ML20141J102
| ML20141J102 | |
| Person / Time | |
|---|---|
| Issue date: | 11/19/1995 |
| From: | Siegel B NRC |
| To: | Stewart Schneider NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-022, AE41-2-22, NUDOCS 9708140397 | |
| Download: ML20141J102 (11) | |
Text
fbk eE-4//-a-Barry Siegel <siegelb9mirlink.wustl.edu>
O. From:
To:
Date:
Stewart Schneider <sxs49nrc. gov >
11/19/95 3:56pm
Subject:
Patient Release Rule Stewart: If you haven't finished adding references to the Reg Guide for the i
Patient Release Rule, you might want to have a look at nice review article by
-Thomson and Harding in November 1995 issue of Nuclear Medicine Communications (16:879-892,1995). See also-immediately preceding editorial in same issue (pp.-877-878 . ,
l l By the way, w) hat is the status of the rule-making package? How many of the 1
' '" technical" corrections recommended by ACMUI were made?
BAS CC: John E. Glenn <jeg@nrc. gov >
O V
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l l 1 FOR: The Commissioners -
FROM: James M. Taylor Executive Director for Operations
SUBJECT:
FINAL AMENDMENTS TO 10 CFR PARIS 20 AND 35 ON CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIAL PURPOSE:
To obtain Commission approval to publish a notice of final rulemaking. in-the Federal Reaister.
O Q BACKGROUND:
On May 21,1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR Part 20, " Standards for Protection Against Radiation." The rule, contained a dose limit of 1 mil 11 sievert (0.1 rem) total effective dose--
p' equivalent for members of the public in 10 CFR 20.1301(a). 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 reinase of patients.
NRC's current patient release criteria are contained in 10 CFR 35.75, " Release of patients or human research subjects containing radiopharmaceuticals or permanent implants." That section states: "
release from confinement for medical care any(a) patientAor licensee may not authorize human research subject administered a radiopharmaceutical until either: (1) The measured dose rate from the patient or human research subject is less than 5 millirems per hour at a distance of 1 meter; or (2) The activity in the patient or human research subject is-less than 30 millicuries;--(b) A licensee may not authorize release from confinement for medical care of-any patient or human research subject administered a permanent implant until the measured dose rate from the CONTACTS:
,A 415-6225
' Stephen A. McGuire, RES 415-6204
(v ') The Commissioners 2 patient or the human research subject is less than 5 millirems per hour at a distance of 1 meter."
Some licensees were uncertain about the effect that the revised 10 CFR Part 20 would have on patient release criteria, and three petitions for rulemaking were received on the issue.' To resolve this uncertainty, two steps were taken.
i
' The short-term resolution was to inform licensees of the NRC's position that 10 CFR 35.75 governed patient release. The Commission was informed in l
SECY-94-01 of the staff's recommendation that 10 CFR 35.75 governs patient release. Information Notice No. 94-09 was issued on February 3, 1994, to inform licensees of this position in accordance with a Staff Requirements Memorandum (SRM) dated January 28, 1994.
l l The longer term resolution was to address this issue through rulemaking, and a l proposed rule was published for comment on June 15, 1994 (59 FR 30724). The pr: posed rule was transmitted to the Commission in SECY-94-054 and responses to questions raised by the Office of the Inspector General are contained in SECY-94-054A.
DISCUSSION:
[m\
(j' The final rule (Attachment 1) takes into consideration the recommendations of the Agreement States, as well as the comment letters received on the proposed rule and the petitions, in all, 232 comment letters were received on the three petitions, and 63 comment letters were received on the proposed rule.
The rule was also discussed with the Advisory Committee on Medical Uses of Isotopas (ACMUI) at several public meetings, the last on October 18 and 19, 1995.
The following summarizes the main features of the amendments:
- 1. The major changes to the final rulemaking are: (1) significant expansion of the discussion on breast-feeding in the Statement of Considerations and (2) explicit use of the term "braast-feeding" in the final rule text to make it clear that breast-feeding women are a class of patients requiring additional records and instructions to limit the dose to the breast-feeding child. The subject of breast-feeding was mentioned in the Statement of Considerations to the proposed rule but not in the proposed rule text.
One commenter raised an issue about contacts allegedly relating to this rulemaking between one of the petitioners and the Office of the Chairman. The staff notes that the final rule is based on the public record associated with (O the rulemaking and that the NRC decision maker with whom contact was made is s
'"') no longer with the Commission. The staff has not included any further comment with respect to this issue in the final rulemaking package.
O V
The Commissioners 3
- 2. The amendments make it clear that patient release is governed by 10 CFR 35.75 rather than by 10 CFR 20.1301(a). There was very broad agreement with this position in the comment letters, with ACMUI, and with the Agreement States.
- 3. The amendments revise the criteria for release of patients administered I radioactive material for medical use under 10 CFR 35.75 to permit a maximum likely total effective dose equivalent of 5 millisieverts l { individual exposed to the patient.0.5 rem), excluding background or any occupation S)ecifying the release criterion in terms of radiation dose requires t1at the NRC provida en acceptable method that relates the cuantity of radioactivity administered to that dose. That relationship will be included in a regulatory guide. A working draft of that guide is attached (Attachment 2); the staff is- still reviewing the guide, but will publish it in final form before the final rule becomes effective.
The guido presents two methods to relate dose to quantity of radioactivity administered. The first method is the use of a default table of release quantities and release dose rates-based on conservative assumptions. For the radioactive material of greatest significance, O
iodine-131, the default table is essentially equivalent to the release criteria in the current regulations. The staff anticipates that nearly all patients will be released based on the-default table of activities.
The second method is to perform a case-specific dose calculation using the method described in the guide. The case-specific method can be less conservative than the default table because it permits a more realistic estimate of how quickly the radioactive material leaves the patient's body. Thus, use of this method would, in some cases, permit the release of patients containing several times more radioactive material than the current regulations permit or allowed with use of the default table.
The authorization to release a patient is based on the licensee's determination that the total effective dose equivalent to an individual from the released patient is not likely to exceed 5 millisieverts (0.5 rem). The dose to the breast-feeding child from breast-feeding is not necessarily a criterion for release since it can be controlled by giving the woman guidance on the interruption of breast-feeding, as required by the amendments (see No. 5).
Overall, a substantial majority of all comments supported an explicit dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material in their bodies. In addition, ACMUI and the Agreement States sup)orted the criterion based on a dose limit. A few commenters who thougit that the present criteria
/'. N were working well and were adequate, opposed allowing the release of
( patients with quantities of radioactive material greater than that permitted under the current regulations.
The Commissioners 4
- 4. The proposed rule would have required licensees to maintain, for 3 years, a record of the basis for the patient's release and the total effective dose equivalent if any individual is likely to receive a dose in excess of 1 milli:lievert (0.1 rem) in a year from a single administration. This requirement was proposed so that records would be available to calculate the dose if a patient received multiple administrations in a year. l c
This proposed recordkeeping requirement met a great deal of opposition.
Commenters were especially concerned about having to retrieve records of j previous administrations, sometimes from another medical facility. Upon l reconsideration, it was decided to delete this requirement because a review of nuclear medicine procedures indicated that there was no significant likelihood of exceeding a 5-mil 11 sievert (0.5-rem) annual dose because of multiple administrations.
In place of the deleted recordkeeping requirement, the final rule contains requirements to maintain: (1) a record for the basis of the release for a limited number of certain radiopharmaceutical administrations (e.g., therapeutic administrations of iodine-131) and (2) a record that instructions were provided to a breast-feeding woman if the administered activity cauld result in a total effective dose m) equivalent to the breast-feeding child exceeding 5 millisieverts
_[V (0.5 rem) if the woman did not interrupt breast-feeding. The requirements (in 10 CFR 35.75(c) and (d)) would affect about 20,000 of the 8 to 9 million administrations done annually.
- 5. The amendments require-that-the patient be given instructions, including-written instructions, on how to maintain doses to others as low as is reasonably achievable f f the dose to an individual is likely to exceed 1 mil 11 sievert (0.1 rem). In general, most commenters agreed with this requirement, although a few did not think that instructions should necessarily have to be written.
The proposed rule had a requirement to provide instructions which would include guidance on breast-feeding children, but-some commenters wanted information on when instructions would have to be given and what the instructions should say about interruption or cessation of breast feeding. The final rule requires that guidance regarding interruption of breast-feeding and consequences be provided if-the released individual may be breast-feeding an infant or child and the total effective dose equivalent is likely to exceed 1 mil 11 sievert (0.1 rem).
The regulatory guide will contain interruption periods that keep the dose from breast-feeding to less than 1 mil 11 sievert (0.1 rem). The purpose of describing the consequences is so that women will understand that breast-feeding after an administration of certain radionuclides could cause harm (e.g., iodine-131 could harm the child's thyroid). In f other cases, the guidance could sim)1y address avoidance of-any unnecessary radiation exposure to tie child from breast-feeding.
i
/ l
(% The Commissioners 5
- 6. The amendments make it clear that the limit on dose in unrestricted i areaspresentedin10CFR20.1301(a)(2)doesnotincludedose contributions from patients administered radioactive material and released in accordt.nce with 10 CFR 35.75. The purpose of this change is to clarify that licensees are not responsible for doses outside of their restricted areas from radiation sources not under their control. The comments supported this position.
The final amendments represent a partial granting of the regulatory relief requested by the petitioners. The request to delete 10 CFR 20.1301(d), was denied because the reference to the Environmental Protection Agency's regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue.- Also, the request to permit licensees to authorize release from hospitalization any patient administered a radiopharmaceutical regardless of the activity in the patient by defining " confinement" to include not only confinement _in a hospital, but also confinement in a private residence was denied. The staff considers it inadvisable to use a patient's home for the purpose of confinement when the activity in the patient is expected to result in a dose exceeding 5 millisieverts (0.5 rem) to another individual.
At its last meeting, held on October 18 and 19, 1995, the ACMUI passed several
,, motions suggesting changes to three aspects of the rule.
First, the ACMUI suggested using the term " rationale" instead of
" consequences" in the requirement, under 35.75 (b), to provide " guidance on the interruption of breast feeding, and information on the consequences of failure to follow the guidance" for cases where failure to follow the instructions could result in a dose to the infant exceeding 1 millisievert (0.1 rem). Since most of the administrations that would be affected by this requirement are technetium-99m administrations, the ACMUI suggested the change because they said that the consequences of low doses of radiation cannot always be explained to the patient without causing unjustified alarm. Also, the ACMUI said that physicians cannot explain with certainty the effects of low doses of radiation, such as would be caused by diagnostic administrations of technetium-99m. The staff did not change the rule in res)onse to the ACMUI comment, because the requirement to provide information on tie consequences is included to primarily protect the breast-feeding infant from therapeutic administrations of radioiodine, which could cause serious thyroid damage.
Regulatory Guide 8.39 will contain guidance on the types of information, including expected consequences, to be provided to patients to meet this requirement.
Second, the ACMUI suggested that the requirement to keep a record if the release was based on "an activity other than the activity administered" be deleted. The ACMUI was concerned that the meaning was not clear, and in addition, the requirement was already implicit in the remainder of the recordkee)ing requirements in 10 CFR 35.75(c). The staff modified the final
[]
-(/
rule by clanging the phrase "other than" to "less than" the activity
-administered for clarity. This information would be needed for cases where a patient would be held for some time period prior. to release. Such cases would I
4 4
. 1
/
(V 4 The Commissioners ~ 6 ,
l not be covered in the default release table that ' appears in the regulatory i guide. In this case, a record is needed to confirm that the licensee has !
released the individual in accordance with the limit in Part 35. Regulatory I Guide 8.39 will provide guidance on cases where such records will be needed for release.
Third, the ACMUI suggested that the term " discontinuation" should be used in conjunction with " interruption" in the requirement to )rovide " guidance on the i interruption of breast-feeding" if' failure to follow tie instructions could result in a dose to the infant exceeding 1 mil 11 sievert (0.1 rem). The ACMUI suggested the change because they said that there is a distinct difference between the two terms. The staff changed the rule in response to the ACMUI ,
comment. As stated in the Federal Register notice, "the instructions must i include guidance on the interruption period for breast-feeding." Table 2 in I the guide gives interruption periods for various radiopharmaceuticals which !
can be temporary (48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> or less) in some cases, or discontinuation (no '
resumption) when necessary, i Finally, the ACMUI recommended that the Commission proceed with the rule as promptly as possible.
RESOURCES: !
h Resources needed to conduct and implement this rulemaking are included in the FY 1995-1999 Five-Year Plan.
COORDINATION:
The Office of the General Counsel has no legal objection to this paper.- !
RECOMMENDATION: -
That the Commission:
1, Approve the notice of final rulemaking for publication (Attachment 1).
- 2. Certify that this rule will not have a significant economic impact on a
, substantial number of small entities; such certification will satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b). '
l -3. Notes:
- a. The final rule will become~ effective 120 days after publication in the Federal Reaister.
-b. A final regulatory guide will be published, for use, before the 4
final rble becomes effective (Attachment 2).
- c. A final regulatory analysis will be available in the Public Document Room (Attachment 3). ,
1 1he Commissioners 7
- d. A final environmental assessment and a finding of no significant impact have been prepared (Attachment 4).
- e. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic. impact on small entities and the reasons for it as required by the Regulatory. Flexibility Act.
- f. The ap3ropriate Congressional Committees will be informed (Attac1 ment 5);. l
.g. A public announcement will be issued (Attachment 6).
.h. The rule contains information collection requirements that are subject to review by the Office of Management and Budget. Upon
);
Commission approval, the OMB supporting statement (Attachment 7) !
will be submitted to OMB for approval.
- i. Copies of the Federal Reaister notice of final rulemaking and the associated regulatory guide will be distributed to all NRC medical licensees and each Agreement State. The notice will be sent to-other interested parties upon request.
James M. Taylor Executive Director for Operations Attachments: As' Stated (7)
i 6 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
(a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).'
(b) The licensee shall provide the released individual with ,
instructions. including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millislevert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 mil 11 sievert (0.1 rem) assuming there were nt, interruption of breast feeding, the instructions shall also include (1) guidance on the interruption or discontinuation of breast-feedin consequences of failure to follow the guidance. g and (2) information on the (c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated (1) using an activity less than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the biological or effective half-life, or_(4) considering the shielding by tissue.
release,.that (d)- The licenseewere instructions shallprovided maintain to a record, for 3 years a breast-feeding after the woman date of if the radiation dose to the infant or child from continued breast-feeding could O result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).
' Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials" (1995), describes methods'for calculating doses to other V individuals and contains ta' ales of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
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