ML20138G543

Requests Comments on Draft Inspection Guidance Constraint Rule,Patient Release Rule & Radiography Equipment Rule

ML20138G543
Person / Time
Issue date:	12/20/1996
From:	Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Hehl C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20136A699	List: ML20136A695 ML20136B882 ML20138G483 ML20138G543 ML20138K367
References
FOIA-97-54 NUDOCS 9612240274
Download: ML20138G543 (21)

Text

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g) ( ,, j t UNITED STATES NUCLEAR REGULATORY COMMISSION o

• WASHINGTON D.C. 20065-0001

• • • • • ' December 20, 1996 HEMORANDUM T0: Those on the Attached List

. s FROM: Donald A. Cool. Directqr' s Division of Industrial bnd

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Medical Nuclear Safety. > j

SUBJECT:

REQUEST FOR COMMENTS ON DRAFT INSPECTION GUIDANCE -

CONSTRAINT RULE. PATIENT RELEASE RULE AND RADIOGRAPHY EQUIPMENT RULE The Commission recently approved, with minor modifications, two final rule packages for publication in the Federal Reaister which have direct applicability in the materials area. The first rule was a revision to 10 CFR Part 20 regarding a constraint for airborne radioactive effluents to the environment. The second rulemaking involves revisions to 10 CFR Parts 20 and Part 35. These revisions clarify that Part 35 is the applicable regulation governing patient release, and arovide revised criteria for release of individuals administered radioplarmaceuticals or pc;manent implants for medical treatment. Background material on these rules are provided in Attachment 1.

It is important that inspection guidance on these rules be finalized prior to the effective date of the rule. We have chosen to revise Inspection Procedure (IP) 87100. "ticensed Materials Programs." and IP 87110.

" Industrial / Academic /Research Program." rather than waiting to incorporate the guidance into the inspection procedures that are currently under development.

and out for regional review. We recognize that several other areas in IP 87100 need to be revised, but given the efforts underway to develop inspection procedures for each type of material use, we have limited changes to only address these two rulemakings and to formalize the guidance that was provided to the staff on the inspection of ancillary radiography equipment (10 CFR 34.20).

Attachment 2 contains the revised final IP 87100. Revised text is highlighted for your review. Similar changes will be inserted in IP 87110 as appropriate.

Attachment 2 also contains the sections of the field notes that have been changed. The IP with associated field notes will be forwarded to Office of Nuclear Reactor Regulation on January 6.1996, for issuance. We will address any major coments that you have with the inspection guidance if received prior to January 3. 1996. Note, any comments not addressed, prior to finalizing IP 87100 and IP 87110. will be addressed during the finalization of the IP 87100 series procedures.

Contact': Cathy Haney. NMSS (301) 415-7844

'A j22.h02-

Multilipe Addressees 2 We also plan to revise IP 87102. " Maintaining Effluents From Materials Facilities As Low As Is Reasonable Achievable (ALARA)." to make it compatible ,

with the constraint rule. The draft revised IP will be forwarded for your i review and comment at a later date. Pendina this revision. use of IP 87102 is susoended. Inspection staff should follow the revised inspection procedures in IP 87100 (Attachment 2) for the constraint rule after its effective date.

January 9,1997, and for the patient release rule.120 days after its publication in the Federal Reaister, i

Attachments: 1. Background Material

2. Revised Inspection Guidance l cc: NTEU IG 1

i

Multilipe Addressees 2 We also plan to revise IP 87102. " Maintaining Effluents From Materials Facilities As Low As Is Reasonable Achievable (ALARA)." to make it compatible with the constraint rule. The draft revised IP will be forwarded for your review and comment at a later date. Pendino this revision. use of IP 87102 is susoended. Inspection staff should follow the revised inspection procedures in IP 87100 (Attachment 2) for the constraint rule after its effective date.

January 9.1997, and for the patient release rule.120 days after its publication in ths Federal Reaister.

Attachments: 1. Background Material

2. Revised Inspection Guidance cc: NTEU IG IMNS r/f n r bile Mk NMSS r/f Distribution - Cover memo and Attachment 2 only CTrottier CJones JKinneman JPotter BJHolt LHowell DFlack SSherbini JDeCicco DOCUMENT NAME: G:1pguidel.cxh To receive a copy of this document, indicate in the box: Copy without attachment / encl.

"E" = Copy with attachment /enci *N" = No copy ,"C"-

n 0FC IM0B IM0B NX8 NAME CManey/ch/11

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Attached List for Memorandum Dated: December 20, 1996

SUBJECT:

REQUEST FOR COMMENTS ON DRAFT INSPECTION

! GUIDANCE - CONSTRAINT RULE, PATIENT RELEASE RULE AND RADIOGRAPHY EQUIPMENT RULE C. W. Hehl, Director Division of Nuclear Materials Safety, Rl Bruce S. Mallett, Director i Division of Nuclear Materials Safety, Rll Cynthia D. Pederson, Director ,

Division of Nuclear Materials Safety, Rlli l Ross A. Scarano, Director Division of Radiation Safety and Safeguards, RIV Larry W. Camper, Chief Medical, Academic and Commercial i Use Safety Branch, IMNS Richard L. Bangart, Director Office of State Programs ,

l James Lieberman, Director Office of Enforcement 6

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l ATTACHMENT 1 l i i

Contents i

1 l 1. Esieral Reaister Notice 65120, December 10,1996, Resolution of Dual  !

Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act  !

I

2. Regulatory Guide 4.20, " Constraint on Releases of Airborne Radioactive )

l Materials to the Environment for Licensees Other Than Power Reactors"'

3. SECY-96-100, " Final Amendments to 10 CFR Parts 20 and 35 on Criteria for l the Release of Individuals Administered Radioactive Material Only Attachment 1 to the SECY Paper is being forwarded for your information. 1 The Regulatory Guide has undergone extensive changes since it was forwarded to the Commission with the rule package. A copy of Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," will be forwarded under separate cover when it is finalized.

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65120 Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1996 / Rules and Regulations NUCLEAR REGULATOflY have been disposed of m accordance inir ' 'e mination that the NRC program COGSMSSION with 40 CFR Part 192. Radon-222 under the Atomic Energy Act provides an emissions from tailings were covered by ample margin of safety to protect public  ;

haw usammM,1W -

10 CFR Part 20 40 CFR Part 61, Subparts T (addressing non operational uranium mill tailings However, EPA continued to express RIN 3166-AF31 piles) and W (addressing operating mill concern regarding the adequacy of the Reedution of Dual Regulation of tallings piles). EPA rescinded Subpart T measures to assure that future emissions f r NRC licensees after Appendix A to from NRC hmnsees will not exceed Airbome Emuents of Radioactive levels that will provide an ample margin Motoriais; Clean Air Act to CFR Part 40 was amended by the Commission to conform to changes EPA of safety. The stay on Subpart I expired .

AosseCY: Nuclear Regulatory issued to 40 CFR Part 192. Subpart W on November 15,1992, and Subpart I Commission. still applies to NRC licensees. Because became effective on November 16,1992. I ACTioed: Final rule. Radon.222 is adequately addressed in Subsequently, in July of 1993, the EPA 13 CFR Part 40. Appendix A, and other Administrator determined that there i suasetAny:The Nuclear Regulatory was insufficient basis at that time to j prtvisions of to CFR Part 20,it is not Commission is amending its regulations covered in this final rulemaking. rescind Subpart I. Consequently, NRC j to establish a constraint of to mrom (0.1 In 1990. Congress enacted and Agreement State licensed facilities '

mSv) per year total effective dose amendments to the CAA. Section were subject to dual regulation of l equivalent (TEDE) for dose to members airborne efDuents of radionuclides of the public from & r emissions of 112(d)(9) of these amendments to the 1 CAA (the Simpson amendment) states: under both the AEA and the CAA, j radionuclides from NRC licensed including regulatory oversight by EPA facilities other than power reactors. This No standard for radionuclide emissions action is necessary to: Provide assurance category or subcategory onsches (or authorized State) and NRC (or

'N A ement State).

to the Environmental Protection Agency (EPA) that future emissions from NRC fmm an]fY 3,, ,, o, an m at t e) is C licensees subject to EPA's Subpart I are also subject to NRC dose required to be promu ed under this licensees will not exceed dose levels section if the Administrator determines, by limits for members of the public ,

that EPA has determined will provide rule, and after consultation with the Nuclear contained in 10 CFR Part 20, Subpart D, an ample margin ofsafety; and to Regulatory Commission, than the regulatory entitled " Radiation Dose 1.imits for 1 i provide EPA a basis upon which to program estabW by the Nuclear individual Members of the Public" rescind its Clean Air Act (CAA) Regulatory Comrnission pursuant to the (Subpart D). Under Subpart D, licensees i regulations as defined in 40 CFR Part 61 Atomic Energy Act for such category or shall ensure that doses to members of su P for NRC licensed facilities (other than ,80 te ubib the public are less than 100 mrem (1.0 power reactors) and Agreement State mSv) per year from all pathways hcensees, thereby relieving these Upon issuance, the effectiveness of (including airborne effluen's) and all l licensees from unne saary dual Subpart I for all NRC licensees was sources associated with the licensee's 'I regulations. immediately stayed by EPA pending operation. In addition, under Subpart D.

EFFECTIVE DATE:This rule will become further evaluation. During the stay entitled "Radiadon Protection effective January 9,1997. Period EPA conducted two studies of Programs," licensees must ensure that Fon FURTHER mFont4ATION CONTACT:

the air emissions from NRC and doses to members of the public be kept Agreement Sts's materials license-s. as low as is reasonably achievable Alan K. Roscklein OfSce of Nuclear Regulatory Research. U.S. Nuc! ear The first was a survey of 367 randomly (ALARA). Based on the studies Regulatory Commission, Washington, selected nuclear materials licensees- conducted by EPA and licensee EPA determined that the highest reporting of doses to members of the DC 20555-0001, telephone (301) 415-6223' ' .tamated dcse to a member of the public from airborne effluents to EPA, it public from air emissions from these is evident that less than to mrem ( 0.1 SUPPLElfENTARY INFORIAATION: facilities was 8 mrem (0.08 mSv) per mSv) per year to the maximally e.,,osed Backgrmnd year, based on very conservative member of the public frorr droorne modeling. In addition,98 percent of the radioactive effluents to the envhonment The EPA promulgated National facilities surveyed were found to have is reasonably achievable.

Emission Standards for Hazardous Air doses to members of the public resulting NRC power reactor licensees subject Pollutants (NESHAPs) for radionuclides from air emissions less than 1 mrem to 10 CFR 50.34a must keep doses to on October 31,1989. Under 40 CFR Part (0.01 mSv) per year. 'the second study members of the public from airborne 61, Subpart I, emissions of evaluated doses from air emissions at 45 effluents consistent with the numerical radionuclides must be limited so that no additional facilities that were selected guidelines in Appendix I to 10 CFR Part member of the public would receive an because of their. potential for air 50. These licensees have reported effective dose equivalent greater than to emissions resulting in signiScant public estimated doses to members of the mrom (0.1 mSv) per year.6 Subpart I of

, exposures. EPA found that 75 percent of public from air emissions well below 40 CFR Part 61 was promulgated to these licensees had air emissions the Subpart I value for many years.

implement the CAA and limit doses to resulting in an estimated maximum Based on the combination of a members of the public from air public dose less than 1 mrem (0.01 mSv) continuing regulatory basis for reduced emissions of radionuclides (other than per year. For the licensees evaluated, air emissions and documented proof of Radon.222) from all NRC licensees other none exceeded 10 mrem (0.1 mSv) per the effectiveness of the NRC program for than limnsees possessing only sealed year. these licensees, EPA rescinded Subpart sources, high-level waste repositories. In its initial proposal to rescind I for power reactors licensed by NRC (60 and uranium mill tailings piles that Subpart I for NRC licensees other than FR 37196; September 5,1995).

power reactors, EPA stated that:

8Subpart I expresses dose in effective does Amendments equivalent (EDE). NRC expresses dose in total Based on the results of the survey effective does equivalent (TEDE). These terms are undertaken by EPA and the commitments The amendments proposed on eaaentially equivalent. made by NRC in the MOU, EPA has made an December 13,1995 (60 FR 63984), and i

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Federal Register / Vol. 61, No. 238 / Tuesday, Des. ember, 10, 1996 / Rules and Regulations 65121 4

finalizeu m aus rule estabbsb a te tde to easure that the constraint is that the constraint was preferable to

_ constraint of to mmm (0.1 mSv) per not again exceeded, a timetable for dual regulation or Subpart I alone.

year TEDE to members of the public implementing the corrective steps, and Those commenting that existing NRC 3 from airborne radioactive effluents to the expected results. Records of the programs are adequate to protect the i tb environment from NRC licensed results of measurements and public cited the two EPA studies on ficilities, other than power reactors, as calculations needed to evaluate the doses from air emissions. Two-thirds of

' a r art of its program to maintain doses r siease of radioactive effluents to the these commenters were opposed to

' AL'RA. Thece amendments codify emironme. t will still be requimd going forward with the constraint numencal values for NRC's application p arsuant to its CFR 20.2103(b)(4). because they believed it - mt needed of ALARA guidelines for radioactive air Exceeding th.s constraint will not and that licensee and regulator costs emissions from its licensees, other than result in a Notice of Violation (NOV) as could not be justifled given the 4

power reactors. For power reactors, would be the case if a limit needed for expectation that risk to public health l ALARA guidelines have already been adequate protection of public health and and safety would not be reduced. These established within to CFR Part 50 and safety were exceeded. In the case of the commenters encouraged NRC to existing facility licensing conditions. constraint rule, an NOV will be issued continue working with EPA to provide These final amendments ensure that air only if and when (1) a licensee fails to sufBcient basis for rescission of Subpart

emissions are maintained at very low report an actual or estimated dose from I without the imposition of an equally a

levels and, taking into consideration the airborne effluent releases from a facility unnecessary regulation. A few elimination of dual regulation, at some that has exceeded the constraint value; commenters stated that the risk was a

reduced cost to licensees. This action or (2) if a licensee fails to institute considerably less than estimated brings consistency between the EPA's agreed upon corrective meanures because excessively conservative dose standard and the NRC's ALARA intended to prevent further altborne calculational methods wem used by

, application, and is expected to be the effluents in excess of those which EPA. A few commenters compared the

, final step in providing EPA with the would result in doses exceedmg the to mrem (0.1 mSv) per year constraint basis to rescind Subpart I as it applies constraint level. to variability in background or doses to NRC-licensed facilities other than The rule applies to airborne effluents from commercial air traffic as evidence power reactors. NRC has been working of radioact ve materials to the that the dose and the risk is trivial.

cooperatively with EPA to achieve environment, other than Radon 222 and Seven commenters cited burden rescission of EPA's standards in 40 CFR daughters, from all NRC licensees reduction ar.d single agency oversight as Part 61. Subpart 1, under Section except power reactors. Power reactors the reasons for agreeing that the 112(d)(9) of the CAA. EPA published a are exempt from this rule because they constraint was preferable to dual proposed rescission of 40 CFR Part 61, aos already required, under to CFR lation or EPA's Subpart I alone.

Subpart I, on December 1,1992 (57 FR 50.34a, to identify design objectives and ' mmenters opposed to the

$6877). On September 28,1995. EPA the tusans to be employed for keeping constraint as a less protective standard, published a notice in the Federal doses to members of the public from air stated that the constraint was based Register reopening the comment period effluents Al. ARA in their license upon a voluntary program (ALARA) I on resciaalon of Subpart I (60 FR 50161). application, Appendix I to to CFR Part and, as such, was not adequate to  !

The objective of this effort is to 50 contains the numerical guidelines to Protect the public. One commenter eliminate duplicative lations that meet this requimment, stated that NRC does not perform provide no incremental  !

efit in terms confirmatory measurements and i of public and environmental protection. Response W= mats therefore, NRC jurisdiction was not '

The regulatory framework that NRC is Fifty-seven individuals and adequate.

providing as a basis for rescission of organhations provided writtea Response:NRC and EPA have .seen EPA's Subpart I consists of the comments on the proposed rule end wMing to develop a basis upon which l requirement in 10 CF1t Part 20 to limit Draft Regulatory Guide DG-8016. dual regulation could be ehminated. '

doses to members of the public to 100 Among the 57 commenters,24 were EPA has stated that there are two mrem (1.0 mSv) per year, and the licensees, seven were professional necessary con'ponents to any finding mquirement to constrain doses to organizations, five were States,16 were that NRC's p is sufficient to members of the public from airborne members of the public, and five were protect the h th and safety of the effluents of radioactive materials to the environmentalorganizations.1 mse public. The first is evidence that doses

, environment from a single licensed many letters commenting on the Draft from air emissions are below to mrem operation to 10 mrem (0.1 mSv) per Regulatory Guide DG-8016 also (0.1 mSv) per year to a member of the 3

year, included comments on the rule, these public. This has been demonstrated utly, under $ 20.1501 licensees comments were also considered in through the two studies by FPA and by 3r ared g to make or cause to be developing the final rule, licenseo seporting of actual air

. .ee surveys that may be necessary to emissions.The second component is a eomply with the regulations in to CFR issue 1-Pmposed Rule Approach program to en=ure that doses remain at Part 20. His data would be made Comments: A total of thirty-one this level. In the absena of rulemaking available to inspectors upon request, if individuals and organizations requiring licensees to maintain doses to '

the limases estimates or measures a commented on the basis for the rule, levels of no more than to mrom (0.1 does to the nearest resident from air Five commenters agreed with the mSv) per year, EPA would not rescind emissions greater than to nuem (0.1 approach and need for the constraint. Subpart I and dual regulation would mSv) per year, the licensee would be Four commented that the rule should continue.

requimd to report the dose to NRC in not be finalized and that EPA's Subpart writing within 30 days, which would na Federal Radiation Council (FRC)

I should remain in effect. Twenty-two was formed in 1959, to provide include the circumstances that led to commenters stated that existing NRC recommendations to the President for the greater than to mrem (0.1 mSv) per programs provided an ample margin of Federal policy regarding radiation year dose, a desaiption of the corrective safety and that the constraint was not matters that affect health. In May 1960, steps the licensee had taken or proposed needed. However, of these, seven agreed FRC set forth basic principles for

65122 Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1906 / liules and Regulations i protectw.4 o, uuth workers and the from individual pathways of exposure continue to protect public health in the public. The council was abolished in and individual radionuclides to ensure future. EPA undertook studies to .

1970 wh-. 's functions were that the total dose does not exceed determine (na level of protection transferred to the EPA Administrator. In recommended levels. Both programs provided by the existing regulatory 1981. EPA published proposed achieve similar levels of protection. program and found that doses were recommendations for new Federal NRC agrees that adoption of the sufficiently low to protect the health guidance for occupational exposure. In constraint ha 6 20.1101(d)is preferable and safety of the public with an ample 1987, President Reagan approved to dual regulation due to the reduction margin of safety. The implementation of recommendations by the EPA in burden on licensees as well as State this mie will ensure that doses to Administrater for new " Radiation and Federal agencies. Under the members of the public from air effluents  ;

Protection Guide.nce to Federal agencies provisions of 40 CFR Part 61, licensees will continue to temain below to mrem for Occupational Exposure." EPA has with doses to members of the public (0.1 mSv) per year and provide evidence not yet issued recommendations on greater than 1 miem (0.1 mSv) per year to EPA that the current level of limits for the public. A working group but less than 10 mrem (0.1 mSv) per protection will continue.

comprised of representatives from year must submit reports. However, The purpose of this rulemaking is not affected Federal agencies and experts on unde 10 CFR 201101(d), these to reduce doses, because it has already radiological health matters has lwn licensees will not have to file reports for been demonstrated that doses are developing these recommendations for doses below the constraint level because sufficiently low. The purpose is to several years and expects ta provide doses can be evaluated during routine ensure that doses are maintained at the them during the next year. inspections. Under the final rule, the low level currently achieved by NRC in 1977, the International Council on burden of calculating doses should be licensees. eliminate unnecessary dual Radiological Protection (ICRP) issued its reduced for most licensees because the regulation. and reduce costs associated Report No. 26 " Recommendations of the proposed guidance for demonstrating with the current level of protection, by International Council on Radiological compliance with to CFR 20.1101(d) providing a basis upon which EPA can Protection"in 1977. These allows significantly more flexibility and find that doses will not increase as a l recommendations concluded that the simpler methods for ca .ulating doses restrit of rescission of Subpart 1.

average doses to members of the public than the model currently used t demonstrate compliance with 40 CFR Issue 2-Promul 8ation of the Constroint should not exceed 100 mrem (1.0 mSv) as mRA per year with a limit of 500 mrem (5.0 Part 61. These new methods for mSv) per year to any individual. calculating doses should result ir. fewer Comments:There were a number of The National Council on Radiation reporting and corrective actions, as commenters who objected to the Protection and Measurements (NCRP) is under EPA's Subpart 1 ALARA basis for the proposed required by Congress to recommend Licensees are required under constraint rule. Some commenters limits for exposure to ionizing radiation. 5 20.2103 to maintain records of surveys objected on the ground that ALARA is In June 1987, NCRP issued its Report required to demonstrate compliance a matter of operating philosophy, good No. 91," Recommendations on Limits with the public dose limit. Review of radiation protection practice and for Exposure to Ionizing Radiation." licensee records used to demonstrate licensee ludgment, and cannot be This report contains recommendations compliance with the public dose limit is translated into an enforceable dose on exposure limits for both pan of the NRC inspection program. number Other commenters objected on ,

occupationally exposed individuals and Confirmatory measurements would the basis that ALARA is inherently site l individual members of the public. The generally not be useful since most specific and cannot be dermed report recommended that doses to licensees in this category do not have generically or that the proposed dose individual members of the public be routine ongoing effluent releases. constraint cannot be ALARA but must limited to 100 mrem (1.0 mSv) per year Finally, concerning those commenters be a limit because the constraint averaged over a lifetime, not to exceed that believe NRC's requirements are less contemplates some enforcement actions 500 mrum (5.0 mSv) in 1 year. safe than Subpart I, Congress enacted for exceedance even if the licensee has In 1991, NRC revised to CFR Part 20 legislation comprehensively amending followed all good radiation protection

" Standards for Protection Against the Clean Air Act (CAA), which practices. Some commenten argued that Radiation." This revision included new included a section addressing the issue the rule cannot be ALARA because it limits for individual members of the of regulatory duplication between EPA adds costs with no safety benefit. Other public.Though both the ICRP and the and NRC in 1990. The 1990 CAA commenters stated that the constraint is NCRP recommended limits of 500 mrem amendments permit the EPA inconsistent with a prior NRC decision (5.0 mSv) in any one year, the NRC Administrator to rescind the CAA in 10 CFR Part 20 (56 FR 23360) on the ,

established a limit of 100 mrem (1.0 standards as they apply to use of " reference levels."

mSv) per year because it was radionuclides, at sites licensed by NRC, Response The Commission has impractical to control dose in terms of and the Agreement States,if he or she retained an ALARA basis for the rule lifetime average without keeping track finds that the NRC regulatory program but recognizes that its use of the term in of individual exposures, in addition, to provides an ample margin of safety to tLis rule may have led to some  ; 1 1

CFR Part 20 requires that licensees use protect public health, confusion.The Commission i procedures and engineering controls to EPA's analysis of the NRC regulatory acknowledges that the ALARA concept maintain doses ALARA. program focused on two generalissues: in 10 CFR 20.1003 is an operating Both the NRC and EPA regulatory (1) whether the implementation of the philosophy which requires gmd programs are designed to achieve NRC regulatory program results in radiation protection practice and the protection of the public with an ample sufficiently low doses to protect the exercise of expert licensee judgement.

margin of safety. The approaches of the health and safety of the public with an The ALARA concept is site specific in two agencies differ. NRC limits TEDE. ample margin of safety; and (2) whether that some of the factors to be considered requires that doses are maintained the NRC program is sufficiently may vary from case to case, as the court ALARA, and maintains an active comprehensive and thorough, and so found in York Committeefor a Safe inspection program. EPA limits dose administered in a manner that will Environment v. NRC,527 F. 2d Bla j

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Federal Register / Vol. 61, No. 238 / Tuesdcy, December, 10, 1996 / Rules and Regulations 65123 (D.C. Cir.1975). The Cnmminion has sense that exceedance will lead to cont A ikwever, the rule can be said )

presumed, without deciding, that the corrective action, but it is not a limit in to of fer a small, but positive, net health ALARA concept in S 20.1003 can be the sense that exceedance per se woum and safety benefit in that it will prevent .

enforced in a particular case so as to constitute a violation of any regulatory a decrease in the level of protection l 4

require a specific radiation protection requirement. A violation occurs only afforded the public if Subpart I were practice, but it is clear that the existing when a licensee fails to report an rescinded in the absence of a rule like j regulation does not translate readily into exceedance or fails to take appropriate the constraint. Under the A LARA a generic dose number, which,if corrective actions. A limit would be concept it is appropriaw to base a l exceeded, will lead to enforcement appropriate if compliance were needed requirement on a small positive health i action. to ensure adequate protection of public and safety benefit when cost savings are The NRC intended the constraint rule health and safety. In this case, the also likely.

to be a somewhat broader concept found constraint is needed only to ensure that The NRC does not expect that any in the governing statute, the Atomic currently afforc.ed levels of protection licensee subject to the rule will be Energy Act of 1954, as amended (Act). are not reduced. This will provide the unable to demonstrate that doses to The Act, as construed by both the basis for rescission of 40 CFR Part 61, members of the public from releases of Commission (e.g.,10 CFR 50.109) and Subpart I by EPA. airborne radioactive materials to the l the courts (Union of Concerned Thus, to say that the constraint rule environment are less than to mrem (0.1 Scientists v. NRC,824 F.2d 108 (D.C. cannot be based on ALARA because it mSv) per year. In the unlikely case that Cir.1987)), contemplates two distinct is in effect a " limit," interchanges a this dose is exceeded or is projected to approaches to radiological regulation. narrow concept of "ALARA" with a he exceeded, due to some temporary First, a level of " adequate protection" broad concept of" limit."If a broad circumstances or lapse in controls, the must be defined and enforced without definition is used, the constraint rule NRC expects the licensee to take regard to economic cost. Second, risk withstands scrutiny as both ALARA and whatever corrective actions are may be reduced to a level below that a limit. In the statutory context of the necessary (if any) to protect public associated with " adequate protection" Atomic Energy Act and general health and safety, to report the dose, to

< to " minimize danger to life or property" principles of administrativo law, the recommend further corrective actions if with economic cost and other factors as constraint rule is a limit based on necessary, and take those corrective permissible balancing considerations. generic ALARA considerations. The actions agreed upon with NRC. NRC See " Revision of Backfitting Process for constraint rule is not a limit needed for staff will review and approve corrective Power Reactors,"(53 FR 20603; june 6, adequate protection and the constraint actions to ensure that they are 1988). It is important to note that rule is something more than a narrow appropriate to reduce airbome Section 161b of the Act authorizes the translation of the particular ALARA emissions sufficiently to comply with Commission to adopt and enforce concept contained in 10 CFR 20.1003. the constraint in the future. In the 1 generic requirements using either The term " constraint" was used for the unlikely case that a licensee is unable to approach. Many recent NRC regulations rule to avoid confusion with the narrow take adequate corrective actions,

' (a g.,10 CFR 50.63) have been directed concepts of ALARA and the limit because of limits in technology or cost at incresnental risk reduction under the employed in radiation protection constraints, these issues can 6e second approach based on a generic discussion. addressed in the future on a case-by-regulatory or backfit analysis which Three matters must be addressed: case basis.

considered and balanced economic and (1) The commant that the rule caanot The application of the ALARA other costs and safety backfits. These be based on ALARA because it will principle used in this rule is not the

" minimize danger" regulations provide result in increased cost with no safety same as the concept of reference level

" limits" because they establish generic bene 6t: which was rejected by the Commission inquirements directly enforceable 9) The problem of the licensee who when to CFR Part 20 was recently against licensees. However, in a broad cannot meet the dose constraint despite revised. Commenters on the 1991 sense they are also ALARA regulations using all good radiation protection revision to 10 CFR Part 20 oblocted to because cost, feasibility, and other practices; and the use of reference levels because they relevant factors identified in to CFR (3) The allegedly inconsistent were implemented exactly the same as 20.1003 are evaluated. Commission discussion of reference adequate protection limits. For that Viewed in its larger statutory context, levels in a recent revision to 10 CFR Part reason, the Commission did not adopt the use of ALARA in to CFR 20.1003 is 20. reference levels in the 1991 revision.

one means to implement the second The Commission disagrees with the Lnplementation of the constraint is approach to radiological regulation. Premise of the first comment. There was different than such a limit because However, other similar requirements no disagruement with the Commission's exceedmg the constraint is not a can also be part of this second approach. conclusica that all of the licensees violation, and only requires the licensee While the ALARA concept in to CFR affected ty the rule are achievin6 a level to report the dose and take corrective 20.1003 may not be consistent with a c' control such that doses are below the actions to redum future doses.

generic enforceable dose requirement, to mrem (0.1 mSv) per year level and other concepts of ALARA premised on so there is no factual dispute over Issue 3-Whether the Constraint Is generic considerations are appropriate. whether this level of radiation Actually a fimit This conapt of ALARA as a broadly p*otection is readily achievable. The Comments: Nine comments were applicable dose requirement based on a final rule and EPA's rescisalon of its received on whether the constraint is or generic weighing and belancing of Clean Air Act emission limitsand abould be a limit. Two commenters Lealth and safety, feasibility, and other related requirements will result in a believed that the constraint was no factors is the basis for the longstanding significant net cost savings to licensees. different than a limit. One commenter limits on nuclear power reactor The NRC acknowledges that the positive agreed with the term constraint. Three emissions in to CFR Part 50, Appendix direu health effects are likely to be commenters expressed concern that the I. and is the basis for the constraint rule, small and possibly nonexistent in tne constraint was an inappropriate The ALARA rule imposes a limit in the near future, given the current level of relaxation of requirements.

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65124 Federal Register / Vol. 61 No. 238 / Tuesday, December, 10, 1996 / Rules and Regulations a

Those commenting that the constraint requirements. Three commenters agreed 20.2203lt))(2) to the constraint. This was a de facto limit interpreted the that this rule should not 1,e codified as section requires reports to contain ,

i requirements to indicate that a second a Division 2 requirement but rather as demographic information on the I exceedance of the constraint would a Division 1 matter of compatibility, exposed individual. These commenters result in enforcement action and Under Division 1, the States would be expressed concern that a member of the therefore the constraint is a limit. Three required to adopt regulations that were public would be under no obligation to commenters indicated that the rule essentially identical. These commenters provide demographic information to should be a strict limit. They expressed believed that if stricter standards were licensees and that licensees would not concern that the constraint was less permitted, reactor and non-reactor always be able to comply with the protective than EPA requirements. Iicensees would be under different requirement.

Response:lf a licensee exceeds a limit requirements and certain practices, such R88Ponse:NRC agrees that members that is needed to protect health and as nuclear medicine, could be of the pubhc may choose to withhold safety, the NRC may take immediate 'eopardized. One commenter noted th t the demographic information from enforcement action. If a licensee ause this is really a limit,it should licensees. Such information is only exceeds a constraint, the licensee will be under 10 CFR 20.1301 and would be needed for occupationally exposed be required to notify NRC, take any a Division 1 matter of compatibility, actions that may be necessary to protect Another commenter stated that NRC individuals to ensure that lifetime exposure records are accurate. Section public health and safety, and implement should have provided a greater 20.2203 has been changed to only opportunity for State involvement in any further corrective actions that NRC i staff agrees are adequate to prevent this rulemaking, and that as a division require such information on further doses in excess of the constraint. 2 rule. Agreement States would have to occupationally exposed individuals.

Ilowever,if the licensee failed to report spend scarce resources to develop a Issue 7-Wee a measured or calculated dose in excess compatible rule.

of the constraint to NRC or failed to Response Section 116 of the Clem Comment: One commenter requested implement appropriate corrective Air Act specifies that nothing precludes that an effective date be added to the actions as agreed upon, enforcement States fro u imposing air emission final rule to coincide with EPA's action would be expected. This is requirements that are more stringent rescission of Subpart 1. Response: The because, unlike an adequate protection than those developed by EPA. Section NRC and EPA will to the extent limit, the constraint is not needed to 116(dl(91, which contains the provisions possible, publish tbth final rules so t' hat provide adequate protection of public related to EPA's margin of safety they become effective concurrently, health and safety. determination for NRC or Agreement The NRC does not agree that the State licenses, specifles that: "Nothing Issue 8-Enforcement constraint is less protective than current in this subsection shall preclude or deny the right of any State or political Comments:Five commenters stated EPA requirements. Both EPA's Subpart that NRC should establish a limit rather I and the NRC constraint require subdivision thereof to adopt or enforce any standard or limitation respecting than a constraint. They believed that if licensees to take actions to ensure that the limit has been exceeded, a notice of doses to members of the public do not emissions of radionuclides which is exceed to miem (0.1 mSv) per year from more stringent than the standard or violation and civil penalt'.es should ambient air emissions. NRC routinely limitation in effect under Section 7411 always result. One commenter inspects hansed facilities to ensure that of this title or this section." The expressed concarn that "self-reporting air effluents do not result in doses to Commission I o eyes that this provision and confession"is not adequate.

members of the public that exceed the clarifies that ;r 3's determination Another stated that because ALARA is regarding NRC and Agreemcat State only guidance, it is not enforce-ble.

requirements in to CFR Part 20. The licensees has no effect on the existing Response: ALARA is not guidance. As Inspection and enforcement program willbe amended as a result of this final authority of States to impose air stated previously, the 1991 revision to rule to review licensee records used to emission standards that are more 10 CFR Part 20 codified ALARA as a demonstrate compliance with the stringent than those of EPA. required part of the licensee's radiation With regard to the comment Frotection Pmgram. A limit often constraint. concerning involvement of the imp lies that doses must be controlled Issue 4-Otizen Suits Agreement States in the development of below that levelin order to provide Comments:Three commenters this rule. NRC has routinely reported its adequate protection of health and safety opposed finahzation of the constraint on progress on providing an adequate basis of the public and workers. To meet the basis that it forfeits citizen rights to upon which EPA could rescind Subpart ALARA requirernents heensees am sue a licensee who exceeds the I to both the Organization of Agreement cunently controlling effluents to levels constraint. States (OAS) and the Conference of below that which would be required Response:The Commission's Radiation Control Program Directors under the constraint. If a licensee regulations in to CFR 2.206 provide the (CRCPD) at each of their annual exceeds the constraint, the rule requires pubhc with the right to petition the NRC meetings. The A greement States were that this be reported and that cxarrective to take enforcement action against a cousulted extensively on this issue over actions be pmmptly taken. If a licensee Licensee for a violation of the the last several years. There were extensive discussions of the conapt does not comply with the obligation to Commission's regulations.This would include the final constraint rule. with the individual States and with the report and take corrective actions.

Executive Board of the OAS.

enforcement action will result. In NRC's issue S-Agreernent State Compatibility judgment, as a matter of enforcement issue 6-Demographic Informotion poucy,it is not necessary to issue a Cornments:Four commenters Contened in Requimd Reports notice of violation or civil penalties addreened the proposal that the constraint be a Division 2 matter of Comments: Seven commenters upon exceedence of the constraint level; addressed the application of the it is sufficient that this be reported and compatibility. Under Division 2, States could adopt similar or more sMngent requirement contained in to CFR that prompt corrective action is taken.

Federal Regist:r / Vol. 61, No. 238 / Tuesday, December, 10. 1996 / Rules and Regulations 65125 Issue 9 Sumptions patients do not need 1o be speciCcally hsponse: Draft Regulatory Guid[

Co.. mum Five commenters stated addressed in the calculation of Jose DG-C16 provides several methods for that the rule should only apply to used to demonstrate compliance with demonstrating comphance with the members of the public offsite. They the constramt. constramt, and only one of the methods cited the EPA's Subpart I requirement to Comments: Four commenters stated described would require direct calculate dose to the nearest resident or that in addition to h222, all dau ters measurement at the receptor location. If offsite individual likelYto receive the Produced after release should also this method is not practical due to the highest dose. Under Subpart I. licensees excluded. emission characteristics of the Response: EPA's Subpart I exempts radionuclide mleases, there are other would not calculate doses from air both 6222 and any daughters emissions to visitors in hospitals, options cited in Draft Regulato Guide produced after telease of Rn-222 workers that are not radiation workers DG-8016 that do not require a within the facility, or other members of because these types of releases are measurement to demonstrate normally not attributable to licensed compliance with the constraint.

the public within the facility. activities. The proposed rule was not Response:The language in the rule Issue 22--Scope of the Rule has been changed to reflect that it is intended to be more stringent than Subpart 1. The rule language has been intended to apply to radioactive #""*"## *"""*""**

changed to reflect this exemption.

airborne effluents to the environment. Comments:Two commenters that ihha must be a constraint, h The Draft Regulatory Guide DG 4016 should apply to all licensees, including recommended that in addition to Ro-will be revised to indicate that the dose 222, h220 and its daughters should Power reactor licensees.

limit is to be calculated or measured at Response: Although this rule only the nearest resident or individual offsite also be exempted. One commenter stated that it was an EPA oversight that applies to licensees other than power likely to receive the highest dose. The led to this erroneous omission from the reactor licensees, the Cownission's final regulatory guide will be available final Subpart I. existing regulations in to CFR Part 50, when the rule becomes effective. Response: h220 is normally Appendix 1, already establiab a similar Comments:Two commenters stated regulatory framework for power attributable to licensed activities. EPA that air emissions from adjacent nearby does not exempt Rn-220 or its reactors. Appendix Iincludes separate exempt uranium mills should not be daughte s from consideration in the requirements to develop desiga included in tbo calculation of dose. One dose calculations in support of objectives and operational levels commenter stated that materials from demonstrating comphance with Subpart sufficient to demonstrate compliance unliansed portions of the facility such I. The commenter's suggestion that an with EPA's Subpart I. In addition, as ore stockpiles should not be oversight led to the erroneous omission reactor licensees must annually mport considered in the calculation of dose. quantitles of radioactive materisis Response: Subpart i does not apply to of this exemption incorrect, fromshould and Rn-220 Subpart notIisbe released into the environment, as well disposal at facilities regulated under 40 excluded from the calculations that are as the resulting doses.

uranium tal p le af r has ne t demonstrate mmpliance with g Issue 12-Locotion of Construint in NRC been disposed of under 40 CFR Part 192.

I" "#

Comments:Six commenters requested ne constraint applies to airborne that in addition to sealed sourms, sealed effluents of only 11 censed materials to The Commission requested specific the environment. Draft Regulatory containers should also be excluded from comment on the question of whether the the rule. to mrem (0.1 mSv) per year constraint Guide DG-8016 will be changed to Response: Paragraph 2(a) of Appendix should be established in 10 CFR Part 20 clarify that windblown particulates from. D to 40 CFR Part of states: Radioactive other licensed facilities or unlicensed as proposed or whether it should be materials in sealed packages that remain established separately in each materials do not need to be considered unopened, and have not leaked during in the calculation of doses used to appropriate part of Title to instead.

the assessment period should not be demonstrate compliance with the included in the calculations." Subpart ! " " ' w constraint. exempts sealed packages, because any po m[ts{,,were One ed that th Cornments: Four commenters stated that att emissions from patients should package that has remained sealed cannot contribute to airborne effluents. Qd n CFR Part 2 * % ther menente stated ende mustnint be exempted from this rule. When a totalinventory of licensed Response:The regulatory unpact materials possessed during the year is should be in each app riate part. o analysis (NUREG-1492) for a recent used to model potential doses,it is """*"*"**

NRC rulemaking analyzed potential unnecessary to include materials that be in $ 20.1301 with the dose limits.

doens from exposure to patients who could not have contributed to airborne Response: While the constraint could were released after administration of effluents. no Regulatory Guide will just as easily be included under other radiopharmaceuticals. nis analysis provide further guidance on this issue. Parts of the regulations, including it in concluded that internal doses from to CFR Part 20 provides unifonnity.

Inhalation of radioactive mtterials in Issue 20~Measurubilityof 20miem(0.1 Because 10 CFR Part 20 is the the exhaled air of a released patient are mSv) Per Yeor tiesignated area for radiation protection trivial For limnsees using an inventory Comments:Three commenters stated standerds and related requirements, it is approach to demonstrating compliance that to mrem (0.1 mSv) per year was not the appropriate location for the with the rule, such as the (X)MPLY measurable. One commenter steted that constraint. The rule will be codified computer code, there is no need to although to mrem (0.1 mSv) per year under $ 20.1101 to make it clear that account specifically for the materials might be easily achievable,it is not although the constraint is not the same that might be released to the air through easily measurable. Another stated that as a limit, licensees are expected to respiration or transpiration by patients. the exposure rate corresponds to 1 develop radiation programs to ensure The Regulatory Guide will make it clear microR (0.01 micro-Sy) per hour and that doses from air emissions are below that dose from air emissions from cannot be measured accurately. 10 mrem (0.1 mSv) per year.

1 Ir

65126 Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1996 / Rules and Regulations Agreement State Compatibility with *he proposed ru.a. The final average 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per response.

The Commisr%u believes that the reguhtory guide will be available by the including the time for reviewing Division 2 compatibility designation for effective date of this rule. itructions, searching existing data the rule is consistent with state Conforming Amendments To NRC's s urces, gathering and maintaining the authority in this area as described in the Enforcement Policy data needed, and completing and Clean Air Act.The Division 2 reviewing the collection ofinformation.

designation means that Agreement By separate notice in the Federal . Send comments on any aspect of this States must address these rules in their Register, tue Commi::sion is modifying collection of information, including regulations but may adopt requirem s its General Statement of Policy and suggestions for further reducing this more restrictive than those of NRC. Procedures for NRC Enforcement burden, to the Information and Records Accordingly, the authrity of the Actions (Enforcement rolicy), t Management Branch (T 6 F33L U.S.

Agreement States to impose air address the new regulation, and to emissions standards under their Atomic Provide an example Severity Level IV Nuclear Washington, Regulatory DC 205554001 Commission'by or au o effxt a "

r8 e a change laternet electronic mail to bd1@nrc. gov; j s so b f he and to the Desk Officer, Office of their existing authority, Under Section Enforcement Policy is reprinted in its 274 of the Atomic Energy Act the entirety in the next revision of NUREG- Inf rmation and Regulatory Affairs.

1600.

EM202, WSMW, Mce of Commission reviews Agreement State Management and Budget Washington' l programs to ensure that adequacy and Small Business Regulatory Fnforcement DC 20503' I compatibility of the State Program is Fairness Act maintained. The Commission has also Public Protection Notification approved procedures ta suspend or In accordance with he Small Business Regulatory Enforcement The NRC may not conduct or sponsor, terminate programs that are not Fairness Act of 1996, the NRC has adequate or compatible. and a person is not required to respond .

detennined that this action is not a to, a collection ofinformation unless it Summary of Changes in the Final Rule " major rule" and has verified this displays a currently vahd OMB control Based on the responses to comments, determination with the Office of number. l a few changes i ere made in the final Information and Regulatory Affairs, rule. Otherwise, the provisions of the Office of Management and Budget. Regulatory Analysis final rule are the same as those Finding of No Significant The NRC has prepared a regulatory presented in the proposed amendments. EnvironmentalImpact analysis for this final rule. The analysis 8 ' ' The Commission has determined examines the costs and benefits of the s d as fol w under the National Environmentaj alternatives considered by the NRC. In (1) Section 20.2203(b)(2) has been chan8ed to require the name, social Policy Act of 1969, as amended, and the the response to comments, the NRC security number, and date of birth only NRC's regulations in Subpart A of 10 concluded that only some minor for occupationally werexposed CFR Part 51, that this rule, if adopted, changes to the draft regulatory analysis l individuals and not for members of th, would not be a major Federal action were necessary, corresponding to some public who have received doses in significantly affecting the quality of the minor procedural changes in the final excess of the public limits, including human environment and therefore, an rule. The regulatory analysis is available the constraint. environmental impact statement is not br inspection in the NRC Public (2) The language of the rule has been required. This action is not expected to Document Room,2120 L Street, NW.

changed to indicate that Rn-222 and all have any signincant environmental (Lower level), Washington, DC 20555-daughters produced after the release of impact because the programs will 0001. Single copies of .ae analysis may I the radon are categorically excluded provide equivalent protection. Also, be obtained from Alan K. Roecklein, I from this rule. airborne effluents of radioactive Office of Nuclear Regulatory Research.

(3)The language of the rule has been materials to the environment are not U.S. Nuclear Regulatory Commission, changed to indicate that the constraint expected to increase. 'The changes to the Washington, DC 20555-0001, telephone applies only to release of airborne final rule are to the procedural methods (301)415 4 223.

radioactive effluents to the environment for demonstrating compliance as well as e and, thus, dose to the nearest resident, licensing and inspection procedums. Regulatory Flexibility Certification offsite business or school, is to be The environmental assessment and in accordance with the Regulatory constrained. finding of no significant impact on Flexibility Act of1980 (5 U.S.C' in addition, the following changes which this determination is based are 605(b)), the Commission certifies that will be made to Draft Regulatory Guide available forinspection and this rule will not have a significant DG-8016: photocopying for a fee at the NRC economic impact on a substantial (1) An inventory of radioactive Public Document Room 2120 L Strert number of small entities. This final rule materials used to model a potential dose NW. (Lower level), Washington, DC.

only impacts NRC licensees with to a member of the public need not include radioactive materials in sealed Paperwork Reduction Act Statement emissions of significant quantities of containers that have remained sealed This final rule amends information radioactive material who would be throughout the compliance period. collection requirements that are subject required to report the exceedance to the (2) Airborne emissions of radioactive to the Paperwork Reduction Act of 1995 NRC. It will alleve licensees from the materials from patients does not need to (44 U.S.C. 3501 et. seq.). These unnecessary burden of dual regulation.

be considered if the materials have requirements wem approved by the The level of air emissions from NRC-already been included in the site Office of Management and Budget, licensed facilities has historically been inventory. approval number 31504014, well below the NRC dose limit and The Regulatory Guide was issued in The public reporting burden for this except for a few unusual cases, readily draft for public comment concurrent collection ofinformation is estimated to met the EPA standard.

1 Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1996 / Rules and Regulations 65127 Backfit Anasysis 206,88 stat.1242, as amended. 1244.1246 $ 20.220$ perrts of exposures, radiation (42 U.S.C. $841,5842,5846). levels, and concentrations of radioactive The NRC has determined that the backfit rule 10 CFR 50.109, does not 2. In 6 20.1003, the definitj.on of material exceeding the constraints or ilmits.

apply to this final rule because it does Constroint is added to read as follows: (a) * *

• not apply to power reactor licensees- (2) * * *

$ 20.1003 Dennhions.

ar.d therefore, a backfit analysis is not . .

required for this final rule because these (vi) The ALARA constraints for air Constraint (dose constraint) means a emissions established under amendments do not involve any value above which specified licensee $ 20.1101(d): or l

provisions which would impose backfits actions are required, (b) * *

• as defined in 10 CFR 50.109(a)(1). . . . . . ...

List of Subjecta In 10 CFR Part 20 3. In S 20.1101, paragraph (d) is added 4 (iv) Corrective steps taken or planned Byproduct material, Criminal to read as follows:

to ensure against a recurrence, including penalties, Licensed material, Nuclear $ 20.1101 fladiation Protecton Pmgrams. the schedufe for achieving conformance materials, Nuclear power plants and . . . . . with applicable limits, ALARA reactors, Occupational safety and (d) To implement the ALARA constraints,generall a plicable j health Packaging and containers, requirements of $ 20.1101 (b), and envir amentalstan s, and l Radiation protection, Reporting and associated license conditions.

notwithstanding the requirements in recordkeeping uirements, Source

$ 20.1301 of this part, a constraint on air (2) Each report filed pursuant to

, material, Specia nuclear material, emissions of radioactive material to the paragraph (a) of this section must Waste treatment and disposal-i environment, excluding Radon-222 and include for each occupationally For the reasons set out in the its daughters, shall be established by overexposed 7 individual: the name, preamble and under the authority of the tjcensees other than those subject to Social Security account number, and 1 Atomic Energy Act of 1954, as amended, S 50.34a. such that the individual date of birth. The report must be the Energy Reorganization Act of 1974, member of the public likely to receive prepared so that this information is ,

as amended, and 5 U.S.C. 553, the NRC the highes' dose will not be expet;.,xi to stated in a separate and detachable part  !

la adopting the following amendments receive a total effective dose equivalent of the report.

to 10 CFR Part 20. I In excess of to mroen (0.1 mSv) per year a * * *

• from these emissions. If a licensee Deted at Pockville, Maryland, this 3rd day E AGA ATION subject to this requirement exceeds this of December,1996.

dose constraint, the licensee shall report For the Nuclear Regulatory Comrnission.

s 1. 'I'ha authority citation for Part 20 the exceedance as provided in $ 20.2203 John C Hoyle, continues to read as follows: and promptly take appropriate Secretaryof the Commission.

! Authority: Secs. 53,63,65,81,103,104, corrective action to ensure against IFR Doc. 9th31221 Filed 12-9-96; a:45 aml 161,182,186,68 stat. 930,933,935,936, McurMnce, ausse coes PsesM 937,948,953,955,as amended. sec.1701, 4. In S 20.2203 the section heading is 106 Stat. 2951,2952,2953 (42 U.S.C 2073, revised, a new paragraph (a)(2)(vi) is ,wn re.go me m a embryo-fetus 2093,2095,2111,2133,2134,2201,2232, added, and paragraphs (b)(1)(iv) and (5 o.:aosi, the identiners should be thoes of the 2236, 2297f); secs. 201, as amended,202, (b)(2) are revised to read as follows: declared pregnant women.

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December 1996 U.S. NUCLEAR REGULATORY COMMISSION lr%q%

REGULATORY GUIDE

@gf),

• • • e OFFICE OF NUCLEAR REGULATORY RESEARCH REGUI.ATORY GUIDE 4.20 (Draft issued as DG-8016)

CONSTRAINT ON RELEASES OF AIRBORNE RADIOACTIVE MATERIALS TO THE ENVIRONMENT FOR LICENSEES OTHER THAN POWER REACTORS A. INTRODUCTION than those subject to 10 CFR 50.34a, such that the individual member of the public likely to receive the In 10 CFR Part 20, " Standards for Protection highest dose will not be expected to receive a total Against Radiation," 5 20.1302(b) requires that: effective dose equivalent in excess of 10 mrem (0.1 A licensee shall show compliance with the annual mSv) per year from these emissions. If a licensee dose limit in i 20.1301 by (1) Demonstrating by subject to this requirement exceeds this dose con-measurement or calculation that the total effective straint, the licensee shall report the exceedance as dose equivalent to the individual likely to receive provided in 10 CFR 20.2203 and promptly take ap-4 the highest dose from the licensed operation does propriate correctie action to ensure against a not exceed the annual dose limit; or (2) Demonstrat- recurrence.

ing that (i) The annual average concentrations of ra-dioactive material released in gaseous and liquid This regulatory guide provides guidance on meth-effluents at the boundary of the unrestricted area do ods acceptable to the NRC staff for compliance with the not exceed the values specified in Table 2 of Appen- constraint on air emissions to the environment. If addi-dix B to Part 20; and (ii) If an individual were contin- tional significant comments are received in the first year uously present in an unrestricted area, the dose following its issuance, the staff will revise the guide as ap-from external sources would not exceed 0.002 rem propriate. Guidance on ALARA programs can be found

' in other regulatory guides. Although these guides deal (0.02 mSv)in an hour and 0.05 rem (0.5 mSv)in a year. primarily with occupational exposure and may be specif-ic to one type of licensee, they contain programmatic in-In addition,10 CFR 20.1101(d) requires that:

formation that may be useful to all licensees. These To implement the ALARA [as low as is reasonably guides are:

achievable] requirements of 6 20.1101(b), and not-withstanding the requirements in i 20.1301 of this

• Regulatory Guide 8.10," Operating Philosophy for part, a constraint on air emissions of radioactive ma- Maintaining Occupational Radiation Exposures As terial to the environment, excluding radon 222 and Low As is Reasonably Achievable." This guide de-its daughters, shall be established by licensees other lineates the components of an ALARA program.

U5NRC REGULArORY CUtDEs he gudos we ammd e m losawg an twund enswa Repdanry casons we asved to eseoes ow make avaiabo ao m pene mace r*rmar ton as meemos acceptano no m NRc mas er enseemereng specac para or to ce+ , po.,R a., e proauca neeGud try to NRC ets$ renew appecames acdees 8 Health r="*"'" ~

and "l:'O!= ",e."'t"."'.m"d.*"ea', *

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-- _. m .-. _ m Wrmen comenmits may t>e submmed to tw RJes Renew arid Dweceves Bree DFIPS. a eteneng aroer t>ene Datets on res sonncemay tie otstaned by wreng NTIS. 6285 Port ADad U S Nucseer Repdmory Commmaan Wennmgtors DC 206S6-0001 Rays Road. Sonngsmed. VA 22101 e

I o Regulatory Guide 8.18, "Information Relev:nt to The NRC staff examines licensee programs to deter-Ensuring that Occupational Radiation Exposures at mine whether they are in compliance with the require-Medicalinstitutions Will Be As Low As Reasonably ments of 10 CFR Part 20. This guide addresses only a Achievable." part of a licensee's overall radiation protection program.

Specifically, is cJdresses methods for demonstrating

• Regulatory Guide 8.31, "Information Relevant to Ensuring that Occupational Radiation Exposures at C mPhance with the constramt on releases of airborne radioactive matenals to the environment. In addition to Uranium Mills Will Be As Low As Is Reasonably c ntrolling doses from the releases of airborne radioac-Achievable." _

tive materials to the environment, h,censees must imple-e Regulatory Guide 8.37, "ALARA Levels for Efflu- ment a radiation protection program that controls liquid ents from Materials Facilities." effluents and dose rates in unrestricted areas.

• Regulatory Guide 10.8," Guide for the Preparation Many NRC licensees possess source, byproduct, or of Applications for Medical Use Programs." Sec- special nuclear material in a form that would not cause tion 1.3 and Appendix G deal specifically with doses to members of the public from releases of airborne ALARA programs for medical facilities. radioactive material to the environment. These licens-In addition, further information can be found in Re. ees include radiographers, well loggers, and other users of sealed sources. These licensees need not take any ac-vision 1 to NUREG-0267," Principles and Practices for tions to demonstrate compliance with the constraint on Keeping Occupational Radiation Exposures As Low As Reasonably Achievable"(October 1982).1 releases of airborne radioactive materials to the The information collections contained in this regu-latory guide are covered by the requirements of 10 CFR CONSTRAINTS Part 20, which were approved by the Office of Manage-ment and Budget, approval number 3150-0014. The A dose limit derived from a basic radiation protec-NRC may not conduct or sponsor, and a person is not re- tion standard is the upper acceptable bound of radiation quired to respond to, a collection ofinformation unless it dose and is needed to protect the health and safety of in-displays a currently valid OMB control number. dividuals; a limit is a value not to be exceeded. Such lim-its should be set with the assumption that effluent re-B. DISCUSSION leases associated with licensed activities would result in The dose limits in 10 CFR Part 20 are based on limit- doses to the public that are substantially below that val-ing dose to an acceptably low level of risk to the exposed ue. Such limits are approached only under unusual cir-individual. However, any radiation exposure may carry cumstances, and only for a small fraction of the exposed some risk. Thus, the NRC requires licensees to take ac- population. A constraint is a dose value above which li-tions, to the extent practicable, utilizing procedures and censees are required to report to NRC and to take cor-engineering controls to further reduce risk below the lev- rective actions to lower the dose below the constraint val-els implicit in the dose limits in keeping with the princi- ue. Enforcement action would only occur if a licensee ple that exposures should be as low as is reasonably fails to report an exceedanx of the L.nstraint or fails to achievable. This is the goal and purpose for radiation take appropriate and timely corrective actions.

protection programs. In order to achieve th,s i goal, h-censees must control the way radioactive material is han. C. REGULATORY POSITION died from receipt through disposal.

1. CONSTRAINT ON ENVIRONMENTAL AIR EMISSIONS ALARA The following methods are acceptable to the NRC Components of an effective radiation protection staff f r determmmg the dose to members of the pubuc program, as required by 10 CFR 20.1101, include radi- fr m exp sure to airborne radioactive material that has ation exposure con.rol, written procedures and policies, been released to the environment by NRC licensees oth-control of radioactive materials, radioactive contamina-er an Power reactors. bcensees skuM che a monb tion control, radioactive waste management, training, toring period (e.g., a year, month, or quarter) to demon-program reviews, and audits. strate compliance with the a,rborne i emissions constraint in accordance with 10 CFR 20.1101(d). For most licens-1 Copies are availatte for purchase from the U.S. Government Prmung ees, the monitoring period will be one year.

Office, PO. Box 37082, Washington DC 20013 - 7082, telephone (202) 512-2249,or from the National Technical Informauon Sernce 1.1 I icensees who (1) operate a nuclear power teac-by wntmg NTIS at 5285 Port Royal Road. Sprmgfield,VA 22161. Co- tot subject to 10 CFR 50.34a or (2) possess and use radio-pies are avadable for mspection or copymg for a fee from the NRC Pub-ler Document Room at 2120 L Street NW. Washmgton.DC,the PDR's nuclides only in the form of sealed sources need not take madmg address is M ail Stop lL-6. Wash mgton. DC 20555,te le phone any actions to demonstrate compliance with the (202)634-3273, fax (202)634-3343 constraint.

4.20 - 2

l The NRC staff examines licensee programs to deter-  ;

o Regulatory Guide 8.18, "Information Relevant to Ensuring that Occupational Radiation Exposures at mine whether they are in compliance with the require-Medicalinstitutions Will Be As Low As Reasonably ments of 10 CFR Part 20. This guide addresses only a Achievable." part of a licensee's overall radiation proicction program.

SPecifically, i. ddresses methods for demonstrating e Regulatory Guide 8.31, "Information Relevant to Ensuring that Occupational Radiation Exposures at c mP liance with the constraint on releases of airborne radioactive materials to the environment. In addition to Uranium Mills Will Be As Low As is Reasonably c ntrolling doses from the releases of airborne radioac-Achievable..,

tive materials to the emironment, licensees must imple-e Regulatory Guide 8.37,"ALARA Levels for Efflu- ment a radiation protection program that controlsliquid ents from Materials Facilities." effluents and dose rates in unrestricted areas.

• Regulatory Guide 10.8, " Guide for the Preparation Many NRC licensees possess source, byproduct, or of Applications for Medical Use Programs." Sec- special nuclear material in a form that would not cause tion 1.3 and Appendix G deal specifically with doses to members of the public from releases of airborne ALARA programs for medical facilities. radioactive material to the environment. These licens-In addition, further information can be found in Re. ces include radiographers, well loggers, and other users of scaled sources. These licensees need not take any ac-vision 1 to NUREG-0267," Principles and Practices for Keeping Occupational Radiation Exposures As Low As tions to demonstrate compliance with the constraint on Reasonably Achievable" (October 1982).I releases of airborne radioactive materials to the The information collections contained in this regu-latory guide are covered by the requirements of 10 CFR CONSTRAINTS Part 20, which were approved by the Office of Manage-ment and Budget, approval number 3150-0014. The A dose limit derived from a basic radiation protec-NRC may not conduct or sponsor, and a person is not re- tion standard is the upper acceptable bound of radiation quired to respond to, a collection ofinformation unless it dose and is needed to protect the health and safety of in.

displays a currently valid OMB control number. dividuals; a limit is a value not to be exceeded. Such lim-its should be set with the assumption that effluent re-B. DISCUSSION leases associated with licensed activities would result in The dose limits in 10 CFR Part 20 are based on limit- doses to the public that are substantially below that val-ing dose to an acceptably low level of risk to the exposed ue. Such limits are approached only under unusual cir-individual. However, aay radiation exposure may carry cumstances, and only for a small fraction of the exposed some risk. Thus, the NRC requires licensees to take ac- population. A constraint is a dose value above which li-tions, to the extent practicable, utilizing procedures and censees are required to report to NRC and to take cor-engineering controls to further reduce risk below the lev- rective actions to lower the dose below the constraint val-els implicit in the dose limits in keeping with the princi- ue. Enforcement action would only occur if a licensee pie that exposures should be as low as is reasonably fails to report an exceedanae of the unstraint or fails to achievable. This is the goal and purpose for radiation take appropriate and timely corrective actions.

protection programs. In order to achieve th,si goal, h,-

censees must control the way radioactive material is han. C. REGULATORY POSITION died from receipt through disposal.

1. CONSTRAINT ON ENVIRONMENTAL AIR ALARA EMISSIONS The following methods are acceptable to the NRC Components of an effective radiation protection staff for determining the dose to members of the public program, as required by 10 CFR 20.1101, melude radi- from exposure to airborne radioactive material that has ation exposure control, written procedures and policies, been released to the environment by NRC licensees oth-control of radioactive materials, radioactive contamina-er than power reactors. Licensees should choose a moni-tion control, radioactive waste management, training, toring period (e.g., a year, month, or quarter) to demon-program reviews, and audits. strate compliance with the airborne emissions constraint in accordance with 10 CFR 20.1101(d). For most licens-

' Copes are availaLic for purchase from the U.S. Government Prmtmg ees, the monitoring period will be one year.

Office, PO. Box 37082, Washmgton, DC 20013 - 7082, telephone (202) 512-2249, or from the National Techmcal lnformation Sernce 1.1 Licensees who (1) operate a nuclear power reac-.

by wntmg NTIS at 5285 Port Royal Road. Sprmgfield, VA 22161. Co-tor subject to 10 CFR 50.34a or (2) possess and use radio-pc:are available for mspectpon or copymg for a fee from the N RC Pub.

lic Document Room at 2120 LStree t NW., Washmgton, DC;the PDR's nuclides only in the form of sealed sources need not take maibngaddressisMailStopLt.-6 Washmston.DC20555, telephone any actions to demonstrate compliance with the (202)634-3273 fax (202)634-3343. .

i constraint.

l 4.20 - 2 l

l

o Regulatory Guide 8.18, "Information Relevant to The NRC staff examines licensee programs to deter.

Ensuring that Occupational Radiation Exposures at mine whether they are in compliance with the require-Medicalinstitutions Will Be As Low As Reasonably ments of 10 CFR Part 20. This guide addresses only a Achievable." part of a licensce's overall radiation protection program.

e Regulatory Guide 8.31, "Information Relevant to SPecifically, i, cddresses methods for demonstrating Ensuring that Occupational Radiation Exposures at C mPhance with the constraint on releases of airborne Uranium Mills Will Bc As Low As Is Reasonably radioactive materials to the environment. In addition to c ntrolling doses from the releases of airborne radioac-Achievable.

tive materials to the environment, licensees must im[ 'e-

• Regulatory Guide 8.37,"ALARA Levels for Efflu- ment a radiation protection program that controls liquid ents from Materials Facilities." effluents and dose rates in unrestricted areas.

e Regulatory Guide 10.8, " Guide for the Preparation Many NRC licensees possess source, byproduct, or of Applications for Medical Use Programs." Sec- special nuclear material in a form that would not cause tion l'3 and Appendix G deal specifically with doses to members of the public from releases of airborne ALARA programs for medical facilities. radioactive material to the environment. These licens-In addition, further information can be found in Re. ces include radiographers, well loggers, and other usets vision I to NUREG-0267," Principles and Practices for of scaled sources. These licensees need not take any ac- ,

Keeping Occupational Radiation Exposures As Low As tions to demonstrate compliance with the constraint on Reasonably Achievable"(October 1982).1 releases of airborne radioactiva materials to the The information collections contained in this regu-latory guide are covered by the requirements of 10 CFR CONSTRAINTS l Part 20, which were approved by the Office of Manage- I ment and Budget, approval number 3150-0014. The A dose limit derived from a basic radiation protec- )

NRC may not conduct or sponsor, and a person is not re- tion standard is the upper acceptable bound of radiation quired to respond to, a collection ofinformation unless it dose and is needed to protect the health and safety ofin- 1 displays a currently valid OMB control number. dividuals; a limit is a value not to be exceeded. Such lim-B. DISCUSSION its should be set with the assumption that effluent re- j leases associated with licensed activities would result in  ;

The dose limits in 10 CFR Part 20 are based on limit- doses to the public that are substantially below that val- l ing dose to an acceptably low level of risk to the exposed ue. Such limits are approached only under unusual cir. '

mdividual. However, any radiation exposure may cany cumstances, and only for a small fraction of the exposed )

some risk. Thus, the NRC requires licensees to take ac- population. A constraint is a dose value above which li- I tions, to the extent practicable, utilizing procedures and censees are required to report to NRC and to take cor-engineering cx ntrols to further reduce risk below the lev- rective actions to lower the dose below the constraint val-els implicit in the dose limits in keeping with the princi- ue. Enforcement action would only occur if a licensee l

, ple that exposures should be as low as is reasonably fails to report an exceedanx of the unstraint or fails to achievable. This is the goal and purpose for radiation take appropnate and timely corrective actions.

protection programs. In order to achieve this goal, h,-

censees must control the way radioactive material is han. C. REGULATORY POSITION died from receipt through disposal.

1. CONSTRAINT ON ENVIRONMENTAL AIR ALARA EMISSIONS w g me am accepta to k N Components of an effective radiation protection staff for determining the dose to members of the public program, as required by 10 CFR 20.1101, include radi-fr m exp sure to airborne radioactive matenal that has ation exposure control, written procedures and policies, een releas t tk egonmenay Mcensees e control of radioactive materials, radioactive contamina-er than power reactors. Licensees should choose a moni-tion control, radioactive waste management, training, toring period (e.g., a year, month, or quarter) to demon-program reviews, and audits.

strate compliance with the airborne emissions constraint in accordance with 10 CFR 20.1101(d). For most licens-ICopies are avaitaLle for purchase from the U.S Government Prmtmg ees, the monitoring period will be one year.

Office. PO. Box 37082, Washmgton, DC 20013 - 7082, telephone (202) 512 -2249, or from the National Techn cal lnformation Se rvice 1.1 Licensees who (1) operate a nuclear power reac-by writmg NTIS at 5285 Port Royal Road,Sprmgfield,VA 22161 Co- .

pies are available for inspection or copymg for a fee from the N RC Pub. tor subject to 10 CFR 50.34a or (2) possess and use radio-hc Document Room at 2120 L Strect NW., Washmpton. DC;the PDR's nuclides only in the form of sealed sources need not take

• • *8'dd'M*'ISt ptL-6.Washmaton.DC20555;teicphone any actions to demonstrate compliance with the (202)634-3273; fax (202)634-3343.

constraint.

4.20 - 2

1.2 Radioactive materials in scaled containers that remain unopened and have not leaked during the assess-C=gy ment p~i~ heed not be included in the calculations. Ex-amples of scaled containers would include radiopharma- Where:

ceuticab in unopened manufacturers packages and materials in undamaged shipping containers. Indepen. C =

Average air concentration at the receptor dent spent fuel storage canisters that do not have vents to (Ci/m or Ci/ml) the atmosphere may also be considered scaled f = Fraction of the time the wind blows toward containers. the receptor of interest (dimensionless)

(For a single " puff" release, the appropri-IJ Effluents fen patients need not be included if compliance with the wnstraint is demonstrated by using ate value is 14 an inventory approach. If compliance with the constraint O =

Effluent release rate (Ci/s) is demonstrated by using measured or calculated con- V = Volumetric flow rate at the point of release centrations of radioactive materials in the environment, 3 (m /s) the contribution from patients is considered insignifi-The " sum of the fractions" technique should be used cant and need not be considered.

to assess compliance for efiluents contammg multiple ra-1.4 Ifit can be determined that some detected mate- dionuclides. With this technique, if radionuclides "a,"

rials did not result from licensed activitics of the licens- "b," and "c" are present in concentrations Ca, Co, and Cc, ee, only radioactive materials from the licensed activity and if the applicable effluent concentrations in Column 1 need be considered. Materials that are windblown from of Table 2 in Appendix B to 10 CFR Part 20 are ECa, other facilities need not be considered. ECb, and ECc respectively, satisfying the following in-equality is sufficient to demoastrate compliance with the 1.5 In determining the member of the public likely constramt.

to receive the highest dose from airborne radioactive material released from licensed operations to the envi-ronment, licensees need not consider nonresidents with- C_,., ,,Cs ,

in the facility boundary. EC, , EC, , _Q- EC, < 0'2

2. CALCULATION OF DOSE TO THE MEMBER 2.3 Additional methods acceptable to the NRC staff OF THE PUBLIC LIKELY TO RECEIVE THE for demonstrating compliance with 10 CFR 20.1101(d)

HIGHEST DOSE FROM AIR EFFLUENTS can be found in the worksheets contained in either in demonstrating compliance with 10 CFR NCRP Commentary No. 3, " Screening Techniques for 20.1101(d), licensees should determine whether there Determining Compliance with Environmental Stan-have been any facility or design modifications, increases dards,"2 or EPA 520/1-89-002, "A Guide for Deter-in radionuclide inventories, or operational changes; li- mining Compliance with the Clean Air Act Standards for censees should determine wl-*her any of these factors Radionuclide Emissions from NRC-Licensed and Non-resulted in variations to airborne emissions since the last DOE Federal Facilities" (Revision 2).3 monitoring period. If licensee operations have not 2.4 Another method that is acceptable to the NRC changed, the review of licensed operations and demon- staff for demonstrating compliance with 10 CFR stration of compliance with the constraint will be rela- 20.1101(d)is the use of the computer code COMPLY.

tively straightforward. COMPLY was developed by the EPA to assess doses by Any of the following methods are acceptable for using site-specific information in the determination of dose. COMPLY has four screening levels. In Level 1, the demonstrating compliance with 10 CFR 20.1101(d).

simplest level, only the quantity of radioactive material 21 The simplest screening technique is to assume possessed during the monitoring period is entered. The that the air concentration at the receptor is equal to the calculations are based on generic parameters. level 4 air concentration measured at the point of release. This produces a more representative dose estimate by provid-is analogous to using Appendix B to 10 CFR Part 20 to ing for more complete treatment of air dispersion by re-demonstrate compliance with the dose limits in Part 20. quiring site-specific information. It is expected that all 2.2 To demonstrate compliance with the constraint 2NCRP Commentary No. 3 was pubitshed in January 1989 and the ad-on air emissions, the licensee should demonstrate, by dendum was published in October 1989. Copies may be purchased measurement or calculation, that the annual average from the National Council on Radiation Protection and Measure-dm nt Avenue,Bethesda,MD concentration of airborne radioactive material released Eg"$NCRPPublicsti ns,7910W to the environment does not exceed 20% of the values in 3 Copies may be obtained from the U.S. Environmental Protection Column 1 of Table 2 in Appendix B to 10 CFR Part 20. Agency,Omce of Radiation andindoor Air 401 M Strect SW., Wash.

The following fumula demonstrates this technique. ington, DC 20460.

4.20 - 3 i

- . --. . . - _. - .~ _ _ _ - .. - -.~_- ~ _ . - - - - - . ~ . . -

NRClicensees will be able to demonstrate compliance at learning of the dose in excess of the constraint, and 10 ,

- <>ne of the four levels.The basis for the compliance mea- CFR 20.2203(b)(i) requires licensees to describe the ex- j

< stees in COMPLY are cr>ntained in " Background Infor- tent of exposure. The report should include the follow-

mation Documenti Procedures Approved for Demon- ing information.

strating Compliance with 40 CFR Part 61, Subpart I"

• An estimate of the dose (EPA 520/1-89-001, October 1989) 4

• The concentrations of the radioactive material If a computer code other than those listed above is released used to demonstrate compliance with the constraint, the j_ licensee should be prepared to demonstrate that the

• The cause of the elevated concentrations in  :

code has undergone verification and validation (V & V). effluents  !

For more information on software quality assurance in-

• The corrective steps taken or planned to ensure ciuding V & V, licensees may refer to NUREG/ I BR-0167, " Software Quality Assurance Program and '88 "***'##" * "*" l j

f Guidelines." This document can be purchased from the

• A schedule for completing the corrective steps. The

. U.S. Government l'rinting Office, P.O. Box 3M2, Wash- report should ccatain enough information to allow I

ington, DC 20402 - 9328. the NRC staff to verify the calculations.

The report should be sent to the U.S. Nuclear Regu-

3. REPORTS TO NRC IF CONSTRAINT HAS BEEN EXCEEDED latory Commission, Document Control Desk, Washing-l ten, DC 20555-0001, with a copy to the appropt' ate If the constraint of 10 mrem (0.1 mSv) per year to ,

NRC Regional Office listed in Appendix D to 10 CFR the member of the Eublic likely to receive the highest Part20'

dose has been exceeded as determined by measurement or calculation,10 CFR 20 2203(a)(2)(vi) requires licens- D. IMPLEMENTATION ces to send a report to the NRC within 30 days after . .

The purpose of th.is section is to provide informa-4 app s ad bmeo aga&g & E dCopicsof the E PA Background information Document and the COM. , .

PLY computer code with its Users Guide may be obtained by writmg to staff,s plans for using this guide.

the Center for Federat Guidance and Air Standards (66021).Orf ce of . .

Radiation and Indoor Air, Environmental Protection Agency, Wash. Except in those cases in which an applicant proposes j mgton DC 20460. It can also be downloaded from the Technology an acceptable alternative method for complying with j l Transfer Network (TTN) Electronpc Bulletin Board under the Office sPecified portions of the NRC's regulations, the meth- ,

1 of Radiauon and Indoor Air techmcal informauon area. The number for the TTN is (919)$41-5742 In addition. EPA has pages on the ods described in this guide will be used in the evaluation 1 world wide Web as another mechamsm to provide computer codes to of applications for new licenses, license renewals, or li-addM5ses SM unftP npnc. epa gov and cense amendments and for evaluating compliance with

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10 CFR Part 20.

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-l REGULATORY ANALYSIS . >

4 '

i j A separate regulatory analysis was not prepared for this regulatory guide. The regulatory i

!- analysis prepared for the amendments to 10 CFR Part 20," Standards for ;'rotection Against  !

] , Radiation," provides the regulatory basis for this guide. A copy of this regulatory analysis is -

available, as an enclosure to SECY-95-133, for inspection or copying for a fee at the NRC i Public Document Room,2120 L Street NW., Washington, DC .l

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RULEMAKING ISSUE l (Affirmation)

May 8, 1996 SECY-96-100 f08: The Commissioners {

fBDM: James M. Taylor Executive Director for Operations

SUBJECT:

FINAL AMENDMENTS TO 10 CFR PARTS 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.

l l

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 millisievert (0.1 rem) total effective dose 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 release of patients.

f

' The subject paper was submitted to the Commission on November 30, 1995 (SECY-M-286). Subsequently, the staff requested withdrawal of the paper to 4 revise tne regulatory analysis (RA) to conform with the new RA guidelines. In a Staff Requirements Memorandum dated Decen.ber 21, 1995, the Commission granted the request. The staff revised the RA (a sumary of major changes is attached to the RA) and made conforming changes to the Federal Register Notice (FRN) and the Environmental Assessment (E,A). These revisions did not affect the content of this staff paper except in items 1 and 5 of the DISCUSSION in which the staff mentioned the expanded discussions of breast-feeding women in the RA.

CONTACTS: NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN Stewart Schneider, RES THE FINAL SRM IS MADE AVAILABLE 415-6225 Stephen A. Hedcire, RES 415-6204 Mx ; gw)y .

4 i

! l 2

l The Comissioners i NRC's current patient release criteria are contained in 10 CFR 35.75, " Release l of patients or human research subjects containing radiopharmaceuticals or 3

' permanent implants." That section states: "(a) A Ifcensee may not authorize J-release from confinement for medical care any patient or human research

,' subject administered a radiopharmaceutical until either: (1) The measured j dose rate from the patient or human research subject is less than 5 millirems '

i p'r 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  ;

l i

release from confinement for medical care of any patient or human research i subject administered a permanent implant until the measured dose rate from the l patient or the human resea,ch subject is less than 5 milliress per hour at a distance of 1 meter."

Some licensees were uncertain about the effect that the revised 10 CFR Part 20  ;

l would have on patient releafeTo criteria, resolveandthisthree petitionstwo uncertainty, forsteps rulemaking were were received on the issue.

4 taken. '

The short-term resolution was to inform licensees of the NRC's position that l 10 CFR 35.75 governed patient release. The Commission was informed in i 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

-infore licensees of this position in accordance with a Staff Requirements  ;

l Memorandum (SRM) d&ted January 28, 1994.

A The longer term resolution was to address this issue through rulemaking.

proposed 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.

In an SRM dated May 11, 1994, the Comission directed the staff

As a result, a draft rule was published i i

to forproceed coment :nwith June the proposed rule.15,1994 (59 FR '0724), and this paper transmitl rule for Commission approval. I

! DISCUSSION:

The final rule (Attachment 1) takes into consideration the recomendations the Agreement States, as well as the comment letters received on the proposed -I

' rule and the petitions. In all, 232 comment letters were received on the three petitions, and 63 coment letters were received on the proposed rule.

The rule was also discussed with the Advisory Comittee on Medical Uses of Isotopes (ACMUI) at several public meetings, the ~1ast on October 18 and 19, 1995.

+  ;

2 One commenter raised an issue about contacts allegedly relating to this The rulemaking between one of the petitioners and the Office of the Chairman.

' staff notes that the final rule is based on the public record associated with the rulemaking and that the NRC decision maker with whom contact was made is no longer with the Commission. The staff has not included any further comment wit

respect to this issue in the final rulemaking package.

i e

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T 3

The Commissioners 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 the regulatory analysis and (2) explicit use of the tem ' breast-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.

2. The amendments make it clear that patient release is governed by i

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.

A

3. The amendments revise the criteria for release of patients administered radioactive material for medical use under 10 CFR 35.75 to permit a maximum likely total effective dose equivalent of 5 millisieverts

' (0.5 res), excluding background or any occupational exposure, to an j individual exposed to the patient. J j

Specifying the release criterion in terms of radiation dose requires -:

that the NRC provide an acceptable method that relates the quantity 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 guide 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, iodine-131, the default table is essentially equivalent to the release criteria in the current regulaticns. 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, pemit the release of patients containing several times more radioactive material than the current regulations permit or allowed with use of the default table.

1 The authorization to release a patient is based on the licensee's detemination that the total effective dose equivalent to an individual from the released patient is not likely to exceed 5 millisieverts

. The dose to the breast-feeding child from breast-reeding is

(0.5necessarily not res). a criterion for release since it can be controlled by i

F

4 4

b The Commissioners giving the woman guidance on the interruption of breast-feeding, as required by the amendments (see No. 5).

i Overall, a substantial majority of all comments supported an explicit dose limit of 5 millisieverts (0.5 res) for individuals exposed to patients released with radioactive material in their bodies. In i addition, ACMUI and the Agreement States supported the criterion based on a dose limit. A few cosmienters who thouaht that the present criteria i

were working well and were adequate opposed allowing the release of.

patients with quantities of radioactive material greater than that pemitted under the current regulations.

l 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 i

effective dose equivalent if any individual is likely to receive a dose in excess of 1 mil 11 sievert (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.

This proposed recordkeeping requirement met a great deal of opposition.

Connienters were especially concerned about having to retrieve records of previous administrations, sometimes from another medical facility. Upon 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-res) annual dose because of multiple administrations.

In place of the deleted recordkeeping requirement,' the final rule cont:i:1s 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 could result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisteverts (0.5 ree) if the woman did not interrupt breast-feeding. The requirements (in 10 CFR 35.75M and (d)) would affect about 20,000 of the 8 to 9 million administrat.ons 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 if the dose to an individual is likely to exceed 1 mil 11 sievert (0.1 res). 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 cosmienters 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

i l l The Commissioners 5 l

i of breast-feeding and consequences be provided if the released individual may ba breast-feeding an infant or child and the total effective dose equivalent is likely to exceed I al111 sievert (0.1 res).

The regulatory guide will contain interruption periods that keep the dose from breast-feeding to less than 1 mil 11 sievert (0.1 ren). 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 other cases, the guidance could simply address avoidance of any unnecessary radiation exposure to the child from breast-feeding. The  !

regulatory analysis indicates the basis for selecting the option of enhancing communications and instructions to breasting-feeding women.

I

6. The amendments make it clear that the limit on dose in unrestricted areas presented in 10 CFR 20.1301(a)(2) does not include dose  ;

contributions from patients administered radioactive material and i released in accordance 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 l hospitalization any patient administered a radiopharmaceutical regardless of  :

J 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 l purpose of confinement when the activity .n the patient is expected to result in a dose exceeding 5 millisieverts (0.5 ree) to another individual. 1 At its last meeting, held on October 18 and 19,1995, the ACWI passed several motions suggesting changes to three aspects of the rule.

First, the ACWI suggested using the term " rationale" instead of

" consequences" in the requirement, under 10 CFR 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 mil 11 sievert <

(0.1 ren). Since most of the administrations that would be affected by this requirement are technetium-99m administrations, the ACWI suggested the change because there was concern that the consequences of low doses of radiation cannot always be explained to the patient without causing unjustified alarm. i Also, there was concern 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 ,

response to the ACW 1 comment because thi requirement to provide information on the consequences is included primarily to protect the breast-feeding infant from therapeutic admiristrations of radiciodine, which could cause serious l

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The Commissioners 6 l thyroid damage. Regulatory Guide 8.39 will contain guidance on the types of i inferination, including expected consequences, to be provided to patients to meet this requirement.

Second. the ACMUI suggested using the phrase "the retained activity rather than the activity administered" instead of "an activity otner than the activity administered" in the requirement under 10 CFR 35.75(c), to maintain a record of the basis for authorizing the release of an individual, if the total effective dose equivalent is calculated. The ACMUI was concerned that the meaning was not clear, and in addition, the requirement was already implicit in the remainder of the recordkeeping requirements in 10 CFR 35.75(c). The staff changed the rule in response to the ACMUI comment. This information l would be needed for cases where a patient would be held for some time period prior to release. Such cases would not be covered in the default release table that appears in the regulatory 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 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 provide " guidance on the interruption of breast-feeding" if failure to follow the instructions could result in a dose to the infant exceeding 1 mil 11 sievert (0.1 res). The ACMUI suggested the change because they said that there is a distinct difference between the two terms. The staff changed tne rule in response to the ACMUI comment. As stated in the Federal Register notice, "the instructions must Table 2 in include guidance on the interruption period for breast-feeding."

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.

Finally, the ACMUI recommended that the Commission proceed with the rule as promptly as possible.

RESOURCES:

Resources needed to conduct and implement this rulemaking are includ'ed in the FY 1995-1999 Five-Year Plan.

COORDINATION:

the Office of the General Counsel has no legal objection to this paper. q RECOPMENDATION: s I

That the Commission:

1. Aporove the notice of final rulemaking for publication (Attachment 1).

l

The Commissioners 7

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).

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 final rule becomes effective (Attachment 2).

< c. A final regulatory analysis will be available in the Public Document Room (Attachment 3).

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 t

Administration will be informed of the certification regarding l' economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.

f. The appropriate Congressional Committees will be informed (Attachment 5);

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.

1. Copies of the Federal Reaister r.otice of rinal 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.

A H~

Ja s M. Ta or ecutive rector for Operations f

Attachments: As Stated (7) 1

I i

8 Commissioners' comments or consent should be provided directly to l the Office of the Secretary by COB Thursday, Muy 23, 1996.

Commission Staff Office comments, if any, should be submitted to the l

Commissioners NLT May 16, 1996, with an information copy to the Ofice  !

of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments any be expected.

This paper is tencatively scheduled for affirmation at an Open NWecing during the Week of May 27, 1996. Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.

i DISTRIBUTION:

Commissioners OGC OCAA OIG OPA -

OCA EDO SECY l

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1

9 ATTAciflEKr 1 FEDERAL REGISTER NOTICE i

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20 and 35 RIN 3150-AE41 Criteria for the Release of Individuals Administered Radioactive Material AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (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 exposed to the patient. The new criteria are consistent with the recommendations of the National Council on Radiation Protection :nd Measurements (NCRP) and the International Commission 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 iur rulemaking regarding the criteria for release of patients administered radioactive material.

EFFECTIVE DATE: (120 days following publication in the Federal Register).

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/8R-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Cormission" (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 Regulat'ory 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/8R-0058 may be purchased at current rates from the U.S. Governmei t 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 23555, telephone (301) 415-6225.

. I. 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

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. . _ _ _ __ _ _ _ _ _ _ _ _ . . m I

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hereinafter referred to as " patients." These patients can expose others around them to radiation until the radioactive material has been excreted from their bodies or the radioactivity has decayed away. l I

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 ray not authorize release from confinement for medical care any patient or human research subject administered a radiopharmaceutical l until either: (1) The measured dose rate from the patient or human research

.tubject is less than 5 millirems per hour at a distance of 1 meter; or (2) The activity in the patient or human resedrch subject is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of l

i any patient or human research subject administered a permanent implant unt 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." l On May 21,1991 (56 FR 23360), the JRC published a final rule that amended 10 CFR part 20, " Standards for Protection Against Radiation." The rule contained limits on the radiation dose for members of the public in i

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 licensees were uncertain about what effect the revised 10 CFR part 20 would have on patient release criteria, and two petitions for rulemaking were received on the issue. On June 12, 1991 (56 FR 2694M , the NRC published in the Federal Register a notice of receipt of, and request for 3 Attachment 1

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-ll) 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 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 I I

(10 CFR 20.1301), reducing both early release of patients and the treatment of patients at home. l II. Publication of the Proposed Rule 4 Attachment 1 i

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 aoministered 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-25-ll). These letters each supported the petition but.did not contain any additional information not covered by the letters on the first two petitions.

1he 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 irclude 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 l contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose was to clarify that licensees would i

not be required to control areas (such as waiting rooms) simply because of the presence of a-patient released purst'nt to 10 CFR 35.75. If a patient has-been released from licensee control pursuant to 10 CFR 35.75, licensees 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) j in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. Patient waiting rooms or hospital rooms would need only be controlled for those patients not meeting the release criteria in 10 CFR part 35.

5 Attachment 1

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 millisievert (5 millirems) per hour at I meter from a patient to a total effective dose equivalent not to exceed 5 millisieverts (0.5 rem) in any I year to an individual from exposure to a released patient. A dose-based limit provides a single limit that could be used to provide 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 millisievert (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 tc any individual other than the released patient is likely to exceed I millisievert (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-feeuing and administered various diagnostic and therapeutic radioactive materials. The purpose of the instructions is to raintain 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 Attachment 1 l

1

- i

.l calculated total effective dose equivalent to the individual likely to receive the' highest dose if the total effective dose equivalent to any individual f other than~the released patient is likely to exceed 1 mi111 sievert (0.1 rem)- 4 in'a year from a single administration. The major purpose was to provide a l 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. i

^

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  :

,2 j

required by 5 35.75(u;" was added to each. The purpose of this change was to i

make Part 35 consistent as to when instructions must be given. l In addition, the NRC concurrently issued an associated draft regulatory l 9

guide and supporting draft regulatory analysis for public comment. The draft regulatory guide, DG-8015. " Release of Patients Administered Radioactive-l 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. f The draft guide also proposed guidelines on instructions for patients on how l 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 proposed rule considered by the NRC.

l I

I 7 Attachment 1 o

III. Public Coments on the Proposed Rule A total of 63 coment letters were received on the proposed rule, the draft regulatory guide, and the draft regulatory analysis. A majority of the coment letters were from medical practitioners and medical organizations, but there were also coment letters from private individuals, public-interest groups, and regulatory agencies in Agreement States. Overall, the majority of 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 coment letters opposed the proposed recordkeeping requirement. The significant comments are discussed below, arranged by subject.

EXCLUSION OF PATIENT RELEASE FROM 520.1301(a)

All the comenters except one suppo:-ted g0verning 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 tha general public who has not consented freely to the dosage. They said that such exposure would lead to widespread morbidity and tr.ortality.

Response. In its revision of 10 CFR part 20 (56 FR 23360; May 21, 1991), the NRC determined that, while doses should be maintained as 8 Attachment 1

low as is resonably achievable, a dose limit of I millisievert (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 recomends public dose limits of  !

I millisievert (0.1 rem) for continuous or frequent exposure and 5 millisieverts (0.5 rem) for infrequent exposure.

The ICRP recomends that the limit for public exposure should be expressed as an effective dose of I mil 11 sievert (0.1 rem) in a year, except that, in special circumstances, the dose could be higher in a single year provided the average over 5 years does not exceed 1 millisievert (0.1 rem) per year. In ICRP Publicatien 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 e dergoing diagnos'.s or treatment." Furthermore, in explaining dose limits in medical exposure, the ICRP stated in the same publication that "the Comission therefore recommends that dose limits should not be applied to i 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 sevision of Part 20 incorporated the long-term objective as the dose limit and included a provision ($ 20.1301(c)) to allow for alternative 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 l

l I

g Attachment 1 l

1 l

l I

1 steps are taken to reduce the dose to as low as is reasonably achievable. The NRC reaffirms that previous determination in this rulemaking.

Ir. 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 millisievert (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.

Consent. One commenter 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 licenad 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 limit is outside the scope of this rulemaking. The issue was dealt with when 10 CFR part 20 was recently revised (56 FR 73360; May 21, 1991). That rulemaking explained the NRC's rationale for adopting the 1-millisievert (0.1-rem) dose limit in 10 CFR 20.1301(a)(1).

ACTIVITY-BASED VS. DOSE-BASED RELEASE LIMIT The issue . 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 I meter, or to -

express the release limit as a dose to an individual exposed to the patient.

10 Attachment I

. _.. -. ._ _.._._ . . _ _ _ . . . . _ . _ . _ ~ . _ . . _ . _ . . . _ . _ . _ _ . - _ _ _ . - . . _ . . . . . _ . _ _ . _ .

i i l l

j The majority of commenters supported the dose-based limit. However, some.

cameenters opposed the dose-based approach.

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Comment. A number of commenters said that 10 CFN 35.75 should not be changed and that the 30 millicurie or 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

. 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 because they thought the dose estimates-to the public -

.wou ld be very inaccurate as these estimates are based on the unreliable method '

of predicting the anticipated time and proximity to others. Commenters also 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 differen'. 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 Attachment 1 ,

E o

-- v-~ -~ , ,, .,

radioactive material in the body of the patient and other factors that vary For these reasons, the NRC is establishing a dose for different materials.

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 recommendations 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 thaa 1 millisievert (0.1 rem).

The NRC believes 6aat 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. 37, " 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 millicuries), 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 Attachment 1

NUREG-1492 cantains 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

' Guide 8.39, " Release of Patients Administered Radioactive Materials," are j l

available as indicated in the ADDRESSES heading.

Comment. A cc.amenter 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 NRC anticipates that nearly all paticr.ts 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 otherWe subject to release under the default values in Regulatory Guide 8.39. Personal information may be necessary for such patient-specific-Cases.

Comment. One comunenter 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 Administered Radioactive Materials,"

13 Attachment 1 4

specifies the dose rate at I meter of commonly 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 millicurd les) of activity. Some commenters were opposed to allowing releases with higher activities than are now permitted.

Consent. Several commenters said that the release of patients with more than 30 millicuries of iodine-131 should not be permitted because of concerns about the risk of internal exposure. One commenter said that doses to family members from the patient vomiting were not adequately considered. The same commenter 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 14 Attachment 1

I released patients have been measured in several studies and in every case were less than 10 percent of the 5-millisievert (0.5-rem) total effective dose equivalent limit and were most often less than 1 percent of the 5-millisievert (0.b-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 items touched by the patient, contamination does not cause unacceptably high l

doses. These findings were true even in the case of a British study where eleven patients volunteered to disregard special precautions against  :

contamination and minimizing spousal and family exposure. These measurements l are discussed in NUREG-1492. Also, the NCRP recently addressed the risk of j intake of radionuclides from patients' secretions and excreta in NCRP f 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, Bethesd*, MD 20814-3095.)

15 Attachment 1

Regarding the coment 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 suggested increased risk of thyroid cancer following ingestion of iodine-131.

Based on the information currently available, the Comission continues to conclude that the benefits outweigh the potential of small increased risks associated with this rule.

Cassent. One comenter noted that hospitals now make great efforts to control contamination from patients who are now hospitalized because they contain more than 30 mil 11 curies of iodine-131. This comenter 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 a.e 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-millisievert 16 Attachment I

(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 is a definite need. This s'pecial limit fits the case of doses received by the household members of a released patient, but do$s not .~it the case of people who frequent a hospital on a routine 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 contamination control achieved in homes is not adequate. Actual measurements )

j of doses to household. members from contamination, as discussed in NUREG-1492, 4 show that the doses from contamination are low, demonstrating that the degree ,

of contamination control that was achieved is adequate. I Consent. One comenter said that the proposed rule did not adequately I

address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in l

4 excess of 30 millicuries.

Response. In comenting on the petitions, a number of States expressed concerns about releasing patients administered 14.8 gigabecquerels (400 millicuries) of iodine-131, which one of the petitioners had requested. ,

i However, the States that comented 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 coments 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 17 Attachment 1

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 millicuries) 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 exceeds 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 ineter is no greater than the value in the table. When the administered activity is greater than the value in the default table, a record of the basis 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 nd safety.

I One commenter said that in some cases it should be permissible l Comment.

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 l

)

18 Attachment 1 l

6 individual exposed to a patient has so little hazard that the NRC should not .

l be concerned with it. }

1. espouse. The NRC does not believe that individuals exposed to a 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 Commission on j

Radiological Protection"; and the recommendations of the NCRP in NCRP Report

~

No.116,' " Limitation of Exposure to Ionizing Radiation." Each of,these recommendations provides a basis for allowing individuals to receive annual J

doses up to 5 millisieverts (0.5 rem) under certain circumstances. Both the

• 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 millisievert (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 i 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 millisteverts (5 rems).

' International Commission on Radiological Protection (ICRP), "1990 Reconnendations of the Inttrnational 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 Ionizing Radiation," NCRP Report No.116 (March 31,1993).

J Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda,

'MD 20814-3095.

19 Attachment 1

'4

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 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 millisievert (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 frcm all administrations would not ,

exceed 5 millisieverts (0.5 rem).

t Consent. Many commenters indicated that this requirement 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 Some recordkeeping would be unnecessary, inappropriate, and impractical . J commenters said that multiple administrations that would result in a total i 20 Attachment 1

3 effective dose equivalent greater than 1 millisievert (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 evidence that a lack of paperwork has resulted in any additional problems.

One commenter said that if 0.5 rem is acceptably safe, why have the documentation required at the 0.1 rem level.

Another comenter said that it cannot be a licensee's responsibility to know tha 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 theiapy procedure.

One comenter 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.

Response. 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 millisievert (0.1 rem). The requirement was proposed so that it would be possibL to account for the dose from multiple administrations in the same year to ensure that the total dose to an inc:ividual exposed to the patient did not exceed 5 millisieverts (0.5 rem).

The NRC has an advisory committee, the Advisory Comittee on the Medical 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 21 Attachment 1 4

i i

1

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 In addition, advice to the NRC during the development of this rule.

Barry A. Siegel, M.D., Chairman of the ACMUI, reviewed the oatient 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 it diagnostic, therapeutic, or a combination of the two, results in multiple large administrations that would be likely to cause the 5-millisievert (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 I millisievert (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."

Comment. Several commenters said that those who pay for health care will put great pressure on physicians to optimize calculations to reduce in-patient 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-millisievert (0.5-rem) limit in 10 CFR 35.75 is met. Regulatory Guide 8.39,

" Release of Patients Administered Radioactive Materials," describes examples of calculations that are acceptable to the NRC.

22 Attachment 1 l

t

• WRITTEN INSTRUCTIONS TO PATIENTS 1

l

~

In general, there was little objection to providing instructions to patients on how to minimize the dose to others, but there was significant opposition to the proposed requirement that the instructions would have to be written. I Comment. One comenter said that the Statement of Considerations for the proposed rule was in error in stating that the existing regulations ,

already required th , 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 commenters 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 time 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.

23 Attachment 1

Response. The NRC believes that providing written instructions has a significant value Decause often patients will not remember all of the instructions given orally. In addition, written instructions can be read by other family members or care givers. The requirement to provide the .

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 yven to patients at nominal cost (less than $1 ner patient). However, oral instructions may also be provided in all cases.

Comment. Several cementers said that dictating to a physician how and what he or she must teli 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 i

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 gecify the details of what the physician must say or must

?( Attachment 1 1

4 a

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 Naierials,"

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."

Cassent. 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. Tbc NRC believes that written instructions are useful and I

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 regulations 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. Seversi commenters asked how the NRC would enforce implementation of the instructions given to the patient. Another commenter

• 25 Attachment I a

l I' asked how the licensee could verify that the instructions are followed.

f 4 Another commenter said that a sizable fraction of patients may not follow  :

i

. radiation safety instructions to protect spouses and may be even less careful l f- '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 nc itend to enforce patient compliance with ,

f 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. ,

t With regard to compliance with the instructions, surveys of patients and  ;

their spouses, as discussed in the supporting regulatory analysis, indicate that rost will attempt to follow tne 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.

Comment. 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 26 Attachment 1

_ .- . -. .. _ . _ _ __m _

4 i

that the burden of requiring instructions cannot be justified. Under the final rule. if the dosa to any individual Exposed to the patient is not likely l l

to exceed 1 millisievert (0.1 rem), instructions are not required but the

]

physician could give any instructions that he or she cc. ;iders desirable.

1 CONFINEMENT OF PATIENTS 4

i i

Comment. Two commenters said that patients cannot be confined against their wishes and that the rule provides no penalty for the patient who leaves 1

4 confinement in the hospital "against medical advice." Another commenter said

' that the rule seems to require that the licensee have control of the patient's activities after release.

Response. The NRC recognizes that patients cannot be held against their will. The rule deals with the conditions under whid 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."

4 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.

27 Attachment 1 M

. .. _ - . . ~ - - -. . - _ _ _ . _ . _ _ _ - _ . - _ .

i l

However, good health physics practice would be to continue to make efforts to

)

l 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. These commenters misunderstood the concept of confinement.

As explained in the Statement of Considerations for the proposed rule l (59 FR 30724), the term " confinement" no longer applies to the revision to l i

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 t

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 traine.d personnel and instrumentation ,

available for making radiation measurements not typically available at the -

patient'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.

Comment. One commenter thought that the rule should define the term  ;

" release."

28 Attachment 1 ,

9 4

I

l d

i 1

Response. The term " release from licensee control," when read in

' context, refers to radiation protection considerations and is sufficiently clear that there is no need to define the term.

I MISCELLANEOUS COMMENTS ON THE RULE Comment. Sever al commenters said that the rule should not be a matter

of Agreement State compatibility at any level.

Response. The NRC does not agree. The NRC conducts an assessment of each proposed requirement or rule to deturmine what level of compat',';ility ,

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 cnmpatibility designations ranging from level 1 (filll 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 commenters said  ;

that consideration of the breast-feeding infant should be under the jurisdiction of the physician, that the issue is a medical issue rather a regulatory issue, and that the NRC should not interfere in medical issues.

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 Attachment 1

~

based on the licensee's determination that the total effective dose equivalent to an individual from the released patient is not likely to exceed The dose to the breast-feeding child from 5-millisteverts (0.5 rem).

breast-feeding is a criterion for release but it can be controlled by giving j

the woman guidance on the interruption or discontinuation of breast-feeding, .

l l

as required by the new 10 CFR 35.75. However, the release could be based on l

the default table of relea:;e activities in the regulatory guide or a The issue l patient-specific calculation, as required by the new 10 CFR 35.75.

f of the dose to the breast-feeding child is discussed in NUREG-1492 and Regulatory Guide 8.39, " Release of Patients Administered kadioactive Materials."

l l

Comment.

One commenter said that the proposed rule did not accurately represent the position of the Advisory Committee on Medical Use of Isotopes.

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 Achul position. The final rule was discussed with the ACMUI on October 18, 1995, and the ACMUI, in general, supported the rule. (for ACMUI's comments and NRC's responses, see V. Coordination with the ACMUI.)

Comment.

One commenter said that its facility treated many foreign These patients frequently may patients with therapeutic pharmaceut'-~.ls.

Thus, there leave the hospital and immediately board a plane to return home.

is a limit to the amount of control that a licensee has over tha patient.

30 Attachment 1

^

l l

l l

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 immediately 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 l

case-specific calculation. Once the patient is released, the responsibility H for following the instructions is entirely the patient's, not the licensee's.

COMMENTS ON THE DRAFT REGULATORY GUIDE Comments were also requested on Draft Regulatory Guide, DG-8015, i

" Release of Patients Administered Radioactive Materials," associated with this rulen.aking. Because the guide is associated with the rule, the comments received on the draft guide are discussed here. Most of the comments concerned the method and the assumptions used to calculate the dose to the individual likely to receive the highest dose.

Consent. Several comenters said that the calculational methodology in the draft guide is too complex and that the assumptions are too con w rvative.

As an example, several commenters said that the assumed 24-hour nonvoiding 31 Attachment 1

assumption used in calculating doses is too conservative. As evidence that  :

the calculations are too conservative, several commenters said that the doses  !

measured using dosimeters were much lower than doses calculated using the models in the draft guide.

I l

Response.

The NRC has revised the guide to use a phased approach for determining when release can be authorized. While the calculations cae.

sometimes be complex, the results of calculations that use conservative assumptions are given in a table of release quantities in Regulatory Of the Guide 8.39, " Release of Patients Administered Radioactive Materials "

8 to 9 million administrations performed annually, in all except about 10,000 cases (radioiodine therapy for thyroid cancer), release can be authorized based on conservative assumptions and using Table 1 with no calculational effort on the part of the licensee and no additional recordkeeping beyond what is already required. For permanent implants, the guide provides dose rates at 1 meter from the patient at which release may be authorized. Thus, for implants, there would be no calculational effort needed.

In addition, the guide provides information on iodine therapy for thyroid cancer that can be used for determining release based on retention and elimination. This additional information in the guide will allow the licensee to perform the calculation with relatively little effort.

With regard to the comments that the methodology is too conservative and that measured values are lower than calculated by the methodology, the methodology in the table giving def ault release quantities is intended to be  !

conservative. The NRC believes it is appropriate and prudent to be conservative when providing generally applicable release quantities that may 32 Attachment 1 l

1

4 1

be used with little consideration of the specific details of a particular patient's release. A review of published information, as described in the regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioacthe Material" (1996), finds that measured doses are generally well below those predicted by the methodology used to calculate the table of default release quantities. Thus, the default release quantities are conservative as the NRC intended. Hawever, the licensee is given the option of using case-specific calculations that may be less conservative.

Nevertheless, the NRC agrees that the assumption used in the draft ouide i

of 24-hour nanvoiding in the thyroid cancer example was overly conservative.

The revised example uses an excretion half-life of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> as reconnended by the ICRP in ICRP Publication 53, " Radiation Dose to Patients from Radiopharmaceuticals. "'

Comment. One commenter said that the occupancy factor (generally j l assumed to be 0.25 at I meter) should not be left to the discretion of the 1 i

licensee because low occupancy factors could easily be justified by providing strict safety instructions without any verification that the instructions will l be followed. Another commenter liked the flexibility provided by being able l to adjust the occupancy factor, but wanted to know if other considerations are

'llowed ar' if it is acceptable to use values lower than 0.125.

' International Commission on Radiological Protection (ICRP), " Radiation Dose to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March 1987). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.

33 Attachment I

. . _ . . . _ . _ _ m . _ _ , _ _ _ . . . _ . . . _ . _ _ _ . . _ _ . . . . _ . .__ __

a Response. Draft Regulatory Guide 8.39 discussed s u uations-in which it might be permissible to lower the occupancy f actor from D.25 to 0.125, but did

i. not recommend occupancy factors less than 0.125. Occupancy factors less than j

0.125 may be difficult to justify because it is generally not realistic to assume that the patient can avoid all contact with others. However, lower

, )

values for the occupancy factor are not prohibited by the regulation, but they ,

must be justified in the record of the calculation, as the record will be f

i subject to inspection.

Consent. Several commen'.ars said that the iodine-131 retention fraction too large of 0.3 used in the draft guide for treatment of thyroid canc and that the correct value should be 0.05 or less. Another cor, er said i

that the biological half-life of extrathyroidal iodine should be 0.5 day for both the euthyroid and hyperthyroid condition. One commenter said that the biological half-lives from ICRP Publication No. 53 should be used for thyroid Cancer The NRC agrees that the commenters raised valid points. In Response.

Regulatory Guide 8.39, the iodine retention fraction for thyroid cancer was The biological half 'ife for the extrathyroidal fraction was f changed to 0.05.

changed to 0.33 day. In addition, the biological half-lives from ICRP Publication No. 53 were used for the thyroid cancer case. )

i Comment. One commenter said the table of release quantities in the strontium-89 draft guide should be expanded to include beta emitters such ae 34 Attachment 1 1

l

and phosphorous-32. Another commer.ter said that the table should be expanded to include chromium-51, selenium-75, ytterbium-90, tin-ll7m, and iridium-192.

Response. Values for the beta emitters strontium-89 and phosphorous-32 have been added to the table of release quantities in Regulatory Guide 8.39.

The table of release quantities was also expanded to add values for chromium-51, selenium-75, ytterbium-90, tin-ll7m, and iridium-192. l Comment. The table of release quantities in the draft regulatory guide

f j

should be expanded to include acceleres r-produced radioactive materials as an

(

aid to Agreenc " States, i

l Response. Several accelerator-produced materials were added to l The  ;

Regulatory Guide 8.39 as an aid to the States and to medical facilities.

NRC has no regulatory authority over the release of patients administered accelerator-produced materials and would not inspect the release of patients administered accelerator-produced materials.

Comment. One commenter said that the regulatory guide should have a table of release quantities based on biological half-life rather than only the physical half-life.

Response. Regulatory Guide 8.39 now provides more information on release quantities for iodine-131 based on biological half-lives.

4 35 Attachment 1 4

I Comment. One commenter said that the factor of 10-' used in the draft guide to estimate internal dose is not well supported for nonoccupational 4

exposures. Another commenter said that the calculation of dose to individuals cxposed to the patient ignores the potential of radiation dose from the excretion of radioactive material from the patient, and this could present a e

significant radiological hazard to family members.

1. esponse. It is true that there is not a great deal of information on the use of the factor in nonoccupational settings, but measurements (described in NUREG-1492) have been made in which iodine uptal.e was measured in people exposed to a patient. These data suggest that the fractional uptake of the 4

administered activity will be on the order of 10. Since iodine is among the most roluble and volatile radiopharmaceuticals, it can be expected that the transfer to others of less soluble and less volatile radiopharmaceuticals would be less than that of iodine.

l In addition, the NCRP recently concluded that, for individuals exposed to radionuclide therapy patients, the risks of external irradiation and potential contamination are minor from a public health viewpoint; therefore a significant intake from a contamination incident is very unlikely.'

Comment. A medical organization commented that the draft guide is not complete and does not provide sufficient comprehensive examples to assist

[ licensees in complying with the rule.

Response. The NRC has expanded the guide to include information and further examples on the biological elimination of iodine-131 and on when 36 Attachment I

4 guidance on the interruption or discontinuation of breast-feeding should be given. Expanded examples are now given in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." The example on thyroid cancer was revised to include more realistic assumptions, and an additional example The NRC believes that the examples provided on hyperthyroidism was added.

illustrate the techniques sufficient to perform the whole range of potential calculations.

Comment.

One commenter said that the draft regulatory guide did not provide enough information on when and for how long breast-feeding of infants should be interrupted.

Response. Regulatcry Guide 8.13 has been greatly expanded with . respect to information on the breast-feeding child, including a table on recommendations for the interruption or discontinuation of breast-feeding for specific raoiopharmaceuticals.

Cossent.

One commenter said that the sample instructions in the draft guide cencerning implants should include a picture of an implan', seed.  !

Response. The sample instructions were not expanded to include this because of graphics limitations, but licensees may add photos if desired.

Comment.

Several commenters asked whether multiple individual >

calculations have to be done or if a generally applicable calculation could be done once and used for many patients. ,

37 Attachment 1 4

Response. The NRC believes that there may be some situations for which The record a case-specific calculation could be done for a class of patients.

for a particular patient's release could then reference the calculation dona for the class nf patient However, depending on a patient's individual status (e.g., lower occupancy factor), there may be cases when the calculation will be done for a specific individual.

Consent. One commenter said that the discussion on radiolabeled antibodies in the draft guide was wrong because antibodies labeled with iodine-131 will be deiodinated in the body and the iodine will . behave like '

other iodine. None of the radiolabeled antibodies now being developed or planned for the future should have an internal dose hazard for the general public.

Response. The NRC agrees with this comment. Statements in Regulatory Guide 8.39 are now modified.

COMMENTS ON THE DRAFT REGULATORY ANALYSIS (DRAFT NUREG-1492)

Cassent. One commenter said that the value of a person-rem should be

$40 rather than $1,000 as used in the draft regulatory analysis for the The commenter cited purpose of evaluating the costs and benefits of the rule.

a 1993 Health Physics Society position paper as a reason that the value should be $40 per person-rem.

38 Attachment 1

_ _ __ ._ . _ _ _ _ . _ _ _ . _ . _ _ _ . _ . . _ - . _ _ _ _ _ ~

, 7 3

e i

Response. The Coseission recently adopted a value of $2,000 per person-rem as explained in Revision 2 of NUREG/8R-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Comission (November 1995),"

I Section 4.3.3, " Evaluation of Values and Impacts." (Single copies of The draft NUREG/BR-0058 are available as indicated in the ADDRESSES heading.)

! regulatory analysis, which was prepared utilizing $1,000 per person-rem, l 1

employed a simple computational model using the physical half-life only of radiopharmaceuticals. The regulatory analysis has been revised to include use i of $2,000 per person-rem, as well as a more realistic dose model based on The more biological retention :nd elimination of the radiopharmaceuticals.

realistic model with a value o ' $2,000 continues to demonstrate the cost-effectiveness of the dose-based limit. Specifically, the savings in - l

' l hospital costs under the earlier release time allowed are estimated at- .

1 l

)

514 million, whereas the collective dose of 2,740 person-rem (at a value of l

$2,000 per person-rem) corresponds to a cost of about $5 million.

l t

NUREG-1492 contains a detailed discussion of the model and the benefits

• and impacts of the dose-based limit. Single copies of the final regulatory

! analysis are available as indicated in the ADDRESSES heading.

e 4

Comment. One comenter said that the benefits of the rule were overestimated because the length of time that a thyroid patient would have to remain in the hospital was overestimated and the cost of a hospital room was overestimated, being $450 per day rather than $1,000 per day as assumed in the draft regulatory analysis.

Response. The commenter is correct that the benefits of the rule were overestimated.

The estimates in the draft regulatory analysis of days of hospitalizaticn requirad did not include biological elimination of the 39 Attachment 1 4

I 1

i radioactive material; only radioactive decay was considered. As a consequence, the draft regulatory analysis, in some cases, overestimated the time that patients would need to be retained under licensee' control, and therefore the costs'of patient retention were too high. The final regulatory analysis corrects the estimates.

The NRC believes that the current cost of $1,000 per day for a hospital-room is not an overestimate. Under 10 CFR 35.315(a)(1), licensees are required to provide a private room with a private sanitary facility for each patient receiving radiopharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75. Considering this NRC requirement and the recent reference cited'in the final regulatory analysis on the cost of hospitalization, 51,000 per day for a hospital 30m is a reasonable estimate.

Comment. One commenter said that the description of the measured doses received by f mily members was not consistent with the reference cited.

Response. The commenter is correct. An incorrect reference was given.

The final regulatory analysis provides the correct reference.

IV. Coordination with NRC Agreement States The NRC staff discussed the status of this rulemaking effort at two public meetings: the Agreement State Managers Workshop held on July.12-14, 1994, and at the All Agreement States Meeting held on October 24-25, 1994.

The Agreement States expressed no objections to the approach in this rule.

V. Coordination with the Advisory Committee on Medical Uses of Isotopes The Advisory Committee on Medical Uses of Isotopes (ACMUI) is an advisory body established to advise the NRC staff on matters that involve the 40 Attachment I

administration of radioactive material and radiation from radioactive material. The NRC staff presented a sumary of the comments on the proposed rule to the ACMUI during a public meWng held in Rockville, Maryland, on November 17 and 18, 1994.

. Drafts of the final rule.and regulatory guide were discussed with ACMUI-in Rockville, Maryland, on October 18 and 19,199h. The ACMUI supported the approach in this rule but suggested some clarifying changes. The NRC-staff made all but one of the suggested changes- The ACMUI suggested using the term

" rationale" instead of " consequences" in the requirement under the revised 35'.75(b), to provide " guidance on the interruption or discontinuation 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 l' mil 11 sievert (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 there was concern that

~

I the consequences of low doses of radiation cannot always be explained to the patient without causing unjustified alarm. Also, there was concern that physicians cannot explain with certainty the effects af low doses of radiation, such as would be caused by diagnostic administrations of f

T technetium-99m. The staff did not change the rule in response to the ACMUI 1

coment. The requirement to provide information on the consequences is included primarily to protect the breast-feeding infant from therapeutic administrations of radioiodine, which could cause serious thyroid damage.

l: Regulatory Guide 8.39 will contain guidance on the types of information, including "pected consequences, to be provided to patients to meet this j requirement. Transcripts of the meetings have been placed in and are available for examination at the NRC Public Document Room, 2120 L Street NW.

)

(Lower Level), Washington, DC.

41 Attachment 1

VI. Discussion of Text of Final Rule This section summarizes the final rule. The NRC is amending 10 CFR 20.1301(a)(1) to state specifically 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 is not a substantive change. It is a clarifying change to make clear that the Commission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.

For the sake of consistency and clarity, the same words are used in i 20.1002, "Secpe"; in i 20.1003, " Definitions" (in the definitions of both public dose and occupational dose); and in i 20.1301, " Dose limits f.,

individual members of the public." A1:0 for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation in medical research programs that are now included in il 20.1002 and 20.1003 are added to i 20.1301(a). In addition, the definition of " member of the public," as published in 60 FR 36038 on July 13, 1995, is revised by removing l the' footnote which read, "Except as d'elineated in other parts of 10 CFR Chapter 1." With the publication of this rule that footnote is no longer needed. l The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that the limit on dose in unrestricted areas does not include dose contributions from individuals administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that after a patient has been released under 10 CFR 35.75, licensees are no longer required to I control radiation from the patient. The regulation uses the term " individual" to refer to the individual to whom the radioactive material has been administered rather than " patient" to clarify that the regulation refers to anyone receiving a medical administration.

42 Attachment 1 4

1 -l 4

1 i

! The NRC is amending 10 CFR 20.1903(b) to use the term " licensee control" rather than " confinement" because the latter term no longer applies to '

~ 10 CFR 35.75. The conforming change is necessary since the term " licensee j.

control" more clearly reflects the NRC's intent in 10 CFR 35.75.

' 1he NRC is adopting a new 10 CFR 35.75(a) to change the patient release criteria from 30 millicuries of activity in a patient or a dose rate of i-5 millirens per hour at 1 meter from a patient to a dose limit of 5 millisieverts (0.5 ren) total effective dose equivalent to an individual j

> from exposure to a released patient. (The dose from the radionuclide involved j

is taken to be the dose to total decay.) A dose-based limit provides a single limit that can be used to provide an equivalent level of protection from risks from all radionuclides. Also, the char,ges are supported by the 1 recomendations of the ICRP and NCRP that an individual can receive an a dose up to 5 millisleverts (0.5 rem) in temporary situations where exposure to .

radiation is not expected to result in annual doses above 1 millislevert (0.1 rem) for many years. Usually, the only individuals likely to exceed a dose'of 1 millisievert (0.l' rem) will be those who ,are aware of the patient's

~

condition such as.the primary care-giver, a family member, or any other individual who spends significant time close to the patient.

This dose-based rule would, in some instances, permit the release of This is especially patients with activities greater than currently allowed.

true when' case-specific factors are evaluated te more accurately assess the dose to other individuals. The individuals exposed to the patient could These receive higher doses than if the patient had been hospitalized longer.

higher doses are balanced by shorter hospital stays and thus lower health care i

costs. In addition, shorter hospital stays may provide emotional benefits to

. patients and their families. Allowing earlier reunion of families can improve j

the patient's state of mind, which in itself may improve the outcome of the treatment and lead to the delivery of more effective health care. l I

Attachment 1 43 1

4 4 e

, , , .,. __. ., -e.- , - - , ,,a . ..-.

The release criteria in 10 CFR 35.75(a) could prevent a woman from being released because of the potential transmission of radioactive materials in breast milk. The dose to the breast-feeding child is controlled by giving the woman guidance, as required by 10 CFR 35.75(b), on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance. The expectation is that the woman would follow the instructions and would interrupt or discontinue breast-feeding.

Finally,10 CFR 35.75(a) includes a footnote to inform licensees that the NRC has made available guidance on rule implementation. The footnote states that Regulatory Guide 8.39, " Release of Patients Administered Radioactive Material," contains tables of activities not likely to cause doses exceeding 5 millisieve*+s (0.5 rem) and describes methods for calculating doses to other individuals.

The NRC is adopting a new 10 CFR 35.75(b) to require that the licensee provide released patients with instructions, including 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 millisievert (0.1 rem). This also requires giving instructions to breast-feeding women if the dose to the child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding. The instructions must include guidance on discontinuation or the interruption period for breast-feeding and the consequences of failing to follow the recommendation. Regulatory Guide 8.39 contains tables that show temporary interruption periods for various radiopharmaceuticals or discontinuation. The temporary interruption periods were calculated based en the determination that the dose to a child from breast-feeding is unlikely to exceed 1 millisievert (0.1 rem). However, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat deoending on the woman's concerns about radioactivity or interruption of breast-feeding.

44 Attachment 1

l l

l' .

l <

L t

l The purpose of describing the consequences is so that women will' l, ,

-understand that breast-feeding. after an administration of. certain l .

radionuclides could cause harm (e.g., iodine-131 could harm the child's

. thyroid). In other cases, the guidance could simply address avoidance of any R unnecessary radiation exposure to the child from breast-feeding.

A requirement for instructions for certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the modified requirement for written instructions adds approximately (a) 50,000 patients per year who are administered iodine-131 for the treatment of hyperthyroidism and (b) 27,000 patients per year, among about 8 million administered radiopharmaceuticals, who may be breast-feeding to whom additional. written ,

-instructions be given. The purpose nf the written instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable.

The instructions may be either written only or written plus oral. The NRC e

believes that written inttructions are necessary so that the patient and tne patient's family and friends will have a document to refer to ratner than having to' rely solely on the patient's memory and understanding of the instructions.

The requirement of 10 CFR 35.75(b), requiring a licensee to provide guidance on discontinuation or the interruption period for breast-feeding'and the consequences of failing to follow the recommendation, presumes that the ,

licensee will make appropriate inquiry regarding the breast-feeding status of. )

l the patient. For breast-feeding women where the dose to the child is likely to exceed 1 millisievert (0.1 rem), the NRC requires that the patient be There orovided +h specific instructions, as described in 10 CFR 35.75(b).

is no specific requirement to maintain a record indicating that breast-feeding status was determined prior to the release of the patient.

The NRC is adopting a new 10 CFR 35.75(c) to require that the licensee maintain a record of the basis for authorizing the release for 3 years if the calculation of the total . effective dose equivalent to other individuals uses l^

45 Attachment 1 J - -+*em=, - ,-n.a -

the retained activity rather than the activity administered, an occupancy factor less than 0.25 at I meter, the biological or effective half-life of the radionuclide, or shielding of radiation by the patient's tissue. Thus, records of release are required when the default assumptions are not used as discussed in Regulatory Guide 8.39. Measurements made in~several studies indicate that the default assumptions should generally overpredict the dose even when instructions are not given or are not strictly followed. If a licensee administers an activity no greater than the value in the default table of release quantities provided in the regulatory guide as the basis for release, no record of release is required.

Licensees are already required by 10 CFR 35.53 to retain records of the measurement of the activity of each dosage of radioactive material administered to a patient; these records are typically maintained in a patient dose log. In addition,10 CFR 35.?2 requires licensees to retain a written airective and a record of each administered radiation dose or radiopharmaceutical dosage for therapeutic administrations and diagnostic ,

administrations of iodine-125 or iodine-131 sodium iodide greater than 30 microcuries. These records can be used in conjunction with Regulatory Guide 8.39 to demonstrate that patient releases meet the requirements of 10 CFR 35.75(a) when no record is required by 10 CFR 35.75(c). When the licensee determines that the patient must be held to allow the reduction of radioactivity and then released, the licensee will need a record of release time to demonstrate that the release criteria have been met. A licensee may use any existing record to establish the release time. If biological elimination of radiciodine is a bacis for release and the licensee uses the information in Regulatory Guide 8.39, a record of the thyroid uptake may be necessary as part of the oasis for reiease t,ecause it is one of the nonstandard conservative assumptions listed in 10 CFR 35.75(c). If other case-specific factors are used as the basis for patient releasa that are in addition to, or modify, the standard conservative assumptions, a record of the 46 Attachment 1

basis for the r' ne, including the assumptions used for the calculations, must also be mairained.

This recordkeeping requirement is a modification of the proposed rule.

l 1he proposed rule would have required that a record be maintained of th. h.:is for the patient's release, including all calculations performed, if the total l

' offective dose equivalent to any individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 ree) in a year from a single Under the proposed rule, the major purpose of the record was l administration. '

to provide the basis for limiting the dose to 5 millisieverts (0.5 rem) to individuals exposed to a patient who may receive more than one administration in a year. Upon reconsideration, based on public comments and consultation with the ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow, the NRC has decided to delete this requirement. A review of medical treatment practices revealed no routine practice that would result in doses exceeding the 5 mil 11 sievert (0.5 rem) limit because of multiple administrations in the same year to the same patient. Without the need to account for the dose from multiple administrations, maintaining records for I the many tens of thousands of patients released when their dose to an f

' individual is likely to exceed 1 mil 11 sievert (0.1 mil 11 sievert) becones an unnecessary burden. The requirement to retain these records has there: fore been deleted. Each patient release is to be treated as a separate event, and licensee knowledge of previous administrations is unnecessary.

The NRC is also adopting a new 10 CFR 35.75(d) to require that the licensee maintain a record that instructions were provided to a breast-feeding i

woman if the administered activity could result in a total effective dose evivalent to the breast-feeding child exceeding 5 millisieverts (0.5 rem) if Thus, the NRC is the mother did not interrupt or discontinue breast-feedir.;,

requiring records for certain radiopharmaceutical administrations (e.g.,

tifrapeutic administrations of iodine-131). The activities of 47 Attachment 1

radiopharmaceuticals that require this record are described in Regulatory Guide 8.39.

Finally, the NRC is deleting its requirements on written instructions in ,

10 CFR 35.315(a)(6) and 35.415(a)(5) because 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 The paragraphs, which was to limit the dose rate at I meter from the patient.

ambiguity was introduced when Part 20 was revised and a conforming char.ge 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).

VII. 0" position of the Petitions for Rulemaking The three petitions for rulemaking submitted by Dr. Marcus (FRM-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 indivk als exposed to radiation from patients receiving radiopharmaceuticals for diag isis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts (0.5 rem). The final rule grants this reouest.

(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 No. 3'7, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."' The final rule does not contain activity limits, but Regulatory Guide 8.39 uses a calculational methodology 48 Attachment I

I

!. 1

1 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.

f (3) Delete 10 CFR 20.1301(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations

! in 40 CFR part 190 in addition to complying with the requirements of i- 10 CFR part 20. The EPA regulations referenced in 10 CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities. Part 190 of Title 40 of the Code of Federal Regulations does not apply to hospitals or to the release of patients.

Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean Air i

Act standards in 40 CFR part 61 that applies to hospitals. The NRC is i

separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean Air Act and to take agreed upon actions that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement State licensees.

Because the reference to EPA regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue, ar.d therefore is outside the scope of this 8 rulemaking, the final rule denies this request.

The requests made by the ACNM and their disposition may be sumarized as follows:

' (1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals The exposed to patients who have been administered radiopharmaceuticals.

final rul 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 privete residence. The final rule denies this request for the reasens described in the discussion on this issue. l 49 Attachment 1  :

_ . - . i

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 October 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 policy 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 s'.atement of the policy is "The NRC will regulate the radiation safety a patients where justified by the risk to patients and where voluntary standards.. or compliance with these standards, are inadequate."

This statement is r,ot relevant to the rule because the rule does not affect the safety of p%ients themselves. The rule instead affects the safety of individuals exposed to patients.

50 Attachment 1

l l

The third statement of the policy reads "The NRC will minimize intrusion into medical judgment:; 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 matter of medical judgment. 4 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 5 20.1003 and the text in i 20.1301(a) that are modified by this rulemaking are Division I 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 sectitA is a general statement of scope of the rule and does not cor.tain 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, 55 35.75(a) and (b) are a Division 2 level of compatibility because the patient release criteria required by the rule are the minimum requirements necessary to ensure adequate protection of the public healt.h and safety. The Agreement States will be allowed to establish I

51 Attachment 1

requirements that are more stringent than the NRC's requirements, but not less stringent. The recordkeeping requirements in 55 35.75(c) and (d) are a Division 3 level of cnmpatibility because uniformity in recordkeeping is not considered essential for this rule.

X. Finding of No Significant Environmental Impact: Availability 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 environment, and therefore an environmental impact .' .tement is not required. The final amendments clarify the pertinent regulatory language to reflect explicitly the relationship between 10 CFR part 20 and part 35 with respect to release of patients, 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 public 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 CONlACT heading.

52 Attachment 1

l XI. 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, searchina existing data sources, gathering and i

maintaining the data needed, and completing and reviewing the collection of

information. Send comments on any aspect of this collection of information, including suggestions foi 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 BJSl@NRC.G0V; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-10202, (3150-0010), Office of Management and Budget, Washington, DC 20503.

l X'I. Regulatory Analysis

\

The NRC has prepared a final re?"latory analysis (NUREG-1492) on this regulation. The analysis examines the oenefits and impacts considered by the NRC. The NRC has received public coments regarding the draft regulatory analysis and has addressed the commc ts (see Coments on the Draft Regulatory The final regulatory Analysis in 111. Public Comments on the Proposed Rule).

nalysis :. Ivailable for inspection at the NRC Public Document Room at 2120 L Street NW. (lower level), Washinoton, DC. Single copies are available as indicated in the ADDRESSES heading.

53 Attachment 1

I XIII. 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 i .;ubstantial number of small entities. This rule affect: medical use of l l byproduct material' licensees. The impact of the final rule will not be ]

significant because the final rule basically represents a continuation of I current practice. l XIV. 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 f 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 CFR part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power  ;

plants and reactors, Occupational safety and health, Prckaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements,  ;

Special nuclear material, Source material, Waste treatment and disposal.  ;

3 Lists of Subjects in 10 CFR part 35 Byproduct -Perial, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, J

Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.

t

[

v 54 Attachment 1 -

I

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization A:t of 1974, as amended; and 5 U.S.C. 552 ana 553; the NRC is adopting the following amendments to 10 CFR parts 20 and 35.

1 PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for part 20 continues to read as follows:

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, ICJ 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).

2. Section 20.1002 is revised to read as follows:

1 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 The under parts 30 through 35, 39, 40, 50, 60, 61, 70, or 72 of this chapter.

limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and J

released in accordance with 6 35.75, or to exposure from voluntary participation in medical research programs.

55 Attachment 1

\

i i

T l

3.- In i 20.1003, the footnote to the definition of member of the public is removed and the definitions of occupational dose and public dose are revised to read as follows: .

~

I 20.1003 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 .;t 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.

Public 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 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: ,

5 20.1301 Dose limits for individual members of the public.

56 Attachment 1 l l

l i

(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 (I mil 11 sievert) in a year, exclusive of the dose contributiens from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with i 35.75, from voluntary participation in medical research programs, and from the licensee's disposal nf radioactive material into sanitary sewerage in accordance with 1 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the de'e contributions from patients administered radioactive material and release s accordance with i 35.75, does not exceed 0.002 rem (0 ?' ,I; ievert) in any one hour.

5. In i 20.1903, paragraph (b) is revised to read as follows:

1 6 20.1903 Exceptions to pos+ing requirements.

(b) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution sians pursuant to 5 20.1902 provided that the patient could be released from licensee control pursuant to 5 35.75 of this chapter.

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

6. The authority citation for part 35 continues to read as follows:

57 Attachment 1

. - ~ .- - - -. _ . _ - - - .. - . - . - _- .-_ ~ .. - - -_

h I Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as 4

l amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as ,

l amended (42 U.S.C. 5841).

4 t

i 7. In Section 35.8, paragraph (b) is revised to read as follows:

5 35.8 Information collection requirements: OMB approval.

• * * *

• j (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, i 35.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, l t'

35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.u6, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641., 35.643, 35.645, and l 1 35.647.

8. Section 35.75 is revised to read as follows:

a l

I35.75 Release of individuals containing radiopharmaceuticals or permanent implants. l 3 (a) The licensee may authorize the release from its control of any l individual who has been administered radiopharmaceuticals or permanent 4 implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to ex-aad 5 millisiever+s (0.5 rem).'

'(b) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to l

Regulatory Guide 8.39, " Release of Patients Administered o$dioactive 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).

58 Attachment 1 l

4

~ ,

maintain doses to other individuals as low as is reasonably achievable if the total effective dose cquivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (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) information on the '

consequences of failure to follow the guidance.

(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 the retained activity rather than the activity administ3 red, (2) using an occupancy factor less than 0.25 at I meter, (3) using the biological or effective half-life, or (4) considering the shielding by tissue.

(d) 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).

5 35.315 (Amended]

9. In -5 35.315, paragraph (a)(6) is removed and reserved.

1 i 35.315 Safety precautions. )

l (a)

(6) (Reserved] l 59 Attachment 1

10. In i 35.415, the introduc?.ory text to paragraph (a) and r paragraph (a)(1) are revised and parigraph (a)(5) is removed.

6 35.415 Safety precautions. ,

(a) For each patient receiving implant therapy and not released from licensee control pursuant to 5 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. l Dated at Rockville, Maryland, this day of , 1996.

For the Nuclear Regulatory Commission. f l

John C. Hoyle,  !

Secretary of the Commission. ,

i h

1 60 Attachment I

ATTACHMENT 2 Contents

1. Draft 87100

2. Addition to Field Notes to Address Constraint Rule

3. Addition to Field Notes to Address Patient Release Rule

4. Revision to Radiography Field Notes 1

NRC INSPECTION MANUAL- IMNS i

INSPECTION PROCEDURE 87100

{

LICENSED MATERIALS PROGRAMS t

PROGRAM APPLICABILITY: 2800 87100-01 INSPECTION OBJECTIVES 01.01 To determine if licensed programs are being conducted in accordance with NRC requirements.

01.02 To determine if licensed activities are being conducted in a manner that will ensure the health and safety of workers and the general public.

i i

87100-02 INSPECTION REQUIREMENTS Review of the licensed activities should be commensurate with the scope of the licensee's progran. To the extent possible, a determination regarding compliance with an NRC requirement should be based on direct observation of a work activity, interviews with workers. a demonstration by a worker of how he/she performs a  !

task that is regulated by NRC, or an independent measurement of radiation  ;

conditions at the facility (rather than exclusive reliance on a review of records). Specific inspection requirements follow:

02.01 Proaram Administration. Review the following elenents in sufficient depth to verify that organization and administrative systems have been established to  !

ensure safe conduct of the licensed activity.

a. Oraanization.

Reference:

Applicable license conditions.

The organizational structures will be found in license applications and i may involve one or more individuals. Examine any changes in the organization with respect to changes that have occurred in personnel, functions, responsibilities and authorities since the previous inspection.

If individuals are named in the license application, an amendment must be provided whenever changes in personnel are made (except for some broad and radiography licenses, where only responsibilities are defined). If there have been no changes in the organization since the )revious inspection, there is no need to pursue that element in any dept 1, except to ask the licensee if there have been changes and to make inquiries of personnel to confirm (to the inspector's satisfaction) that no changes have taken  !

place.

b. 0A Proaram and licensee Audits.

References:

Medical QA program to mitigate therapeutic misadministrations (only if the program being Issue Date: 01/XX/97 87100 l

)

l inspected nas OA requirements in the license). Applicable license l conditions.

l The quality assurance program will be in the form of proce'iures specified l in the license and covering a variety of activities and methodologies.  !

Generally, the procedures will specify limitations. 'do's." and " don'ts." i and how to perform one or more tasks. In any event, the licensee is bound i to the procedures. The inspector should verify (preferably by direct i observation) the implementation of a selection of procedural activities to the extent that the inspector is satisfied that procedures are being i followed. j The inspector also should verify that internal audits are performed, as required. The results of audits of activities will be found in records  ;

of audits. Examine those records with par ticular attention to deficien- '

cies found by the auditors and note corrective actions taken as a result i of deficiencies found. If no corrective actions were indicated whenever i deficiencies were found. ask the licensee's representatives what actions l were taken and determine why they were not noted in the records.

Audits of field radiography sites are especially important. If at all practicable, accompany a licensee's auditor to a field site (this may require special scheduling). Other kinds of internal audits for different categories of licensees may involve such determinations as the use of syringe shields (hospitals), whether technetium generators are pro)erly shielded (hospitals), and whether established ALARA programs are )eing implemented (all licensees). These are only a few examples: the inspector should examine the licensee's comitments in the license to determine the kinds and extent of audits required.

As one part of assist inspections, the inspector should determine that the licensee's internal inspection arogram is actually being carried out in that facility. For example, tie date of the last internal inspection findings and those corrective actions taken should be determined. The above information should be included in the inspection summary report sent to the home region and, if negative, so stated.

c. Medical Licensees. Radiation safety quality assurance procedures for radioactive drug and device research programs may be found in the US Food and Drug Administration (FDA) accepted investigational new drug (IND) or investigational device exemption (IDE) applications. These procedures should be audited by the RSO and/or the Radiation Safety Committee (RSC).

For nuclear medicine and teletherapy secondary checks of dose calcuhtions should be done to provide assurance that the final treatment plan will provide the dose prescribed on the patient's chart, if required in the license.

d. Trainina.

References:

10 CFR 19.12. Instructions to workers.

10 CFR 34.31. 35.900-972. 39.61. Training.

Applicable license conditions.

Certain kinds of training and instruction are found in the regulations; how they are imalemented will be found in the license. The inspector should verify tlat proper training and initial instructions are being accomplished as specified in the license or regulations. Discuss with 87100 Issue Date: 01/XX/97 i

licensee's representatives how and by whom the training is conducted and

. -l the content of the tr aining (generally found in the license application).

Verify, pursuant to 10 CFR 19.12 that the initial instructions have been given to workers who enter restricted areas. Under the basic instruc-tions. it is management's responsibility . to inform the workers of

= precautions to take when entering a restricted area, kinds and uses of radioactive materials-in that area, exposure levels, and the types of protective equipment to be used. The workers should also be informed of the pertinent. provisions of' NRC regulations and the license and the -

requi rement to notify management of conditions observed that may, if not I corrected, result in a violation of NRC requirements. j Of the training program elements in the license application, training given to authorized users is of primary importance. One or more users of l radioactive materials should be interviewed to determine that they have i received the required training both in the basic instructions and that specified in the license application. For medical licensees, this includes specific training needed to perform infrequent medical procedures and prepare and use radioactive material in medical research studies.

For the radiographers. the initial training should cover 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of l classroom instruction in those topics in Appendix A of 10 CFR Part 34. l The 40 hour4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> classroom training may vary by 120% as long as all topics in  !

Appendix A are covered. To become a radiographer, a radiographer's i assistant must have completed 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> of on-the-job training as a l minimum.- The training must include the topics in 10 CFR Part 34. Appendix i A. and the operating and emergency procedures.

Randomly examine records of training of personnel and attendant tests or examinations (if applicable) to the extent that the inspector is satisfied  ;

that the training program is being implemented as required. Where l examinations are required, read a few of the examination questions to ascertain that they are indicative of what the worker should know to carry out his/her responsibilities.

For radiographers, a written test consisting of approximately 50 practical questions should be taken dealing with the topics in Appendix A of Part

34. A field examination also should _ be given to determine that the individual is competent to perform all assigned operations. The ,

competence of an 'ndividual who has been a radiographer for another l licensee should be determined. As a minimum, that individual must be instructed in the operating and emergency procedures and the use of equipment. The individual also must take the written and field examinations. Whenever possible, observe a radiographic operation.  !

including the conduct of surveys, to determine the adequacy of a  !

radiographer's training.

e. Doeratina and Emeraency Procedures. Safety Comoonent Defects.

Reference:

10 CFR 34.32, 10 CFR 39.63. Operating and emeroency procedures. 1 10 CFR 21.21 Notification of failure to comT,; or existence of a defect  :

anfitsfevaluation. ,

?pplicable'licensb conditions.

Operating and emercency procedures will be found in license applications  !

and may vary from step-by-step procedures for radiogra ahy programs to more generalized procedures for lower inspection prior'ty licenses. The Issue Date: 01/XX/97 _87100 l

i i

procedures eill' be approved by the NRC and reviewed and updated by the licensee. Any revision requires an amendment to the license except for broad licenses.

. Examine the emergency procedures to determine that the procedures are as approved by NRC. Discuss with the licensee's representatives, or obsr 've (for the higher priority licensees), the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of radioactive material. Also verify that operational procedures are being followed by observation of personnel performing tasks at selected work stations and comparison of their activities with operational procedure requirements.

For the larger licensees there may be agreements with other agencies to respond to emergencies. Such agreements may be in writing and include state regulatory commissions (or equivalent) and hospitals. Generally, there will be no agreements in writing with fire departments. Discuss with licensee's representatives what has been done to ensure that agencies (for which agreements are in effect) understand their roles in emergency responses. Also, inquire if fire departments are knowledgeable of fires involving large quantities of radioactive materials and high radiation levels and whether they are equipped to fight such fires.

The inspector may, at his option, visit one or more agencies or departments to determine their understandings of their roles in responding to emergencies.

Inspectors should verify that licensees have arocedures for reporting defects. The complexity of the procedures w'11 vary. Manufacturers should have detailed procedures to evaluate the safety significance of identified defects. Other licensees need only to address identification and reporting requirements,

f. Reoorts and Notifications.

References:

10 CFR 19.13 Notifications and reports to individuals.

10 CFR 20.2201 Reports of theft or loss of licensed material.

10 CFR 20.2202 Notifications of incidents.

10 CFR 20.2203iReports oflexposuresErediaticrGev61Cand' concentrations

~ yradioactivernatedaliexceedingsthesconstrairytsfor; o

limits!

10"CFRt20.12206?

10'CFR'20.408 ~ RepcFt: Reportslop;individusUmanitoring?

c, idr:bndcMhitbring On tcW=tien cf c pley ent er werk.

10 CFR 31.5 Certain measuring, gauging. or controlling devices.

10 CFR 32.12 Records and material transfer reports.

10 CFR 32.16 Certain items containing byproduct material reports of transfer: Records and reports of transfer 10 CFR 32.20 Records and material transfer reports.

10 CFR 32.25 Conditions of licenses issued under S32.22: Quality control. labeling and re) orts of transfer.

10 CFR 32.29 Conditions of licenses ssued under 532.26: Quality control. labeling and reports of transfer.

10 CFR 32.52 Material transfer reports and records.

10 CFR 34.25 Leak testing, repair, tagging, opening, modification and replacement of sealed sources.

87100 Issue Date: 01/XX/97 4

e

r o 10 CFR 35.21(a) and (b)(2)(xi) Internal audits or inspections and r ecords of the audits.

10 CFR 35.33(a) Reports of therapy misadniinistrations.

10 CFR 35.33(c) Reports of diagnostic misadministrations.

10 CFR 150.20 Recognition of Agreement State licenses.

. Applicable license conditions.

1. 10 CFR 19.13 requires that licensees provide individuals with reports of external and internal exposures on an annual basis On'" if the individual request the reports.

The i=pector need not incuirc Of licensect that they have provided report; u^'es a worker f'!= a cq'aint that he w= not "^rovided '

a report w"cn hc requested it. For those employees who worked under contract temporarily and for permanent employees who have left the '

company the licensee must provide the report within 30 days. An exception is that when licensees file a report to the NRC, they must ,

also provide reports (of excessive exposures) to the workers '

involved. The regional offices that receive the reports should exaaine them for accuracy and completeness. ,

i- Prompt follow-up of reports of excessive exposures under certain conditions may be necessary: for example, reports filed under 10 CFR 20;2202(a) and (b) may require prompt follow-up to determine if adequate medical care is being provided. Other essential items (including medical care) that are missing from the reports (initially reported by telephone. telegraph, etc.) may be obtained by telephone or by dispatch of an inspector to the site to determine the causes '

of overexposure and adequacy of corrective actions.

In the case of high exposures to personnel, if the exposure is believed to be valid, an inspector must be dispatched to the site to conduct an ins)ection to support possible escalated enforcement action. This i sc applic; te report; filed only under 10 CFR 20.105 i' exp0:ure: are greater than 3 rc= but lcz th= 5 re :. depending

On the circuttances. ?

impccter need not be di ntched to : site prc ptly if. for ex: ple, the report sub-itted urcr 10 CFR 20.105 show 3.01 re . In these cases, an inspection should be scheduled as soon as practicable. However, this decision is best left to the judgment of the region, depending on the circumstances set forth in

the reports and by telephone communications.

During routine inspections, inspectors need only inquire if 10 CFR 20.2206 reports have been submitted without going into further depth, unles's the Office of Resource Management has requested a follow-u) because no report was submitted. E c :: = applic: under 10 CFl r 20.108 for teminated 0-^10yecc. Those reports should only be examined at random so th"at the inspector is satisfied that the 4

reports are being generated.

2. 10 CFR 20.2201 requires licensees to reports losses or theft of licensed radioactive material when a substantial hazard may result to persons in unrestricted areas.

• Because of the legalitic: and details inv0 bed for i=:cction =d follow u ^" poses, two interpretive guider. wer^ devc' 0^cd. Se guides n0Eid be used for follow up on lozo!w theft Ofradic=

tive = terial The guide; are entitled "10 CFR 20.102: ' Lost or Issue Date: 01/XX/97 87100 A

I N

l l

. Stole- Tisci g) Radic=tive Materim at Licen:ce': Frilitic:'" hnd'

, "20.102: Tran; port: tion. " Lost Or Stolen Radicactive S0urce:

Invched in Tran pert: tion.'" Th0:e ^uide: . y be fcund 1- the "10 4

CFR" ^ction Of the In;pection M:nud

3. The remaining reports listed in 02.01f deal with leak tests above limits _(10 CFR 31.5, 34.25.): materials transfer reports for manufacture or transfer of certain items (10 CFR 32.12, 32.16, 32.20, i 32.25, 32.29. 32.52): reports of medical therapeutic and diagnostic misadministrations [10 CFR 35.33(a)) and (c)] and Form 241.. reports of activities conducted in Agreement States-(10 CFR 150.20). ,

4. Inspections should be done for therapy misadministrations that result in serious illness or death, etc. Depending on the content of the reports, where significant cause appears to exist for follow-up, the follow-up shall be done promptly to gather additional details about the cause of the event and the circumstances under which the event ,

occurred. Reports that indicate moderate health and safety problems may be followed up during the next inspection unless there appears to be sufficient cause for possible escalated enforcement actions. ,

The occurrence of a misadministration is not, in and of itself- the  !

basis for enforcement action unless there is a failure to timely and properly report the misadministration as required in 10 CFR 35.33 or there is a violation of other applicable requirements. ,

g. Records.

References:

10:CFRt20 Subpart T @ JRecordi 10!CFRL20/110llRadiation: Protection 1Prbgramst 10 CFR 30:41 ^ Trans fer~of ~ byproduct"materi al .

10 CFR 30.51 Records.

10 CFR 34.24 Radiation survey instruments.

10 CFR 34.25 Leak testing, repair, tagging, opening, modification, and replacement of sealed sources.

10 CFR 34.26 Quarterly inventory.

10 CFR 34.27 Utilization logs..

10 CFR 34.28 Inspection and maintenance of radiographic exposure.  ;

devices. storage containers and source chargers, i 10 CFR 34.31 Training.

10 CFR 34.33 Personnel monitoring.

10 CFR 34.43 Radiation surveys. _

10 CFR 35.33 NotificationKreportsEandirecords of misadministrations-10 CFR 35.59(e)~~' Leak testing sealed ~ sources 10;.CFRi3525?gRelease ofJ,indiWduals;contajriingTadiopnejiandsetical@ .

mneanenttieplants:

10 CFR 35.632 N11 calibFa; ion ~ measurements 10 CFR 35.634 Periodic s>ot checks 10 CFR 35.630 Dosimetry Equipment 10 CFR 35.961 Teletherapy physicist 10 CFR 40.61 Records.

Applicable license conditions.

During the course of an inspection, most items examined will have attendant records to support each portion of the licensed activity. Some records should be only randomly examined; i.e., spot-checked to the satisfaction of the inspector that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel exposure records) should all be examined.

87100 Issue Date: 01/XX/97

However, examinations of records should not be construed as the primary

. part of the inspection program. Rather, observations of areas where personnel work, equipment, usage, etc., will give the inspector a better idea of what is going on than records review and may also support what the records reveal. During examinations of records. look for trends, such as trends in air sampling. Records such as surveys, waste disposal. effluent release, receipt and transfer of radioactive materials, training.

utilization logs, and air sampling may be examined randomly until the inspector is satisfied that the records are being maintained and are complete.

Records that should be examined in their entirety include 3ersonnel monitoring: leak testing of sealed sources: instrument cali) rations:

radiography quarterly inventory of devices and sources: inspection and maintenance of radiographic exposure devices; source changers used; storage devices used: receipt and transfer records; final radiation surveys of radiographic exposure devices upon completion of usage: pocket dosimeter results and calibrations: and for telethera)y units, full calibration, spot-check measurements and records of cali) ration of dose calibrators and checks of dose calibrators. Other records to be examined may be found in license conditions such as ALARA records, records of safety committee minutes, etc.

The extent to which records are to be examined, either randomly or in their entirety, will depend on the category of the licensee as well as the history of noncompliance of the licensee inspected. In each case.

Judgment will need to be exercised so that the inspector is satisfied that the licensed program is being operated safely to protect the health and safety of the workers and general public. .

As a general rule, records should be examined for the preceding three-year period or back to the last inspection, whichever is less. Older records preceding the three-year period should be inspected if warranted by circumstances such as a history of non-compliance or high radiation exposures.

02.02 Authorized Materials. Uses. and Users. Determine from reviewing records, observing the use of radioactive material, and discussing the activities with licensee personnel, that the ty>e. quantity, and use of material at the licensee's facility are authorizec by the license. Specific records and areas to be reviewed are as follows:

a. Receiots. Transfers. and Packaoe-handlina Procedures.

References:

10 CFR 20.1906'ProMIWs forTreceWi@ind1op~eni'ngTp^ahkages?~

10 CFR 30.41~ 'Tra, ir of bypFoduct material.

10 CFR 40.51 Trar 'er of source or byproduct material.  !

Applicable license conditions.

1 Depending on the size of the licensed program, the procedures (a few or  ;

many) will be found in the license application. The procedures should be 1 carefully reviewed before an inspection is conducted. The reason for such a review is to determine completeness, repeated procedures that may be

contradictory, and procedures that should be in the application but are missing.

The procedures for picking up, receiving, and opening packages should include how and wtien packages will be picked up, radiation surveys and

, Issue Date: 01/XX/97 87100 l l l l

i I

l

eipe tests of packages upon receipt and procedures for opening packages, such as where in the facility packages are received, surveyed. and opened.

The procedures also should include what actions are to be taken if packages are contaminated in excess of specified limits and radiation i levels are higher than limits (the. latter would depend on the package index. i.e.. the dose rate at 3 feet for each category). If packages have l arrived during the course of an inspection, observe the person performing '

the surveys as an indication of training.

The inspector should randomly examine records of surveys of packages  !

received and also determine if inventories for each licensed nuclide is within the license limits. In .this regard, records of inventories following receipt and transfer should always show that the materials on hand at any one time are within the license limit. The records examined  ;

should be compared with the physical inventories of materials possessed.  ;

By discussions with the licensee, inquire if the procedures have been changed or added to (requiring license amendment except for broad scope licenses and. in general, medical licensees that can change minor procedures by regulation). Randomly examine procedures used by the i licensee to determine if they are in accordance with those in the license i a) plication (if the licensee's procedures are supplementary to those in f

, t1e license application, or if the changes in certain procedures were  !

minor.) ,

b. Authorized Users.

References:

10 CFR 33.17 Conditions of specific licenses of broad scope.  !

10 CFR 34.25 Leak testing, repair. tagging, opening. modification, and j replacement of sealed sources. .

Applicable license conditions.  !

Authorized users will normally be named in the license application, or. l if the license is a broad license, will be appointed as authorized users by the radiation safety committee or isotopes committee, t

~ The inspector should determine during an inspection that named authorized i users are doing the work authorized rather than someone else not named in i the license. This will depend on the wording in the license with phrases '

such as "used by or under the supervision of" except for radiography licensees in which supervision for users is defined in 10 CFR Part 34.

Guidance on the phrase "used by or under the supervision of" may be found

• in the "10 CFR" Section of the IE Manual under 10 CFR Part 30 issued on 10/1/79 entitled " License Condition '...used by or under the supervision i of.. .'" For some specific or broad licenses (Types A. B, and C), the. ,

phrase for users is "under the direct supervision of" which implies the t L authorized user should be present at the facility for easy. contact or to observe the individual (s) working under the authorized user.

I

However, another phrase not often seen in licenses is "under the direct supervision and )hysical presence of" which means the authorized user must -l directly superv'se and be present at the work station. Another phrase 2 l used for physicians doing patient therapy states "may only be used by." l yl The inspector must use more than the usual amount of judgment during

. inspections to interpret the role of the authorized users, considering the many license condition phrases used above. First, a determination of

. qualifications should be made. Second, for the broad licenses, the t

87100 Issue Date: 01/XX/97

1 i

1 radiation safety committee 3ppointe the authorized users based on

. qualifications.  !

For a determination of required training, see " Training" under 502.01d of .

this procedure. In general. - authorized users must be specifically I licensed by the Commission or otherwise listed in the license application  !

and in a license condition for. specific tasks that only the individual (s) l named can perform. This includes leak testing of sealed sources. ,

replacement of sealed sources, modification and opening for purposes of 1 repairing or replacing sealed sources in teletherapy units and for '

radiography programs, changing sources from source changers or containers.

Such authorized users may not be those of the licensee but of a separate  !

firm specifically authorized by the Commission.

c. Authorized Uses.

References:

10 CFR 33.13 Requirements for the issuance of a Type A specific license -

of broad scope.

10 CFR 33.14 Requirements for the issuance of a Type B specific license of broad scope. 1 10lCFR034:20MPerformanceirequirene'n tsYfoF?radiopaphKegsipmentd 10~CFR'35:100"Hedicaru'ses ^6f byproduct"mateFiartor uptake and dilution ,

studies. i 10 CFR 35.200 Use of radiopharmaceuticals, generator, and reagent kits  ;

for imaging and localization studies.  ;

10 CFR 35.300 Use of radiopharmaceuticals for therapy.

10 CFR 35.400 Use of sources for brachytherapy. '

10 CFR 35.500 Use of sealed sources for diagnosis. '

10 CFR 35.600 Use of a sealed source in a teletherapy unit.

Applicable license conditions. i

- Authorized uses of radioactive materials, excluding broad license applications will be found in the licenses and license applications. i S)ecific licenses will list the isotopes, physical or chemical forms, and ,

tie maximum quantities. The inspector should physically examine the inventory of radioactive material on hand or examine records of receipt and transfer to determine that quantities and forms are as cuthorized. s For medical licenses of broad scope (Type A. B C) the maximum quantities are listed (or narrated for Type A) in 10 CFR 33.100. For broad licenses.  ;

any chemical or physical form is authorized.

The inspector must determine that nuclides are used as authorized. '

particularly for human use, that could otherwise become a misadministra-tion if not used as authorized. For medical facilities or institutions, examine patient log books to determine that radioactive materials are used in proper chemical form on patients.

InspectorsTshould ?confi #that~alliseiledIsources RsourWassemblies))

radiography devicest(cameras)8and source changersfused by;thelicensees lunless specifically exampted)?neety10LCFRi34i2OirgquirementsERADIGtEF contains;informationiconcemingtequipment ;couplianceVwitht10iGR f 34120 requirementsl ano i should 9 be s reviewed ni feceu pliamesquestianse arise.i InspectorsOshouldiverballysconfirm?thats11censees7aretaware5that associated? equipment needs(toecomplyswiths10iCFRi34120!DNoweveci inspectorsTshould not attempt to confirm 1thattassociated equipment?used bylicenseestcomplieslwith:10'CFR-34.20 exceptwhen anyincidentforievent maythavejresultedifrom1equipmenti failuregtheQusejofgan2 associated.

Issue Date: 01/XX/97 87100

e(juipmentMcomponent!would/ create f anLapparent publici health andisafety threatnalcomponentiis'being-used with a;nontcompatible systemnor if:it z associatediequipment7doesnot comply 2 ForJexamplenuse offa non:typicalf15 clearly obvious:to the " '

ga_rdenihosehiokaniendistopj tapedi tol:a.Lguideitubet

-d. Material Control.

References:

10CFR20Subpart?ISBStorageland5Contr6Fof!LicensedjMaterialsy 10 CFR 34.22 ~ Locking of ra'diographic exposure devices, storage contain-ers, and source changers.

10 CFR 34.23 Storage precautions.

Applicable license conditions.

The inspector should examine storage areas in unrestricted and restricted areas. Such storage areas should be locked and have limited and controlled access. In general, there will be procedures for access controls. Additional controls should include logging out radioactive material from storage areas and logging it in after use. This is especially important for medical institutions because of the use of small implant seeds for therapy. In the past. many seeds have been lost because of the failure of controls. The inspector also should determine that radioactive storage devices and source changers are locked when in storage and that storage areas also are locked when not in use. ,

e. Area Radiation and Contamination Control.

References:

10 CFR 19.11, 10 CFR 21.6 Posting of notices to workers.

10 CFR 201Subpart!DMcQRadiation DosellimitFforilndivjdsal; Members;of the 10 CFR 20 SubpartKF M Surv!Public!eys and Monitoring .

10 CFR 20 Subpart GCOControl1ofdwezFrom!sxtern.al?

- -~~- -

So' urcis91ri

~~

~^

10 CFR 20.1901 Caution signs. ~  ;

RAequirements?

10CFRf20:1902LPosti1 10 CFR:20;1903 Excep tons,topostinf"requirementsi

~~~ '~

10 CFR'20i1904? Labeling! containers: '

101CFR120:1905 Exem  !

Appl i cable 'l iscEn~ e ^ ptions; conditions; ~~ toilabeli ng~containern

~ ~ ~ ~

The inspector should ensure. during observation and by direct measurement. i that the radiation levels in unrestricted areas are within the limits of  ;

10 CFR 20.1302(b). The limits-aee ist2 mR in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> er 100 " per ' l cichever 1: cre rc;trictive. For this regulation. 'I

~

con ccutive ty occu)ancy is agi a factor. The inspector may ask the licensee to spot-checc radiation levels in selected areas using the licensee's own instrumentation. However. readings of radiation levels using the licensee's instruments shall not be considered as valid. The ins >ector must use his/her own instruments that have been calibrated, source clecked prior to leaving the regional office and checked upon return to see if the calibration is valid.

By definition, surveys of radioactive materials or radiation areas are supposed to be done before the fact, not after an individual gets exposed.

If practicable, observe how licensees conduct surveys to determine the adequacy of surveys, particularly during the conduct of radiography 87100' Issue Date: 01/XX/97 i 9

I

operations. Also, note the types of instruments used, and whether they are designed for the type of radiation being measured.

During the physical operations review (facility walkthrough) observe that proper caution signs are being used at access points to areas containing radioactive materials. radiation areas, and those areas containing airborne radioactive materials. Randomly observe labeling on packages or other containers to determine that proper information is recorded such as isotope, quantity, and date of measurement. Title 10 CFR 20.1903 provides exceptions to posting caution signs, primarilj^for medical institutions.

~

Some types of licenses, such as those for teletherapy rooms, radiography (fixed or permanent facilities), and irradiator operations also require signals or alarms, both visible and audible.

The inspector should examine these to determine operability. In addition, during the walkthrough examine locations where notices to workers are posted. These should be located so that employees may examine them on their way to and from work locations.

f. Packaaina and Transoortation.

References:

10 CFR Part 71 Packaging of Radioactive Material for Transport and Transportation of Radioactive Materials Under Certain Conditions.

49 CFR Parts Use Inspection Procedure No. 86740. " Transportation" 170-199 as applicable.

g. Waste Handlina. Use Inspection Procedure No. 84850 " Radioactive Waste Management - Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61." '

h. Performance Evaluation Factors. Use performance evaluation factors (PEFs) to assess the potential for degraded safety perforrance in priority 1. 2.

and 3 licensees. See Inspection Procedure 87101 for requirements and guidance concerning PEFs.

02.03 Physical Plant Facilities and Eauioment General. Most of the following line items are found in license applications and will vary, depending on the type of licensed activity, and may not be all inclusive. These items should be inspected during the facility tour (operations review). Other items may be identified in the regulations and also may be repeated in the license application for implementation of the requirements.

References:

I 10 CFR 20.1003 Unrestricted area (Definitions.)  !

Radiation area l High radiation area l 10 CFR 20 Subpa~rtil Storage and Control of Licensed Material l 10 CFR 34.21 Limits on levels of radiation for radiographic exposure o devices and storage containers.

10 CFR 34.29 Permanent radiographic installations. ,

10 CFR 34.41 Security, l 10 CFR 35.632-647 Teletherapy requirements Issue Date: 01/XX/97 87100 l

Review and verify that the equipment and the physical facility promote safe conduct of the licensed activity. The facility and equipment should conform to that described in the license application and the equipment should be operable.

Systems, subsystems, and equipment important to the safe handling of materials and protection of operating aersonnel and the public should be (1) examined for operability and (2) designec to carry out intended functions.

Examine records of the most recent five-year teletherapy maintenance program.

Some specific items which may need maintenanpe include the following, although these are not the only items to be serviced

a. Field-light Cord Reel,

b. Source drawer solenoids.

c. Low air pressure switch,

d. Air hoses and fittings,

e. Treatment timer.

02.04 Radiation Protection.

, a. General. Use Inspection Procedure 83822 " Radiation Protection" as applicable.

FOLLOWING1.- GUIDANCE fTO ? BEf U. SED 3 A~FTER s19972 REVISIONjiTO,[10. ECFRi35275.1 BECOMES b) 4edicalTicensees9

References:

10 CFRL35.751 iRelease of indiVidualfcont6in;ing radiophsrmaceuticalstod permanent =impiantsj

~

Determine lby observing?and discussinglithithe711csn5bb5thaFa4r6dess exists to'.establishithatra:patientTadministered" radioactive (materialiis relc ssable from control:under:10 CFR135Y75MDetermineithatiaimechanism released exi sts : for?

indi vidual s on provi ding

actions 9 appropri t recomended ate itos $ writtenRinstructions maintain fdosest ALARAlt fi %to?l doses (to other; individuals

aretlikely to exceed 0;1f resMVerjff thatithsilicensee  ;

1s recordi ng ! (a); the basis ; for; releasef of? patients #when s necessaryRand  !

(b)ethatJinstructions1were! provide!tosa!breastsfeedingiwoman$whenethe total! effecti ve = dose: equivalentV(TEDE)it t6 t the; bpeast;feedingichild ifrom continued breast-feedingicould;exceedt0i5! rem;! ~~~ ~ ~ ~ ~ ~-' ~

4 A

02.05 Radioactive Effluents and Waste Disoosal. Regulatory references and license applications:

10:CFR120;1101 U Radiation: Protection! Programs?

1 10'CFR'20 Subpart Def;PublicRadia tionj Dose': Limi tsj foOndi vidualj HembeF53fit 10TCFRf20isubpart K h-1tWaste Disposal 10 Cm 20.30. Met' icd'for obtdining jpprod of proposed disposcl procedures.

10 CFR 20.305 Treat ent of disposa, by incineration 1

May not be applicable to all types of units.

87100 Issue Date: 01/XX/97

.1

10 CFP 20.306 Disposal._cf f cci{ic =

10!CFRi20:2101 % Generaliprovisions 4Reco;tes.

10fCFRf20:2103) LRecordstofisurveys? ' ~rds D Recordstofiwaste disposalV""

10:CFRT20.2108?

10iCFR120!2107f (BRecordsYoffdoselto{individdalimembeFFofsthelp

~~ "

10lCFR?20;2110 M"Forolofj"ecordsT ' ~

'~

10 CFR^30.51 ~ Records. '

Review and verify that waste-handling equipment, monitoring equipment and/or

. administrative controls are adequate to maintain radioactive effluents within the limits established by the license and other regulatory requirements and are ALARA.

daughteas Veriffithetitheilicenseets d have!notiemeeded (theic?ai r7 effluents N#xcludi R Radon 2222?sndiit onstraint411mitRin3101 J 201110109 1ffthe licenseelhasiexceeded ithe? constraint % veri fy;thatsthedicenseelhasinati fiedithe IWClasiroquired by;10;CFRL20f2203MIfstheilicenseelhasinotified;the 10tCithetitts ai heffluentsihave Texceeded ithelconstraintil imit g^ review;the?

^~ ~ ~ "~~~

effectiveness?and ~~

t. M nessloffthe gicensee g gorrective M ons[

Examine the waste release records generated since the last inspection. all annual or semiannual reports, all pertinent non-routine event reports, and a random selection of liquid and airborne waste release records. Randomly select procedures for both liquid and airborne systems and verify that the procedural steps are being followed. The verification should be made by whatever means are available: 1.e. perform an observation of an operation, a review of selected records, etc.

02.06 Confirmatory Measurements. Compare / verify on a sampling basis survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Examples of confirmatory measurements are:

a. physical surveys. using the region's own instrumentation.

b. split samples etc. l 02.07 Reauired Scoce of Selected Materials Insoections. The attachments contain standard formats for recording the results of inspections of radiography, well logging, nuclear medicine and teletherapy licensees. Individual topics define the required scope of inspection for NRC inspections of these types of licensees.

87100-03 INSPECTION GUIDANCE General. All inspections should include a mix of records and procedures review.

observations, confirmatory measurements, and discussions with personnel involved in the " hands on" work.

03.01 Proaram Administration

a. The regulatory requirements related to the organization and administration of the licensed program will be contained in license conditions. The organization should be examined to verify that the responsibilities and authorizations of designated individuals comply with license conditions,

b. The inspection is a verification of implementation of the recuired t,rogram. In the review to verify implementation, the inspector should pay Ottention to the scope of the programs; frequency of licensee audits: the use of qualified auditors: procedure for recording and reporting Issue Date: 01/XX/97 87100

t I deficiencies to management; methods and conpletion of follow-up actions

- by management: and the policy regarding announced and unannounced audits.

c. No guidance.

d. In verifying the implementation of the approvid or required training program, pay attention to completion of requirements related to: initial training, periodic retraining, on-the-job craining, and tests and examinations of trainees (if applicable).

Inspectors should verify that procedures have been developed to implement the program, and that the staff has been trained in using these procedures. It is not the intent that inspectors routinely review and cite against internal procedures and protocols for the administration of byproduct material for medical use. Only in instances where there has been an event. misadministration, or evidence of a loss of management control is an in-depth review of internal procedures and protocol indicated. In such cases, the review should determine that necessary procedures are in place, and that adequate training or instruction has

, taken place prior to the administration of byproduct material. Failure to provide adequate procedures, and/or training could be a violation of 10 CFR 35.25(a).

In those instances where a performaace error has resulted in the administration of byproduct material not in accordance with the physician's directions and also involves the failure to follow the

, instructions of the authorized T, or supervising authorized user, the procedures of the Radiation Safety Officer. or to comply with the regulations or licensing conditions, there could be a violation of 10 CFR 35.25(b) for lack of adequate supervision. If however, the event or misadministration was more clearly an isolated human error, e.g..

distraction due to heavy workload, picking up the wrong container of radiopharmaceutical, etc., then 10 CFR 35.25 should not be cited.

10 CFR 35.25 should only be cited in instances where no other regulation is applicable to the violation. In other words, this regulation should

not be used as a catch-all for poor programmatic management which is not s)ecific to supervision and training. It is imperative to determine w1 ether adequate supervision has been provided, the supervised individual has followed instructions or whether human error has occurred. If indicated. the appropriate section of 10 CFR 35.25 should then be cited.

e. Regulatory requirements related to procedures will be contained in license conditions. It is necessary to verify that operating and emergency procedures have been developed, are adequate and functional, and have been

- reviewed and approved by management.

f. No guidance.

g. No guidance.

03.02 Authorized Materials. Uses. and Users General. Authorized materials, uses, and users are generally described and authorized by the license, or as otherwise authorized in 10 CFR 33.

a. Receipt and transfer of materials should generally be detailed in procedures sufficient to provide assurance of compliance with regulatory 87100 Issue Date: 01/XX/97

l requirements. Specific requirements are set forth in 10 CFR 20.1906. It is necessary to assure that only authorized persons are involved'in the t j transfer and receipt of materials.

The frequency of inventories is dictated by need or as specifically set forth in certain parts of 10 CFR or in license conditions. License inventories can be used for two purposes: (1) to track the use of .

material, and (2) to verify that the licensee is only receiving materials j authorized in the amounts listed in the license. '

b. No guidance,

c. poent:UsediiEindinitiFia17FadiographiVbpirs teriah Jhese~

ations;:seet certaincriteria?

minimimicr1include meeting the10iCFR 3430 piiMdes'tM i

~ irements scocifiedjin Americanlistional Standardsfinstitute19432-1980  !

nil 432M labeling 9sealedisourcelanedevicesMadditiess1Rsafety  :

. features forgcranir-cutiradiograph associatedtequi 10 CFRF34120(e)pmentgandiscurce;y:devicesEperfo securingisystension2 source < changers?

n specifiesythatgall tradiographiciemposureidevices Rand associated ~ equipment (in: usef afterfJanuary; 10 h19965 musticesp1fiwith ithe  !

requirementstofnthet 4:section & Associated laquipmentthesibeenVdenti fied as< the source drive;systessi(chbless cranks ncontrolitubes)Rguidel tubes?

exposure . heads / source? stops a and col limetersis IgICiis;retevalusting ;the applicability of the standard AllSI;1143241900;to"esociated:equipmentalNIC .

staff is currently. developing a proposed rulemaking this : area?

packape'in;to confim Pending this:mview/rulemskingsinspectorls should nattattempta thetiassociated equipmentiused!bydicenseestcomplies?with:10;CFRM20  ;

except when an incident or: event"may have resulted;from equipmentyfailurel i the uceaofdan!associatediequipment componentlemldJcreatefacapparent 1 public health Pand1 safety %threatMa ; coeponentMistheingfused2 with Fa  !

non-compatibleisystesh orMsit11s(clearly,obviousito Ahednspectotthet i ancassociatedlequipmentidoes;noticomp1f! '

d. Various strategies for control of materials should be in place. These are i generally defined by procedures and should ensure that use is limited to authorized users and that secure storage is provided.

e. No guidance, j

f. Specific guidance is set forth in Inspection Procedure 86740.

g. Specific guidance is set forth in Inspection Procedure 8485G.

h. Follow the guidance on PEFs in Inspection Procedure 87101.

'00.03 Physical Plant Facilities and Eauioment. Descriptions of the >hysical plant are generally found in the applications for a 'icense and su) sequent  ;

amendments that are usually tied down to a license condition. The actual or as- '

built f6cility should be configured to provide safe working areas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry.

The facility should include utilities and other services sufficient to cope with emergencies, such as loss of power, loss of contamination control, etc.

Plant equipment is generally described in documents as noted above. Plant equipment should be appropriate to the scope of the licensed program. Processing equipment associated Vocess control equipment and ventilation and exhaust systems should be sufficient to provide safe use, handling. and storage of the materials in use.

Issue Date: 01/XX/97 87100

't

For the five-year maintenance of teletherapy units, critical re) airs and maintenance may be recommended by service representatives, but n.ig1t not be completed by the licensee. Talk to licensee representatives about any needed repairs, and get comitments to complete repairs immediately.

03.04 Radiation Protection.

4] Specific guidance is set forth in NRC Inspection Procedure 83822.

FOLLWING EFFECTIVE [GUIDANCEsT018ElUSEDI AFTERR99]iREVISIO lhilhspectibi6fithi^ i&formance!besed!

b@"TheHospectorfshould;patientTN16esiWitE6Csitsbf

~~

be) familisriwitR the tcontentio@ Regulatory 2 Guide 8!395% ease sof?PatientsyAhinistered(AedioactiveRMeterialsSe Four distinctobjectjvesimust[bedaddrefsedijniestablj stlingicomplianceiwith;10 78 # 255 (1)NThe ~ patient"rel4sse icF1terispermitf!11censeift6"N16ssE fWdiiiidGals

~ "" fromi centro 181 fithe 8TEDEitolanylotheck indMdual31si nots 11kely tto exceedt 0;5 freeinThe 2 quantities 9 off rediophenmaceuticals%( ' )'

ahinistered5toipatientsefor::mosteifinotsallMdiagnostica es wi l l / del l verilesLthan ;0 :5? remitoi otherlindividualsMThe3 teenses should belfamiliar;with Regulatory Guide ~8 39MThednspector/should bringis this% RegulatoryW den to Athe a attentioniof ; '~ 1 ate individualssifEheMicensee$1ssnottfamiliarsith?thE ideOln particular$the slicenseei should y bey famili ars with;theX tableXof activitiettand doseirates;for authorizinIpatient! release!and giving instructions M usingy the t tableshi n k the Regulstory@$N f4theilicensee Li sino idesfas7theibasishf&#releasin licensee'syj.hticesishould(beitgleuedF "^~getheyp'atient$~the

~ ~ ^ ~ ~ ~ ~ '

~(2)'D':The 211censee "shouldibei fami l faE'WithitWNgdi rement@ihiloiCFR 35;75(b) to providetinstructions to releasedtindividuals9f4the:: dose to any otherdndividualtisJikely toLenceed:0itrem5in' bthe licensee ai s 2 requi red %to s gives;11nstmetionsMinc1turitten instructionsFon how;to saintiin' doses tofotherdindivi W asilow as;1s' reasonably'achievableMihelie w ic#should detensine hosthe licensee (153 demonstratine n comp 11anceMthathis5 requirement 4by reviewinia sampleiinstruction'and/or1 discussing;the! content lofithe instmet' ons with!aco11 cable *staffMifstheilicenseefisWquired'by therrule s tok provide linstructions% toi breestifeedinTgsisomen a the inspectorfshould'confirmthetithe! instructions $includ'Npidanceion e the interruption:or discontinuatice of breast 4 feeding and;nformation ~'~^~ ^

onithe;consequencesichfajiureito;fohtf(guidancef

'(3~)0 Veri ff thetitheilitensis"asihtainiifofidiree9)6aiWiTNcor(6fithsreleased activityglrather%then  % the tactivitynadstnisteredh occw'ancy factorJ1ess'thanMats1 enterM3Eusineithe (2) @using han biological b

or?effectWe half-11feKort(4);considering;the?shieIding$yltissue!

IfitheilicenseeMnotius1lngitiqs;criterja dnofecord R release  !

1strequired; (4)%IfsthelTEDEftoiaFbreastifeedirii7 child could? exceed?0!5fressif!the

~" breast 4 feeding twere ~ continued n thenithes instructions ? g'i ven! tolthe woman!requirediby;35.75(b)(mustibe;documentedD EVerify3thatithe 1

l 87100 Issue Date: 01/XX/97 i i

i i

i

I licens#is? documenting? thattinctructions7aret beingsprovided las

~ ~ " ' ' ~ ' ~ ~ ~

. requ!re( bylthe;J0 iCFR A 75(d)g l

, 03.05 Radioactive Effluents and Waste Discosal. Review the reports and records  !

j for obvious mistakes, anomalous measurements, trends, missing data (compare the recorded data with the requirements), and verify the accuracy of the data in the report or record with the licensee if any of these aspects are identified or suspected.  !

t Verify;that?ths711tenseeTair;6ff1GentWekcludinFRadon7222 andtits7daughtersk i 4

havednot3ezeededithelconstraintt11mithins10f C9U 20:1101MInfora. non evaluatingtairreffluentsbisfava11ablesin RegulatoryiGuide*20kConstraintion '

Releases of Airborne Radioactive Meterialsito the Environmentsforlicensees Other inaniPoweriReactors3  :

nearestMadiv. idusUse%IfRthesitcensee/

mbee:fof%ths[ pub 12:fece #ein estimated toremesseswd@ithen110::;

em4 ssionsierester perKveernthe11toonseefshould have:mtified;the lflCi(10;;CFAr20:2203(a)(2)(iv)3 '

Ifsthed11censeelhasinotifiedithe IIICtthatAitsnii6effluentsihevetencoededithe constraint %11mitHthedinspiectori should !reviewithei effectivenabstand Ltimelinessi of thellicensee!s correctivefactionsMRecordsief1theLresultsTof measurweeptstand calculations erivironment3re!Mre j neededitoi(tevaluate A the sreleasefofd radioactiveMffluentsit pursuantitoJ10.lCFRi20j2103(b)(MF - ' ~~ ~ '

NoteHMheedihg?thWconstfaintI11mit3itillThotWesultiinTNoticuibf! Violation ,

(NOV) M In 4the

• case: ofi the!constraintf ruleNaniNOWanill! belissued ;onl whent(1 )t a ilicenseelfailsi toi reportTanf actua Ror:J estimetodidose9fron(y airborne M fiani effluent.: releases;from:affacility;that has5 exceeded;the constraintWaluedor:!(2) iffa;1icenseetfailsitodostitute agreediupon;correctivelseasuressintendednto prevent furthernatrinorne effluentstin excess of thoseA' ~ich would resultt~in" doses

' ' ' " ~ ' ~ ' ~

emeeding;the Sonstraintd eve K ~ .

i 03.06 Confirmatory Measurements. Confirmatory measurements should be in sufficient scope to verify survey results or data as found in the licensee's i records. Examples: radiation levels in an unrestricted area: airflow to process i i or fume hoods: and air samples in process areas. l i l f 87100-04 ADDITIONAL REFERENCES l

Proaram Administration (Section 03.01)

RG 7.1 Administrative Guide for Packaging and Transporting Radioactive Material.

RG 7.7 Administrative Guide for verifying Compliance With Packaging Requirements for Shipments of Radioactive Materials.

RG 8.2 Administrative Practices in Radiation Monitoring.

Operating Philosophy for Maintaining Occupational Radiation Exposures RG 8.10 As Low As Is Reasonably Achievable.

RG 8.13 Instruction Concerning Prenatal Radiation Exposure.

RG 8.15 Acceptable Programs for Respiratory Protection.

RG 8.18 Information Relative to Ensuring Tnat Occupational Radiation Ex)osures at Medical Institutions Will Be As Low As Reasonably

Ac11evable.

RG 10.1 Compilation of Reporting Requirements for Persons Subject to NRC l Regulations. 1 RG 10.2 Guidance to Academic Institutions Applying for Specific Byproduct  ;

Materials Licenses of Limited Scope. l l

Issue Date: 01/XX/97 87100

4 i

RG 10.3 Guide for the Preparation of Applications for a Special Nuclear

. Material License of Less Than Critical Mass Quantities.

RG 10.5 Applications for Type A Licenses of Broad Scope.

RG 10.6 Guide for the Preparation of Applications for Use of Sealed Sources and Devices for the Performance of Industrial Radiography, i RG 10.7 Guide for the Preparation of Applications for Licenses for Laboratory 4 .

Use of Small Quantities of Byproduct Material.

RG 10.8 Guide for the Preparation of Applications for Medical Programs.

RG 10.9 Guide for the Preparation of Applications for Licenses for the Use of Gamma Irradiators.

~

DRAFT RG Guide for the Preparation of Applications-for Licenses in Medical Teletherapy Programs.

Authorized Materials. Uses. and Users (Section 03.02)

RG 6.1 Leak Testing Radioactive Brachytherapy Sources.

- RG 7.2 Packaging and Transporting of Radioactively Contaminated Biological Materials.

RG 7.3 Procedures for Picking up and Receiving Packages of Radioactive Material.

RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials.

RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants.

Physical Plant Facilities and Eauioment (Section 03.03)

RG 3.2 Efficiency Testing of Air-Cleaning Systems Containing Devices for Removal of Particles.

RG 8.1 Radiation Symbol.

RG 8.5 Immediate Evacuation Signal.

Radiation Protection (Section 03.04)

RG 8.3 Film Badge Performance Criteria.

RG 8.4 Direct-Reading and Indirect-Reading Pocket Dosimeters.

RG 8.6 Standard Test Procedures for Geiger-Mueller Counters.

RG 8.7 Occupational Radiation Exposure Records System.

RG 8.9 Acceptable Concepts. Models. Equations. Assumptions for a Bioassay Program.

RG 8.14 Personnel Neutron Dosimeters.

RG 8.15 Acceptable Programs for Respiratory Protection.

RG 8.20 Applications of Bioassay for I-125 and I-131.

RG 8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants.

RG 8.23 Health Physics Surveys at Medical Institutions.

RG 8.25 Calibration and Error Limits of Air Sampling Instruments for Total Volume of Air Sampled.

RG 8.28 Audible Alarm Dosimeters.

%218;392f Releasefof@tients@istered[RadjoactiMHateff 41s; Radioactive Effluents and Waste Discosal (Section 03.05)

RG 4.15 Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment.

M s4J 20 C Constrainti onlReleasesi ofs Airborne iRadioactive; MatefialgtMthe Environment for:LicenseestOther:Than Power 1Reactorsr RG 7.1- Administrative ~ Guide for" Packaging"snd Transporting Radioactive Material.

87100 Issue Date: 01/XX/97

i RG 7.4 Leakage Tests on Packages for Shipment of Radioactive Materials. ,

. Requirements for Shipments of Radioactive Materials.

RG 7.5 Administrative Guide for Obtaining Exemptions From Certain NRC Requirements Over Radioactive Material Shipments.

RG 7.7 Administrative Guide for Verifying Compliance with Packaging.

Appendices:

i A. Medical Teletherapy Inspection Field Notes. I B. Nuclear Medicine Inspection Field Notes l C. Well Logging Inspection Field Notes l D. Industrial Radiography Inspection Field Notes '

E. Industrial / Academic Inspection Field Notes

, F. Commercial Irradiator Inspection Field Notes SP3MediciU8 road-Scope _InspectichiField! Notes HilRadiophemcylinspectjpnfjeldiNotes~ ~"

END i l

i 1

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)

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Issue Date: 01/XX/97 87100

t ADDITION TO FIELD NOTES TO ADDRESS CONSTRAINT RULE 4

The following sections will be revised in the IP 87100 Field Notes for Nuclear Medicine. Industrial / Academic. Medical Broad-Scope, and Radiopharmacy programs and IP 87110 Field Notes for Industrial / Academic /Research programs.

Note, subsections under the radioactive waste section where no changes are not

, shown but will remain unchanged.

XX. RADI0 ACTIVE WASTE B. Effluents '

4. Control of air effluents [20?l101. 1201.1301,

" ~ ~ ~

1501, 2001. L/C]

{SeealsoIP87102.RG8.37} g)N/6 g7e7AINfflhtNRM10Teresi

' "constraintilisit:(20J1101]selfdGBy][Q)1N

~'

bF ilffiesfilitinhesTreportidfapproprintu

! VLij!t M ?[L j information;.to NRC L i adi(3}]E{ DIN l a ? Corrective? actions EENC 3 2 2 2[ [ G j f d splementedland;on.ischedUldI Q iyd $ Q XX. NOTIFICATIONANDREPQRTS A. Licensee in com)liance with [19.13] (reports to individuals. pu)lic and occupational.

monitored to show compliance with Part 20) ( ) None ( ) Y ( ) N B. Licensee in compliance with [20.2201]

(theft or loss) ( ) None ( ) Y ( ) N C. Licensee in compliance with [20.2202]

(incidents) ( ) None ( ) Y ( ) N D. Licensee in compliance with [20.2203)

(overexposures and high radiation levels) ( ) None ( ) Y ( ) N E. Licensee aware of NRC Ops Center phone number ()Y()N S~MLicenseelinTcomplfancelwith1[20

^

~~(constrai.nt(oniairiemij.sions)Q i 2203) gig 3GN&ieXQiHHHW l

I l

l l

ADDITION TO FIELDNOTE TO ADDRESS PATIENT RELEASE RULE The following section will be added to the Nuclear Medicine and Broad Scope Medical Fieldnotes.

FOLLOWING GUIDANCE TO BE USED AFTER 1997 REVISION TO 10 CFR 35.75 BECOMES l EFFECTIVE - If using this section, do not answer items 8.C. and 9.C. in the field notes. l X. Patient Release ( ) N/A A. Individuals released when TEDE less than ( )Y ( ) N 0.5 rem [35.75(a)]

B. Instructions on ALARA provided to ( )Y ( ) N to individuals when TE)E exceeds 0.1 rem [35.75(o)]

C. Instructions to breast-feeding women ( )Y ( ) N include appropriate information [35.75(b)]

D. Release records maintained if 35.75(c) ( )Y ( ) N criteria is met [35.75(c)]

E. Records of in',tructions given to breast- ( )Y ( ) N l feeding women maintained, if appropriate [35.75(d)] ( )Y ( )N ( )N/A j I

l

REVISION TO RADIOGRAPHY FIELD NOTES The following section will be revised in the IP 87100 Radiography Field

7. EQUIPMENT

^ Expesurc devices ;nd ster ge centaincr: .ect

4. nn.l. au. n.1 e.s A. i. .s &...

1 4 m.

4. +. .r, nne

r. TOA.

m 01.3 1 /, \ , V, /,

\

, M.

O. .

. . . . .e 4. km .s .n.

n.ar.r. e nnr. 4. 31 .nn

. u, .r. , 4.r. nm.~an.

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14. r ..

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c. . n. m.,

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,,n n ,.. . . y 4. . nA. ..&.n 3.,.n. .. o,.

/\ V U

/, ,\

e nn,i

. . . ...4. c am. ~^n. .t e..n f. F,O A, .mOfi*l . ,

Ali'iRadiography"devicesh sourcelassemblibss?andisource!

' f changerstin use meetithefrequirements of4[34:20]4,1"?iQ)~!Q~ ); ^

5the.

Associated recytirementsi lequipmentiin;

[34;20] t : Nuse . appears

• ++1"i  ; to; ~comply. withi ~SR)f

' ..* ~JT ~

CL'(LicenseeVislawarel t1 associated 4 equipment?sust comply,with [34.20]' n .._ ' .i . "riWMgCDIQJN ~^~'"*"~^ ' "

DJi;3 Source:chr.viirandTstorage?containersLeeet P~

.iM 3D. 5 Q~ ~1YX

'~ ~~ G ~~N EgaEqu radiationilevele11mits

emaptedi.from 34120); / per/[34.21]L1;ificHicense%i spec

!w . license. comm_itmen.t. __ ?N tionLuse.diin.E

-~ -

, ~.i _ .

i i

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1 i.

i e

n l December 23, 1996 MEMORANDUM TO: ThoseonAttbchedList

[ FROM: _ Donald A. Cool, Director optgineistandW b j

Division of-Industrial and Medical Nuclear Safety, NMSS gr " g u

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I SU8 JECT: ROUTINE AND REACTIVE INSPECTION GUIDANCE FOR l 10 CFR 35.32 .'JdD 35.33, " QUALITY MANAGEMENT PROGRAMS" AND NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" On August 1, 1996, Temporary Instruction (TI) 2800/025, " Quality Management

! Program and Misadministration Rule, Revision I," expired. .As a. result, the

Division of Industrial and Medical Nuclear Safety (INNS) provided the regions interim guidance in a memorandum dated August 1, 1996, (Attachment 1). Since

! then, IfGIS has developed two sets of guidance: (1) "QM Inspection Procedures:

New and Regularly Scheduled Inspections," (Attachment 2), and (2) " Reactive

Inspections of Quality Management _ Programs," (Attachment 3).

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Begin using these draft inspection procedures immediately for inspection of both_ regularly scheduled and reactive inspections. Comments received from the.

i regions within 60-days from the date of this memorandem will be considered for incorporation into the final guidance. l The procedure fer inspection of. new and regularly scheduled inspections will ultimately be pravided to the working group revising Inspection Procedures

-(IP) 87100 for it.clusion, and the procedure for reactive inspections will become a part of IP 87103. Manual Chapter 2800 was reviewed, and no changes were needed to accommodate these new procedures.

Attachments: 1. Interim Guidance dated 8/1/96 <

2. "QM Inspection Procedures: l New and Regularly Scheduled Inspections"

3. " Reactive Inspections of.

Quality Management Programs" CONTACT: Sally L. Merchant, NMSS :i (301) 415-7874 '

DISTRIBUTION: _

i JRicci, TTC IMNS Central File IMA8 r/f NRC File Center RFonner,0GC NMSS r/f REGCHFS REGSL .i Public Doc Rm PCVacca HP Data,lM08 thK. H R8angart, OSP MLMcLean, RIV EU11 rich, RI

_.A1.tashat' auidansa_itated_at_ Sitz 100 J B C = C0VER E = C0VER & Attachment N = NO COPY Nemo: G:\1MNS5476. SLM l OFC IMA8 6 [ Mil, k i ;MQQ IMi@ ,

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MEMORANDUM TO

THOSE ON ATTACHED LIST DATE: December 23, 1996 l

SUBJECT:

ROUTINE AND REACTIVE INSPECTION GUIDANCE FOR 10 CFR 35.32 AND 35.33, " QUALITY MANAGEMENT PROGRAMS" AND

, NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" Attached List:

Charles W. Hehl, Director

. Division of Nuclear Materials Safety, RI j I-Bruce S. Mallet. Director I Division of Nuclear Materials Safety, RII '

Cynthia D. Pederson, Director Division of Nuclear Materials Safety, RIII Ross A. Scarano, Director I Division of huclear Materials Sifety, RIV  ;

]

l James Lieberman, Director  ;

Office of Enforcement  ;

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i Attachment 1

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• UNITED STATES 7

NUCLEAR REGULATORY COMMISSION E E wAsamorow, o.c. aseswooi l

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• • • • • August 1, 1996

I f MD10 RAND (M TO: Those on Attached List 3

! FRON: Donald A. Cool, Directo bi 47 l

Division of Industrial and Medical Nuclear Safety, NMSS ' h ---

! SU8 JECT: IMPLDIENTATION OF 10 CFR 35.32 and 33

" QUALITY MANAGDIENT AND MISA0 MINISTRATIONS" i

L, l On August 1, 1996, Temporary Instruction (TI) 2800/025, " Quality Management j Program and Misadministration Rule, Revision 1," expires. The TI implemented  ;

i the inspection procedures for the rule, and established the areas of

!. inspection and procedures for determining compliance with the performance-

!- based portions of the rule. This memorandum provides guidance for inspection

! of the requirements set forth in 10 CFR 35.32, " Quality Nanagement program,

! and 35.33, " Notifications, reports, and records of misadministration," after i the TI expires.

l After August 1,1996, inspectors will no longer complete the QM fleid notes (Attachment A of the TI) during routine inspections (for reactive inspections, see instructions in item 2 below). Inspectors are required to submit copies of the QM fleid notes, completed before August 1, by August 9, 1996. This information is needed to complete the data collection so that the Headquarters l

i staff may begin the analysis of the TI findings.

The staff is revising Manual Chapter 2800 and Inspection Procedure 87100 to i

include field notes for both routine and reactive inspections of qual:ty j uanagement programs. In the interim, inspectors should implement the fc11owing procedures:

1. [or - " routine in _tions, inspectors are instructed to implement a more performance based approach to the review of licensees' activities intended to comply with 10 CFR 35.32. In an unobtrusive manner, j inspectors should verify that: a, quality management program (QMP) commensurate with the licensee's activities is being implemented; all j

modalities of use under the license are included; the licensee is conducting a review of the QM program at least annually; and the records of the review are maintained in an auditable form for 3 years. If i

during the ananal review the licensee identified recordable events, f

assure that an evaluation was performed and that any appropriate j corrective actions were taken. This evaluation should be completed as j part of the normal inspection of a medical use program. The applicable sections of the existing QN field notes are to be used to verify the i

four key elements previously discussed as part of the performance i

! CONTACT: Sally L. Merchant,1.45 i (301) 415-7874 l Mc o-!cD v ~bope s,y)-

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oriented inspection until the new field notes are available. The extent

! of documentation required should closely follow the performance oriented inspection.

2. For re:ctive insoections, inspectors should follow the guidance provided

in Management Directive 8.10, "NRC Medical Event Assessment Program,"

l and, for the modality involved with the event, e.g., fodine therapy or

high dase rate afterloading brachytherapy, etc, (1) review the Itcensee's written QMP; (2) follow the existing guidance in TI 2800/025

' to ensure that the licensee's QMP has been implemented; and, (3) review the findings of the annual reviews for the last 3 years. Only the l

modality involved should be evaluated as part of this inspection.

3. For misadministrations, (1) follow the procedure for reactive j inspections (above), and (2) ensure that the licensee has complied with i

the reporting requirements described in 10 CFR 35.33, " Notifications,

reports, and records of misadministrations."

In addition to reviewing QMPs during event investigations, QMPs submitted with i new license applications should continue to be reviewed following the guidance i

provided in Policy and Guidance Directive PG 3-15.

4

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During the past two years, the inspectors have devoted considerable time and j effort to completing the extensive field notes associated with the TI. This information will be analyzed to determine the manner and degree of success in j which Itcensees implemented the QM rule. This information will be of substantial value in informing the Commission of the outcome of the rule and l

in making recommendations for future consideration.

Attachment:

PG 3-15 DISTRIBUTION:

JRicci, TTC IMS Central File .INA8 r/f . NRC File Center REGSL RFonner,0GC MSS r/f REGCHFS HP Data,IMDB Public Doc Rm PCVacca R8angart, OSP MLMcLean, RIV EU11 rich, RI C = COVER E = COVER & Attfihnent N = NO COPY G:\ Implement. SLM OFC IMA8 [ 38 8. f, . LMQl0 NAIE StNant ).h br Miccone auh i- =

OFC DD/IlttS _ (M h.

NAME F[ombs kM4 dk OATE / h/ /96 Y/ MNi

s M6 TO: THOSE ON ATTACHED LIST DATE: July 12, 1996 SU8 JECT: IMPLEMENTATION OF 10 CFR 35.32 and 33 " QUALITY NANAGEMENT AND MISADMINISTRATIONS#

Attached List:  !

James Lieberman, Director <

Office of Enforcement Charles W. Hehl, Director  ;

Division of Nuclear Materials Safety, RI l

Bruce S. Mallet Director )

Division of Nuclear Materials Safety, RII l 1

Cynthia D. Pederson, Director j

Division of Nuclear Materials Safety, RIII Ross A. Scarano, Director Division of Nuclear Materials Safety, RIV 1

l' i i

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I Attachment 2

QM INSPECTION PROCEDURES New and Regularly Scheduled Inspections Quality Manaaement Proaram (OMP)

For routine inspections of applicable facilities, inspectors are instructed to implement a performance based approach to the review of licensees' activities intended to comply with 10 CFR 35.32. Inspectors should observe and interview individuals as they perform applicable duties to ensure that the QMP, as implemented, provides high confidence that byproduct material, or radiation from byproduct material, will be administered as directed by the authorized user.

General Guidance:

i

a. This guidance applies to those medical licensees who are authorized to possess and use byproduct material for applications involving the following modalities:

1. Quantities greater than 30 microcuries of either sodium iodide I-125 or I-131;

2. Therapeutic administrations of a radiopharmaceutical, other than sodium iodide I-125 or I-131; J 3. Brachytherapy, including High-Dose-Rate Remote Afterloading and Strontium-90 eye applicat us; 4

4. Teletherapy; and

5. Gamma Stereotactic Radiosurgery.

b. The intent of the inspection is to determine if the licensee effectively implements policies and procedures designed to meet the objectives and requirements in 10 CFR 35.32, and the notification, reporting, and record keeping requirements in 35.33.

The inspection should include consideration of the licensee's implementation of a continuous improvement process in the QMP. This review should include (1) the monitoring process - has the licensee been looking for unintended deviations (e.g., errors, mistakes, or omissions) that could h.ie led to a misadministration; (2) the identification process - has the licensee found unintended deviations (e.g., through reviews or representative sampling) that could have led to a misadministration; (3) the evaluation process - has the licensee made assessments of the unintended deviations (e.g., what, when, how, or why the events occurred, including an analysis of any trends and patterns) that could have led to a misadministration; (4) the corrective action process - has the licensee implemented an action plan to fix the unintended deviations that, if not addressed, could have led to a misadministration; and (5) the preventive measures process - has the licensee instituted actions to prevent recurrence of the unintended deviations (e.g., modifications to the policies or procedures) that could have precluded the likelihood of a misadministration?

Review of all records associated with the licensees' QMP is not necessary unless: (1) there is reason to suspect that the QMP has not been appropriately implemented; (2) all modalities requiring a QMP have not been addressed; (3) a recordable event occurred, and the licensee did not identify, evaluate and institute corrective actions; or, (4) an unreported or previously unidentified misadministration was identified during the inspection.

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. a. Scone of - 0MP Verify that a written QMP, commensurate aith the r .

- licensee's activities, has been established and implemented. It is 4 not necessary to perform an in-depth review of the written program unless this is a new license or modality (e.g., brachytherapy has-been added requiring a QMP). However, the inspector should verify

. - that the QMP includes procedures to address each of the applicable

- objectives set forth in 10 CFR 35.32. Ensure that all applicable

, modalities of use identified on the license are included. The QMP need not be maintained in totality in one location, but may be

! segmented in various areas of use (e.g., radiopharmaceutical J

" therapy, brachytherapy, teletherapy, etc.). _

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b. Annual Review of QBf The frequency of - the review may vary.

4 However,10 CFR 35.32(b)(1) requires that a review of the QMP be

.perfomed at intervals of no greater than 12 months. Verify that a

, review of the QMP has been performed, at least, at this interval.

Ensure that the review . includes: (1) a representative sample of ,

patient- (and human research) administrations; (2) all recordable 1

events; and, (3) all misadministrations. Ensure that.the reviews 1 were evaluated to determine the effectiveness of the QMP, and if  ;

i required, modifications to the QMP were made and implemented. ,

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} c. Records Verify that records of.each annual review, including each l written directive, a record of each administered dose or dosage, and ,

the evaluations and findings, are maintained, in an auditable form, )

i, ~for three years.

d. For recordable eventi if the recordable event was self-identified (identified by the licensee), verify that an. evaluation was l

• performed within 30 days after discovery of the event, and note the R corrective actions that were taken. . If no or inadequate corrective 2 actions were taken, determine whether the lack of corrective action caused the license to be in non-compliance with regulatory

requirements. If a recordable event is identified by the inspector, bring the event to the attention of the licensee. The licensee has

30 days in which to evaluate the event,- and take any necessary 3

corrective action. '

i e. For misadministrations: if during an inspection, a previously i unidentified misadministration is identified by the inspector: (1) i follow the procedure for reactive inspections (Attachment 3), and

(2) remind the licensee-of the need to comply with the reporting requirements described in 10 CFR 35.33, " Notifications, reports, and records of misadministrations."

f. For all reactive inspections, inspectors should follow the guidance provided in Management Directive 8.10, "NRC Medical Event Assessment Program," and follow the procedure for reactive inspections (Attachment 3).

4 Issue Date: 12/ /96 i

1 1

QM FIELD NOTES New and Regularly Scheduled Inspections Oualii.y Manaaement A. Scope of Quality Manacement Proaram (0MP)

(1) Written QMP commensurate with the licensee's activities established and implemented. ()Y()N (2) All modalities of use under the license included ()Y()N (3) QMP includes procedures to address each of the applicable objectives:

1 OBJECTIVE 1 Written directives (a) prepared for each patient

[35.32(a)(1)) ()v()N (b) OBJECTIVE 2 Licensee uses more l than one method to ve-ify patient's I identity [35.32(a)(2)) ()Y()N j (c) OBJECTIVE 3 Procedures implemented to verify final plans of treatment and related calculations in accordance  ;

with written directives [35.32(a)(3)) ()Y()N l (not applicable to radiopharmaceutical i therapy including sodium iodides)  ;

i (d) OBJECTIVE 4 Procedures implemented to  ;

verify, prior to administration, specific  !

details in accordance with written '

directive [35.32(a)(4)) ()Y()N (e) OBJECTIVE 5 Procedures implemented to ensure unintended deviations identified, evaluated, and corrective action taken

[35.32(a)(5)] ()Y()N B. Annual Review of OMP The frequency of the review may vary.

However, 10 CFR 35.32(b)(1) requires that:

1. QMP reviewed within 12 month intervals ()Y()N Review includes:

(a) Representative sample of patient (and human research) administrations ()Y()N (b) All recordable events ()Y()N (c) All misadministrations ()Y()h 12/ /96

2

2. Effectiveness of the QMP was evaluated ()Y()N

3. If needed, modifications to the QMP were made and implemented ()Y()N C. Records:

Records of each annual review, including:

written directive, record of each administered dose or dosage, and evaluations and findings, maintained, in auditable form, for three years. ()Y()N J

D. Recordable Events and Misadministration:

(1) Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:

(2) Procedures implemented to evaluate & respond within 30 days to each recordable event i dis: overed [35.32(c)] ()Y()N (3) If no, was there a potential violation of NRC regulations (-) Y ( ) N (4) Recordable events identified by inspector ( )-Y ( ) N (5) Licensee identified misadministration (s) since the last inspection ()Y()N l (6) If response is yes to item D.5., licensee met the requirements of 10 CFR 35.33 ()Y()N j

, (7) Inspector identified misadministration (s) ,

since the last inspection (not previously identified by the licensee ()Y()N i

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i Issue Date: 12/ /96 i

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Attachment 3 l

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l REACTIVE INSPECTION OF QUAL.ITY MANAGEMENT PROGRAMS INSPECTION REQUIREMENTS:

The following requirements should be completed for reactive inspections of medical l licensees who are required to implement a Quality Management Program (QMP). The

' inspector should determine licensee compliance with 10 CFR 35.32 and 35.33, as

' applicable. For any investigation that includes a medical event, the inspector ,

must first follow NRC Management Directive 8.10, "NRC Medical Assessment Program"  !

to ensure that medical events are reviewed in a manner that is timely, objective,  !

systematic, and technically sound; that factual information pertaining to the I events is documented; and that probable causes are documented.

Inspectors are reminded that an event evaluation is not complete without an evaluation of the root cause. In addition, if the licensee is not in compliance, then the regien should take appropriate enforcement action.

The regional inspector should complete the "QM field Notes" given in Attachment A, as applicable.

General Guidance:

a. This guidance applies to those medical licensees who are authorized to possess and use byproduct material for applications involving the following modalities:

1. Quantities greater than 30 microcuries of either sodium iodide I-125 or I-131;

2. Therapeutic administrations of a radiopharmaceutical, other than sodium iodide I-125 or I-131;

3. Brachytherapy, including High-Dose-Rate Remote Afterloading and Strontium-90 eye' applicaters;

4. Teletheraoy; and

.5. Gamma Stereotactic Radicsurgery.

b. The intent of the inspection is to determine if the licensee effectively ,

implements policies and procedures designed to meet the objectives and j requirements in 10 CFR 35.32, and the notification, reporting, and record '

keeping requirements in 35.33. In addition, a determination should be made between the caliber and implementation of the licensee's QM program in relation to the misadministration event. The emphasis during the reactive inspection will be on the analysis of the sequence of events and the conditions that existed at the time these events occurred. The analysis should lead to the determination of contributing factors and root causes. l and to the formulation of corrective actions to prevent recurrence. i d

c. Review the licensee's policies and procedures for instruction of supervised individuals in the QMP. Verify that the staff training has occurred. 1 Inspectors should interview individuals present. If an apparent failure in the QMP is identified, determine whether the failure could be attributed to ,

poor, inadequate, or no instruction in the area of the failure. Determine l l

l 12/ /96

REAdIVE INSPECTION OF QMP 2 if the failure is isolated, broad or involves other individuals.

Additionally, determine if the failure represents an implementation problem involving only specific areas of the department's QMP, or general aspects of the institution's entire QMP.

d. If the subject event is a misadministration, ensure that the licensee has complied with appropriate notification, reports, and records as required in 10 CFR 35.33.

Description:

The QM Fleid Notes for the QMP are provided in the form of a reactive inspection cover document and a series of modules, each containing a checklist for a specific modality of use. As part of the preparation for inspection, the inspector should read the licensee's submitted QMP and any modifications, and assemble available details of the misadministration or other event. The inspector should enter the available information on the cover document as part of the inspection preparation.

The inspector should be familiar with the licensees QMP in order to compare the written program with the prograrr as implemented. The inspector should not attempt to determine that the program, as written, is acceptable, but rather should determine as a result of the inspection, that the licensee's program as implemented, meets the objectives of 10 CFR 35.32.

Since all information needed to complete the field notes on notifications, reports, and records of misadministration may not be available at the time of the inspection, the inspector should provide the information that is known, and complete the notes as information becomes available.

1 Specific Guidance:

1. Although only the modality for which there was an incident /

misadministration need be inspected, confirm that the licensee has a written QMP(s) that specifically addresses each modality that is utilized by the licensee. ,

1

2. For all medical misadministrations, the inspector must follow the guidance  :

provided in NRC Management Directive 8.10. "NRC Medical Assessment Program."

3. Confirm that the QMP includes written policies and procedures that require a written directive and program review.

4. Interview supervised individuals (e.g., technologists, dosimetrists, l physicists, or physicians) to determine if these individuals are familiar l with and have been instructed to use and follow their QMP (e.g., written policies and procedures that address each objective, and procedures to conduct the required review). Confirm that the licensee has a system in place whereby the licensee's staff clearly understands the assignment of daily activities that relate to the effective implementation of the QMP.

Instruction should be specific and appropriate to each individual's use of byproduct material as required by 10 CFR 35.25. Inspectors should document the names and positions of all individuals who have not received training in the licensee's QMP.

Issue Date: 12/ /96

1 REACTIVE I'!SPECT10N OF QMP 3 Additionally, document the reasons given for the failure to instruct as stated by the individual, the radiation safety officer, and the supervising authorized user.

5. Confirm that the licensee has selected and reviewed a representative sample of patient administrations within each 12 month period. The licensee may use any representative sampling methodology to confirm that there are no previously unidentified recordable events or misadministrations. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptabic.

6. Select a random sample of patient administrations to review in each modality l using the following multi-step process: ,

a. Request licensees to provide the approximate total number of administrations requiring a written directive since the last I inspection. In order to eliminate any bias in the sample, the administrations to be reviewed should be selected randomly. Document the total number of administrations for the subject modality.  !

b. A target sample is calculated, using the table supplied in Attachment A for each modality of use. If recordable events are identified in the review of the target sample for the specific modality, the target sample should be increased until the inspector believes he has  :

assessed the extent of the problem.

7. Based on the review of the representative sample, confirm that the ,

objectives for each modality have been met and that appropriate records were i retained.  !

8. If the licensee failed to follow their QMP procedures, it may not '

i necessarily be a violation. The inspector should determine if the objective was met. The inspector should make the licamaa aware of any identified  :

weaknesses.

9. Ask individuals to explain how the patient's identity is verified by more l' than one method, prior to the administration, as the individual named in the written directive, if possible, observe the individuals to confirm their understanding and effective implementation of redundant identification  ;

procedures.  ;

10. Interview individuals (e.g., radiation oncologists or radiation therapists, i neurosurgeons, clinical medical physicists, dosimetrists, or radiation therapy technologists) in each applicable modality who are involved in the final plans for radiation therapy treatment of patients. Ask individuals to j explain how they verify that the final plans of treatment and related  ;

calculations are in accordance with the written directive. Confirm that the i licensee performs checks of dose calculations. If the licensee uses .

treatment planning or dose calculating computer programs for dose '

calculations, ask if the licensee has implemented procedures for acceptance testing before first use of the program for patient dose calculations. l i

12/ /96 I

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REACTIVE INSPECTION OF QMP 4 l

11. Ask individuals to explain how the specific details of the administration ,

are verified, before administering agh radiation dose or  !

radiopharmaceuti'a1 dosage, in order to be in accordance with the written  :

directive.  ;

12. After administering a radiopharmaceutical dosage or radiation dose, the j licensee must make, date, and sign or initial a written record that  ;

' documents the administered dosage or dose, as a minimum, in the patient's I chart or other appropriate record. This documentation should serve as an  !

additional check, after the administration has been performed, for the '

' licensee to compare the prescribed with the administered dosage or dose.-

13. Ask individuals whether any. policy exists that requests workers to seek guidance if they do nct Mderstand how to carry out the written directive.

Additionally, determine if the department encourages workers to ask questions about what.to do or how it should be done rather than continuing a procedure when there-is any doubt.

14. Review the licensee's implementation-of procedures to identify, evaluate, and - take - appropriate corrective action when uncovering any unintended deviations from the written directive. This objective should be a key part of the licensee's continuous improvement process in their QMP and'should include procedures for monitoring, identification, evaluation, corrective actions, and preventative measures. If the licensee identified unintended deviations from the written directive since the last inspection, track the licensee's processing of the unintended deviations from beginning to end.

Describe any unintended deviations from the written directive that were-identified by yourself.

15. Examine the licensee's reviews of their QMP, performed at intervals'not to exceed 12 months, for each applicable modality. If.the licensee identified any recordable events since the last inspection, the inspector should review the documentation of the licensee's evaluation of the event, and any corrective action that was taken by the licensee within 30 days after discovery.

16. Based on the administrations sampled and reviewed in the target sample, document any recordable events or misadministrations identified by yourself that the licensee failed to identify.-

17. Any. identification by the licensee of misadministrations that were not subsequently reported to the NRC should be closely reviewed to determine the  ;

cause of the licensee's failure to report the misadministration. j l

18. For misadministrations that were reported, review documentation and/or i copies of notifications, reports, and records.

Issue Date: 12/ /96

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4 REACTIVE INSPECTION OF QMP 5 I STATISTICAL DATA REPORTING:

All direct reactive inspection effort expended should be charged to Inspection Procedure 87103.

Attachment:

A. Field Notes - Quality Management Program (QMP)

J Modules:

i A-1. Na! I-125 or I-131 > 30 Ci and Radiopharmaceutical Therapy A-2. HOR Remote Afterloading Brachytherapy A-3. Brachytherapy (Other than HDR) 3 A-4. Strontium-90 Eye Applicators  !

A-5. Teletherapy

] A-6. Gamma Stereotactic Radiosurgery l

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12/ /96

ATTACHMENT A OUALITY MANAGEMENT PROGRAM (OMP)

OM FIELD NOTES FOR REACTIVE INSPECTIONS

1. GENERAL A. Facility name(s):

B. License number (s):

C. Docket number (s):

D. Last inspection date(s):

E. Current inspection date(s):

2. PREPARATION A. Be familiar with the submitted QMP and any modifications in preparation for inspection of the licensee's implemented QMP.

Familiarization should focus upon awareness of the submitted program in order to compare the written program with the program as implemented.

3. MODALITY:

A. Identify applicable modd l ties listed on the license:

Module:

1. Nal I-125 or I-131 > 30 Ci and/or Therapeutic radiopharmaceutical other than Nal ()Y()N

2. High-Dose-Rate Remote Afterloading Brachytherapy ( ) Y ( ) N

3. All Other Brachytherapy ()Y()N

4. Strontium-90 eye applicator ()Y()N

5. Teletherapy ()Y()N

6. Gamma Stereotactic Radiosurgery ()Y()N B. Verify, through interview or observation, that a QMP has been implemented for each modality listed on the license. (only the modality where the event occurred need be inspected)

I C. Identify modality where the event (s) or misadministration (s) occurred, and attach appropriate inspection module (s): i

4. Incident:

A. Misadministration ()Y()N B. Other incident ()Y()N If yes, briefly state what type:

C. Modality of event or misadministration: ,

i D. Therapeutic or diagnostic event: l l

E. Date of event:

F. Date of discovery:

G. Identified by:

2 H. Licensee implemented a QMP for this modality

[10CFR35.32] ()Y()N

5. DESCRIPTION OF EVENT A. Event classified as misadministration [35.2] ()Y()N If yes, which paragraph (s) under 35.2 best describes the event:

B. Describe sequence of events leading to misadministration. If not a misadministration, go to C:

C. Describe the event:

If necessary, attach separate sheet.

D. Number of patients or others exposed / overexposed:

E. Time period:

F. Occupational workers exposed ()Y()N If yes, describe:

G. Licensee evaluation and actions

1. Calculated prescribed and actual doses ()Y()N Prescribed: Actual:

2. Evaluated effect on patient ()Y()N Describe:

3. Corrective actions taken to prevent recurrence ()Y()N Describe:

4. If licensee did not evaluate or take action, reason provided:

6. EVALUATION OF THE EVENT A. Cause of event:

1. Human error ()Y()N

2. Patient intervention ()Y()N

3. Mechanical error ()Y()h

a. Manufacturer / vendor: --

b. Serial number:

c. Model number:

Issue Date: 12/ /96

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4. Computer software error ()Y()N

! a. Manufacturer / vendor:

l b. Version:

I c. Serial number:

d. Model number:

l Remarks:

5. Failure to follow QMP ()Y()N  ;

a. Authorized user 1:35.32(a)) ()Y()N

b. Supervised indiv dual [35.32(a)(2)) ()Y()N

Describe

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l B. Root cause(s) and contributing factor (s) that led to this incident: l j 1. Identified by licensee: l l

l 2. Evaluated by inspector: '

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7. NOTIFICATIONS A. NRC's Operations Center within next calendar dey

! after discovery [35.33(a)(1)) ()Y()N Report Number and date:

l B. Referring physician notified ()Y()N j Patient notified within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after ,

j discovery [35.33(a)(3)) ()Y()N j

! (Referring physician may inform the licensee either

that he will inform the patient; or that, based on medical judgement, telling the patient would be harmful)

I C. If patient was notified, patient also notified in writing l within 15 days after discovery (35.33(a)(4)) ()Y()N

If not within 15 days, date notified

,

l What information was provided in the report: 1 l

l D. If patient was not notified, the licensee ootified the responsible relative or guardian ()Y()N If no, licensee documented justification for decision ( ) Y ( ) N Remarks:

. 8. Attach appropriate module (e.g. Module 2 ' 2R")  !

4 i 12/ /96 I i

i i i . __ , l

-~ _ . . .- . __

l i

l MODL,LE Al l

RAD 10 PHARMACEUTICAL THERAPY INCLUDING j GREATER THAN 30 MICR0 CURIES NAI I-125 or I-131

1. SAMPLING (Inspector random sample of each radiopharmaceutical in use):

d Total Written Directives Minimum Taraet Samole 4

1 to 5 All 5 to 100 5

> 100 5% Total Target Number Written ingp.lg Reviewed D1E

1. Na! I-125 or 1-131 > 30 pCi

2. Radiopharmaceutical: ,

(Name:)

If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.

2.- SUPERVISION l A. Supervised individual (s) instructed in QMP applicable

, to the modality of use [35.25(a)(1)) ()Y()N List individual (s) found to be inadequately trained:

3. 0BJECTIVES:

OBJECTIVE 1 Number Missed A. A written directive (order for a specific patient, djLtid & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient (35.32(a)(1)) ()Y()N

~

B. Written directives for sodium iodide: i required dosage information [35.2] ()Y()N l C. Written directives radiopharmaceutical therapy: radiopharmaceutical, dosage, and route of administration (35.2) ()Y()H 1

i- 0 Exceptions to written directives are documented l

[ footnote to 35.32(a)(1)) (.) N/A

1. Written revisions ()Y()N i 2. Oral revisions ()Y()N ,

3. Oral directives ()Y()N l S

l Mouule A-1 2 OBJECTIVE 2 A. Licensee uses more than one method to verify the .

patient's identity [35.32(a)(2)] ()Y()N OBJECTIVE 3 (Does not apply)

OBJECTIVE 4 A. Procedures implemented to verify, prior to  ;

administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N

8. Procedures may include: (not reauirements) ,

! 1. Dosage measured prior to administration ()Y()N l 2. Parameters confirmed

! Just prior to administration ()Y()N l C. Record of administration maintained in auditable l form [35.32(d)(2)] ()Y()N OBJECTIVE 5 l A. Procedures implemented to ensure that unintended

deviations are identified, evaluated, and

! correct h a action taken [35.32(a)(5)] ()Y()N  ;

l.

l 1. Recordable event (s) self-identified siace the ,

l last inspection [35.32(c), 35.2) ()Y()N  !

l Dates of events: 4

2. Recordable events identified by inspector l [35.32(c),35.2] ()Y()N

3. Misadministration resulted from the unintended I deviation ()Y()N

(

B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)) ()Y()N ,

C. Procedures may include: (not recuirements)

I i 1. Assemble relevant facts including cause ()Y()N i'

2. Identify corrective action to prevent recurrence ( ) Y ( ) N  !

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection {35.33(a)) ()Y()N ,

E. Licensee identified misadministrations that were aqi

()Y()N l subsequently reported [35.33(a))

If ves. clarify: l Issue Date: 12/ /96 l

Module A-1 3

4. PERIODIC REVIEWS OF THE QMP A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Objectives (35.32(b)(2)] ()Y()N F. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

12/ /96 o

~_ _

MODULE A-2 HIGH-DOSE-RATE REMOTE AFTERLOADING BRACHYTHERAPY l

1. SAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Sample I to 5 All 5 to'100 5

> 100 5% Total Target Number  ;

Written Sample Reviewed j Qir. I

1. HDR remote afterloading brachytherapy  !

If two (2) or more written directives are incomplete or missing, the i review must be expanded to assess whether this is an isolated occurrence l or represents a substantial failure of the QMP. j i

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N ,

List individual (s) found to be inadequately trained:

, 3. OBJECTIVES:

OBJECTIVE 1 A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patiert (35.32(a)(1)] ()Y()N B. Written directives contain required information:

4 isotope, treatment site, & total dose (35.2] ()Y()N 4 C. Exceptions to written directives are documented

[footnoteto35.32(a)(1)] ( ) N/A  ;

l

1. W-itten revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N f DBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N i

Module A-2 2 0 EJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures Egy include: fnot recuirements)

1. Check of dose calculations by an authorized user or a qualified ' person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N

2. Performing acceptance testing (based on licensee's specific needs & applications) on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Other, describe:

OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures any include: fnot recuirements)

1. Plan of treatment prepared in accordance with the written directive ()Y()N ,

2. Pe; ,on administering therapy treateent confirms the prescribed radioisotope, site, & total dose ( ) Y ( ) N

3. Owell times and positions verified prior to ,

start of treatment ()Y()N '

4. Verify source position using dummy sources or l fixed geometry applicators prior to inserting l sealed sources ()Y()N

5. Prompt record by the authorized user, of the treatment parameters and signing or initialing patient's chart or appropriate record ()Y ()N

6. Other, describe:

C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N

!ssue D.te: 12, iH

l l  !

l . .

M ul A-2 3  :

0NECTIVE. 5 A. Procedures implemented to ensure that unintended i

deviations are identified, evaluated, and ,

j corrective action taken [35.32(a)(5)) ()Y()N P

1. Recordable event (s) self-identified since the  ;

last inspection [35.32(c), 35.2) .( ) Y ( ) N j Dates of events:  ;

2. Recordable events identified by inspector ,

[35.32(c),35.2) ()Y()N

3. Misadministration resulted from the  :

unintended deviation ()Y()N  ;

B. Procedures implemented to evaluate & respond within 30 t days to each recordable event discovered [35.32(c)) ()Y()N C. Procedures may include: (not reautrements)

I

1. Assemble relevant facts including cause ()Y()N i

2. Identify corrective action to prevent recurrence ( ) Y ( ) N l

3. Retain a record of items I and 2 ()Y()N l D. Licensee reported misadministration (s) since the last.

inspection (If yes, also complete module 7) [35.33(a))( ) Y ( ) N ,

E. Licensee identified misadministrations that were D91 subsequently reported (If yes, also complete module 7)

[35.33(a)) ()Y()N

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP at intervals no greater than12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient l administrations including all recordable events and I misadministrations [35.32(b)(1)(1)(ii)(iii)) ()Y()N The licensee should utilize a representative sampling process which ,

embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of l 10 CFR 32.110 and assuming an error rate of 2%. If the tables in l 10 CFR 32.110 are used, any table is acceptable. I C. If review identified recordable events or misadministrations, not previously identified, the ,

review was expanded by the licensee to ensure the <

events were isolated ()Y()N i

I I l

12/ /96

d l Module A-2 4, 1

D. Licensee evaluated each review to determine the

, effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made I modifications to mett Objectives [35.32(b)(2)]. ()Y()N F. Mcdifications sent to NRC within 30 days

[35.32(e)) ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N  ;

l

5. RESULTS OF REVIEW 1 I

Briefly describe the overall implementation of the QMP and summarize the i inspection findings.

l 4

Issue Date: 12/ /96 r

I MODULE A-3 BRACHYTHERAPY (OTHER THAN HDR REMOTE AFTERLOADING)

1. SAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Sample 1 to 5 All 5 to 100 5

> 100 5% Total Target Number Written Egmalg Reviewed D.iL.

1. Brachytherapy i

If two (2) or more written directives are incomplete or missing, the l review must be axpanded to assess whether this is an isolated occurrence 1 or represents ,. <.ubstantial failure of the QMP.

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)j ()Y()N l List individual (s) found to be inadequately trained: 1

3. OBJECTIVES:

OBJECTIVE 1 A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is l prepared for each patient [35.32(a)(1)) ()Y()N i B. Written directives contain required information (35.2):

1. Prior to implantation: radioisotope, i number of sources, and source strengths ()Y()N I

2. After implantation & prior to completion of procedure: radioisotope, site, total source strength & exposure time (or total dose) ()Y()N i C. Exceptions to written directives are documented l

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)) ()Y()N i

Module A-3 2 OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives (35.32(a)(3)]( ) Y ( ) N B. Irocedures Ely include: (not reautrements)

1. Check of dost calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculaticas ()Y()N

2. Performing acceptance testing (based on licensee's specific needs and applications) on each treatment plar.ning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Other, describe:

OBJECTIVE 4

, A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures Ely include: (not reouirements)

1. Plan of treatment prepared in accordance with the written directive ()Y()N

2. Person administering treatment confirms prescribed radioisotope, number of sources, source strengths, treatment site, loading sequence, & total dose ()Y()N

3. Verify source position using dummy sources or fixed geometry applicators prior to inserting sealed sources ()Y()N J

4. Prompt record by the authorized user, of the number of sources, the actual loading sequence of sources implanted (location of each sealed l

source in a tube, tandem, or cylinder) and I signing or initialing the patient's chart or appropriate record ()Y()N

5. Ensure that soarce will not move or dislodge while implanted ()Y()N

6. Inspect implanted sources ()Y()N Frequency:

Inspecting dividual trained ()Y()N Issue Date: 12/ /96

Muuule A-3 3

7. Other, describe:

I C. Record of administrat' ion ma'intained.in auditable form (35.32(d)(2)] ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective. action is taken (35.32(a)(5)] ( ) Y (-) N

1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ( ) Y (_) N Dates of events:

2. Recordable events identified by inspector

[35.32(c),35.2] ()Y()N

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures gay include: -(not reeuirements)

. 1. Assemble relevant facts including cause- ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N 3.- Retain a record of items 1 and 2_ ( )_Y ( ) N D. Licensee reported misadministration (s) since the'last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were agl subsequently reported (If yes, also complete module 7)

[35.33(a)) ()Y()N

4. PERIODIC REVIEWS OF THE GM PROGRtM fl0 CFR 35.32(bil A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which  !

embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CF81 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.

12/ /96 i i

)

_ m.. . . _ . _ . _ . . . _ _ _ _ - - . _ _ ___.__. _. _ _ . . . . . ._

^

Mod 11e A-s 4 C. If review identified recordable events or misadministrations not previously identified, the

.,' review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)) ()Y()N

~

E. Based on' evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N

- F. Modifications sent to NRC within 30 days

[35.32(e)] ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N

5. RESULTS OF REVIEW l - Briefly describe the overall implementation of the QMP and summarize the inspection findings.

i

}

i-1 I

a J

4 i Issue Date: 12/ /96 4

a

l MODU!.E A-4 STRONTIUM-90 EYE APPLICATORS

1. 185PLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Samole  !

I to 5 All l 5 to 100 5 l

> 100 5% Total Target Number q Written SamDie Reviewed j'

' Dir.

l. Strontium-90 Eye Applicator: l If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.

l

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable  ;

to the modality of use [35.25(a)(1)] ()Y()N l List individual (s) found to be inadequately trained: I

3. OBJECTIVES:

OBJECTIVE 1 A. A written airective (order for a specific' patient, dated a sianed by authorized user (a.u.)

or physician under supervieion of an a.u.) is prepared for each patient (35.32(a)(1)) ()Y()N 1

B. Written directives contain required information:

source strength, site, & exposure time or total dose [35.2) ()Y()N C. Exceptions to written directives are documented

[ footnote to 35.32(a)(1)] ( ) N/A

l. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee usec more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

. . . - . . - .. - -- = . - .- - . . . ..

Module A-4 2  :

H OBJECTIVE 3 A. Procedures implemented to verify that final plans l of treatment and related calculations are in - l accordance with written directives [35.32(a)(3)]( ) Y ( ) N

8. Procedures may include: (not recuirements)  !

l

1. Plan of treatment prepared in accordance with the written directive ()Y()N

2. Assess quantity of material remaining after decay (decay chart or other method) ()Y()N

3. ^ther, describe:

OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures may include: (not reauirements)

I

1. Method used to time the administration ()Y()N

2. Person administering treatment confirms the prescribed site and the total dose, or source strength and exposure time ()Y()N

3. Other, describe.

C. Record of administration maintained in auditable  !

fcrm (35..,2{d)(2)] ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection (35.32(c), 35.2] ()Y()N Dates of events:

2. Recordable events identified by inspector

[35.32(c),35.2] ()Y()N

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N Issue Date: 12/ /96

% 1. A-4 3 B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)) ()Y()N C. Procedures any include: (not recuirements)

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were nat subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N

4. PERI 001C REVIEWS OF THE OMP A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)]

()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all. recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which' embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the-acceptance sampling tables of 10 CFR 32.110 an 100 5% Total Target Number Written Sample Reviewed D.iL.

1. Strontium-90 Eye Applicator:

If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.

$ 2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:

3. OBJECTIVES:

QRJECTIVE 1 A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is i prepared for each patient (35.32(a)(1)] ()Y()N <

B. Written directives contain required information, total dose, dose per fraction, site, & overall treatment period (35.2] ()Y()N C. Exceptions to written directives documented

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions ()Y()N l

2. Oral revisions ()Y()N

3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

1 l

Module A-5 2 l

OBJECTIVE.3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures gn.y include: (not reauirements)

1. Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible i 2

did not make the original calculations ()Y()N

2. Performing acceptance testing (based on l licensee's specific needs and applications) i on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Determining transmission factors for beam modifying devices before first use and after  !

replacement of the source ()Y()N  !

4. Output measurements for treatment parameters not addressed in the most recent full calibration ()Y()N

5. Checking dose calculations administration in l fractions (procedure should include consideration  !

of number of fractions and specified time within l which the check should be performed) ()Y()N l

6. Other, describe:

i OBJECTIVE.4 A. Procedures implemented to verify, prior to administration, that the specific details are in  :

accordance with written directive [35.32(a)(4)] ( ) Y ( ) N  ;

B. Procedures any include: (not reouirementil

1. Plan of treatment prepared in accordance with the written directive ()Y()N

2. Person administering treatment confirms the written directive and plan of treatment. At a minimum, the verification of treatment site and dose per fraction ()Y()N

3. Other, describe:

l Issue Date: 12/ /96

. - - . . .= _

= . - . .-

e Module A-5 3 B. Record of each administration or fraction maintained in auditable form ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is t den [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:

2. Recordable events identified by inspector

[35.32(c),35.2] ()Y()N

3. Nisadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include: (not recuirements)

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadininistrations that were asi subseque..cly reported (If yes, also complete module 7)

[35.33(a)) ()Y()N

4. PERIODIC REVIEWS OF THE QMP A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:  !

B. Review includes a representative sample of all patient .'

administrations includi' ng all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFP 32.110 are ned, any table is acceptable.

12/ /96

t Modui. A-5 4 C. If review identified recordable events or 4 misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on the evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days

_ [35.32(e)] ( ) Y ( ) N ( ) N/A G. Records of reviews including the evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N Remarks: .

t

5. RESULTS OF REVIEW i Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

l i

l i

1 issue Date: 12/ /96

i

. .. l MODULE A-6 GAMMA STERE 0 TACTIC RADIOSURGERY l 9

4

1. SAMPLING (Inspector random samplo of each modality) l Iotal Written Directives Minimum Taraet Samole 1 to 5 All 5 to 100 5

> 100 5% Total Target Number l Written Sample Reviewed h l

1. Gamma Stereotactic Radiosurgery If two (2) or more written directives are incomplete or missing, the  !'

review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP. j i

2. SUPERVISION  !

1

, A. Supervised individual (s) instructed in QMP applicable  !

to the modality of use [35.25(a)(1)] ()Y()N  !

List individual (s) found to be inadequately trained:  :

1

3. OBJECTIVES: 1 OBJECTIVE 1 A. A written directive (order for a specific patient, dit.ed & signed by authorized user (a.u.) i or physician under supervision of an a.u.) is

prepared for each patient (35.32(a)(1)) ()Y()N j

B. Written directives contain required information, target coordinates, collimator size, plug pattern,  ;

and total dose [35.2) ()Y()N C. Exceptions to written directives are documented l

[ footnote to 35.32(a)(1)) ( ) N/A

1. Written revisions ()Y()N

()Y()N

2. Oral revisions

3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

. -... . . - . . _ - . - _ . . - - - - - - - . . . .-- ~__ .

MODULE A-6 2  ;

4 OBJECTIVE 3

!: A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3))( ) Y ( ) N B. Procedures any include: (not reeuirements)

1. Check of dose calculations by an authorized  ;

user or a qualified person under supervision  ;

of an authorized user who whenever possible i did not make the original calculations ()Y()N

!' 2. Performing acceptance testing (based on .

licensee's specific needs and applications)  ;

, on each treatment planning or dose 1

calculating computer program that could be i j used for dose calculations ()Y()N

3. Plan of treatment prepared in accordance with the written directive ()Y()N

4. Imaging and localization precision assured. ()Y()N

a. Stereotactic frame aligned and affixed ()Y()N

b. Imaging films correctly centered & labeled ( ) Y ( ) N

5. Verify correct helmet & plug pattern selected ()Y()N

6. Verify computer. generated dose calculations were j correctly entered into unit and that the computer  :

print out shows correct data for the patient were used in the calculations ()Y()N

7. Other, describe:

'i 0BJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive (35.32(a)(4)] ( ) Y ( ) N B. Procedures gay include: fnot reautrements)

1. Check of treatment parameters by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N issue Date: 12/ /96

l MbDULEA-6 3

2. Verify stereotactic frame coordinates on the patient's skull match the plan of treatment ()Y()N

3. Person administering treatment confirms prescribed target coordinates, collimator size, plug pattern, and total dose prior to administration ()Y()N I

4. Prompt record'of treatment parameters and signing or initialing of the patient's chart or appropriate record ()Y()N

5. Other, describe:

i

8. Record of administration maintained in auditable i form (35.32(d)(2)] ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended I deviations are identified, evaluated, and l corrective action is taken-[35.32(a)(5)] ()Y()N j i

1. Recordable event (s) self-identified since the l last inspection [35.32(c), 35.2] ()Y()N  !

Dates of events:

2. Recordable events identified by inspector (35.32(c),35.2] ()Y()N

3. Misadministration resulted from the unintended de lation.(If yes, also complete module 7) ()Y()N j

~

B. Procedures implemented to evaluate & respond within 30 i days to each recordable event discovered (35.32(c)] ()Y()N i C. Procedures may include: (not reauirements)

1. Assemble relevant facts including cause ()Y()N I

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) (35.33(a)]( ) Y ( ) N

E. Licensee identified misadministrations that were agl  ;

subsequently reported (If yes, also complete module 7) 1 (35.33(a)) ()Y()N j 12/ /96-

l huudt.i A-6 4 l

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N l Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and l misadministrations [35.32(b)(1)(1)(ii)(iii)) ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of j 10 CFR 32.110 and assuming an error rate of 2%. If the tables in  !

10 CFR 32.110 are used, any table is acceptable.  !

C. If review identified recordable events or i misadministrations not previously identified, the '!

review was expanded by the licensee to ensure the  ;

events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] ()Y()N E. Based on the evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ( ) Y ( ) N ( ) N/A F. Modifications sent to NRC within 30 days

[35.32(e)) ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years (35.32(b)(3)): ()Y()N

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

Issue Date: 12/ /96