Current Federal Rulemaking

Current Federal Rulemaking Information, Etc.
[Page created 4/14/04]

CRCPD Notes of April 2004

This is a directory of Federal rulemaking, guidance development, and related announcements on radiation related subjects, with titles and web links to the agency's lists and to specific files from those lists that seemed likely to be of particular interest to CRCPD members. CRCPD Staff expect to update the information quarterly. More urgent news will be sent by e-mail.

Contributions and corrections will be appreciated; please forward these to tdevine@crcpd.org
or Ph. 502/227-4543 x 2223.

                        O Rulemaking at FDA
                        O Rulemaking at NRC
                        O Rulemaking at EPA
                        O Rulemaking at DOT
                        O Rulemaking at DOL/OSHA & MSA
                        O Rulemaking at DOE

For reference: O Federal Register (by year, day, item)
O Index to CFR

Food and Drug Administration (from their web site 4/1/04)

FDA's main menu: http://www.fda.gov/cdrh/rad-health.html

Specific entries that seemed likely to be of interest to CRCPD members are:

-> Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components. Federal Register: December 10, 2002 (Volume 67, Number 237)] [Proposed Rules] [Page 76055-76094] Proposed Rule </OHRMS/DOCKETS/98fr/02-30550.htm>

TEPRSSC meetings, complete list:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm

One item of interest to CRCPD members:
-> Meeting of the National Mammography Quality Assurance Advisory Committee
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=507

Index to 21 CFR, Food and Drugs http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321
Note part 315 Diagnostic Radiopharmaceuticals; most radiation rules are among parts 800-1299

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Nuclear Regulatory Commission (from their web site 4/1/04)

NRC's main menu http://www.nrc.gov/what-we-do/regulatory/rulemaking.html

Rulemaking Plans http://ruleforum.llnl.gov/cgi-bin/rulelist?type=plan

Advance Notice of Proposed Rulemaking http://ruleforum.llnl.gov/cgi-bin/rulelist?type=anpr

Proposed Rules http://ruleforum.llnl.gov/cgi-bin/rulelist?type=prule
Likely of interest to some CRCPD members

-> Revision of fee schedules http://ruleforum.llnl.gov/cgi-bin/rulemake?source=FEE04_PRULE&st=prule

-> Medical use of Byproduct Materials: Recognition of Specialty Boards
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=SB_PRULE&st=prule

-> Security Requirements for Portable Gauges Containing Byproduct Material (RIN 3150-AH06)
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=gauges_prule&st=prule

-> Transfers opf Certain Source Materials by Specific Licensees (RIN 3150-AO64)
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=transfers&st=prule

Draft Rule for Comment http://ruleforum.llnl.gov/cgi-bin/rulelist?type=risk

Proposed Policy Statements http://ruleforum.llnl.gov/cgi-bin/rulelist?type=policy

Direct Final Rules http://ruleforum.llnl.gov/cgi-bin/rulelist?type=directfr

Final Rules and Policy Statements http://ruleforum.llnl.gov/cgi-bin/rulelist?type=final

Of interest, Compatibility with IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments (RIN 3150-AG71) <http://ruleforum.llnl.gov/cgi-bin/rulemake?source=PART71_PRULE&st=final>

Rulemaking Petitions, Active http://ruleforum.llnl.gov/cgi-bin/rulelist?type=petitions-a

Likely of interest to some CRCPD members (titles paraphrased here):

-> re Dosimetry service
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=ICN_PRM&st=petitions-a

-> Revision of Part 36 - Panoramic Irradiators
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=IR_PETITION&st=petitions-a

-> re source material license exemption
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=RR_PETITION&st=petitions-a

-> re control of DU aircraft counterweights
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=DB_PETITION&st=petitions-a

-> Exemption of Th in a catalytic device
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=HEE_PRM&st=petitions-a

-> Safeguards for nuclear waste shipments
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=NV_PETITION&st=petitions-a

        Rulemaking Petitions, Completed http://ruleforum.llnl.gov/cgi-bin/rulelist?type=petitions-c
        Of interest to some:
        ->    To improve hydrogen control in NPR's
                 http://ruleforum.llnl.gov/cgi-bin/downloader/BC_PETITION_lib/673-0003.htm?st=petitions-c
        ->    Special requirements for Pu shipments
                http://ruleforum.llnl.gov/cgi-bin/rulemake?source=PS_PETITION&st=petitions-c

        Other Rulemaking Comment Requests http://ruleforum.llnl.gov/cgi-bin/rulelist?type=ipcr
        Likely of interest to some CRCPD members (titles are paraphrased here):
          ->   Controlling the Disposition of Solid Materials http://ruleforum.llnl.gov/cgi-bin/rulemake?source=SM_RFC&st=ipcr

-> NRC Staff Assessment of Utah's Proposed Alternative Standard to Use Utah's Existing Groundwater Regulation in Lieu of the NRC's Regulations <http://ruleforum.llnl.gov/cgi-bin/rulemake?source=UTAH_RFC&st=ipcr>

-> High-Level Guidelines for Performance-Based Activities <http://ruleforum.llnl.gov/cgi-bin/rulemake?source=PBA_RFC&st=ipcr>

-> Proposed criteria for treatment of individual requirements in a regulatory analysis
http://ruleforum.llnl.gov/cgi-bin/rulemake?source=ra_guidelines&st=ipcr

        Draft Regulatory Guides http://ruleforum.llnl.gov/cgi-bin/library?source=*&library=rg_lib&file=*&st=draftrg
        Likely of interest to CRCPD members (titles are paraphrased here):
              ->       Standard Format and Content of Part 71 Applications for Approval of Packaging for Radioactive Material

              ->      Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material
                ->      Inspection procedure for diagnostic nuclear medicine program (pdf files on the list of Guides)
                ->      Inspection procedure for diagnostic and therapeutic nuclear medicine programs
                ->      Inspection procedure for gamma stereotactic radiosurgery and teletherapy programs
                ->      Inspection procedure for brachytherapy programs
                ->      Inspection procedure for medical broad-scope programs

Final Rules and Policy Statements http://ruleforum.llnl.gov/cgi-bin/library?source=*&library=final_lib&file=*

        Regulatory Agenda: Semiannual Report, July.- Dec. 2003
        http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr0936/

        NRC Regulations (10 CFR) http://www.nrc.gov/reading-rm/doc-collections/cfr/

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Environmental Protection Agency (from their web site 4/1/04)

Laws and regulations: http://www.epa.gov/epahome/lawregs.htm

Regulations & Proposed rules: http://www.epa.gov/epahome/rules.html#proposed

Semiannual Regulatory Agenda: http://ciir.cs.umass.edu/ua/Spring2003/tables/ENVIRONMENTAL_PROTECTION_AGENCY_(EPA).html

Some specific entries likely to be of interest to CRCPD members:

-> Sequence Number 3243, SAN No. 4054, Environmental Radiation Protection Standards for the Disposal of Low-Activity Mixed Radioactive Waste. Regulation Identification Number 2060-AH63 http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2003&query=and&doc_id=3243

-> Sequence Number 3244, SAN No. 4003, Technical Change to Dose Methodology for 40 CFR Part 190, Subpart B and 40 CFR 191, Subpart A, Regulation Identification Number 2060-AH90, http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2003&query=and&doc_id=3244

-> Sequence Number 3245, SAN No. 4403, Revision of the 40 CFR Part 194 Waste Isolation Pilot Plant Compliance Criteria. Regulation Identification Number 2060-AJ07

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2003&query=and&doc_id=3245

-> Sequence Number 3326, SAN No. 4743, Land Disposal Restrictions: Determination of Equivalent Treatment for Macroencapsulation of Radioactive Lead Solids; Definition of Macroencapsulation. Regulation Identification Number 2050-AF12

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2003&query=and&doc_id=3326

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Department of Transportation (from their web site 1 April '04) http://hazmat.dot.gov/rulemake.htm

-> RSPA-99-5013 (HM-229); Hazardous Materials: Revisions to Incident Reporting Requirements and the Hazardous Materials Incident Report Form; Final rule; Published 12/3/2003; Effective Date: July 1, 2004; 68 FR 67745.

SUMMARY: RSPA is revising the incident reporting requirements of the Hazardous Materials Regulations and the hazardous materials incident report form, DOT Form F 5800.1. The major changes adopted in this final rule include: Collecting more specific information on the incident reporting form; expanding reporting exceptions; expanding reporting requirements to persons other than carriers; reporting undeclared shipments of hazardous materials; and reporting non-release incidents involving cargo tanks. These revisions will assure an increase in the usefulness of data collected for risk analysis and management by government and industry and, where possible, provide relief from regulatory requirements

-> RSPA-99-6283 (HM-230) TITLE: Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency; Notice of proposed rulemaking (NPRM); Published 4/30/2002; 67 FR 21327. http://hazmat.dot.gov/rules/99_6283_1.htm

-> 10 CFR Part 71 Compatibility With IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments; Proposed Rule [Page 21390] http://hazmat.dot.gov/rules/67fr-21390.htm

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Department of Labor (from their web site 4/1/04)

Occupational Safety and Health, Proposed rules.
http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=FEDERAL_REGISTER&p_toc_level=2&p_keyvalue=Proposed_Rules&p_text_version=FALSE

         Of interest to CRCPD members
      ->   Assigned Protection Factors
               http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=18096

Mine Safety and Health, Proposed rules
http://www.dol.gov/msha/regs/fedreg/proposed/main.htm#content

No specific text was recognized as likely of interest to CRCPD members.

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Department of Energy (from their web sites 11/18/03

DOE Directives, Regln's. & Standards;
current, archived or draft: http://www.directives.doe.gov

        DOE Directives, Regln's, Standards, Guides
        Among the Rad. related are DOE G 440.1, 441.1, 420.1, 421.1
                http://www.directives.doe.gov/cgi-bin/explcgi?EH+%3Cin%3E+org;maxdocs=300;app=onixdoe;collection=neword,newguide,newmanual,newpolicy,newnotice,old,oldordguide,oldordmanual,oldordnotice,oldordpolicy;up=current.html;interface=1window

DOE EH policy sites: http://tis.eh.doe.gov/portal/policy.html

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Index to the Code of Federal Regulations
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1

        In particular,
        ->      Index to 10 CFR. The DOE Occupational Radiation Protection is 10 CFR 835
                http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200310

FDA NRC EPA DOT DOL/OSHA & MSA DOE Federal Register Index to CFR

Index to the Federal Register (by year, day and item)
http://www.access.gpo.gov/su_docs/fedreg/frcont03.html

This material was prepared by Terry Devine, Ph.D.
Conference of Radiation Control Program Directors, Inc.
205 Capital Avenue
Frankfort, KY 40601
www.crcpd.org

Contact Terry Devine

Contact Web Manager