ML20217M604

Responds to from L Faircloth Re Natl Academy of Sciences,Institute of Medicine Rept, Radiation in Medicine: Need for Regulatory Reform

ML20217M604
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Issue date:	12/06/1996
From:	Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM)
To:	Faircloth L HOUSE OF REP., ENVIRONMENT & PUBLIC WORKS
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4 UNITED STATES g

kg NUCLEAR REGULATORY COMMISSION WASHINotoN. O C, PMW4001 December 6, 1996 CHAl9 MAN The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, D.C. 20510-6175

Dear Mr. Chairman:

I am responding to your letter dated October 8, 1996, concerning the National Academy of Sciences, Institute of Medicine (10M) report entitled, " Radiation in Medicine: A Need for Regulatory Reform." The Commission's responses to your specific questions are enclosed (Enclosure 1).

The NRC intends to respond to the 10M recommendations through a deliberate process. The NRC is currently completing an agency-wide Strategic Assessment j and Rebaselining initiative. As part of the Strategic Assessment initiative. l the Commission continues to review carefully the 10M report. A general discussion, categorization, and summary of the broad range of comments received on the report are enclosed (Enclosures 2 and 3).

The Steering Committee for the NRC's Strategic Assessment initiative identifieo five-options on NRC's future role in the medical program. These options ranged from expanding the program, to retaining and revising the existing program, to entirely eliminating the medical regulatory program. The specific options considered were (1) increase NRC's regulatory responsibility with the addit von of X-ray, accelerators, and naturally occurring and accelerator-produced radioactive materials; (2) continue with the current decrease oversight of low-risk activities with program continuedwith improvements; emphasis on high-ris (3)k activities; (4) discontinue regulation of all medical activities except for NRC oversight of devices and manufacturers; and (5) discontinue the NRC's medical program.

On September 16, 1996, the Commission published for comment its preliminary l views on 16 strategic program areas, including medical use. The Commission's preliminary view and current consensus is that the NRC would retain its

' regulatory authority for the medical use of byproduct material, but should 4 make modifications to the current program utilizing a risk-informed, performance-based ap3 roach while protecting public health and safety, e.g.,

focusing on high-ris( procedures (Option 2). Where regulations can be relaxed or eliminated without undue increases in risk, it would be our intent to amend our regulations (Option 3). Such modifications would require rulemaking that

-likely would be initiated in 1997. The opportunity for input will be afforded a gG000 9708250073 970812 PDR COMMS NRCC CORRESPONDENCE PDR

2 to the regulated community, professional organizations, the Agreement States, the public, and others. The public comment period closed December 2,1996.

The Commission expects to make a final decision on the specific direction of the medical use program after consideration of public comments in early 1997.

Regarding the 10H report, the Commission has been concerned that the report's l conclusions were not substantiated. The report recommends removing NRC's authority and relying more on the States and the Conference of Radiation Control Program Directors (CRCPD) to increase uniformity. It should be noted that the CRCPD commented that the absence of federal authority in medical use may have immediate and undesirable consequences. Further, the CRCPD stated that it does not support automatic selection of the Department of Health and Human Services (DHHS) as the lead federal agency, as recommended in the 10M report. The Organization of Agreement States (OAS) and others highlighted the need for federal oversight. Some States identified the NRC as the federal agency of' choice. Some non-Agreement States expressed significant concern regarding the lack of State resources to assume more regulatory responsibility. The DHHS commented that the ION report does not make a compelling health and safety argument for the DHHS to take on such a substantial new role, and that it is unlikely that the DHHS would have adequate resources made available to assume such responsibility. A copy of the DHHS letter is enclosed (Enclosure 4).

Particularly noteworthy in the IOM re) ort is the dissenting opinion of Mr.

Robert S. Adler, a University of Nort1 Carolina law professor. Mr. Adler strongly disagrees that a case was made to repeal Federal authority over medical uses of ionizing radiation and states that the 10M Committee's recommendations lack supporting evidence and constitute unwise public policy.

Also worthy of mention is that during the public Strategic Assessment meeting .

conducted in Washington, D.C., the American College of Nuclear Physicians and Society of Nuclear Medicine indicated that they have modified their previous support for the IOM position and now support the Commission's preliminary views on its medical use regulatory program.

Such comments, combined with acknowledgement in the report that the extent of State regulatory programs varies, that the CRCPD guidelines are adopted to varying degrees by individual States, and that the lack of data for comparing the risks associated with different types of ionizing radiation limited the scientific basis of the 10M Committee's findings, have caused the NRC to question the report's conclusions and recommendations.

Like the 10H, the NRC recognizes the benefits derived from the use of ionizing radiation in medicine, its. potential for harm, and the need to achieve the appropriate balance between the costs and benefits of regulation in this area.

Most importantly, the NRC takes very seriously its responsibility to protect patients, workers, and the public as described in the agency's 1979 Medical Use Policy Statement (Enclosure 5). In adhering to the policy statement and recognizing the unique hazards and benefits associated with the deliberate administration of byproduct material for medical use, the NRC regulates this area very differently from others. Since 1992, the NRC has made three revisions to its medical use regulations using a performance-based approach to provide. greater flexibility to its licensees in the areas of reportable

3 misadministrations, the practice of radiopharmacy, and criteria for the release of patients from confinement post-treatment. As a result, members of the general public could receive a dose of up to five times that allowed from other types of licensed operations.

! Regarding the safety risks associated with accelerator-produced versus byproduct material, there is nothing unique about radioactive materials originating from a nuclear reactor (byproduct material). Generally, the same safe handling and use techniques apply to both. However, under its Atomic Energy Act (AEA) authority and responsibility, the NRC develops regulations and associated guidance for the safe medical use of byproduct material only.

While the 10M has stated that the NRC only regulates approximately 10 oercent of medical use, that percentage includes virtually all_ of the high ris(

procedures, with the exception of linear accelerator therapy. In addition, the NRC's regulatory program impacts significant portions of the remaining non-NRC regulated medical use. For example, the CRCPD and some States have used NRC's regulatory products for their own programs.

Regarding the effectiveness of State radiation control programs, the NRC conducts periodic reviews of Agreement State materials programs in the 29 Agreement States, including byproduct medical use programs. The NRC does not review the effectiveness of State radiation control programs as they relate to the non-Atomic Energy Act areas in any State. Therefore, the NRC is not aware of specific problems or deficiencies in how the States have handled the regulation of ionizing radiation, other than byproduct material, in medicine.

The NRC reviews reported events and maintains an event database to identify  ;

root cause and generic implications and determine whether modifications to its regulatory program are needed to further reduce errors. Neither the 10M nor the NRC ie aware of a similar event database, maintained by the States, for i events involving non-AEA material.

-I will continue to keep you informed about significant Commission decisions concerning this issue. If I can be of further assistance to you on this issue, please contact me.

Sincerely, b

Shirley. Ann Jackson

Enclosures:

1. Responses to Questions

2. General discussion of comments on 10M report

3. Specific Comments on 10M report

4. DHHS letter

5. 1979 Medical Use Policy Statement cc: . Senator Bob Graham Ei

l RESPONSES TO OVESTIONS QUESTION 1. Regarding the use of radiopharmaceuticals for diagnostic treatments for the period that such records are available:

How many associated Unusual incidents have been noted? How many of these were only administrative in nature and how many involved actual misapplications? Of the latter, how many resulted in patients, occupational workers, or members of the general public receiving hEEf.gl levels of diagnostic or therapeutic radiopharmaceuticals? And of those receiving harmful levels, how many actually have displayed symptoms of radiation sickness?  !

After providing specific numerical responses for the above categories, please provide any other quantifiable information that is available and may help to put the data into proper perspective.

ANSWER.

The NRC has required reporting of misadministrations involving radiopharmaceuticals since 1980. For the period between 1980 and 1991, diagnostic misadministrations of radiopharmaceuticals averaged approximately 400 per year, while therapeutic misadministrations (involving radiopharmaceuticals and sealed sources) averaged approximately 30-40 per year. In January 1992, the NRC revised its misadministration definitions and has not required reporting of unusual incidents involving the administration of diaanostic radiopharmaceuticals, with the exception of the use of greater Enclosure '

QUES 110N 1. (Continued) than 30 microcuries of sodium iodide. The 30 microcuria reporting threshold for sodium iodide was selected because it results in a dose to the thyroid gland (approximately 50 Rem) consistent with other NRC regulatory limits for an individual organ dose. The 1992 revision was based on the relatively low risk to public health and safety associated with the administration of most radiopharmaceuticals used for diagnostic purposes. As a result of the revised ,

I misadministration definitions, from 1992 through 1995, misadministrations involving radiopharmaceuticals have averaged approximately 7' per year. The IOM report estimates that over 8 million diagnostic radiopharmaceutical procedures are performed annually, and references an NRC estimate of 60,000 therapeutic radiopharmaceutical procedures annually, it is important to note that the cited 8 million diagnostic procedures annually consists primarily of administrations of technetium-99m which is rarely subject to misadministration because of the higher dose threshold associated with reporting of diagnostic misadministrations.

Regarding the administrative nature of some niisadministrations, the NRC revised its misadministration definitions and associated record keeping, reporting, and notification requirements based on potential harm to a patient rather than root cause. As a result, the NRC receives reports of events that meet the misadministration definitions and associated requirements, but could be considered by some to be administrative in nature (e.g.. correct dosage l delivered in the absence of a complete written prescription). Such events tend to be in the minority.

Reference:

NUREG-1272 - AE00 annual report for calendar years 1992, 1993, and fiscal years 1994 and 1995. Data for 1996 is not yet published.

i MESTION 1. (Continued) Very few of the reported misadministrations involving radiopharmaceuticals

\

resulted in harm to an individual. However, there are isolated examples, such

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as a-1991 event involving the administration of a diagnostic dosage of sodium f

iodide for whole body scanning to a nursing female patient occurred at Tripler i Army Hospital in Hawaii. As a result, the nursing infant received an ,

j unintended radiation dose that destroyed the function of her thyroid gland.  ;

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i Events such as the Tripler incident, or other cases resulting in harm to individuals from the medical use of byproduct matcrial, are reported as i Abnormal Occurrences (AO) to Congress on an annual basis, from May 1990 in May 1995, there have been 20 A0s i_nvolving radiopharmaceuticals reported tc  :

Congress. Although some A0s_resulted in unintended or increased radiation doses to an individual or organs such as the thyroid or bladder, in most cases, a medical consultant determined that no harmful effects to the patient were anticipated as a result. Selected portions of the A0 reports involving t radiopharmaceuticals, from 1990 to present, are included in Attachment 1.

The NRC is aware of misadministrations involving sealed sources administered ,

for therapeutic purposes that have resulted in harm or potential harm to a patient. for example, in November 1992, a patient undergoing a sealed source implant for the treatment of cancer subsequently died after receiving-a ,

significant radiation. overdose due to the failure of a sealed source device.

Currently, the NRC is reviewing the-circumstances and potential patient harm associated with approximately 100 misadministrations involving a sealed source used to treat an eye disease referred to as pteryg(um. Each misadministration l

QW ST10N 1. (Continued) l event is reviewed by the NRC to determine whether modifications to its existing regulatory program are needed to further reduce the likelihood of similar events.

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I OVESTION 2 What studies or any other work has the NRC performed or had performed to compare either the cost of compliance of its regulatory program with the benefits of the medical use of byproduct material, or to compare other statistical evidence assoc hted with the use of radiopharmaceuticals with similar i types of statistical evidence associated with the success or failure of medical procedures not involving radioactive material?

MIEG.

The NRC has not conducted studies specifically to compare the cost of regulatory compliance with the societal benefit of a given technology. The benefits of the technology are assumed to be the same with or without regulatory oversight. However, the costs associated with every rulemaking are analyzed. The cost data are summarized and submitted to the Office of Management and Budget (OMB) as part of the clearance process associated with information collection rulemaking. The most recent NRC submittals to the OMB for 10 CFR Part 35 are provided in Attachment 2. Although it is difficult to make precise quantitative comparisons regarding costs versus benefit given the general lack of availability of statistical evidence in this and other medical areas,-the NRC believes that the costs associated with compliance are commensurate H th the benefits to public health and safety by ensuring the safe use of byproduct material and reducing the likelihood of misadministration .

1 y OUESTION 3. What is the range of costs that medical facilities must incur for compliance, inspection, and licensing? Has NRC done a cost versus risk assessment to form an opinion as to whether the costs are reasonable? If so, what is that opinion?

MiW.LB.

The NRC developed a fee structure, which is set forth in 10 CFR Parts 170 and 171, to facilitate 100 percent recovery of its budget as required by the i

( _0mnibus Budget Reconciliation Act of 1990. These parts set forth the schedule of annual fees charged for licensing and other forms of registration or certification, and inspections. Fees are set annually by rulemaking.

Attachment 3 provides a copy of 10 CFR Parts 170 and 171.

The NRC charges a fee for a license application, amendment and renewal. These costs range from $400 to $6,000, depending on the scope of the program. The annual fee for facilities subject to Part 35 ranges in cost from $5,000 to

$25,000 depending on the scope of the program. According'to the estimate submitted to'the OMB for the information collections requirements in Part 35, the annual cost of compliance averages $25,000 per licensee.

The NRC performs a regulatory impact analysis, including a cost benefit analysis, with each rulemaking, including medical use. The NRC estimates costs associated with implementation of its regulations and-submits these estimates for OMB review. The costs to individual medical facilities vary due to the significant variations in the scope of. licensee. programs and their

QUESTION 3. (Continued) efficiency at achieving cost reduction. Also, it is difficult to separate the costs that would be incurred regardless of HRC involvement. However, the NRC believes that the costs associated with t.omplit :e are commensurate with the l benefits to public health and safety by ensuring the safe use of byproduct material and reducing the likelihood of misadministrations.

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- QUEST 10N-4. What-views has the Commission formed on any of the recommendations on page 22 of the report? If the Commission l has not yet reached a consensus on any particular l recommendation, what positions have any of the individual Commissioners fonced? What information is the Commission awaiting that is imperative for determining a complete response to this report's recommendations?

ANSWER.

l The Commission has considered the 10M recommendations within the framework of

( the agency's Strategic Assessment and Rebaselining initiative, which began in 4

August 1995. As a result, on September 16, 1996, the Commission made its preliminary views on t.he medical use regulatory program publicly available for comment. The current consensus of the Commission is that the NRC would maintain its current regulatory program for the medical use of byproduct material, but should make modifications to the current program, utiluing a risk-informed, performance-based approach with opportunity for input from the regulated-industry, professional organizations, the Agreement States, the public and others. The Strategic Assessment public comment period closes-December 2, 1996. Shortly thereafter, the staff will review, collate, and summarize the public comments. The staff expects to provide a summary of the public comments to the Commission and the public in early 1997, after which a final Commission decision on the specific direction of the medical use program will be made. For your information, Strategic Assessment Direction-Setting t

l 0'!!$110N 4. (Continued) Issues paper number 7. "Haterials/Hedical Oversight," and number 12 " Risk-l informed, Performance-Based Regulation " are attached (Attachment 4 and 5, respectively).

OVES 1101LE. With regard to the individual public opinions on NRC oversight in the nuclear medicine field tl.at may be received from the Strategic Assessment Rebaselining process, do you expect those additional public opinions to reflect new, important views outside the range of comments that have already been received?

ANSWER, l )

l As mentioned previously, the Strategic Assessment public comment period closes December 2, 1996. It would be premature for the Commission to prejudge what opinions public conmenters might express. After careful review of the public comments received, the Commission expects to make a final decision on the specific direction on the medical use regulatory program and provide direction to the staff.

Attachments:

A. Selected portions of A0 reports B. Supporting Statement for 10 CFR Part 35 C. 10 CFR Parts 170 and 171 D. DSI No. 7, " Materials / Medical Oversight" E. 0S1 Wo.12, " Risk-Informed, Performance-Based Regulation" Y

General Discussion of Comments on IOM Report NRC has sought a broad range of public comments on the report. NRC provided prepublication copies of the report to all Agreement States, non-Agreement States, and U.S. Territories; appropriate Federal agencies (U.S. Departments j of Health and Human Services, Veterans Administration, Defense Labor, and Transportation, and Environmental Protection Agency); the Conference of  !

Radiation Control Program Directors (CRCPD); the Organization of Agreement i States (OAS); Congressional Oversight Committees; and NRC's Advisory Committee on the Medical Uses o. Isotopes (ACMUI). In addition, we published a federal Reaister notice (61 FR 1648) on January 22, 1996, and issued a press release acknowledging receipt of the report and requesting comments on the possible ,

impactr of the report, to include any views on policy, legislative. l rulemaking, and guidance issues. The NRC staff conducted an analysis of the conclusions and cata used by the IOM to support its preferred alternative regulatory structure and the eight recommendations for its implementation.

The staff discussed the report with the ACMul on February 21-22, 1996, and at an NRC and Agreement State Technical Workshop conducted March 5-6, 1996. On february 27, 1996, members of the 10M committee, and on May 3, 1996, the ACMUI and Robert S. Adler (10M committee member with dissenting view) briefed the Commission. The Commission has also directed the staff to consider the 10M report and comments received within its strategic assessment and rebaselining efforts.

To date, the NRC has received 50 letters, containing 47 comments on the report. Three of the letters stated that they would continue to consider the issues, and provide comments at a later time. A breakdown by category of respondent is attached. The staff has reviewed all the comments received and grouped them by broad category. The two major categories of responses are either in support of, or opposition to, the overall recommendations of the 10M committee. However, within each of these major categories, there are subsets with respect to the specific direction or focus of the comments. None of the comments received specifically indicated that there should be no Federal involvement.

The Deaartment of Health and Human Services (DHHS), the federal agency that would ae most likely to assume more regulatory oversight if the 10M recommendations were implemented, indicated that the report does not make a compelling public health argument for DHHS to assume the recommended new role.

Furthermore DHHS raised a concern that Congress would not provide resources commensurate with the added responsibilities.

The majority of comments received (32 out of 47) did not endorse the full  ;

range of recommendations put forth by the IOM committee. Specific comments are summarized in a table provided as Enclosure 3 to the letter, four of the 14 respondents that supported the recommendations indicated that the-recommendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the 10M report, indicated that legislative initiatives should ensure that federal facilities are not subject to State and local regulations. >

Enclosure 2 ,

Other comments varied widely in the focus of their viewpoints and opinions.

The degree of regulatory reform perceived to be necessary ranged from simply recognizing the merits of the issues raised by the 10M committee to a need for a complete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substantial financial impact of the recommendations and the issue of this being, in effect, an unfunded Federal mandate. For example, as indicated in the response from Hawaii, public health and safety could be jeopardized in those States with l

I insufficient resources or capability to implement adequately the regulation of byproduct materials. The Department of Defense response, which summarized the responses from the three Service Medica 1 0esartments (Army, Navy, and Air ,

) Force), supported the need to re-evaluate t1e current regulatory structure, but emphasized the need for a uniform regulatory authority. There were several responses that recommended the need for Federal oversight for all uses of radiation. For exam)1e, the OAS response provided a summary of the consensus opinions of tie partici) ants at the NRC and Agreement State technical workshop conducted Marci 5-6, 1996, which represented 18 Agreement States and two non-Agreement States. The CRCPD response expresses the concern that the absence of Federal authority in the medical use area may have immediate and undesirable consequences on citizens in non-Agreement States, and long-term consequences for Agreement States trying to maintain a nationally consistent program. CRCPD does not support automatic selection of the DHHS as the agency to provide a leadership role. The staff is continuing to evaluate the responses as they are received, and will consider them in the broader context of its agency-wide strategic assessment and rebaselining effort, ,

Categories of Responses Received on 10M Report Federal Aaenciest  ;

Department of Defense (000) - consolidates views for three services Department of Health and Human Services (DHHS)

Department of Labor, Occupational Safety and Health Administration (054A)

Department of Veterans Affairs (DVA) i Environmental Protection Agency (EPA) i Agtgement States l Arkansas California Florida (Office Radiation Control) - R  ;

Florida (State Health Office) - H Illinois Kentucky Maryland New Mexico New York Dept. Environmental Conservation) - E New York Dept. Health) - H New York Dept. Labor) - L Tennessee Texas Utah Vermont Washington Non-Aareement States / Territories:

Alaska American Samoa Delaware Hawaii Massachusetts New Jersey Virginia Wyoming

Oraanizations/Committeest American Association of Physicists in Medicine (AAPM)

American College of Cardiology (ACC)

American College of Medical Physics (ACMP)

American College of Nuclear Physicians / Society of Nuclear Medicine (ACNP/SNM)

Amer <can College of Nuclear Physicians - California chapter I

[ACNP-CA)

Amer 9canCollegeofRadiology(ACR)

American Pharmaceutical Association (APHA)

American Society of Nuclear Cardiology (ASNC)

Conference of Radiation Control Program Directors (CRCPD)

NRC'sAdvisoryCommitteeonMedicalUspsofIsotopes(ACMUI)

Organization of Agreement States (OAS)

I Q1her Resoondents CBeasley, St. John's Regional Health Center, Springfield, M0

! MHafermann, Virginia Mason Cancer Center, Seattle, WA DJones, Northwest Medical Physics Center, Lynnwood, WA CMarcus, University of California, Los Angeles, CA CPerez, Washington University, St. Louis, M0 l GPoteat, OH l JRieke, Virginia Mason Cancer Center, Seattle, WA DSchumacher, Northwest Medical Physics Center, Lynnwood, WA MSelikson, RSO, University of Pennsylvania, Philadelphia, PA St. John's Hospital, Jackson, WY

' The OAS coment provided the recommendations of and consensus views reached at the NRC and Agreement State Technical workshop. The session on the NAS report included representatives from 18 Agreement States (CA, NY, SC, NV, IL, WA, TX, MS, TN, GA, NE, 00, KY, KS, NYC, FL, AR, AZ) and two non-Agreement States (OH, PA).

General Coments on 10M Report Rassendants in favor of ION rec =- ndations:

Support I M report /reconeendations as written AAPM ACNP/SNM ASNC DVA NM

! MHafennann (Virginia Mason Cancer Ctr)

I DJones (Northwest Medical Physics Ctr)

CMarcus (UCLA) l CPerez(WashingtonUniv) '

JRieke (Virgin'a Mason Cancer Ctr) 0Schumacher (Northwest Medical Physics Ctr)

Support 10N report /reconeendations, but as applied to all naterials:

FL R)

NY H)

NY L)

ACNP-CA th nondents not in aereement with 10M recommendations:

Support concept of regulatory refora l but retain Federal authorit/:

DHHS oversight: ACMul, CA NRC oversight: EPA,ACMP,ACR,HI,KY,NY(E),UT,WA,GPoteat(OH)

Unspecified oversight: DHHS', D00, ACC, AK, DE, TN, VA, WY a

It should be pointed out that the degree of regulatory reform perceived to be necessary by different respondents varied from recognizing the concerns raised by the ION to a drastic change in the approach to regulation of medical uses.

3 Some States (e.g., VA, WY, DE) were primarily concerned with the substantial financial impact of the NAS recommendations and the issue of unfunded Federal mandates, rather than more specific concerns on the overall approach for regulation.

' DHHS did not address the issue of regulatory reform, Federal authority, or concerns raised by the 10H, but focussed on the implications of the recomendation to DHHS.

[ Support concept of regulatory refore, but after additional analysis:

CBeasley (St John's Regional Health Center)

MSelikson (RSO, Univ. of Pennsylvanie)

MJ St. John's Hospital Support concept of uniforwits for all radianctive naterials regulation with federal oversight:

CRCPD OAS APHA AR (NRC as lead agency)

FL(H)

Il MA MD TX tesnandants indicatine resort under review 1 DOL AS VT

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Enclosure-3

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Specific Comments on IOM Report Category of Response Respondent Specific Comments RESPONDENTS IN AGREEMENT WITH ION RECOMMOSATIONS The Veterans Health Administration generally concurs with and 1 Support IOM report / DVA endorses the findings and recommendations of IOM. Principal I recommendation as concern is lack of specifics regarding regulation of Federal written entitities and also the regulation of medical research programs.

New Mexico Agrees with IOM recommendation that Congress remove regulation of possession and use of material subject to AEA from NRC's purview. Supports leadership role of DltiS so long as all states maintain regulatory programs that measure comprehensive standards of performance and effectiveness.

AAPM AAPM fundamentally supports position, conclusions, and recommendations of the IOM report. NRC should be removed from its current regulatory role for medical use. Establish programs for implementing States' regulations monitored by appropriate Federal health agency with assistance of user community and professional organizations.

ACNP/SNM The ACNP and SNM believe the report proposes a sourd and thoughtful approach to the regulation of nuclear medicine and urges NRC to implement the ION recommendations, allowing for comment on specific means to achieve implementation.

ASNC Concur with the 10M's conclusions and support their recommendations for a uniform policy to be set at Federal level which can be enforced by the States. DHHS should include medical radiation safety as part of its health care management plan.

MHafermann Endorses reconnendations of 10M. Does not agree with sentiments of Robert Adler in Appendix L.

i Category of Response Respondent Specific Comments RESPONDENTS IN AGREEMENT WITil 10M REC 0fWlENDATIONS DJones Endorses recommendations of 10M. Does not agree with l Support 10M report / sentiments of Robert Adler in Appendix L.

recommendation as written CMarcus Supports the IOM report and expresses disagreement with statements made t3 Robert Adler in his supplemental statement (Appendix L)

CPerez Expresses strong support for many of recomzendations.

JRieke Endorses recommendations of IOM. Does not agree with l sentiments of Robert Adler in Appendix L.  !

DSchumacher Supports recommendations proposed by IOM committee.

Support ION report / Florida Support idea of delegating regulation of medical byproduct recommendations, but as (Rad. Control) material to states 'n addition to all agreement materials.

applied to all New York Support the 10M's conclusion that the regulation of medical materials (Dept. Health) use of byproduct materials should be carried out at the state level. Encourages the NRC to not limit its response to the IOM report to the narrow medical focus of the report.

New York Support: the 10M's recommendation that NRC discontinue (Dept. Labor) regulation of medical use of byproduct materials, but considers it illogical to limit the recommendation to this one area (should include nuclear pharmacies, manufacturers, distributors, and industrial users)

ACNP-CA NRC's entire materials program should be given to the States and Federal entities ..

Category of Response Respondent Specific Comments RESPONDENTS NOT IN AGREEMENT WITH IOM RECOMMENDATIONS Support r9ncept of ACMUI ACMUI indicated a preference for a variant of the ION regulatory reform but preferred alternative in which there would be substantial retain Federal Federal oversight of State programs with a mechanism to authority ensure compliance of States and users. State programs should be monitored by a Federal agency with overall medical use perspective (DHHS).

DHHS Report does not make a compelling public health argument for DHHS taking on a substantial new role. The probability is ,

l low that Congress would provis:e adequate resources. DHHS does not support the recomme.,detion.

D00 Federal regulatory authority over medical use of byproduct material should be reevaluated and perhaps relaxed and restructured, but not abolished in favor of a voluntary or State-operated system.

EPA Report reflects the concerns of the regulated community more than the public at large. There may be aspects of NRC's program that can be improved, but NRC should continue to assure public is protected.

ACC Tran'Ter of oversight of the medical use of isotop-; to the l States seems reasonable. However, strongly encoura;c ~deral j oversight of this state initiative. An obvious drax_;f<

would be if all States had separate regulations for licensure and compliance.

ACHP Supports the need for a drastic chatge in regulation of radiation in medical use including use of Advisory Panels (comprised of users, manufacturers, and public) to determine the regulatory framework to be applied uniformly in medical profession. Current regulations should be modifi$d.

ACR In lieu of Congressional action to eliminate NRC's medical use program, the ACR believes that NRC's medical use program must be rebuilt and its objectives thoroughly reassessed.

I Category of Response Respondent Specific Comments RESPONDENTS NOT IN AGREEMENT WITH IOM RECOMMEW ATIONS (continued)

Support concept of Alaska This would not be a cost effective nor efficient reform for regulatory reform but Alaska. It is in the best interest of the State to support retain Federal the existing method of regulating nuclear medicine licensees authority (continued) by a Federal agency.

California In view of split regulatory authority at federal level and I apparent reluctance of NRC to expand jurisdiction, agree that Congress remove NRC's authority. DHHS should be given authority to ensure that every state maintains a radiation program that meets minimum, comprehensive, cor.sensus standards of performance and effectiveness.

Delaware The impact of the IOM recommendations would be substantial in terms of our increased need for funding, staffing, training and infrastructure requirements.

Hawaii Does not have resources or capability to adequately implement regulation of byproduct materials. Without assistance (training and development) to States, the removal of NRC's authority may significantly jeopardize public health and safety.

Kentucky A better approach would be to have NRC revise its medical program to go along with the recommendations the Institute has given in preferred alternative D.

New York Many unforeseen consequences may occur if AEA is modified.

(Dept. Environ. Commission should proceed cautiously in pursuing 10M Conservation) recommendations that may alter the present AEA.

Tennessee While the findings of the Committee have some merit, there is no conclusive support provided to document them. Sweeping changes are not well thought out and may result in chaos.

Utah State legislatures may view this as another unfunded Federal mandate and may provide no additional support to the State program. Medical community should work with NRC, States, and other parties to resolve the regulation issue.

Category of Response Respondent Specific Comments RESPONDENTS NOT IN AGREEMENT WITH ION REC 0fMEISATIONS (continued)

Support concept of Virginia The Connonwealth is in no position to assume any additional regulatory reform but unfunded Federal mandates. 'Could only assume regulatory retain Federal responsibility if NRC provides funds to defray cost of authority (continued) implementing the program.

Washington NRC should focus on radiation safety of worker and non-patient public (oversight of production, distribution, and handling of byproduct materials) while protection of patient is best handled through State boards of medicine and pharmacy.

Wyoming The conclusions of the report neglect the considerable hardship to be incurred by smaller, less populods, and less affluent States. Only through continued Federal regulatory participation can the goals of uniformity and public access to safe medical procedures be achieved.

GPoteat Potential decrease in safety may result from a transfer to State regulators of NRC's authority. Minor changes ard necessary but overall NRC's regulations balance the need to protect workers, patient and the public with the requirements of medical practice.

i Category of Response Respondent Specific Consnents RESPONDENTS NOT IN AGREEMENT WITH ION RECONMENDATIONS (continued)

Support concept of New Jersey If NJ chose not to become an Agreement State, public may not regulatory reform, but be assured of adequate protection. If adopting the after additional recommendations, NRC and Congress should not act analysis precipitously, but allow the States to prepare for assuming regulatory programs in orderly fashion.

University of Before moving in the direction of a State-based decentralized

- Pennsylvania system, a better evaluation of potential both for increased risk to the public and increased cost to the medical industry is necessary.

St. John's Urges NRC to give every consideration to IOM report, Hospital particularly the review of risk assessment.

CBeasley The report missed part of its stated intended goal to review the current system of regulation (the issues of uniformity among states was not fully explored). Proposes review in more detail the regulation of non-nuclear medicine radiology and question of uniformity between states.

Support concept of OAS At NRC/ Agreement State Technical Workshop, consensus was uniformity for all reached that all radiation use (regulated currently under NRC, FDA, EPA, and OSHA) should be consolidated under a radioactive materials single Federal agency.

regulation with Federal oversight CRCPD Absence of federal authority in medical use area may have immediate and undesirable consequences on citizens in non-Agreement States and long term consequences for Agreement States trying to maintain a nationally consistent program.

CRCPD does not support automatic selection of DHHS as the agency to provide leadership role.

APHA All ionizing radiation should be grouped together under a uniform regulation. Transfer responsibility for medical uses of any ionizing radiation to the States. Some Federal authority should remain over the medical uses of ionizing radiation (NRC or a similar federal agency).

Category of Response Respondent Specific Consnents 4

RESPONDEATS NOT IN AGREEMENT WITH ION RECOMMENDATIONS (continued)

Support concept of Arkansas The NRC should consider alternative A2 (status quo modified).

uniformity for all If major changes are to be made, centralization of regulation radioactive materials within one Federal agency (NRC) would be the best approach i regulation with Federal for all uses of radiation. Congress would be required to oversight (continued) expand the role of NRC and a change in the agency would be necessary. Expand current Agreement State program.

Florida Support . idea that regulatory authority of all agreement (Health materials be turned over to the states with consolidation of Office) federal radiation oversight, guidance, and regulatory functions into one agency, not necessarily DHHS.

Illinois Prefer CRCPD proposed new organizational concept that recommends some consolidation of all radiation regulatory functions at federal level. Revise QM and pharmacy rules.

Prepare white paper to use as a policy basis to clearly delineate the respective authority and responsibilities of various Federal and State agencies.

Maryland Rather than revoke NRC's authority and repeal the Federal regulations, such authority should be expanded to incorporate NARM, and the Federal regulations should be thoroughly reviewed and amended to clarify regulatory responsibility.

DHHS does not have necessary expertise.

Massachusetts Do not support elimination of all aspects of NRC's medical program, but support relaxation of overly prescriptive and unnecessarily costly requirements. Support intent of single Federal agency providing a single leadership role but do not support automatic selection of DHHS.

Texas The basis for the report's recommendations do not seem to be substantiated. The merging of all federal radiation control oversight into a single regulatory program should be considered. The NRC should enhance the partnership with the States to jointly determine compatibility requirements. ,

is i

j t t stcattaav o, -c <v ans + cto% oc rotos

.~o -oi~ 5t a ccos MAY 8 ;iii The Honorable Shirley Ann Jackson .

l Chairman l Nuclear Rrgulatory Commission Washington D.C. 20555-0001 1

Dear Ms. Jackson:

This is in response to your letters to me and to Commissioner 1 Kessler requesting the Department's review of the report of theA Institute of Medicine (IOP) entitled " Radiation in Medicine:

l l F=ed for Regulatory Reform." We appreciate the opportunity to conment as your Commission assesses its Medical Use Program.

I regret the delay in responding.

The report examines several alternatives to your agency's current

-regulation of the medical use of radioactive materials generated by nuclear reactors (" byproducts"). It recommends that the states take on this obligation in addition to their current range of regulatory responsibilities for the medical use of other radiation sources. It suggests that this Department provide leadership and collaboration as the States develop new guidelines and model state regulations for this purpose.

We do not believe, however, that the report makes a compelling

.public health argument for this Department's taking on such a substantial new role. . We-would also comment that, in the unlikely event that new legislation for such a purpose should be enacted,-the probability is low that the Congress would provide the Department with resources commensurate with such responsibilities. Therefore, we cannot support the recommendation.

We trust these comments are helpful and that the process of

'public comment and review of the IOM report will prove useful.

Sinh

/ Yy l D a1 . alala Enclosure 4

-. . . or.. . .. . . . . . - .,6- . - -

m 9

RUtt$ AND REGULATIONS 8242 g m ralb oriented tos ard succ Ientnrtwt or Ocnut Poti:T Quahfied phystelans in dise n a r C'r.C

[7590-01-M) Thb NRC pohey statement ts in inetr responsibilities to catiew HM

% % gnergy tended to inform NRC bcensees, ointr eser. regulation b) AEC NRC rx U

• I'*' ""h" "#"N CHAPfit I-NUCit At REGUL ATORY fy@;[gfhe r m ton e eral n nearb ony um W the me o COMM11510N tention regarding the regulation of f*

• L*P' "# I " "' " "

the medical uses of radioisotopes tm W bmse'"st Wam u ,

P ART 10-NUMAN Ult 5 OF It is expected that future NRC actU a. d BYPRODUCT MAT [IlAt$

itles in the medical ares, such as pro-mulgation of new regulations and de-f ts[

(FD A) e atmpted from au recart.

VDgrn:nt of cooperative relaticnships for new drugs au Etyviellen of the Medical Uses of sith other Federaj agencies. milj ments radiopharmaceuticals regulated by tediolselspes; $letement of Gomer* follow this statement of NRC polley, AEC. During this period AEC regulst-cl Policy Bued on put experience and the ed the radiation safety of mothers and comroents and adytee of the public.

AGENC7 Nuclear Regulatory Com- other FYderal agencies, the Ststes. and the geriers) public and the safet) and NRC's Adytsory Comrnittee on the efficacy of radioactive drugs and de-mtaston. W ltea10ses of 1sotopes, the Comints. vlees sith respect to patients AEC ACTION: Final Policy Statement. cle hu developed the following state- regulation included production of the radioisotope, manuf acture of the fmal SUMM ARY: The Nuclear Regulatory trvnt of genersi pollerto rulde its ret- radioactive drug product or device, du Ctmmtaslon (NRC) hu the following ulation orthe meoicaJ uses of radiotso- tribution, use and disposal of the prod-polley statement retarding NRC's topes:'

Jk 1. The NRC will continue to regulate ucts. I;.19M. the FDA terminated the future role in regulating the medical the medical uses of radsotsotopes u e semptioh for radiopharmaceuticMs-uses of radaoisotopes. This NRC policy necessary to provide for the radistion stating that it would now regulate tiie statement is intended to mform NRC safety of sorkers and the general &&fety and efficacy of radioactn e licensees, other Federal and State public, drugs with respect te patients 4 As agencies and the public of the Com- .

s ate the radb noted later in this statement. FDA mtsa.on's general interatton regarding

• stlo safety of patients where lustified does not regulate the physician s rN l the regulation of the medical uses of by the rtst to pattmts and shm vob tine use of radiopharmaceuticat< t At radioisotopes It is expected that u tary staridards. or compliance with the same time. NRC withdres from future NRC activttles in the medwal these standards, are inadequate. regulatmg radioactive drug safet) and area, such u promulgation of new reg. K 3. The NRC will mmimne intruston ef ficacy, stating that it sould reg.Jate l ulations and development of coopera. tnto medical JWrmenu af'ecting pa. the radiatton salcty of the somrs tive relationships sith other Federal tienu and into ot5e areu traditional' and the public. The 1976 Mecical assnctes. Will follow this statement of ly considered tc oe a part of the prac' Device Amendments to the Food. Dri.e NRC policy. tice of medleme, and Costnette Act eatended FDA s a thority over medical devices (includ.ng EFFECTIVE DATE. Februar) 9.1919 tt,Raggenagg devices contatning rsdioactise r%teri-FOR FURTHER INFORMATION The NRC and its predecessor the als) in a way samtlar to its authoria CONTACT' Atomic Energy Commission have regu. over drugs. l lated the medical uses of radiotsotopes NRC's authority to regulate domes-Mr. Edward Pode:st. Office of since 1946. AEC tecogTuxed that physt' tically the medJeal uses of byproduct (

Standards Development. U.S. Nuct?. clans have the primary responstbtlity matertal is found in the Atomic at Regulatory Commission. Wuh. for the protection of their patiente Energy Act of 1954. u arnended For ington D C. 20555 (Phone: 301443 and designed its regulations accortung* exa.mple, sectit n 81 of that Act autho Sg60)* ly. The ph/stelans were requtred to be fizes NRC "to tsaue general or speci!!c SUPPLEMENTAL INFORMATION; Itcensed by the State, and their apptb licenses to applicants seeking to use The NRC hu det eloped the following cable training and expertence were byproduct materlat for * *

• med.eal evaluated in cosuultation with the Ad- therapy * ' '." Section 81 directs NRC three part polley statement regstdtng vtsory Committee on the Medical Uses to regulate the manuf acture. produe-NRC medical a future role uses of in regulating On radiotsotopea. the of Isotopes. This regulation hu been tion, transfer, receipt in interstate ,

commerce, acquisalon, ownership. pos-March 11.19ie. the three part policy session. Import and taport of byprod-statement su published in the Fttra. 'NRC tteensu radiouotopa in three cate-u- matettal. Ptnally. Section 81 also AL RtctsTta (43 FR 11208) for public 'sortes. typroduct. scurce and special nucie. dt, 'ts that:

at malertal. The NRC coes not regulate nat-comment. Copies of the policy state, urally occurrins or accelerator produced ra The Commisaton thatt not permit the ots ment sere sent to all NRC medical Ib stotnotopes The term bypmdket matertog tribution of any byproduct materut to any censees. the States and 25 prof essional means any rastosettve matenst teacent see, heensee, ano shall recatt ce order the recan societies. Federal agencies, and indt- etal nuclear materst) ytetoed in or made ts. of any certbutes material from any beens.

uduals The corranent period expired esosctive my exposure to the radiatten tnet, et. she 1 not eeutooed to observe or taas to May 16.1918. "I4enty two comments sent to the process of prod., as or uttltstris, observe such safety standartis to crotect spectal nuclear ruste-tal. The term soure health u mmy de mabluhM ey W W s ere received Nine commenters f a. matanal maans ui uraruurn. .honum er any mission or sho uses each materist in uou g sored all three pans of the policy combtnation theren in m.ny smsical e, tion of tas or regulation of the Comm.smon statement four commenters opposed chemtec ierm or (21 cres shtch contain gy e. In a manner other than u otscloseo in I one part of the policy statement and ,etsht oneawentieth of one percent to on. ..ne appttention theref or or sporoved ti me nine commenters addressed specifle or more of til ursatum. titi thortum of altt> CommisstorL issues dtscussed m the March 11. 1918 any cometnation therect. Source material Commission regulations. for the coes not tnclude special nuclear matertat PtttRAL Rtctstra notice The com. special nuetter matartel means its otutoru- most part set f orth in 10 CFR Parts 30 ments are discussed in Section 11, " "

Copies of the comments may be exam' u"o'5 2N fn'the uNe*Nh'd iSr $'y through 35 were out the broadp?omulgated regulatory schemeto carry en.

ined in the NRC Public Document matertal arttricially enttchea my any of the visaged by section 81. For examrnc.

Room at Illi H Street. N W.. Wash- foresotns. But does not include source r ate. Part 35 estabitshes regu)ations spec he ington. D.C. rtal. f 0

nonu mm. m u. s.o. n_nion, nuut, t me 0 Enclotfre 5 l,

8M3

' RUL15 AND REGULATIONS The NAS BETR 8 report d.scusses The regulauons tr> to find a ta:ance to human uses of byproduet matenal limiting the esposure cf the popu;n betseen adecuate controts and at oid FDA's statutory authorit y ( Fede ral to medica) apphest: ens of icnn.g ance of undue interf erence m rech Food. Drug and Cosmetic Act. as tion rs&ation. That repo*t. s h:c.1 incNdes 3sg rents A censecuence of tN amended. 21 U S C 301 e! seg i does much regulation could be poor er not dirnmash NRC s author'tb There au ruedical uses of tormg ru.ation heatih este delttery to patents A con NRC s and FDA's author:tles overlap.radiopharrnacevucals shoas an average dose of I este

-remfro 5 smence of leanns to physte:ans the gear the respectise authenties can be hat. and an sierage dose rate f rom c.ag- res Jent y of the dectstoru conce -ur c rnenned by tntertgency agreement. nostic twLology of .. mrem S car m tw mm uM W m m The centrsJ cuestion ts a question of name y 1970 p0hei not oextent utAonly' The followtog quotat.cn is frorn the {([a ,

To shat s hot.:s the protee. N AS-BETR report. g ,

,:on of the pattent t>e coruidered m not be able to prevent future inetdents NRC s regulation of the med. cal use of In the foreseeable future, tr e ms;or con tnbutors in rassuon esposure of the pcpu- in the medical uses of rsdJouotopes ,

Omroduct material The Commission recogntres that j From the standpoint of 48.thonly, it lauen wiu continue to be natural ba.c a . -

is clear that NRC can regulate the pound sith to aversse shole bodt done of FDA regulates the manuf teture and medicaJ uses of byproduct material to about 100 mretnnear. and med; cal applica. tnterstate distribution of drugs,includ-Horg which noe conmbute comparsbie en. ltig those that are radioactne. FDA protect the health Lnd safety of users poeurve to esi6ous tissues cf the bodr. MedF also regulates the intestigational and cf thts instertal. for tnstance, patienta. cal exposures are not under control or esiid.

In licenstng the possession a.nd use of ance bF regWation or law at present The research uses of drugs as scU as the byproduct material. NRC establishes * *I 88 * ^8 r*8800" LD S'd8Clo' L8 of specific ruldince on doses and proce-limtts within which physicatru exer. "# ' dures found in the product labckng etse professional dtscretion. From the ,[oY,',"' stn can Nom Rosever. FDA does not have the sit.

standpoint of pohey. these limits phshed without loss of benefn and at reis. thority to restrict the routtne use of depend upon how NRC news the po- tivett low cost The atm ts not erur to drugs to procedures (described in the tential hazard to the patient's health reduce the rsdiation exposure to the anda product labelmg) FDA has approsed and safety in the uses of the b> prod. wual but also to have procecres camed u safe and e!!ecthe. Indeed. NRC c uct matentl. The tienter the potential out enn sitn mazunum efficiency be a conticutns so that

.ncreue tr.ere tne only Federal Agency that ts e r.

in mecan hatard to a patient f rom the byprod. beneina accomcaaled by a rurumurn rac' rently authorpo to regulate the ros uct matenal or its use by e physittan. anon ecosm tine use of r&&oacute drtes from the the more NRC may elect to circum scribe steu that might otherwise be NRC stil act tn he'p ensure that ra- standpumt of reducing unnecessa.r> ta d.ation exposure to pauents.

restroed u sithin the discret on of distion exposure to patients is u nos The Corratussion beltetes that the as is reasonably achievable, consutent the physician.

The first part of NRC's policy state. sith competant medical care and stth d. agnostic use of ra&oactne drucs 65-mtalmaj intruston into medjeal Judg- En most cases, clearly an area of los ment Indiestes that NRC sti continue radiation risk to patients. Therefore to regulate the medical uses of radiot ment . NRC s'lll not exercise regula'. NRC sill not control physictan s pre-setopes a.s necessary to prende for the tory control tn these steu there radiation safety of worters and the upon careful examination. It deter' rogatives on pauent aslecuon. truiru-general puolic) This is the traditional mmes that there are adequate regula. ment selection, procedure selection.

regulatory function of NRC for all tions by other Federst or State agen- drug selection and dose level for most uses of byproduct, source and special ties or nell administered professional datgnosuc usa of rsdiotsotopes. For nuclear matentl. It u a regulatory standards. Wherever possible. NRC slj therapeutic uses of radioactis e role that sas not quesuoned by any of *ttl work closely with Federal and drugs, and in c=:rtAm dittnostic uses-the commenters but rather, it a a.s State agencies and professional stoups for example, the use of puosphorus J.

in designing new voluntary guidance for localtzation of eye tumors-tbc consistently recogTu2ed as a necessary for practitioners to h:r.1% urmecessary ruk to ptuents ts not los. The rtst of role m the medical uses of radiouo. patient radiation exposure, tissue or organ damage tot even death' to pes.

The th.trrl part of NRC's policy state. ts inherent in the use of therapeuue NRC's regulation of the radiation merit tridleates that NRC stil mtni- levels of rsd.ioactive drugs. NRC m13 safety of s orters and the general mire its Intrusion tnto medical juda. contmue to restrtet the uses of thern-pt'bhc topes tsinrelinqu!shed the medical byuses NRC of to radioiso. As ree. ments t!!eenns the patient and into peuuc and certam diagnostic radion.c-other treas traditionally corutdered to the drugs to the indicated procedures ment States'. does not oserlap uth be a part of the practice of meitme. that have been approved by FDA The FDA 5 Ectivities, ts In harmony sith The Comtnission recognizes that phy- NRC wdl not control the physicians' regulation by the Department of Transportation, Social Secu ity Ad. slettru for thehave the pruntry protection respor.s:

of their butty prerog.auves on patient selection a.nd patienta mmistration and the Joint Commis. The Commtssion beheves that taste tnstrument selection fof therapy pro-sion on Accreditation of llespitals, and decisions conceW_v W diagnosa and cedures, because these procedures are dosetath s it h Occupational Galety trettment of d$sease t.? a ptri of the so specialized and patitM toectite.

and 1.lealth Administration regulation phystelan. patient relattorchip and are Congress recently gave FDA authon-of the work place for the use of natu. traditionally coruidered to be a part of ty to regulate medical deMcts. simaint tally occurftng and accelerator pro, the pracuee of nedlema. 4RC regutt- to FDA's authonty to regulate drugs.

duced radioactive materials Mons are pudicaW on W aasumpuon but with addauonal authority to re-The second part of NRC's policy stnct W toutme use of medicat &

statement indtestes that NRC stit reg. s e ske d i nces pa. as may M necMstn W prod ulate the radittton safety of pattents %[g*,L[,* gg 'd o ys e ,nterest of the.treason 4ble assura.nce of their s4.fety I s here jusuited by the risk to patents U' " and effectiveness. FDA has nat yet and shere voluntary standards, or had sufficient time to tinglerrent its compliance sith these standards. tre 'NationaJ Acaderny of Sc1nces Adusory full authority to regulate meoiet! de-inadequate. As noted before. NRC hu Comrnattee on the Biolestcal E!!eeu of lon vices containmg byproduct. Sourte or the authority to reguiste the radiation tung Radations (N A.SBEUU reoort De special n clear matertti. Therefore.

saf ety of pttlents. EJJects o*i Populatsons of grposve to Lote NRC will continue to restrict physt-Letels c/ fonutme R a dia tiu'L AoWot Accamy of ScwMees-Nenomel Res(C Th Clan 5 uses oI theSe Medi AI deOCTI-Doth for diagnosts and therspy. to

'The V7Tn eertertl nublic in this state CosmciL Wasrtingun. D C ttMR ment soecifically escludes oauenu fl0tett StGt1TT1, VdL 44, WO. NttpaT, filsWaeY e. Mre -

RULES AND ttGULATION5 8244 As noted in the proposed ru Two commenters objected to NRC s statement. NRC ts studying the ur those procedures tnat NRC hu det:r. regulation of cattent rad:stion safety tous aJhed health ce rtificatio n tre mined tm coruultation rath tu Adytso. because they bellene that NRC does grams currentti in ef fect or te rr ry Comtnittee on the Medical t?ses of not have the authority te regWate pa- crafted by other Federat State aM hotopes, to be safe and effective. tier:t safety They note tnat NRC s en. professional troups 11 the cotersee The Commission does not consider abling legislation does not spee of fier'ly protided by these programs is not aor equipment caubration, qualificattora ps.

Quate to protect the patient from un of paramedical personnel or reportingtients. mention the radlation safety They behe n e that patient necessary radiation exposure. NRC to NRC mtsadmitustrations of radiose.

toe material to be exclusnely the safety is the respermb!nty of the pny.

a H1 aora a!th these groups to des elop a nes NRC proposed rule for the practice of medicme or a otrt of physs- stelan. a respotutbJtty that etnnot be of al!!cd health persorne' training eian patient relationsntps The Com- shared They bellene that the Cer-tras.

musuon mtenas to regulate these ateu ston is in error to couate patients sithThere tere five comments on the of patient radiation safety there just!' the public and to consider patients u specific subject of nuclear pharmatics fied by the rask to patients and there users rather than recipients of rad.o. tradiopharmseles t One commenter urged NRC to dts voluntary standards, or comp!!ance active material.

As noted in the Entlysis of the sim!. tlnguish between radiopharmacists tith these standards are inadecuate. lar comment above, the NRC's overrid- working in a hospital setting and those

!!!. Disevssion or Pvstre CowwtNTs ing congTeastonsJ mandate is to pro, working in a retall environment (com A cowwtNTs on THE Pottev staturm7 tect the health and safety of the mercial nuclear pharmacyl. This comof public. The patient ts a member of the menter also noted the complexit)

One commenter opposed the use of public, notwithstanding the Commis- the problem of definition t hen the the general term " radioisotopes" in slon's recognition of physicians' prima, hospital bued radiophumacy pro-the first part of the policy statement. ry respo.ulbthty for protection of vides radiopharmteeuticals to other This commenter su concerned that' their patients. The policy statement hospitals and practitioners in its area If taken out of the context of the foot. and, indeed, t!! of the Commission's As noted in the proposed pohc) note,it could be mterpreted to include settoru in regulating the medical uses statement, the NRC w!Il defer to the naturally occurring and accelerator of radioisotopes, teknostedte the see Food and Drug Administration (FDA >

produced radiotsotopes ondary but necessary role of NRC in restrdmg a determmation of those at The Commission oelieves that the resulating the rsdjation safety of pa. livities of nuclear pharmacles that tiu eentral terin "radiotsotopes" is plain tientJ. The Commlaston also coruiders be considereo manuf acture and thcsc Ensilsh and euity recognaed by the patient.s to be both users and recipl. tetivtt es that will be considered the public. It su property footnoted in ents of radlotettve material Homeser, ordinary practice of pharmacy (com-the poisey statement to include the the distinction .betteen rectlpt and P0"Dd'AI "Ed d'8D'0830I h more cumbersome but specific terms: use of radioacthe mat?rtals ts not Four commenters objected to NRC 5 byproduct, source and special nuclear meaningful in this cue because NRC lleensing nuclear pharmacies to d.s-matettal and to exclude n.turally oc. regulates, among other thtngs. recetpt. tribute only those products that they curring and accelerator produced ra- posseaston, use and transfer of byprod- have prepared from FDA.approsed dioactive matertal. uct. source and specist nuclear materl- epharmaceuucab

• w ""#""

narmt W One commenter. In opposition to al in protecttng the health and safety "' # **

NRC's regulation of patient rsdittion nuclear pharmactes supplytng radio-sif ety, suggested that N"C limit its of the public. chemicals to researchers w ho use of the hos, role to the radiation SAf' a.cohortNTs on Srtetric tsstrs:s them on humans under their own patal staff and the geisvrt! patient FDA "Nottee of Citimed InvestJgation-

)

There were six comments cr. the al Exemgtton fer a New Drug" tIND population.

dostmetry is a He believesofthat responsiblitty patient cuestion of reporttr's mtsadministra- One commenter noted that FDA the in. [ p dividualinstitution and not NRC.This tt na f rsdtomettve material. Three mits nuclear pha macies to operate in commenter feels that NRC should e mmenters opposed any mtsadmint> the absence of a itnal determination of first require adequate staffing,includ- trstion r; porting and three com. their status. providing they eneet all ing a board certt!!ed physician or rs, menters offered suggestloru on how State and local phannaceutical regula-dropharmactst and a rsdiation safety they thould be reported. All of the tions. The two other commenters c!! seer. and then essentittly leave the comments will be conaldered in dealing charsetertzed the NRC's restriettons of institution alone regarding dostmetry' with NRC's newly proposed misadmin. on the distribution instrumentation. calibration, drug pro 1stration reporttng requirement that rsdtopharmaceutletls by nuclear phar.

curement or any other function con. wu published in the F*etx4L Racisism macies as an unwarranted intrusion sidered to be tne practice of medicine. for public comment on July 7,1978 (43 into the prsettce of pharmacy thich ts NRC does require the licensee to FR 292971, regulated by the States.

staff its operation with a radiation There were sta comments on the spe. NRC licenses nuclear charmacies to safety officer and & phystetan (not cific tssue of partmedteal training. distribute radiotetive drugs that nue necessarily board certilled) trained to Three commenters believe that it is been approved by FDA. This includes administer radioactive matertti or ra. unnecessary for NRC to become in, rtdlotetive drugs subject to an FDA; ,

diation to patients However, the Com. volved in paramedlett tiatning because approved "New Drug Appheation mission cannot limit its regulatory role several organizatt:ns tr? already pro. INDA) or " Notice of Clatmed Intesti; i

to protecting the hospital staff and viding or develop'ng minimum stand. rations! Exemption for a New Drug J

the general patient population and at ards, guidelines or certtitestion. One (INDL NRC rettes on FDA approsal of the same time ful!!!! Its congTessional corntnenter heltevad that NRC should radioactive drugs because NRC hu roandate to protect the health and be involved in this area because the not regulated the safety and effectne-safety of the public as regards source l technologist. not the phystettn. does ness of radioattive drugs since 194 byproduct and special nuclear materl most of the work with radictsotopes, Also, there are not many States tr'at al. The patient being treated or drag. Two commenters believe that radlolog. are equipped to regulate radioactne nosed with radioactive materlat as leal physicists should be separated out drug safety and ef fectiveness well as the general public who may be from other partmedical personnel and Dated at Washington. D.C this ist exposed to radiation as a result of that one of these commenters offered a day of February 1919.

treatment, are all members of the definition of tsdictortcaJ phystetst.

pubite to be protected by NRC. ,

Ptbtt At slot $ tit. VOt. 44. NO 2hmoaY, fitsuatY e.1979 .

t e

f

l 824$

tutt$ AND tt2ULATION$

, cier m as criticued by tes tral commen Por the Nuclear Regulator) Com. Issuers eligible to use the form for pro tators sho noted that mtny comps mary offerings to include those t hose nses sith no rubtley held gottng mission r"*nts do not guarantee thelf securs Sawcet J Outut. ties u to principal and interest ud rnst be better establahed than t tith such stoc t3 AMordtDgl the Secretarv o/ Ote communon also allow be u e of th( form for the (F"R Doc. TMitt hled 2 819 el aml tyytstratton of equity securttlesleue of amendments 33 5923 allow the use that sete adopt in Re-Form S-

- such tuvers. In addition to the general 16 by issuers sith no 14cl> held recultements for the use of Form S 16 votmg stocs then the uer is a ma.

gggy and the market espitalization require, Jority otTitd subsidlar ud it.s parent market espital-ment of the parent, the eligibility crl-le IF-Commodity and $eevrities tena proposed in Releue 33 5914 for tr.ation meets the 850 millt reQutrem . a.nd guarantees gggg g,, eubsidiaries included (!) the ertstence the se*urttles principal a.nd Inter-of eutstanding debt of equity securt. est.

ties held by nona.ff t!!stes, sith an ar- Release 33 5974, subsc-C PTrt IL5tCUtiftI5 AND gregate prtne.fpal arnount or market cuent to As noted adoption of these n. mend-I ANGE COMMl1510N ralue of at least 8250 million, the offer ments, f her comments were re-Nos. 33 4420 lC.103711 or sale of which has been regutertd eetved the effect that severst sub-(Itele pursuant to the provisions of Section 6 s2ar mus, such as (mance and PAlf2 -40tMS PatScatst0 of the hues Act. W comphance utill compantes, are among the larg.

UNDit M CUtlTIES ACT OF tm with certain specified aarnings to timed est nd best estabitshed bustness con.

charges rataos (vsrytag according to c and frequently finance enternal-Siwt Fece fo the Registration of industry) for the most recent itacaj . Substantial public infortnation is period reported, and (31 the estatene, vallable regarding these Lasuers in 5 ties of at least 2.SM accurtty holders who view of their pretious Lesuance of secu-AGENCY; Securit s and Exchange receive annual reports from the tatuer rities and reperting history. It wu f ur-Comrnission, conta.ining certilled financlaj stat ther suggested that, in view of ti.e ments. Quality of these subaldlary issuers.

ACTION; Tinal rules. This release contains a general is. parent companies generally need not

SUMMARY

The C misdon is eussion of the backsinund an pur, and do not guarantee their securities.

adopting amendments the short pose of the amendmeats pro ents re, in Ir tight of these concerns, the Com-form S-16 in order to f ur er expand Releue No. 33 5914, the cc mtulon in Releue 33 5914 woposed its use for primary offering y subsid- ceived on the proposal.' and he Com, amendments to the form that a ould sarses of certain issuers. Th unend' mission's response to thos omments. enable subsidiary issuers to use the should be IMm (M p nary oHutngs m the ab ments atil enable certain subs lary is' The test of the amendme suers sho otherwise satisfy the ener* consuRed for a corople understand, sence that they of meet a parent guarantee certain prouded criterna intend-al requttercents of the form to the ins of the near provtsto j form for prttnary offerings of s urg, ed to assure the satisf action of stmtlu BacsonocwD 3 Petrost ties if they have outstandmg secart es standards of information dissemina- I held by non-a.fft!!stes tith an as On Aprtl It.191. the Commission in tion and significant interest by securt.

ties professionais that must be met br gate principal amount or market valu Secunties Act ene No. 5923 H3 FR their parent companies. These addp of at leut 8250 rolllion, the offer or 16672) anno the adoption of sale of which has been reststered pur- endments aktrig Forro A16 avail- tional criteria proposed in Releue 33-suant to the Securities Act of 1933 le i r th trat time for petmary of- 5914 the comments received thereon.

and the Commtaston's response as re-and at leut 1,000 security holders sho le gs by uers under certain spect. flected in the final amendments are f receive annual reports containing cer, fe con part tWna. The amendments re-the recomtnendation of dLacussed immediately below.

tihed Itnancial statements of the flec isory Committee on Corportte Anortion or RsoctarwrtrT or 8250 tasuer* the (" Advisory Committee") PoinctraL Mt!.Lio e Accascart EFFECTIVE DATE: March 15.1919; D 5-16 be avstlable for the AwouwT on Mannst Vatur or OUT-however, persons destring to use the th Fo testi of securttles to be offered stanotnc Saccattles rettsed form prior to that date may do r trectly to he public by a "small top In addition to the generst require.

so. prWded they comply with all sp. tier of com es * *

• which usually pitcable provisions of the new f orm, provide his quality corporste com- ments that the issuer satisfy the rules POR FURTHER INFORMATIO munication d uments, including 1934 for the use of Form S-1

• and that its CONTACT'. Act reporta. * ' whose corporate in.

1o.

formation is wid y disseroinated * * '  % coments cokted at Ptte No $1-Steven 3. Paggioll. Office of f andl which ut idcly folloted by its.

sure Policy and Proceedin Dtvf. " *'*

ston of Corporstion Finance urt. debt and equity an ysta."' One of the g[,M',*ET[n, "

g"[,7,,[f p,M major conditions u imately adopted ties and Exchange Comm lon. 500 North Capnot Street, thington, in f urtherance of ide t!ying a catego. of securistes resutered under scenon a12clus e requirement

1. which reoutre an tasuer iet to hate or 1.

ry of such lasuers was ding voting te suejeet to the recorune reowrements of D.C. 20549 (202/316-60 that an issuer have outa RMATION. with an ar- section 1Nds of the tWursues Exchange Act SUPPLEMENTARY the Commis7 stock held by least $50 market nonaffilistgregate of 1934. m to hanof value ten sunnect to the re-On September 1.19 outremenu of scettoru 12 or IS<st and to

' ston authorised to pu' blication pro- million. the relatter of tt require. hase filed all sooncable reports for 3s esirn

{ posed amendrnen to Form S-16 (11 m to W hu's Wing a k hot- dar monms prior to filme tne reststration statement and here tamely ined alt requir,3 i CFR 239.21) a rrn for the rettstra. -

reporu for the past it catenaar roonths. ici Lion of certain urttles under the Sc.  % comments collected at Ptte o F1- L' h**' h*a no oetsen sn paymenu on pre curities Act a et 1933 ("Securttles Act") 184- '""d ***^d***'** ' * ' * * " * " "

(15 U.S.C. seq. as amended by * *'" th' ^8

• C' " '" money or lona term leases curtns the past orporate Ductosun to me Secursues '"o 36 monsha. and id t to have had consotsdated n

Pub.1. N . 94-29 (June 4.197511.

Release No. 5914 (43 FR . Exchance commi.anton FReport*i. Ho Secu-rities net tneome of at tesst stso o00 for 3 of the 41052 nvited coroments on these pro- Commutee on interstate and Foreism Co tut 4 tisest retts. tneludmg the most recent poS amendments whtCh would gen- mern. eSth Cone.. Ist SesL Committ Itscal year. Iset IT CTR 2J9 26.

y expand the class of subsidiary Print 95 29 at 433 34.

er 19r9 F104aat alO;1 Tit. VOt. a4. WO. y94efonT, R&auser

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