Information File : Sterigenics

April 12, 2006 - Information file: the FANC announces the first elements of the
investigation into a radiation exposure accident at the Sterigenics facility in Fleurus.

A radiation accident that occurred at the Sterigenics facility in Fleurus on March 11th,
2006 was reported to the FANC on March 31st, 2006. An employee entered for about 20
seconds a radiation cell while no production was in progress. After exhibiting symptoms
(vomiting, hair loss) indicating a irradiation exposure after the incident, the employee
informed his occupational physician three weeks later. The dose received by the
employee was very high and is estimated between 4,4 Gy and 4,8 Gy.

Since March 31st, 2006, the FANC has been investigating to determine the causes and
the circumstances of this accident. In this information file, the Agency communicates the
first elements of the investigation and the first actions that were taken to ensure the
safety at the Sterigenics site.

1. STERIGENICS and its radiation techniques

STERIGENICS Fleurus performs medical device and food sterilization. This facility operates two
irradiators using gamma radiation emitted from cobalt 60 (Co-60) radioactive sources. The
GAMMIR I irradiator produces continuous radiation exposure while GAMMIR II is a batch irradiator.
Co-60 radioactive sources are contained in irradiation cells whose 2-meter thick concrete walls
protect the employees against radiation when the irradiator is operated. During an irradiation
process, the access doors to the cell are closed and locked so that nobody can enter the cell.

When no production is carried out, these sources are stored in a 5 to 6-meter deep water pool.
Water acts as a biological shield against radiation so that employees can enter the cell to perform
maintenance works or necessary interventions. A radiation detector, placed inside the cell,
indicates that there is no radiation exposure within the vessel and that the employee can enter it
safely.

2. The radiation exposure accident and its consequences for the operators

On March 11th, 2006 an operator was called in by one of his colleagues when a radiation detector
alarm was recorded outside the GAMMIR II irradiator cell with no production in progress. He
aknowledged and reset the alarm and noticed nothing abnormal. The lead door was open and the
safety procedure requires verifying before closing the door that nobody is left inside the cell. As a
result, the operator must enter the radiation cell and activate a switch at the rear of the cell to
validate the monitoring. After having pressed the button, he left the cell and closed the door.
Some moments later, this operator started suffering nausea and vomiting but did not consider this
to be related to his intervention in the radiation cell. Moreover, his family doctor considered that he
was suffering from digestive troubles.

Some three weeks later, he reported hair loss to his occupational physician, what suggested that
he could have received a irradiation dose. Blood analyses were immediately performed and
indicated a strong suspicion that he might have been exposed to a radiation dose as high as 4 Gy.

On March 31st, 2006 the employee was transferred to a French hospital specialized in the
treatment of radiation exposure. It is now confirmed that his whole body was irradiated and the
radiation dose is estimated between 4,4 Gy and 4,8 Gy.

The investigation showed that four other operators were present on the site when the alarm of the
detectors placed outside the radiation cell activated.

The dosimeters of these persons have been tested and showed no abnormal exposure. Morever,
blood analyses were conducted on these four operators but revealed no anomaly. So it can be
concluded that these operators were not exposed to excessive levels of radiation. Chromosomal
tests are being conducted in order to be completely sure. Definitive conclusions should be known
by the end of April 2006.

The field investigation conducted by the FANC revealed no new element indicating that these
employees had suffered an incidental over exposure.

This irradiation accident was rated as level 4 on the INES scale.

3. Causes of the accident

The main hypothesis on the origin of the accident is related to a defect of the hydraulic control
system that would have caused oscillatory and emplamed movements of the radioactive source in
the GAMMIR II cell, removing the source from its deepest position in the pool. These movements
possibilly are generated by interferences between the hydraulic systems of GAMMIR I and GAMMIR
II.

This hypothesis tends to be confirmed by the source movements recorded and subsequently
collected by the FANC. External experts in hydraulics are analyzing the hydraulic system as a
whole.

The FANC investigation also aimed at pointing out the potential secondary causes that could have
made the event more serious. The FANC and AVN - the recognized control organization that is in
charge of controlling the nuclear safety at the Fleurus site - are currently conducting general
investigations in order to determine all the elements that had an impact on the circumstances and
the seriousness of the accident.

4. Measures taken by the FANC

After the first investigations on March 31st, and April 1st, 2006 the FANC decided to shut down and
seal the GAMMIR II radiation cell. As a result, no production can be carried out. The access doors
to this cell have been sealed. The seals can only be taken off by a FANC nuclear inspector after an
expert’s report on the causes of the accident has been completed and after all the modifications
necessary to increase the facility’s safety have been implemented.

For preventive and precautionary reasons, it was also decided to place the access to the GAMMIR I
radiation cell under seals until the results of the investigation of the accident are available. Since
this radiation cell is continuously loaded from outside by conveyor belts without door openings, the
operation of this irradiator could carry on.

In both cases the seals shall only be taken off when the additional securing conditions imposed by
the FANC on the company have been complied with, checked and approved. In this respect, the
FANC – with the collaboration of AVN and the Federal Public Service « Work, Employment and
Social Dialogue » - imposed on Sterigenics an action program including the implementation of
redundant hydraulic, electrical and mechanical safety systems.

Preliminary conclusions

The FANC is currently performing further investigations with the collaboration of AVN and the
Federal Public Service « Work, Employment and Social Dialogue » in order to point out the causes
of the accident and to take all the measures necessary for preventing any similar accident in the
future.
Information File : Sterigenics

May 15, 2006: STERIGENICS: the FANC has started an investigation and informs the
public

On 10 th and 11th, May 2006, the media revealed alarming information about an over-
exposure of the whole personnel of Griffith Mediris, now Sterigenics, as a result of an
incident at the Fleurus site in 1999.

The FANC has started an investigation and informs the public.

1. introduction

A former Griffith Mediris employee, who died of a heart attack in 2003, left a sort of “will” to his
close relations. When they made it public, the national press reported some elements about work
conditions and unacceptable levels of exposure in the facility where irradiators are operated.
The FANC expresses no opinion concerning work relations between the workers and the former or
current management. The FANC does not either give any conclusion as to the medical follow-up of
the workers as this falls within the competence of the occupational medicine. As in the case of the
irradiation of a worker that occurred in this Sterigenics facility on 11 March 2006, the FANC
investigated into the aspects related to the protection of the workers and the environment against
the dangers of ionizing radiation

2. Controlled areas and people occupationally exposed to radiation at the Sterigenics facilities

STERIGENICS Fleurus performs medical device and food sterilization. This facility operates two
irradiators using gamma radiation emitted from cobalt 60 (Co-60) radioactive sources. Co-60
radioactive sources are contained in radiation cells whose 2-meter thick concrete walls protect the
operators against radiation when the irradiator is operated. During an irradiation process, the
access doors to the cell are closed and locked so that nobody can enter the cell.
When no production is carried out, these sources are stored in a 5 to 6-meter deep water pool.
Water acts as a biological shield against radiation so that employees can enter the cell – called
“controlled area” - to perform maintenance works or necessary interventions. These operators are
considered “occupationally exposed”.
Dose rates were measured outside the radiation cells during the formal acceptance of the
irradiators and were periodically followed-up by the facility’s Physical Surveillance Service. The
dose rates were lower than the limits fixed at the time of the formal acceptance of the irradiators.
Subsequently, the Physical Surveillance Service did never notice any anomaly during the periodic
follow-up tests.

3. Results of the investigation conducted by the FANC as a result of the comments made by a
former employee

The FANC investigation of the crawler incident on 26 October 1999 and its consequences for the
personnel concludes that:

1. the analysis of the dosimetry for the whole personnel occupationally exposed to ionizing
radiation in 1999 and 2000 indicates a maximum individual dose, on annual basis, which is
25 times lower than the limit value of the time and 10 times lower than the current limit
value. However, it is not sure that every worker was wearing effectively a dosimeter every
time that he entered the controlled area, but it is unlikely that an over-exposure problem
could have occurred without being detected during the follow-up tests on a group of
workers who were all supposed to wear personal dosimeters.
2. Every staff member, occupationally exposed or not, undergoes an annual medical
examination by the occupational physician. The management of the company voluntarily
set up this medical test program. The medical examinations of these employees never
showed any abnormal levels of exposure at any time in the past.
3. The former employee, who left a “will” to his family, was an administrative employee first
at the IRE and subsequently at Mediris. He was not occupationally exposed to ionizing
 radiation since his job did not require his presence in the controlled area. Therefore, he had
no dosimetric follow-up but he had annual medical exams like every staff member of the
company. The cause of his death in 2003 could not be related with some effect of ionizing
radiation.
4. The former colleague of the worker who left the “will” died in 2002 from leukemia. The
analysis of the doses that he received since the irradiators were commissioned in 1978 and
during his whole professional career resulted in annual maximum values that were
significantly lower than the regulatory limits. The highest annual dose was 12 times lower
than the permitted limit. A direct link between his illness and an exposure to ionizing
radiation could not be established.
5. Dose rates outside and in the neighborhood of the radiation cells were periodically
measured by the control organization in charge of monitoring the radiation protection in
the facilities housing the irradiators. These measures did not reveal any anomaly, ruling out
the hypothesis of an abnormal exposure in the office where the former colleague who died
in March 2002 used to work.

4. Improvement actions that are being implemented at the Sterigenics fac

While pointing out the reassuring elements listed here above, the investigation conducted by the
FANC as a response to the exposure accident suffered by Mr SOMMAVILLA on March 11th, 2006
also revealed some issues that can and must be improved at the facility and in its organization in
order to increase the safety level of the operation and to prevent any similar accident in the future.
The first actions imposed by the FANC just after that the accident were made public on 31st, March
2006 already aimed at optimizing the protection of the workers within the facility. An in-depth
analysis of how the facility is designed and how to secure it is still in progress. This analysis is likely
to result in improvements to be brought to the facilities and to the operation processes.
Nonetheless, the FANC authorized the continued operation of the GAMMIR I irradiator until these
improvement measures are implemented, imposing a strict securing procedure and strengthening
its monitoring action with the collaboration of the recognized control organization AVN and the
Federal Public Service « Work, Employment and Social Dialogue ».

The FANC regularly informed about the major elements of the accident as well as on the progress
of the investigation. These press releases and news files can be accessed by clicking here.

The FANC wishes to provide an objective, neutral and verifiable information in order to fulfill one of
the missions that were entrusted by the legislator to the FANC.

Press Releases and News Files : Sterigenics

April 3, 2006 - Press Release: The FANC places under restrictions an irradiation facility of
the company, Sterigenics, located in Fleurus.

Following the accidental irradiation of an operator at Sterigenics, the FANC ensures its
continued investigation into the matter and is taking all necessary measures.

The FANC was informed March 31, 2006, of an accident that occurred at the company which
affected a worker. The victim was urgently transported to a French hospital that specializes in the
treatment of irradiated victims. The FANC was immediately called to the scene of the accident,
accompanied by the authorized organization, AVN.

Sterigenics is a company that uses cobalt-based radioactive sources to sterilize medical material
and food. On March 11, 2006, an operator entered the irradiation facility and stayed there
approximately 20 seconds. Three weeks later, the operator complained to his doctor of hair loss,
which led to suspicions of possible irradiation. The blood analysis indicated high doses of
irradiation.

The accident may have resulted from the malfunctioning of a technical hydraulic system, which in
turn may have caused movements of the cobalt-based source being used at the facility. The
investigations are ongoing and their follow-up is assured by the FANC. The FANC has already taken
the decision to restrict access to the facility. It will take other additional measures, if necessary.
The FANC is the public authority in Belgium that is in charge of protecting the population, workers
and environment against the dangers of ionized radiation.

Point of contact for the press:GP-Presse@fanc.fgov.be.

April 5, 2006 - Press Release: The FANC follows up on the Sterigenics investigations.

A nuclear inspector for the FANC is in permanent contact with the authorized
organization in charge of running the company where a worker has been accidentally
irradiated.

The accident that occurred in Fleurus, at the Sterigenics site, has been provisionally placed at a
level 4 on the INES scale. The FANC investigation is onsite to determine the technical causes of the
accident. It is also investigating the adequate precautionary measures, in order to avoid a similar
accident reoccurring. In addition, it is maintaining its restrictions on the facility.

The suspicion of an operator’s significant irradiation, as the FANC announced in its press release of
April 3, 2006, is today confirmed. The victim is being treated in a French hospital that specializes in
the treatment of irradiated people.

The verification of the dosimeters (radiation detectors) of the company’s workforce does not show
any abnormal exposure. The examinations of other operators at Sterigenics has not revealed any
anomalies.
The FANC is the public authority in Belgium that is in charge of protecting the population, workers
and environment against the dangers of ionized radiation.

Point of contact for the press:GP-Presse@fanc.fgov.be.

April 12, 2006 - Press Release: Accidental irradiation of an operator at the Sterigenics
site in Fleurus: The FANC communicates the initial points of the investigation.

On March 31, 2006, the FANC was informed that an irradiation accident at Sterigenics’ site in
Fleurus had occurred on March 11, 2006. Since then, the Agency has imposed the necessary
measures to avoid a similar accident from occurring. The initial results of the ongoing investigation
make up the related dossier of information.

This dossier explains the radiation techniques used by Sterigenics and the context in which the
accident occurred. It also describes the presumed circumstances of the accident and the
consequences for the operating staff. The estimation of the dose received as a result of the
accident has been reviewed and is slightly higher than the figure announced Thursday, April 6,
2006. Four other operators working in proximity of the zone at the time of the accident are being
closely monitored by medical staff. The onsite investigation led by the FANC has not yet provided
additional elements that can determine the accidental exposure to these four other people.

The initial analyses of the accident indicate that its cause was a failure of the command-control
hydraulic system. Other studies are being conducted in order to determine any possible secondary
causes. Precautionary measures to prevent another accident were put in place by the Agency,
which included not only shutting down the irradiation unit, GAMMIR II, where the accident
occurred, but also by imposing restrictions on access to GAMMIR I. These restrictions can only be
removed once the additional security conditions imposed by the FANC are clearly met, verified and
approved. The Agency is continuing its investigations.

The Auditorat of work in Charleroi has opened a dossier on the work-related accident and is
collaborating with the Agency and Service for Public, Federal Employment, Work and Workers’
Roundtables. A doctor and an engineer are in charge of all communication, in collaboration with the
Agency.

The FANC is the public authority in Belgium that is in charge of protecting the population, workers
and environment against the dangers of ionized radiation.

Point of contact for the press:GP-Presse@fanc.fgov.be.

May 15, 2006 - Press Release : Sterigenics : The FANC has investigated the dossier and
published its findings.

The FANC has already undertaken various actions following the irradiation accident that occurred at
Sterigenics’ Fleurus site on March 31, 2006 (see our press releases dated April 3, 5 and 12, 2006).
Today, the FANC is making clear its position concerning the new information available in the press
during these past few days, relating to the declarations regarding a former worker for the
company, who died in 2003.

The FANC has thoroughly investigated the various elements concerning the protection of the
workers and the environment from the dangers of ionized radiation, and is making public its
principal conclusions.
The maximum level of exposure of personnel to ionized radiation in 1999 and 2000 was 25 times
less than the limit fixed at the time, or 10 times less than today’s norm. Even if it is impossible to
guarantee that all workers were always carrying a dosimeter (radiation detector), it is unlikely that
an eventual problem of overexposure would have escaped detection.

The entire workforce in the company, whether or not they are exposed during the course of their
jobs, benefit from an annual state medical exam at work. These exams were unable to conclude
that there has been any abnormal exposure to the employees.

The former worker, whose testimony was mentioned in the media, had an administrative function:
he was not a person who was exposed in his working environment to ionized radiation. His cause of
death in 2003 was totally unrelated to the effect of ionized radiation.

The other worker cited in the press coverage, a colleague of the aforementioned worker, died in
2002 from leukemia. The examination of his radiation exposure over the entirety of his professional
career indicated a yearly exposure level greatly below the regulated limits. A direct link between
his illness and his exposure to ionized radiation has not been established.

The organizations that ensured the control of irradiation protection in the facilities did not uncover
any anomalies. Consequently, this excludes the so-called abnormal exposure in the office that had
been occupied in the past by the worker who died in March 2002.

Having said this, the investigation that was led by the FANC, following the accident of March 11,
2006, revealed the existence of specific issues — points that must be improved upon in the facility
and its organization, in order to better secure the facility and prevent a similar accident from
happening in the future. The first measures that the FANC has imposed were aimed at protecting
the factory workers in an optimal way. An in-depth analysis of the concept and how to best secure
the facility is currently under way. The improvements to the facilities and the work procedures will
more than likely be implemented once this analysis has been completed.

During the waiting period before these improvements are put in place, the FANC has authorized
GAMMIR I to continue operating, and has imposed a procedure for strict security in collaboration
with the authorized organization AVN, and the Ministry of Employment, Work and Workers’
Roundtables.

A dossier of detailed information has been published on FANC’s web site.

The FANC is the public authority in Belgium that is in charge of protecting the population, workers
and environment against the dangers of ionized radiation.

Point of contact for the press:GP-Presse@fanc.fgov.be.

April 24, 2006- News: Incidental irradiation of an operator at the Sterigenics facility in
Fleurus: the FANC took the seals off the access to the GAMMIR I radiation facility.

Since 31 March 2006 the FANC is investigating in order to determine the causes and circumstances
of this accident. The FANC already revealed in its information file the first elements of the
investigation and the first actions that were taken to ensure the safety of the facilities on the
Fleurus site.
The FANC reminds that, after the first investigations on 31 March and 1 April 2006, it decided to
seal the GAMMIR II radiation cell where the accident occurred.

Moreover, for preventive and precautionary reasons, it had been decided to place under seals the
access to the other radiation cell called GAMMIR I. Since this radiation cell is continuously loaded
from outside by conveyors belts without door openings, the operation of this irradiator could carry
on. Only personnel access in the cell was forbidden.

The seals could only be taken off when the additional securing conditions imposed by the FANC –
with the collaboration of AVN and the Federal Public Service « Work, Employment and Social
Dialogue » - on the company would have been complied with, checked and approved.

These additional securing measures, including redundant hydraulic, electrical and mechanical
safety systems and procedures, were implemented by the company and approved by AVN and the
Federal Public Service « Work, Employment and Social Dialogue ».

Conclusion

The FANC decided on Saturday 15 April 2006 to take the seals off the switch giving access to the
GAMMIR I radiation cell.

The GAMMIR II facility remains however under seal.

June 29, 2006 - News : Sterigenics Dossier: Having implemented modifications aimed at
increasing the level of safety at the irradiation facility, the FANC has decided to lift restrictions that
were imposed on the irradiation facility GAMMIR II.

Since March 31, 2006, the FANC has been analyzing the facts in this matter with the goal of
determining exactly what happened during the accidental irradiation of a worker at Sterigenics, and
the cause of the accident. The Agency has already communicated in its dossier of information the
first elements of the investigation, as well as the initial actions taken, with the objective of
guaranteeing the protection of the workers and the security of Sterigenics’ facilities.

A bit of history: As a first step, the Agency sealed the two irradiation facilities, GAMMIR 1 and
GAMMIR II. On April 24, 2006, it announced the lifting of the restrictions on the irradiation facility,
GAMMIR I.
The lifting of the restrictions could not take place until the additional security conditions imposed
on the company by the FANC (in collaboration with the authorized organization, AVN, and with the
Ministry of Employment, Work and Workers’ Roundtables) were satisfied, verified and approved.

At this time, the technical modifications that will assure an improvement in the level of safety have
also been implemented at GAMMIR II. They are the result of an in-depth analysis of the facility, led
by a team of experts in the areas of hydraulic, mechanical, electrical and nuclear engineering.

Furthermore, higher security measures, including the putting in place of redundant hydraulic,
electrical and mechanical systems and their associated procedures, have been implemented, and
have been approved by the authorized organization, AVN, and the Ministry of Employment, Work
and Workers’ Roundtables.
Personnel have been trained to implement these procedures.

Following the modifications to the facility, with the goal of increasing the safety level, the FANC
then decided on Friday, June 23, 2006, to lift the restrictions imposed on the irradiation facility,
GAMMIR II, and authorized Sterigenics to restart its production.

The Agency will continue to communicate via its web site, step by step, any new information
concerning the dossier.