Animal & Veterinary
CVM Staff Member Honored Among FDA’s Other Late Duty Officers
by Jon F. Scheid, Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No IV
The Commissioner of Food and Drugs, Dr. Andrew von Eschenbach, in August recognized the contribution of volunteers for the Food and Drug Administration’s Late Duty Officer Response Team, a program that draws volunteers from across the Agency to be on-call outside normal business hours to respond to emergency phone calls involving FDA-regulated products.
FDA has approximately 50 Late Duty Officer Response Team volunteers, who, for a week at a time, make themselves accessible at night and on weekends to deal with emergencies that consumers, health care professionals, veterinarians, and others report via FDA’s emergency phone system.
Dr. von Eschenbach sent each volunteer a “Commissioner’s Special Citation” plaque acknowledging his or her participation in the program.
One of the plaques went to Fredda Shere-Valenti, a consumer safety officer in the Center for Veterinary Medicine’s Office of Surveillance and Compliance. She has volunteered for the Late Duty Officer program since it began 4 years ago, and volunteered for similar programs before it.
The Late Duty Officer Response Team program is operated by FDA’s Office of Emergency Operations (OEO), which is part of the Office of the Commissioner. OEO is staffed by FDA employees during regular working hours, 8:00 a.m. to 4:30 p.m. (Eastern), Monday through Friday (except holidays). During those hours, an emergency call goes to one of the regular OEO staff members. After hours, the Late Duty Officer program takes over.
Any after-hours call placed to the emergency number goes first to an answering service, which contacts the Late Duty Officer with the information necessary for returning the call. All domestic calls are returned.
In a recent interview, Mrs. Valenti said no one can predict the number or type of calls that will come in. Not all of the calls require further action, she added. Some can be handled on the spot. Others can wait until business hours the next day. Each morning, the Late Duty Officer reports to OEO all activities, including calls that need further attention during business hours.
However, when a caller needs an immediate response, Mrs. Valenti explained, the Late Duty Officer has access to an OEO backup staff member, as well as contact information for key staff members in all parts of FDA.
Not all calls involved products for humans. Pet food or animal feed contamination cases are sometimes reported on FDA’s emergency phone system.
OEO Director Dorothy Miller explained that volunteers for Late Duty Officers do not need any specialized training or backgrounds. They are given general instruction and a manual that sets out guidelines for responses.
Beyond that, Mrs. Valenti said, the Late Duty Officer relies on experience and knowledge of the Agency to make sure all calls are properly handled.
Late Duty Officers work one-week shifts during which they are on call whenever the OEO office is closed, starting Monday afternoon at the close of business and ending the following Monday morning at the start of the business day.
When a Late Duty Officer begins a week-long shift, OEO provides a “kit” that includes a beeper, a cell phone, and a book with contact information for all key FDA staff.
Before the OEO was established, Mrs. Miller said, the after hours duty was assigned to personnel from FDA’s Office of Regulatory Affairs. After the “9/11” tragedy, when officials across the Federal Government wanted to elevate the emergency response functions within their organizations, FDA moved its emergency response to the Commissioner’s Office. OEO officially became part of the Commissioner’s Office in 2003.
Within the Commissioner’s Office, OEO is assigned to the Office of Crisis Management, which has responsibility for coordinating FDA counterterrorism and emergency exercises; planning, developing, and directing physical and personnel security programs; coordinating Agency evaluation of emergencies to determine appropriate responses; and coordinating intra-agency and interagency emergency preparedness.
The Office of Crisis Management also is responsible for activating FDA’s Emergency Operations Center, a physical facility that is staffed during emergencies to coordinate FDA’s response. The center was activated for several weeks during the recall of melamine-contaminated pet food and animal feed.
Mrs. Miller said that using volunteers to staff the Late Duty Officer Response Team program has several advantages over assigning the after-hours duty to FDA staff.
One advantage that the volunteer process offers is far less employee stress. Emergency response work is demanding. Calls must receive a prompt and accurate response, even when they come in the middle of the night, Mrs. Miller said. Individuals required to do that sort of work regularly for any length of time can burn out, she added. With a group of volunteers, the work is spread out. A typical volunteer does a Late Duty shift only once during the year, and normally the volunteer gets to choose which week to work.
A second advantage, perhaps more important, is that the cadre of Late Duty Officer volunteers gives FDA a large pool of emergency workers from which to draw. Through the Late Duty Officer program, the volunteers gain experience in emergency operations, which makes them a valuable resource to be called on when an emergency threatens to overwhelm FDA’s regular response resources. Mrs. Miller called the reserve of trained individuals FDA’s “surge capacity.”
Mrs. Miller cited the need for this surge capacity when Hurricane Katrina hit Louisiana, and the Federal response lasted for weeks. A more recent example was the melamine-contaminated pet food recall. Mrs. Miller explained that, during the recall, FDA received more than 19,000 calls about pet food in the course of just a few months. Normally, FDA receives only about 5,000 calls a year for all the products it regulates.
In addition, she added, the National Response Plan, developed by the U.S. Department of Homeland Security as a blueprint for a U.S. response to terrorist attacks, calls for the use of volunteers.
Mrs. Valenti started volunteering to be the after-hours contact in 1985. She has continued doing it because the program gives her a “great opportunity to touch somebody’s life, to make a difference,” she said.
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In August, the Center for Veterinary Medicine’s Fredda Shere-Valenti received a Special Citation plaque from the Commissioner of Food and Drugs for her participation in the Food and Drug Administration’s Late Duty Officer Response Team program. Approximately 50 volunteers from across FDA received plaques. As a member of the Late Duty Officer Response Team, Mrs. Valenti volunteers her time for a week or more per year to respond to after-hour and weekend calls made to FDA’s emergency phone system. During regular hours, she is a member of the Bioresearch Monitoring and Administrative Actions team in CVM’s Office of Surveillance and Compliance. In that capacity, she issues assignments to FDA’s field organizations to inspect the work of clinical investigators, sponsors, monitors, and non-clinical laboratories to determine compliance with the regulations. She reviews the data the inspectors gather. She also helps train CVM’s animal drug reviewers and members of FDA’s field organizations.