November 28, 2007

William A. Passetti, Chief

Bureau of Radiation Health Control

Department of Health

4052 Bald Cypress Way, Bin C21

Tallahassee, FL 32399-1741

Dear Mr. Passetti:

We have reviewed the proposed changes to the Florida regulations Control of Radiation Hazard

Regulations, Chapter 64E-5, received by our office on October 4, 2007. These regulations

were reviewed by comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in

10 CFR Parts 20, 30, 31, 32, 34, 39, 71, 150 and the requirements of the seven amendments

identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review

of the regulations with Mike Stephens on November 1, 2007.

As a result of our review, we have two comments which stand from letter dated April 23, 2007

that have been identified in the enclosure. Please note that we have limited our review to

regulations required for compatibility and/or health and safety. Under our current procedure, a

finding that the Florida regulations meet the compatibility and health and safety categories of

the equivalent NRC regulation may only be made based on a review of the final Florida

regulations. However, we have determined that if your proposed regulations were adopted,

incorporating our comments and without other significant change, they would meet the

compatibility and health and safety categories established in the Office of Federal and State

Materials and Environmental Management Programs (FSME) Procedure SA-200.

We request that when the proposed regulations are adopted and published as final regulations,

a copy of the “as published” regulations be provided to us for review. As requested in FSME

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes, and provide a copy to Division of Materials Safety and State Agreements, FSME.

The SRS Data Sheet summarizes our knowledge of the status of other Florida regulations, as

indicated. Please let us know if you note any inaccuracies, or have any comments on the

information contained in the SRS Data Sheet. This letter, including the SRS Data Sheet, is

posted on the FSME website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm. 
William A. Passetti, Chief -2- November 28, 2007

If you have any questions regarding the comments, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact Kathleen

Schneider, State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

\RA By A.D. White For\

Robert J. Lewis, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: 

As stated
William A. Passetti, Chief -2- November 28, 2007

If you have any questions regarding the comments, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact Kathleen

Schneider, State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

\RA By A.D. White For\

Robert J. Lewis, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: 

As stated

Distribution:

DIR RF (7-77) SUNSI Review Complete

DCD (SP05) : Publicly Available G Non-Publicly Available

DJanda, RSAO : Non-Sensitive G Sensitive

MOrendi, [FL] File

DOCUMENT NAME: C:\FileNet\ML073320022.wpd 

ML of Incoming Document:ML072780580

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure 

"N" = No copy

OFFICE SAISB SAIS OGC SAIS:BC MSSA:DD

NAME MOrendi KSchneider FCameron DWhite RLewis

DATE 11/02/07* 11/05/07* 11/20/07* 11/28/07* 11/28/07*

ML073320022 OFFICIAL RECORD COPY PKGML073320025
RESPONSES TO ISSUES IDENTIFIED IN THE OCTOBER 3, 2007 LETTER FROM MICHAEL

STEPHENS, FLORIDA

1) Florida’s response to Comment 11 from letter dated April 23, 2007: While this section of the

General License Rule is held in abeyance, the action limits NRC indicated missing are in 64E5.206(4)(c)(5). 

Per a discussion with Mr. Stephens it was discovered that Florida applies the

0.005uCi or more removable radioactive material limit to the entire regulation and

does not need to repeat its value as originally stated in NRC’s comment 11 from

letter dated April 23, 2007. Outcome: Comment 11 resolved 64E-5.206(4)(c)(5).

2) Florida’s response to Comment 7 from letter dated April 23, 2007: The change requested to

64E-5.319(g)(1) and (2) is correct in our current rule. Enclosed is a copy of the rule from the

Florida Administrative Code website.

After review of the submitted regulation it has been determined that the error has

been corrected. Outcome: Comment 7 resolved: 64E-5.319.

3) Florida’s response to Comment 21 from letter dated April 23, 2007: Please note that 64E5.210(4)(i)(8) is essentially identical to 10 CFR 32.52(a)(5).

After re-review of Florida’s regulations it has been determined that 64E5.210(4)(i)(8) is essentially identical to 10 CFR 32.52(a)(5). Outcome: Comment

resolved: 64E-5.210(4)(i)(8).

4) Florida’s response to Comment 3 from letter dated April 23, 2007: In Florida's letter dated

February 4, 2002 which we submitted final rules for RATS 1995-1, 1997-5, 1998-4, 1997-6, we

clearly identified a major deviance from 10 CFR Part 34 was the temporary job site definition

(RATS 1997-5). We stated, "Florida's temporary job site definition that was adopted in 1993

applies to all licensees, not just industrial radiography. This definition is "a site, base or facility

that is created and maintained to support a single job lasting for less than 2 years." Florida

regulations also require a separate license for sites that do not meet our definition of temporary

job site, 64E-5.213(6). This definition has been in place since 1993 to recover the Bureau's

program costs and it addresses health and safety issues that come with extended use of

radioactive materials of all licensees at job sites." 

NRC's April 24, 2002 reply to this rule package only identified minor changes needed to

sections 64E-5.429 (Utilization logs) and 64E-5.434 (Training). These changes became

effective September 28, 2006. Our 1993 definition addresses our belief that any licensee that is

at a single location for more than two years must obtain a separate license to adequately

address health and safety concerns. We also believe that any licensee that dispatches multiple

jobs from a single location is not a temporary job site. In order to adequately address health

and safety concerns, we require a separate license for the location from which multiple jobs are

dispatched. This requirement has been in place since 1993 for all licensees.
We do not think it is appropriate to set a different, less restrictive, standard for industrial

radiography (an Increased Control licensee) at temporary job sites, than those imposed on

lower risk licensees such as portable gauge licensees.

NRC’s definition of temporary jobsite is designated as a Compatibility Category

B. This means that Agreement States should adopt an essentially identical

definition to the definition listed in 10 CFR 34.3. 10 CFR 34.3 lists this definition

as “a location where radiographic operations are conducted and where licensed

material may be stored other than those location(s) of use authorized on the

license.” NRC’s definition does not specify a specific time limit. By adding the

requirement that a temporary jobsite is “a site, base, or facility that is created and

maintained to support a single job lasting less than 2 years” Florida makes their

definition more restrictive than NRC’s definition. In order to meet the Compatibility

Category B designation assigned to the definition of temporary jobsite Florida

would have to remove the “less than 2 years” requirement from their definition.

Outcome: Comment stands: 64E-5.101(154).
COMPATIBILITY COMMENTS ON FLORIDA PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 64E5.101(154)34.3 1997-5 B Definitions: Temporary Jobsite

Florida’s definition is more restrictive

than NRC’s definition for “temporary

jobsite.” Florida’s definition specifies

that the site supports a “single job

lasting for less than 2 years.” NRC’s

definition does not quantify a time

frame.

Florida needs to remove the

requirement for less than 2 years to

meet the Compatibility Category B

designation assigned to 10 CFR 34.3

Definition Temporary jobsite. 

Comment Stands: From letter

dated April 23, 2007.

2 64E-5.206(4)

(c)(12)

31.5(c)(13) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

64E-5.206(4)(c)(12)(a) indicates that

all devices need to be registered,

except tritium exit signs. Under

31.5(c)(13)(i), only those devices

containing certain isotopes above a

certain threshold activity level need to

be registered. By not listing the

specific isotopes and their threshold

activities Florida’s regulation is more

restrictive. 

Florida needs to add the isotopes and

their threshold activities indicated in

31.5(c)(13)(i) to meet the

Compatibility Category B designation

assigned to section 31.5(c)(13). 

As noted in the September 28, 2005

All Agreement States Letter STP-05-

072, the determination on this

provision will be held in abeyance

until such time that the NRC

completes its review and response to

the Organization of Agreement State

on compatibility changes for the GL

rule.

COMMENT STANDS: FROM

LETTER DATED April 23, 2007
STATE REGULATION STATUS

State: Florida[7 Amendments were reviewed and identified by a i Tracking Ticket Num

at the beginning of each equivalent NRC requirement.] Date: Novemb

NRC Chronology Identification FR Notice

(Date due for State)

RATS ID Proposed (P)

/ Final (F) RuleLicenseCondition (LC) ML #5

NRC  Y, N

Safety Requirements for Radiographic EquipmentPart 34 55 FR 843; (1/10/94) 1991-1 F N 1ASNT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 

Standards for Protection Against Radiation-Part 20 56 FR 23360; 56 FR 61352;

57 FR 38588; 57 FR 57877;58 FR 67657; 59 FR 41641; 60 FR 20183; (1/1/94)

1991-3 F6

ML010250079

N 2ML0

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F N 1Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F N 1

Eliminating the Recordkeeping Requirements for Departuresfrom Manufacturer's Instructions-Parts 30,35

57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination:Documentation Additions [Restricted areas and spill sites]-Parts 30, 40 

58 FR 39628; (10/25/96) 1993-1 F N 1

Licensing and Radiation Safety Requirements for IrradiatorsPart 36 58 FR 7715; (7/1/96) 1993-2 F N 1Definition of Land Disposal and Waste Site QA Program-Part61

58 FR 33886; (7/22/96) 1993-3 

Self-Guarantee as an Additional Financial Mechanism- Parts30, 40, 70 

58 FR 68726; 59 FR 1618;(none)

1994-1 

Uranium Mill Tailings Regulations: Conforming NRCRequirements to EPA Standards-Part 40

59 FR 28220; (7/1/97) 1994-2 

Timeliness in Decommissioning Material Facilities-Parts 30,40, 70 

59 FR 36026; (8/15/97) 1994-3 F N 1
NRC Chronology Identification FR Notice

(Date due for State)

RATS ID Proposed (P)

/ Final (F) RuleLicenseCondition (LC) ML #5

NRC  Y, N

Preparation, Transfer for Commercial Distribution, and Use ofByproduct Material for Medical Use-Parts 30, 32, 35

59 FR 61767; 59 FR 65243;60 FR 322; (1/1/98)

1995-1 F

ML020460297

N 4ML0

Frequency of Medical Examinations for Use of RespiratoryProtection Equipment-Part 20 

60 FR 7900; (3/13/98) 1995-2 F N 1

Low-Level Waste Shipment Manifest Information andReporting-Parts 20, 61

60 FR 15649; 60 FR 25983;(3/1/98)

1995-3 F N 1

Performance Requirements for Radiography Equipment- Part34

60 FR 28323; (6/30/98) 1995-4 F N 1

Radiation Protection Requirements: Amended Definitions andCriteria-Parts 19, 20 

60 FR 36038; (8/14/98) 1995-5 F N 1

Clarification of Decommissioning Funding Requirements-Parts30, 40, 70

60 FR 38235; (11/24/98) 1995-6 F N 1

Medical Administration of Radiation and RadioactiveMaterials-Parts 20, 35

60 FR 48623; (10/20/98) 1995-7 F

ML010250079

N 2ML0

10 CFR Part 71: Compatibility with the International AtomicEnergy Agency-Part 71

60 FR 50248; 61 FR 28724; (4/1/99)

1996-1 F

ML010250079

N 2ML0

One Time Extension of Certain Byproduct, Source andSpecial Nuclear Materials Licenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: RecordkeepingRequirements-Parts 20, 30, 40, 61, 70

61 FR 24669; (6/17/99) 1996-3 F

ML010250079

N 2ML0

Resolution of Dual Regulation of Airborne Effluents ofRadioactive Materials; Clean Air Act-Part 20

61 FR 65120; (1/9/00) 1997-1 F

ML010250079

N 2ML0

Recognition of Agreement State Licenses in Areas UnderExclusive Federal Jurisdiction Within an Agreement State-Part150

62 FR 1662; (2/27/00) 1997-2 F

ML010250079

N 2ML0

Criteria for the Release of Individuals AdministeredRadioactive Material-Parts 20, 35

62 FR 4120; (5/29/00) 1997-3 F

ML010250079

N 2ML0

Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 
NRC Chronology Identification FR Notice

(Date due for State)

RATS ID Proposed (P)

/ Final (F) RuleLicenseCondition (LC) ML #5

NRC  Y, N

iLicenses for Industrial Radiography and Radiation SafetyRequirements for Industrial Radiography Operations-Parts 30,34, 71, 150

62 FR 28947; (6/27/00) 1997-5 R8

ML072780580

Y 11ML0

Radiological Criteria for License Termination-Parts 20, 30, 40,70

62 FR 39057; (8/20/00) 1997-6 F

ML020460297 

N 4ML0

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea-Part 30 

62 FR 63634; (1/02/01) 1997-7 F

ML010250079

N 2ML0

Deliberate Misconduct by Unlicensed Persons-Parts 30, 40,61, 70, 150

63 FR 1890; 63 FR 13773;(2/12/01)

1998-1 F

ML010250079

N 2ML0

Self-Guarantee of Decommissioning Funding by Nonprofit andNon-Bond-Issuing LicenseesParts 30, 40, 70

63 FR 29535; (none) 1998-2 

License Term for Medical Use Licenses- Part 35 63 FR 31604; (none) 1998-3 Licenses for Industrial Radiography and Radiation SafetyRequirements for Industrial Radiographic Operations-Part34

63 FR 37059; (7/9/01) 1998-4 F

ML020460297

N 4ML0

Minor Corrections, Clarifying Changes, and a Minor PolicyChange-Parts 20, 35, 36

63 FR 39477; 63 FR 45393;(10/26/01)

1998-5 F

ML010250079

N 2ML0

Transfer for Disposal and Manifests: Minor TechnicalConforming Amendment-Part 20

63 FR 50127; (11/20/01) 1998-6 F

ML070510098

N 4/ML0

Radiological Criteria for License Termination of UraniumRecovery Facilities-Part 40

64 FR 17506; (6/11/02) 1999-1 

Requirements for Those Who Possess Certain IndustrialDevices Containing Byproduct Material to Provide RequestedInformation-Part 31

64 FR 42269; (none) 1999-2 

iRespiratory Protection and Controls to Restrict InternalExposure - Part 20

64 FR 54543; 64 FR 55524;(2/2/03)

1999-3 R8

ML072780580

N 11ML0

iEnergy Compensation Sources for Well Logging and OtherRegulatory Clarifications - Part 39

65 FR 20337; (5/17/03) 2000-1 R8

ML072780580

N 11ML0
NRC Chronology Identification FR Notice

(Date due for State)

RATS ID Proposed (P)

/ Final (F) RuleLicenseCondition (LC) ML #5

NRC  Y, N

 New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 F

ML070510098

N 4/ML0

iRequirements for Certain Generally Licensed IndustrialDevices Containing Byproduct Material - Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 R8

ML072780580

Y 11ML0

Revision of the Skin Dose Limit-Part 20 67 FR 16298; 4/5/05 2002-1 F

ML070510098

N 4/ML0

Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; 10/24/05 2002-2Financial Assurance for Materials Licensees – Parts 30, 40,70 

68 FR 57327 12/3/06 2003-1 F

ML070510098

N 4/ML0

iCompatibility with IAEA Transportation Safety Standardsand Other Transportation Safety Amendments - Part 71

69 FR 3697; (10/01/07) 2004-1 R8

ML072780580

N 11ML0

Security Requirements for Portable Gauges ContainingByproduct Material - Part 30

70 FR 2001; (7/11/08) 2005-1 F

ML070510098

N 4/ML0

Medical Use of Byproduct Material - Recognition of SpecialtyBoards - Part 35

70 FR 16336; 71 FR 1926 (4/29/08) 2005-2

Increased Controls for Risk-Significant Radioactive Sources(NRC Order EA-05-090)7

70 FR 72128; (12/1/05) 2005-3 LC

ML052700048

N 9/ML0

Minor Amendments - Parts 20, 30, 32, 35, 40, and 70 71 FR 15005 (3/27/09) 2006-1iNational Source Tracking System - SerializationRequirements - Part 32 with reference to Part 20 Appendix E

71 FR 65685 (2/6/07) 2006-2 P

ML072780580

N 11ML0

iNational Source Tracking System - Part 20 71 FR 65865 72 FR 59162 

(01/31/09)

2006-3 P

ML072780580

N 11ML0
NRC Chronology Identification FR Notice

(Date due for State)

RATS ID Proposed (P)

/ Final (F) RuleLicenseCondition (LC) ML #5

NRC  Y, N

1. Or other generic Legally Binding Requirements.2. (Y/N) means “Yes,” there are comments in the review letter that the state needs to address.

N means “No,” there are no comments in the review letter.

3. Not required means these regulations are not required for purposes of compatibility.4. A State need not adopt a specific regulation if the State has no licensees that would be subject to that regulation. See: “Final P

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p

1995

5. ADAMS ML number.6. Proposed modifications were made to be compatible with Part 20 as requested in NRC letter dated 11/24/97.7. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were 

legally binding requirements satisfying the requirements of NRC Order EA-05-090.

8. R stands for proposed changes made to final regulations.

Medical Use of Byproduct Material - Minor Corrections andClarifications - Parts 32 and 35

72 FR 45147, 54207 (10/29/10) 2007-1