Page 47 - Breeding Edge ebook

Chinese scientists have published dozens of papers on their use of CRISPR techniques, while the

agriculture ministry is finishing work on its regulations for gene editing, according to FAS.

In Japan, the government has been handling gene edited products “on a case-by-case basis,”
according to the FAS report. “Consequently, researchers have been taking a relatively
conservative and cautious position towards R&D.” South Korea, which hasn’t decided how to
regulate gene editing yet, “is closely watching developments in other countries to determine how
they can regulate innovative technologies,” FAS said.

But in South America, Argentina and Chile have decided that some plant products of certain gene
editing techniques as well as conventional breeding may not be regulated as GMOs when the traits could
be obtained through conventional breeding or mutagenesis, according to the FAS survey. Products will
have to be considered on a case-by-case basis, however.

Brazil’s agriculture ministry has not finalized that country’s policy. However, based on what has been
proposed so far “it seems that all these three countries are going in the same direction,” said Diego
Risso, executive director of the Seed Association.

The industry may have to live with the idea that products will be assessed on a case-by-case basis,
however. “We need to accept that it’s the way the regulators feel more comfortable,” Risso said,
speaking at the American Seed Trade Association’s annual meeting in December.

The South American countries’ policies are also expected to apply to gene editing of animals, according
to the FAS survey.

Even in Europe, where there has been strong resistance to biotechnology, some governments want to
take a different approach to regulating gene editing, at least when it comes to plants.

Several members of the European Union are awaiting a European Court of Justice opinion clarifying

whether products of gene-editing techniques that are considered mutagenesis would be regulated as
GMOs. A non-binding advisory opinion provided by the court’s advocate general in January was mixed.

A final decision by the court is expected this summer.

The Netherlands, meanwhile, has proposed to the European Commission that many gene edited products
be exempt from regulations as GMOs if the same modifications could be achieved through conventional
breeding. FAS cautions that a decision by the Commission could take years.

Back in the United States, the proposed Part 340 revisions also came under fire from groups traditionally
critical of biotechnology. The Center for Food Safety (CFS) criticized APHIS’s proposal to exclude
three classes of organisms from regulation, saying that “would allow GE organisms that could cause
(Plant Protection Act) risks to entirely escape review and regulation by APHIS.”

“Any type of change in a gene sequence can potentially cause phenotypic changes that have
significant consequences, whether the change could occur naturally or not,” CFS said in its
comments. “Moreover, genome editing methods are still in early development, and risks of their
use are not known well enough to predict impacts” without actually observing how they work in

nature.

BIO, meanwhile, "believes APHIS could go a long way in improving the current regulatory system in

the near term without revising the regs while still moving forward with rulemaking on a parallel track in
the longer term.”

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