WWW.WAS.ORG • WORLD AQUACULTURE • SEPTEMBER 2019 25 Early, Non-food Life Stages The MUMS Act and agency policy recognize that treatments of eggs, larvae and even fingerlings are less likely to impart a health risk to the product when harvested months or years later and indexing has clearly been allowed by defining these as non-food life stages. However, by restricting this option to “very limited circumstances,” we have failed to fully achieve what is possible under the law. If the law allows indexing for early life stages where safety for humans is demonstrated, why change that to very limited circumstances? As an interesting and admittedly extreme example, one of the longest running Investigative New Animal Drug (INAD) projects is for the use of 17α-methyltestosterone (MT) to masculinize firstfeeding tilapia. For the first 21 days of feeding, they are provided with feeds that contain 60 mg MT/kg feed. Studies indicate that levels return to normal within weeks of termination of feeding MT. Depending on temperature and culture methods, the resulting crop of all-male fish is harvested for food a year or more later. Would full approval as a new animal drug provide any reduction of the risk or provide any more reasonable certainty that those tilapia fry will not be eaten compared to simply indexing? Rely on the Expert Panel Indexing requires the creation of an expert panel to review the request, the pertinent literature available and make a recommendation for final label instructions. Reasonable certainty that the animal and any edible products are not used for human food or fed to a food-producing animal should be a separate section of the expert panel’s responsibility, including recommendations on labeling language to assure this. Having served on both expert panels for the only two indexed drugs for aquaculture, I can attest that that was part of our duties and is clearly reflected in the final index labels. Accusations that someone might eat an animal are often the result of lack of understanding of the realities of commercial aquaculture, a situation that is addressed by having true experts in aquaculture serve on these panels. If there is concern about a product used on broodstock being a human health risk in the resulting offspring, the expert panel should include a fish physiologist or endocrinologist to specifically address the risks of vertical transfer. The Label is the Law Labels are the law in the US and are the crux of the problem that created MUMS in the first place. Index labels are not an approval by FDA but simply provide legal access to a product. To provide reasonable certainty that the animal being treated and its edible products will not be used for food, labels for indexes might read: Broodstock treated with this product and their edible products, including eggs, shall not be consumed, or sold for consumption by humans or any food-producing animal. This product is limited for use on eggs, larva and fry in the hatchery, which shall not be consumed or sold for consumption, by humans or any food-producing animals. This product is only to be used in species X where there is reasonable certainty that the animal and its edible products will not be used for human consumption or fed to another food-producing animal. If someone violates that label, the crime, and thus the liability is squarely on them. Labels for drugs, pesticides and many other chemicals used daily include language designed to address the risks with improper or unapproved applications and provide the reasonable certainty that an agency like CVM or a product sponsor needs to protect their liability. Moving Forward Many more products for treating broodstock, eggs and other early, non-food life stages for aquaculture could be indexed if the language of the law is used to inform approval decision-making. If a sponsor can demonstrate, with reasonable certainty, that the animal being treated will not be eaten, sold as human food or used as food for a food-producing animal, CVM should embrace the request for indexing and not reject it. Index labels can easily include specific language to further provide the reasonable certainty needed to move forward. Congress, the Secretary of Health and Human Services, the MUMS coalition and CVM staff worked together to develop a new paradigm for getting products legally available for not just aquaculture but the myriad other animals that are deemed minor species. To have only 13 indexed products, not 240, 14 years after MUMS became law, is a disappointment for everyone involved, and if the failure is due to policy and not the law, this policy should be abandoned. While the MUMS coalition participated in early versions of the Act, it was primarily written by CVM and other federal staff. Their careful choice of wording was typical of such an effort. Instead of looking at only non-food early life stages, under very limited circumstances, let’s consider and approve index labels when there is reasonable certainty that the compound won’t enter the human food chain as the law clearly intended. Notes Craig Watson, Director – Tropical Aquaculture Laboratory, University of Florida, Institute of Food and Agricultural Sciences, 1408 24th Street SE Ruskin, FL 33570, Author email: cawatson@ ufl.edu In addition to his role as Director of the University of Florida’s Tropical Aquaculture Laboratory, Craig Watson also serves on the Board of Directors of the National Aquaculture Association, which supports the recommended change in CVM’s interpretation of the law for indexing. Many more products for treating broodstock, eggs and other early, non-food life stages for aquaculture could be indexed if the language of the law is used to inform approval decisionmaking. If a sponsor can demonstrate, with reasonable certainty, that the animal being treated will not be eaten, sold as human food or used as food for a food-producing animal, CVM should embrace the request for indexing and not reject it. Index labels can easily include specific language to further provide the reasonable certainty needed to move forward.
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