NRC 10 CFR Part 35 Update

As you know the American College of Nuclear Physicians and the Society of Nuclear Medicine have long maintained that the NRC's regulations governing the medical uses of isotopes are largely an exercise in unnecessary regulation. ACNP and SNM actively participated in the Part 35 rulemaking; petitioned the NRC to reduce the regulation of diagnostic nuclear medicine; and, finally turned to Congress for legislative relief.

On November 2, Congress passed and sent to President Bush, the FY 2002 energy and water appropriation bill which contains the following language:

Provided further, That, notwithstanding any other provision of law, no funds made available under this or any other Act may be expended by the Commission to implement or enforce any part of 10 C.F.R. Part 35, as adopted by the Commission on October 23, 2000, with respect to diagnostic nuclear medicine, except those parts which establish training and experience requirements for persons seeking licensing as authorized users, until such time as the Commission has reexamined 10 C.F.R. Part 35 and provided a report to the Congress which explains why the burden imposed by 10 C.F.R. Part 35 could not be further reduced.

In the Conference Committee Report, the conferees stated that:

The conference agreement includes language prohibiting the implementation or enforcement of the revised 10 C.F.R. Part 35, as adopted by the Nuclear Regulatory Commission on October 23, 2000, with respect to diagnostic nuclear medicine, except for those parts of the new rule which establish revised training and experience requirements for persons seeking licensing as authorized users, until after the Commission has provided a report to the House and Senate Committees on Appropriations explaining why the regulatory burden could not be reduced further in the new rule without adversely affecting public health and safety. The conferees direct the Commission to submit this report not later than January 31,2002. The language included in the conference agreement is only an interim measure until a more permanent solution can be reached, either by the authorization committees or through a revised rulemaking.

This is a major victory for ACNP and SNM and the rest of the diagnostic nuclear medicine community. For the first time, Congress has told the NRC that it has gone too far.

The task ahead is to engage the NRC in a dialogue so that the nuclear medicine community has a meaningful say in what happens next. Our discussions with the NRC will take place against the background of our newly found Congressional influence.

For further information contact Bill Uffelman at wuffelman@snm.org.

 

 

November 9, 1998

The Honorable Shirley Ann Jackson
Chairman, U.S. Nuclear Regulatory Commission
Mail Stop 016G15
Washington, DC 20555

Dear Chairman Jackson:

Enclosed is the response and comments of the California Chapter of the American College of Nuclear Physicians (ACNP) to the NRC's proposed revision of 10 CFR Part 35. This response was developed by our Government Relations Committee and approved by our Executive Committee.

The California Chapter of the ACNP believes that the proposed revision of Part 35 is seriously flawed and that a one year delay is required in order to resolve the many outstanding problems. This could not be accomplished in the public hearings because responses were severely limited by the frame of reference and restricted questions imposed unilaterally by the NRC's "Working Group" and "Steering Group". The California Chapter believes that the restrictive format is a large handicap that prevents us from commenting on each of the proposed new regulations. Our response, therefore, takes the form of an Executive Summary of our comments and concerns followed by a detailed discussion of these matters with suggested language for many revised regulations.

A one year delay in the revision of Part 35 should give ample time for the success of a good faith effort of the NRC and concerned professional organizations to resolve the many remaining problems.

Sincerely yours,

Marvin B. Cohen, M.D.
President, California Chapter
American College of Nuclear Physicians

MBC:sfd

 

A CRITIQUE OF MEDICAL
REGULATIONS, LICENSE CONDITIONS, RISK
CONSIDERATIONS, AND COST ANALYSIS
PROPOSED BY THE
NUCLEAR REGULATORY COMMISSION
(Fed Reg. 63(156): 43516-43586, 13 Aug 98;
NUREG-1556, Vol. 9; OMB [7590-01-P] )

by

THE AMERICAN COLLEGE OF
NUCLEAR PHYSICIANS
CALIFORNIA CHAPTER

NOVEMBER, 1998

 

Table of Contents
    EXECUTIVE SUMMARY
    SPECIFIC COMMENTS
  1. MEDICAL POLICY STATEMENT
  2. RISK ANALYSIS AND RELATIVE RISK
  3. PERFORMANCE STANDARDS
  4. PUBLIC PARTICIPATION
  5. UNACCEPTABLY SHORT COMMENT PERIOD
  6. UNACCEPTABLE VAGUENESS
  7. "GRANDFATHERING" OF NUCLEAR MEDICINE AND NUCLEAR PHARMACY COMMENTS, LETTERS, TRANSCRIPTS, MEETINGS, ETC. SINCE 1985
  8. AGREEMENT STATE ADEQUACY AND COMPATIBILITY REQUIREMENTS
  9. OMB ESTIMATE
  10. QUALIFICATIONS FOR PHYSICIANS
  11. PROCEDURE OVERLOAD
  12. RECORDKEEPING
  13. THE QUALITY MANAGEMENT (Q/M) RULE REMAINS, FOR THERAPY AND NOW IN ESSENCE FOR DIAGNOSIS
  14. PATIENT NOTIFICATION
  15. PATIENT DISCHARGE RULE
  16. PREGNANCY AND LACTATION
  17. MEDICAL RESEARCH
  18. FORBIDDEN MATHEMATICS
  19. DOSE CALIBRATORS
  20. SEALED SOURCES, SOLID SOURCES, LEAK TESTING
  21. MOLYBDENUM BREAKTHROUGH
  22. LABELING OF VIALS, SYRINGES, AND SYRINGE SHIELDS
  23. GENERAL COMMENTS
  24. REGULATORY DEATHS
  25. THE CHAIRMAN'S FAILURE
  26. UNBUDGETTING NRC POSITIONS
  27. WHAT THE NEW PART 35 SHOULD SAY

     

    EXECUTIVE SUMMARY

    The California Chapter of the American College of Nuclear Physicians (ACNP) represents the nuclear medicine physician specialists of the State. California performs about 20% of the nation's yearly 10-12 million nuclear medicine procedures, 99.5% of which are diagnostic and 0.5% of which are therapeutic. Our members also belong to the Northern and Southern California Chapters of The Society of Nuclear Medicine (SNM).

    Nuclear medicine began in California in 1936, and this State has played an outstanding role in the research and development of this field. California was one of the first Agreement States, and has had a fine record of safe and responsible radiation regulation. In response to a mandate from Governor Wilson, and the personal and professional commitment of Edgar Bailey, Chief of the Radiologic Health Branch of the California Department of Health Services, the Medical Program in California is undergoing progressive improvement with the participation and cooperation of the nuclear medicine community. We believe that California's Medical Program should remain completely independent of NRC so that it can continue to improve.

    We testified at the Agreement States meeting in October 1997 with the expectation that NRC would listen to the advice of the regulated community and would produce meaningful changes based on this input. We have been grossly disappointed. We believe that such a massive undertaking as a complete revision of 10 CFR Part 35 can not be fast tracked and requires sufficient time for all parties to communicate fully and for all disputes to be adjudicated and resolved. We, therefore, request that the finalization of Part 35 be delayed for one year. To expedite this process, The California Chapter of ACNP offers its critique of the "strawman" version of the revised Part 35. Rather than responding to each regulation in this "strawman" version, which we consider to be seriously flawed, we will critique the concepts that form the base for the proposed revisions.

    The U.S. Nuclear Regulatory Commission (NRC) embarked upon a "fast track" effort to improve all its medical regulations after the publication of a National Academy of Sciences-Institute of Medicine (NAS-IOM) report entitled "Radiation in Medicine: A Need for Regulatory Reform". This $2.25 million, 2 year, 300-page study was contracted by NRC at the urging of its Advisory Committee on Medical Uses of Isotopes (ACMUI). The report, published in early 1996, contained strong

    objections to NRC's medical program, and the NAS-IOM recommended that statutory authority in this area be removed from the NRC and given to the States, as intended in Sec. 274 of the Atomic Energy Act (AEA) as amended.

    The NRC responded with a one-sentence insult to the NAS-IOM charging that its recommendations were "not substantiated", and refused to scientifically or medically defend against a single NAS-IOM criticism over the nearly three years that have passed since the publication of the report. Instead, NRC proposed a "partnership process" with the nuclear medicine community, vowing to make extensive use of the advice of nuclear medicine professionals gained at public meetings and through public comment. The Commissioners of NRC gave assurance that the new medical regulatory construct would be completely based upon scientifically valid risk assessment and that performance standards would replace prescriptive regulation. NRC management publicly promised the nuclear medicine community that NRC would begin a reconsideration of its entire medical program with "a clean sheet of paper". In response to a strong recommendation for appropriate general licensing and an abandonment of the grossly inappropriate present licensing process, NRC promised very serious consideration of this request.

    The 1/30/98 draft of 10 CFR Part 35 clearly demonstrated that virtually none of NRC's vows and assurances were kept. Despite extensive comment by the professional nuclear medicine community, the Draft Proposed Rule published 13 Aug. 98 and the associated licensing NUREG are far worse than the 1/30/98 draft. The Commission Staff Requirements Memorandum (SRM), written before the public meetings, used no risk analysis whatever, and instructed staff to basically tweak the program a bit. The staff deliberately refused to use any risk analysis in its evaluations, claiming that the Commissioners had not given them enough time to prepare one. At a public meeting in Chicago in November of 1997, it was pointed out that at least two risk analyses for nuclear medicine exist, both paid for by the NRC. One appears in Chapter 4 of the NAS-IOM report, and the other is NCRP Commentary no. 7, published in 1991. At that public meeting, the participants representing nuclear medicine, radiation oncology, nuclear cardiology, nuclear endocrinology, nuclear pharmacy, nuclear medicine technology, the National Association for Cancer Patients, and the American Hospital Association voted unanimously to strongly recommend that the Commission revise its SRM, and that it be based on a valid risk analysis. Again, this has been completely ignored. The concept of general licensing was abandoned immediately by NRC without any public discussion at all. It appears to have been a ruse. At NRC request, a risk analysis was submitted to NRC by SNM/ACNP in final draft form in Dec., 1997 and in final form in Aug., 1998, but NRC now denies that appropriate risk data exist at all.

    The "partnership process" excluded one half of the "partnership". NRC appointed its own "Working Group" and "Steering Group", and excluded partnership control, or any control at all, by SNM or ACNP. The NRC also decided which concepts and regulations would be discussed publicly. Others were to be ignored. While the Nuclear Medicine community is free to comment, we have no power.

    Not unexpectedly, the resulting Proposed 10 CFR Part 35 resembles a confusing, alarming and unnecessary collection of proposed regulations, some of which were wisely avoided by a previous Commission, including astonishing requirements that would cause patient and staff morbidity and mortality. It is especially disturbing that nearly all of the proposed regulations are scientifically without valid basis. The Proposed Part 35 package restricts qualified nuclear medicine physicians from freely choosing among drugs for various patient conditions by limited procedure by procedure licensing. It restricts qualified nuclear pharmacists and physicians in the compounding of radiopharmaceuticals for patient use. It has an "emerging technology" clause which is undefined and may be used arbitrarily to restrict the use of any radiopharmaceutical, including radiobiologicals such as monoclonal antibodies. It has expanded a preposterous "misadministration" standard for therapy of ± 20% to include a ± 20% requirement for diagnosis as well. It has sneaked in a dangerous pregnancy rule and kept a terrible lactation rule. It plans to interfere with research. It invites reasons to remove the 500 mrem Patient Discharge Rule without data. It forbids nuclear medicine professionals from using established mathematics to calculate radioactivity, and demands measurements instead. It denies that appropriate data exist for a risk analysis and has spent our User Fee money to support a scientifically worthless poll by Scientech to evaluate radiation risk. This flawed poll appears clearly designed to provide a basis for unscientific claims, which might impact the Final Rule. The Proposed Part 35 decreases the requirements for Authorized User status in nuclear medicine by the ruse of NRC evaluation of draft specialty boards questions. The NRC has never demonstrated the medical expertise for such a task. This will result in more licensees, create more User Fees, but will further detract from the quality of nuclear medicine practiced in this country. The NRC is not even limiting boards to those recognized by the American Board of Medical Specialties. The Proposed Part 35 will deal the Agreement State Program a death blow, by demanding that every Agreement State adopt the essential portions of NRC's new Part 35 under threat of not only being "incompatible", but also "inadequate". This may cause states to give back their programs, forcing licensees to pay NRC instead of their states. The procedure requirements, recordkeeping requirements, and "inspectability" requirements have expanded, and patient privacy and confidentiality is ignored with a requirement to have NRC records of the patient's name, social security number, or hospital number for every dose, diagnostic and therapeutic, and with instructions concerning lactation precautions and personal behavior after receiving therapeutic radionuclides. Contrary to NRC claims, performance standards have not been substituted for prescriptive regulation. The coup de grace is an alarming reinterpretation of Section 104 of the AEA. NRC now proclaims that it has complete jurisdiction over all of nuclear medicine, and that the "minimal regulation" in the law only refers to the use of "special nuclear material". In addition, NRC conveniently "forgets" its transfer of responsibility for byproduct tracers for clinical and research use to FDA in 1975.

    NRC has now proclaimed dual regulatory privilege and superior regulatory power over 50 State Boards of Medicine and 50 of Pharmacy, the FDA, JCAHO, OPRR, OSHA, and professional medical quality assurance programs. It has ignored the Declaration of Helsinki, and imposed enormous cost, which HCFA refuses to reimburse. After the NAS-IOM Report, the Commission failed to prevent threatened employees from bending the truth to avoid regulating themselves out of jobs.

    We object to this work product in its entirety: the Proposed Rule, the Medical Policy Statement, the Licensing NUREG, the OMB Submission, the Regulatory Analysis, the SRM upon which the Proposed Rule was based, the constitution of the "Working Group", the constitution of the "Steering Group", the arbitrary limitation of items to be discussed, and the ludicrous NRC claim that this is a "partnership process" with "public participation". There may be no way to use this proposed rulemaking package for negotiation, because it is completely unacceptable as a starting point. NRC has failed scientifically and medically to substantiate almost everything in it. A one-year delay is needed to resolve these problems.

    We formally object to NRC's process as well as its product. Our more detailed criticisms of the rulemaking package follow, but we have also included some of the draft regulatory language that we want and deserve, based upon our own knowledge and the recommendations of the NAS-IOM. We have submitted this before, but NRC has not commented meaningfully upon our recommendation.

     

     

    SPECIFIC COMMENTS

    1. MEDICAL POLICY STATEMENT
      2.

      "1. The NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public."

      SNM and ACNP agree, provided "radionuclides" is changed to "source, by- product, and special nuclear material", and believe that this goal is adequately served by assuring substantial qualifications, including evidence of mastery, of basic nuclear and radiation sciences of those professionals involved in nuclear medicine. The standards of 10 CFR Part 20 apply here, and are sufficient. In accordance with NAS-IOM recommendations and 10 CFR Part 20.2301, the recordkeeping requirements should be removed virtually entirely. Nuclear medicine has been practiced in this country since 1936, and NRC has no evidence that qualified nuclear medicine professionals do not already adequately provide for the radiation safety of workers and the general public. As has been continually shown, all of nuclear medicine of reactor and accelerator origin, is low radiation risk to workers, members of the general public, and patients.

      "2. The NRC will not intrude into medical judgments affecting patients except as necessary to provide for radiation safety of workers and the general public."

      SNM and ACNP believe that this sentence should end with the word "judgments". The rest is unacceptable. We are already required to conduct our practices in accordance with the standards of 10 CFR Part 20. None of the medical judgments of qualified nuclear medicine professionals harm workers or members of the general public, but NRC is setting the stage for widespread, onerous, heavy handed control of medicine and pharmacy with this statement.

      "3. NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physician's directions."

      SNM and ACNP disagree vehemently with the NRC. This is the appropriate function of medically competent oversight groups, such as professional quality assurance programs, (e.g. ACNP Practice Audit Program), JCAHO, and State boards of Medicine and Pharmacy. NRC's disastrous foray into this area has been a contemptible failure, creating "sin" and "malpractice" where it did not exist, such as its ± 20% "misadministration" rule. At the meeting of the Organization of Agreement States in Oct., 1997, and the public meeting in Chicago in Nov., 1997, all of the representatives at both meetings voted unanimously to insist that NRC abandon its "Quality Management" and related rules. The NAS-IOM strongly recommended the same, as have SNM, ACNP, other medical groups, and the OMB. NRC's own report showed the failure of the Quality Management rule to accomplish anything. Nevertheless, NRC is keeping this rule for therapy and essentially expanding it to include diagnosis.

      It is interesting that the word "primarily" did not exist in the 1/30/98 draft. What other areas of medical interference does NRC have in mind? It is quite apparent that NRC intends to control which drugs are used for which diseases. Given the lack of medical competence of the NRC, and the fact that such essentials of medical practice are already in the hands of appropriate regulators of drugs and medical and pharmacy practice, this is unacceptable in the extreme. Several near-deaths caused by NRC's drug restrictions in the 1987 10 CFR Part 35 resulted in NRC requesting a petition to remedy the situation. A petition worked on by both SNM/ACNP and NRC, submitted in 1989, had 496 comment letters, all but about three in support of the Radiopharmacy Rule. NRC is proposing to take this rule away by licensing, and this must stop.

      Section 104 of the AEA is clear about the minimization of NRC intrusion into medicine. While NRC Office of General Counsel has recently argued that this section only compels NRC to minimally regulate the medical use of special nuclear material (e.g. uranium, thorium, plutonium), we disagree with this recently spin-doctored interpretation of the law. Uranium, thorium, and plutonium have never been used as treatments for patients in nuclear medicine. It would be preposterous to imagine that the Congress sought to deregulate something non-existent and dangerous, but maximally regulate very low risk nuclear medicine instead. The "special nuclear material" alluded to in this section of the AEA is the reactor fuel needed to make radionuclides for nuclear medicine use. All medical uses of the resulting radionuclides were included for minimal regulation. NRC's Medical Policy should come from Section 104 of the AEA, as interpreted by the mainstream of nuclear professionals, knowledgeable lawyers, the Congress, the Atomic Energy Commission, and the NRC itself for 40 years.

      "4. The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety."

      We believe that this statement does not belong in a Policy Statement, and in any case, NRC has always said this and always ignored it. NRC should not make any regulations or license requirements out of industry or professional standards. Rather, it should recognize that these standards exist to be implemented by other appropriate oversight bodies, and that therefore NRC is not needed and has no place here at all. For example, USP writes standards for radiopharmaceutical quality. These are enforced for manufacturers by FDA, and for physicians and pharmacists by State boards of Medicine and Pharmacy, with FDA as a "safety net" regulator. NRC has no business or competence here at all, and should not try to make regulations out of USP standards, which NRC has nevertheless done, and done very badly. For example, NRC uses the USP standard for a target molybdenum/technetium-99m generator. Such generators have not been used in the United States for several decades, and their USP standards are not appropriate to the generators we have been using. In addition, the appropriate USP standards apply to the manufacturers only, which answer to FDA. The purchaser of the generator does not have to prove that the generator meets USP standards, any more than a pharmacist or a physician has to weigh aspirin tablets to make sure that each weights 325 mg.

    2. RISK ANALYSIS AND RELATIVE RISK
      3.

      All of nuclear medicine is low risk, both absolute and relative. In its 21 July 98 SRM, the Commission finally understood that radioiodine therapy, the highest risk of our low risk procedures, is also low risk. This should have set the stage for the deregulation of nuclear medicine.

      Initially, the Commission required that a valid risk analysis be performed for all requirements. The staff refused to perform a risk analysis, complaining that it did not have "enough time". Existing risk analyses (by the NAS-IOM, NCRP, and SNM/ACNP) were ignored. At a meeting of the Working Group in late 1997, Kathy Haney announced that NRC would use its "best hunches" instead. The final rulemaking package claims that it is "risk-informed", but this defies credibility. No risk analysis was done for anything. At the Agreement States meeting in October, 1997, Don Cool asked SNM/ACNP to submit a risk analysis that could be used by NRC. This was done. Why was it not used?

      On p. 43583 of the Federal Register article, NRC commits the startling act of denying that appropriate data for risk analysis exists at all, and further states that even if data for relative risk were available, it could not be used because the AEA requires the use of absolute risk. While NRC's contorted argument is fundamentally illogical---nothing in the AEA prevents NRC from using relative risk--- the logical conclusion to NRC's weak claim that it cannot use relative risk is that it must deregulate medicine completely. Medicine is, after all, an exercise in relative risk.

      We start with sick or injured patients; this is the baseline risk. The object is to improve the patient's outcome (assuming that nothing were to be done) by using procedures with appropriate risk relative to the baseline risk. The object is an improved outcome. Very high-risk procedures are perfectly reasonable with very high baseline risk. That is medicine.

      If NRC cannot play in the relative risk arena, it must leave medicine. The only way to remove all risk from medical procedures is to stop doing all the procedures. This is "regulation by obliteration", and appears to be the goal of some of NRC's employees.

      NRC's actual statement is as follows:

      "The Commission (as well as others, such as NAS and ACMUI) has recognized the lack of acceptable data to compare the risks from medical use of byproduct material with risks in other medical modalities. In the absence of acceptable data, regulation on the basis of "comparable risk" would be regulation to an inadequately understood level of risk. In addition, there is not an expressed authorization in the AEA to regulate any use of byproduct material on the basis of an insufficiently known "comparable risk". Without acceptable data or an express statutory authorization, justifying the significant departure from the Commission's established policy with respect to risk to patients would be, at a minimum, problematic."

      Well, problematic though it may be, NRC needs to embrace it. What do we call it when NRC removes Part 20 standards in emergency situations (10 CFR Part 20.2) and recommends no more than 50 rem to workers during that emergency? Sounds like a Commission policy of "relative risk", doesn't it?

      We also call the Commission's attention to a section of the Federal Register article, p. 43527(G)(1)(b). This section appears to have been added after the Commission and the ACMUI reviewed the original rulemaking package. The section alludes to a "study" on risk being performed by NRC. This appears to be a study contracted out to Scientech, Inc. This "study" is not a scientifically valid study at all. It is a "touchy-feely", "Do you still beat your wife?"- type questionnaire, or poll, put out on the internet, asking the public how it "feels" about radiation risk to members of the public and to radiation workers. It is obviously constructed to produce material to be used in the production of unscientific anti-nuclear medicine claims. The second part of this "study" is a scientifically valueless questionnaire for Agreement State regulators, the purpose of which appears also to provide material for unscientific claims. The Scientech "study" is not an example of mere NRC lack of scientific competence. It appears purposeful and calculated, funded by the misallocation of User Fee money.

      We ask that the Chairman direct the Inspector-General to investigate all NRC personnel responsible for the Scientech "study" and its interpretation.

      In its earlier comments to the Commission on this Proposed Rulemaking, ACNP and SNM strongly recommended that NRC use the final report of the Presidential/Congressional Commission on Risk Assessment and Risk Management for its analysis. The report is entitled, "Risk Assessment and Risk Management in Regulatory Decision-Making". There is a companion report entitled "Framework for Environmental Health Risk Management", and a summary entitled "A Public Health Approach to Environmental Protection". All three documents were published in 1997. NRC has not used the information in these documents, and has not even alluded to them in this Federal Register article. We believe that their use is the appropriate way to perform a risk analysis, and we ask to Commission to explain why it was not used.

    3. PERFORMANCE STANDARDS
      4.

      NRC states repeatedly that the proposed rule is "performance based". This is untrue. The NRC has taken precise prescriptive regulation and substituted vague prescriptive regulation. Because licensees are free to write their own procedures, and NRC will not review these procedures before issuing a license, NRC erroneously call this "performance based". However, in the event of a mistake, NRC inspectors will review the procedures to see if they are "adequate". "Adequacy", according to Joseph Delmedico of the Office of Enforcement on 10/21/98 at a NRC public meeting, is that it is comparable to the model procedures in NUREG-1556 Vol. 9. This will result in massive disagreement over "adequacy", huge costs, and probably lawsuits. This is certainly not an improvement. It is worse than before.

      NRC's model procedures in NUREG-1556 Vol. 9 are unacceptably poor; it would be difficult to ever practice nuclear medicine at all complying with these procedures. However, there is no guarantee that NRC will accept an alternative, and it will not be approved at the time of licensing. Alternate procedures will be seen only by an inspector not qualified to practice nuclear medicine. This is unacceptably risky.

      If, as NRC repeatedly states, licensees may have the flexibility to write their own procedures, then NRC must realize that there are many acceptable procedures to accomplish a specified goal. Why should a licensee be forced to pick one and only use that one? Why couldn't a licensee use any of a large number of procedures, as long as the performance standard is met? If the NRC truly doesn't care which procedure a licensee uses, it should not care if a licensee uses many.

      These procedures become prescriptive requirements.

      We want no prescriptive requirements or prescriptive regulations at all, precise or vague.

      We want performance standards.

    4. PUBLIC PARTICIPATION
      5.

      Despite the repeated claims by NRC that this rulemaking provided for much more public and professional input than usual, virtually none of the important recommendations of the nuclear medicine professionals were heeded. The concept of "professional participation" is purely for show.

      The NRC Commissioners convinced the nuclear medicine community to help reform NRC's regulations as a "partnership process". Then, when we accepted, we were effectively removed from the entire endeavor. Not one representative from ACNP (or SNM) were on either the "Working Group" or the "Steering Group". On p. 43581 of the Federal Register, NRC states that the meetings and workshops with the nuclear medicine community "…were not designed to seek "consensus" in the sense that there is agreement on how each issue should be resolved…".

      What then, is a "partnership process", if not to establish "consensus"?

    5. UNACCEPTABLY SHORT COMMENT PERIOD
      6.

      We are used to getting 90-120 days to comment on a new rule; longer for licensing guides. This rulemaking is over 100 new rules, license conditions, model procedures with hidden requirements, and interpretations of rules, licensing conditions, and model procedures with hidden requirements. We would need at least a year for commenting on anything this massive. The NRC is trying to railroad through a huge regulatory package---over 800 pages. This is foolish and dangerous for the nation's patients and healthcare providers.

      The added insult of announcing on 16 Sept. 98 that a new regulatory guide for broad licensees is available, with comments due by 7 Dec. 98; makes the public review process a sham. It also leads us to question the NRC internal review process. We sincerely doubt that very many individuals at NRC have read this entire package carefully, and that this is the reason for questionable material which appeared in the final document. It also helps to explain the very poor quality of the technical work, although it is questionable whether more time would have improved it very much.

      We ask that the entire rulemaking package---Medical Policy Statement, Proposed Rule, NUREG-1556 (9), the OMB submission (7590-01-p), and the Regulatory Analysis---be retracted to correct inaccuracies and permit time for revision of problematic issues.

    6. UNACCEPTABLE VAGUENESS
      7.

      Precise regulation and licensing requirements may be debated pro and con because one knows what they mean.

      Vague regulation and licensing requirements cannot be adequately debated because their interpretation is unknown. Vagueness itself is a reason to condemn a rule or requirement for the very reason that it cannot be understood.

      As an example, let us take 35.1000. Why is it here? It appears to limit us in excess of sections D and E. The proposed license requirements negate the rights of 35.300 under Subpart E. What is going on? This seems to say that NRC will ordinarily not allow unlabeled indications except perhaps for broad licensees, and possibly only as research. This is not only vague and confusing, but appears to be dangerous and will negatively impact the delivery of high quality healthcare. This is the opposite of the NRC's stated intention.

      As another example, what is an "emerging technology"? NRC tried several years ago to call monoclonal antibodies new and dangerous. While it is completely inappropriate to call monoclonal antibodies an "emerging technology", or new, or dangerous, will NRC try to do so and limit their use? We do not know what NRC will do or what this phrase means.

    7. "GRANDFATHERING" OF NUCLEAR MEDICINE AND NUCLEAR PHARMACY COMMENTS, LETTERS, TRANSCRIPTS, MEETINGS, ETC. SINCE 1985

      One of the most frustrating aspects of this rulemaking is that we have been saying the same things over and over again to NRC since 1985. By judiciously keeping the Commissioners ignorant of history, NRC staff wastes our valuable time. Numerous cubic meters of material have been sent to NRC since 1985 pertaining to all aspects of this rulemaking.

      We insist that all of nuclear medicine and nuclear pharmacy comments, letters, transcripts and minutes of meetings be "grandfathered" as comments for this rulemaking. We are not prepared to waste our valuable time continually repeating ourselves.

    8. AGREEMENT STATE ADEQUACY AND COMPATIBILITY REQUIREMENTS

      We reject nearly all of NRC's plan on Agreement State adequacy and compatibility. The practices of medicine and pharmacy do not have "transboundary implications", and should be changed from "B" to "D". These are state functions. All category "C" items should be changed to "D" because they are too restrictive.

      All "Health and Safety" (H and S) requirements for adequacy should be removed because they are not necessary for "Health and Safety". "Health and Safety" is accomplished by starting with qualified professionals who follow professional standards.

      Despite the NRC's contention otherwise, there is no State in the United States in which citizens are inadequately protected from the hazards of byproduct material.

    9. OMB ESTIMATE

      The OMB estimate is severely flawed, grossly underestimating the costs of nuclear medicine compliance by conveniently omitting numerous big ticket items. These include writing procedures for everything one could possibly imagine doing in such a way as to outwit NRC inspection and enforcement police, an entirely separate and new recordkeeping mechanism for administered doses that maintains patient confidentiality, the huge costs of writing procedures because NRC's model procedures are useless, increased legal costs, increased amendment costs, costs from discarded diagnostic doses, etc. Hundreds of millions of dollars are "missing" from this estimate.

      HCFA has decided not to pay for any of these regulatory costs. HCFA is correct---they have no added value to healthcare. However, HCFA needs to convince Congress to cut the costs, by eliminating unnecessary regulations and requirements, or Chairman Jackson needs to convince HCFA to pay for them. The government can't have it both ways without regulating much of nuclear medicine out of existence.

    10. QUALIFICATIONS FOR PHYSICIANS

      11. We firmly believe that NRC should limit its requirements for physicians to those necessary for expertise in radiation safety. We believe that these qualifications must be substantial and comprehensive, as the physician must not only handle radioactive material, but also supervise and instruct others in safe procedures for their handling of radioactive material as well. Often, the physician is the Radiation Safety Officer, and is broadly responsible for all radiation activities at his institution. Compliance with 10 CFR Part 20 requires substantial knowledge of basic nuclear and radiation science.

      Physicians need to be knowledgeable enough to handle misshipments of incorrect radionuclides and incorrect quantities, accidents involving spills of radioactive material, mistakes involving the administration of radioactive material to the wrong patient, mistakes involving the wrong radioactive material given to the correct patient, the overall management of radioactive material in their practice, and the supervision of technologists and others. We disagree with NRC's implied concept of "proportional" radiation safety. That is, the fewer the procedures one does the less one needs to know about radiation safety. While one needs less clinical knowledge and experience if one performs few rather than many different procedures, the basic nuclear and radiation science knowledge needed for radiation safety is the same. For example, it doesn't matter whether one uses the radioactive decay equation for one radionuclide or ten. It takes the same time to learn it.

      We fear that the Proposed Part 35 will cause NRC to define "competence" at such a low level that the quality of physicians licensed to use byproduct material will be even lower than it is now. At present, we feel that a substantial proportion of physicians licensed by NRC do not possess adequate levels of working knowledge of basic nuclear and radiation sciences, but judgments of their competence seem nevertheless to be made by NRC employees who themselves lack the level of basic nuclear and radiation science competence needed to appropriately and safely practice nuclear medicine. Furthermore, the NRC has a conflict of interest, and will act in such a manner as to bring in increased User Fees, even if it licenses physicians with questionable qualifications. We therefore believe that the assessment of specialty boards questions needs to be made by a separate group with respected standards for nuclear medicine, not NRC with lack of competence and obvious conflict of interest. In addition, we insist that the JCAHO standard of using only ABMS approved boards should be very seriously considered by NRC. Otherwise, the whole mechanism breaks down, as there is no limit to how low the standard can sink.

      We also firmly believe that substantial and comprehensive medical qualifications to practice nuclear medicine need to be enforced by medical groups such as JCAHO, Practice Privilege Committees, and State Boards of Medicine. NRC should make it clear in writing that it expects these qualifications to come from and be enforced by the medical sector, and that NRC licensure is a measure of radiation safety training and should never be used as an indication of medical competence.

      For comparison, it is instructive to look at the situation in Canada. In that country, all nuclear medicine procedures are performed by physicians who are board certified in nuclear medicine. This is accomplished by denying payment for nuclear medicine services to any physician not board certified in this specialty. Due to the cheapening of qualifications for licensure by NRC, the odds of an American having a nuclear medicine procedure performed by a physician board certified in nuclear medicine is now less than 1 in 5. The "Balkanization" of nuclear medicine in order to optimize User Fee income is destroying nuclear medicine as a specialty and bodes ill for patient care.

    11. PROCEDURE OVERLOAD
      12.

      Once NRC has made the determination that a physician is competent to handle radioactive material safely, the regulations and requirements must reflect that determination of competence. Instead, the present and proposed regulations assume virtually no competence at all. No written procedures of any kind need to be submitted to NRC for review or need to be "promised" for later review, and no procedures should be license conditions. This goes for diagnostic procedures, therapy procedures, laboratory procedures, procedures for checking packages, procedures for monitoring work areas, procedures for patient identification, etc. What we need, and what we have stated repeatedly for over a decade, is a performance standard. As long as NRC cannot show that public dose limits, worker dose limits, or environmental limits are exceeded, and after 62 years of our specialty, NRC cannot show any such valid data at all, the NRC should be content to leave oversight of the practice of nuclear medicine and nuclear pharmacy to the appropriate medical and pharmacy professionals.

      For example, a diagnostic procedure manual is a general guide written by the Authorized User Physician to his/her technologists. It will be departed from frequently, as patients differ, practice parameters change and resources change, and the manner in which a procedure manual is to be interpreted is between the physician and the technologist. It is an internal document, and by nature incomplete, as procedures are infinitely variable. The "control freak" mentality with which NRC proposes to rigidly hold us to our diagnostic procedure manual tells us much about the lack of medical expertise of NRC. The only effective purpose of the proposed manual really is to give NRC a tool with which to abuse doctors. It will not improve patient care or radiation safety. A deviation from the manual by NRC thinking is a "violation". NRC has no ability to comment in any valuable way about the medical quality of the procedures themselves, and never has. NRC has no valid evidence that any of these procedures is a danger to workers or the general public. NRC will merely keep an army of bureaucrats busy pretending to review procedures which are none of NRC's business, and apparently intends to license physicians procedure by procedure, and drug by drug. This is not only an abuse of the NRC's duties and the AEA of 1954, but is also scientifically and medically absurd, horribly time consuming for the person writing the procedures, and of no earthly value. It is dangerous to patients, and will produce a mindless NRC bureaucracy of paper pushing personnel which costs hundreds of millions of dollars in compliance costs to support. The cost is not in User Fees, so much as in the non-reimbursed cost in valuable hours to produce all the paper NRC craves to keep its paper people looking busy, be they licensing people or inspectors. All the procedure manual requirements in the Proposed Part 35 draft should be omitted.

      NRC's "procedure mania" appears to have come from the dominance of NRC's nuclear navy mentality, in which every activity is prescriptively carved in stone in a couple of procedure manuals. We do not presume to pass judgment on the running of the nuclear navy, but we will say that it has nothing of value to pass on to the practices of medicine and pharmacy. The NRC does not understand the differences between the rigidity of mechanical systems and the wide normal variations inherent in biological systems. No other field of medicine is cursed with procedure mania, and no other field of medicine is safer than nuclear medicine. We categorically reject the notion that NRC has any need for us to produce or comply with written procedures, so long as only qualified physicians are permitted to handle or supervise the handling of radioactive material in the first place. That many of us will continue to have internal procedures for other purposes is the business of medical professionals, not NRC.

    12. RECORDKEEPING
      13.

      The exhaustive record-keeping requirements of NRC, like "procedure overload", serve no legitimate safety purpose. What national database is being built, and for what scientifically appropriate reason? What is the question being asked, and how will these data be analyzed to answer it? Will the answer be important? What will it lead to? There are no acceptable answers to these questions, because there is no legitimate purpose to this excessive record keeping in the first place.

      The purpose of the proposed record keeping appears to be to produce massive quantities of meaningless paper for swarms of NRC inspectors to inspect. NRC will insist to OMB every time that this is the only way NRC can assure compliance with its requirements.

      In fact, the only valid way to assure compliance is to inspect process. A competent inspector will watch worker technique, observe the types of radiation monitoring equipment on hand, and observe certain facilities, such as a place for storage to decay. Very few pieces of paper are needed to know whether a facility is using radioactive material safely. That is, if the inspector is competent. Most of NRC's inspectors are graduates of a 5-week crash course in how to be a radiation inspector, and lack the scientific background, intrinsic education, training, and experience to infer compliance by observing process. Their job has therefore been reduced to the inspection of paper, and creating and filing this paper in an immediately retrievable manner costs us many millions of dollars a year with no demonstrable benefit in improved patient care or radiation safety of the public or of workers. All states already require certain records from practitioners of medicine and pharmacy.

      ACNP-CA, therefore, recommends that all record-keeping requirements be removed except: (1) documentation of worker overdoses, (2) documentation of general public overdoses, (3) documentation of exceeding the environmental standards of Part 20, (4) documentation of leaky commercially available sealed sources. Recording of patient doses is a JCAHO requirement, and NRC need not dual regulate here. The total national yearly record-keeping for nuclear medicine would effectively be reduced to a few pages, but that is all that would be necessary to record. After all, hazard is seldom involved. The standards are set so conservatively that even substantial noncompliance does not result in true hazard.

    13. THE QUALITY MANAGEMENT (Q/M) RULE REMAINS, FOR THERAPY AND NOW IN ESSENCE FOR DIAGNOSIS
      14.

      Despite an NRC report documenting the failure of the Q/M rule to accomplish anything, despite the extreme opposition to this rule by ACNP, SNM, ACR, the ACMUI twice, the NAS-IOM, the OMB, the Agreement States, and all representatives at the Chicago public meeting on this rulemaking, NRC has not only kept it in with some cosmetic change, but by a combination of regulation and license condition, imposed it on diagnosis as well. This is absolutely unacceptable, will be terribly destructive to the practice of diagnostic nuclear medicine, and is nonsensical. We oppose the Q/M rule for therapy and diagnosis.

      California has never accepted NRC's Q/M rule. There has been one nuclear medicine therapy "misadministration" in the past 6 years, and the physician was not board certified in nuclear medicine. This record is so superior to NRC's record that NRC needs to learn from California.

      When did the Commission order a Q/M rule for diagnosis? Why was it never discussed in the public meetings? Why was it not presented to the ACMUI for their consideration? Why was it not in the 1/30/98 draft? Where is NRC's risk analysis? Why this ugly stealth? We would like to remind NRC that in the ACNP/SNM lawsuit against the Q/M rule, NRC testified that it would not be applied to diagnosis. Has NRC forgotten?

    14. PATIENT NOTIFICATION
      15.

      The standard of medical practice is to inform patients as appropriate. This professional standard should substitute for NRC's Patient Notification rule. We reject NRC's requirement and we also reject NRC's analysis of the AMA Guidelines; AMA itself rejected this when NRC's analysis first appeared in 1994.

      NRC's notification rule would force physicians to "lie" to patients, indicating that a mistake has happened and that they got the "wrong" amount of a radiopharmaceutical when they merely exceeded an arbitrary ± 20% window for dosage. This is outrageous for nuclear medicine (we are not addressing radiation oncology here). The physician should decide the range permitted, which may well differ for different patients, and should not tell the patient of a "mistake" unless the physician's range was not adhered to and harm can be expected as a result. When two physicians, treating the same Graves' disease patient, can vary their prescriptions by 600%, or by 1000% for an I-131 metastatic survey, a ± 20% window is absurd.

    15. PATIENT DISCHARGE RULE
      16.

      With no scientifically valid database for back up, the Commission has requested comments on the 500-mrem Patient Discharge rule. There seems to be a collaboration with The Conference of Radiation Control Program Directors (CRCPD) who do not know how to regulate patient contamination in sanitary landfills and object to going out when radiation meters set near background are triggered.

      This represents a failure of CRCPD and a failure of NRC, because patient contamination has always gone to sanitary landfills, is not hazardous, and can be "cured" by setting the thresholds higher. However, NRC will not write standards, nor will CRCPD, and it is every state for itself.

      California does not have a serious problem with contamination due to the Patient Discharge Rule (the California version) and Los Angeles County Radiologic Health has had no problem at all. However, in California, the 500 mrem Patient Discharge Rule is only for those physicians who understand the physics and will counsel their patients in radiation protection.

      Perhaps that is the secret. Smart doctors and smart regulators mean that there is no problem and large cost savings. So, we wish to keep the 500 mrem rule, California-style.

      Managed care organizations which try to disallow payment for appropriate hospitalization of radionuclide therapy patients need to be "educated" by the regulated community and the State Radiological Health entity. This is not a significant problem, and is not a valid reason to remove the rule.

    16. PREGNANCY AND LACTATION
      17.

      This Proposed Part 35 has slipped in a new requirement concerning pregnancy that a previous, wiser Commission avoided. The ACMUI recommended against it as well. While the comments of ACMUI members are on the public record, the essentials of the arguments are as follows:

      The overwhelming majority of nuclear medicine procedures are safe to perform on pregnant patients. In fact, they are often the tests of choice, as other radiologic procedures frequently involve higher radiation doses. In the limited situations in which it is important to avoid giving a radiopharmaceutical to a pregnant woman, usually involving NaI-131, pregnancy information is ascertained in a careful manner. Usually, this involves a pregnancy test. However, this costs money. If a woman has had a hysterectomy, why should she pay for a pregnancy test? If a nun swears chastity, why should she? So occasionally, a pregnancy test is not done, almost always, for good reason.

      Once in a great while, a patient lies or is misinformed, refusing a pregnancy test and denying the possibility of pregnancy, only to be found to be pregnant later, after the administration of NaI-131. In a very rare event like this, the mother is counseled that the baby may be born without a normal thyroid and therefore be on one synthroid pill a day for life. As spontaneous congenital absence of a functioning thyroid is common, we know that such babies on thyroid hormone replacement for life are perfectly normal otherwise.

      This is a complex medical situation, and involves the state of pregnancy, the personal ethics of abortion, and the possibility that under certain circumstances it may be necessary to knowingly harm the baby to treat the mother. This is all none of NRC's business; it is the essence of a very private patient-physician relationship.

      NRC is now making it effectively mandatory to get a pregnancy test on every woman of childbearing age before performing many nuclear medicine procedures, diagnostic as well as therapeutic. As a urine test is not as sensitive as a blood test, a blood test will be done. It may take one or several days to get the results, and the results may be unexpected and bear repeating. Necessary nuclear medicine tests will be held up for one or more days. Patients will refuse to pay for the pregnancy tests. Physicians will refuse to do the nuclear medicine procedures. As the blood pregnancy test will be negative in early pregnancy, it is still possible to have a pregnant patient without knowing it.

      The bottom line will be that some women of childbearing age will be denied care or get alternative radiology procedures that have more radiation dose than a nuclear medicine procedure, if that alternative is available, and even if it costs more. Many physicians, all too aware of the vicious misrepresentation of events by NRC, and huge costs of NRC-inspired inspections and lawsuits, will simply refuse to perform any nuclear medicine procedures on women of childbearing age, period. Many women will not have diseases recognized in time, or will be treated for diseases they do not have because documentation of absence of that disease was not available. Some will suffer permanent disability. Some will die. The Commissioners of NRC will be at fault.

      Lack of adequate data make it virtually impossible to accurately calculate radiation doses to embryos and fetuses at various gestational periods from various radiopharmaceuticals. "Conservative" calculations can be gamed to achieve doses of 500 mrem or more quite easily, the dose limit in NRC's rule. Given the fact that 500 mrem is not a "hazard"---this is somewhat less than the yearly background rate in Denver, CO---this NRC requirement will only cause hysteria. Why doesn't the NRC recognize the potential to create needless hysteria?

      We have been told that the pregnancy rule had to be inserted into the new Part 35 because of the latest set of "Abnormal Occurrence" (AO) criteria by which

      NRC chooses to report events to Congress. It is not Congress that sets out AO criteria, it is NRC. The most recent set of AO criteria was not approved by the ACMUI. The same staff who tried in vain to make a pregnancy rule in previous years helped put it in the AO Criteria, thereby creating this byzantine situation of regulatory complexity.

      The simple solution is to throw out the pregnancy rule and the AO criteria, and only report radiation-induced injuries and deaths from radiopharmaceuticals and radiologic devices that were due to accidents and that were NOT reportable to FDA. There has been one such event involving a radiopharmaceutical in the United States in the past 62 years, and over 300,000,000 non-events. The NRC should stop disguising its reactor problems by inventing medical "problems" for the Congress. That would be a good thing.

      The Lactation Rule is a similar situation, but it was sneaked into another rule in January, 1997. It was piggybacked onto an unrelated rule regarding patient discharge after radiopharmaceutical administration. It was based on one incident involving a patient who was a nurse who hid both her pregnancy and her lactation from her physicians. The lack of good faith behavior of the NRC regarding this rule has been completely covered in public documents submitted by NRC's medical consultant on that case. The Lactation Rule needs to be exorcised along with the pregnancy rule.

      The standard of medical practice adequately covers situations of pregnancy and lactation, as it is even more important to other areas of medicine with drugs that create real hazard. NRC should not regulate in these areas at all.

      The other point, of course, is that NRC regulation in this area does no good. It has no national value. NRC simply publicly punishes mothers and physicians. By identifying the licensee and the approximate date, patient confidentiality is blown.

    17. MEDICAL RESEARCH
      18.

      In 1975, the NRC relinquished radiopharmaceutical drug review for byproduct material to the FDA. NRC also relieved itself of oversight of drug research for eventual drug approval, and research with byproduct tracers for non-drug-approval purposes, such as basic biochemistry and physiology research. The human research with investigational drugs went under FDA requirements, and the tracer research for non-drug approval required new FDA regulation (21 CFR 361.1).

      About 15 years later, NRC bureaucrats decided to regulate this research again, creating more regulatory work for themselves of a completely dual regulatory nature. There is no need for any NRC involvement in nuclear medicine research. Between the FDA and the Office of Protection from Research Risks (OPRR), both under the Department of Health and Human Services, we have all the regulation we need, and more.

      In this Proposed Part 35, NRC tries to take research that is not regulated under the Federal Policy for the Protection of Human Subjects for itself. However, FDA is not a signatory of the Federal Policy; it has its own, similar requirements. The draft as it stands thus has dual regulation by NRC and FDA. As NRC doesn't even understand any of this, and as the FDA/OPRR duo controls all of our research, it is time NRC disappeared once more, as it did in 1975.

      All the present Commissioners were sent a copy of the 17-page 1975 Federal Register article chronicling FDA "lifting its exemption" for byproduct material (upon insistence by NRC). It was NRC's plan to then end the medical program. After all, FDA had received statutory authority over radiation-producing machines in 1968, and board certification for nuclear medicine occurred in 1972, and it was felt that by giving byproduct radiopharmaceuticals and tracers to FDA, that NRC no longer had a unique role.

      That was the last time NRC made any sense on this issue. Twenty years later, the NAS-IOM said the same thing. We'll say it again now. NRC's medical program has no unique function, and should no longer exist. It is not only dual-regulatory, it is dangerous.

      In this Proposed Part 35, under section 35.6, provisions for research involving human subjects, NRC states (p. 43529): "…the Commission is soliciting comments on whether this section should be revised to require that licensees develop, implement, and maintain procedures for evaluating when a medical procedure would be considered to be a research procedure". Such ignorance on the part of the Commission is astonishing. Medical procedures are primarily performed for the patient, and may include established, new, or untried approaches. Research procedures are done for the primary purpose of collecting scientific information and may also include established, new, or untried approaches. It is primary intent that distinguishes them. Medical institutions and government agencies other than the NRC already have sufficient controls over medical research, including the use of ionizing radiation.

      What is really going on here? Has NRC staff arranged to get an opinion from an FDA employee that unapproved drugs and unlabeled indications are called "investigational" by FDA, are therefore "research", and doing such procedures requires IRB approval, consent forms, and of course, no reimbursement? This is not so far-fetched, considering that an FDA employee tried recently to accomplish this for PET radiopharmaceuticals, and was, in the end, overturned by Commissioner David Kessler after being approached by an angry Senator. Considering that this FDA employee is married to an NRC employee working on the new Part 35, it is worrisome. NRC is now using a claim of possible radiation hazard by FDA to forbid intravascular radiation therapy with byproduct material, even though this is rapidly becoming the standard of practice in outstanding radiation therapy departments. Patients deprived of this procedure may suffer myocardial infarctions or leg amputations. What is NRC doing? It is evident that the Commission has not read the Declaration of Helsinki. Article II (1) states, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health, or alleviating suffering."

      The United States honors the Declaration of Helsinki for research and for clinical care, and NRC is therefore expected to comply as well.

    18. FORBIDDEN MATHEMATICS
      19.

      Proposed 35.63(c) says that dosage must be determined by direct measurement or a combination of measurement and calculations. This situation is completely inappropriate. Often only mathematics is needed.

      The rationale is simple, really. The inspectors, as well as the staff and management, do not fully understand the mathematics of radioactive decay, of radiopharmacokinetics, of internal dosimetry, of external dosimetry, of generator elution, or of basic statistical analysis. Having avoided math whenever possible, and having actually published statistical nonsense (e.g. in the sampling method for the Q/M Rule), radiopharmacokinetic junk (Reg. Guide 8.39, now Appendix U), and external dosimetry showing inability to use time, distance, and shielding correctly (the Indiana, PA accident), NRC has apparently decided to stop being criticized for incompetence and disallow as much math as possible. This is fascinating, because in draft 35.292(b)(1)(iii), NRC requires physicians to learn "mathematics pertaining to the use and measurement of radioactivity". That is, we must learn math, but we may not use it fully because the inspectors are not smart enough to keep up with us.

      Another example concerns NRC's request for comments on whether radiopharmaceutical therapy patients must have private rooms and baths. If NRC could do the dose calculations, it would not ask such an unnecessary question. If we assume two thyroid cancer patients in a room together, each receiving 200 mCi I-131, 2 meters a part, for 48 hours, occupancy factor 1.0, with a 1% I-131 uptake in the residual thyroid and a 12 hr. halflife for renal clearance, then using the corrections for shielding and line source (Sparks RB, Siegel JA, Wahl RL. Health Physics 75 (4): 385-388, 1998), the radiation absorbed dose from Patient A to Patient B is about 85 mrem ede. The radiation absorbed dose from Patient A to himself is about 385,000 mrem ede. Regardless of the fact that NRC has not done any risk analysis, and has denied the use of "relative risk" in its entirety as being against the AEA, the answer to a competent professional is that of course two therapy patients can be together. One could even justify the company of a non-therapy patient.

      Another example is limits, in dpm/100 cm2 of removable contamination. First, the whole concept of numerical limits is flawed, and the old 2000 dpm/100 cm2 for all radionuclides except I-131, which was 200, is already arbitrary and capricious. Only radiation absorbed dose matters. However, without a shred of scientific justification, NRC lowers the 2000 to 1000, keeps the 200 for I-131, and makes a limit of 20dpm/100 cm2 for I-125. Radiation absorbed dose from such levels of I-125 are absurdly miniscule. We do not even have equipment that can detect this. Background in a NaI (Tl) system at the I-125 setting is commonly about 30 cpm, and in a typical liquid scintillation counter is about 35 cpm. Efficiency for a NaI (Tl) bioassay system is about 1%.

      NRC's thyroid bioassay requirements for NaI-131 are outdated and unnecessary. All commercial products are stabilized against volatility, and have been so for over 10 years. NRC has been sent the full scientific database at least three times showing extremely low volatility. Why cannot NRC understand and use these data? In California, thyroid bioassay is not required when using stabilized products.

      The Commission needs to be concerned about the apparent lack of technical expertise among its staff and management. Its medical expertise is even worse. The requirement in Appendix X to remove the sharps from the sharps box to avoid any shielding is a massive OSHA violation. It could, for example, kill workers from hepatitis B or C, or AIDS.

    19. DOSE CALIBRATORS
      20.

      Nuclear medicine in its present form began in 1936, with accelerator-produced radiopharmaceuticals. During the Second World War, the secret reactor built at Oak Ridge sent medical isotopes to Berkeley, and they were then distributed as though they were accelerator produced. After the war, reactors were built all over the nation, and many medical schools used their own for radionuclide production. "Dose calibrators", which are simply ion chambers with variable potentiometers, made it easier to determine the activity of various radionuclides because of the ease of building in, or dialing in, calibration factors. We in nuclear medicine did without "dose calibrators" for 35 years (we used math and physics and other radiation detectors), and many did not use the first "dose calibrator" models, which were not sophisticated instruments. NRC's regulators still do not really understand how modern (silicon chip, not vacuum tube) dose calibrators work, or their calibration needs. NRC does not, and has not, even understood that the accuracy needed depends on the procedure, not the state of the art of technology, at any cost. The accuracy needed is up to the physician. If the accuracy of a medical procedure requires knowing the administered activity of a radiopharmaceutical ± 30%, why worry about accuracy of ± 5% or 10% which will require NIST-traceable calibration sources at significant expense?

      No qualified nuclear medicine physician ever prescribed " 1 teaspoonful of Tc-99-radiopharmaceutical". We have ways of estimating activity within the needed accuracy.

      NRC should omit all dose calibrator requirements, and all requirements to tell it how we ascertain activity. NRC determines that we are competent; after that it should omit such elementary considerations from its regulations altogether. "Dose calibrator fixation" is another source of volumes of paper for NRC inspectors to inspect. Why? It has no effect on basic radiation safety. The dose recorded does not necessarily match the dose administered. If the physician knows that the difference is unimportant, why is NRC concerned?

    20. SEALED SOURCES, SOLID SOURCES, LEAK TESTING
      21.

      The construction of certain types of sealed sources can fail and the sources can leak. Solid sources, such as dry radionuclides embedded in acrylic, cannot leak. There is no reason to leak test them. It is a waste of time and money. Although NRC's unyielding fixation of leak testing creates huge amounts of paper for inspectors to inspect, it is an obvious example of overregulation in nuclear medicine. Exempt solid sources.

      How many nuclear medicine sources have leaked over the last 20 years? If any have, has radiation dose to anyone been significant? What is the fuss about? If we find a leaky commercial source, we should notify the manufacturer, who will contact others who have that source to make sure the others do not leak. The manufacturers report these defects to FDA Center for Devices and Radiologic Health. Of what value is NRC here? Such information, on RADSAFE, will reach the whole country (and other countries) in one day. What does NRC do with the information that the licensee, the manufacturer, and the FDA haven't done already?

    21. MOLYBDENUM BREAKTHROUGH

      22. NRC should remove itself completely from issues of radiopharmaceutical quality control. This is safely in the hands of far more qualified groups, such as USP, FDA, and 50 State Boards of Pharmacy and of Medicine. Sec. 35.204 should be removed. NRC has no understanding of this area, and no one needs NRC to dual regulate those who do.

      The USP standards apply to those who manufacture generators. Those who use them need not show that USP standards are met, as FDA has already checked the manufacturer's compliance. The Mo-99 standard is not a hazardous amount, and does not represent a safety limit. If NRC would perform the dosimetry, it would understand that. In addition to adding a needless quality control exercise, NRC is using the wrong standard. It is using the standard for target Mo-99. We have used fission Mo-99 for over two decades, and the USP standards for the manufacturer are different.

    22. LABELING OF VIALS, SYRINGES, AND SYRINGE SHIELDS
      23.

      Sec. 35.69 should be removed in its entirety. This is another example of NRC regulating pharmacy and medical practice, when other more qualified regulators are in firm control. A variety of circumstances will result in variation in information labeling, none of which are radiation hazards or NRC's concern.

      If NRC ended this regulation, nothing would change. Appropriate labeling is the standard of medical and pharmacy practice.

      As far as classic syringe shields are concerned, they may generally be regarded as an ALARA violation. One receives more radiation dose screwing on the syringe shields than one gets using other techniques. Syringe shields are a patient hazard, in that they do not permit efficient venipuncture and often obscure subtle visualization of syringe contents.

    23. GENERAL COMMENTS
      24.

      There are many other comments that could be made in the same vein as the previous ones. Basically, we are asking NRC to remove itself from medicine, pharmacy, research, and related areas now that other regulators have jurisdiction. We require a valid risk analysis for every other requirement. We require good science and correct math.

      Twice before, NRC has tried to end its medical program, and twice it has been stopped. Commissioner E. Gail de Planque and Chairman Selin tried to do it a third time a few years ago, but failed. Chairman Selin did not feel NRC could ever end its own program because of the bureaucratic survival activities of so many of its employees. He advised us a month before he resigned to get some legislation to Congress and he would support it. We did not use this opportunity, but may have little choice now. The current direction of NRC will destroy much of our specialty in the United States.

    24. REGULATORY DEATHS
      25.

      We believe that the issue of risk analysis is a critical one, and that it is essential that NRC stop ignoring an absolutely essential component of a valid risk analysis, which is the risk of regulatory cost in general, by any agency. For every approximately $9 -$12 million spent in regulatory compliance, one random person dies. This is because the money was not spent on other aspects of safety. For example, a patient who spends an extra $100 on a nuclear medicine procedure because of the cost of NRC compliance does not have that money to buy better tires for his car. In any case, a regulator has to weigh the people he will kill by the very cost of regulation against the number that he will save. If NRC's present proposed regulations were similarly adopted by Agreement States and for accelerator as well as byproduct material, the cost of nuclear medicine regulation has been estimated to be roughly $1 billion/year. That means that 83 people/year would be killed by NRC's medical regulatory cost alone. If NRC saved 10,000 people a year, it might be worth it. However, there is no evidence that NRC saves any patients a year because of its nuclear medicine regulations. Therefore NRC's nuclear medicine program is a net hazard to the United States. NRC is not "just being careful". NRC kills people. And, by restricting radiopharmaceutical use and adding its pregnancy rule, it will kill even more.

    25. THE CHAIRMAN'S FAILURE

      None of the NRC management will take personal responsibility for this rulemaking. Hugh Thompson, Carl Paperiello, Don Cool, and Kathy Haney have all blamed the Chairman. The Chairman has refused to meet with nuclear medicine leadership, refused to consider the unanimous vote at the Chicago public meeting to significantly revise the original SRM, refused virtually all our recommendations and refused even to be educated by a member of the NAS-IOM Committee, SNM's Past President, Dr. Barbara Croft, who graciously offered her services.

      The Chairman has failed to lead and to administrate. Deceived by her underlings, she signed off on a potentially grotesque regulatory disaster. The Chairman is a clear and present danger to patients and to nuclear medicine healthcare professionals trying to care for them.

    26. UNBUDGETTING NRC POSITIONS

      The NRC Medical Program staff, management, and support staff and management (OGC, OI, OE) have no function any longer. Originally set up to "mind the store" until appropriate medical specialties were established, the bureaucracy, once settled in, refused to go away.

      FDA was given responsibility for radiation-producing machines in 1968, and radiopharmaceuticals in 1975. The EPA was given radiation standards in 1970. OSHA handles workplace safety. Board certification for Nuclear Medicine was established in 1972, for Nuclear Pharmacists in 1982 and for Nuclear Medicine Technologists in 1978. As over 90% of the use of radiation in medicine is not regulated by NRC, all states have radiation regulators for that 90%. (Wyoming, which closed its tiny program, can always restart it if needed.) JCAHO and professional Q/A programs oversee medical quality and 50 state boards of medicine and boards of pharmacy oversee professional behavior. There is nothing left for NRC to regulate EXCEPT BY DUAL REGULATION. As this is unwelcome and counterproductive, Chairman Jackson should simply unbudget the Medical Program personnel.

    27. WHAT THE NEW PART 35 SHOULD SAY

      28. The new Part 35 should heed the findings of the NAS-IOM, the recommendations of the leadership of professional nuclear medicine, and the recommendations of Commissioner E. Gail de Planque and Chairman Ivan Selin. NRC's regulations should, at this point in time, focus only on worker, non-patient public, and environmental safety, a program requiring minimal FTE's because nuclear medicine has not been shown to be a significant risk in these areas.

      Part 35 should address basic nuclear and radiation science qualifications of Authorized Users, and the designation of professionally competent outside groups for testing purposes. NRC should not try to validate medical board exam questions or make competency decisions itself.

      Part 35 should require that a licensee submit the name, address, phone, fax, and e-mail numbers of its Administrator and of its designated radiation management individual (whether called a "Radiation Safety Officer" or a more appropriate term).

      The licensee should inform NRC of any radioactive material, sealed or unsealed, which could represent a public health and safety hazard in the event of a catastrophe which could effectively remove it from the usual competent oversight, such as a fire or severe earthquake.

      The licensee should be licensed for atomic no. 1-83, in any chemical or physical form and in any activity needed for medical use, teaching, research and development (human, animal, or laboratory), calibration, quality control, and related professional purposes. "Medical use" includes nuclear pharmacies as well as healthcare organizations and private practices.

      The requirements of Part 20 should be lifted, except for the essence of this part: the dose limits to workers, members of the public, and the environment.

      Due to the inherent safety of nuclear medicine in the hands of qualified professionals the burden of proof will be on NRC to show that the licensee is not safe. The licensee should not have to prove it is safe. The difference between these two concepts is hundreds of millions of dollars a year.

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