Peter G. Crane; Denial of Petition for Rulemaking, 29445-29450 [E8-11344]

Download as PDF 29445 Proposed Rules Federal Register Vol. 73, No. 99 Wednesday, May 21, 2008 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 [Docket No. PRM–35–18; NRC–2005–0020] Peter G. Crane; Denial of Petition for Rulemaking Nuclear Regulatory Commission. ACTION: Petition for rulemaking: Denial. cprice-sewell on PROD1PC69 with PROPOSALS AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking (PRM–35–18) submitted by Peter G. Crane (petitioner). The petitioner requested that the NRC amend the regulations that govern medical use of byproduct material concerning release of individuals who have been treated with radiopharmaceuticals. The petitioner believes that this regulation is defective on legal and policy grounds. The petitioner requested that the patient release rule be partially revoked insofar as it allows patients to be released from radioactive isolation with more than the equivalent of 30 millicuries of radioactive iodine I–131 (I–131) in their bodies. The NRC, for the reasons described in the SUPPLEMENTARY INFORMATION of this document has determined that the issues raised in the petition do not justify a rule change. DATES: The docket for the petition for rulemaking PRM–35–18 is closed on May 21, 2008. ADDRESSES: You can access publicly available documents related to this petition for rulemaking using the following methods: Federal e-Rulemaking Portal: Go to http://www.regulations.gov and search for documents filed under Docket ID [NRC–2005–0020]. NRC’s Public Document Room (PDR): The public may examine and have copied for a fee publicly available documents at the NRC’s PDR, Public File Area O–1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 NRC’s Agency Wide Document Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available electronically at the NRC’s electronic Reading Room at http://www.nrc.gov/ reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC’s public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR reference staff at 1–800–397–4209, 301–415–4737, or by e-mail to pdr.resource@nrc.gov. FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone 301–415– 6843, e-mail Neelam.Bhalla@nrc.gov. SUPPLEMENTARY INFORMATION: The Petition On December 21, 2005 (70 FR 75752), the NRC published a notice of receipt of a petition for rulemaking dated September 2, 2005, filed by Peter G. Crane. The petitioner requested that the NRC revoke the 1997 amendment to 10 CFR 35.75, ‘‘Release of individuals containing unsealed byproduct material or implants containing byproduct material’’ (62 FR 4120; January 29, 1997, Patient Release Criteria Rule), insofar as it allows the release of patients from radioactive isolation with more than the equivalent of 30 millicuries of radioactive I–131 in their bodies. Subsequently, during the public comment period, the petitioner filed a document dated January 30, 2006, in which he stated that after filing the petition, additional information relevant to the issue of criteria for the release of patients treated with radioactive I–131 had come to his attention and some of the comments filed warranted a response from the petitioner. In the January 30, 2006, document, the petitioner further clarified his grounds for filing the petition. In addition, the petitioner submitted an additional comment on March 6, 2006, as corrected by a submittal dated March 10, 2006. The NRC considered these documents together with the original petition. NRC’s patient release criteria are specified in 10 CFR 35.75. This regulation was amended in 1997 and PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 authorizes the release of patients from licensee control if the total effective dose equivalent (TEDE) to any other individual from exposure to the released individual is not likely to exceed 5 millisievert (mSv) (0.5 rem) (Typical natural background radiation in the United States is 0.3 rem per year). Before that time, NRC regulations required hospitalization of patients until the radioactivity in their bodies decreased to the equivalent of 30 millicuries (mCi) of I–131. The provisions of the current rule allow outpatient treatment for greater than 30 mCi of I–131 based on the licensee’s determination that the TEDE to an individual from the released patient is not likely to exceed 5 mSv (0.5 rem). The petitioner requested NRC to revoke the current rule and re-adopt the release criteria that existed before 1997. The petitioner believes that this regulation is defective on legal and policy grounds. The petitioner asserts that the 1997 rulemaking was defective on legal grounds because it was purportedly adopted in response to a petition from a member of the public; however, the petition was actually drafted at the request of the NRC staff, with NRC staff assistance, under NRC staff specifications. The petitioner alleges that the NRC violated its own rules because (1) the NRC staff failed to disclose in papers forwarding the rulemaking, that the staff had assisted the former petitioner by encouraging the individual to submit the petition and (2) the NRC did not mention any such assistance in its rulemaking notices in the Federal Register. The petitioner supports this assertion by referring to a memorandum from the Executive Director for Operations (EDO) dated February 23, 1994, addressed to ‘‘All NRC Employees, ‘‘ that discusses the requirements in 10 CFR 2.802(b), which limits the assistance that the NRC may give prospective petitioners. The petitioner states that the memorandum advised that every year after 1991, the EDO had issued an announcement to NRC employees which clarified the permissible scope of NRC staff interaction with a prospective petitioner for rulemaking. The memorandum stated that should any NRC staff assistance be provided to a prospective petitioner regarding technical or substantive issues, that assistance must be disclosed to the Commission in the E:\FR\FM\21MYP1.SGM 21MYP1 cprice-sewell on PROD1PC69 with PROPOSALS 29446 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Proposed Rules paper forwarding the rulemaking action for approval. Also, NRC staff assistance must be noticed in any public notice regarding the petition and any rulemaking that may result from the petition that is published in the Federal Register. The petitioner asserts that ‘‘assistance’’ as defined by the NRC includes encouraging a prospective petitioner to submit a petition, and that the NRC staff in its rulemaking notices in the Federal Register did not mention any such encouragement to the former petitioner to file the petition. The petitioner also asserts that the release of patients under the current rule creates an unwarranted hazard to the public and patient’s family, particularly children. The petitioner’s safety concerns are summarized as follows: 1. Dose to family members, especially children. The petitioner argues that patients treated for thyroid cancer with I–131 are being sent home under conditions that guarantee that family members will receive large and potentially harmful doses of radiation under uncontrolled conditions. The petitioner expresses concern for exposure to children stating that children are more radiationsensitive than adults and argues that children deserve more protection, not less. 2. Dose to members of the public during patient transport. The petitioner expresses concern about dose to members of the public during transport from patients who have been administered large amounts of I– 131. The petitioner states that by reverting to the 1997 release criteria, the exposure to members of the public will be less because patients being transported home will not be released with large amounts of radioactivity in their bodies. 3. Contamination and dose concerns due to vomiting. The petitioner expresses concern about the risks of vomiting of the I–131 dosage, with resultant exposure to family members in cleaning patient vomit, and a loss of the administered dose to the patient. 4. Hypothyroid patients are not able to fully comprehend or remember the instructions provided to them. The petitioner asserts that although the patients are supposed to receive instructions on minimizing exposure to others, patients may have trouble comprehending and remembering the guidance, given their hypothyroid state. The petitioner draws from personal experience and states that the severe hypothyroid state impairs a person’s ability to follow safety guidelines for the VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 protection of family members and other members of the public. 5. NRC has allowed for reduction of exposure to hospital employees and clergy members at the expense of elevated exposure to family members, and particularly, children. The petitioner has referred to a discussion in the statements of consideration of the final rule published on January 29, 1997 (62 FR 4120) of relevant benefits and risks associated with the options of patient release and hospitalization. The petitioner asserts that the NRC acknowledged that family members of patients would receive higher doses of radiation, and justified this in part by arguing that members of the clergy who visit hospitals frequently would receive lower doses of radiation because cancer patients would be at home instead of in the hospital. Public Comments on the Petition The notice of receipt of the petition for rulemaking invited interested persons to submit comments. The comment period closed on March 6, 2006. NRC received 48 comment letters including 3 submittals from the petitioner. There were 14 letters in support of the petition. These were primarily from cancer patients who had been treated with I–131 and released under the provisions of 10 CFR 35.75 or the equivalent State regulations. These patients expressed concern that they had to take care of themselves. However, had they been hospitalized, they would have been taken care of by the hospital staff. Several of these commenters expressed concern about exposure to family members and others, in particular from patient vomiting. One commenter supported the petition for a concern not cited by the petitioner. This commenter stated that the current release criteria have resulted in an increase in the number of events when radiation monitoring equipment detects radiation at municipal wastehandling facilities and that the States have to respond to these events. Commenters opposing the petition generally included physicians, medical physicists, and radiation safety officers, as well as several medical professional organizations. These professional organizations included the American Society of Therapeutic Radiation Oncologists (ASTRO), the American Association of Physicists in Medicine (AAPM), the American Board of Nuclear Physicians (ABNP), the American Thyroid Association, the Endocrine Society, the American College of Radiology (ACR), the Society of Nuclear Medicine (SNM), the National Association of Nuclear Pharmacists, the PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 American Pharmacists Association, and the Council on Radionuclides and Radiopharmaceuticals (CORAR). Commenters opposing the petition stated that reverting from the current release criteria back to the 30-mCi rule would result in additional and unnecessary healthcare costs, and would unnecessarily limit access to treatment for patients who cannot afford hospitalization. Commenters opposing the petition also stated that the provisions of the current rule provide patients the comfort and convenience of being in their homes, rather than the confinement in a hospital environment. Many physicians opposing the petition disagreed with the petitioner’s assertion that the patients are released while they are a risk of exposure to others. These physicians commented that they carefully interview the patients and assess their ability to follow and understand radiation safety precautions and their living conditions at home, and then decide on outpatient treatment. These physicians also stated that they discuss with their patients arrangements to have any children in the households stay away from their homes during the initial week of their treatments. With regard to the petitioner’s concern about patient vomiting, some physicians stated that they provide special instructions to the patients to handle the vomitus and prescribe anti-nausea medication, if needed. These commenters indicated that vomiting is a rare complication with these patients. One commenter generally opposed the petition but noted the recommendations of the International Commission on Radiological Protection (ICRP), in ICRP Publication 94 (published in 2004), entitled, ‘‘Release of patients after therapy with unsealed radionuclides.’’ The commenter stated that ICRP Publication 94 now recommends that doses to children be constrained to less than 1 mSv (100 millirem) and that doses to children from patient contamination have the potential to be far greater than from external exposure. In light of this, the commenter suggested that there may be a need for NRC to consider adding instructions in NUREG–1556, Volume 9, ‘‘Consolidated Guidance About Material Licenses: Program Specific Guidance About Medical Use Licenses,’’ regarding the avoidance of exposure to children to patient contamination. NUREG–1556, Volume 9, Appendix U, ‘‘Model Procedures for Release of Patients or Human Research Subjects Administered Radioactive Materials,’’ provides instructions to minimize exposure to family members and other members of E:\FR\FM\21MYP1.SGM 21MYP1 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Proposed Rules the public (U.2.3.1). Although these instructions include precautions to reduce the spread of contamination, the instructions do not specifically caution against avoiding exposure of children to patient contamination. Therefore, the commenter suggested that NRC revise NUREG–1556, Volume 9, to include specific guidance for patients on precautions to avoid children’s exposure to radioactive contamination. cprice-sewell on PROD1PC69 with PROPOSALS Petition Resolution After reviewing the information provided in the petition, as supplemented, and the comments, the NRC has determined that the issues raised in the petition do not justify a rule change. The NRC believes that the current NRC regulations provide adequate protection to family members and other members of the public. The NRC’s responses to the petitioner’s specific concerns are provided below. NRC Responses to the Issues Raised by the Petitioner The petitioner asserts that the 1997 rulemaking was defective because it was purportedly adopted in response to a petition from a member of the public submitted in December 1990, but was actually drafted at the request of the NRC staff, and according to NRC staff specifications. The petitioner asserts that the NRC staff’s failure to disclose this fact to the Commission in the rulemaking documents and the failure to notice this assistance in the Federal Register violated the Commission’s rules. The petitioner asserts that NRC staff offered inappropriate assistance to the rulemaking petitioner. However, there were neither NRC regulations nor internal policies that addressed the staff role or level of assistance that could be provided to potential petitioners at the time that the alleged staff assistance occurred. In any event, a decision to initiate rulemaking to adopt the petitioner’s proposals could not rest on a question of staff compliance with internal NRC procedures. However initiated, the 1997 rulemaking involved broad participation with 63 commenters, including medical practitioners and medical organizations, regulatory agencies in Agreement States, public interest groups and private individuals. Moreover, the American College of Nuclear Medicine and the American Medical Association filed petitions later that were included in the rulemaking. Their independent proposals as well as the broad participation by interested parties negate the inference drawn by the petitioner that the resulting rulemaking VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 was merely the product of staff influence. To reopen the earlier rulemaking would require evidence that alleged procedural defects substantively affected the final rule in a manner requiring that additional rulemaking be initiated. No such evidence has been brought to our attention, nor is the Commission aware of any basis for such a conclusion. Thus, even assuming that the petitioner’s allegations of undue staff assistance were true, the petitioner has not demonstrated a substantive basis for reopening the earlier rulemaking or for initiating rulemaking in response to this petition. Dose to Family Members, Especially Children The petitioner asserts that patients treated for thyroid cancer with I–131 are being sent home under conditions that guarantee that family members will receive large and potentially harmful doses of radiation under uncontrolled conditions. The petitioner expresses particular concern for exposure to children because children are more radiation-sensitive than adults. The concerns related to doses to the family members and members of the public from released patients were extensively considered during the development of the current patient release criteria rule. By way of background, in 1991 (56 FR 23360, May 21, 1991) NRC published a final rule that amended 10 CFR Part 20 ‘‘Standards for Protection Against Radiation’’ to include a change to the dose limits for individual members of the public in 10 CFR 20.1301. The rule lowered dose limits for members of the public from 500 millirem per year to 100 millirem per year. However, the criteria for the release of patients under 10 CFR 35.75 had been based on a dose limit of 500 millirem to members of the public. When 10 CFR Part 20 was issued, there was no discussion in the supplemental information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients. Some stakeholders were uncertain about what effect the revised 10 CFR Part 20 would have on patient release criteria and subsequently, three petitions for rulemaking were received related to this issue. One petition was received from Dr. Carol Marcus, one from the American College of Nuclear Medicine (ACNM), and one from the American Medical Association (AMA). Dr. Marcus, and the ACNM petitions requested the NRC to amend the revised Part 20 and 10 CFR 35.75 to raise the annual radiation dose limits to members of the public from 1 millisievert (0.1 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 29447 rem) to 5 millisieverts (0.5 rem) from patients administered radioactive materials, and the AMA petition requested that patient release be regulated by Part 35 rather than Part 20. NRC decided to resolve all of these petitions in a single rulemaking. In June 1994 a proposed rule was published to amend 10 CFR 20.1301(a)(1) to specifically clarify that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients released under 10 CFR 35.75. 59 FR 30724 (June 14,1994). However, the dose limits in the revised Part 20 were not changed. In the proposed rule, the NRC also proposed to amend 10 CFR 35.75 to change the patient release criteria from 30 millicuries of activity in a patient or a dose rate of 5 millirems per hour at 1 meter from a patient, to a dose-based criteria where the TEDE to an individual from exposure to a released patient is not likely to exceed 5 mSv (0.5 rem). Under the regulations in effect before 1997, activity within a patient was measured to determine whether a patient could be released from licensee control. However, the NRC determined that this type of an approach was not dependable, in that there were variants among the isotopes that would cause variations in the dose that would result to another individual from exposure to the released patient. The NRC believed that the primary consideration in the release of patients should not be the activity within the patient, but the potential doses to other individuals. NRC concluded that basing the patient release criteria on the dose to individuals exposed to a patient (i.e. dose-based regulation) would provide a consistent, scientific basis for such decisions that treats all radionuclides on a risk-equivalent basis. A dose-based rule was therefore proposed that would allow consideration of case-specific factors to more accurately assess the dose to other individuals. The final rule amending Part 20 and Part 35 to incorporate these changes was published in 1997 (62 FR 4120, January 29, 1997). In April 1997, the NRC also published a report ‘‘Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material’’ (NUREG–1492). The report assessed the potential internal and external doses to individuals exposed to patients who have been administered radiopharmaceuticals and performed a comprehensive risk/benefit analysis for adopting the 5 mSv (0.5 rem) TEDE criterion for patient release. The report stated that the criterion was based on the ICRP Publication 60, ‘‘1990 E:\FR\FM\21MYP1.SGM 21MYP1 cprice-sewell on PROD1PC69 with PROPOSALS 29448 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Proposed Rules Recommendations of the International Commission on Radiation Protection,’’ and the recommendations of the NCRP in NCRP Report No. 116, ‘‘ Limitation of Exposure to Ionizing Radiation.’’ Each of these reports provided a basis for allowing individuals to receive annual doses up to 5 mSv (0.5 rem) under certain circumstances. These recommendations of the ICRP and NCRP were based on a finding that annual doses in excess of 1 mSv (0.1 rem) to a small group of people, provided that they do not occur often, need not be regarded as unduly hazardous. The dose-based release limits also used assumptions that the internal doses for individuals who may come in contact with released patients were very small compared with doses from external exposures. The petitioner has not provided any data to refute the analysis provided in NUREG–1492. However, one commenter noted that ICRP Publication 94 now recommends that doses to children be limited to less than 1 mSv (100 millirem) and that doses to children from patient contamination have the potential to be far greater than from external exposure. The commenter recommended that NRC consider adding instructions in NUREG–1556, Volume 9, regarding the avoidance of exposure of children to patient contamination. The NRC carefully considered this issue in reviewing the petition and reviewed ICRP Publication 94. The recommendations in the report do not explicitly state that patients should be hospitalized. However, ICRP recommends that public dose limits and dose constraints for others be observed, and be followed with optimization, realizing that procedures of optimization and their effects on individual behavior will differ among individuals and their circumstances. In addition, ICRP recommends: ‘‘Since high absorbed thyroid dose may occur in infants and young children from contamination, and children’s thyroids are very radiosensitive for carcinogenesis, this population should be restricted to the public dose limit of 1 mSv/year.’’ The report states that although the dose to adults exposed to released patients is mostly from external radiation, children may receive a dose from contamination. Therefore, restrictions following the release of patients should focus on infants and children. Recently, ICRP has also published a comprehensive revision to its recommendations made in 1991, in ICRP Publication 103. ICRP Publication 103 repeats the recommendations made in ICRP Publication 94 that young children and infants, as well as visitors VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 not engaged in the care of patients, should be limited to a dose of 1 mSv (0.1 rem) per year. This recommendation represents a departure from previous ICRP recommendations, which did not make a distinction for children or infants. Therefore, NRC considered the following regulatory options for limiting the exposure to children and infants from released patients: (1) Amend 10 CFR 35.75 to limit children and infants exposure to 1 mSv (0.1 rem); (2) Amend 10 CFR 35.75 (b) to include special instructions if the dose to an infant or child could exceed 1 mSv (0.1 rem); or (3) Revise the guidance in NUREG– 1556, Volume 9, to include the ICRP Publication 94 recommendations and issue a Regulatory Issue Summary (RIS) to medical licensees to make them aware of the ICRP recommendations. Option (1) Amend 10 CFR 35.75 to Limit Children and Infants Exposure to 1 mSv (0.1 rem) NRC has determined not to change the rule to adopt a lower limit for children and infants. The NRC does not believe that such a rule change would be effective because it is difficult to meaningfully estimate the doses that may result from patient contamination. The factors involved in assessing such doses are largely indeterminate, and even assumptions are likely to be so much in error as to be meaningless. For example, the amount of iodine in the patient’s saliva is highly variable even for patients receiving the same treatment, and the amount of saliva that may be ingested by a child is dependent on the details of the family’s living arrangements, family habits and the age of the child, and cannot be reliably assumed to assess the dose to the child or the infant. This makes a dose-based approach to protecting children from patient contamination an impractical choice. NRC believes that an alternative approach that is more likely to provide better protection for children and infants would be for patients to take precautions to maintain the dose to children and infants as low as is reasonably achievable (ALARA). NRC therefore has determined that the instructions to the patients, as well as any guidance to physicians, should be modified to stress the need to keep children and infants away from any possible sources of contamination. 10 CFR 35.75(b) requires licensees to provide instructions, including written instructions on actions recommended to maintain doses to other individuals ALARA. Therefore, NRC determined PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 that this guidance should be strengthened to protect children and infants from any sources of patient contamination. To achieve this goal, NRC has revised the guidance in NUREG 1556, Volume 9 and has developed a Regulatory Issue Summary (RIS) to convey to the licensees the concerns expressed in ICRP Publications 94 and 103 about doses to children from patient contamination and the actions licensees and patients should take to keep children away from any sources of patient contamination. These actions would be based on the individual patient’s circumstances and may include hospitalization of the patient based on the patient’s family situation. NRC will issue the RIS and the revised guidance in NUREG 1556, Volume 9, to all medical use licensees and to the Agreement States concurrent with the issuance of this petition resolution. NRC believes that enhancing the guidance is a more efficient way of protecting children and infants than amending the regulations. In addition, in considering the disposition of a petition for rulemaking, NRC must consider whether addressing the topics raised in the petition are likely to result in a significant increase in safety or security for all affected stakeholders. As explained above, NRC does not believe that the issues raised in this petition significantly impact safety and security such as would warrant a rulemaking. Additionally, the NRC must consider the potential impact of a rulemaking on the agency’s efficiency and effectiveness. NRC has limited resources for rulemaking; therefore any topic to be considered in the NRC rulemaking process must have a strong technical basis before it can be considered in the agency’s prioritization process for rulemaking. In any given budget cycle, only a limited number of rulemakings can be funded. Topics with minimal safety or security impact may not reach the funding threshold. The NRC does not believe that there is a sufficiently strong technical basis to consider the issues in this petition in a rulemaking. Option (2) Amend 10 CFR 35.75 (b) to Include Special Instructions if the Dose to an Infant or Child Could Exceed 1 mSv (0.1 rem) NRC determined that it is not necessary to amend 10 CFR 35.75(b) to require that special instructions be provided if the dose to an infant or child could exceed 1 mSv (0.1 rem). Section 35.75(b) presently requires a licensee to provide the released individual, or the individual’s parent or guardian with instructions, including written E:\FR\FM\21MYP1.SGM 21MYP1 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Proposed Rules cprice-sewell on PROD1PC69 with PROPOSALS instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable (ALARA), if the TEDE to any other individual is likely to exceed 1 mSv (0.1 rem). The requirement that instructions be provided if the TEDE is likely to exceed 1 mSv to any other individual includes that these instructions must be provided if the TEDE to children and infants is likely to exceed 1 mSv (0.1 rem). Option (3) Revise the Guidance in NUREG–1556, Volume 9, to Include the ICRP 94 Recommendations and Issue a Regulatory Issue Summary (RIS) to Medical Licensees to Make Them Aware of the ICRP Recommendations As discussed under Option (1), NRC determined to revise the guidance in NUREG–1556, Volume 9, and issue a RIS to make licensees aware of the ICRP’s new recommendations, and to heighten licensees’ awareness of the requirements of the regulations in 10 CFR 35.75(b). NRC believes that the protection for children is best achieved through maintaining doses ALARA. NRC believes that this can be accomplished under the current patient release criteria, but that the instructions to the patients, as well as any guidance to physicians, need to be modified to emphasize the need to keep children away from any possible sources of contamination. The guidance needs to be sufficiently flexible so that the patient’s physician has the option of keeping the patient in the hospital for longer periods than currently required if the patient’s living conditions warrant such a decision. The NRC believes that these actions will adequately protect infants and children. The petitioner also asserts that NRC has allowed for reduction of exposure to hospital employees and clergy members at the expense of elevated exposure to family members. The petitioner’s assertion is based upon a misinterpretation of a response to a comment on the proposed rule as discussed in the Statements of Consideration of the final rule published on January 29, 1997 (62 FR 4120). Specifically, a commenter had noted that it would not be possible to maintain the same level of contamination control at home that could be maintained in a hospital. In responding to this comment, the NRC noted that the two situations were not comparable because areas in hospitals have potential for contamination from many patients, and that people who frequent the hospital, such as clergy, would therefore have the potential to be exposed to contamination from many VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 patients. However, in the case of a released patient at home, therapeutic administrations usually occur no more than once a year and probably no more than once in a lifetime. The reference to exposure of hospital clergy to contamination from many patients was intended as an example, and was not intended to imply that removing patients from the hospital would constitute a benefit to clergy that would compensate for an additional risk to a patient’s children. Rather, the Statements of Consideration in the 1997 final rule explain that NRC considered the results of studies and recommendations current at the time, evaluated the benefits to patients from being home, and concluded that doses to household members from one patient would be low, compared to increased exposure to hospital personnel from recurring administrations. NRC believes that the current rule provides adequate protection of the public and family members and minimizes exposure of hospital employees. Dose to Members of the Public During Patient Transport The petitioner expresses concern about dose to members of the public during transport from patients who have been administered large amounts of I– 131. The guidance in NUREG–1556, Volume 9, provides adequate instructions for the patient to minimize time in public places (for example, public transportation, grocery stores, and shopping centers). Also, ICRP Publication 94 concludes that patients traveling after radioiodine therapy rarely present a hazard to other passengers if travel times are limited to a few hours. From the comments received, it appears that a vast majority of the patients return home in private vehicles. Other than describing a single anecdotal account of an I–131 patient who allegedly traveled home on a bus, vomited, and exposed her husband and children to radiation, the petitioner provides no specific data in support of his position. Contamination and Dose Concerns Due to Vomiting In support of his petition, the petitioner expresses concern about dose to family members who clean up the patient’s vomit, and a loss of administered dose to the patient. Although the petitioner describes a case that he states is known to him, the petitioner provides no specific data in support of his concern. Some physicians have commented on the petitioner’s concern and stated that the incidence of vomiting in their experience is rare, and PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 29449 that the physicians are able to prescribe anti-nausea drugs, if needed. The same view was expressed by physician members of the Advisory Committee on the Medical Uses of Isotopes at its November 2006 meeting. In addition, some physicians stated that they provide special instructions to their patients regarding handling of the vomitus and prescribe anti-nausea drugs, if needed. Hypothyroid Patients Are Not Able to Fully Comprehend or Remember Instructions. The petitioner expresses concern that most patients are in a hypothyroid state and, therefore, are unable to fully comprehend or remember the instructions provided to them. The petitioner describes these patients as ‘‘sick, and quite possibly stressed, groggy, and mentally fogged, to remember the guidance and follow it.’’ The petitioner does not provide any new or specific information in support of his concern. The regulations in 10 CFR 35.75(b) require instructions be provided to the individual, or the individual’s parent or guardian, including written instructions, on actions recommended to maintain doses to other individuals ALARA if the TEDE to any other individual is likely to exceed 1 mSv (0.1 rem). In the 2002 revision to Part 35 (67 FR 20249; April 24, 2002), 10 CFR 35.75(b) was revised to specify that licensees may provide instructions to either the released individual or to the individual’s parent or guardian, to acknowledge that it is not appropriate to provide the individual being released with instructions in some cases (e.g., the individual is a minor or incapable of understanding the instructions). In addition, the regulations do not mandate the release of patients. Physicians always have the option of hospitalizing individuals based on their judgment of an individual’s condition. One of the commenters, a physician, noted that at his institution if a patient is determined to be incontinent, incapable of self-care, or unable to adhere to the instructions, then the patient is treated as an inpatient. Waste Issue One commenter in support of the petition stated that the rule has resulted in an increase on the burden of State responders due to an increase in the alarms triggered at the municipal waste handling facilities. Although this issue was not raised by the petitioner, the NRC staff reviewed this concern. These alarms are generally triggered by any radioactivity detected at these facilities. E:\FR\FM\21MYP1.SGM 21MYP1 29450 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Proposed Rules The commenter did not provide any data on how many or what fraction of these alarms are triggered by the wastes from these patients. With regard to the environmental pathways of radioiodine, ICRP Publication 94 states that ‘‘regarding the release of patients from the hospital, the radioiodine is in the patient where it decays or is excreted primarily in urine, and finds its way into the environment.’’ According to the report, the impact of the released I–131 on the environment should be minimal, considering that I–131 has a relatively short half life of 8 days. The time it takes for the excreta of patients to be processed and returned to the ecosystem is relatively long. In addition, the impact of I–131 on the environment from this pathway is usually independent of whether the patient is hospitalized after treatment or released to go home. cprice-sewell on PROD1PC69 with PROPOSALS Conclusion The decision to deny the petition is consistent with NRC’s Strategic Plan for Fiscal Years 2008–2013. NRC’s strategic safety goal to ‘‘ensure adequate protection of public health and safety and the environment’’ would continue to be maintained because NRC believes that the current rule is adequate to protect public health and safety from the release of these patients. The decision is also consistent with the Strategic Plan’s focus on Organization Excellence. Specifically, the openness objective was accomplished by soliciting and considering public comments on the petition. It is expected that denying this petition will continue to maintain the NRC’s effectiveness objective because reverting to the 1997 release criteria as requested by the petitioner would place a significant regulatory burden on licensees with no commensurate benefit to public health and safety. In conclusion, NRC finds that the arguments presented in PRM–35–18 do not support a rulemaking to revoke the patient release criteria in 10 CFR 35.75. Reverting to the 1997 patient release criteria would impose unnecessary regulatory burden and is not warranted for the protection of public health and safety. To address the petitioner’s concern for exposure to children and infants, NRC has prepared a RIS and additional guidance which will be issued to all NRC medical use licensees, and to the Agreement States, concurrent to the resolution of this petition. For the reasons cited in this document, the NRC denies this petition for rulemaking. VerDate Aug<31>2005 14:18 May 20, 2008 Jkt 214001 Dated at Rockville, Maryland, this 7th day of May 2008. For the Nuclear Regulatory Commission. R.W. Borchardt, Executive Director for Operations. [FR Doc. E8–11344 Filed 5–20–08; 8:45 am] BILLING CODE 7590–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 35 [Docket No. AD08–8–000] Demand Response in Organized Electric Markets May 13, 2008. Federal Energy Regulatory Commission, DOE. ACTION: Supplemental Notice of Technical Conference. AGENCY: SUMMARY: The Commission is providing an agenda for the technical conference to be held in this proceeding on May 21, 2008, from 9 a.m. to 4:30 p.m. (EST), and detailed information regarding attendance, internet access, and transcripts. This conference will provide a forum to consider issues related to demand response in organized electric markets, as discussed in the Commission’s Notice of Proposed Rulemaking which was issued on March 8, 2008 in Commission Docket Nos. RM07–19–000 and AD07–7–000. FOR FURTHER INFORMATION CONTACT: Ryan Irwin, Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, (202) 502–6454, Ryan.Irwin@ferc.gov. Elizabeth Arnold, Office of the General Counsel—Energy Markets, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, (202) 502–8818, Elizabeth.Arnold@ferc.gov. On April 10, 2008, the Commission issued a Notice (April 10 Notice) scheduling a staff technical conference in the above-captioned proceeding. As stated in the April 10 Notice, the conference will provide a forum to consider issues related to demand response in organized electric markets, as discussed in the Notice of Proposed Rulemaking issued in Docket Nos. RM07–19–000 and AD07–7–000. Wholesale Competition in Regions with Organized Electric Markets, 73 FR 12,576 (Mar. 7, 2008), FERC Stats. & Regs. ¶ 32,682 at P 95 (2008) (Competition NOPR). The technical PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 conference will be held on May 21, 2008, from 9 a.m. to 4:30 p.m. (EST), in the Commission Meeting Room at the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. The conference will be open for the public to attend and advance registration is not required. Members of the Commission may attend the conference. The agenda for this conference is attached. If any changes occur, the revised agenda will be posted on the calendar page for this event on the Commission’s Web site, http:// www.ferc.gov, prior to the event. A free webcast of this event is available through http://www.ferc.gov. Anyone with internet access who desires to view this event can do so by navigating to the Calendar of Events at http://www.ferc.gov and locating this event in the Calendar. The event will contain a link to its webcast. The Capitol Connection provides technical support for the free webcasts. It also offers access to this event via television in the Washington, DC area and via phone-bridge for a fee. If you have any questions, visit http:// www.CapitolConnection.org or contact Danelle Perkowski or David Reininger at (703) 993–3100. Transcripts of the conference will be available immediately for a fee from Ace Reporting Company (202–347–3700 or 1–800–336–6646). They will be available for free on the Commission’s eLibrary system and on the Calendar of Events approximately one week after the conference. Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an e-mail to accessibility@ferc.gov or call toll free 1–866–208–3372 (voice) or 202–208–1659 (TTY), or send a FAX to 202–208–2106 with the required accommodations. For more information about this conference, please contact: Ryan Irwin, Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, (202) 502–6454, Ryan.Irwin@ferc.gov. Elizabeth Arnold, Office of the General Counsel—Energy Markets, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC E:\FR\FM\21MYP1.SGM 21MYP1

Agencies

[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Proposed Rules]
[Pages 29445-29450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11344]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / 
Proposed Rules

[[Page 29445]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-18; NRC-2005-0020]


Peter G. Crane; Denial of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking: Denial.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking (PRM-35-18) submitted by Peter G. Crane (petitioner). 
The petitioner requested that the NRC amend the regulations that govern 
medical use of byproduct material concerning release of individuals who 
have been treated with radiopharmaceuticals. The petitioner believes 
that this regulation is defective on legal and policy grounds. The 
petitioner requested that the patient release rule be partially revoked 
insofar as it allows patients to be released from radioactive isolation 
with more than the equivalent of 30 millicuries of radioactive iodine 
I-131 (I-131) in their bodies. The NRC, for the reasons described in 
the SUPPLEMENTARY INFORMATION of this document has determined that the 
issues raised in the petition do not justify a rule change.

DATES: The docket for the petition for rulemaking PRM-35-18 is closed 
on May 21, 2008.

ADDRESSES: You can access publicly available documents related to this 
petition for rulemaking using the following methods:
    Federal e-Rulemaking Portal: Go to http://www.regulations.gov and 
search for documents filed under Docket ID [NRC-2005-0020].
    NRC's Public Document Room (PDR): The public may examine and have 
copied for a fee publicly available documents at the NRC's PDR, Public 
File Area O-1F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland.
    NRC's Agency Wide Document Access and Management System (ADAMS): 
Publicly available documents created or received at the NRC are 
available electronically at the NRC's electronic Reading Room at http:/
/www.nrc.gov/reading-rm/adams.html. From this page, the public can gain 
entry into ADAMS, which provides text and image files of NRC's public 
documents. If you do not have access to ADAMS or if there are problems 
in accessing the documents located in ADAMS, contact the NRC PDR 
reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
pdr.resource@nrc.gov.

FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-
6843, e-mail Neelam.Bhalla@nrc.gov.

SUPPLEMENTARY INFORMATION:

The Petition

    On December 21, 2005 (70 FR 75752), the NRC published a notice of 
receipt of a petition for rulemaking dated September 2, 2005, filed by 
Peter G. Crane. The petitioner requested that the NRC revoke the 1997 
amendment to 10 CFR 35.75, ``Release of individuals containing unsealed 
byproduct material or implants containing byproduct material'' (62 FR 
4120; January 29, 1997, Patient Release Criteria Rule), insofar as it 
allows the release of patients from radioactive isolation with more 
than the equivalent of 30 millicuries of radioactive I-131 in their 
bodies.
    Subsequently, during the public comment period, the petitioner 
filed a document dated January 30, 2006, in which he stated that after 
filing the petition, additional information relevant to the issue of 
criteria for the release of patients treated with radioactive I-131 had 
come to his attention and some of the comments filed warranted a 
response from the petitioner. In the January 30, 2006, document, the 
petitioner further clarified his grounds for filing the petition. In 
addition, the petitioner submitted an additional comment on March 6, 
2006, as corrected by a submittal dated March 10, 2006. The NRC 
considered these documents together with the original petition.
    NRC's patient release criteria are specified in 10 CFR 35.75. This 
regulation was amended in 1997 and authorizes the release of patients 
from licensee control if the total effective dose equivalent (TEDE) to 
any other individual from exposure to the released individual is not 
likely to exceed 5 millisievert (mSv) (0.5 rem) (Typical natural 
background radiation in the United States is 0.3 rem per year). Before 
that time, NRC regulations required hospitalization of patients until 
the radioactivity in their bodies decreased to the equivalent of 30 
millicuries (mCi) of I-131. The provisions of the current rule allow 
outpatient treatment for greater than 30 mCi of I-131 based on the 
licensee's determination that the TEDE to an individual from the 
released patient is not likely to exceed 5 mSv (0.5 rem). The 
petitioner requested NRC to revoke the current rule and re-adopt the 
release criteria that existed before 1997.
    The petitioner believes that this regulation is defective on legal 
and policy grounds. The petitioner asserts that the 1997 rulemaking was 
defective on legal grounds because it was purportedly adopted in 
response to a petition from a member of the public; however, the 
petition was actually drafted at the request of the NRC staff, with NRC 
staff assistance, under NRC staff specifications. The petitioner 
alleges that the NRC violated its own rules because (1) the NRC staff 
failed to disclose in papers forwarding the rulemaking, that the staff 
had assisted the former petitioner by encouraging the individual to 
submit the petition and (2) the NRC did not mention any such assistance 
in its rulemaking notices in the Federal Register.
    The petitioner supports this assertion by referring to a memorandum 
from the Executive Director for Operations (EDO) dated February 23, 
1994, addressed to ``All NRC Employees, `` that discusses the 
requirements in 10 CFR 2.802(b), which limits the assistance that the 
NRC may give prospective petitioners. The petitioner states that the 
memorandum advised that every year after 1991, the EDO had issued an 
announcement to NRC employees which clarified the permissible scope of 
NRC staff interaction with a prospective petitioner for rulemaking. The 
memorandum stated that should any NRC staff assistance be provided to a 
prospective petitioner regarding technical or substantive issues, that 
assistance must be disclosed to the Commission in the

[[Page 29446]]

paper forwarding the rulemaking action for approval. Also, NRC staff 
assistance must be noticed in any public notice regarding the petition 
and any rulemaking that may result from the petition that is published 
in the Federal Register. The petitioner asserts that ``assistance'' as 
defined by the NRC includes encouraging a prospective petitioner to 
submit a petition, and that the NRC staff in its rulemaking notices in 
the Federal Register did not mention any such encouragement to the 
former petitioner to file the petition.
    The petitioner also asserts that the release of patients under the 
current rule creates an unwarranted hazard to the public and patient's 
family, particularly children. The petitioner's safety concerns are 
summarized as follows:
    1. Dose to family members, especially children.
    The petitioner argues that patients treated for thyroid cancer with 
I-131 are being sent home under conditions that guarantee that family 
members will receive large and potentially harmful doses of radiation 
under uncontrolled conditions. The petitioner expresses concern for 
exposure to children stating that children are more radiation-sensitive 
than adults and argues that children deserve more protection, not less.
    2. Dose to members of the public during patient transport.
    The petitioner expresses concern about dose to members of the 
public during transport from patients who have been administered large 
amounts of I-131. The petitioner states that by reverting to the 1997 
release criteria, the exposure to members of the public will be less 
because patients being transported home will not be released with large 
amounts of radioactivity in their bodies.
    3. Contamination and dose concerns due to vomiting.
    The petitioner expresses concern about the risks of vomiting of the 
I-131 dosage, with resultant exposure to family members in cleaning 
patient vomit, and a loss of the administered dose to the patient.
    4. Hypothyroid patients are not able to fully comprehend or 
remember the instructions provided to them.
    The petitioner asserts that although the patients are supposed to 
receive instructions on minimizing exposure to others, patients may 
have trouble comprehending and remembering the guidance, given their 
hypothyroid state. The petitioner draws from personal experience and 
states that the severe hypothyroid state impairs a person's ability to 
follow safety guidelines for the protection of family members and other 
members of the public.
    5. NRC has allowed for reduction of exposure to hospital employees 
and clergy members at the expense of elevated exposure to family 
members, and particularly, children.
    The petitioner has referred to a discussion in the statements of 
consideration of the final rule published on January 29, 1997 (62 FR 
4120) of relevant benefits and risks associated with the options of 
patient release and hospitalization. The petitioner asserts that the 
NRC acknowledged that family members of patients would receive higher 
doses of radiation, and justified this in part by arguing that members 
of the clergy who visit hospitals frequently would receive lower doses 
of radiation because cancer patients would be at home instead of in the 
hospital.

Public Comments on the Petition

    The notice of receipt of the petition for rulemaking invited 
interested persons to submit comments. The comment period closed on 
March 6, 2006. NRC received 48 comment letters including 3 submittals 
from the petitioner. There were 14 letters in support of the petition. 
These were primarily from cancer patients who had been treated with I-
131 and released under the provisions of 10 CFR 35.75 or the equivalent 
State regulations. These patients expressed concern that they had to 
take care of themselves. However, had they been hospitalized, they 
would have been taken care of by the hospital staff. Several of these 
commenters expressed concern about exposure to family members and 
others, in particular from patient vomiting.
    One commenter supported the petition for a concern not cited by the 
petitioner. This commenter stated that the current release criteria 
have resulted in an increase in the number of events when radiation 
monitoring equipment detects radiation at municipal waste-handling 
facilities and that the States have to respond to these events.
    Commenters opposing the petition generally included physicians, 
medical physicists, and radiation safety officers, as well as several 
medical professional organizations. These professional organizations 
included the American Society of Therapeutic Radiation Oncologists 
(ASTRO), the American Association of Physicists in Medicine (AAPM), the 
American Board of Nuclear Physicians (ABNP), the American Thyroid 
Association, the Endocrine Society, the American College of Radiology 
(ACR), the Society of Nuclear Medicine (SNM), the National Association 
of Nuclear Pharmacists, the American Pharmacists Association, and the 
Council on Radionuclides and Radiopharmaceuticals (CORAR).
    Commenters opposing the petition stated that reverting from the 
current release criteria back to the 30-mCi rule would result in 
additional and unnecessary healthcare costs, and would unnecessarily 
limit access to treatment for patients who cannot afford 
hospitalization. Commenters opposing the petition also stated that the 
provisions of the current rule provide patients the comfort and 
convenience of being in their homes, rather than the confinement in a 
hospital environment.
    Many physicians opposing the petition disagreed with the 
petitioner's assertion that the patients are released while they are a 
risk of exposure to others. These physicians commented that they 
carefully interview the patients and assess their ability to follow and 
understand radiation safety precautions and their living conditions at 
home, and then decide on outpatient treatment. These physicians also 
stated that they discuss with their patients arrangements to have any 
children in the households stay away from their homes during the 
initial week of their treatments. With regard to the petitioner's 
concern about patient vomiting, some physicians stated that they 
provide special instructions to the patients to handle the vomitus and 
prescribe anti-nausea medication, if needed. These commenters indicated 
that vomiting is a rare complication with these patients.
    One commenter generally opposed the petition but noted the 
recommendations of the International Commission on Radiological 
Protection (ICRP), in ICRP Publication 94 (published in 2004), 
entitled, ``Release of patients after therapy with unsealed 
radionuclides.'' The commenter stated that ICRP Publication 94 now 
recommends that doses to children be constrained to less than 1 mSv 
(100 millirem) and that doses to children from patient contamination 
have the potential to be far greater than from external exposure. In 
light of this, the commenter suggested that there may be a need for NRC 
to consider adding instructions in NUREG-1556, Volume 9, ``Consolidated 
Guidance About Material Licenses: Program Specific Guidance About 
Medical Use Licenses,'' regarding the avoidance of exposure to children 
to patient contamination. NUREG-1556, Volume 9, Appendix U, ``Model 
Procedures for Release of Patients or Human Research Subjects 
Administered Radioactive Materials,'' provides instructions to minimize 
exposure to family members and other members of

[[Page 29447]]

the public (U.2.3.1). Although these instructions include precautions 
to reduce the spread of contamination, the instructions do not 
specifically caution against avoiding exposure of children to patient 
contamination. Therefore, the commenter suggested that NRC revise 
NUREG-1556, Volume 9, to include specific guidance for patients on 
precautions to avoid children's exposure to radioactive contamination.

Petition Resolution

    After reviewing the information provided in the petition, as 
supplemented, and the comments, the NRC has determined that the issues 
raised in the petition do not justify a rule change. The NRC believes 
that the current NRC regulations provide adequate protection to family 
members and other members of the public. The NRC's responses to the 
petitioner's specific concerns are provided below.

NRC Responses to the Issues Raised by the Petitioner

    The petitioner asserts that the 1997 rulemaking was defective 
because it was purportedly adopted in response to a petition from a 
member of the public submitted in December 1990, but was actually 
drafted at the request of the NRC staff, and according to NRC staff 
specifications. The petitioner asserts that the NRC staff's failure to 
disclose this fact to the Commission in the rulemaking documents and 
the failure to notice this assistance in the Federal Register violated 
the Commission's rules.
    The petitioner asserts that NRC staff offered inappropriate 
assistance to the rulemaking petitioner. However, there were neither 
NRC regulations nor internal policies that addressed the staff role or 
level of assistance that could be provided to potential petitioners at 
the time that the alleged staff assistance occurred. In any event, a 
decision to initiate rulemaking to adopt the petitioner's proposals 
could not rest on a question of staff compliance with internal NRC 
procedures. However initiated, the 1997 rulemaking involved broad 
participation with 63 commenters, including medical practitioners and 
medical organizations, regulatory agencies in Agreement States, public 
interest groups and private individuals. Moreover, the American College 
of Nuclear Medicine and the American Medical Association filed 
petitions later that were included in the rulemaking. Their independent 
proposals as well as the broad participation by interested parties 
negate the inference drawn by the petitioner that the resulting 
rulemaking was merely the product of staff influence. To reopen the 
earlier rulemaking would require evidence that alleged procedural 
defects substantively affected the final rule in a manner requiring 
that additional rulemaking be initiated. No such evidence has been 
brought to our attention, nor is the Commission aware of any basis for 
such a conclusion. Thus, even assuming that the petitioner's 
allegations of undue staff assistance were true, the petitioner has not 
demonstrated a substantive basis for reopening the earlier rulemaking 
or for initiating rulemaking in response to this petition.

Dose to Family Members, Especially Children

    The petitioner asserts that patients treated for thyroid cancer 
with I-131 are being sent home under conditions that guarantee that 
family members will receive large and potentially harmful doses of 
radiation under uncontrolled conditions. The petitioner expresses 
particular concern for exposure to children because children are more 
radiation-sensitive than adults.
    The concerns related to doses to the family members and members of 
the public from released patients were extensively considered during 
the development of the current patient release criteria rule. By way of 
background, in 1991 (56 FR 23360, May 21, 1991) NRC published a final 
rule that amended 10 CFR Part 20 ``Standards for Protection Against 
Radiation'' to include a change to the dose limits for individual 
members of the public in 10 CFR 20.1301. The rule lowered dose limits 
for members of the public from 500 millirem per year to 100 millirem 
per year. However, the criteria for the release of patients under 10 
CFR 35.75 had been based on a dose limit of 500 millirem to members of 
the public. When 10 CFR Part 20 was issued, there was no discussion in 
the supplemental information on whether or how the provisions of 10 CFR 
20.1301 were intended to apply to the release of patients.
    Some stakeholders were uncertain about what effect the revised 10 
CFR Part 20 would have on patient release criteria and subsequently, 
three petitions for rulemaking were received related to this issue. One 
petition was received from Dr. Carol Marcus, one from the American 
College of Nuclear Medicine (ACNM), and one from the American Medical 
Association (AMA). Dr. Marcus, and the ACNM petitions requested the NRC 
to amend the revised Part 20 and 10 CFR 35.75 to raise the annual 
radiation dose limits to members of the public from 1 millisievert (0.1 
rem) to 5 millisieverts (0.5 rem) from patients administered 
radioactive materials, and the AMA petition requested that patient 
release be regulated by Part 35 rather than Part 20. NRC decided to 
resolve all of these petitions in a single rulemaking.
    In June 1994 a proposed rule was published to amend 10 CFR 
20.1301(a)(1) to specifically clarify that the dose to individual 
members of the public from a licensed operation does not include doses 
received by individuals exposed to patients released under 10 CFR 
35.75. 59 FR 30724 (June 14,1994). However, the dose limits in the 
revised Part 20 were not changed.
    In the proposed rule, the NRC also proposed to amend 10 CFR 35.75 
to change the patient release criteria from 30 millicuries of activity 
in a patient or a dose rate of 5 millirems per hour at 1 meter from a 
patient, to a dose-based criteria where the TEDE to an individual from 
exposure to a released patient is not likely to exceed 5 mSv (0.5 rem). 
Under the regulations in effect before 1997, activity within a patient 
was measured to determine whether a patient could be released from 
licensee control. However, the NRC determined that this type of an 
approach was not dependable, in that there were variants among the 
isotopes that would cause variations in the dose that would result to 
another individual from exposure to the released patient. The NRC 
believed that the primary consideration in the release of patients 
should not be the activity within the patient, but the potential doses 
to other individuals. NRC concluded that basing the patient release 
criteria on the dose to individuals exposed to a patient (i.e. dose-
based regulation) would provide a consistent, scientific basis for such 
decisions that treats all radionuclides on a risk-equivalent basis. A 
dose-based rule was therefore proposed that would allow consideration 
of case-specific factors to more accurately assess the dose to other 
individuals.
    The final rule amending Part 20 and Part 35 to incorporate these 
changes was published in 1997 (62 FR 4120, January 29, 1997). In April 
1997, the NRC also published a report ``Regulatory Analysis on Criteria 
for the Release of Patients Administered Radioactive Material'' (NUREG-
1492). The report assessed the potential internal and external doses to 
individuals exposed to patients who have been administered 
radiopharmaceuticals and performed a comprehensive risk/benefit 
analysis for adopting the 5 mSv (0.5 rem) TEDE criterion for patient 
release. The report stated that the criterion was based on the ICRP 
Publication 60, ``1990

[[Page 29448]]

Recommendations of the International Commission on Radiation 
Protection,'' and the recommendations of the NCRP in NCRP Report No. 
116, `` Limitation of Exposure to Ionizing Radiation.'' Each of these 
reports provided a basis for allowing individuals to receive annual 
doses up to 5 mSv (0.5 rem) under certain circumstances. These 
recommendations of the ICRP and NCRP were based on a finding that 
annual doses in excess of 1 mSv (0.1 rem) to a small group of people, 
provided that they do not occur often, need not be regarded as unduly 
hazardous. The dose-based release limits also used assumptions that the 
internal doses for individuals who may come in contact with released 
patients were very small compared with doses from external exposures.
    The petitioner has not provided any data to refute the analysis 
provided in NUREG-1492. However, one commenter noted that ICRP 
Publication 94 now recommends that doses to children be limited to less 
than 1 mSv (100 millirem) and that doses to children from patient 
contamination have the potential to be far greater than from external 
exposure. The commenter recommended that NRC consider adding 
instructions in NUREG-1556, Volume 9, regarding the avoidance of 
exposure of children to patient contamination.
    The NRC carefully considered this issue in reviewing the petition 
and reviewed ICRP Publication 94. The recommendations in the report do 
not explicitly state that patients should be hospitalized. However, 
ICRP recommends that public dose limits and dose constraints for others 
be observed, and be followed with optimization, realizing that 
procedures of optimization and their effects on individual behavior 
will differ among individuals and their circumstances.
    In addition, ICRP recommends: ``Since high absorbed thyroid dose 
may occur in infants and young children from contamination, and 
children's thyroids are very radiosensitive for carcinogenesis, this 
population should be restricted to the public dose limit of 1 mSv/
year.'' The report states that although the dose to adults exposed to 
released patients is mostly from external radiation, children may 
receive a dose from contamination. Therefore, restrictions following 
the release of patients should focus on infants and children. Recently, 
ICRP has also published a comprehensive revision to its recommendations 
made in 1991, in ICRP Publication 103. ICRP Publication 103 repeats the 
recommendations made in ICRP Publication 94 that young children and 
infants, as well as visitors not engaged in the care of patients, 
should be limited to a dose of 1 mSv (0.1 rem) per year.
    This recommendation represents a departure from previous ICRP 
recommendations, which did not make a distinction for children or 
infants. Therefore, NRC considered the following regulatory options for 
limiting the exposure to children and infants from released patients:
    (1) Amend 10 CFR 35.75 to limit children and infants exposure to 1 
mSv (0.1 rem);
    (2) Amend 10 CFR 35.75 (b) to include special instructions if the 
dose to an infant or child could exceed 1 mSv (0.1 rem); or
    (3) Revise the guidance in NUREG-1556, Volume 9, to include the 
ICRP Publication 94 recommendations and issue a Regulatory Issue 
Summary (RIS) to medical licensees to make them aware of the ICRP 
recommendations.

Option (1) Amend 10 CFR 35.75 to Limit Children and Infants Exposure to 
1 mSv (0.1 rem)

    NRC has determined not to change the rule to adopt a lower limit 
for children and infants. The NRC does not believe that such a rule 
change would be effective because it is difficult to meaningfully 
estimate the doses that may result from patient contamination. The 
factors involved in assessing such doses are largely indeterminate, and 
even assumptions are likely to be so much in error as to be 
meaningless. For example, the amount of iodine in the patient's saliva 
is highly variable even for patients receiving the same treatment, and 
the amount of saliva that may be ingested by a child is dependent on 
the details of the family's living arrangements, family habits and the 
age of the child, and cannot be reliably assumed to assess the dose to 
the child or the infant. This makes a dose-based approach to protecting 
children from patient contamination an impractical choice. NRC believes 
that an alternative approach that is more likely to provide better 
protection for children and infants would be for patients to take 
precautions to maintain the dose to children and infants as low as is 
reasonably achievable (ALARA). NRC therefore has determined that the 
instructions to the patients, as well as any guidance to physicians, 
should be modified to stress the need to keep children and infants away 
from any possible sources of contamination.
    10 CFR 35.75(b) requires licensees to provide instructions, 
including written instructions on actions recommended to maintain doses 
to other individuals ALARA. Therefore, NRC determined that this 
guidance should be strengthened to protect children and infants from 
any sources of patient contamination. To achieve this goal, NRC has 
revised the guidance in NUREG 1556, Volume 9 and has developed a 
Regulatory Issue Summary (RIS) to convey to the licensees the concerns 
expressed in ICRP Publications 94 and 103 about doses to children from 
patient contamination and the actions licensees and patients should 
take to keep children away from any sources of patient contamination. 
These actions would be based on the individual patient's circumstances 
and may include hospitalization of the patient based on the patient's 
family situation. NRC will issue the RIS and the revised guidance in 
NUREG 1556, Volume 9, to all medical use licensees and to the Agreement 
States concurrent with the issuance of this petition resolution.
    NRC believes that enhancing the guidance is a more efficient way of 
protecting children and infants than amending the regulations. In 
addition, in considering the disposition of a petition for rulemaking, 
NRC must consider whether addressing the topics raised in the petition 
are likely to result in a significant increase in safety or security 
for all affected stakeholders. As explained above, NRC does not believe 
that the issues raised in this petition significantly impact safety and 
security such as would warrant a rulemaking. Additionally, the NRC must 
consider the potential impact of a rulemaking on the agency's 
efficiency and effectiveness. NRC has limited resources for rulemaking; 
therefore any topic to be considered in the NRC rulemaking process must 
have a strong technical basis before it can be considered in the 
agency's prioritization process for rulemaking. In any given budget 
cycle, only a limited number of rulemakings can be funded. Topics with 
minimal safety or security impact may not reach the funding threshold. 
The NRC does not believe that there is a sufficiently strong technical 
basis to consider the issues in this petition in a rulemaking.

Option (2) Amend 10 CFR 35.75 (b) to Include Special Instructions if 
the Dose to an Infant or Child Could Exceed 1 mSv (0.1 rem)

    NRC determined that it is not necessary to amend 10 CFR 35.75(b) to 
require that special instructions be provided if the dose to an infant 
or child could exceed 1 mSv (0.1 rem). Section 35.75(b) presently 
requires a licensee to provide the released individual, or the 
individual's parent or guardian with instructions, including written

[[Page 29449]]

instructions, on actions recommended to maintain doses to other 
individuals as low as is reasonably achievable (ALARA), if the TEDE to 
any other individual is likely to exceed 1 mSv (0.1 rem). The 
requirement that instructions be provided if the TEDE is likely to 
exceed 1 mSv to any other individual includes that these instructions 
must be provided if the TEDE to children and infants is likely to 
exceed 1 mSv (0.1 rem).

Option (3) Revise the Guidance in NUREG-1556, Volume 9, to Include the 
ICRP 94 Recommendations and Issue a Regulatory Issue Summary (RIS) to 
Medical Licensees to Make Them Aware of the ICRP Recommendations

    As discussed under Option (1), NRC determined to revise the 
guidance in NUREG-1556, Volume 9, and issue a RIS to make licensees 
aware of the ICRP's new recommendations, and to heighten licensees' 
awareness of the requirements of the regulations in 10 CFR 35.75(b). 
NRC believes that the protection for children is best achieved through 
maintaining doses ALARA. NRC believes that this can be accomplished 
under the current patient release criteria, but that the instructions 
to the patients, as well as any guidance to physicians, need to be 
modified to emphasize the need to keep children away from any possible 
sources of contamination. The guidance needs to be sufficiently 
flexible so that the patient's physician has the option of keeping the 
patient in the hospital for longer periods than currently required if 
the patient's living conditions warrant such a decision. The NRC 
believes that these actions will adequately protect infants and 
children.
    The petitioner also asserts that NRC has allowed for reduction of 
exposure to hospital employees and clergy members at the expense of 
elevated exposure to family members. The petitioner's assertion is 
based upon a misinterpretation of a response to a comment on the 
proposed rule as discussed in the Statements of Consideration of the 
final rule published on January 29, 1997 (62 FR 4120). Specifically, a 
commenter had noted that it would not be possible to maintain the same 
level of contamination control at home that could be maintained in a 
hospital. In responding to this comment, the NRC noted that the two 
situations were not comparable because areas in hospitals have 
potential for contamination from many patients, and that people who 
frequent the hospital, such as clergy, would therefore have the 
potential to be exposed to contamination from many patients. However, 
in the case of a released patient at home, therapeutic administrations 
usually occur no more than once a year and probably no more than once 
in a lifetime. The reference to exposure of hospital clergy to 
contamination from many patients was intended as an example, and was 
not intended to imply that removing patients from the hospital would 
constitute a benefit to clergy that would compensate for an additional 
risk to a patient's children. Rather, the Statements of Consideration 
in the 1997 final rule explain that NRC considered the results of 
studies and recommendations current at the time, evaluated the benefits 
to patients from being home, and concluded that doses to household 
members from one patient would be low, compared to increased exposure 
to hospital personnel from recurring administrations. NRC believes that 
the current rule provides adequate protection of the public and family 
members and minimizes exposure of hospital employees.

Dose to Members of the Public During Patient Transport

    The petitioner expresses concern about dose to members of the 
public during transport from patients who have been administered large 
amounts of I-131. The guidance in NUREG-1556, Volume 9, provides 
adequate instructions for the patient to minimize time in public places 
(for example, public transportation, grocery stores, and shopping 
centers). Also, ICRP Publication 94 concludes that patients traveling 
after radioiodine therapy rarely present a hazard to other passengers 
if travel times are limited to a few hours. From the comments received, 
it appears that a vast majority of the patients return home in private 
vehicles. Other than describing a single anecdotal account of an I-131 
patient who allegedly traveled home on a bus, vomited, and exposed her 
husband and children to radiation, the petitioner provides no specific 
data in support of his position.

Contamination and Dose Concerns Due to Vomiting

    In support of his petition, the petitioner expresses concern about 
dose to family members who clean up the patient's vomit, and a loss of 
administered dose to the patient. Although the petitioner describes a 
case that he states is known to him, the petitioner provides no 
specific data in support of his concern. Some physicians have commented 
on the petitioner's concern and stated that the incidence of vomiting 
in their experience is rare, and that the physicians are able to 
prescribe anti-nausea drugs, if needed. The same view was expressed by 
physician members of the Advisory Committee on the Medical Uses of 
Isotopes at its November 2006 meeting. In addition, some physicians 
stated that they provide special instructions to their patients 
regarding handling of the vomitus and prescribe anti-nausea drugs, if 
needed.

Hypothyroid Patients Are Not Able to Fully Comprehend or Remember 
Instructions.

    The petitioner expresses concern that most patients are in a 
hypothyroid state and, therefore, are unable to fully comprehend or 
remember the instructions provided to them. The petitioner describes 
these patients as ``sick, and quite possibly stressed, groggy, and 
mentally fogged, to remember the guidance and follow it.'' The 
petitioner does not provide any new or specific information in support 
of his concern.
    The regulations in 10 CFR 35.75(b) require instructions be provided 
to the individual, or the individual's parent or guardian, including 
written instructions, on actions recommended to maintain doses to other 
individuals ALARA if the TEDE to any other individual is likely to 
exceed 1 mSv (0.1 rem). In the 2002 revision to Part 35 (67 FR 20249; 
April 24, 2002), 10 CFR 35.75(b) was revised to specify that licensees 
may provide instructions to either the released individual or to the 
individual's parent or guardian, to acknowledge that it is not 
appropriate to provide the individual being released with instructions 
in some cases (e.g., the individual is a minor or incapable of 
understanding the instructions). In addition, the regulations do not 
mandate the release of patients. Physicians always have the option of 
hospitalizing individuals based on their judgment of an individual's 
condition. One of the commenters, a physician, noted that at his 
institution if a patient is determined to be incontinent, incapable of 
self-care, or unable to adhere to the instructions, then the patient is 
treated as an inpatient.

Waste Issue

    One commenter in support of the petition stated that the rule has 
resulted in an increase on the burden of State responders due to an 
increase in the alarms triggered at the municipal waste handling 
facilities. Although this issue was not raised by the petitioner, the 
NRC staff reviewed this concern. These alarms are generally triggered 
by any radioactivity detected at these facilities.

[[Page 29450]]

The commenter did not provide any data on how many or what fraction of 
these alarms are triggered by the wastes from these patients. With 
regard to the environmental pathways of radioiodine, ICRP Publication 
94 states that ``regarding the release of patients from the hospital, 
the radioiodine is in the patient where it decays or is excreted 
primarily in urine, and finds its way into the environment.'' According 
to the report, the impact of the released I-131 on the environment 
should be minimal, considering that I-131 has a relatively short half 
life of 8 days. The time it takes for the excreta of patients to be 
processed and returned to the ecosystem is relatively long. In 
addition, the impact of I-131 on the environment from this pathway is 
usually independent of whether the patient is hospitalized after 
treatment or released to go home.

Conclusion

    The decision to deny the petition is consistent with NRC's 
Strategic Plan for Fiscal Years 2008-2013. NRC's strategic safety goal 
to ``ensure adequate protection of public health and safety and the 
environment'' would continue to be maintained because NRC believes that 
the current rule is adequate to protect public health and safety from 
the release of these patients. The decision is also consistent with the 
Strategic Plan's focus on Organization Excellence. Specifically, the 
openness objective was accomplished by soliciting and considering 
public comments on the petition. It is expected that denying this 
petition will continue to maintain the NRC's effectiveness objective 
because reverting to the 1997 release criteria as requested by the 
petitioner would place a significant regulatory burden on licensees 
with no commensurate benefit to public health and safety.
    In conclusion, NRC finds that the arguments presented in PRM-35-18 
do not support a rulemaking to revoke the patient release criteria in 
10 CFR 35.75. Reverting to the 1997 patient release criteria would 
impose unnecessary regulatory burden and is not warranted for the 
protection of public health and safety. To address the petitioner's 
concern for exposure to children and infants, NRC has prepared a RIS 
and additional guidance which will be issued to all NRC medical use 
licensees, and to the Agreement States, concurrent to the resolution of 
this petition.
    For the reasons cited in this document, the NRC denies this 
petition for rulemaking.


    Dated at Rockville, Maryland, this 7th day of May 2008.

    For the Nuclear Regulatory Commission.
R.W. Borchardt,
Executive Director for Operations.
[FR Doc. E8-11344 Filed 5-20-08; 8:45 am]
BILLING CODE 7590-01-P