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Guidance Document for Request for Exemption of Select Agents and Toxins for Public Health or Agricul

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The document provides guidance for requesting exemptions from regulations concerning select agents and toxins under the Public Health Security and Bioterrorism Preparedness and Response Act. It outlines the process for submitting APHIS/CDC Form 5 to obtain exemptions for investigational products or in response to public health or agricultural emergencies. The form requires detailed information about the entity, the nature of the exemption requested, and justifications for the request.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Is HPAI a select agent?

HPAI viruses are considered select agents by the USDA Veterinary Services and are subject to select agent regulations 9 CFR Part 121.

Is botulinum toxin a controlled substance?

Because its a controlled substance, you must be counseled about its use and a thorough medical history must be taken to see if you have any contra-indications that would suggest you not get the injection. Conditions that signal a person shouldnt receive Botox include: Hemophilia.

Which types of agents are not on the select agents list?

Excluded Attenuated Strains of HHS Select Agents, Section 73.3 (e) Botulinum neurotoxin producing species of Clostridium. Coxiella burnetii. Eastern equine encephalitis virus. Ebolavirus. Francisella tularensis. Junn virus. Lassa fever virus. Monkeypox virus.

What are select agents in NIH?

A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.

Is polio a select agent?

In contrast, polio is not a Select Agent despite its ability to cause crippling disease and death. Polio virus is endemic in some countries, and is therefore difficult to restrict. Moreover, the availability of effective vaccines reduce the threat posed by this virus.

Is Brucella no longer a select agent?

On 12/17/2024 the Federal Select Agent Program (FSAP) announced that Brucella melitensis, Brucella abortus, and Brucella suis are being removed from the list of regulated select agents, effective 1/16/2025.

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