Select Agents

Select Agents
Safety, Security and Compliance

Requirements for "select agents" are changing rapidly. Most notably, new regulations require:

registration for possession of agents (previously only transfer)
application to the Department of Justice for individuals working with agents
additional security requirements as referenced in the newly published "Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents"

This page has been created to assist with new safety, security and compliance measures. Use the list of select agents and their exemptions to determine if you fall under the new application requirements. If not, you still must follow many of the safety and security requirements. Additional information below is broken into NEWS, GUIDANCE DOCUMENTS and REGULATIONS. Additional information will be added as it becomes available. Please contact EHS for additional information and assistance.

NEWS

**Locks and Safes for Select Agent Storage

**Balancing Scientific Publication and National Security Concerns: Issues for Congress

**Select Agent Destruction Procedures and Form now available.

**Compliance Dates (additional information) - Note the following compliance dates:

February 7 - All sections of regulations relating to purpose and scope, prohibitions, listed agents/toxins/pathogens and exemptions, RO, safety & emergency response (incl. training), records, inspections, notification of theft/loss/release, penalties, appeals

March 12 - Application due, certifying compliance with effective sections and that the applications for DOJ review for entity and RO are submitted, Transfer Provisions in effect

April 12 - Application for DOJ review for individuals submitted, Entity and RO review completed by DOJ

June 12 - Individual DOJ review complete, Security Plan development complete

September 12 - Security Plan implemented, Training for security provisions completed.

November 12 - Full compliance required, Registration section effective

**Work with New Agents - If you have not received approval to work with a select agent under the old system prior to February 7, 2003, you will not be entitled to the transition process currently outlined in the regulations. If an entity first begins working with a select agent after February 07, 2003, then that entity will be required to be in compliance with the new regulations sooner than if you had been working with select agents prior to February 7, 2003.

**Toxin Exemptions - The new regulations do allow exemptions for toxins. Toxins are regulated based on potency and quantity (as opposed to potency only or LD50 values under the previous regulations). Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation:

Abrin (100 mg)

Botulinum neurotoxin (0.5 mg)

Clostridium perfringens epsilon toxin (100 mg)

Conotoxins (100 mg)

Diacetoxyscirpenol (1000 mg)

Ricin (100 mg)

Saxitoxin (100 mg)

Shiga-like ribosome inactivating proteins (100 mg)

Shigatoxin (100 mg)

Staphylococcal enterotoxin (5 mg)

Tetrodotoxin (100 mg)

T-2 (1,000 mg)

GUIDANCE DOCUMENTS

FAQ for New Select Agent Regulation (42 CFR 73) (issued by the Centers for Disease Control and Prevention {CDC})
Laboratory Security and Emergency Response Guidance for Laboratories Working with Select Agents (guidance document issued by the CDC in December of 2002 through its Morbidity and Mortality Weekly Report)
Select agent list with exemptions

REGULATIONS