1887

Chapter 26 : Licensing and Approval of Antimicrobial Agents for Use in Animals

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Preview this chapter:
Zoom in
Zoomout

Licensing and Approval of Antimicrobial Agents for Use in Animals, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555819804/9781555819798_Chap26-1.gif /docserver/preview/fulltext/10.1128/9781555819804/9781555819798_Chap26-2.gif

Abstract:

Veterinary medicines and vaccines are indispensable for the treatment and prevention of farm animal and pet diseases around the world. To ensure that these medications are high quality and appropriately produced, countries require that animal health medicines are manufactured to specific standards of quality, with proven safety and efficacy. The responsible authority in a given country must authorize that a veterinary medicine can be manufactured, sold, and used. The marketing authorization, also known as “registration” or “license,” implies that the responsible authority has approved not only the product to be marketed, but also the conditions that will characterize the use of the product. These conditions become part of the labelling, packaging, and information leaflets of the product and include (i) the characteristics of the active substance, its purity and concentration, and the complete composition of the medicinal product; (ii) the pharmaceutical form in which the medicine will be delivered (e.g., tablet, powder, cream, solution for injection), and the way it will be administered to the animal (e.g., injection, by mouth, in feed or water, or by topical application); (iii) the animals for which it is intended to be used, including specific ages and weights where relevant; (iv) what diseases or conditions it can be used to prevent, treat, or control, also known as the “indications”; (v) the dosages for each indication, the duration of treatment, and the withdrawal period, which means the number of days the medication must be withheld from farm animals prior to their produce entering the food system; and (vi) other circumstances regarding its use, including storage, shelf life, safety warnings, disposal instructions, and possible contra-indications. The sponsor develops this data package (or “application” or “dossier”) according to the testing requirements and standards of the authorizing legislation in place in the jurisdiction. Authorised veterinary medicines have a clear positive benefit associated with their use while considering the risk to public health, animal health, and the environment. The authorization and production of veterinary medicinal products also require manufacturing controls for the active substance(s) and the final product and sampling and testing of products. Regular manufacturing site inspections and pharmacovigilance ensure continued monitoring once the medicine has been authorised and is being marketed. Additionally, many countries have monitoring systems in place to ensure compliance with maximum residue limits (MRLs). This means that any residues of the medicine in food from its use in food-producing animals must remain below the established safe levels for the consumer.

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Highlighted Text: Show | Hide
Loading full text...

Full text loading...

Figures

Image of Figure 1
Figure 1

Partial decision tree/flow diagram for veterinary medicinal products used for aquaculture according to the Ecotoxicity Phase II VICH Harmonized Tripartide Guideline GL38 ( ).

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Permissions and Reprints Request Permissions
Download as Powerpoint
Image of Figure 2
Figure 2

Chain of events that may lead from use of antimicrobials in animals to a compromised antimicrobial treatment in humans.

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Permissions and Reprints Request Permissions
Download as Powerpoint

References

/content/book/10.1128/9781555819804.chap26
1. Randell AW,, Whitehead AJ . 1997. Codex Alimentarius: food quality and safety standards for international trade. Rev Sci Tech 16 : 313 321.[CrossRef][PubMed]
2. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2003. VICH Harmonized Tripartite Guideline GL27. Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/antimicrobial-safety.html.
3. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2008. VICH Harmonized Tripartide GL43. Target animal safety for veterinary pharmaceutical products. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
4. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration Center For Veterinary Medicine . 1996. CVM GFI #49. Target animal safety and drug effectiveness studies for anti-microbial bovine mastitis products (lactating and non-lactating cow products). https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm053411.htm.
5. European Medicines Agency . 2017. Guideline on the conduct of efficacy studies for intramammary products for use in cattle. EMA/CVMP/344/1999-Rev.2. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/01/WC500220206.pdf.
6. Storey S . 2005. Challenges with the development and approval of pharmaceuticals for fish. AAPS J 7 : E335 E343.[CrossRef][PubMed]
7. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2001. VICH harmonized tripartide guideline GL6. Environmental impact assessment (EIAS) for veterinary medicinal products (VMPS) - ECOTOXICITY PHASE I. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
8. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2004. VICH harmonized tripartide GL38. Environmental impact assessment (EIAs) for veterinary medicinal products (VMPs): ecotoxicity phase II. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/environmental-safety.html.
9. Joint FAO/WHO Expert Committee on Food Additives (JECFA) . 2016. Guidance document for the establishment of acute reference dose (ARfD) for veterinary drug residues in food. http://www.who.int/foodsafety/chem/jecfa/Guidance_ARfD.pdf.
10. Spaepen KRI,, Van Leemput LJJ,, Wislocki PG,, Verschueren C . 1997. A uniform procedure to estimate the predicted environmental concentration of the residues of veterinary medicines in soil. Environ Toxicol Chem 16 : 1977 1982.[CrossRef]
11. Manaia CM . 2017. Assessing the risk of antibiotic resistance transmission from the environment to humans: non-direct proportionality between abundance and risk. Trends Microbiol 25 : 173 181.[CrossRef][PubMed]
12. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2009. VICH harmonized tripartide guideline GL33. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
13. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2002. VICH harmonized tripartite guideline GL31. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (90-day) toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
14. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2004. VICH harmonized tripartite guideline GL37. Studies to evaluate the safety of residues of veterinary drugs in human food: repeat-dose (chronic) toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
15. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2001. VICH harmonized tripartite guideline GL22. Studies to evaluate the safety of residues of veterinary drugs in human food: reproduction testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
16. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2001. VICH harmonized tripartite guideline GL23. Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
17. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2002. VICH harmonized tripartite guideline GL32. Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
18. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2012. VICH harmonized tripartite guideline GL36. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/antimicrobial-safety.html.
19. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2016. VICH harmonized tripartide GL54. Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD). http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/toxicology.html.
20. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2011. VICH harmonized tripartite guideline GL46.Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-safety/metabolism-and-residue-kinetics.html.
21. European Medicines Agency . 2016. Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances. EMA/CVMP/627/2001-Rev.1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/02/WC500200984.pdf.
22. European Medicines Agency . 2010. Guideline on statistical principles for veterinary clinical trials. EMA/CVMP/EWP/81976/2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500097081.pdf.
23. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) . 2000. VICH harmonized tripartite guideline GL9. Good clinical practice. http://www.vichsec.org/guidelines/pharmaceuticals/pharma-efficacy/good-clinical-practice.html.
24. Australian Pesticides and Veterinary Medicines Authority . 2009. Veterinary Manual of requirements and guidelines. Part 10. Special data: antibiotic resistance.
25. Graveland H,, Wagenaar JA,, Heesterbeek H,, Mevius D,, van Duijkeren E,, Heederik D . 2010. Methicillin resistant Staphylococcus aureus ST398 in veal calf farming: human MRSA carriage related with animal antimicrobial usage and farm hygiene. PLoS One 5 : e10990.[CrossRef][PubMed]
26. Persoons D,, Haesebrouck F,, Smet A,, Herman L,, Heyndrickx M,, Martel A,, Catry B,, Berge AC,, Butaye P,, Dewulf J . 2011. Risk factors for ceftiofur resistance in Escherichia coli from Belgian broilers. Epidemiol Infect 139 : 765 771.[CrossRef][PubMed]
27. Vose D,, Acar J,, Anthony F,, Franklin A,, Gupta R,, Nicholls T,, Tamura Y,, Thompson S,, Threlfall EJ,, van Vuuren M,, White DG,, Wegener HC,, Costarrica ML, Office International des Epizooties ad hoc Group . 2001. Antimicrobial resistance: risk analysis methodology for the potential impact on public health of antimicrobial resistant bacteria of animal origin. Rev Sci Tech 20 : 811 827.[CrossRef][PubMed]
28. World Organisation for Animal Health (OIE) . 2011. Terrestrial Animal Health Code, chapter 6.10. www.oie.int/doc/ged/D10905.pdf.
29. Codex Alimentarius Commission . 2005. Code of practice to minimize and contain antimicrobial resistance. CAC/RCP 61-2005. http://www.fao.org/input/download/standards/10213/CXP_061e.pdf.
30. Codex Alimentarius Commission . 2011. Guidelines for risk analysis of foodborne antimicrobial resistance. CAC/GL 77-2011. www.fao.org/input/download/standards/11776/CXG_077e.pdf.
31. World Trade Organization . 2018. The WTO agreement on the application of sanitary and phytosanitary measures (SPS agreement). https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm#fnt1.
32. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine . 2003. Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. CVM GFI # 152. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf.
33. European Medicines Agency . 2015. Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals. EMA/CVMP/AWP/706442/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500183774.pdf.
34. Health Canada, Veterinary Drugs Directorate . 2005. Current thinking on risk management measures to address antimicrobial resistance associated with the use of antimicrobial agents in food-producing animals. http://www.hc-sc.gc.ca/dhp-mps/vet/antimicrob/amr-ram_rep-rap_06_05-eng.php.
35. Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR) . 1999. The Use of Antibiotics in Food-Producing Animals: Antibiotic-Resistant Bacteria in Animals and Humans. Appendix 8. Antibiotic imports to Australia, 1992-97. Commonwealth Department of Health and Aged Care and Commonwealth Department of Agriculture, Fisheries and Forestry, Canberra, Australia.
36. EMEA/CVMP . 2006. Reflection paper on the use of fluoroquinolones in food producing animals: precautions for use in the SPC regarding prudent use guidance. EMEA/CVMP/416168/2006-FINAL). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf.
37. EMEA/CVMP . 2009. Revised reflection paper on the use of 3rd and 4th generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health. EMEA/CVMP/SAGAM/81730/2006-Rev.1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf.
38. EMA/CVMP . 2011. Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf.
39. EMA/CVMP . 2010. Opinion following an Article 35 referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Quinolones_containing_medicinal_products/vet_referral_000039.jsp&mid=WC0b01ac05805c5170.
40. EMA/CVMP . 2012. Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Cephalosporins/vet_referral_000056.jsp&mid=WC0b01ac05805c5170.
41. European Medicines Agency . 2013. Reflection paper on the risk of antimicrobial resistance transfer from companion animals. EMA/CVMP/AWP/401740/2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500181642.pdf.
42. Pomba C,, Rantala M,, Greko C,, Baptiste KE,, Catry B,, van Duijkeren E,, Mateus A,, Moreno MA,, Pyörälä S,, Ružauskas M,, Sanders P,, Teale C,, Threlfall EJ,, Kunsagi Z,, Torren-Edo J,, Jukes H,, Törneke K . 2017. Public health risk of antimicrobial resistance transfer from companion animals. J Antimicrob Chemother 72 : 957 968.[PubMed]
43. World Health Organization, Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) . 2016. Critically Important Antimicrobials for Human Medicine, 4th rev. 2013. http://apps.who.int/iris/bitstream/10665/251715/1/9789241511469-eng.pdf?ua=1.
44. WHO . 2017. WHO guidelines on use of medically important antimicrobials in food-producing animals. World Health Organization, Geneva, Switzerland.
45. World Organisation for Animal Health . 2015. OIE list of antimicrobial agents of veterinary importance. http://www.oie.int/fileadmin/Home/eng/Our_scientific_expertise/docs/pdf/Eng_OIE_List_antimicrobials_May2015.pdf.
46. European Medicines Agency . 2014. Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals. EMA/381884/2014. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/07/WC500170253.pdf.
47. European Medicines Agency . 2016. Sales of veterinary antimicrobial agents in 29 European countries in 2014. EMA/61769/2016. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/10/WC500214217.pdf.
48. European Medicines Agency, Committee for Medicinal Products for Veterinary Use (EMA/CVMP) . Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Colistin_35/WC500093733.pdf.
49. Catry B,, Cavaleri M,, Baptiste K,, Grave K,, Grein K,, Holm A,, Jukes H,, Liebana E,, Navas AL,, Mackay D,, Magiorakos A-P,, Romo MAM,, Moulin G,, Madero CM,, Pomba MCMF,, Powell M,, Pyörälä S,, Rantala M,, Ružauskas M,, Sanders P,, Teale C,, Threlfall EJ,, Törneke K,, Van Duijkeren E,, Torren Edo J . 2015. Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health. Int JAntimicrob Agents 46 : 297 306.[PubMed]
50. Catry B,, Threlfall J . 2009. Critically important antimicrobial--or not? Clin Infect Dis 49 : 1961 1962, author reply 1962–1963.[CrossRef]
51. RONAFA . 2017. EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety. EFSA J 15 : e4666.[CrossRef]
52. Pardon B . 2012. Morbidity, mortality and drug use in white veal calves with emphasis on respiratory disease. PhD thesis, Ghent University, Ghent, Belgium.
53. Catry B,, Duchateau L,, Van de Ven J,, Laevens H,, Opsomer G,, Haesebrouck F,, De Kruif A . 2008. Efficacy of metaphylactic florfenicol therapy during natural outbreaks of bovine respiratory disease. J Vet Pharmacol Ther 31 : 479 487.[CrossRef][PubMed]
54. Filippitzi ME,, Sarrazin S,, Imberechts H,, Smet A,, Dewulf J . 2016. Risk of cross-contamination due to the use of antimicrobial medicated feed throughout the trail of feed from the feed mill to the farm. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 33 : 644 655 10.1080/19440049.2016.1160442.
55. Catry B,, Dewulf J,, Maes D,, Pardon B,, Callens B,, Vanrobaeys M,, Opsomer G,, de Kruif A,, Haesebrouck F . 2016. Effect of antimicrobial consumption and production type on antibacterial resistance in the bovine respiratory and digestive tract. PLoS One 11 : e0146488.[CrossRef][PubMed]
56. Barnum DA,, Newbould FH . 1961. The use of the California mastitis test for the detection of bovine mastitis. Can Vet J 2 : 83 90.[PubMed]
57. Giguère S . 2017. Treatment of infections caused by Rhodococcus equi. Vet Clin North Am Equine Pract 33 : 67 85.[PubMed]
58. NethMap . 2016. Consumption of antimicrobial agents and antimicrobial resistance among medically important bacteria in The Netherlands in 2015. http://www.wur.nl/upload_mm/0/b/c/433ca2d5-c97f-4aa1-ad34-a45ad522df95_92416_008804_NethmapMaran2016+TG2.pdf.
59. Hanon J-B,, Jaspers S,, Butaye P,, Wattiau P,, Méroc E,, Aerts M,, Imberechts H,, Vermeersch K,, Van der Stede Y . 2015. A trend analysis of antimicrobial resistance in commensal Escherichia coli from several livestock species in Belgium (2011–2014). Prev Vet Med 122 : 443 452.[CrossRef][PubMed]
60. Catry B,, Van Duijkeren E,, Pomba MC,, Greko C,, Moreno MA,, Pyörälä S,, Ruzauskas M,, Sanders P,, Threlfall EJ,, Ungemach F,, Törneke K,, Munoz-Madero C,, Torren-Edo J, Scientific Advisory Group on Antimicrobials (SAGAM) . 2010. Reflection paper on MRSA in food-producing and companion animals: epidemiology and control options for human and animal health. Epidemiol Infect 138 : 626 644.[CrossRef][PubMed]
61. DANMAP . 2016. DANMAP 2015: Use of Antimicrobial Agents and Occurrence of Antimicrobial Resistance in Bacteria from Food Animals, Food and Humans in Denmark. http://www.danmap.org/∼/media/Projekt%20sites/Danmap/DANMAP%20reports/DANMAP%20%202015/DANMAP%202015.ashx.

Tables

Generic image for table
Table 1

Derivation of ADI from data

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Generic image for table
Table 2

Risk analysis frameworks in the approval of veterinary medicinal products containing antimicrobial substances

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Generic image for table
Table 3

Summary of WHO recommendations on use of medically important antimicrobials in food-producing animals

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017
Generic image for table
Table 4

Categories of antimicrobials according to the annex of the FDA guidance

Citation: Pomba C, Catry B, Edo J, Jukes H. 2018. Licensing and Approval of Antimicrobial Agents for Use in Animals, p 549-567. In Schwarz S, Cavaco L, Shen J (ed), Antimicrobial Resistance in Bacteria from Livestock and Companion Animals. ASM Press, Washington, DC. doi: 10.1128/microbiolspec.ARBA-0016-2017

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error