By Ed Maltby, NODPA Executive Director
Meloxicam: This article builds on the article in the September NODPA News which laid out the process the NOSB Livestock Subcommittee took in presenting a recommendation for voting by the full NOSB Board. Approving the addition of Meloxicam to the National List for use of all organic livestock was an issue that drew many farmer, veterinarian and industry commentators, all of whom believed that the drug would be a useful addition to existing drugs to relieve pain. In virtual and in-person comments, the major difference commenters had was the process that the Livestock subcommittee had followed in reaching a decision that the drug could be used on all livestock.
NODPA joined with Organic Farmers Association (OFA), National Organic Coalition (NOC), Western Organic Dairy Producers Alliance (WODPA) and other producers to urge the Board to support the use of Meloxicam, annotated only for the dehorning or disbudding of bovine calves under one year, and recommend that the Board send the broader uses of Meloxicam back to the Livestock Subcommittee and request an outside Technical Review to inform decision-making regarding potential uses for other livestock, including poultry. The Board’s main argument for moving swiftly was that the petition came from producers. While the petitioners’ companies do represent large volumes of organic milk sold in the US, (one of the petitioners is Aurora, the largest organic dairy in the US) the petition does not represent the views of all organic dairy producers and other livestock producers. Brands such as Maple Hill Creamery and milk buyers, for example Upstate Niagara, were not signatures to the petition. The petitioners were advised and assisted by past NOSB member John Foster of Wolf Associates.
In the 3 minutes allowed by the NOSB process, NODPA made the following points:
“The petition and Subcommittee review focused on Meloxicam as it applies to bovines rather than all livestock, and we have the following concerns with the Subcommittee decision to do an internal review rather than an independent Technical Review (TR):
An independent TR ensures the integrity of the NOSB process and verifies what is presented in a petition and the subcommittee review.
An independent TR provides a reference for all NOSB members, community members, reporters and concerned consumers on recommendations made.
A TR allows future Boards to understand the rationale behind the recommendation.
A TR provides an independent scientific assessment that will be used during the process of rule writing and review by different departments within the USDA and other agencies, especially the USDA Office of the General Council. An internal review by a FACA committee, which NOSB is, has little standing within the process.
The Subcommittee review has no mention of the qualifications of the committee members who completed the internal technical review, no printout of the internal TR, or any detailed notes in the Subcommittee minutes to show the discussion on the veracity of the review.
Approval of new drugs should not be based solely on ease of use, cheap cost, long-lasting effect, or animal welfare requirements of any one milk buyer but on following the NOSB process ensuring transparency and integrity. US consumers value less drugs used in organic and more reliance on herd health through practices that support natural behavior and herd immunity.”
In the unusual, precedent-setting, and sometimes quirky, presentation by the two members of the Livestock subcommittee, they appealed to the emotional argument for animal welfare rather than the science of human health, protecting consumers and organic integrity. While showing a PowerPoint presentation of snapshots of the two Board members on the farm or lying against a cow when they were young, they produced a copy of an internal technical review. They requested that this review be introduced into the record. This was the first time that this document had become public and was not in the minutes of the subcommittee meetings. The presentation urged the Board to trust FDA, veterinarians, the detailed petition and the internal review just presented as describing the effectiveness of enforcement and control of the drug entering the food system. There was no reference to FDA records of the disciplinary action taken when products had tested positive. There was no data on how much testing is done for the drug which is commonly used conventionally for everything from scours for calves to increasing milk production for freshly lactating cows. While no one doubts the need for the highest standard of animal welfare and the experience of veterinarians, recommendation for withdrawal periods are standard practice within organic recommendations on the National List, even under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). These annotations are easily referenced by producers and certifiers and ensure consistency across all operations. At this meeting, the Board approved prescription products to stay on the National List, all of them with annotated organic-specific withdrawal periods. Incredibly, the presentation also made the claim that Meloxicam would increase the production of organic pork and make it safer for kids to administer drugs to livestock. In answering questions from the Board, the Board members making the presentation admitted there was a lack of transparency and a lack of process, and they would learn to do better. After 5 years on the Board, they have run out of time to learn as their term on the NOSB Board ends at the end of the year.
The full Board, with one abstention, voted to approve the recommendation of the livestock subcommittee and allow the use of Meloxicam for all livestock under prescription by a veterinarian and with a withdrawal period two times what is required by FDA.
This recommendation now moves to the NOP for rulemaking. For producers, once approved through rulemaking, using Meloxicam will be the same process that they are accustomed to with other prescription drugs they use under their valid veterinary-client relationship.
On October 25, 2024, NODPA sent a letter to the NOSB Board Chair and the NOP because the NODPA Board “are alarmed and displeased, that over the last few NOSB meetings in which farmers participated, we have noticed that farmers who have made the effort to make comments, have not received the respect they deserve.’ The letter goes on to say, “What steps can be taken to ensure that commenters can feel respected and make their comments in a safe environment, free of any concern that they may be subject to toxic questioning?” The letter requests the NOSB adds some language to the Policy and Procedures manual to ensure Board members address commenters respectfully.
The following were approved to stay on the National List with no votes against:
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(3) Atropine (CAS #-51-55-8)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(ii) A meat withdrawal period of at least 56 days after administering to livestock intended for slaughter; and a milk discard period of at least 12 days after administering to dairy animals.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (16) Iodine.
§ 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable. (4) Iodine.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (19) Magnesium sulfate.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(23) Parasiticides—prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(23) Parasiticides—prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (24) Peroxyacetic/peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing equipment.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(30) Xylazine (CAS #-7361-61-7)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(i) Use by or on the lawful written order of a licensed veterinarian, and;
(ii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.
§ 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (29) Tolazoline (CAS #-59-98-3)—federal law restricts this drug to use by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:
(iii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.
§ 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable. (8) Oxalic acid dihydrate—for use as a pesticide solely for apiculture.
§ 205.603(d) As feed additives. (1) DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog calcium (CAS #’s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic poultry production
§ 205.603(d) As feed additives. (2) Trace minerals, used for enrichment or fortification when FDA approved.
§ 205.603(d) As feed additives. (3) Vitamins, used for enrichment or fortification when FDA approved.
Vote: Motion to amend the annotation of DL-Methionine on the National List at 7 CFR 205.603(d)(1) as follows:
§ 205.603(d) As feed additives.
(1) DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy analog calcium (CAS #’s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic poultry production at the following pounds of synthetic 100 percent methionine per ton of feed in the diet, maximum rates as averaged per ton of feed over the life of the flock: Laying chickens—2 pounds; broiler chickens—2.5 pounds; turkeys and all other poultry—3 pounds.
Yes: 14; No: 0; Abstain: 0; Recuse: 0; Absent: 1. Motion succeeds.
Vote: Motion to send this back to subcommittee. Yes: 14; No: 0; Abstain: 0; Recuse: 0; Absent: 1. Motion carries to send this issue back to the subcommittee.
* This article concentrates on the Livestock Sub-committee work as that is the most relevant to NODPA producers. The next issue of NODPA News will have a more general report on the meeting. Thank you to the Cornucopia Institute for their excellent detailed recording of the meeting which was used in the recording of votes for this article.
Posted: to Policy in the News on Sun, Nov 3, 2024
Updated: Sat, Nov 9, 2024
