At the request of several clients in the pharmaceutical industry, Datamation Systems sponsored an industry-specific forum to discuss current mail handling procedures with respect to the recent anthrax concerns and biological contaminants in general. The forum was held on December 12, 2007 at the office of Datamation Systems. The following minutes were compiled from information contributed by representatives of Novartis, Pharmacia, Schering Plough, Johnson & Johnson (by e-mail) and other firms surveyed who were not in attendance. Jerry Raymond, Dag Gonzalez and Paul Jenssen of Datamation Systems also attended.

The forum was informal, permitting participants to freely discuss issues and introduce topics of immediate importance. It became clear from the beginning that there were common themes in establishing new mail handling procedures and corporate policies, although there were a number of issues and strategies that were new to each of the participants.

The participants all consented to the preparation of summary minutes which they said could be shared with others in the industry.

What is the concern: dangerous items, cross-contamination or both?
1. The participants all agreed that "anthrax may go away but it will be replaced by something else."
2. All seemed to agree that pharmaceutical and consumer products businesses are high profile, high risk targets. Even with their resources and internal expertise, they have to exercise a high degree of care.
3. Most of the actions taken protect employees and improve chances of identifying suspicious items that meet postal protocols. However, a significant amount of "normal" consumer mail has to be handled even though it looks suspicious. This puts the corporate mail center in a difficult position.
4. With a few exceptions, very few of the actions taken address the threat of crosscontamination, which remains a concern, pending the identification of effective technologies for treating mail and packages.

Recommended Precautions When Handling Mail
1. All clerical staff are wearing appropriate surgical gloves, protective clothing and/or disposable masks when handling mail. It was suggested that employees be trained in the proper use of protective items. In addition, gloves and masks should be properly disposed of after use. [Some organizations have not provided proper training or leave it up to employees to decide if they want to use protective gear. The consensus of the participants was that it is important to convey a concern for employee safety, but that certain minimum standards should be required.]
2. All mail and packages are visually screened for signs of tampering, suspicious packaging, origins and signs of contaminants. Most of the companies use x-ray screening equipment to detect explosives and other suspicious matter. Both letters and packages are screened, including items coming through carriers other than the United States Postal Service. [Some screening is done off-site, either by a service bureau or in a segregated facility on a multi-building campus.]
3. If suspicious items are found, clearly defined procedures are immediately followed. In most cases, the suspicious item is placed in a biological safety container and the supervisor is notified. In addition, the security department is notified and, if warranted, the appropriate law enforcement agency. First response agencies vary according to facility location and most be determined in advance.
[Most of the participants had identified a very small number of suspicious items that were worthy of special handling. Very few items, if any, had been turned over to the police.]
4. Mail Center employees for all the participants are required to attend workshops for managing all types of suspicious mail and coping with the stress of the new workplace. [Training was repeatedly stressed as an important component of employee safety and the effectiveness of a screening program. It was also mentioned as a means of upgrading the skills of the mail center personnel.]

Operational and Logistical Changes
1. Isolating incoming mail at secured facilities is a strategy used by Pharmacia, Schering and a third firm not present at the meeting. For Pharmacia, mail is routed to a central facility in Piscataway (maintained by its outsourcing firm) where it is screened. Suspicious items are taken to an enclosed room and opened by employees wearing hazmat suits and other protective items. If the materials are suspicious, local law enforcement agencies are notified. While the facility supports more than one client, they reported that there is minimal delay in the processing of mail when routing to the remote facility. Schering also handles incoming mail screening at a mail center that is in its own building (shared with its print/copy operation). The building is on the corporate campus. Another firm not in attendance has a more extensive screening process which includes testing mail for the presence of biological contaminants before it is cleared for delivery in the facility. All their mail is first brought to a secured facility, away from the main employee complexes. It is screened, swabbed for samples of contaminants and held, pending test results. The swabs are sent to a corporate lab at another location, and, when
the results are returned as negative, the mail is released to clients, resulting in a 3-4 day delay. [Novartis reported that they do not allow any mail to be brought into laboratory facilities, even after it has been screened. The mail is allowed in adjoining office areas, but not in labs.]
2. Another valuable operational change implemented by one of the companies is the accounting of employee movement and work. In the event a contaminated item is received, law enforcement agencies require a complete accounting of employee movement and all work responsibilities. Schering requires that all employees sign a login
sheet before beginning any type of work so they will be able to reconstruct which employees worked on which mail-runs or sorting stations at a particular time. In addition, these employees also keep accurate records on their movements throughout the facility.
3. Receipt of mail needs to be controlled and managed by single corporate group. After careful analysis, participants mentioned that unforeseen sources of mail deliveries were discovered. In one case, an executive arranged to have his personal mail sent to a post office box. The mail, coming from a high risk postal facility, was brought into the company without passing through the mail center screening processes. In another
instance, a corporate division had its own mail and shipping department. When the FDA incident occurred a few weeks ago, this division was not notified of the corporate decision to suspend incoming mail until the threat to the company was properly evaluated. While nothing happened, this could have compromised the security and safety
measures being implemented.
4. All outgoing mail is metered or identified in some manner to identify its origin. Postal Inspectors recommend that mail be metered, in some way, to help identify its origin should a postal facility become contaminated. Schering meters outgoing personal employee mail with a zero-cents indicia before consolidating its delivery at a central site. In this manner, the mail is still consolidated, but an identifier is given to note the original location where it entered the postal stream.

Methods for Treating Mail
1. At present, most organizations do not sterilize mail. As part of their screening process, Schering, J&J and Novartis place suspicious mail in a biological safety cabinet or glove box and open it. It was noted by Schering that any method of treatment needs careful coordination with internal security and health departments.
2. Schering and Novartis had contacted a facility in New Jersey that could treat pallets of mail using an "ETO" process. However, the facility was told that the EPA would not let them perform the service because of concerns of residues and the effect on pharmaceuticals and food products sent in the mail. The process had no guarantee of effectiveness.
3. It was noted by Datamation Systems that there are some new methods available that are promising for treating the types and quantity of material handled by a typical corporate mail center. Existing processes could handle 2-16 bins of mail at a time, perform autoclaving, ozone or chemical treatments, and sanitize mail within 3-4 hours of total time. Total treatment will minimize the threat of unseen cross-contaminated material. At present, no system is in place to visually screen spores on the outside of any envelope. [The "pros" of these systems: no environmental hazards or special facilities required; allows on-site processing; uses existing, tested technology; effectiveness based on well-established scientific research. The "cons": no out-of-the-box products; systems would be made to order; not inexpensive (although they represent the only realistic option at this point).]
4. Another alternative which was discussed is the use of electronic document imaging equipment to scan mail outside the facility. The idea is that the only way to absolutely assure that there is no contamination brought into a facility by mail is to not bring mail into the facility at all. Several large organizations, such as USAA in Texas, have imaged mail correspondence to facilitate its delivery and minimize storage of paper documents. For all practical purposes, high speed scanners are available that can accurately scan mail, store the images on DVDs or CDs and electronically distribute the images to clients. Alternatively, the images could be printed in-house and distributed in clean paper form. Outsource companies could perform the initial opening, sorting, prepping and
scanning, eliminating the danger to employees and facilities. We have heard of one firm in the area that has been scanning, but we have not gotten any details. The forum concluded on a very positive note with emphasis on the acknowledged importance of the mail center. According to Novartis, mail center employees are receiving
financial and corporate recognition for their dedication and growth during difficult circumstances. The Schering representative spoke about the high level of appreciation and recognition shown to mail center personnel during the crisis. According to Pharmacia, companies need to acknowledge the need to maintain and employ the highest quality personnel. The sustained effort to handle mail safely requires a total company commitment. The challenges of these times will require ongoing diligence and awareness by all levels of management.