[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]



 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 
    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 
    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 

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].



    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 
    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 
    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]