Statement Regarding Plants That Produce Pharmaceutical and Industrial Products

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In order to clarify the views of BIO member companies working in this area, we provide below a statement developed by our members and to which they subscribe. BIO policies are voluntary, and adherence to these policies is not a pre-condition for membership. However, this statement does reflect policies and governmental actions that our member companies would have BIO encourage.

1. We support strong regulatory oversight for all products of crop biotechnology. Detailed scientific and regulatory analyses confirm that plants that produce pharmaceutical and industrial products can be safely planted, grown and harvested in an agricultural region where all of the appropriate production, confinement, and handling practices are implemented.
2. Plants that produce pharmaceutical or industrial compounds are an emerging technology, and we believe that government policies should reflect appropriate measures to avoid adverse consequences that would follow from a breach of confinement or containment. Based on current knowledge and experience, BIO member companies working in this area previously agreed to voluntarily limit growing these articles except under conditions of substantial spatial isolation from major areas of crop production intended for animal or human consumption, until such time as a scientifically proven track record of safe handling is established and demonstrated.
3. We encourage and invite alternative approaches to this issue that would deliver at least equivalent assurances for the integrity of the food supply and export markets.
4. We believe that permits should continue to be required by USDA/APHIS for the interstate movement, field testing, and commercial planting of all regulated articles that are not intended to be used for human food or animal consumption, including pharmaceutical-producing plants and plants that produce industrial products.
5. We encourage all BIO members to submit detailed confinement and handling plans and standard operating procedures with each of their mandatory permit applications to USDA/APHIS.
6. We strongly encourage the USDA to treat these plans and procedures as mandatory permit conditions, subject to mandatory audit and inspection.
7. We support recent efforts of the FDA and USDA to provide draft guidance for industry in the production and use of pharmaceutical producing plants. Further, we will defer to and encourage absolute compliance with whatever future guidance or regulations may be issued by these Federal agencies.