[Federal Register Volume 62, Number 11 (Thursday, January 16, 1997)]
[Notices]
[Pages 2395-2399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-716]


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NUCLEAR REGULATORY COMMISSION


Commonwealth of Massachusetts: Staff Assessment of Proposed 
Agreement Between the Nuclear Regulatory Commission and the 
Commonwealth of Massachusetts

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of proposed Agreement with the Commonwealth of 
Massachusetts.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received, 
from the Governor of the Commonwealth of Massachusetts, a proposal to 
enter into an Agreement pursuant to Section 274 of the Atomic Energy 
Act of 1954, as amended (Act). The proposed Agreement would permit 
Massachusetts to assume certain portions of the Commission's regulatory 
authority. As required by the Act, NRC is publishing the proposed 
Agreement for public comment. NRC is also publishing a summary of the 
NRC staff assessment of the proposed Massachusetts radiation control 
program. Comments are requested on the proposed Agreement, especially 
public health and safety aspects, and the assessment.
    The Agreement will effectively release (exempt) persons in 
Massachusetts from certain portions of the Commission's regulatory 
authority. The Act also requires that NRC publish those exemptions. 
Notice is hereby given that the pertinent exemptions have been 
previously published in the Federal Register and are codified in the 
Commission's regulations as 10 CFR Part 150.

DATES: The comment period expires January 23, 1997.

    Comments received after this date will be considered if it is 
practical to do so, but the Commission is able to assure consideration 
only for comments received on or before this date.

ADDRESSES: Written comments may be submitted to Mr. David L. Meyer, 
Chief, Rules Review and Directives Branch, Division of Freedom of 
Information and Publications Services, Office of Administration, 
Washington, DC 20555-0001. Copies of comments received by NRC may be 
examined at the NRC Public Document Room, 2120 L Street, NW. (Lower 
Level), Washington, DC. Copies of the proposed Agreement, along with 
copies of the request by Governor Weld including referenced enclosures, 
applicable legislation, regulations for the control of radiation, and 
the full text of the NRC staff assessment are also available for public

[[Page 2396]]

inspection in the NRC's Public Document Room.

FOR FURTHER INFORMATION CONTACT: Richard L. Blanton, Office of State 
Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001. Telephone (301) 415-2322 or e-mail <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="8edcc2cccec0dccda0c9c1d8a0">[email protected]</a>

SUPPLEMENTARY INFORMATION: The Commission has received a request from 
Governor William Weld of Massachusetts to enter into an Agreement 
whereby the NRC would discontinue, and the Commonwealth would assume, 
certain regulatory authority as specified in the Act. Section 274 of 
the Act authorizes the Commission to enter into such an agreement.
    Section 274e of the Act requires that the terms of the proposed 
Agreement be published for public comment once each week for four 
consecutive weeks. This notice is being published in the Federal 
Register in fulfillment of the requirement.

I. Background

    (a) Section 274d of the Act provides the mechanism whereby a State 
may assume regulatory authority, otherwise reserved to the NRC, over 
certain radioactive materials <SUP>1 and uses thereof. In a letter 
dated March 28, 1996, Governor Weld certified that the Commonwealth of 
Massachusetts has a program for the control of radiation hazards that 
is adequate to protect health and safety of the public within the 
Commonwealth with respect to the materials covered by the proposed 
Agreement, and that the Commonwealth desires to assume regulatory 
responsibility for these materials. Included with the letter was the 
text of the proposed Agreement, which is shown in Appendix A to this 
notice.
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    \1\ The materials, sometimes referred to as ``agreement 
materials,'' are: (a) Byproduct materials as defined in Section 
11e.(1) of the Act; (b) Byproduct materials as defined in Section 
11e.(2) of the Act; (c) Source materials as defined in Section 11z. 
of the Act; and (d) Special nuclear materials as defined in Section 
11aa. of the Act, restricted to quantities not sufficient to form a 
critical mass.
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    The specific authorities requested by the Commonwealth of 
Massachusetts under this proposed Agreement are (1) the regulation of 
byproduct materials as defined in Section 11e.(1) of the Act, (2) the 
regulation of source materials, (3) the regulation of special nuclear 
materials in quantities not sufficient to form a critical mass, (4) the 
evaluation of the safety of sealed sources and devices (containing 
materials covered by the Agreement) for distribution in interstate 
commerce, and (5) the land disposal of low-level radioactive waste (as 
defined in the Low-Level Radioactive Waste Policy Amendments Act of 
1985, 42 U.S.C. 2021b) received from other persons. The Commonwealth 
does not wish to assume authority over the regulation of byproduct 
materials as defined in Section 11e.(2) of the Act, that is over 
tailings from the recovery of source materials from ore, but does 
reserve the right to apply at a future date for an amended agreement to 
assume authority in this area.
    (b) The proposed agreement contains nine articles that (1) list the 
materials and activities to be covered by the Agreement; (2) specify 
the activity for which the Commission will retain regulatory authority; 
(3) allow for future amendment of the Agreement; (4) allow for certain 
regulatory changes by the Commission; (5) reference the continued 
authority of the Commission for purposes of safeguarding nuclear 
materials and restricted data; (6) commit the Commonwealth and NRC to 
exchange information necessary to maintain coordinated and compatible 
programs; (7) recognize reciprocity of licenses issued by the 
respective agencies; (8) identify criteria for the suspension or 
termination of the Agreement; and (9) specify the proposed effective 
date. The Commission reserves the option to modify the terms of the 
proposed Agreement in response to comments, to correct errors, and to 
make editorial changes in style. Also, because of several issues posed 
by this request which required resolution before the Agreement could be 
concluded, the effective date requested by the Governor could not be 
realized. The final text of the Agreement, with the actual effective 
date, will be published after the Agreement is approved by the 
Commission.
    (c) The Massachusetts radiation control program currently regulates 
users of naturally-occurring and accelerator-produced radioactive 
materials, and users of certain radiation-producing electronic 
machines. The program was enabled by Massachusetts law (Massachusetts 
General Law [M.G.L.] Chapter 111, Sec. 5B) in 1958. This statute was 
later replaced by M.G.L. Chapter 111, Sections 5M through 5P. In 1987, 
M.G.L. Chapter 111H was added to provide for the regulation of low-
level radioactive waste. Section 7 of the legislation contains the 
authority for the Governor to enter into an Agreement with the 
Commission.
    The Massachusetts regulations contain provisions for the orderly 
transfer of authority over NRC licenses to the regulatory control of 
the Commonwealth. After the effective date of this proposed Agreement, 
licenses issued by NRC will continue in effect under Massachusetts 
regulatory authority until these licenses expire or are replaced by 
Commonwealth issued licenses.
    (d) The NRC staff assessment finds the proposed Massachusetts 
program adequate to protect public health and safety, and compatible 
with the NRC program for materials regulation.

II. Summary of the NRC Staff Assessment of the Massachusetts 
Program for the Control of Agreement Materials

    NRC staff has examined the proposed Massachusetts radiation control 
program with respect to the ability of the program to regulate 
agreement materials. The examination was based on the Commission's 
policy statement ``Criteria for Guidance of States and NRC in 
Discontinuance of NRC Regulatory Authority and Assumption Thereof by 
States Through Agreement'' (referred to herein as the ``criteria'') (46 
FR 7540; January 23, 1981, as amended).
    (a) Organization and personnel. The proposed program unit 
responsible for regulating agreement materials will consist of 13 
technical/professional positions within the existing radiation control 
program of the Massachusetts Department of Public Health. The 
qualifications for staff members specified in the personnel position 
descriptions, and the qualifications of the current staff members, meet 
the criteria for education, training and experience. All current staff 
members hold at least bachelor's degrees in physical or life sciences, 
or have a combination of education and experience at least equivalent 
to a bachelor's degree. Most staff members hold advanced degrees, and 
have had additional training and experience in radiation protection. 
Senior staff have more than five years experience each in radiation 
control programs. The program director has a master's degree in public 
health and 15 years experience in regulatory health physics.
    (b) Legislation and regulations. The Massachusetts Department of 
Public Health is designated by statute to be the radiation control 
agency. The Department is provided by statute with the authority to 
promulgate regulations, issue licenses, issue orders, conduct 
inspections, and to enforce compliance with regulations, license 
conditions, and orders. Licensees are required by law to provide access 
to inspectors.
    The Department has adopted regulations (Massachusetts Regulations 
for the Control of Radiation or MRCR) providing radiation protection 
standards essentially identical to the standards in

[[Page 2397]]

10 CFR Part 20. Technical definitions in the MRCR are also essentially 
identical. The MRCR require consideration of the total radiation doses 
to individuals from all sources of radiation (except background 
radiation and radiation from medical treatment or examinations, as is 
the case in the NRC rules), whether the sources are in the possession 
of the licensee or not. The MRCR also require appropriate surveys and 
personnel monitoring under the close supervision of technically 
competent people, and the use of radiation labels, signs and symbols 
essentially identical to those contained in 10 CFR Part 20. Posting 
requirements and instruction of workers requirements adopted in the 
MRCR are compatible with the equivalent current requirements of the 
NRC.
    Nothing in the Massachusetts statutes or regulations seeks to 
regulate areas not permitted by the Atomic Energy Act. The MRCR contain 
a provision to avoid interference with those regulatory requirements 
imposed by NRC pursuant to the Act, and for which Commonwealth 
licensees have not been exempted under the agreement.
    (c) Storage and disposal. The MRCR also contain compatible 
requirements for the storage of radioactive material, and for the 
disposal of radioactive material as waste. The waste disposal 
requirements cover both waste disposal by material users and the land 
disposal of waste received from other persons. The NRC staff noted some 
differences in the MRCR waste regulations as compared to the NRC 
regulations in 10 CFR Part 61, but determined that the differences are 
related either to the prohibition of shallow land burial as a disposal 
technology or to the ownership of the disposal site by the 
Massachusetts Low-Level Radioactive Waste Management Board. Because of 
these special provisions, NRC staff determined that the differences in 
the regulations do not reduce the ability of the Massachusetts 
radiation control program to protect health and safety, nor reduce the 
compatibility of the program or the regulations themselves.
    (d) Transportation of radioactive material. The MRCR contains rules 
equivalent to 10 CFR Part 71 as in effect prior to April 1, 1996. 
Effective on that date, the NRC amended Part 71. Under current policy, 
an existing Agreement State is allowed up to three years after NRC 
adopts a final rule to adopt a compatible rule, or to impose each 
regulatory provision of the rule using an alternate legally binding 
requirement (LBR), such as an order or license condition. A State 
seeking an agreement is expected to have effective rules or LBRs 
compatible with those of NRC in effect at the time the agreement 
becomes effective. The intent of this expectation is to spare licensees 
in the new Agreement State from the ``whipsaw'' effect of being 
subjected first to the new NRC requirements, then the old requirements 
when the agreement takes effect, then again to the new requirements 
when later adopted by the State. Massachusetts is in the process of 
adopting rules compatible with the revised 10 CFR Part 71. However, 
these rules may not become effective before the Agreement is signed. 
Massachusetts intends to impose the requirements of the new Part 71 
rules in the interim by issuing appropriate orders to the affected 
licensees.
    (e) Recordkeeping and incident reporting. The MRCR incident 
reporting requirements are similar to the requirements in the NRC 
rules. The NRC staff noted that for some NRC rules that specify a 
records retention period of less than five years, the retention period 
specified in the MRCR is shorter. The NRC staff concluded, however, 
that the retention periods specified in the MRCR rules are adequate 
since the retention periods are long enough to permit examination of 
the records during routine inspections. The MRCR imposes retention 
requirements similar to the NRC rules for records which must be 
retained indefinitely or until the license is terminated.
    (f) Evaluation of license applications. The MRCR contains 
requirements equivalent to the current NRC regulations specifying the 
required content of applications for licenses, renewals, and 
amendments. The MRCR also provide requirements equivalent to the NRC 
requirements for issuing licenses and specifying the terms and 
conditions of licenses. The agreement materials program unit has 
adopted a procedure for processing applications that assures the 
regulatory requirements will be met, or, if appropriate, exceptions 
granted. The program unit has the authority by Statute to impose 
requirements in addition to the requirements specified in the 
regulations. The program unit also retains by regulation the authority 
to grant specific exemptions from the requirements of the regulations. 
The MRCR specifies qualifications for the use of radioactive materials 
in or on humans that are similar to the NRC requirements in 10 CFR Part 
35.
    The Massachusetts licensing procedures manual, along with the 
accompanying regulatory guides, are adapted from similar NRC documents 
and contain adequate guidance for the agreement materials program unit 
staff to use when evaluating license applications.
    (g) Inspections and enforcement. The Massachusetts radiation 
control program has adopted a schedule providing for the inspection of 
licensees as frequently as, or more frequently than, the inspection 
schedule used by NRC. The agreement materials program unit has adopted 
procedures for the conduct of inspections, the reporting of inspection 
findings, and the report of inspection results to the licensees. The 
program has also adopted procedures for enforcement in the MRCR.
    (h) Regulatory administration. The Massachusetts Department of 
Public Health is bound by procedures specified in Commonwealth statute 
for rulemaking. The program has adopted procedures to assure fair and 
impartial treatment of license applicants.
    (i) Cooperation with other agencies. The MRCR deems the holder of 
an NRC license on the effective date of the Agreement to possess a like 
license issued by Massachusetts. The MRCR provides that these former 
NRC licenses will expire either 90 days after receipt from the 
radiation control program of a notice of expiration of such license or 
on the date of expiration specified in the NRC license, whichever is 
earlier. The MRCR also provides for ``timely renewal.'' This provision 
affords the continuance of licenses for which an application for 
renewal has been filed more than 30 days prior to the date of 
expiration of the license. Licenses in timely renewal are not excluded 
from the transfer continuation provision. The MRCR provide exemptions 
from the Commonwealth's requirements for licensing of sources of 
radiation for NRC and U.S. Department of Energy contractors or 
subcontractors.
    The Department of Public Health and the Department of Labor and 
Industries have entered into a Memorandum of Understanding, as 
authorized elsewhere in Massachusetts law, which provides for the 
Department of Public Health to exercise the responsibility and 
authority of the Department of Labor and Industries with respect to 
radiation and radioactive materials. The Department of Environmental 
Protection is designated as the agency to adopt the suitability 
standards for any proposed disposal site under the Massachusetts Low-
Level Radioactive Waste Management Act. The Department of Public Health 
will license and regulate the site only after the Executive Secretary 
for Environmental Affairs has determined that the report on the site 
characterization study is in conformance with the suitability 
standards, and the Low-Level

[[Page 2398]]

Radioactive Waste Management Board has selected the operator.
    The proposed Agreement commits the Commonwealth to use its best 
efforts to cooperate with the NRC and the other Agreement States in the 
formulation of standards and regulatory programs for the protection 
against hazards of radiation and to assure that the Commonwealth's 
program will continue to be compatible with the Commission's program 
for the regulation of like materials. The proposed Agreement stipulates 
the desirability of reciprocal recognition of licenses, and commits the 
Commission and the Commonwealth to use their best efforts to accord 
such reciprocity.

III. Staff Conclusion

    Subsection 274d of the Act provides that the Commission shall enter 
into an agreement under subsection 274b with any State if:
    (a) The Governor of the State certifies that the State has a 
program for the control of radiation hazards adequate to protect public 
health and safety with respect to the materials within the State 
covered by the proposed Agreement, and that the State desires to assume 
regulatory responsibility for such materials; and
    (b) The Commission finds that the State program is in accordance 
with the requirements of Subsection 274o, and in all other respects 
compatible with the Commission's program for the regulation of such 
materials, and that the State program is adequate to protect public 
health and safety with respect to the materials covered by the proposed 
Agreement.
    On the basis of its assessment, the NRC staff has concluded that 
the Commonwealth of Massachusetts meets the requirements of Section 274 
of the Act. The Commonwealth's statutes, regulations, personnel, 
licensing, inspection, and administrative procedures are compatible 
with those of the Commission and adequate to protect public health and 
safety with respect to the materials covered by the proposed Agreement. 
Since the Commonwealth is not seeking authority over byproduct material 
as defined in Section 11e.(2) of the Act, Subsection 274o is not 
applicable to the proposed Agreement. The language of the Agreement 
requested by Governor Weld has been revised to reflect that the 
effective date of the proposed Agreement and the location at which it 
will be signed remain to be determined. Certain conventions have been 
used to highlight the proposed revisions. New language is shown inside 
boldfaced arrows, while language that would be deleted is set off with 
brackets.

IV. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget (OMB).

    Dated at Rockville, Maryland, this 19th day of December 1996.

    For the U. S. Nuclear Regulatory Commission.
Paul H. Lohaus,
Acting Director, Office of State Programs.

Appendix A--Proposed Agreement

Agreement Between the United States Nuclear Regulatory Commission 
and the Commonwealth of Massachusetts for the Discontinuance of 
Certain Commission Regulatory Authority and Responsibility Within 
the Commonwealth Pursuant to Section 274 of the Atomic Energy Act 
of 1954, as Amended

    Whereas, The United States Nuclear Regulatory Commission 
(hereinafter referred to as the Commission) is authorized under Section 
274 of the Atomic Energy Act of 1954, as amended (hereinafter referred 
to as the Act), to enter into agreements with the Governor of any State 
providing for discontinuance of the regulatory authority of the 
Commission within the State under Chapters 6, 7, and 8, and Section 161 
of the Act with respect to by-product materials as defined in Sections 
11e.(1) and (2) of the Act, source materials, and special nuclear 
materials in quantities not sufficient to form a critical mass; and,
    Whereas, The Governor of the Commonwealth of Massachusetts is 
authorized under Massachusetts General Laws, Chapter 111H, to enter 
into this Agreement with the Commission; and,
    Whereas, The Governor of the Commonwealth of Massachusetts 
certified on [June 1, 1995,] >March 28, 1996,< that the Commonwealth of 
Massachusetts (hereinafter referred to as the Commonwealth) has a 
program for the control of radiation hazards adequate to protect [the] 
public health and safety with respect to the materials within the 
Commonwealth covered by this Agreement, and that the Commonwealth 
desires to assume regulatory responsibility for such materials; and,
    Whereas, The Commission found on [November 1, 1995,] >(date to be 
determined)< that the program of the Commonwealth for the regulation of 
the materials covered by this Agreement is compatible with the 
Commission's program for the regulation of such materials and is 
adequate to protect public health and safety; and,
    Whereas, The Commonwealth and the Commission recognize the 
desirability and importance of cooperation[s] between the Commission 
and the Commonwealth in the formulation of standards for protection 
against hazards of radiation and in assuring that Commonwealth and 
Commission programs for protection against hazards of radiation will be 
coordinated and compatible; and,
    Whereas, The Commission and the Commonwealth recognize the 
desirability of reciprocal recognition of licenses and exemptions from 
licensing of those materials subject to this Agreement; and,
    Whereas, This Agreement is entered into pursuant to the provisions 
of the Atomic Energy Act of 1954, as amended;
    Now, Therefore, It is hereby agreed between the Commission and the 
Governor of the Commonwealth, acting in behalf of the Commonwealth, as 
follows:

Article I

    Subject to the exceptions provided in Articles II, IV, and V, the 
Commission shall discontinue, as of the effective date of this 
Agreement, the regulatory authority of the Commission in the 
Commonwealth under Chapters 6, 7, and 8, and Section 161 of the Act 
with respect to the following materials:
    A. By-product materials as defined in Section 11e.(1) of the Act;
    B. Source materials;
    C. Special nuclear materials in quantities not sufficient to form a 
critical mass; and,
    D. Licensing of Low-Level Radioactive Waste Facilities.

Article II

    This Agreement does not provide for discontinuance of any authority 
and the Commission shall retain authority and responsibility with 
respect to regulation of:
    A. The construction and operation of any production or utilization 
facility;
    B. The export from or import into the United States of by-product, 
source, or special nuclear material, or of any production or 
utilization facility;
    C. The disposal into the ocean or sea of by-product, source, or 
special nuclear waste materials as defined in regulations or orders of 
the Commission;

[[Page 2399]]

    D. The disposal of such other by-product, source, or special 
nuclear material as the Commission from time to time determines by 
regulation or order should, because of the hazards or potential hazards 
thereof, not be so disposed of without a license from the Commission; 
and,
    E. The extraction or concentration of source material from source 
material ore and the management and disposal of the resulting by-
product material.

Article III

    This Agreement may be amended, upon application by the Commonwealth 
and approval by the Commission, to include the additional area(s) 
specified in Article II, paragraph E, whereby the Commonwealth can 
exert regulatory control over the materials stated therein.

Article IV

    Notwithstanding this Agreement, the Commission may from time to 
time by rule, regulation, or order, require that the manufacturer, 
processor, or producer of any equipment, device, commodity, or other 
product containing source, by-product, or special nuclear material 
shall not transfer possession or control of such product except 
pursuant to a license or an exemption from licensing issued by the 
Commission.

Article V

    This Agreement shall not affect the authority of the Commission 
under Subsection 161b or 161i of the Act to issue rules, regulations, 
or orders to protect the common defense and security, to protect 
restricted data or to guard against the loss or diversion of special 
nuclear material.

Article VI

    The Commission will use its best efforts to cooperate with the 
Commonwealth and other Agreement States in the formulation of standards 
and regulatory programs of the Commonwealth and the Commission for 
protection against hazards of radiation and to assure that Commonwealth 
and Commission programs for protection against hazards of radiation 
will be coordinated and compatible. The Commonwealth will use its best 
efforts to cooperate with the Commission and other Agreement States in 
the formulation of standards and regulatory programs of the 
Commonwealth and the Commission for protection against hazards of 
radiation and to assure that the Commonwealth's program will continue 
to be compatible with the program of the Commission for the regulation 
of like materials. The Commonwealth and the Commission will use their 
best efforts to keep each other informed of proposed changes in their 
respective rules and regulations and licensing, inspection and 
enforcement policies and criteria, and to obtain the comments and 
assistance of the other party thereon.

Article VII

    The Commission and the Commonwealth agree that it is desirable to 
provide reciprocal recognition of licenses for the materials listed in 
Article I licensed by the other party or by any other Agreement State. 
Accordingly, the Commission and the State agree to use their best 
efforts to develop appropriate rules, regulations, and procedures by 
which such reciprocity will be accorded.

Article VIII

    The Commission, upon its own initiative after reasonable notice and 
opportunity for hearing to the Commonwealth, or upon request of the 
Governor of the Commonwealth, may terminate or suspend all or part of 
this Agreement and reassert the licensing and regulatory authority 
vested in it under the Act if the Commission finds that (1) such 
termination or suspension is required to protect public health and 
safety, or (2) the Commonwealth has not complied with one or more of 
the requirements of Section 274 of the Act. The Commission may also, 
pursuant to Section 274j of the Act, temporarily suspend all or part of 
this Agreement if, in the judgement of the Commission, an emergency 
situation exists requiring immediate action to protect public health 
and safety and the Commonwealth has failed to take necessary steps. The 
Commission shall periodically review this Agreement and actions taken 
by the Commonwealth under this Agreement to ensure compliance with 
Section 274 of the Act.

Article IX

    This Agreement shall become effective on [April 24, 1996,] >(date 
to be determined)< and shall remain in effect unless and until such 
time as it is terminated pursuant to Article VIII.

    Done at [Boston, Massachusetts] >(location to be determined)<, 
in triplicate, this [24]th Day of [April, 1996] >(date to be 
determined)<.

    For the United States Nuclear Regulatory Commission.
Shirley Ann Jackson,
Chairman.
    For the Commonwealth of Massachusetts.
William F. Weld,
Governor.
[FR Doc. 97-716 Filed 1-15-97; 8:45 am]
BILLING CODE 7590-01-P


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