Call to Action: Carbadox Comments Due 6/10

June 3, 2022 — 

The FDA has extended the comment period on scientific data and information related to concerns over residues of carbadox (Mecadox), which is used in swine feed. If FDA removes the approved residue testing method for carbadox the product could no longer be marketed.

NPPC would like to thank those individuals who have previously submitted comments and participated in the virtual public hearing March 10th!

With the extension to the comment period, we are asking others to consider contributing comments as well; outlining the ways carbadox is used, the withdrawal periods that are observed, impacts to animal health, and the potential influence on antimicrobial resistance due to the switch to medically important antimicrobials for humans in the event carbadox is no longer available will be impactful. Finally, our collective ask of FDA is to work with the drug sponsor (Phibro) to develop a new residue method as a solution to their concern.

Please CLICK HERE to find a letter with some suggested comments. Enter your personal information in the highlighted areas, unhighlight, and save before submitting them as formal comments.

Comment submission: Deadline 6/10; to electronically submit your comments to the docket, please visit www.regulations.gov/ and type FDA-2021-N-1326 in the search box.

Next:

• Select the box to the left that reads "Only show documents open for comment"
• Click on Proposed Rule.
• Then click on the square blue box that says "Comment".
• Go to "Attach files" and drop in the prepared letter that you have completed.
• Finally, complete the bottom of the page and click on "Submit Comment".

*As mentioned above, NPPC has provided you with a letter that requires you to just add your personal information and field experience with carbadox. Please feel free to add other pertinent information. If you prefer you can mail your letter to the address provided in the docket.

Focus points:

• Withdrawal time -
• Carbadox has been effectively used by most pork producers for decades to support animal health while adhering to the 42-day withdrawal period.
• Since carbadox is mainly used in pigs at the nursery stage, the 42-day withdrawal period is likely to extend to 60 days or more, resulting in an additional safety buffer against residues.
• PQA+ - Pork producers prioritize the avoidance of violative residues of all animal health products, as evidenced by the high level of participation in the industry's Pork Quality Assurance Plus certification program and the extremely low level of all violative residues in market swine tested by the USDA's Food Safety Inspection Service.
• Antimicrobial resistance -
• If carbadox is taken off the market, hog farmers will be forced to treat their pigs with antibiotics that are important to fighting human infections, thereby potentially increasing the reservoir of antimicrobial resistant bacteria of concern to both human and animal health.
• The removal of carbadox from the marketplace would inevitably increase the use of other antibiotics and increase the likelihood of difficult-to-control antimicrobial resistance in important bacterial pathogens.
• Diverting valuable resources and treatment options away from the practice of medicine benefits neither patient nor owner.

You can find the full FDA announcement HERE.

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Anna Forseth, Director of Animal Health, National Pork Producers Council