---
kind: "section"
citation: "21 C.F.R. § 317.2"
title: "21"
number: "317.2"
heading: "List of qualifying pathogens that have the potential to pose a serious threat to public health."
url: "https://uscodex.org/cfr/21/317.2"
---

# §317.2. List of qualifying pathogens that have the potential to pose a serious threat to public health.


The term “qualifying pathogen” in [section 505E(f)](/cfr/21/505E.md?p=f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:

- (a) **Acinetobacter—** species.
- (b) **Aspergillus—** species.
- (c) **Burkholderia cepacia—** complex.
- (d) **Campylobacter—** species.
- (e) **Candida—** species.
- (f) **Clostridium difficile.**
- (g) **Coccidioides—** species.
- (h) **Cryptococcus—** species.
- (i) **Enterobacteriaceae.**
- (j) **Enterococcus—** species.
- (k) **Helicobacter pylori.**
- (l) **Mycobacterium tuberculosis—** complex.
- (m) **Neisseria gonorrhoeae.**
- (n) **Neisseria meningitidis.**
- (o) **Non-tuberculous mycobacteria species.**
- (p) **Pseudomonas—** species.
- (q) **Staphylococcus aureus.**
- (r) **Streptococcus agalactiae.**
- (s) **Streptococcus pneumoniae.**
- (t) **Streptococcus pyogenes.**
- (u) **Vibrio cholerae.**

## Notes

### Authority

Authority: 21 U.S.C. 355f, 371.

### Source

Source: 79 FR 32480, June 5, 2014, unless otherwise noted.