against the chemical until its procedural mistake had been corrected. The injury caused by such an announcement, how* ever, probably would carry less stigma than would accompany pub lication of a proposed ban .under section .8 of the CPS Act, which would be the CPSC's next logical step if it decided to regulate PERC. Furthermore, the Commission's provisional classification system would have provided an additional opportunity to vindicate the chemical, one that is not afforded by section 8 itself.11* 5* IRLG Document, supra note 195. Although it did not purport to be a proposed nil* or otherwise have decisional weight in individual substance-specific regulatory proceedings, the IRLG ageodsa invited public comment on their statement of principles. See T. MeGarity, The Occupational Safety and Health Administration's Genarie Carcinogen Policy: Rulemaking Under Scientific and Legal Uncertainty 10 (unpublished paper on file with the Virginia Law Review Asaoriation). -- These esses included Continental Air Lines, Inc, v. CAB. 522 F.2d 101 (D.C. Clr. 1974), rehearing n bone, 322 F4d 122 (1975V, Piekus v. United States Board of Parole, 507 F.2d 1107 (D.C. Or. 1974); Padfle Gee * Elec. Co. v. FPC, 505 VM 33 (DC. Cir. 1974); Texaco, Inc. v. FPC, 412 F.2d 740 (3d Cir, 1959); St, Francis Memorial Hoap. v. Weinberger, 413 F. Supp. 323 (N.D CaL 1975). " Although PERC remains on the government*! agenda as a candidate for regulation, no formal action baa been initiated to ban or limit its use. 1304 Virginia Law Review (VoL 67:1261 This is not to suggest that the CPSC was sure-footed in publish ing the. policy without prior public comment It would have been prudent for the agency to have invited comment on a proposal before issuing its policy in final form.*** Alternatively, the agency might have been successful in announcing ita scientific criteria without prior comment had it given the "policy" a less formal ap pearance.1** Nonetheless, one can understand why the agency thought ita approach appropriate. The published principles were to be treated simply as guidelines. The Commission staff needed some criteria for evaluating cbemicali that might pose a risk of cancer. Postponing evaluation of, or action on, any chamieulB until a final policy could be promulgated seemed unnecessary. B. Determinants of the CPSC's Agenda The projects to which the CPSC devotes resources generally are identified through one of two procedures: (a)'the public petition process, and (b) staff identification and evaluation; of product hazards that merit the agency's attention. 1. The Petition Process The CPS Act authorizes interested persons to petition the CPSC to initiate proceedings to establish a consumer product safety rule Such is approach would haw boon indlspansibt* if th* Mtnqr had desired to malt* the scientific principles binding in aubsaquenE'ptocesdlnp, as (on* Commissioners report edly urged i" ' *** Tba CPSC cancar policy bon some taeemblaiMe to tha SPA announcement, diacuasad at note IBS eupro, with two dlffsiancea. First, EPA promiaad explicitly to avaluat th* coata of regulation ooc* a lubstanc* was classified ta a praaumptiv* eancer risk. Th* CPSC hai avoidad aueh a commitment. Perhaps mon important. EPA consciously refrained from gW- fog it* policy th* appaaranot of a regulation. No CJ.R. saettaa number* appeared in tha docuaant and much of tha supporting aarratlva appeared in smaller. tppendbt-style type. To adopt a substantive nila. as agency must follow tha procaduxaa prescribed by sactlon 553 of tha APA, which requires publication of a "general notlca of propoaad rulazstldaf'1 and "an opportunity Ifor tboaa affected] to participate la tha rulemaking." 5 U.S.C. f 553 (b), {} (L975K Although ganatal statement* of policy art excepted from this procedure, courts have construed this exception narrowly; "The basic policy of Section (5531 *t least requires that whan a propoaad regulation of general applicability has a substantial Impact on th* regulated industry ... notice and opportunity for comment should first b* pro vided-" Pharmaceutical Mfti Aaeoe. v. Fineh. 307 F. Supp. 858, 883 (D. DeL 1970). SPA'* description of th* criteria it intended to follow In evaluating potential carcinogens, however, was never challenged for failure to comply with tha APA, perhaps because tha document did not convey tba Impression that thee* criteria warn not open to dispute in specific case*. 1981] Cancer Risks 1305 (standard or ban) and mandates a response by the agency within 120 days.*** This process has influenced the CFSC's general agenda, and most of the agency's actions against carcinogens have followed the filing of petitions by public interest groups.*** Cognizant of the 120-day statutory time limit for response,**4 the CPSC accords petitions priority over projects identified through internal evaluation.*** So long as the statute or the agency's view of its requirements remains unchanged, the petition process will contJnue to play a major role in determining winch substances the Commission selects for regulatory action. Members of the Commis sion have always disagreed on whether the agency could legiti mately decline to act on a petition on the ground that the agency's resources were already fully committed to other projects, some of which might have been stimulated by petitions.*** The view that such refusal is proper seems convincing, but it has not been tested in court. In 1976, the Subcommittee on Oversight and Investiga tion of ths House Committee on Interstate and Foreign Commerce issued a report indicating that the Commission could and often should refuse to act on public petitions.1** The legality of such a refusal might depend on the Commission's adherence to a rational priority-setting system. For example, candidate chemicals could be selected for regulation based upon such criteria as degree of toxic ity, prevalence of use, or level of potential exposure. Using such a system, the Commission could develop an agenda that is less vul nerable to outside pressures and that concentrates resources on substances that pose the greatest risk. Such an approach, however; has limitations. The CPSC has es tablished a system for determining which chemicals should receive attention, but this internal review process has not yet produced candidates for regulatory action.*** Evaluation has been hampered 19 U.S.C. | 2059(a), <d> (1976). " It action* against vinyl ehloride, chlorofluorocarbon*, THIS, bsnisns. patching com. pounds and emberiting msUriah containing rasplrablo asbestos. and hand-held hairdryers containing ubeatoa all followed the filing of petitions by public interest groups. ** $" 16 U.5.C. | 2059(d) (1976). M One agtncgr official remarked that petitions "go to ths tap of the pile." Freuse Inter, view, tupm note 32. *** Decision of the CPSC Regarding Agency Prioridee for 1980) Dtasentinr Opinion of Coausienoner Stuart M. Sutler, Dec. 20, 1979, at 9 [hereinafter cited ea CPSC Priorities). *" Moss Rookt, tupn not# 91, at 193, 242. ** Asbestos has been a long-standing CPSC concern, and tbs Commiseion's 1980 Advance i j ] ! !- i i AP00017094 1306 Virginia Law Review [VoL 67:1261 both by ignorance about product composition and by the difficulty of determining levels of human exposure to chemicals in many con sumer products. Furthermore* staffing the review process requires scarce human and monetary resource*. Prudential considerations may also dictate departures from a formal priority system. The CPSC desires flexibility in responding to two sources of unanticipated problems.1** First, some petitions ere likely to be the product of new scientific evidence that should place a chemical high on the Commission's agenda. Second, the agency may value the ability to respond to demands for action against hazards that have a high profile. Still, it will always be dif ficult to know how much such a response reflects concern about public relations and how much it represents a desire to meet more serious hazards. 2. Internal Review of Candidates for Regulation The CPSC's internal "system** for evaluating chemicals that might be candidates for regulation was carried out initially through the project management system.*4* The Program Manager for Chronic Hazards in effect served as the "team leader" of a group of professionals, drawn primarily from the Office of Health Sci ences and the Directorate for Hazard Identification. Now under the direction of the new Directorate for Health Sciences, the group is responsible for identifying and preliminarily evaluating potential chronic hazards. The group prepares briefing packages on chemi cals identified as deserving high priority; these packages outline criteria to assist the Commissioners in deciding whether to seek more data, initiate regulation, or defer action. A chemical selected for regulation is dealt with through the usual team or project system. In its initial efforts to identify possible chronic hazards in con sumer products, the review group concentrated on existing lists of Notie* of PropoMd Rulaaakfaf reflect* it* ova initiative, but this action was not precipi tated by any ayatamatie study of chronic hasarda in conmaar product*. " Th* CPSC ia taking th(* approach with it* currant budget and oparatlac plan. 1111i baud on th* eacassary aaauaptioa that th* agency's effort! to rank regulatory tufita on an intamai axenda will withstand chaUtngae from nonpriority petitioner* who damand action, pursuant to the statute, regardless of th* Commission's budgetary merva* or priorities. Th* CPSC had no internal ``eyete'* for identifyina and evaluating chemicals thafc night ba candidate* for regulatory action until 1976. Prauss Interview, supra not* 32. ) ii i i f )j AP00017095 1981] Cancer Ricks 1307 chemicals identified as potential human carcinogens.*41 The review group then attempted to answer a series of questions about each of the chemicals on these overlapping lists, including: (1) Has the substance been shown to be carcinogenic in humans, or in animaja as a result of well-designed studies?*41 (2) Is the substance present in consumer products? (3) Are products in which the substance is used subject to CPSC jurisdiction? <4) What is the extent of human exposure to the substance in such products? In answering the first of these questions, the staff has relied heavily on the find* legs of other bodies, including other regulatory agencies.*4* In an swering the other questions, the staff has relied primarily on ex isting information. The CPSC has not conducted, or contracted with others to conduct, additional testing of any chemical, nor has it authorized major new investigations of product formulations or assessments of likely human exposure. Such inquiries apparently await an initial determination by the Commissioners that a sub stance warrants regulation or further study. Until recently, the re view group has not performed quantitative risk assessments in identifying chemicals as potential targets for regulation.*44 In 1980, the Commission accepted an outside proposal to broaden the approach of its chronic hazards review group.*4* It *** ThM included the approximately 20 chemical* characterised by tba International Agency for Research on Cancar aa human or *">"*! carcinogens; tha mort than-100 chemi- __eala onwblch-the National Cancer Institute haacompUted blotawya. with specific attention ^to those with partitive malts in the studies; the chemical* nominated for tasting priority by the Interagency Tasting Committee; and the several chemicals being regulated by tha other agendas who are member* of the IRLG, There ere sufficient external sources of candidate* for evaluation that the Commiseion staff should not need to Identify new targets of its own. *** The extant to which the Commission staff has undertaken to reach an independent judgment on this threshold iaauo is undear. Given the agency's leek of expertise in this area, tha staff should rely primarily on other bodies for this judgment. The Commission's ap proach to tha evaluation of formaldehyde's carcinogenicity I* a healthy sign that It appradatea its limitations. *** S*e Hutt Comments, supra note ISA for **mpia, the agency relied on data provided to OSHA In heimtwg vinyl chloride, on the National Academy of Sciences and the Interagency Tads Force on Inadvertent Modification of the Stratosphere for evidence of the risk of chlorofluorocarbon*, aad on Information already accepted by the ether three IRLG agen cies to regulate asbestos in patching and embariring compounds. In the case of hand-held hairdryer*, the CPSC did arrange for its own testing to determine the extent aabestoe was available for human uptake, but it relied on the common body of information to find that eabeetoe posed a Health risk. *** Preus* Interview, supra note 32. " UL X308 Virginia Law Review (VoL 67:1261 granted in principle an Environmental Defense Fund (EDF) peti tion recommending that the agency identify products whose use entails exposures of a kind that could present serious health 'hazards if the products released carcinogenic materials.*4* One cur rent agency project* suggested fay EDF, Involves evaluation of room deodorizers to identify their constituents* determine their potential carcinogenicity and teratogenicity, and verify the premise for their selection to be regulated, namely, that room deodorizers are a sig nificant source of inhaled materials.*4* The staff contemplates that the Commission may issue special orders under section 27(b) of the CPS Act requiring major manufacturers to reveal the composition of their products and to submit currently available data on toxicity. The agency has found this internal review process difficult to manage. One impediment to a systematic review function has been the agency's "matrix" organization, which stresses flexibility at the expense of continuity. This structure does not lend itself readily to the formation of a staff-level group with continuing responsibility for reviewing substances that may never become regulatory projects. The absence of a fixed timetable governing review of, and actions on, substances identified by the review group also has impeded the CPSC's efforts to formulate its own regulatory agenda.*4* Although several chemicals have been identified prelimi narily as candidates for potential regulation, the Commission has initiated action against only one.*4* Furthermore, before the recent changes in the Commission's organization, the ill-defined arrange ments between the Office of Health Sciences and the OPM Chron-* *** let *** Heller Interview, supra not* 32. The Commission also has wttNIshad project to evaluate aeroeotixed products that contain hydrocarbon propellents. Id. This project, too, railacts a preliminary judgment that consumers are exposed to hydrocarbon propellant# la increasing quantities and may suffer serious adverse health affects It these material# are chronically toxie. Both projects contemplate that the Commotion may Issue special order* under j 27(b) of the CPS Act requiring major manufacturers to reveal the composition of their products and to submit data on toxicity. *** Thie flexibility is in contrast to the 120*day statutory deadline for answering public petitions demanding afeney action under | 8 of the CPS Act. IS U.S.C. { 2059(d) (1978). *" Thle exception is urea formaldehyde foam insulation, which the agency has proposed to ban. 48 Fed. Reg. 1UW (1981) (to be codified in 18 C.F.R. | 1306). St* notes 508-32 infra and accompanying text. Among the substances still under review are a large number of dyes and asbestos, which still appears in many consumer products. 1981] S Chck. Rea. Ran. (BNA) 129. 1981] Cancer Risks 1309 ic Hazards Program left unclear which component had responsibil ity for determining the priorities for work on specific chemicals and scheduling that work1* completion. C. Internally Generated Regulatory Actions To date, the CPSC has not regulated a carcinogen identified through its internal review of chemicals or product exposures.*** In fact, even before recent cutbacks in ita budget,**1 the Commission may have lacked the capability to mount a major program to regu late toxic chemicals. Its relatively modest resources1** have always had to be spread across a wide range of consumer product hazards. The agency has never possessed the scientific staff or facilities to undertake substantial testing on its own, and unlike EPA and FDA, it has no licensing programs that routinely generate test data from the private sector.*** Furthermore, the CPSC'* authority to mandate product safety testing remains unconfirmed.1** Finally, the Commission^ preoccupation with public petitions has forced it to neglect other regulatory priorities.*** Despite these difficulties, the CPSC has several chronic hazards projects on its agenda that were identified through the petition process or staff recommendations. The CPSC has published an ad vance notice of proposed rulemaking addressing the use of asbestos in consumer products.*** It contemplates a series of actions pursu ant to this notice, including the issuance of special orders under *** The agency's UMated evaluation of PERC under its 1376 cancer policy, i<( notes 209* SI tupra and accompanying wxt. was Its first such attempt. The Commission'* proposal to ban urea formaldehyde foam Insulation is iu only other initiative against a ehemieal that baa sot bean regulated by another agency. 5r* notes 516*19 infra and accompanying text m 5m note 2S supra. M The CPSC budget la minuscule in comparison with thoaa of other agendas raaponaible for regulating health hazards. EPA*i proposed budget for fiscal year 1962 it 51.29 billion; IDA'i proposed budget total* 5536 million. By contrast, the Office of Management and Budget has recommended a 533 million budget for the CPSC, which itself la a concession, tor tha Raagan administration has announced its desire to abolish the Commission as a separate agency and merge its functions into the Department of Commerce. Because the CPSC budget has always been imail, the cuts demanded by the Raagan administration may be felt more sharply than thoaa Inflicted upon its aister agencies. (19811 4'Chsm. Rxo. Rxp. (BNA) 1577*80,1621. ** 5 note 638 infra and accompanying text ** St* notea 135*36 supra and accompanying text *** St* notea 543-48 infra and accompanying text M 4+Fe<ybc* 60,057 (1999). 1310 Virginia Law Review [VoL 67:1281 section 27(b)(1) to obtain formulation and safety data;1** this may lead ultimately to the banning of some uses or products. The agency has proposed to ban urea formaldehyde as a component of foam insulation.11* It continues to regard PERC as a candidate for regulation.11* Its staff has been considering recommended regula tory actions on n-Hexane, a substitute for benzene in adhesives, and on benzidine dyee,1** both of which are the subjects of public petitions. Other projects on the Commission's agenda include hy drocarbon propellants and solvents. Given the CFSC'a continued interest in chronic hazards regulation, it is appropriate to evaluate its past performance in greater detail. IV. CPSC Regulatory Actions Against Carcinogens The administrative proceedings examined in this section consti tute virtually all of the CPSC*s attempts to regulate substances that pose a risk of human cancer.111 This survey highlights recur rent issues in the agency's decisionmaking and compares its ap proaches to different substances. Certain common threads run through all of the regulatory ac tions discussed in this section. Each administrative action was un dertaken following, although not necessarily as a result of, the sub mission of petitions by public interest groups. With the exception of TRIS* each substance*that the CPSC attempted to regulate had already been regulated by at least one other agency; as a result, in no case was the underlying issue of carcinogenicity seriously dis puted. The central questions for the CPSC revolved around the issue of human exposure. Manufacturers of the products targeted for regulation usually acquiesced in the agency's insistence that use of the subject material be halted; where litigation ensued, it cen tered on the disposition of products already in commerce. The CPSC's actions display no systematic approach toward balancing risks and benefits, nor do they reveal a clear view about the impor-* *** M* Id. at 60,ose, " 46 Fad. Reg. 11,133 (1981). *** Heller interview, supra sott 32. Ste U Fed. Re*. 78,387, 78^88 (1979). M> The agency also derates resource* to the evaluation of other chronic hazards and to joint activities with other regulatory agendas. 1981] Cancer Risks 1311 tasce of economic effects in decisionmaking under the CPS Act or the FHSA A Aerosolized Vinyl Chloride Vinyl chloride was the first carcinogen that the CPSC attempted to regulate. The Commission joined a multi-agency response to pe* titions filed by the Health Research Group (HRG) before the CPSC, FDA, and EPA requesting that each agency ban the use of the chemical in products within its jurisdiction.*** The HRG peti tions relied on recently reported findings*** of a rare form of liver cancer, angiosarcoma, in workers exposed to vinyl chloride. The CPSC was the last of the three agencies to respond.**4 On May 6, 1974, the CPSC announced its preliminary determi nation that consumer products containing vinyl chloride created a "substantial product hazard" under the CPS Act, and it ordered the manufacturers of consumer products suspected of containing vinyl chloride to submit formulation information.*** Two weeks later, the Commission proposed to declare household products con taining vinyl chloride "banned hazardous substances'* under sec tion 2(q)(l)(B) of the FHSA.*** Its proposal cited data from both human experience and animal studies reported previously to OSHA,*** and relied on actions of sister agencies.*** It reported that OSHA had published an Emergency Temporary Standard for *** The FDA proposal apptari at 39 Fad. JUf.14,218 (1974), EPA'* emergency order sus pending registrations for pesticide spray products containing vinyl chloride at 39 Fed. Ref. 14,783 (1974), and tha CPSC's initial notice at 39 Fad. Ref. 18,118 (1974). *" Meet of the studies dted is the CPSC notice were experiments, although epi demicloficai data from BJ. Goodrich employeaa axpoeed to vinyl chiwide provided con* vindnf support for the extrapolation to humans. The major laboratory experiment relied upon as performed by Dr. Cesar* Maltoni, of tfaa Institute di Oneoiofia, Bologna, Italy. It indicated earrinegenetis in laboratory exposed to vinyl chloride concentrations as low as 280 parts per million (ppa). 39 Fed. Rtf. 18,118 (19741. ** The agencies proposed actions in the following sequence: OSHA on April 5,1974; FDA on April 22,1974; EPA on April 28, 1974; and the CPSC on May 2S. 1974. ** 39 Fed. Rsg. 18,811 (1974). *** 39 Fed. Ref. 18.115 (1974). *** This data came from two sources: (1) reports of an Increased incidence of liver cancer among occupationally exposed workers at BJ. Goodrich, Union Carbide, end Goodyear fee* toriae, and (2) studiee conducted on three rodent aperies by Dr. Cesar* Maltoni, a well, known Italian toxicologist, which demonstrated that vinyl chloride could induce liver tumors at concentrations as low as 250 ppm. Id. ** Set id. at 18,116. 1312 Virginia Law Review [VoL 67:1261 vinyl chloride, setting an occupational exposure limit of 50 ppm in air.*** The Commission noted that OSHA had later proposed a per manent exposure standard of no detectable level,*7* and that the FDA had proposed to forbid the use of vinyl chloride aa an ingredi ent in aerosolized drug and cosmetic products.**1 EPA had pub lished an emergency order suspending the registrations of pesticide products that contained vinyl chloride aa a propellant and an nounced its intent to cancel the registrations of such products.*** The EPA proposal received special attention because it reported the preliminary results of a new experiment that observed angi osarcoma in mice that had been exposed to vinyl chloride concen trations as low aa 50 ppm. According to the Commission, EPA had calculated that under "reasonable conditions of use of self-pres surized products'* the level of human exposure to vinyl chloride might be as high aa 400 ppm.*** The Commission's rationale for banning vinyl chloride appeared in a single paragraph: Ample evidence in the form of scientific studies and chemical re ports is available to establish the carcinogenicity of vinyl chloride monomer by inhalation and to demonstrate that human exposure to vinyl chloride monomer can result in angiosarcoma of the liver, a highly malignant, irreversible neoplasm. Because no safe level of human exposure to vinyl chloride monomer has bees established, the Commission finds that adequate cautionary labeling cannot be written under the Federal Hazardous Substances Act for self-pres* - surized household products' containing vinyl chloride monomer. Tim formulation of proper labeling under that act requires consid eration of the possibility of latent injury from overexposure to a tingle dose, from frequent exposure to small doses, and infrequent exposure to small doees. The Commission has determined that the degree and nature of the hazard presented by the use of seif-pres surized household products containing vinyl chloride monomer is such that the public health and safely can be adequately served only by keeping thoae products out of channels of interstate com merce, and takes this action to classify all such products as banned hazardous substances without regard to the date on which those -- See 39 Pad. Rag. 12.343 (1974). * Set 3d Pad. Rf. 16,896 (1*74). > See 39 Pad. Ref. 14J18 (1974). *" See 39 Fad. Rag. 14.733 (1974). " 39 Fed. Ref. 18,115. 18.116 (1974). I L 1981] Cancer Risks 1313 product! were introduced into interstate commerce ,,..*** The Commission thus concluded that inhalation of vinyl chloride could be hazardous. The agency found "that any use of a self-pressurfeed product exposes the consumer to Inhalation of some of its contents/' and therefore it determined that "precautionary label ing would be insufficient to protect the public health."*7* Accordingly, it proposed to ban vinyl chloride from all self-pressurised products in interstate commerce.17* This would have required man ufacturers to repurchase such products from consumers.*" By the time the CPSC published its proposed ban,*7* the vast majority of manufacturers of household products had ceased using vinyl chloride as an ingredient or propellant. Thus, the Commis sion's proposal focused on those completed products that had not yet been sold or consumed. The few comments received--two from manufacturers and one from a trade association--did not oppose the agency's ultimate objective.*7* Rather, they urged that the ban apply only to products introduced into interstate commerce after its effective date. This modification would have relieved manufac turers of any obligation under section 15 of the FHSA to repur chase products already in commercial distribution or in consumer hands.*** The Commission rejected these suggestions to make the ban only prospective.**1 It reiterated EPA's finding that vinyl chloride may .... .... be present in the air-in concentrations as high as 400 ppm after use of self-pressurized containers, and it observed that liver tumors had been induced in mice after exposure to concentrations as low as 250 ppm.*** Furthermore, since publication of the CPSC propo sal, OSHA bad received information that liver tumors had been observed in rata exposed to vinyl chloride monomer at 50 ppm. The Commission cited OSHA's computation that the incidence of "* 39 F*d. R*f. SO,1X2. 30,113*14 (1974). m 39 Fad. Rag. 18,115,18,110 (1974). ** Id. *" St* nets* 178*79 mipm and Meoapanying text m St* 39 Fad. Rag. 30,112, 30,113 (1974). m Additional conusant* oo th* proposal war* racatvtd from two eoaaumar group* and four Individuals, The** gtnaraily favored tha pxopoaad ban. Id. at 30.112*13. Id. m Id. at 30,113*14. " Id. at 36,113. ( AP00017t 02 13X4 Virginia Law Review IVoL 67:1261 angiosarcoma among workers exposed at the workplace to vinyl .chloride was approximately 1 per lt000v compared with a rate of approximately 1 per 10,000,000 in the unexposed population."* It observed that neither the manufacturer nor the trade association commenting on the proposal had submitted information that would permit establishment of a safe level of exposure to vinyl chloride. The Commission therefore concluded that the risk posed by products already in commerce was not speculative or minimal, and it refused to make Its ban prospective only."* w[T]he potential hazard of exposure to vinyl chloride monomer from self-pres surized products used in households is sufficiently serious and im mediate to warrant repurchase under provisions of section 15 . . . The Commission also disputed comments suggesting that the repurchase provisions of section 15 were designed to assure re imbursement of consumers and to provide a means for retailers and distributors to recover economic losses rather than to effect the recall of hazardous products."* The Commission's "final order*' provided that persons adversely affected by the ben could submit objections and request a formal evidentiary hearing."' Reciting current FDA regulations,1" the agency noted that "[i]f a hearing Is requested, the objections must state the issues for the hearing. A hearing will be granted if the objections are supported by grounds legally sufficient to justify the relief sought."** Apart from this language, the agency did not sug gest that facially adequate objections would be scrutinized to de termine whether they justified a hearing. The CPSC received only four requests for hearings on its ban of vinyl chloride,"* all asserting that the repurchase requirement would work "financial hardship** upon them.**1 It concluded that *" Id. ** id. *" id * Id ** Tfali 1* mandated by f 701(e) of the FDiC Act. 21 U.S.C. S 371(e) (1976). ** 39 Fed. Ref. 30,112. 30,114 (1974). The Commission Inherited the FDA'e regulations implementing the procedure! requirement! of the FHSA when it waa given authority to administer that statute in 1972. * Id. " 39 Fed. Ref. 35.57ft 38,377 (1974). **' The parties submitting objection* wiQ not be affected by the ban. end did not object to it, insofar aa it prohibits the future sale of self-pressurized household products 1931] Cancer Risks 1315 none of the following principal objection* justified a bearing: (1) The Commission characterized the claim that its action rep resented an abuse of discretion as "a legal question which cannot be resolved in an evidentiary hearing."*** (2) It characterized the claim that it should have acted under the CPS Act as a legal objection. Furthermore, the agency stressed that it could not conscientiously find, as section 30(d) of the CPS Act then required, that the hazard of vinyl chloride could not be eliminated or reduced sufficiently under the FHSA.*** (3) The agency at once avoided and disputed the objectors* claim that it had failed to consider economic hardships: Although the Commission is not required by the Federal Hazard ous Substances Act to consider the economic consequences of its actions, s a matter of policy the Commission has weighed eco nomic factors in deciding upon courses of action. Such was the case with the vinyl chloride ban, for the Commission had before it and did consider the economic repercussions of its order. Since the ob jection is predicated upon an incorrect statutory interpretation . . . and since the contention is factually incorrect on its face, the Commission considered the objection frivolous and legally insuffi cient to warrant a section 701(e) bearing.*** (4) The agency rejected the claim that it had failed to make available the scientific data on which it relied.*** (5) The Commission insisted that it had found specifically that cautionary labeling would be inadequate to avert the hazard of vinyl chloride, and it asserted that an objection that this finding lacked substantial evidence was, "without more, insufficient to re quire a section 701(e) hearing."** The Commission concluded with the following paragraphs, which clearly contributed to the subsequent judicial reversal of its deri sion that no hearing was required: containing vinyl chlcrid* monomir. The objection* focused on the Fact that tha ban appliaa to product* alraady In tha hand* of consumers and suppHtra and requires that such products ba rapurchuad by tha manufacturer. Tha objectors dain that tha ro* purchase requirement will work financial hardship upon than. Id. ( *" Id. " Id AP00017104 1316 Virginia Law Review IVoL 67:1261 All of the statement* filed regarding the order raise objections dealing with the facts upon which the order is based. The Commis sion has carefully examined the objections and finds that none of them disputes the truth of the data relied upon by the Commis sion. The vast majority of these objections merely say that the Commission's data are not enough, that more is needed to support the Commission's action or that the data do not apply to the prod ucts being banned. The section 701(e) hearing was not placed in the statute so that parties regulated by agency action can require the agency to present evidence, more evidence, and still more evi dence until the affected parties ere finally satisfied that enough evidence has been presented. Whether the Commission's conclu sions are reasonable cannot be resolved by an evidentiary hearing. The hearing is directed to receiving factual evidence and expert opinion testimony, not arguments regarding conclusions drawn from tiie evidence. The objections are practically void of any references to, or offers to present, factual information which the'Commission believes would lead to a conclusion contrary to that reached by it. Such information as has been referred to, even if true, la not legally suf ficient to invalidate the ban order. Whether the Commission's conclusion that this and other infor mation before tt necessitated the ban order was a reasonable con clusion is not a matter which can be resolved by an evidentiary hearing. The facte on which tiie ban order are baaed can be dis puted, or other facts necessitating a contrary decision can be presented in an evidentiary hearing, but an evidentiary hearing for any other purpose would serve no valid function. In the present instance the Commission ia concerned with pro tecting the public from a hazard which is highly severe. Angi osarcoma of the liver it a highly malignant, lethal neoplasm. To delay the effectiveness of the ban and leave products which have known dangers in the hands of dealers and consumers while an evi dentiary hearing ia being conducted to test the reasonableness of the Commission's decision on the basis of the information it had before it can serve no valid purpose and would be a mockery of the Commission's congressional mandate to protect the public from hazardous substances.*** The frustrated objectors, motivated primarily by the require- "* Id. at 36,577-78. i 1981] Cancer Risks 1317 meat to repurchase ell outstanding product* containing vinyl chlo ride, challenged the CPSC's "final order*' review in the United States Court of Appeals for the Ninth Circuit.*** The court held that the Commission had acted unlawfully in revising to conduct the evidentiary hearing required by section 701(e) of the FD&C Act.*** The objectors had filed timely objections that took issue with certain scientific studies the CPSC had relied upon to support its ruling. They also had sought a hearing to explore the potential health effects of the expected exposure levels of vinyl chloride in household products, which were expected to be much lower than those encountered by exposed industrial workers who developed liver cancer. The court concluded: Our examination of the legislative history of section [701(e)] con vinces us that the Commission's regulations end procedures, inso far ss they allow the Commission to deny a hearing when the ob jections adduced in good faith raise material issues that are not frivolous or inconsequential* are contrary to the statutory schema established by Congress. We hold that section [701(e)] leaves the agency no discretion to rule on the quality and validity of the objections prior to the for' wml hearing, so long as they are made la good faith and draw In question in a material way the underpinnings of the regulation at issue. It is inconsistent with the statutory scheme to require the objecting party to allege anything more.*** The Ninth Circuit's decision returned the issue of vinyl chloride regulation to the CPSC, although use of the chemical in consumer products had long since ceased. Thus, the court's ruling meant only that the agency could not assure the recall of products already Psctra Indus., be. v. CPSC, 565 F.2d 677, 878 (9th Cir. 19T7). id at 684. *** Id. The court stated further: This is net a css* when th* objections simply raise 1(b1 challenges to weU>s*etled principles of taw. Psctra's objections raise meteriel issues thst should not be dispelled at the outsat without a hearing. The objections era neither frivolous nor inconsequen tial, end by raising the issue whether the products are hazardous within th* statutory definition end whether th* protection of the public could be served as well by means other than by classifying the preduets as bannsd hazardous substances, the company has repressed legitimate doubts ss to th* factual and legal premises of the Commis sion's order. Id. c I AP00017106 1318 Virginia Law Review [VoL 67:1281 introduced in interstate commerce at the tim* of its original decision. In early 1978, the CPSC concluded this episode by publishing a new "final" regulation declaring vinyl chloride a banned hazardous substance when used in seif-pressurized household products.1*1 The purpose of this action was simply to prevent future use of vinyl chloride in household products,*** and the Commission's rea sons paralleled those set forth in its original ban.*** The agency made no attempt to correlate the human exposure to vinyl chloride resulting from the use of household products with the exposures of workers or test animals. It merely recited that "no safe level of human exposure to vinyl chloride monomer has been established e* The Commission's 1978 "final order," like Its predecessor, in vited persons adversely affected to submit objections and requests for a formal evidentiary hearing.*** None were filed, and thus the renewed ban became effective. B. Chlorofluorocarbon Propellants la 1977, the CPSC contemplated banning, and ultimately pro posed to require warning labels on, products containing chlorofluorocarbon propellants.4** The announced basis for the proposal was that the propellants increased the risk of human skin cancer by depleting atmospheric ozone.*** Thus, unlike other car cinogens the CPSC has attempted to regulate, chlorofluoiocarbona do not directly damage the DNA of vulnerable cells; rather, they increase the risk of human cancer, if at all, indirectly, by increas- *" 43 Fed. Ref. 12J0S (1978). " Id *** Tht agency reiterated itf conclusions that vinyl chloride had bean shown capable at causing Uvr cancer in humans exposed by inhalation, that turnon had boas induced in mica a/tar axposurs to concentrations as low as 250 ppm, and that eoneratNtfons m high aa 400 pptB may rtmaia In tha air after household um of nlf-preeaurised products. Id at 124)09. " Id at 1W10. *** Id Tht 1973 ban ostensibly appllsd to all products containing vinyl chloride aa a pro* pellaat and thus apparently required repurchase by manufacturers. Manufacturers, how. v*r, had no reason to demand a hearing on this issue because product supplies bed been exhausted in tha intervening yean *"* The CPSC'* regulation of chlorofluorocarbon propellants was undertaken in conjunc tion with ERA and FDA. 43 Fed. Ref. 21,307, 21,808 (1978). i t ) l s ) AP00017107 1981] Cancer Risks 1319 tag human exposure to the ultraviolet radiation filtered through the ozone layer.4** Furthermore, the Commission did not have to confront the problem of measuring human exposure because the anticipated damage to the ozone layer, and thus the increased risk of cancer, Is believed to be a function of the total quantity of chlorofluorocarbon propellants released into the atmosphere. In a rough sense, therefore, the level of usage could be taken as a mea sure of the level of human risk* In the early 1970's, scientists first suggested that the release of chlorofluorocarbon* into the atmosphere might deplete atmo spheric ozone.*0* In June 1975, the Federal Interagency Task Force on Inadvertent Modification of the Stratosphere (IMOS)*4* recom mended federal regulatory action to ban the use of certain fluoro carbons unless a contemporaneous National Academy of Sciences (NAS) study concluded that such action was not necessary.*14 The NAS study questioned the need for immediate regulatory action, but it confirmed IMOS's scientific hypothesis.*4* EPA, FDA, and the CPSC interpreted this conclusion as justifying prompt action to terminate most uses of chlorofluorocarbon propellants.*1* The Natural Resources Defense Council (NRDC) had previously petitioned the CPSC to ban chlorofluorocarbon propellants in products within its jurisdiction. The agency had denied the peti tion on the ground that it lacked adequate supporting data and because the NAS ^report was expected soon.*14 In November 1976, however, following'renewed petitions from NRDC citing the IMOS Task Force recommendation and anticipating the NAS conclu sions, the Commission announced its preliminary conclusion that chlorofluorocarbon propellants presented an unreasonable risk of injury to consumers and that the risk could not be corrected by a product safety standard.*1* This announcement was not accompa-* *** M 412 Fed. Reg. 21,807 (1977). *** Stt id. for a description of the early studies, whieh demonstrated the plausibility of their theory through computer models and other simulation techniques. Thle showing, cou pled with the eeriouineM of the consequences If their theory were valid, prompted the two sujor scientific reviews, discussed at notes 310*12 infra and eeoapaaytrif text. " 42 Fed. Reg. 21,807 (1977). * Id. id. " Id. m* 40 Fed. Reg. 36,419, 36,420-21 (1975). *> 42 Fed. Reg. 21,607 (1977). 1320 Virginia Law Review (VoL 67;12S1 nied by a formal proposal to baa, because coatemplated EPA ac tion under the TSCA would terminate production of the propel* lanta for all nonessential usee, and thua render CPSC action unnecessary.*** In January 1977, the Chemical Specialties Manufacturers Associ ation petitioned the CPSC to require consumer products contain ing chlorofluorocarbon propellants to bear labels stating their in gredients.*1* Although the Commission declined to act under the FHSA, it concluded that some fora of labeling might be required under the CPS Act.*1* The Commission published a proposal to require products to bear warning labels and to require manufactur ers of products in self-pressurized containers to report their com position.*1* This proposal relied on section 27(e) of the CPS Act.*** The agency explained that tha warning was an interim measure designed' to "decrease the sale of such products by allowing con sumers to choose between products that contain chlorofluoro carbon* and products that are either non-aerosols or that contain another propellant.**"1 The Commission did not attempt to docu ment the hazard associated with tha use of chlorofluorocarbon pro pellants; it simply recited the findings of the 1MOS Task Force "* Id. ml " Id. * Id. at 21,808. . *** Section 27(e> of the Act aathcctiee the agency by Rile to " require any manufacturer of consumer products to provide to the Commission such performance and technical dam related to performance and safety as may be required to carry out tha purpoaee of this (Act), and to |ivs such notification of such perform- anca and technical data at tha time of original purchase to prospective purchaser* and to tha first purchaser of sueh product for purpoaaa other than resale, as it deter* aioea oscesetry to cany out tha purpose of this [Act}. IS US.C. | 2076(a) (1979), cited at 42 fed. Ref. 21,607, 21308 (1977). la support of it* proposal, eba Commission offered tha following expl&oatioiE While It is anticipated that the osa of chlorofluorocarbon! wfil ultimately be halted, auch regulatory action may taka one year or longer to become effective. In the mesatime, however, labels oq the container* of aerosol consumer products propelled by ehiorofiuorocarbona informing consumer* of the presence of tha propellant and wanting t&am of the possible haxard of aeons depletion would decreets the sale of auch products by ailowing consumers to choose between products that contain ehiorofiuorocarbona and products that are either oon-aeroeoia or that contain another propellant Thua, by reducing tha use of ehiorofiuorocarbona during thfe Interim pe riod, the amount of ozone ultimately depleted could be reduced. Id. at 2130& "* 42 Fed. Reg. 3130?. 21,306 (1977). 1981] Cancer Risks 1321 and the NAS. Nor did it attempt to quantify the risk associated with the propellants or to assess the economic effects of its propos als, even though it acknowledged that one of its objectives was to discourage use of products containing chlorofluorocarbon propel lants prior to EPA's anticipated ban.*1* On May 13,1977, EPA and FDA proposed to ban the production and use of chlorofluorocarbon propellants in all but certain "essen tial** consumer and drug products.*** The CPSC announced con temporaneously that the proposed EPA ban rendered any ban of its own unnecessary.*14 The Commission also reminded observers that its own warning label proposal remained outstanding.11* On August 24, 1977, the CPSC adopted a final rule requiring this warning and requiring manufacturers of seif-pressurized prod ucts to report their formulations to the agency*.11* [S]mce the proposed EPA ban will not apply to every consumer product containing thtse propellants, and since the EPA proposal would not prohibit the tale of products subject to the ban that are told and introduced into commerce by the processor by April I5r 1979, the Commission has decided to require that the aerosol con sumer products within its jurisdiction that contain chlorofluoro carbon propellants shall bear a label stating that the product con tains a chlorofluorocarbon and that such compounds may harm the public health and environment by reducing ozone in the upper atmosphere.11* The Commission's label rule required consumer products shipped after February 20,1978, but prior to the effective date of EPA's proposed ban, to bear the following statement: "WARN ING--Contains a chlorofluorocarbon that may harm the public health and environment by reducing ozone In the upper atmo sphere.*'111 The rule's preamble dealt mainly with the twenty-one comments received on the proposal. Most comments had favored the proposed warning or more aggressive action by tha agency to * Id. at 21.807-0S. *** 42 Fad. Rag. 24,536 (1977} (FDA Proposal); 42 Fad. Rag. 24,542 (1977) (EPA Proposal). w 42 Fad. Bar. 24,560 (1977). * Id. -- 42 Fad. Rag. 42.780 (1977) (codlfiad at 16 CJPJL $ 1401 (1960)1. "Id. " Id. ( AP000I7110 1322 Virginia Law Review [VoL 67:1261 baa chlorofluorocarbon propallaata.*** To thoaa commentators who viewed the hazard as unconfirmed or aa not serious enough to war rant a warning, the agency responded: {T]he great weight of current scientific opinion is that continued use of these compounds will result in a depletion of the ozone layer. Although there la some controversy as to the exact degree of ozone depletion, the Commission concludes that at any level within the range that la currently estimated by National Academy of Sciences* committees and other current researcher*, the risk of harm is substantial. The Commission also believes that providing the identification and warning statement on the containers of these products will substantially reduce the demand for them during the period that these products are available before the proposed EPA ban becomes effective. In addition, a number of products subject to Part 1041 are not affected by the initial phase of EPA regulation.*** Most manufacturers of products subject to the CPSC's warning label requirement had complied voluntarily before the rule be came'effective.*** On March 17, 1973, EPA banned production of chlorofluorocarbon propellants under the TSCA for all but "essen tial" usee,*** and the CPSC announced contemporaneously that there waa no need for it to take similar action under its statutory authority.*** The CPSC played only a minor role in the combined federal ef forts to regulate chlorofluorocarbon propellants. Consumer prod ucts other than foods, drugs, and cosmetics constituted a very small percentage of the market,*** and the Conunisson's staff -- Id. at 42,781-82. ** id. at 42,783 (footnote omitted). Pox, Mmtaphtric Oton* issue Loom* Agavt, Cxsmical & Snoimbximci News, Oct. IS, 1279. at 2& " 43 Fed Reg. 1UI8, U4tSl9 (1978). 43 Fad Ref. 11,328 (1978). ** At the tbs*. American production of fluorocarbons amounted to approximately 1 bil lion pounds annually, foot which the principal u*a* ware aa aeroaol propellant* <50%) and refrigerants (28%). FDA had jurisdiction over nearly 80% of the fluorocarbons ussd in the United States aa prepalliate la self-pmaurized containers, primarily for cosmetics sad drugs; the CPSC was responsible for only a small pert of the market, because most house hold products even thea contained propellants other than fluorocarbons. See Council on Enyixonmsmtal Quaurr, Fluoxocajuions ws tkb Enyikohmxnt, Rnroar or FKnsftAi. Task Forc* on iNAOwmNT Modification or thb SfUAToaraxsa 4 (June 1976). riled at 41 Fed. c 1961] Cancer Risks 1323 played a subordinate role in the evaluation of the hazard. After its initial labeling proposal, the agency deferred to EPA and FDA*" C. TRlS-treated Children's Garments On April 8,1977, the CPSC announced that it considered TRIStreated garments for children to be "banned hazardous sub stances" within the meaning of section 2(q)(l)(A) of the FHSA*" The events leading to this announcement are not atypical of gov ernmental responses to discoveries that a substance poses a risk of human cancer. Unhappily, they depict Commission decisionmaking at its most inept. Long before the Commission's 1977 announcement CPSC scien tists, aware that a Commerce Department standard for flame re tardant fabrics would increase the use of new chemicals in the pro duction of clothing, had urged unsuccessfully that the agency establish a program to evaluate new flame retardants in consumer garments.*" Meanwhile, the National Cancer Institute's (NCI) Chemical Selection Work Group had nominated TRIS for carcino genicity testing based on its chemical structure and on its growing use as a flame retardant.*" Chronic feeding studies in rats and mice were commenced within a year.*** Evidence incriminating TRIS as a potential carcinogen slowly began to accumulate. On October 29,1975, EPA advised the CPSC that TRIS had been found mutagenic in short-term testing.*4* On March 19,1976, the Director of the CPSC's Bureau of Biomedical Sciences received a telephone call from Dr. Bruce Ames,*41 a re nowned microbiologist and developer of a well-known test for mutagens. Ames said that on the basis of extensive testing, he con sidered TRIS to be a mutagen and probably a carcinogen, and he Rtf. 52,070, 52,072 (1976) (copy oa flit with tht Virginia Law Rtritw Aaaodatfon). " 42 Ftd. Rtf. 42,780 (1977)"" 42 Ftd Rtf. 18,549, 18,853 (1977). *** Subcomu. oh Oversight mo XnranoAnoxs or tub How Comm, oh Ihwwtat* and Fomich Commkkcz, 95th Coho* 2d Scat* Retort oh th* Consumes Jfeoovor Samir Com* mission9! Regulation or TRIS: Th* Need roe An Errecnvs Chbonjc Firx,f>* Program 8 (Comm. Print 1978) (btrtlnafttr dtad u TRIS Rsein]. " /A m /A at 9. ** Id. r " Id. at 10. AP000I7112 1324 Virginia Law Review [VoL 67:1261 urged the Commission to ban the use of TRIS in consumer products. Less than a week later, the EDF petitioned the Commission to promulgate a rule "[rjequiring a label on sleepwear [containing TRIS] warning consumers of the potential hazard and recom mending that sleepwear be pro-washed three times prior to use, a practice which would reduce, although not eliminate, the expo sure.*TM* The EDF petition cited studies that concluded that rats absorbed significant amounts of TRIS through their akin and pointed out that large amounts of TRIS could be found on the sur face of treated garments. The petition contended that children could easily taka up significant levels of the chemical through skis absorption or by mouthing of treated garments.*4* Although the agency staff reviewing the petition dismissed a memorandum from the principal domestic manufacturer of TRIS that challenged the EDF's characterization of TRIS as a potential hazard,*44 it for warded no recommendation to the Commissioners. The EDF was informed that the agency would not act on ita petition until the results of the ongoing NCI rat and mouse studies*4* were available. In the same month, the staff received a report from FDA about the results of three new short-term tests that demonstrated that TRIS was capable of causing mutagenic effects.*4* The problem facing the Commission changed when production of new TRIS-treated fabrics ceased*--at least temporarily. For a ban to have reduced exposure immediately, it would have had to apply, to articles in the manufacturing pipeline. The business com munity would have opposed this, but would not have opposed a ban on future use of TRIS, because that would not have required any recall of outstanding stocks.*4* Such a delayed ban would have exposed the Commission to sharp criticism by consumer groups, however, and probably to suit by the EDF. On February 4, 1977, the NCZ provided the CPSC with prelimi nary reports of the recently concluded rodent bioessays.*4* The*** *** Id. (quoting ED? petition). Id. *** Id. kt 10*11. ** Id. it 11. Id. H 11 a.193. **' Krtilwieh Interview, supra now 36. 42 R*g. 16,849, 18,850 (1977). 1981] Canewr Risks 1326 EDF also obtained the NCI data, and within two weeks it submit ted a second petition, demanding that tha Commission ban TRIStxaated garments as an "imminent hazard to the public health'* under the FHSA.*4* Sometime later, the EDF also filed suit against the agency "seeking an immediate Commission ban on the sale of TRIS-treated garments."*** This suit's contribution to the public perception of bureaucratic foot-dragging led to frantic discussions within the agency. Several weeks prior to the tiling of the lawsuit. Commission staff members beld a public meeting with EDF representatives to dis cuss the scientific basis for the request for action and to examine the regulatory options available to the agency.**1 The Commission ers held separate public meetings with NCI biostatistidan Marvin Schneideroan*** and with both EDF and Industry representa tives.*** On March 25,1977, the NCI's data evaluation group veri fied the results of the rodent bioassays.**4 As press and congres sional interest mounted, the Commission undertook its own studies on the extent of human exposure to THIS from treated garments. The agency also authorized the staff to develop estimates of the risk.*** On April 7,1977, the CPSC announced its response to the EDF petition and its actions on THIS. Though it was entitled "Interpre tation,'* the agency's derision was published in the Rules and Reg ulations section of the next day's Federal Register.*** The agency construed section 2(q)(l)(A) of the FISA es automatically render ing TRIS-treated garments "banned hazardous substances":**1 Section 2(f)(1)(A). . . defines "hazardous substance" u "any sub stance or mixture of substances which is toxic * * * if such sub stance or mixture of substances may cause substantial personal in- *** THIS Rimkt, tupn sou 337, at 13 (quoting SDF petition). *** Id. (quoting Environmental Defence Fund v. CPSC, Civ. No. 77*517 (DD.C^ filed March 23,1977)). *" Interview with AUnShakin, Attorney in the CPSC General Counsel'* Qfflee, in Wuh* ingtoa. D.C. (Aucuat 14, 1979) (hereinafter dted u ShaldR Interview) (cepjr of note* from interview on file eith the Virginia Lew Review Aeeodetfoo). *m**/<u*. ~ 42 Fed. Reg. 18.849, 18,850 (1977). *** Shekin Interview, supra note 361. *** 42 Fed. Reg. 18,849 (1977). ** Id. it 18,853. AP00017114 1326 Virginia Law Reuimw [VoL 67:1261 jury or substantial illness during or as a proximate mult of any customary or reasonably foreseeable ingestion by children," Sec tion 2(g) of the FHSA. . .stitee that Mtt}he term `toxic* shall ap ply to any substance which has the capacity to produce per sonal injury or illness to man through ingestion, inhalation, or absorption through any body surface." Section 2(q)(l)(A) of the FHSA . .. defines "banned hazardous substance" aa "any toy, or other article intended for use by chil dren, which is a hazardous substance, or which bean or contains a hazardous substance in such manner as to be susceptible cf access by a child to whoa such toy or other article is entrusted." . .. The Commission finds that children's wearing apparel contain ing TRIS that it currently in interstate commerce or will be Intro duced into Interstate commerce In the future is a banned hazard ous substance according to these applicable provisions of the FHSA. In addition, any children's wearing apparel containing TRIS that has not been washed, even if it has already been sold, is also banned as hazardous. Such wearing apparel is toxic and presents a substantial risk of cancer as a result of its foreseeable absorption through the skin and ingestion by mouthing. It is also of course intended for use by children.*** Anticipating legal challenges to its failure to afford any opportu nity for public comment, the CPSC emphasized that it was simply interpreting the self-executing language of section 2(q)(l)(A). The agency observed that the APA's rulemaking requirements do not apply to statements of agency policy or to interpretative rules, and contended further that even if the APA's rulemaking requirements were formally applicable, the hazard posed by TRIS-treated gar ments provided good cause to dispense with notice and opportu nity for comment.*** The Commission's cryptic explanation of its legal theory ulti mately proved unconvincing. Its discussion of the health risk asso ciated with TRIS in children's garments was more careful, if no less controversial. The agency cited the NCI animal data and ob served that any compound capable of inducing cancer in laboratory animals must be considered a risk to humans.*** It identified expo- Id. at 18,85243. Id. At 18453. Id. At 13450. 1981] Cancer Risk* 1327 sure data assembled by three different sources, including the EDF, and referred to three quantitative estimates of the human cancer risk which projected increases in the incidence of cancer among ex posed children ranging from 25 to 17,000 per million population.***1 2 The CPSC acknowledged that TRIS-treated fabrics provided a health benefit by reducing the risk that children would be seri ously burned if their clothing caught fire, but it concluded that the standard requiring children's garments to be flame retardant could be met by other materials.*** The Commission's "ban" on children's garments did not extend to unfinished TRIS-treated fabric supplied by mills to garment manufacturers, although it was intended to reach uncut fabric in tended for sale directly to consumers. The agency also specifically excepted TRIS-treated children's garments that had already been washed, on the theory that the process of washing reduced sub* stantially the amount of TRIS to which children were likely to be exposed.*** The CPSC's April 7 announcement sparked a whirlwind of legal Ml The proposal lUtid: The Commiteion hat considered risk assessments that ere baaed on the estimates of exposure.... The methods used to prepare the estimates are described la a Muck 1977 paper entitled, Estimates ofHuman Lifetime Gardnogaaie Risk Aon Exposure to TRIS, prepared bp Dr*. Charles Brown, Marvin Schnslderaan. and Kenneth Chu of the National Cancer Institute. The statistical extrapolations are baaad on the usa of two mathematical models: The single.hit modal (linear no threshold) and tha log* probtt medal (Mantei-Brjraa). .. . (1) Bureau af Biomtdieai Science. BBS baa projected cancer Incidence ratio baaed on fta exposure aetisataa and on data from tha NCI study. Tbaae projected rates show tha kidnap to ba tha primary target organ. Tbs bast estimates [sic] of BBS la approximately 300 kidney eancara par male population. For Amales the pro jected rata is about oae-fifth that of males. Bated on the single hit model tha BBS aatimataa for lifetime risk of cancer of tha kidney is between SO and 1.800 cates per mtilioa mala population. Per the Ion probit model the estimates range from 25 to 5,100 eases per million males. All of these esti mate* ir lifetime risk or lifetime incidence estimates, (2) Enoirmwicntaf Dr/ena* Fund, EDF also provided its estimates on human expo sure to NCI which used the aaaa models, and tbaae data provided estimates of a lifetime incidence of cancer of ae high ee 6,000 par million male population, based on exposure, tha rat kidney and tha log probit modal (3> Hooper and Am*#. Hooper and Ames estimate that for we year of exposure, 1.7 percent of tire children would develop cancer (174)00 caiaa/mUUoa). An exposure throughout childhood would give a higher risk .... Id, at 18,851 (document numbers omitted). *** Id. at 18351*52. Id at 18383. i r i AP000171I6 1328 Virginia Law Review [VoL 67:1261 and political controversy. As association of g&rmentmaken quickly sued the Commission* seeking expansion of the ban to include fabrics they had already purchased from the mills but had not yet incorporated into finished garments.*** Such an expansion would have required repurchase by the fabric mills. Anticipating a judi cial ruling that its action had been too limited, the Commission extended ita ban to include uncut TRIS-treated fabric and other component products.*** The agency's original decision to limit its ban to finished children's garments had been designed to comport with its legal theory, namely that die Act defined as a "banned hazardous substance" any product that was (a) toxic and (b) there fore hazardous and (c) capable of absorption or ingestion by chil dren.*** Its later expansion of the ban rested on the theory that the FHSA authorized regulation of components, as well as finished products sold at retail.*** The Commission's decision to extend the FHSA'a repurchase re* qulrement to the fabric mills precipitated immediate legal chal lenges from producers of TRIS-treated fabric, one of which re sulted in decision that undercut the agency's legal theory. In Springs Mills, Inc. v. CPSC,*-- the district court held that the agency's failure to engage in rulemaking before declaring TRIStreated fabrics and garments "banned hazardous substances" amounted to a denial of due process.*** It was not sufficient for the Commission simply to announce its interpretation of section 2(q)(l)(A). Because of the "continuous reference to 'regulation' in the applicable parts of the statute and in the legislative history," the court concluded that Congress Intended to require rulemaking for any ban under the statute.*** In rejecting the CPSC's reliance " American Textfl* Mfrt. hat r. CPSC; No. 77-S& (DJX&, OUd April 20.1977). cited at 42 Fad. Rag. 28.059 (1977). " 42 ?*L R*f. 28,059, 2&064 (1977). *"* See Memorandum to tha < from Ala C. Shafrin, Office of th* General CoubsoU Option* for CoaaUrioB Action u to Wearing Apparai Containing THIS 3 (Peb. 25, 1977) (copy on ffi* with the Virginia Low Ravtaw Aiaodatfoa). * SM 42 Pad. Rag. 28,059, 28,083 (1977). " M P. Supp. 418 (DS.C. 1977). "Id. at 418, 435. "Id. at 430. Th* court obaarrad: Th* coatimtou* Tifinac* to "TOularien'* is th* applfcabl* parts of th* ytatuta and la th* bfWatfra hiatory dearly iadicata tha confwittmal intent that tha Commiaaton procaad with nila.aakinf procedures, a* s*t forth in tha Pood, Drag and Coaaatio Act, and not attempt to malt* final dadaioaa having nationwide Impact without if. 1981] Cancer Risks 1329 on the APA exemption for "interpretative rules and statements of policy,"*" the court emphasized the disruptive impact of the Com mission's announcement. Noting that the ban set in motion the re purchase requirements of section 15, which it termed "one of the moat drastic procedures known to law/'*" the court observed: [Defendants'] position is not supported by the language of the statute or by the legislative history. This history. . shows clearly that Congress intended the Secretary to act "by regulation" which would mean undai the rule-msldng process. Congrsss also indi cated its concern for the powers given CPSC by requiring rule making under the Federal Food, Drug and Cosmetic Act rather than the Administrative Procedure Act in matters relating to haz ardous substances.. . . Obviously, Congress did not intend for matters under the Federal Hazardous Substances Act to be han dled or decided on the basis of ex parte communications with members of the Commission or without effective notice so that ob jecting parties could appear, present evidence and test the validity of the information presented. . . . . The fact that children may be involved does not obviate the necessity that CPSC by proper rule-making procedure determine that an article is a "hazardous substance," before it may go on to find that it is a "banned hazardous substance."*" The court set aside the Commission's revised June 1 ruling and enjoined the agency "from attempting to apply or enforce against any party, any article, fabric, yam, or fiber any of its previously adopted THIS regulations . . . .""4 llus ruling caused the CPSC to revise its regulatory posture. First, it settled several enforcement proceedings"* on terms that effectively precluded requiring manufacturers of TRIS-treated fabric to repurchase material from their customers."* Second, the* ** fording affaetad partita tha basic taquiramsnta of dot proem. ** 6 U.S.C. | 563(d)(2) (1976). " 434 F. Supp. at 430. " Id. at 431-32. ** Id. at 436. m Tha CommiuioQ originally brought suit in Now York agamat savant othtt fabric nulla In addition to Springs Mills. That action waa latar tranafamd to tha Diatrict of South Caro lina, whara it was aaaignad to tha samo diatrict judft who praaidad In tha Springs Mills etas. *** Krulwich Intamrw, supra nota 36; Shiltfri Interns*, supra note 351. 1330 Virginia Law Review [VoL 67:1281 agency tried to salvage its original legal theory. It formally with* drew its April 8 "interpretation" that the FHSA automatically de fined TRIS-treated garments as "harmed hazardous substances,""7 and simultaneously substituted a statement of policy that reiter ated its original legal position."9 The agency made dear that it did not regard Springs Mills as precluding initiation of court proceed ings to enforce its original interpretation of the FHSA, end noted that it had undertaken a number of suits against manufacturers and sellers of finished children's garments. The Commission explained Its earlier action in the following terms: The interpretations were intended to state the Commission's enforcemeat policy and forewarn that individual enforcement actions would be filed in Federal District court whenever the Commission found a violation of the FHSA to be associated with any THIS products that art banned hazardous substances. As interpretations, however, the April 8 and June 1 document* could not be relied on by the Commission to prove that any THIS products are banned hazardous substances under the FHSA.*** It then proceeded to reiterate a disclaimer that had never been ex plicit in its earlier announcements: Similarly, the Commission cannot and will not rely on its new statement of policy to prove that any hazards are associated with THIS products. In any enforcement action the Commission files, it is prepared to prove that the THIS products are banned hazardous substances and that judicial relief ia therefore necessary. In thee#' enforcement actions, then, any affected party will be provided an opportunity to litigate the merits of the Commission's claim and thus will be afforded due process.*** The CPSC brought several cases during 1977 and 1978. In one. United States u. Articles of Hazardous Substancethe owner of seized garments challenged the agency's enforcement action on grounds similar to those accepted by the Springs Mills court. But the United States Court of Appeals for the Fourth Circuit ac- " 42 F*d. R*f. 81,593 [1977). m 42 FL R*f 61,621 (1977). " t Id. *** 588 F.2d 39 (4th Cir. 1978). | I J ) AP00017119 1981] Cancer Risks 1331 knowledge that the FHSA provides the Commission alternative ways of regulating some hazardous substances: Under FHSA a substance may be a "banned hazardous sub stance" either by meeting the statutory definition in Section 1261(q)(l)(A), or by being so defined by regulation after formal rule-making under Sections 1261(q)(l)(B) and (q)(2). Similarly, substance may be a "hazardous substance" if it meets the statutory definition contained hi Section 1261(f)(1)(A) or has been so de fined by regulation under 15 U.S.C. 11262(a). From our examina tion of the statutory structure, it appears that the Commission may proceed against a substance by regulation pursuant to its rulemaking authority, or may go directly to court upon its allegation that the goods or substances meet the statutory definition under Section 1261(q)(l)(A). W# agree with the district court that where the Commission elects to follow the letter courts in a Section 1265 proceeding, the issue of whether TRIS-treated children's sleep* wear is, in fact, a "banned hazardous substance* is a question to he later determined in a hearing on the merits in the condemna tion proceeding.*** The CFSC continues to enforce the FHSA'a "ban" against TRIS-treated garments, but it has not engaged in rulemaking to extend that "ban" to unfinished fabric. The agency thus has never confronted squarely the scientific issue raised by its May 1, 1977 announcement;-the extent of the risk posed by TRIS in children's garments remains a matter of conjecture.*** The different, and pro- ** Id. t 12 (emphasis edded>. lUs statamant both acknowledges tbs Coamluion'B pri mary juriadictios to dadara a substance or produce banned through a formal administrative proceeding and confirms that If the agency instead proceed! to enforce the atatutory prohi bition of section 2(q}(l)(A>, the Issue of whether several articles poee a hesard will be for the court to dedde la the first instance. Cf. United States v. Tuteg Pharmaceuticals, lac* 602 F.2d 1387 (10th CLr. 1979) (FDA may find that a new drug requires a new drug applica tion with or without in edaimatrative teeoid). ** On June 4, 1981, the Subcommittee oa Oversight and Investigations of the Keuae Committee on Interstate and Foreign Commerce released a study prepared by the Cemmiaainn on the risk paeed by TRIS-treated children'* pajanaa. The study found, Brit, that THIS can be absorbed through the akin, and, second, that rewashing of treated garmeate does not remove all of the chtmicaL According to prase accounts, the study concluded that "the risk of contracting cancer from wearing children's pajamas treated with TRIS is seven rimes greater than previously thought" (19611 5 Ctcnt Rw. Rep. (BNA) 300. This estimate ha* not been subjected to challange In eny public proceeding or reviewed by independent scientists. The primary atudlaa include Nicholson, Cast Study l; Mbsttos--Th* TLV Approach, 271 N.Y. Acad. Set 162 (1976); Selikoff, Hammond A Chivy. Canbtoftnicity of Amotite 1332 Virginia Law Review [VoL 67:1261 sumably lesser, risk associated with the unfinished fabric that the agency later sought to regulate also remains unexplored. The use of THIS in producing flame retardant fabric has, however, long since ceased. D. Patching Compounds and Emberizing Materials Containing Asbestos Evidence has been accumulating since the 1920*s that asbestos can produce serious chronic adverse effects in humans, including lung cancer; most of this evidence has come from studies of work ers exposed to asbestos on the job.**4 By 1976, FDA, EPA, and OSHA had initiated regulation of exposures within their respective jurisdictions,*** In July of that year, the NRDC*** petitioned the CPSC to ban wall-board patching compounds containing asbestos as "hazard ous" under the FHSA. The next year, the Commission received a consumer complaint*** about the potential health hazards of asbes tos used in artificial emberizing compounds, materials used on arti ficial logs and fireplace floors to simulate live embers and ashes.*** The CPSC responded by publishing a proposal to ban both patch ing compounds and artificial emberizing materials containing re spirable asbestos.*** The Commission relied on section 8 of the CPS Act,*** and it justified its preference for the CPS Act on two grounds. First, the agency argued that rulemaking under the CPS Act would be more expeditious and less costly than under the FHSA; Second, it contended that the informality of the process Aabtttot, 25 Ascx. Emv. Kcaltw IBS <1972); Selfltoff, Hammond & Seidmin, Canter Ruk of Inaulotion Worktrt in tht United State*. Lvtwnational Acomcv ton Resiaxch on Canckk 209 (1973). S*t ftntnily M. Skapo. A Nation or Cvwsa Ptoe 191-217 (1979). ** The advene effect* attributable to aebeetoe expoaure tadude (1) aebeetoaie, oonxnaligaaat scarring of tht lunge; (2) bronchogenic carcinoma, a malignancy of the inte rior of the lung; (3) smoththorns, e dlfftiee malignancy of the lining of the dint cavity or of the lining of the abdomen; sod (4) cancer of the stomach, colon, and rectum, 42 Fed. Reg. 38,783, 38,784 (1977). " St* 38 Fed. Reg. 27,078 (1973) (FDA proposal): 40 Fed. Reg. 1,379 (1974) (EPA propo sal); 40 Fed. Reg. 47,652 (1975) (OSHA proposal). -- 42 Fed. Reg. 38,731, 33,783 (1977). *** Id. The EOF later supported the consumer complaint. "* id. "* Id. at 38.783, 38.790-91 (codified at 16 CJ.R. J| 1304-1305 (1980)). * Id. at 38,782. 1981] Cancer Risks 1333 would facilitate public participation.**' The proposal's summary of the evidence of the health hazards of asbestos noted that moat available human data concerned exposure in the workplace. The agency added, however, that advene effects had been observed in individuals--notably families of work ers--who did not themselves handle asbestos.*** Furthermore, it stated that "[a]U commercially available forms of asbestos which have been tested are carcinogenic in mice, rata, hamsters, and rab bits."*** The hazard appeared dependent on the likelihood of in halation and thus was a function of the form of asbestos. The agency acknowledged that evidence of chronic risk associ ated with short-term exposure to asbestos was limited,*** end it conceded that "faluantitatlve dose-response relationships between asbestos inhalation and related disease have not been determined for animals or humans , . . "*** Still, the Commission noted that laboratory rats exposed once to respirable asbestoe for as short a period as seven hours developed tumors, including mesothe liomas.*** In addition, studies of industrial employees who did not work with asbestos, but who were exposed intermittently on the job site, revealed a heightened risk of mesothelioma.**' Moreover, "evidence has indicated that asbestos also acta as a lung carcinogen at levels much below those which will produce asbestosis."*** The Commission assessed consumer exposure to asbestos as JoIIowk v Reports of the hazard*' or potentiaHor hazard, from exposure to asbestos resulting froa'uas of asbestos-containing consume; prod ucts are vary Hmit--*- The only known quantitative study of asbes tos levels in products regulated fay this Commission [concerned] as bestos fiber concentrations measured during the use of consumer padding patching and taping compounds. Thia study indicated that airborne fiber concentrations, exceeding the interim OSHA al lowable excursion exposure level, were detected during application Id. at 38,783. * Id. at 38,784-85. *** Id. t 38,784 (dtatfoa omitted). " Id at 38,785-88. * Id st 38,784. Id t 38,785. Id at 38,78548. " Id at 38,786. 1334 Virginia Law Review [VoL 67:1201 and cleanup operations. Fibers wars detected in adjacent rooms during mixing operations and it was reported that ["]* * 9 signifi cant concentrations of asbestos remained suspended and could per vade living quarter* for a considerable duration of time ***** The authors suggest that tbs us# of speckling and other patching com pounds (in mixing, and sanding and cleanup operations) may ex pose the user end other members of the household to "* * sig nificant concentrations of asbestos.*** Asbestos in the household presents s great risk due to the pres ence in the household of persons, such as children, who may be particularly vulnerable to carcinogens. It is generally observed that, because of the long latency period, exposure to inbalable asbestos in the some (sic) can be life-shortening for children. . . . The Commission concludes that exposure to asbestos from either patching compounds or artificial emberizing materials presents an unreasonable risk of injury sufficient that either product standing alone should be banned. The Commission also notes that consum ers are exposed to asbestos from sources other than the products proposed for banning. . . . Consumem who are exposed to asbestos fibers from artificial embers and ash and patching compounds thus receive additional doses of asbestos end can be presumed to face a greater risk than members of the population who are not so ex posed, and a greater cumulative risk than if no asbestos were pre sent in the general environment.*"* The agency concluded that a "no effect** level for asbestos had not been demonstrated. Although a threshold dose may exist for some individuals, "other individuals may have cancer induced by doses so low as to be effectively 2*ro The Commission focused specifically on the risk associated with asbestos in patching compounds: la assessing the degree and nature of the risk of injury to con sumers, the Commission has reviewed experimental data and human experience information. In addition, on the basis of data by Rohl, et aL . . ., the Commission** Health Sciences staff has calcu lated an aMesement of the risk of consumer exposure which is available at the Office of the Secretary. The calculations are based on the application of a theoretical model ... to epidemiological data cited in the literature. . . . For purposes of this assessment. *** Id. (citation emitted). * Id. (eitatioa omitted). Tbo proportion that no doae of a oaremofoa oaa bo eootMorod nfi doM not dntinyuiih aatoatoa. Sn. RLG documtne, tupra not# 195. 1981] Cancer Risks 1335 the Commission considered the use of patching compounds by a consumer, for six hours a day four times a year, to be a high yet reasonably foreseeable yearly exposure. The increased risk of death from respiratory cancer induced by this yearly exposure is esti mated at between 10 and 2,000 per million. For five years of exposura at these levels, the risk increases geometrically and is esti mated at between 1,000 end 12,000 per million. Based on current information, the Commission estimates that the lower estimate of 10 per million is closer to the actual risk for a one year exposure. Nevertheless, in view of the seriousness of the injury and the cu mulative effects of asbestos exposure, even this minimum figure represents an unacceptable risk. The Commission believes that re ducing exposure to respirable free-form asbestos in the home rep resents a substantial decrease in risk to consumers, since, for many people, the major exposure to inhalable asbestos is in the home.4*1 In addressing the availability of substitute materials, the agency conceded that asbestos possessed unique qualities such as strength, pliability, and temperature resistance. Alternatives had not been found for all products, and the substitution of more costly materi als could lead to ten to fifteen percent higher prices.401 But the Commission noted that "(m]any producers are . . . either pres ently marketing asbestos-free materials or expect to in the near future."49* In short, consumers would have asbestos-free patching compounds, but at higher prices.404 The Commission purported to consider the commercial impact and the relative health effects of various possible effective dates of. a ban--ranging from 30 to' 360 days after promulgation. It con cluded that the manufacture, sale, importation, and distribution of patching compounds containing asbestos should be prohibited thirty days after publication of a final rule.401 This choice of date would have forced the recall of some products. The CPSC'a analysis of artificial embermng materials was more condusory. The Commission made no attempt to quantify the risk posed by these products.404 The agency identified three substitutes* *** *** 42 Fed. Ref. 38,781, 38,787 (19TT) (citations omitted). -- Id -- Id ** Id * Id st 38,788. *** Tbs proposal listed: Messursasats sre not available of the amount* of asbestos ta the air from aibea- 1336 Virginia Law Review [VoL 67:1261 for asbestos already in use, but noted that at least one was more expensive and that another was a leas realistic mimic of the " `glowing' look** of real ashes.4** With this cursory explanation, the agency proposed that its ban taka effect Immediately upon publi cation of a final ban.40* The agency's treatment barely concealed its disdain for the consumer demand satisfied by this group of products. In the final section of its proposal, the Commission concluded that it could legitimately tingle out and ban individual ingredients or kinds of products. The agency cited its similar action banning unstable refuse bins,40* and then explained: The Commission believes that not all patching, compounds pre sent an unreasonable risk of injury to the public, only patching compounds containing respirable free-form asbestos. The hazard associated with thia product is the free form in which the asbestos appears. While a safe patching compound can be manufactured, it is sot possible to manufacture a safe patching compound contain ing respirable free-form asbestos because a safe level of exposure to free-form asbestos is unknown. Therefore, it does not appear that a standard for patching compounds containing respirable free-form asbestos is feasible at this time.41* On August 15,1977, the CPSC conducted the hearing required411 to afford interested persons an opportunity to express their views. Seven witnesses appeared at the one-day hearing, four of whom represented manufacturing interests and three of whom spoke for consumers. In addition, the Commission received thirty written comments on it* proposal^ of which ten (including,those of five- toe-containing embertting material* la boat*. However, H appear* that til* amount of airbora* aibesto* la auch horn** would locrtaa* whan dr current* is tb* boa* *r* created by downdraft* from * fireplace chimney or other activities that stir air la any room. Since emberistaf material* may contain up to 80 percent asbestos, which if not permanently bound into artificial fireplace log* would be la respirable form, the risk associated with mb*rizfny materials to considerable since it continue# to exist 24 hours a day. Id. Id. ** Id. Id. at 38,789 (citing 43 Fed. Re*. 30.29S (19T7. 4W " Section 9(a)(2) of the CPS Act, IS U.S.C. J 2058(a)(2) (Supp. HI 1979), requires the Commission to give interested persona an opportunity to present thsir view* before it promulgates a nils. 1981] Cancer Risks 1337 manufacturers) supported the agency's contemplated ban.41* The low level of interest in the agency's proposal probably reflected the slight importance of the products and the relative ease with which manufacturers of patching compounds found adequate substitutes. The Commission published its final banning regulation and its response to comments on December 15,1977.4U In a separate doc ument, the agency determined formally, in accordance with section 30(d) of the CPS Act,414 that It was in the public interest for the agency to regulate the two products under the CPS Act rather than the FHSA.41* It noted that "several persons in the marketing chain commented approvingly on the decision to regulate under the [CPS Act] because the [CPS Act] does not require repurchase of banned hazardous products."4'* For the same reason, unidenti fied "consumer-oriented interests" disputed the agency's failure to invoke the mandatory repurchase requirement of the FHSA. The Commission held to its initial view, concluding that prompt issu ance of a final ban outweighed any need for repurchase.41* The preamble to the final rule addressed several comments that focused on the scope and implementation of the ban.41* Opposition to the agency's decision focused primarily on deficiencies in its risk analysis and on its rather perfunctory assessment of economic ef fects. The agency adhered to Its conclusion that the emberizing materials should be banned immediately,41* but it set two effective dates for consumer patching compounds in an attempt to soften --the-economic effects of.its ban.4^ Several, comments .questioned whether exposure to the levels of asbestos found in the banned products presented a serious health risk. The Commission ac knowledged its reliance on the occupational evidence,4*1 but in sisted that it was relevant to the consumer contest. The agency again cited one report that documented significant levels of respir able asbestos in rooms adjacent to those in which patching com- *u 42 Ftd. Rtf. 63,334, 63,333 (127?) (document no. 2). Id. 15 U.S.C. ) 2078(d) (1976). 42 Ftd. Rtf. 63434 (1977) (document no. 1). Id. *" Id. 4M 42 Ftd. Rtf. 63454, 63455-60 (1977) (document no. 2). * Id. it 63438. Id. at 63457-58. Id. at 63438. i AP00017I26 1338 Virginia Law Review tVoL 67:1261 pounds were being used/** and it speculated--without providing supporting data--that where background levels of asbestos were low, "exposure in the home to asbestos fibers released from consumer products could represent the major exposure."4** Comments specifically challenged the Commission's risk esti mate for the patching compounds. One commentor submitted a study involving an actual product that contained much less asbes tos than those hypothesized in the agency's risk assessment. The accompanying analysis estimated the risk associated with five year's exposure to be as low as one lifetime excess cancer death per million population. The agency responded that "while asbestos levels may vary, they do not change the fact that there is no known level below which inhalable asbestos may be considered safe."414 It discounted any differences in asbestos exposure between com pounds mixed by the consumer and those sold in premixed form,41* and argued that "no data were submitted" to show that its own exposure estimate was inflated.41* The Commission did not stand squarely behind its original risk assessment, but it did decline to conclude that the risk from patching compounds was insignifi cant4*1 Although the Commission agreed that further study of the many possible substitutes for asbestos was needed, it insisted that "the known risk from inhalable asbestos requires the banning of these products at this time."4** The CFSC also answered criticisms of its original estimate of the* ** ** * Id. ** id. w Id. at 63^59. ** Id. ** Id. The Commission's estimate assumed expoaura for four day*. eight hours a day. Id. ** Id. at 63,36041. Tha Commission uaad the statutory characterization "unreaionsble" to describe tha risk Tha Implication was that. Ca tha context, any risk of cancar was "unreaunable" la light of tha recant Suprema Court ruling on benzene, requiring that a risk of cancar ba "significant" bafort OSHA caa restrict worker expoaura, ate Industrial Union Dep't, A7L*CI0 v. American Petroleum Inst* 448 U.S. 607 (I960), any coacaeelcn that tha risk was remote could have undermined the CPSC't regulatory authority. " 42 Fad. Ref. 63,354, 63,359 (1977) (document bo. 2}. The Commission stated: Tor tha fibrous day minerals which may ba usad is asbestos eubetltutaa luch as wollaetonita. kaoUnite, sepiolite and bentonite, the Commission la aware that there la a lack of conclusive date on the hazard potential associated with theea minerals. Addi tional etudy is needed to evaluate tha risk of inhalation exposure to such small min eral fibers. Nevertheless, tha Commission believes that tha known risk from inhalabl* aibestoe requires the banning of these produett at this tin*. Id. 1981] Cancer Risks 1339 han't economic effects. The agency acknowledged that some small manufacturers might be unable to afford to reformulate, that the initial expense of reformulation could add as much as twenty-five percent to the product costs, and that the reformulated products would not perform aa well aa those made with asbestos.41* The Commission again provided no detailed discussion of economic ef fects, however, and made no quantitative comparison of the eco nomic costs and the health benefits.41* The CPSC's ban became effective as scheduled. No petition for judicial review was filed. Because the agency scheduled the ban to minimize its effect on current inventories, no manufacturer of patching compounds or embeming materials remained interested in using asbestos as an ingredient in these products.. E. Consumer Products Containing Benzene Concern about the health effects of benzene, which has led EPA and OSHA, as well as the CPSC, to regulate human exposure within their jurisdictions, has likewise been triggered by occupa tional evidence.411 The CPSC relied heavily on the work of these other agencies in its efforts to eliminate the use of benzene as an ingredient in consumer products, such as paints, paint removers. *** Tfa* report observed: As to indicated in the proposal. the Cocuniuion to awere that economic impact* of varying degreee wiU occur a* a reault of the ban on inhalable ubcatoa containing (etc) patching compound* and unberisfng material* containing respirable free-for tabestoe. Also, the Commission is awr that technology for producing asbestos-free patch, tug-compound formulations la becoming moia generally available. The economic im pact dl tend to be reduced over time as noa-aibestoe formulation technology becomes more widespread and a* slitting recent formulations are improved by manufacturer*. Id. at 63,360. The Commiaeion concluded its report with the finding required by the etatuta: "la determining that the risk of cancers to unreasonable, the Commission concludes that the degree and nature of the risk of injury and the probability that the risk will result in harm outweigh* the rules' effect on the products' utility, coet and availability to the consumer." Id. at 63,361. <*' Concern about the health effects of benzene hae focused primarily on occupational exposures. Even before the enactment of the OSH Act la 1970,29 US.C. Si 651-650 (1976 A Supp. in 1979), moat producers and industrial usere of benzene observed a voluntary stan dard designed to limit employee exposure. In late 1976, a study ef two Ohio industrial plants revealed that workers exposed to benzene exhibited a dramatically increased risk of death from leukemia. The study rekindled effort* to persuade OSHA to revise die prevailing standard. 42 Pad Reg. 22,518 (1977), AP00017128 1340 Virginia Law Review [VoL 67:1261 and rubber cements.4**** Prompted by the findings of an epidemiological study on which OSHA based an Emergency Temporary Standard sharply decrees* ing worker exposure to benzene,4** the HRG filed a petition in May 1977, requesting that the CPSC declare benzene a banned hazardous substance under the FHSA. The petition sought to re quire removal of "all products containing benzene from the mar ketplace/*4*4 In granting the petition, the CPSC relied primarily on information assembled in hearings on OSHA*a proposed perma nent standard for benzene and on exposure data assembled by its staff from the scientific literature.4** Hie agency chose to act under section 8 of the CPS Act rather than under the FHSA,4** again observing that the newer law provided for informal rulemak ing that permitted speedier action and facilitated public participa tion. The agency also noted that a ban under the CPS Act would not automatically require manufacturers to repurchase products already distributed.4** The Commission proposed a rule that would (1) ban benzene as an intentional ingredient In all consumer products except gasoline and laboratory chemicals and (2) baa all consumer products con taining benzene as a contaminant at levels of 0.1% or higher.4** The agency's preamble underscored OSHA's earlier actions,4** and EPA's recent decision to list benzene as a hazardous air pollu tant.44* Although acknowledging that benzene produced acute health effects, the agency made clear that ita proposal was a re sponse to the chemical's chronic effects, particularly evidence that occupational exposure to benzene caused leukemia.441 * 43 Fad. R*f. 21,839. 21,847 (1978) (appendix). Benxen# ta now used primarily u in intermediate In the production of other chemical*. It 1* also usad aa a component of un> leaded laaoliae, ae a tolvant and reaction agent 1b chemical bboretoriee. and in the manu facture of deterrents and peatiridee. Id. at 21,840; 42 Fed. Ref: 22,916. 22417 (1977). * $<* 42 Fed. Ref. 22.516, 22417 (1977). -- 43 Fed. Reg. 21439, 21439 (1978). Id. t 21440*41. ** Id. at 21438-39. Id. at 21438. Id. at 21,841-42. * Id. at 2144a " Id. SPA acted under $ 112 of the Clean Air Act, 42 U.S.C. | 7412 (Supp. HI 1979). Hl Although the CommiMran noted that **[t)he acuta (beta of bantene ezpoeure include drowsinasa and lota of eonsefoueneaa at hlfh doac*," 43 Fed. Rag. 21439,21,840 (1978), the chemical'* chronic health effect* prompted ite proposal. The Commierioa appended a tech- AP00017129 1981] Cancer Risks 1341 The CPSC recognized that levels of consumer exposure to ben* zene were likely to be much lower than those experienced by work ers exposed occupationally. Still, it noted that blood disorders had been observed in workers exposed "at levels reported to be as low as 10-15 ppm," and concluded "that a serious health hazard to consumers may be presented by the use of benzene-containing con sumer products.**441 The CPSC Attempted to translate this occupa tional evidence into an estimate of the risk for consumers; [T]h* Commission's Health Sciences stiff has calculated an awiratment of the leukemia risk from consumer exposure to benzene-contaming paint strippers. . . . For purposes of this assessment, the Commission considered the use of a paint stripper containing 52 percent benzene by a consumer, for 5 hours a day ten times in his life, to be e reasonably foreseeable lifetime exposure. The increased lifetime risk of death from myelogenous and monocytic leukemia induced by this exposure is estimated by the assessment at be- nicai report prepared under contract by Dr. Michael L. Freedman of New York University Medical Center, which lilted the chronic effect* of benzene under three senera! headings: "(I) pancytopenia (a decrease of all the formed elements of the blood--red cells, white cells, and plateleti); (2) chromosomal abnormalities; and (3) leukemia, particularly acuta myologe* aoui (produced (s the bone marrow) leukemia.'* Id. at 21^0. The Commission's proposal stated: In a recent study of workers ezpoeed to benzene from 1040*1949 in two Ohio plants manufacturing the product "Pliofilm," Infante . . . demonstrated a five-fold axceisive risk of death from all leukemias and a ten-fold excess of death* from myeloid and moaccytie leukemias, in' the study population compared with the number ex pected in a nan-exposed cohort. Infante stated that benzene concentrations at the two plants ranged from 0 to 10 or 15 parts per million. Thic study ce well cs other occupational studies noted in the Freedman report argue convincingly that benzene is a fcunaa leukemogen. The Commission recognizee that much of the documentation in the consultant's report concern benzene exposure in an industrial setting. However, as tha (Freedman] report indicates, in 1977 tha National Institute for Occupational Safety and Health conducted an experiment to measure the amount of benzene exposure to a person using a paint remover containing 32 percent benzene by volume .... An end table eras stripped in a horns garage having essentially no air circulation. Five sequen tial. five minute air samples from the worker's breathing zone were taken. The ben zene concentration ranged from 73 to 225 ppm with a mean of 130 ppm. In addition, the Commission notsa that values from 1971 exist for expawm levels in one man or husband-wife combination commercial paint stripping operations utilizing paint stripper* containing approximately 40 percent benzene. The breathing zone avenge atmospheric concentration of benzene ranged from 24 to 1218 ppm in 8 such establishments. Id. at 21,841 (reference numbers omitted). -* Id. 1342 Virginia Law Review (VoL 67:1261 tween 142 and 349 per million exposed. This is equivalent to a benzene-induced increased risk of be tween 16.2 percent and 37.1 percent due to the use of such paint strippers. While the Commission is not relying upon a specified percentage of increased risk in issuing this ban. the Commission believes that in view of the seriousness of the risks of injury from benzene exposure, any increased risk is unacceptable.44* The Commission thus disclaimed reliance on any quantitative assessment of the risk of benzene exposure; its position essentially was that no exposure should be accepted. It acknowledged that no more than one percent of paint strippers then in use contained benzene as an ingredient,444 but emphasized "that once the carci nogenicity of a substance has been established qualitatively, any exposure must be considered to be attended by risk when consider ing any given population, because individual susceptibility to a carcinogen varies widely."44* Because "there is no known safe level of exposure to a carcinogen,... it is appropriate that exposure to benzene be reduced to the lowest feasible level."44* The Commission's proposed ban exempted gasoline, however, because it concluded that the economic consequences of banning that use would be substantial: [Tibs Commission believes that any attempt to eliminate benzene from gasoline would have e major economic impact, necessitating thorough feasibility studies which are beyond the scope of this pro posal. In this regard the Commisaion notes that benzene is present in gasoline as a contaminant and In unleaded gasoline, as an inten tional Ingredient used to increase the octane rating. The use of benzene and its closely related aromatic distillate#, xylene and tol uene, has Increased in the past few years because the distillates are the principal substitutes for tetraethyl lead. The Commission has Information indicating that the removal of benzene from gasoline motor fuel would entail major adjustments in the petroleum refin ing industry in terms of capital equipment and performance and price and availability of gasoline as well as other petrochemicals Id, ** Id, at 21343. Id. at 21341. This conclusion may not suffice to support regulation under the CPS Act after the Supreme Court'* decision is Industrie} Union Dep't, AFL-CIO . American Petro leum Inifc, 448 U.S. 607 (1980). See notes 482-84 in/ns and accompanying text. M* 43 Fed. Reg. 21339, 21,841 (1978) (footnote omitted). AP00017131 c 1931} Car%cer Risks 1343 and has, therefor*, concluded that the use of benzene m amnwo product gasoline should not be restricted at this time.44* The Commission's proposal also exempted benzene sold for use as a laboratory solvent and reagent This decision reflected the Commission's awareness of the chemical's unique qualities, coupled with the belief that in the laboratory setting, cautionary labeling would induce the care necessary to minimize human exposure.44* The agency selected 0.1% as the mirimum permissi ble level for benzene as a contaminant because this limit was achievable by most manufacturers of petroleum products. The agency emphasized that "benzene cannot be eliminated entirely from all products . . . because of the physical properties of pe trochemical refining process. . . . [WJithout resorting to extremely expensive special techniques, these refining processes do not result in chemically pure products.*TM* The Commission's analysis of the proposed ban's impact on products containing benzene as an ingredient is illuminating. The agency identified only two such products: paint removers and rub ber cement.490 It reported that only two of the forty-nine firms manufacturing paint removers were then using benzene, and it es timated that "less than 1 percent of the paint removers currently on the market contain benzene as an intentional ingredient.'*4*1 The Commission suggested that several chemicals might be substi tuted for benzene in paint removers, although it acknowledged that the most effective was also more expensive and perhaps even *** Id. at 21342. Tb proposal alio stated; Whflt DMtt gasoline It specifically for us* with motor vthieitt tad would oppoor to ho considered "motor vehicle equipment" excluded from Coomitsioa authority undtr tht [CPS Act). . thr Commission notes that tom* gasoline i used by consumers "in or around a parmantnt or temporary household or residence, a school, la recrea tion, or othtrwfM." , . . However, line* this gasoline generally comes from the same source (i.e. the retail pumps) as motor vehicle gasoline end may be subject to refuta tion by OSHA, SPA. and/or the National Hifhway Traffic Safety Administration (NHTSA), the Commission la of the opinion that exposure to beuxsn* from gasoline la a complex interagency problem which would probably beat be resolved on an intar* agency basta rd (citation omitted). /d * Id. m Id. at 21343. c Id. :* APbddl7132 1344 Virginia Law Review [VoL 67:1261 mors hazardous,4** and therefor* invited comment on the health hazardi of possible substitutes. Similarly, the agency determined that only one of fifty-two rubber cement producers was still uag benzene as an ingredient and estimated that less than 0.1% of the rubber cements on the market contained' benzene.4** The agency also noted that sales of rubber cements had dropped sharply be- tween 1963 and 1973 as the product was displaced by other adhesives.4*4 - The CPSC thus found that only a very small percentage of two classes of products would be affected by its proposed ban on ben- zene. Although the agency speculated generally about the conse quences of a ban, there Is no evidence that it attempted to quanti- ty the economic effecU or to compare those effects with the risks associated with exposure to benzene in the two groups of products. The agency proposed that the portion of the ban directed at benzene as s contaminant should apply only to products manufac tured or imported 120 days after publication of a final order.41* This timing obviated any repurchase of products already in com- mercial channels. The Commission explained that any exposure from these products would not be high and that extending the ban "might result in a chaotic situation."4** It proposed alternative ef fective dates for products containing benzene as an ingredient. Under the first, the ban would apply to products manufactured or imported sixty or more days after publication; no recall or repur chase would be required. Perhaps concerned that this schedule might appear to trivialize the risk, the agency offered an alterna tive that would ban products initially introduced into commerce fifteen days after publication of its final order and that would ban the sale of the products thirty days after publication, no matter when they were introduced into commerce. The agency stressed that this alternative would not have "major economic impact," be cause so few companies were using benzene as an ingredient,4** but it did not advert to the relationship between the extent of use and the degree of human risk. "* Id. at 21,843-44. The substitute wss mathylin* chloride. "* Id. at 2143. *** Id, m Id. at 21.844. Id. ** Id. i | ! j j ! i ) i AP00017133 L 1981] Cancer Risks 1345 Three years after publishing the proposed ban, the CPSC pro posed to withdraw it.4** After its initial proposal, the agency on several occasions extended the time for completing the rulemaking process.4** Few products would have been affected by the ban as originally proposed. By 1980, the agency believed that no products were being manufactured containing benzene as an Intentional in gredient and that only four classes of products--stove and lantern fuels, brush cleaners, lacquer thinners, and rubber ce ments--contained benzene as an impurity at a Isvel higher 0.1%. None of these contained over 0.25% benzene.4** Agency staff members accordingly questioned the need for a final ban.4*1 Their reservations were strengthened by the Supreme Court's derision in Industrial Union Department, AFL-CIO v. American Petroleum Institute,*** overturning OSHA's permanent standard for benzene on the ground that OSHA had failed to show that worker exposure to ten ppm benzene posed a "significant" risk. CPSC staff mem bers understandably questioned whether the agency could legally sustain a ban on even lower exposures, particularly whan its own proposal had relied almost entirely on the epidemiological evidence assembled by OSHA. The plurality opinion in American Petroleum Institute faulted OSHA'b failure to document the probable advene, health effects of benzene exposure at ten ppm, the prevailing Labor Department standard. One estimate of the risk, submitted on behalf of the American Petroleum Institute during OSHA's rulemaking proceed ing, predicted a maximum of two cases of cancer among exposed workers each six years.44* It was partially OSHA's failure to re spond to this submission on the merits--by demonstrating its in accuracies or by characterizing the estimated risk as "signifi cant*--that led the Court to set aside its standard. " 48 Fed. Rtf. 3,034 (1981). 5m, *. 44 Fed. R*f. 22,499 (1979); 43 Fed. Ra* 47,197 (1978); 43 Fad. Ref. 21338 (1978). 46 Fad. Re*. 3,034, 3,038 (1981). ** The tfancy haa considered staff proposals that it eoatnet for a study of bumaa axp^ aura to benzene from currant and fonsar usaa, as wall as tuftastiona that it adopt a rula, under section 27(b) of the CPS Act, that would require manufacturer! to notify the agency if they subsequently decided to add benzene to consumer products. Krulmch Interview, Mupn note 38. ^ 448 UA 607 (1980). C "* Id. at 853-64. * AP00017134 1346 Virginia Law Review [VoL 67:1261 In insisting that OSHA can regulate only "significant" risks. Justice Stevens's plurality opinion relied on language in the OSH Act defining an occupational health standard as one "reasonably nec essary or appropriate to provide safe or healthful employment . . . ,"4** The similarity of this language to section 9(c) of the CPS Act, a provision that expressly limits the Commission's authority rather than defines other terms in the law, suggests that the CPSC likewise is obligated to demonstrate the "significance" of any risk it attempts to regulate. F. Hairdryers Containing Asbestos The CPSC successfully effected the removal of hairdryers con taining asbestos from the consumer market without any formal ad ministrative proceedings or any systematic assessment of the health risks or economic costs. As in other cases, the Commission acted under heavy public pressure generated by press reports of a health hazard. In July 1973, representatives of WRC, a Washington, D.C., tele vision station, sought information from the CPSC about the preva lence of asbestos insulation is hand-held hairdryers. The agency responded by making available a consultant's study that estimated the levels of asbestos , in all consumer , products.4** This "Kearney Report" stated that although asbestos had once been used in sev eral brands of hand-held hairdryers, only one manufacturer was currently using the material.4** The Report further surmised that the asbestos in hairdryers could present a consumer health hazard only if the products malfunctioned. In January 1979, a CPSC scientist circulated within the agency a memorandum confirming the presence of asbestos in a number of current brands of hand-held hairdryers and posed questions about potential human exposure.4*' The memorandum recommended that the agency undertake tests to determine whether the asbestos was discharged when the hairdryers were used. Apparently, no for- ** 29 U.S.C. i 662(8) (1978) (nphasie added). *** A.T. Kearney, Ire., Review of Asbestce Uit in Consumer Product* (April 1979) (un* published report cited t 44 Fed. Ref. 60,087, 60,088 (1979)). 4M CPSC Omcc or Bu&cir, Pxogkam PtANNmG & Evaluation, Rxvmr or Commission Actions on Asssstos in Kais Daren* 3 (June 27. 1979) [hereinafter cited as Walton Rs> font] {copy on file with the Virginia Law Review Association). *** Fausett Interview, supra note 32. c 1981] Cancer Risks 1347 mal action was taken in response to this memorandum, although CPSC Chairman King later testified before Congress that the de lay waa attributable partly to government contracting proce dures.*** As late as March 1979, the public record revealed no evi dence that the Commission was concerned about the problem. On March 28,1979, WRC ran a news story describing Its earlier inquiry and reporting the results of laboratory tests for which it had contracted.4** The tests found that after two hours of continu ous use, all six models of hairdryers tested released some quantity of asbestos. The older models released considerably more asbestos than newer products.47* WRC bad provided the Commission with a copy of the laboratory's report four days earlier.471 Very soon thereafter, the agency arranged with the National Bureau of Stan dards to perform tests on at least two models of hairdryers to ver ify whether those containing asbestos could discharge the.material in normal use.*" On March 29, 1979, the EOF petitioned the agency to act under section 15 of the CPS Act to declare hairdryers containing asbestos a "substantial product hazard'* and to order repurchase of hairdry ers already in consumer hands.*7* Acting under sections 5 and 27(b)(1) of the CPS Act, the agency ordered nine manufacturers and four retailers to proride information about the use of asbestos in their products.*4* These special orders required responses'within ten days; they also requested that the companies submit informa tion respecting any testing they had performed to determine the potential for asbestos discharge or the health hazard of discharged asbestos. The Commission accompanied these special orders with requests that representatives of each of the firms attend a meeting with the agency's staff on April 5,1979.*" Fearing adverse public ity, J.C. Penney and Montgomery Ward promptly announced that " PouiblM Throat to ths Contumar Postd by Emission of Asbestos from Certain HandHeld EUetrie Hair Drysm Hearings Before the Subcamm. for Consumer* of the Sonata Comm, on Commons, Seienee and Transportation, 96th Coot, lie San. 30 (1979> Utata- jovnt of Sums Kiel). "Id.*t 25. m Id. at 3-14. <n Id. it 26. Id. *** Id. at 6 (itatvment trf Laa Thonpaon). *** Id. at 2 (sUttmeat of Sumh Kiny). 4W Id. at 26-27. APOOOt 7156 1348 Virginia Law Review [VoL 67:1261 they were voluntarily removing hairdryer* containing asbestos from their stores and expressed a willingness to reimburse custom ers who returned hairdryers containing the material Both E.J. Korvette and Sean also expressed their willingness to repurchase hairdryers that contained asbestos from consumers who desired to return them, but at that point declined to withdraw these hairdry ers from their stores.4*9 Hours after the issuance of the' special orders, the CPSC ar ranged with the National Institute for Occupational Safety and Health (NIOSH) to teat fifty models of hand-held hairdryers to determine whether they could discharge asbestos and to estimate the quantity of asbestos discharged into the atmosphere by each use.4" The agency expected to have results from those tests within thirty days,499 but it was not until several months later that NI OSH reported its teat results to the Commission.47* On April 2, CPSC Chairman King and General Counsel Krulwich appeared before the Senate Subcommittee for Consum ers. They testified that they regarded section 15 of the CPS Act as the most likely basis for any CPSC regulatory action.4" Krulwich emphasized the Commission's need to identify all of the manufac turers currently marketing hairdryers containing asbestos before publicizing brand and model information to consumers.4"1 Their testimony implied that if large numbers of hairdryers were found to contain asbestos, the Commission would order use of the mate rial stopped and would recall outstanding products if manufactur ers and retailers did not voluntarily agree to a corrective action plan.4** m Id. at 6*T (rUtement ot Lea Thompson). m Id. at 27 (statement of Sums King). /<. *** This daisy was caused by diffleultise ia dawloping an appropriate teat protocol. Walton Rvovr, supra note 466. Id. ** Sactioa 6 of tha CPS Act restrains tha Commission from publicizing produet hazard Information before it has verified its accuracy and afforded affactad manufacturers an op. portunity to comment on it St* CPSC . GTE Sylvania,.44? U& 102 (1960), holding that | 6 applies to raapoaseo to Freedom of Information Act request* as wall as to affirmative disclosures by tha agoncy, thus limiting its ability to provide information to tha public. Con* gram vary recently amended tha CPS Act to restrict avaa Author tha Commission's author ity to r#Iea product-rotated data. Consumer Product Safety Amendments of 1981, Pub. I* No.____ | 1204.___Stat.___ (amending 18 U.9.C. I 2055 (1978)). "* Krulwich Interview, supra note 36. 1981] Cancer Risks 1349 At a public meeting with the agency's compliance staff, the hair dryer manufacturers and retailers made dear their general willingness to effect a marketplace recall of hairdryers containing asbestos and to repurchase hairdryers from consumers. The repre sentatives seemed eager to achieve a voluntary resolution of the problem, rather than face formal proceedings under the CPS Act4** In conformity with agreements negotiated following this meeting, the CPSC's Directorate of Compliance and Enforcement Issued preliminary determinations of substantial product hazard under section 15 of the CPS Act to all slaves manufacturers and retailers that had attended the meeting.4*4 The agency received formal, voluntary agreements for corrective action from all eleven firms, which reportedly accounted for ninety percent of the hair dryers containing asbestos then in consumer hands or in commer cial channels.4** The Commission also issued a list of brands of hairdryers containing asbestos, based upon information supplied at the meeting with the manufacturers and retailers.4** It is unclear whether the CPSC ever systematically considered whether the risk posed by hairdryers in consumer hands was great enough to warrant the cost of recall and repurchase. The agency certainly did not then conduct, nor arrange for anyone else to con duct, a quantitative assessment of the risk posed by continued use of hairdryers already purchased. Tha alacrity with which the man ufacturers and retailers agreed to repurchase deflated interest In such an assessment. The agency also did not disclose whether it had considered the possibility that manufacturers might resort to substitutes for asbestos that might pose health hazards themselves, including an increased risk of fire. The Commission appears simply to have concluded that asbestos, a known human carcinogen, was present in, and likely to be discharged in some quantities by, the hairdryers. By late summer 1979, tha CPSC had concluded recall agree ments with all major distributors of hairdryers containing asbestos. The agency waa thus able effectively to "ban" such products from commerce without initiating formal proceedings, but it.was not en- -- Id. -* id. ** id. *" Fkh nluiN w*r* inuad April 6, April 17, ud May 3,1979. St* id. 1350 Virginia Law Review fVoL 67:1261 tirely successful in terminating human exposure to the products. A recent evaluation of recalls as a regulatory device reported that, notwithstanding the public awareness of the hairdryer episode and the Commission's efforts to notify users, only twenty percent of all units covered by recall agreements were ever returned by consumers.4** The hairdryer episode convinced many CPSC staff members that the agency could regulate products effectively without pro tracted administrative proceedings or procedural missteps. The agency's success strengthened the position of officials who believed that regulation of chronic hazards should play a larger role.4** The episode also caused the Commissioners to order a staff study eval uating and recommending changes in its internal procedures.4** The resulting study concluded that the Commission had acted only after WRC had broadcast the results of its own investigative reporting.4** Staff members were chagrined that the agency had missed an opportunity to act before events made it appear that once again it was responding only under pressure. The staff study found a need to improve communication between agency compo nents and criticized the CPSC's difficulty in arranging tasts to de termine the kinds and quantities of asbestos emitted from the hairdryers.4*1 The study also stressed the importance of early eval uation- of. regulatory options, by'the Commissioners. Apparently, agency staff members had considered using section 15 long before the television reports galvanized the agency into action, but this approach had not been discussed at the Commission level.49* Thus, there was considerable uncertainty about what facta were impor tant as well as what procedures the agency should follow: [T]he existing procedures do not provide an adequate framework for reaching e decision relative to what further information is necessary, obtaining the information and bringing it before the Commission for a quick decision. The question of which regulatory ** Product Recalls; Do Thajr Work, CFA N*ws, February, 199ft. *** Ob* result of this txpsrtaoc* has bsaa the establishment by tho Commission of a small asbestos testing laboratory sc NIOSH's facilities la Cincinnati. Krulwich Interview, supra not* 3& ** S# Walton Retort, supra not* 469. ** Id. at 4. Id. at 5-8. -- Id. at 7-9. APOOOf 7139 1981] Cancer Risk* 1351 option to pursue is a recurring on*, with significant policy implica tions. Goners! guidelines would not be helpful because each case usually has unique set of circumstances. Procedures are needed to assure that in important cases this issue is raised to the AED'e and Executive Director for a full assessment by the staff and General Counsel, and presented quickly to the Commission for decision/** G. Pending GPSG Actions 1. Asbestos In October 1979, the CPSC announced a cooperative effort with EPA to reduce public exposure to asbestos. In concurrent Advance Notices of Proposed Rulemakings (ANPRa), the two agencies stated their intentions to regulate sources of asbestos exposure within their respective jurisdictions. Their snnounced objectives were to exchange information and to avoid duplicative regulations.4** The CPSC'e notice asserted three reasons why consumer prod ucts that release asbestos pose unique problems. First, products used in a household setting subject young children and infants to exposure. Second, asbestos fibers released into living quarters can pose a continuing risk by remaining in a confined space and set tling and resuspending in the air, rather then dispersing into the general environment, finally,1 unlike- moist workers exposed on* the job, household members have little protection from asbestos fibers released from consumer products.40* In this notice, the Commission set a huge task for itself. Drawing primarily on the Kearney Report, the agency listed ninety-six cater gories of consumer products containing asbestos.4** Even though many of these categories may be found to pose no health risk or to fall outside the Commission's jurisdiction, the investigation neces sary to make these judgments may prove difficult. To assemble the data needed to determine whether regulatory action may be neces sary, the CPSC intends to require that manufacturers submit in- -- Id. at 8*9, 44 Fad FUg 60,056 (1970). 44 F*& Rtf. 60,057, 60,067 (2979). " Id. at 60,060-61. 13S2 Virginia Law Review [VoL 67:1281 formation on the uw of asbestos in specified consumer products.4** The ANPR sets forth six criteria for ranking the products to be investigated: (1) the number of units of the product estimated to be in use by consumers; (2) the form end location of the asbestos in the product; (3) the frequency, duration, manner, and location in the con' Sumer's environment of product use, including such factors as the expected useful life of the product and the presence of heat and/or moisture end the likelihood of abrasion during use or fbneeable misuse; (4) the likely availability and feasibility of substitutes for asbestos in the product; (3) the relative ease of data collection and analysis by the Commission and the reporting burden on industry; and (6) the degree of potential overlap of CPSC reporting require' meats with the information gathering efforts of other regulatory agendas, particularly the Environmental Protection Agency.4** In describing the possible regulatory responses to the discovery that a consumer product posee a risk of. asbestos exposure, the ANPR lists virtually every weapon in the agency's regulatory arsenal.*** The CPSC's current approach to asbestos has two distinctive features. First, the Commission proposes initially to focus on, and ban, all "aosuMntial" usee of asbestos in consumer products. The agency stated that any action to eliminate nonessential uses would rely simply on the fact of asbestos fiber emission rather than on any quantitative assessment of risk.*** The Commission noted that in prior cases, after considering the effects on the utility, availabil ity, and costof products, it had approved regulatory'action when' there was aiT "absence of compelling evidence of unacceptable so cial or economic costs associated with removal of asbestos from the This would be den* pursuant to 12? of the CPS Act; 19 U&C. f SOTS (1976 4 Supp. m 1979). ** 44 Fed. Reg, 60,067, 60,OSS (1979). * Id. at 60,059. Although the Comnisalon referred to its pewere under both the CPS Act and the FHSA, it did not mention the possibility of s ban against products posing a risk of exposure to children pursuant to f 2(q)(l)(A> of the FHSA--tbs weapon It attempted to us* gainst TRIS-treated garments. ** Id. at 60,0549. There Is considerable doubt, after the Supreme Court's benzene rul. tag; whether this approach is sustainable. See notaa 462.84 supra and accompanying text. Moreover, It conflicts directly with the regulatory approach announced the same day by EPA, which eontampiatas the usa of quantitative risk assessment; 44 Fed. Reg. 60,061, 60,063 (1979). 1981} Cancer Rieka 1353 product.*"*1 Accordingly, It concluded that the extent of risk would be sufficient to justify action once any release of asbestos is found during reasonably foreseeable use or misuse of a consumer product. Only unacceptable social or economic costs would justify a differ* ent response.*** The Commission said that it would consider a number of factors when deciding whether a particular use of asbes tos is subject to its proposed "generic ban**: "the function per formed by the asbestos in the product, the benefit derived from the use of asbestos in the product; and the availability and cost of substitutes for the asbestos; end the safety of such substitutes.***** The second novel feature of the CPSC's asbestos notice is the agency's announced intention to regulate categories of products that share a similar use of asbestos as a component. The agency's regulatory options include action to reduce consumer exposure against any product at the site where asbestos is released or regula tion of a category of products that releases asbestos, in addition to the more traditional product-by-product approach.**4 The ANPR reveals several unresolved issues in the CPSC's cur rent approach to asbestos. The agency requested comment on whether its list of consumer products possibly containing asbestoe was complete. It also invited comment on whether its focus on nonessentiai uses of asbestos was sound; on what constitutes an essential use of asbestos in consumer products; on whether the emission of asbestos, without more, should be sufficient to trigger : action against a nonessential use; and on whether "generic** regula' tion is legally supportable or advantageous. The CPSC has taken additional steps related to regulation of asbestos exposure since publication of the ANPR. First, it cospon sored with EPA a public "Workshop on Substitutes for Asbestos1* to gather information on the potential health hazards of products containing asbestos and of substitutes for asbestos.*** Second, the CPSC approved a general order requiring 1,200 manufacturers to * 44 Fed. Iter* 60.057. 60.058 (1979). Id at 60,058-59. Id at 60.059. ** Id. ** 45 Fad. R#f. 35,414 (1980). Th* workshop* vara to iacludt talks on technical, eco nomic, and regulatory aspect* of asbestos substitutes and th* difficulty of substitution, s rsvtew of approximately 10 categorise of asbestos products, and meeting* on the health im plications of potential altareathm to asbestos. Id. 1354 Virginia Law Review [VoL 67:1261 submit information concerning the use of asbestos in certain con sumer products.*0* Commissioner Zagoria dissented from the order, arguing that the request was too broad and that demands for infor mation should be limited to matters "demonstrably necessary" for the CPSC to cany out its responsibilities.*** 2. Formaldehyde In its evaluation of the carcinogenicity of formaldehyde, the CPSC experimented with a novel procedure for assessing the risk of a substance in consumer products. The agency drew explicitly on the scientific expertise of other components of the federal gov ernment, perhaps setting a useful precedent Formaldehyde*** is an ingredient in urea formaldehyde foam in sulation, which has been installed in many private homes. In 1979, the Formaldehyde Institute, an industry trade association, re ported to the CPSC that the preliminary results from tests con ducted by the Chemical Industry Institute for Toxicology (COT)*** indicated that formaldehyde had caused nasal cancer in rats ex posed to 15 ppm of the substance.*1* Six government pathologists representing the CPSC and other federal agencies visited the CUT laboratory and confirmed these interim findings.*11 Several other long-term animal studies conducted to determine the teratogenic and carcinogenic potential of formaldehyde have yielded negative - Th* manufacturer* wiH braskadto. - --" (d}eecrib th* usual marketing tad us* pattern* ot each product identified, including: pricas (*.g^ price lists or schedules); promotional materials (to th* axtant they ralata to potential consumer uses); typical distribution channels (*.f., wholesale only, cata logue salsa only, wholesale and retail); regional distribution patterns (*.g^ nationwide. Northwest mtiy): and intended usee, functions, and applications. (1980} 4 Crsm. Ran. Rip. (SNA) 207-68. ** Id. at 267. ** Formaldehyde he* e variety of Important Industrial ueee, ex. hr tanning and textile manufacturing, but it la also found in consumer products. *** The COT it, as the name tmpUee, a research laboratory funded by private commercial source^ which test* chemicals to determine their health affects and teaks to develop and Improve test protocols. It is located in th* Research Triangle to North Carolina sad enjoy* a reputation for high-quality scientific work. M 48 Fed. Reg. 34,031,34.031 (1980). Th* CUT study was to be completed by mid-1980. More recent CUT date reveals that rats exposed to 6 ppm of formaldehyde contract tumor*. <?* Comments on a Preliminary Draft of this article by Jean* Gallagher (Oct. I, 1981) (hereinafter cited ce Gallagher Comment*] (copy on file with the Virginia Law Review Association). 1,1 46 Fed. Reg. 34.031. 34.031 (1980). 1931] Cancer Risk* 1355 results, but another recent study suggests that formaldehyde may have co-carcinogenic potential.*1* Confronting these findings, the CPSC took two preliminary actions. First, it requested that the National Toxicology Program (NTP)*1* empanel a group of government scientists to review the CUT study and assess the human health implications of exposure to formaldehyde. This group was to evaluate the evidence of for maldehyde's carcinogenicity, mutagenicity, and teratogenicity in animals.*14 The review group's report, originally expected by the end of July, was delayed until November 1980.*1* The CPSC's effort to obtain the expert views of scientists outside the agency is noteworthy. The agency's decision to seek the help of the NTP in evaluating the CUT data was joined by other members of the IRLG, some of which are also interested in formal dehyde's hazards. The approach not only enabled the CPSC to gain the support of more distinguished scientists than could be found among its own staff; it enhanced the credibility of the as sessment of risks on which the agency ultimately relied. Nor did the decision to go outside the agency for the initial assessment of carcinogenicity delay the CPSC's action. Unlike asbestos, benzene, and vinyl chloride, whose carcinogenicity was well established before the agency acted, formaldehyde presented a new issue, not ^just for tfcs-GPSC, but.'for-tha other-IRLG agencies as welL---?--- `The CPSC's second action was a proposal to require disclosure of the risk posed by urea formaldehyde (UF) foam insulation.*1* Based on demonstrated acute and noncardnogenic chronic effects*** *** 45 Fed. Reg. 39,434, 39,438 (1980). Ia other words, "formaldehyde may iaereeee th* Incidence of turnon when combined with a different aubetanc* that ia known to be e carcin ogen.** Id. " Th* NTP wta eetabliahed is lata 1978 by tbea-Seentaiy of Health, Education h WaU fin Califhno. 43 Fed. Res. 53.069 (1978). The purpoa* of the prafnm was to cantralixa and strengthen th* Department** toxicological rasearch and teating programs and to provide ad. vie* and information to research and regulatory agencies. Four agencies of HEW compos* the NTP: the National Center for Toxicological Reaaareh (a component of FDA with hand ing aa well from E?A); the NCI; NIOSH (part of th* Center toe Diieen Control); and the National Institute of Environmental Health Sdesc*a (part of th* National Institute* of Health). 1 NTP Technical Bulletin 2 (1979) (copy on file with the Virginia Law Review Association). " 45 Fad. Reg. 34,031,34,031 (1980). 111 The panel, which consisted of 18 senior government scientists, delivered it* report on November 21, 198a 48 Fed. Reg. 11,188, 11,190 (1981). 45 Fed. Reg. 39,434 (1980). AP00017144 1366 Virginia Law Review [VoL 67:1261 in humans exposed to formaldehyde gas, the Commission proposed that manufacturers of UF foam insulation provide specific per formance and technical data to prospective purchasers to alert them about the insulation's possible adverse health effects.*** The agency specifically kept open the possibility that the final rule might require notice of the cancer risk or of other chronic hazards. The preamble called attention to the ongoing scientific review of the CIIT study.*1* The CPSC's discussion of the economic effect of disclosure was decidedly conclusory. Though the agency conceded that the result ing decrease in demand for UP foam insulation had not been de termined, it asserted that the adverse economic consequences probably would not be significant. It did not discuss the economic effects of requiring a cancer warning.*** More troubling, the propo sal made no attempt to explain why notification of consumers might be appropriate in this context when the agency declined to consider it for other cancer hazards, such as hairdryers containing asbestos. The CPSC's more dramatic initiative began in February 1981, following its evaluation of the NTP work group's assessment of formaldehyde's carcinogenicity. The agency concurred in the NTP 39,439. , _____ 7[Do commenting-on this proposal. interested persons should take Into account the possibility that, based oa tbs utwasnt of existing information by the panel of fed eral scientists as well as additional information that Is obtained during this rulemak ing, the Commission may decide to include information concerning the possible long- tsrm health affects la the notification If tba Comaissioa issuas a final rule. In this regard ths Commission could: (3) Issut a requirement for a notification that includes a atatamaat concerning ths carcinogenic potential to humans of azposurs to formaldehyde. Tha Commission raqussts intsrastad psraoat eoaunantiag oa this proposed regula tion to address that# possibilities. Id. Id. at 39,43*49. ** Ths CPSC's proposad notification rule would not apply (a all context* in which con sumers are expoaod to insulation containing formaldehyde. Manufacturers of UF fosa insu lation would bs required to notify prospective purchaser* of ths product to bs used in pri vate construction. Use of the product in commercial building*, recreational facilities, schools, and ochsr public buildings would ba excluded, however, because "moat of ths com plaints . . . received to date concern homes or residences.'* Tha proposed rule also would net extend to insulation sold to builders for Installation in homes later sold to consumers or to sailers of homes in which the insulation had already been installed. The Commission believed that section 27(e) of the CPS Act would not extend to those settings. Id. at 39,435. 1991] Cancer Risks 1357 panel9* judgment that the material had been shown to cause cancer in rata and probably in mice, and it proposed to ban future instal lation of TJF foam insulation in homes and businesses. The Commission's preamble represents its most recent discus sion of the criteria it follows in regulating carcinogens in consumer products, and therefore merits special attention. The CPSC ac knowledged that the health hazards of UP foam insulation were first brought to its attention when the Denver District Attorneys' Consumer Office in 1976 filed a petition asking the agency to set a safety standard for the product The preamble summarizes the agency's rationale for proposing to ban the material. Unlike its ear lier ANTE for asbestos, which suggests that any exposure would pose an unreasonable risk, the CPSC's evaluation of formaldehyde discusses prevailing levels of human exposure and provides a quan titative assessment of the risk of cancer.*** Several features of the CFSC's formaldehyde proposal war rant comment First the agency made clear that any ban would apply only to future installations, and would not require retrofit ting of buildings in which UP foam insulation had been installed previously.*** Second, in sharp contrast with its professed skepticism of quan titative risk assessment in the asbestos ANPR, the agency em- biaced the tedinique, albeit cautiously, and concluded. that as many as twentyrthree additions! cancers might occur each year among residents of newly buildings if UP foam insulation were not banned.*** The risk assessment was performed by the CPSCs staff, based upon the NTP panel's analysis of the dose- response relationship displayed by the CUT data.*** After estimat ing the dose-response curve for formaldehyde, the staff projected the incidence of cancer among persons exposed to formaldehyde gas in insulated homes. To determine levels of exposure, the staff relied on actual measurements of formaldehyde obtained in insu lated homes whose owners had complained about noxious odors and on laboratory simulations of levels occurring in homes with ** 48 FkL R*f. 11,180 (1981). td. *t 11,189. " Id. *t 11,193. *H J it 11,190*92. 1358 Virginia Law Review [VoL 67:1261 lower concentrations.*14 It estimated that the so-called "complaint homes*' represented 6*9% of all UP foam-insulated residences, and concluded that of the 120,000 people exposed, as many as thirtyfive would contract cancer.11* The agency did not acknowledge that these "additional" cancers would not be prevented by its ban, which would not apply to insulation already installed. In compar ing the health benefits of its proposed action with the economic costs, however, the agency counted only the twenty-three "addi tional" cases likely to occur among residents of homes yet to be insulated.**4 The Commission's assessment of the economic effects of a ban of UP foam insulation Is at once the moat elaborate it has performed for any chronic hazard and the most seriously deficient. The agency identified the groups primarily affected as chemical manu facturers and importers; foam insulation contractors; and consum ers, who would forgo energy savings or possibly experience a reduc tion in real estate values. The agency's analysis of the anticipated costs for those three groups is thoughtful but inconclusive, in that it does not attempt to estimate the aggregate costs of a ban. For the first group, the Commission concluded: "The maximum impact of a ban for manufacturers and distributors of the component materials used to make UP*, foam Insulation may be the exodus of 19 firms from the industry, with a loss is employment of approxi mately 250 to 350 persons."*" The Commission made no attempt to place a dollar figure on this outcome. Its analysis of the effects on the. 600 to 800 installers of insulation, who currently receive up to $120. million each year for sales of UF foam insulation,111 does not suggest any magnitude. The Commission's discussion of the energy savings that owners would forgo because their buildings could not be insulated effectively with substitutes for UF foam is more convincing. The staff estimated that owners of such resi dences would forgo energy savings of between $204,000 to $518,000 each year that insulation could not be installed. It assumed that energy prices would rise at the rate of between five and ten percent * Id. at 11,192*93. Id. at 11,194. Id. at 11,195. ** Id. at 11,200. "* Id. APOOOf7147 1981] Cancer Bisks 1359 a year during a predicted ten-year period before alternative insu lating materials became available.*** The third notable feature of the proposal is the CPSC's self-con scious attempt to weigh the costs and benefits of the ban. The agency construed the relevant case law as requiring that "the bene fits of the regulatory action . .. bear a reasonable relationship to the costs."*** Although it asserted that it had no obligation to quantify costs and benefits, the agency nonetheless concluded that whether assessed qualitatively or quantitatively, the benefits of a ban would bear a reasonable relationship to the coats.*41 It then attempted to demonstrate that the prevention of an estimated twenty-three additional cases of cancer a year would be worth the economic costs of banning UF foam insulation: The principal measure of the direct societal costs of a ban of UF. foam insulation would be the foregone energy savings (or higher future energy costs) resulting from the buildings that are not insu lated because of die absence of UF. foam insulation from the market . . . . . . The foregone energy savings from these homes is estimated to be 35 to 87 billion Btu's, with a value of 8204,000 to $518,000, at 1980 energy prices. The staff has evaluated future foregone energy savings by discounting these savings to their present value. Based on these calculations, the present value of foregone energy savings resulting from * ban of UF.foam insulation would range from ap- - =pro*imately ll.^miHion-to JS^imllion't. ' If die estimated value of foregone energy savings is compared to the estimated risk of 23 cases of cancer that might eventually re sult from these installations each year, based on the upper value of the estimated range of risk, the calculated cost per cancer avoided would range from $70,000 to $226,000 per year. This rang* addresses only the benefits of avoided incidences of cancer in terms of foregone energy savings. Although additional benefits can not be reliably quantified, a ban would also benefit society in the following ways: (1) avoidance of the costs of lives lost and the medical and social costs for treatment of cancer; (2) reduc ing the costa of advene acute health effects caused by formalde hyde; (3) avoidance of the costs of remedial measures to attempt to correct problems in future installations, including the costs of re- " Id. at 11,202. " Id. it 11401. " Id. v AP00017I48 1360 Virginia Law Review [VoL 67:1261 moving foam from residences; and (4) avoidance of coots incurred duo to time loot from work, rental of other residences, and coats of litigation involving installations. When the benefits of avoided incidences of cancer and the addi tional benefits described above are considered in relationship to the facts thst the ban is likely to result in s relatively minor im pact to the economy as a whole, end will result in minimal energy losses because of the ready availability of substitute types of insu lation for most applications, the Commission preliminarily con cludes that the benefits of the ban do bear a reasonable relation ship, and do in fact justify, the costs of the regulatory action."* V. Analysis and Conclusions The CPSC has not played a decisive role is regulating potential carcinogens. It has assumed a reactive posture, largely responding to hazards identified by other bodies and by public petitions. In all but two instances, the CPSC has acted only after other agencies initiated regulation, and usually after manufacturers ceased using the substances in consumer products. In some cases, the Commis sion's intervention has amounted to little mors than a gesture. Earlier sections of this article have described difficulties encoun tered by the CPSC in regulating chronic health hazards. This sec tion speculates about their causes and suggests solutions. Before ^discussing these problems, however, three preliminary observations are tajordw._FIrst* certain difficulties are inherent In the 'Commis sionYlnission and organizational structure. The Commission's ju risdiction over all "consumer products" embraces a boundless ar ray of articles and potential health hazards. Furthermore, a multi member agency inevitably faces unique problems in internal com munications and in reaching consensus. These functions are fur ther complicated by the formal requirements of the Sunshine Act.*** Second, any agency responsible for regulating potential human carcinogens confronts large scientific uncertainties. Determinations of carcinogenic potency and human exposure often rest on specula tive evidence, which may frustrate quantification. The limits of sci entific understanding are a continuing impediment to intelligent Id. it 11,202 (footnote onitted). Government ia the Sunshine Act, 9 U.5.C. | 552t> (1977). C 1981] Cancer Risks 1361 regulation. Furthermore, all health regulatory agencies**4 depend on data from outside sources, both in deciding what substances to regulate and is determining what controls to impose. Third, the current Commissioners ere aware of the agency's ear lier missteps. They have, for example, improved the agency's inter nal system for identifying and evaluating substances that warrant regulation.*** It is not yet clear, however, whether recent agency initiatives, which have yet to be tested in specific regulatory pro ceedings, will avoid the difficulties experienced in the past A. The Commissions Agenda The CPSC has been frustrated in its efforts to establish and fol low priorities for regulating chronic health hazards. Its main diffi culty has not been in identifying substances that may pose a risk of cancer if present in consumer products; the Commission has re lied largely on outside scientific bodies and published research to C identify suspected carcinogens.*** Instead, the agency has faced its major difficulty in setting and following priorities for investigating and regulating suspected carcinogens. Several circumstances have impeded the Commission's efforts to set and follow these priorities............... :. , , L. :r - . -> V i. Agency Jurisdiction The Commission's statutory jurisdiction encompasses an unusu ally broad and diverse universe of products. Although FDA and EPA also have broad responsibilities, they have been able to create subunits responsible for such relatively discrete categories as food, drugs, cosmetics, and pesticides.**9 Moreover, unlike the CPSC, " /.*., FDA. EPA. OSHA. the CPSC, and tha Food Safety and Quality Sarviee of the Department of Agriculture. ** 5m notes 240-49 supra and accompanying text *"* 5m note 348 supra and accompanying text FDA and EPA aro both organised around their special anas of responsibility. FDA is divided into aix product-specific bureaus (foods, drugs, veterinary medicine, radiological health, biologies, end medial devieee) end Wo functional offices (National Center for Toxi cologies! Research and Executive Director for Regional Operations). Each bureau is Author subdivided according to regulatory function. The Bureau of Drugs, for example, comprises the following function-oriented components: Information Systems, Biometrics and Epidemi c ology, Pharmaceutical Reeetrch and Testing, Drug Monographs, New Drug Evaluation, and Compliance. EPA is organised both by function and statutory responsibility. The first tier of offices APObOl7150 1362 Virginia Law Review (VoL 67:1261 thou agencies administer licensing schemes for many classes of products. Required premsrket approval permits discovery of many potential problems before public exposure occurs, and forces pro ducers to generate much of the data needed for regulatory deci sionmaking.*4* Although manufacturers are formally required to notify the CPSC of "substantial product hazards1* presented by marketed products,*** they have little incentive to test their prod ucts for nonobvious The Commission must discover most of the hazards to which consumers are exposed on its own. This task is complicated by the lack of an accurate inventory of prod ucts available for consumer use and by the paucity of ready infor mation about their design and formulation. Ignorance about poten tial human uptake of materials used in consumer products increases the difficulty of identifying regulatory targets. With the exception of chlorofluorocarbon propellants, each carcinogen that the CPSC has attempted to regulate has presented the agency with unique exposure issues.*4* Z Agency Resources The CPSC*s limited budget and scientific resources have frus trated its attempts to set regulatory priorities within its broad po tential jurisdiction. Establishing priorities would be difficult enough if the agency were concerned only with chronic hazards, - but.it also has the additional, and perhaps primary, responsibility / of regulating products posing risks of acuta injury or illness.*41 consist! of th Assistant Administrators for Planning and Management, Research and De velopment, Watar and Hazardous Materials, Air and Waste Management, and Enforcement The second tier reflects EPA'i subject mattar mponsibflitiea. For example, the Office of Water and Hazardous Materials enoompasaee the offices of Pesticide Pretrains, Toxic Substance* Water Planning tad Standards, Water Program Operations, and Watar Supply. Thesa structures contribute to the agendas* continuity, and minimise the risk of ad hoc distraction* to which leea-spedalizad organizational structures are susceptible. (1074) FDA Ann. Rif. 907,1000,1054: U-S, ENvrt. Phottctton Acimcv, Operating Ytar Ouidanet far Cht FUal Ytar 1991, fa EPA Mahval (February 1990f: UJ3. Ewn Ptortcnon Aocnct, Finding Your Way Through EPA, in SPA Duuctory (June 1976). ** Heller Interview, supra ooto 32. CPS Act ! 15. 15 U.S.C. f 2064 (1976). Exposure to subetancea la eeasuser products can occur through inhalation, dermal contact, and ingestion. Furthermore, the frequency, duration, and manner of use of con- turner products vary widely. M1 See discussion at notes 22*28 supra and accompanying text regarding the Commis sion's reticence about entering the chronic hazards regulation area. AP00017151 1981] Cancer Risks 1363 Thu*, the agency must initially determine what portion of its lim ited resource* it should devote to chronic hazards.*4* Within thfa more limited universe, it must then set its agenda of specific regu latory targets. 3. Vulnerability to Petition* Public petitions have played an important role in determining the substances that the CPSC has chosen to regulate.*41 AH seven of the CPSC's regulatory actions against carcinogens were begun after the agency received petitions from one or more outside orga nizations.*44 In the Instance# where the Commission staff bad com menced evaluation of the substances before a petition was filed, other agencies already had initiated regulatory proceedings. Although the petition process may assure CPSC responsiveness to immediate public concerns, the attention given to petitions by both the staff and the media can distort judgments about how the agency should allocate its limited resources. The potential for dis ruption is substantial, given that a majority of the petitions re ceived by the CPSC have been submitted by industry groups.*4* This workload depletes agency resources because the statutory time limit for response has led the Commission routinely to under take immediate review of petitions.*4* The CPSC should explore ways to coordinate its handling of pa rtition* with, pursuit.of it* own priorities^ The agency could "ac cept" petitions and'then assign them priorities determined by its ' own criteria. Alternatively, it might "grant" facially meritorious petitions by publishing ANPRs calling for public comment, thus satisfying the 120-day period for response. Finally, the agency could grant or deny petitions based on the availability of agency*** *** Ste note SS supn for a diacQurfoB of the CPSC budget " St* aoUt 5445 tupra and accompanying tsxt for dbcuMlon of the potation proem. ** Stt note* 262406 jupra and accompanying taxi (vinyi chloride); note* 306*35 tupra and accompanying text (ebtorofloorocarbona); note* 336*83 tupra and accompanying test (TRISH sotee 364-430 tupra and accompanying tact (aabettea fa* patching compound* and etoberizinf materiale); note* 481*64 tupra rad accompanying test (bernene); notes 466-33 tupra and accompanying text (hairdzyan mt*iwfan aibactoe); notee 50642 tupra and ac companying taxt (urea formaldehyde foam insulation). CPSC Priorities, tupra note 838, at 6 (Statlax, Conun'r, dimenting). Ait ttt id., Con curring Opinion of Comstissfoner tL David little, Jan. 29,1980, at 5-U (arguing that indus try groups have not flooded the agency with petition*). *** Pnuaa Interview, tupra note 32. See notes 232-36 tupra and eoromponying text. 1 1364 Virginia Law Review (VoL 67:1261 resources.*4* Although these approaches might stretch the statu tory language,14* courts should be persuaded that the CPS Act's requirements are sufficiently flexible to embrace these or other means of responding to petitions instead of allowing them to dic tate the agency's agenda. A more skeptical approach to public petitions would have two advantages. First, it would give the CPSC greater control over the allocation of Its limited resources, thereby facilitating more sys tematic responses to chronic hazards. Second, the agency's adher ence to its internal agenda would strengthen its image as an effective regulator. 4. Internal Review Procets The Commission established an Internal -review system for chronic hazards late in 1978.*4* Poetising on lists ofsuspected car cinogens assembled by outside groups, the review group deter mines whether such substances are found in products within the agency's jurisdiction and estimates the extent of potential human exposure. The CPSC has not yet regulated any substance identi fied by this review system, but several substances are current can didates for regulation.*1* The review procedure confronts two inter nal problems. First, there is no time limit for action on internally developed priorities.111 The resulting competition for resources and consequent unpredictability impede creation of A coherent system a..: -^ ..thatLwould allow fche-ragencyrto control Its agenda.' Second, it re* - mains unclear which office within the agency will set the priorities among substances found to merit attention. The official in charge of the Commission's chronic hazards program is primarily respon sible for the internal review, but until very recently he lacked for- / *** CPSC Prioritiee, supra not* 228, it 6*6 (Sutler, Coam'r, dissenting). ** Section 10(e) of the CPS Act provide* "The Commission may hold a public hearing or may conduct such investigation or proceeding u it deem expropriate la order t determine whether or sot such petition should be fronted." 18 U.S.C. | 2059(c) (1978) (emphasis ad ded). Section 10(d) state* "Within 120 days after filing of a petition ... the Commission hall grant or dany the petition." 15 U.S.C. f 2059(d) (1978). Thu*. a formal investigation la not requited, although surely Congreea expected some Inquiry. *** Gallagher Intend**, supra note 22; Heller Interview, supra note 32; Preuae Interview, supra note 32. *** These subataneea Include respirable aaheetoa. hazardous dyea, and perdtloroethylene. (198l| 4 Cum. Rsg. Rev. (BNA) 1621. *** Krulwich Interview, supra note 38. | APOOOI7153 X98X] Cancer Risks 1365 mal authority to assign work* allocate resources, or fix deadlines.*** B. Criteria for Regulation S. Risk, Cost, and Benefit Analysis The CPSC rarely has analyzed carefully the health or economic consequences of its actions involving carcinogens. The agency's for mal statements often have been conclusory, sometimes reciting simply that the Commission "carefully considered" pertinent fac tors.*** The passages from the documents quoted in Section IV re present the agency's full explanation of its decisions. In three in stances, the Commission attempted to quantify a product's risks,**4 but on occasion, it also has spurned such axudysis.1** The- agency has not explained the weight accorded such factors as the avail ability of substitutes for a banned substance, the effect of regula tion on product price, performance and availability, and the costs of repurchase. The agency's discussions of exposure levels often have betrayed a lack of both data and investigation.*** One explanation for the CPSC's apparent superficiality is tech nical. Quantification of human risk requires accurate estimates of human exposure. The agency not only faces technological problems* in measuring many-: exposures',-but it also possesses limited re sources for the necessary teste. Measurement of consumer exposure often requires novel methods that are expensive to develop.**9 The technical difficulties of risk quantification are not the full explana tion, however. The CPSC has denied that it is legally required to quantify risks or costs.*** The CPS Act requires that it weigh cer- * id. ** See, S-, 3S Fed. Re*. 30,112 (1974) (CPSC tea of asroseliwd tM chloride); 42 Fed. R*f. 42,780 (1977) (final statement of CPSC on eUerafluoroearboB propellants). *** Stt 4$ Fed. Re*. 21439.21440-41 (1978) (proposal to regulate benzene); 42 Pad Rag. 18,850k 184&0-51 (1977) (interpretation of THIS as a banned haaardous substance); 46 Pad. Rtf. 11,188,11,19048 (1981) (proposed ban ef urea formaldehyde insulatlon). See Advance Notice of Proposed Rulemaking on Asbestos, 44 fed. Rag. 60,057,60,087 (1979). *** See, ths afences proposed rule on besxsne, in which ft remarked: "While the Com&lutDR recogntiea that much of the data discussed below concern bsnsene exposure a an Industrial aettinf, the Commission points out that It does have son# information con esminf consumer exposure." 48 Fed. Reg. 2143% 21439 (1978). *** Krulwtch Interview, supra note 8% Pnuu Interview; supra note 32. *** St* notes 84*113eupm and eeeompanyinf text fee a description ef tha criteria UMd by the CPSC. In its proposed ban of urea formaldehyde insulation, the scene? migrated its 1366 Virginia Lew Review [VoL 67:1261 tain risk and cost factors,*** but the legislative history indicates that a formal cost-benefit analysis is not mandated.*4* Prior to its proposed ban on formaldehyde, the Commission had rejected argu ments that the statutory language requiring that product safety rules be "reasonably necessary1* to eliminate a risk of injury or ill ness required quantification of health benefits.**1 The CPSC has combined two approaches in evaluating consumer exposure. Usually, it has made an informed guess about whether consumers will be exposed significantly to a hazardous material in consumer products. In its proposal to ban benzene, the Commis sion apparently made a "seat-of-the-pants" judgment about how much benzene a "typical'* product user might encounter,*** Invari ably, however, the Commission has gone on to emphasize that safe levels for carcinogens have not been known, and that any con firmed exposure warrants regulatory action unless there is a com pelling reason to allow continued use of the material. The CPSC used this approach in its action against patching compounds and, again hypothetically, in its ANPR on asbestos.*** The Commission has not yet confronted the question of what formula it will employ when it finds the use of a carcinogen in a consumer product impor tant, but the issue appears inescapable after the Supreme Court's recent decision overturning OSHA's exposure standard for -benzene.**? = 2. Scientific Criteria No one haa seriously challenged the CPSC's characterization of any chemical as a carcinogen, but the agency has never relied solely on its own scientists to support its judgment The CPSC's acceptance of other agencies* judgments concerning vinyl chloride. position: "Tha statut* dots sot require th* Commiaaios to quantify the potential cotta and besefita baler* taking regulator? action.'* 44 Pad. Rag. 11,188, 11,201 (1941) (citation omittad). Cautious aftar th* Industrial (Mian decision, bostw, the CPSC did attempt aucfa an analysis. Id. at U.I88-21L m CM Art | 9(e), 15 VAC. | 2038(c) (1978). " Set not# 90 supra and accompanying text, M< Sat Advance Notice of Proposed Rulemaking on Asbeetce, 44 Fad. Rag. 80,057 (1979). S generally CPSC Cancer Policy, 43 Fad. Rag. 23.638 (1978). ** Ste notee 443-48 supra and accompanying text. *** Stt not#* 399-401 supra and accompanying text. Set alto Advise* Notica of Propoaad Rulemaking on Aibaatoa, 44 Fad. Rag. 60,057, 60,058 (1979). Set notaa 482-84 supra and accompanying text. i i AP000I7155 c 1981] Cancer Risks 1367 asbestos, benzene, and chlorofluorocarbon propellants demon strates that it has adhered to the same tenets in identifying carcin ogens and in evaluating their risks as have other federal agencies. TTiese precepts include the acceptance of positive results in animal experiments as evidence of potential human risk, a skepticism to ward negative epidemiological studies, and the assumption that no level of a carcinogen can be shown to be safe for all exposed indi viduals. These tenets formed the basis of the Commission's 1978 cancer policy, which was sat aside in the Dow Chemical case and was replaced subsequently by the IKLG's own statement of princi ples for evaluating carcinogens.*** Tbs CPSCY reliance on outside agencies also reflects its shortage of trained scientists. As late as 1978, the agency employed only one toxicologist, who worked in bath the acute and chronic hazards programs.*** The CPSCY over worked staff, shortage of resources for in-house testing and analy sis, and general lack of experience also contribute to its reactive posture. Gaps in the agency's scientific analysis often betray defi ciencies in the available data. Information about exposure levels and human uptake is typically sparse. In many cases, no methodol ogy has been developed to measure human exposure, or levels may be too low to be measured. - -4: . C. Execution of Regulatory Actions- 2. Statutory Options " Section 30(d) of the CPS Act permits ths Commission to choose the legal remedy best suited to fulfilling the "public interest.1TM7 Neither the statutory language nor the legislative history offers guidance in applying this standard beyond suggesting that the agency should have flexibility in selecting its regulatory tools. In the proceedings the agency has begun, it has relied on five differ ent statutory provisions.*** The Commission's disparate ap- *** See notes 182-231 supra end accompanying text for discussion of the 1978 earner policy and the Data Chsmieal case. On tha IRLG cancer policy, aa T. McGarity, supra note 227, at 9-1L *** Preuts Interview, supra note 32. *** Section 30(d) identiffea tha FHSA, the Poiaon Prevention Ptckaginv Act, and tha Flammable Fabrics Act as statutat under whleh tha CPSC may ra*ulate risks of injury assndated with oonsumtr producte. 18 U.S.C. | 2079(d) (1978). Tha Commission has relied on tha "banned hazardous subetanca* authority of tha FHSA (vinyl chloride; THIS), tha labeling requirements of tha CPS Act (chlorofluoro- r AP6bbi7f56 1368 Virginia Law Review [VoL 67:1261 proaches to vinyl chloride, THIS, benzene, and asbestos in hairdry ers are difficult to reconcile on theoretical grounds; it appears simply to have seized upon the statutory options that have permit ted it to act promptly and, when possible, without having to con duct a formal hearing. As a general approach, this is sure to be controversial. The CPSC understandably desires to reduce con sumer exposure to carcinogens as promptly as possible, but it should not be able to avoid systematic examination of the risks posed by consumer products and the costs of their control. The Commission's actions against vinyl chloride and TRIS were awkward, if not inept. They were taken in disregard of obvious le gal risks,m and both met judicial reversal. The CPSC has dis played greater skill in more recent actions. Its ban of patching compounds and emberizing materials containing respirable asbes tos was completed within approximately six months without any loss of opportunity for interested parties to participate, although by the time the agency commenced rulemaking, asbestos use in these products had ceased voluntarily.*1* Where the costa of elimi nating or reducing exposure are higher, however, the Commission cannot expect lack of interest to clear its path, i,. CPSC officials have expressed pride in their handling of regula tion ofhairdryers containing asbestos, noting the speed with which the effective "ban" waa implemented."1 This result was achieved, however, at the expense of both internal analysis and public under standing. No contemporaneous study was made of the dimensions of the risk associated with those products or of the costs of a com prehensive recall. Nor was any legislative authority formally in voked to effect the recall; it was undertaken voluntarily, because the retailers and manufacturers did not wish to jeopardize their goodwill with consumers. carbons; urea formaldehyde Insulation), tha "substantial produet hazard" provision of the CPS Act (hairdryer* containing asbestos), and tha administrative banning authority of the CPS Act (patching compounds containing asbestos; benisns). *** S*e notes 262-205 supra and accompanying taxt (discussion or vinyl chloride action): notas 338-83 supra and accompanying text (discussion of TRIS action). m Sts notaa 384430 supra and accompanying text (discussion of patching compounds/ embtrizing materials actions). *" Krulwfch Interview; supra note 36. AP00017157 1981] Cancer Risks 1369 2. Importance of Recall and Repurchase A recurrent point of controversy in CPSC actions against carcin ogens has been the status of existing product stocks. In no com pleted CPSC action have manufacturers disputed the ultimate fate of the challenged substance, and in three instances use of the sub stance was discontinued before the agency commenced regulation. In several cases, however, the disposition of unsold inventory be came a major issue. The CPSC's action against vinyl chloride would not have been contested had the agency not insisted on ex tending its ban to cover products already distributed, thereby trig gering the automatic repurchase provisions of the FHSA.**" Simi larly, the agency's assault on THIS foundered over the scope and incidence of repurchase obligations.*9* By-contrast, the ban on patching compounds and embetizing materials containing asbestos, which scarcely touched outstanding products, was not contested.*94 This does not suggest that the CPSC should ignore products al ready distributed and focus only on future use of carcinogenic sub stances. Sometimes human exposure to outstanding stocks may be too significant to neglect, although none of the actions examined here appears to have posed such a case; The case studies, however, do illustrate the practical importance of the repurchase/recall de cision. The agency should assess the risks posed by distributed products independently and consider their disposition as an issue separate from the broader question of whether continuing use of a substance poses an unacceptable risk. D. Program Management Both the CPSC's organization and some of its policies have re peatedly impeded its performance in regulating cardnogens. 2. Internal Organization Recognizing the wide range of products subject to its jurisdic tion, the Commission initially chose an organizational structure that would give it maximum flexibility. Under the agency's matrix " Sec notes 298-300 tupn and accompanying text for discussion of th# chaHong* to the recall and repurchase order fas th* action against vinyl chloride. *n See notes 388-74 tupn and accompanying text. *" Sec notes 384-430 tupn and accompanying text. 1370 Virginia Law Review [VoL 67:1261 organization, the persons responsible for preparing briefing materi als and regulatory documents often changed with each assignment. For regulatory actions against many product hazards, assembling teams of staff specialists on an ad hoc basis may be a practical approach. For chronic hazards, however, such an approach ulti mately is frustrating. Effective regulation of carcinogens requires a staff that is familiar with and understands the scientific principles involved. Only by moving toward a structure of fixed personnel as signments for chronic hazards has the CPSC's staff begun to de velop the kind of experience that will permit sophisticated evalua tion of carcinogens in consumer products. 2. Openness The Commission's ritualistic observance of the Government in the Sunshine Act17* and the Freedom of Information Act97* (FOIA) also has hampered its effectiveness. The agency's view of the Sun shine Act is that all meetings involving the Commissioners as a group and the agency staff must occur in public. These include preliminary briefings, discussions about regulatory options, and de bates over agency priorities. This approach has Impeded the Com missioners* ability to provide direction to the staff and has discouraged candid discussion of regulatory strategies, because attorneys representing affected firms attend the critical meetings. All discussions- between industry representatives and the Commis sioners or agency staff also occur in public. This inhibits candid negotiations and discourages voluntary disclosure of sensitive product information."7 The CPSC has adopted an equally generous reading of the FOIA. Staff documents ordinarily can he released to the public as soon as one office--at any level--approves them and passes them along the bureaucratic chain. Thus, staff recommendations are sometimes publicly available before they are discussed with the Commissioners. These documents do not ordinarily reflect official policy, and they may contain misleading information. Further- m 5 U.S.C. i 552(b) (1976). For general diacuufona, see Sutler, Ltt tkt Sunshins Ini, 07 AJ3.A.J. 573. 575 (May 1961); Mas* Rcronr. tupns note 91, at 241. m 5 U.S.C. f 552 (1976). Stt also Sutler, supra note 675; Mott Rsvoxr, supra note 91, at 241. m Sutler, supra note 575, at 574. 1981] Conor Risks 1371 more, early access to staff documents may provide intelligence to potential regulatory targets that can be used to impede Commis sion action*"1 The consequences of the CPSC'e historic dedication to "open ness" as an agency objective recently provoked the following com ments from one member, Conmtissoner Statler, who recently served as Acting Chairman of tha Commission: Instead of weighing the competing values of consumer protection and open decision making, the commission simply assumed that total openness could be obtained without detracting from its safety mandate. It was felt that openness could only enhance the quality of decisions affecting consumer health and safety. e . . . [R]egulatory agenda* must accord top priority to their substantive mandates, to what Congress originally asked of them, to their raison d'etre. Adding other laudable alms to their task--openness, among them--has taken its toll. At times the added burdens have impaired the ability of these agencies to ac complish their primary mandates. Even praiseworthy means, such as open decisions openly arrived at, do not justify poor regulatory results. When a formal regulatory decision is at hand, openness should be preserved to the extent possible... . But .when an agency is simply exploring issues devoid;of^toy immediate regulatory- im-.pect--and especially at jin' early or preliminary stags--unfettered discussion should be encouraged. If candid dialogue is inhibited by openness and the overriding public interest does not suffer from any one person's exclusion, then preserving openness In those cir cumstances may be unwarranted."* E. Conclusion The CPSC's contribution to the federal effort to regulate expo sure to carcinogens defies simple assessment. Perhaps the Commis sion's role is largely redundant The statutory authorities and ad ministrative bodies existing prior to adoption of the CPS Act probably could have dealt adequately with the substances that the Id at 575. m Id st 573, 575. But n Daciaion of tha CPSC Raganllng CPSC Maattagi Poliey, DisMating Opinion ot Commission*? R. David Pittla, Oct. 32.1980. ComaiaaiOMr Pittla is tha Commiasion'a currant VIca Chairman. 1372 Virginia Law Review [VoL 67:1261 CPSC has regulated Before the Commission began Its action against vinyl chloride based on the FHSA, FDA, which originally administered the FHSA, had already regulated other usee of vinyl chloride. Although the agency relied on the GPS Act in regulating chlorofluorocarbon propellants and benzene, it acted against ben* zene only after other agendas had regulated the more significant uses and after manufacturers of consumer products had ceased us ing the ingredient. The FDA and EPA actions against chloro fluorocarbon propellants ultimately made a CPSC response unnec essary. Asbestos use in mbarising materials and caulking compounds had ceased by the time the Commission completed its rulemaking. Still, it would he premature to suggest that the CPSC has no role to play in reducing exposure to carcinogens, or that the CPS Act has been unnecessary. Not all hazardous materials in consumer products fall within the jurisdiction of other agencies or are likely to be affected by the actions they taka. Asbestos may be an exam ple. Routine reliance on the FHSA to regulate such substances in consumer products would be unsatisfactory. The CPS Act offers a broader range of regulatory tools, including mors authority to mandat# disclosure of information, and more expeditious rulemak ing procedures.*** ___ Despite, many past xaissteps,_ the CPSC has.begun to mount a more "sophisticated,^ program for regulating- chronic* hazards. Theagency has several suspected carcinogens on its current list of pri orities that are not likely to receive attention from other federal agencies.**1 It has attempted improvements in its internal review and investigatory procedures. There are also signs that the Com mission is recognizing its scientific limitations and is relying more heavily on other regulatory agencies and the scientific components of the government. The CPSC precipitated the first governmentwide effort to evaluate the carcinogenicity of formaldehyde, a sub stance potentially of multi-agency interest. CPSC staff members reportedly have been among the most vigorous proponents of coor- Sa | 27 of tha CP3 Act, 15 V3.C. | 2076 (1976 * Supp. m 1979), foe detail* of what i* obtainable. "* Of tba currant CPSC projact*, hauidous dyaa may ba tha naxt Urpt for rofulitlon. If banridina dy*a ara not u**d primarily by consumer*. howavar, OSHA may hav* primary rasponsibility. Stt 11960] 4 Chim. Rio. Rxr. (BNA) 1070. 1981} Cancer Risk9 1373 dinated regulatory proceedings within the IRLG. There is an irony, and a warning, in the CPSC's current efforts to upgrade its performance in regulating carcinogens. Its past regu latory initiatives have contributed comparatively little to reducing human exposure to harmful agents. The costs it has imposed, al though Indeterminate, also probably have been modest.*** To the extent the Commission now begins to tackle more serious problems, its regulatory apparatus will be tested more severely. Its scientific judgments will be contested more sharply. It will be forced to document exposure estimates with greater care and preci sion, and to perform quantitative assessments of risk. The in creased economic stakes will not only require more thoughtful analysis of the costa of regulation; they will also more frequently require the agency to prove its case in a public forum. It is still much too early to judge whether the CPSC, as currently structured and staffed, can meet these challenges. Epilogue The Reagan administration's efforts to eliminate the CPSC and transfer its important functions to other bodies, principally the ^Department of Commerce, stimulated critical examination of the agency's performance during Congress's recant consideration of reauthorization legislation, intimately, Congress voted to continue the CPSC for two additional yean but with a substantially reduced budget.*** The reauthorization legislation also made important changes in the laws that the Commission administers. Some of these changes are pertinent to the subject of this article and there fore are described briefly bare. Neither time nor space permits thorough analysis of their likely impact on the CPSC's regulation of chronic hazards. Although Congress focused on the CPS Act, it also enacted *" The coats of some CPSC sedan*, howror, may b* Mtthar mod**! nor reasonable. S* Linneman, Tht Effmcts of Consumer Saftty Standard*: Th* 1873 ifattrtu Flammability Standard, 24 J.L. 4 Scow. 461 (1981). **" Consumer Produce Safety Amendments of 1981, Pub. L. No. __ f 1214,___Stet ___ (amendinf IB US.C. f 2081 (1976 & Supp. IH1976)). Coapeea ewthoraed 833 million for fiscal year 1982, and 835 aOIloa for fiscal ytar 1983. i APOOOI7162 1374 Virginia Law Review [VoL 67:1261 changes, largely parallel, in other laws administered by the CPSC.**4 This discussion deals only with the amendments to the CPS Act, which has been changed substantially in three pertinent areas: (1) the Commission's rulemaking authority and procedures; (2) the Commission's duty to respond to public petitions; and (3) the Commission's scientific evaluation of products thought to pre sent cancer hazards. Rulemaking authority. The CPSC must now commence any proceeding to ban, or establish a standard for, a product by pub lishing an advance notice of proposed rulemaking that describes the risk of injury to be controlled and invitee the development of a voluntary Industry standard. Before the agency can establish a mandatory standard or ban, it must conclude that a voluntary standard is unlikely to eliminate or reduce the hazard. In any such proceeding, the agency must perform both a preliminary and a fi nal regulatory analysis, which assess the potential costs and bene fits of the action as well as alternatives to it. The amendments supplement the Commission's duties under section 9(c) of the Act, requiring specifically that it find that a voluntary standard is not likely to deal with the hazard, that the benefits of its rule "bear a reasonable relationship to" its costs, and that the rule imposes the least burdensome requirements necessary to address the hazard. These findings are in some sense a synthesis of the teaching of the Aqua Slide decision1** and President Reagan's regulatory reform order.1** They obviously push the CPSC toward cost-benefit analy sis and require more comprehensive evaluation of the economic effecte'of reg&afion-tHazi'tbe -Commission usually has~conducted.: ' :' :Public petition$, Congress has freed the CPSC from the bur dens of responding within 120 days to public petitions, imposed by the original section 10 of the CPS Act. That provision has been repealed, leaving the Commission subject simply to the obligations imposed by the APA, which imposes no time limit on responding to petitions.*** Although a rather blunt response, this change should permit the CPSC greater freedom to set its own agenda, a ** Stt, t.g., id. 11203 (amending rulemaking procedures for both tha CPS Act, 15 U.S.C. | 2058 (1976) and the FHSA, IS U.S.C. ] 1262 (1976)). Por a dbcusalon of the CPSC** governing atatutea, im not** 56*181 tupra and accompanying text. M Stt ootM 93*109 tupn and accompanying test. ** Exec. Order No. 12,291, 46 Ftd. EUf. 13,193 (1981). See 5 U.S.C. iS 551*75 (1976). J c 1981] Cancer Risks 1375 goal urged in this article. Advisory panels. The amended CPS Act requires the Commie** sion to appoint and consult with a Chronic Hazard Advisory Panel,*** composed of scientists nominated by the National Acad* emy of Sciences, whenever it contemplates regulating a substance believed to present a risk of cancer, birth defects, or gene muta tion. The Commission must ask the panel to report whether the substance is a carcinogen and, where possible, to provide an esti mate of its probable harm to Human health. Each panel will be established for the purpose of reporting on a particular substance, in the fashion of the NTP committee assembled to review formal dehyde, rather than as a standing advisory committee. Although the panel's report technically will be advisory, it will become part of the agency's rulemaking record and, as a practical matter, prob ably will be conclusive on the issues it addresses. It is appropriate here to mention one change made in the CPSC's internal operations since this article was written. In lata 1980 the Commission voted to make the Health Sciences division a separate Directorate, elevating both the responsible DAED and the visibility of the chronic hazards program. Responsibility for over seeing staff work on chronic hazards, including the agency's inter nal review of candidates for regulation, was assigned to the new Directorate, in effect eliminating the intermediary role of the Of- j:;/7;^.0qq:soL.?gogitf,,- Management,*** .These, important institutional changes" are entirely consistent with the views stated in the article.*** There is an irony in thi* juxtaposition of very recent changes in the CPSC's authority and organization. Although the reforms ef fected by the Commission on its own Initiative were obviously designed to enhance its ability to deal with chronic hazards, the amendments made by Congress are likely, and perhaps intended, to encumber and delay Commission action in this Held. *** Consumer Product Safsty AmtndmsnU of 1981, Pub. L. No. __ $ 1206.___Stat. __ (amending 15 U.S.C. $ 2077 (1975)). *** Set Gallaghsr Comments, supra not* 510. *** Stt notes 29*39, 549*52 supra and accompanying text APOOOf7164