Comment from Beth E Burrows, Edmonds Institute

Comment from: Edmonds Institute 20319-92nd Avenue West Edmonds, WA 98020 425-775-5383 beb@igc.org To USDA-APHIS Re: Docket ID, APHIS-2007-0023 In response to permit application 06-363-103r from SemBioSys, Inc. for a field-test to produce human proinsulin in genetically engineered safflower seeds, USDA-APHIS has issued an "environmental assessment" and called for comment. The following comments are submitted by Beth Burrows, the president/director of the Edmonds Institute, on behalf of the Institute, a 501(c)(3) public interest, non-profit organization incorporated in the State of Washington and focused on environment and technology. The Edmonds Institute has long-standing and well-demonstrated interest in biosafety. As we have noted to USDA-APHIS in the past, the Institute generally does not recommend outdoor production of drugs and industrial compounds in food crops because we consider that (1) genuine containment in the out-of-doors is difficult, if not impossible over time, and (2) the lower costs of production attributed to chemical and pharmaceutical production in crop plants are not well-demonstrated and certainly not worth risking the safety and reputation of the nation?s food and food production systems. Summary: In the case of permit application 06-363-103r, the Institute urges USDA-APHIS to take NO ACTION until such time as SemBioSys substantiates its ability to import into Canada the seeds to be harvested from the crop proposed for planting in Lincoln County, Washington. While the Edmonds Institute takes issue with several other details of the risk assessment, it is our concern regarding the post-harvest fate of the seeds in particular that leads us to recommend that NO ACTION be taken on this permit. In April of this year, an article that appeared in several Canadian newspapers (See attached pdf.). The article described a shipment of genetically engineered seed that was ?stranded? at a port in Chile because a permit for importation into Canada had not yet been issued. At the time the article appeared, the importation had not been authorized. It was some time later, the Edmonds Institute learned (telephone conversation with Stephen Yarrow, of the Canadian Food Inspection Agency, July 12, 2007), that the importation was ?authorized?. Given that export of one shipment of genetically engineered seed destined for processing at the SemBioSys facility in Canada was once delayed until appropriate ?authorization? was secured, the Edmonds Institute was concerned that another such delay could happen again. That in mind, the director of the Institute telephoned the Canadian Food Inspection Agency to ask whether SemBioSys had obtained an import permit from the Agency for genetically engineered seeds containing human proinsulin, i.e., the seeds that are the subject of permit application 06-363-103r. The director was told that the respondent was ?not aware of any import permit application?. The Institute reasoned that if there were no evidence on July 12, 2007 - the day of the telephone call - of an import permit application to Canadian authorities, any assurances about exportation from the US (to SemBioSys?s Calgary facilities) after harvest, particularly statements made in SemBioSys?s application to USDA-APHIS for a field test, could not be substantiated at the time those assurances were made. The apparent lack of substantiation about the fate of the seeds (after harvest) was further magnified by the apparent lack of any provision for secure storage facilities within the United States, should the company be unable to export the seeds immediately after harvest. If the seeds could not be immediately exported, they presumably were going to have to be stored somewhere and presumably, USDA-APHIS would want assurances that the storage space was adequate and secure. We found no such assurances in the risk assessment. In short, we were concerned that since SemBioSys did not have a permit to import the proinsulin safflower seed into Canada at the time the company applied to USDA-APHIS for a field test, what was the company going to do if the seeds were held up at the US- Canadian border, as other seeds had been delayed at other borders? (The Institute did substantiate that the rules for seed importation into Canada were the same whether the seeds came from Chile or from the U.S.) Since so much of the USDA-APHIS risk assessment has to do with assessing the quality of the stewardship of the seed in order to prevent the seed from either accessing the food system or escaping into the environment, the apparent lack of application for an import permit into Canada seemed egregious. Where were the seeds going to go if they could not go to Canada immediately after harvest? Who would guarantee safe storage (no access to the environment or to the food system) until the seeds were able to be exported to Canada?. What could be the meaning of such USDA-APHIS statements as ?After harvest, seed will be shipped...? (see page 10 of risk assessment) or ?Viable plant material should not remain at the test site following termination? (see page 40 the risk assessment) if no permit for import into Canada had even been applied for when those statement were written? The Edmonds Institute strongly recommends that USDA-APHIS require applicants for field tests to demonstrate that all necessary substantiating permits and authorizations are in place BEFORE USDA-APHIS grants any permit for field tests. Without assurances that such permits and authorizations are in place, or that there are back-up plans should such permits and authorizations not be granted in a timely manner, the responsible stewardship of the seed, i.e., the chain of custody, is not demonstrated. Thus, in the case of the proinsulin safflower, the Edmonds Institute is forced to recommend NO ACTION on the SemBioSys application. We further suggest that after SemBioSys either produces copies of the appropriate authorizations to substantiate its ability to import the seeds into Canada or indicates how the company proposes to store the seed until export is achieved, USDA-APHIS should reissue its risk assessment and ask the public for comment. To ask for comment before the chain of custody is substantiated is to risk trust in the regulatory system. Note: The lack of evidence of application for an import permit into Canada was not the only concern the Edmonds Institute had with the risk assessment. In part, we are also concerned about: (a) The assumptions made about the feeding habits of seed-eaters (We are told [page 8 of the assessment] that, compared to the safflower seeds in question, nearby cereal grains are the more likely target of seed scavenging animals. We are also told that small animals will be deterred by the size of the 50 foot fallow zone and the hazards presented by crossing the zone to feed. However, we are not given much data to substantiate the feeding preferences of small or large animals, especially under conditions of intense competition for food. If the population of scavengers is large or the wheat and barley harvests poor or the pest control efforts of the barley and wheat farmers diligent [all reasonable possibilities], under conditions of intense competition for food, some of the animals may choose less desirable foods and be more willing to risk exposure to gain food. Further, some of the scavengers may feed at night and so the size of the fallow zone would not necessarily present them with a perceived hazard. Finally, in the case of birds, we are told [page 11 of the assessment] that the variety being grown is not ?as palatable? to birds as the white hulled variety, but we are not told, nor is it substantiated, that the striped variety is unpalatable to the bird species present in Lincoln County under all conditions that are reasonably to be expected [including adverse events in the surrounding wheat and barley fields, such as unusually high temperatures, drought, etc.].) (b) The thoroughness of the analysis of impacts on species at risk (No consideration is given to species that are candidates for the federal Threatened and Endangered species list. The sage grouse is one such candidate for the federal list. It has been listed as a ?threatened? species by the State of Washington since 1998. Once plentiful in Lincoln County, the sage grouse prefers sagebrush-steppe ecosystems. The field test site in Lincoln County is described in the risk assessment as containing ?a mix of agricultural sagebrush-steppe ecosystems.? If the concern for species at risk is genuine and not simply a compliance with the letter of the law, one would expect an analysis of potential adverse effects of this project on any of the various sage grouse conservation and habitat recovery programs ongoing in the region.) (c) The likelihood of seed dispersal by humans (We are told [on page 12 of the assessment] that human error is the ?most likely? mechanism contributing to the breakdown of confinement and movement of seed.? We are also told that APHIS has reviewed the company?s Standard Operating Procedures detailing the chain of custody. Presumably, news of that review is meant to reassure us about any potential for unwanted seed dispersal. Unfortunately, because of Confidential Business Information, we will not allowed to judge for ourselves whether the arrangements are adequate, especially the arrangements for overseeing the humans involved in the field test. To make matters worse (and trust more difficult), no reason is given for the company?s request for CBI designation for its SOPs. Further, although we are told that site managers, farmers, and technicians have been given a copy of the SOPs - the SOPs that we are not allowed to see - and that those personnel are to be trained in the implementation of those SOPs, inexplicably, we are not told of any plan to oversee the implementation of those SOPs. The lack of a plan (with clear lines of responsibility) for oversight of implementation of SOPs is neither reassuring nor acceptable. All in all, we find the arrangements, as described, unconvincing and insufficient to prevent human error.) (d) The arrangements for monitoring beyond the perimeter zone and the potential for impact on Washington agriculture and beyond (We are told that the test site and the fallow 50-foot surrounding perimeter zones will be monitored for a year after the field test. We are also told that on the other side of the fallow strips will be fields of wheat and barley, presumably being grown for commercial purposes. Unfortunately, we are not told of any plans for monitoring the wheat and barley fields. If, by whatever means, any safflower seed accesses the wheat and barley fields and persists to the next season, there will be a possibility of in-mixing of safflower and wheat or barley at harvest time. Given the large combine method by which most Washington wheat is harvested, it is not far-fetched to imagine that the proinsulin safflower might go unnoticed (particularly by the drivers of large combines). Should that be the case, a ?mixed?, e.g.,?wheat/safflower? might come to be exported from Washington State - again, not a far- fetched possibility given how wheat is stored and shipped throughout the world. Should such such a wheat-safflower mixture be discovered, say, in a country that has not authorized importation of this particular transgenic safflower, it could have highly adverse effects on the market for Washington wheat or even the market for US wheat. Should the wheat-safflower mixture access, for example, Egypt, one of Washington State?s largest customers for wheat and a center of diversity for safflower - not to mention a member country of the Convention on Biological Diversity and of the Cartagena Protocol on Biosafety - that country might choose to take precautionary measures. To guard the purity of its indigenous safflower, Egypt might decide to (a) disallow further imports from Washington State or (b) require testing of all future wheat imports from Washington State, with testing costs to be paid by the exporter. Unless SemBioSys is to be held liable for the full chain of custody of its proinsulin safflower - and such liability was not mentioned in the risk assessment - either measure on the part of Egypt - or on the part of any country with something to lose by the unwanted import of the particular transgenic safflower - might prove costly to Washington farmers and, by extension, to all US wheat farmers. Although the likelihood of such events may seem small, it is instructive to remember that the likelihood of a catastrophic in-mixing of genetically modified corn and soy also once seemed small. But the unlikely happened and the cleanup was costly and so was the subsequent loss of markets to US farmers. It cannot be assumed that seed which may access nearby fields will not survive and germinate. Nor should it be assumed that safflower plants will be discovered easily should the seed somehow survive and germinate. It would be wiser to require what is absent from the current assessment, notably, a plan to monitor all nearby fields for a year after the test, particularly those fields in which crops are being grown for export without milling. Given that one day the proposed safflower may be grown out on a larger scale, it would be useful to have the data from those nearby fields, particularly should any proinsulin safflower come to be found there. Further, as the Institute has noted on another occasion, corollary to the possibility for in-mixing with another crop is an ethical dilemma. While ethical dilemmas may seem beyond the scope of risk assessments of field trials, they are not beyond the scope of Executive Order 12114, ?Environmental Effects Abroad of Major Federal Actions?. Because this particular ethical dilemma has potential for greatly impacting Washington State farmers, we do not hesitate to mention it here: Given even the small risk of in-mixing as described above, what should be done? Should those who import wheat from Washington State be alerted to the small-risk possibility? Should those who allow the field trial or those who grow wheat nearby the field site alert importers in countries of origin of safflower? If such countries are alerted and if, like Egypt, they are parties to the Convention on Biological Diversity, they may want to take precautionary measures to protect their local biodiversity. Such measures might include testing of imports for the presence of transgenic safflower or reducing the level of allowable wheat imports from countries where such safflower is being grown. [As already noted, either measure would adversely effect Washington wheat farmers.] If, on the other hand, such countries were not alerted to the in- mixing possibility and that possibility were to occur and the presence of transgenic safflower to be detected in a shipment being imported into their country, if the importing country came to know that Washington exporters or US regulators were aware of the in- mixing possibility beforehand and did not alert them, they might frown on further dealings with Washington state farmers. In such a scenario, it would not be farfetched to expect a loss of market for and trust in Washington wheat. In such a damned-if-you-do,damned-if-you-don?t scenario, the need for a plan to monitor nearby wheat and barley fields for a year after the safflower test becomes even more apparent. In the long run, monitoring will likely be cheaper than not monitoring. Clearly then, there is pressing merit in requiring a plan for checking nearby wheat and barley fields for a year after the test.) (e) The potential for adverse effects on organic producers (If the potential for genetically engineered safflower in the fields of nearby crops has been underestimated, and we believe that it has been, then the potential impact on raw agricultural commodities, as well as on organic growers, also will have been underestimated. If, in the season following the trials, unnoticed safflower comes to maturity and is harvested in nearby fields of other crops, there could be grave economic consequences for Washington state farmers. [See discussion in (d) above.] If those fields happen to be those of organic farmers, the farmers may be more profoundly affected. While it is true that the discovery of ?adventitious? transgenic safflower is not cause for rescinding a farm?s official US designation as ?organic?, such discovery can be expected to affect the ability of the farmer in whose field the ?in-mixing? took place to market his/her products as ?organic?, particularly in those countries where consumers have demonstrated a clear aversion to any products of genetic engineering or any products that contain genetically engineered components. It is cynical to think that the only adverse effects on ?organic? farmers will have to do with the official ?organic? designation.) For the reasons above and in particular for the lack of substantiation of the company?s ability to import the seeds to be harvested into Canada or to securely store them on site until export from the US is possible, the Edmonds Institute strongly recommends that USDA-APHIS take NO ACTION on the application under consideration. In order to ensure that the text of our comment is transmitted and understood as written, we attach a pdf copy of the text to this submission.