[Federal Register Volume 70, Number 244 (Wednesday, December 21, 2005)]
[Proposed Rules]
[Pages 75752-75753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7641]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-18]
Peter G. Crane; Receipt of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; Notice of receipt.
-----------------------------------------------------------------------
SUMMARY: The Nuclear Regulatory Commission (NRC) has received and
requests public comment on a petition for rulemaking filed by Peter G.
Crane (petitioner). The petition has been docketed by the NRC and has
been assigned Docket No. PRM-35-18. The petitioner is requesting that
the NRC amend the regulation that governs medical use of byproduct
material concerning release of individuals who have been treated with
radio pharmaceuticals. The petitioner believes that this regulation is
defective on legal and policy grounds. The petitioner requests that the
patient release rule be partially revoked to not allow patients to be
released from radioactive isolation with more than the equivalent of 30
millicuries of radioactive iodine I-131 in their bodies.
DATES: Submit comments by March 6, 2006. Comments received after this
date will be considered if it is practical to do so, but assurance of
consideration cannot be given except as to comments received on or
before this date.
ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number (PRM-35-18) in the subject line of
your comments. Comments on petitions submitted in writing or in
electronic form will be made available for public inspection. Because
your comments will not be edited to remove any identifying or contact
information, the NRC cautions you against including personal
information such as social security numbers and birth dates in your
submission.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555. Attention: Rulemaking and Adjudications staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address comments
about our rulemaking Web site to Carol Gallagher, (301) 415-5905; (e-
mail [email protected]). Comments can also be submitted via the Federal
eRulemaking Portal http:www.regulations.gov.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland,
between 7:30 a.m. and 4:15 p.m. on Federal workdays.
Publicly available documents related to this petition may be viewed
electronically on the public computers located at the NRC Public
Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville
Pike, Rockville, Maryland. The PDR reproduction contractor will copy
documents for a fee. Selected documents, including comments, may be
viewed and downloaded electronically via the NRC rulemaking Web site at
http://ruleforum.llnl.gov.
Publically available documents created or received at the NRC after
November 1, 1999 are also available electronically at the NRC's
Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html.
From this site, the public can gain entry into the NRC's Agencywide
Documents Access and Management System (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 a copy of the petition, write to Michael T. Lesar, Chief, Rules
and Directives Branch, Division of Administrative Services, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555. Telephone: 301-415-7163 or Toll-Free: 1-800-368-5642 or E-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
The NRC has received a petition for rulemaking dated September 2,
2005, submitted by Peter G. Crane (petitioner) entitled ``Re: Petition
for Partial Revocation of the Patient Release Criteria Rule.'' The
petitioner is an attorney who was formerly employed in the NRC's Office
of the General Counsel from 1975 until his retirement from the NRC in
1999. The petitioner requests that the NRC amend 10 CFR part 35,
``Medical Use of Byproduct Material.'' Specifically, the petitioner
requests that the 1997 amendment to 10 CFR 35.75, ``Release of
Individuals Containing Radiopharmaceuticals or Permanent Implants'' (62
FR 4120; January 29, 1997 (Patient Release Criteria Rule), be partially
revoked.
The petitioner believes the Patient Release Criteria Rule is
defective on both legal and policy grounds. The petitioner recommends
that 10 CFR 35.75 be amended to prohibit the release of patients from
radioactive isolation with more than the equivalent of 30 millicuries
of radioactive iodine-131 (I-131) in their systems. The NRC has
determined that the petition meets the threshold sufficiency
requirements for a petition for rulemaking under 10 CFR 2.802. The
petition has been docketed as PRM-35-18. The NRC is soliciting public
comment on the petition for rulemaking.
Discussion of the Petition
The NRC amended its patient release criteria in 10 CFR Part 35 in
1997 to allow the release of patients from licensee control who had
been administered unsealed by product material if the total dose
equivalent to any other individual from exposure to the released
individual is not likely to exceed 5 mSv. (0.5rem). Prior to that time,
NRC regulations required the hospitalization of patients with the
equivalent of 30 millicuries or more of radioactive iodine 131 (I-131)
in their systems, a dose which the petitioner believes is consistent
with the International Basic Safety Standards on radiation protection.
The petitioner objects to the release of patients with more than
the equivalent of 30 millicuries of I-131 in their systems. The
petitioner clarifies that his objection to the patient release criteria
rule is based on both legal and policy grounds. On legal grounds, the
petitioner asserts that the 1997 rulemaking was ``a sham'' in that it
was ``legally tainted'' by collusion between the NRC staff and a
petitioner. Specifically, the petitioner asserts that a former member
of NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI) who
submitted a petition for rulemaking in 1991 requesting the patient
release criteria rule, submitted the petition at the NRC staff's
request with NRC staff assistance, in violation of NRC regulations.
[[Page 75753]]
The petitioner also objects to the patient release criteria rule on
policy grounds, stating that it creates unwarranted hazards with regard
to the radioactive iodine treatment of thyroid patients. The
petitioner's concern is that there is no ``hard and fast limit on the
amount of I-131'' administered to an outpatient, and that a licensee
must only perform a calculation showing that no one will receive a dose
that exceeds a prescribed limit. However, the patient release criteria
rule means that patients who are sick, stressed, hypothyroid,
potentially nauseous, and highly radioactive are being ``sent out the
door,'' where they may come into close contact with family members and
members of the public, and although they are supposed to receive
instructions on minimizing exposure, may have trouble comprehending and
remembering the guidance they are given. The petitioner expresses
particular concern regarding how children of released patients will be
adequately protected from radiological exposure, stating that children
are more radiation-sensitive than adults and deserve more protection.
The petitioner also expresses concern that there is a likelihood of
vomiting and that, unlike hospital staff who wear protective clothing
to protect against radiological contamination encountered while
cleaning up, family members caring for patients at home will be
unlikely to take such precautions.
The petitioner also claims that during the 1997 rulemaking, when
the NRC gave notice of the receipt of the petition for rulemaking, it
received numerous adverse comments from the ACMUI, Agreement States,
and other commenters. However, according to the petitioner, the NRC
proceeded to issue the proposed rule and largely ignored comments that
ran counter to the NRC staff's preferred approach. In fact, the
petitioner asserts that the notice of the final rule misrepresented
critical comments on the release of patients with I-131 in their
systems.
The petitioner states that the NRC acknowledged in promulgating the
1997 final rule that family members of patients would receive higher
doses of radiation, but justified this in part by arguing that members
of the clergy who visit hospitals frequently would receive lower doses
of radiation as a result of patients having been sent out of the
hospital, and by referring to the emotional benefit of releasing these
patients. Specifically, the petitioner asserts that the NRC claimed in
the final rule (see, 62 FR 4129) that although individuals exposed to
the patient could receive higher doses than if the patient had been
hospitalized longer, ``these higher doses are balanced by shorter
hospital stays and thus lower health care costs. In addition, shorter
hospital stays may provide emotional benefits to patients and their
families. Allowing earlier reunion of families can improve the
patient's state of mind, which in itself may improve the outcome of the
treatment and lead to the delivery of more effective health care.''
The petitioner argues, however, that the NRC's reasoning ignored
his and other thyroid patients' comments that some ``patients may
experience greater `emotional benefit' from knowing that by receiving
their treatment as in-patients, they are protecting their families from
unnecessary radiation exposure.'' Moreover, the petitioner is skeptical
of the NRC's rationale that releasing patients with treatment doses of
radioactivity in their bodies will reduce exposure to clergy who
regularly visit hospitals, or hospital orderlies.
Finally, the petitioner takes issue with other aspects that he
notes constituted part of the NRC staff's rationale for the patient
release criteria rule. Specifically, he contests the NRC's assertion
that I-131 treatment for thyroid cancer occurs ``probably no more than
once in a lifetime,'' the NRC's implication that no harm is done by
exposing family members to the exposure from just one treatment, and
the implication that it is not ``reasonably achievable'' to keep
radiation exposure to family members low by treating patients in
radioactive isolation.
The Petitioner's Conclusion
The petitioner concludes that the patient release criteria rule is
irredeemably flawed, as was the rulemaking that produced that rule. The
petitioner therefore requests that the NRC institute rulemaking to
rescind that portion of 10 CFR 35.75 that allows patients to be
released from radiological isolation with I-131 in their systems in
amounts greater than 30 millicuries. The petitioner requests that this
rulemaking be undertaken expeditiously.
Dated at Rockville, Maryland, this 15th day of December, 2005.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. E5-7641 Filed 12-20-05; 8:45 am]
BILLING CODE 7590-01-P