Summary Information Format for Environmental 

Releases

I. INTRODUCTION 

The information requested in the “Summary Information Format for Environmental 

Releases” is used by the Center for Veterinary Biologics (CVB) to evaluate the safety 

characteristics of the vaccine microorganism within the context of the target environment. 

This information is provided to determine: 1) the location and characteristics of the 

release site; 2) the test dose and total amount of the experimental biologic to be used in 

the proposed study; 3) the frequency and duration of exposure to the test material; 4) 

potential escapes into occupational, residential, or outdoor environments; and 5) the 

individuals, populations, or ecosystems that will be, or may be, exposed to the 

experimental biologic. 

An Environmental Release refers to the release of an experimental vaccine 

microorganism to the accessible environment. The Accessible Environment is defined as 

the environment that can be reached by the vaccine microorganism and its progeny. 

II. ENVIRONMENTAL RELEASE 

The progression to determine the safety characteristics of an experimental vaccine 

microorganism eventually requires research involving planned introductions into the 

environment. Planned Introductions into the Environment refers to the deliberate release 

of live microorganisms from contained facilities to the environment. CVB recommends 

and encourages the use of small-scale field tests, when appropriate. 

A. Location of test site 

Identify the exact location of the test site. For proposed commercial uses, the 

conditions under which the vaccine will be used should be identified; e.g., 

unlimited commercial distribution and use, restricted for use by veterinarians 

only, small animal veterinary hospitals, commercial poultry houses, etc. 

B. Characteristics of the test site 

Identify the size of the test site, including relevant geographical and 

environmental information. A description of the area surrounding the test site 

should be provided, including the presence of non-target animal species. The 

condition of the test site should be documented, as well as previous studies 

conducted on the test site. 
C. Personnel 

Identify the personnel conducting the study, including their qualifications, 

training, and specific role in the study. Appropriate safeguards, education, and 

training should be provided as needed. 

D. Experimental design 

Identify the objectives of the release. For small-scale field tests, the protocol of 

study should include the following information, as appropriate: 1) the number of 

animals; 2) a description of the animals; 3) the route of administration; 4) the 

dose; 5) the total amount of test material; 6) frequency and duration of exposure; 

7) the method of disposing waste; and 8) decontamination of the test site. 

CVB recommends the application of Good Developmental Practices (GDP) in the 

design of the study. These guidelines were specifically devised by the 

Organization for Economic Co-Operation and Development (OECD) for smallscale field research with genetically modified plants and microorganisms. The 

GDP concept is applicable to field tests conducted with vaccine microorganisms. 

The goal is to design an experiment that will minimize the dissemination of the 

microorganism, and control the transfer of heterologous genetic material. 

E. Potential for escape and dispersal in the environment 

The potential for escape and dispersal from the release site should be assessed. 

Possible exposure to the area surrounding the test site should be considered and 

evaluated, including the probability of non-target animal exposure. 

F. Potential for establishment in the environment 

The habitability of the test site and/or environments for the introduced vaccine 

microorganism is appraised. The following environmental characteristics are 

evaluated, as appropriate: 1) the presence of other biological organisms; 2) the 

nutrient status; 3) physicochemical factors; and 4) the presence of toxic chemicals 

and metabolites. 

G. Monitoring 

Environmental monitoring is crucial for the success of the risk analysis process; 

monitoring is an essential part of ensuring that unacceptable or unexpected 

adverse events do not occur. Thus, appropriate methods and procedures for 

monitoring the released vaccine microorganism in and around the test site should 

be identified prior to initiating the study. The monitoring methods should be 

sensitive and specific. Provisions for recording the results of the monitoring 

should be in place. 
H. Contingency plans in case of adverse event 

The sponsor of the proposed study should identify contingency plans in case an 

adverse event occurs. Contingency plans should include procedures for 

terminating the study as quickly as possible, and identify methods to stop the 

shed, spread, or dispersal of the vaccine microorganism once released in the 

environment.