Currently there's almost no regulation for synbio products yet manufacturers are forging ahead with development

EXCERPT (item 1): Seven of the ten largest pharmaceutical companies are already partnering with synthetic biology companies to develop synbio production routes for pharmaceuticals previously processed from plant sources.

1. Synbio – the scariest GMOs you’ve never heard of
2. Regulate synthetic biology now: 194 countries

1. Synbio – the scariest GMOs you’ve never heard of

By Pat Thomas
Beyond GM, October 9, 2014
http://beyond-gm.org/synbio-the-scariest-gmos-youve-never-heard-of/
[References at the link above]

When we think of GMOs, the first thing that comes to mind is probably a field of corn, soya, or cotton. Less talked about, but the subject of intense research and development activity, is synthetic biology “synbio”.

This extreme form of genetic engineering seeks to “design and construct new biological parts, devices and systems that do not currently exist in the natural world, or to tweak the designs of existing biological systems…to construct designer organisms that perform specific tasks.”[1]

In essence, instead of using existing DNA from plants or animals synthetic biology involves scientists creating entirely new DNA sequences in the lab and using them to create new synthetic life forms or splicing this DNA into naturally occurring DNA.

It is a new science, the products of which have no transparent or agreed rules for safety testing. Being man-made, synbio products are fully patentable and have the full protection of the law and, in theory at least, are able to freely enter the marketplace. Cosmetics and food are considered two of the most attractive markets for synthetic biologists.

Currently well-publicised applications range from the creation of the petri dish patty to herbal medicinal constituents and fragrance components. Many of the extracts that scientists are developing are genetically engineered versions of natural extracts traditionally produced from plants cultivated in developing nations such as vanilla, saffron, vetiver, coconut, and wormwood.

Currently there exists almost no regulation for synbio products. Recently a group of 116 consumer, food safety, environmental, sustainable agriculture, parent, public health, and faith based organisations signed a document called “Principles for the Oversight of Synthetic Biology”.[2]

The document outlines the need to safeguard public health and the environment from the novel risks of synthetic biology and to ensure open, meaningful and full public participation in decisions regarding its uses.

A necessity?

The natural extracts in the sights of the synbio industry are not necessarily in short supply, but are typically high value or geographically specific. Plans to market synbio vanillin as "natural" directly threaten the agricultural income of an estimated 200,000 farmers in Madagascar, the island of Réunion, Mexico, and Tahiti. Without adequate labelling regulations, consumers are prevented from voting with their wallets.

Synbio semi-synthetic artemesinin (SSA) released in 2013 has already impacted on the market for naturally grown sweet wormwood, Artemisia annua.[3]  Until this time, sweet wormwood, grown by around 100,000 small-scale farmers and wild-harvesters in Asia, Africa, and China was the sole source of artemisinin for malaria treatment ACTs (Artemisinin-combination therapies).

The release of the new SSA extract, heavily funded, threatens further development of agricultural cultivation as trust in potential markets is lost and prices unstable. But it is necessary? Could farmers sustainably produce enough natural wormwood to meet global ACT demand, and in doing so support rural employment and respect the growers valuable role in producing crops that safeguard health?

According to the Royal Tropical Institute of the Netherlands, by increasing Artemisia annual cultivation to around 17,000-27,000 hectares, the answer is "yes".[4]

Accessible malaria treatments are vital for millions, but removing agricultural income from small-scale farmers and moving chemical production to Western pharmaceutical laboratories furthers drives poverty and ill-health for those most at risk.

What’s the scope of the problem?

A conservative estimate is that at least 50% of today’s commercial pharmaceutical compounds are derived from plants, animals and microorganisms. Seven of the ten largest pharmaceutical companies are already partnering with synthetic biology companies to develop synbio production routes for pharmaceuticals previously processed from plant sources.[5]

It’s full steam ahead – the UK’s Department for Business, Innovation and Skills estimates that the global market for synthetic biology products will exceed £7 billion by 2016.[6]

A greener economy?

Synbio is touted by its advocates as the path to a greener “Bio Economy” since it uses genetically modified yeast and bacteria to create plastics, chemicals, and fuel instead of using petrochemicals.

To feed synthetic biology’s microbial fermentations on an industrial scale, vast volumes of plant matter, "biomass", would be needed. Given that we are currently already using an estimated 1.5 planet’s worth of resources, this puts further pressure on already overstretched ecosystems.

Where would this biomass come from? A report by the World Bank in 2009 notes that global investors acquired 111 million hectares of agricultural lands over four years, 75 percent of which were in Africa.5 In 2011, the Bank reported a 12-fold increase in the amount of agricultural land acquired by foreign investors.[7]

The rapidly growing synthetic biology industry is likely to drive destructive agriculture deeper into rainforests, reduce biodiversity by increasing monocultures of crops such as sugar cane (with its poor record of labour conditions), and fuel rural landlessness and poverty.

Where will it end?

Cultural heritage, conservation, biodiversity, and the livelihood of those who depend on cultivating natural resources is being lost in the drive to make patentable extracts owned by a minority of organisations. If we focus too hard on the cells in the petri dish, will we look up to see the world outside the laboratory collapsing?

2. Regulate synthetic biology now: 194 countries

SynBioWatch, 20 Oct 2014
http://www.synbiowatch.org/2014/10/regulate-synthetic-biology-now-194-countries/

* SynBio industry’s wild west days are numbered

In a unanimous decision of 194 countries, the United Nation’s Convention on Biological Diversity (CBD) today formally urged nation states to regulate synthetic biology (SynBio), a new extreme form of genetic engineering. The landmark decision follows ten days of hard-fought negotiations between developing countries and a small group of wealthy biotech-friendly economies. Until now, synthetic organisms have been developed and commercialized without international regulations; increasing numbers of synthetically-derived products are making their way to market. The CBD’s decision is regarded as a “starting signal” for governments to begin establishing formal oversight for this exploding and controversial field.

“Synthetic Biology has been like the wild west: a risky technology frontier with little oversight or regulation,” Jim Thomas of ETC Group explained from CBD negotiations in Korea. “At last the UN is laying down the law.”

“This international decision is very clear,” Thomas added. “Not only do countries now have to set up the means to regulate synthetic biology, but those regulations need to be based on precaution and not harming the environment.”

“The good news is that precaution won the day.”

This decision comes at a critical time. The SynBio industry is bringing some of its first products to market, including a vanilla flavour produced by synthetically modified yeast and specialized oils used in soaps and detergents derived from synthetically modified algae. In December, bay area SynBio firm Glowing Plants Inc. intends to release synthetically-engineered glow-in-the-dark plants to 6,000 recipients without government oversight. The United States is not a signatory to the CBD, making it one of only three countries that will not be formally bound by this decision (the other 2 are Andorra and the Holy See).

Compared to conventional genetic engineering, synthetic biology poses serious risks to the environment, biodiversity and health as well as to the cultures and livelihoods of Indigenous peoples and local communities. Scientists warn that modified algae and yeast could have unpredictable effects if they escape. New applications could also disrupt the behaviour of plants, insects and potentially whole ecosystems. For example, dsRNA crop sprays[1] disrupt the action of genes, which may kill targeted pest, but will also affect other organisms in unpredictable ways by silencing genes.

“The multibillion-dollar SynBio industry has been slipping untested ingredients into food, cosmetics and soaps; they are even preparing to release synthetically modified organisms into the environment,” said Dana Perls of Friends of the Earth-U.S. “This decision is a clear signal that synthetic biology urgently needs to be assessed and regulated.

“Governments need to step in to do that.”

Many of the diplomats negotiating at the UN Convention had instructions to establish a complete moratorium on the release of synthetically modified organisms. However, they faced stiff opposition from a small group of wealthy countries with strong biotech industries, particularly Brazil, Canada, New Zealand, Australia and the UK.

After a week of negotiations, battle lines were drawn between the pro-SynBio states on one side and African, Asian, Caribbean, and Latin American countries on the other side. Notable among the latter group were: Malaysia, Bolivia, Philippines, Saint Lucia Antigua, Ethiopia, Timor Leste, and Egypt.

Global South representatives raised concerns that synthetic biology products intended to replace agricultural commodities could devastate their economies and degrade biodiversity. Many delegates were also concerned that synthetically modified organisms could create biosafety risks – e.g. the possibility of synthetic algae escaping into waterways, producing a solar-powered oil spill.

A network of international organizations including Friends of the Earth, ETC Group, Econexus and the Federation of German Scientists had been closely monitoring the negotiations and providing input for over 4 years. Civil society groups first raised the topic of synthetic biology at the CBD in 2010.

“It was good to see delegates of the South stand up for the interests of their farmers, peasants and biodiversity here in Pyeongchang,” said Neth Dano, Asia Director of ETC Group. “This is not the moratorium many of us wanted, but it’s a good step in the right direction.”

“Synthetic biology involves many novel, experimental, little understood techniques and outcomes, and this greatly increases the risks involved to the environment, human health, food security and livelihoods,” said Helena Paul of EcoNexus. “Our technical cleverness tends to blind us to our ignorance; the UK wishes to play a leading role in synthetic biology and does not seem to want precaution to stand in the way, so this COP decision is a helpful corrective to that dangerous policy.”

What’s in the CBD decision?

The CBD’s three-page decision outlines its recommendations for member countries’ approaches to synthetic biology. The CBD urges all member countries to:
* Follow a precautionary approach to synthetic biology.
* Set up systems to regulate the environmental release of any synthetic biology organisms or products. These regulations must ensure that activities in one country cannot harm the environment of another. (Article 3 of the CBD)
* Ensure that no synthetic biology organisms are released for field trials without a process of formal prior risk assessment.
* Submit synthetic biology organisms, components and products to scientific assessments that consider risks to conservation and sustainable use of biodiversity as well as human health, food security and socio-economic considerations.
* Encourage research funds to assess the safety of synthetic biology as well the socio-economic impacts of the technology.
* Support developing countries to develop their capacity to assess synthetic biology.

The decision also:
* Establishes an ongoing process within the Convention on Biological Diversity, including an expert group which will establish a definition of synthetic biology and identify whether existing governance arrangements are adequate.
* Invites other UN bodies to consider the issue of synthetic biology as it relates to their mandates.

The full text of the decision agreed by COP 12 of the CBD is available here:
http://www.cbd.int/doc/meetings/cop/cop-12/insession/cop-12-L-24-en.pdf