Bactericidal Considerations to the FDA Briefing Document
As you may or may not have heard, the FDA has released a Briefing Document in March of 2020 that proposes an alternative organism panel from the Tentative Final Monograph (TFM) for consumer and healthcare antiseptics. Amongst growing interest from our clients on this topic, we have authored this article to provide additional information about what the briefing document means.
TFM Alternative Organism Panel Proposal
The FDA Briefing Document released on March 11, 2020 (https://www.fda.gov/media/135559/download), proposes an alternative organism panel from the TFM (https://www.federalregister.gov/documents/2016/06/30/2016-15410/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for).
Below are the in vitro panels of organisms for antiseptics, such as hand rubs, in the TFM for consumer and health care industries and in the Briefing Document for consumer and health care, and food handler industries:
What’s In The Existing TFM
Consumer and Healthcare Antiseptics Panel listed in the TFM:
Haemophilus influenzae, Bacteroides fragilis, Enterobacter species, Burkholderia cepacia (ATCC 25416 and ATCC 25608), Escherichia coli (ATCC 11775 and ATCC 25922), Klebsiella pneumoniae (ATCC 13883 and ATCC 27736), Pseudomonas aeruginosa (ATCC 15442 and ATCC 27853), Serratia marcescens (ATCC 8100 and ATCC 14756), Campylobacter jejuni (ATCC 33291 and ATCC 49943), Salmonella enterica, Serovar Enteritidis (ATCC 13076) and Serovar Typhimurium (ATCC 14028), Shigella sonnei (ATCC 9290 and ATCC 25931), Enterococcus faecalis (ATCC 19433 and ATCC 29212), Staphylococcus aureus (ATCC 6538 and ATCC 29213) and methicillin-resistant Staphylococcus aureus (ATCC 33591 and ATCC 33592), Streptococcus pyogenes (ATCC 14289 and ATCC 19615), Listeria monocytogenes (ATCC 7644 and ATCC 19115), and Streptococcus pneumoniae (ATCC 6303 and ATCC 49619)
What’s In The New FDA Briefing Document
Proposed Consumer and Healthcare Antiseptics Panel in the Briefing Document:
Staphylococcus aureus (ATCC 6538 and 29213), Staphylococcus epidermidis (ATCC 12228), Staphylococcus hominis, Staphylococcus haemolyticus, Staphylococcus saprophyticus, Micrococcus luteus (ATCC 7468), Streptococcus pyogenes, Enterococcus faecalis (ATCC 29212), Enterococcus faecium, Streptococcus pneumoniae, Acinetobacter species, Bacteroides fragilis, Haemophilus influenzae, Escherichia coli (ATCC 11229 and 25922), Klebsiella species, Klebsiella pneumoniae, Pseudomonas aeruginosa (ATCC 15442 and 27853), Proteus mirabilis, Serratia marcescens (ATCC 14756), Candida species, and Candida albicans
Proposed Food Handler Antiseptics Panel in the Briefing Document:
Salmonella spp., Salmonella Typhi, Campylobacter jejuni, Yersinia enterocolitica, Vibrio parahaemolyticus, Coxiella burnetiid, Brucella spp., Vibrio cholerae serogroups O1 and O139 including non-O1 and non-O139, Vibrio vulnificus, Vibrio parahaemolyticus, Cronobacter (Enterobacter sakazakii) spp., Aeromonas hydrophila and other spp., Plesiomonas shigelloides, Misc. bacterial enterics, (Klebsiella, Enterobacter, Proteus, Citrobacter, Aerobacter, Providencia, Serratia), Francisella tularensis, Enterotoxigenic E. coli (ETEC), Enteropathogenic E. coli (EPEC), Enterohemorrhagic E. coli O157:H7 (EHEC), Enteroinvasive E. coli (EIEC), Clostridium perfringens, Staphylococcus aureus, Listeria monocytogenes, Enterococcus, Shigella spp. (causes shigellosis), Bacillus cereus and other Bacillus spp., Streptococcus spp. Streptococcus pyogenes, Mycobacterium bovis, Clostridium botulinum, Clostridium perfringens, Cryptosporidium spp., Cyclospora cayetanensis, E. coli producing toxin, and Shiga toxin-producing E.coli
FDA Is Altering Organism Panels
The FDA is altering the organism panels based on the statistics of illness in the applicable industries. Based on our review of the documents and our industry experience, one can reasonably assume that organism panels will continue to be updated according to the most current and available health data provided by the CDC.
Both documents have clarified that the FDA will issue guidance for food handler antiseptics in a separate and distinct monograph. We will continue to monitor the guidance released from regulatory agencies to ensure our testing compliance.
As always, Q Laboratories is available to assist you with your Time-Kill, Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) testing needs.
Please contact us to learn more about how we can support your business needs.