NRC Commissioners

Briefing:

Implementation of Energy

Policy Act of 2005

Sally W. Schwarz, M.S., B.C.N.P.

Nuclear Pharmacy Representative,

Advisory Committee Medical Use of

Isotopes (ACMUI)

May 15, 2006
Acronyms Used

in Presentation

* PET: Positron Emission Tomography

* FDG: Fluorine-18 fludeoxyglucose

* NH3: N-13 ammonia

* Rb: Rubidium-82 Chloride

* IMV: Information Means Value-Research

Marketing Analysis

* FLT: Fluorine-1 8 flurothymidine

* FMISO Fluorine-1 8 fluoromisonidazole

* Cu-ATSM: Copper-64 diacetyl-bismethylthiosemicarbazone

2
Acronyms Used

in Presentation

* F-RGD: Fluorine-1 8 cyclo(-Arg-Gly-Asp-D-PheLys-(sugar amino acid)-)

* FDOPA: Fluorine-18 fluorodopa

* PIB: Carbon-11 Pittsburgh compound B

* F-Amyloid: Fluorine-18 amyloid

* ACMUI: Advisory Committee Medical Use of

Isotopes

* T&E: training and experience

* NARM: Naturally occurring or Accelerator

produced Radioactive Material 3
Acronyms Used

in Presentation

* CT/PET: Computedtomography/PET

* R&D: Research and development

* RAM: Radioactive Materials

* FDOPA: Fluorine-18 fluorodopa

* FDA: Food and Drug Administration

* IAEA: International Atomic Energy Agency

4
Importance of PET

* PET is an integral part of clinical Nuclear

Medicine--field rapidly advancing the

diagnosis and treatment of the most

prevalent diseases:

-Cancer: >90% of all studies-FDG

-Cardiovascular Disorders:

Perfusion; NH3, Rb; Viability; FDG

Brain disorders (dementia, seizures)-

FDG

5
PET Statistics

* Number of Cyclotrons USA: 2005: 177;

2006:185

* Number of PET scanners USA: 2005: 1280

* Number of PET scans performed

-2000: 211,600

2005: 1,180,625

2010 (projected): 2,086,647

Data from IMV Research

6
Current PET Advances

* Research and Development

-Cancer diagnosis: proliferation: FLT;

hypoxia: FMISO, Cu-ATSM; Monitoring anti-angiogenesis: F-RGD

Neurological Disorders, Alzheimer's

(FDOPA, PIB, F-Amyloid)

-Cardiovascular PerfusionNiability (F-1 8

flow agent)

- Monitoring Therapy

* CT/PET

7
Accelerator-produced

Radioactive Material

* ACMUI supports proposed categorization

of accelerators

* ACMUI endorses Not regulating therapy

accelerators

* ACMUI supports High compatibility across

state lines for

Mobile PET licenses

- Centralized nuclear pharmacies

Standardized T&E requirements 8
ACMUI Concerns

* Maintaining availability of PET

radiopharmaceuticals for research & clinical

practice is essential

* Noncommercial distribution of PET

radionuclides for R&D

* Impact of Decommissioning Financial

Assurance

-Creates special hardship for older facilities

Concerns regarding 16 MeV cyclotrons

9
ACMUI Concerns (continued)

Aggressive implementation schedule may

be difficult for new NARM licensees and

NRC

-mobile PET, free standing PET facilities

* License guidance needed at publication

date of the final rule, which has been

vetted

ACMUI must review prior to publication

to refine and clarify

10
ACMUI Comments

* NRC moving all RAM under single

umbrella, similar to State regulation for

~40 years

* Must allow sufficient time interval for all

states to come into compliance

* FDA has been "in process" of establishing

regulations for FDG since 1995

* Medicare: May 8, 2006 extended

coverage to cover all cancers under the

new PET registry
Ra-226 Discrete Sources

* Obsolete for medical/clinical applications

since ~1989

* No other discrete sources (similar to Ra226) expected for medical or medical

research use

* Number of Ra-226 sources remaining in

inventory is unknown

- But << IAEA Code of Conduct Category

2 sources

12
Organization of Agreement States NRC Commission

Brie in

May 15, 2006

Jared W. Thompson, Past-Chair

Organization of Agreement

States

Pearce O'Kelley, Chair

Conference of Radiation Control

Program Directors
OriNtonof A nARM Rulemaking

Compatibility designation for

definition of "byproduct material"

- States have regulated NARM for

over 40 years

- Management Directive 5.9

specifically addresses the use of

the term "radioactive material" in

lieu of "byproduct material"

2
Organization of Agreement States

NARM Rulemaking

* 33 of 34 Agreement States support a

Compatibility Category "D1

designation

* 26 of 34 Agreement States are

concerned they may have to seek

legislative changes to amend the

definition of "byproduct material"

* 34 of 34 Agreement States already regulate NARM in a manner

consistent and compatible with

other byproduct material

3
Organization of Agreement States b

NARM Rulemaking

Congress directed:

"The Commission...to the

maximum extent practicable-

(i) cooperate with the States;

and (ii) use model State

standards in existence on the

date of enactment of this Act

4
Organization of Agreement States

NARM U lemaking

* To this end, the Compatibility

Category for this and other

definitions arising from the

EPAct should be a "Ds".

5
Organization of Agreement States NARM Rulemakingi

As an alternative, the

Statements of Consideration

should acknowledge that

certification by the Governor

that the State has an adequate

NARM program which should

preclude definitional changes

6
Organization of Agreement States

Sections 656 and 652

* Support NRC staff recommendationSection 656 - Implement via Order

to high-risk and high-priority

licensees to meet deadline

Section 652 and 656 - Proceed in

parallel to address imports,

exports and domestic

transfers/access comprehensively

7
Comments on the Draft NARM

Rulemaking & Secure Transfer

Roy W. Brown

Senior Director, Federal Affairs

Council on Radionuclides and Radiopharmaceuticals

C R
Acronyms Used

in Presentation

NARM =Naturally occurring or Accelerator produced Radioactive Material

CORAR =Council on Radionuclides and

Radiopharmaceuticals

AU =-Authorized User

ANP -Authorized Nuclear Pharmacist

PET =Positron Emission Tomography

DAC =Derived Air Concentration (Part 20)

ALI =Annual Level of Intake (Part 20)

CRAR 2
General Comments

on NARM Rulemaking

Staff has completed a tremendous

amount of work in a short time frame.

Staff has been very helpful and

understanding to the medical

community's needs.

CORAR members are generally pleased with draft rulemaking.

Rulemaking needs some minor fixes

to assure smooth transition for

medical community.

CgRAR 3
Favorable Sections

of Draft Rulemaking

Delineation of three types of

cyclotrons and their handling in

rulemaking is appropriate.

Grandfathering of Part 35 AUs &

ANPs will be helpful to licensees.

NRC's waiver will allow seamless

operations until final rule is in place.

CORAR is pleased another workshop

will be held for regulated community.

CRAR 4
Concerns With

Draft Rulemaking

-Although Compatibility Level B will

provide some uniformity, CORAR

fears some inconsistency among

states will remain.

Reciprocity between states needs to

be improved.

-PET community needs specific DACs

and ALIs for 0-1 5 and N-1 3.

QRAR
Concerns With

Draft Rulemaking (Cont'd)

Low energy (1 1 eMV) PET

cyclotrons which are self-shielded

should not be required to have

financial assurance for

decommissioning.

-PET community needs cyclotron

operators and engineers recognized

as Part 30 AUs as is done in several

states, and be grandfathered.

CRAIR

6
Concerns With

Draft Rulemaking (Cont'd)

-The new fee structure in Part 170 will

negatively impact facilities located in

non-Agreement states, which will

now be under NRC's jurisdiction.

CRAR 7
Comments on Secure

Transfer Portion of EPAct

-CORAR feels radiopharmaceutical and medical radionuclide shipments do not warrant inclusion in secure

transfer rulemaking.

-Congressional intent (from '03 cmte

report) was to exclude these

materials: "The NRC should focus particular

attention on identifying radiopharmaceuticals and other

medical materials for appropriate exemption from the

new regulations, to assure the uninterrupted availability

of these materials to patients that need them"

CgRAR 8
Comments on Secure

Transfer Portion of EPAct

(ContId)

-Although CORAR has not seen the

draft rulemaking, we understand it is

NRC staff's intent to exclude these

materials from the rulemaking.

CRAR

9
Summary

Thank you for opportunity to present

our comments directly to you.

We will continue to work with NRC

staff on the NARM rulemaking.

-We hope we have the opportunity to

directly interact with the Commission

in the future.

CRAR 10
4

Briefing on Status of

Implementation of

the- Energy Policy Act

of 2005

May 15, 2006
Acronym Slide

* ACMUI - Advisory Committee on the Medical Uses of Isotopes

* CORAR - Council on Radionuclides and Radiopharmaceuticals

* CRCPD - Conference of Radiation Control Program Directors

* DHS - U.S. Department of Homeland Security

*; DOT - U.S. Department of Transportation

* EPAct - Energy Policy Act of 2005

* H&S - "Health and Safety" (adequacy designation)

* NARM - Naturally Occurring and Accelerator-produced Radioactive

Material

* NMSS - NRC's Office of Nuclear Material Safety and Safeguards

* NORM - Naturally Occurring Radioactive Material

*; OAS - Organization of Agreement States

* SECY - NRC's Office of the Secretary of the Commission

* SGI - Safeguards Information

* TSA - Transportation Security Administration

2

4
OIverall Status of

Implementation Activities

* Many implementation Actions'

Completed

* Majority of Remaining Actions on

Schedule

* Several of Remaining Actions will be

Discussed in More Detail

- Sections 651(e), 652 and 656

3
Section 651(e)

Accelerator-Produced and

Other Radioactive Material

Amend definition of byproduct material

to include:

* Accelerator-produced radioactive material

* Discrete sources of radium-226

* Discrete sources of other NORM that pose

a threat similar to discrete sources of

radium-426-

4
Section 651(e) Waivers

* EPAct allows the Commission to grant

waivers to allow current programs to

continue regulating

* NRC issued waiver on August 25, 2005

* Waiver was published in the Federal

Register on August 31, 2005

(70 FR 51581)

5
Section 651(e) - Outreach

Stakeholder Input

* To the maximum extent practicable,

NRC will:

- Consult and cooperate with States

Use model State standards

* Other stakeholders - Consultation

6
Outreach (cont'd)

Public Meeting

* Roundtable Discussion, 11/9/2005

Interagency Meeting

Discussion of definition of "discrete

sourc e, 11/1 7/2005

7
Outreach (cont'd)

State Involvement

* FL, Ml, OR, and TX on NARM

Rulemaking. Working Group

* AR (OAS) and CA'(CRCPD)

representatives on Steering Committee

* OR (CRCPD) and NC (OAS) participated

on NMSS EPAct Task Force

* CA and IL served as resource members

for NMSS EPAct Task Force

8
Outreach (cont'd)

Staff Presentations

* OAS Annual Meeting, 10/4/2005

* U.S. Food and Drug Administration Meeting, 11/17/2005

* CORAR Manufacturing, Quality, and Safety Committee Meeting, 121712005

* Interagency Steering Committee On Radiation Standards

Meeting, 1/26/2006

* High Country Nuclear Medicine Conference, 2/27/2006

* Advisory Committee on Nuclear Waste Presentation, 4/18/2006

* Advisory Committee on the Medical Uses of Isotopes Presentation, 4/2512006

* U.S. Department of Veterans Affairs Master Materials License

Meeting, 5/3/2006

* CRCPD Annual Conference, 5/9/2006

9
Section 651(e) - Status

* Proposed Rule developed

(SECY-06-0069)

* Draft Proposed Rule and SECY Paper

publicly available on NRC's RuleForumwebsite (as of -4/7/2006)

* Final Rule due no later than 2/7/2007

(required by EPAct)

10
Section 651(e)- Rulemaking

Key Issues

Defin ition of, "d iscrete source

* Exercise: of. authority over acceleratorproduced radioactive material in

accelerators

* Regulatory approach for certain

discrete sources of radium-226

* Waiver termination strategy

11
Section 651(e) - Compatibility

* Staff applied the process described in

Management Directive 5.9

* Staff recommends a designation of "H&S" for

the definition of byproduct material

* Program elements with a designation of

"H&S" are required to be addressed as part

of an Agreement program, as a matter of

adequacy, and therefore are reviewed by

NRC staff

12
Compatibility cont'd)

State members of'the 'Steering Committee,

and the Agreement States in general, did

not agree with the "H&S" designation

* OAS and CRCPD letters on this issue are

attached to-the Commission Paper

* Program elements with Compatibility "D"

are not a required part of an Agreement

program, and therefore are not reviewed

by NRC staff

13
Compatibility cont'd)

"If the definition of the term byproduct

material or another term (such as radioactive

material) which encompasses all of the

byproduct materials regulated by the State

were not somewhere within the State

program (i.e., in statute or in regulations) it is

possible that some byproduct material could

escape regulatory oversight with a result of

exposure to an individual in excess of the

Part 20 limits"

14
Section 651(e)-

Summary and Next Steps

* Staff developed a draft proposed rule,

in a very short time period, that

addresses a number of EPAct issues

The proped rulemaking under

Section 651(e) is a key expansion of

NRC's authority

15
Summary and Next Steps

(cont'd)

* Once the proposed rule is published,

staff will continue to reach out to

Agreement States, non-Agreement States, the public, and affected industry

stakeholders

* The staff will hold a public meeting

during the public comment period

* Achieving the 2/7/2007 Final Rule date

remains a challenge

16
Section 656 - Secure Transfer

of Nuclear Materials

For materials transferred or received in the U.S. by

any party pursuant to an NRC import or export

license, the Commission shall establish a system

such that:-

a. Materials are accompanied by a manifest

describing type and amount of materials

b. Each individual receiving or accompanying the

transfer shall be subject to a security background check conducted by appropriate

Federal entities

17
Secure Transfer of Nuclear

Materials (cont'd)

Issue regulations not -later than 1 year

after date of EPAct, identifying materials

and classes of individuals that are

appropriate exceptions

18
Section 656 - Status

* Staff is drafting a proposed rule

* Staff is coordinating with Agreement States, DOT, DHSITSA, and US Coast Guard

* Draft Proposed Rule is due to the

Commission on 6/1/06

Manifest requirements are already- covered

by existing DOT and NRC regulations

* System for- security background checks has

proven to be' challenging in advance of the

broader Section 652 rulemaking

19
l

Section 656-

Recent Developments

Agreement States and DOT have raised

concerns about the proposed rule.

Some States-want the requirements to

apply to importers and exporters only (exclusive NRC jurisdiction)

* Establishing exceptions now may set a

precedent for the broader Sec 652 rule

on fingerprinting and criminal history records check

20
Recent Developments (cont'd)

* In, response, staffWis considering an

approach that initially focuses- on the

mo'stsignificant quantities of material

This approach would allowNRC to

address fingerprinting through Orders

until the broader Section 652 rulemaking could be completed -

* Staff would clarify these issues in the

Statement of Considerations on the

Section 656 rule

21
Section 656 - Next Steps

* Complete Draft Proposed Rule and send to

Commission

* Inform Congress, about timing of Final Rule

* Continue- outreach with Agreement States, DOT, DHS/TSAA, and US Coast Guard

* Revise/supplement Orders to require fingerprinting and criminal history records

check, where appropriate

* Address broader fingerprinting and criminal

history records check issues through the

Section 652 rulemaking

22
Section 652 - Fingerprinting for

Criminal History Records Check

The Commission shall require to be

fingerprinted any individual who:

* is permitted unescorted access to-- - a utilization facility; or

- radioactive, material or other property

subject to regulation by the Commission

that the Commission determines to be of

such significance; or

* is permitted access to safeguards information under section 147

23
Fingerprinting for Criminal

History Records Check

(cont'd)

All fingerprints shall be submitted to the

U.S. Attorney General for identification

and a criminal history records check

24
Section 652 - Status

* The statute requirements for

fingerprinting for access to SGI are

effective now, and-staff is developing

Orders

* Staff is proceeding to develop Orders

to require fingerprinting for access to

radioactive material

25
Section 652 - Schedule

* Section 652: requirements are being

incorporated through:

- Current 73.21 rule package for

access to safeguards information

- Future 'rule to address access to

material

26
Schedule (cont'd)

Schedule for Section 652 Orders and

rulemakings to address fingerprinting and criminal history records check:

- Order supplements/revisions:

Under development

i Final 73.21 rule to Commission:

Approximately 10/06

- Final Section 652 rule to

Commission: 09/08

27
EPAcI of 2005 - Summary

* Beginning in August 2005, NRC

immediately began activities to

implement the Energy Polity Act of

2005

NRC has made significant progress

over the past eight months and

continues to move rapidly

28
EPAct of 2005 - Summary

(cont'd)

* NRC reached out to stakeholders within

the short time frames given in the

statute, and involved States in the

"NARM rulemaking" in an

unprecedented manner

* While NRC has clear accomplishments,

the Energy Policy Act requirements still

present challenges for the staff

29
Background Material
Energy Policy Act of 2005 Implementation Activities

EPcN Ttl cin. Schede.

Sec. * Milest.ne,

601-609 Price-Anderson Act Renewal Issue Final Rule amending regulations to Implement revised P-A Act Complete

622 NRC Scholarship and Fellowship Provide Commission with draft program description On Track

Program _ ._ _

623 Cost Recovery from Government - Issue proposed FY06 Fee Rule Complete

Agencies - - - Issue Final Rule On Track

624 Elimination'of Pension Offset for - Issue draft MD Co' plete - Certain Rehired Federal Retirees Issue Final MD -On Track

625 Antitrust Review Issue Final Rule amending regulations to reflect elimination of antitrust reviews Complete

629 Whistleblower Protection - Complete Review of Management Directives On Track - Incorporate contract clauses Ongoing

630 Medical Isotope Production Issue Final Rule amending Part 110 to reflect revised export licensing criteria Complete

632 Prohibition on Nuclear Exports to Issue Final Rule amending Part 110 to prohibit export licenses to countries TBD

Countries that Sponsor Terrorism identified as engaged in State-Sponsored terrorism

637 NRC User Fees and Annual - Issue proposed fee rule for FY07 On Track

Charges - Issue Final Rule On Track

638 Standby Support for Certain Provide first quarterly report to Commission on status of licensing actions TBD

Nuclear Plant Delays associated with facilities covered by DOE program

639 Conflicts of Interest Relating to - Submit proposed conflict of interest policy for Commission approval Complete

Contracts and Other, - Incorporate conflict of interest policy into MD 11.7 On Track

Arrangements

644 Next Generation Nuclear Plant Joint NRC/DOE report to Congress on a licensing strategy for a prototype On Track

Project (NGNPP) reactor.
Energy Policy Act of 2005 Implementation Activities

ffPA .. Ti * ,e Acto Sch'd;l

645 Project Timelines and - Transfer of funds from DOE to NRC TBD

Authorization of Appropriations for - Issuance of license On Track

NGNPP

651 (a)(1) Security Evaluations - Provide proposed rule to Commission amending Part 73 On Track - Provide to Commission Congressional Annual Report on security force On Track

evaluation results On Track - Provide to Commission Final Rule amending Part 73

651 (a)(1) Design Basis Threat Rulemaking - Issue proposed rule amending DBT - Complete - Provide to Commission Final Rule On Track

651 (a)(3) Federal Security Coordinators Assign Federal Security Coordinator to each Region Complete

651(b) Backup Power for. Certain Issue Confirmatory Order to Indian Point to provide backup power for Complete

Emergency Notification Systems Emergency Notification System

651(c)(1) Provision of Support to University -Issue draft program description On Track

Nuclear Safety, Security, and - Issue Management Directive On Track

Environmental Programs

651 (c)(3) Expenses Authorized to be Paid - Issue draft program description Complete

by the Commission - Amend Memorandum of Understanding with State Department Compete

651 (c)(4) Partnership Program with - Develop policy and procedures On Track

Institutions of Higher Education - Award initial grants to qualified institutions On Track

651(d)(1) Radiation Source Protection, Issue Final Rule to amend Part 110 Complete Import/Export Controls

651 (d)(1) Radiation Source Protection, - Provide Final Rule to Commission for National Source Tracking System Complete

Tracking System - Provide to Commission information paper on Category 3 sources Complete

651 (d)(1) Radiation Source Protection, -Award grant to NAS Complete

National Academy of Sciences - Provide report to Congress on NAS study results On Track

Study . ._.
Energy Policy Act of 2005 Implementation Activities

SEcd. M letone

651 (d)(1) Radiation Source Protection, Task - Finalize Task Force Charter Complete

Force on Radiation Source - Provide first Task Force Report to Congress On Track

Protection and Security

651(e) Treatment of Accelerator- - Provide proposed rule to Commission Complete

(1) (4) Produced and Other Radioactive - Issue Final Rule On Track

Material as Byproduct Material - Issue transition plan for States concerning regulation of NARM and NORM On Track

652 Fingerprinting and Criminal History - Provide proposed rule to Commission amending 73.21 Copplete

Record Checks - Provide proposed rule to Commission amending 73.55 On Track

- Provide proposed rule to Commission for other entitiesAndividuals On Track

653 Use of Firearms by Security - Provide proposed rule to Commission amending On Track

Personnel - Provide Final Rule to Commission On Track

654 Unauthorized Introduction of - Issue proposed rule On Track

Dangerous Weapons - Issue Final Rule On Track

655 Sabotage of Nuclear Facilities, - Issue proposed rule On Track

Fuel, or Designated Material - Issue Final Rule On Track

656 Secure Transfer of Nuclear - Provide proposed rule to Commission Pending

Materials - Issue Final Rule Pending

657 Department of Homeland Security Develop protocol with DHS on security consultation process and provide to On Track

Consultation Commission

953 Advanced Fuel Cycle Initiative Provide to Commission information on policy and resource implications Complete