Letter to The Honorable Greg Jaczko

Letter

The Honorable Greg Jaczko
Chairman
Nuclear Regulatory Commission
11555 Rockville Pike
Rockville, MD 20852

Dear Chairman Jaczko:
I am writing to inform you of several findings the Subcommittee on Energy and Environment staff have made in the investigation the Subcommittee has undertaken into the manner in which NRC had regulated and overseen the release of patients treated with radioactive materials from hospitals. Since the Nuclear Regulatory Commission (NRC) plans to hold two meetings related to the use of medical isotopes and other medical issues that are within the Commission's jurisdiction today and tomorrow, I also ask for your prompt response and commitment to address these findings.

The Subcommittee's investigation, which drew from a survey of more than 1,000 thyroid cancer survivors' experiences, indicates that there is a strong likelihood that members of the public have been unwlling exposed to radiation from patients who are discharged after being treated with radioisotopes, and that this has occured because of weak NRC regulations, ineffective oversight of those who administer these medical treatments, and the abesence of clear guidance to patients and to physicians that provide procedures to ensure that such exposures do not occur.

As you know, in 1997, the Nuclear Regulatory Commission (NRC), in response to a proposal initiated by its own staff, weakened its rules surrounding the release of patients treated with radioactive iodine. The rules were changed from the prior practice -- still followed in Europe and other countries -- whcih requires the hospitalization of patients emitting high levels of radiation in order to pretect children and other members of the public from being irradiated, to one that allows most treatments to be performed on a less expensive outpatient basis.

NRC's weaker, current regulations depends on the ability of medical professionals to assess the living conditions of patients and use the results of this assessment to calculate the likely radiation dose to those people that patient might come into contact with. IT is unclear whether such a calculation could be accurately performed for a patient choosing to recover from treatment with radioactive iodine in a hotel, since it would be impossible to characterize every hotel's layout, or know whether hotel occupants or employees include the most vulnerable populations such as pregnant women or children. Additionally, despite s commitment made by NRC in 2008 to develop guidance specifically for patients being released to recover in hotels, the NRC had yet to do so. Furthermore, the NRC actually twice voted to reject proposals that would have required reports of dangerous radiation doses delivered to members of the public, through exposure to released patients, to be submitted to the NRC -an active choice by the Commission to ignore the problem of unwitting and inappropriate public exposures.

On March 18, 2010 the Energy and Environments Subcommittee released a staff report that discussed in detail issues related to the immediate release of patients treated with radioiodine, including the lack of enforceable regulations to ban or otherwise limit the release of treated patients from recovering in hotels. This staff report was forwarded to the NRC for review, and the NRC Inspector General is currently investigating conflicting statements made by the NRC Office of General Counsel, including a statement made in a court of law regarding NRC's policy of releasing treated patients to recover in hotels.

Since the staff report was issued, the Subcommittee on Energy and Environment has taken subsequent actions to further investigate this subject. The first was a series of letters sent to all 37 NRC Agreement States to gather information about the licensees' discharge practices and the second was a survey of more than 1,00 thyroid cancer patients. The response from the 34 Agreement States indicate that:

All but one State default to NRC regulations, with Florida being the only state that retained the more stringent pre-1997 release criteria for a large portion of its licensees (58 out of 308 Florida licensees amended their licenses to release patients under NRC's current dose based criteria (10 CFR 37.75))

Four Agreement States (Minnesota, Florida, Massachusetts and Washington) indicated that they have provided explicit guidance recommending against discharging patients to hotels, but only Florida attempts to ascertain whether or not licensees are following the guidance.

One Agreement State (New Jersey) reported issues with discharge patients taking public transportation and subsequently setting off radiation alarms in tunnels and bridges, and three Agreement States (Florida, New Mexico, and Illinois) indicated that they provide explicit State guidance instructing licensees to inform patients that public transportation should be avoided in the day immediately following their treatment. All other states indicate that they refer their licensees to guidance NRC development in 2008 which says that licensees may include a recommendation for patients to avoid the use of public transportation, but doe snot make this mandatory.

Two States (Maryland and Massachusetts) acknowledge one of the compounding problems of outpatient treatment with I-131 is the contamination of household waste that is being picked up and transfered to waste management facilities such as landfills. The vehicles hauling this waste often set off radiation alarms requiring the dismantling of the trash load and the examining and sampling of the contents-- exposing sanitation workers and investigators to biological as well as radiological hazards.

All states with the exception of Illinois were unaware of any release of patients to hotels. In Illinois, a patient was released to a hotel in 2007 and contaminated the bed, linens and other items in both her room and throughout the hotel - but this was only discovered because two nuclear power plant workers who were equipped with radiations monitors subsequently stayed in the same hotel and set off alarms when reporting to work.

There have been several cases in the last 10 years in Arizona, California, Illinois, Maryland, New Jersey, New Mexico, Ohio, and Pennsylvania in which state inspectors have revealed that licensees were not performing the required individualized dose of calculation to ensure that they would not contaminate those they came into proximity to with radiation, but the destination of theses patients after release from the hospital was never recorded.

The Subcommittee on Energy and Environment staff also developed an online survey whcih was taken by 1,080 thyroid cancer survivors, 781 of whom were treated as outpatients after 1997, in order to better understand how theses patients have been educated and cared for by the doctors and facilities where their treatmet has occurred. This staff's analysis of this survey indicates that:

Most I-131 treatments are now performed on an outpatient basis, and insurance providers deny inpatient stays to some who request it

-Only 27% (292) of survey responders indicated that there were treated with I-131 as inpatients and therefore were allowed to stay overnight in a hospital or other facility. Insurance companies denied requests for inpatient stays associated with 10.4% of the treatments received after 1997.
-In only 6.8% of treatments with I-131 were patients given a choice as to whether their treatment should occur on an inpatient or outpatient basis.
-Although most treatments with radioactive iodine occurred on an outpatient basis, only 10.7% (102) of these treatments involved quantiles of I-131 below 33 being identified by NRC or State inspectors, even though doctors frequently know about their patients' post-treatment recovery choices. Moreover, although it is possible that neither NRC nor the Agreement States were aware of the extent to which patients were recovering from their treatment in hotel, taking taxis or public transportation or otherwise exposing vulnerable populations to radiation (despite the fact that this concern has been repeatedly brought to the NRC's attention), this is not because such exposures were not occurring. Rather, the Subcommittee's investigation demonstrates that this is likely because NRC has failed to address these practices though the provision of clear guidance to Agreement States or to licensees. As a result, physicians fail to properly instruct patients, and these patients are then left with the impossible choice of exposing their family member or exposing strangers since inpatient stays are simply no longer viable options for most.

In previous correspondence, you stated your belief that NRC's regulations adequately protect the public provided that "adequate instructions are given at discharge to patients and family members." It is difficult to conclude cased on the survey results that this belief is justified.

I am also concerned that the NRC has compounded this problem by voting in 2000 and again in 2002 not to even be informed when its licensees learn that a member of the public has received or is estimated to have received a does exceeding 5rem -a dose that is 10 times as high as NRC's own safe does limits for released patients - from a patient who has been discharged from treatment with radioisotopes. The decisions to not requite reporting of such exposure is , in my view, inconsistent with the NRC's responsibility to protect public health and safety.

Given the Commission's plan to host meeting today and tomorrow to discuss the medical policy issues associated with NRC's regulations, I call on you and the entire Commission to take all necessary steps to appropriately revise and modernize the patient release criteria to ensure the protection of public health. I provide to you the following recommendations for immediate consideration and discussion at today's meeting.

1) The NRC should immediately commence a rulemaking to revise its 1997 regulations surrounding the treatment of patients with radionuclides, and ensure that these regulations are made to be consistent with and as protective of the most vulnerable populations as policies that are in place in other developed countries. Hospitalization should be mandatory for those patients who are treated with doses of I-131 above internationally accepted threshold limits.

2) The new regulations should ensure that patients who are released from the hospital after treatment are prohibited from recovering from such treatments in hotels or taking taxis or public transportation in the days that immediately follow treatment, and that specific written and verbal guidance prohibiting such activities is provided both to medical licensees and to patients. Enforcement actions should be taken against medical licensees who fail to provide such guidance to patients, or otherwise fail to advise a patient planning to violate the prohibitions that the regulations do no permit such activities. In cases where the patients cannot identify a suitable outpatient facility in which to recover, NRC regulations should mandate in-patient stays.

3) The NRC should aggressively enhance its oversite of both its medical licensees and the Agreement States to better identify, track and respond to potential regulatory violations. NRC should pay particular attention to whether New Hampshire, Arkansas and Alabama are capable of implementing NRC regulations in the area, in light of these states failure to respond to requests for informations.

4) NRC should immediately implement a reporting requirement for incidents that should have resulted in unintended radiation exposures from patients treated with radioactive isotopes, and ensure that data related to reports of such incidents are promptly made public in a centralized location such as the NRC website.

Please prove me with the Commission's view on each of the above recommendations as well as the Commission's plan and timeline for evaluating, discussing, and implementing each of the above recommendations. I request that you provide me with you response no later than Friday November 5th, 2010. Thank you very much for your prompt attention to this important matter. If you have any questions or concerns please have you staff contact Dr. Avenel Joseph of my staff or Dr. Michal Freedhoff of the Energy and Environment Subcommittee Staff at 202-225-2836.

Sincerely,
Edward J. Markey
Chairman
Energy and Environment Subcommittee

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