[Federal Register Volume 66, Number 10 (Tuesday, January 16, 2001)]
[Notices]
[Pages 3620-3621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1173]



[[Page 3620]]

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NUCLEAR REGULATORY COMMISSION

[NRC License No. 29-30458-01]


SteriGenics International, Somerset, NJ: Exemption From 10 CFR 
36.23(a); Environmental Assessment, Finding of No Significant Impact, 
and Notice of Opportunity for a Hearing

AGENCY: Nuclear Regulatory Commission.

ACTION: SteriGenics International, Somerset, NJ: Exemption from 10 CFR 
36.23(a); Environmental Assessment, Finding of No Significant Impact, 
and Notice of Opportunity for a Hearing.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is considering 
authorizing SteriGenics International, Inc. (SteriGenics or the 
licensee) an exemption to use a cell door which prevents an individual 
in the radiation room from leaving.

SUPPLEMENTARY INFORMATION:

Proposed Action

    SteriGenics is licensed by the NRC to irradiate materials, except 
explosives, flammables, and corrosives using cobalt-60 in a panoramic 
wet-source-storage irradiator. The licensee requested, in a letter 
dated September 26, 2000, that the NRC grant an exemption from 10 CFR 
36.23(a) to use a cell door which prevents an individual in the 
radiation room from leaving. SteriGenics has been conducting 
irradiations using this cell door since the license was issued on 
February 1, 1999. The NRC staff has determined during an inspection of 
the facility, that the cell door does not meet 10 CFR 36.23(a) which 
requires that doors and barriers not prevent an individual in the 
radiation room from leaving.

Need for the Proposed Action

    Part 36 irradiators use high activity sealed sources of radioactive 
material in a facility constructed so that the sealed sources and 
material being irradiated are contained in a shielded volume (radiation 
room). In many units, sources are stored under water (wet-source-
storage). Irradiator facilities typically incorporate the use of a 
shielded ``maze'' which allows an individual to move to a shielded area 
within the radiation room and a door to the radiation room which allows 
an individual to exit the radiation room at any time.
    The exemption is needed so that SteriGenics can carry out its 
business of irradiating materials in this irradiator. The door to the 
radiation room of this irradiator serves as an integral part of the 
shielding and must be closed prior to exposing the radioactive sources 
to conduct an irradiation. The design of the irradiator control system 
does not allow the radioactive sources to be raised unless the door is 
closed. Once closed, an individual located in the radiation room cannot 
open the door and, therefore, is unable to leave the radiation room as 
required by 10 CFR 36.23(a). An individual in the radiation room with 
the door closed can prevent the sources from rising by pulling a cord 
on the room wall and thereby prevent radiation exposure.
    SteriGenics has proposed modifications which provide a level of 
safety equivalent to that which is provided by compliance with 10 CFR 
36.23(a). Currently, there are two pull cords inside the radiation 
room. One runs the length of two of the room walls, the second the 
length of the third. The fourth wall is covered by equipment. The 
presence of equipment in the radiation room forces individuals in the 
radiation room to be near one of these cords. Both of these cords must 
be actuated as part of the irradiator startup sequence. This actuation 
assures that the cords are functional and that the operator has 
searched the cell prior to beginning an irradiation. Once the startup 
sequence has been completed, the pull cords change function and pulling 
either cord will prevent the sources from rising or cause them to 
return to the shielded position if they have begun to rise. SteriGenics 
proposes to modify the irradiator control circuit logic so that if an 
individual pulls one of these cords twice, in addition to the sources 
returning to the shielded position, the cell door will open after a 
short delay. The control system logic will assure that the door does 
not open until and unless the sources are in the fully ``down'' 
position and radiation levels in the room are normal. The delay is 
caused by the operation of this logic and the fact that it takes 
between 15 and 30 seconds for the door to open.
    SteriGenics will also relocate the ``set-up'' key switch to the far 
corner inside the radiation room. Currently, this switch is located 
outside the cell door. Inserting the key and turning this switch begins 
the sequence which eventually allows moving the sources. Within 90 
seconds of turning the switch, the operator must search the radiation 
room, pull each cord once, exit the room and close the shield door. The 
operator must then place the key in the control console and may then 
move the sources. Placing the switch in the room forces the operator to 
bring the key which is used to move the sources (as required by 10 CFR 
36.31(a)) into the radiation room during the ``set-up'' process. This 
increases the assurance that this requirement will be met by 
substituting an active control for the current administrative control 
(the operator is required by existing procedure to take the key into 
the room). Taking the key into the room during ``setup'' assures that 
no one other than that operator can move the sources.

Environmental Impacts of the Proposed Action

    No radioactive material is released into the environment, all of 
the radioactive material is wholly contained within the shielded 
irradiator and there will be no changes to radiation dose rates outside 
the irradiator. The radiation dose rate outside this irradiator meets 
regulatory requirements and is similar to the dose rate outside 
traditional panoramic wet-source-storage irradiators which meet the 
requirement in 36.23(a). Therefore, the modification will not result in 
any significant environmental impacts.

Alternatives to the Final Action

    As required by Section 102(2)(E) of NEPA (42 U.S.C. 4322(2)(E)), 
the staff has considered alternatives to the final action including 
denying the exemption or requiring that SteriGenics comply with 10 CFR 
36.23(a). These options were not adopted because they would provide no 
gain in protection of the human environment and they would be 
significantly detrimental to SteriGenics. Denying the exemption request 
would result in SteriGenics ceasing all irradiations and either 
redesigning and substantially modifying the physical facility or 
disposing of the radioactive sources and decommissioning the facility. 
In order for SteriGenics to comply with 10 CFR 36.23(a) they need to 
extensively modify the existing irradiator to incorporate a shield 
maze. This would be expensive and would prevent the use of the existing 
conveyor system, requiring additional expenditures for modifications.

Alternative Use of Resources

    Alternative use of resources was considered as stated above.

Agencies and Persons Consulted

    Agencies or persons outside the U.S. Nuclear Regulatory Commission 
were not consulted because there will be no significant impact on the 
environment from the proposed activity.

Identification of Sources Used

    Letters from SteriGenics to the U.S. Nuclear Regulatory Commission, 
Region I, dated:


[[Page 3621]]


1. January 5, 2000 (ML003676755)
2. February 4, 2000 (ML003684178)
3. September 26, 2000 (ML003754079)

Finding of No Significant Impact

    Based on the above EA, the Commission has concluded that 
environmental impacts that would be created by the proposed action 
would not have a significant effect on the quality of the human 
environment and a Finding of No Significant Impact is appropriate. 
Accordingly, the preparation of an Environmental Impact Statement is 
not warranted.

Documents

    Documents submitted by SteriGenics are available for public 
inspection from the Publicly Available Records (PARS) component of the 
NRC's document system (ADAMS). ADAMS is accessible from the NRC Web 
site at http://www.nrc.gov/NRC/ADAMS/index.html (the Public Electronic 
Reading Room). Assistance with the Public Electronic Reading Room may 
be obtained by calling (800) 397-4209. The accession numbers for the 
licensee's documents referred to in this Assessment are listed next to 
the document date above.

Opportunity for a Hearing

    Any person whose interest may be affected by the issuance of this 
action may file a request for a hearing. Any request for hearing must 
be filed with the Office of the Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, within 30 days of the publication of 
this notice in the Federal Register; be served on the NRC staff 
(Executive Director for Operations, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852), and on the licensee 
(SteriGenics International, 210 Clyde Road, Somerset, NJ 08873); and 
must comply with the requirements for requesting a hearing set forth in 
the Commission's regulations, 10 CFR part 2, subpart L, ``Information 
Hearing Procedures for Adjudications in Materials Licensing 
Proceedings.''
    These requirements, which the request must address in detail, are:
    1. The interest of the requestor in the proceeding;
    2. How that interest may be affected by the results of the 
proceeding (including the reasons why the requestor should be permitted 
a hearing);
    3. The requestor's areas of concern about the licensing activity 
that is the subject matter of the proceeding; and
    4. The circumstances establishing that the request for hearing is 
timely--that is, filed within 30 days of the date of this notice.
    In addressing how the requestor's interest may be affected by the 
proceeding, the request should describe the nature of the requestor's 
right under the Atomic Energy Act of 1954, as amended, to be made a 
party to the proceeding; the nature and extent of the requestor's 
property, financial, or other (i.e., health, safety) interest in the 
proceeding; and the possible effect of any order that may be entered in 
the proceeding upon the requestor's interest.

    Dated at King of Prussia, Pennsylvania, this 4th day of January 
2001.
    For the Nuclear Regulatory Commission.
John D. Kinneman,
 Chief, Nuclear Materials Safety Branch 2, Division of Nuclear 
Materials Safety Region I.
[FR Doc. 01-1173 Filed 1-12-01; 8:45 am]
BILLING CODE 7590-01-P