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