Multi-Agency Radiological Laboratory Analytical Protocols Manual

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Federal RegisterDec 27, 2004
69 Fed. Reg. 77228 (Dec. 27, 2004)

AGENCIES:

Department of Defense; Department of Energy; Department of Homeland Security; Environmental Protection Agency; Nuclear Regulatory Commission; National Institute of Standards and Technology, Commerce; United States Geological Survey, Interior; and Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The participating agencies are announcing the availability of the “Multi-Agency Radiological Laboratory Analytical Protocols” (MARLAP) Manual. The MARLAP Manual provides guidance for the planning, implementation, and assessment phases of projects that require the laboratory analysis of radionuclides. MARLAP's basic goal is to provide guidance for project planners, managers, and laboratory personnel to ensure that radioanalytical laboratory data will meet a project's or a program's data requirements. The manual offers a framework for a performance-based approach to achieving data requirements that is both scientifically rigorous and flexible enough to be applied to diverse projects and programs. This framework will promote national consistency in the generation of radioanalytical data of known quality that are appropriate for its intended use. Examples of radiological data collection activities that MARLAP supports include: site characterization, site cleanup and compliance demonstration, decommissioning of nuclear facilities, emergency response, remedial and removal actions, decontamination activities, effluent monitoring of licensed facilities, environmental site monitoring, background studies, and waste management activities. The MARLAP Manual, now finalized, is a multi-agency consensus document. The agencies previously sought public comment in order to receive feedback from the widest range of interested parties and to ensure that all information relevant to developing the document was received and addressed to the extent possible. The interagency MARLAP work group reviewed all public comments received as well as comments from a concurrent, independent technical peer review. Suggested changes were incorporated, where appropriate, in response to those comments.

ADDRESSES:

Copies of the draft and the final MARLAP Manual, along with public and technical peer review comments received, may be examined or copied for a fee at the EPA Public Reading Room, Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20004. The room is open to the public on all Federal Government work days from 8:30 a.m. to 4:30 p.m.

Printed and CD-ROM versions of MARLAP (NTIS PB2004-105421) may be purchased from the National Technical Information Service (NTIS). NTIS may be accessed online at http://www.ntis.gov. The NTIS Sales Desk can be reached between 8:30 a.m. and 6 p.m. Eastern Time, Monday through Friday, at 1-800-553-6847; TDD (hearing impaired only) at 703-487-4639 between 8:30 a.m. and 5 p.m. Eastern Time, Monday through Friday; or fax at 703-605-6900.

The manual is also available through the Internet at http://www.epa.gov/radiation/marlap or http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1576/. The NRC document number is NUREG-1576, and the EPA document number is EPA 402-B-04-001A-C (in three volumes).

FOR FURTHER INFORMATION CONTACT:

EPA: John Griggs, U.S. Environmental Protection Agency, Office of Radiation and Indoor Air, NAREL, 540 South Morris Avenue, Montgomery, AL 36115-2601, (334) 270-3450, griggs.john@epa.gov; Eric Reynolds, U.S. Environmental Protection Agency, Office of Superfund Remediation and Technology Innovation (5204G), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, (703) 603-9928, reynolds.eric@epa.gov. DoD/Air Force: Dale Thomas, Detachment 1, Human Systems Center/OEBA, 2402 E. Drive, Brooks AFB, TX 78235-5114, (210) 536-5816, dale.thomas@brooks.af.mil. DoD/Army: Ronald Swatski, U.S. Army Center for Health Promotion and Preventive Medicine, Attn: MCHB-TS-LRD, 5158 Blackhawk Road APG, MD 21010-5403, (410) 436-3983, ronald.swatski@amedd.army.mil. DoD/Navy: Commander William Adams, Navy Sea Systems Command, SEA 04N, 1333 Isaac Hull Ave., SE., Washington, DC 20376-4120, (202) 781-2414, AdamsWJ@navsea.navy.mil. Army Corps of Engineers: Jan Dunker, U.S. Army Corps of Engineers, (Attn: CENWO-HX-C), 12565 West Center Road, Omaha, NE 68144-3869, (402) 697-2566, jan.w.dunker@usace.army.mil. DHS: Carl V. Gogolak, U.S. Department of Homeland Security, Environmental Measurements Laboratory, 201 Varick Street, 5th Floor, New York, NY 10014, (212) 620-3635, cvg@eml.doe.gov. DOE: Mary Verwolf, U.S. Department of Energy, National Analytical Management Program, MS4149, 850 Energy Drive, Idaho Falls, ID 83402, (208) 526-7001, verwolmc@id.doe.gov; Emile Boulos, U.S. Department of Energy, Office of Air, Water and Radiation Policy and Guidance (EH-41), Room 3G-089, 1000 Independence Avenue, SW., Washington, DC 20585, (202) 586-1306, emile.boulos@eh.doe.gov. NRC: Rateb (Boby) Abu Eid, U.S. Nuclear Regulatory Commission, Mail Stop T-7J8, Washington, DC 20555, (301) 415-5811, bae@nrc.gov. NIST: Kenneth Inn, National Institute of Standards and Technology, Building 245, Room C114, MS 8462, Gaithersburg, MD 20899-8462, (301) 975-5541, kenneth.inn@nist.gov. USGS: Ann Mullin, U.S. Geological Survey, National Water Quality Laboratory, PO Box 25046, Denver Federal Center, Bldg. 95 Ent E3, Mail Stop 407, Denver, CO 80225-0046, (303) 236-3480, ahmullin@usgs.gov. FDA: Edmond Baratta, U.S. Food and Drug Administration, Winchester Engineering and Analytical Center, 109 Holton Street, Winchester, MA 01890, (781) 729-5700 (x728), edmond.baratta@fda.gov.

SUPPLEMENTARY INFORMATION:

The MARLAP Manual provides guidance for the planning, implementation, and assessment phases of those projects that require the laboratory analysis of radionuclides. This guidance is intended for project planners, managers, and laboratory personnel. MARLAP was developed collaboratively over the past eight years by the technical staffs of eight Federal agencies. State participation in the development of the manual involved contributions from representatives from the Commonwealth of Kentucky and the State of California. Contractors of the DOE, EPA, and NRC, and members of the public, have been present during the open meetings of the MARLAP work group and were provided opportunities for input.

MARLAP is organized into two parts. Part I, intended primarily for project planners and managers, provides the basic framework of the directed planning process as it applies to projects requiring radioanalytical data for decision making. Part II is intended primarily for laboratory personnel. Seven appendices provide complementary information and additional details on specific topics.

Because of its length, the printed version of MARLAP is bound in three volumes. Volume I (Chapters 1 through 9 and Appendices A through E) contains Part I. Part II is split between Volumes II and III. Volume II (Chapters 10 through 17 and Appendix F) covers most of the activities performed at radioanalytical laboratories, from field and sampling issues that affect laboratory measurements through waste management. Volume III (Chapters 18 through 20 and Appendix G) covers laboratory quality control, measurement uncertainty and detection and quantification capability. Each volume includes a table of contents, list of acronyms and abbreviations, and a complete glossary of terms.

The MARLAP Manual benefitted from extensive internal, public, and technical peer reviews. Before the publication of the draft version for public comment, the participating agencies conducted internal reviews. These internal review comments were addressed before public comments were requested. The public review was a necessary and important step in the development of the final multi-agency consensus document. The document also received formal technical peer review under the auspices of the EPA Science Advisory Board (SAB). SAB's comments and EPA's responses are available at http://www.epa.gov/science1/fiscal03.htm.

In addition to commenting on individual chapters and appendices, reviewers were requested to address the following questions while reviewing the MARLAP Manual:

(1) Is the performance-based approach for the planning, implementation, and assessment phases of projects technically sound, and is the approach reasonable in terms of ease of implementation by project managers and laboratories? Does the approach effectively link the three phases of a project, and is the guidance on quality control appropriate and supportive of a performance-based approach?

(2) Is the guidance on laboratory operations in Part II technically accurate and useful?

(3) Are the concepts covered under measurement statistics, specifically measurement uncertainty and detection and quantification capability, presented accurately and appropriately?

(4) Is the information understandable and presented in a logical sequence? How can the presentation of material be modified to improve the manual?

The participating agencies continue to solicit comments arising from review and use of the final MARLAP Manual. Comments will be reviewed periodically by the participating agencies, resolved as appropriate, and incorporated into future revisions of the manual. Members of the public are invited to submit written comments to: U.S. Environmental Protection Agency, EPA Docket Center (EPA/DC), Air and Radiation Docket and Information Center, Docket No. OAR-2004-0096, MC 6102T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460. Comments may be submitted electronically at http://www.epa.gov/radiation/marlap.

Compliance With the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 601 et seq.)

NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

For the Department of Defense, dated this 10th day of December, 2004.

Alex A. Beehler,

Assistant Deputy Under Secretary of Defense (Environment, Safety and Occupational Health).

For the Department of Energy, dated this 17th day of August, 2004.

Andy Lawrence, Deputy

Assistant Secretary for Environment.

For the Department of Homeland Security, dated this 11th day of August, 2004.

Bert M. Coursey,

Director, Office of Standards, DHS/S&T Directorate.

For the Environmental Protection Agency, dated this 11th day of August, 2004.

Elizabeth Cotsworth,

Director, Office of Radiation and Indoor Air.

For the National Institute of Standards and Technology, dated this 6th day of August, 2004.

Lisa R. Karam,

Chief, Ionizing Radiation Division.

For the Nuclear Regulatory Commission, dated this 6th day of August, 2004.

John T. Greeves,

Director, Division of Waste Management and Environmental Protection, Office of Nuclear Material Safety and Safeguards.

For the U.S. Geological Survey, dated this 16th day of August, 2004.

Robert M. Hirsch,

Associate Director for Water, U.S. Geological Survey.

For the Food and Drug Administration, dated this 29th day of September, 2004.

Thomas S. Savage,

Acting Director, Division of Field Science, Office of Regulatory Affairs.

[FR Doc. 04-28201 Filed 12-23-04; 8:45 am]

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