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,antog UNITEJ STATES N
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B NUCLEAR REGULATORY COMMISSION (f*
WASHINGTON. D.C. 901 4 0001 hw May-22, 1996 h
i HEMORANDUM T0:
Stewart Schneiv'er Radiation Prottction and Health Effects Branch 7
,i Off c/of.
clear Re ulatory Research g-4/-
di aeI. W 7 FRON:
- Lesar, ief Rules Review Section Rules Review and Directives Branch Division of Freedom of Information and Publications Services Office of Administration
SUBJECT:
REVIEW OF SECY-95-286 " FINAL RULE ON CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMIWISTERED RADI0 ACTIVE MATERIAL"
-The Rules Review Section har reviewed SECY-95-286 that clarify the relationship between Parts 20 and 35 with respect to release of patients and revises the release criteria for patients receiving radioactive material for medical use from an activity-based standard to dose basis.
We have attached a marked copy of the final rule that presents minor editorial and format corrections. These corrections should be made before the rule is forwarded for publication in the Federal Register.
The Small Business Regulatory Enforcement Fairness Act of 1996 provides Congress with the opportunity to review agency rules before they go into effect (5 U.S.C.. Chapter 8). The Act requires agencies to submit a re) ort transmitting a copy of each final rule to each House of Congress and tie General Accounting Office before the rule takes effect. The report must include a concise general statoment concerning the final rule, indicate whether the action is a " major" rule as defined by the legislation and determined by the Office of Management and Budget, and state the anticipated effective date of-the final rule.
The report must be accompanied by a copy of any applicable analyses developed in support of the final rule.
In addition, the legislation mandates that the effective date for a " major" rule may be no earlier than 60 days after the date of Congressional receipt of the required material or publication of the final rule in the Federal Register, whichever is later. We have attached a list of addresses for the required communication and inserted necessary language in the text of the final rule.
Your staff should contact Trip Rothschild, Office of the General Counsel, to coordinate with the Office of Information and Regulatory Affairs (0 IRA, Office of Management Budget concerning whether the action-is a " major) rule" as defined in Section 804 of the Act.
A copy of the final rule was mailed to the Information and Records Management Brancb..IRM, for their comment or concurrence concerning the paperwork managements aspects of the subject document. We have requested that they respond directly to you.
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9708150249 970007 62 4120 PDR
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Stewart Schneider If you-have any. questions regarding the marked copy, please contact me on extension 415-7163 or Alzonia Shepard on extension 415-6864.
. Attachments: As stated-
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ATTACHMENT B - ADDRESSEES FOR LETTERS TRANSMITTING FINAL ACTIONS FOR CONGRESSIONAL REVIEW The Honorable Newt Gingrich Speaker, United States House of Representatives H-209, The Capitol Washington, DC 20515 1
The Honoratile Al Gore President of the United States Senate S-212. The Capitol Washington, DC 20510.
Mr. Robert P.. Murphy General Counsel General Accounting Office Room 7175 441 G St..'NW, Washington, DC 20548 9
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ATTACHMENT D - SAMPLE LETTER FOR A NON-MAJOR ACTION Hr. Robert P. Murphy i
General Counsel General Accounting Office l
Room 7175 l
441 G St., NW, Washington, DC 20548 1
Dear Mr. Murphy:
l Pursuant to Subtitle E of the Small Business Regulatory Enforcement fairness Act of 1996, 5 U.S.C. 801,.the Nucleat Regulatory Commission (NRC) is submitting a final rule that will strengthen the Commission's control over radioactive waste coming into and leaving the United States by requiring specific NRC licensing of radioactive waste imports and exports.
The final rule will help to ensure that transactions involving the import and export of radioactive waste are subject to the approval of the U.S. Government and the consent of other involved parties. The new regulations will conform U.S.
policies with the IAEA approved voluntary Code of Practice, which was adopted to guide Nation States in the development of policies and laws on the transboundary shiprtents of radioactive wastes.
We have determined that this rule is not a major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule, which is being transmitted to the Federal Register for publication.
The Regulatory Flexibility Certification is included in the final rule. Also enclosed is a copy of the regulatory Analysis for this final rule that contains the NRC's cost-benefit determinations.
This final rule is scheduled to become effectiv days after publication in the Federal Register.
1o Sincerely,
\\") bthhun
. John-Gv4toyle Secr4tary-of-the Comm4* ion
Enclosures:
Final Rule Regulatory Analysis g g m% $,
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NUCLEAR REGULATORY COMMISSION i
l 10 CFR Parts 20 and 35 RIN 3150-AE41 l
Criteria for the Release of Individuals Administered Radioactive Material AGENCY: Nuclear Regulatory Comission.
3 l
ACTION:
Final rule.
SUMMARY
- The Nuclear Regulatory Comission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based-on the potential dose to other individuals exposeo to the patient. The new criteria are consistent with the recomendations of the National Council on Radiation Protection and Measurements (NCRP) and the International Comission on Radiological Protection (ICRP). This final rule requires the licensee to provide written instructions to patients on how to maintain the doses to others as low as.is reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely-to exceed -1 mil 11 sievert (0.1 rem).. This final rule responds to three petitions for rulemaking regarding the criteria for reiease of patients
- administared radioactive material.
EFFECTIVE DATE:
(120 days following publication in the Federal Register)..
t l
1 ADDRESSES: Copies of Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials"; the final regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (1996); Revision 2 of NUREG/BR-0058, ' Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (1996); and the public comments received on the proposed rule may be examined and copied for a fee in the Commission's Public Document Room at 2120 L Street NW. (Lower Level),
Washington, DC.
Single copies of Regulatory Guide 8.39 may be obtained free of charge by writing the Office of Administration, Attn:
Distribution and Services Section, USNRC, Washington, DC 20555, or by fax at (301) 415-2260.
Single copies of NUREG-1492 and NUREG/BR-0058 may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone (202) 512-1800); or from the National Technical Information Service at 5285 Port Royal Road, Springfield, VA 22161.
FOR FURTHER INFORMATION CONTACT:
Stewart Schneider or Stephen A. McGuire, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225.
===1.
Background===
Each year in the United States, radioactive pharmaceuticals or compounds or radioactive implants are administered to approximately 8 to 9 million individuals for the diagnosis or treatment of disease or for human research.
These individuals to whom radioactive materials have been administered are 2
3...
4 i
hereinafter referred to as " patients." These patients can expose others around them to radiation until the radioactive material has been excreted from l
1 their bodies or the radioactivity has decayed away.
{
1 NRC's current patient release criteria in 10 CFR 35.75, " Release of patients or human research subjects containing radiopharmaceuticals or permanent implants," are as follows:
"(a) A licensee may not authorize release from confinement for medical l
l care any patient or human research subject administered a radiopharmaceutical I
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 patient or human research subject is less than 5 millirems per hour at a distance of 1 meter."
i On ay 21,1991 (56 FR 23360), the NRC published a final rule that amended 0 CFR t 20, " Standards for Protection Against Radiation." The L
rule contained limits on the radiation dose for members of the public in 10 CFR 20.1301.
However, when 10 CFR part 20 was issued, there was no discussion in the supplementary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
Some 1 censees were uncertain about what effect the revised j
/
10 CF part 2 would have on patient release criteria, and two petitions for ruleabngwerereceivedontheissue.
On June 12, 1991 (56 FR 26945), the NRC published in the Federal Register a notice of receipt of, and request for 3
achmen
?
s comment on, a petition for rulemaking (PRM-20-20) from Dr. Carol S. Marcus, in addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her position.
On March 9,1992 (57 FR 8282), the NRC published a notice of receipt and request for comment in the Federal-Register on another petition for rulemaking (PRM-35-10) on patient release criteria from the American College of Nuclear Medicine (ACNM).
On May 18,1992 (57 FR 21043), the NRC published in the Federal Register notice of an amendment submitted by the ACNM to its original petition (PRM-35-10A).
In addition, a third petition (PRM-35-11) dealing, in part, with these same issues was submitted by the American-Medical Association (AMA).
That petition was noticed in_the Federal Register on July 26, 1994 (59 FR 37950).
The main point raised in the petition was that the radiation dose limits in 10 CFR part 20 should not apply to individuals exposed to the patient and that G
the dose limit to the individuals should be 500 millirems per year.
The AMA believed that 10 CFR 20.1301 would have an adverse impact on the availability and the cost of treatment of thyroid disease, which would outweigh the advantages of reduced radiation exposure to the public.
The AMA stated that treatment of up to 10,000 cancer patients annually for thyroid carcinoma would require the hospitalization of the patients under the revised regulation (10 CFR 20.1301), reducing both early release of patients and the treatment of patients at home..
II.
Publication of the Proposed Rule 4
tachment
i e
l On June 15, 1994 (59 FR 30724), in response-to the first two petitions, the NRC published a proposed rule on criteria for the release of patients administered radioactive material.
The proposed rule discussed the public comment letters received on the first two petitions. Three additional comment letters were received on the third petition (PRM-35-ll).
These letters each supported the petition but did not contain any additional information not covered by the letters on the first two petitions.
The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically state that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75.
This was to clarify that the Commission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.
The NRC proposed to amend 10 CFR 20.1301(a)(2) to specifically state that the limit on dose in unrestricted areas does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose was to clarify that licensees would not be required to control areas (such as waiting rooms) simply because of the.
presence of a patient released pursuant to 10 CFR 35.75.
If a patient has been released from licensee control pursuant to 10 CFR 35.75, licensecs would
.not be required to limit-the radiation dose-from a patient to members of the public (e.g.,-visitors in a waiting room) to 0.02 mil 11 sievert (2 millirems) in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. Patient wafting rooms or hospital rooms would need only be controlled for those pa nts not meeting the release criteria in 10 CFR part 35.
N S
s e
e The NRC proposed to adopt a new 10 CFR 35.75(a) to change the patient release criteria from 1,110 megabecquerels (30 millicuries) of activity in a patient or a dose rate of 0.05 mil 11 sievert (5 millirems) per hour at 1 meter from a patient to a total effective dose equivalent not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual from exposure to a released patient. A dose-based limit provides a single limit that could be used to rrovide an equivalent level of risks from all radionuclides. Also, the proposed changes were supported by the recommendations of the ICRP and the NCRP that an individual could be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations when exposure to radiation is not expected to result in annual doses above 1 mil 11 sievert (0.1 rem) for long periods of time.
The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that the licensee provide released patients with written instructions on how to maintain doses to other individuals as low as is reasonably achievable if-the total effective dose equivalent to any individual other than the released-patient is likely to exceed 1 mil 11 sievert (0.1 rem) in any 1 year. A requirement to give instructions to certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the proposed requirement would also require instructions for an additional 50,000 individuals who are administered iodine-131 for the treatment of hyperthyroidism and another 27,000 individuals who are breast-feeding anu administered various diagnostic and therapeutic radioactive materials. The purpose of the instructions is to maintain doses to individuals exposed _ to patients as _ low as is reasonably achievable.
The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that
-licensees maintain, for 3 years, a record of the released patient and the 6
@ chment
4 calculated total effective dose equivalent to the individual likely to receive the highest dose if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration. The major purpose was to provide a record to allow licensees to assess the need to limit the dose to individuals exposed to a patient who may receive more than one administration in a year.
Finally, the NRC proposed to amend its requirements on instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already required instructions (not necessarily written) in certain cases, but the phrase "if required by 5 35.75(b)" was added to each.
The purpose of this change was to make Part 35 consistent as to when instructions must be given.
In addition, the NRC concurrently issued an associated draft regulatory a
guide and supporting draft regulatory analysis for public comment.
The draft regulatory guide, DG-8015, " Release of Patients Administered Radioactive Materials," proposed guidance on determining the potential doses to an individual likely to receive the highest dose from exposure to a patient and established appropriate activities and dose rates for release of a patient.
The draft guide also proposed guidelines on instructions for patients on how to maintain doses to other individuals as low as is reasonably achievable and it described recordkeeping requirements. The draft regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (May 1994), examined the benefits and impacts of the proposeu rule considered by the NRC.
[tachment1 7
a Public Comments on the Proposed Rule A total of 63 comment letters were received on the proposed rule, the draft regulatory guide, and.the draft regulatory analysis.
A majority of the connent letters were from medical practitioners and medical organizations, but there were also comment letters from private individuals, public-interest groups, and regulatory agencies in Agreement States. Overall, the majority of j
comment letters supported a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material.
- However, about one-fourth of the comment letters opposed the proposed recordkeeping requirement. The significant comments are discussed below, arranged by subject.
EXCLUSION OF PATIENT RELEASE FROM i 20.1301(a)
All the commenters except one supported governing patient release by the regulations in 10 CFR 35.75 and excluding the dose to individuals exposed to a released patient from 10 CFR 20.1301(a).
Comment. One commenter, representing a public-interest group, objected to any exposure of a member of the general public who has not consented freely to the dosage. They said that such exposure would lead to widespread j
morbidity and mortality.
k Response.
In its revision of 10 CFR part 20 (56 FR 23360; May 21, 1991), theNRCdeterminedthat,whi$edosesshouldbemaintainedas g achment 1 8
e low as is reasonably achievable, a dose limit of 1 mil 11 sievert (0.1 rem), or a dose limit of 5 millisieverts (0.5 rem) in certain special circumstances, provides adequate protection. The revised Part 20 is based, in part, upon the recomendations of the International Commission on Radiological Protection (ICRP) and the recomendations of the National Council on Radiation Protection and Measurements (NCRP). The NCRP recommends public dose limits of 1 mil 11 sievert (0.1 rem) for continuous or frequent exposure and 5 millisieverts (0.5 rem) for infrequent exposure.
The ICRP recommends that the limit for public exposure should be I
expressed as an effective dose of 1 mil 11 sievert (0.1 rem) in a year, except that, in special circumstances, the dose could be higher in a single year I
provided the average over 5 years does not exceed 1 mil 11 sievert (0.1 rem) per
- year, in ICRP Publication 60, in defining medical exposure, ICRP stated that medical exposure includes " exposures (other than occupational) incurred knowingly and willingly by individuals helping in the support and comfort of patients undergoing diagnosis or treatment." Furthermore, in explaining dose limits in medical exposure, the ICRP stated in the same publication that "the Commission therefore recommends that dose limits should not be applied to medical exposures." Thus, in ICRP's opinion, family members who are helping in the support and comfort of patients would not be restricted under the dose limit stated above.
The revision of Part 20 incorporated the long-term objective as the dose limit and' included a provision ($ 20.1301(c)) to allow for alternatin limits on an occasional basis.
Section 20.1301(c) provides that an annual dose of up to 5 millisieverts (0.5 rem) is acceptable if there is a need for it and if Y
9
@tachmentJ
5 e
steps are taken to reduce the dose to as low as is reasonably achievable. The NRC reaffirms that previous dttermination in this rulemaking.
In the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 mil 11 sievert (0.1 rem) because large therapeutic doses (greater than 3,700 megabecquerels (100 millicuries)) are rarely administered more than once to the same patient in a given year.
Comment. One connuenter said that the NRC should change the 0.1 rem dose limit for the public in 10 CFR 20.1301(a)(1) to 0.5 rem for all licensed activities because a dose limit of 0.5 rem offers adequate protection and is a dose that has no proven effects.
Response.
This issue of the general public dose limi is outside the scope of this rulemaking.
The issue was dealt with when CFR part 20 was
=
recently revised (5G FR 23360; May 21, 1991).
That rulemaking explained the NRC's rationale for adopting the 1-millisievert (0.1-rem) dote limit in 10 CFR 20.1301(a)(1).
ACTIVITY-BASED VS. DOSE-BASED RELEASE LIMIT The issue is whether to retain the current patient release limit in 10 CFR 35.75, which is expressed as an activity limit together with an alternative but approximately equivalent limit on dose rate at 1 meter, or to express the release limit as a dose to an individual exposed to the patient.
10 Qtiachment
4 The majority of commenters supported the dose-based limit.
However, some comenters opposed the dose-based approach.
Cotment. A number of commenters said that 10 CFR 35.75 should not be changed and that the 30 millicurie ci 5 millirem per hour release criteria should be retained because they are working well.
Some commenters said that a dose-based release limit as proposed would cause confusion and potential 1
I problems. One commenter said that the Part 20 revision was not intended to alter the status quo for patient release.
Commenters objected to the dose-based release limit becaust they thought the dose estimates to the public would be very inaccurate as chese estimates are based on the unreliable method f
of predicting the anticipated time and proximity to others.
Commenters also I
said that dose estimation and the subsequent recordkeeping would be time consuming and would add to the cost of treatment without a probable significant decrease in radiation exposure.
Response. The NRC is adopting a dose-based limit rather than an activity-based limit because the dose-based limit better expresses the NRC's primary concern for the public's health and safety. A single activity requirement was not retained because different radionuclides with the same activity can give very different doses under identical exposure conditions.
Likewise, a single dose rate requirement for all radionuclides was not retained because different radionuclides with the same dose rate, at the time of release, can give very different doses depending upon the half-life of the radionuclide. The total dose depends on the effective half-life of the 11 met
\\
l radioactive material in the body of the patient and other factors that vary for different materials.
For these-reasons, the NRC is establishing a dose limit rather than an activity or dose rate limit.
The NRC is establishing a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual from exposure to the released patient for each patient release. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627; July 26, 1985), the reconnendations of the NCRP and the ICRP, and the provisions in 10 CFR 20.1301(c) pertaining to temporary situations in which there is justification for a dose limit higher than 1 mil 11 sievert (0.1 rem).
The NRC believes that the dose-based release limit can and will work well because the associated Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," can be used to relate the dose to the quantity of activity in the patient.
The guide provides conservative estimates of activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in the final rule.
The approach used in the regulatory guide is based on NCRP Report No. 27, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."' In the case of iodine-131, the most significant radionuclide, the release quantity based on the standard conservative assumptions is 1,221 megabecquerels (33 mil 11 curies), which is essentially the same as the current release quantity.
' National Council on Radiation Protection and Measurements (NCRP),
" Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37 (October 1, 1970).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
12
a NUREG-1492 contains a detailed examination of the benefits and impacts of the final rule that includes dose estimation, recordkeeping, and radiation exposure.
Single copies of the final regulatory analysis and Regulatory l
Guide 8.39, " Release of Patients Administered Radioactive Materials," are l
available as indicated in the ADDRESSES heading.
Comment.
A commenter said that the calculational approach in the rule would require the physician to ask many personal questions of the patient.
Response. The commenter is incorrect in believing that the dose-based approach will generally require personal information from the patient.
The l
NRC anticipates that nearly all patients will be released based on default assumptions which do not require any personal information from the patient.
A table of release quantities, based on standard conservative assumptions, is provided in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." However, the rule does allow the physician to calculate patient-specific dose estimates to allow early release of a patient not otherwise subject to release-under the default values in Regulatory Guide 8.39.
Personal information may be necessary for such patient-specific Cases.
Comment. One commenter said that it should continue to be acceptable to release patients based on the dose rate at 1 meter.
Response. The rule authorizes release of patients based on the dose in a year. However, release quantities based on dose rate and conservative assumptions can be calculated.
The table of release quantities in Regulatory Guide 8.39, " Release of Patients /.1 ministered Radioactive Materials,"
13 pitachmen
specifies the dose rate at I meter of comonly used radionuclides that allow licensees to authorize patient release.
RELEASE QUANTITIES Using a dose-based system based on a dose to the most highly exposed individual of 5 millisieverts (0.5 rem) would, in some circumstances, allow release of_ a patient with more than 1,110 megabecquerels (30 mil 11 curies) of activity.
Some comenters were opposed to allowing releases with higher activities than are now permitted.
Comment.
Several comenters said that the release of patients with more than 30 mil 11 curies of iodine-131 should not be permitted because of concerns about the risk of internal exposure. One comenter said that doses to family members from the patient vomiting were not adequately considered. The same comenter also said that a study indicated that in-home contamination by patients dosed with I-131 could double family members' risk of developing thyroid cancer.
Response. The concern over contamination is not justified by the radiation doses that are likely to be caused by the removal of radionuclides from the patient's body by the pathways of exhaled air, feces, saliva, sweat, urine, and vomit. Measurements from several studies, as discussed in the supporting regulatory analysis, have shown that a relatively small proportion of the radioactive material administered will appear as contamination.
Doses to family members exposed to contamination from living in close contact with J
Qttachment1) 14
released patients have been measured in several studies and in every case were less than 10 percent of the 5-mil 11 sievert (0.5-rem) total effective dose l
equivalent limit and were most often less than 1 percent of the 5-m1111 sievert (0.5-rem) limit.
In addition, the internal doses resulting from contamination were always less and generally far less than the external dose, meaning that contamination was the less important source of radiation exposure.
These measurements show that even if the family members repeatedly touched household l
items touched by the patient, contamination does not cause unacceptably high doses. These findings were true even in the case of a British study where eleven patients volur.teered to disregard special precautions against contamination and minimizing spousal and family exposure. These measurements are discussed in NVREG-1492. Also, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. II, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "... a contamination incident that could lead to a significant intake of radioactive material is very unlikely."'
In general, the physical reactions (e.g., vomiting) that a patient may experience from'the administration of any radiopharmaceutical are rare.
Vomiting is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility since orally administered radiopharmaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.
' National Council on Radiation Protection and Measurements, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commentary No. 11 (February 28,1995).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
15
(%tlachment
Regarding the comment on the doubling of risk of developing thyroid cancer, there is no scientific consensus by the United Nations Scientific Committee on the Effects of Atomic Radiation, ICRP, or NCRP to support the i
suggested increased risk of thyroid cancer-following ingestion of iodine-131.
L Based on the information currently available, the Commission continues to conclude that the benefits outweigh the potential of small increased risks associated with this rule.
-Consent. One commenter noted that hospitals now make great efforts to i
control contamination from patients who are now hospitalized because they contain more than 30 mil 11 curies of iodine-131. This commenter stated that it would not be possible to maintain the same level of contamination control at these patients' homes if these patients were released with more than 30 millicuries of iodine-131.
Response. The NRC agrees that, even though released patients are given instructions on how to limit the hazard from contamination, contamination control in a hospital can be more effective than contamination control out of the hospital. However, the two situations are not really comparable.
In the case of the released patient at home,. therapeutic administrations almost never occur more than once in a year and only rarely occur more than once in a lifetime; but in the case of a hospital, large therapeutic administrations are done repeatedly on many patients. Therefore, areas in hospitals have the potential for contamination from many patients, and people who frequent the hospital (e.g., clergy or a hospital orderly) have the potential to be exposed to contamination from many patients.
In addition, the 5-mil 11 sievert 16
@tachment
(0.5-rem) limit that is applied to household members exposed to a patient is a special limit that is appropriate for only occasional use and for use where there s a definite need.
This special limit fits the case of doses received by the household members of a released patient, but does not fit the case of people who frequent a hospital on a reutine basis.
Lastly, in limiting doses, the NRC considers what is reasonably achievable.
The mere fact that a home cannot control contamination as well as a hospital does not mean that the I
1 contamination control achieved in homes is not adequate. Actual measurements I
of doses to household members from contamination, as discussed in NUREG-1492, l
show that the doses from contamination are low, demonstrating that the degree of contamination control that was achieved is adequate.
l Comment. One commenter said that tne proposed rule did not adequately address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 mil 11 curies.
Response.
In commenting on the petitions, a number of States expressed concerns about releasing patients administered 14.8 gigabecquerels (400 millicuries) of lodine-131, which one of the petitioners had requested.
However, the States that commented were generally favorable to the proposed rule limiting the dose to the most exposed individual to 5 millisieverts (0.5 rem), and none of the States indicated that their concerns were misrepresented.
In fact, one Agreement State commented that it was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC.
The dose-based limit would generally permit releases if the dose to another individual would not be likely to exceed
{ Attachment [ v 17
o 5 millisieverts (0.5 rem).
For example, if a licensee uses the default table of release quantities provided in the regulatory guide as the basis for release, a patient administered 1,221 megabecquerels (33 mil 11 curies) or less of iodine-131 could be immediately released and no record of release is required. However, if the licensee wishes to release a patient with an activity that is greater than the value in the default table, the licensee must do a dose calculation using case-specific factors to demonstrate compliance with the release criteria.
Furthermore, if the table is used as the basis for release but the administered activity excceds the value in the table, the licensee must hold the patient until the time at which the retained activity is no greater than the quantity in the table or the dose rate at 1 meter is no greater than the value in the table. When the administered activity is greater than the value in the d<., fault table, a record of the basis I
for the release must be maintained for NRC review during inspection.
Regardless of the method used by the licensee to authorize release, the dose limit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75 applies. By identifying more than one method for calculating the release of a patient in accordance with 10 CFR 35.75, the NRC provides greater flexibility for licensees to achieve compliance with the new requirement while still providing adequate protection of public health and safety.
Comment. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member might exceed 0.5 rem because the release might be beneficial and acceptable to family members. Another commenter said that a dose of 0.5 rem to an
[ Attachment 18 t
l
individual exposed to a patient has so little hazard that the NRC should not be concerned with it.
Response.
The NRC does not believe that individuals exposed to a
{
1 patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem). This is consistent with the recommendations of the ICRP in ICRP Publication 60,' "1990 Recommendations of the International Comission on Radiological Protection"; and the recommendations of the NCRP in NCRP Report No.116,' " Limitation of Exposure to lonizing Radiation."
Each of these recommendations provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances. Both the l
ICRP and the NCRP recommend that an individual can receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to result in doses above 1 mil 11 sievert (0.1 rem) per year for a long period of time, as would be the case for doses from released patients.
In NCRP Commentary No.11,
- Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients,"' the NCRP recommended a dose limit of 5 millisieverts (0.5 rem) annually for members of the patient's family.
However, on the recommendation of the treating physician, the NCRP considered it acceptable that members of the patient's family be permitted to receive doses as high as 50 millisieverts (5 rems).
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to Innizing Radiation," NCRP Report No. 116 (March 31, 1993).
Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3096.
tachm[
19
O The NRC does not agree that the latter NCRP recommendation should apply in general. The NRC believes that if the dose to another individual is likely to exceed 5 millisieverts (0.5 rem), the patient should remain under the control of the licensee.
Licensee control is necessary to provide adequate protection l
l to the individuals exposed to the patient.
RECORDKEEPING The strongest opposition to the-proposed rule was to the proposed requirement to maintain a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the highest dose if the dose to that person is likely to exceed 1 mil 11 sievert (0.1 rem).
Under the proposed rule, if a patient had or might have had one or more administrations within the same year, the licensee would use the records to determine the dose from the previous administrations so that the total dose to an individual exposed to a patient from all administrations would not exceed 5 millisieverts (0.5 rem).
Consent. Many commer.ters indicated that this requireinent would cause excessive costs in time, effort, and money to track down records of previous administrations, to perform calculations, and to keep records of all the work and asked that the requirements to make calculations and keep records be-removed. The commenters believed that the work would not produce an increased level of safety, that the NRC greatly underestimated the cost, and that the recordkeeping would be unnecessary, inappropriate, and impracticalc Some commenters said that multiple administrations that would result in a total f
ttachmend 20
effective dose equivalent greater than 1 mil 11 sievert (0.1 rem) are not done to the same patient routinely.
Other commenters said that there have been decades of experience unencumbered by any paperwork burden at all with no-l evidence that a lack of paperwork has resulted in any additional problems.
j One commenter said that if 0.5 rem is acceptably safe, why have the documentation required at the 0.1 rem level.
Another commenter said that it cannot be a licensee's responsibility to l
know the details of a radionuclide therapy performed by another licensee in l
terms of which members of the public received the most radiation dose from that other licensee's therapy procedure.
One commenter said that the-excessive recordkeeping cost would be a nonreimbursable cost, and the burden will cause many physicians to stop offering iodine therapy, which would force patients to travel to-large medical facilities in cities and cause problems with patient access in sparsely populated areas.
- esponse. Upon reconsideration, the NRC has decided to delete the requirement to keep records when the dose to the most highly exposed individual is likely to exceed 1 mil 11 sievert (0.1 rem). The requirement was proposed so that it would be possible to account for the dose from multiple administrations in the same year to ensure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem). -
The NRC has an advisory committee, the Advisory Committee on the Modical Uses of Isotopes, or "ACMUI " which advises the NRC on rulemakings and other initiatives related to the medical use of byproduct materials.
The NRC also has a' visiting medical fellows program that recruits selected physicians or P
21 tachmentJ
~
4 l
pharmacists to work for the NRC for a period of 1 to 2 years.
Both the ACMUI and the current Visiting Medical Fellow, Myron Pollycove, M.D., provided advice to the NRC during the development of this rule.
In addition, Barry A. Siegel, M.D., Chairman of the ACMUI, reviewed the patient records at his medical facility for the 1-year period from July 1,1993, to June 30, 1994 (Mallinckrodt Institute of Radiology, St. Louis, Missouri).
Drs. Siegel and Pollycove concluded that no routine nuclear medicine practice, be u diagnostic, therapeutic, or a combination of the two, results in multiple large administrations that would be likely to cause the 5-millistevert (0.5-rem) dose limit to be exceeded because of multiple administrations in a year.
While the-proposed requirement to maintain a record of the dose to another individual if the dose is likely to exceed 1 mil 11 sievert (0.1 rem) has been deleted, a recordkeeping requirement with a reduced impact has been retained as discussed under the heading, " Discussion of Text of Final Rule."
Consent. Several commenters said-that those who pay for health care will put great pressure on physicians to optimize calculations to reduce in-pat' int days and to justify out-patient treatments.
Response. There is no objection to optimizing calculations to reduce in-patient days as long as the calculations are realistic and the 5-mil 11 sievert (0.5-rem) limit in 10 CFR 35.75 is met.
" Release of Patients Administered Radioactive Materials," describes examples of calculations that are acceptable to the NRC.
W
[tachment I
22
WRITTEN INSTRUCTIONS TO PATIENTS In general, there was little objectic.n to providing-instructions to
-j patients on how to minimize the-dose to othes, but there was significant opposition to the proposed requirement that the instructions would have to be written.
Comment. One commenter said that the Statement of Considerations for the proposed rule was in error in stating that the existing regulations already-required that the instructions to patients be written.
Response. The commenter is correct.
The Statement of Considerations was in error on that point. The existing regulations do not specify that instructions have to be in written form.
Comment. A number of comenters said that-instructions should not need to be written and that oral instructions should be permissible.
Some of these comenters said that oral instructions are more effective and that how the instructions should be given is within the province of the doctor-patient relationship and that the NRC and its regulations should not interfere with that relationship. One comenter said that the physical condition of the patient could lessen the patient's ability to follow the instructions.
Another comenter said that the standard written instructions require too much th-explaining how each patient varied from the standard instruction sheet.
However, one Agreement State and a major health maintenance organization strongly-supported the requirement that the instructions be written.
3-
@tachmentJ 23
Response. The NRC believes that providing written instructions has'a significant value because often patients will not remember all of the-t instructions given orally.. In addition, written instructions can be read by other family members or care givers.- The requirement to provide the l
instructions in written form was also supported by the ACMUI.
This regulation allows the licensee to determine the form of the written instructions. The NRC believes that for the majority of releases requiring written instructions, the written instructions can-be prepared in a generic form.
For example, the Society of Nuclear Medicine has prepared a brief
-pamphlet, " Guidelines for Patients Receiving Radioiodine Treatment," which can be given to patients at nomina' cost (less thaa $1. per patient).
- However, oral instructions may also be provided in all cases.
}.
Consent.
Several commenters said that dictating to a physician how and what he or she must tell a patient is not the purview, mandate, or competence of the NRC and interferes with an essential part of medical practice, which is communication between physician and patient.
Response.
In a policy statement published on February 9,1979 (44 FR 8242),. entitled " Regulation of the Medical Uses of Radioisotopes; Statement of General Policy," the NRC made.three specific statements.
The third statement of the policy is "The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The final rule is consistent with this statement-because it does not dictate the choice of medical treatment or diagnosis, does not specify the details of what the physician must say or must Qtachment 24
include in the contents of the written instructions, and is directed at minimizing the risk to the patient's family who have no doctor-patient relations to-the prescribing or. administering personnel-However, Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials,"
recommends contents of the written instructions.
Further discussion of the 1979 Medical Policy Statement is presented under the heading, "VIII. Consistency with 1979 Medical Policy Statement."
Comment. Several commenters asked whether written instructions were appropriate if the patient was blind, illiterate, or did not read English.
Another commenter said that the instructions should be both written and oral and should be in the primary language of the patient.
Response. The NRC believes that written instructions are useful and should be required.
If the patient is blind, illiterate, or does not read English, it is likely that someone else will be able to read the instructions for the patient.
NRC considers it too much of a burden to require that-the instructions be given in the primary language of the patient, although-the
.regulatio'ns do not preclude foreign language written instructions if the licensee chooses to provide them.
In most situations, it will be possible to find someone who can translate for the patient if necessary.
The requirement that written instructions be given to the patient does not preclude additional oral instructions.
Consent. Several commenters asked how the NRC would enforce implementation of the instructions given to the patient.
Another commenter 25 t'talhmen
~
a
asked how the-licensee could__ verify-that-the instructions are followed. "
Another commenter said that a-sizable fraction of patients may not follow-radiation safety instructions to protect spouses and may be even less careful about protecting total strangers.
This commenter also asked whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others.
Response. The NRC does not intend to enforce patient-compliance with the instructions nor is it the licensee's responsibility.. However, it is the responsibility of licensees to provide instructions to the patients.
Following the instructions is normally the responsibility of the patient.
However, American medical practice routinely depends on patients following instructions, such as instructions on when and how to take medications.
With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that mot,t will attempt to follow the instructions faithfully, especially with regard to protecting their children, although some patients and their spouses indicated that they might not keep physically distant from their spouse for prolonged periods of time.
Consent. One commenter said that instructions should be given for all administrations of radioactive material, regardless of the quantity administered.
Response. The NRC does not agree.
In some _ cases, particularly in the large number of diagnostic administrations, the potential doses are so small
{A3achment]
26
that the burden of requiring instructions cannot be justified. Under the final' rule,. if the dose to any individual exposed to.the patient is not likely 3
to exceed 1 millisievert (0.1 rem), instructions are not required but the
)
physician could give any instructions that he or she considers desirable.
l CONFINEMENT OF PATIENTS 1
Comment. Two commenters said that patients cannot be confined against their wishes and that the rule provides no penalty for the patient who leavt3 confinement-in the hospital "against medical advice." Another commenter said that the rule seems to r4 quire that the licensee b3ve control of the patient's activities after release.
Response. The NRC recognizes that patients cannot ce held against their will. The rule deals with the conditions under which the licensee may authorize release. The NRC would not penalize a licensee for the activities of the patient after release or if the patient were to leave "against medical advice."
Consent. One commenter asked whether a patient who was releasable but was still hospitalized for other reasons would still be considered under the licensee's control.
Response. Once the licensee has authorized the release of the patient, there is no need to keep the patient under licensee control for radiation protection purposes if the patient remains hospitalized for other reasons.
P 27 d tachment I w
4.s
- However, good ' health' physics practice would be to continue to make efforts 'to maintain doses to people at the facility as low as is reasonably achievable.
- Comment. Commenters also asked how a patient can be confined to his or her house.
Response. lThese commenters misunderstood the concept of confinement.
As-explained in the Statement of Considerations for the proposed rule (59 FR 30724), the term " confinement" no longer applies to the revision to 10 CFR 35.75.
Instead, the text of-the rule uses the phrase " licensee control" to more clearly reflect the NRC's intent.
The NRC believes that there is a distinct difference between a patient being under licensee-control in.a hospital or other licensee facility (e.g., a hospice or nursing home) and being at home.
In 'a hospital or other area or address of use listed on the NRC license, the licensee has control over access to the patient as well as having trained personnel and instrumentation available for making radiation measurements not typically available at the
- pati ent 's : home.
In addition, while under. licensee control, a licensee has
- control over the dose by limiting the amount of time that individuals are in close proximity to the patient. A patient who goes home-is released from licensee control.
Consent. One commenter thought that the rule should define the term
" release.":
28 achmenb
-Response. The term " release from licensee control," when read in context, refers to radiation protection considerations and is sufficiently i
clear that there is no need to define the term.
l MISCELLANE0US COMMENTS ON THE RULE Comment. Several commenters said that the rule should not be a matter of Agreement State compatibility at any level.
l Response. The NRC does not agree.
The NRC conducts an assessment of each proposed requirement or rule to determine what level of compatibility -
will be assigned to the rule. These case-by-case assessments are based,-for the most part, on-protecting public health and safety. NRC has evaluated the final rule and assigned compatibility designations ranging from level 1 (full compatibility required) to level 3 (uniformity not required) as detailed later in this Federal Register notice..
Consent. Several commenters said that a breast-feeding. infant should not be considered as an individual exposed to the patient for the purposes of determining whether patient release may be authorized. These commente l
- that consideration of the breast-feeding infant should be under the &
f jurisdiction of the physician, that the issue is a medical issue ratyerga regulatory issue, and that the NRC should not interfere in medical is s.
Response. The NRC does not agree. The NRC has a responsibility to-protect the public health and safety, and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including breast-feeding children. When the release is authorized, it is 29
7 l
l based _on the licensee's determination that the total effective dose equivalent to an ' individual from the released patient is not likely to exce d_
i 5 millisieverts (0.5 rem). The dose to the f ast-feeding hild from breast-feeding is a criterion for release but it can be controlled by giving the woman guidance on the interruption or discontinuation of breast-feeding, as required by the new 10 CFR 35.75. However,' the rclease could be based on the default table of release activities in the regulatory guide or a patient-specific calculation, as required by the new 10 CFR 35.75. The issue of the dose to the breast-feeding child is discussed in NUREG-1492 and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials."
Comment. One comenter said that the proposed rule did not accurate 1h(nut) "
represent the position of the Advisory Comittee on Medical Use of Isotopesp Response. A review of the transcript for the ACMUI meeting in May 1992 shows that the Federal Register Notice provided an accurate description of the ACMUI position. The final rule w s discussed with the ACMUI on October 18, 1995, and the ACMUI, inJeneral supported the rule.
(ForACMUI'scomments k#elicn and NRC's responses, see V. Coordination with the ACMUI.)
A Comment. One comenter said that its facility treated many foreign patients with therapeutic pharmaceuticals. These patients frequently may leave the hospital and imediately board a plane to return home. Thus, there is a limit to the amount of control that a licensee has over-the patient.
P
{ 6 hme 30
Response. The NRC recognizes that the licensee has no control over the patient after the patient has been released. The quantities for release listed in Table 1 of Regulatory Guide 8.39,- " Release of Patients Administered Radioactive Materials, were calculated using conservative assumptions (for example, by using the physical half-life of the radioactive material rather than the more realistic effective half-life). Thus, the NRC considers it unlikely that the dose to an individual in real circumstances would approach 5 millisieverts (0.5 rem).
In special situations, such as when a released patient would imediately board an airplane and would therefore be in close contact with one or more individuals, it may be necessary to base-the release on a more realistic case-specific calculation. Once the patient is released, the responsibility for following the instructions is entirely the patient's, not the licensee's.
COMMENT!
.N THE DRAFT REGULATORY GUIDE
{
Coments were also requested on Draft Regulatory Guide, DG-8015,
Release of Patients Administered Radioactive Materials," associated with this rulemaking.
Because the guide is associated with the rule, the coments-received on the draft guide are discussed here. Most of the coments concerned the method and the assumptions used to calculate the dose to the individual likely to receive the highest dose.
Comment. Several comenters said that the calculational methodology in the draft guide is too complex and that the assumptions are too conservative.
As an example, several comenters said that the assumed 24-hour nonvoiding
/
31
( Aftachme g
assumption used in calculating doses is too conservative. As evidence that the calculations are too conservative, several commenta8.39.
Finally, the NRC is deleting its requirements on written instructions in 10 CFR 35.315(a)(6) and_35.415(a)(5) bect.ase those paragraphs are redundant now that 10 CFR 35.75 has requirements for instructions.
In addition, 10 CFR 35.415(a) and a(1) are reworded to clarify the original intent of the paragraphs, which was to limit the dose rate at 1 meter from the patient.
The b
ambiguity was introduced when Part 20 was revised and a conforming change was made in 10 CFR 35.415. The conforming change that was made was not fully consistent with the original intended meaning of 10 CFR 35.415(a) and (a)(1).
i VII.
Disposition of the Petitions for Rulemaking The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-20),
the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-11) requested that the NRC amend the revised 10 CFR part 20 and 10 CFR part 35.
These requests and their disposition by this rulemaking are discussed below.
The requests made by Dr. Marcus and their disposition may be summarized as-follows:
(1)-Raise-the annual radiation dose limit in 10 CFR 20.1301(a) for l
l individuals-exposed to radiation from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts (0.5 rem).' The final rule grants this request.
(2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-millicurie) limit for iodine-131, but provide an activity limit for other radionuclides consistent with the calculational methodology employed in the National Council on Radiation Protection and Measurements (NCRP) Report l
No. 37, " Precautions in the Management of Patients Who Have Received l
Therapeutic Amounts of Radionuclides."2 The final rule does not contain l
activity, limits, but Regulatory Guide 8.39 uses a calculational methodology-
~
48
based on NCRP Report No. 37 to relate the dose _ to the quantity of activity in the patient. Therefore, the wish of the petitioner to have an easy method to determine when the patient may be released is granted in Regulatory Guide 8.39.
1 (3) Delete 10 CFR 20.1301(d), which requires licensees to comply with-y provisiopof the Environmental Protection Agency's environmental regulations in 40 CFR mi Jart 190 in addition to complying with the requirements of
\\
FRptr't-20.(The 10 P regulations referenced in 10 CFR 20.1301(d) are contT1n$d 40CFRpart 90, which deals only with doses and airborne emissions from uran fuel cycle facilities.
Part 190 of Title 40 of the Code of Federal Regulations does not apply to hospitals or to the release of j.
patients.
l w
l Furthermore, 10 CFR'20 1301(d) does not incorporate the EPA's Clean Air Act standards in 40 FRyart 1 t$at applies to hospitals.
The NRC-is separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean ir Acts and to take agreed upon actions that will s
V y
lead to EPA recision of 40 FR part 61 for NRC and Agreement State licensees.
Because the reference to EPA g ations in 10 CFR 20.1301(d) has nothing to do with the patient release issue, and therefore is outside the scope of this rulemaking, the final rule denies this request.
The requests made by the ACNM and their disposition may be summarized as follows:
(1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients who have been administered radiopharmaceuticals. The final rule grants this request.
(2) 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.
The final rule dentes this request for the reasons described in the discussion on this issue.
~f 49 )
~
s
Finally, the requests made by the AMA did not all pertain to the issue of patient release. The final rule grants the request pertaining to patient release, i.e., that the radiation dose limits in 10 CFR 20.1301 should not apply to individuals exposed to the patient and that the dose limit to the individuals should be 500 millirems. The request to change the term
" hospitalized" in 10 CFR 35.310(a) and 35.315(a) to the term " confined" was denied for the reasons discussed above. The request not related to the subject of patient release (that it should be clear in Part 20 that Part 20 does not limit the intentional exposure of patients to radiation for the purpose of medical diagnosis or therapy) was addressed in another rulemaking,
" Medical Administration of Radiation and Radioactive Materials," which was published as a final rule on September 20, 1995 (60 FR 48623), and became effective on Octcber 20, 1995.
VIII. Consistency with 1979 Medical Policy Statement On February 9,1979 (44 FR 8242), the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radioisotopes.
The first statement of the polky reads "The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public." The rule is consistent with this statement because its purpose is to provide for the safety of individual members of the public exposed to patients administered radioactive materials.
The second statement of the policy is "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate."
This statement is not relevant to the rule because the rule does not affect the safety of patients themselves. The rule instead affects the safety of individuals exposed to patients.
meh 1 50 a
The third statement of the policy reads "The NRC will minimizo intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The rule is consistent with this statement because it places no requirements on the administration of radioactive materials to patients and because the release of patients administered radioactive materials has long been considered a matter of regulatory concern to protect members of the public rather than solely a i
matter of medical judgment.
Thus, the final rule is considered to be consistent with the 1979 Medical Policy Statement.
IX.
Issue of Compatibility for Agreement States The NRC considers the definitions contained in i 20.1003 and the text in i 20.1301(a) that are modified by this rulemaking are Division 1 levels of compatibility.
The definitions and text in these sections must be the same for all NRC and Agreement State licensees so that national consistency can be maintained.
Section 20.1002, " Scope," is a Division 3 level of compatibility because this section by nature is not a regulatory requirement and many States are prohibited by their administrative procedures act from including such sections in their rules. The scope section is a general statement of scope of the rule and does not contain specific requirements that are not. presented in other sections of Part 20.
Rules at the Division 3 level would be appropriate for Agreement States to adopt, but they do not require any degree of uniformity between NRC and State rules.
Additionally, il 35.75(a) and (b) are a Division 2 level of compatibility because the patient release criteria required by the rule are j
the minimum requirements necessary to ensure adequate protection of the public health and safety. The Agreement States will be allowed to establish o
51 chment 1
requirements that are more stringent than the NRC's requirements, but not less stringent. The recordkeeping requirements-in il 35.75(c) and (d) are a Division 3 level of compatibility because uniformity in recordkeeping is n t consideredessengajforthisrule.
a 5
c4 A r%ft tQ h &
X[FindingofNoSignificantEnvironmentalImpact: Availability i
The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR part 51, that the amendments are not a major Federal action significantly affecting the quality of the human environt.ient, and therefore an environmental impact statement is not required. The final amendments clarify the pertinent regulatory language to reflect explicitly the relationship between10CFRpart20andpart35withrespecttoreleaseofpatients,and the amendments ' revise the release criteria for patients receiving radioactive material for medical use from an activity-based standard to a dose basis, it is expected that there will be relatively little change in radiation dose to the puolic or to the environment as a result of the revised regulation.
The final environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the environmental assessment and the finding of no significant impact are available as indicated in the FOR FURTHER INFORMATION CONTACT heading.
/%,&
52 Attachment Is
/15&Ak' Y'.
\\
f Sfnall Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.
I S Z - /]
gh Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
These requirements were approved by the Office of Management and Budget, approval number 3150-0010.
The public reporting burden for this collection of information is estimated to average 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per licensee per year, including the time for
}
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of this collection of information, including suggestions for reducing the burden,' to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS19NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-10202, (3150-0010), Office of Management and Budget, Washington, DC 20503.
I MI JH.
Regulatory Analysis The NRC has prepared a final regulatory analysis (NUREG-1492) on this regulation. T d analysis examines the benefits and impacts considered by the NRC. The NRC as received public comments regarding the draft regulatory analysis a, a
addressed the comments (see Comments on the Draft Regulatory Analysisil Pub,11c Corments on the Proposed Rule).
The final regulatory analysis is avai dff f'ofr nspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC. Single copies are available as indicated in the ADDRESSES heading.
N 53-
\\
v X
- r. Regulatory flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the NRC certifies that this rule will not have a significant economic impact-on a substantial number of small entities.
This rule affects medical use of byproduct material lice' sees. The impact of the final rule will not be significant because th fina* rule basically represents a continuation of current practice.
g Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule, and therefore, that a backfit analysis is not required for this rule, because these amendments do not involve any provisions that impose backfits as defined in 10 CFR 50.109(a)(1).
Lists of Subjects in 10 C R rt 20 himJt./ Andh)
Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and hecith, Packaging and containers, ity, Radiation protection,-Reporting and recordkeeping requirements,
/
Special nuclear material, Source material, Waste treatment and disposal.
/
ListsofSubjeksin10CFRpart35 S
By;roduct material, Criminal spenait. Drugs, Health facilities, Health
-professions, Incorporation by r ference, Medical devices, Nuclear materials, Occupational safety and health,
% Radiation protection, Reporting and recordkeeping requirements.
54
e for the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 1 CFR arts 20 and 35.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION Theauthoritycitation1fppart20continuestoreadasfollows:
1.
9 Authority:
Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
i 2.
Section 20.1002 is revised to read as follows:
6 20.1002 Scope.
The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under ts 0 through 35, 39, 40, 50, 60, 61, 70, or 72 of this chapter.
The limits in this part do not apply to doses due-to background radiation, to l
exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with 5 35.75, or to exposure from voluntary participation in medical research programs.
p-55
)
kw
/
O e
3.
In i 20.1003, the footnote to the definition of member of the pubife is removed and the definitions of occupational dose and pubife dose are revised to read as follows:
i20.1003 Definitions.
Occupational dose means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person.
Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 5 35.75, from voluntary participation in medical research programs, or as a member of the public.
Pubife dose means the dose received by a member of the public from exposure to radiation or radioactive material released by a licensee, or to any other source of-radiation under the control of a licensee.
Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from l
exposure to individuals administered radioactive material and released in
-accordance with 5 35.75, or from voluntary participation in medical research programs.
4.
In i 20.1301, paragraph (a) is revised to read as follows:
i 20.1301 Dose limits for individual members of the public.
56 i
o e
0 (a) Each licensee shall conduct operations so that--
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mil 11 sievert) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 5 35.75, from voluntary participation in medical research programs, and from l
the licensee's disposal of radioactive material into sanitary sewerage in accordance with 5 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and i
released in accordance with i 35.75, does not exceed 0.002 rem (0.02 mil 11 sievert) in any one hour.
5.
In i 20.1903, pa.agraph (b) is revised to read as follows:
i 20.1903 Exceptions to posting requirements.
(b) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to 5 20.1902 provided that the patient could be released from licensee control pursuant to i 35.75 of this chapter.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL 6.
The authority citation for part 35 continues to read as follows:
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O
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Authority:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
7.
In Section 35.8, paragraph (b) is revised to read as follows:
6 35.8 Information collection requirements:
OMB approval.
l l
(b) The approved information collection requirements contained in this part appear in il 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, 35.27, 35.29, 35.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, 1
35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, and 35.647.
8.
Section 35.75 is revised to read as follows:
i 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 werial 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).2 (b) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to
' Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
~d 58 achment
q l
l maintain doses to other individuals as low as is reasonably achievable if the tota 1' effective dose equivalent to any other individual is likely to exceed 1 mil 11 sievert (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 no interruption of breast-feeding, the instructions shall also include 1 (guidance on the interruption or discontinuation of breast-feeding.and(2)fnformation on the p
consequences of failure to follow the guidance.
I (c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years aft r the date of release, if the total ' effective dose equivalent is calculated flj sing 4)e retained activity rather than the activity administered, (2 s4ng jn occupancy factor less than g
0.25 at-1 meter, (3)gsingpe biological or effective half-life, or (4) 3 (d) considering the shielding by tissue.
The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the-infant or child from continued breast-feeding could result.in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem),
i 35.315 (Amended]
9.
In i 35.315, paragraph (a)(6) is removed and reserved.
6 35.315 Safety precautions.
(a)
(6)
(Reserved]
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f N./ h 59
[ Attachment 1
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E'
-10.
In i 35.415, the introductory text to paragraph (a) and
. paragraph (a)(1) are revised and paragraph (a)(5) is removed.
I35.415 Safety precautions.
(a) For'each patient receiving implant therapy and not released from licensee control pursuant to n 35.75 of this part, a licensee shall:
(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy.
Dated at Rockville, Maryland, this day of
, 1996.
For the Nuclear Regulatory Comission.
John C. Hoyle, Secretary of the Comission.
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m 60 LAttachment1
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