BerandaComputers and TechnologyAbout the Regulation of Biofabricated Wildlife Products

About the Regulation of Biofabricated Wildlife Products

(*But Were Afraid to Ask)

The 18th meeting of the Conference of the Parties (CoP18) to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) looms large this August. Previously scheduled for late May 2019 in Colombo, Sri Lanka, but moved to Geneva, Switzerland over security concerns, CoP18 is of great importance to Pembient. That is because it potentially marks the halfway point in a global struggle over how to regulate certain wildlife products produced through biotechnology, including biofabricated rhino horns. Surprisingly, this struggle has received little attention in the press despite its possible impact on a range of medicines and materials. Additionally, the broader biotechnology industry has all but ignored it.

Before continuing, however, it might be useful to review CITES and what is at stake. CITES is an international treaty designed to protect wild plants and animals from over-exploitation. It has been in force since 1975. Almost every country in the world is a party to CITES, and each signatory agrees to pass legislation to implement CITES directives. The result is that rulings made under the auspices of CITES effectively become the law everywhere. Some view CITES as an efficient way to limit and, in extreme cases, halt the trade in endangered species. Others believe it disempowers people, especially indigenous communities, and prevents the development of specialized or localized responses to specific conservation dilemmas.

Approximately every three years, the parties to CITES gather at a Conference of the Parties (e.g., CoP18). Qualified observers, such as activists, academic institutions, and private sector entities, attend too. Together, they discuss possible changes to CITES in the form of amendments, resolutions, and decisions; although, the parties, and only the parties, actually vote on which ones to adopt. Of the changes under consideration, amendments are the most significant as they usually list a species to one of the treaty’s appendices, thus granting it legal protection. Resolutions, alternatively, are aimed at lastingly improving the scope and effectiveness of CITES. Decisions are similar to resolutions, but shorter in duration. The conclusion of a Conference of Parties kicks off a cycle of interim meetings, eventually culminating in another CoP. These interim meetings include meetings of the Animals Committee (e.g., AC29), a group of scientific experts, and the Standing Committee (e.g., SC69), a group of policy experts. The CITES Secretariat, a permanent administrative office based out of Geneva, Switzerland, coordinates all of the above activities.

When a species becomes CITES-listed, any trade restrictions thereby secured apply not only to live animals but also to carcasses and readily recognizable parts or derivatives thereof. With Resolution Conf. 9.6 (Rev. CoP16), the term “readily recognizable part or derivative” has been expanded to “include any specimen which appears from an accompanying document, the packaging or a mark or label, or from any other circumstances, to be a part or derivative.” Interestingly, the same resolution implies that urine and feces are not parts or derivatives as long as they are “naturally excreted.” The unstated assumption being that these waste products would be parts or derivatives if they were somehow invasively extracted. In this context, it is unclear whether a biofabricated rhino horn, appropriately labeled, should be considered to be derived from a rhinoceros. The final determination, just as in the case of waste products, may depend entirely upon its production method.

Background

The notion that CITES might cover certain bioengineered wildlife products first arose during CoP12 in Santiago, Chile in 2002. It was then that Switzerland, on behalf of the Standing Committee, proposed to exempt synthetically produced drugs and DNA, along with urine and feces, from CITES. That effort, and a subsequent one at CoP13 in Bangkok, Thailand in 2004, floundered. The issue reentered the spotlight in 2015 when Pembient announced its intentions to biofabricate rhino horns. Shortly after that, as chronicled below, a new policy cycle began.

CoP17, Johannesburg (South Africa), September 2016

Going into CoP17, the United States circulated a document prepared by the International Environmental Law Project (IELP) and endorsed by several activists. The authors of this document argued that CITES already covered trade in bioengineered wildlife products. More specifically, they interpreted the term “readily recognizable part or derivative” broadly. For them, the totality of the circumstances determined whether a product qualified as a specimen of a CITES-listed species. Or, in other words, what mattered was the form of the product, not its production method. Nonetheless, the authors sought to revise Resolution Conf. 9.6 (Rev. CoP16) to include any products that scientifically tested to be specimens of CITES-listed species, even if their physical components did not originate from an actual plant or animal. Fortunately, cooler heads prevailed, and the Conference of Parties adopted Decisions 17.89 to 17.91 on “specimens produced from synthetic or cultured DNA.” The gist of these decisions was that the Secretariat and the various committees of CITES would further review the issue with the aim of making recommendations for consideration at CoP18 in 2019.

AC29, Geneva (Switzerland), July 2017

The 29th meeting of the Animals Committee focused, among other things, on finalizing the terms of reference for a study on “wildlife products produced from synthetic or cultured DNA.” The task fell to an in-session drafting group whose membership consisted of the United States, Canada, Mexico, South Africa, and a representative of Europe. What was decided was that the study would have three parts. The first part would describe ways of artificially producing DNA and wildlife products. The second part would explore regulatory options for bioengineered wildlife products, with an emphasis on operationalizing the terms “parts” and “derivatives” in Resolution Conf. 9.6 (Rev. CoP16). Finally, the third part would discuss anti-counterfeiting measures for the detection of bioengineered wildlife products and related technical matters. The Secretariat committed to hiring a consultant to conduct the study using $20,000 donated by the United States.

SC69, Geneva (Switzerland), November 2017

During the 69th meeting of the Standing Committee, an intersessional working group on “synthetic or cultured DNA” was established. This group’s purpose was to review the consultant’s report, once available, and formulate recommendations. Austria, Cameroon, Canada, China, Israel, Peru, Republic of Korea, South Africa, Switzerland, the United Kingdom, and the United States joined the working group, and Mexico became its chair. A slew of activists also joined, chief among them the IELP and its clients: the Center for Biological Diversity and the World Wildlife Fund.

AC30, Geneva (Switzerland), July 2018

By the time of the 30th meeting of the Animals Committee, the Secretariat had hired a consultant, Dr. Julian Kinderlerer, an esteemed law professor. He presented a partially completed report at the meeting. This draft fulfilled most of the study’s terms of reference, except it omitted the second part concerning regulatory options.

Unfortunately, his report was not well received. Some felt it was overly broad and needlessly detailed. They did not understand the necessity of reviewing technologies ranging from DNA synthesis to cell culture to tissue engineering. Nor did they grasp the salient differences between production methods and how those differences could have regulatory ramifications. Others expressed concern that the draft mentioned potential positive impacts of bioengineering wildlife products despite activists’ misgivings. Regardless, there was a consensus that nothing should be done pending the completion of the full report—ostensibly pushing the specter of regulation off until CoP19 in 2022.

One critical thing that the draft brought to the fore was that the term “cultured DNA” was nonstandard. This realization resulted in a formal change of title for the subject matter from “specimens produced from synthetic or cultured DNA” to “specimens produced through biotechnology.”

SC70, Sochi (Russia), October 2018

Dr. Kinderlerer submitted his full report to the intersessional working group prior to the start of the 70th meeting of the Standing Committee. Nevertheless, even with the inclusion of a section on regulatory options, many concluded that the study did not provide sufficient direction to help the working group advance. So, at the opening of SC70, there was still a need to find agreement on whether and how to regulate bioengineered wildlife products linked to CITES-listed species.

Two lines of thought emerged. Activists, concerned that bioengineered wildlife products could reach the market before CoP19 in 2022, urged the immediate application of Resolution Conf. 9.6 (Rev. CoP16). Various policymakers, on the other hand, expressed concern that the term “readily recognizable part or derivative” used in Resolution Conf. 9.6 (Rev. CoP16) had become antiquated and needed modernization.

The Chair of the Standing Committee convened an in-session working group to address these issues and forge a way forward. Four countries and four organizations formed this working group. The countries were Mexico, France, Norway, and the United States. The organizations were the IELP and the Center for Biological Diversity, as per usual, along with China Wildlife and San Deigo Zoo Global. A set of four recommendation came out of the deliberations, the first three of which either affirmed the immediate applicability of Resolution Conf. 9.6 (Rev. CoP16) or explicitly broadened it. Fortunately, the European Union, not always perceived as a friend of biotechnology, blocked the first three recommendations on technical grounds:

This outcome all but guaranteed that nothing of permanence would happen at CoP18, and that debate on the topic would continue at least up to CoP19.

Coda

Perhaps the most enduring takeaway from Dr. Kinderlerer’s study is that there are three possible regulatory scenarios for a wildlife product produced through biotechnology. In the first scenario, the product is treated as if harvested from a member of a CITES-listed species. For biofabricated rhino horn, this scenario is tantamount to prohibition since CITES affords maximum protection to all rhino species. In the second scenario, the product is treated as a novel substance and is freely tradable. This scenario is the laissez-faire case. The third and final scenario involves treating the product as being related to, but not the same as, a product harvested from a member of a CITES-listed species. In this scenario, international trade in the bioengineered product could be allowed, but only if it did not negatively impact the survival of the species in the wild. Dealings would require CITES permits containing a new source code indicating the product came from a biotechnological process as opposed to an animal in the wild or captivity.

Of course, things are more complicated than that. CITES deals in “parts,” defined as objects coming from an animal (e.g., skin), and “derivatives,” identified as any processed part of an animal (e.g., watch strap). These definitions place products produced through specific biotechnological processes firmly within the purview of CITES. For instance, a biofabricated rhino horn grown from a biopsy is a derivative in the context of CITES, although one hopes Dr. Kinderlerer’s third scenario would govern it. Beyond that lies a realm in which CITES loses applicability.

In the limit, suppose water could be squeezed from rhinos, filtered, and traded. Moreover, assume this “rhino water” was indistinguishable from bottled water or, at the very least, not “readily recognizable” as coming from a rhino. Could CITES intervene here? If so, would the trade in bottled water be banned following the logic of Dr. Kinderlerer’s first scenario? Or, would bottled water now require CITES permits attesting to its origin in line with Dr. Kinderlerer’s third scenario? Or, again, would a chemical marker have to be added to non-rhino water to make it distinguishable from rhino water?

Somewhere between the above two extremes, a line must be drawn. Thankfully, the United States government has provided a workable delineation in its domestic regulations on wildlife. According to a memorandum from the U.S. Fish and Wildlife Service (USFWS), Chinese Hamster Ovary (CHO) cells are wildlife parts; however, this designation does not extend to bioengineered products extracted from them. That is, synthetic DNAs inserted into CHO cells, and any recombinant proteins produced from said DNAs, are not wildlife products. Intuitively, the USFWS’s ruling makes sense. If there is a clear break in the chain of physical descent from a wild animal, or if that link never existed in the first place, why would the USFWS have jurisdiction? The ruling also comports with real-world practice. The USFWS does not regulate digital DNA sequences. Nor does it regulate biomolecules directly or indirectly synthesized from digital DNA sequences.

There are serious consequences should CITES attempt to override the USFWS’s precedent. Take the case of squalene, a moisturizer, for example. Shark liver oil contains squalene, and sharks have traditionally been a major source of this chemical. Now that several species of shark are CITES-listed, a couple of companies have started to manufacture either squalene or squalane, its hydrogenated cousin. One company uses genetically modified yeast. Another employs genetically modified tobacco. The upshot is that, given a sample, there is no way to determine its origin, except maybe via an expensive isotopic analysis. The instant CITES covers bioengineered wildlife products, producers of synthetic squalene and squalane will face an uncertain future. They may have to choose between denaturing their products or obtaining export permits for them. Further, it is not clear how far down the cosmetics supply chain permitting would have to extend. Conceivably, their products could even be banned.

Squalene is just one example. If CITES redraws the regulatory line, it subjects a host of substance to new controls. Of these substances, allopathic ones are the most worrisome. Patients, doctors, and pharmacists may find that the synthetic form of ursodeoxycholic acid (UDCA), the active ingredient in bear bile, is less readily available for the treatment of gallstones. Likewise, biotechs may disinvest from synthesizing Factor C, an endotoxin-detecting agent found in the blood of the vulnerable horseshoe crab, lest the species gets listed. From cosmetics and drugs to foods, flavors, and fragrances, CITES seems poised for a massive expansion. Overreaching could lead to disaffected parties invoking the doctrine of rebus sic stantibus. That is to say, CITES could become unenforceable because the parties never intended for an international wildlife treaty to regulate the development of biotechnology.

If the parties want to modify CITES radically, they should first amend it to cover the captive breeding of animals and the artificial propagation of plants. Yet, the parties struggle to address these modalities even though the drafters of the treaty foresaw them. Therefore, rather than attempt to address biotechnology via Resolution Conf. 9.6 (Rev. CoP16), it would behoove the parties to take their time to develop a coherent framework governing all alternative means of production. The broader biotechnology industry must stand ready to assist them in this endeavor.

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