Limit Pharmaceutical Plants to Greenhouses; Closely Monitor All Operations;
Enforce Strict Regulations; and Maintain a Fully Transparent Permitting System:
Comments of the Organic Trade Association on APHIS Docket No. 03-031-1
Submitted by Tom Hutcheson
Associate Policy Director
May 9, 2003
The Organic Trade Association (OTA) is pleased to have this opportunity to offer comments on APHIS’ strengthened regulations regarding plants genetically engineered to produce pharmaceutical and industrial compounds.
Although OTA applauds stricter controls, OTA believes that the proposed revisions to APHIS’ permit conditions and administrative procedures are not sufficient to prevent contamination of food crops.
Changes in Permit Conditions
Fallow zones versus greenhouses
Regarding Docket Section V.3., OTA urges APHIS to require that all plants genetically engineered to produce pharmaceutical and industrial compounds be grown in greenhouses. This requirement is clearly feasible for field-testing purposes and would obviate many problems related to possible contamination of food crops.
Absent that requirement, OTA notes that organic farmers have a great deal of experience with “buffer zones”, or what APHIS terms “fallow zones”, as a partial means of preventing unwanted agricultural materials from entering the organic system. One lesson learned by the organic sector is that no set distance—whether 25, fifty, or more feet—is necessarily adequate to ensure the purpose of the plan. Rather than set a de facto maximum distance through defining a separation zone by measurement, APHIS should not only institute a 50-foot minimum distance but also require a performance-based fallow zone practice standard sufficient to accomplish the purpose of non-contamination. Absent a requirement for greenhouse growing, OTA urges APHIS to consult with NRCS on this matter to create a technically defensible practice standard.
Dedicated machinery and facilities
OTA strongly supports requiring dedicated machinery and facilities for use with plants genetically engineered to produce pharmaceutical and industrial compounds.
Field Test Permit Conditions
OTA strongly supports the adoption of the higher standards regarding field test permit conditions. In addition, regarding Docket Section V.3., APHIS should require monitoring of pollen at distances at and beyond one mile to assess the effectiveness of the one-mile standard. The monitoring protocol should include sampling during various meteorological conditions, including storms and high winds.
Without such testing, there will not be an adequate baseline of scientific information, for ensuring that the confinement is adequate, as regards Docket Section V.2.
Regarding Docket Section V.2., OTA strongly supports increasing the number of field site inspections, though these should be maintained in perpetuity, beyond the current growing season. The recent cases of the uncontrolled release of soybeans genetically engineered to produce pharmaceutical compounds demonstrate the need for constant vigilance. The examples given in this docket should all be included for all field tests of plants genetically engineered to produce pharmaceutical and industrial compounds.
In addition, regarding Docket Section V.3., inspections should be performed by independent third parties. This would avoid the appearance of the conflict of interest in having inspections done by permittees, as outlined in the docket. Such independent inspections are a regular part of organic production and, far from being onerous to the industry, have contributed to the public’s enthusiastic embrace of the organic production system.
OTA applauds APHIS for seeking greater transparency for what has been an unusually opaque development in agricultural development. APHIS may be aware that there is a significant market for foods that have not been genetically engineered. Some of that market is currently being supplied by the organic industry.
Regarding Docket Section V.1., in order that organic farmers, who do not use genetic engineering, may continue to supply that market, OTA requests that APHIS communicate to the public and to USDA’s National Organic Program the locations of test fields so that neighboring organic farmers can communicate with the permitted operation to help the permitted operation avoid coincidental planting and the subsequent overlap in anthesis (Docket Section II.2.A.). If this action is not taken, and contamination of organic product occurs, leading to the decertification of the organic product, the organic producer will have a strong argument that the resulting damage was avoidable through USDA and permittee action, and that USDA and the permittee are liable for the damage.