§ 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:
Acinetobacter(a) species.
Aspergillus(b) species.
Burkholderia cepacia(c) complex.
Campylobacter(d) species.
Candida(e) species.
Clostridium difficile.(f)
Coccidioides(g) species.
Cryptococcus(h) species.
(i) Enterobacteriaceae.
Enterococcus(j) species.
Helicobacter pylori.(k)
Mycobacterium tuberculosis(l) complex.
Neisseria gonorrhoeae.(m)
Neisseria meningitidis.(n)
(o) Non-tuberculous mycobacteria species.
Pseudomonas(p) species.
Staphylococcus aureus.(q)
Streptococcus agalactiae.(r)
Streptococcus pneumoniae.(s)
Streptococcus pyogenes.(t)
Vibrio cholerae.(u)
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.