Baxter Health Care, Aibonito, PR; Confirmatory Order Modifying License (Effective Immediately), 5707-5708 [05-2026]
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Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices
On
September 21, 1999, the National
Science Foundation issued a five-year
permit (ACA #2000–001) to Dr. Steven
D. Emslie after posting a notice in the
August 17, 1999 Federal Register.
Public comments were not received. A
request to modify the permit was posted
in the Federal Register on December 20,
2004. No public comments were
received. The modification was issued
by the Foundation on January 19, 2005.
SUPPLEMENTARY INFORMATION:
Polly A. Penhale,
Environmental Officer.
[FR Doc. 05–2011 Filed 2–2–05; 8:45 am]
BILLING CODE 7555–01–M
NUCLEAR REGULATORY
COMMISSION
[Docket No. 30–19882, License No. 52–
21175–01, EA–04–118]
Baxter Health Care, Aibonito, PR;
Confirmatory Order Modifying License
(Effective Immediately)
Baxter Health Care Corporation
(Baxter or Licensee) is the holder of
NRC License No. 52–21175–01 (License)
which authorizes the Licensee to
operate an irradiator at its facility in
Aibonito, Puerto Rico.
On October 25, 2004, the NRC issued
a Notice of Violation and Proposed
Imposition of Civil Penalties (Notice) in
the amount of $44,400 to Baxter
Healthcare Corporation (Baxter) based
on six violations of NRC requirements.
The circumstances associated with these
violations were reviewed by the NRC
during an Augmented Inspection Team
(AIT) inspection conducted between
April 22, 2004, and June 1, 2004, after
a Baxter representative informed the
NRC on April 21, 2004, that an event
had occurred at the facility. The event
involved two individuals (an irradiator
operator and assistant) bypassing safety
interlocks and entering the irradiator at
a time when an irradiator source rack
(containing 2,000,000 curies of cobalt60) was stuck in an unshielded position.
The three most significant violations
cited by the NRC in its October 25, 2004
Notice were described in Section I. The
first violation cited in Section I of the
Notice involved the failure to adhere to
emergency and abnormal event
procedures when the safety interlocks
were bypassed even though the
irradiator source rack fault indicator
was illuminated and the source travel
alarm had sounded for an extended
period. This occurred on at least three
occasions, including when the source
rack was stuck in the unshielded
position on April 21, 2004. This created
VerDate jul<14>2003
19:18 Feb 02, 2005
Jkt 205001
the potential for a lethal exposure to
radiation for the two individuals who
entered the area while the sources were
exposed, since, as previously indicated,
the individuals passed through an area
with a radiation level at least as high as
1600 rads/hour, and were planning to
enter an area with much higher
radiation levels (as high as 100,000
rads/hour in the irradiator cell). By
bypassing the safety interlocks, a system
designed to prevent a serious safety
event was rendered inoperable, which
created the potential for significant
injury and loss of life. Therefore, in the
Notice, the NRC classified this violation
at Severity Level II and proposed a civil
penalty in the amount of $28,800
($9,600 for each of the minimum three
occasions that the violation occurred).
The second violation cited set forth in
Section I involved the failure to perform
an adequate survey prior to the two
individuals entering the irradiator on
April 21, 2004. Prior to the entry, the
operators did not adequately check the
irradiator cell radiation monitor, did not
adequately check the radiation levels
outside the irradiator facility, and did
not adequately do other such surveys as
were reasonable to determine that a
source rack was stuck in the unshielded
position and had not returned to the
fully shielded position. The NRC also
classified this violation at Severity Level
II and proposed a $9,600 civil penalty
for the violation.
The third violation cited by the NRC
in Section I of the Notice involved the
failure by the irradiator operator to
supply his assistant an individual
radiation monitoring device when the
two individuals entered the irradiator
on April 21, 2004, while a source rack
was stuck in the unshielded position.
Based on the OI investigation, the NRC
concluded that this violation was
willful. The NRC classified this
violation at Severity Level III and
proposed a $6,000 civil penalty.
The letter transmitting the Notice also
described the Licensee’s corrective
actions, which included, but were not
limited to: (1) Revision to procedures for
responding to emergency conditions
and performing necessary surveys; (2)
plans to annually review the standard
operating procedures for adequacy; (3)
upgrade of the training program and
retraining of staff on revised procedures,
survey techniques, and dosimetry use;
and (4) increased management oversight
of the irradiator program, including: (a)
Monthly reviews of the irradiator
department by the Plant General
Manager, Manufacturing Director,
Radiation Safety Officer (RSO), and the
assistant RSO (ARSO); (b) annual
internal audits of the irradiator by the
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
5707
Environmental Health and Safety
Manager and RSO; and (c) additional
periodic audits of the irradiator by the
corporate environmental health and
safety group as well as by an external
consultant.
The other three violations cited in the
Notice were described in Section II and
the NRC classified those violations at
Severity Level IV.
In response to the October 25, 2004
Notice, Baxter requested use of the NRC
Alternate Dispute Resolution Process
(ADR) to resolve differences it had with
the NRC concerning the Notice. ADR is
a process in which a neutral mediator
with no decision-making authority
assists the NRC and Baxter in reaching
an agreement on resolving any
differences regarding the enforcement
action. An ADR session was held
between Baxter and NRC in
Philadelphia, Pennsylvania on
December 13, 2004, and was mediated
by a professional mediator, arranged
through Cornell University’s Institute of
Conflict Management. During that ADR
session, a settlement agreement was
reached. The elements of the settlement
agreement, which were documented in
a letter from Mr. Peter Etienne, Senior
Counsel, Baxter, to the NRC on
December 17, 2004, consisted of the
following:
A. Baxter agrees to pay a civil penalty
of $31,200.00 for Violations I.A, I.B and
I.C. The NRC will characterize these
violations as a Severity Level II
problem.
B. Baxter and the NRC agree to
disagree on the willful characterization
of Violation I.C.
C. NRC agrees to treat Violations II.A,
II.B, and II.C as non-cited violations.
D. Baxter agrees to implement the
corrective action as documented in
Baxter’s letter dated August 23, 2004,
except that with respect to item 1(c) in
that letter, (‘‘Additional External Review
by Outside Consultant’’), that item is
replaced by the terms of the December
13, 2004, settlement. Specifically,
Baxter agrees to provide for reviews of
irradiator operations to be conducted by
a qualified consultant, with such review
to include a review of operations,
maintenance, radiation safety and the
RSO and ARSO functions. Review
results will be documented and made
available to NRC during inspections
conducted by the NRC. Such reviews to
be conducted as noted below.
E. A review by the qualified external
consultant will be conducted in 2005 of
the RSO and ARSO function to
supplement the reviews done in 2004.
F. In 2007, a qualified external
consultant will conduct a full review as
listed in Item D.
E:\FR\FM\03FEN1.SGM
03FEN1
5708
Federal Register / Vol. 70, No. 22 / Thursday, February 3, 2005 / Notices
G. In 2007 after the full review, Baxter
will discuss with NRC whether Baxter
will need to continue to use a qualified
external consultant. It is anticipated that
the last external consultant review will
be completed in 2007. In no event shall
such review extend beyond one
additional review in 2009 in the context
of this Agreement.
H. Baxter will submit to the NRC a
letter within two weeks (by December
27, 2004) which documents the
Agreement. (Met by Baxter’s December
17, 2004 letter).
I. Upon issuance of a Confirmatory
Order by the NRC, confirming the
Agreement reached by the parties on
December 13, Baxter will pay the Civil
Penalty in the amount of $31,200.00
within thirty days of the date of
issuance of that Confirmatory Order.
Since the licensee has agreed to take
additional actions to address NRC
concerns, as set forth in Item III above,
the NRC has concluded that its concerns
can be resolved through the NRC’s
confirmation of the licensee
commitments as outlined in this Order.
I find that the licensee’s commitments
as set forth in Section III above are
acceptable and conclude that with these
commitments, the public health and
safety are reasonably assured. However,
in view of the foregoing, I have
determined that public health and safety
require that these commitments be
confirmed by this Order. Based on the
above and the licensee’s consent, this
Order is immediately effective upon
issuance. The licensee is required to
provide the NRC with a letter
summarizing all of its actions, up to and
including, its last external consultant
review that is to be completed in 2007.
Accordingly, pursuant to Sections 81,
161b, 161i, 161o, 182, and 186 of the
Atomic Energy Act of 1954, as amended,
and the Commission’s regulations in 10
CFR 2.202 and 10 CFR part 30, It is
hereby ordered, effective immediately
that:
A. Baxter pay a civil penalty of
$31,200.00 for Violations I.A, I.B and
I.C. set forth in the NRC October 25,
2004 Notice. (The NRC will characterize
these violations as a Severity Level II
problem. Also, Baxter and the NRC
agree to disagree on the willful
characterization of Violation I.C, and the
NRC agrees to treat Violations II.A, II.B,
and II.C as non-cited violations).
B. Baxter implement the corrective
actions a documented in its August 23,
2004, letter except that with respect to
item 1(c) in that letter (‘‘Additional
External Review by Outside
Consultant’’), that item is replaced by
the terms of the December 13, 2004,
settlement. Specifically, Baxter will
VerDate jul<14>2003
19:18 Feb 02, 2005
Jkt 205001
provide for reviews of irradiator
operations to be conducted by a
qualified consultant with such review to
include a review of operations,
maintenance, radiation safety and the
RSO and ARSO functions. Review
results will be documented and made
available to NRC during inspections
conducted by NRC. Such reviews to be
conducted as noted below.
1. A review by the qualified external
consultant will be conducted in 2005 of
the RSO and ARSO function to
supplement the reviews done in 2004.
2. In 2007, a qualified external
consultant will conduct a full review as
listed in Item B.
3. In 2007 after the full review, Baxter
will discuss with NRC whether Baxter
will need to continue to use a qualified
external consultant, although it is
anticipated that the last external
consultant review will be completed in
2007, and in no event, shall such review
extend beyond one additional review in
2009 in the context of the Agreement.
The Director, Office of Enforcement
may relax or rescind, in writing, any of
the above conditions upon a showing by
the licensee of good cause.
Any person adversely affected by this
Confirmatory Order, other than the
licensee, may request a hearing within
20 days of its issuance. Where good
cause is shown, consideration will be
given to extending the time to request a
hearing. A request for extension of time
must be made in writing to the Director,
Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555, and must include a statement
of good cause for the extension. Any
request for a hearing shall be submitted
to the Secretary, U.S. Nuclear
Regulatory Commission, ATTN: Chief,
Rulemaking and Adjudications Staff,
Washington, DC 20555. Copies of the
hearing request shall also be sent to the
Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission,
Washington DC 20555, to the Assistant
General Counsel for Materials Litigation
and Enforcement, to the Director of the
Division of Regulatory Improvement
Programs at the same address, and to
Baxter. Because of continuing
disruptions in delivery of mail to United
States Government offices, it is
requested that answers and requests for
hearing be transmitted to the Secretary
of the Commission either by means of
facsimile transmission to (301) 415–
1101 or by e-mail to
hearingdocket@nrc.gov and also to the
Office of the General Counsel by means
of facsimile transmission to (301) 415–
3725 or e-mail to
OGCMailCenter@nrc.gov. If such a
person requests a hearing, that person
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
shall set forth with particularity the
manner in which his interest is
adversely affected by this Order and
shall address the criteria set forth in 10
CFR 2.309(d).
If a hearing is requested by a person
whose interest is adversely affected, the
Commission will issue an Order
designating the time and place of any
hearing. If a hearing is held, the issue to
be considered at such hearing shall be
whether this Confirmatory Order shall
be sustained. An answer or a request for
a hearing shall not stay the effectiveness
date of this order.
Dated this 26th day of January 2005.
For the Nuclear Regulatory Commission.
Frank Congel, Director,
Office of Enforcement.
[FR Doc. 05–2026 Filed 2–2–05; 8:45 am]
BILLING CODE 7590–01–P
SECURITIES AND EXCHANGE
COMMISSION
Issuer Delisting; Notice of Application
of Boston Restaurant Associates, Inc.
To Withdraw Its Common Stock, $.01
par value, From Listing and
Registration on the Boston Stock
Exchange, Inc.; File No. 1–13320
January 28, 2005.
On January 11, 2005, Boston
Restaurant Associates, Inc., a Delaware
corporation (‘‘Issuer’’), filed an
application with the Securities and
Exchange Commission (‘‘Commission’’),
pursuant to Section 12(d) of the
Securities Exchange Act of 1934
(‘‘Act’’) 1 and Rule 12d2–2(d)
thereunder,2 to withdraw its common
stock, $.01 par value (‘‘Security’’), from
listing and registration on the Boston
Stock Exchange, Inc. (‘‘BSE’’).
On December 23, 2004, the Board of
Directors (‘‘Board’’) of the Issuer
approved a resolution to withdraw the
Issuer’s Security from listing and
registration on the BSE. The Issuer
stated: (1) That on December 20, 2004,
the BSE notified the Issuer that the BSE
would suspend trading of the Security
at the close of business that same day.
The suspension was the result of a
failure of the Issuer to maintain a
minimum of $500,000 of stockholder’s
equity as required by the BSE. (2) After
careful consideration the Issuer decided
to request a voluntary delisting of the
Security from the BSE. The Issuer stated
that the Security currently trades on the
OTC Bulletin Board.
The Issuer stated in its application
that it has complied with BSE
1 15
2 17
E:\FR\FM\03FEN1.SGM
U.S.C. 78l(d).
CFR 240.12d2–2(d).
03FEN1
Agencies
[Federal Register Volume 70, Number 22 (Thursday, February 3, 2005)]
[Notices]
[Pages 5707-5708]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2026]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 30-19882, License No. 52-21175-01, EA-04-118]
Baxter Health Care, Aibonito, PR; Confirmatory Order Modifying
License (Effective Immediately)
Baxter Health Care Corporation (Baxter or Licensee) is the holder
of NRC License No. 52-21175-01 (License) which authorizes the Licensee
to operate an irradiator at its facility in Aibonito, Puerto Rico.
On October 25, 2004, the NRC issued a Notice of Violation and
Proposed Imposition of Civil Penalties (Notice) in the amount of
$44,400 to Baxter Healthcare Corporation (Baxter) based on six
violations of NRC requirements. The circumstances associated with these
violations were reviewed by the NRC during an Augmented Inspection Team
(AIT) inspection conducted between April 22, 2004, and June 1, 2004,
after a Baxter representative informed the NRC on April 21, 2004, that
an event had occurred at the facility. The event involved two
individuals (an irradiator operator and assistant) bypassing safety
interlocks and entering the irradiator at a time when an irradiator
source rack (containing 2,000,000 curies of cobalt-60) was stuck in an
unshielded position.
The three most significant violations cited by the NRC in its
October 25, 2004 Notice were described in Section I. The first
violation cited in Section I of the Notice involved the failure to
adhere to emergency and abnormal event procedures when the safety
interlocks were bypassed even though the irradiator source rack fault
indicator was illuminated and the source travel alarm had sounded for
an extended period. This occurred on at least three occasions,
including when the source rack was stuck in the unshielded position on
April 21, 2004. This created the potential for a lethal exposure to
radiation for the two individuals who entered the area while the
sources were exposed, since, as previously indicated, the individuals
passed through an area with a radiation level at least as high as 1600
rads/hour, and were planning to enter an area with much higher
radiation levels (as high as 100,000 rads/hour in the irradiator cell).
By bypassing the safety interlocks, a system designed to prevent a
serious safety event was rendered inoperable, which created the
potential for significant injury and loss of life. Therefore, in the
Notice, the NRC classified this violation at Severity Level II and
proposed a civil penalty in the amount of $28,800 ($9,600 for each of
the minimum three occasions that the violation occurred).
The second violation cited set forth in Section I involved the
failure to perform an adequate survey prior to the two individuals
entering the irradiator on April 21, 2004. Prior to the entry, the
operators did not adequately check the irradiator cell radiation
monitor, did not adequately check the radiation levels outside the
irradiator facility, and did not adequately do other such surveys as
were reasonable to determine that a source rack was stuck in the
unshielded position and had not returned to the fully shielded
position. The NRC also classified this violation at Severity Level II
and proposed a $9,600 civil penalty for the violation.
The third violation cited by the NRC in Section I of the Notice
involved the failure by the irradiator operator to supply his assistant
an individual radiation monitoring device when the two individuals
entered the irradiator on April 21, 2004, while a source rack was stuck
in the unshielded position. Based on the OI investigation, the NRC
concluded that this violation was willful. The NRC classified this
violation at Severity Level III and proposed a $6,000 civil penalty.
The letter transmitting the Notice also described the Licensee's
corrective actions, which included, but were not limited to: (1)
Revision to procedures for responding to emergency conditions and
performing necessary surveys; (2) plans to annually review the standard
operating procedures for adequacy; (3) upgrade of the training program
and retraining of staff on revised procedures, survey techniques, and
dosimetry use; and (4) increased management oversight of the irradiator
program, including: (a) Monthly reviews of the irradiator department by
the Plant General Manager, Manufacturing Director, Radiation Safety
Officer (RSO), and the assistant RSO (ARSO); (b) annual internal audits
of the irradiator by the Environmental Health and Safety Manager and
RSO; and (c) additional periodic audits of the irradiator by the
corporate environmental health and safety group as well as by an
external consultant.
The other three violations cited in the Notice were described in
Section II and the NRC classified those violations at Severity Level
IV.
In response to the October 25, 2004 Notice, Baxter requested use of
the NRC Alternate Dispute Resolution Process (ADR) to resolve
differences it had with the NRC concerning the Notice. ADR is a process
in which a neutral mediator with no decision-making authority assists
the NRC and Baxter in reaching an agreement on resolving any
differences regarding the enforcement action. An ADR session was held
between Baxter and NRC in Philadelphia, Pennsylvania on December 13,
2004, and was mediated by a professional mediator, arranged through
Cornell University's Institute of Conflict Management. During that ADR
session, a settlement agreement was reached. The elements of the
settlement agreement, which were documented in a letter from Mr. Peter
Etienne, Senior Counsel, Baxter, to the NRC on December 17, 2004,
consisted of the following:
A. Baxter agrees to pay a civil penalty of $31,200.00 for
Violations I.A, I.B and I.C. The NRC will characterize these violations
as a Severity Level II problem.
B. Baxter and the NRC agree to disagree on the willful
characterization of Violation I.C.
C. NRC agrees to treat Violations II.A, II.B, and II.C as non-cited
violations.
D. Baxter agrees to implement the corrective action as documented
in Baxter's letter dated August 23, 2004, except that with respect to
item 1(c) in that letter, (``Additional External Review by Outside
Consultant''), that item is replaced by the terms of the December 13,
2004, settlement. Specifically, Baxter agrees to provide for reviews of
irradiator operations to be conducted by a qualified consultant, with
such review to include a review of operations, maintenance, radiation
safety and the RSO and ARSO functions. Review results will be
documented and made available to NRC during inspections conducted by
the NRC. Such reviews to be conducted as noted below.
E. A review by the qualified external consultant will be conducted
in 2005 of the RSO and ARSO function to supplement the reviews done in
2004.
F. In 2007, a qualified external consultant will conduct a full
review as listed in Item D.
[[Page 5708]]
G. In 2007 after the full review, Baxter will discuss with NRC
whether Baxter will need to continue to use a qualified external
consultant. It is anticipated that the last external consultant review
will be completed in 2007. In no event shall such review extend beyond
one additional review in 2009 in the context of this Agreement.
H. Baxter will submit to the NRC a letter within two weeks (by
December 27, 2004) which documents the Agreement. (Met by Baxter's
December 17, 2004 letter).
I. Upon issuance of a Confirmatory Order by the NRC, confirming the
Agreement reached by the parties on December 13, Baxter will pay the
Civil Penalty in the amount of $31,200.00 within thirty days of the
date of issuance of that Confirmatory Order.
Since the licensee has agreed to take additional actions to address
NRC concerns, as set forth in Item III above, the NRC has concluded
that its concerns can be resolved through the NRC's confirmation of the
licensee commitments as outlined in this Order.
I find that the licensee's commitments as set forth in Section III
above are acceptable and conclude that with these commitments, the
public health and safety are reasonably assured. However, in view of
the foregoing, I have determined that public health and safety require
that these commitments be confirmed by this Order. Based on the above
and the licensee's consent, this Order is immediately effective upon
issuance. The licensee is required to provide the NRC with a letter
summarizing all of its actions, up to and including, its last external
consultant review that is to be completed in 2007.
Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182, and
186 of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202 and 10 CFR part 30, It is hereby ordered,
effective immediately that:
A. Baxter pay a civil penalty of $31,200.00 for Violations I.A, I.B
and I.C. set forth in the NRC October 25, 2004 Notice. (The NRC will
characterize these violations as a Severity Level II problem. Also,
Baxter and the NRC agree to disagree on the willful characterization of
Violation I.C, and the NRC agrees to treat Violations II.A, II.B, and
II.C as non-cited violations).
B. Baxter implement the corrective actions a documented in its
August 23, 2004, letter except that with respect to item 1(c) in that
letter (``Additional External Review by Outside Consultant''), that
item is replaced by the terms of the December 13, 2004, settlement.
Specifically, Baxter will provide for reviews of irradiator operations
to be conducted by a qualified consultant with such review to include a
review of operations, maintenance, radiation safety and the RSO and
ARSO functions. Review results will be documented and made available to
NRC during inspections conducted by NRC. Such reviews to be conducted
as noted below.
1. A review by the qualified external consultant will be conducted
in 2005 of the RSO and ARSO function to supplement the reviews done in
2004.
2. In 2007, a qualified external consultant will conduct a full
review as listed in Item B.
3. In 2007 after the full review, Baxter will discuss with NRC
whether Baxter will need to continue to use a qualified external
consultant, although it is anticipated that the last external
consultant review will be completed in 2007, and in no event, shall
such review extend beyond one additional review in 2009 in the context
of the Agreement.
The Director, Office of Enforcement may relax or rescind, in
writing, any of the above conditions upon a showing by the licensee of
good cause.
Any person adversely affected by this Confirmatory Order, other
than the licensee, may request a hearing within 20 days of its
issuance. Where good cause is shown, consideration will be given to
extending the time to request a hearing. A request for extension of
time must be made in writing to the Director, Office of Enforcement,
U.S. Nuclear Regulatory Commission, Washington, DC 20555, and must
include a statement of good cause for the extension. Any request for a
hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory
Commission, ATTN: Chief, Rulemaking and Adjudications Staff,
Washington, DC 20555. Copies of the hearing request shall also be sent
to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, Washington DC 20555, to the Assistant General Counsel for
Materials Litigation and Enforcement, to the Director of the Division
of Regulatory Improvement Programs at the same address, and to Baxter.
Because of continuing disruptions in delivery of mail to United States
Government offices, it is requested that answers and requests for
hearing be transmitted to the Secretary of the Commission either by
means of facsimile transmission to (301) 415-1101 or by e-mail to
hearingdocket@nrc.gov and also to the Office of the General Counsel by
means of facsimile transmission to (301) 415-3725 or e-mail to
OGCMailCenter@nrc.gov. If such a person requests a hearing, that person
shall set forth with particularity the manner in which his interest is
adversely affected by this Order and shall address the criteria set
forth in 10 CFR 2.309(d).
If a hearing is requested by a person whose interest is adversely
affected, the Commission will issue an Order designating the time and
place of any hearing. If a hearing is held, the issue to be considered
at such hearing shall be whether this Confirmatory Order shall be
sustained. An answer or a request for a hearing shall not stay the
effectiveness date of this order.
Dated this 26th day of January 2005.
For the Nuclear Regulatory Commission.
Frank Congel, Director,
Office of Enforcement.
[FR Doc. 05-2026 Filed 2-2-05; 8:45 am]
BILLING CODE 7590-01-P