24 SEPTEMBER 2019 • WORLD AQUACULTURE • WWW.WAS.ORG The problem appears that the law starts out with the term “minor species” and then talks about the “animal” and “edible products.” Current policy has determined that the entire species, not the animal being treated, is what determines eligibility for indexing and has gone on to conclude that edible products include any resulting offspring. If someone ever eats that species, or feeds that species to another food-producing animal, then no animals within that species are eligible for indexing, including broodstock. However, one can also read this section to say that indexing is not available for major species and that it is the animal being treated or its edible products that allow or disallow indexing. Further, since we can recognize early life stages as non-food, it seems reasonable that offspring should not be considered as edible products of the animal except where there is reasonable certainty that the product may remain or cause health considerations in those offspring. The choice of how to transfer the law into policy and guidance can also be seen in the policy guidelines where the term “reasonable certainty” no longer is used and the term “very limited circumstances” has been added. I assert that this is a large reason why we have 13 and not 240 indexed products. Same Species, Different Animal Within many individual minor species are animals that, with reasonable certainty, will or will not be eaten by humans or other food-producing animals, depending on their life stage or production circumstances. Aquacultural practices, especially commercial aquaculture, include clear cases where this is true within a species. In almost all cases, broodfish are not eaten, sold as food or fed to food-producing animals. Eggs and larvae in a hatchery are not eaten, sold as food or fed to food-producing animals, something actually recognized in law and policy. Even with caviar-producing species, eggs collected for spawning are treated differently than those going on a plate of food. Eggs for caviar are almost always harvested before they ovulate and are never fertilized or allowed to incubate and are subject to strict federal and state food safety HACCP regulations. Treatments for incubating and hatching eggs therefore have a strong reasonable certainty of not being used for caviar. For example, if a gravid female Russian sturgeon Acipenser gueldenstaedtii is going to be harvested for caviar, that animal and her edible products are ineligible for indexing. However, if eggs or other early life stages from another Russian sturgeon need to be treated for fungus in the hatchery, indexing should be allowed. Beyond aquaculture there are numerous examples where a minor species has animals that are food in one situation but not in another (e.g. a pet rabbit or a rabbit being raised as food, a deer for venison production or a deer in a zoo). Offspring as Edible Products The assertion that a treatment used on broodstock for a food species, especially for inducing reproduction, will become a human food safety issue when the offspring are sold is based on a zero-risk approach and not the facts. Research on modern products to induce ovulation or spermiation in broodstock has shown that these products clear the bloodstream of sexually mature fish quickly, are not transferred to gametes or embryos and thus have no reasonable way to directly impact the resulting offspring and their meat. Other broodstock treatments, especially those used after spawning, also have little to no risk of being transferred to gametes and therefore the resulting offspring need not be considered as edible products. If and when there is a legitimate, science-based argument to the contrary, eligibility for indexing can and should be denied, but not without such evidence. Edible products should be restricted to only the actual parts of the animal that might be eaten, including eggs within a female, and not extended to the next generation. TABLE 2. The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Generic name Trade name Thiafentanil oxalate Thianil sGnRHa + domperidone Ovaprim Metomidate hydrochloride Aquacalm Naltrexone hydrochloride Trexonil Buprenorphine extended-release injection Buprelabrat Benzalkonium chloride and polyhexanide topical solution F10 brand Antiseptic Solution Benzalkonium chloride and polyhexanide topical ointment F10 brand Antiseptic Barrier Ointment Benzalkonium chloride, polyhexanide and cypermethrin topical solution F10 brand Antispectic Wound Spray with Insecticide Benzalkonium chloride, polyhexanide and cypermethrin topical ointment F10 brand Antiseptic Barrier Ointment with Insecticide Poly (acetyl, arginyl) glucosamine Synoplex Deslorelin acetate Suprelorin F Buprenorphine extended release injectable suspension Ethiqa XR Hemoglobin crosfumaril (bovine) Oxapex IDX
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