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Harvard Biosafety



Introduction:

As a result of legislation dating from 1997 possession of ~100 biological agents requires permission from the US Government. They are called "Select Agents." Investigators working with these agents must register
with the US government. Two agencies are involved: the Department of Health and Human Services and the Department of Agriculture. Select Agent List in Word or pdf. The list was up to date on 2 July 2007.

Permission from the USDA or the DHHS is required before you can recieve any Select Agents. Of course forms are required. Links to the forms are at this page. Read the instructions carefully. A full application requires a CDC/APHIS form, a FBI form and fingerprints taken at your local constabulary.

Every member of the lab with acess to Select Agents will have to be reported to CDC/APHIS/FBI.. Those deemed by CDC/APHIS and the Justice Department to be "Restricted Persons" will not be permitted to work with Select Agents. Characteristics of "Restricted Persons." Penalties for violating the law are severe. They range up to $500,000 and 10 years in jail.

The following are three full texts of the Special Agent Rules; one from the Department of Health and Human Services, two others from the US Department of Agriculture. [Note: In late August 2007 several minor changes were made in the regulations. The changes are not refelected in the links below.]

Summary of Changes, USDA
USDA, Title 7 (Plant Targets) In Word In PDF
USDA, Title 9 (Animal Targets) In Word In PDF
DHHS, Title 42 (Human Targets) In Word In PDF

You can keep up to date by checking these web sites occasionally:
USDA Bioterrorism Site
CDC Select Agent Site and
Exclusions from the Select Agent Rule

Links to Major Bioterrorism Web Sites


Acronyms

COMS: Regulations | Forms | Resources | About COMS | COMS home  

ORSP: About | Human | Animal | COMS | ORSP home  

Mail comments to abraun@hms.harvard.edu. Page last updated December 26, 2007   
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