No NBAF in Kansas

Real Biosecurity for the Heartland

Past Releases of Foot and Mouth Disease and Other Dangerous Pathogens

Posted by nonbafks on August 11, 2008

We found no evidence that the study examined data from past releases of FMD—particularly the release of FMD on Plum Island in 1978—or the history of internal releases at PIADC. The study did not assess the general history of accidents within biocontainment laboratories, and it did not consider the lessons that can be learned from a survey of the causes of such accidents. Such a survey would show that technology and operating procedures alone cannot ensure against a release, since human error can never be completely eliminated and since a lack of commitment to the proper maintenance of biocontainment facilities and their associated technology—as the Pirbright facility showed—can cause releases.

The study panel members we interviewed said that no data on past accidents with or releases of either FMD or other pathogens was systematically presented or discussed. Rather, the panel members recalled that they relied on their own knowledge of and experience with the history of releases in a general discussion.

The release of FMD virus from facilities is very rare. In fact, the incidence of the release of any dangerous pathogen from modern containment facilities is quite low. During the vast majority of the time, such facilities have been operating safely. Some releases have occurred, however. Table 2 lists known and attributed releases of FMD virus from laboratories worldwide, including those that produce vaccines.

25As required by the National Environmental Policy Act, DHS must prepare an EIS for each of the six potential NBAF sites. DHS told us that each EIS will contain an analysis of site-specific environmental consequences, given, among other things, an accidental release of FMD at the site. However, DHS would not give us specifics on what this analysis will contain or which accident scenarios are being considered. DHS told us that the draft EIS for each site is due at the end of May 2008.

Table 2: Years Foot-and-Mouth Virus Is Known or Believed to Have Been Released from Laboratories

Year

Country

1960, Jan.

United Kingdom

1968

Denmark

1969

Czechoslovakia

1972

Hungary

1974

Germany

1975

Czechoslovakia

1976

Germany

1977

Germany

1978, Sept.

United States

1979

Spain

1987

Germany

1988

Germany

1993

Russia

2007, July

United Kingdom

Source: GAO analysis of UK’s Department of Environment, Food, and Rural Affairs.

A particular deficiency in the 2002 USDA study was the omission of any explicit analysis of the release of FMD virus from Plum Island itself in 1978. In September of that year, FMD virus was found to have infected clean animals being held outside the laboratory compound in the quarantined animal supply area of PIADC. The exact route by which the virus escaped from containment and subsequently infected the animal supply was never definitely ascertained. An internal investigation concluded that the most probable routes of escape of the virus from containment were (1) faulty air balance of the incinerator area, (2) leakage through inadequately maintained air filter and vent systems, and (3) seepage of water under or through a construction barrier near the incinerator area. Animal care workers then most likely carried the disease back to the animal supply area on the island, where it infected clean animals being held for future work. (See table 3.)

Table 3: Deficiencies Noted as Contributing to a 1978 Release of FMD Virus at Plum Island

Issue

Deficiency

Air balance

Deficient recordkeeping

Exhaust air filters in poor state of repair

Improperly wired exhaust air handling units

Failure to follow normal procedures

Exhaust air filters

Failure to inspect and test new filters after changing

Failure to maintain filter gaskets

Insufficient personnel

Movement of personnel

Change in procedures

New construction

Containment barrier removed before building replacement barrier

Improperly built temporary construction barrier

Source: GAO analysis of USDA data.

An analysis of the deficiencies underlying these probable routes of escape noted during the investigation show that all were related to human error and that none were related to insufficient containment technology. Any one of these deficiencies could happen in a modern facility, since they were not a function of the technology or its sophistication, procedures or their completeness, or even, primarily, the age of the facility. The deficiencies were errors in human judgment or execution and, as such, could occur today as easily as they did in 1978.

In addition, a number of incidents at PIADC have resulted in internal releases such that animals within the laboratory compound inadvertently became infected, although no FMD virus was released outside the facility. These incidents show that technology sometimes fails, facilities age, and humans make mistakes. Table 4 lists known internal releases of FMD virus at PIADC since 1971.

Table 4: Internal Releases of Foot-and-Mouth Virus at Plum Island, 1971–2004

Date

Incident

Probable cause

Sept. 1971

A scientific publication in the proceedings of the 75th Annual Meeting of the U.S. Animal Health Association in 1971 identified the accidental infection of two steers. The infection was believed to have been caused by an air leak found in a door gasket. This resulted in an infectious aerosol being drawn into the room because of lower air pressure. Two steers in the acute clinical stage of infection with FMD had been moved through an adjacent corridor; 5 days later, the two steers maintained in the room had clinical signs and lesions of FMD of the same virus type as the animals in the adjacent corridor. The door seals in use at that time were not self-inflating. This problem is addressed today with inflatable seals that close the gap around doors and prevent aerosol entry.

An air leak in a door gasket

Apr.12, 1974

Two steers in the West Animal Wing developed symptoms of FMD. The animals had never been inoculated with intentionally exposed to any infectious agents, but both exhibited signs of disease and both were determined to be infected with FMD. An investigation determined that FMD probably came into the animal room through leaks in the walls. A power failure may also have resulted in a difference in pressure between two rooms, causing virus to flow from an infected room into the one housing the steer. Preventative maintenance of the rooms was conducted to prevent re-occurrence.

Leaks in the walls combined with a power failure

Aug. 21, 1980

Eighteen steers being used in a vaccine trial had been vaccinated with a Type C PIADC-produced FMD vaccine. Before challenge, approximately half the animals were found to have fever and lesions indicative of FMD. Further study identified that the animals had Type O and Type C antibodies. Because they had not been vaccinated for the Type O strain, these antibodies were related to an unknown exposure. The actual cause of this outbreak was not identified, but it could have been a mechanical transfer in which a laboratory worker carried the virus into the facility and transmitted it to the animals.

Mechanical transfer by a laboratory worker

Feb. 24, 1981

Four steers vaccinated 60 days earlier with FMD Type O were found to be infected with Type A. The actual cause of this incident was not identified; it was determined that cross-contamination from other areas in the laboratory was the most likely cause.

Cross-contamination from an unknown source

May 26, 1987

One of two Heifers housed in the East Animal Wing was found to be infected with FMD without previous inoculation or known exposure to the virus. On testing, the animal was found to be infected with FMD virus Type O. Investigation determined that Type O virus had been used in research experiments in two nearby rooms. The infected animals in these other rooms had been euthanized and the carcasses transported down the outside corridor. It was determined that the potential cause of the incident was fluids leaking during transport or an aerosol created from the bags used for transport. Negative air pressure in the animal room could then have resulted in cross-contamination from the hallway. Actions were taken to replace equipment used in transport and to decontaminate corridors more thoroughly.

June 24, 2004

Two cattle in the East Wing, Room 1178, not involved in live virus research were observed with clinical signs of FMD. Testing identified them as being infected with Type O FMD. In addition, on July 19, 2004, four pigs in a separate, Orient Wing room not involved in live virus research were observed with clinical FMD. Subsequent testing revealed a different strain Type O. Although no specific cause was found for either incident, the most likely cause was cross-contamination from other areas in the laboratory. New animal care protocols were instituted to restrict direct access from the laboratories to the animal wings. The new protocols included a single point of entrance to animal wings for authorized personnel who had undergone extensive training in biosafety measures, laboratory clothing exchanged before entering the animal wing, mandatory showering on exiting from animal rooms (even if they contained uninfected animals), and decontamination of all laboratory samples coming in or being removed from the animal rooms. Since this new control was initiated, there have been no other instances of cross-contamination inside the animal wing.

Cross-contamination from an unknown source

Source: GAO analysis of DHS and USDA data.

These incidents involved human error, lack of proper maintenance, equipment failure, and deviation from standard operating procedures. Many were not a function of the age of the facility or the lack of technology and could happen in any facility today. While these incidents did not directly result in any external release, they could have been useful in the 2002 study in illustrating the variety of ways in which internal controls—especially in large animal biocontainment facilities—can be compromised.

Given the rarity of the release of FMD virus from laboratories, and how relevant its release is to the question of moving FMD work off its present island location, we believe that the 2002 study was remiss in not more explicitly considering this matter. In fact, members of the panel we spoke with could recall little, if any, discussion of incidents of release at Plum Island.

Beyond the history of incidents at Plum Island, we found no evidence that the study considered the history of accidents in or releases from biocontainment facilities generally. Had the study considered this history, it would have shown that no facility for handling dangerous pathogens can ever be completely safe and that no technology can be totally relied on to ensure safety.

25As required by the National Environmental Policy Act, DHS must prepare an EIS for each of the six potential NBAF sites. DHS told us that each EIS will contain an analysis of site-specific environmental consequences, given, among other things, an accidental release of FMD at the site. However, DHS would not give us specifics on what this analysis will contain or which accident scenarios are being considered. DHS told us that the draft EIS for each site is due at the end of May 2008.

Keywords: accidents; releases

Source: Page 13-17 GAO-08-821T

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