By Ed Maltby, NODPA Executive Director
On February 6th, 2024, four employees of organic dairy buyers/brands/manufacturers petitioned the NOP to add Meloxicam (a non-steroidal pain reliever) to the National List, as a synthetic substance allowed for use in organic livestock production. This drug would be listed under the Organic Foods Production Act, (OFPA) category Livestock parasiticides and medicines. In the petition, the use of Meloxicam was centered on dehorning of calves and the need to improve the products available to minimize and relieve the pain of the animal during the process. This petition started the NOP process of consideration that is given to every request to be added to the National List. NOP states that this process will usually take at least a year; it usually takes longer. The subject of many media stories, and questions from the media to NODPA, about whether organic products are free of chemicals, is the questioning of the many chemical additives allowed in certified organic production and the transparency of the process that permits those drugs. The integrity of the Organic Seal is tied to the transparency of its process, especially in rule making and use of products in production.
The National List outlines what non-organic substances may be used in organic production and handling. It is organized according to three scopes: crop (§§ 205.601 - 205.602), livestock (§§ 205.603 - 205.604), and handling (§§ 205.605 - 205.606) (processing). In general, nonsynthetic (natural) substances are allowed unless specifically prohibited and synthetic substances are prohibited unless specifically allowed. In organic production, nonagricultural synthetic, nonagricultural non-synthetic (natural), and non-organic agricultural substances are only allowed if included on the National List. Some substances on the National List include annotations which restrict how the substance is used.
On receiving the Meloxicam petition, the NOP reviewed it to determine whether the petition was complete. NOP determined Meloxicam is eligible for petition under the OFPA and its implementing regulations and the proposed use is approved under the statutory and regulatory authority of the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), or another applicable appropriate federal agency. NOP completed their review and determined the petition was complete.
They passed it to the NOSB Livestock Subcommittee (LS) Chair for the next stage of the process. At their meeting on 3/19/2024, the LS assigned two members to lead the committee in discussion as to the petition’s sufficiency and the need for a Technical Review (TR) by independent experts. A TR is not required for each petition or sunset review, but the subcommittee must follow certain steps in deciding the need for a third-party expert. The steps include determining whether the subcommittee has the expertise needed to address the questions related to the petition, the impact on the environment, human health, and sustainability plus compatibility with organic principles. Two advantages of a TR are, first, it takes a work burden away from the NOSB members who volunteer their time and allows them to concentrate on other NOSB work, and second, the TR provides transparency and independence in a report that can be referred to in future years. At their subcommittee meeting on 6/4/2024 the committee determined they would not need a TR. The petition was not discussed at either of the next two Livestock sub-committee meetings on 6/18 and 7/16/2024. On 8/6/2024 the committee made a recommendation to approve the petition for use by all livestock.
At the time of writing this article (8/30/2024), the NOP has today published more subcommittee notes and their final recommendation. The sub-committee plans to make a proposal to the full NOSB committee at the upcoming NOSB meeting in October in Oregon to approve the use of the drug for all livestock. Comments must be submitted to the NOP by September 30. Depending on that vote, the recommendation will be passed to the NOP for further action on rule making.
Motion by the Livestock Sub-Committee:
Motion to add meloxicam (CAS #-71125-38-7) at §205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
In accordance with approved labeling for organic livestock; 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 two-times that required by the FDA
Questions on the Petition
Most organic dairy producers welcome the addition of Meloxicam to the basket of products they can use, especially its reputation for providing longer lasting pain relief at times of stress for livestock and the ease of application. There are many requirements under the NOP regulations on animal welfare. Meloxicam will greatly assist producers in reaching the high standards required by organic certification and by their own commitment to their animals.
Producers and other stakeholders are concerned about organic integrity and the confidence of consumers in the NOP and third-party certification. In a marketplace that is full of imitations, the organic seal must remain the gold standard to ensure the retail premium that can fund a sustainable pay price for producers and their families.
Having read all 501 pages of the petition (some of which made me wish that I had paid better attention during my science classes at school), and the 5 pages of the Livestock Subcommittee review and recommendation, there are many questions that the petition and the LS do not answer satisfactorily. This is not a criticism of the petition presenters or NOSB members but more their choice to include the use for all livestock. What might have been relatively simple to annotate its use for organic dairy livestock under one year of age (as the petition’s proposed use suggested), it becomes very complicated by its inclusion as a multi-species proposal that would include sheep, goats, swine, lactating and mature cattle, and pregnant livestock.
Sometimes less is more and we must “think critically so that productivity and urgency, does not lead us to barreling ahead with the risk of making irreversible damage” (National Organic Coalition draft community agreement). There is an identified and researched need for the use of Meloxicam to prevent pain and suffering during de-horning of young calves who are not close to entering the food system. There is a good case for the use of Meloxicam in other species of livestock, but we are currently lacking the research that there is no harm to humans or other species. In fact, we have proof that in conventional use, traces are found in consumer products and that there are side-effects for humans. The NOSB subcommittee decided not to ask for an independent assessment with a Technical Review of this increasingly complicated, unlimited use of the drug in all livestock, no matter age or species.
The NOSB would better serve all of the organic community with a recommendation that Meloxicam is listed on the National List with a annotation (restriction) that it is just for use in dairy and beef cattle under the age of one year with a withdrawal time of 3 months. This does not stop the NOSB or the petitioners from recommending increasing the parameters of its use in the future. In fact, it has been done many times for different products as we accumulate more knowledge and research.
Timeline of review of the petition by the NOP and NOSB from NOSB published notes (notes are not edited except to remove initials of names).
2/6/2024 USDA NOP receives petition from Meggan Hain, Animal Care Specialist and Managing Veterinarian, CROPP Cooperative/Organic Valley/Organic Prairie; Megan Sutton, Associate Manager-Regulatory, Horizon Organic Dairy; Britt Lundgren, Senior Director of Sustainability and Government Affairs, Lactalis/Stonyfield Farms; and Dr. Juan Velez, Chief Agricultural Officer at Aurora Organic Dairy.
NOP determines the petition is complete.
3/19/2024 Meloxicam petition -assign lead/discuss. The NOSB received a petition for meloxicam. The petition came from a group of veterinarians, not a manufacturer.
4/2/2024 Meloxicam -Petition sufficiency and Technical Review (TR) determination. The Livestock Subcommittee (LS) members briefly discussed the petition for meloxicam, noting that it is FDA approved, and has no known side effects.
4/16/2024 Meloxicam -TR determination. The lead reached out for feedback from a veterinarian about possible excluded methods used in the manufacture process. The leads do not think there is a need for a TR, but would revisit if there was space for an additional TR. The petition was thorough and Board member background and expertise, combined with feedback from stakeholders and veterinarians; they are going to move forward with a proposal. A member emphasized the need to justify why they would not request a TR for a new petitioned material.
5/21/2024 Not on their agenda
6/4/2024 Meloxicam: The leads compiled a review of the petition using the evaluation criteria as a guide, to assist the LS in its determination about requesting a new TR. Members view the petition as thorough and comprehensive, providing all the appropriate information they needed to make a decision. However, they will confirm materials used in manufacturing do not raise concerns about excluded methods. The Subcommittee will proceed to a proposal and will discuss and vote at a future call.
6/18/2024 Meloxicam: Not on the agenda
7/16/2024 Meloxicam. Not on the agenda
8/6/2024 Meloxicam. The lead summarized the petition which was submitted by a cohort of veterinarians. Meloxicam is used as a pain management tool. It is a chemical formulation and does not involve the potential use of excluded methods, has no environmental concerns based on manufacturing, and appears to be needed by the industry. In lieu of requesting a TR, the leads included additional information gleaned from personal research and the petition, and felt they had all the information they needed. The co-lead highlighted the language about the use of this material under the order of a veterinarian. The LS moved to a vote.
Motion to classify meloxicam as synthetic Motion by: NPP Seconded by: KH Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 0
Motion to add meloxicam to the National List at § 205.603(a) Motion by: KH Seconded by: NPP Yes: 5 No: 0 Abstain: 0 Recuse: 0 Absent: 0
