USDA Docket APHIS-2018-0034-0037 

The “Coordinated Framework for the Regulation of Biotechnology” fails to account for the unique risks of genetic engineering, using existing laws like the Plant Protection Act to address issues for which they were not designed. This proposal weakens the APHIS regulations even more.

All genetically engineered (GE) organisms—plants, animals, or microorganisms—should be subjected to systematic assessments of human and environmental effects and indirect economic effects (such as contamination of organic or non-GE crops leading to rejection in foreign markets, spread of resistant pests, etc.) before being allowed on the market. These assessments must be made available to the public for comment. All products from GE organisms in the marketplace must be labeled as such to allow consumer choice and to permit tracking of unintended health effects. Companies that develop GE organisms should be required to disclose any GE trait, marker genes, or other genetic constructs that might be present in a commercial GE seed product, including traits and genes for obsolete, no longer marketed traits. In addition, the definition of genetic engineering should be broad enough to include all the newer genetic engineering techniques such as RNAi or the new gene-editing technologies (such as CRISPR-cas9, TALEN, ZNF, and meganucleases).

In particular, APHIS regulations should:

• Base the regulation of GE organisms on the unique hazards they present;
• Include “synthetic biology” in the definition of regulated genetic engineering;
• Prohibit developers from exempting themselves from regulation;
• Regulate PMPIs—plant-made pharmaceutical and industrial chemicals;
• Ensure that PIPs –plant incorporated protectants—are regulated at all scales;
• Address hazards other than “plant pest” risks, including: The unwelcome presence of GE genes in neighboring fields of organic or identity-preserved crops, the creation of new compounds in a plant, formed in the plant's detoxification of herbicides, the movement of genes for manufacture of industrial or pharmaceutical chemicals into crop plants, the creation of “superweeds” (plant pests) through selection for resistance to herbicides continually used on GE crops, the overuse of herbicides in cropping systems dependent on the use of herbicides sprayed over herbicide-tolerant crops, destruction of habitat adjacent to farm fields by overuse of nonselective herbicides sprayed over herbicide-tolerant crops, selection for resistance in insects targeted by PIPs, reduction in populations of insects due to effects of PIPs and destruction of habitat adjacent to fields sprayed by nonselective herbicides over herbicide-tolerant crops, and health effects suffered by those exposed to excessive use of herbicides.