The new Class II protected species status will at least restrain consumption of the horseshoe crab as food. It remains unclear, however, what the change will mean for production of TAL. Will the tougher protections save this ancient animal?<\/p>\n
What will Class II status mean?<\/h2>\n
The Wildlife Protection Law<\/a> sits at the top of China\u2019s system of environmental legislation and regulation, providing protections for many rare wild animals. The List of Wildlife under Special State Protection<\/a>, which encompasses Class II protected species, sits within the framework of the law. Inclusion on it can often be a turning point for the fate of an endangered species.<\/p>\n In the case of the horseshoe crabs, things could be a little more complicated.<\/p>\n Provincial-level protections for the animal were already in place in coastal provinces Fujian, Guangdong, Guangxi and Jiangsu. The effect of the shift to national protections depends on what was already in place in each province.<\/p>\n In Guangdong<\/a>, Jiangsu<\/a> and Fujian<\/a> it was legal to fish for horseshoe crabs, as long as a permit from the county wildlife management authorities was obtained, and quotas were abided by. Now, those permits will need to come from the provincial authorities, making them harder to obtain, given the potentially higher scrutiny at that level of government.<\/p>\n But in Guangxi<\/a>, the horseshoe crabs\u2019 main habitat, provincial-level permits were already being issued in line with the requirements for Class II protected species. The change will therefore make little difference. Lin Wuying, a member of the International Union for Conservation of Nature (IUCN) Species Survival Commission\u2019s horseshoe crab sub-group, thinks Guangxi may now be stricter with horseshoe crab quotas given the upgraded protection under the national law. \u201cThe fishery authorities may lower their quotas for the species. They\u2019re also going to be tougher on which firms are allowed to catch the crabs, and won\u2019t be handing out permits as easily as before.\u201d <\/div><\/p>\n The change in conservation status means tougher penalties for illegal catches. In Guangdong and Jiangsu, the potential fines will now be higher. Even before the change, those found catching horseshoe crabs without, or in breach of, a permit, could see their catch, their fishing gear and any income confiscated, and permits revoked.<\/p>\n The Wildlife Protection Law makes allowances for the use of protected species in special circumstances, such as scientific research or medical use. This allows their trade and use, if permission is granted by provincial wildlife authorities. So use of horseshoe crabs for medicine will face a new type of supervision under its Class II protected status. In its 2018 Annual Report, Xiamen Bioendo Technology, a company that produces TAL reagents, said its suppliers had purchased and extracted blood from horseshoe crabs, but as the Chinese horseshoe crab was not then included on the List of Wildlife under Special State Protection, those suppliers neither needed, nor could apply for, permits. It is not yet clear what approach provincial authorities will take when handing out those permits in the new circumstances. In May, Caixin Weekly reported<\/a> that authorities had not yet decided on policies for TAL producers, who would have to wait until the following month to make applications and find out how horseshoe crabs could be used under the new rules.<\/p>\n Although the effects of the changes remain uncertain, companies have been quick to respond.<\/p>\n Two weeks after the update to the List of Wildlife under Special State Protection, Zhanjiang A & C Biological Ltd, one of China\u2019s five largest TAL producers, published a press release saying it would halt supply of several products that required large quantities of horseshoe crab blood to make. The firm offered two new solutions, both of which use less blood.<\/p>\n After that press release was published, both Fuzhou Xinbei Biochemical Industry Ltd.<\/a> and Xiamen Bioendo Tech<\/a> stated they would continue to manufacture the products that Zhanjiang A & C Biological Ltd was discontinuing, but also research ways to reduce the use of horseshoe crab blood. <\/div><\/p>\n The use of LAL\/TAL to detect bacterial endotoxins was pioneered in the US in the 1950s. In 1980<\/a>, the method was included in the United States Pharmacopoeia, before being added<\/a> to pharmacopoeias in Europe, Japan, the UK and China. It became a globally accepted test for endotoxins, and the healthcare industry has relied on horseshoe crab blood to ensure safety ever since.<\/p>\n Of the four existing horseshoe crab species, only the Chinese horseshoe crab and the Atlantic horseshoe crab are used to produce TAL and LAL. The Chinese horseshoe crab is found mainly on China\u2019s southwest coast, while the Atlantic horseshoe crab is found on the eastern coast of North America. Currently, the IUCN\u2019s Red List of Threatened Species lists the Atlantic horseshoe crab as \u201cvulnerable\u201d \u2013 the same category as the giant panda. The Chinese horseshoe crab is classed as \u201cendangered\u201d, meaning it is at risk of extinction.<\/p>\n According to an article<\/a> in the journal of the National Audubon Society, a US environmental group, pharmaceutical firms carry out 70 million endotoxin tests a year, in a normal year. The vaccines and therapies being developed in response to the coronavirus pandemic mean demand has rocketed. And that means more horseshoe crab blood being used.<\/p>\n In China, the increased demand will clash with increased protections, and the industry is watching closely to see how conservation and healthcare will be balanced under the Wildlife Protection Law framework. There is only one line in the law about the use of wildlife in medicine. It states that use of wildlife or wildlife products in medicinal products must also abide by pharmaceutical laws and regulations. An industry expert who prefers to remain anonymous told China Dialogue this language is aimed at the use of wildlife in Chinese medicine, but horseshoe crab blood is being used to manufacture testing reagents \u2013 a different application. This means producing TAL from the blood may fall outside the framework of the law, so companies will probably be able to continue using it.<\/p>\n What are the prospects for developing replacements? The pharmaceutical industry\u2019s answer so far is not definitive.<\/p>\n Back in 2003<\/a>, Jeak Ling Ding of the National University of Singapore used genetic engineering to produce Recombinant Factor C, or rFC, a substitute for horseshoe crab blood, one of several that have been developed around the world. An industry insider familiar with the matter told China Dialogue that while the properties of crab blood can vary across batches, rFC is more stable, more resistant to interferences, and can be supplied more sustainably. But rFC endotoxin testing remained relegated to an appendix in China\u2019s 2020 Pharmacopoeia<\/a>, meaning it is to be used when other methods are not available, rather than as an alternative of equal standing.<\/p>\n After Zhanjiang A & C Biological Ltd\u2019s statement, the industry\u2019s awareness of the problems associated with TAL testing rose, prompting increased sales of rFC products. With the horseshoe crab now protected, the industry is having to think seriously about alternatives.<\/p>\n Lin Wuying points out that while TAL reagents are still being used, more research into horseshoe crabs is needed to help set catch quotas; and governments need to do more monitoring of catches, usage and how companies return horseshoe crabs to the wild.<\/p>\n \u201cThe issuing of permits needs to be based on scientific research. We need to know how many crabs we can use. But currently there is a lack of such data.\u201d Lin also told China Dialogue that there were small-scale surveys of horseshoe crab populations done in the 1970s and 1980s, with trawl nets used to bring them up for counting. But now the crabs are so scarce that, even using bigger nets, too few can be caught to calculate population size. Plus, trawling does damage to the seabed. The only research has been into population density of juvenile crabs and spawning rates in a limited number of regions, with that data then used to extrapolate to population figures. But those indirect methods are less reliable.
\n![\"Fishing](\"https:\/\/dialogue.earth\/content\/uploads\/2021\/09\/fishing.jpg\")
No sudden halt<\/h2>\n
\n![\"Extracting](\"https:\/\/dialogue.earth\/content\/uploads\/2021\/09\/blood.jpg\")
Blood transfusions?<\/h2>\n
Oversight still needed<\/h2>\n
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![\"Research](\"https:\/\/dialogue.earth\/content\/uploads\/2021\/09\/research.jpg\")