[Federal Register Volume 62, Number 1 (Thursday, January 2, 1997)]
[Notices]
[Pages 117-121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33252]
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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
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 [email protected].
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 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
[[Page 118]]
(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 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
[[Page 119]]
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 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
[[Page 120]]
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;
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
[[Page 121]]
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.
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Shirley Ann Jackson,
Chairman.
For the Commonwealth of Massachusetts.
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William F. Weld,
Governor.
[FR Doc. 96-33252 Filed 12-31-96; 8:45 am]
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