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}{\fs28\insrsid9729503\charrsid9729503 The Radiation Control}{\fs28\insrsid15337363 for Health and Safety}{\fs28\insrsid9729503\charrsid9729503 Act of 1968: \par History, Accompl}{\fs28\insrsid5197850 ishments, and }{\fs28\insrsid9729503\charrsid9729503 Future \par }{\insrsid9729503 \par \par }{\insrsid71090 \par \par }{\insrsid9729503 \par \par \par \par \par Vivi Tran \par Class of 2006 \par May 2006 \par \par Course and Third Year Written Work Requirement}{\insrsid9729503\charrsid9729503 \sect }\sectd \pgnrestart\linex0\endnhere\sectlinegrid360\sectdefaultcl\sectrsid6365170\sftnbj \pard\plain \qc \li0\ri0\sl480\slmult1 \widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6365170 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\scaps\insrsid6365170\charrsid6365170 Abstract \par }\pard \ql \fi720\li720\ri720\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid853478 {\insrsid13634397 Prior to 1968, }{\insrsid6365170 control}{\insrsid13634397 of radiation-emitting electronic devices}{ \insrsid6365170 was left to state and local governments}{\insrsid13634397 , whose regulations proved both inconsistent and ineffective. This was highlighted by General Electric\rquote s 1967 recall of 90,000}{\insrsid5197850 television sets believed to }{\insrsid13634397 emit dangerous levels of radiation. Congress soon proposed a federal radiation control bill. The hearings revealed the general lack of data on the harms of radiation exposure and}{\insrsid5197850 the}{ \insrsid13634397 vast amount of unnecessary radiation that Americans were exposed to each year. As enacted on October 18, 1968, the Radiation Control for Health and Safety Act authorized the }{\insrsid13831028 Food and Drug Administration}{ \insrsid853478 }{\insrsid8061151 to set federal radiation standards, to monitor compliance,}{\insrsid5197850 and}{\insrsid8061151 to conduct res}{\insrsid5197850 earch}{\insrsid8061151 . }{\insrsid13831028 The FDA}{\insrsid8061151 \rquote s Bure}{ \insrsid13831028 au of Radiological Health }{\insrsid8061151 active}{\insrsid13831028 ly administered the act}{\insrsid8061151 . The act has pro duced safe electronic products, considerable scientific knowledge, and a public well aware of the risks of radiation exposure. But for all of its successes, the act has also had its problems. The act does not require pre}{\insrsid7034746 -}{ \insrsid14972294 market approval, choosing instead to respond once problems arise. }{\insrsid2572271 The FDA has also seen significant budget cuts and must prioritize its obligations under all the acts it administers. The FDA has turned to the internet to communicate its message to manufacturers and consumers, but at the same time must counter the rise of the popular media and its ability to excite the public regarding }{\insrsid8855691 potential }{\insrsid2572271 radiation hazards.}{\insrsid8855691 H}{\insrsid853478 ow the FDA allocates its decreasing}{ \insrsid8855691 funds}{\insrsid5197850 and works with the mass media}{\insrsid8855691 will }{\insrsid853478 determine the future of the act. \par \par \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid853478 {\scaps\insrsid4880085\charrsid11039173 I. }{\scaps\insrsid14908102\charrsid11039173 Introduction}{\scaps\insrsid4880085\charrsid11039173 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid2118636 \tab A child swallows a }{\insrsid401560 penny, and his father can}{\insrsid2118636 watch the penny move through the child \rquote s body using a fluoroscope.}{\cs16\super\insrsid2118636 {\*\bkmkstart _Ref134138932}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Ricki Lewis, }{\i\insrsid4204783 Radiation Continuing Concern With Fluoroscopy}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{ \insrsid4204783 , Nov. 1993, at 18, 18.}}}{\insrsid2118636 {\*\bkmkend _Ref134138932} A person injures his}{\insrsid401560 leg, and his doctor can }{\insrsid2118636 use an x-ray device to determine the extent of the injury. }{\insrsid13904217 A worker \rquote s c}{\insrsid401560 offee is cold, and he can}{\insrsid13904217 heat it quickly in a microwave. }{\insrsid8127318 The twentieth century saw a proliferation of new technology that had the potential to protect people\rquote s health and to provide consumer convenience and entertainment. The x-r}{\insrsid11291445 ay was discovered in 1895 by Wilhelm}{\insrsid8127318 Roe}{\insrsid10241955 ntgen}{\insrsid11291445 .}{\cs16\super\insrsid11291445 {\*\bkmkstart _Ref133967149} \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Egon Weck, }{\i\insrsid4204783 A Primer on Medical Imaging \endash Part One}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Apr. 1989, at 24, 24.}}}{\insrsid9569153 {\*\bkmkend _Ref133967149} The x-ray\rquote s benefits for medical diagnosis were}{ \insrsid10241955 }{\insrsid15540673 discovered}{\insrsid10241955 soon after}{\insrsid15540673 .}{\insrsid8127318 As the century progressed, consumer goods such as color televis}{\insrsid15540673 ion sets provided}{\insrsid8127318 in-home entertainment, while the microwave oven provided}{\insrsid9569153 }{\insrsid8127318 convenience to an increasingly busy population. }{\insrsid15540673 Tanned skin was becoming more popular, which resulted in the increased us}{\insrsid1586534 e of }{\insrsid15540673 sunlamps. }{\insrsid5663070 These new and ex}{\insrsid9791959 citing products seemed to increase the overall quality of life. In 1967, however, a General Electric}{\insrsid1586534 (\'93GE\'94)}{\insrsid9791959 recall of 90,000 television sets alerted Americans to the risks of using these products.}{\insrsid8127318 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid1586534 \tab GE}{\insrsid9791959 discovered that its sets were emitting excessive radiation that had the potential to harm viewers who sat near the set}{\insrsid401560 s}{\insrsid9791959 . However, }{\insrsid4880085 the radiation exceeded only voluntary industry-set standards, as t here was no federal regulation of radiation emitting products. State and local governments provided some }{\insrsid6377902 regulation, but it was both inconsistent and ineffective.}{\insrsid1472698 Bills were introduced in both the House of Representatives and the Senate in 1967 to enact a radiation control act. Congress quickly realized that the problem extended far beyond color televisions. X-ray examinations represented ninety percent of human radiation exposure, and the techniques and equipment were resulting in unnecessary exposure to both the patient and the physician. Congress also realized that scientists knew very little about the dangers of radiation. Witnesses testified that b}{\insrsid401560 iological harm could be caused b}{\insrsid1472698 y much lower amounts of radiation as a result of a lifetime of e}{\insrsid1586534 xposure}{\insrsid1472698 , and that harm could result not just from ionizing radiation such as x-rays, but also from non-ionizing radiation such as microwaves and visible light. }{\insrsid1586534 An }{\insrsid1472698 accident in Pennsylvania}{\insrsid1586534 during the legislative hearings}{\insrsid1472698 prompted passage of the Radiation Cont}{\insrsid10241955 rol for Health and Safety Act of}{\insrsid1472698 1968}{\insrsid1586534 (\'93RCHSA\'94)}{\insrsid1472698 .}{\insrsid9791959 \par }{\insrsid1472698 \tab While the act was admittedly a compromise weakened by manufact}{\insrsid5376775 urers\rquote lobbying efforts, it }{\insrsid1472698 still provided the}{\insrsid5849329 Food and Drug Administration}{\insrsid1586534 (\'93FDA\'94)}{ \insrsid5376775 with vast authority}{\insrsid1472698 }{\insrsid5376775 to conduct research, }{\insrsid1472698 to set safety standards}{\insrsid5376775 ,}{\insrsid1472698 to monitor compliance, and to impose civil penal}{\insrsid10241955 ties}{ \insrsid5376775 . Research quickly led to technological advances in the electronic devices themselves}{\insrsid401560 and contributed}{\insrsid5376775 to a better understanding of the biological harms }{\insrsid5849329 associated with radiation exposure. The FDA al so began a public education campaign to alert consumers to the protective measures they should take in using certain electronic products. The primary focus of the act, however, was the setting of enforceable radiation standards. }{\insrsid15940839 The early standards revealed that measures needed to produce safe electronic products were typically low cost and easy.}{\insrsid8532055 In the absence of enforceable standards,}{\insrsid401560 however,}{\insrsid8532055 there had been little incentive to expend }{\insrsid13652315 resources in this area.}{\insrsid13114373 \par \tab The RCHSA\rquote s early success is partially attributable to the cooperation between the Bureau of Radiological Health and the manufacturers, and the commitment of federal resources to achieve the act\rquote s goals. Both factors are now declining. }{\insrsid13258780 }{\insrsid13114373 The FDA must now prioritize its activities under not just the RCHSA, but related statutes such as the Medical Devices}{\insrsid16731 Amendments and the Mammography Quality Standards Act}{\insrsid13114373 . With the rapid development of}{\insrsid16731 technology, it is expected}{\insrsid13114373 that new radiation-emitting products will be produced. Should the FDA invest resources to determine the dangers of these products, or s}{\insrsid401560 hould it}{\insrsid16731 trust professional organizations to set appropriate standards}{\insrsid13114373 and instead devote its resources to monitoring and enforcement? The FDA\rquote s ability to spread its message on the internet }{\insrsid10619867 quickly }{\insrsid13114373 is countered by the rise of a rather uninformed popular media more interested in ratings than science. }{\insrsid10619867 T}{\insrsid13114373 he media has great power to promote a single unsubstantiated study}{\insrsid10619867 or freak accident}{\insrsid13114373 and consequently}{\insrsid10619867 the ability to undo years }{\insrsid13114373 of research and publ}{\insrsid10619867 ic education by the FDA.}{\insrsid401560 Well-considered collaboration with the popular media may be the next logical step in ensuring a safe and knowledgeable citizenry.}{\insrsid13258780 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid10619867 Not to be overlooked, however, is the fact that the prob}{\insrsid10241955 lems facing the FDA regarding}{ \insrsid10619867 radiation exposure are relatively mild when compared to the problems of the 1970\rquote s and 1980\rquote s. Radiation-emitting electronic products that comply}{\insrsid11276866 with federal }{\insrsid10619867 standards are now safe}{ \insrsid401560 , and concern has shifted to improper uses}{\insrsid10619867 . While the FDA may have more trouble detecting the rog ue manufacturer trying to save a little money by producing substandard products, many factors other than the chance of FDA detection }{\insrsid1114424 strongly }{\insrsid4347211 advise against short cuts. }{\insrsid11276866 Unlike the manufacturers in the 1970\rquote s who had to conduct expensive research to produce safe products}{\insrsid4156976 , the technology }{\insrsid14680842 is now well-developed and commonplace in the manufacturing of electronic product}{ \insrsid10241955 s}{\insrsid14680842 . The RCHSA accomplished the goals set by Congress in 1968, and, consequently, today\rquote s regulators are left with a l}{\insrsid5197850 esser burden. The FDA\rquote s }{\insrsid14680842 ch allenge will be with newer technol}{\insrsid8914303 ogy whose long-term effects are not yet known.}{\insrsid14908102 \par }{\insrsid5197850 This paper discusses the progress of the Radiation Control for Health and Safety Act of 1968. It begins with an extensive discussion of the legislative history. A thorough u nderstanding of the state of the law and of science prior to the passage of the act is essential to evaluate properly the contributions the act has made. It then discusses the major provisions of the act, the extent of the FDA\rquote s authority, and the adminis trative network in which it operates. This is followed by a discussion of the regulation of specific products, namely, x-ray devices, microwaves, sunlamps, lasers, and cell phones. The history of the regulation of these products further explains the FDA \rquote s authority under the RCHSA. The final section summarizes the contributions the act has made to society by discussing the value of both the enforceable standards and the commitment to public education. The RCHSA has resulted in products that are protect ive of human health and a public that is aware of the dangers of excess radiation and is changing some of its behaviors accordingly. \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11039173 {\scaps\insrsid10241955\charrsid11039173 II. The Road to Federal Radiation Control}{\scaps\insrsid14908102\charrsid11039173 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 \tab The Radiation Control for Health and Safety Act was enacted on October 18, 1968, as an amendment to the Public Health Service Act \'93to provide for the protection of the public health from radiation emissions from electronic products.\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131003293}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Pub. L. 90-602, 82 Stat. 1173 (1968).}}}{\insrsid14908102 {\*\bkmkend _Ref131003293} Prior to its enactment, radiation exposure had been regulated largely by the states}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref130977613}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The Atomic Energy Act of 1946 gave the Atomic Energy Commission ( \'93AEC\'94) authority to regulate certain artificial radioactive materials, but its jurisdiction did not extend to consumer goods or medical devices. Alan R. Bennett & Robert A. Dormer, }{\i\insrsid4204783 FDA and Radiological Health: Pro tecting the Public From Radiation Hazards}{\insrsid4204783 , }{\i\insrsid4204783 in}{\insrsid4204783 }{\scaps\insrsid4204783 II Fundamentals of Law and Regulation}{\insrsid4204783 299, 299 \endash 300 (David G. Adams, Richard M. Cooper, & Jonathan S. Kahan eds., 1997). }}}{\insrsid14908102 {\*\bkmkend _Ref130977613} based on recommendations from the Advisory Committee on X-Ray and Radiation Protection.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref130980766}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 299. The organizat ion was composed of industry representatives and was later renamed the National Council on Radiation Protection. Though it received a congressional charter in 1964, it remained a private body. }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{ \insrsid14908102 {\*\bkmkend _Ref130980766} \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 High dose radiation had long been known to be fatal. Large-scale atmospheric testing of nuclear weapons and the resulting radioactive fallout prompted the Eisenhower Administration to unify radiation control activities in the Public Health Service in 1958}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref130981203}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Robert T. De Vore, }{\i\insrsid4204783 New FDA Resource: Consumer Radiation Protection}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Papers}{ \insrsid4204783 , Oct. 1971, at 4.}}}{\insrsid14908102 {\*\bkmkend _Ref130981203} and to create the Federal Radiation Council in 1959.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{ \insrsid4204783 , at 300. Like the National Council on Radiation Protection, the Federal Radiation Council served solely as an advisory body. It was composed of heads of executive agencies but relied on the President to direct other agencies to comply with the standards it suggested. }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The National Center for Radiological Health (\'93NCRH\'94 ) was established in 1967.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . The Center also served a purely advisory function. It later became the Food and Drug Administration\rquote s (\'93FDA\'94) former Bureau of Radiological Health and is now the Center for Devices and Radiological Health (\'93CDRH\'94). }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 However, as the nation entered the \'93electronics age\'94 and saw a \'93 vast expansion in the number, diversity, and usefulness of electronic products,\'94 the reliance on advisory committees and inconsistent state regulations proved insufficient.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 4.}}}{\insrsid14908102 Potentially dangerous radiation was now known to emit not just from x-ray machines and nuclear weapons, but also }{\insrsid7086891 from }{\insrsid14908102 standard consumer goods such as color televisions and microwave ovens.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The need for uniform and enforceable federal safety standards was clear. \par }{\insrsid7086891 A. The TV D}{\insrsid14908102 ebacle \par The shortcomings of the absence of federal regulation of radiation-emitting products were revealed i}{\insrsid1586534 n May 1967 when GE}{\insrsid14908102 recalled 90,000 color television sets believed to emit dangerous levels of radiation. Representative Paul G. Ro}{\insrsid7086891 gers noted that GE}{\insrsid14908102 notified NCRH in January of that year of t he potential problem but delayed taking immediate action in favor of conducting new studies.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131003307}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 113 }{\scaps\insrsid4204783 Cong. Rec.}{\insrsid4204783 13628 (1967) (statement of Paul G. Rogers), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 I }{\scaps\insrsid4204783 Legislative History of Radiation Control for Health and Safety Act of 1968}{\insrsid4204783 2 (U.S. Bureau of Radiological Health 1975) [hereinafter \'93I }{\scaps\insrsid4204783 Legislative History\'94]}{\insrsid4204783 .}}}{\insrsid14908102 {\*\bkmkend _Ref131003307} A letter issued by NCRH on May 18, }{\insrsid7086891 1967, commended GE}{ \insrsid14908102 \rquote s voluntary recall and simply stated that \'93[a]s of now there is no evidence in the hands of NCRH}{\insrsid10241955 to suggest that any television}{\insrsid14908102 receivers\'85 have excessively exposed viewers of television sets.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 113 }{\scaps\insrsid4204783 Cong. Rec. }{\insrsid4204783 13628, 13629}{\scaps\insrsid4204783 (1967), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 2}{\scaps\insrsid4204783 }{\insrsid4204783 (letter of James G. Terrill, Jr.).}}}{ \insrsid14908102 Rogers informe}{\insrsid1586534 d the House that he wrote to the Department of Health, Education, and Welfare (\'93HEW\'94)}{\insrsid14908102 regarding his concern over potential radiation emissions from televi sions and was told that any radiation emission was negligible. }{\cs16\super\insrsid14908102 }{\insrsid14908102 Rogers learned the morning of May 23, 1967, that the Public Health Service believed \'93 that the level of radiation could reach as much as 600 times of the amount recognized as the safe level\'94 yet had taken no action. He called for public hearings to determine the extent of the danger and to take effective action.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 On June 13, 1967, Rogers and John Jarmin introduced House Bill 10790, which eventually became the Radiation Control for Health and Safety Act.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Radiation Control for Health and Safety Act of 1967, H.R. 10790, 90th Cong. (1967), }{\i\insrsid4204783 reprinted in }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst { \insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 4.}}}{ \insrsid14908102 \par On June 22, 1967, Representative John E. Moss, Chairman of the Subcommittee on Commerce and Finance, discussed his findings concerning the}{\insrsid10241955 NCRH letter}{\insrsid14908102 . Concerned about James Terrill\rquote s statement that viewers were not known to have been excessively exposed to radiation, Moss asked Terrill to explain the basis for NCRH\rquote s determination. Moss described the reply as \'93at the very minimum\'85 startling.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 113 }{ \scaps\insrsid4204783 Cong. Rec. }{\insrsid4204783 16964, 16965 (1967), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{ \insrsid4204783 , at 6 (statement of John E. Moss).}}}{\insrsid14908102 Terrill revealed that although the radiation leakage beam was directed downward, NCRH believed that the height at which some televisions were placed did result in exposure to excessive radiation. Additionally, people sitting close to televisions could be exposed to excessive radiation. The radiation was not ex}{\insrsid14881004 pected to affect people who}{\insrsid14908102 watched television in \'93normal viewing\'94 conditions, thou}{\insrsid14881004 gh it was possible that even tho}{\insrsid14908102 se people could be overexposed. Terrill concluded that \'93 any color television receiver suspected of emitting excessive X-radiation which could expose individuals in other than a normal viewing situation should not be operated in that location [until repaired].\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . (letter of James G. Terrill, Jr.).}}}{\insrsid14908102 Based on NCRH\rquote s verification of the dangers, Moss asked for hearings to reassure the public that the government would prevent unsafe products from entering the marketplace.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par The Senate introduced versions of the bill to the Committee on Commerce}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 S. 2067, 90th Cong. (1st Sess. 1967), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 12.}}}{\insrsid14908102 and the Committee on Labor and Public Welfare}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 S. 2075, 90th Cong. (1st Sess. 1967), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 14.}}}{\insrsid14908102 on July 10, 1967. The House introduced a total of seven bills between June and August of 1967.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 301.}}}{\insrsid14908102 Representative Jarmin announced that the House Subcommittee on Public Health and Welfare would begin hearings on x-radiation related to color televisions on August 14, 1967.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 113 }{\scaps\insrsid4204783 Cong. Rec. 20483 (1967),}{ \insrsid4204783 }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 19}{\scaps\insrsid4204783 .}}}{\insrsid14908102 \par B. The Initial House Hearings \par The initial hearings on House Bill 10790 concerned radiation emissions from televisions. Several government witnesses noted that federal regulation }{\insrsid14881004 would have protected consumers from unnecessary and excessive radiation exposure by preventing the GE}{\insrsid14908102 televisions from e}{\insrsid14881004 ver reaching the marketplace}{\insrsid14908102 . The existing laws provided the federal governm ent with no authority to enforce standards or to require testing or reporting of potential radi}{\insrsid14881004 ation hazards. GE}{\insrsid14908102 acted responsibly in recalling and repairing the televisions, but it was not compelled to do so by law. }{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131022469}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Radiation Control for Health and Safety Act of 1967: Hearings on H.R. 10790 Before the House Subcomm. of Pub. Health and Welfare of the Comm. on Interstate and Foreign Commerce}{\scaps\insrsid4204783 ,}{ \insrsid4204783 90th Cong. 8 (1st Sess. 1967) (statement of Horace R. Kornegay), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{ \insrsid4204783 , at 82 [hereinafter \'93}{\i\insrsid4204783 1967 House Hearings}{\insrsid4204783 \'94]. General Electric (\'93GE\'94) actually provide d technical assistance to NCRH during the hearings regarding its improved testing procedures, and NCRH modeled its study of televisions on the revised GE monitoring program. }{\i\insrsid4204783 Radiation Control for Health and Safety Act: Supplemental Hearing on H.R. 10790 Before the House Subcomm. on Pub. Health and Welfare of the Comm. on Interstate and Foreign Commerce}{\insrsid4204783 , 90th Cong. 20 (2d Sess. 1968) (statement of James G. Terrill, Jr.) [hereinafter \'93}{\i\insrsid4204783\charrsid2848475 1968 House Hearings}{\insrsid4204783 \'94], }{\i\insrsid4204783 reprinted in}{\insrsid4204783 II}{\scaps\insrsid4204783 Legislative History of Radiation Control for Health and Safety Act of 1968}{\insrsid4204783 637, 649 (U.S. Bureau of Radiological Health 1975) [hereinafter \'93II }{\scaps\insrsid4204783 Legislative History\'94].}}}{\insrsid14908102 {\*\bkmkend _Ref131022469} Wilbur }{\insrsid5660799 J. Cohen }{\insrsid14908102 stated that 7.4 mill ion color television receivers had been manufactured in the United States in the previous two years but that no one knew how many of those sets were emitting hazardous radiation. While the Public Health Service had begun a program to evaluate radiation e xposure from television sets, little was being done about other electronic devices also believed to emit radiation. Cohen supported the bill\rquote s grant of authority and responsibility to HEW to conduct research and control radiation hazards.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 5 \endash 6 (Letter of Wilbur J. Cohen).}}}{\insrsid14908102 \par The increasing use of electronic products that inherently release radiation reinforced awareness of the dearth of knowledge regarding the dangers of radiation exposure. Following the television recall and the government\rquote s conflicting statements regarding potential dangers, consumers were left with little confidence that their home products were safe. Representative Jarmin summarized the current state of the knowledge: \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid14908102 It is my understanding that, unless exposure has been sufficiently intense to produce bodily injury which would be quickly apparent, the health effects from radiation may not appear for years and even may not become manifest except in some aberration in children born to a parent who had been unknowingly irradiated. What confronts us is an invisible enemy of human health which often may work in ways imperceptible to the victim of [sic] his or her physician to produce effects which may be harmful to more than one generation of a family. Electromagnetic radiation, which many kinds of electronic products produc e in various forms, is something that all persons should avoid completely.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 8 \endash 9 (Statement of Horace R. Kornegay).}}}{\insrsid14908102 \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid5261810 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 Dr. William H. Stewart, Surgeon General, elaborated: \'93I think the odds [of genetic damage res}{\insrsid11272448 ulting from the GE}{\insrsid14908102 televisions] are very low. When one is talking odds there is always that one or two. That is why we feel it is terribly important that these sets get back.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 16 (Statement of Dr. William H. Stewart). }}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid11272448 Congress}{\insrsid14908102 recognized that the general lack of knowledge had to be corrected before effective standards could be established.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 10 (Statement of L. H. Fountain).}}}{\insrsid14908102 Among the potential }{\insrsid1586534 known }{\insrsid14908102 dangers of r adiation exposure in general were leukemia and other cancers, cataracts, burns, sterility, and other birth defects. While the dangers of high dose radiation exposure were well documented, the effects of low dose exposure resulting from standard consumer products in the home represented a major gap in knowledge.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 14 \endash 15 (Statement of Dr. William H. Stewart). Dr. Stewart testified in detail about the potential dangers related to t he GE televisions and the 1,800 sets that GE had not been able to recover. His full testimony can be found in the 1967 Hearings at 10 \endash 18. James G. Terrill, Jr., the director of NCRH, provided testimony on the technical details of radiation, including h ow electronic products generate radiation, why the GE televisions leaked radiation, the potential biological effects of excessive radiation exposure, and other potential emitters of radiation. Mr. Terrill also presented a study entitled \'93 Radiation Exposure in Parents of Children with Mongolism (Down\rquote s Syndrome),\'94 which concluded that \'93there appears to be a definite association between maternal exposure to ionizing radiation and Mongolism.\'94 }{\i\insrsid4204783 Id}{ \insrsid4204783 . at 18 \endash 76. Technical testimony on different types of radiation and ways manufacturers could protect consumers from excessive radiation was provided by James F. Young, Vice President of Engineering for General Electric. }{ \i\insrsid4204783 Id}{\insrsid4204783 . at 150 \endash 189.}}}{\insrsid14908102 The need for a federal research program was clear. Of particular concern in establishing a research program was the large number of programs involved in the current }{ \insrsid5197850 f}{\insrsid14908102 ederal regulatory system. Representative L. H. Fountain estimated that federal grants included \'93more than 175 general programs funded under more than 400 separate agencies\'85 administered by 19 different departments and agencies and by more than 140 separate Federal bureaus and divisions.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 1967 House Hearings}{\insrsid4204783 , }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 10 (Statement of L. H. Fountain).}}}{\insrsid14908102 The proposed bill would authorize the Secretary of HEW to administer the radiation program within its current structure and would eliminate the need for another new agency or bureau.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par The House debates initially}{\insrsid11272448 focused on the GE}{\insrsid14908102 televisions but qui ckly expanded to include other radiation concerns. The hazards of increased medical and dental x-ray use and methods currently utilized to limit radiation exposure were thoroughly discussed.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 193 \endash 208 (Statement of James W. Nelson, Jr.).}}}{\insrsid14908102 The American College of Radiology urged enforceable national standards and \'93federal responsibility for fixing and enforcing standards for medical x-rays.\'94 The College requested that funding be provided for research and training to minimize radiation exposure not just to the patient, but also to the radiologists and x-ray technologists who are constantly exposed to x-ray machines.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . at 320 \endash 29 (Statement of the American College of Radiology).}}}{\insrsid14908102 Dr. Karl Z. Morgan, Director of the Health Physics Division at Oak Ridge National Laboratory, believed the primary concern should be the elimination of unnecessary or wasteful diagnosti}{\insrsid5197850 c exposure. Noting that over ninety}{ \insrsid14908102 percent of all exposure in the United States was due to medical exposure, Dr. Morgan believed total exposure to manma}{\insrsid5197850 de sources could be as low as nineteen}{\insrsid14908102 percent of the current value if the use of x-ray diagnostic procedures were more carefully scrutinized.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 363 \endash 67 (Statement of Dr. Karl Z. Morgan).}}}{\insrsid14908102 Dr. Morgan disputed the assumption of some doctors that the probability of pregnancy was low and that x-ray examinations therefore resulted in very little hazard.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 366 \endash 67. In fact, a report of the U .S. Public Health Service indicated that 4.1 million women had live births in 1963. Of these women, 915,000 had one or more medical x-ray visits during pregnancy, while 420,000 had one or more dental x-ray examinations. The report estimated that twenty- two percent of pregnant women had one or more x-ray examinations during pregnancy. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 367.}}}{\insrsid14908102 He was particularly concerned about a March 1957 re port that stated that some obstetricians advocated the use of pelvimetry as part of a routine examination.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 367. Dr. Morgan admitted that studies of the relationship between in utero exposure and childhood cancer were mixed, but that a report by Dr. Brian McM ahon combined all of the data and found that mortality from leukemia and other cancers was 40 percent higher in children who had been exposed to diagnostic x-ray in utero. The excess risk due to in utero exposure amounted to about one cancer death per 2, 000 children exposed. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 369 \endash 70.}}}{\insrsid14908102 Dr. Morgan also confirmed that occupational exposure had previously resulted in short}{\insrsid11272448 er}{\insrsid14908102 life spans for radiologists but that current t}{\insrsid2123127 echniques had }{\insrsid14908102 eliminated the risk.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 371.}}}{ \insrsid14908102 Dr. Morgan concluded by providing a list of sixty-three ways to reduce medical diagnostic exposure.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 375 \endash 377. The recommendations covered such topics as education and training; rules, records, legal matters, and inspections; x-ray equipment and safety devices; x-ray films and associated equipment; and techniques and procedures.}}}{\insrsid14908102 \par The American Dental Association (\'93ADA\'94) contested the conclusions drawn by Dr. Morgan and others who testified before the House. D r. Albert G. Richards, speaking for the ADA, emphasized the importance of dental x-rays and the level of training dentists and hygienists receive}{\insrsid11272448 d}{\insrsid14908102 regarding radiology and radiation protection. Dr. Richards discussed the ADA\rquote s private efforts to educate it s members through videos, essays, and clinical presentations, and its public efforts to register x-ray units and to encourage compliance with state radiation laws.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 408 \endash 12 (Statement of Dr. Albert G. Richards).}}}{\insrsid14908102 Dr. Richards\rquote statements were in direct contradiction to a survey of dental x-ray units in Pinellas Count}{\insrsid11272448 y}{\insrsid14908102 , Florida. The survey concluded that dental x-rays constituted an important source of unnecessary exposure; that a large percentage of dentists and dental technicians had inadequate training; that x-ray sales and repair personnel were inad equately trained to make proper adjustments to protect patients and office personnel; that the greatest source of unnecessary exposure resulted from bad technique; and that public health or other government involvement was necessary for optimum protection .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 George R. McCall & Clyde H. Stagner, }{\i\insrsid4204783 Report of Initial Survey of Dental X-Ray Units, Pinellas County (Fla.) Health Department}{\insrsid4204783 , }{\i\insrsid4204783 reprinted in 1967 House Hearings}{\insrsid4204783 , }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 413. Pinellas County began surveying dentists\rquote offices in 1961 but decided to resurvey the offices following a request from a dentist. The second survey determined that the dentist had been overexposing h imself to radiation for five years. Another survey revealed that a dentist and his assistant had received excessive radiation to their hands due to the practice of holding dental film in patients\rquote mouths during x-ray exposure. Of the forty-three offices and seventy-one dental x-ray units surveyed, \'93 34 timers were inaccurate, 15 required additional filtration, 8 required proper collimation. Three offices had inadequate x-ray protection for personnel, two dental units lacked preset timers to stop x-ray exp osures, and in seven dental offices personnel were holding the dental film during x-ray exposures. In addition, gonadal shielding was used in only five offices and only fourteen dark rooms were adequately light tight. In almost every office recommendati ons were made for the reduction of personnel exposure to radiation\'85.\'94 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 415.}}}{\insrsid11272448 }{\insrsid14908102 Rogers commended the ADA on its awareness of the problem of unnecessary radiation exposure and its efforts to regulate privately but noted that considerable work needed to be done at a mo}{\insrsid11272448 re accelerated pace}{\insrsid14908102 .}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 416.}}}{\insrsid14908102 \par At the close of the 1967 hearings, an accident occurred at the Van de Graaff accelerator facility at Gulf Oil\rquote s Research and Development Laboratory in Pennsylvania that}{\insrsid13065359 further}{\insrsid14908102 demonstrated the problems resulting from the absence of federal regulation.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 301.}}}{\insrsid14908102 On October 4, 1967, three employees at the facility were conducting}{\insrsid13065359 a}{\insrsid14908102 standard x-ray analysis on an oil sample. The oil sample was pl}{\insrsid2123127 aced in the accelerator in the target room}{\insrsid14908102 and the employees returned to the accelerator control console. The target room and the control console were separated by tw o doors, and the accelerator, control console, and doors were connected by a safety interlock system. After the sample had been irradiated, the op}{\insrsid13320738 erator removed the}{\insrsid14908102 key from the control console,}{\insrsid13320738 proceeded through the two doors, and removed the sample.}{\insrsid14908102 The employees noticed}{\insrsid13320738 that}{\insrsid14908102 the cooling system was not working properly. While one chemist left with the sample, the two other men remained in the room to try to repair the system. One man began feeling ill some time after and was sent to the hospital. An evaluation of the film badges the men had been wearing revealed that they had all been exposed to relatively high levels of radiation. The accelerator had not shut off after irradiating the sample}{\insrsid13320738 despite the four separate measures that should have shut it off}{\insrsid14908102 . Exposure was believed to be as long as twenty-four minutes. It was unclear if this was due to human error or the failure of the safety interlock system.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 426 \endash 28 (Statements of James G. Terrill and Dr. Raymond T. Moore).}}}{ \insrsid14908102 \par Further investigation indicated that the company received the results of the film badge evalu ations two days after the accident and immediately notified the Pennsylvania Department of Health. NCRH was not notified until October 10, or six days after the accident, as there was no duty to notify the federal government following serious x-ray expos ure. The interlock system had not been checked prior to the accelerator\rquote s activation because the state and the company did not require routine checks. The target room provided no visible or audible indication that the accelerator had not been turned off. Dr. Raymond T. Moore, who visited the facility after the incident, stated that it would be very difficult for an individual to identify the noise of a running accelerator. Mr. Terrill and Dr. Moore recommended mandatory notification in cases of serious x-ray exposure to ensure high quality medical care, and a requirement to check f}{\insrsid10241955 ail-safe systems}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 430 \endash 31.}}}{ \insrsid14908102 This incident concluded the initial hearings on House Bill 10790.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131769364}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Several statements were submitted for the record following the close of the hearings. Professor Russell H. Morgan recomme nded that the bill include only ionizing radiation because it was the only form of radiation known to produce biological effects. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 435. However, this seemed clearly to contravene a central purpose of the bill, which was to understand the effects of all forms of radiation on consumers to ensure maximum protection. The American College of Radiology noted that the benefits of properly administered x-ray procedures outweighed the risk but recognized that other consumer goods provided no comparable ben efit and should not require technical proficiency for safe operation. It therefore supported federal standards for all radiation emitting products. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 441 \endash 42. Two studies on microwave ovens were also presented. }{\i\insrsid4204783 See}{\insrsid4204783 H. S. Seth & S. Michaelson, }{\i\insrsid4204783 Microwave Hazards Evaluation}{\insrsid4204783 , 35 }{\scaps\insrsid4204783 Aerospace}{\insrsid4204783 , Aug. 1964, }{\i\insrsid4204783 reprinted in 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 453; Joseph H. Vogelman, }{\i\insrsid4204783 A Comparative Analysis of Biological Effects of Microwave Energy}{\insrsid4204783 , }{\i\insrsid4204783 reprinted in 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 460.}}}{\insrsid14908102 {\*\bkmkend _Ref131769364} \par }{\insrsid10241955 C}{\insrsid14908102 . The Initial Senate Hearings \par The initial Senate Hearings on Senate Bill 2067 began on August 30, 1967.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131177846}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783\charrsid13065359 Radiation Control for Health and Safety Act of 1967: Hearing}{\i\insrsid4204783 s}{ \i\insrsid4204783\charrsid13065359 on S. 2067 Before the Senate Comm. }{\i\insrsid4204783 o}{\i\insrsid4204783\charrsid13065359 n Commerce}{\insrsid4204783 , 90th Cong. 1 (1st Sess. 1967), }{\i\insrsid4204783 reprinted in }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 364 [hereinafter \'93}{\i\insrsid4204783 1967 Senate Hearings}{\insrsid4204783 \'94 ].}}}{\insrsid14908102 {\*\bkmkend _Ref131177846} The Senate began by modifying the act to provide more discretion to HEW by expanding coverage to include, but not be limited to, the entire range of radiation emitting devices.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 1967 Senate Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131177846 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003100370037003800340036000000}}}{\fldrslt {\insrsid4596385 44}}}{\insrsid4204783 , at 3.}}}{\insrsid2123127 }{\insrsid14908102 Senator E.L. Bartlett stated that a federal radiation control program would supplement current state, local, and regional programs. The Senate\rquote s current bill only regulated standards prior to introduction into commerce, with inspections and regulations post-sale being left to the states. Senator Bartlett noted, h owever, that the course of the hearings could reveal the need for federal regulation post-sale following the model of the Atomic Energy Commission}{\insrsid2123127 (\'93AEC\'94)}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 5.}}}{ \insrsid14908102 \par The testimony of Hanson Blatz, director of the Office of Radiation for the New York City Department of Health, illustrated the strengths and weaknesses of local regulation. While the New York City Department of Health had adopted and enforced standards to protect citizens from excessive or unnecessary radiation, citizen inquiries and complaints reveal e d that unnecessary radiation was being emitted from wrist and pocket watches; religious articles; static eliminators; voltage rectifier tubes; radioactive blankets; bandages; electric heating pads; and television sets. Additionally, considerable quantiti es of radium had been lost by phys}{\insrsid10241955 icians, generally the result of}{\insrsid14908102 carelessness on the part of the shippers, users, and carriers. However, a local law that revoked physicians\rquote licenses to possess radium if the loss occurred due to carelessness had been successful in essentially eliminating losses.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 11 \endash 12 (Statement of Hanson Blatz). Between 1963 and 1965, there had been nine losses of r adium, all due to carelessness. After the health commissioner notified the physicians of the revocation policy, only one loss occurred. The lost radium was eventually recovered. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 12.}}}{\insrsid14908102 New York State required the licensing of x-ray technicians, a clear step to improve the quality and safety of x-ray procedures, but Mr. Blatz noted that only fifteen percent of x-ray operators fell within this ca tegory. The majority of owners and users of x-ray equipment were physicians in private offices who had no formal training in radiology. Shielding of x-ray equipment to protect passersby was dependent on an honor system that many operators overlooked. T he New York City system actually represented what Mr. Blatz believed was the most comprehensive radiation control program in the country.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 16 \endash 18. New York City had an office and laboratory with forty-five people devoted to radiation control. Other cities had programs through their states\rquote health departments, and none exercised the control that New York City did over radiation emissions. New York State had a division of radiological health, b ut it depended on counties to develop individual programs. It had no enforcement authority, which resulted in some counties being quite inactive. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 17.}}}{\insrsid14908102 Though Mr. Blatz did not believe that a federal research program for x-rays was necessary,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Mr. Blatz believed the hazards of x-rays and the methods of limiting excess or unnecessary radi ation exposure were well known and therefore did not require additional research. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 18. He submitted an article that detailed his research on radiation exposure and methods of reduction. Hanson Blatz, }{ \i\insrsid4204783 Common Cause of Excessive Patient Exposure in Diagnostic Radiology}{\insrsid4204783 , }{\i\insrsid4204783 reprinted in }{\i\insrsid4204783\charrsid9529827 1967 Senate Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{ \insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131177846 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003100370037003800340036000000}}}{\fldrslt { \insrsid4596385 44}}}{\insrsid4204783 , at 25. Dr. Karl Z. Morgan disagreed with Mr. Blatz\rquote s conclusions, however. Dr. Morgan believed that research in the United States was actually lagging be hind research conducted by the Soviet Union regarding the effects of ionizing radiation on the central nervous system. While Dr. Morgan agreed with Mr. Blatz\rquote s statement that more was known about the effects of radiation than other environmental hazards, he noted that the fortunate lack of radiation accidents had resulted in limited data on the effects on humans. Dr. Morgan therefore suggested improved mandatory training in radiology; a federal research program; federal inspections of x-ray devices (both he and Mr. Morgan noted the common use of outdated x-ray devices and the attendant dangers); and specific standards for maximum dose exposure. }{\i\insrsid4204783\charrsid9529827 1967 Senate Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{ \insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131177846 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003100370037003800340036000000}}}{\fldrslt { \insrsid4596385 44}}}{\insrsid4204783 , at 35 \endash 38.}}}{\insrsid14908102 he supported federal radiation standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783\charrsid9529827 1967 Senate Hearings}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131177846 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003100370037003800340036000000}}}{\fldrslt {\insrsid4596385 44}}}{\insrsid4204783 , at 18 \endash 20. Mr. Blatz also noted that enforcement of standards was actually fairly easy. An example included watches that were manufactured with radium to allow them to glow. It was discovered that young people often placed the watches near their abdomens, only inches from their reproductive organs, and that the watches exceeded allowable exposure limits set out in the New York City Health Code. Mr. Blatz\rquote s department notified the manufacturers and policed a few store s where the watches were sold. The manufacturers learned quickly that the watches could not be sold in New York City and removed them from the market. Mr. Blatz believed that the watches were exported to be sold elsewhere. }{\i\insrsid4204783 Id}{ \insrsid4204783 . at 18 \endash 19.}}}{\insrsid2123127 He }{\insrsid14908102 agreed that authority should be given to set standards for microwave ovens, laser equipment, and electronic}{\insrsid2123127 heating equipment}{\insrsid14908102 .}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . at 23.}}}{\insrsid14908102 \par The current federal regulatory regime was outlined towards the end of the hearings. Government regulation of radiation was \'93 divided among the fifty State governments, several city governments which have been granted such authority, six Federal departments, a Federal Council, and a Federal Commission.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Warren H. Donnelly, }{\i\insrsid4204783 Federal Authority to Set Standards for Radiation}{\insrsid4204783 , }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\i\insrsid4204783\charrsid9529827 1967 Senate Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131177846 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003100370037003800340036000000}}}{\fldrslt {\insrsid4596385 44}}}{ \insrsid4204783 , at 339, 358.}}}{\insrsid14908102 The Department of Agriculture set standards for bacon ir radiation. HEW administered the Public Health Service and NCRH, but neither department had authority to enforce standards. The FDA regulated the effects of radiation}{\insrsid9529827 in food processing but not}{\insrsid14908102 the effects of exposure on the processors or the public. The Department of Interior had authority to regulate health effects related to mining, which technically c}{\insrsid2123127 overed exposure to radiation}{\insrsid14908102 . The Department of Transportation regulated the transport of dangerous materials, including radioactive materials. The Dep artment of Labor had recently begun regulating radiation exposure in uranium mining. The Bureau of Standards of the Department of Commerce had been conducting research on x-rays but had no authority to set standards. The Federal Radiation Council advise d the President on radiation matters but also had no enforcemen}{\insrsid2123127 t authorities. The AEC}{\insrsid14908102 had the most extensive experience and regulatory authority, but its aut}{\insrsid87600 hority was limited to the use of source, byproduct, and special nuclear material}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 358 \endash 60.}}}{\insrsid14908102 The study recom mended further research prior to setting standards and a federal radiation program in the model}{\insrsid2123127 of the AEC}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 371.}}}{ \insrsid14908102 \par Several months after the close of the initial Senate Hearings, Senator Bartlett summarized the }{\insrsid5197850 current state of }{\insrsid14908102 radiation exposure.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 113 }{\scaps\insrsid4204783 Cong. Rec.}{\insrsid4204783 36229 (1967), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 I Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131003307 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000300033003300300037000000}}}{\fldrslt {\insrsid4596385 11}}}{\insrsid4204783 , at 618.}}}{\insrsid14908102 Radiation exp osure had become a serious problem because of the increased use by physicians, dentists, radiologists, engineers, and other professions, and because technological advances had created many new sources of radiation.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 36231.}}}{\insrsid14908102 Senator Randolph noted that there was l ittle current consumer danger related to microwaves and lasers because most uses were within the government. Consequently, the biological effects of radiation from microwave or laser use had not been well studied. Senator Bartlett anticipated, however, t hat technological advances would greatly increase their use in basic consumer products and noted that further hearings would be held to discuss these sources.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref134273161}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 36240. Testimony was eventually received on the Army's policy regarding x-rays and lasers. }{\i\insrsid4204783 Radiation Control for Health and Safety Act: Hearings on S. 2067, S. 3211, and H.R. 10790 Before the Comm. on Commerce}{\insrsid4204783 , 90th Cong. 764 (2d Sess. 1968), }{\i\insrsid4204783 reprinted in}{\insrsid4204783 }{\scaps\insrsid4204783 II Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 736, 934 [hereinafter \'93}{\i\insrsid4204783 1968 Senate Hearings}{\insrsid4204783 \'94]. }}}{\insrsid14908102 {\*\bkmkend _Ref134273161} \par }{\insrsid10241955 D}{\insrsid87600 . The Passage of }{\insrsid14908102 House Bill 10790 \par In President Lyndon Johnson\rquote s February 6, 1968, message to Congress, he advocated passage of the Hazardous Radiation Act: \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid14908102 It has been said that each civilization creates its own hazards. Ours is no exception. While modern technology has enriched our daily lives, it has sometimes yielded unexpected and unfortunate side effects\'85 Now modern science must be put to work on these hazards \endash particularly the hazards which confront the consumer. The [Radiation Control for H}{\insrsid87600 ealth and Safety Act] will give}{\insrsid14908102 the Secretary of Health, Education, and Welfare authority to conduct intensive studies of the hazards and set and enforce standards to control them, [and] require manufacturers to recall defective equipment and devices.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Lyndon Johnson, }{\i\insrsid4204783 Consumer Interest Message to Congress}{\insrsid4204783 , Feb. 6, 1968, }{\i\insrsid4204783 reprinted in}{\insrsid4204783 26 }{\scaps\insrsid4204783 Cong. Q.}{\insrsid4204783 255 }{\scaps\insrsid4204783 (1968).}}}{\insrsid14908102 \par }{\insrsid5261810 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid16059413 On March 2}{\insrsid14908102 0, 1968, the House of Representatives passed and sent to the Senate House Bill 10790. The Hou se Interstate and Foreign Commerce Committee weakened the bill before passage by extending the time for compliance with federal standards from between six months and one year to one year and two years, respectively, and by reducing the maximum civil fine from $400,000 to $200,000. The House Committee also required that the Secretary of HEW consult with the Commerce Secretary for programs on testing and evaluating radiation and added a provision allowing appeals to the courts.}{ \cs16\super\insrsid14908102 {\*\bkmkstart _Ref134373518}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\insrsid4204783\charrsid5197850 114}{\insrsid4204783 }{\scaps\insrsid4204783\charrsid16059413 Cong. Rec.}{\scaps\insrsid4204783 }{\insrsid4204783 7062 (1968), }{\i\insrsid4204783 reprinted in }{\insrsid4204783 II }{ \scaps\insrsid4204783 Legislative History}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 713. }{\i\insrsid4204783 See also}{\insrsid4204783 }{\i\insrsid4204783 Floor Action: Radiation Control}{\insrsid4204783 , 26 }{\scaps\insrsid4204783 Cong. Q.}{\insrsid4204783 696 (1968).}}}{\insrsid14908102 {\*\bkmkend _Ref134373518} The House Committee\rquote s version passed by a 382-0 roll-call vote.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Floor Action: Radiation Control}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref134373518 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330034003300370033003500310038000000}}}{\fldrslt {\insrsid4596385 59}}}{\insrsid4204783 , at 696.}}}{\insrsid12653459 The Senate responded by holding further hearings to understand the full extent of the radiation problem.}{\cs16\super\insrsid12653459 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 1968 Senate Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst { \insrsid4204783 NOTEREF _Ref134273161 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330034003200370033003100360031000000}}}{\fldrslt {\insrsid4596385 57}}}{\insrsid4204783 . The hearings included updates on the current state of scientific knowledge, statements from government agencies, and testimony from affected parties.}}}{\insrsid14908102 The Senate Commerce Committee reported its version of the bill on July 17, 1968. }{\cs16\super\insrsid5767685 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \scaps\insrsid4204783 Sen. R. No. 90-1432 (1968).}}}{\insrsid14908102 The Senate strengthened th}{\insrsid87600 e bill by adding provisions }{\insrsid14908102 directing the Secretary of HEW to conduct specific studies.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Committee Roundup: Radiation Control}{\insrsid4204783 , 26 }{\scaps\insrsid4204783 Cong. Q. 2054, 2056 \endash 57 (1968).}{\insrsid4204783 Specifically, the Senate version called for \'93(1) a study of present state and federal control of health hazards from electronic products radiation and other types of ionizing radiation; (2) a study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes; and (3) a study of the development and procedures for the detection and measurement of electronic product radiation from products manufactured or imported prior to the effective date of any applicable standard.\'94 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 2057.}}}{ \insrsid14908102 The Senate also increased the maximum civil fine back to $400,000 but added a provision allowing the Secretary of HEW discretion to remit or mitigate penalties.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 2057.}}}{ \insrsid14908102 The Senate Committee estimated its modifications would increase the costs of the radiation control program from $8.5 million to $10.3 million but believed this was necessary to }{\insrsid2123127 deal properly with the }{ \insrsid14908102 absence of federal regulatory authority, state programs that were \'93inadequate to provide uniform, coordinated controls,\'94 and voluntary standards that were inadequate to guarantee compliance.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id. }{\insrsid4204783 (internal quotations omitted).}}}{\insrsid14908102 \par The Senate added three amendments prior to its final passing of the bill on October 3, 1968. Senator Hugh Scott\rquote s amendment required that performance standards apply only to components \'93 in the context of the fully assembled products for which they were intended.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Floor Action: Radiation Control}{\insrsid4204783 , 26 }{\scaps\insrsid4204783 Cong. Q.}{\insrsid4204783 2725, 2732 (1968). Senator Scott explained that some components of electronic products may emit excessive radiation but that proper shielding in the completed product could eliminate the risk.}}}{\insrsid14908102 Senator Ralph W. Yarborough\rquote s amendment extended protection under the act to workers as well as consumers.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The f inal amendment by Senator Paul J. Fannin exempted electrical products used by licensed doctors, dentists, or hospitals. The amendment was believed to be needed to appease the medical profession.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 This was not enough to appease the House, however. The House, which started a bill that was eventually backed by the President and that all of Congress seemed to agree was necessary, fell to strong lobbying efforts by the electronics industry.}{ \cs16\super\insrsid14908102 {\*\bkmkstart _Ref134273844}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 House-Weakened Radiation Control Bill Cleared}{\insrsid4204783 , 26 }{\scaps\insrsid4204783 Cong. Q. }{\insrsid4204783 2971 (1968). The lobbying effort was financed by the Electronic Industries Association and led by former Postmaster General J. Edward Day.}}}{\insrsid14908102 {\*\bkmkend _Ref134273844} \par Representative Rogers adamantly opposed Senate language allowing the seizure of products found to be in violation, extending protection to workers on assembly lines, and allowing the Secretary of HEW broad discretion to inspect plants. The Senate conceded to Rogers to ensure passage of the bill before Congress adjourned. The final bill as passed was severely weakened. Inspections were allowed only in limited circumstances. Workers were no longer protected. Manufacturers were granted much more time to come into compliance with standards. The maximum civil penalty decr eased from $400,000 to $300,000. Senate language requiring review of standards at least once every two years was dropped. Advisory standards for the licensing and training of x-ray technicians were dropped.}{\cs16\super\insrsid14370537 {\*\bkmkstart _Ref133953906}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Senator Jennings Randolph pushed for years follow ing enactment of H.R. 10790 to add this provision. He secured Senate committee approval of mandatory standards for training and licensing of x-ray machine operators several times. However, obstacles to enactment included anti-regulatory moods in Congres s, House objections, and complaints of high cost by the American Medical Association, the ADA, and the Carter administration. One of Randolph\rquote s biggest complaints was that the Bureau of Radiological Health was not urging mandatory licensing when it was aware of the problems. }{\i\insrsid4204783 See}{\insrsid4204783 Elizabeth Wehr, }{\i\insrsid4204783 Senate Panel Backs Federal Standards for X-ray Operators}{\insrsid4204783 , }{\scaps\insrsid4204783 Cong. Q.}{\insrsid4204783 2779, 2779 \endash 2781 (1980). Senator Randolph finally tucked the provision into a reconciliation bill in 1981. }{ \i\insrsid4204783 See}{\insrsid4204783 Ann Pelham, }{\i\insrsid4204783 Health Spending Cut by 25 Percent}{\insrsid4204783 , }{\scaps\insrsid4204783 Cong. Q.}{\insrsid4204783 1501, 1501 (1981).}}}{\insrsid14908102 {\*\bkmkend _Ref133953906} The House did accept a modified provision requ iring manufacturers to repair or replace defective products and did drop the language granting exemptions to licensed physicians, dentists, or hospitals. The conference report was adopted by the House and Senate on October 11, 1968, though without the si gnature of Senator Yarborough, who believed the compromised bill was too weak.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 H.R. Rep. No. 90-1971 }{\insrsid4204783 (1968). }{\i\insrsid4204783 See also}{\insrsid4204783 }{\i\insrsid4204783 House-Weakened Radiation Control Bill Cleared}{\insrsid4204783 , }{\i\insrsid4204783 supra }{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref134273844 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330034003200370033003800340034000000}}}{\fldrslt {\insrsid4596385 69}}}{\insrsid4204783 ,}{\i\insrsid4204783 }{\insrsid4204783 at 2981. Day\rquote s language was adopted nearly verbatim for the provision regarding plant inspections. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 2972.}}}{\insrsid14908102 Congress passed the bill on October 18, 1968.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132395052}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Pub. L. No. 90-602, 82 Stat. 1173 (1968). The Radiation Control for Health and Safety Act has not undergone any major substantive amendments. It was recodified in 1990 as part of the Federal Food, Drug, and Cosmetic Act (\'93FDCA\'94 ) and renamed the Electronic Product Radiation Control (\'93EPRC\'94) provisions of the FDCA. It was originally codified as part of the Public Health Service Act at 42 U.S.C. 263c \endash 263n. 21 U.S.C. \'a7 360hh \endash 360ss (2005). }{ \i\insrsid4204783 See also}{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 303 n.17; }{\scaps\insrsid4204783 Peter Barton Hutt & Richard A. Merrill, Food and Drug Law}{\insrsid4204783 794 (2d ed. 1991). This paper will refer to the act by its original title.}}}{\insrsid14908102 {\*\bkmkend _Ref132395052} \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11039173 {\scaps\insrsid16152102\charrsid11039173 III. The Basic Workings of the Radiation Control for Health and Safety Act of 1968}{ \scaps\insrsid14908102\charrsid11039173 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The RCHSA is administered by the Secretary of Health and Human Services}{\insrsid10829986 (\'93HHS\'94)}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Formerly the Department of Health, Education, and Welfare. The department names are used interchangeably throughout this paper.}}}{\insrsid14908102 through the FDA. The FDA\rquote s Center for Devices and Radiological Health (\'93CDRH\'94 ) is charged with the responsibility of carrying out the provisions of the RCHSA.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131377135}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 303. }{\i\insrsid4204783 See also}{\insrsid4204783 Center for Devices and Radiological Health, }{\i\insrsid4204783 Electronic Product Radiation Control}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cdrh/c omp/eprc.html (last visited Mar. 29, 2006). The CDHR, then the Bureau of Radiological Health, was assigned to the FDA on May 17, 1971, and \'93 thus became responsible for reducing unnecessary human exposure to man-made radiation in the use of electronic products and in the application of radiation in the healing arts.\'94 }{\i\insrsid4204783 Radiological Health Protection}{\insrsid4204783 , }{ \scaps\insrsid4204783 FDA Papers, }{\insrsid4204783\charrsid13111760 Dec. 1971 \endash Jan.}{\insrsid4204783 1972, at 43, 43. CDRH also administers its program under the authority of the Medical Devices Amendments to the FDCA and the Mammo graphy Quality Standards Act (\'93MQSA\'94). Center for Devices and Radiological Health, }{\i\insrsid4204783 The CDRH Radiological Health Program: Adapting to Current Public Health Needs: 2005 \endash 2010}{\insrsid4204783 5 (2005), }{ \i\insrsid4204783 available at}{\insrsid4204783 http://www.fda.gov/cdrh/radhlth/rhprogram.pdf [hereinafter \'93CDRH, }{\i\insrsid4204783 Adapting}{\insrsid4204783 \'94].}}}{\insrsid14908102 {\*\bkmkend _Ref131377135} The act applies to any electronic product, defined as \'93(A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits \'85 electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (}{\insrsid10829986 A) and which in operation emits}{\insrsid14908102 \'85 such radiation.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{ \insrsid4204783 21 U.S.C. \'a7 360hh(2) (2005). }}}{\insrsid14908102 This section begins by outlining the }{\insrsid11350113 major provisions of the act, }{\insrsid14908102 FDA actio}{\insrsid11350113 ns pursuant to those provisions, and}{ \insrsid14908102 the scope of FDA authority under the act. It concludes by discussing the interaction of}{\insrsid16152102 the}{\insrsid14908102 RCHSA with other fed}{\insrsid4861489 eral statutes later enacted}{\insrsid14908102 . \par }{\insrsid10241955 A. The Major P}{\insrsid14908102 rovisions of}{\insrsid16152102 the}{\insrsid14908102 RCHSA \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10241955 {\insrsid14908102 The RCHSA directs the Secretary to \'93 establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360ii(a). \'93 Electronic product radiation\'94 is defined as \'93(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or (B) any sonic, infrasonic, or ultrasonic wave, which is emi tted from an electronic product as the result of the operation of an electronic circuit in such product.\'94 21 U.S.C. \'a7 360hh(1) (2005). Ionizing radiation creates electrically charged ions capable of disrupting life processes. X-rays are an example. Tho ugh nonionizing radiation cannot create ions, it can adversely affect human health. Examples include microwaves and light. }{\i\insrsid4204783 See}{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst { \insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{\insrsid4204783 , at 4.}}}{ \insrsid14908102 Specifically, the Secretary is directed to \'93prescribe performance standards for electronic products to control the emission of electronic product radiation;\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360kk(a)(1) (2005).}}}{\insrsid14908102 to \'93 plan, conduct, coordinate, and support research, development, training, and operational activities to minimize the emissions of and the exposure of people to, unnecessary electronic product radiation;\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360ii(a)(2).}}}{\insrsid14908102 to \'93develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation;\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360ii(a)(5).}}}{ \insrsid14908102 to refuse admission of electronic products offered for importation which fail to comply with the act;}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360mm(a).}}}{ \insrsid14908102 and to inspect facilities when the \'93Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety \'85 may not be adequate or reliable.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360nn(a).}}}{\insrsid14908102 }{\insrsid13320738 The major provisions of the act are discussed below}{\insrsid14908102 .}{\insrsid10241955 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 1. Pe}{\insrsid13320738 r}{\insrsid14908102 formance Standards \par Radiation safety performance standards are the crux of the act. In setting the standards, the Secretary must consider \'93 the latest available scientific and medical data in the field of electronic product radiation; the standards currently recommended by (i) other Federal agencies\'85 and (ii) public or private groups with expertise in the field\'85 ; and the reasonableness and technical feasibility of such standards\'85.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The Secretary must also consult with the Technical Electronic Product Radiation Safety Standards Committee.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360kk(f). The Committee is composed of five members from governmental agencies, five members from affected industries, and five members from the general public, including one representative of organized labor. The Committee\rquote s Charter is available at www.fda.gov/cdrh/panel/charter/charter-teprssc.doc.}}}{\insrsid14908102 Standards may prescribe maximum radiation emission levels and }{\insrsid16152102 require }{\insrsid14908102 certification by the manufacturer that the product conforms to federal standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 304.}}}{\insrsid14908102 }{\insrsid13320738 \'93 Such standards may include provisions for the testing of such products and the measurement of their electronic product radiation emissions, may require the atta chment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such products.\'94}{\cs16\super\insrsid13320738 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13320738 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360kk(a)(1) (2005).}}}{ \insrsid13320738 }{\insrsid14908102 Each regulation must take effect no sooner than one year and no later than two years after the date on which the standard is issued.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360kk(c).}}}{ \insrsid14908102 Judicial review of regulations is allowed in the federal courts of appeals.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360kk(d).}}}{\insrsid14908102 The first four standards set by the FDA are discussed briefly below. Their progression and current statuses are discussed more thoroughly in Part IV. \par The television receiver standard went into effect on January 15, 1970, and was carried out in three phases, with the third phase to conclude on June 1, 1971.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 8.}}}{\insrsid14908102 Testing on 259 televisions during the second phase revealed that all receivers had met the operating conditions required during that phase. This was a remarkable success, as evidenced by comparison to a study by the National Committee on Radiation Protection and Measurements (\'93NCRP\'94 ) conducted between December 1967 and January 1968. NCRP tested 1,124 c olor televisions of various makes and models and found 268 to emit measurable levels of radiation. Two sets had radiation emissions exceeding the scale reading of the survey instrument. NCRP concluded that the absence of radiation emissions from more th an three quarters of the televisions indicated that industry could, and for the most part was, manufacturing safe televisions.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See }{\insrsid4204783 National Center for Radiological Health, }{\i\insrsid4204783 A Survey of X-Radiation from Color Television Sets in the Washington, D.C. Metropolitan Area}{\insrsid4204783 11 \endash 12, 20 (1968), }{\i\insrsid4204783 in 1968 House Hearings}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 25.}{\i\insrsid4204783 }}}{\insrsid14908102 \par The microwave ove}{\insrsid16152102 n}{\insrsid14908102 standard was issued on October 6, 1970, with compliance required by October 6, 1971. The setting of the microwave standard demonstrated the effectiveness}{\insrsid16152102 of}{\insrsid14908102 the bill. }{\insrsid13320738 A 1967}{\insrsid14908102 Department of Defense}{\insrsid13320738 survey}{\insrsid14908102 found that twenty four out of thirty microwave ovens at Walter Reed Hospital leaked potentially hazardous radiation. One leaked radiation sufficient to produce eye cataracts. The Department estimated that 40,000 microwave ovens would be purchased that year, and that the total could eventually rise to half a million if development continued as anticipated.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref134239426 }\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 Sen. R. No. 90-1432 4 (1968).}}}{\insrsid13320738 {\*\bkmkend _Ref134239426} }{\insrsid13320738\charrsid13320738 }{\insrsid13320738 A survey of 4,700 microwave ovens conducted in 1970 rev ealed that ten percent of the ovens leaked radiation above the voluntary industry maximum. The industry voluntarily took corrective measures on the estimated 10,000 ovens believed to have a \'93strong potential\'94 to exceed the industry maximum.}{ \cs16\super\insrsid13320738 {\*\bkmkstart _Ref131769675}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13320738 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Radiological Health Protection}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 45.}}}{\insrsid13320738 {\*\bkmkend _Ref131769675} When the sta ndard became effective, the FDA c}{\insrsid2848475 ould state that microwaves were safe for consumers to use}{\insrsid13320738 . }{\insrsid14908102 \par The third standard applied to electronic equipment used in high school and college science classes. Electron tubes used for demonstrations were found to leak rad iation in excess of the recommended maximum for students under the age of eighteen. The sole manufacturer of the tubes agreed to stop sales of the tubes and}{\insrsid13111760 to}{\insrsid14908102 recall them from distributors. The manufacturer eventually redesigned two types of tubes and stopped making the third.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 9.}}}{\insrsid14908102 \par The fourth standard applied to x-ray equipment, the hazards of which were thoroughly discussed in the hearings. The standard aimed to reduce both p}{\insrsid5712403 atient and operator exposure. Patient overexposure during examinations resulted }{ \insrsid16152102 primarily from the use of primary}{\insrsid5712403 beams of x-ray that were larger than the film being use}{\insrsid13460147 d}{\insrsid5712403 . The first x-ray standards, enacted}{\insrsid16152102 on}{\insrsid5712403 August 1, 1974, included over sixty performance specifications, including}{\insrsid16152102 required}{\insrsid5712403 use of a device that could restrict the x-ray beam to the size of the film being used.}{\cs16\super\insrsid5712403 {\*\bkmkstart _Ref133822951}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 X Rays: Focusing on Patient Protection}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , June 1975, at 8, 9.}}}{\insrsid5712403 {\*\bkmkend _Ref133822951} The FDA helped manufacturers come into compliance by designing the device needed to restrict the x-ray beams.}{\insrsid14908102 \par Performance standards have now been issued for fluoroscopic equipment,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 C.F.R. \'a7 1020.32 (2005).}}}{\insrsid14908102 computed tomography (CT) equipment,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 1020.33. }}}{\insrsid14908102 cabinet x-ray systems,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 1020.44. Cabinet x-ray systems include baggage x-ray machines at airports. Between 1968 and 1972, there were 147 attempted hijacks of U.S. aircraft, ninety one of which were successful. The President directed the Federal Aviation Administration (\'93 FAA\'94) to begin screening passengers. The original screening program was done by hand and relied on the screeners\rquote determination that a passenger looked suspicious. When the use of x-ray systems became more common, states turned to the FDA for guidance on safety for screeners and passengers. The greatest concern was possible human exposure to the primary beam of radiation. Some of the systems in use at the time allowed ope r ators to hold bags in the machines and to directly expose their hands. A secondary concern was damage to undeveloped photographic film. The FDA quickly issued recommended safety guidelines, which were soon adopted by all but four states. The remaining four states had already established more detailed and in some cases more restrictive requirements. The standard became effective on April 10, 1975. }{\i\insrsid4204783 See}{\insrsid4204783 Michael E. Shaffer, }{\i\insrsid4204783 X-Raying Baggage To Thwart Skyjackers}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer,}{\insrsid4204783 July \endash Aug. 1974, at 16.}}}{\insrsid14908102 laser products,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 C.F.R. \'a7 1040.10 (2005).}}}{\insrsid14908102 sunlamps,}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . \'a7 1040.20.}}}{\insrsid14908102 mercury vapor lamps,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 1040.30. Mercury vapor lamps are more efficient and longer lasting than regular lamps. The lamp is surrounded by a hard borosilicate glass envelope to filter out shortwave radiation produced by the electr ical current passing through the mercury-argon vapor. In December 1974, the FDA learned that eight people who had been playing volleyball in a school gym had suffered burns from ultraviolet radiation exposure. A mercury vapor lamp in the gym had been b roken but continued to burn. Further investigation revealed at least eight other incidents. Annabel Hecht, }{\i\insrsid4204783 Shedding Some Light On Light}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Sep. 1976, at 10, 13. The current standards require that self-extinguishing lamps cease operation within fifteen minutes of breakage or removal of the outer envelope. 21 C.F.R. \'a7 1040.30(d) (2005).}}}{\insrsid14908102 and ultrasonic therapy equipment.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 C.F.R. \'a7 1050.10 (2005).}}}{\insrsid14908102 \par }\pard \ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid13460147 {\insrsid14908102 2. Research \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The Congressional hearings demonstrated the clear need for a federal research program. The FDA was charged with controlling m an-made radiation in electronic products and medical products, while environmental radiation and radioactive materials were regulated by the Environmental Protection Agency (\'93EPA\'94 ) and AEC, respectively. In 1971, forty percent of the Bureau of Radiological Health\rquote s resources were transferred to the EPA. Of the remaining $10.3 million, $2.9 million was allocated to grants and contracts to support research and training and applied research.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Radiological Health Protection}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 43.}}}{\insrsid14908102 \par While}{\insrsid14168230 the biological effects of high-}{\insrsid14908102 dose}{\insrsid14168230 ionizing}{\insrsid14908102 radiation from such products as x-ray machines were well-known,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Short term effects included nausea, anemia , fatigue, blood and intestinal disorders, and loss of hair. Long term effects included cancers and cataracts. Very high exposure was believed to cause injury to the central nervous system and possibly death. In children, small increases in ionizing ra diation exposure were believed to increase the risk of leukemia. De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{\insrsid4204783 , at 5. For a detailed explanation of radiation and its effects as understood in 1979, see Bill Rados, }{\i\insrsid4204783 Primer on Radiation}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1979, at 4.}}}{ \insrsid14908102 little was known about the effects of repeated low-dose radiation and of exposure to non-ionizing radiation, such as microwaves and light. Because scientists had not identified a safe level of radiation, t hey believed that all forms of radiation included some risk to human health. The rise in use of electronic products such as microwave ovens, lasers, and ultrasound equipment further amplified the need for research on the biological effects of non-ionizin g radiation. Early studies revealed that x-ray or ultraviolet light exposure increased the probability that certain cells would develop tumors.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 5.}}}{\insrsid14908102 Other studies involved the effects of microwaves on monkeys and on military occupations involving the use of microwaves.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Radiological Health Protection}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 46.}}}{\insrsid14908102 A detailed discussion of specific studies and their use in setting standards is discussed in Part IV. \par The Bureau\rquote s research also contributed technological devices to aid }{\insrsid14168230 in }{\insrsid14908102 the reduction of radiation emissions. The Bureau quickly developed in struments to help in the detection of radiation emissions from televisions and supported the development of a laser radiation detection monitor.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 Different instruments were developed for testing in the factory and for use by television servicemen.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{\insrsid4204783 , at 9.}}}{\insrsid14908102 A sep arate meter was developed to detect radiation leakage from microwave ovens.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The Bureau also developed technology to aid in its research, such as a chamber capable of controlling animal research environments.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 5.}}}{ \insrsid14908102 \par }{\insrsid14168230 CDRH was created in 1982 to combine the FDA\rquote s activities under the RCHSA and the Medical Devices Amendments. The centralization of the FDA\rquote s research programs has reduced inefficiencies, thus allowing for a more focused and effective research program. \par }{\insrsid14908102 3. Enforcement \par The FDA\rquote s enforcement authorities under the RCHSA include recalls, seizures, and regulation of imports. If a }{\insrsid7996492 manufacturer determines that its}{\insrsid14908102 product is not in compliance with federal standards, it must notify the FDA.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360ll (2005).}}}{\insrsid14908102 The manufacturer must make the initial determination of the signifi cance of risk associated with the defect. If it determines the risk is low, it can request an exemption from a mandatory duty to notify consumers.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360ll(a)(2).}}}{ \insrsid14908102 Similarly, the FDA has a duty to notify a manufacturer if the FDA discovers a violation of its standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 360ll(e).}}}{ \insrsid14908102 The manufacturer is provided a regulatory hearing in which it may explain why an exemption should be granted, but the hearing lacks procedural protections provided by a traditional trial.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{ \insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt { \insrsid4596385 4}}}{\insrsid4204783 , at 306. The Commissioner of Food and Drugs appoints a presiding officer who is \'93free from bias or prejudice.\'94 Parties may pr esent evidence and cross examine witnesses, but the manufacturers may not call agency staff as witnesses. The Federal Rules of Evidence do not apply, thus preventing manufacturers from challenging the authenticity and reliability of documents presented by the FDA. }{\i\insrsid4204783 Id}{\insrsid4204783 . For a more detailed discussion of the proceedings, see Ronald J. Greene, }{\i\insrsid4204783 Informal FDA Hearings}{\insrsid4204783 , }{\scaps\insrsid4204783 Food Drug Cosm. L.J. }{\insrsid4204783 354 (1977).}}}{\insrsid14908102 If no exemption from public notification is granted, the manufacturer must correct the defect at its own expense or refund the purchase price.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360ll(f) (2005).}}}{\insrsid14908102 The FDA may seize non-compliant products if a manufacturer fails to institute a recall.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Marie A. Urban, }{\i\insrsid4204783 The FDA\rquote s Policy on Seizures, Injunctions, Civil Fines, and Recalls}{\insrsid4204783 , }{ \scaps\insrsid4204783 47 Food & Drug L.J.}{\insrsid4204783 411, 411 (1992).}}}{\insrsid14908102 \par Historically, the FDA rarely instituted adversarial proceedings pursuant to the RCHSA. \'93 A basic precept of FDA enforcement authority is the belief that a majority of persons desire to comply with the law and will comply voluntarily when given information as to what is required and what violations appear to exist.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . }}}{\insrsid14908102 The FDA and manufacture}{\insrsid7996492 r}{\insrsid14908102 s developed a non-adversarial relationship early as they worked together to develop the standards. Almost all actions brought by the FDA settled before trial.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{ \insrsid4204783 , at 307 \endash 308. From the 1968 enactment of the RCHSA to 1996, only thirty-two actions had been brought. Only three went to trial. It has bee n suggested, however, that the recodification of the RCHSA as part of the FDCA and the consolidation of the Bureau of Radiological Health into the more general Center for Devices and Radiological Health will end the non-adversarial relationship. }{ \i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 Manufacturers also rarely challenged the FDA\rquote s enforcement authority. Only two adversarial administrative hearings have occurred since enactment of the RCHSA. \par The first adversarial hearing began in 1974 with routine testing of television sets.}{\insrsid7996492 The FDA removed a component from}{\insrsid14908102 a color television to simulate a failure and found that this caused ex cess radiation emission in violation of federal standards. Further testing of other models by the same manufacturer revealed that 300,000 to 400,000 color television sets posed the same risk. Matsushita Electric Company, J.C. Penney, and W.T. Grant, def ined as manufacturers under the RCHSA, were granted an administrative hearing to challenge the FDA\rquote s findings. The companies sought an exemption based on their findings that a failure like}{\insrsid7996492 the}{\insrsid14908102 one the FDA had simulated had never occurred and was unlikely ever to occur. The companies stated that their quality control programs were sufficient to ensure this. The FDA rejected the claim for exemption.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132923385}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Wal ter E. Gundaker, }{\i\insrsid4204783 Getting the Picture On TV Recall}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. 1975, at 8, 13.}}}{\insrsid14908102 {\*\bkmkend _Ref132923385} The manufacturers chose not to seek judicial review and instead submitted the required corrective action plan in which they agreed to recall the televisions.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{ \insrsid4204783 , at 309.}}}{\insrsid14908102 \par The second proceeding involved 36,000 microwaves }{\insrsid7996492 manufactured by GE}{\insrsid14908102 . The FDA had determined that the microwaves leaked radiation in excess of the federal perform}{\insrsid7996492 ance standard. GE}{\insrsid14908102 sought an exemption from notification and corrective action. The hearing officer determined that G}{\insrsid7996492 E}{\insrsid14908102 had not proven that no person would or could be injured by the excess radiation, and G}{\insrsid7996492 E}{ \insrsid14908102 eventually submitted a corrective action plan to repair the microwaves.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par In addition to seeking injunctions and requiring recalls and repairs, the FDA }{\insrsid14944082 also relies}{\insrsid14908102 on the imposition of civil penalties. The RCHSA authorizes a civil penalty of not more than $1000 for each product involved or for each act or omission in violation of the statute, with the maximum penalty for}{\insrsid7996492 a single party for}{ \insrsid14908102 any related series of violations limited to $300,000.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132198281}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360pp(b) (2005). In 2004, the penalties were raised to $1,100 per violation a nd $330,000 maximum, in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990. U.S. Food and Drug Administration, Compliance Policy Guides Manual Sec. 390.300, 2004 WL 3363378 (updated July 29, 2004) [hereinafter \'93 FDA, Compliance Policy\'94 ]. The FDA also has authority to impose civil penalties under the National Childhood Vaccine Injury Act of 1986, the Prescription Drug Marketing Act of 1987, The Safe Medical Devices Act of 1990, the Mammography Quality Standards Act of 1992, the Gen eric Drug Enforcement Act of 1992, and the Food Quality Protection Act of 1996. Marc J. Scheineson & Robert J. Kaufman, }{\i\insrsid4204783 FDA Lacks Authority to Impose Civil Monetary Fines}{\insrsid4204783 , }{\scaps\insrsid4204783 Legal Backgrounder}{ \insrsid4204783 , Oct. 17, 2003.}}}{\insrsid14908102 {\*\bkmkend _Ref132198281} The FDA\rquote s stated policy is not to warn manufacturers prior to considering pe}{\insrsid7996492 nalties when it determines}{\insrsid14908102 that \'93 a violative product will cause serious adverse health consequences or death, or where responsible persons show intentional disregard for the law.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 FDA, Compliance Policy, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132198281 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003100390038003200380031000000}}}{\fldrslt {\insrsid4596385 120}}}{ \insrsid4204783 . These actions include failure to notify the FDA of a known defect; the failure to submit required reports related to defective products; issuance of false certifications; refusal to permit entry or to allow inspection as required b y the RCHSA; distribution of known non-compliant products; and refusal to initiate corrective action. }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The FDA generally warns manufacturers before imposing fines for distribution of non-compliant products; refusal to notify purchasers; failure to implem ent an order to notify within a reasonable time; inadequate record keeping; and failure to implement an adequate recall due to inadequate distribution records. Fines will generally not be imposed for minor violations, defined as those that present little or no risk of injury or danger to health.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 Because \'93manufacturer\'94 is defined as \'93 any person engaged in the business of manufacturing, assembling, or importing of electronic products,\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360hh(3) (2005).}}}{\insrsid14908102 individuals can be held personally liable for the violations of the co mpany. This allows the FDA to impose civil penalties on both the corporation and individuals for the same set of violations.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 United States v. Hodges X-Ray, Inc., 759 F.2d 557 (6th Cir. 1985) (holding that the FDA had authority under RCHSA to fine both the company and the principle shareholder).}}}{\insrsid14908102 \par The FDA also has the power to regulate importation of electronic products. The FDA may deny entry of products offered for importation that do not comply with federal standards. If the FDA believes}{\insrsid7996492 that a product denied entry}{ \insrsid14908102 cannot be brought into compliance, the manufacturer must export}{\insrsid7996492 the product}{\insrsid14908102 at its own expense. Failure to export within ninety days grants the FDA the right to seize and destroy the non-compliant products.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 U.S.C. \'a7 360mm (2005).}}}{\insrsid14908102 The importation of multisystems is illustrative of the FDA\rquote s authority. Multisystems are televisions that can receive international broadcast systems. The FDA determined non-compliant multisystems did n ot pose a hazard to public health if sold in the United States because they were not designed to operate on standard United States power sources. They were allowed on the understanding that the importers would eventually sell the multisystems to consumer s who were traveling or relocating overseas, referred to as an \'93import-for-export\'94 exemption.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 K & K Merchandise Group, Inc. v. Shalala, No. 95 Civ. 10082, 1996 WL 183023, *1 \endash 2 (S.D.N.Y. Apr. 17, 1996).}}}{\insrsid14908102 \par By 1985, the FDA believed multisystems had become operable in the United States and required that all multisystems operable in the United States meet the television receiver standards. In 1988, the FDA issued an \'93import alert\'94 that instructed FDA field inspectors to \'93detain all shipments of uncertified [multisystem] receivers until the importer establishes that the pr}{\insrsid7996492 oduct}{\insrsid14908102 in question is labeled for export only and cannot receive the [U.S.] NTSC 3.58 broadcast system.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at *2.}}}{\insrsid14908102 The FDA remained concerned that multisystems were entering the United States market illegally, and in 1991 required that all multisystems, including those intended solely for export, meet the television}{\insrsid15946238 receiver standard. In 1992}{ \insrsid1537746 ,}{\insrsid14908102 the FDA detained multisystems}{\insrsid15946238 imported by K & K Merchandise}{\insrsid14908102 Group (\'93K & K\'94) for noncompliance with federal performance standards. K & K claimed that the FDA\rquote s policies regarding noncompliant imported electronic products constituted improper rulemaking. The court dismissed K & K\rquote s claim for lack of standing. The court held that K & K had alleged no concrete injury \'93 because [K & K] has no legal right to import or sell its noncompliant multisystem television receivers in the United States.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at *3.}}}{ \insrsid14908102 The court affirmed Congress\rquote intent that any noncompliant good qualifying for an exemption would be exported directly, not sold to U.S. distributors to later export.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at *5.}}}{ \insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1406705 {\insrsid14908102 While K & K\rquote s troubles resulted from products that exceeded the ma ximum radiation emissions standards, the FDA also has the authority to seize products that meet the emission standards but violate other provisions of the RCHSA. In September 1991, the FDA placed a customs hold on 30,000 television sets manufactured by G oldstar due to irregularities in its testing methods at its Korean factory. Further investigation revealed similar problems at Goldstar\rquote s factory in Mexico, resulting in Goldstar\rquote s voluntary withholding of another 130,000 televisions from importation. Whi le the test methods were determined acceptable, the instruments were not. The company was also found to have falsified x-ray test data and to have relabeled and reboxed televisions without proper quality control testing. Goldstar eventually submitted a c orrective action plan and retested samples of its stock. On November 27, 1991, the FDA released the televisions from detention. This delay cost Goldstar tens of millions during the height of the selling season. None of the televisions was ever found to emit excess radiation, a problem the FDA had not seen in many years.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132923600}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Goldstar Rocked by Obsolete X-Ray Rule}{\insrsid4204783 , }{\scaps\insrsid4204783 Consumer Electronics}{\insrsid4204783 , Feb. 17, 1992, at 9. }}}{\insrsid8747447 {\*\bkmkend _Ref132923600} }{\insrsid1406705 \par }{\insrsid15946238 Decreased funding has required the FDA to refocus its enforcement efforts, particularly regarding fieldwork. CDRH plans to emphasize inspections of manufacturers and conduct field and lab tests on a for cause basis only. Additionally, CDRH will increasingly use outside sources for data}{\insrsid2441285 on adverse events}{\insrsid10829986 and initiate enforcement actions accordingly}{\insrsid2441285 .}{\insrsid15946238 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 B. Interaction with Other Statutes and Agencies}{\cs16\super\insrsid5839686 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 This section is drawn largely from Bennett & Dormer, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 313 \endash 20.}}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 In addition to the Radiation Control for Health and Safety Act, the FDA\rquote s regulation of electronic products also comes under the Medical Devices Amendments (\'93MDA\'94) to the FDCA and the Mammography Quality Standards Act of 1992 (\'93MQSA\'94).}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132395378}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 A diagram of the FDA\rquote s overlapping enforcement authorities can be found at http://www.fda.gov/cdrh/radhlth/pdf/overlap.pdf (last visited Apr. 9, 2006) [hereinafter \'93FDA Diagram\'94].}}}{\insrsid14908102 {\*\bkmkend _Ref132395378} The FDA shares its regulatory authority with the Consumer Product Safety Commission, the Nuclear Regulatory Commission}{\insrsid10829986 (\'93NRC\'94)}{\insrsid14908102 , and the Environmental Protection Agency.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra} {\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt { \insrsid4596385 4}}}{\insrsid4204783 , at 318 \endash 20.}}}{\insrsid14908102 This section will briefly describe the role other statutes and agencies play in regulating electronic products. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 Radiation emitting electronic products that are also medical devices, such as x-ray equipment, microwave diathermy, and surgical lasers, are also regulated by the Medical Devices Amendments of 1976.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Other electronic products regulated under the Medical Devices Ame ndment include diagnostic ultrasound, radiation therapy, MRI, ophthalmic instruments, sunlamps, and lithotriphter. FDA Diagram, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132395378 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003300390035003300370038000000}}}{\fldrslt {\insrsid4596385 132}}}{\insrsid4204783 .}}}{\insrsid14908102 The MDA was a response to the growing number and increasing complexity of medical devices. }{\insrsid2441285 }{\insrsid14908102 The FDA was required to classify all medical devices in terms of safety and effectiveness. The FDA was granted comprehensive control over the market introduction of medical devices. Congress also chose to enact special rules for specific devices.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \scaps\insrsid4204783 Hutt & Merrill}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132395052 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003300390035003000350032000000}}}{\fldrslt {\insrsid4596385 72}}}{\insrsid4204783 , at 744 \endash 46.}}}{\insrsid14908102 While the RCHSA protects the public from unnecessary radiation from electronic products, the MDA ensures that marketed medical devices are safe and effective for their intended use. A product that violates the RCHSA is typically considered adulterated or misbranded under the MDA.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 313 \endash 14. Bennett and Dormer note that an x-ray machine that failed to take x-rays of proper clarity would theoretically also be in violation of the RCHSA because patients would be exposed to r adiation without any offsetting benefit. However, the FDA has not advanced this argument.}}}{\insrsid14908102 \par The MDA was originally implemented by the Bureau of Medical Devices. Recognizing the interrela}{\insrsid1537746 tions of the MDA and RCHSA, }{\insrsid4861489 HHS}{\insrsid14908102 merged the agencies in 1982, forming the Center for Devices and Radiological Health. The conjunctio n of the acts grants the FDA more alternatives for enforcement. Under the MDA, the FDA can institute a suit to seize a device, a source of contention that the Senate lost on during the legislative hearings for the RCHSA. Other administrative actions pur sued by the Senate during the hearings, such as detention of suspected non-compliant devices, are available under the MDA. The FDA can also pursue criminal penalties against manufacturers under the MDA.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 314 \endash 15.}}}{\insrsid14908102 The Safe Medical Devices Act of 1990 (\'93SMDA\'94) prov ided the FDA with further regulatory authority. Civil penalties were made available, and the regulated entities were broadened to include facilities and device distributors in addition to manufacturers. The SMDA also eliminated the \'93state-of-the-art \'94 def ense to the refund, repair, and replace requirement for defective products, which aligned the SMDA with the RCHSA in this respect. The process for setting performance standards was relaxed in an attempt to allow the FDA to establish performance standards with the same relative ease as under the RCHSA. The FDA believes that the administration of the medical devices acts by the same agency that administers the radiation control act has minimized inconsistent and duplicative regulations. Though the standar ds for many medical devices are established by the RCHSA, the MDA essentially controls regulation of radiation emitting medical devices.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 315.}}}{ \insrsid14908102 \par The Mammography Quality Standards Act of 1992 regulates mammography facilities and the use of mammography equipment \'93to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. \'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132389208}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid15217690 About MQSA}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cdrh/mammography/mqsa-rev.html (last visited Apr. 9, 2006) [h ereinafter \'93FDA, }{\i\insrsid4204783\charrsid15217690 About MQSA}{\insrsid4204783 \'94].}}}{\insrsid14908102 {\*\bkmkend _Ref132389208} }{\insrsid13321439 Because mammography is a type of x-ray device, it is simultaneously regulated by the RCHSA. }{ \insrsid14908102 MQSA is part of the Public Health Services Act, where the RCHSA was codified prior to its move to the FDCA.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 42 U.S.C. \'a7 263b (2005).}}}{\insrsid1537746 }{ \insrsid14908102 MQSA requires that all mammography facilities be certified by the FDA}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 263b(b).}}}{\insrsid14908102 and establishes quality standards for mammography equipment and personnel.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 263b(f).}}}{\insrsid14908102 Facilities are subject to regular inspections}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . \'a7 236b(g).}}}{\insrsid14908102 and sanctions including civil monetary fines.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 263b(h).}}}{ \insrsid14908102 The act was reauthorized in fall 2004 to extend to 2007.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 FDA, }{\i\insrsid4204783 About MSQA}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132389208 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003300380039003200300038000000}}}{\fldrslt {\insrsid4596385 139}}}{\insrsid4204783 .}}}{\insrsid13321439 }{ \insrsid14908102 \par Mammography originally suffered from poor technique. High quality images and well-trained interpreters are needed to diagnose a breast tumor before a lump develops.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{ \insrsid4204783 , at 316.}}}{\insrsid14908102 Improper film processing and improper use of image receptors resulted in poor images. Because the FDA had no authority to regulate procedures within a facility, the American College of Radiology began accrediting mammography facilities through a voluntary }{\insrsid13321439 program. Medicare also required}{\insrsid14908102 facilities that wanted to seek reimbursement to meet quality standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Marian Segal, }{\i\insrsid4204783 Mammography Facilities Must Meet Quality Standards}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. 1994, at 8, 11.}}}{\insrsid1537746 }{\insrsid14908102 MQSA was needed to ensure mandatory participation in certification programs. Improvements in mammography equipment and techniques have made the process the most effective measure for early detection of breast cancer. Image quality has improved significantly, while radiation exposure is up to fifty times less today than it was twenty years ago.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid5468723 Frequently Asked Questions About MQSA}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/CDRH/MAMMOGRAPHY/cons-faq2.html#facilities (last visited Apr. 10, 2006).}}}{\insrsid14908102 \par The Nuclea}{\insrsid4861489 r Regulatory Commission }{\insrsid14908102 shares authority with the FDA for the regulation of radiation therapy systems. When the RCHSA passed in 1968, the A}{\insrsid2441285 EC}{\insrsid14908102 believed that the authority granted under the act did not affect the AEC. The Atomic Energy Act of 1954 had charged the AEC with the control of radiation hazards, but its authority was limited to responsibility for the \'93 public health and safety in connection with construction and operation of nuclear facilities and the use of source, byproduct, and special nuclear material.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 Sen. R. No. 90-1432 33 (1968) (}{ \insrsid4204783 Letter of Glenn T. Seaborg)}{\scaps\insrsid4204783 .}}}{\insrsid14908102 The AEC believed the definition of \'93electronic product radiation\'94 limited authority under the act to radiation from products that used electronic circuits and therefore distinguished it from the radiation from nuclear sources that the AEC regulate d. However, the AEC requested and was granted a provision stating that the act \'93shall not be construed as superseding or limiting the functions, under any provision of law, of any officer or agency of the United States.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Pub. L. No. 90-602 sec. 4, 82 Stat. 1187 (1968).}}}{\insrsid14908102 The AEC fully admitted that the provision was intended to protect its authority.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 Sen. R. No. 90-1432 31 (1968) (}{ \insrsid4204783 Letter of E.J. Bloch).}}}{\insrsid14908102 \par Technological advances have resulted in the use of special nuclear material in medical therapy, which implicates the NRC\rquote s authority. The NRC is charged with licensing physicians and facilities that use nuclear material in radiation therapy.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 42 U.S.C. \'a7 2134(a) (2005); Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 319.}}}{\insrsid14908102 The NRC\rquote s stated objective is to \'93 provide for the radiation safety of workers, the general public, patients, and human research subjects.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 10 C.F.R. \'a7 35.1 (2005).}}}{\insrsid14908102 The requirements for licensing include maintenance of records;}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{ \insrsid4204783 . \'a7 35.5.}}}{\insrsid14908102 the protection of human research subjects;}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 35.6.}}}{\insrsid14908102 radiation safety aspects for medical use of byproduct material;}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . \'a7 35.12.}}}{\insrsid14908102 and notification.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . \'a7 35.14.}}}{\insrsid14908102 Because radiation therapy systems are not considered electronic products, the FDA regulates them as medical devices under the MDA. The FDA and NRC generally share data on radiation hazards and knowledge of incidents of patient exposure through an informal process. Because the FDA has a broader range of regulatory options under the MDA, the NRC typically defers to the FDA when regulatory ac tion is needed. The agencies have entered into a Memorandum of Understanding \'93to coordinate existing NRC and FDA regulatory programs for medical devices, drugs, and biological products utilizing byproduct, source, or special nuclear material.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 58 Fed. Reg. 47,300 (Sep. 8, 1993); Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 319. }}}{\insrsid14908102 \par The Consumer Product Safety Commission (\'93CPSC\'94 ) regulates consumer products, including those that emit radiation but excluding medical devices. Products that come under the regulation of both the FDA and the CPSC include televisions and microwave ovens. The Consumer Product Safety Act (\'93CPSA\'94 ) was enacted in 1972 in response to Congress\rquote determination that an unacceptable number of consumer products distributed in commerce presented an unreasonable risk of injury and that existing federal, state, and local control was inadequate.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 15 U.S.C. \'a7 2051 (2005).}}}{\insrsid14908102 The CPSA was modeled after the RCHSA, resulting in enforcement authority that is essentially identical. This includes a repair, replace, or refund provision and the right to impose civil penalties. Unlike the RCHSA, however, the CPSA pro vides for criminal sanctions and seizure of noncompliant products. The CPSA typically defers to CDRH regarding radiation emissions, with deference becoming even more common with reductions in funding.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{ \insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt { \insrsid4596385 4}}}{\insrsid4204783 , at 318.}}}{\insrsid14908102 \par The }{\insrsid4861489 Environmental Protection Agency}{\insrsid14908102 is \'93technically the lead federal agency in establishing federal policy on radiation.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 319.}}}{ \insrsid14908102 It is charged to \'93advise the President with respect to radiation matters, directly or indirectly affecting health, including guidance for all Federal agencies in the formulation of radi ation standards and in the establishment and execution of programs of cooperation with States.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 ., citing Federal Radiation Council Authority, Pub. L. No. 86-373, 73 Stat. 688 (1959), transferred to EPA by Reorganization Plan No. 3 of 1970, as codified at 42 U.S.C. \'a7 2021(h).}}}{\insrsid14908102 However, the EPA has typically deferred to the FDA}{\insrsid13321439 and}{\insrsid14908102 to }{\insrsid13916512 CDRH}{\insrsid14908102 regarding medical devices and electr}{\insrsid13321439 onic products to ensure that it}{\insrsid14908102 s actions do no}{\insrsid2441285 t}{\insrsid14908102 conflict with the FDA\rquote s \'93responsibilities for developing product performance standards.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Bennett & Dormer, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{ \insrsid4204783 , at 320, citing 51 Fed. Reg. 27,318, 27,321 (July 30, 1986). Bennett and Dormer cite the EPA\rquote s proposed recommendations regarding public exposure to radio frequency radiation as an example. The EPA recognized CDRH\rquote s jurisdiction in this area and believed FDA performance standards could more readily control excess radiation exposure. The EPA proposed to exclude from its consideration exposure resulting from electronic consumer products.}}}{\insrsid13321439 The FDA remains the lead agency in radiation regulation.}{\insrsid14908102 \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11039173 {\scaps\insrsid4861489\charrsid11039173 IV. Major Electronic Products Regulated by the RCHSA}{\scaps\insrsid14908102\charrsid11039173 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The effectiveness of the RCHSA can be seen best in the FDA\rquote s actio ns regarding studies and regulations of specific products. The FDA\rquote s actions include setting standards, conducting research, and educatin}{\insrsid13321439 g manufacturers and consumers}{\insrsid14908102 . The current status of electronic products considered possibly dangerous to human healt h in 1968 demonstrates the tremendous success of a federal regulatory program. While the granting of authority to enforce standards cannot be underscored in the success of the RCHSA, it is the extensive research program and the FDA\rquote s efforts at educating the public that have proved to be the true successes. }{\insrsid13321439 \par }{\insrsid14908102 During the congressional debates, witnesses repeatedly emphasized the lack of knowledge regarding the biological effects of radiation. The concern was not just for the lay consumers; it was also for }{\insrsid13321439 the educated professionals who had}{\insrsid14908102 repeated contact with radiation emitting devices. While scientists sensed that low-dose and non-ionizing radiation were toxic to human health, there was a complete lack of reliable evidence. The setting of enforceable standards indicated Congress \rquote commitment to the elimination of unnecessary radiation}{\insrsid13321439 . While some combination of concern for human health and the avoidance of adverse publicity would have led manufacturers to eliminate excess radiation to the extent feasibl e, the RCHSA undoubtedly accelerated the process. Congress\rquote commitment to radiation protection extended not just to standard setting and enforcement, but also to a federally-funded research and education program. This section begins with a discussion of the products Congress identified as possibly dangerous in 1967 and 1968 to demonstrate the significant progress the RCHSA has made. It}{\insrsid14908102 conclud}{\insrsid2441285 es with a discussion of cell}{\insrsid14908102 phone regulation because it demonstrates the interaction of the FDA\rquote s obligations under the RCHSA with other federal statutes and agencies}{\insrsid13321439 and is the area with the least definitive research and, cons}{\insrsid2441285 equently, the most controversy}{\insrsid13321439 today}{\insrsid14908102 . \par }{\insrsid4861489 A. Diagnostic X-Rays: Controlling the Main Source of Radiation Exposure}{\insrsid14908102 \par The regulation of x-ray machines represents perhaps the greatest success under the RCHSA. In 1968, medical and dental x-ray procedures represented ninety percent of human exposure to radiation.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 For an explanation of how medical x-rays work, see Robert T. De Vore, }{\i\insrsid4204783 Seeking the Safest X-Ray Picture}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. 1979, at 24.}}}{\insrsid14908102 Dr. Karl Z. Morgan acknowledged the great value of x-ray procedures but noted that better screening to determine when x-rays were appropriate and better designed devices could significantly decrease unnecessary human exposure.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783\charrsid2441285 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 364.}}}{\insrsid14908102 \par Following enactment of the RCHSA and growing public awareness of the possible da}{\insrsid13321439 ngers, patients began }{\insrsid14908102 asking how safe x-ray exposure was. Like Dr. Morgan, the FDA was careful not to undercut the tremendous benefits of x-ray procedures. The Bureau acknowledged that \'93 [t]ens of thousands of accident victims are saved every year because a physician can see on x-ray film exactly what is wrong,\'94 while \'93[o]thers would have died in childhood of heart defects or obstructed digestive tracts\'94 without x-rays.}{ \cs16\super\insrsid14908102 {\*\bkmkstart _Ref131519227}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Robert T. De Vore, }{\i\insrsid4204783 Diagnostic X Rays: How Safe Are They?}{\insrsid4204783 , June 1973, at 4, 5.}}}{\insrsid14908102 {\*\bkmkend _Ref131519227} However, repeated exposure to low-dose ionizing radiation did pose a real threat. The Bureau believed that physicians and dentists had a duty to determine when x-ray diagnoses were actually needed and to use methods that produced the lowest possible exposure. By 1970, x-ray examinations had seen a ten percent per capita increase but had resulted in a drop in gene}{ \insrsid13321439 tically significant dose}{\insrsid14908102 . This indicated the ability to deliver \'93the best possible diagnostic information for the least possible x-ray exposure.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par The first set of standards aimed to reduce unnecessary x-ray exposure by requiring beam restricting capacities. All sta tionary devices were required to be able to restrict the beam to the film size. Bureau engineers designed a device, known as a collimator, to perform this task automatically. A feature to allow images to be reproduced was required to reduce unnecessary exposure from retakes.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{ \insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 5 \endash 7. }}}{\insrsid14908102 As enacted on August 1, 1974, the standard contained over 60 performance specifications. The FDA devised a three-pronged approach to enforcement. First, the FDA intended to \'93evaluate[] reports on quality control and testing programs submitted b}{ \insrsid13321439 y x-ray equipment }{\insrsid14908102 manufacturers, and [to] supplement this information with factory inspections to verify that adequate testing was being conducted.\'94 Second, the FDA inspectors, with the aid of State inspectors, would inspect \'93hospitals, clinics, and other facilities to determine if the systems [had] been assembled and [were] performing in accordance with the standard.\'94 And third, the FDA would \'93test[] x-ray components and some fully assembled systems in its laboratory to check for compliance.\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131520202}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 X-Rays: Focusing on Patient Protection}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133822951 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003800320032003900350031000000}}}{\fldrslt {\insrsid4596385 93}}}{\insrsid4204783 , at 8, 9.}}}{\insrsid14908102 {\*\bkmkend _Ref131520202} The F}{\insrsid13321439 DA would notify}{\insrsid14908102 manufacturers if their products failed t}{\insrsid13321439 his line of testing and would require}{\insrsid14908102 that defective products be repaired or replaced free of charge.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The current standards are available at 21 C.F.R. \'a7 1020.30 (2005).}}}{\insrsid14908102 \par The first case to go to trial under the RCHSA involved a firm that assembled and instal led medical x-ray systems. Walter Wilder, owner of X-Ray of Greenville, attempted to save $2500 per installation by using manual collimators rather than the automatic collimators required under FDA regulations. Automatic collimators sense the size and s hape of the film being used and adjust the x-ray beam to limit the positive beam exposure. Wilder attempted to evade detection by not reporting the faulty }{\insrsid4861489 x-ray machines to the FDA as }{\insrsid14908102 required by law. He went so far as to prepare fictitious bills of sale claiming that the machines had been previously owned by physicians. This would allow him to avoid installing the expensive collimators under an exception allowing upgrading of old equipment. An inspection of a chiropractic clinic in February 1983 reveal ed that the unit did not have the proper safety features. The FDA sent a letter to X-Ray of Greenville and received no response, thus prompting a visit to Wilder\rquote s office. He refused access to his company\rquote s records, except the fictitious bills of sale. N orth and South Carolina state radiation control officials helped the FDA locate eleven systems installed by Wilder that had not been reported. A U.S. District Court magistrate found against Wilder on all counts. He was ordered to \'93 provide [automatic coll imators] on systems he had installed or to refund the purchase price to his customers; to give the FDA access to all sales invoices and other relevant business records; to file reports of assembly and certification for all units that he had installed but not reported; and to pay $6900 in civil penalties.}{\insrsid2441285 {\*\bkmkstart _Ref132998341}\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref134276129}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Carolyn Hommel & Richard C. Thompson, }{\i\insrsid4204783 X-ray Installation Scam Exposed}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , June 1986, at 29.}}}{\insrsid14908102 {\*\bkmkend _Ref132998341}{\*\bkmkend _Ref134276129} \par }{\insrsid2441285 Another }{\insrsid923767 FDA concern included decreasing the dangers of x-ray examinations in general by restricting dangerous products and by educating those who administered x-rays.}{\insrsid14908102 In the early 1970}{ \insrsid1537746 \rquote }{\insrsid14908102 s, the FDA discove red that an imported dental x-ray device sold as a 60,000-volt device was actually functioning at only 45,000 volts. The machines required at least five times as much exposure to produce a proper image. The FDA suspended sales of the machines and instit uted actions for their replacement or correction. The FDA}{\insrsid923767 also}{\insrsid14908102 helped institute training programs in medical and graduate schools and continued to}{\insrsid923767 conduct its own short courses o}{\insrsid14908102 n radiological health for health professionals.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 An example is the Radiological Health Sciences Learning Laboratory. Developed by the FDA and the University of California Medical Center at San Francisco, the Learn ing Laboratory is a comprehensive education system in diagnostic radiology. \'93It covers selection of patients for x-ray examinations, x-ray examination procedures, and interpretation of results\'85 It provides the basic information to enable physicians to make sound judgments on the desirability of x raying a patient.\'94 The FDA also has a series, \'93Radiation Protection During Medical X-Ray Examinations,\'94 that teaches technologists how to protect themselves and their patients from unnecessary exposure. }{\i\insrsid4204783 X Rays: Focusing on Patient Protection}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst { \insrsid4204783 NOTEREF _Ref133822951 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003800320032003900350031000000}}}{\fldrslt {\insrsid4596385 93}}}{\insrsid4204783 , at 11. As discussed in }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133953906 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003900350033003900300036000000}}}{\fldrslt {\insrsid4596385 70}}}{\insrsid4204783 , these training programs could not be made mandatory until 1981.}}}{\insrsid14908102 The chief source of unnecessary radiation remained, however, the use of x-ray examinations that were not needed for meaningful diagnoses.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131519227 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500310039003200320037000000}}}{\fldrslt {\insrsid4596385 166}}}{ \insrsid4204783 , at 6. For example, x-rays were sometimes ordered to allay patients\rquote fears or to provide physicians a record for malpractice suits, rather than when they were actually necessary for diagnosis.}}}{\insrsid923767 Widespread public education appeared to be the solution.}{\insrsid14908102 \par One of the Bureau\rquote s earliest actions involved public education regarding the proper use of x-rays. X-rays were commonly used in the 1940\rquote s and 1950\rquote s to screen for tuberculosis (\'93TB\'94),}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132644929}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Community funds often made the x-ray screenings free to the public. Valerie Britain, }{\i\insrsid4204783 Mass Chest X Rays Are On The Way Out}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Feb. 1973, at 14, 15.}}}{ \insrsid14908102 {\*\bkmkend _Ref132644929} but the development of the tuberculin skin test provided a safer alternative. The Bureau and the American College of Chest Physicians issued a joint statem ent in 1972 recommending that the use of mass chest x-ray}{\insrsid6506656 s}{\insrsid14908102 for the detection of TB and other cardiopulmonary diseases be discontinued. The value of early detection of TB in the 1940\rquote s was believed to outweigh the risk. By 1973, however, the Bureau\rquote s research had identified five reasons to dis}{\insrsid2441285 continue mass chest x-rays.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 15 \endash 16. First, the mass screenings were never really effective at detecting TB. More than ninety-five percent of infected people were detected through other means. Mass screening only detected TB in fewer than 1/20th of 1 percent. Second, TB was on the decline, which further decreased the likeliness that chest x-rays would detect an infection. Third, the tuberculin skin test served a s a safer and more accurate screening device. Fourth, the x-ray screening exposed the population to unnecessary radiation when compared to the likelihood of detection. Fifth, the mobile devices often used for mass screenings tended to expose people to te n times more radiation than fixed x-ray units.}}}{\insrsid2441285 The once common practice }{\insrsid4861489 soon }{\insrsid2441285 ended.}{\insrsid14908102 \par A }{\insrsid1537746 second public education concern was}{\insrsid14908102 the advis}{\insrsid6506656 ability of x-ray examinations for}{\insrsid14908102 p}{\insrsid6506656 regnant women}{\insrsid14908102 . During the initial House hearings, Dr. Morgan expressed his concern regarding the practice of some doctors to require pelvimetries as part of routine examinations of pregnant women.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132645185}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 }{ \i\insrsid4204783\charrsid6506656 1967 House Hearings}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131022469 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003000320032003400360039000000}}}{\fldrslt {\insrsid4596385 22}}}{\insrsid4204783 , at 367. A pelvimetry uses x-rays to compare the size of the birth canal to the baby \rquote s head. It was originally used to determine if an ir regular pelvis required delivery by Caesarian section. It later came to be used when physicians were considering Caesarian deliveries for other reasons. The usefulness of pelvimetries has also been questioned. First, small, trouble-causing pelvises are less common now. Second, babies\rquote heads tend to \'93give\'94 sufficiently for safe vaginal delivery, and pelvimetries cannot predict the amount of \'93give.\'94 Third, other diagnostic techniques such as ultrasound can determine the need for Caesarian section without the use of x-rays. Roxanne Smith, }{\i\insrsid4204783 X-rays For Childbirth: Risky, Costly, Not Always Helpful}{\insrsid4204783 , }{ \scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Feb. 1982, at 21, 21 \endash 22.}}}{\insrsid14908102 {\*\bkmkend _Ref132645185} FDA studies indicated that the risk of danger to the fetus from x-ray exposure was actually quite low and depended on many f actors. X-ray procedures of areas other than the abdomen resulted in almost no radiation exposure to the fetus. A single, properly conducted x-ray exa}{\insrsid6506656 mination of the abdomen was}{\insrsid14908102 very unlikely to cause birth defects. Animal studies indicated a slight eff ect on intelligence and behavior, though scientists were unsure if diagnostic x-ray exposure would produce the same result. Still, several studies indicated that x-ray exposure did increase the risk of leukemia. Additionally, unusually high levels of ex posure from repeated x-ray examinations over a short time period also posed a serious threat.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131528457}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 James L. Morrison & Mark Barnett, }{\i\insrsid4204783 X Rays And Pregnancy}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May 1977, at 24, 24 \endash 25.}}}{\insrsid14908102 {\*\bkmkend _Ref131528457} The FDA\rquote s education program sought to instruct physicians on the dangers of radiation to the human embryo, to encourage physicians to ask female patients routine ly if they were pregnant, and to consult radiologists when considering abdominal x-rays on pregnant patients.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 X Rays: Focusing on Patient Protection}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133822951 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003800320032003900350031000000}}}{\fldrslt {\insrsid4596385 93}}}{ \insrsid4204783 , at 11.}}}{\insrsid14908102 The FDA also encouraged women to be proactive in protecting their fetuses from unnecessary radiation}{\insrsid2441285 by taking such simple measures as informing their doctors of possible pregnancies. The FDA continued to stress, however,}{\insrsid14908102 that properly performed x-ray procedures were safe enough that they should not be avoided if doctors determined them to be necessary.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Morrison & Barnett, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131528457 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500320038003400350037000000}}}{\fldrslt {\insrsid4596385 177}}}{\insrsid4204783 , at 25.}}}{\insrsid14908102 \par }{\insrsid2441285 By 1979,}{\insrsid14908102 the Bureau of Radiological Health believed that x-rays were still over}{\insrsid2441285 -}{\insrsid14908102 prescribed. John C. Villforth, director of the Bureau, believed that as many as thirty percent of the 278 million diagnostic x-rays performed in the previous year may not have been necessary.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131546356} \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 John C. Villforth, }{ \i\insrsid4204783 The X Raying of America}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Dec. 1979 \endash Jan. 1980, at 13.}}}{\insrsid14908102 {\*\bkmkend _Ref131546356} Villforth explained that the FDA\rquote s concern about overuse of x-rays was motivated by both health and cost concerns. He estimated that medical and dental x-rays cost the American public as much as $6 billion each year.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 He also noted that \'93nonradiologists \'85 who provided their own x-ray services used those services almost twice as often as physicians who referred patients to consulting radiologists,\'94 and believed that physicians and dentists did not fully appreciate the risks they were imposing on their patients.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 15 \endash 16.}}}{\insrsid14908102 The federal gov ernment, however, did address the concerns articulated by Villforth. A presidential directive instructed Federal agencies to reduce unnecessary diagnostic x-rays. On May 29, 1980, the Public Health Service asked all of}{\insrsid4861489 its agencies, HHS}{\insrsid6506656 , and twenty-eight other f}{\insrsid14908102 ederal departments and agencies to \'93 review their current procedures, eliminate chest x-ray screening not supported by the guideline, and justify any screening that would be continued.\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132645000}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 X\rquote ing Out Unneeded X Rays}{ \insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Apr. 1981, at 19.}}}{\insrsid14908102 {\*\bkmkend _Ref132645000} The result was the elimination of approximately 150,000 former}{\insrsid6506656 ly required chest x-rays and}{ \insrsid14908102 saving}{\insrsid6506656 s}{\insrsid14908102 of approximately $4 million a year.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6506656 {\insrsid14908102 Villforth also noted that the advances in mammography demonstrated technology\rquote s ability to meet changing needs. Mammography was recognized as an effective tool for early detection of breast cancer. A low energy x-ray beam is used to get a good contrast between normal tissue and a lump or mass in the breast. The process results in less radiation reaching the film and more being absorbed by the body. Prior to the Bureau\rquote s involvement, radiation exposure from mammography varied widely among hospitals and clinics. Improper techniques and equipment further exacerbated the already high levels of radiation produced by mammography.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Annabel Hecht, }{\i\insrsid4204783 Using X Rays To Detect Breast Cancer}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Apr. 1976, at 14.}}}{\insrsid14908102 With FDA support, better x-ray films and intensifying screens were developed that provided \'93a sharper, clearer, more defined image on the film at a much lower dose of x rays to the patient than previously had been possible.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Villforth, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131546356 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500340036003300350036000000}}}{\fldrslt {\insrsid4596385 180}}}{ \insrsid4204783 , at 15.}}}{\insrsid14908102 While such technology would have been developed eventually, Villforth believed the widespread concern from physicians and consumers about the dang}{\insrsid6506656 ers of unnecessary radiation do}{ \insrsid14908102 s}{\insrsid6506656 e}{\insrsid14908102 in mammography accelerated the process.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid6506656 \par The progress of x-ray radiation control is remarkable.}{\insrsid14903629 While many in Congress were disappointed that the FDA had not pushed for more authority to regulate x-ray use,}{\cs16\super\insrsid14903629 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133953906 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003900350033003900300036000000}}}{\fldrslt {\insrsid4596385 70}}}{ \insrsid4204783 .}}}{\insrsid14903629 the concerns that arose during the legislative hearings}{\insrsid1537746 were successfully addressed b}{\insrsid7614171 ecause the FDA developed a broad radiation control program that encompassed not just enforcement of the RCHSA but also a public education program}{\insrsid14903629 . S}{\insrsid6506656 ome patients may still demand unnecessary procedures,}{ \insrsid14903629 but}{\insrsid6506656 the vast majority of the public and the medical profession recognize the inherent dangers of excess radiation exposure. The combination of widespread education and b}{\insrsid14903629 etter technology has produced }{\insrsid6506656 a society much less likely to be exposed to excessive x-ray radiation. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 B. }{\insrsid4861489 Microwave Ovens: }{\insrsid14908102 Space-Age Cooking Devices \par Microwaves were experiencing a significant increase in popularity at the same time the RCHSA was being passed. While Dr. Russell Morgan\rquote s statement about the lack of evidence of biological effects from microwaves may have been technically correct, }{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 See supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131769364 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700360039003300360034000000}}}{\fldrslt {\insrsid4596385 43}}}{\insrsid4204783 .}}}{\insrsid14908102 the FDA believed the absence of proof did n}{\insrsid15670578 ot indicate that}{\insrsid14908102 microwaves were actually safe. The FDA\rquote s research indicated that many microwaves were leaking radiation above the voluntary industry recommendation.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131769675 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700360039003600370035000000}}}{\fldrslt {\insrsid4596385 91}}}{ \insrsid4204783 and accompanying text.}}}{\insrsid14908102 The first microwave oven standard went into effect on October 6, 1971, and was set well below the lowest level known to cause biological effects.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131781988}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Robert T. De Vore & Albert Van De Griek, }{\i\insrsid4204783 The Microwave Oven Safety Debate}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Apr. 1973, at 25.}}}{\insrsid14908102 {\*\bkmkend _Ref131781988} That did not sa tisfy }{\i\insrsid14908102 Consumer Reports}{\insrsid14908102 , however, which found \'93\lquote measurable radiation leakage\rquote in 15 leading models and warned the public not to purchase those ovens.\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131786356}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 FDA Actions: Microwave Ovens}{\insrsid4204783 , 31 }{\scaps\insrsid4204783 Cong. Q. }{\insrsid4204783 850 (1973).}}}{\insrsid14908102 {\*\bkmkend _Ref131786356} Dr. Milton Zaret testified before Congress that several years of such exposure could lead to the development of cataracts.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id.}}}{\insrsid14908102 }{\i\insrsid14908102 Consumer Reports}{\insrsid14908102 claimed that no amount of leakage could be considered acceptable.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore & Van De Griek, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131781988 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700380031003900380038000000}}}{\fldrslt {\insrsid4596385 191}}}{\insrsid4204783 , at 25.}}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The FDA and the Association for Home Appliance Manufacturers disputed that assessmen}{\insrsid15670578 t. The FDA indicated that }{\insrsid14908102 common consumer goods such as shavers, food mixers, vacuum cleaners, and other appliances with electric motors would have to be banned under a zero-radiation policy.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}} {\insrsid14908102 The FDA also criticized }{\i\insrsid14908102 Consumer Reports\rquote }{\insrsid14903629 erroneous interpretation of the FDA\rquote s}{\insrsid14908102 policy for causing unnecessary concern among the public. The FDA claimed }{ \i\insrsid14908102 Consumer Reports}{\insrsid14908102 inappropriately compared the FDA\rquote s microwave }{\i\insrsid14908102 emissions}{\insrsid14908102 standards to the Soviet Union\rquote s microwave }{\i\insrsid14908102 exposure}{\insrsid14908102 standards in concluding that the Soviet Union\rquote s standards were 500 times lower than the American standard. The emission level at the source was very different from the actual exposure received.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131790652}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . The Soviet standard was for whole body exposure for a working day of eight hours or more. If a microwave emitted radiation at the maximum allowed level, \'93 one could stand within four feet of it for over eight hours per day or within 14 inches for two hours a day without reaching Russian exposure limits.\'94 Additionally, if a microwave leaked from mult iple points, then fewer points of the human body would be exposed to radiation, further reducing the danger to humans. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 26. }{\i\insrsid4204783 Consumer Reports}{\insrsid4204783 refused to acknowledge the inaccuracies in its April 1973 report and instead declared in August 1973: \'93Microwave Ovens: Still Not Recommended.\'94 Thomas V. DiBacco, }{\i\insrsid4204783 Microwave\rquote s Generation: America Begins Cooking to a Different Beep}{\insrsid4204783 , }{\scaps\insrsid4204783 Wash. Post}{\insrsid4204783 , May 31, 1990, at T28.}}}{\insrsid14908102 {\*\bkmkend _Ref131790652} The Bureau assured the public that a properly manufactured and operated microwave oven was safe for human use, and that the Bureau would continue to test microwaves i n homes, commercial establishments, and on dealer and distributor premises to ensure compliance with federal standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore & Van De Griek, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131781988 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700380031003900380038000000}}}{\fldrslt {\insrsid4596385 191}}}{ \insrsid4204783 , at 26. The Bureau also assured that it carefully monitored manufacturer quality control and test procedures and would use its authority to withhold non-compliant microwave ovens from the market.}}}{\insrsid14908102 The Association of Home Appliance Manufacturers asserted that all leakage cited in the }{\i\insrsid14908102 Consumer Reports}{\insrsid14908102 article was \'93\lquote well within the limits\rquote set by the government.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 FDA Actions: Microwave Ovens}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131786356 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700380036003300350036000000}}}{\fldrslt {\insrsid4596385 192}}}{\insrsid4204783 .}}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The FDA continued to adjust its microwave standard to protect the public. The FDA proposed amendments to its standards in 1973 to require ovens to shut off automatically if the safety interlocks that prevented the ovens fr om operating when the door was open had failed. By October 3, 1975, manufacturers were required to attach permanent labels warning users how to avoid exposure to excessive microwave energy.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131789530}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Valerie A. Britain, }{\i\insrsid4204783 Microwave Oven Labeling}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1975, at 16. The current labeling requirement remains the same: \'93 Precautions for safe use to avoid possible exposure to excessive microwave energy. DO NOT attempt to operate this oven with: (a) object caught in door, (b) door that does not close properly, (c) damaged door, hinge, latch, or sealing surface.\'94 21 C.F.R. \'a7 1030.10(c)(6)(i) (2005).}}}{\insrsid14908102 {\*\bkmkend _Ref131789530} In issuing the labeling requirement, the FDA assured the public that it reflected the FDA\rquote s belief that a safe product as manufactured could pose a risk to consumers if used or serviced improperly. The FDA emphasized that there had be}{\insrsid15670578 en no documented cases of injur}{\insrsid14908102 ies associated with microwave ovens that complied with federal standards. The FDA confirmed, however, that extra precautions were necessary because of the uncertainties about possible radiation effects.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Britain, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131789530 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700380039003500330030000000}}}{\fldrslt {\insrsid4596385 199}}}{ \insrsid4204783 , at 16. In particular, microwave radiati on can cause heating within the body without activating temperature sensors on the skin. While these sensors can warn users of dangers from gas or electric ovens, they may not always function when exposed to microwave radiation.}}}{\insrsid14908102 The standards are now a mix of performance standards and warnings through labels and instruction manuals for consumers and repair personnel.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 21 C.F.R. \'a7 1030.10 (2005).}}}{\insrsid14908102 \par Despite fears of uncertainty, these \'93space-age\'94 cooking devices became commonplace as prices dropped. The first models were priced at $1500. By 1968, the price had dropped but was stil}{\insrsid15670578 l very high at $995. A}{\insrsid14908102 bout 100,000 ovens were sold in 1971, when the first standards were enacted. In April 1973, when }{\i\insrsid14908102 Consumer Reports}{\insrsid14908102 warned consumers not to buy microwave ovens, sales were predicted to reach 800,000. By 1981, forty-five companies were manufacturing microwaves. Tw o years later, one in every four American homes owned a microwave, now priced at just $399. By 1990, seventy-five to eighty percent of American homes had microwaves, which were now manufactured to fit every individual\rquote s needs.}{ \cs16\super\insrsid14908102 {\*\bkmkstart _Ref131854639}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Di Bacco, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131790652 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003700390030003600350032000000}}}{\fldrslt {\insrsid4596385 196}}}{\insrsid4204783 , at T28. Note, however, that many still questioned the safety of microwave ovens. Joanne Barron of CDRH stated that the department still received two to twenty complaints of radiation leaka ge each year. Most turned out to be false alarms. The real problems were often due \'93to abuse of the oven or improper servicing.\'94 Dixie Farley, }{\i\insrsid4204783 Keeping Up with the Microwave Revolution}{\insrsid4204783 , }{ \scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. 1990, at 17, 18. }{\i\insrsid4204783 See also}{\insrsid4204783 Jane Clarke, }{\i\insrsid4204783 Radiate a Little Goodness}{\insrsid4204783 , }{\scaps\insrsid4204783 Times}{ \scaps\insrsid4204783\charrsid7562499 }{\scaps\insrsid4204783 London}{\insrsid4204783 , Features, Apr. 19, 2005 (noting that a major objection to microwave ovens is a safety concern regarding the use of radiation to heat food).}}}{\insrsid14903629 {\*\bkmkend _Ref131854639} Currently, as many as ninety-five percent of American homes owns a microwave.}{\cs16\super\insrsid14903629 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Cornell Researchers Explanation Why Some Microwaved Foods Explode Could Revolutionize Microwave Cooking and Sterilization}{ \insrsid4204783 , }{\scaps\insrsid4204783 Cornell News}{\insrsid4204783 , June 23, 1998, }{\i\insrsid4204783 at}{\insrsid4204783 }{\insrsid4204783\charrsid14903629 www.news.cornell.edu/releases/June}{\insrsid4204783 98/microwave.ift.ssl.html (last visited Apr. 29, 2006).}}}{\insrsid14908102 \par The generally accepted safety of microwave ovens changed the focus of the FDA\rquote s concerns from radiation emission to the contents of microwave-packaged foods, the materials used in the packaging, and the proper techniques for microwave cooking. Microwave packaged food sales had risen from $53 million in 1983 to $3 billion in 1992. When packaging materials were first regulated as passive or active indirect food additives, the FDA did not consider the pos sible effects high temperature could have on the migration of components of the packaging material. In 1987, FDA scientists noticed that the heat-susceptor}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 \'93 [H]eat-susceptor packaging is usually metalized polyethylene terephthalate (PET) film lami nated to paperboard with adhesive. This metalized film absorbs the microwave energy in the oven and, with most of the microwaves absorbed, the package becomes a little \lquote frying pan\rquote that actively participates in the cooking.\'94 Dixie Farley, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131854639 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003800350034003600330039000000}}}{\fldrslt {\insrsid4596385 202}}}{\insrsid4204783 , at 19.}}}{\insrsid14908102 portions of microwavable popcorn bags would burn through. Further investigation indicated that the heat-susceptors helped, rather than prevented, the migration of components into foods. The FDA was unsure of the health effects of such migrations but used the opportunity to urge safe use of microwaves. While the FDA repeated safety measures outlined in instruction manuals, the U.S. Department of Agriculture issued its instructions on proper microwave cooking of meats.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 20.}}}{ \insrsid14908102 The current trend in FDA regulation of microwaves is a significant advance from the days when people thought microwave cooking made the food radioactive. \par C. }{\insrsid7562499 Sunlamps and Sunbathing: }{\insrsid14908102 There Is No Such Thi}{\insrsid7562499 ng as a}{\insrsid14908102 Safe Tan \par The FDA also expended great effort in public education concerning sunlight and }{\insrsid6365170 sun tanning}{\insrsid14908102 . While scientists in the 1970\rquote s agreed that the sun was the leading cause of sk in cancer, the public was not so informed. Sunbathing and the use of sunlamps were rather common, with little notice paid to the estimated 6}{\insrsid222948 ,}{\insrsid14908102 500 to 7}{\insrsid222948 ,}{\insrsid14908102 500 deaths in the United States annually from skin cancer.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Robert T. De Vore, }{\i\insrsid4204783 Sunbathing and Skin Cancer}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May 1977, at 15.}}}{\insrsid14908102 The FDA sought to educate the public about the dangers of ultraviolet radiatio}{\insrsid14903629 n}{\insrsid14908102 , particularly because it was believed that a ninety-eight to one hundred percent cure rate was possible with consumer awareness and early detection.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 When the FDA began promoting public awareness, ninety-five percent of skin cancer patients were fully cured. Skin cancer differs from other cancers because \'93it can be seen [and] can almost always be detected and treated in an early stage.\'94 }{ \i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par The concerns about ultraviolet radiation were similar to the concerns about microwave radiation: both are invisible and cannot be felt at the time of exposure. Biological effects appear later and may include eye injury, sunburn, skin eruptions, premature aging of the skin, and skin cancer. The short wavelengths of ultravi olet radiation emitted by some sunlamps were believed to be highly dangerous to cell structure.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 16. The FDA noted that the ozone layer filtered most of the dangerous short wavelengths from the sun, but the severe ozone depletion since the 1970\rquote s has renewed concerns about such exposure.}}}{\insrsid14908102 Repeated exposure to ultraviolet radiation, even when a person never burns, was believed to be damaging in the long run. While people under twenty rarely deve lop skin cancer, the rate of skin cancer increases until about the age of seventy five. Dermatologists strongly advised against excessive sunbathing, believing that many sunbathers relied on inaccurate assumptions to justify their actions.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The FDA cited two common justifications. First, the sun stimulates vitamin D production. Experts countered that a proper diet provided sufficient vitamin D. Second, sunscreen lotions allowed tanning without burning, and therefore was safe for the skin. The experts countered that a \'93tanned skin is a damaged skin.\'94 Even in the absence of burning, ultraviolet radiation can damage DNA. }{\i\insrsid4204783 Id}{\insrsid4204783 .}} }{\insrsid14908102 The use of sunlamps further increased the potential for damage. \par The FDA published its first proposed standards for sunlamps on December 30, 1977.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Sunlamps: Putting Safety First}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. 1978, at 16, 19.}}}{\insrsid14908102 Sunlamps were being used primarily for tanning, though they were also used to treat acne and other skin problems. At the time the standards were first proposed, thousands were treated annually for injuries from sunlamps, which typically occurred when users failed to follow instructions. Many fell asleep under the lamps, failed to use timers or goggles, or tried exposures that were too long. The proposed regulations would require sunlamps to have timers t}{\insrsid14903629 hat shut the }{\insrsid14908102 lamp off automatically after ten minutes or less. Sunlamp bulbs that fit into conventional sockets would not be allowed to ensure that they could only be used with timers. Sunlamps would not be allowed to emit excessive short wavelengths of radiation. Protective eyewear would be required. Finally, better warning labels and instructions would be required.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id.}}}{\insrsid14908102 The FDA also suggested safety precautions for those who insisted on using sunlamps.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 These precautions included makeshift options that reflected the concerns addressed in the proposed standards, such as using loud kitchen timers when a sunlamp does not have an automatic one and using some form of eye protect ion. Practical precautions included not using sunlamps if a person has fair skin and only using sunlamps as recommended in the instructions. A surprising precaution was not to use sunlamps after a shower or sauna because natural oils that can absorb som e of the ultraviolet rays have been washed off. }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The first sunlamp standards went into effect on May 7, 1980.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The current standards are at 21 C.F.R. \'a7 1040.20 (2005).}}}{ \insrsid14908102 \par As the FDA was researching the dangers of sunlamps, tanning booths and huts in salons began to grow in popularity, particularly in sunny states where bronzed skin was equated with wealth.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Harold Hopkins, }{\i\insrsid4204783 Tan Now, Pay Later?}{ \insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Apr. 1982, at 9, 11.}}}{\insrsid14908102 The new tanning booths were using ninety-five percent UV-A radiation and only five percent UV-B radiation, leading to claims that tanning booths were a safer alternative.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 A Careful Look Into Tanning Booths}{ \insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Oct. 1980, at 20, 23.}}}{\insrsid14908102 While UV-B radiation was believed to be the cancer-ca using radiation, the FDA did not support the safety claim. At the time, UV-A radiation was known to penetrate deeper into the skin and was believed to cause aging and skin sagging, but no direct connection to cancer had been established. The FDA was cer t ain, however, that some chemicals increased sensitivity to UV-A radiation and could cause damage. The FDA also rejected the claim that goggles were not needed. Both types of radiation could cause eye burning and other corneal irritations and could incre ase the risk of cataracts. Additionally, the amount of light provided by the booths was as high as \'9310 times the irradiance of noon summer sunlight.\'94 In other words, there was enough radiation to serve as a \'93 successful experimental tool for generating skin cancer in animals.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 \par By 1987, the FDA believed the first generation to understand the risks of too much sun had arrived. The problem remained, however, that tanning was becoming more popular than ever. While only one in 1}{\insrsid222948 ,}{\insrsid14908102 500 persons in the United Stat es was expected to develop melanoma in 1930, the expected rate in 1980 was one in 250. Scientists estimated that it could rise as high as one in 100. The FDA also determined that the assertion that UV-A tanning booths were safer than UV-B sunlamps was w rong.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131880703}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Richard C. Thompson, }{\i\insrsid4204783 Out of the Bronzed Age}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , June 1987, at 21, 22.}}}{\insrsid14908102 {\*\bkmkend _Ref131880703} UV-B radiation was originally believed to be more dangerous because it burned the skin faster, but research indicated that the effects of UV-A radiation were just as harmful. The effects of UV-A radiation were merely delayed because the radiation p enetrated deeper into the skin.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131881634}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Scientists debate whether UV-A radiation is actually more harmful because it damages the dermis \endash \'93the inner layer of skin that contains the blood vessels, hair follicles, and nerve endings. \'94 Alexandra Greeley, }{\i\insrsid4204783 No Safe Tan}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May 1991, at 16, 19.}}}{\insrsid14908102 {\*\bkmkend _Ref131881634} Following its duty to protect the public, the FDA prohibited manufacturers and sunlamp operators from making such health claims as \'93improves immunity\'94 and \'93treats disease.\'94 \'93No harmful rays\'94 and \'93no harmful effects\'94 were also prohibited. The FDA used its seizure and enforcement authority to intercept imported sunlamps because they lacked required safety features. The FDA also seized installed equipment and shut down salons for unsafe equipment and operation. State and local governments developed their own regulations requiring tanning salons to properly inform and protect customers.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Thompson, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131880703 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003800380030003700300033000000}}}{\fldrslt {\insrsid4596385 217}}}{\insrsid4204783 , at 22.}}}{\insrsid14908102 The 1978 requirement of the \'93 sun protection factor\'94 (\'93SPF\'94) indicating the degree of protection a sun-blocking agent supplied had led to a growth in the sun products industry, suggesting some success.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The cosmetics industry quickly picked up on the SPF trend and began applying these numbers to their products. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 23.}}}{\insrsid14908102 \par Yet despite the FDA\rquote s efforts at public education and the availability of sunscreens, skin cancer rates continued to grow. A University of Florida study found that ninety percent of those s urveyed knew the basic harms of sunlight and understood the SPF system. However, only half used sunscreen regularly, and most still insisted that a \'93tan is healthy.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 The FDA began to publish regularly its recommendations against sunlamps and tanning booths and its suggestions for protecting against sun exposure.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131883944}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See, e.g.}{\insrsid4204783 , Greeley, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131881634 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003800380031003600330034000000}}}{\fldrslt {\insrsid4596385 218}}}{\insrsid4204783 ; Paula Kurtzweil, }{\i\insrsid4204783 Seven Steps to Safer Sunning}{\insrsid4204783 , } {\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , June 1996, at 6; Michelle Meadows, }{\i\insrsid4204783 Don\rquote t Be in the Dark About Tanning}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Nov. \endash Dec. 2003, at 17; Carol Rados, }{\i\insrsid4204783 Teen Tanning Hazards}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Mar. \endash Apr. 2005, at 8. Carolyn J. Strange, }{\i\insrsid4204783 Thwarting Skin Cancer With Sun Sense }{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1995, at 10.}}}{\insrsid14908102 {\*\bkmkend _Ref131883944} \par The trend in recent years has been the use of sunless spray tans. Some credit designer Coco Chanel with starting the tanning craze by returning from her yachting vacation with a tan. Tanned skin was soon equated with great wealth, leisure time, social status, and high fashion, a complete departure from the previous association of tanned skin with outdoor laborers.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Greeley, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131881634 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003800380031003600330034000000}}}{\fldrslt {\insrsid4596385 218}}}{\insrsid4204783 , at 17.}}}{\insrsid14908102 When celebrities began turning to sunless tans as a safer }{\insrsid222948 and easier}{\insrsid14908102 alternative, the public followed. Many salons now offer spray tans that look a bit unnatural but are much safer. \par Sunless spray tans contain the color additive dihydroxyacetone (\'93DHA\'94), which interacts with skin cells to darken the skin color. The FDA approved DHA for use in tanners in 1977, though it was used at that time only in over-the-counter lotio}{ \insrsid13715815 ns and creams. Doctors now}{\insrsid14908102 encourage teenagers to use self-tanners as opposed to sunbathing or sunlamps.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Rados, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131883944 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003800380033003900340034000000}}}{\fldrslt {\insrsid4596385 222}}}{ \insrsid4204783 , at 9.}}}{\insrsid14908102 }{\insrsid222948 Excessive sunbathing remains a problem, however. While sunless tanning is growing in popularity, it also indicates that Americans still associate tanned skin with good health and wealth. The }{\insrsid13900469 federal standards ensure that tanning booths are}{\insrsid7614171 as}{\insrsid13900469 safe as possible, but the FDA\rquote s efforts in changing people\rquote }{\insrsid7562499 s mindsets have yet to succeed.}{\insrsid14908102 \par }{\insrsid1276773 D. Lasers: Disco Fun and Medical Wonder}{\insrsid14908102 \par Lasers are composed of concentrated beams of visib}{\insrsid13900469 le light, which distinguishes them}{\insrsid14908102 from other forms of radiation like microwaves and ultraviolet light that can cause cancer and genetic damag e. The high concentration, or coherence, of the light waves in laser beams makes them potentially dangerous despite the absence of cancer causing properties.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131955604}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 Center for Devices and Radiological Health} {\insrsid4204783 , }{\scaps\insrsid4204783 Laser Light Show Safety: Who\rquote s Responsible?}{\insrsid4204783 5, 7 (rev. ed. 1986), }{\i\insrsid4204783 available at}{\insrsid4204783 http://www.fda.gov/cdrh/radhlth/pdf/llsgde01.pdf [hereinafter \'93 CDRH, }{\scaps\insrsid4204783 Laser Light Safety}{\insrsid4204783 \'94].}}}{\insrsid14908102 {\*\bkmkend _Ref131955604} The nature of lasers allowed them to be used in a wide variety of areas in the early years of t he RCHSA. Lasers had been used as highly}{\insrsid13900469 accurate surveying tools; as }{\insrsid14908102 tool}{\insrsid13900469 s}{\insrsid14908102 to perform delicate surgical procedures of the eye and throat; as supermarket checkout scanners; and as tools for drilling, cutting, and welding materials. Other popular uses included \'93 communications, fingerprint identification, pollution detection, cell measurement, [and] tailoring.\'94}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131951979}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Annabel Hecht, }{\i\insrsid4204783 Entertainment Lasers: Approach With Care}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Sep. 1978, at 20, 22.}}}{\insrsid14908102 {\*\bkmkend _Ref131951979} \par The first laser standard went into effect on August 1, 1976. Lasers were classified into four categories depending }{\insrsid13900469 o}{\insrsid14908102 n their ability to injure peop le and the intensity of the radiation from the beam. Class I lasers are known to have no biological effects. Class II }{\insrsid13900469 lasers can produce eye damage from}{\insrsid14908102 long, direct exposure. Class III lasers can injure tissues after short, direct exposure. Class IV lasers can cause injury from reflected light and after the beam has scattered.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 C.F.R. 1040.10(b) (2005).}}}{\insrsid14908102 Lasers used for demonstration purposes were generally in Class I or Class II, but the growing popularity of laser light shows, which require Class III or even Class IV lasers to be effective, concerned the FDA. \par The first laser light show was introduced in Los Angeles in 1973 and was immediately successful. Jus}{\insrsid13900469 t five years later, laser light}{\insrsid14908102 show}{\insrsid13900469 s}{\insrsid14908102 became popular in planetariums in at least twenty cities in the United States, Canada, Britain, and Japan. Additionally, rock bands and discotheques began using laser light shows to entertain patrons.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Hecht, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131951979 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900350031003900370039000000}}}{\fldrslt {\insrsid4596385 226}}}{ \insrsid4204783 , at 20.}}}{\insrsid14908102 While lasers at planetariums posed little threat to patrons, reports of uncontrolled or unsafe use by rock bands were common. One per former directly sprayed the audience with laser beams from a device on his wrist. Another show involved beams bounced from mirrored walls and mirrored balls. One report stated that a rock band\rquote s laser was so powerful that a stagehand used it to light a cigarette.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 23.}}}{\insrsid14908102 The FDA repudiated the belief that quick moving lasers were safe. Rather, lasers can strike a shiny surface at any time and reflect into the eyes of patrons, causing serious vision impairment. The shows were being designed by people who had l ittle knowledge of the dangers of lasers, and the shows were virtually unregulated. The FDA began an investigation into who the producers of the shows and the manufacturers of the equipment were, and into what the spec}{\insrsid4525381 ific hazards were. The FDA interpreted}{\insrsid14908102 \'93manufacturer\'94 to include persons who receive compensation from laser light shows, who sell services as an assembler of such shows, or who create the show and perform in the show. Laser light shows were technically required to seek variances, though gu idelines established situations in which variances were unnecessary.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Hecht, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131951979 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900350031003900370039000000}}}{\fldrslt {\insrsid4596385 226}}}{\insrsid4204783 , at 24. The guidelines required that the radiation exposure to the audience be no greater than a Class I laser. Lasers must be operated at least three meters above where the audience may stand. Equipment was required to have a shut off mechanism. Notification to the FDA was required. The FDA retained the right to inspect the shows and to impose civil fines up to $300,000. A detailed explanation of the guidelines can be found in CDRH,}{\scaps\insrsid4204783 Laser Light Safety,}{ \insrsid4204783 }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131955604 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900350035003600300034000000}}}{\fldrslt {\insrsid4596385 225}}}{\insrsid4204783 , at 17 \endash 20.}}}{\insrsid14908102 The FDA required variances for Class III-b and Class IV lasers beginning in 1985.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\scaps\insrsid4204783 CDRH, Laser Light Safety}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst { \insrsid4204783 NOTEREF _Ref131955604 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900350035003600300034000000}}}{\fldrslt {\insrsid4596385 225}}}{\insrsid4204783 , at 18.}}}{ \insrsid14908102 To provide substance to the guidelines, the FDA does inspect shows when possible.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131966429}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Rebecca D. Williams, }{\i\insrsid4204783 Non-Medical Lasers: Everyday Life in a New Light}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1991, at 32, 34.}}}{\insrsid14908102 {\*\bkmkend _Ref131966429} \par The guidelines also regulate outdoor laser shows that may affect airline pilots. The FDA originally believed the chance of harm was very low,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 CDRH, }{ \scaps\insrsid4204783 Laser Light Safety}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131955604 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900350035003600300034000000}}}{\fldrslt {\insrsid4596385 225}}}{\insrsid4204783 , at 20.}}}{\insrsid14908102 but by 1993, that view had changed. High-powered outdoor laser light shows had become extremely popular in Las Vegas as a means o f attracting tourists. Late that year, a pilot was treated for corneal irritation after laser lights interfered with his vision on take-off. By late 1995, the FAA reported to the FDA a total of fifty-two incidents of aircraft illuminations from laser li ght shows, eleven of which resulted in temporary blindness of the flight crew members, and twenty four of which took place during critical flight times. The temporary blinding of an airline pilot }{\insrsid13715815 on October 30, 1995}{\insrsid7614171 ,} {\insrsid13715815 }{\insrsid14908102 was so severe that his captain had to t ake control until the pilot regained his eyesight. Investigations revealed numerous violations of FDA standards, including operating without a variance, failing to employ spotters to warn of incoming and outgoing planes, failing to maintain documented qu ality control procedures, and failing to provide certificates of proper operator training. In December 1995, the FDA de}{\insrsid4525381 clared a temporary moratorium on}{\insrsid14908102 laser light shows in Las Vegas.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Paula Kurtzweil, }{\i\insrsid4204783 Laser Light Shows Nixed Until Fixed}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May 1996, at 31.}}}{\insrsid14908102 In July 1999, the FDA completed a memorandum of understanding with the FAA to coordinate their programs and research on laser light displays.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\insrsid4204783\charrsid12528370 Memorandum of Understanding Between the Food and Drug Administration and the Federal Aviation Administration}{ \insrsid4204783 , }{\insrsid4204783\charrsid4525381 64}{\insrsid4204783 Fed. Reg. 40603 (July 27, 1999).}}}{\insrsid14908102 \par The predominant use of lasers remains in the medical field. The FDA\rquote s authority to regulate medical uses of lasers comes under both the RCHSA and the Medical Devices Amendment}{\insrsid12528370 s}{\insrsid14908102 . Las ers provide benefits in medicine that traditional tools cannot. Lasers have the potential to vaporize or mend tissue with minimal scarring.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Williams, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131966429 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900360036003400320039000000}}}{\fldrslt {\insrsid4596385 232}}}{ \insrsid4204783 , at 32.}}}{\insrsid14908102 They can cut through tissue with minimal bleeding because they actually help coagulate the tissue. They reach pa rts of the body that a doctor with a scalpel cannot reach. Selection of wavelengths allows doctors to target specific tissues without affecting others.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref131972067}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Alexandra Greeley, }{\i\insrsid4204783 Cosmetic Laser Surgery: A High-Tech Weapon in the Fight Against Aging Skin}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May \endash June 2000, at 34, 36.}}}{\insrsid14908102 {\*\bkmkend _Ref131972067} Technology has since allowed lasers to be used for a }{\insrsid13715815 variety of }{\insrsid7562499 other }{\insrsid14908102 purposes. The FDA has approved}{\insrsid12528370 the}{\insrsid14908102 use of lasers by dentists for soft tissue surgery, an option favored by many patients because recovery is less painful.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Ricki Lewis, }{ \i\insrsid4204783 Lasers In Dentistry}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Jan. \endash Feb. 1995, at 15.}}}{\insrsid14908102 A laser to treat tooth decay has also been approved.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Laser Treatments OK\rquote d For Tooth Decay, Astigmatism}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1997, at 2. Laser treatment was found to be just as effective as traditional drilling and required the use of less anesthetics. }{\i\insrsid4204783 See also}{\insrsid4204783 Paula Kurtzweil, }{\i\insrsid4204783 Dental More Gentle with Painless Drillings and Matching Fillings}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May \endash June 1999.}}}{\insrsid14908102 Laser eye surgery can correct myopia, hyperopia, and astigmatism with minimal pain and minimal recovery time.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Carol Lewis, }{\i\insrsid4204783 Laser Eye Surgery: Is It Worth Looking Into?}{\insrsid4204783 , }{ \scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , July \endash Aug. 1998, at 32.}}}{\insrsid14908102 Cosmetic uses include skin resurfacing, a controlled burning of the skin to remove wrinkles, lines, scars, and superficial growths,}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Greeley}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131972067 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003900370032003000360037000000}}}{\fldrslt {\insrsid4596385 237}}}{\insrsid4204783 , at 35.}}}{\insrsid14908102 and hair removal.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See }{\insrsid4204783 Marian Segal, }{\i\insrsid4204783 Hair Today, Gone Tomorrow}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Sep. 1996, at 21.}}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12528370 {\insrsid14908102 The increasing popularity of lasers among consumers has added to the FDA\rquote s concerns, particularly for children. The decreasing price of lasers allowed for their greater use by teachers and lecturers, but the FDA feared the promotion of lasers as toys.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783 FDA Issues Warning on Misuse of Laser Pointers}{\insrsid4204783 (1997), }{\i\insrsid4204783 available at}{\insrsid4204783 http://www.fda.gov/bbs/topics/NEWS/NEW00609.html.}}}{\insrsid14908102 The Laser Institute of America reported that some mothers bought lasers for their children to simulate Star Wars characters.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Linda Bren, }{\i\insrsid4204783 Illuminating Facts About Laser Pointers}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , May \endash June 2005, at 18.}}}{\insrsid14908102 The availability of lasers on the internet further exacerbated the situation. High-powered green lasers were being modified to emit radiation far in excess of the FDA\rquote s standards and were being u sed for such activities as aiming at airplanes in flight. The FDA issued a warning to consumers that lasers purchased over the internet might not comply with federal safety regulations and that illegal lasers from outside the United States could be denie d entry.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783 Important Information to Consumers on Internet Sales of Laser Products}{\insrsid4204783 ,}{\i\insrsid4204783 at}{\insrsid4204783 }{\insrsid4204783\charrsid8142342 http://www.fda.gov/c drh/comp/internetlasers.html}{\insrsid4204783 (last visited Apr. 6, 2006).}}}{\insrsid12528370 Unlike other devices regulated by the FDA, lasers are dangerous for contradictory reasons: people are either unaware of the dangers, or they are aware and exploit their knowledge. In addition to educating the public about the true dangers of las ers, the FDA must seek to control their availability.}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 E. Cell Phones}{\insrsid7614171 : Renewed Radiation Concerns}{\insrsid14908102 \par The proliferation of cellular telephones and other wireless electronic devices has renewed concerns about dangerous radiation emissions. Similar to the concerns about microwave ovens, the public was aware that some form of radi}{\insrsid13715815 ation was emitting from cell }{\insrsid14908102 phones but was unsure of just how dangerous the radiation was. Cell phones emit radiation in the form of non-ionizing radiofrequency (\'93RF\'94) energy, the same type of energy used in microwave ovens. RF energy can be harmful at high levels because it can heat living tissue and cause biological damage. RF energy from cell phones comes mainly from the antenna and dissipates quickly with distance. Many experts believe that the six tenths of a watt of power emitted from cell phones cannot possibly affect human health. \'93[F]rom the physics standpoint, biological effects from mobile phones are \lquote somewhere between impossible and implausible.\rquote \'94}{ \cs16\super\insrsid14908102 {\*\bkmkstart _Ref132050491}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Tamar Nordenberg, }{\i\insrsid4204783 Cell Phones & Brain Cancer: No Clear Connection}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Nov. \endash Dec. 2000, at 19, 19 \endash 21.}}}{\insrsid14908102 {\*\bkmkend _Ref132050491} Extensive resea}{\insrsid13715815 rch has been conducted}{\insrsid14908102 to verify this assumption and in response to lawsuits and general public concerns. \par The FDA has collaborated with the Federal Communications Commission (\'93FCC\'94) in its research and public education program.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The Environmental Protection Agency and the Occupational Safety and Health Administration also have a regulatory duty regarding cellular telephones. U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid5468723 Wireless Phones: Additional Information}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cellphones/additional.html#1 (last visited Apr. 6, 2006).}}}{\insrsid14908102 The results of studies have been conflicting. Proving a cause-and-effect relationship in epidemiological studies is difficult because of the many variables involved in a person\rquote s life. Brain cancers can also take years or even decades to develop, while lifestyle factors such as the posi tion in which a person holds the phone create additional difficulties. Animal studies are easy to control, but correlating animal-testing results to human health effects is difficult. In addition, researchers in animal studies tend to use animals geneti cally altered to be predisposed to cancer and expose the animals to much more radiation than is consistent with normal cell phone use.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref132051849}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Nordenberg, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132050491 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003000350030003400390031000000}}}{\fldrslt {\insrsid4596385 246}}}{ \insrsid4204783 , at 21. Scientists note the difficulty of correlating nearly continuous, whole body RF exposure of rats predisposed to develop cancer with the much briefer, head-only radiation typical of normal human cell phone use.}}}{\insrsid14908102 {\*\bkmkend _Ref132051849} The FDA admits that some test results may warrant further investigation,}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref133965640}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 In one study, tumor patients reported that the tumor developed on the side they tend to hold their cell phones, but researchers believed the recollections were biased by knowledge of which side the tumor was on. A different study found no association between c e ll phone use and a type of brain cancer called glioma. However, there appeared to be an increase in one rare type of glioma. Researchers believed this was due to chance because the risk tended to decrease with greater cell phone use. A cognitive functi on test in which participants were exposed to simulated phone signals indicated no impairment in cognitive skills. People exposed to the signals actually responded more quickly in one of the tests. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 23.}}}{ \insrsid14908102 {\*\bkmkend _Ref133965640} but no studies have demonstrated a clear connection between cell phone radiation exposure and biological health effects.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 The studies that demonstrate a possible conn ection have suffered from design defects. }{\i\insrsid4204783 See supra}{\insrsid4204783 notes }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132051849 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003000350031003800340039000000}}}{\fldrslt {\insrsid4596385 248}}}{\insrsid4204783 \endash }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133965640 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003900360035003600340030000000}}}{\fldrslt {\insrsid4596385 249}}}{\insrsid4204783 and accompanying text; }{\i\insrsid4204783 infra}{ \insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133965687 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003900360035003600380037000000}}}{\fldrslt { \insrsid4596385 271}}}{\insrsid4204783 .}}}{\insrsid14908102 A concern e}{\insrsid7614171 xists, however, because the studies averaged}{\insrsid14908102 three years}{\insrsid7614171 of phone use}{\insrsid14908102 and therefore cannot make credible predictions of long-term effects.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid5468723 Questions and Answers about Wireless Phones}{\insrsid4204783 , }{ \i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cellphones/qa.html#25 (last visited Apr. 6, 2006).}}}{\insrsid14908102 \par Cell phone regulations and standards are set by the FCC.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 47 C.F.R. \'a7\'a7 1.1307(b), 2.1091, 2.1093 (2005).}}}{\insrsid14908102 After the passage of the National E}{\insrsid13715815 nvironmental Policy Act}{ \insrsid14908102 , the agency adopted guidelines for electromagnetic radiation emissions.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 In re Wireless Tele. Radio Frequency Emissions Products Liab. Litig., 216 F. Supp. 2d 474, 484 n.6 (D. Md. 2002), }{\i\insrsid4204783 rev\rquote d sub nom.}{\insrsid4204783 Pinney v. Nokia, Inc., 402 F.3d 430 (4th Cir. 2005), }{\i\insrsid4204783 cert. denied}{\insrsid4204783 Nokia, Inc. v. Naquin, 126 S.Ct. 551 (2005), }{\i\insrsid4204783 and cert. denied }{\insrsid4204783 Cellco P\rquote ship v. Pinney, 126 S.Ct. 552 (2005).}}}{\insrsid14908102 As an agency without expertise on health and safety matters, the FCC relied on standards promulgated by the American National Standards Institute (\'93ANSI\'94 ), an organization also consulted by the FDA in setting its standards. The final standards, however, were established based on consultations with the FDA regarding the FDA\rquote s obligations under the RCHSA. The FDA advised the FCC to decline ANSI \rquote s recommendation to exempt wireless phones and other low-power devices from federal RF standards, and the FCC deferred to the FDA\rquote s expertise. This resulted in the FDA\rquote s characterization of the RF requirements as \'93 a significant step towards achieving a consensus guideline on RF exposure which will have the support of the federal agencies responsible for protecting the public from nonionizing radiation injury.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 In re Wireless}{\insrsid4204783 , 216 F. Supp. 2d at 486.}}}{\insrsid14908102 \par The FDA\rquote s and FCC\rquote s assertions regarding the s afety of cell phones have not stopped the proliferation of law suits, however. In 2000 neurosurgeon Chris Newman filed an $800 million lawsuit against Motorola alleging his brain tumor was caused by nine years of cell phone use. Motorola\rquote s response echoed the assertions of the FDA: \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid14908102 Since 1992, we have seen this same issue raised }{\insrsid11277134 in }{\insrsid14908102 a limited number of other cases. One by one, these have been dismissed by the courts or withdrawn by the plaintiffs. This trend reflects a fundamental reality: the claim of a link between wireless phone use and adverse health effects is groundless and unsupported by a substantial amount of scientific knowledge accumulated from decades of research related to the possible health effects of radio waves.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Craig T. Liljestrand, }{\i\insrsid4204783 Cell Phone Suits Have No Basis in Science or Law}{\insrsid4204783 , }{\scaps\insrsid4204783\charrsid11277134 Legal Backgrounder}{\insrsid4204783 , Dec. 15, 2000.}}}{\insrsid14908102 \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid5261810 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11277134 {\insrsid14908102 Newman stirred public concerns about cell phone safety, but his claim eventually failed.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Newman v. Motorola, Inc., 218 F. Supp. 2d 769 (D. Md. 2002), }{\i\insrsid4204783 aff\rquote d }{\insrsid4204783 78}{\i\insrsid4204783 }{\insrsid4204783 Fed.Appx. 292 (4th Cir. 2003).}}}{\insrsid14908102 The district court rejected his expert witnesses for failing to meet the requirements for reliability under }{\i\insrsid14908102 Daubert v. Merrell Dow}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 509 U.S. 579 (1993).}}}{\insrsid14908102 The court cited the vast array of studies published in peer}{\insrsid13715815 -}{\insrsid14908102 reviewed journals that all found no reliable link between cell phones and brain tumors.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Newman}{\insrsid4204783 , 218 F. Supp. 2d at 773 \endash 74.}}}{\insrsid14908102 Newman\rquote s expert witnesses, on the other hand, relied on \'93reasoning, theories, and methodology [that] have not gained general acceptance in the scientific community.\'94}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{ \i\insrsid4204783 Id}{\insrsid4204783 . at 783. }}}{\insrsid14908102 While Motorola presented established and highly-credentialed experts, Newman presented witnesses who appeared to manipulate the results of their own research to provide the desired result. No one had replicated or validated their studies, while mos t outright rejected them. Other expert witnesses proffered by Newman were deemed irrelevant.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . }}}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The result was hardly unexpected. A Florida district court had rejected a wrongful death case against a cell phone company for the same reason five years before Newman filed his suit.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Reynard v. NEC Corp., 887 F. Supp. 1500 (M.D. Fla. 1995).}}}{\insrsid14908102 The plaintiff alleged his wife had died of a brain tumor either caused or accelerated by the use of a cell phone. The plaintiff\rquote s expert witnesses had misrepresented the conclusions of the studies on which they had relied. Summary judgment was granted for the defendants for lack of evidence.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 1508.}}}{ \insrsid14908102 \par A district court acknowledged the importance of the RCHSA in }{\i\insrsid14908102 Schiffner v. Motorola, Inc.}{\insrsid7614171 , }{\insrsid14908102 when it rejected the plaintiff\rquote s argument on federal preemption grounds.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Schiffner v. Motorola, 697 N.E.2d 868, 870 (Ill. App. 1 Dist. 1998).}}}{\insrsid14908102 The plaintiffs\rquote causes of action included failure to warn consumers of risks associated with cell phone use and false pronouncements of proven safety. The court held that the RCHSA preempted state regulations despite the fact that the FDA was not affirmatively regulating cell phones. Allowing states or courts to set standards would usurp power granted to the FDA by Congress under the RCHSA and could create conflicts between federal and state standards.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 873.}}}{ \insrsid14908102 This holding has been called into question by }{\i\insrsid14908102 Pinney v. Nokia, Inc.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 402 F.3d 430 (4th Cir. 2005).}}}{\insrsid14908102 The Fourth Circuit held that a well-pleaded complaint could avoid the substantial federal question doctrine.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 446 \endash 47.}}}{\insrsid14908102 The court stated that FCC standards were merely evidence to be considered in determining if a product was defectively designed; a ruling for either side would not question the FCC\rquote s decisions. The dissenting judge stated that \'93 the case cannot be resolved without proving that the FCC's RF radiation emission standards are too high to protect the consuming public.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 459 (Kiser, J., dissenting).}}}{\insrsid14908102 Rejecting the majority\rquote s assertion that all claims could be proven without reference to the FCC\rquote s standards, Judge Kiser characterized the case as a \'93 thinly-disguised attack on the validity of the FCC standards [that] raises a substantial federal question.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 While federal preemption was not a proper affirmative defense to raise in the removal hearing, the majority did reject a similar argument couched as a federal question issue.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 448. The court did consider the question of complete federal preemption, in which Congress \'93so completely preempt[s] a particular area that any civil complaint raising th[e] select group of claims is necessarily federal in character.\'94 The court held that the FCA did not establish the exclusive claim for alleging cell phone injuries. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 449, quoting Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 63 \endash 64 (1987).}}}{\insrsid14908102 \par For the most part, however, cell phone law suits eventually fail, primarily due to}{\insrsid7614171 the}{\insrsid14908102 lack of scientific evidenc e establishing a link between cell phone use and brain cancer. While other mass tort claims have succeeded despite the lack of evidence, cell phone suits have not. It has been suggested that }{\insrsid13715815 the }{\insrsid14908102 absence of any evidence of a cover up of by the cell phone industry of alleged fault may account for the difference.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Benjamin J. Wolf, }{\i\insrsid4204783 \'93Can You Hear Me Now?\'94: Cellular Phones and Mass Tort Litigation After Newman v. Motorola, Inc.}{ \insrsid4204783 , 14 }{\scaps\insrsid4204783\charrsid11277134 Alb. L.J. Sci. & Tech.}{\insrsid4204783 267, 272 \endash 73 (2003).}}}{\insrsid14908102 While research thus far has failed to find a link, the research continues, particularly concerning the long-term effects of cell phone use.}{\cs16\super\insrsid14908102 {\*\bkmkstart _Ref133965687}\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 In April 2006, Dr. Lennart Hardell, the expert witness discredited by the court in }{\i\insrsid4204783 Newman v. Motorola}{\insrsid4204783 , released a study finding a correlation between cell phone use and increased risk of brain cancer. His study was reported by major news outlets and is raising concerns similar to those raised during Dr. Newman\rquote s suit. The FDA stated that it planned to convene a meeting to evaluate the study, but its initial review of the study revealed many defects that have led to past rejections of Hardell\rquote s research. In particular, the research relied on mailed questionnaires and a few follow-up interviews conducted by telephone. Hardell failed to make st atistical adjustments for all confounding factors other than time of diagnosis. He also lacked an established mechanism of action and supporting animal studies. The FDA again noted that Hardell\rquote s study was contrary to other published studies of long-term cell phone use and brain cancer. U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid13715815 Use of Wireless Communications Devices and the Risk of Brain Cancer}{\insrsid4204783 , } {\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cdrh/wireless/braincancer040606.html (last visited Apr. 6, 2006).}}}{\insrsid14908102 {\*\bkmkend _Ref133965687} \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11039173 {\scaps\insrsid1276773\charrsid11039173 V. The Accomplishments of the RCHSA}{\scaps\insrsid14908102\charrsid11039173 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The Radiation Contr ol for Health and Safety Act has been exceedingly successful in remedying the concerns addressed during the 1967 and 1968 congressional hearings. During the hearings, witnesses consistently pointed to a lack of research and general knowledge of radiation risks as a driving force behind the failure to protect the public. The absence of federal authority to regulate was of course a problem, but Congress admitted upon passage of the act that more research was needed before enforceable standards could be set . The FDA currently has standards for}{\insrsid5637054 12}{\insrsid14908102 categories of electronic products, and manufacturers for the most part comply with these standards. The act also resulted in increased public awareness and a strong public education program that helped drive a chan ge in behavior, so much so that other countries cite the act as the model to follow in protecting their citizens from radiation.}{\cs16\super\insrsid11277134 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Vanguard, }{ \i\insrsid4204783 Consumer Protection: The Right of Every Nigerian}{\insrsid4204783 , }{\scaps\insrsid4204783 Africa News}{\insrsid4204783 , Jan. 14, 2004 (stating that Nigeria should follow the FDA\rquote s lead and protect its citizens by regulating radiation-emitting products, particularly cell phones).}}}{\insrsid14908102 This section discusses the accomplishments of the act but in doing so also acknowledges areas where results have not be}{ \insrsid7614171 en quite as successful.}{\insrsid14908102 \par A. }{\insrsid4457539 Research and Standard Setting}{\insrsid14908102 \par A physician who testified during the congressional hearings urged that the RCHSA be limited to only ionizing radiation, as that was the only type of radiation known to cause biological damage. That statem ent was questionable at the time and has since been soundly rejected. In addition, the dangers of long-term or low-dose ionizing}{\insrsid4457539 radiation}{\insrsid14908102 exposure, a little explored area in the 1960\rquote s, are now much more established. The FDA\rquote s radiation research program , first through the Bureau of Radiological Health and now through the Center for Devices and Radiological Health, in conjunction with other federal safety statutes and regulatory agencies, has supported extensive research and contributed greatly to scient ific knowledge.}{\insrsid4457539 The commitment to research has allowed standards to be set at levels that the FDA can say is truly protective of human health. Before enactment of the RCHSA}{\insrsid14908102 , electronic products were regulated loosely by the states and by voluntary standards from professional groups.}{\insrsid13323247 The absence of federal enf}{\insrsid13715815 orceable standards required }{\insrsid6035744 consumers to rely on companies \rquote self-policing. As evidenced by the GE television recall, self-policing does work because companies are concerned about their reputations. }{\insrsid4457539 H owever, the lack of enforceable standards at the manufacturing and market entry stages led to excessive radiation exposure}{\insrsid11277134 for consumers}{\insrsid4457539 .}{\insrsid3878846 }{\insrsid11277134 In addition to serving a preventative function, e}{\insrsid3878846 nforceable standards were able to serve as a}{\insrsid7614171 technology-forcing device}{\insrsid3878846 .}{\insrsid14908102 \par }{\insrsid15215160 Innovation occurs over time, and televisions unquestionably would have become safer in the absence of federal standards. While rogue players will always exist}{\insrsid7562499 ,}{\cs16\super\insrsid7562499 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783\charrsid1276773 See, e.g.}{ \insrsid4204783 , the X-Ray of Greenville case, discussed }{\i\insrsid4204783 supra}{\insrsid4204783 Part IV(A).}}}{\insrsid15215160 }{\insrsid1380198 most manufacturers will design safe consumer devices, if not to protect consumers, then at least to protect their reputations. When the safety measures are relatively low-cost and can be passed to consumers, manufacturers have little incentive to produce a slightly cheaper but dangerous product, particularly when their competitors are produci ng safe prod}{\insrsid12143731 ucts. Hard deadlines quicken this}{\insrsid1380198 process.}{\insrsid15215160 }{\insrsid9919326 The GE television recall occurred in 1967. The public awareness of radiation emissions from televisions persuaded the government to recommend that viewers sit at least six feet from their sets. By 1 971, when the final phase of the first television standard was enacted, the government believed it was safe to watch television from any distance.}{\cs16\super\insrsid3167190 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 9.}}}{\insrsid3948869 Limiting emissions proved to be quite easy and cheap.}{\cs16\super\insrsid1276773 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1276773 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 \'93 [S]pecial voltage hold-down circuits were put into use in all color sets, causing them to fail rather than exceed [the] specified level; picture tube shielding was imp roved, and, coincidentally, sets went solid state, removing [the] power tube as a possible radiation source.\'94 }{\i\insrsid4204783 Goldstar Rocked by Obsolete X-Ray Rule}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132923600 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003900320033003600300030000000}}}{\fldrslt {\insrsid4596385 130}}}{ \insrsid4204783 . }}}{\insrsid1276773 }{\insrsid15692151 }{\insrsid1276773 Consequently,}{\insrsid15692151 }{\insrsid1276773 v}{\insrsid1380198 iolations of the }{\insrsid12143731 emissions limits}{\insrsid1380198 are}{\insrsid12143731 uncommon}{ \insrsid3948869 . The 1974 Matsushita television recall was based on possible radiation emissions should part of the circuit board fail. While the FDA rejected its defense, Matsushita claimed that no similar failure had ever occurred, nor was one likely to occur.}{ \cs16\super\insrsid3948869 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Gundaker, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132923385 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003900320033003300380035000000}}}{\fldrslt {\insrsid4596385 117}}}{\insrsid4204783 , at 11.}}}{\insrsid6161468 The 1991}{\insrsid3948869 Goldstar violations were due to poor }{\insrsid15692151 testing procedures. Everyone agreed that no Goldstar televisions had ever been found to emit excess radiation.}{\cs16\super\insrsid15692151 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Goldstar Rocked by Obsolete X-Ray Rule}{ \insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132923600 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003900320033003600300030000000}}}{\fldrslt {\insrsid4596385 130}}}{\insrsid4204783 .}}}{\insrsid9919326 \par }{\insrsid12143731 In addition to standards setting, t}{\insrsid6161468 he RCHSA required th}{\insrsid14763804 e FDA to support research. This}{\insrsid6161468 included both the dangers of radiation exposure and the }{\insrsid5190526 innovations needed to reduce radiation.}{\insrsid14763804 Research under the RCHSA has alerted the scientific community and the public to the danger}{\insrsid13715815 s of microwave radiation, ultra}{\insrsid14763804 violet light from the sun, and laser lights directed towards the eyes, all non-ionizing forms of radiation previously thought to have negligible harms.}{\insrsid9589775 However, research has also contributed to the development of safer products, the primary goal of the RCHSA. The Bureau of Radiological Health q uickly developed devices to study the effects of the radiation, but it also designed cheap and effective tools to be used in the field to detect radiation emission.}{\cs16\super\insrsid9589775 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130981203 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900380031003200300033000000}}}{\fldrslt {\insrsid4596385 6}}}{ \insrsid4204783 , at 7. The meter to check microwave ovens for radiation leakage was designed using parts readily available to oven servicemen. The Bureau\rquote s device cost $150, while commercial microwave measuring instruments at the time cost $800. A similar x-ray detection instrument was designed as an \'93easy-to-use\'94 and inexpensive device for television servicemen for use on home receivers.}}}{ \insrsid12402230 The Bureau\rquote s research also directly improved the safety of radiation emitting products. One example is the automatic collimator.}{\cs16\super\insrsid12402230 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 De Vore, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131519227 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500310039003200320037000000}}}{\fldrslt {\insrsid4596385 166}}}{ \insrsid4204783 , at 5 \endash 6.}}}{\insrsid12402230 Unlike the detection devices and the television modifications, the collimator was comparatively expensive to install.}{\cs16\super\insrsid12402230 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 In the X-Ray of Greenville case, Wilder saved $2500 by foregoing the use of automatic collimators in favor of manual collimators, a decision that was both in violation of the standards and potentially dangerous. }{\i\insrsid4204783 See}{\insrsid4204783 Hommel & Thompson, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref134276129 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330034003200370036003100320039000000}}}{\fldrslt {\insrsid4596385 171}}}{\insrsid4204783 .}}}{\insrsid2704628 However, its ability to reduce excess radiation exposure in the source that provided ninety percent of Americans\rquote overall exposure led to its inclusion in the x-ray standards.}{\cs16\super\insrsid2704628 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 21 C.F.R. \'a7 1020.30(h) (2005).}}}{\insrsid741901 While manufacturers\rquote lobbying efforts succeeded in weakening the bill in 1968, consumer safety, not cost-benefit analysis, remains the primary goal of the RCHSA.}{\insrsid6161468 \par }{\insrsid6106165 Enforcement actions for violations of RCHSA standards }{\insrsid8597936 are rare. While this i}{\insrsid9399323 s certainly due to the traditional cooperation between the FDA and the manufacturers, it must also be related to the fact that violations are not common. Certainly some violations go unde tected, but the cost of compliance, particularly after the technology has been developed by manufacturers and by the FDA, is low compared to the cost of being found in violation. Both the Matsushita and Goldstar violations were det}{\insrsid11746134 ected during routine inspe}{\insrsid16465509 ctions. For Goldstar, the money saved by lax recordkeeping and improper on-site testing resulted in the loss of tens of millions of dollars in sales when its products were kept off the market during the peak sales season.}{\insrsid8870617 }{ \insrsid12143731 Goldstar}{\insrsid4790499 }{\insrsid8870617 was also required to implement a }{\insrsid4790499 Corrective Action Plan}{\insrsid8870617 , which}{\insrsid4790499 required it to redesign its quality control program and retest samples of its stock.}{\cs16\super\insrsid4790499 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid8870617 The imposition of civil fines on companies and on individuals for violation}{ \insrsid7614171 s by the company further reduces any financial gain a company may seek}{\insrsid8870617 . The FDA\rquote s trend towards combining enforcement under the RCHSA with other safety acts adds the possibility of criminal prosecution. These penalties assume companies care only about the bottom line and leave out the possibility that man ufacturers also recognize the dangers of radiation and understand their duty to produce safe products.}{\insrsid3155687 Whatever the reasons, the combination of extensive research and standards enforceable through inspections, forced recalls, and fines has resulted in much safer consumer products and has met the goals Congress set for the RCHSA.}{\insrsid3878846 \par B}{\insrsid14908102 . Education and Behavior \par }{\insrsid5318983 While public education is not technically required by the RCHSA, the FDA\rquote s radiation control program has always included an effort to educate consumers and users to achieve the goals of the act. }{\insrsid14908102 Public awareness of the dangers of radiation emitting products is essential in reducing unnecessary exposure. CDRH has four goals for its radiological health program: \par }\pard \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 {\insrsid14908102 (1) A public able to make informed choices abo ut their own exposure to radiation-emitting products in the medical, occupational and home setting; \par }\pard\plain \s19\ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14908102 (2) Users of radiation-emitting products able to minimize their own exposures and those of people they expose; \par }\pard\plain \ql \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid5261810 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14908102 (3) Manufacturers of radiation-emitting produ cts able to understand their responsibilities and sensitive to radiation risk issues}{\insrsid13715815 ; and}{\insrsid14908102 \par (4) FDA and State radiation control programs that actively encourage and assist users in minimizing radiation exposure and risk.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 CDRH, }{\i\insrsid4204783 Adapting}{\insrsid4204783 , }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 9.}}}{\insrsid14908102 \par }{\insrsid5261810 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 Public disclosure has the potential to lead to greater fears regarding previously unknown risks, but it can also allay fears created by popular press or other unreliable sources. It can also change behavior. Behavior does change in the absence of federal regulation, but change is often s lower or, as in the case of the fluoroscope, is in response to a really bad practice. A fluoroscope is \'93an x-ray device that provides images of internal body parts as they move.\'94}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Lewis, }{\i\insrsid4204783 supra}{\insrsid4204783 note } {\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref134138932 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330034003100330038003900330032000000}}}{\fldrslt {\insrsid4596385 1}}}{ \insrsid4204783 , at 18.}}}{\insrsid14908102 It requires high levels of radiation exposure, and often for longer periods of time, to produce useable images. Fluoroscopes were common in doctors\rquote offices during the 1950\rquote s because they were very effective diagnostic tools. When they were first developed, however, they were considered novelties that drew in people\rquote s attention and consequently were used for rather impractical reasons. Shoe stores used th}{ \insrsid12143731 em to see the bone structure}{\insrsid14908102 in customers\rquote feet. Customers, particularly children, liked seeing the bones in their feet move when they wiggled their toes, and shoe stores like d the increased business. The use was quickly discontinued when scientists discovered the potential harm.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 18 \endash 19. Note, however, that some doctors continued to use fluoroscopes despite awareness of the high radiation emissions and potential risks. Technology to allow lower doses was not developed until the 1960\rquote s, and it was not until the 1990\rquote s that cameras and computers could enhance images to further reduce exposure. Even today, while the radiation doses have decreased, the lengthy time of exposure for proper diagnosis remains a concern. }{\i\insrsid4204783 Id}{\insrsid4204783 . at 20. For an explanation of the current state of fluoroscope technology, see Paula Price, }{\i\insrsid4204783 Equipment Safety and Risk Management}{\insrsid4204783 , 75 }{\scaps\insrsid4204783 Radiologic Tech.}{\insrsid4204783 197 (2004).}}}{ \insrsid14908102 The correct decision for human health was made before anyone ever consid}{\insrsid5318983 ered a radiation control bill.}{\insrsid14908102 \par A fairly bad practice that was remedied by the RCHSA was the excessive use of x-ray diagnoses. The value of x-ray technology was never question}{\insrsid13715815 ed, but as discussed in Part IV(}{\insrsid14908102 A}{\insrsid13715815 )}{\insrsid14908102 , the technology was being used in unwarranted situations. Mass chest x-rays to detect tuberculosis}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 Britain, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132644929 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003600340034003900320039000000}}}{\fldrslt {\insrsid4596385 174}}}{\insrsid4204783 , at 15.}}}{\insrsid14908102 or as part of routine government physicals}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See}{\insrsid4204783 }{\i\insrsid4204783 X\rquote ing Out Unneeded X Rays}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132645000 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003600340035003000300030000000}}}{\fldrslt {\insrsid4596385 183}}}{\insrsid4204783 , at 19.}}}{\insrsid14908102 were common, as were pelvimetries of pregnant women in some parts of the country.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See }{\insrsid4204783 Smith, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132645185 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003600340035003100380035000000}}}{\fldrslt {\insrsid4596385 176}}}{\insrsid4204783 , at 21.}}}{\insrsid14908102 Patients often demanded x-ray examinations as further assurance of their good health, while doctors commonly provided x-rays to establish evidence in the event of a malpractice suit.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See }{\insrsid4204783 De Vore, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131519227 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500310039003200320037000000}}}{\fldrslt {\insrsid4596385 166}}}{\insrsid4204783 , at 6.}}}{\insrsid14908102 X-ray procedures expose patients to radiation but are justified on the basis of their diagnostic value. When medical diagnoses can be made effectively without the use x-rays, the use of such procedures represents nothi ng more than unnecessary and excessive radiation exposure. Informing the public that excessive x-ray exposure posed long-term risks was not difficult. However, the FDA was then faced with a public fearful of all x-ray examinations. The FDA had to conve y that properly prescribed x-ray examinations provided benefits that far outweighed the risks, and that no one x-ray examination would cause cancer.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See id. }{\insrsid4204783 at 5}{ \insrsid4204783 .}}}{\insrsid14908102 \par One method of reducing fears was to educate both patients and physicians regarding the measures that can be taken to reduce potential risks. The scientific community generally recognized that radiation that posed almost no risk to adults could have a much greater biological effect on indi}{\insrsid14828470 vidual reproductive cells and on}{\insrsid14908102 developing fetuses. A mutation in a single sperm or egg cell }{\insrsid13715815 later used in reproduction can}{\insrsid14908102 cau}{\insrsid13715815 se genetic defects that can}{\insrsid14908102 pass for generations,}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 James Morrison & Mark Barnett, }{ \i\insrsid4204783 Reducing Genetic Risk From X Rays}{\insrsid4204783 , }{\scaps\insrsid4204783 FDA Consumer}{\insrsid4204783 , Feb. 1977, at 16, 17.}}}{\insrsid14908102 while a single mutation in the cells of }{\insrsid13715815 a fetus\rquote developing organs can}{\insrsid14908102 lead to birth defects.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Morrison & Barnett, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131528457 \\h }{ \insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003500320038003400350037000000}}}{\fldrslt {\insrsid4596385 177}}}{\insrsid4204783 , at 24.}}}{\insrsid14908102 Both risks are unlikely, but simple measures such as using gonad shields to cover male and female reproductive organs and informing doctors of possible pregnancies would further reduce the already minimal risks. The FDA stressed that patients should ask their physicians why x-rays are necessary and about p rotective measures that can be taken.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Weck, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref133967149 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330033003900360037003100340039000000}}}{\fldrslt {\insrsid4596385 2}}}{\insrsid4204783 , at 27.}}}{\insrsid14828470 }{\insrsid5318983 Radiation exposure was further reduced by }{\insrsid14908102 better technology that allowed for safer x}{\insrsid5318983 -rays, and by}{\insrsid14908102 the development of other medical imaging devices that did not use ionizing radiation. \par Another }{\insrsid9528963 interesting education program involves}{\insrsid14908102 the dangers of sun tanning,}{\insrsid14828470 discussed in Section IV(C)}{\insrsid14908102 . FDA regulations have made sunlamps and tanning booths as safe as possible, and the public appears well aware of the risks, but it continues to regard tanned skin as a sign of good health. The FDA maintains a webpage entitled \'93 The Darker Side of Tanning\'94 that warns consumers of the dangers of UV-A and UV-B}{\insrsid9528963 radiation}{\insrsid14908102 .}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Center for Devices and Radiological Health, }{ \i\insrsid4204783\charrsid5468723 The Darker Side of Tanning}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cdrh/consumer/tanning.html (last visited Apr. 12, 2006).}}}{\insrsid14908102 Consumers\rquote behavior in this area appears quite irrational but might be explained by the fact that the harms of UV radiation appear much later in life. Most skin cancers are also curable if}{\insrsid14828470 detected early, which may }{\insrsid14908102 lead people to belie}{\insrsid9528963 ve that skin cancer is }{\insrsid14908102 not that dangerous. The FDA also had to contend with manufacturer and tanning salon claims that tanning beds that u sed UV-A radiation were safer than natural sunlight. While such claims are no longer allowed, their effects remain.}{\cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 .}}}{\insrsid14908102 Self-tanners were often r}{\insrsid13715815 ejected because they looked}{ \insrsid14908102 unnatural, but }{\insrsid14828470 the }{\insrsid14908102 proliferation of self-tanning by celebrities wanting a safe, year-round tan has rejuvenated that market.}{\insrsid13715815 The FDA\rquote s challenge will be t}{\insrsid1276773 o convey to the public that pale skin is healthy skin}{\insrsid13715815 .}{\insrsid14908102 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid14908102 The area of perhaps greatest interest is the effects of RF emissions from cell phones. As the number of cell phone users }{\insrsid9528963 grew, so did the concerns about}{\insrsid14908102 new sources of radiation. In 2002, the FDA established a website entitled \'93Cell Phone Facts\'94 that explained RF emissions, federal regulatory standards, and the current research demonstrating the safety of cell phone use.}{ \cs16\super\insrsid14908102 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 U.S. Food and Drug Administration, }{\i\insrsid4204783\charrsid5468723 Cell Phone Facts}{\insrsid4204783 , }{\i\insrsid4204783 at}{\insrsid4204783 http://www.fda.gov/cellphones/ (last visited Apr. 12, 2006). }{\i\insrsid4204783 See also}{ \insrsid4204783 Federal Communications Commission, }{\i\insrsid4204783 FDA-FCC Cellular Phone and Radiofrequency Energy Website Posted for Public Use and Comment}{\insrsid4204783 , 2002 WL 920836 (May 8, 2002).}}}{\insrsid14908102 While all credible research has indicated that cell phones emit too little radiation to cause biological harm, cell phone companies have continued to face lawsuits regarding the alleged dangers of their devices. This is complicated by the lack of sufficient long- term studies, a result of the relatively recent phenomenon of cell phone technology and regular cell phone use. Additionally, the media has hampered the FDA and FCC\rquote s efforts at properly informing the public. The media has jumped on the various lawsu}{\insrsid7230474 its and created concern that has}{\insrsid14908102 no basis in fact. After Dr. Newman\rquote s suit was filed, Larry King had an \'93expert\'94 on his show defending Newman\rquote s claim and telling the public that cell phones caused brain tumors.}{\cs16\super\insrsid14828470 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Nordenberg, }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref132050491 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330032003000350030003400390031000000}}}{\fldrslt {\insrsid4596385 246}}}{\insrsid4204783 , at 19.}}}{\insrsid14908102 Newman\rquote s suit was determined by the court and by well-established scientists to be based on inconsistencies and questionable witnesses whose research techniques had been rejected by the scientific community.}{\insrsid7230474 The researcher rejected in Newman \rquote s suit released a study in April 2006 that purports to prove that long-term cell phone use increases the risk of cancer.}{\insrsid6913141 The FDA immediately posted a}{\insrsid5318983 notice to consumers on }{\insrsid15171451 its}{ \insrsid14828470 cell}{\insrsid6913141 phone website stating that it would evaluate Dr. Hardell\rquote s conclusions but also informing consumers of the}{\insrsid15171451 flaws it detected in Dr. Hardell\rquote s methods. However, the story reached the publ}{\insrsid9528963 ic not through the FDA\rquote s considered}{\insrsid15171451 statement on its website, but through the popular media that reported Hardell\rquote s conclusions without evaluating his methods. Consequently, cell phone risks are now a renewed concern despite the vast amount of evidence indicating a lack of danger}{\insrsid14908102 . This hardly means an end to cell phone use, but it can lead to more law suits and potential plaintiff success. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid15494036 The FDA\rquote s education program historically relied on publications to communicate}{\insrsid9528963 with}{ \insrsid15494036 manufacturers and consumers, while health care professionals were provided with instructional courses. The internet now provides the easiest and most effective tool to communicate}{\insrsid3801914 the FDA\rquote s research and policies. CDRH\rquote s electronic product radiation website provides the regulations for each electronic product regulated by the FDA, basic information about each product, answers to frequently asked questions, forms for manufacturers}{ \insrsid6293977 , and updates on research. The challenge will be to alert the public that this credible resource exists. }{\insrsid6365170 Collaboration}{\insrsid6293977 with the popular media, perhaps by having the media refer the public to the FDA \rquote s website for further information on their stories, may provide the public with the most complete information and avoid repeats of the Larry King cell phone misinformation.}{\insrsid15494036 \par }\pard \qc \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11039173 {\scaps\insrsid4341156\charrsid11039173 VI. Conclusion \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid2558979 The Radiation Control for Health and Safety Act}{\insrsid4341156 succeeded because the federal government was committed to understanding the effects of radiation and protecting the p}{\insrsid12526272 ublic from it. The Bureau of Radiological Health was dedicated to determining safe levels of radiation emissions and establishing enforceable standards that reflected its research. Similarly, manufacturers understood the importance of working with the FDA in establish ing standards and developing technique}{\insrsid14118434 s}{\insrsid12526272 to meet the standards.}{\insrsid6238527 Radiation-emitting electronic products are now considered safe, which has shifted the FDA\rquote s concerns from product design to misuse of products by consumers.}{\insrsid12526272 Over the years, however, the FDA has seen a reduction in federal funds earmarked for radiation }{\insrsid6238527 control activities. }{\insrsid4003690 \par }{\insrsid6238527 In light of the different circumstances in which }{\insrsid13916512 CDRH}{\insrsid4876397 finds itself}{\insrsid6238527 , it has reconfig}{\insrsid4003690 ured the goals of the radiation control program}{\insrsid4814092 . Included in these goals are the acknowledgement of \'93the availability of national and international voluntary standards\'94 ; an awareness of radiation emitting products; the dissemination of useful public health information to industry, users, the public, and regulators; and continued research to address radiation risks.}{\cs16\super\insrsid4814092 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 CDRH, }{\i\insrsid4204783 Adapting}{\insrsid4204783 , } {\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 5.}}}{\insrsid4814092 Specific changes are proposed for each of the }{ \insrsid7538243 five major program elements: standards, monitoring, education, research, and program management.}{\insrsid7347033 While CDRH will maintain its existing standards, it believes a move toward voluntary con sensus standards for other products may be necessary,}{\insrsid7810266 and it is seeking \'93legislative changes to allow adoption and enforcement of voluntary consensus standards.\'94}{\cs16\super\insrsid7810266 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 Id}{\insrsid4204783 . at 7.}}}{\insrsid7810266 CDRH plans to change its monitoring program to devote resources to inspections of manufacturers rather than product testing}{\insrsid13916512 . It also plans on reducing}{\insrsid4876397 the}{\insrsid13916512 content of required reports from manufacturers.}{\cs16\super\insrsid4876397 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 Extensive recordkeeping was considered necessary in the early years of the act in the event of a recall, but the general safety of products today reduces the need to maintain this expensive practice. } }}{\insrsid4876397 }{\insrsid13916512 The education program will rely on the World Wide Web to deliver user-friendly radiological health messages. CDRH will also train \'93State and Federal personnel who can deliver critical radiological health messages to users and the public.\'94 Research will focus on high priority radiological health activities, as determined by the Science Prioritization Oversight Committee. CDRH believes the success of its program requires \'93endorsement and active participation by }{\insrsid16147461 [the Office of Regulatory Affairs] and the States.\'94}{\cs16\super\insrsid16147461 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid4204783 \chftn }{\insrsid4204783 CDRH, }{\i\insrsid4204783 Adapting}{\insrsid4204783 , }{\i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref131377135 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330031003300370037003100330035000000}}}{\fldrslt {\insrsid4596385 74}}}{\insrsid4204783 , at 8 \endash 10.}}}{\insrsid4003690 \par }{\insrsid4876397 The criticisms the FDA faced in the 1970\rquote s have been resolved over the years. The RCHSA does not grant the FDA authority to require pre-market approval of radiation-emitting products}{\insrsid5115492 , so while the early standards involved known dangerous products, the later standards arose as responses to problems. Since enactment of the RCHSA, Congress has enacted several other consumer safety statute s that provide more extensive authority to the FDA and other agencies. Consequently, dangerous products are generally prevented from entering the market. As an agency with expertise, the FDA }{\insrsid9971051 has }{\insrsid5115492 administered the act as well as any other }{\insrsid2900860 agency }{\insrsid5115492 could have. T}{\insrsid9971051 hi}{\insrsid2558979 s is evidenced by the deference agencies such}{\insrsid5115492 as the EPA and the FCC}{\insrsid9971051 have granted} {\insrsid5115492 to the }{\insrsid9971051 F}{\insrsid2558979 DA}{\insrsid9971051 }{\insrsid5115492 in the setting of standards. While some may disagree with the allocation of funds within the FDA, the fact remains that electronic products are now safe, sc ientists understand the biological harms of all types of radiation, and consumers understand the general hazards of excess radiation.}{\insrsid4876397 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5261810 {\insrsid803423 All major devices that emit radiation are now regulated by the federal government, either through the }{\insrsid5318523 RCHSA or another federal act. When accidents happen, people become concerned that federal regulation is insufficient to protect the public.}{\cs16\super\insrsid5318523 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid4204783 \chftn }{\insrsid4204783 }{\i\insrsid4204783 See }{\insrsid4204783 Bennett & Dormer, }{ \i\insrsid4204783 supra}{\insrsid4204783 note }{\field{\*\fldinst {\insrsid4204783 NOTEREF _Ref130977613 \\h }{\insrsid4204783 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000e0000005f005200650066003100330030003900370037003600310033000000}}}{\fldrslt {\insrsid4596385 4}}}{\insrsid4204783 , at 310 (noting Senator John Glenn\rquote s concerns following a case in which a radioactive tip broke off a radiation therapy device and resulted in the death of the patient due to extreme radiation exposure).}}}{\insrsid5318523 However, the radiation standards were set so far below the known }{\insrsid3427072 dangerous levels that variation}{\insrsid5318523 from the standards may not }{\insrsid3427072 actually }{\insrsid5318523 endanger human health.}{\insrsid1856347 Additionally, th}{\insrsid3427072 e }{\insrsid2558979 FDA has established a system that}{\insrsid3427072 strongly encourages manufacturers to comply with the regulations and to cooperate with the FDA in remedying violations. Though the FDA rarely resorts to adverse proceedings, it re tains that authority. The Senate certainly wanted a stronger bill in 1968, but the FDA\rquote s achievements under the compromised bill }{\insrsid2558979 have sufficiently addressed }{\insrsid1856347 Congress\rquote concerns as it debated the bill.}{ \insrsid3427072 Th}{\insrsid1856347 e budget cuts may force the FDA to allocate its resources to what it considers more pressing matters, but that certainly does not mean the RCHSA will cease to be important. Whil}{\insrsid12207731 e some companies will }{\insrsid1856347 cut corners, it would be illogical to think that these companies would completely abandon their obligations to the consuming public and begin producing dangerous products. A more reasonable concern is that technology allows for the rapid development of increasingly complicated and potentially hazardous electronic products, and the FDA may not be }{ \insrsid12207731 financially }{\insrsid1856347 equipped to conduct research and establish new standards. Hopefully, the FDA will discover the most appropriate manner in which to explo}{\insrsid4147439 it the mass communications market to co}{ \insrsid2775515 n}{\insrsid2558979 vey its knowledge, policies, and concerns}{\insrsid4147439 to}{\insrsid2558979 manufacturers and to}{\insrsid4147439 the general public.}{\insrsid5115492 \par }}